СПОСОБ И СИСТЕМА КОНТРОЛЯ КОЭФФИЦИЕНТА НАСТРОЙКИ В СВЯЗИ С ЗАМЕНОЙ ДАТЧИКА ДЛЯ КОНТРОЛЛЕРА С ОБРАТНОЙ СВЯЗЬЮ ПРИ ИСКУССТВЕННОЙ ПОДЖЕЛУДОЧНОЙ ЖЕЛЕЗЕ

Группа изобретений относится к медицинской технике. Способ управления системой для лечения диабета осуществляется с использованием контроллера с прогнозирующей моделью. Система содержит инфузионный насос с микроконтроллером для управления насосом и получения данных от датчика глюкозы. Способ включает измерение концентрации глюкозы, определение изменения точности системы, которое включает определение снижения точности системы в ответ на то, что датчик глюкозы был заменен новым датчиком глюкозы в пределах заданного временного интервала, и определение повышения точности системы в ответ на калибровку датчика глюкозы, установку коэффициента настройки для контроллера с прогнозирующей моделью в микроконтроллере на завышенный коэффициент настройки в ответ на определение снижения точности системы или на агрессивный коэффициент настройки в ответ на определение повышения точности системы. При вычислении количества инсулина используют коэффициент настройки, чтобы вычислить количество инсулина для введения ...

ГИБКИЙ АППЛИКАТОР ДЛЯ ДОСТАВКИ ЖИДКОСТИ И МОНИТОРИНГА АНАЛИТОВ ТЕЛА

... 1. Система мониторинга аналита тела, содержащая: ! гибкий аппликатор, выполненный с возможностью ношения на коже живого тела; ! подкожный сенсор аналита, интегрированный с гибким аппликатором; ! источник питания, интегрированный с гибким аппликатором; и ! контроллер, интегрированный с гибким аппликатором, при этом контроллер получает питание от источника питания и выполнен с возможностью управления сенсором аналита. ! 2. Система мониторинга по п.1, дополнительно содержащая передатчик, интегрированный с гибким аппликатором, при этом передатчик получает питание от источника питания, управляется контроллером и выполнен с возможностью передачи данных из сенсора аналита в другое устройство. ! 3. Система мониторинга по п.2, дополнительно содержащая гибкую антенну, интегрированную с гибким аппликатором, при этом антенна служит для передачи сигналов из передатчика. ! 4. Система мониторинга по п.1, дополнительно содержащая приемопередатчик, интегрированный с гибким аппликатором, при этом приемопередатчик ...

УЧЕТ ОСТАТОЧНОГО КОЛИЧЕСТВА АКТИВНОГО ИНСУЛИНА В СИСТЕМЕ ИСКУССТВЕННОЙ ПОДЖЕЛУДОЧНОЙ ЖЕЛЕЗЫ

MEDICINE PRODUCT FOR THE ANALYTENÜBERWACHUNG AND DRUG DELIVERY

VORRICHTUNG ZUR TRANSKUTANEN, IN-VIVO MESSUNG DER KONZENTRATION ZUMINDEST EINES ANALYTEN IN EINEM LEBENDEN ORGANISMUS

Die Erfindung betrifft eine Vorrichtung zur transkutanen, in-vivo Messung der Konzentration zumindest eines Analyten in einem lebenden Organismus (A) mit einem in den Organismus einbringbaren Träger und einem auf dem Träger immobilisierten Lumineszenzindikator (15), der auf eine Änderung der Konzentration des zu messenden Analyten mit einer Änderung zumindest einer optischen Eigenschaft reagiert, wobei der Lumineszenzindikator (15) mit einer Quelle (16) zur Bereitstellung der Anregungsstrahlung (a) und einem Detektor (17) zur Erfassung der Messstrahlung (m) transkutan in Verbindung steht. Erfindungsgemäß ist der Lumineszenzindikator (15) am äußeren Umfang eines Katheters (10) immobilisiert, der zur Abgabe eines flüssigen Mediums, beispielsweise eines Medikamentes, in den Organismus (A) oder zum Absaugen einer Körperflüssigkeit dient.

VORRICHTUNG ZUR TRANSKUTANEN, IN-VIVO MESSUNG DER KONZENTRATION ZUMINDEST EINES ANALYTEN IN EINEM LEBENDEN ORGANISMUS

LIQUID DELIVERY DEVICE REGULARLY BY A ANALYTEN AND A MONITORING OF THE ANALYTEN

Use of electrochemical impedance spectroscopy (EIS) in continuous glucose monitoring

USE OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY (EIS) IN CONTINUOUS GLUCOSE MONITORING A method of performing diagnostics on a subcutaneous or implanted sensor having at least one working electrode, comprising: defining a vector containing values associated with one or more electrochemical impedance spectroscopy (EIS)-based parameters and values associated with one or more non-EIS-based parameters; defining a respective threshold value for each of said EIS based parameters and each of said non-EIS-based parameters; performing a first EIS procedure to generate a first set of data for said values associated with the one or more EIS-based parameters; after a calculated time interval, performing a second EIS procedure to generate a second set of data for said values associated with the one or more EIS-based parameters; updating the vector with said first and second sets of data; and monitoring said vector values to determine whether the sensor has lost sensitivity.

Advance diagnosis of infusion device operating mode viability

A method of operating an infusion device to deliver fluid to a user in accordance with an operating mode, the method comprising: obtaining operational information pertaining to one or more prior instances of the operating mode; obtaining status information pertaining to the infusion device; determining a diagnosis time based at least in part on the operational information, the diagnosis time being prior to a subsequent instance of the operating mode; automatically determining viability of the subsequent instance of the operating mode based at least in part on the status information at the diagnosis time; and automatically generating a notification indicative of a recommended action for the user based at least in part on the viability.

Glycemic urgency assessment and alerts interface

Systems and methods are disclosed that employ several or numerous factors in the determination of a glycemic urgency index (GUI), which may be based on a measured blood glucose level as well as other factors. The other factors may include time derivatives of the glucose level and/or other factors, e.g., user - entered data, data measured by other sensors or received from a network source, or historical data. The GUI is then presented to the user in an interesting way, e.g., via a background color or other inconspicuous notifier, e.g., on a mobile device such as a smart phone. The GUI may also be employed in the triggering of actionable alerts and alarms on an electronic device for the user. The GUI, or another index calculated from combinations of the variables and parameters described, may further be employed to drive a medicament delivery device such as a pump. 0) E r-~ cz1 < <1 00 0I C\j _r _r *o 'o ii I 10 * ID C) C)C) )CDC C* I' )U' D *o :1 * l/w :1onE ...

Methods and systems for improving the reliability of orthogonally redundant sensors

A method of calibrating an orthogonally redundant sensor device for determining the concentration of glucose in a body of a user, said sensor device including at least an electrochemical glucose sensor and an optical glucose sensor, the method comprising: receiving a first signal from the electrochemical glucose sensor; receiving a second signal from the optical glucose sensor; performing a respective integrity check on each of said first and second signals; determining whether the first signal can be calibrated, and whether the second signal can be calibrated, wherein said determination is made based on whether the first signal and the second signal pass or fail their respective integrity checks; if it is determined that the first signal can be calibrated, calibrating said first signal to generate an electrochemical sensor glucose (SG) value; if it is determined that the second signal can be calibrated, calibrating said second signal to generate an optical sensor glucose (SG) value; and ...

Flexible patch for fluid delivery and monitoring body analytes

A wearable, conductive textile patch Is provided that may include any of a number of features for monitoring body analytes and/or delivering fluids to a body. In one embodiment of the invention, a single, patch-mounted system monitors glucose levels of a diabetic person and provides appropriate doses of insulin in response to the glucose measurements. A hand-held user interface can be provided for wirelessly controlling the system and/or receiving information from it. Conductive pathways can be formed in the fabric of the patch. Components that can be integrated into the flexible patch include a power source, controller, transmitter, antenna, temperature and other sensors, fluid pump, infusion set, electrical pathways, switches, controls, electrodes, connectors, resistors and other circuit elements. Such components can be embedded, interwoven or coated on to the flexible patch instead of or in addition to surface mounting. Methods associated with use of the flexible patch system.

REAL TIME SELF-ADJUSTING CALIBRATION ALGORITHM

Blood monitoring system

Medical device for analyte monitoring and drug delivery

MEDICAL DEVICE FOR ANALYTE MONITORING AND DELIVERY 5 Disicosed is an ingestible, implantable or wearable medical device comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical 10 parameter data of an interaction between the disease marker biological analyte with the bioactive agent; a biometric recognition device capable of comparing the physical parameter data with an analyte interaction profile; optionally a therapeutic agent releasing device capable of controlling release of the therapeutic agent from the reservoirs; an interface device capable of facilitating communications between the microarray scanning 15 device, biometric recognition device and the therapeutic agent releasing device ...

Metronomic convection enhanced delivery of intrathecal chemotherapy using an implanted magnetic breather pump (MBP) for leptomeningeal carcinomatosis

Application of electrochemical impedance spectroscopy in sensor systems, devices, and related methods

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the ElS-based diagnostics, fusion algorithms, and other processes based on measurement of ElS-based parameters.

Methods and systems for improving the reliability of orthogonally redundant glucose sensors

Methods and systems for sensor calibration and sensor glucose (SG) fusion are used advantageously to improve the accuracy and reliability of orthogonally redundant glucose sensor devices, which may include optical and electrochemical glucose sensors. Calibration for both sensors may be achieved via fixed-offset and/or dynamic regression methodologies, depending, e.g., on sensor stability and Isig-Ratio pair correlation. For SG fusion, respective integrity checks may be performed for SG values from the optical and electrochemical sensors, and the SG values calibrated if the integrity checks are passed. Integrity checks may include checking for sensitivity loss, noise, and drift. If the integrity checks are failed, in-line sensor mapping between the electrochemical and optical sensors may be performed prior to calibration. The electrochemical and optical SG values may be weighted (as a function of the respective sensor's overall reliability index (RI)) and the weighted SGs combined to obtain ...

Methods of measuring the concentration of an analyte in a subject

CLOSED LOOP SYSTEM FOR CONTROLLING INSULIN INFUSION

A closed loop infusion system controls the rate that fluid is infused into the body of a user. The closed loop infusion system includes a sensor system, a controller, and a delivery system. The sensor system includes a sensor for monitoring a condition of the user. The sensor produces a sensor signal, which is representative of the condition of the user. The sensor signal is used to generate a controller input. The controller uses the controller input to generate commands to operate the delivery system. The delivery system infuses a liquid into the user at a rate dictated by the commands from the controller. Preferably, the sensor system monitors the glucose concentration in the body of the user, and the liquid infused by the delivery system into the body of the user includes insulin. The sensor system uses the sensor signal to generate a message that is sent to the delivery system. The message includes the information used to generate the controller input. The sensor may be a subcutaneous ...

DELIVERY DEVICE WITH SENSOR AND ONE OR MORE CANNULAS

The invention concerns a base part for a medication delivery device. The base part is during use fastened to a patient's skin and connected to a cannula part which cannula part is positioned at least partly subcutaneous. The base part is also connected to a sensor unit which can detect one or more components e.g. glucose content in the patients blood. The base part comprises fastening means (15) which fastening means (15) releasably attach the reservoir/delivery part to the base part during use and a first fluid path or means corresponding to a first fluid path from a reservoir permitting a flow of fluid between the reservoir/delivery part and the base part when the reservoir/delivery part is attached to the base part, the first fluid path comprises means (17) for interrupting the fluid flow when the detachable reservoir/delivery part is not attached to the base part (1) and opening the fluid path (19) when the delivery part is attached to the base part (1). The base part (1) also comprises ...

AUTOMATED SYSTEM FOR MONITORING A PATIENT'S BLOOD SUGAR

L'invention concerne un système automatisé de contrôle de la glycémie d'un patient, comportant un capteur de glycémie (101) et une unité de traitement et de contrôle (105), dans lequel l'unité de traitement et de contrôle (105) est configurée pour calculer, à partir d'un premier modèle mathématique fCR spécifique au patient et en tenant compte d'une unique valeur de glycémie Gr mesurée par le capteur, un coefficient CR représentatif de la sensibilité à l'insuline du patient.

MAINTAINING MAXIMUM DOSING LIMITS FOR CLOSED LOOP INSULIN MANAGEMENT SYSTEMS

A system and a method for management of diabetes are provided. The system includes an infusion pump, glucose sensor, and controller that is programmed to control insulin delivery based upon at least one stored variable. The controller calculates a maximum insulin delivery rate based on the default basal insulin delivery rate, temporary basal insulin delivery rate, extended bolus rate, or a combination thereof.

USE OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY (EIS) IN CONTINUOUS GLUCOSE MONITORING

RESPIRATORY PARAMETER GUIDED AUTOMATED IV ADMINISTRATION AND IV TUBE CLAMP ACTIVATION

Disclosed is a system that includes a sensor for acquiring a physiological bioelectrical impedance signal from a patient functionally connected to the computing device. The computing device preferably analyzes the physiological bioelectrical impedance signal and provides outputs an assessment of minute ventilation of the patient based on the analyzed bioelectrical impedance signal. Preferably, the system monitors the signal over time, provides a control signal to an IV pump that instructs the IV Pump to automatically adjust medication levels by automatically lowering medication levels when respiration levels fall or completely stopping flow of the medication.

APPARATUS FOR ASSESSMENT OF MICROVASCULAR DYSFUNCTION

Methods and devices for assessment of microvascular dysfunction, such as microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to successfully diagnose, restore patency, open and preserve flow, and limit reperfusion injury in organs and cases with microvascular dysfunction. The present subject matter provides apparatus and method to detect, measure and treat microvascular dysfunction in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction - primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others. The present subject matter provides various systems including an infusion and sensing catheter ...

AUTOMATED SYSTEM FOR REGULATING A PATIENT'S BLOOD GLUCOSE LEVEL

L'invention concerne un système automatisé de régulation de la glycémie d'un patient, comportant : un capteur de glycémie (101); un dispositif d'injection d'insuline (103); et une unité de traitement et de contrôle (105) adaptée à prédire, à partir d'un modèle physiologique,l'évolution future de la glycémie du patient sur une période de prédiction, et à commander le dispositif d'injection d'insuline (103) en tenant compte de cette prédiction, dans lequel l'unité de traitement et de contrôle (105) est adaptée à : a) calibrer le modèle physiologique en tenant compte de la glycémie mesurée par le capteur (101) au cours d'une période d'observation passée; b) à l'issue de la calibration, calculer un indicateur représentatif de l'erreur entre la glycémie estimée à partir du modèle et la glycémie réelle mesurée par le capteur; et c) ajuster la période de prédiction en tenant compte de la valeur de l'indicateur.

CONTROLLED RELEASE DEVICE AND METHOD USING ELECTROTHERMAL ABLATION

Devices and methods are provided for the controlled release or exposure of reservoir contents. The device includes a reservoir cap formed of an electrically conductive material, which prevents the reservoir contents from passing out from the device and prevents exposure of the reservoir contents to molecules outside of the device; an electrical input lead connected to said reservoir cap; and an electrical output lead connected to said reservoir cap, such that upon application of an electrical current through the reservoir cap, via the input lead and output lead, the reservoir cap ruptures to release or expose the reservoir contents. The reservoir contents can comprise a release system containing drug molecules for release or can comprise a secondary device, such as a sensor. In one embodiment, the controlled release system is incorporated into an implantable drug delivery device.

CLOSED-LOOP DRUG DELIVERY SYSTEM

A delivery system for a drug or bioactive agent includes an implantable pump and a delivery conduit that may be implanted in an organ or other tissue (e.g., the central ox the peripheral nervous system) of a subject. A sensor is also implanted, and a controller unit receives the sensor output and directs drug delivery from within the patient pump accordingly. The sensor directly measures a primary biochemical material or state in the tissue or organ system, and the monitoring unit effects closed loop feedback control of the pump to achieve a desired end. The end may be the regulation of metabolism or maintenance of a stable metabolic or other state, or may be treatment regimen, e.g., by delivery of a dosage level or distribution of a drug in specific brain or nervous system tissue. The sensed material may be the agent itself, a metabolite, or a related native material, tissue state or condition.

INSULIN MANAGEMENT

A method of administering insulin includes receiving blood glucose measurements (BG) of a patient (10) at a data processing device (112) from a glucometer (124). Each blood glucose measurement (BG) is separated by a time interval (TNext) and includes a blood glucose time ( BG-Time) associated with a time of measuring the blood glucose measurement. The method also includes receiving patient information (208a) at the data processing device and selecting a subcutaneous insulin treatment program for tube-fed patients (1000) from a collection of subcutaneous insulin treatments (900, 1000, 1100, 1200, 1300, 1400). The selection is based on the blood glucose measurements and the patient information. The subcutaneous insulin treatment program for tube-fed patients determines recommended insulin doses based on the blood glucose times. The method also includes executing, using the data processing device, the selected subcutaneous insulin treatment program for tube-fed patients (1000).

CALIBRATION OF GLUCOSE MONITORING SENSOR AND/OR INSULIN DELIVERY SYSTEM

Disclosed are methods, apparatuses, etc. for calibrating glucose monitoring sensors and/or insulin delivery systems. In certain example embodiments, blood glucose reference samples may be correlated with sensor measurements with regard to a delay associated with the sensor measurements. In certain other example embodiments, one or more parameters of a probability model may be estimated based on blood glucose reference sample-sensor measurement pairs. Based on such information, function(s) for estimating a blood-glucose concentration in a patient may be determined.

METHODS AND SYSTEMS FOR IMPROVING THE RELIABILITY OF ORTHOGONALLY REDUNDANT SENSORS

Methods and systems for sensor calibration and sensor glucose (SG) fusion are used advantageously to improve the accuracy and reliability of orthogonally redundant glucose sensor devices, which may include optical and electrochemical glucose sensors. Calibration for both sensors may be achieved via fixed-offset and/or dynamic regression methodologies, depending, e.g., on sensor stability and Isig-Ratio pair correlation. For SG fusion, respective integrity checks may be performed for SG values from the optical and electrochemical sensors, and the SG values calibrated if the integrity checks are passed. Integrity checks may include checking for sensitivity loss, noise, and drift. If the integrity checks are failed, in-line sensor mapping between the electrochemical and optical sensors may be performed prior to calibration. The electrochemical and optical SG values may be weighted (as a function of the respective sensor's overall reliability index (RI)) and the weighted SGs combined to obtain ...

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the ElS-based diagnostics, fusion algorithms, and other processes based on measurement of ElS-based parameters.

Medical device for glucose monitoring or regulation

A medical device comprisingapressure generating means adapted to deliver a liquid, asensoradapted to measure aflow resistance, and an implantablemember comprising an analyteresponsive porous membrane whichreversiblychanges its porosity subject to changes in analyteconcentrationoccurring in the solution surrounding the implantablemember. The analyte may in particular be glucose. The medicaldevice may also be used for drug administration.

System for management of diabetes

COMBINAÇÃO MODULAR DE INFUSÃO DE MEDICAÇÃO E MONITORAÇÃO DE ANALITOS

Metod och anordning för att logga injektioner av läkemedel som görs av en medicinteknisk anordning med injektionsorgan

INSULIN PUMP

The present invention relates to a controller unit and methods for controlling an insulin pump. The controller unit includes a user input that receives a gain factor. The gain factor has been calculated based on historical data in relation to a patient. The controller unit includes a measurement input for receiving data representative of a measured blood glucose level for the patient. Processing logic of the controller unit is configured to apply the measured blood glucose level to a pancreatic beta-cell insulin secretion computational model to predict an insulin output level, apply the gain factor to the predicted insulin output level to determine a patient insulin deficiency level, and calculate a control signal for controlling the insulin output level of the insulin pump based on the patient insulin deficiency level. Methods are provided for optimising the gain factor based on the historical data in relation to the patient.

SPRAY ADMINISTRATION OF COMPOSITIONS INCLUDING ACTIVE AGENTS SUCH AS PEPTIDES TO THE GASTROINTESTINAL TRACT

Methods of administering an active agent such as an active pharmaceutical ingredient by spraying a composition comprising the active agent at a luminal wall of the gastrointestinal tract are disclosed. Also disclosed are devices for administering a composition suitable for implementing the disclosed method. Also disclosed is the use of a peptide as an active agent for the manufacture of a sprayable composition for use in the treatment of a subject by gastrointestinal administration.

DETECTING A TEMPORAL ALTERATION OF AN OPTICAL PROPERTY OF A SUBCUTANEOUS LAYER FOR DRUG DELIVERY

Arrangement for detecting a temporal alteration of an optical property of a subcutaneous layer in vivo, drug delivery device (400) comprising the arrangement and method for drug delivery are described. For an optimized control of drug delivery by a transdermal drug delivery device an optical feedback control is described, which allows to detect the alteration of an optical property of a subcutaneous layer caused by an injected fluid from a fluid jet; and to control an actuator of the micro- jet pump in response to the fluid administered under the skin of a subject. If no drug is delivered transdermally the injection speed may be increased and the frequency as well as the injection speed may be controlled in dependence of each other following lookup tables that are generated during calibration of the device. A drug delivery device and a method for drug delivery make use of the optical detection for in situ and real time monitoring of injected substances.

DEVICE FOR THE TRANSCUTANEOUS, IN VIVO MEASUREMENT OF THE CONCENTRATION OF AT LEAST ONE ANALYTE IN A LIVING ORGANISM

The invention relates to a device for the transcutaneous, in vivo measurement of the concentration of at least one analyte in a living organism (A), comprising a carrier which can be introduced into the organism, and a luminescence indicator (15), which is immobilized on the carrier and which reacts to a change in the concentration of the analyte to be measured with a change in at least one optical property, wherein the luminescence indicator (15) is transcutaneously connected to a source (16) for providing the excitation radiation (a) and a detector (17) for detecting the measuring radiation (m). According to the invention, the luminescence indicator (15) is immobilized on the outer circumference of a catheter (10), which is used to dispense a fluid medium, for example a medication, into the organism (A) or to drain a body fluid.

COMBINED DRUG DELIVERY AND ANALYTE SENSOR APPARATUS

Embodiments of the present invention provide methods and apparatuses for analyte sensing combined with drug delivery in an integrated system. In an embodiment, a device may be utilized to sense an analyte, and in response to a measurement obtained therefrom, introduce a controlled amount of a drug to a user as a corrective action.

System, Devices, and Methods For Detecting Occlusions In A Biological Subject

Systems, devices, and methods are described for detecting an embolus, thrombus, or a deep vein thrombus in a biological subject.

SELECTIVELY MECHANICALLY ACTIVATABLE PREFILLED INFUSION-PUMP DEVICES

This invention provides a prefilled selectively activatable body-worn infusion-pump assembly for rapid delivery of large volumes or highly viscous volume comprising a housing; a pre-filled aseptically-sealed flexible drug reservoir-containing assembly; a conjoined, coordinately controlled and perpendicularly arranged cannulated needle dispensing and needle insertion assembly operationally connected to and in fluid connection with the pre-filled aseptically-sealed drug reservoir-containing assembly, wherein the cannulated needle dispensing assembly projects generally perpendicularly to a generally planar surface of the housing, promotes insertion of the cannulated needle in skin of a subject and promotes retraction of the needle within the cannulated needle dispensing assembly thereafter, and wherein the needle insertion assembly projects generally in a parallel orientation to a generally planar surface of the housing, which projection initiates opening a fluid path with the pre-filled aseptically-sealed ...

Analyte detection system with user interface providing event entry

An embodiment of an analyte detection system includes a fluid transport network having a patient end configured to provide fluid communication with a body fluid in a patient and a body fluid analyzer accessible via the fluid transport network. The body fluid analyzer is configured to measure a level of an analyte of interest in the body fluid. A pump unit is coupled to the fluid transport network. The pump unit has a sample input mode and an infusion mode. In the sample input mode, the pump unit is operable to transport a sample of the body fluid from the patient end and toward the body fluid analyzer. In the infusion mode, the pump unit is operable to transport an infusion fluid toward and out the patient end. The analyte detection system also includes a user interface for communication with the body fluid analyzer. The user interface includes an input element configured to accept user input corresponding to a patient health event. In some embodiments, the patient health event includes ...

Controlled release device and method using electrothermal ablation

Devices and methods are provided for the controlled release or exposure of reservoir contents. The device includes a reservoir cap formed of an electrically conductive material, which prevents the reservoir contents from passing out from the device and prevents exposure of the reservoir contents to molecules outside of the device; an electrical input lead connected to said reservoir cap; and an electrical output lead connected to said reservoir cap, such that upon application of an electrical current through the reservoir cap, via the input lead and output lead, the reservoir cap ruptures to release or expose the reservoir contents. The reservoir contents can comprise a release system containing drug molecules for release or can comprise a secondary device, such as a sensor. In one embodiment, the controlled release system is incorporated into an implantable drug delivery device.

Method and system for providing integrated medication infusion and analyte monitoring system

Method and system for integrating infusion device and analyte monitoring system including medication infusion device such as an insulin pump and an analyte monitoring system such as a glucose monitoring system are provided.

ADVANCE DIAGNOSIS OF INFUSION DEVICE OPERATING MODE VIABILITY

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a user in accordance with an operating mode involves obtaining operational information pertaining to one or more prior instances of the operating mode, obtaining status information pertaining to the infusion device, and determining a diagnosis time based at least in part on the operational information. The diagnosis time is prior to a subsequent instance of the operating mode. At the diagnosis time, the method automatically determines the viability of the subsequent instance of the operating mode based at least in part on the status information and automatically generates a notification indicative of a recommended action for the user based at least in part on the viability.

Detecting sleep

A system includes one or more sensors and a processor. Each of the sensors generates a signal as a function of at least one physiological parameter of a patient that may discernibly change when the patient is asleep. The processor monitors the physiological parameters, and determines whether the patient is asleep based on the parameters. In some embodiments, the processor determines plurality of sleep metric values, each of which indicates a probability of the patient being asleep, based on each of a plurality of physiological parameters. The processor may average or otherwise combine the plurality of sleep metric values to provide an overall sleep metric value that is compared to a threshold value in order to determine whether the patient is asleep.

TEAR DUCT RESISTANCE MEASURING SYSTEM

A system for measuring the flow properties of a tear duct, to ascertain its flow resistance, includes a syringe communicating with a cannula to supply liquid to a punctum of an eye, the cannula having a tip to seal to the punctum. A motor is arranged to actuate the syringe. A pressure sensor monitors the pressure of the liquid supplied to the punctum. A monitoring circuit provides an indication of the flow resistance. A feedback circuit controls the motor in accordance with the measured pressure, to maintain a preset liquid pressure, or to ensure that the liquid pressure does not exceed a preset threshold. The system may include means to prevent flow through the other punctum of the eye. If the flow rate of the liquid supplied to the punctum is also monitored, the monitoring circuit is arranged to determine the flow resistance from the pressure and the flow rate.

Calibration of glucose monitoring sensor and/or insulin delivery system

Disclosed are methods, apparatuses, etc. for calibrating glucose monitoring sensors and/or insulin delivery systems. In certain example embodiments, blood glucose reference samples may be correlated with sensor measurements with regard to a delay associated with the sensor measurements. In certain other example embodiments, one or more parameters of a probability model may be estimated based on blood glucose reference sample-sensor measurement pairs. Based on such information, function(s) for estimating a blood-glucose concentration in a patient may be determined.

Methods and systems for improving the reliability of orthogonally redundant sensors

Methods and systems for sensor calibration and sensor glucose (SG) fusion are used advantageously to improve the accuracy and reliability of orthogonally redundant glucose sensor devices, which may include optical and electrochemical glucose sensors. Calibration for both sensors may be achieved via fixed-offset and/or dynamic regression methodologies, depending, e.g., on sensor stability and Isig-Ratio pair correlation. For SG fusion, respective integrity checks may be performed for SG values from the optical and electrochemical sensors, and the SG values calibrated if the integrity checks are passed. Integrity checks may include checking for sensitivity loss, noise, and drift. If the integrity checks are failed, in-line sensor mapping between the electrochemical and optical sensors may be performed prior to calibration. The electrochemical and optical SG values may be weighted (as a function of the respective sensor's overall reliability index (RI)) and the weighted SGs combined to obtain ...

Gateway platform for biological monitoring and delivery of therapeutic compounds

The invention relates to methods and devices for remote or distributed continuous monitoring of physiologically relevant states. The invention provides for methods to automatically detect deviations or other states in physiological parameters and automatically alert a measured subject, user or other authorized party. The device provides for a universal platform for sensors, and further provides for the automatic compensation or distribution of devices or bioactive agents at appropriate levels and/or intervals in response to deviations or other states sensed in various physiological parameters.

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

INFUSION SET COMPONENT WITH INTEGRATED ANALYTE SENSOR CONDUCTORS

An infusion set component for a fluid infusion device that delivers fluid to a patient is presented here. The component includes a tube formed from tubing material having an interior fluid canal defined therein to provide a fluid pathway from the fluid infusion device to the patient, a plurality of sensor conductors incorporated with the tubing material to facilitate sensing of an analyte of the patient by the fluid infusion device, and a combined infusion-sensor unit coupled to the tube and to the plurality of sensor conductors. The infusion-sensor unit accommodates delivery of fluid from the tube, and it also accommodates sensing of the analyte. The component may also include a connector assembly coupled to the tube and to the plurality of sensor conductors, to fluidly couple the fluid canal to a fluid reservoir of the fluid infusion device and to electrically couple the sensor conductors to an electronics module of the fluid infusion device.

Blood glucose control system with carbohydrate therapy indication

A blood glucose control system can generate an indication of total carbohydrate therapy over a period during use by a subject. The system can be connected to a medicament pump configured to deliver insulin therapy, other types of medicament therapy, or a combination of medicament therapies to the subject. The system can determine an amount of a counter-regulatory agent to respond to an impending risk of hypoglycemia or an episode of hypoglycemia and determine a dose of carbohydrate therapy based at least in part on the amount of the counter-regulatory agent. The system can track determined doses of carbohydrate therapy to generate the indication of total carbohydrate therapy over the period.

METABOLITE MANAGEMENT SYSTEM

ANALYTE-CONTROLLED LIQUID DELIVERY DEVICE AND ANALYTE MONITOR

INTEGRATED CLOSED-LOOP ARTIFICIAL PANCREAS

СРЕДСТВО НАГЛЯДНОГО ПРЕДСТАВЛЕНИЯ И АНАЛИЗА ДЛЯ СИСТЕМЫ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ

Изобретение относится к медицинской технике, а именно к средствам визуализации и анализа для системы доставки инсулина, такой как искусственная поджелудочная железа, в котором инсулин доставляют на основе системного алгоритма с использованием насоса, которым пациент может управлять, чтобы регулировать доставку инсулина относительно величины базального введения; например предварительно заданной величины базального введения, и с использованием датчика для измерения уровня глюкозы. Средство выполнено с системным контроллером для обнаружения и регистрации событий, основанных на различиях между фактически доставленным системой количеством инсулина и величиной базального введения. Эти обнаруженные события представляют собой показатели, которые содержат информацию, связанную с терапевтической значимостью системы, которая без таких показателей может быть проигнорирована или упущена, в результате чего укрепляется доверие и уверенность в системе доставки. Кроме того, предоставляется информация, которая ...

ПОДДЕРЖАНИЕ МАКСИМАЛЬНЫХ ПРЕДЕЛОВ ДОЗИРОВАНИЯ ДЛЯ СИСТЕМ УПРАВЛЕНИЯ ВВЕДЕНИЕМ ИНСУЛИНА С ОБРАТНОЙ СВЯЗЬЮ

Группа изобретений относится к медицине и может быть использована для управления введением инсулина. Предложена система для реализации способов, причем система содержит: монитор глюкозы непрерывного действия, выполненный с возможностью предоставления уровней глюкозы пользователя через одинаковые интервалы времени в виде данных измерения глюкозы; инсулиновую инфузионную помпу, выполненную с возможностью введения инсулина; и контроллер, функционально соединенный с инсулиновой инфузионной помпой и монитором глюкозы непрерывного действия, в котором контроллер выполнен с возможностью прогнозирования по меньшей мере одного будущего значения глюкозы на основе предыдущих данных измерения глюкозы от монитора глюкозы непрерывного действия, и определения максимальной скорости введения инсулина для инсулиновой инфузионной помпы через одинаковые интервалы времени на основе: базальной скорости введения инсулина, заданной по умолчанию, через заданные интервалы времени в течение заранее определенного периода ...

СПОСОБ МОНИТОРИНГА ИНСУЛИНОВОЙ ТЕРАПИИ ДИАБЕТА

Изобретение относится к области медицины, в частности к методам и средствам инсулиновой терапии больных диабетом. Проводят мониторинг инсулиновой терапии диабета, основанный на оптических и/или электрохимических измерениях характеристик исследуемой, например, подкожной среды или цельной крови. При этом периодически вводят контрольные дозы (ультра) короткого инсулина в месте измерений и используют перепад в результатах измерений, возникающий после каждой импульсной дозы инсулина, для определения текущего уровня глюкозы на данном интервале измерений. Причем вводят инсулин с помощью инсулиновой помпы с программным управлением через канюлю, которую закрепляют пластырем на теле пациента, а рядом с местом ввода инъекций располагают чувствительные к глюкозе элементы измерений. Инсулин вводят через интрадермальный порт той или иной конструкции и, кроме того, через интрадермальный порт в подкожную среду периодически погружают электрохимический датчик (электрод), чувствительный к глюкозе. В промежутках ...

СПОСОБ И УСТРОЙСТВО ДЛЯ ПОДКОЖНОЙ ИНЪЕКЦИИ С ЭЛЕКТРИЧЕСКОЙ СТИМУЛЯЦИЕЙ НЕРВА

Изобретение относится к медицинской технике, а именно к устройству для введения текучей среды в анатомическое пространство. Устройство содержит: систему инъекции для управления потоком текучей среды из резервуара текучей среды к игле, причем игла выполнена с возможностью введения под кожу субъекта-млекопитающего; датчик для определения характеристики, указывающей давление текучей среды в игле, причем датчик выполнен с возможностью непрерывного определения характеристики при введении иглы в тело пациента; и элемент для электрической стимуляции нерва для обеспечения электрической стимуляции нерва в области кончика иглы или рядом с ним. Причем элемент для электрической стимуляции нерва обеспечивает электрическую стимуляцию нерва пациента после того, как датчик определит характеристику давления текучей среды, указывающую давление текучей среды, превышающее верхнее пороговое значение. 4 н. и 41 з.п. ф-лы, 14 ил.

МОДУЛЬНОЕ ОБЪЕДИНЕНИЕ ИНФУЗИИ ЛЕКАРСТВЕННОГО СРЕДСТВА И КОНТРОЛЯ АНАЛИТОВ

Группа изобретений относится к медицине. Модульная система содержит сменный первый модульный компонент, выполненный с возможностью доставки лекарственного средства, причем первый модульный компонент включает в себя соединительное гнездо. Сменный второй модульный компонент выполнен с возможностью контроля физиологического состояния и допускает соединение с соединительным гнездом первого модульного компонента для установления электрического контакта с первым модульным компонентом. Третий модульный компонент подсоединяется к соединительному гнезду первого модульного компонента, когда первый модульный компонент отсоединен от второго модульного компонента. Первый модульный компонент функционирует, когда третий модульный компонент подсоединен к соединительному гнезду первого модульного компонента. На гнезде создается, по существу, водонепроницаемое уплотнение, когда соединяют первый и второй модульные компоненты, или когда соединяют первый и третий модульные компоненты. Раскрыт способ доставки ...

СПОСОБ И УСТРОЙСТВО ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ

Изобретение относится к медицинской технике, а именно к устройствам для доставки лекарственных средств пациенту, в частности к устройствам для подкожной инфузии лекарственных средств или веществ, использующим источники энергии для повышения эффективности введения лекарственных средств. Устройство для доставки терапевтического вещества в тело пациента содержит инфузионный катетер, элемент прикрепления катетера, кожух, терапевтический элемент и контроллер. Инфузионный катетер выполнен с возможностью вставления в телесную ткань, расположенную на участке вставки на теле пациента, и с возможностью доставки терапевтического вещества в тело пациента в области инфузии. Область инфузии включает объем ткани тела, окружающий участок вставки. Элемент прикрепления катетера выполнен с возможностью прикрепления к коже пациента и с возможностью прикрепления инфузионного катетера к коже. Кожух содержит устройство доставки вещества, предназначенное для введения терапевтического вещества в инфузионный катетер ...

СПОСОБ И УСТРОЙСТВО ДЛЯ ПОДКОЖНОЙ ИНЪЕКЦИИ С ЭЛЕКТРИЧЕСКОЙ СТИМУЛЯЦИЕЙ НЕРВА

Изобретение относится к медицинской технике, а именно к устройству для введения текучей среды в анатомическое пространство. Устройство содержит: систему инъекции для управления потоком текучей среды из резервуара текучей среды к игле, причем игла выполнена с возможностью введения под кожу субъекта-млекопитающего; датчик для определения характеристики, указывающей давление текучей среды в игле, причем датчик выполнен с возможностью непрерывного определения характеристики при введении иглы в тело пациента; и элемент для электрической стимуляции нерва для обеспечения электрической стимуляции нерва в области кончика иглы или рядом с ним. Причем элемент для электрической стимуляции нерва обеспечивает электрическую стимуляцию нерва пациента после того, как датчик определит характеристику давления текучей среды, указывающую давление текучей среды, превышающее верхнее пороговое значение. 4 н. и 41 з.п. ф-лы, 14 ил.

МИНИАТЮРНЫЕ ПОРОГОВЫЕ ДАТЧИКИ

... 1. Датчик, содержащий: множество электродов; и покрытие, внешнее к электродам, при этом покрытие является внешним к датчику, причем покрытие взаимодействует с состоянием цели, что приводит к изменению, по меньшей мере, одного из физического свойства, электрического свойства и химического свойства на поверхности электродов, причем изменение преобразуется электродами в электрический сигнал. ! 2. Датчик по п.1, причем датчик используется в полости. ! 3. Датчик по п.2, причем датчик используется в материальной полости. !4. Датчик по п.3, причем материальная полость выбирается из группы, состоящей из: желудочно-кишечного тракта, брюшинной полости, брюшной полости, спинно-мозгового пространства, легкого, мочеполовой полости, сосудистого тракта, подкожного места и внутримышечного места. ! 5. Датчик по п.2, причем полость выбирается из группы, состоящей из: архитектурного места, подземного места, водного места, воздушного места, сельскохозяйственного места и места, встречающегося в природе. ! 6 ...

GESCHLOSSENER REGELKREIS FÜR DIE INFUSION VON INSULIN

KENNZEICHENMONITORINGSYSTEM WITH TELEMETERING

PROOF OF SLEEP

A DISPOSABLE NEEDLE ASSEMBLY HAVING SENSORS FORMED THEREIN PERMITTING THE SIMULTANEOUS DRAWING AND ADMINISTERING OF FLUIDS AND METHOD OF FORMING THE SAME

Analyte-controlled liquid delivery device and analyte monitor

Subcutaneous insertion systems, devices and related methods

Embodiments relate to subcutaneous insertion systems comprising a surface device to be applied to a patient's skin and an insertion system for applying the surface device to the patient, wherein the applying can include subcutaneous insertion of a cannula or other element, and related devices and methods. The surface device comprises a surface for application to the skin of a patient and a subcutaneous element, such as a cannula, wire, filament or other device, extending from the skin's surface at an angle greater than 0 degrees and less than 90 degrees.

Analyte monitoring and fluid dispensing system

Systems for determining, and devices for indicating, viable life of replaceable components thereof and methods therefor

A system capable of monitoring a replaceable component is provided. The system includes a controller for controlling operation of the system; programming instructions according to which the system is configured to: accept input of a viable life for the component, calculate an accumulated amount of distress experienced by the component based on each set of previously collected use data associated with each previous use of the component, and determine, based in part on the accumulated amount of distress, a used portion of the viable life that the component has experienced as a result of the previous use(s) thereof and an unused portion of the viable life; and a feedback device configured to provide to an operator of the system an indication of at least one of the unused and used portions of the viable life of the component. Methods of monitoring a replaceable component of a system are also provided.

Application of electrochemical impedance spectroscopy in sensor systems, devices, and related methods

A method of calibrating a sensor, the method comprising: defining an electrochemical impedance spectroscopy (ES)-based sensor status vector (V) for each one of a plurality of sensor current (Isig)-blood glucose (BG) pairs; monitoring the status vectors for the plurality of Isig-BG pairs over time; detecting when there is a difference between a first status vector for a first Isig-BG pair and a subsequent status vector for a subsequent Isig-BG pair, said first Isig-BG pair having assigned thereto a first offset value; and if a magnitude of said difference is larger than a predetermined threshold, assigning a dynamic offset value for said subsequent Isig-BG pair that is different from said first offset value so as to maintain a substantially linear relationship between said subsequent Isig and said subsequent BG.

Fluid delivery and infusion devices, and methods of use thereof

A medical device comprising an infusion device comprising a fluid reservoir to contain a therapeutic fluid and a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool configured to deliver the therapeutic fluid subcutaneously to a patient; wherein the infusion device operates in a stand-by mode prior to the therapeutic fluid being introduced into the fluid reservoir; wherein the infusion device operates to deploy the transcutaneous access tool within a predetermined deployment time period upon filling the fluid reservoir to a predetermined fill level with the therapeutic fluid.

Insulin management

A method of administering insulin includes receiving blood glucose measurements (BG) of a patient (10) at a data processing device (112) from a glucometer (124). Each blood glucose measurement (BG) is separated by a time interval (T ...

Methods and systems for improving the reliability of orthogonally redundant glucose sensors

Methods and systems for sensor calibration and sensor glucose (SG) fusion are used advantageously to improve the accuracy and reliability of orthogonally redundant glucose sensor devices, which may include optical and electrochemical glucose sensors. Calibration for both sensors may be achieved via fixed-offset and/or dynamic regression methodologies, depending, e.g., on sensor stability and Isig-Ratio pair correlation. For SG fusion, respective integrity checks may be performed for SG values from the optical and electrochemical sensors, and the SG values calibrated if the integrity checks are passed. Integrity checks may include checking for sensitivity loss, noise, and drift. If the integrity checks are failed, in-line sensor mapping between the electrochemical and optical sensors may be performed prior to calibration. The electrochemical and optical SG values may be weighted (as a function of the respective sensor's overall reliability index (RI)) and the weighted SGs combined to obtain ...

Diabetes management system with automatic basal and manual bolus insulin control

Systems and methods for diabetes management with automatic basal and manual bolus insulin control are presented. An exemplary system includes a delivery device, a glucose sensor, and a controller. The delivery device delivers insulin and the glucose sensor measures glucose levels of the subject. A basal insulin dose is calculated using a model predictive control algorithm and physiological data of the subject including desired glucose levels, amounts of the delivered insulin and the measured glucose levels. A manual bolus insulin dose is initiated by the subject. The manual bolus insulin dose is modified based on one or both of the model predictive control algorithm and the physiological data of the subject. A total insulin dose is determined based on the modified manual bolus insulin dose and the calculated basal insulin dose, and delivered to the subject.

Application of electrochemical impedance spectroscopy in sensor systems, devices, and related methods

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the ElS-based diagnostics, fusion algorithms, and other processes based on measurement of ElS-based parameters.

Wireless implantable power receiver system and methods

A method and system is presented for an implantable wireless power receiver for use with a medical stimulation or monitoring device. The receiver receives transmitted energy through one or more non-inductive antenna(s), utilizes microelectronics to perform rectification of the received signal for generation of a DC power supply to power an implantable device, and may also utilize microelectronics to provide parameter settings to the device, or stimulating or other waveforms to a tissue.

DEVICE AND METHOD FOR TREATING WEIGHT DISORDERS

REAL TIME SELF-ADJUSTING CALIBRATION ALGORITHM

A method of calibrating glucose monitor data includes collecting the glucose monitor data over a period of time at predetermined intervals. It also includes obtaining at least two reference glucose values from a reference source that temporally correspond with the glucose moinitor data obtained at the predetermined intervals. Also included is calculating the calibration characteristics using the reference glucose values and the corresponding glucose monitor data to regress the obtained glucose monitor data. And calibrating the obtained glucose monitor data using the calibration characteristics is included. In pereferred embodiments, the reference source is a blood glucosemeter, and the at least two reference glucose values are obtained from blood tests. In additional embodiments, the calculation of the calibration characteristics is obtained using linear regression and inparticular embodiments, least squares linear regression. Alternatively, the calculation of the calibration characteristics ...

METHODS AND DEVICES FOR RENAL NERVE BLOCKING

FLUID INFUSION SYSTEMS

A fluid infusion system such as a portable fluid infusion device includes a housing to accommodate a fluid reservoir. The housing has a largest dimension and a smallest dimension. The fluid infusion device includes a drive system to be serially coupled to the removable fluid reservoir such that a combined dimension of the drive system and the fluid reservoir is less than or equal to the largest dimension. The fluid infusion device includes a planar battery configured to supply power to the drive system. The planar battery has a plurality of faces with one or more faces having a largest area, and the planar battery is situated such that the one or more faces are parallel to the largest dimension and the smallest dimension.

SUBCUTANEOUS INSERTION SYSTEMS, DEVICES AND RELATED METHODS

Embodiments relate to subcutaneous insertion systems comprising a surface device to be applied to a patient's skin and an insertion system for applying the surface device to the patient, wherein the applying can include subcutaneous insertion of a cannula or other element, and related devices and methods. The surface device comprises a surface for application to the skin of a patient and a subcutaneous element, such as a cannula, wire, filament or other device, extending from the skin's surface at an angle greater than 0 degrees and less than 90 degrees.

AUTOMATED SYSTEM FOR CONTROLLING THE BLOOD GLUCOSE LEVEL OF A PATIENT

L'invention concerne un système automatisé de régulation de la glycémie d'un patient, comportant : un capteur de glycémie (101); un dispositif d'injection d'insuline (103); et une unité de traitement et de contrôle (105) adaptée à prédire l'évolution future de la glycémie du patient à partir d'un modèle physiologique et à commander le dispositif d'injection d'insuline (103) en tenant compte de cette prédiction, dans lequel : le modèle physiologique comporte un système d'équations différentielles décrivant l'évolution d'une pluralité de variables d'état en fonction du temps; et l'unité de traitement et de contrôle (105) est adaptée à mettre en oeuvre une étape de calibration automatique du modèle physiologique comprenant une étape d'estimation de valeurs initiales des variables d'état par minimisation d'une grandeur représentative de l'erreur, pendant une période d'observation passée, entre la glycémie estimée à partir du modèle physiologique et la glycémie mesurée par le capteur (101).

ADVANCE DIAGNOSIS OF INFUSION DEVICE OPERATING MODE VIABILITY

PSEUDO-ORTHOGONAL REDUNDANT GLUCOSE SENSORS, SYSTEMS, AND METHODS

A pseudo-orthogonally redundant glucose sensor device may include one or more electrochemical peroxide-based glucose sensor(s) and one or more electrochemical oxygen-based sensor(s). The electrochemical peroxide-based glucose sensor(s) may operate as traditional peroxide-based sensor(s), which may include a chemistry stack with glucose oxidase as a catalytic agent. The electrochemical oxygen-based sensor(s) may be used to measure oxygen, as well as to measure glucose by computing differences in oxygen between two working electrodes. In embodiments of the invention, one of the oxygen-based sensors may be used directly as a diagnostic to determine whether each peroxide-based glucose sensor is functioning properly, as well as to determine which modality of sensing to use. Because of the internal oxygen-based reference, the glucose sensor device provides oxygen-resistant glucose sensing, as well as near-orthogonal redundancy.

THERAPY SPECIFIC, PRE-PROGRAMMED AUTO INJECTION DEVICE

A therapy specific, pre-programmed, hand-held auto-injection device for delivering a drug to a patient and a method of using the hand-held auto-injection device. The auto-injection device includes a housing, a plurality of syringes carried by the housing, at least one actuator disposed within the housing, and a controller disposed within the housing and communicatively coupled to the at least one actuator. The controller is configured to receive an infusion and aspiration profile, which includes an infusion and aspiration protocol for controlling at least one of the plurality of syringes. The controller is also configured to operate the at least one actuator based on the infusion and aspiration protocol to expel a fluid from a respective barrel of the plurality of syringes into the infusion and aspiration location and/or draw a fluid from the infusion and aspiration location into a respective barrel of the plurality of syringes.

SYSTEMS AND METHODS FOR DRUG INFUSION WITH FEEDBACK CONTROL

A system for infusing a drug (10) under continuous positive pressure (suc h as convection enhanced deliver) to a target tissue (12) to be treated is p articularly useful for post- resection anticancer drug therapy. The system c omprises a drug infusion catheter (16) having an expandable device (28) whic h is expanded within the target tissue such that the target tissue conforms to an outer surface of the expandable device, thereby creating a form of sea l around the target volume in order to maintain an effective drug pressure g radient within the target tissue. The system further comprises a sensor (50, 52,54,56) to measure a parameter which can be correlated to the degree of co nformance between the target tissue and the outer surface of the expandable device. The sensor is coupled to a feedback control system (22) to determine whether there is a loss of conformance, and to adjust the expansion of the expandable device in order to maintain good conformance.

FLUID COMPONENT ANALYSIS SYSTEM AND METHOD FOR GLUCOSE MONITORING AND CONTROL

Disclosed are methods and apparatus for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment drug (e.g. insulin or glucose) and provide glycemic control. The dose of the treatment drug may be based on the concentration of the analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte.

RESERVOIR PLUNGER HEAD SYSTEMS AND METHODS

A casing may be configured to envelop at least a portion of a plunger arm (126) attached to a plunger head located in a reservoir (100). A plunger head (120) moveable in a reservoir may have a front portion (122) comprising a first material compatible with fluidic media in an interior volume (112) of the reservoir. A seal member having a first end and a second end that taper to a mid-portion may be positioned between a reservoir and a plunger head. A bias member (153) may be configured to force a plunger arm operatively connected to a plunger head against a drive member to operatively engage the plunger arm to the drive member (140). A plunger head moveable in a reservoir may have a first ridge, a second ridge, a seal member adjacent at least one of the ridges, and protrusions arranged around at least one of the ridges.

SENSOR FOR MEASURING THE ACTIVITY OF .BETA.-PANCREATIC CELLS OR OF ISLETS OF LANGERHANS, MANUFACTURE AND USE OF SUCH A SENSOR

L'invention concerne un capteur (2) comprenant : un ensemble de microélectrodes (21 ); et des cellules ß-pancréatiques (23) ou des îlots (230) de Langerhans en culture sur l'ensemble de microélectrodes (21 ); caractérisé en ce que l'ensemble de microélectrodes (21 ) est adapté pour mesurer dynamiquement, en temps réel et en continu, des signaux électriques (V) produits par les cellules (23) ß-pancréatiques ou les îlots (230) de Langerhans lors de leur activation physiologique. L'invention concerne également le domaine des dispositifs pouvant être implantables dans le corps d'un patient, et comprenant un distributeur à insuline pour distribuer une quantité d'insuline. L'invention concerne également un procédé pour fabriquer un tel capteur et un tel dispositif et une utilisation d'un tel capteur.

REAL-TIME SELF-CALIBRATING SENSOR SYSTEM AND METHOD

TRANSCUTANEOUS SENSOR INSERTION SET

An insertion set (10) is provided for transcutaneous placement of a sensor ( 12) such as a glucose sensor at a selected site within the body of a patient. The insertion set (10) comprises a slotted insertion needle (14) extending through a mounting base (26) adapt ed for mounting onto the patient's skin. A flexible thin film sensor (12) includes a proximal segment (20) carried by the mounting base (26 ) and defining conductive contacts unnumbered, adapted for electrical connection t o a suitable monitor (22), and a distal segment (16) pro truding from the mounting base (26) with sensor electrodes (18) for transcutaneous p lacement. The distal segment of the sensor extends withi n a protective cannula (15), a portion of which is slidably disposed within the insertion needle (14). Placement of the mounting base (2 6) onto the patient's skin causes the insertion needle (14) to pierce the skin for t ranscutaneous placement of the cannula (15) with the sen sor (12) therein.

Medical device for glucose monitoring or regulation

A medical device comprising a pressure generating means adapted to displace a liquid, a sensor adapted to measure a flow resistance, and an implantable member comprising an analyte responsive porous membrane which reversibly changes its porosity subject to changes in analyte concentration occurring in the solution surrounding the implantable member. The analyte may in particular be glucose. The medical device may also be used for drug administration.

Real-time self-calibrating sensor system and method

A system and method for calibrating a sensor of a characteristic monitoring system in real time utilizes a self-calibration module for periodic determination of, and compensation for, the IR drop across unwanted resistances in a cell. A current-interrupt switch is used to open the self-calibration module circuit and either measure the IR drop using a high-frequency (MHz) ADC module, or estimate it through linear regression of acquired samples of the voltage across the sensor's working and reference electrodes (Vmeasured) over time. The IR drop is then subtracted from the closed-circuit value of Vmeasured to calculate the overpotential that exists in the cell (Vimportant). Vimportant may be further optimized by subtracting the value of the open-circuit voltage (Voc) across the sensor's working and reference electrodes. The values of Vmeasured and Vimportant are then controlled by respective first and second control units to compensate for the IR drop.

Determination and application of glucose sensor reliability indicator and/or metric

Disclosed are a system and method for determining a metric and/or indicator of a reliability of a blood glucose sensor in providing glucose measurements. In one aspect, the metric and/or indicator may be computed based, at least in part, on an observed trend associated with signals generated by the blood glucose sensor.

Adhesive and peripheral systems and methods for medical devices

Fill stations and base stations are provided for personal pump systems. The fill stations may be opened and closed to accept a reservoir and to allow fluid to be introduced into the reservoir for use with personal pump systems. The fill stations may hold the reservoir at a tilt relative to an underlying surface and may discourage overfilling of the reservoir. The filling stations may also include viewing windows having fluid lines marked thereon for indicating volume of fluid within the reservoir.

Patch-sized fluid delivery systems and methods

A patch-sized fluid delivery device may include a reusable portion and a disposable portion. The disposable portion may include components that come into contact with the fluid, while the reusable portion may include only components that do not come into contact with the fluid. Redundant systems, such as redundant controllers, power sources, motor actuators, and alarms, may be provided. Alternatively or additionally, certain components can be multi-functional, such a microphones and loudspeakers that may be used for both acoustic volume sensing and for other functions and a coil that may be used as both an inductive coupler for a battery recharger and an antenna for a wireless transceiver. Various types of network interfaces may be provided in order to allow for remote control and monitoring of the device.

Adhesive and peripheral systems and methods for medical devices

A repeater system may control a pump by using a repeater and a user interface. An adhesive patch system may be used for affixing a pump or other object to a human body. Such an adhesive patch system may include two sets of adhesive members, each member including an adhesive material on at least one side so as to attach to the body. The members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and the members of the second set are spaced to allow members of the first set to detach from the body without detaching the members of the second set. Also, fill stations and base stations are provided for personal pump systems.

Integrated delivery device for continuous glucose sensor

Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, and optionally a single point glucose monitor are provided. Manual integrations provide for a physical association between the devices wherein a user (for example, patient or doctor) manually selects the amount, type, and/or time of delivery. Semi-automated integration of the devices includes integrations wherein an operable connection between the integrated components aids the user (for example, patient or doctor) in selecting, inputting, calculating, or validating the amount, type, or time of medicament delivery of glucose values, for example, by transmitting data to another component and thereby reducing the amount of user input required. Automated integration between the devices includes integrations wherein an operable connection between the integrated components provides for full control of the system without required user interaction.

System and Method for Mitigating the Effects of Tissue Blood Volume Changes to Aid in Diagnosing Infiltration or Extravasation in Animalia Tissue

A system including a sensor and a device coupled to the sensor. The sensor is configured to detect in Animalia tissue (i) a first electromagnetic radiation extinction dominated by absorption of a first wavelength and (ii) a second electromagnetic radiation extinction dominated by scattering of a second wavelength. The device is configured to aid in diagnosing at least one of infiltration and extravasation in the Animalia tissue based on the first and second electromagnetic radiation extinctions detected by the sensor.

Patch-sized fluid delivery systems and methods

A patch-sized fluid delivery device may include a reusable portion and a disposable portion. The disposable portion may include components that come into contact with the fluid, while the reusable portion may include only components that do not come into contact with the fluid. Redundant systems, such as redundant controllers, power sources, motor actuators, and alarms, may be provided. Alternatively or additionally, certain components can be multi-functional, such a microphones and loudspeakers that may be used for both acoustic volume sensing and for other functions and a coil that may be used as both an inductive coupler for a battery recharger and an antenna for a wireless transceiver. Various types of network interfaces may be provided in order to allow for remote control and monitoring of the device.

DEVICE FOR DRUG DELIVERY

Delivery of more than one therapeutic fluid as a means to control symptoms of a health conditions is disclosed. More than one therapeutic fluid may be dispensed from more than one reservoir and delivered to a user's body via one or more cannula that penetrate the skin. The therapeutic fluids may be delivered by action of one or more pumping mechanisms that may be controlled by a processor in a portable, ambulatory device. The therapeutic fluids may optionally be insulin and one or more of an amylin analog, pramlintide acetate and an exenatide, and the health condition may optionally be diabetes. This device can be used in combination with a glucometer. 1. A portable therapeutic fluid delivery device having a form factor that permits ambulatory use by a user , the device comprising:a first reservoir for containing a first therapeutic fluid;a second reservoir for containing a second therapeutic fluid;at least one cannula in fluid communication with the first and/or second reservoir, the at least one cannula being disposed to penetrate the user's skin to deliver the first and/or the second therapeutic fluid subcutaneously at a dosing rate;at least one pumping mechanism that delivers the first therapeutic fluid from the first reservoir at a first dosing rate and delivers the second therapeutic fluid from the second reservoir at a second dosing rate to the at least one cannula and into the user; anda processor that controls the at least one pumping mechanism.2. The portable therapeutic fluid delivery device as in claim 1 , wherein the at least one cannula comprises a first cannula in fluid communication with the first reservoir and a second cannula in fluid communication with the second reservoir.3. The portable therapeutic fluid delivery device as in claim 1 , wherein the first dosing rate is different from the second dosing rate.4. The portable therapeutic fluid delivery device as in claim 1 , wherein the at least one pumping mechanism comprises a first pumping ...

Prosthesis management of body physiology

An apparatus, such as an implantable medical device, including an implantable device configured to cause trauma in an inner ear and/or a middle ear recipient. In an exemplary embodiment, the implantable device is a cochlear implant. In an exemplary embodiment, the implantable device is configured to deliver a therapeutic substance to body tissue of the recipient.

CLOSED-LOOP CONTROL BASED ON PREDICTED TRAJECTORIES

Disclosed herein are techniques for closed-loop control based on predicted trajectories. The techniques may involve predicting a trajectory of a glucose level of a patient based on past observations of the glucose level. The techniques may further involve determining a cost expression based on the predicted trajectory. The cost expression may be based on a duration of time that the trajectory is predicted to extend outside of a target glucose concentration range. Additionally, the techniques may involve affecting, based on the cost expression, at least one future command to at least one infusion pump so as to shorten the duration of time that the trajectory is predicted to extend outside of the target glucose concentration range. 1. A processor-implemented method comprising:predicting a trajectory of a glucose level of a patient based on past observations of the glucose level;determining a cost expression based on the predicted trajectory, wherein the cost expression is based on a duration of time that the trajectory is predicted to extend outside of a target glucose concentration range;affecting, based on the cost expression, at least one future command to at least one infusion pump so as to shorten the duration of time that the trajectory is predicted to extend outside of the target glucose concentration range.2. The method of claim 1 , wherein the at least one infusion pump comprises an insulin infusion pump.3. The method of claim 1 , wherein the at least one infusion pump comprises a glucagon infusion pump.4. The method of claim 1 , wherein the cost expression is defined to cover a set duration in the future.5. The method of claim 1 , wherein the predicting claim 1 , the determining claim 1 , and the affecting are performed on command intervals.6. A system comprising:one or more processors; and predicting a trajectory of a glucose level of a patient based on past observations of the glucose level;', 'determining a cost expression based on the predicted ...

DEVICE FOR SUBCUTANEOUS DELIVERY OF FLUID MEDICAMENT

An improved device delivers a fluid medicament to the subcutaneous tissue of a user. The device is better suited for patients with Parkinson's Disease and other central nervous system disorders, than conventional infusion devices. The device can include a reusable part including a drive component (e.g., motor) and control electronics and a disposable part including a medicament reservoir. Medicament can be evacuated from the medicament reservoir by a plunger assembly that includes a plunger attached to a lead screw that is rotated by a nut, all within the disposable part. The device can be fluidically coupled with the tissue via a flexible cannula. Various embodiments relate to an improved cannula insertion mechanism that delivers the cannula under a force applied by a spring. Various embodiments relate to improved filling of the device, for example, using a vial adapter and an automated filling station. 1. A device for delivering a fluid medicament to a user , the device comprising: a drive component, and', 'a control unit for controlling the drive component; and, 'a reusable part comprising a reservoir for containing the fluid medicament,', 'a plunger for driving the fluid medicament out of the reservoir,', 'a lead screw attached to the plunger, and', 'a nut operable to displace the lead screw, wherein when the reusable part and the disposable part are attached, the nut is operably coupled with the drive component., 'a disposable part attachable to the reusable part, the disposable part comprising2. The device of claim 1 , wherein the reservoir contains the fluid medicament comprising a liquid formulation of at least one of levodopa and carbidopa.3. The device of claim 1 , wherein at least one of the reusable part and the disposable part further comprises a battery for powering the drive component.4. The device of claim 1 , wherein the drive component comprises a motor assembly.5. The device of claim 4 , wherein the motor assembly comprises a motor and a planetary ...

METHODS AND DEVICES FOR THE DIAGNOSIS AND TREATMENT OF DIABETES

Methods and devices for the diagnosis and treatment of diabetes are disclosed in which an analyte concentration within a peritoneal fluid of a human subject may be determined by implanting an analyte sensor apparatus in the subject where the apparatus may comprise a housing and a flexible sensing catheter which has a lumen with a plurality of apertures and an exterior surface with an analyte sensor affixed thereto. The catheter may comprise a proximal end attached to the housing and the remaining end may be positioned freely within the peritoneal space to contact peritoneal fluid where an analyte concentration in the peritoneal fluid may be sensed. The housing may be anchored at a subcutaneous site proximate the peritoneal space. The sensed analyte concentration may then be transduced into a transmittable electrical signal. 1. A method of determining an analyte concentration within a peritoneal fluid of a human subject , comprising:implanting an analyte sensor apparatus in the subject, the apparatus comprising a flexible sensing catheter and a housing, the catheter comprising a lumen with a plurality of apertures and an exterior surface with an analyte sensor affixed thereto, the catheter comprising a proximal end attached to the housing, wherein the implanting step comprises positioning the sensing catheter freely within the peritoneal space and anchoring the housing at a subcutaneous site proximate the peritoneal space;contacting the analyte sensor with a peritoneal fluid sample outside the sensing catheter;sensing an analyte concentration in peritoneal fluid sample; andtransducing the sensed analyte concentration into a transmittable electrical signal.2. The method of wherein implanting the analyte sensor apparatus at a subcutaneous site proximate the peritoneal space comprises anchoring the housing of apparatus using tissue in-growth cuffs attached to the exterior surface of the catheter to a tissue site within the abdominal wall.3. The method of wherein ...

Devices, Methods and Systems for Wireless Control of Medical Devices

A medical device system. The system includes a first medical device, a first remote interface, and a second remote interface in communication with the first remote interface and the first medical device, wherein the first medical device sends a command to the first medical device through the second remote interface, and wherein when the second remote interface receives the command, the command must be confirmed by the second remote interface before the command is send by the second remote interface to the first medical device. 1. A medical device system comprising:a first medical device;a first remote interface; anda second remote interface in communication with the first remote interface and the first medical device,wherein the first medical device sends a command to the first medical device through the second remote interface, andwherein when the second remote interface receives the command, the command must be confirmed by the second remote interface before the command is send by the second remote interface to the first medical device.2. The medical device system of claim 1 , wherein the first medical device is an infusion pump.3. The medical device system of claim 1 , wherein the first remote interface is a medical device data system.4. The medical device system of claim 1 , wherein the second remote interface is not a medical device data system.5. The medical device system of claim 1 , wherein the system further comprising a blood glucose meter in communication with the second remote interface.6. The medical device system of claim 1 , wherein the system further comprising a continuous glucose monitor transmitter in communication with the second remote interface.7. The medical device system of claim 1 , wherein the first remote interface:receives a command related to the communication of safety critical information to the first medical device;displays a message that the communication of the safety critical information to the first medical device requires ...

DIABETES MANAGEMENT SYSTEM WITH AUTOMATIC BASAL AND MANUAL BOLUS INSULIN CONTROL

Systems and methods for diabetes management with automatic basal and manual bolus insulin control are presented. An exemplary system includes a delivery device, a glucose sensor, and a controller. The delivery device delivers insulin and the glucose sensor measures glucose levels of the subject. A basal insulin dose is calculated using a model predictive control algorithm and physiological data of the subject including desired glucose levels, amounts of the delivered insulin and the measured glucose levels. A manual bolus insulin dose is initiated by the subject. The manual bolus insulin dose is modified based on one or both of the model predictive control algorithm and the physiological data of the subject. A total insulin dose is determined based on the modified manual bolus insulin dose and the calculated basal insulin dose, and delivered to the subject. 1. A diabetes management system comprising:a delivery device for delivering insulin to a subject;a glucose sensor for measuring glucose levels of the subject;a bolus calculator into which a manual bolus insulin dose is initiated by the subject, the manual bolus insulin dose being determined by the bolus calculator as a function of a difference between a present glucose level of the subject, a glucose sensitivity of the subject, and an on-board insulin level of the subject; and receive glucose levels of the subject from the glucose sensor on a periodic basis,', 'automatically calculate a basal insulin dose using a model predictive control (MPC) algorithm and physiological data of the subject including desired glucose levels, amounts of the delivered insulin, and the measured glucose levels of the subject,', 'receive the manual bolus insulin dose determined by the bolus calculator,', 'modify the manual bolus insulin dose based on the physiological data,', 'determine a total insulin dose based on the modified manual bolus insulin dose and the calculated basal insulin dose, and', 'deliver the total insulin dose to ...

METHODS AND DEVICES FOR DETERMINING OPTIMAL AGENT DOSAGES

The present invention is generally directed to methods and devices for determining dosing for a medical agent. In some embodiments, a mathematical algorithm is employed for computing erythropoiesis-stimulating agents dosing for treating anemia in a subject, e.g., a human subject. Any suitable dosing may be used, e.g., intravenous, subcutaneous, or oral dosing. In some cases, dosing for a wide range of subject types and health conditions can be achieved using the devices and methods disclosed herein. 146-. (canceled)47. A method for treating anemia in a subject , comprising:(a) determining a concentration of at least one biochemical property in the subject;(b) using a feedback controller to calculate a dosage of an erythropoiesis-stimulating agent based on the concentration of the at least one biochemical property, wherein the controller comprises an algorithm including an integrator or an approximated discrete-time integrator;(c) administering the dosage of the erythropoiesis-stimulating agent to the subject; and(d) repeating steps (a) through (c) a plurality times.48. The method of claim 47 , wherein the subject is human.49. The method of claim 47 , wherein the subject has renal failure.50. The method of claim 47 , wherein said biochemical property is hemoglobin concentration.51. The method of claim 47 , wherein said biochemical property is iron concentration.52. The method of claim 47 , wherein the erythropoiesis-stimulating agent comprises erythropoietin (EPO) and/or recombinant human erythropoietin (rHuEPO) and/or novel erythropoiesis stimulating protein (NESP) and/or HIF stabilizing agent.54. The method of claim 53 , wherein said discrete-time integrator is selected from the following: Forward Euler claim 53 , Backward Euler claim 53 , Trapezoidal method claim 53 , second-order accurate method claim 53 , or third order accurate method.55. The method of claim 47 , wherein the feedback controller encodes Equations 1-5.56. A device for treating anemia in a subject ...

Predictive infusion device operations and related methods and systems

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves determining a current value for a physiological condition of the user influenced by the fluid violates a first threshold value, determining a predicted value for the physiological condition of the user violates a second threshold value, and automatically altering operation of the infusion device to modify delivery of the fluid to the user after determining the predicted value violates the second threshold value when the current value violates the first threshold value.

TIME AVERAGED BASAL RATE OPTIMIZER

Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, a controller module, and optionally a single point glucose monitor are provided. Integration may be manual, semi-automated and/or fully automated. 1. A method for optimizing a basal rate profile for use with continuous insulin therapy , comprising:providing a programmed basal rate profile for insulin therapy, wherein the basal rate profile comprises an insulin delivery schedule that includes one or more blocks of time, and wherein each block of time defines an insulin delivery rate;periodically or intermittently updating the programmed basal rate profile based on a retrospective analysis of continuous glucose sensor data over a predetermined time window; andadjusting the basal rate profile of the updated programmed basal rate profile in response to real time continuous glucose sensor data indicative of actual or impending hyperglycemia or hypoglycemia.2. The method of claim 1 , wherein the programmed basal rate profile is pre-programmed by a patient or healthcare provider.3. The method of claim 1 , wherein the basal rate profile is selected by a user from a list of predetermined basal rate profiles.4. The method of claim 1 , further comprising iteratively repeating the providing and periodically or intermittently updating claim 1 , wherein the programmed basal rate profile is an updated basal rate profile from a previous iteration.5. The method of claim 4 , wherein the previous iteration is from about one day to one week previous to the iteration.6. The method of claim 1 , wherein the basal rate profile consists of a single rate of insulin infusion over 24 hours.7. The method of claim 1 , wherein the basal rate profile comprises a plurality of rates associated with different time blocks spanning 24 hours.8. The method of claim 1 , wherein the retrospective analysis comprises a time-averaging of the continuous glucose sensor data.9. The method of claim ...

BLOOD GLUCOSE CONTROL SYSTEM WITH REAL-TIME GLYCEMIC CONTROL OPTIMIZATION

A blood glucose control system is configured to modify therapy provide to a subject and determine whether the modified therapy results in a statistically significant improvement in glycemic control. The system obtains glycemic control information resulting from delivery of first therapy using a first value of a control parameter and determines a first effect corresponding to the first therapy. The control parameter is set to a second value that differs from the first value. The system obtains glycemic control information resulting from the delivery of the second therapy using the second value of the control parameter and determines a second effect corresponding to the second therapy. The system can perform a comparative assessment and determine whether the second value for the control parameter results in a statistically significant improvement in glycemic control for the subject. 1. A computer-implemented method of modifying therapy provided to a subject using a blood glucose control system , the method comprising: receiving a glucose level signal from a glucose level sensor operatively connected to the subject;', 'causing first therapy to be delivered by the blood glucose control system to the subject during a first therapy period, wherein the first therapy is delivered based at least in part on a first value of a control parameter used by a control algorithm to generate the dose control signal, wherein the control parameter is used by the control algorithm to account for accumulation of insulin in the subject, thereby controlling an insulin dosing response of the control algorithm to a blood glucose excursion in the subject as indicated by the glucose level signal;', 'obtaining a first therapy data comprising glycemic control information resulting from the delivery of the first therapy;', 'determining a first effect corresponding at least in part to the first therapy over a first time period, wherein the first effect is determined based at least in part on the ...

BLOOD GLUCOSE CONTROL SYSTEM WITH CONTROL PARAMETER MODIFICATION

A blood glucose control system is configured to modify therapy provided to a subject. The system can cause first therapy to be delivered by the blood glucose control system to a subject during a first therapy period. The first therapy can be delivered based at least in part on a first value of a control parameter used by a control algorithm to generate a dose control signal. The system can determine a first effect corresponding at least in part to the first therapy and autonomously generate a second value of the control parameter. The system can cause second therapy to be delivered by the blood glucose control system to the subject during a second therapy period, wherein the second therapy is delivered based at least in part on the second value of the control parameter. 1. A computer-implemented method of modifying therapy provided to a subject using a blood glucose control system , the method comprising: receiving a glucose level signal from a glucose level sensor operatively connected to the subject;', 'causing first therapy to be delivered by the blood glucose control system to a subject during a first therapy period, wherein the first therapy is delivered based at least in part on a first value of a control parameter used by a control algorithm to generate the dose control signal, wherein the control parameter is used by the control algorithm to account for accumulation of insulin in the subject, thereby controlling an insulin dosing response of the control algorithm to a blood glucose excursion in the subject as indicated by the glucose level signal;', 'determining a first effect corresponding at least in part to the first therapy, wherein determining the first effect comprises analyzing glycemic control of blood glucose in the subject as indicated by the glucose level signal;', 'autonomously generating a second value of the control parameter, wherein the autonomously generated second value is determined as a function based on the first value and the first ...

Blood glucose control system with automated backup therapy protocol generation

An automated blood glucose control system is configured to generate a backup therapy protocol comprising insulin therapy instructions derived from autonomously determined doses of insulin. The system generates a dose control signal using a control algorithm configured to autonomously determine doses of insulin to be infused into a subject for the purpose of controlling blood glucose of the subject based at least in part on a glucose level signal received from a glucose sensor. The system can track insulin therapy administered to the subject over a tracking period, including storing an indication of the autonomously determined doses of insulin delivered to the subject as basal insulin, as correction boluses of insulin, or as mealtime boluses of insulin. The system can generate a backup injection therapy protocol or a backup pump therapy protocol with insulin therapy instructions based at least in part on the insulin therapy administered to the subject over the tracking period.

METHOD FOR INCREASING BUCK REGULATOR EFFICIENCY USING CHARGE RECAPTURING IN AN IMPLANTABLE CARDIAC DEVICE

A typical power switch in a Buck Regulator requires a pre-driver to ensure rapid transition from its ON to OFF states. In this invention, the shoot through current in the pre-driver and the power switch's gate-charge in a Buck regulator is itself recaptured in the capacitor of the buck regulator. The recapturing of this otherwise wasted shoot-through current and gate charge allows for increased efficiency of the regulator. The recapture may be selectively disabled to accommodate high power operations of the system, if such are used; the recapture may in an alternative mode be always performed. As a result, reduced power consumption can be achieved. 1. An implantable cardiac device comprising:a battery;a high power circuit for therapy delivery having an enabling input which determines whether the high power circuit is active or inactive;a control circuit that provides the enabling input to the high power circuit; anda buck-regulator based power supply having a buck oscillator and a resonant circuit controlled in a duty cycled manner by the buck oscillator, the resonant circuit including a maintaining capacitor for maintaining a reference voltage for use as an output from the buck regulator;the improvement comprising a shoot-through current and switch gate-charge re-capture circuit coupled to the buck oscillator, an internal ground of the medical device, the enabling input for the high power circuit, and the maintaining capacitor such that:when the enabling input is set to render the high power circuit active, the shoot through capture circuit directs a shoot-through current from the buck oscillator to ground; orwhen the enabling input is set to render the high power circuit inactive, the shoot through capture circuit directs the shoot-through current and switch gate-charge from the buck oscillator to the maintaining capacitor.2. The implantable cardiac device of wherein the buck oscillator comprises at least pre-driver that provides a low output or a high output in ...

Insulin Management

A method of administering insulin includes receiving glucose measurements of a patient at a data processing device from a continuous glucose monitoring system. The glucose measurements are separated by a time interval. The method also includes receiving patient information at the data processing device and selecting a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments. The selection is based on the glucose measurements and the patient information. The selection includes one or more of a subcutaneous standard program, a subcutaneous program without meal boluses, a meal-by-meal subcutaneous program without carbohydrate counting, a meal-by-meal subcutaneous program with carbohydrate counting, and a subcutaneous program for non-diabetic patients. The method also includes executing, using the data processing device, the selected subcutaneous insulin treatment. 1. A computer-implemented method when executed on data processing hardware causes the data processing hardware to perform operations comprising:obtaining a glucose measurement of a patient from a continuous glucose monitoring system in communication with the data processing hardware;determining a glucose type of the received glucose measurement; and obtaining a Carbohydrate-to-Insulin Ratio for the patient;', 'determining an adjustment factor based on the received glucose measurement;', 'adjusting the Carbohydrate-to-Insulin Ratio for the patient by dividing the Carbohydrate-to-Insulin Ratio by the adjustment factor;', 'determining a recommended meal bolus for the determined glucose type based on the adjusted Carbohydrate-to-Insulin Ratio; and', 'displaying, on a display in communication with the data processing hardware, the recommended meal bolus., 'when the determined glucose type comprises one of a pre-lunch glucose measurement or a pre-dinner glucose measurement2. The method of claim 1 , wherein the operations further comprise claim 1 , when the determined glucose type ...

Long-term implantable monitoring system & methods of use

Methods and systems include a long-term implantable ultra-filtrate monitoring system that uses micro-porous membranes to produce an ultra-filtrate of tissue interstitial fluid or blood plasma. The ultra-filtrate is transported through a sensor to detect a level of analyte in the ultra-filtrate. The long-term implantable fluid monitoring system thus includes a first porous catheter, a second porous catheter, a sensor configured to measure an amount of analyte in fluid, and a pump configured to move fluid through the first porous catheter to the sensor and from the sensor through the second porous catheter.

INTEGRATED ANALYTE SENSOR AND INFUSION DEVICE AND METHODS THEREFOR

Method and system for providing an integrated analyte monitoring system and on-body patch pump with multiple cannulas and a sensor combination is provided. 1. An integrated therapy management system , comprising:a first cannula for transcutaneous placement under a skin layer of a patient at a first infusion site for a first time period;a second cannula for transcutaneous placement under the skin layer of the patient at a second infusion site for a second time period; and 'wherein the first cannula and the second cannula are configured to deliver a therapeutic agent to the patient during the predetermined time period.', 'an analyte sensor configured for fluid contact with an analyte of the patient for a predetermined time period;'}2. The system of further including a housing claim 1 , wherein the first cannula claim 1 , the second cannula and the sensor are coupled to the housing.3. The system of further including a housing claim 1 , wherein the first cannula and the sensor are coupled to the housing.4. The system of wherein the second cannula is connected to the housing by an infusion tubing.5. The system of wherein the first infusion site and the second infusion site are separated by a predetermined distance.6. The system of wherein the predetermined time period includes approximately seven days.7. The system of further including a reservoir coupled to the first cannula and the second cannula.8. The system of further including a first reservoir coupled to the first cannula claim 1 , and a second reservoir coupled to the second cannula.9. The system of wherein when the second cannula is transcutaneously positioned claim 1 , the first cannula is withdrawn from the first infusion site.10. The system of wherein the sensor includes an analyte sensor.11. The system of wherein the therapeutic agent includes insulin.12. A method claim 1 , comprising:positioning a portion of a first cannula under the skin of a patient;positioning a portion of a sensor under the skin of the ...

Insulin Management

A method of administering insulin includes receiving blood glucose measurements of a patient at a data processing device from a glucometer. Each blood glucose measurement is separated by a time interval and includes a blood glucose time associated with a time of measuring the blood glucose measurement. The method also includes receiving patient information at the data processing device and selecting a subcutaneous insulin treatment for tube-fed patients from a collection of subcutaneous insulin treatments. The selection is based on the blood glucose measurements and the patient information. The subcutaneous insulin treatment program for tube-fed patients determines recommended insulin doses based on the blood glucose times. The method also includes executing, using the data processing device, the selected subcutaneous insulin treatment. 1. A method comprising: display, in the graphical user interface, a patient information window, a blood glucose information window, and a meal intake information window;', 'receive, in the patient information window, patient information comprising a weight of the patient;', 'receive, in the blood glucose information window, a blood glucose input for a blood glucose measurement of the patient;', 'obtain a blood glucose time associated with measuring the blood glucose measurement, and', 'receive, in the meal intake information window, a carbohydrate input indicating a number of carbohydrates the patient is about to consume or has begun consuming;, 'executing, by a data processing device, an intravenous treatment program configured to display on a screen in communication with the data processing device a graphical user interface, wherein the intravenous treatment program is configured todetermining, by the data processing device, an insulin infusion rate to administer to the patient based on the weight of the patient, the blood glucose measurement of the patient, and the number of carbohydrates the patient is about to consume or has ...

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters. 1. A method of calculating a single , fused sensor glucose value based on respective glucose measurement signals of a plurality of redundant sensing electrodes , comprising:performing respective electrochemical impedance spectroscopy (EIS) procedures for each of the plurality of redundant sensing electrodes to obtain values of at least one impedance-based parameter for each said sensing electrode;measuring the electrode current (Isig) for each of the plurality of redundant sensing electrodes;calibrating each of the measured Isigs by using a blood glucose (BG) value to obtain respective calibrated sensor glucose values; calculating a first similarity index to determine an amount of divergence between respective Isigs of at least a first one and a second one of said plurality of redundant sensing electrodes;', 'calculating a second similarity index to determine an amount of divergence between respective values of the at least one impedance-based parameter for said at least first one and ...

Device to Determine Volume of Fluid Dispensed

An apparatus for determining the volume of fluid dispensed. The apparatus has an acoustic volume sensor that acoustically excites a reference volume and a measurement chamber with a loudspeaker and measures the acoustic response with microphones acoustically coupled to the reference and the measurement chamber. The loudspeaker and sensing microphones are connected to the measurement chamber by separate ports. A detachable dispensing chamber is coupled to the acoustic volume sensor. The volume of the fluid dispensed is determined by a processor based on the acoustic response of the microphones to acoustic excitement by the loudspeaker.

TIME AVERAGED BASAL RATE OPTIMIZER

Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, a controller module, and optionally a single point glucose monitor are provided. Integration may be manual, semi-automated and/or fully automated. 1. A method for optimizing a basal rate profile for use with continuous insulin therapy , comprising:providing a programmed basal rate profile for insulin therapy, wherein the basal rate profile comprises an insulin delivery schedule that includes one or more blocks of time, and wherein each block of time defines an insulin delivery rate;periodically or intermittently updating the programmed basal rate profile based on a retrospective analysis of continuous glucose sensor data over a predetermined time window; andadjusting the basal rate profile of the updated programmed basal rate profile in response to real time continuous glucose sensor data indicative of actual or impending hyperglycemia or hypoglycemia.2. The method of claim 1 , wherein the programmed basal rate profile is pre-programmed by a patient or healthcare provider.3. The method of claim 1 , wherein the basal rate profile is selected by a user from a list of predetermined basal rate profiles.4. The method of claim 1 , further comprising iteratively repeating the providing and periodically or intermittently updating claim 1 , wherein the programmed basal rate profile is an updated basal rate profile from a previous iteration.5. The method of claim 4 , wherein the previous iteration is from about one day to one week previous to the iteration.6. The method of claim 1 , wherein the basal rate profile consists of a single rate of insulin infusion over 24 hours.7. The method of claim 1 , wherein the basal rate profile comprises a plurality of rates associated with different time blocks spanning 24 hours.8. The method of claim 1 , wherein the retrospective analysis comprises a time-averaging of the continuous glucose sensor data.9. The method of claim ...

Blood Glucose and Insulin Control Systems and Methods

Embodiments of the invention provide a system and method for administering a pharmaceutical to an individual through a dispenser control system. Input data is acquired from an input device coupled to a controller of the dispenser control system. The controller is in communication with the input device and configured to execute a stored program to calibrate pump settings of the dispenser control system based on the acquired input data. The stored program also computes a delivery schedule based on the pump settings for the individual and activates the dispenser control system to deliver at least one dose of the pharmaceutical according to the delivery schedule. The delivery schedule is characterized by a waveform other than a square-wave. 1. A method for administering a pharmaceutical to an individual through a dispenser control system , the method comprising: calibrate pump settings of the dispenser control system based on the acquired input data;', 'compute a delivery schedule based on the pump settings for the individual; and', 'activate the dispenser control system to deliver at least one dose of the pharmaceutical according to the delivery schedule, wherein the delivery schedule is characterized by a waveform other than a square-wave., 'acquiring input data from an input device coupled to a controller, the controller in communication with the input device and configured to execute a stored program to2. The method of wherein the delivery schedule is determined based on a basal rate.3. The method of wherein the delivery schedule is determined based on a carbohydrate ratio.4. The method of wherein the delivery schedule is determined based on an insulin sensitivity.5. The method of wherein the delivery schedule is determined based on a carbohydrate sensitivity.6. The method of wherein the delivery schedule is determined based on carbohydrate ingestion data.7. The method of wherein the delivery schedule is determined based on an amount of insulin delivered to the ...

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters. 16-. (canceled)7. A method for detection of sensitivity loss for a working electrode of a sensor , the method comprising:accessing, by a microprocessor, multiple sets of impedance related data for the working electrode over time, wherein an electrochemical impedance spectroscopy (EIS) procedure is performed to generate the multiple sets of impedance related data, and each of the multiple sets of impedance related data includes data for at least one impedance-related parameter that is substantially glucose-independent;based on multiple sets of impedance related data, calculating, by the microprocessor, real impedance values at 0.105 Hz and voltages at the working electrode;determining, by the microprocessor, based on the real impedance values and voltages over time, that the working electrode is experiencing an oxygen deficiency-led loss of sensitivity based on the real impedance values becoming more positive over time and the voltages reaching a rail voltage; andbased on the ...

TIME AVERAGED BASAL RATE OPTIMIZER

Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, a controller module, and optionally a single point glucose monitor are provided. Integration may be manual, semi-automated and/or fully automated. 1. A method for optimizing a basal rate profile for use with continuous insulin therapy , comprising:providing a programmed basal rate profile for insulin therapy, wherein the basal rate profile comprises an insulin delivery schedule that includes one or more blocks of time, and wherein each block of time defines an insulin delivery rate;periodically or intermittently updating the programmed basal rate profile based on a retrospective analysis of continuous glucose sensor data over a predetermined time window; andadjusting the basal rate profile of the updated programmed basal rate profile in response to real time continuous glucose sensor data indicative of actual or impending hyperglycemia or hypoglycemia.2. The method of claim 1 , wherein the programmed basal rate profile is pre-programmed by a patient or healthcare provider.3. The method of claim 1 , wherein the basal rate profile is selected by a user from a list of predetermined basal rate profiles.4. The method of claim 1 , further comprising iteratively repeating the providing and periodically or intermittently updating claim 1 , wherein the programmed basal rate profile is an updated basal rate profile from a previous iteration.5. The method of claim 4 , wherein the previous iteration is from about one day to one week previous to the iteration.6. The method of claim 1 , wherein the basal rate profile consists of a single rate of insulin infusion over 24 hours.7. The method of claim 1 , wherein the basal rate profile comprises a plurality of rates associated with different time blocks spanning 24 hours.8. The method of claim 1 , wherein the retrospective analysis comprises a time-averaging of the continuous glucose sensor data.9. The method of claim ...

Garment system providing biometric and environmental monitoring for medical condition assessment

A garment (e.g., a shirt) for monitoring biometric properties of the wearer of the garment is disclosed. The garment may include sensors for monitoring or assessing the vital signs and body position of the wearer. A processor associated with the garment may provide an output indicative of an assessed condition of the wearer based on the assessed vital signs and the assessed body position of the wearer of the fabric. The garment may include an injector assembly that is used to administer a drug injection to the wearer when the assessed condition indicates that the wearer is in an alert condition.

Angiogram injections using electrocardiographic synchronization

An injection system is described that receives, from one or more sensors, a first group of one or more signals indicating a current volume of injection fluid dispensed from a fluid reservoir at a first time. The injection system determines, based on the first group of one or more signals, that a difference between a dispensed volume limit and the current volume of the injection fluid dispensed from the fluid reservoir at the first time is less than a necessary volume of fluid required to complete both a systolic injection phase and a diastolic injection phase. The injection system further, responsive to determining that the difference is less than the necessary volume of fluid required to complete both the systolic injection phase and the diastolic injection phase, controls the injection system to refrain from performing each of the systolic injection phase and the diastolic injection phase.

CONTROL MODEL FOR ARTIFICIAL PANCREAS

A multivariate parameter adaptation approach is disclosed for long-term use of an artificial pancreas using a dual-layer control scheme. The adaptation problem, which can be treated as an optimization problem with an unknown objective function and constraints, may be solved by the proposed BO-assisted multivariate optimization approach. Results showed that the algorithm was able to identify the improperly tuned parameters and smoothly adjust them for improved glucose regulation, despite lifestyle disturbances. 1. A system for managing the glucose of a patient , the system comprising:an artificial pancreas comprising a pump configured to deliver insulin into a patient;a memory containing machine readable medium comprising machine executable code having stored thereon;a glucose sensor configured to output glucose readings based on the blood glucose level of the patient;a memory containing machine readable medium comprising machine executable code having stored thereon; periodically update a carbohydrate parameter of a control model based on a set of postprandial glucose readings previously output from the glucose sensor over a first time period;', 'periodically update a basal rate parameter of the control model based on a set of fasting glucose readings previously output from the glucose sensor over a second time period;', 'receive a set of glucose readings output from the glucose sensor;', 'periodically process the set of glucose readings with the control model to determine an amount of insulin to deliver; and', 'send a command to the artificial pancreas to deliver the amount of insulin using the pump., 'a control system coupled to the memory comprising one or more processors, the control system configured to execute the machine executable code to cause the control system to2. The system of claim 1 , wherein the first and second time period is a week claim 1 , two weeks claim 1 , five days claim 1 , or 2 days.3. The system of claim 1 , wherein the basal rate ...

Systems and Methods for Pressure-Facilitated Therapeutic Agent Delivery

A therapeutic agent delivery system includes a catheter, a vascular occluder, a pressure sensor system, and a pump system. The vascular occluder is provided at the distal end of the catheter. The pressure sensor system is provided to sense pressure at the distal end of a catheter lumen, and provides feedback to the pump system. The pump system is adapted to control the rate of infusion of the therapeutic agent through the lumen of the catheter based on the pressure sensed by the pressure sensor system. A method includes deploying the occluder in a vessel, and then sensing a pressure in the vessel. The therapeutic agent is infused into the vessel at a flow rate based on the sensed pressure. 1. A system for delivery of a therapeutic agent into a vessel having a vessel wall , comprising:a) a catheter having a proximal end, a distal end, and a lumen extending between the proximal and distal ends;b) an occluder provided at the distal end of the catheter, the occluder having a non-deployed configuration and a deployed configuration, the occluder having an expanded diameter in the deployed configuration relative to a diameter in the non-deployed configuration, such that when in the deployed configuration the occluder extends across the vessel into contact with the vessel wall;c) a pressure sensor configured to sense a fluid pressure in the vessel on a distal side of the occluder;d) a pump communicating with the pressure sensor, the pump adapted to infuse the therapeutic agent through the lumen of the catheter at multiple flow rates, and wherein the pump is configured to adjust the flow rate of the therapeutic agent through the lumen of catheter based on the fluid pressure sensed by the pressure sensor.2. The system of claim 1 , wherein:the occluder is dynamic such that it automatically moves to change size in response to surrounding fluid pressure conditions such that when higher fluid pressure is exerted on the proximal side of the valve than at the distal side of the ...

METHOD AND APPARATUS FOR ANALYTE MEASUREMENT, DISPLAY, AND ANNOTATION

Systems for rapid and accurate analyte measurement are described. For example, periodic glucose measurements can be achieved with high accuracy in a critical care environment by drawing blood into a device more than once per hour, analyzing blood (for example using infrared radiation through plasma). Safety and accuracy can be achieved by improved fluid control and avoidance of clotting. Data can be conveyed (e.g., displayed) to a user. A user can be allowed to annotate the data. For example, a touchscreen or other interface can allow addition of notes on a running graph of data, indicating events or other items of interest that may correspond to data readings or to particular times. 14.-. (canceled)5. An analyte detection and treatment dosing system comprising:a fluid transport network configured to provide fluid communication with a body fluid in a patient through a patient end;a body fluid analyzer accessible via the fluid transport network, the body fluid analyzer configured to measure a characteristic of at least one analyte in the body fluid;at least one pump system coupled to the fluid transport network, the pump system having a sampling mode in which the pump system is operable to withdraw a sample of bodily fluid from the patient end and transport said sample of bodily fluid toward the body fluid analyzer, and an infusion mode in which the pump system is operable to transport an infusion fluid to the patient;a processor configured to:determine the concentration of the at least one analyte from the measured characteristic; andpredict a value for the concentration of the at least one analyte at a future time; anda user interface configured to display the determined concentration as a graphic icon, a characteristic of the graphic icon being varied based on the predicted value for the concentration of the at least one analyte at a future time.6. The analyte detection system of claim 5 , wherein further comprising a treatment pump is configured to deliver an ...

BLOOD GLUCOSE CONTROL SYSTEM WITH CARBOHYDRATE THERAPY INDICATION

A blood glucose control system can generate an indication of total carbohydrate therapy over a period during use by a subject. The system can be connected to a medicament pump configured to deliver insulin therapy, other types of medicament therapy, or a combination of medicament therapies to the subject. The system can determine an amount of a counter-regulatory agent to respond to an impending risk of hypoglycemia or an episode of hypoglycemia and determine a dose of carbohydrate therapy based at least in part on the amount of the counter-regulatory agent. The system can track determined doses of carbohydrate therapy to generate the indication of total carbohydrate therapy over the period. 120-. (canceled)21. A computer-implemented method of generating an indication of carbohydrate therapy using a glucose level control system configured to generate a dose output for administration of at least insulin therapy to a subject , the computer-implemented method comprising: determining an amount of counter-regulatory agent to respond to an impending risk of hypoglycemia or an episode of hypoglycemia in the subject;', an equivalency between carbohydrates and the counter-regulatory agent;', 'an indication by the subject of an amount of carbohydrates typically consumed in response to impending risks of hypoglycemia or episodes of hypoglycemia;', 'a lookup table comprising relationships between amounts of the counter-regulatory agent and carbohydrate therapy;', 'a carbohydrate characteristic;', 'a carbohydrate type;', 'a clinical comparison of the counter-regulatory agent and carbohydrates;', 'a physiological characteristic of the subject;', 'a counter-regulatory agent type; and', a constant;', 'a counter-regulatory agent characteristic;', 'a characteristic of the subject;', 'a blood glucose level setpoint for the subject;', 'a pharmacokinetic setting of a control system comprising the hardware processor; and', 'a carbohydrate source;, 'a second function, wherein the second ...

SYSTEM AND METHOD FOR MANAGING ADMINISTRATION OF INSULIN TO A USER

A system for managing administration of insulin to a user having: a first subsystem to effect controlled delivery of insulin; a second subsystem to generate an input to the first subsystem to cause insulin delivery; a third subsystem configured to: a) be programmed with a baseline user insulin delivery program; and b) make a calculation of insulin to be delivered according to the baseline insulin delivery program or according to a modified baseline insulin delivery program based upon user input data; and a fourth subsystem configured to receive and process input data related to a user's nutritional intake and communicate the same to the third subsystem which modifies the baseline delivery program. The fourth subsystem has a database of information for a pre-established relationship between each of a plurality of intake items and a parameter. The user provides an input to identify each intake item whereby the related parameters are communicated by inputs to the third subsystem. 1. A system for managing administration of insulin to a user , the system comprising:a first subsystem configured to effect a controlled delivery of insulin from a source to a user;a second subsystem configured to generate an input to the first subsystem to cause the first subsystem to effect insulin delivery;a third subsystem configured to; a) be programmed with a baseline insulin delivery program for a user; and b) make a calculation of insulin to be delivered to the user according to the baseline insulin delivery program or according to a modified baseline insulin delivery program generated in response to user input data; anda fourth subsystem configured to receive and process input data related to a user's nutritional intake and communicate the user input data derived from the user's nutritional intake to the third subsystem for processing by the third subsystem to allow the third subsystem to modify the baseline delivery program and communicate an input to the second subsystem correlated ...

Insulin Management

A method of administering insulin includes receiving blood glucose measurements of a patient at a data processing device from a glucometer. The blood glucose measurements are separated by a time interval. The method also includes receiving patient information at the data processing device and selecting a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments. The selection is based on the blood glucose measurements and the patient information. The selection includes one or more of a subcutaneous standard program, a subcutaneous program without meal boluses, a meal-by-meal subcutaneous program without carbohydrate counting, a meal-by-meal subcutaneous program with carbohydrate counting, and a subcutaneous program for non-diabetic patients. The method also includes executing, using the data processing device, the selected subcutaneous insulin treatment. 1. A system comprising:a glucometer measuring blood glucose measurements separated by a time interval; and receiving blood glucose measurements of a patient from the glucometer;', 'receiving patient information; and', determines a blood glucose type of the received blood glucose measurement; and', {'br': None, 'sub': x', 'x', 'Target, 'CB=(BG−BG)/CF;'}, 'determines a correction insulin dose based on the blood glucose type by calculating], 'selecting a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments based on the blood glucose measurements and the patient information, the selected subcutaneous insulin treatment includes one or more of a subcutaneous standard program, a subcutaneous program without meal boluses, a meal-by-meal subcutaneous program without carbohydrate counting, a meal-by-meal subcutaneous program with carbohydrate counting, and a subcutaneous program for non-diabetic patients, wherein during the standard subcutaneous program, the dosing controller, {'sub': x', 'x', 'Target, 'wherein CBis the correction dose based on blood glucose type X, ...

Adhesive and Peripheral Systems and Methods for Medical Devices

A repeater system may control a pump by using a repeater and a user interface. An adhesive patch system may be used for affixing a pump or other object to a human body. Such an adhesive patch system may include two sets of adhesive members, each member including an adhesive material on at least one side so as to attach to the body. The members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and the members of the second set are spaced to allow members of the first set to detach from the body without detaching the members of the second set. Also, fill stations and base stations are provided for personal pump systems.

METHOD AND SYSTEM FOR VERIFYING WHETHER A NON-MEDICAL CLIENT DEVICE IS OPERATING CORRECTLY WITH A MEDICAL DEVICE CONTROLLED BY THE NON-MEDICAL CLIENT DEVICE AND CAUSING A NOTIFICATION TO BE GENERATED

A method and system are provided for verifying whether a non-medical client device is operating correctly with a medical device controlled by the non-medical client device (NMCD) and causing a notification to be generated. In accordance with the method, an application at the non-medical client device monitors for occurrence of a trigger event and when a trigger event is detected, the application can perform one or more diagnostic checks to verify whether a medical control application at the NMCD is operating correctly. When the application determines that the one or more diagnostic checks have failed, the medical control application can attempt to initiate one or more remedial correction measures to restore the medical control application so that it is operating correctly. When the one or more remedial correction measures were unsuccessful, the application causes the notification to be generated via a user interface of the non-medical client device. 1. A method for verifying whether a non-medical client device is operating correctly with a medical device controlled by the non-medical client device and causing a notification to be generated , the method comprising:monitoring for occurrence of a trigger event via an application at the non-medical client device;performing, via the application at the non-medical client device when the application at the non-medical client device detects occurrence of the trigger event, one or more diagnostic checks to verify whether a medical control application at the non-medical client device is operating correctly;attempting to initiate one or more remedial correction measures to restore the medical control application at the non-medical client device so that it is operating correctly when the application at the non-medical client device determines that the one or more diagnostic checks have failed; andcausing, via the application at the non-medical client device, the notification to be generated via a user interface of the non- ...

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters. 1. A method for real-time detection of sensitivity loss for a working electrode of a sensor , the method comprising:periodically performing an electrochemical impedance spectroscopy (EIS) procedure to generate multiple sets of impedance-related data for said working electrode, wherein each of the multiple sets of impedance-related data includes data for at least one impedance-related parameter that is substantially glucose-independent;for each of said multiple sets of impedance-related data, calculating, by a microprocessor, respective values of 1 kHz imaginary impedance and relatively-higher frequency phase angle;monitoring, by said microprocessor, said respective values over time;based on said monitoring of the respective values, determining, by said microprocessor, when said respective values of relatively-higher frequency phase angle become more negative over time, that said working electrode is experiencing an oxygen deficiency-led loss of sensitivity;based on the determination that ...

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters. 1. A method for real-time detection of sensitivity loss for a working electrode of a sensor having a plurality of redundant working electrodes , the method comprising:periodically performing an electrochemical impedance spectroscopy (EIS) procedure to generate multiple sets of impedance-related data for each of the plurality of redundant working electrodes, wherein each of the multiple sets of impedance-related data includes data for at least one impedance-related parameter that is substantially glucose-independent;for each of said multiple sets of impedance-related data, calculating, by a microprocessor, respective values of relatively-higher frequency phase angle for each said redundant working electrode;monitoring, by said microprocessor, said respective values over time;based on said monitoring of the respective values, determining, by said microprocessor, when said respective values of relatively-higher frequency phase angle become more negative over time for at least one of said ...

Ambulatory medicament device alarm system

Systems and methods relate to an ambulatory medicament device that can generate a dose control signal to cause a medicament pump to infuse medicament into a subject. The system can analyze status to determine whether an alarm condition for the ambulatory medicament device or for a subject is already present in a list of pending alarm conditions. If the alarm is not present, the system can determine a severity level of the alarm condition from among a plurality of severity levels and annunciate the alarm condition using one or more annunciation patterns selected based on the severity level of the alarm condition for the medicament device or for the subject. The system may maintain an indication of the alarm condition on the list of pending alarm conditions until the alarm condition is resolved.

SYSTEMS, METHODS, AND DEVICES ADDRESSING THE GASTRO-INTESTINAL TRACT

Various embodiments disclosed herein relate to an implantable device, systems, and methods related thereto, that includes at least one sensor and/or therapeutic agent delivery depot. In one embodiment, the system and device include means for detecting general or specific biological agents in a subject's intestinal tract, and utilizing the information from the detection for determining the timing and content of any therapeutic treatment needed by the subject. 1. A device , comprising:at least one housing unit with one or more intestinal wall-attachment components;at least one depot including one or more therapeutic or nutraceutical agents;at least one sensor; andat least one switch operably coupled to the one or more intestinal wall-attachment components and configured to detach the device from the intestinal wall upon activation of the switch.2. The device of claim 1 , wherein the at least one housing unit includes at least one of a fluid claim 1 , gel claim 1 , synthetic polymer claim 1 , foam claim 1 , hydrogel claim 1 , suspension claim 1 , sol claim 1 , gel-sol claim 1 , silk claim 1 , microparticle suspension claim 1 , or nanoparticle suspension.3. The device of claim 1 , wherein the at least one housing unit includes at least one anti-inflammatory composition.45.-. (canceled)6. The device of claim 1 , wherein the intestinal wall-attachment component includes at least one of mechanical or chemical means for attachment to the intestinal wall of a subject.7. The device of claim 1 , wherein the intestinal wall-attachment component includes at least one of a screw claim 1 , suture claim 1 , staple claim 1 , clip claim 1 , anchor claim 1 , hook claim 1 , brace claim 1 , reversibly inflatable bladder claim 1 , projection claim 1 , umbrella connector claim 1 , barb claim 1 , latch claim 1 , or adhesive.8. The device of claim 7 , wherein the reversibly inflatable bladder is configured claim 7 , when at least partially inflated claim 7 , to secure the device within a ...

INTELLIGENT PREDICTION-BASED GLUCOSE ALARM DEVICES, SYSTEMS, AND METHODS

Glucose-related alarms may be generated based on glucose predictions, which may be short-to-medium term. The glucose predictions, in turn, may be computed based on a multiplicity of input data sources which may be indicative of the current and future states of the user, as well as the user's infusion pump and overall glucose management system. The input data may include, e.g., meal information, motion/exercise information, insulin information, glucose, and pump- and sensor-related metrics. In addition, the computed glucose predictions may be based on the system's expected insulin-delivery response. The computed glucose predictions inform the determination as to whether, when, and how, to sound a certain glucose alarm, or display a certain glucose alert to the user. 119-. (canceled)20. An insulin infusion pump capable of providing an actionable notification to a user of the insulin infusion pump , the insulin infusion pump being configured to:receive a signal indicative of a glucose level of the user of the insulin infusion pump;generate a predicted glucose profile for the user based on the glucose level and based on meal information, activity information, and insulin information;determine whether the predicted glucose profile is expected to reach an acceptable level within an expected time window, wherein the predicted glucose profile is expected to reach an acceptable level when the user's glucose level is expected to reach a therapy target range within the expected time window;make a determination as to whether a notification should be generated to alert the user when the predicted glucose profile is not expected to reach an acceptable level within the expected time window; andprovide the notification to the user when the notification is generated.21. The insulin infusion pump of claim 20 , comprising a display.22. The insulin infusion pump of claim 21 , wherein the predicted glucose profile is displayed to the user on the display.23. The insulin infusion pump of ...

DETERMINATION AND APPLICATION OF GLUCOSE SENSOR RELIABILITY INDICATOR AND/OR METRIC

Disclosed are a system and method for determining a metric and/or indicator of a reliability of a blood glucose sensor in providing glucose measurements. In one aspect, the metric and/or indicator may be computed based, at least in part, on an observed trend associated with signals generated by the blood glucose sensor. 1. A method comprising:determining an indicator of reliability of a blood glucose sensor, the blood glucose sensor comprising two or more pairs of sensor elements, said indicator of reliability of said blood glucose sensor being based, at least in part, on an observed correlation of output signals generated by at least a first pair of said pairs of sensor elements; andgenerating a signal to suggest replacement of said blood glucose sensor based, at least in part, on said indicator of reliability of said blood glucose sensor.2. The method of claim 1 , wherein said indicator of reliability of said blood glucose sensor is further based claim 1 , at least in part claim 1 , on an additional observed correlation of output signals generated by at least a second pair of said pairs of sensor elements.3. The method of claim 1 , and further comprising displaying an image on a display based claim 1 , at least in part claim 1 , on said indicator of reliability.4. The method of claim 1 , wherein said blood glucose sensor is coupled to an insulin pump as part of a system to provide closed-loop continuous insulin infusion to a patient claim 1 , the method further comprising transitioning said system from closed loop operation to an open loop or manual operation based claim 1 , at least in part claim 1 , on said indicator of reliability.5. The method of claim 1 , and further comprising displaying an indicator requesting additional or more frequent metered blood glucose reference samples for calibration of said blood glucose sensor in response to said indicator of reliability to thereby extend an operating life of said blood glucose sensor.6. The method of claim 1 , ...

METHOD AND APPARATUS TO CONTROL CONDUCTION THROUGH THE HEART TO TREAT CARDIAC CONDITIONS

Control of conduction through a heart is described. A lead with a proximal end and a distal end is provided. The distal end of the lead is inserted into a target area. An agent is delivered through the lead to the target area. Delivery of the agent is monitored via a closed loop feedback system. 121-. (canceled)22. A method of treating atrial fibrillation in a patient , the method comprising:delivering a therapeutic agent directly into AV nodal tissue of the patient in response to a determination of atrial fibrillation to decrease ventricular rate;monitoring an electrical response by the heart to the delivered therapeutic agent via a closed loop system, wherein monitoring the electrical response comprises monitoring AV conduction time; andadjusting a quantity of the therapeutic agent delivered directly to the AV nodal tissue using the closed loop system until a preferred AV conduction time is attained.23. The method of claim 22 , further comprising:determining whether AV conduction time is greater than 100 ms;determining whether AV conduction time is less than 250 ms; andcontinuing to deliver the therapeutic agent directly into AV nodal tissue until preferred AV conduction time is attained if the AV conduction time is greater than 100 ms and less than 250 ms.24. The method of claim 22 , further comprising:determining whether AV conduction time is less than 100 ms; andceasing delivery of the therapeutic agent in response to determining AV conduction time is less than 100 ms.25. The method of claim 24 , further comprising:continuing to monitor AV conduction time upon ceasing delivery of the therapeutic agent in response to determining AV conduction time is less than 100 ms; anddelivering therapeutic agent directly into AV nodal tissue if AV conduction time becomes greater than 100 ms after delivery was previously ceased.26. The method of claim 22 , further comprising:determining whether AV conduction time is greater than 250 ms; anddetermining whether AV block III is ...

Insulin Management

A method of administering insulin includes receiving blood glucose measurements of a patient at a data processing device from a glucometer. The blood glucose measurements are separated by a time interval. The method also includes receiving patient information at the data processing device and selecting a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments. The selection is based on the blood glucose measurements and the patient information. The selection includes one or more of a subcutaneous standard program, a subcutaneous program without meal boluses, a meal-by-meal subcutaneous program without carbohydrate counting, a meal-by-meal subcutaneous program with carbohydrate counting, and a subcutaneous program for non-diabetic patients. The method also includes executing, using the data processing device, the selected subcutaneous insulin treatment. 1. A method comprising:Receiving, at data processing hardware, a blood glucose measurement of a patient from a glucometer;determining, by the data processing hardware, a blood glucose type of the received blood glucose measurement; and obtaining, by the data processing hardware, a Carbohydrate-to-Insulin Ratio for the patient;', 'determining, by the data processing hardware, an adjustment factor based on the received blood glucose measurement;', 'adjusting, by the data processing hardware, the Carbohydrate-to-Insulin Ratio for the patient by dividing the Carbohydrate-to-Insulin Ratio by the adjustment factor;', 'determining, by the data processing hardware, a recommended meal bolus for the determined blood glucose type based on the adjusted Carbohydrate-to-Insulin Ratio; and', a doser; and', 'an administration computing device in communication with the doser, the administration computing device configured to cause the doser to administer a number of units of insulin to the patient using the recommended meal bolus., 'transmitting the recommended meal bolus to an administration device in ...

Measurement device

A measurement device includes a housing to which a biosensor having a reagent is attachable and which is carriable by a user, the reagent selectively responding to a specific analyte in a biological fluid. An analyte measurer measures a concentration of the specific analyte, using the biosensor, a motion measurer measures vibration applied to the housing, as a motion amount, and a living activity calculator calculates a living activity amount based on the measured motion amount. A recorder records the living activity amount output by the living activity calculator and a controller causes the recorder to record the specific analyte concentration measured by the analyte measurer and an event of the living activity, the concentration and the event being associated with each other, the event of the living activity being estimated based on the living activity amount recorded in the recorder.

Modulated Drug Delivery

A method of delivering a therapeutic and/or diagnostic agent to tissue is provided including the steps of inserting a catheter into a bodily cavity, the catheter having a proximal balloon and a distal balloon, inflating the proximal and distal balloons to create a chamber between the proximal and distal balloons, delivering the therapeutic and/or diagnostic agent to the chamber, measuring fluid pressure in the chamber, measuring at least one fluid dynamic characteristic of a subject, and adjusting the delivery of the therapeutic and/or diagnostic agent based at least in part on the measured volumetric pressure in the chamber and the at least one fluid dynamic characteristic of the subject. 1. A method of delivering a therapeutic and/or diagnostic agent to tissue , comprising the steps of:inserting a catheter into a bodily cavity, said catheter comprising a proximal balloon and a distal balloon;inflating the proximal and distal balloons to create a chamber between the proximal and distal balloons;delivering the therapeutic and/or diagnostic agent to said chamber;measuring fluid pressure in said chamber;measuring at least one fluid dynamic characteristic of a subject; andadjusting the delivery of the therapeutic and/or diagnostic agent based at least in part on said measured fluid pressure in said chamber and said at least one fluid dynamic characteristic of the subject.2. The method of claim 1 , wherein said at least one fluid dynamic characteristic of the subject is measured via at least one sensor positioned on the subject.3. The method of claim 1 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of diastolic pressure and systolic pressure.4. The method of claim 1 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of a lymphatic fluid dynamic characteristic claim 1 , a blood dynamic characteristic claim 1 , a cerebrospinal fluid dynamic characteristic claim 1 , an interstitial ...

DATA MODIFICATION FOR PREDICTIVE OPERATIONS AND DEVICES INCORPORATING SAME

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves obtaining a sequence of measurements indicative of a condition of the user that is influenced by the fluid and modifying one or more unusable measurements in the sequence using one or more other usable measurements in the sequence to obtain a modified sequence of measurements. The method continues by determining a predicted value for the condition of the user at a time in the future based at least in part on the modified sequence of measurements and operating the infusion device in a manner that is influenced by the predicted value. 1. A method of operating a device , the method comprising:obtaining a sequence of measurements indicative of a condition of a user;modifying one or more unusable measurements in the sequence using one or more other measurements in the sequence to obtain a modified sequence of measurements;determining a predicted value for the condition based at least in part on the modified sequence of measurements; andoperating the device in a manner that is influenced by the predicted value.2. The method of claim 1 , the device comprising an infusion device capable of delivering fluid to the user claim 1 , the fluid influencing the condition of the user claim 1 , wherein operating the device comprises operating the infusion device in a manner that is influenced by the predicted value.3. The method of claim 2 , the infusion device being capable of delivering insulin to the user claim 2 , wherein:obtaining the sequence of measurements comprises obtaining a sequence of glucose measurements;modifying one or more unusable measurements in the sequence comprises modifying one or more unusable glucose measurements in the sequence using one or more usable glucose measurements in the sequence to obtain a modified sequence of glucose measurements;determining the predicted value comprises ...

SYSTEMS AND METHODS FOR CLOSED-LOOP CONTROL OF INSULIN-GLUCOSE DYNAMICS

The present disclosure provides for systems and methods for maintaining glycemic control of a patient. An exemplary method can provide for first receiving glucose data from at least one sensor in an intraperitoneal space of the patient. The method can then provide for processing the received glucose data at a glucose monitoring system to yield processed data. The method can then provide for instructing, by the glucose monitoring system, an insulin infusion pump. Instructing the insulin infusion pump can be based on a closed-loop PID control algorithm and the processed data. 1. A system for maintaining glycemic control of a patient , comprising:at least one sensor configured to detect glucose in an intraperitoneal space of the patient;an insulin infusion pump configured to inject insulin into the intraperitoneal space; and receive data from the at least one sensor; and', 'send instructions to the insulin infusion pump, wherein the instructions are based on a general control algorithm and the received data., 'a glucose monitoring system, wherein the glucose monitoring system is configured to2. The system of claim 1 , wherein the general control algorithm comprises a closed-loop proportional-integral derivative (PID) algorithm claim 1 , the closed-loop PID control algorithm being an optimization-based transfer function matching method.3. (canceled)4. The system of claim 1 , wherein the general control algorithm comprises a closed-loop proportional-integral derivative (PID) algorithm claim 1 , the closed-loop PID control algorithm being a discrete-time transfer function model.5. The system of claim 4 , wherein the discrete-time transfer function model compensates for steady-state gain contributed by poles of the discrete-time transfer function model.6. The system of claim 4 , wherein the discrete-time transfer function model includes a total daily insulin intake for the patient.7. The system of claim 1 , wherein the general control algorithm comprises a closed-loop ...

DETERMINATION OF ADJUSTMENTS TO FLUID DELIVERY SETTINGS

Disclosed are techniques related to determination of adjustments to fluid delivery settings. The techniques may involve accessing an input meal size category, where the input meal size category is selected from among a plurality of meal size categories via a user interface; accessing a plurality of groups of historical meal events for a person, where each group of the plurality of groups is associated with a respective meal size category of the plurality of meal size categories and includes respective historical meal events for the person categorized in the respective meal size category; identifying a group, in the plurality of groups of historical meal events for the person, having ane associated meal size category that matches the input meal size category; identifying a person-specific carbohydrate amount representative of the historical meal events in the identified group; and determining a bolus dosage value of insulin based on the person-specific carbohydrate amount. 120-. (canceled)21. A device comprising:one or more processors; and{'claim-text': ['accessing an input meal size category, wherein the input meal size category was selected from among a plurality of meal size categories via a user interface;', 'accessing a plurality of groups of historical meal events for a person, wherein each group of the plurality of groups is associated with a respective meal size category of the plurality of meal size categories and includes respective historical meal events for the person categorized in the respective meal size category;', 'identifying a group, in the plurality of groups of historical meal events for the person, having an associated meal size category that matches the input meal size category;', 'identifying a person-specific carbohydrate amount representative of the historical meal events in the identified group;', 'determining a bolus dosage value of insulin based at least in part on the person-specific carbohydrate amount; and', 'causing administration of ...

DRUG DELIVERY SYSTEM WITH SENSOR HAVING OPTIMIZED COMMUNICATION AND INFUSION SITE

A drug delivery system having a drug delivery device and an associated sensor is provided. The sensor can be associated with a sensing site on user. The drug delivery device can be positioned over the sensor in any rotational position and can be associated with an infusion site on the user. The close positioning of the sensor and the drug delivery device allows data from the sensor to be relayed to the drug delivery device and then on to a remote control device. Further, the drug delivery device can be replaced at the end of its duration of use, which is shorter than the duration of use of the sensor, without disturbing the sensor. Subsequent drug delivery devices can then be used with the sensor while allowing each corresponding infusion site to be changed, thereby providing more efficient operation of the drug delivery system. 1. A method , comprising:positioning a sensor on a body of a user;attaching the sensor to the body of a user with a first adhesive component positioned on a bottom surface of the sensor;positioning a drug delivery device over the sensor, the sensor positioned within a central opening of the drug delivery device, the drug delivery device covering all portions of the sensor except the bottom surface of the sensor attached to the user, the drug delivery device including a reservoir configured to store a liquid drug and a drug delivery component configured to extract the liquid drug from the reservoir for delivery to the user;attaching the drug delivery device to the body of the user with a second adhesive component positioned on a bottom surface of the drug delivery device;extending a sensing cannula from a center of the bottom surface of the sensor into the user; andextending an infusion cannula from a periphery of the bottom surface of the drug delivery device, the first infusion cannula spaced a predetermined distance from the sensing cannula.2. The method of claim 1 , wherein positioning the drug delivery device over the sensor further ...

MONITORING A PHYSIOLOGICAL PARAMETER ASSOCIATED WITH TISSUE OF A HOST TO CONFIRM DELIVERY OF MEDICATION

A physiological parameter associated with tissue of a host may be monitored in the tissue to confirm subcutaneous delivery of medication to the host. More particularly, such may involve delivering medication subcutaneously to the host with a medical device which includes a sensor used to measure the physiological parameter, particularly within a predetermined time period after delivery of the medication. Such may also or otherwise involve forming a depot in the tissue with the medication, and using the sensor to measure the physiological parameter while the sensor is at least partially within the depot. 1. A method of treating a host with a medication , the method comprising:providing a medication delivery device which delivers medication into tissue of the host, wherein the medication delivery device includes a sensor operable to measure a physiological parameter associated with the tissue;introducing the medication delivery device including the sensor into the tissue;delivering the medication into the tissue of the host;forming a depot in the tissue with the medication, wherein the depot is disposed between the sensor and the tissue; andconfirming delivery of the medication from the medication delivery device to the host, wherein confirming delivery of the medication comprises using the sensor to measure the physiological parameter of the tissue after a predetermined time period following delivery of the medication.2. The method of further comprising introducing the medication delivery device including the sensor into the tissue such that the tissue is in contact with the sensor.3. The method of wherein the tissue in contact with the sensor comprises extracellular fluid claim 2 , and wherein the depot reduces contact of the extracellular fluid with the sensor.4. The method of wherein the depot reduces contact of the extracellular fluid with the sensor by the depot at least partially surrounding the sensor within the depot.5. The method of wherein the predetermined ...

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters. 1. A method of performing real-time sensor diagnostics on a subcutaneous or implanted sensor of a sensor system , said sensor including at least one working electrode and said sensor system including a microprocessor that is operatively connected to said sensor , the method comprising:(a) periodically performing an electrochemical impedance spectroscopy (EIS) procedure to generate multiple sets of impedance-related data for said at least one working electrode;(b) calculating, by said microprocessor, respective values of a plurality of impedance-related parameters based on said multiple sets of impedance-related data, said plurality of parameters including impedance, phase angle, and Nyquist slope; and (i) performs a first test based on values of real impedance or phase angle;', '(ii) performs a second test based on values of respective frequencies at which successive EIS procedures are performed;', '(iii) performs a third test based on a comparison of current and post-sensor ...

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters. 1. A method of performing real-time sensor diagnostics on a subcutaneous or implanted sensor of a sensor system , said sensor including at least one working electrode and said sensor system including a microprocessor that is operatively connected to said sensor , the method comprising:(a) periodically performing an electrochemical impedance spectroscopy (EIS) procedure to generate multiple sets of impedance-related data for said at least one working electrode;(b) calculating, by said microprocessor, respective values of a plurality of impedance- related parameters based on said multiple sets of impedance-related data, said plurality of parameters including impedance, phase angle, and Nyquist slope; and (i) performs a first test based on values of real impedance or phase angle;', '(ii) performs a second test based on values of respective frequencies at which successive EIS procedures are performed;', '(iii) performs a third test based on a comparison of current and post-sensor ...

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters. 1. A method of performing real-time sensor diagnostics on a subcutaneous or implanted sensor of a sensor system , said sensor including at least one working electrode and said sensor system including a microprocessor that is operatively connected to said sensor , the method comprising:(a) periodically performing an electrochemical impedance spectroscopy (EIS) procedure to generate multiple sets of impedance-related data for said at least one working electrode;(b) calculating, by said microprocessor, respective values of a plurality of impedance-related parameters based on said multiple sets of impedance-related data, said plurality of parameters including impedance, phase angle, and Nyquist slope; and (i) performs a first test based on values of real impedance or phase angle;', '(ii) performs a second test based on values of respective frequencies at which successive EIS procedures are performed;', '(iii) performs a third test based on a comparison of current and post-sensor ...

BLOOD GLUCOSE RATE OF CHANGE MODULATION OF MEAL AND CORRECTION INSULIN BOLUS QUANTITY

Disclosed are a system, methods and computer-readable medium products that provide bolus dosage calculations by a control algorithm-based drug delivery system that provides automatic delivery of a drug, such as insulin or the like, based on sensor input. Blood glucose measurement values may be received at regular time intervals from a sensor. Using the blood glucose measurements, the control algorithm may perform various calculations and determinations to provide an appropriate bolus dosage. The appropriate bolus dosage may be used to respond to a trend in a trajectory of blood glucose measurements. In addition, a bolus dosage may also be determined by the disclosed device, system, method and/or computer-readable medium product in response to an indication that a user consumed a meal. 1. A non-transitory computer readable medium embodied with programming code executable by a processor , and the processor when executing the programming code is operable to perform functions , including functions to:receive a number of blood glucose measurement values over a period of time;calculate a correction bolus dosage based on a latest blood glucose measurement value of the number of blood glucose measurement values;determine a rate of change of blood glucose values from the number of blood glucose measurement values over the period of time;calculate a revised bolus dosage using the determined rate of change and the latest blood glucose measurement value,apply a function to the correction bolus dosage and the revised bolus dosage;determine a final insulin value based on an output from the function;set an insulin bolus dosage using the determined final insulin value; andactuate delivery of insulin according to the set insulin bolus dosage.2. The non-transitory computer readable medium of claim 1 , further embodied with programming code executable by the processor claim 1 , and the processor when executing the programming code is operable to calculate the correction bolus dosage ...

Method And Device For Drug Delivery

Systems, devices and methods for delivery of a chemical substance to the body of the patient are provided. Such embodiments may include an infusion catheter configured to be inserted into tissue, a catheter securing element configured to be adhered to the skin of the patient and further configured to secure the infusion catheter to the skin, a drug delivery pump configured to infuse a drug into the infusion catheter for delivery to a drug infused region on the body of the patient, and a treatment element configured to apply a treatment to the drug infused region to improve pharmacodynamics of the drug during a period of delivery of the drug to the patient.

Application of Electrochemical Impedance Spectroscopy in Sensor Systems, Devices, and Related Methods

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters. 1. A method of calculating a single , fused sensor glucose value based on respective glucose measurement signals of a plurality of redundant sensing electrodes , comprising:performing respective electrochemical impedance spectroscopy (EIS) procedures for each of the plurality of redundant sensing electrodes to obtain values of at least one impedance-based parameter for each said sensing electrode;measuring the electrode current (Isig) for each of the plurality of redundant sensing electrodes;calibrating each of the measured Isigs to obtain respective calibrated sensor glucose values;calculating a plurality of reliability indices for each said sensing electrode based on said values of the at least one impedance-based parameter, said plurality of reliability indices including a dip reliability index and a sensitivity-loss reliability index, wherein said sensitivity-loss reliability index is calculated based on trending of said values of the at least one impedance-based parameter; ...

SYSTEMS AND METHODS FOR TREATING CANCER AND/OR AUGMENTING ORGAN FUNCTION

Systems, methods and devices for controlled sympathectomy procedures for neuromodulation in the treatment of subjects having neoplastic conditions are disclosed. Systems, methods, and devices for interventionally treating a cancerous tumor and cancer related pain are disclosed. 1. A method , comprising:blocking at least one of one or more nerves and one or more lymphatic ducts coupled to at least one of a tumor and a metastatic cell within a body.2. The method of claim 1 , wherein the blocking step isolates at least one of the tumor and the metastatic cell within the body.3. The method of claim 1 , wherein the blocking step alters growth rates of at least one of the tumor and metastatic cell within the body.4. The method of claim 1 , wherein the blocking step is performed by injecting a neurolytic agent into at least one of the one or more nerves claim 1 , the one or more lymphatic ducts claim 1 , and nearby tissue.5. The method of claim 1 , wherein the blocking step further comprises injecting a mild inflammatory agent into at least one of the nerves and the lymphatic ducts.6. The method of claim 1 , wherein at least one of the one or more nerves and the one or more lymphatic ducts being blocked is at least 10 mm claim 1 , 20 mm claim 1 , or 25 mm in length.7. The method of claim 1 , further comprising accessing at least one of the one or more nerves and the one or more lymphatic ducts via one of a nearby artery claim 1 , a vein and a duct.8. The method of claim 1 , wherein the blocking step further comprises altering the structure of a perineural sheath of one or more nerves.9. The method of claim 1 , wherein the blocking step further comprises performing architectural destruction of at least one of nerve tissue and lymphatic ductal tissue via inflammation.10. The method of claim 1 , wherein the blocking step further comprises forming scar tissue along at least one of the one or more nerves and the one or more lymphatic ducts.11. The method of claim 1 , wherein ...

SYSTEMS AND METHODS FOR REGULATING ORGAN AND/OR TUMOR GROWTH RATES, FUNCTION, AND/OR DEVELOPMENT

A system for controlled neuromodulation procedures is disclosed. A system for controlled micro ablation procedures is disclosed. Systems and methods for imaging, monitoring, stimulating, and/or ablating neurological structures coupled to one or more organs of the lower urinary tract (LUT) are disclosed. Such processes may be used to alter the hormonal secretions from one or more organs, to modulate the growth of an organ, alter the growth rate or rate of perineural invasion of a tumor, or the like. In particular such processes may be used to slow, halt and/or reverse the growth of a prostate gland or a prostate tumor. 1. A method , comprising:blocking at least one of one or more nerves and one or more lymphatic ducts coupled to at least one of a tumor and a metastatic cell within a body.2. The method of claim 1 , wherein the blocking step isolates at least one of the tumor and the metastatic cell within the body.3. The method of claim 1 , wherein the blocking step alters growth rates of at least one of the tumor and metastatic cell within the body.4. The method of claim 1 , wherein the blocking step is performed by injecting a neurolytic agent into at least one of the one or more nerves claim 1 , the one or more lymphatic ducts claim 1 , and nearby tissue.5. The method of claim 1 , wherein the blocking step further comprises injecting a mild inflammatory agent into at least one of the nerves and the lymphatic ducts.6. The method of claim 1 , wherein at least one of the one or more nerves and the one or more lymphatic ducts being blocked is at least 10 mm claim 1 , 20 mm claim 1 , or 25 mm in length.7. The method of claim 1 , further comprising accessing at least one of the one or more nerves and the one or more lymphatic ducts via one of a nearby artery claim 1 , a vein and a duct.8. The method of claim 1 , wherein the blocking step further comprises altering the structure of a perineural sheath of one or more nerves.9. The method of claim 1 , wherein the blocking ...

DECISIONS SUPPORT FOR PATIENTS WITH DIABETES

A decision support system includes a measurement device configured to continuously measure a physiological parameter of a patient. An insulin delivery device provides insulin to the patient per an initial basal profile and the parameter measurements. A storage device holds historical data of insulin delivery to the patient. A processor determines deviations of the delivery of insulin from the basal profile for one or more time period(s) using the historical data, computes a respective first basal-profile adjustment for each of the one or more time period(s) using the determined deviations, and annunciates the computed first basal-profile adjustment(s). A method of recommending a basal-rate adjustment includes measuring the parameter, infusing the patient with insulin and storing the historical data, determining the deviations from the basal profile, computing the first basal-profile adjustments, and annunciating the computed first basal-profile adjustment(s). 1. A decision support system for a patient , the system comprising:a) a measurement device configured to continuously measure a physiological parameter of the patient;b) an insulin delivery device configured to provide insulin to the patient according to an initial basal profile and the continuous measurements of the physiological parameter;c) a storage device holding historical data of insulin delivery to the patient by the insulin delivery device; and i) determine deviations of the delivery of insulin from the basal profile for one or more time period(s) using the historical data;', 'ii) compute a respective first basal-profile adjustment for each of the one or more time period(s) using the determined deviations; and', 'iii) annunciate the computed first basal-profile adjustment(s)., 'd) a processor coupled to the storage device, the processor being configured to2. The system according to claim 1 , wherein the one or more time period(s) include a plurality of time periods and the processor is further adapted ...

CORRECTION FACTOR TESTING USING FREQUENT BLOOD GLUCOSE INPUT

An apparatus comprises receiving a user prompt in a blood glucose (BG) management device to start a determination of an effective correction factor, receiving sampled blood glucose data of a patient obtained during a specified time duration, including a time duration after delivery of an initial insulin correction bolus, determining the effective correction factor using the BG management device according to a determined decrease in the blood glucose level of the patient and an amount of insulin in the initial insulin correction bolus, and cancelling the determination of the effective correction factor if a blood glucose level of the patient is outside of a specified range of blood glucose levels. 1. (canceled)2. An ambulatory insulin pump system , comprising:a pump configured to deliver insulin to a user;a user interface including a display;a memory; and receiving sampled glucose level data of the user obtained during a specified time duration;', 'causing the pump to deliver an initial insulin correction bolus to the user during the specified time duration;', 'determining from the sampled glucose level data a decrease in the glucose level of the user during the specified time duration;', 'calculating an effective correction factor for the user based on the decrease in the glucose level and an amount of the initial insulin correction bolus; and', 'saving the effective correction factor in memory., 'a controller in electrical communication with the pump, the memory and the user interface, the controller configured to determine an effective correction factor for the user by conducting a correction factor test, the correction factor test comprising3. The ambulatory insulin pump system of claim 2 , wherein the controller is configured to conduct the correction factor test in response to a prompt from a user received through the user interface.4. The ambulatory insulin pump system of claim 2 , wherein the controller is configured to display information relating to the ...

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters. 120-. (canceled)21. A method of performing sensor diagnostics on a subcutaneous or implanted sensor of a system , the subcutaneous or implanted sensor including at least one working electrode and the system including a microprocessor that is operatively coupled to the subcutaneous or implanted sensor and performs the sensor diagnostics , the method comprising:periodically performing an electrochemical impedance spectroscopy (EIS) procedure to generate multiple sets of impedance-related data for the at least one working electrode, the impedance-related data comprising impedance magnitudes and phase angles;calculating a slope of the impedance magnitudes across a frequency band of the multiple sets of impedance related data;accessing a phase angle of the phase angles of the multiple sets of impedance related data;detecting a pullout of the subcutaneous or implanted sensor based on at least one of: the slope of the impedance magnitudes or the phase angle; andnotifying an alert based on ...

Subcutaneous insertion systems; devices and related methods

Embodiments relate to subcutaneous insertion systems comprising a surface device to be applied to a patient's skin and an insertion system for applying the surface device to the patient, wherein the applying can include subcutaneous insertion of a cannula or other element, and related devices and methods. The surface device comprises a surface for application to the skin of a patient and a subcutaneous element, such as a cannula, wire, filament or other device, extending from the skin's surface at an angle greater than 0 degrees and less than 90 degrees.

Model-Based Personalization Scheme of an Artificial Pancreas for Type I Diabetes Applications

A model-based control scheme consisting of either a proportional-integral-derivative (IMC-PID) controller or a model predictive controller (MPC), with an insulin feedback (IFB) scheme personalized based on a priori subject characteristics and comprising a lower order control-relevant model to obtain PID or MPC controller for artificial pancreas (AP) applications. 1. An insulin pump controller configured with a model-based personalization scheme for an artificial pancreas (AP) system , wherein the controller comprises a discrete control-relevant model with a priori subject information as design criteria , wherein a scaling factor based on the actual value of the subject's basal insulin injection profile is incorporated to attune the controller's action in cases of model and patient mismatch , and an insulin feedback scheme (IFB) , which accelerates the apparent insulin pharmacokinetic profile.2. The controller of wherein the controller is a model predictive control (MPC) feedback controller.3. The controller of wherein the controller is an internal model control (IMC) based design of a proportional-integral-derivative (PID) controller.4. The controller of where a total daily insulin (TDI) clinical parameter is also incorporated to further attune the controller's action in cases of model and patient mismatch.5. The controller of wherein the controller requires only a single tuning parameter to modify controller performance.6. The controller of integrated in an artificial pancreas system further comprising a subcutaneous continuous glucose monitor (CGM) and a continuous subcutaneous insulin injection (CSII) pump to deliver insulin.7. The controller of integrated in an artificial pancreas system further comprising a subcutaneous continuous glucose monitor (CGM) and a continuous subcutaneous insulin injection (CSII) pump to deliver insulin.8. The controller of integrated in an artificial pancreas system further comprising a subcutaneous continuous glucose monitor (CGM) ...

Infusion systems and related personalized bolusing methods

Infusion systems, infusion devices, and related operating methods are provided. A method of operating an infusion device involves determining a reference insulin absorption curve for the patient based at least in part on demographic data associated with the patient, determining a contextual adjustment factor based at least in part on a current patient context, calculating an adjusted insulin absorption curve for the patient as a function of the reference insulin absorption curve and the contextual adjustment factor, and determining a bolus dosage of the insulin based at least in part on the adjusted insulin absorption curve.

SWITCHING BLOOD GLUCOSE CONTROL SYSTEM EXECUTION WITHOUT INTERRUPTION OF THERAPY DELIVERY

Systems and methods are disclosed herein for switching control of an ambulatory medical device from an application executing on the ambulatory medical device to a safe version or a new version of the application without interrupting therapy provided by the ambulatory medical device to a subject. The ambulatory medical device can maintain copies of a safe version and a new version of the application. The disclosed systems and methods can execute the new version, while the prior version of the application continues to execute, determine whether a minimum set of operating conditions are satisfied by the new version, and switch control of the ambulatory medical device from the prior version to the new version. The systems and methods can also automatically revert to the safe version of the application case the current version is malfunctioning without interrupting therapy provided to the subject. 1. A computer-implemented method of updating an application executing on an ambulatory medical device without interrupting therapy provided by the ambulatory medical device to a subject , the computer-implemented method comprising: receiving an indication that an application update comprising an update to a first application executing on the ambulatory medical device is available;', 'establishing a communication connection to a host computing system configured to host a second application comprising the application update;', 'downloading the second application from the host computing system to obtain a downloaded copy of the second application;', 'initiating an installation process of the downloaded copy of the second application without interrupting therapy provided by the ambulatory medical device to the subject;', 'executing the second application while the first application continues to execute;', 'determining that a minimum set of operating conditions are satisfied, wherein the minimum set of operating conditions relate to maintaining therapy provided by the ambulatory ...

METHODS AND DEVICES FOR THE DIAGNOSIS AND TREATMENT OF DIABETES

Methods and devices for the diagnosis and treatment of diabetes are disclosed in which an analyte concentration within a peritoneal fluid of a human subject may be determined by implanting an analyte sensor apparatus in the subject where the apparatus may comprise a housing and a flexible sensing catheter which has a lumen with a plurality of apertures and an exterior surface with an analyte sensor affixed thereto. The catheter may comprise a proximal end attached to the housing and the remaining end may be positioned freely within the peritoneal space to contact peritoneal fluid where an analyte concentration in the peritoneal fluid may be sensed. The housing may be anchored at a subcutaneous site proximate the peritoneal space. The sensed analyte concentration may then be transduced into a transmittable electrical signal. 12.-. (canceled)3. A method of infusing insulin within a human subject , comprising:inserting a flexible catheter into a peritoneum by positioning the catheter within a peritoneal space and tunneling a proximate end through a subcutaneous space, the catheter comprising a lumen and being fluidly attached to a pump located externally of the subject;positioning the pump along an external surface of the subject, wherein the catheter is reversibly attached to the pump; andinfusing insulin from the pump, subcutaneously through the catheter, and into the peritoneal space.4. The method of wherein inserting a flexible catheter comprises anchoring the catheter using tissue in-growth cuffs attached to an exterior surface of the catheter to a tissue site within an abdominal wall of the subject.5. The method of wherein positioning the catheter within the peritoneal space comprises positioning the catheter within a true pelvis.6. The method of further comprising flushing the lumen of the catheter with a fluid.7. The method of wherein flushing the lumen of the catheter with a fluid occurs intermittently.8. The method of wherein flushing the lumen of the ...

DEVICE AND METHODS FOR TRANSVASCULAR TUMOR EMBOLIZATION

A method of embolizing a tumor includes advancing a distal end of a device having a catheter body and an occlusion structure to a target tumor site within a blood vessel of a body. The occlusion structure is activated within the blood vessel, and a real time pressure measurement in the vascular space distal to the activated occlusion structure is monitored. The method further includes waiting for a pressure drop in the vascular space distal to the activated occlusion structure and for the pressure drop to cause a blood flow reversal in branch vessels antegrade to the occlusion. An embolic substance is injected from the distal end of the delivery device to permit the reversed blood flow to carry the embolic substance into the vasculature of the target tumor and the device is withdrawn from the body. Other catheter assemblies and methods of use are also disclosed. 1. A method of embolizing a tumor , the method comprising:advancing a distal end of a device including a catheter body and an occlusion structure to a target tumor site within a blood vessel of a body;activating the occlusion structure within the blood vessel;monitoring a real time pressure measurement in the vascular space distal to the activated occlusion structure;waiting for a pressure drop in a vascular space distal to the activated occlusion structure and for the pressure drop to cause a blood flow reversal in branch vessels antegrade to the occlusion;injecting an embolic substance from the distal end of the delivery device to permit the reversed blood flow to carry the embolic substance into the vasculature of the target tumor; andwithdrawing the device from the body.2. The method of claim 1 , further comprising a step of signaling a procedural endpoint based on the monitoring of the pressure measurement.3. The method of claim 2 , wherein the signaling of the procedural endpoint occurs when a predetermined pressure is reached in the vascular space distal to the activated occlusion structure.4. The ...

CARRIER APPARATUS TO DELIVER A SUBSTANCE AND METHODS THEREOF

Systems, apparatuses, kits, and methods may provide a substance. A carrier apparatus may include a reservoir to hold a payload, a sensor to detect a target in a subject and generate data corresponding to the target, a processor to allow the payload to be accessible from the reservoir based on the data, and/or a biocompatible carrier composition to hold the reservoir, the sensor, and/or the processor. The reservoir may include a placebo reservoir, a medication reservoir, a diagnostic reservoir, and/or a modification reservoir. The payload may be made available based on a diagnosis, a detection of a target in a body, a level of the target in the body, and/or a context in which the carrier apparatus is deployed. The carrier apparatus may also include a wireless rechargeable battery to power a component of the carrier apparatus. The carrier apparatus may provide diagnostic and/or therapeutic functionality. 1. A carrier apparatus to deliver a substance comprising:a reservoir to hold a payload;a sensor to detect a target in a subject and generate data corresponding to the target;a processor to allow the payload to be accessible from the reservoir based on the data; anda biocompatible carrier composition to hold the reservoir, the sensor, and the processor.2. The carrier apparatus of claim 1 , further including a ligand functionalizing one or more of an internal portion of the carrier apparatus or an external portion of the carrier apparatus which when coupled is to allow the sensor to detect the target.3. The carrier apparatus of claim 1 , further including a pump to one or more of couple a sample with the sensor or make available the payload from the reservoir.4. The carrier apparatus of claim 1 , further including a wireless rechargeable battery to power one or more components of the carrier apparatus.5. The carrier apparatus of claim 1 , wherein the processor is to:evaluate an amount of target; andallow an amount at least of medication payload to be released ...

Ambulatory medical device data access management via wireless wide area network

Systems and methods presented herein relate to managing ambulatory medical device data access. A computing system of a networked computing environment can establish a direct end-to-end data connection to an ambulatory medical device via a wireless wide area network. A public key of the computing system may be transmitted to the ambulatory medical device permitting the ambulatory medical device to encrypt data to be transmitted to the computing system. The computing system may receive, via the direct end-to-end data connection, encrypted data from the ambulatory medical device, and upon decrypting the data can generate a therapy report based at least in part on the therapy data. This therapy report may include time-series therapy data relating to the therapy delivered by the ambulatory medical device over a particular time period. The computing system can restrict access to the therapy report to authorized users.

METHOD FOR RELEASING A SUBSTANCE INTO A SUBJECT USING AN INSERTION ARRANGEMENT (as amended)

An exemplary tissue detection and location identification apparatus can include, for example, a first electrically conductive layer at least partially (e.g., circumferentially) surrounding a lumen, an insulating layer at least partially (e.g., circumferentially) surrounding the first electrically conductive layer, and a second electrically conductive layer circumferentially surrounding the insulating layer, where the insulating layer can electrically isolate the First electrically conductive layer from the second electrically conductive layer. A further insulating layer can be included which can at least partially surrounding the second electrically conductive layer. The first electrically conductive layer, the insulating layer, and the second electrically conductive layer can form a structure which has a first side and a second side disposed opposite to the first side with respect to the lumen, where the first side can be longer than the second side thereby forming a sharp pointed end via the first side at a distal-most portion. The exemplary configuration can be used for (a) determination/detection of a tissue type using impendence of the electrically conductive layers, and/or (ii) determination of a location of at least one portion or the insertion device/apparatus. Another exemplary apparatus can include, for example, a base structure comprising a lumen extending along a length thereof, and at least one optically-transmissive layer circumferentially surrounding the base structure and provided at least at a distal end of the base structure. For example, in operation, the optically-transmissive layer can be configured to transmit a particular optical radiation at the distal end thereof toward a target tissue.

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

USER-MOUNTABLE ELECTRONIC DEVICE WITH ACCELEROMETER-BASED ACTIVATION FEATURE

A user-mountable electronic device includes a housing, an accelerometer located within the housing, and at least one processor located within the housing. The accelerometer measures acceleration of the user-mountable electronic device and is configured to generate an output in response to detecting acceleration of the user-mountable electronic device that is greater than a minimum acceleration threshold. The at least one processor controls operation of the user-mountable electronic device. The at least one processor is configured to receive the output generated by the accelerometer and, in response thereto, to transition from a dormant or standby state of the user-mountable electronic device to an active state of the user-mountable electronic device.

METHOD AND SYSTEM FOR CONTROLLING A TUNING FACTOR DUE TO SENSOR REPLACEMENT FOR CLOSED-LOOP CONTROLLER IN AN ARTIFICIAL PANCREAS

Described and illustrated is a system for management of diabetes that includes an infusion pump, glucose sensor and controller with a method programmed in the controller. The infusion pump is configured to deliver insulin. The glucose sensor senses glucose levels in the subject and provide output signals representative of the glucose levels in the subject. The controller is programmed receives signals from at least one of the glucose sensor and the pump and configured to issue signals to the pump to deliver an amount of insulin determined by a feedback controller that utilizes a model predictive control based on desired glucose levels, insulin amount delivered and measured glucose levels of the subject. The controller is also configured to deliver insulin using a tuning factor (R) for a model predictive controller in the microcontroller as a conservative setting otherwise the system maintains a current tuning factor (R) for the controller. 1. A method to control an infusion pump with a microcontroller to control the pump and receive data from at least one glucose sensor , the method comprising:measuring glucose level in the subject from the glucose sensor to provide at least one glucose measurement in each time interval in a series of discrete time intervals;determining whether the glucose sensor has been replaced by a new glucose sensor within a predetermined time interval;if the determining step is true, setting a tuning factor (R) for a model predictive controller in the microcontroller as a conservative setting otherwise if the determining step is false, maintaining a current tuning factor (R) for the controller;calculating an insulin amount for delivery by the microcontroller based on a model predictive controller that utilizes the tuning factor (R) so as to provide a calculated insulin amount to be delivered to the subject for one or more of the discrete time intervals; anddelivering via actuation of a pump by the microcontroller of the insulin amount ...

DEVICE FOR SUBCUTANEOUS DELIVERY OF FLUID MEDICAMENT

An improved device delivers a fluid medicament to the subcutaneous tissue of a user. The device is better suited for patients with Parkinson's Disease and other central nervous system disorders, than conventional infusion devices. The device can include a reusable part including a drive component (e.g., motor) and control electronics and a disposable part including a medicament reservoir. Medicament can be evacuated from the medicament reservoir by a plunger assembly that includes a plunger attached to a lead screw that is rotated by a nut, all within the disposable part. The device can be fluidically coupled with the tissue via a flexible cannula. Various embodiments relate to an improved cannula insertion mechanism that delivers the cannula under a force applied by a spring. Various embodiments relate to improved filling of the device, for example, using a vial adapter and an automated filling station. 1. A device for delivering a fluid medicament into or through the skin of a user , the device comprising: a drive component; and', 'a control unit for controlling the drive component; and, 'a reusable part comprising a first reservoir for containing the fluid medicament, wherein the first reservoir comprises a first bushing;', 'a first plunger head moveable by a first lead screw in the first reservoir; and', 'a first nut concentrically secured by and rotatable in the first bushing, the first nut threadedly engaged with a thread of the first lead screw, wherein when the reusable part and the disposable part are attached, the first nut is operably coupled with and rotatable by the drive component in a direction controllable by the control unit, and wherein the first nut is configured, upon rotation of the first nut in the first bushing, to linearly displace the first lead screw in a direction dependent on a rotation direction of the first nut., 'a disposable part engageable with the reusable part, the disposable part comprising2216.-. (canceled)217. The device of ...

METHOD AND DEVICE FOR INTRODUCING AT LEAST ONE QUANTITATIVELY DETERMINED EXOGENOUS SUBSTANCE INTO AN ENDOGENOUS LIQUID

The present invention relates to a device for recognising, measuring and quantitatively determining at least one exogenous substance in an endogenous liquid. According to the invention, the device comprises: —a means for suctioning () an endogenous liquid containing at least one exogenous substance; —a means for collecting () the endogenous liquid containing at least one exogenous substance; —a spectrometer (), preferably a Raman or infrared spectrometer, capable of acquiring and analysing said collected liquid; —a database-type data storage means comprising spectra relating to at least one exogenous substance; —a means for comparison between the spectrum or spectra acquired and the spectrum or spectra of the database; —a means () for controlled introduction of at least one exogenous substance into the endogenous liquid, as a function of the result of said comparison. The invention also relates to the method implemented by such a device. 110.-. (canceled)11. A device for recognizing , measuring and dosing at least one exogenous substance into an endogenous liquid , comprising:a means for suction of an endogenous liquid containing at least one exogenous substance;a collector for the endogenous liquid;a spectrometer configured to acquire and analyze the collected endogenous liquid;a processor containing a database comprising spectra relating to at least one exogenous substance and configured to compare spectrum or spectra acquired by the spectrometer and the spectrum or spectra in the database;at least one pump for controlled introduction of at least one exogenous substance into the endogenous liquid, as a function of the result of the spectral comparison.121. The device according to claim , wherein the spectrometer is a Raman or infrared spectrometer.131. The device according to claim further comprising a display of a measurement of , a dose of , a nature of at least one exogenous substance contained in the endogenous liquid.141. The device according to claim wherein ...

SYSTEM FOR PREDICTING A PATIENT'S BLOOD GLUCOSE LEVEL

An automated blood glucose control system, including a processing and control unit capable of predicting, based on a mathematical model, the future trend of the patient's blood glucose G(t), wherein the model takes as inputs: a variable EE(t) representative of the time variation of the patient's energy expenditure; variable IOB(t) representative of the time variation of the patient's quantity of insulin on board; and a variable COB(t) representative of the time variation of the patient's quantity of glucose on board, and wherein the mathematical model is a model of black box type, that is, a non-physiological model only defined by the observation of the effects of input variables EE(t), IOB(t) and COB(t) on output variable G(t), without taking into account the different known physiological mechanisms operating in the patient's body. 1. An automated system for controlling a patient's blood glucose , comprising a processing and control unit capable of predicting , based on a first mathematical model , the future trend of the patient's blood glucose G(t) over a prediction period , wherein the first model takes as inputs:a variable EE(t) representative of the time variation of the patient's energy expenditure;a variable IOB(t) representative of the time variation of the patient's quantity of insulin on board; anda variable COB(t) representative of the time variation of the patient's quantity of carbohydrate on board,and wherein the first mathematical model is a model of black box type, that is, a non-physiological model only defined by the observation of the effects of input variables EE(t), IOB(t) and COB(t) on output variable G(t), without taking into account the different known physiological mechanisms operating in the patient's body, [{'br': None, 'i': t', 'I', 't−k', 'h', 'k, 'sub': k=0', 'IOB, 'sup': 'K', 'IOB()=Σ()*(), and'}, {'br': None, 'i': t', 'CHO', 't−k', 'h', 'k, 'sub': k=0', 'COB, 'sup': 'K', 'COB()=Σ()*(),'}], 'wherein, in operation, the control and ...

SINGLE-SITE INSERTION OF MULTIPLE MEDICAL DEVICES

In some embodiments, an apparatus may comprise a first insertion needle and a second insertion needle. The first insertion needle may be configured to carry a first medical device (e.g., a sensor) through an opening in an apparatus housing. The second insertion needle may be configured to carry a second medical device (e.g., a cannula) along a curved path that passes through the opening in the apparatus housing such that a distal end of the first medical device becomes increasingly displaced from the distal end of the second medical device as the distal end of the second medical device is carried along the curved path. 1. An apparatus comprising:a first insertion needle configured to carry a distal end of a first medical device along a curved path that passes through an opening in the apparatus housing; anda second insertion needle configured to carry a distal end of a second medical device through the opening in the apparatus housing,wherein the first insertion needle carries the distal end of the first medical device such that the distal end of the first medical device becomes increasingly displaced from the distal end of the second medical device as the distal end of the first medical device is carried along the curved path.2. The apparatus of claim 1 , wherein the first medical device is a fluid delivery conduit and the second medical device is an analyte sensor.3. The apparatus of claim 2 , wherein the fluid delivery conduit is a cannula.4. The apparatus of claim 1 , wherein the second insertion needle is configured to releasably carry the second medical device based on accommodating the second medical device within the second insertion needle.5. The apparatus of claim 1 , wherein the first insertion needle is configured to releasably carry the first medical device based on being at least partially inserted within a lumen defined by the first medical device.6. The apparatus of claim 1 , wherein the first insertion needle is configured to release the first ...

MONITORING A PHYSIOLOGICAL PARAMETER ASSOCIATED WITH TISSUE OF A HOST TO CONFIRM DELIVERY OF MEDICATION

A physiological parameter associated with tissue of a host may be monitored in the tissue to confirm subcutaneous delivery of medication to the host. More particularly, such may involve delivering medication subcutaneously to the host with a medical device which includes a sensor used to measure the physiological parameter, particularly within a predetermined time period after delivery of the medication. Such may also or otherwise involve forming a depot in the tissue with the medication, and using the sensor to measure the physiological parameter while the sensor is at least partially within the depot. 2. The fluid delivery device of claim 1 , further comprising a monitor test strip disposed within the second lumen claim 1 , wherein the sensor is coupled to the monitor test strip.3. The fluid delivery device of claim 1 , further comprising a second opening through the sidewall of the cannula claim 1 , the second opening providing access to a second sensor within the second lumen.4. The fluid delivery device of claim 3 , wherein the opening and the second opening are positioned axially adjacent one another.5. The fluid delivery device of claim 3 , the cannula comprising a proximal end opposite a distal tip claim 3 , wherein the opening is positioned closer to the distal tip than the second opening.6. The fluid delivery device of claim 1 , further comprising a transcutaneous access tool insertion mechanism for deploying the transcutaneous access tool.7. The fluid delivery device of claim 1 , further comprising a fluid drive mechanism for driving the fluid out of the reservoir.8. The fluid delivery device of claim 1 , wherein the sensor is a glucose sensor.9. The fluid delivery device of claim 1 , wherein the first lumen has a circular profile claim 1 , and wherein the second lumen has a rectangular profile.10. A transcutaneous access tool claim 1 , comprising:a needle within a first lumen of a cannula, the needle operable to deliver a fluid from a reservoir to a ...

APPLICATION OF ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY IN SENSOR SYSTEMS, DEVICES, AND RELATED METHODS

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters. 1. A method for real-time detection of a signal dip for a working electrode of a glucose sensor , the method comprising:periodically performing an electrochemical impedance spectroscopy (EIS) procedure to obtain values of real impedance for said electrode;monitoring, by a microprocessor, said values of real impedance over time;based on said monitoring of said values of real impedance, determining, by said microprocessor, whether a dip exists in the signal generated by said working electrode; andbased on the determination that a dip exists in said signal, determining, by said microprocessor, that said working electrode is unreliable for measuring glucose.2. The method of claim 1 , wherein said EIS procedure is performed for a predetermined range of frequencies.3. The method of claim 1 , wherein said values of real impedance are obtained for a range of frequencies where real impedance for the working electrode is substantially glucose-independent.4. The method of claim 3 , wherein said ...

SYSTEMS AND METHODS FOR FLOW STAGNATION CONTROL

The present disclosure describes flow stagnation control components that allow improved flow control in systems including injection members, while also limiting the creation of regions of little to no flow in the vasculature, resulting in low flow zones or dead zones. The flow stagnation control components can be formed as an imposed minimum conductance component or a controlled flow partitioning system. 1. A system comprising: a flow port for returning blood from the extracorporeal circuit to a vasculature of a region of a body; and', 'at least one injector member comprising a lumen, the at least one injector member being configured to cause blood to flow at a vascular injection point; and, 'an extracorporeal circuit comprisingan imposed minimum conductance component disposed proximate to a distal tip of the at least one injector member.2. The system of claim 1 , wherein the extracorporeal circuit is configured such that fluid is injected at the at least one injector member at a flow rate that causes fluid to flow through the imposed minimum conductance component to flush the proximal vasculature either constantly or regularly.3. The system of claim 1 , wherein the imposed minimum conductance component comprises a balloon.4. The system of claim 1 , wherein the imposed minimum conductance component comprises at least one of an atraumatic surface claim 1 , a hydrophilic coating claim 1 , or a drug coating.5. The system of claim 1 , wherein the imposed minimum conductance component comprises a biased valve claim 1 , a discrete lumen claim 1 , or a spring driven membrane having at least one opening formed therethrough.6. The system of claim 1 , wherein the imposed minimum conductance component comprises one or more biased valves coupled to a port of a lumen.7. The system of claim 6 , wherein the one or more biased valves are configured to maintain the blood flow at a fixed or averaged value that is equal to a predetermined minimum flow rate such that a region of the ...

DEVICES AND METHODS FOR LOW PRESSURE TUMOR EMBOLIZATION

A method of transarterial embolization agent delivery at a low pressure is provided. The method comprises advancing a delivery device with an occlusion structure in a retracted non-occlusive configuration through a supply artery to a vascular position in the supply artery that is in the vicinity of a target anatomical structure, the target structure having terminal capillary beds, expanding the occlusion structure from the retracted non-occlusive configuration to an expanded occlusive configuration, lowering a mean arterial pressure in a vascular space distal to the expanded occlusion structure, redirecting fluid flow from the collateral vessels toward the lowered pressure vascular space and into the target anatomical structure, injecting an embolization agent through the delivery device and into the lowered pressure vascular space, and delivering the embolization agent from the lowered pressure vascular space into the target anatomical structure. Other catheter assemblies and methods of use are also disclosed. 1. A method of transarterial embolization agent delivery at a low pressure , the method comprising:advancing a delivery device with an occlusion structure in a retracted non-occlusive configuration, through a supply artery having a plurality of collateral vessels that branch therefrom and being in fluid communication with a target anatomical structure, to a vascular position in the supply artery that is in the vicinity of the target anatomical structure, the target structure having terminal capillary beds;expanding the occlusion structure from the retracted non-occlusive configuration to an expanded occlusive configuration;lowering a mean arterial pressure in a vascular space distal to the expanded occlusion structure;redirecting fluid flow from the collateral vessels toward the lowered pressure vascular space and into the target anatomical structure such that a fluid flow direction is reversed in at least some of the collateral vessels;injecting an ...

REMOTE ANALYTE MONITORING AND INSULIN DELIVERY SYSTEM

In one aspect, an analyte monitoring and insulin delivery system is provided. The system may include an analyte sensor configured to convey sensor data indicative of a measurement of one or more detectable properties based on an amount or concentration of an analyte. The system may include a transceiver configured to receive the sensor data and calculate an analyte level based on the sensor data. The system may include a display device configured to receive calculate an adjusted insulin delivery rate for an insulin pump and display the received analyte level and/or the adjusted insulin delivery rate. The system may include the insulin pump configured to increase, decrease or maintain a first insulin delivery rate based on the adjusted insulin delivery rate. The display device may further display icons corresponding to the system components and an operational status indicator for each icon. 1. An analyte monitoring and insulin delivery system comprising:an analyte sensor including an analyte indicator that produces one or more detectable properties based on an amount or concentration of an analyte in proximity to the analyte indicator, wherein the analyte sensor is configured to convey sensor data indicative of a measurement of one or more of the detectable properties; receive the sensor data conveyed from the analyte sensor,', 'calculate an analyte level using at least the received sensor data, and', 'convey the analyte level;, 'a transceiver configured toan insulin pump; and receive the analyte level conveyed from the transceiver,', 'calculate, based at least on the received analyte level, an adjusted delivery rate for the insulin pump,', 'convey the adjusted delivery rate to the insulin pump,', 'display, via a user interface, a first display comprising the received analyte level and the adjusted delivery rate, and', 'display, via the user interface, a second display comprising: (i) a sensor icon and a sensor status indicator indicating an operational status of the ...

TECHNIQUES FOR OPTIMIZING USAGE OF AN AUTOMATIC DRUG DELIVERY SYSTEM

The provided examples of systems, devices and techniques improve systems and methods for keeping users of automatic drug delivery systems engaged and assisting with the optimal use of the drug delivery system. The automatic drug delivery system may include a drug delivery device and a controller. Through the use of an attrition prevention engine in a cloud-based services system that cooperates with an attrition prevention application executing on the controller of the drug delivery device, notifications that include instructions for adjusting operation of the drug delivery device as well as offer assistance to the patient to optimize performance of the drug delivery system for the patient may be provided. Optimizing the performance of the drug delivery system has been shown to prevent attrition of patients from using the drug delivery system. 1. A treatment plan management system , comprising:a drug delivery device operable to expel a drug according to a programmed drug treatment plan;an analyte sensor operable to measure analytes in blood of a patient and output signals related to analyte measurement values of the measured analytes;a controller operable to provide control commands to the drug delivery device, receive inputs from the drug delivery device and the analyte sensor, and execute an attrition prevention application; and receive status signals from the controller;', 'compare the received status signals to status signals stored in the data storage;', 'based on a result of the comparing, generate a notification indicating a response to be generated by the attrition prevention engine; and', 'forward the notification to the attrition prevention application for implementation of the response., 'a server communicatively coupled with the controller and a data storage and operable to execute an attrition prevention engine, wherein the server executing the attrition prevention engine is operable to2. The system of claim 1 , wherein the received status signals ...

METHODS AND SYSTEMS FOR IMPROVING THE RELIABILITY OF ORTHOGONALLY REDUNDANT SENSORS

Methods and systems for sensor calibration and sensor glucose (SG) fusion are used advantageously to improve the accuracy and reliability of orthogonally redundant glucose sensor devices, which may include optical and electrochemical glucose sensors. Calibration for both sensors may be achieved via fixed-offset and/or dynamic regression methodologies, depending, e.g., on sensor stability and Isig-Ratio pair correlation. For SG fusion, respective integrity checks may be performed for SG values from the optical and electrochemical sensors, and the SG values calibrated if the integrity checks are passed. Integrity checks may include checking for sensitivity loss, noise, and drift. If the integrity checks are failed, in-line sensor mapping between the electrochemical and optical sensors may be performed prior to calibration. The electrochemical and optical SG values may be weighted (as a function of the respective sensor's overall reliability index (RI)) and the weighted SGs combined to obtain a single, fused SG value. 1. A method of calibrating an orthogonally redundant sensor device for determining a concentration of glucose in a body of a user , the method comprising:receiving a first signal from a electrochemical glucose sensor;receiving a second signal from a optical glucose sensor;determining whether the first signal can be calibrated and whether the second signal can be calibrated; and using the second signal to correct said first signal and generate a corrected first signal;', 'calibrating the corrected first signal to generate an electrochemical sensor glucose (SG) value;', 'calibrating said second signal to generate an optical sensor glucose (SG) value; and', 'fusing said electrochemical SG value and said optical SG value to obtain a single, fused sensor glucose value for the orthogonally redundant sensor device., 'in response to determining that the first signal cannot be calibrated and that the second signal can be calibrated2. The method of claim 1 , ...

SINGLE NEEDLE INTEGRATED ARTIFICIAL PANCREAS

Disclosed is a single needle integrated artificial pancreas, wherein the single needle integrated artificial pancreas comprises a fluid reservoir unit; a fluid driving unit connected to the drug reservoir unit; an indwelling unit connected to the fluid reservoir unit and comprising a glucose sensor, an insulin indwelling cannula, a puncture needle and an inserter; wherein the glucose sensor and the indwelling cannula are simultaneously implanted in the same subcutaneous tissue in a patient via the inserter under the aid of the puncture needle; and the puncture needle is a steel puncture needle or groove puncture needle; and a glucose monitoring and insulin delivery control unit is respectively connected to the fluid reservoir unit, the fluid driving unit and the indwelling unit. The single needle integrated artificial pancreas reduces the chance of a diabetic patient being infected and is simple in installation and convenient to use.

Pumping fluid delivery systems and methods using force application assembly

A method of dispensing a therapeutic fluid from a line includes providing an inlet line connectable to an upstream fluid source. The inlet line is in downstream fluid communication with a pumping chamber. The pumping chamber has a pump outlet. The method also includes actuating a force application assembly so as to restrict retrograde flow of fluid through the inlet while pressurizing the pumping chamber to urge flow through the pump outlet. A corresponding system employs the method.

Remote closed-loop titration of decongestive therapy for the treatment of advanced heart failure

An apparatus comprises one or more physiological sensing circuits that generate a sensed physiological signal and at least one of the physiological sensing circuits is implantable, a measurement circuit configured to recurrently measure one or more physiological parameters that indicate a status of heart failure of the subject, a comparison circuit configured to compare the one or more physiological parameter measurements to one or more physiological parameter target values, a therapy circuit configured to control delivery of one or more drugs to treat heart failure, and a control circuit in electrical communication with the comparison circuit and the therapy circuit and configured to recurrently adjust delivery of drug therapy according to the comparison of the measured physiological parameters to the physiological parameter targets.

Recovering analytes by reverse plasmaporation

A subject's skin is exposed to non-thermal plasma, thereby enabling analytes in the interstitial fluid in the subject's body to migrate to the surface of the subject's skin. The concentration of analytes in the subject's blood can be determined based on the amount of these analytes.

LOW PROFILE INFUSION PUMP WITH ANTI DRUG DIVERSION AND ACTIVE FEEDBACK MECHANISMS

A low profile and volumetrically efficient medication delivery device configured to be placed on the body of a patient during fluid delivery to the patient is provided. The device incorporates a low profile actuator assembly that causes fluid delivery by displacing a collapsible reservoir in response to receiving an electrical current or charge input from a programmable controller and a power supply. Additional components help prevent drug theft or abuse, measure actuator pressure, displacement and temperature in real time providing active feedback to the controller that is controlling the actuator. The device also has wireless communication capabilities. 143-. (canceled)44. A low profile medication delivery device comprising:a chassis having an internal fluid reservoir and internal pump mechanism for pumping fluid from an internal fluid reservoir,wherein the internal reservoir has a fluid inlet accessible from an exterior of the chassis for filling the internal fluid reservoir, and an inlet valve in fluid connectivity between the inlet and the reservoir; anda fluid outlet exiting the chassis, and one or more exit valves in fluid connectivity between the reservoir and the fluid outlet.45. The device of claim 44 , wherein the inlet comprises a rigid inlet fluid channel with one or more bends of at least 90° claim 44 , and/or wherein the inlet valve comprises an one way anti siphon valve.46. The device of claim 44 , wherein the inlet is covered by a septum that can be pierced claim 44 ,and the septum is held in place by a rigid housing with an internal fluid channel in fluid connectivity with the inlet valve.47. The device of claim 44 , wherein the fluid outlet comprises a rigid fluid channel with one or more bends sufficient to impede access by a needle claim 44 , preferably totaling at least 90° in fluid connectivity between the reservoir and the outlet valve claim 44 , and optionally further comprising a second collapsible tube valve between the reservoir and the ...

Pulmonary Embolism Apparatus

An apparatus and methods for use are provided, where the apparatus includes: (a) a first catheter having a proximal end and a distal end, and wherein a distal portion of the first catheter includes a first one or more outlets, (b) a first tubular housing having a proximal end and a distal end, wherein the first tubular housing is coupled to the first catheter proximal to the at least one first outlet, (c) one or more pressure sensors coupled to the distal end of the first tubular housing, and (d) a second catheter having a proximal end and a distal end, wherein a distal portion of the second catheter includes a second one or more outlets, and wherein the distal end of the second catheter is configured to be positioned substantially within one of (i) the first catheter or (ii) a second tubular housing coupled to one or more of the first catheter and the first tubular housing, when the second catheter is in a first position. 1. An apparatus comprising:a first catheter having a proximal end and a distal end, and wherein a distal portion of the first catheter includes a first plurality of outlets;a first tubular housing having a proximal end and a distal end, wherein an exterior surface of the first tubular housing is coupled to an exterior surface of the first catheter proximal to the first plurality of outlets;one or more pressure sensors coupled to the distal end of the first tubular housing;a second tubular housing having a proximal end and a distal end, wherein an exterior surface of the second tubular housing is coupled to one or more of the exterior surface of the first catheter and the exterior surface of the first tubular housing proximal to first plurality of outlets of the first catheter; anda second catheter having a proximal end and a distal end, wherein a distal portion of the second catheter includes a second plurality of outlets, wherein the distal end of the second catheter is configured to be positioned substantially within the second tubular housing ...

Modulated Drug Delivery

A method of delivering a therapeutic and/or diagnostic agent to tissue is provided including the steps of inserting a catheter into a bodily cavity, the catheter having a proximal balloon and a distal balloon, inflating the proximal and distal balloons to create a chamber between the proximal and distal balloons, delivering the therapeutic and/or diagnostic agent to the chamber, measuring fluid pressure in the chamber, measuring at least one fluid dynamic characteristic of a subject, and adjusting the delivery of the therapeutic and/or diagnostic agent based at least in part on the measured volumetric pressure in the chamber and the at least one fluid dynamic characteristic of the subject. 1. A system for delivering a therapeutic and/or diagnostic agent to tissue , comprising:a catheter having a delivery port and a lumen through which a therapeutic and/or diagnostic agent is communicated to the delivery port;at least one first sensor that measures pressure of the therapeutic and/or diagnostic agent being delivered via said port and generates a signal indicating the pressure;a processor that receives the signal from said at least one first sensor; andat least one second sensor that measures at least one fluid dynamic characteristic of a subject and transmits a signal indicating the at least one fluid dynamic characteristic to said processor;wherein said processor adjusts the delivery of the therapeutic and/or diagnostic agent based at least in part on said measured pressure of the agent and said at least one fluid dynamic characteristic of the subject.2. The system of claim 1 , wherein said at least one fluid dynamic characteristic of the subject comprises at least one of diastolic pressure and systolic pressure.3. The system of claim 1 , wherein said at least one fluid dynamic characteristic of the subject comprises a lymphatic fluid dynamic characteristic.4. The system of claim 1 , wherein said at least one fluid dynamic characteristic of the subject comprises a ...

Computerized apparatus with ingestible probe

An endoscopic apparatus including a probe which is introduced into, for example, the intestinal tract of a living organism and which operates therein, adapted to perform one or more functions. In one embodiment, the probe communicates wirelessly with a portable electronic device outside the organism, the portable device which acts to relay data between the probe and a remote networked entity. In one variant, the probe includes an accelerometer to, for example, wake the probe up from a sleep mode when the organism is awake or ambulatory.