МЕДИЦИНСКИЙ НАБОР ДЛЯ РАЗМЕЩЕНИЯ ПОДСИСТЕМЫ И МЕДИЦИНСКОЕ УСТРОЙСТВО ДЛЯ ЕЕ ВВЕДЕНИЯ В ТЕЛО СУБЪЕКТА

Группа изобретений относится к медицине. Медицинский набор для размещения подсистемы выбранной из сенсора аналита для определения по меньшей мере одного аналита в ткани организма и устройства для введения в организм субъекта по меньшей мере одного лекарственного средства, содержащий по меньшей мере одну одноразовую тару, по меньшей мере один стерильный контейнер, расположенный внутри одноразовой тары с возможностью извлечения из нее, и по меньшей мере одну подсистему, по меньшей мере частично вводимую в тело субъекта и помещенную в стерильный контейнер. Стерильный контейнер имеет по меньшей мере одно выходное отверстие для выхода вводимой подсистемы. Выходное отверстие закрыто образованным защитной пленкой затвором наложенным на выходное отверстие. Образованный защитной пленкой затвор присоединен к одноразовой таре с возможностью его автоматического снятия с выходного отверстия при извлечении стерильного контейнера из одноразовой тары. Медицинское устройство для введения в тело субъекта ...

СИСТЕМА ДЛЯ ОБНАРУЖЕНИЯ АНАЛИТА В ЖИДКОСТИ ТЕЛА

Группа изобретений относится к медицинской диагностике. Система для определения по меньшей мере одного аналита в жидкости тела, такой как кровь и/или интерстициальная жидкость, в частности для определения уровня глюкозы в крови, выполнена с возможностью генерации образца жидкости тела и по меньшей мере частичного переноса указанного образца в по меньшей мере один тестовый элемент в область тестирования с помощью ланцета, выполненного в виде по меньшей мере частично открытого капилляра. Объем образца составляет менее 1 мкл. Система выполнена таким образом, что период времени между генерацией образца и нанесением на тестовый элемент составляет менее 1 с, предпочтительно менее 500 мс. Раскрыты варианты системы, отличающиеся конструктивным выполнением. Технический результат состоит в повышении точности за счет исключения влияния на результаты анализа изменения количества образца. 3 н. и 14 з.п. ф-лы, 6 ил., 1 табл.

СПОСОБ И УСТРОЙСТВО ДЛЯ КОНТРОЛЯ ЗА СОСТОЯНИЕМ ЗДОРОВЬЯ И СМЕННЫЙ КОМПОНЕНТ ТАКОГО УСТРОЙСТВА

... 1. Устройство для контроля за состоянием здоровья, предназначенное для измерения показателей крови или тканевой жидкости и содержащее основание (6), имеющее первое отверстие (5) и второе отверстие (4), прокалывающее средство (7), прикрепленное к основанию и имеющее прокалывающую головку, установленную с возможностью выдвижения из первого отверстия (5) в основании, при этом прокалывающее средство (7) установлено с возможностью взведения и последующего спуска для прокалывания кожи посредством прокалывающей головки, и конструктивно связанную с основанием (6) полость (11) для размещения в ней тест-полосок (12) с возможностью их поочередного выдвижения из устройства через второе отверстие (4) в основании в позицию для анализа, отличающееся тем, что дополнительно содержит шторку (1), плотно закрывающую в своей первой позиции первое и второе отверстия в основании (6) и способную к перемещению во вторую позицию с открыванием первого и второго отверстий (5, 4) основания с обеспечением возможности ...

ДИАГНОСТИЧЕСКАЯ СИСТЕМА

... 1. Комбинированная диагностическая система с несущим элементом, содержащая:место сбора физиологической жидкости, размещенное с обеспечением сбора физиологической жидкости, выпущенной в результате наложения на человека элемента для проникновения через мембрану,резервуар, выполненный с возможностью содержания используемой для тестирования текучей среды, иактиватор доставки текучей среды, причем активация указанного активатора приводит к выпуску текучей среды из резервуара.2. Комбинированная диагностическая система по п.1, в которой используемая для тестирования текучая среда выпускается в заранее заданное место.3. Комбинированная диагностическая система по п.2, которая дополнительно содержит используемый для тестирования элемент, размещенный в несущем элементе, причем при выпуске используемой для тестирования текучей среды она вступает в контакт с используемым для тестирования элементом.4. Комбинированная диагностическая система по п.1, в которой активатор выполнен с возможностью ручного ...

Stechvorrichtung für eine Blutprobenentnahme und Verfahren zum Entnehmen einer Blutprobe

Die Erfindung betrifft eine Stechvorrichtung für eine Blutprobenentnahme mit einer verlagerbaren Halteeinrichtung für ein Stechmittel, mit einer Linearführung zum Führen der verlagerbaren Halteeinrichtung, mit Mitteln zum Antreiben der verlagerbaren Halteeinrichtung und mit einer Auslöseeinrichtung zum Auslösen einer Stechbewegung des Stechmittels, bei welcher nach einem manuellen Betätigen der Auslöseeinrichtung die verlagerbare Halteeinrichtung mittels der Antriebsmittel translatorisch verlagert werden kann, wobei die Antriebsmittel eine Kurvenbahn aufweisen, in welcher die verlagerbare Halteeinrichtung unmittelbar eingreift, wodurch der Stechvorrichtung ein besonders einfacher konstruktiver Aufbau verliehen wird.

Detektionselement zur Positionsbestimmung eines Lanzettenelements in einer Stechhilfe

Vorrichtung zur Punktion der Haut eines Patienten

Vorrichtung zur Punktion der Haut eines Patienten, mit einer Buchse (1), einem Druckelement (2), das an einem Ende der Buchse (1) angeordnet ist und eine Fläche (9) aufweist, einem Kolben (5) mit einer Punktionsspitze (8), der verschiebbar innerhalb der Buchse (1) angeordnet ist, und einer Antriebsfeder (10), die zwischen der Fläche (9) des Druckelements (2) und dem Kolben (5) angeordnet ist, dadurch gekennzeichnet, daß das Druckelement (2) ein darin drehbar angeordnetes Punktionskraft-Einstellglied (38) aufweist, das ein nach innen gerichtetes Paar schiefer Halbringglieder (39, 40) aufweist, die im Gebrauch auf die Schubstange (6) des Kolbens (5) drücken.

Providing an id-verified blood test

Drug delivery or lancet assembly for use with an actuator

An assembly 200 for use with an actuator 10 comprises a housing 250, having a channel (106) that may comprise a drive pin which transmits the force of the hammer 20 to the skin piercing element 110. Mechanisms to indicate and or disable the assembly after use are disclosed. The actuatable members that indicate or disable the assembly may lock the skin piercing element within the channel or prevent it leaving the channel after first actuation, or may destroy a frangible cover on the outside of the stem.

A method of measuring the glomerular filtration rate of a patient and a self-use kit for providing blood samples

A device for puncturing patient's skin

A device for puncturing pateint's skin

A device for puncturing patient's skin comprising a sleeve, a push element mounted on one end of the sleeve, a piston with puncturing tip slidably mounted inside the sleeve, and a drive spring positioned between the face of the push element and the piston, characterised by that the push element (2) comprises a turnably mounted therein puncturing force adjusting member (38), which comprises inwardly directed stair shaped members (42, 43) pressing the push rod (6) of the piston (5) in operation or which comprises inwardly directed pair of oblique half-ring members (39, 40) pressing the push rod (6) of the piston (5) in operation.

Combination device for injection and blood sampling

Self use kit for providing blood samples for use in measuring glomerular filtration rate

A self-use kit for providing blood samples for use in measuring the glomerular filtration rate of a patient, said kit comprising: a container that is adapted to be sent by post; one or more pieces of absorbent substrate of a quality and consistency suitable for the collection of blood spots for diagnostic analysis; and a timer comprising a user-operable actuator, recording means for recording the time the or each time the actuator is operated, and means for extracting said time or times from the timer; whereby a patient obtains one or more timed samples of capillary blood after being intravenously injected at a known time with a filtration marker, collecting a blood spot on the or a respective one of said pieces of absorbent substrate, and actuating said actuator upon obtaining the or each sample to record the time of the or each sample; whereafter the piece or pieces of absorbent substrate and the timer may be packaged in the container and sent by post to a laboratory for analysis of the ...

Providing an ID-verified blood test

Providing an ID-verified blood test, in one aspect, may include enabling a user to press a finger against a fingerprint-reading panel and reading a fingerprint of the user. A blood sampling device coupled to the fingerprint-reading panel may be activated while the user has the finger against the fingerprint-reading panel to sample blood from the finger. Blood may be sampled from the user via the blood sampling device while the user has the finger against the fingerprint-reading panel. A test may be performed on the sampled blood to determine a level of specified chemical in the blood. User identification may be determined based on the fingerprint. The determined user identification and the level of the specified chemical may be returned.

Lancet

ADJUSTABLE POINT FOR LANZETTENVORRICHTUNG

LANZETTENAUSLÖSUNGSMECHANISMUS

DEVICE TO THE MONITORING OF THE STATE OF HEALTH AND PROCEDURE

SAMPLE PRODUCTION SYSTEM FOR WINNING A LIQUID SAMPLE

MEDICINE PRODUCT FOR THE ANALYTENÜBERWACHUNG AND DRUG DELIVERY

EQUIPMENT FOR THE PRODUCTION AND ANALYSIS OF A BLOOD TEST

LANZETTENVORRICHTUNG

ANALYTIC AID WITH LANZETTE AND TEST ELEMENT

DEVICE FOR A STINGING INTO THE SKIN FOR UNIQUE USE

SMALL-VOLUMED SENSOR TO IN-VITRO REGULATION

MIKROKLINGEANORDUNGSAUFPRALLAPPLIKATOR

Compact Fluid Analysis Device And Method To Fabricate

In one aspect, a device is disclosed. In one embodiment, the device comprises: a substrate having a microfluidic component formed therein, the microfluidic component 5 configured to propagate a fluid sample via capillary force through the microfluidic component; a lid coupled to the substrate, the lid configured to at least partially cover the substrate and to enclose at least a portion of the microfluidic component, the lid including at least one waveguide configured to enable irradiating the fluid sample present in the enclosed portion of the microfluidic component with an excitation, the 10 substrate further including one or more filters configured to filter the excitation from an emission generated by the fluid sample in response to the excitation. [Figure 26] r-i 0r 0 /0 ...

A LANCET DEVICE

Push activation lancet device

A lancet device including a lancet having a puncturing element disposed within a two-piece housing including a rear housing and a forward housing. Relative axial movement of the rear housing toward the forward housing directly drives the lancet to a puncturing position wherein the puncturing element extends through the forward housing. During such relative axial movement, a drive structure applies a driving force against the lancet and disengages from the lancet based on deflecting structure in the housing, thereby releasing the driving force applied to the lancet. A retention member then retracts the lancet back within the housing, with the drive structure maintained disengaged from the lancet to prevent re-use.

Personal diagnostic devices and related methods

Body fluid sampling device

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 ...

System and method for analyzing a body fluid

The invention relates to a system for analyzing a body fluid, comprising a collecting element (14) that accommodates the body fluid (32) in a reservoir (28), a test element (18) designed to detect an analyte in the body fluid (32), a transfer device (20) for establishing a fluid connection between the collecting element (14) and the test element (18), and a detection unit (22) that captures an analyte-specific measurement signal on the test element (18) during a measurement interval. According to the invention, the transfer device (20) always brings the test element (18) into contact with the body fluid (32) located in the reservoir (28) during the measurement interval, and the transfer device (20) is equipped to separate the test element (18) and the collecting element (14) again after the measurement interval.

Method for producing an analytical magazine

A method for producing an analytical magazine (110) is proposed. The analytical magazine (110) is designed for receiving a plurality of analytical aids (134) in a plurality of chambers (122). The method comprises the following steps: - providing at least a first component (112) of the analytical magazine (110), wherein the first component (112) comprises a plurality of receptacles (120), - providing a plurality of analytical aids (134), wherein the analytical aids (134) are connected to one another, and preferably aligned in relation to one another, by at least one holding element (144), - introducing the analytical aids (134) into the receptacles (120); and - separating the analytical aids (134) from the holding element (144).

Filtering blood

An independent blood filter device depends on flow geometry to deliver blood serum or plasma free of detrimental levels of hemoglobin. It depends critically on an upstream flow rate or pressure differential limiting control element or device that limits the rate of change of pressure differential across the filter element. Pre-evacuated versions can be used to simultaneously draw blood from a living being and provide pressure differential across the filter element between an evacuated collector and a supply end open to atmosphere. A unit pressurized by hand motion employs the external shape of a partially filled blood collection tube as a piston to produce pressure in advance of the control element or device to create the pressure differential across the filter element to a collector vented to atmosphere. The control element or device is disclosed in numerous forms, including specially sized flow constrictions and compliant arrangements.

DELIVERING AND/OR RECEIVING FLUIDS

The present application generally relates to receiving bodily fluid through a device opening. The device includes a flow activator arranged to cause fluid to be released from a subject. A deployment actuator may actuate the flow activator in a deployment direction, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator.

DEVICE AND METHOD FOR POSITIONING A BODY PART

ELECTROCHEMICAL TEST STRIP WITH AN INTEGRATED MICRONEEDLE AND ASSOCIATED METHODS

Methods and devices for electrochemically detecting a change in the viscosity of a fluid are provided. In the subject methods, a fluid sample (e.g., a whole blood sample) is introduced into an electrochemical test strip's electrochemical cell using a micro-needle integrated into one of oppositely spaced apart working and reference electrodes. An electric potential is applied to the electrochemical cell to first achieve a steady state cell current. A decrease in the steady state cell current is then detected and related to a change in viscosity of the sample. In many embodiments, the sample is blood and the change in viscosity is related to the onset of coagulation in the blood sample, and often the PT of the blood sample. An electrochemical test strip includes an electrochemical cell and an integrated micro-needle. The electrochemical cell includes oppositely spaced apart working and reference electrodes and a reagent mixture (e.g., a redox couple and a coagulation catalyzing agent). The ...

LANCET DEVICE

The lancet device includes a housing and a lancet having a puncturing element. The lancet is disposed within the housing and is adapted for axial movement between an initial or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward opening in the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet toward the puncturing position, and a retraction or return spring for returning the lancet to a position within the housing where the puncturing element is disposed within the housing. The retraction spring thereafter maintains engagement with the lancet to assist in preventing the puncturing element from again projecting outward from the forward opening in the housing.

PUNCTURE DEVICE AND PUNCTURE NEEDLE CARTRIDGE

A needle insertion instrument has a plunger (2) provided with a lever (3) whose rotation is partly restricted, and the needle insertion instrument is constructed as follows: forwardly directed urging force is applied to the lever (3) by contracting restoring force of a pulling spring (4), and, when the lever (3) is further advanced by inertia of the plunger (2) from a position after which the urging force is not applied to the lever (3), the lever (3) functions as a lever to again extend the pulling spring (4), causing the plunger (2) to be urged in the direction to a rear end by restoring force of the spring. Further, an insertion needle cartridge has a lancet body (203) having an insertion needle and an insertion needle holder (201) for movably receiving the lancet body (203). The lancet body (203) has an arm means (302), and the insertion needle holder (201) has in it a to-be-engaged means (403) cooperating with the arm means (302). The construction above enables a production process ...

DEVICES FOR PHYSIOLOGICAL FLUID SAMPLING AND METHODS OF USING THE SAME

Methods and devices are provided for determining a suitable site for sampling physiological fluid. In the subject methods, a potentially suitable physiological sampling site is selected, the fluid flow of the site is characterized and the site is then determined to be suitable based on the whether the site has high or low flow. Suitability may also be determined based on the type of sample obtainable firm the silt, where the order of the above-described steps may be altered. The subject devices include at least one silo flow characterization element for determining the flow characteristics of a potential physiological sampling site and/or at least one sample type characterization element for determining whether the vasculature is arterial, venous or neither, i.c., an interstitial fluid sampling site. The subject methods and devices are particularly suited for use in the detection of physiological sampling sifts in the fingers, arms, legs, earlobes, heels, feet, nose: and toes. Also provided ...

OPTICAL VOLUME SENSOR

An optical sensor for measuring the volume of an object, the object having a top and a side. The optical sensor com-prises a source of light and a light sensor adapted to measure the amount of light reflected off the side and off the top of the object, wherein the measured amount of the light reflected off the side and the top of the object correlates to a height and a diameter of the object. At least one optical device is adapted to direct light reflected off the side of the object to the light sensor, and at least one optical device is adapted to direct light reflected off the top of the object to the light sensor.

LANCET DEVICE FOR PUNCTURING THE SKIN

A lancet device (10) for puncturing the skin (11) of mammals, in particular of the human being, is proposed, including both a punch element (12), provided with a manipulator (13), and a bushing element (14), provided with a grip (15), for the internal (28), axially (16) displaceable reception of the punch element (12), the punch element (12) on its free end (17) pointing away from the manipulator (13) having a lancet (18), provided with a sharp tip (19), for intentionally entering the skin (11), and the lancet (18), via the punch element (12), by means of a force acting in the axial (16) direction on the free end (21) of the bushing can be made to enter the skin (11) from the end of the bushing outward with a preadjustable momentum, and blocking means are provided, which once the lancet (18) has entered the skin (11) prevent the possibility of a reentry. To that end, in the interior (28) of the bushing element (14), a sleeve element (35) displaceable axially in it is disposed, which has ...

DISPOSABLE TEST VIAL WITH SAMPLE DELIVERY DEVICE

A disposable body fluid or tissue collection vial (30) is disclosed. The vial has a sample accessing tool (34) and a sample delivery member (40) for dispensing a sample of body fluid or tissue into a reagent (56). The vial (30) also has a base (54), a sample delivery sleeve (48), a sample accessing sleeve (36), and a cap (32). The sample delivery sleeve (48) detachably attaches to the base 54, the sample accessing sleeve (36) detachably attaches to the sample delivery sleeve (48), and the cap (32) detachably attaches to the sample accessing sleeve (36). The base (54) may contain one or more reagents (56) suitable for diagnostic or other uses.

BODY FLUID SAMPLING SEVICE

... ²²²Body fluid sampling device comprising a sampling element (10) having a fluid ²pathway (11) for receiving body fluid, at least a portion of said fluid ²pathway is open to the environment and further comprising a fluid receiving ²means (40) being spaced from said fluid pathway so that fluid in said pathway ²will not contact the fluid receiving means initially. Said fluid receiving ²means has two or more test zones (45) for performing analytical reactions. ²Fluid from said channel is contacted with said fluid receiving means either by ²bringing the fluid receiving means and the fluid into mechanical contact or by ²electrically transporting fluid from the channel onto the fluid receiving ²means.² ...

LANCING DEVICE WITH A FLOATING PROBE FOR CONTROL OF PENETRATION DEPTH

A lancing device includes a lancing mechanism, a floating probe and a pressure tip. The lancing mechanism includes a lancet carriage, a lancet holder slidably connected to the lancet carriage, and a lancet attached to the lancet holder. The pressure tip of the lancing device is configured for engaging a target site and creating a target site bulge. The floating probe is adapted to floatably contact the target site bulge and to operatively interact with the lance carriage to control a penetration depth of the lancet into the target site bulge. A method for lancing a target site includes providing the lancing device describe above and contacting the pressure tip of the lancing device with the target site. The pressure tip is then urged towards the target site to create a target site bulge with the floating probe of the lancing device floating on a surface of the target site bulge. Next, the target site bulge is lanced while the floating probe operatively interacts with the lance carriage ...

METER AND TEST SENSOR BANK INCORPORATING RE-WRITABLE MEMORY

... ²²²A system (2A; 2B) for conducting a test for an analyte in a physiological ²fluid comprising a test sensor bank (1B) including more than one test sensor, ²at least initially, for testing for an analyte, a re-writable memory device ²(1B;1C) associated with said test sensor bank, a meter (1 A) for conducting a ²test using a test sensor from the bank, the meter comprising reading means for ²reading information from the re-writable memory device and a writing means for ²writing information to the re-writable memory device, and transmission means ²(100A; 100B, 102B) for transmitting information between the rewritable memory ²and the meter. This invention provides systems, meters and devices, and ²methods of their use, for measuring a quantity in relation to an analyte in, ²for example, a physiological fluid.² ...

LANCET DEVICE FOR GENERATING A PUNCTURE WOUND, AND LANCET DRIVE ASSEMBLY

The invention relates to a lancet device for generating a puncture wound in a skin surface, comprising a housing (2), in which a lancet (4) can be moved on a puncturing path, a lancet drive (9) with a drive rotor (12) that can be driven by a drive spring (11), a lancet coupling mechanism (24) that transforms a rotational motion of the drive rotor (12) into a puncturing and returning motion of the lancet (4) during a working cycle of the lancet drive (9), a reference element (14) that is mobile relative to the lancet (4) and relative to the housing (2) and is fixed in a defined position relative to the lancet drive (9) during the puncturing and rests against the surface of the skin with a contact surface (15) thereof such that a puncture wound with a reproducible puncturing depth is generated by the puncturing motion, and a reference element coupling mechanism (38,39) that is coupled to the lancet drive (9) in order to move the reference element (14). The invention further relates to a suitable ...

INTRACUTANEOUS EDGED MICRONEEDLE STRUCTURE

A hollow microneedle with a substantially sharp edge is provided that includes at least one longitudinal blade at the top surface or tip of the microneedle to aid in penetration of the stratum corneum of skin. The blade's edge can run the entire length of the microneedle from its very top surface to its bottom surface where it is mounted onto the substrate, or the edge can be discontinued partway down the length of the microneedle. In a preferred embodiment, a three pointed star-shape is used, in which each blade has an isosceles triangular cross-section when viewed from the top of the microneedle. At least one hole through the substrate is located near the side surfaces of the pairs of blades of the solid microneedle.

CAP FOR A LANCING DEVICE

A cap for a lancing device for lancing dermal tissue is provided. The cap includes a cap body having a proximal end for connecting to the distal end of the housing of the lancing device and a contact ring attached to the distal end of the cap body. The contact ring includes an opening for a portion of the lancet of the lancing device to pass therethrough. The contact ring has a multi-contoured surface oriented generally about an axis distinct from the axis of motion of the lancet. The multi-contoured surface is designed to pressure the dermal tissue to facilitate expression of a fluid sample after lancing the dermal tissue. The fluid sample can include blood, interstitial fluid, or both.

INTEGRATED SAMPLE TESTING METER

... ²²²An integrated sample testing meter, for instance for measuring blood, ²comprising a lancing device, an electrochemical sensor and a test strip ²cartridge disposed in a single modular housing. The test strip cartridge ²includes a stack of test strips suitable for performing an electrochemical or ²photometric analysis of a blood sample. The integrated test system ²automatically dispenses and positions a test strip in proximity to a lancet ²puncture site, automatically transfers a blood sample to the test strip from ²the lancet puncture site and automatically analyzes the blood sample after the ²test strip collects the sample from the puncture site.² ...

LANCET DEVICE WITH LANCE RETRACTION

A lancet device comprises a hollow housing defining a cavity and having a proximal end and a distal end. It also comprises a slider slidable at least partially within the cavity of the hollow housing along a longitudinal axis from an outward position to a pushed position. The slider extends outside of the cavity beyond the proximal end of the hollow housing when it is in the outward position. The lancet device also comprises a needle holder holding a lance. The needle holder is rotatable about and translatable along the longitudinal axis when moved from an initial position to an extended position. When the needle holder is in the initial position, the slider is in the outward position. When the needle holder is in the extended position, the lance extends outside of the cavity beyond the proximal end of the hollow housing. The sliding of the slider from the outward position to the pushed position urges the needle holder to the extended position. There is also a first biasing member positioned ...

PRIME AND FIRE LANCING DEVICE WITH CONTACT BIAS DRIVE AND METHOD

Described and illustrated herein is an exemplary lancing device. The lancing device includes a first housing, second housing, movable member, lancet, and lancet depth adjustment member. The lancet depth adjustment member is captured by both the first and second housings so that the lancet depth adjustment member is rotatable relative to both housings to provide for a plurality of stop surfaces to the movable member. Other exemplary embodiments are also described.

A SINGLE USE LANCET ASSEMBLY

A single use lancet device (10) having a housing (20) with an open interior (28), an access opening (22) with a piercing tip (34), a driving assembly (38) structured to move a lancet (30), and a restrictor assembly (60) having a shoulder (62) and a restrictor panel (64).

METHOD AND APPARATUS FOR MEASURING AN ANALYTE IN A BODY FLUID

An apparatus and method for analyzing an analyte in a body fluid sample using a lancing device (10) having a hollow lancet are disclosed. According to one embodiment, the method comprises the acts of lancing the skin of a test subject with the hollow lancet (18) having an interior of the hollow lancet (18) that forms a capillary channel, collecting a body fluid sample from the lanced skin in the capillary channel of the hollow lancet (18), and analyzing the body fluid sample for determining the analyte concentration in the body fluid sample while the collected body fluid sample remains in the lancet (18).

MICRONEEDLES FOR MINIMALLY INVASIVE DRUG DELIVERY

The present invention provides a microneedle incorporating a base that is broad relative to a height of the microneedle, to minimize breakage. The microneedle further includes a fluid channel and a beveled noncoring tip. Preferably arrays of such microneedles are fabricated utilizing conventional semiconductor derived microscale fabrication techniques. A dot pattern mask is formed on an upper surface of a silicon substrate, with each orifice of the dot pattern mask corresponding to a desired location of a microneedle. Orifices are formed that pass completely through the substrate by etching. A nitride pattern mask is formed to mask all areas in which a nitride layer is not desired. A nitride layer is then deposited on the bottom of the silicon substrate, on the walls of the orifice, and on the top of the silicon substrate around the periphery of the orifice. The nitride layer around the periphery of the orifice is offset somewhat, such that one side of the orifice has a larger nitride layer ...

DAMPING SYSTEM FOR A LANCET USING COMPRESSED AIR

A lancing device comprises a cylinder, a plunger, a piston, a spring and an actuator. The cylinder includes a valve that is adapted to allow air to flow into the cylinder. The cylinder further forms an aperture. The plunger housing is adapted to seat a lancet therein. The piston is adapted to move within the cylinder. The piston is adapted to inhibit most of the air located within the cylinder from escaping between the cylinder and piston. The piston is attached to the plunger housing. The spring is located within the cylinder. The spring is located adjacent the piston opposite from the plunger housing. The actuator includes an inner shaft in which the inner shaft of the actuator extends into the cylinder through the aperture formed in the cylinder. The inner shaft is attached to the piston opposite from the plunger housing.

USABILITY METHODS OF CALIBRATING AN ANALYTE MEASUREMENT METER USING RFID

An analyte measuring system including a meter and a vial of test sensors, whereby calibration information specific to a particular vial of test sensors is transmitted wirelessly from a radio frequency identification (RF or RFID) tag incorporated within the vial, at a predefined time or within a predefined period, to a reader housed within the meter.

ADJUSTABLE LANCET DEVICE AND METHOD

Lancet device that includes a body (1). A front cover (3) includes a skin engaging end (P) that includes a lancet opening (LO) through which a lancet needle extends. A holding member (4/5) is movably mounted within the body (1). The holding member (4/5) includes a front end and a rear end. The front end is configured to receive a lancet (10). A main spring (6) is disposed between the front and rear ends of the holding member. A first stop surface is arranged on a front portion of the holding member. A second stop surface is axially retained to a front portion of the body. At least partial rotation of the front cover causes the skin engaging end (P) to move axially relative to the second stop surface.

METHOD FOR PRODUCING A HOLE ON THE SKIN AND SUITABLE HAND-HELD DEVICE THEREFOR

The invention relates to a method for producing a hole in the skin in order to remove a body fluid sample from the body part, wherein an opening (21) is produced on the skin on the point of the hole in the epidermis (20) in the skin-opening step. Then, a sample removing hole is created by means of a pricking element (11) in the sample removing step, wherein the skin opening (21) is deepened by means of the pricking element (11) and then a hole, which is used to remove the sample, is produced. The invention also relates to a hand-held device for carrying out said method.

SAMPLING INSTRUMENT

LASER SKIN PERFORATOR

A laser perforator (10) for perforating skin (36) of a patient and obtaining of blood samples consists of laser light source (12) for producing an output laser beam, a focusing arrangement (14) for focusing the output laser beam at a skin area selected for perforation, a guiding arrangement, a power supply unit (16) and a retaining arrangement (18) for retaining the skin area. The retaining arrangement (18) is formed to intensify blood circulation in the skin area selected for perforation.

PORTABLE INTERSTITIAL FLUID MONITORING SYSTEM

A strip-like microneedle device is provided that includes an array of hollow microneedles, a diaphragm pump to extract interstitial fluid from skin, and a sensor that detects the concentration of the fluid. The microneedle device can be interfaced to an external sensor to produce a reading, or can be self- contained. One version uses an attachable/detachable microneedle array as a single-use, disposable unit. The device is portable, and is used by placing one finger on the microneedle array, and actuating the diaphragm pump with another finger, thereby obtaining the fluid sample. Solid coated or transparent microneedles could instead be used as an in-situ sensor, with either electrodes or an optical sensor.

LANCING DEVICE

A lancing device comprising a movable parallelogram-shaped rack. The rack rotates a linearly fixed pinion which drives a slider-crank system. The slider-crank system in turn drives a lance holder. The parallelogram-shaped rack defines one or more predetermined paths along which the pinion moves. The lance holder is prevented from being extended be- yond a predetermined depth when the pinion reaches a predetermined position along the one or more predetermined paths. The pinion is mechanically stopped from further progress by intersecting two legs of the parallelogram-shaped rack. Teeth of the rack may be modified to reduce the chance the pinion may jam in the rack.

OPTICAL VOLUME SENSOR

An optical sensor for measuring the volume of an object, the object having a top and a side. The optical sensor com- prises a source of light and a light sensor adapted to measure the amount of light reflected off the side and off the top of the object, wherein the measured amount of the light reflected off the side and the top of the object correlates to a height and a diameter of the object. At least one optical device is adapted to direct light reflected off the side of the object to the light sensor, and at least one optical device is adapted to direct light reflected off the top of the object to the light sensor.

SINGLE USE LANCET DEVICE

A compact single use lancet device wherein a lancet is movably disposed. A driving element is further provided and is structured to move the lancet into a piercing orientation wherein a piercing tip protrudes from the device and can pierce a patient's skin. A retention assembly maintains the lancet in a tensioned, ready to fire orientation and prevents both inward and outward movement of the lancet, until released by an actuator. The actuator is structured to engage a patient and be urged inwardly into the housing in order to bring about the release of the lancet from its tensioned, ready to fire orientation and result in driven movement of the lancet into the piercing orientation. A protective cover is also included to engage the lancet and shield a piercing tip thereof, as well as to shield the actuator and prevent inward movement of the actuator as a result of the protective covers engagement with the retained lancet.

BLOOD-COLLECTION DEVICE FOR NEWBORN BABIES AND INFANTS

The invention relates to a blood-collection device for newborn babies and infants, comprising a cannula, which is provided with a blood inlet and outlet and is located in a holder (2) that has a grip region (7). Said collection device is equipped with a bow-shaped bridging element (6) that connects the grip region to the holder.

METHOD AND KIT OF COMPONENTS FOR DELIVERING BLOOD TO A PORTABLE CLINICAL ANALYZER

A kit and a method are provided for facilitating point-of-care testing of bodily fluid. The kit includes a point-of-care testing cartridge and a plastic fitting for use with a syringe to deliver the fluid sample to the testing cartridge. In other embodiments, the kit includes a plastic cannula in place of a fitting. The syringe and plastic cannula can be used with an IV access kit to obtain a sample of fluid. The syringe and plastic cannula then can be used to deliver the fluid to the reservoir the testing cartridge.

CONTINUOUS GLUCOSE MONITORING SYSTEM AND METHOD

A continuous glucose monitoring system and method has an inserter assembly for inserting a sensor through the skin and into subcutaneous tissue where an inserter housing with the sensor remains on the skin after insertion, a sensor housing cover attachable to the sensor housing after insertion where the sensor housing cover has an electronic module and a battery, and an electronic device equipped with wireless communication for communicating with the electronic module of the sensor housing cover assembly, the electronic device configured for receiving input signals from the sensor, converting the input signals to analyte date, displaying the analyte data on a user interface of the electronic device, storing the data for recall, and creating and/or sending reports of the data.

METHODS AND APPARATUS FOR EXTRACTING AND ANALYZING A BODILY FLUID

MICROBLADE ARRAY IMPACT APPLICATOR

An applicator device (10) is provided for applying a patch (44) having an array of microprotrusions (90) to the stratum corneum. The applicator device (10) includes a device body (12) and a piston moveable within the device body (12). A cap (16) is provided on the device body (12) for activating the device (10) to impact the stratum corneum with a microprotrusion array (44, 90). The device (10) is capable of being cocked by one handed operation of the user which allows the device (10) to be used by patients having neither the strength nor the manual dexterity to cock other types of applicator devices.

BLOOD EXPRESSION DEVICE

INTEGRATED LANCE AND STRIP FOR ANALYTE MEASUREMENT

The present invention relates, in general, to lancing elements for use in drawing bodily fluids out of a patient and, more particularly, to an improved lancing element including first and second elements positioned relative to each other such that an incision formed by the first element is held open by the second element and bodily fluids are pulled up the lancing element by surface tension on the first and second lancing elements.

METHOD OF ANALYTE MEASUREMENT USING INTEGRATED LANCE AND STRIP

The present invention relates, in general, to lancing elements for use in drawing bodily fluids out of a patient and, more particularly, to an improved lancing element including first and second elements positioned relative to each other such that an incision formed by the first element is held open by the second element and bodily fluids are pulled up the lancing element by surface tension on the first and second lancing elements.

LANCET DEVICE

A lancet device (10) including a housing (20) with an at least partially open interior, a cocking seat (30) moveably coupled with the housing and structured to define an open interior therewith, a lancet with a piercing tip (42) moveably disposed within the open interior, and a biasing assembly (50) engaging the lancet. The cocking seat (30) is structured to engage the lancet (10) and move the lancet against a force of the biasing assembly (50) so as to increase a potential energy of the biasing assembly.(50). A release element (56) is provided to at least partially disengage the lancet from the cocking seat such that the potential energy of the biasing assembly moves the lancet relative to the cocking seat and drives the piercing tip of the lancet at least temporarily into a piercing orientation.

BLOOD WITHDRAWAL SYSTEM

Blood withdrawal system for withdrawing blood for diagnostic purposes, comprising a housing with a lancet, which can be moved within the housing, and a lancet drive with a drive spring and a cocking mechanism, wherein the cocking mechanism (13) includes an actuation element (14), which is coupled through an input-side coupling mechanism (29) to the drive spring (16) such that the drive spring (16) is tensioned during a cocking phase of the motion of the lancet drive (9) by moving the actuation element (14). The actuation element of the cocking mechanism is coupled to a track control mechanism comprising as components of the track control mechanism a control track part (45) and a control traveller (46), wherein the control traveller (46) performs a relative motion with respect to the control track part (45) during at least a part of the cocking phase, in which motion it travels along the control track (47) of the control track part (45), whereby at least a part of the motion of the lancet ...

METHOD AND APPARATUS FOR ULTRASONIC DETERMINATION OF HEMATOCRIT AND HEMOGLOBIN CONCENTRATIONS

An ultrasonic field-portalbe system for accurately measuring hematocrit (HCT) and hemoglobin concentration (HGB) in small food samples. The system includes an analyzer (10) that allows extremely accurate measurements of blood hematocrit from only one or two drops of +>>d collected in a disposable sampling device (12) that is then iserted into the analyzer (10). The system is compact enough to package into a point of care device, making it a point of care device with accuracy comparable to larger CBC lab equipment.

LANCING MECHANISM

A lancing mechanism for puncturing skin is provided. The lancing mechanism comprises a lance having a penetration end which is adapted to puncture skin. The penetration end of the lance is movable from a first position to a second position during a forward stroke and between the second position and the first position during a return stroke. A forcing plunger applies a force to the lance to move the lance from the first position to the second during the forward stroke. The forcing plunger is adapted to engage the lance during the forward stroke to move the penetration end of the lance from the first position to the second position and to disengage the lance when the penetration end of the lance approaches the second position. A first resilient member coupled to the lance moves the first end of the lance from the second position to the first position during the return stroke.

SINGLE USE LANCET DEVICE

A single use lancet device (10) having a housing (20), a lancet (24) with a piercing tip (25) movably disposed in the housing (20) and structured to move between a cocked orientation and a piercing orientation, and a driving assembly structured to move the lancet (24) into the piercing orientation. A retention member and an engagement hub are further provided and structured to be cooperatively engaged with one another upon the lancet being disposed in the cocked orientation so as to maintain the lancet in the cocked orientation until released by an actuation assembly (40). Specifically, the actuation assembly (40) is structured to move between an actuated and an unactuated orientation, movement into the actuated orientation releasing the retention member and the engagement hub from their cooperative engagement with one another and thereby result in movement of the lancet into the piercing orientation. The device also includes a restrictor assembly structured to substantially prevent the ...

INTRAVENOUS CATHETER INSERTING DEVICE

An intravenous catheter inserting device includes a catheter hub engaging an open forward end of a barrel and having a duct that communicates with a passage of the barrel. A tubular catheter is disposed to communicate with the duct, and permits a needle cannula to pass therethrough. A plunger is received in the passage and extends rearwardly of the barrel so as to be manually operable. The plunger has a cavity containing fluid at a reduced pressure, and is coupled with the needle cannula within the passage such that the needle cannula can be retracted into the cavity due to a pressure difference between the ambient air and the reduced pressure.

INTEGRATED BLOOD SAMPLING ANALYSIS SYSTEM WITH MULTI-USE SAMPLING MODULE

... ²²²A simple, miniaturized, disposable acquisition and test module for monitoring ²glucose or other analytes successively for multiple times. The blood sampling ²system (108) is designed to collect and test small volumes of blood in a ²single step. The system (108) includes a disposable sampling module (100) and ²a reader device (102). Many samples can be acquired and analyzed using a ²single disposable sampling module (100), minimizing the number of disposables.² ...

SAMPLING DEVICES AND METHODS UTILIZING A STEPPED CAPILLARY PASSAGEWAY

Systems and methods for the sampling of bodily fluid from an incision in the skin utilize a capillary passageway (18) having a first, upstream portion (39) and a second, downstream portion (41), with the downstream portion (41) having a higher capillary affinity for the bodily fluid than the upstream portion (39). Therefor, when the first portion (39) is filled and the fluid contacts the second portion (41), the fluid is drawn up into the second portion (41) due to the greater capillary affinity. The capillary affinities are controlled by the cross-sectional area of the passageway (18), the use of different materials or coatings to define the passageway, the treatment of the interior wall of the passageway, the use of wicking materials, and the like. The capillary sampling systems and methods are optionally combined with incising, expressing and/or testing systems, particularly in a single, integrated device.

DIAGNOSTIC TAPE UNIT AND A PROCESS FOR ITS PRODUCTION

The invention concerns a process for producing a diagnostic tape unit (10) i n which disposable test units (20) are applied to a rollable transport tape (18) and the transport tape (18) is wound onto an unwinding spool (14) and is connected t o a take-up spool (16) such that the test units (20) can be successively made available to a user by winding on the transport tape (18). According to the invention it is proposed that the leading end of the transport tape (18) is connected to the take-up spool (16) by means of an auxiliary tape (24) and/or the trailing end of the transport tape is connected to the unwinding spool (14) by means of an auxiliary tape (24', 24").

FULLY INTEGRATED WEARABLE OR HANDHELD MONITOR

An arrangement comprises a housing containing one or more components configured for at least one of body fluid sampling and analysis. The arrangement includes a housing containing one or more components configured for at least one of body fluid sampling and analysis, and a body attachment element. The housing and the body attachment element are connected by a quick- release mechanism configured to facilitate removal of the housing from the body attachment element.

BIOLOGICAL FLUID SAMPLING TRANSFER DEVICE AND BIOLOGICAL FLUID SEPARATION AND TESTING SYSTEM

A biological fluid sampling transfer device that is adapted to receive and separate a multi-component blood sample is disclosed. After separation, the biological fluid sampling transfer device is able to transfer a plasma portion of the blood sample to a point-of-care testing device. The biological fluid sampling transfer device of the present disclosure also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with an anticoagulant. The biological fluid sampling transfer device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid sampling transfer device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

BLOOD SAMPLING TRANSFER DEVICE

A blood sampling transfer device that includes a lancing tape having a flow channel and a transfer cartridge removably connected to the lancing tape is disclosed. The blood sampling transfer device provides a closed system that reduces the exposure of a blood sample to both skin and environment and provides fast mixing of a blood sample with a sample stabilizer.

BIOLOGICAL FLUID COLLECTION DEVICE AND BIOLOGICAL FLUID COLLECTION AND TESTING SYSTEM

A blood collection device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the blood collection device separates a plasma portion from a cellular portion. After separation, the blood collection device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood collection device of the present disclosure also provides a closed collection and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The blood collection device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood collection device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

BIOLOGICAL FLUID SEPARATION DEVICE AND BIOLOGICAL FLUID SEPARATION AND TESTING SYSTEM

A biological fluid separation device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid separation device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid separation device of the present disclosure also provides a closed separation and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid separation device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

BIOLOGICAL FLUID COLLECTION DEVICE AND BIOLOGICAL FLUID SEPARATION AND TESTING SYSTEM

A biological fluid collection device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. After collection of the blood sample, the plasma portion is separated from the cellular portion. After separation, the biological fluid collection device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid collection device also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid collection device is engageable with a biological fluid testing device for closed transfer of a portion of the plasma portion from the biological fluid collection device to the biological fluid testing device. The biological fluid testing device is adapted to receive the plasma portion to analyze the blood sample.

SYSTEM FOR DETECTION OF AN ANALYTE IN A BODY FLUID

A system (110) is proposed for detection of at least one analyte in a body fluid, in particular for detection of blood glucose. The system (110) is designed in order to generate a sample (130) of the body fluid and to transfer at least part of it to at least one test element (128), in particular a test panel (129). The system (110) is designed such that a time period between the generation of the sample (130) and the application to the test element (128) is less than 1 s, preferably less than 500 ms.

SYSTEM AND METHOD FOR ANALYZING A BODY FLUID

The invention concerns a system for analyzing a body fluid comprising a collecting element (14) which receives the body fluid (32) in a reservoir (28), a test element (18) designed to detect an analyte in the body fluid (32), a transfer device (20) for making a fluidic connection between the collecting element (14) and the test element (18), and a detection unit (22) which detects an analyte-specific measurement signal on the test element (18) during a measurement interval. According to the invention it is proposed that the transfer device (20) always brings the test element (18) into contact with the body fluid (32) located in the reservoir (28) during the measurement interval and that the transfer device (20) is configured to physically separate the test element (18) and the collecting element (14) from one another after the measurement interval.

HANDHELD MEDICAL DIAGNOSTIC DEVICES WITH SAMPLE TRANSFER

A lancet housing assembly (30; 400; 430; 452; 500; 600) includes a housing structure comprising multiple lancet compartments (40; 405; 444; 458; 505; 605). At least one of the lancet compartments comprises an outer facing side (64) and an inner facing side (66). A floor (70, 84; 424) extends between the outer facing side and the inner facing side (66). A reagent material (72; 426; 436; 478; 532; 650) is located on the floor and within the lancet compartment. A lancet structure (24; 406; 432; 450; 506; 606) is located in the at least one lancet compartment. The lancet structure comprises a skin penetrating end (90; 408; 434; 462; 508; 608) and a blood transport portion (92; 410; 464; 510; 610). The blood transport portion is arranged and configured to receive the amount of blood from the skin penetrating end and to carry the amount of blood away from the skin site and to the reagent material.

SENSOR STRIP POSITIONING MECHANISM

A blood sample test device has a continuous strip sensor which is advanced through the device so that multiple blood sample tests can be conducted on a single strip. The device is provided with a sprocket having an encoder which engages sprocket holes on the strip to precisely control the advancement of the strip through the device.

METHOD OF MANUFACTURING MICRONEEDLE STRUCTURES USING SOFT LITHOGRAPHY AND PHOTOLITHOGRAPHY

A method for manufacturing microneedle structures is disclosed using soft lithography and photolithography, in which micromold structures made of a photoresist material or PDMS are created. The micromold manufacturing occurs quite quickly, using inexpensive materials and processes. Once the molds are available, using moldable materials such as polymers, microneedle arrays can be molded or embossed in relatively fast procedures. In some cases a sacrificial layer is provided between the forming micromold and its substrate layer, for ease of separation. The microneedles themselves can be solid projections, hollow "microtubes," or shallow "microcups." Electrodes can be formed on the microneedle arrays, including individual electrodes per hollow microtube.

DRAWWORKS

In the case of a drawworks (100) for a drilling device for lowering and withdrawing a load, in particular a drill string or parts thereof, having a frame (1), having a winding drum (2) and having a bearing device (5), connected to the frame (1), for the winding drum (2), the centres (Z) of the bearing forces are located at precisely three points (S, S2, S3) of the frame (1).

LANCER

A lancer device that enables a user to draw blood from a patient and discard the used lancet without touching it. The device also has an adjustable tip for selecting the depth of stylet penetration into the patient and a triggering mechanism that utilizes a yoke latch and a leaf spring to discharge the lancet. The lancer also has a dampening feature to reduce vibrations when the lancet is moving.

ПРОНИКНОВЕНИЕ АНЕСТЕЗИРУЮЩИХ СРЕДСТВ ДЛЯ МЕСТНОГО ВОЗДЕЙСТВИЯ, ОСУЩЕСТВЛЯЕМОЕ С ПОМОЩЬЮ ЛАЗЕРА

... 1. Способ введения терапевтически эффективного количества фармацевтической композиции с использованием лазера, включающий изменение проницаемости кожи с помощью лазерного луча, имеющего плотность энергии, достаточную для облучения кожи на глубину рогового слоя без достижения капиллярного слоя для создания места альтерации с диаметром от 0,5 мкм до 5,0 см; и нанесение терапевтически эффективного количества фармацевтической композиции в месте альтерации. 2. Способ по п.1, в котором лазер выбирают из группы, состоящей из лазера Er:YAG, импульсных СO2 -лазеров, лазеров Ho:YAG, Er:YAP, Er/Cr:YSGC, Ho:YSGC, Er:GGSG, Er:YLF, Tm:YAG, Ho:YAG; Ho/Nd:YALOs, кобальт:МgF2 , химического на HF, химического на DF, на монооксиде углерода, лазеров дальнего УФ-диапазона и лазера Nd:YAG с утроением частоты. 3. Способ по п.1, в котором лазер представляет собой лазер Er:YAG. 4. Способ по п.1, в котором лазер представляет собой модулируемый лазер, выбираемый из группы, состоящей из лазеров с непрерывным излучением ...

穿刺装置

... 穿刺装置(A)具有位于穿刺针(L)的前端部旁侧的辅助部件(8)。通过使辅助部件(8)移动，能够增加或减少穿刺针(L)的前端部由辅助部件(8)的前端部(8a)突出的尺寸(S)。通过改变该尺寸(S)，可使穿刺针(L)恰以所需量正确地刺入使用者的皮肤(99)。 ...

Analyte sensor

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Injection device with puncture function, method for controlling injection device with puncture function, chemical solution administration device, and method for controlling chemical solution administration device

An injection device with a puncture function includes, in a single casing, a cylindrical cartridge in which insulin is enclosed, a cartridge holder to which the cartridge is inserted, a needle inserted at a front end of the cartridge, a reciprocation unit for reciprocating the cartridge toward the needle, and an extrusion member for extruding the insulin from a rear end of the cartridge toward the needle, and the motion speed and the motion amount of the reciprocation unit are made variable.

Bodily fluid composition analyzer with disposable cassette

Disclosed is an apparatus for analyzing the composition of bodily fluid. The apparatus can include a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid in a patient and a pump unit in operative engagement with the fluid handling network. The pump unit can have an infusion mode, in which the pump unit is operable to deliver infusion fluid to the patient through the patient end, and a sample draw mode, in which the pump unit is operable to draw a sample of the bodily fluid from the patient through the patient end. The apparatus can include a spectroscopic analyzer positioned to analyze at least a portion of the sample; a processor in communication with or incorporated into the spectroscopic analyzer; and stored program instructions executable by the processor to obtain measurements of two or more properties of the sample.

Systems and methods for collecting fluid from a subject

Systems and methods for delivering to and/or receiving fluids or other materials, such as blood or interstitial fluid, from subjects, e.g., from the skin. Beading disruptors and/or capillaries may be used for facilitating the transport of fluids from a subject into a device. Beading disruptors may disrupt the “pooling” of bodily fluids such as blood on the surface of the skin and help influence flow in a desired way. A capillary may conduct flow of fluid in the device, e.g., to an inlet of a channel or other flow path that leads to a storage chamber. A vacuum (reduced pressure relative to ambient) may be used to receive fluid into the device, e.g., by using relatively low pressure to draw fluid into the inlet of a channel leading to a storage chamber. The vacuum source may be part of the device.

Tissue penetration device

A body fluid testing device has at least one penetrating member and a penetrating member driver configured to be coupled to the at least one penetrating member. A plurality of analyte sensors are coupled to a spoked disk substrate. Each of a penetrating member can pass between spokes of the disk substrate to provide that a used penetrating member can be removed and a new penetrating inserted without removing the disk. A disposable houses the at least one penetrating member and the plurality of analyte sensors.

Manufacturing electrochemical sensor module

Certain processes for manufacturing an electrochemical sensor module include assembly first and second housing portions of sensor modules; dispensing a sensor fiber across multiple first housing portions; joining the first and second housing portions; and separating the sensor modules by cutting the sensor fiber.

Inserter for a Multiplicity of Subcutaneous Parts

A holding device and an inserter are provided. The holding device includes a casing providing a cavity including walls, the was encompass a subcutaneous unit. The cavity includes a first side having an outlet opening, the outlet opening before use is covered with a penetrable or removable cover, and a second side comprising a layer having an outer surface and being penetrable, removable or flexible to transfer an impact from outside the layer to the subcutaneous unit. The casing includes a releasable attachment member corresponding to a member on the subcutaneous unit and a needle secured to the casing. An impact towards the outer surface of the layer pushes the subcutaneous unit at least partly out of the casing into a subcutaneous position, when the unit is in the subcutaneous position the releasable attachment member of the casing is released allowing detachment of the unit from the casing.

Diagnostic system

A composite diagnostic system comprising a support member having a membrane penetration element; a bodily fluid collection point positioned for collection of a bodily fluid released by application of the membrane penetration element to a user's body; a test material positioned in the support member such that in use the bodily fluid is brought into contact with the test material.

Delivering and/or receiving fluids

The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. A deployment actuator may actuate the flow activator in a deployment direction, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, a device actuator may enable fluid communication between the opening and the vacuum source and the flow activator may be actuated after the enablement of fluid communication.

ANALYTIC TEST UNIT AND TEST SYSTEM

This disclosure relates to an analytic test unit for use in a test device for detecting an analyte in a bodily fluid, having at least one test element with a carrier film and a reagent layer, the latter being affixed on the carrier side of the carrier film and it being possible to apply bodily fluid on said reagent layer, wherein the light-transparent carrier film can be positioned in the beam path of a photometric measuring unit for optically scanning the reagent layer. According to this disclosure, it is proposed that the carrier film has a surface, modified by a raised surface structure, for reducing reflections in the beam path of the measuring unit. 1. An analytic test unit for use in a test instrument for detecting an analyte in a bodily fluid , comprising:a test element having a light-transmissive carrier film; anda reagent layer applied to a carrier side of the carrier film and to which bodily fluid can be applied;wherein the carrier film can be positioned in the beam path of a photometric measuring unit for optically scanning the reagent layer, further wherein the carrier film comprises a raised surface structure configured to reduce reflections in the beam path of the measuring unit.2. The analytic test unit as claimed in claim 1 , wherein the surface structure continuously changes the refractive index of the carrier film in the direction of the surface normal or forms optics for deflecting disturbing reflections out of the beam path of the measuring unit.3. The analytic test unit as claimed in claim 1 , wherein the raised surface structure is arranged on the carrier side and/or on the rear side of the carrier film and faces away from the carrier film and can be directed at the measuring unit.4. The analytic test unit as claimed in claim 1 , wherein the raised surface structure is arranged on the carrier side of the carrier film and forms a moth's eye structure.5. The analytic test unit as claimed in claim 1 , wherein the surface structure has a structure ...

BODY FLUID MONITORING AND SAMPLING DEVICES AND METHODS

An integrated monitoring and body fluid sampling device constructed to permit digital as well as alternate-site body fluid sampling and analysis, the device comprising: a housing; at least one skin-penetration member; and a member constructed for the application of circumferential or vacuum pressure to an appendage; wherein the member is detachably or retractably connected to the housing in a manner such that the integrated monitoring and body fluid sampling device can perform digital or alternate-site body fluid sampling and analysis. Additional arrangements and techniques are also described. 138.-. (canceled)39. A method for sampling a body fluid from a digit:positioning the digit between a first arm and a second arm of a catalyst device;moving the digit relative to the catalyst device to apply pressure to the digit with the catalyst device near a sampling site of the digit; andpiercing the sampling site with a skin penetration member of a sampling device to collect a sample of the body fluid.40. The method of wherein the sampling device comprises a housing claim 39 , wherein the housing comprises a footprint.41. The method of further comprising positioning the digit relative to the footprint.42. The method of wherein the catalyst device comprises a U-shaped channel comprising the first and second arms.43. The method of wherein the sampling device comprises a mechanism for moving the catalyst device relative the digit claim 39 , and wherein moving the digit relative to the catalyst device comprises moving the catalyst device with the mechanism.44. The method of wherein the mechanism comprises a motor and a linkage connecting the catalyst device to the linkage. The present invention relates to devices, arrangements and methods involving body fluid sampling with the assistance of a catalyst. In certain embodiments, the present invention is directed to integrated monitoring and body fluid sampling devices and methods that permit both digital and alternative-site body ...

LANCET CARTRIDGE

A lancet cartridge is provided with a skin contact section that is held in the interior of a lancet holder and that includes a second pricking opening. A first pricking opening is formed to a size such that a skin contact section can be accommodated therein. Upon pressing in the pricking direction, the skin contact section is accommodated in the first pricking opening, and the leading end section of a pricking member protrudes through the second pricking opening. 1. A lancet cartridge provided with:a lancet that moves along a pricking track in a pricking direction and that has a pricking member having a leading end section for pricking skin, and a main body section to which a rear end section of the pricking member is fixed; anda lancet holder that accommodates the lancet and that has a first pricking opening at a leading end,the lancet cartridge further having:a skin contact section, held in the interior of the lancet holder, and having a second pricking opening;wherein the first pricking opening is formed to a size such that the skin contact section can be accommodated therein,the lancet cartridge being configured such that when the skin contact section is pressed in the pricking direction, the skin contact section is accommodated in the first pricking opening, and the leading end section of the pricking member protrudes through the second pricking opening.2. The lancet cartridge according to claim 1 , further comprising:a protective section that is connected to the skin contact section and that covers the leading end section of the pricking member; anda coupling section that connects the protective section and the main body section so as to cover the periphery of the pricking member,wherein when the protective section is pressed in the pricking direction together with the skin contact section, in a state where the main body section is fixed to the lancet holder, the coupling section breaks and the protective section separates from the main body section, and ...

Low pain penetrating member

Reducing the volume or drag on skin or sharpness of the penetrating member entering the wound during the cutting process will reduce the pain associated with lancing, and result in less power desired for retraction of the penetrating member from the skin. A variety of other penetrating member configuration as shown in the application.

CONICAL TIP POLYMERIC LANCET

A lancet having a conical body incorporating multiple lancet gauge levels defining specific penetration depths to generate varying sample production. The conical body has a narrow tip and a large base, and may be formed of a polymeric material. 1. A lancet comprising:a lancet body; anda lancet tip comprising generally conical tip element having a tapered surface extending between a sharp apex and a wider base, the tapered surface configured to define a plurality of different lancet gauge levels corresponding to a plurality of different penetration depths.2. The lancet of claim 1 , wherein the body tapered surface comprises a slope that is configured to define a change in penetration depth that is substantially equivalent to a change in gauge level.3. The lancet of claim 1 , wherein the body tapered surface comprises a consistent slope.4. The lancet of claim 1 , wherein the body tapered surface comprises a continuously-variable slope.5. The lancet of claim 1 , wherein the body comprises a conical geometry with a tip angle of between about 2°-10°.6. The lancet of claim 1 , comprising a tip height of between about 2 mm to about 6 mm.7. A lancet comprising:a lancet body; anda sharp tip projecting from the lancet body and comprising a polymeric material, the sharp tip comprising an acutely-angled tapering outer surface and a base comprising a surface area that is larger than the sharp tip.8. The lancet of claim 7 , wherein the sharp tip is integrally formed with the lancet body as a unitary piece.9. The lancet of claim 7 , wherein the sharp tip outer surface has a smooth and continuous taper.10. The lancet of claim 7 , wherein the sharp tip has a substantially conical geometry.11. The lancet of claim 1 , wherein the sharp tip outer surface taper comprises a plurality of different penetration depth zones and a slope that is configured to change one standard lancet gauge level with a change in one penetration depth zone.12. A method of controlling penetration depth of a ...

Allowing measurements to be made of a blood sample

An apparatus and a method for measuring a property of a blood sample is shown. The apparatus comprises of a housing having an aperture; a shaft mounted inside the housing; a testing member rotatably mounted on the shaft; an actuating member coupled to the housing and configured to exert a force against the testing member; and a lancet for eliciting a blood sample fixedly coupled to and protruding substantially radially from the testing member and configured to co-rotate with the testing member. The apparatus is further configured such that the lancet is aligned with the aperture in the housing when the testing member is in a first position. The testing member is configured, in the presence of a force exerted against the testing member by the actuator member, to translate to a second position in which the lancet is in a skin penetrating position.

Providing an id-verified blood test

Providing an ID-verified blood test, in one aspect, may include enabling a user to press a finger against a fingerprint-reading panel and reading a fingerprint of the user. A blood sampling device coupled to the fingerprint-reading panel may be activated while the user has the finger against the fingerprint-reading panel to sample blood from the finger. Blood may be sampled from the user via the blood sampling device while the user has the finger against the fingerprint-reading panel. A test may be performed on the sampled blood to determine a level of specified chemical in the blood. User identification may be determined based on the fingerprint. The determined user identification and the level of the specified chemical may be returned.

Safe and convenient, disposable automatic lancet

An improved safe and convenient disposable automatic lancet, comprising a housing ( 1 ), a needle core ( 2 ), a spring ( 3 ) and a protective rod ( 4 ), wherein, a pressing arm of a trigger button ( 10 ) is divided into a first pressing leg ( 11 ) and a second pressing leg ( 19 ), and the first pressing leg ( 11 ) is used for triggering an elastic arm in a locking structure to form a press-type trigger structure, and the second pressing leg ( 19 ) fits with a safety sleeve ( 20 ) and a press-down channel ( 17 ) to achieve a safety function of the trigger button ( 10 ); a barb ( 12 ) on the second pressing leg ( 19 ) fits with a self-locking hook ( 13 ) on the housing ( 1 ) so as to achieve a self-locking function after one press. In order to shorten the exposed needle length of a needle body on the needle core ( 2 ), in the automatic lancet, the distance between the second pressing leg ( 19 ) and the needle tip ( 7 ) is designed to be less than the distance between the first pressing leg ( 11 ) and the needle tip ( 7 ). Since the exposed needle length depends on the position of the safety sleeve ( 20 ), the exposed needle length is shortened, therefore the puncture performance increases, which enables the design of the lancet to be more reasonable and practical.

Sensor module with enhanced capillary flow

A sensor module is disclosed herein. The sensor module includes a main housing defining an analysis zone within the housing. The sensor module also includes a skin piercing member mounted within the main housing. The skin piercing member is movable relative to the main housing between a retracted position and an extended position. The main housing of the sensor module defines a fluid sample flow passage that extends from a sampling end of the main housing to the analysis zone. The fluid sample flow passage includes a funnel structure through which the skin piecing member extends when in the extended position. The fluid sample flow passage also includes capillary flow enhancing slots that extend outwardly from opposite sides of the funnel structure.

Fluid handling cassette

A fluid handling module that is removably engageable with a bodily fluid analyzer is provided. The module may comprise a fluid handling element, and a fluid component separator that is accessible via the fluid handling element and configured to separate at least one component of a bodily fluid transported to the fluid component separator. The fluid handling element may have at least one control element interface.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 119-. (canceled)20. A glucose monitoring system comprising: the glucose sensor, wherein a distal end of the glucose sensor is configured to be inserted under skin of the subject;', 'a distal surface including an adhesive layer, wherein the distal surface is configured to be positioned on the skin of the subject such that the adhesive layer adheres to the skin of the subject;', 'an interior of the insertion assembly including a first spring in a loaded position, a second spring, a sliding member, and a straight track having a length, wherein the sliding member is configured to move only within the straight track; and', wherein the button is further configured to release the first spring from the loaded position upon being pressed, such that the first spring causes the sliding member to move within the straight track along a second axis different from the first axis, wherein the second axis is defined by the length of the straight track,', 'wherein movement of the sliding member within the straight track causes an actuator to advance in a distal direction along an insertion axis different from the first axis and the second axis, wherein advancement of the actuator causes advancement of a sharp and the glucose sensor in the distal direction along the insertion axis such that the distal end of the glucose sensor is inserted under the skin of the subject,', 'wherein the sliding member is further configured to continue moving within the straight track after the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis,', 'wherein the sliding member is operatively engaged with the actuator throughout the movement of the sliding member within the straight track,', 'wherein, the second spring is configured to expand and retract the sharp in a proximal direction along the insertion axis while the distal ...

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 119-. (canceled)20. A glucose monitoring system comprising: the glucose sensor, wherein a distal end of the glucose sensor is configured to be inserted under skin of the subject;', 'a distal surface including an adhesive layer, wherein the distal surface is configured to be positioned on the skin of the subject such that the adhesive layer adheres to the skin of the subject;', 'an interior of the insertion assembly including a first spring in a loaded position, a second spring, a sliding member, and a straight track having a length, wherein the sliding member is configured to move only within the straight track; and', wherein the button is further configured to release the first spring from the loaded position upon being pressed, such that the first spring causes the sliding member to move within a first section of the straight track along a second axis different from the first axis, wherein the second axis is defined by the length of the straight track,', 'wherein movement of the sliding member within the first section of the straight track causes an actuator to advance in a distal direction along an insertion axis different from the first axis and the second axis, wherein advancement of the actuator causes advancement of a sharp and the glucose sensor in the distal direction along the insertion axis such that the distal end of the glucose sensor is inserted under the skin of the subject,', 'wherein the sliding member is further configured to move within a second section of the straight track, and wherein the movement of the sliding member within the second section of the straight track causes the actuator to move in a proximal direction along the insertion axis,', 'wherein the second spring is configured to expand and retract the sharp in a proximal direction along the insertion axis while the distal end of the glucose sensor ...

Lancet device with depth adjustment and lancet removal system and method

Lancet device includes a housing, a removable front cap mounted to the housing, a lancet holding member, and a trigger. A system is utilized for placing the lancet device in a trigger-set or armed position. A depth adjustment system includes a member that is at least partially rotatably mounted and that has an axis of rotation arranged substantially perpendicular to a center axis of the lancet holding member. An ejection system is utilized for at least one of preventing axial movement of the lancet holding member and removing or ejecting a lancet from the lancet holding member.

METHOD AND SYSTEM FOR PROVIDING AN INTEGRATED ANALYTE SENSOR INSERTION DEVICE AND DATA PROCESSING UNIT

Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is provided. 118-. (canceled)19. An apparatus , comprising:an introducer including a lower portion having a sharp distal end configured for piercing through a skin layer;an analyte sensor; anda guard segment for the analyte sensor and the introducer.20. The apparatus of claim 19 , wherein the guard segment is configured to substantially cover the lower portion of the introducer and a lower portion of the analyte sensor.21. The apparatus of claim 20 , wherein the lower portion of the analyte sensor is disposed within the lower portion of the introducer.22. The apparatus of claim 19 , wherein the guard segment is configured to maintain the lower portion of the introducer and the analyte sensor in a substantially sterile environment.23. The apparatus of claim 19 , wherein the guard segment is configured to be removed from the lower portion of the introducer prior to placement of the sharp distal end and a portion of the analyte sensor through the skin layer.24. The apparatus of claim 19 , further comprising a data processing unit claim 19 , wherein the data processing unit includes an aperture through which the introducer and the analyte sensor pass.25. The apparatus of claim 24 , wherein the aperture comprises a self-sealing aperture.26. The apparatus of claim 24 , wherein the guard segment comprises a proximal end and a distal end claim 24 , wherein the proximal end of the guard segment is adjacent to a bottom surface of the data processing unit.27. The apparatus of claim 26 , wherein the distal end of the guard segment covers the sharp distal end of the introducer.28. The apparatus of claim 26 , further comprising an adhesive patch claim 26 , wherein the adhesive patch includes an opening through which the introducer and the analyte sensor pass.29. The apparatus of claim 28 , wherein the opening of the adhesive patch and the aperture of the data processing unit are ...

Medical device inserters and processes of inserting and using medical devices

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter.

Medical Device Including An Air Evacuation System

Medical device assemblies capable of aspirating liquid into a syringe barrel or other medical devices while evacuating any air from the syringe are described. An exemplary medical device includes a syringe barrel, plunger rod and stopper assembly having an air permeable and liquid impermeable porous portion and structure for forming a vacuum within either the stopper or the plunger rod. Described is a medical device including a syringe barrel, plunger rod and stopper assembly having an air permeable and liquid impermeable porous portion and structure for forming a vacuum within chamber between the stopper and plunger rod wherein the plunger rod includes a sealing edge and is moveable relative to the stopper. Exemplary medical devices may include a vent for allowing air that permeates through the porous portion to escape to atmosphere. Methods for aspirating a syringe barrel with a liquid are also provided.

Lancet ejection and advancement mechanism for multi-lancet cartridge

A lancing device includes an advance-and-eject mechanism with a positioning member for manipulating a series of interconnected lancets. The advance-and-eject mechanism includes an actuator, a control channel, a cam-and-follower mechanism, one or more axial-contact members, and one or more angular-contact members. Actuating the actuator relative to the control channel imparts rotational and axial forces on the positioning member, and the cam-and-follower mechanism selectively restricts rotational and/or axial motion of the positioning member to induce first-stage rotation, second-stage translation, third-stage rotation, and fourth-stage translation. The first-stage rotation rotates the axial-contact members into an interference position, the second-stage translation advances the axial-contact members and the lancet, the third-stage rotation rotates the angular-contact members and the lancet to sever its rearside connection, and the fourth-stage translation advances the axial-contact members and the lancet to a position free of the serial-interconnected lancets thereby ejecting it from the lancing device.

Lancing Actuator

A lancing actuator () includes a drive element () for driving a lancing element, the drive element being guided within a housing (), a combined compression and torsion element () which, by a relaxing movement thereof, is adapted to drive the lancing motion, a combined triggering and driving device () having an actuating element () and a locking device (), wherein the actuating element has an initial state and an actuated state and is accessible from the outside of the housing, wherein, in the initial state, the drive element is locked in the locking device under a torsional stress exerted by the combined compression and torsion element, wherein the combined triggering and driving device is configured in a manner that, when the actuating element makes a movement along an actuation path from the initial state into the actuated state, a torque is exerted on the drive element which prevails over the torsional stress exerted by the combined compression and torsion element such that the drive element is released from the locking device, which results in a triggering of the lancing motion. 1. A lancing actuator for driving a lancing element for sampling a body fluid , comprisinga drive element adapted for driving the lancing element to perform a lancing motion, the drive element being guided within a housing of the lancing actuator,a combined compression and torsion element which, by a relaxing movement of the combined compression and torsion element, is adapted to drive the lancing motion,a combined triggering and driving device having an actuating element and a locking device, wherein the actuating element has an initial state and an actuated state and is accessible from the outside of the housing, wherein, in the initial state, the drive element is locked in the locking device under a torsional stress exerted by the combined compression and torsion element, wherein the combined triggering and driving device is configured in a manner that, when the actuating element ...

ADJUSTABLE LANCET DEVICE AND METHOD

Lancet device that includes a body. A front cover includes a skin engaging end that includes a lancet opening through which a lancet needle extends. A holding member is movably mounted within the body. The holding member includes a front end and a rear end. The front end is configured to receive a lancet. A main spring is disposed between the front and rear ends of the holding member. A first stop surface is arranged on a front portion of the holding member. A second stop surface is axially retained to a front portion of the body. At least partial rotation of the front cover causes the skin engaging end to move axially relative to the second stop surface. 1. A lancet device , comprising:a removable cover comprising a skin engaging end that includes a lancet opening through which a lancet needle may extend;a axially movable holding member comprising a front end and a rear end;the front end being configured to receive a lancet;a first spring disposed between the front and rear ends of the holding member;a first stop surface arranged on a front portion of the holding member;a fixed second stop surface; anda back cap configured to move between a retracted position and an original position,wherein at least partial rotation of the front cover causes the skin engaging end to move axially relative to the second stop surface, andwherein contact between the first and second stop surfaces defines a puncturing position of the lancet needle.2. The lancet device of claim 1 , wherein the back cap is configured to move the holding member to a retracted position.3. The lancet device of claim 1 , wherein the back cap is coupled to a surface that engages the rear end of the holding member.4. The lancet device of claim 1 , wherein the back cap includes a surface that engages the rear end of the holding member.5. The lancet device of claim 4 , wherein the back cap comprises an opening that receives a rear end of the holding member.6. The lancet device of claim 1 , wherein the back cap ...

LANCING DEVICE

A lancing device comprises a lancet drive to cause a lancet to effect a puncturing movement, a housing that encloses the lancet drive, and a touching element with an opening for applying a part of a body in which a prick wound is to be produced, the touching element being movable relative to the lancet drive for the purpose of adjusting the puncturing depth in a puncturing direction. The touching element is connected rotatably by means of a screw thread to an intermediate piece and is movable in the puncturing direction, while the intermediate piece is rotatable and movable relative to the housing. A guide prevents rotation of the touching element relative to the housing, and the touching element is enclosed by the intermediate piece at least over part of its length. 1. A lancing device comprising:a lancet drive adapted to drive a lancet to effect a puncturing movement;a housing that encloses the lancet drive; and the touching element is adapted to directly contact the body when the prick wound is produced,', 'the touching element is rotatably connected by a screw thread to an intermediate piece and is movable in the puncturing direction,', 'the intermediate piece is rotatable relative to the housing,', 'the lancing device comprises a guide that prevents any rotary movement of the touching element relative to the housing, and', 'the touching element is enclosed by the intermediate piece at least over part of its length., 'a touching element comprising an opening for applying to a part of a body in which a prick wound is to be produced, the touching element being movable to adjust the puncturing depth in the puncturing direction relative to the lancet drive, wherein2. The lancing device of claim 1 , wherein the guide comprises a guide element that extends in the puncturing direction and is arranged between two stops relative to which it is movable in the puncturing direction.3. The lancing device of claim 2 , wherein the guide element is configured as a lug disposed ...

TRANSCUTANEOUS ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 1. A sensor system for measuring an analyte concentration in a host , the sensor system comprising:a sensor comprising at least one electrode; andsensor electronics configured to measure the analyte concentration in the host when the sensor is implanted therein, wherein the sensor electronics comprise a data sampling portion in data communication with the at least one electrode, wherein the data sampling portion comprises an analog portion configured to measure the current flowing at the at least one electrode and to convert the current measurement to digital values representative of the current, wherein the digital values are acquired at a predetermined time interval.2. The system of claim 1 , wherein the predetermined time interval is programmed.3. The system of claim 1 , wherein the predetermined time interval is programmable.4. The system of claim 1 , wherein the predetermined time interval is programmable at an interval from about 6 seconds to about 3600 seconds.5. The system of claim 1 , wherein the sensor electronics comprise a transmitter portion for transmitting a signal indicating a level of the analyte in the host at a programmable transmission interval.6. The system of claim 5 , wherein the programmable transmission interval is a multiple of the predetermined time interval.7. The system of claim 5 , wherein the transmission interval is programmable from about 30 seconds to about 60 minutes.8. The system of claim 1 , wherein the sensor electronics are configured to measure the current flow in at least a picoAmp range.9. The system of claim 1 , wherein the sensor electronics comprise an integrated circuit.10. The system of claim 9 , wherein the integrated circuit comprises the data sampling portion.11. The system of claim 1 , wherein ...

VACUUM ASSISTED LANCING SYSTEM WITH ELECTIVE VACUUM RELEASE AND METHOD FOR BLOOD EXTRACTION WITH MINIMAL PAIN

A vacuum assisted lancing system for blood extraction can include a tubular body having a vacuum chamber, a lancing mechanism configured to removably couple with a lance, a vacuum mechanism including a piston slideably coupled within the body, a release mechanism for selectively holding the vacuum mechanism in an energized state, and an opening for allowing fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The system can include means for selectively commencing dissipation of the vacuum and a fixed or adjustable depth controller. A method of manipulating a surface for blood extraction can include coupling the lancing system to the surface, blocking the opening, creating a vacuum, moving the lance coupler from a first position distal from the surface to a second position proximal to the surface, maintaining the vacuum for a period of time, and commencing dissipation of the vacuum by unblocking the opening. 1. A vacuum assisted lancing system for blood extraction , comprising:a tubular body having a central longitudinal axis, a lancing end and a free end;a lancing mechanism coupled with the body and configured to removably couple with a lance;a vacuum mechanism coupled with the body and including a piston slideably coupled within the body so that a vacuum chamber is formed between the piston and the lancing end of the body;a release mechanism configured to selectively hold the vacuum mechanism in an energized state; andan opening through the body between the piston and the lancing end of the body that allows fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber.2. The lancing system of claim 1 , wherein the opening is configured to be sealingly engaged by a user so that the user can selectively block and unblock the opening.3. The lancing system of claim 1 , wherein the release mechanism further comprises a release claim 1 , and wherein the opening is disposed in the release.4. ...

BLOOD COLLECTION APPARATUS

A blood collection apparatus is provided with a blood collection assembly including blood collection tubes, adapter assemblies each including a first tube extending out of one end and a second tube extending out of the end to insert into one of the blood collection tubes, and a casing tube including a forward nose, connectors each connected to the first tube of each adapter assembly, and a rear flange having a flexible projection; a butterfly needle assembly mounted to the nose of the casing tube; and a plunger slidably disposed in the casing tube and including a forward plug and an elongated arm having cavities. A pulling of the plunger moves the plug rearward and pivots the projection to engage in one cavity so as to flow blood from the tube casing to one blood collection tube via one connector and one adapter assembly.

Contact Activated Lancet Device

A lancet device including a housing and a lancet structure having a puncturing element. The lancet structure disposed within the housing and adapted for movement between a retaining or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releasing the lever from interference engagement with the lancet structure.

VACUUM ASSISTED LANCING SYSTEM WITH ELECTIVE VACUUM RELEASE AND METHOD FOR BLOOD EXTRACTION WITH MINIMAL PAIN

A vacuum assisted lancing system can include a tubular body having a vacuum chamber, a lancing mechanism configured to removably couple with a lance, a vacuum mechanism including a piston slideably coupled within the body, a release mechanism for selectively holding the vacuum mechanism in an energized state and an opening for allowing fluid communication between the vacuum chamber and an atmosphere. A method of manipulating a surface for blood extraction can include coupling a lancing system to the surface, blocking an opening, creating a vacuum, moving a lance coupler from a first position distal from the surface to a second position proximal to the surface, maintaining the vacuum for a period of time and commencing dissipation of the vacuum by unblocking the opening. 120-. (canceled)21. A vacuum assisted lancing system for blood extraction , comprising:a tubular body having a central longitudinal axis;a lancing end;a free end longitudinally opposite the lancing end;a lancing mechanism coupled with the body and configured to removably couple with a lance;a vacuum mechanism coupled with the body and including a piston slideably coupled within the body;a vacuum chamber between the piston and the lancing end;a release mechanism configured to selectively hold the vacuum mechanism in an energized state; andan opening between the piston and the lancing end that allows air to flow into the vacuum chamber from an atmosphere surrounding the system.22. The lancing system of claim 21 , wherein the opening is configured to be sealingly engaged by a user's fingertip for selectively blocking and unblocking the opening.23. The lancing system of claim 21 , wherein the release mechanism comprises a release and wherein the opening is disposed in the release.24. The lancing system of claim 23 , wherein the opening is configured to be at least partially blocked when the release is in an activated position.25. The lancing system of claim 21 , further comprising a valve coupled to the ...

METHOD FOR PENETRATING TISSUE

A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface. 1. A method for injecting an agent to a tissue site , comprising:measuring an amount of elastic tenting of skin of the body part when a penetrating member depresses the skin in a direction inward below a surface of the skin to determine elasticity of the skin;storing in a processor the amount of elastic tenting of the skin;selecting a driver profile from a set of alternative driver profiles stored in the processor that includes elastic tenting of the skin and a depth setting using stored tenting information in the processor, which is dependent on a value of the measured amount of elastic tenting and influences the injection of the agent;settling at the depth setting for a certain period of dwell time before starting to withdraw from the withdrawal site;injecting an agent;wherein the dwell time is related to the amount of elastic tenting of the skin depressed by the penetrating member trying to puncture the surface of the skin and variance in skin deformation.2. The method of claim 1 , wherein selecting a setting includes determining at least one of the penetrating member position and acceleration.3. A method for injecting an agent to a tissue site claim 1 , comprising:measuring an amount of elastic tenting of skin of the body part when a penetrating member depresses the skin during a number of agent injections, the elastic skin tenting being in a direction inward below a surface of the skin;storing in a processor the amount of elastic tenting of the skin;selecting a driver profile from a set of alternative driver profiles stored in the processor that includes ...

Safety lancing device

A kind of safety lancing device has a front cap and lancet holder with feature: the front cap and lancet holder are connected in insert-plug type, and the front cap is equipped with connecting block at connection end and the lancet holder is equipped with slot at connection end. And the slot includes slideable slot and deadlock slot. The slideable slot is located in front of deadlock slot. The latch is set at the flexible arm end of ejection pin and the latch is equipped with bayonet at the front end and equipped with latch hook at rear end; the width of slideable slot and deadlock slot is larger than that of latch; the slideable slot is equipped with a blocking shoulder at rear end and the deadlock slot is equipped with latching shoulder at front end.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. 119-. (canceled)20. A glucose monitoring system comprising: the glucose sensor, wherein a distal end of the glucose sensor is configured to be inserted under skin of the subject;', 'a distal surface including an adhesive layer, wherein the distal surface is configured to be positioned on the skin of the subject such that the adhesive layer adheres to the skin of the subject;', 'an interior of the insertion assembly including a first spring in a loaded position, a second spring, a sliding member, and a straight track having a length, wherein the sliding member is configured to move only within the straight track; and', wherein the button is further configured to release the first spring from the loaded position upon being pressed, such that the first spring causes the sliding member to move within the straight track along a second axis different from the first axis, wherein the second axis is defined by the length of the straight track,', 'wherein movement of the sliding member within the straight track causes advancement of a sharp and the glucose sensor in a distal direction along an insertion axis different from the first axis and the second axis such that the distal end of the glucose sensor is inserted under the skin of the subject,', 'wherein the sliding member is further configured to continue moving within the straight track after the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis,', 'wherein the second spring is configured to expand and retract the sharp in a proximal direction along the insertion axis while the distal end of the glucose sensor remains under the skin of the subject, and wherein expansion of the second spring does not stop before the sliding member has stopped moving,', 'wherein the second spring is a compression spring, and', 'wherein the glucose sensor is ...

Analyte sensors, systems, testing apparatus and manufacturing methods

In some aspects, an analyte sensor is provided for detecting an analyte concentration level in a bio-fluid sample. The analyte sensor may include one or more conductors received in a hollow portion of a hollow member. The first conductor may be made, at least in part, of a semiconductor material and an active region may be provided in contact with at least the first conductor. The analyte sensor may, in one aspect, include a lancet and an integrated sensor. Manufacturing methods and apparatus and systems utilizing the analyte sensors are provided, as are numerous other aspects.

Medical device inserters and processes of inserting and using medical devices

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

Apparatus for Eliciting a Blood Sample

The present application relates to an apparatus for eliciting a blood sample. The apparatus has a housing having an aperture. A shaft extends in the housing and a testing member is mounted on the shaft which rotates with the shaft. A lancing member is pivotably mounted to the testing member and a lancet protrudes from the lancing member. The lancing member is arranged to pivot relative to the testing member from a retracted position to a skin penetrating position in which the lancet extends into or through the aperture when the testing member is rotated so that the lancing member is coincident with the aperture. 116-. (canceled)17. An apparatus for eliciting a blood sample comprising:a housing having an aperture;a shaft extending in the housing;a testing member mounted on the shaft and configured to rotate with the shaft;a lancing member pivotably mounted to the testing member; anda lancet protruding from the lancing member;wherein the lancing member is configured to pivot relative to the testing member from a retracted position to a skin penetrating position in which the lancet extends into or through the aperture when the testing member is rotated so that the lancing member is coincident with the aperture.18. An apparatus according to claim 17 , further comprising an actuating element configured to act on the lancing member so that the lancing member pivots from a retracted position to a skin penetrating position when the lancing member is coincident with the aperture.19. An apparatus according to claim 18 , wherein the actuating element is configured to bias the lancing member against the housing when the lancing member is in a retracted position.20. An apparatus according to claim 19 , wherein the actuating element is a resilient member configured to act on the lancing member.21. An apparatus according to claim 20 , wherein the actuating element extends from the testing member to act on the lancing member.22. An apparatus according to claim 21 , wherein the ...

Electrochemical sensor module

Certain embodiments of a sensor cartridge element include a sensor module, an electrode arrangement installed on the sensor module, and a delivery arrangement securely coupled to the sensor module. The sensor module includes an analysis cell and a skin piercing member. The electrode arrangement generates an electrical signal when exposed to a fluid sample collected in the analysis cell. The delivery arrangement includes a drug reservoir, a piston chamber, and a valve arrangement providing selective fluid communication between the drug reservoir and the piston chamber. Metering electronics and an actuator can manage collection of fluid samples and/or dispensing of drug doses.

Contact Activated Lancet Device

A lancet device including a housing and a lancet structure having a puncturing element. The lancet structure disposed within the housing and adapted for movement between a retaining or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releasing the lever from interference engagement with the lancet structure.

Body fluid sampling arrangements

An arrangement for producing a sample of body fluid from an opening created in a skin surface at a sampling site including a cartridge with a plurality of compartments and a plurality of sampling sites, and a detector assembly. Each sampling site includes a skin-penetration member having a first end configured to pierce the surface of the skin and an inner lumen in communication with the first end, a spring actuator operatively associated with the skin-penetration member, and a needle hub connecting the skin-penetration member and the spring actuator. The needle hub includes a reagent pad and the spring actuator is configured to drive the skin-penetration member to form the wound opening. Each compartment at least partially encloses the skin-penetration member, the spring actuator, and the needle hub of a respective sampling site.

Methods and Structures for Assembling Lancet Housing Assemblies for Handheld Medical Diagnostic Devices

A method of assembling a lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is disclosed. The method includes forming a plurality of lancet structures in a lancet sheet. The lancet sheet has a removable ledge for releasing the lancet structures. The removable ledge of the lancet sheet is flexed for releasing the lancet structures from the removable ledge. 1. A lancet sheet providing multiple lancets for a lancet housing assembly for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient , the lancet sheet comprising:a removable ledge formed of material forming the lancet sheet;a plurality of lancet structures formed of material forming the lancet sheet, the plurality of lancet structures comprising a skin penetrating end and a blood transport portion adjacent the skin penetrating end, wherein the skin penetrating end is shaped and sized to penetrate the patient's skin at the skin site to provide an amount of blood; anda plurality of spring components formed of material that forms the lancet sheet that releasably connect the plurality of lancet structures to the removable ledge.2. The lancet sheet of claim 1 , wherein the plurality of spring components comprise:an attachment spring arm connected to a lancet structure of the plurality of lancet structures; anda ledge attachment arm that connects the attachment spring arm to the removable ledge.3. The lancet sheet of claim 2 , wherein the attachment spring arm is connected to the lancet structure by a lancet attachment arm claim 2 , wherein the lancet attachment arm is connected at a first end of the attachment spring arm claim 2 , the attachment spring arm being connected at a second opposite end to the ledge attachment arm.4. The lancet sheet of claim 3 , wherein the lancet attachment arm is connected to the lancet structure by a breakable finger.5. ...

BLOOD GLUCOSE MANAGEMENT

This disclosure provides equipment and processes for blood glucose management. Embodiments may comprise a lancet device that includes a base that supports a lancet and a cover. The cover can move controllably from an un-depressed position to a depressed position when a predetermined force is applied. The cover can provide access to the lancet in the depressed position. In another aspect, a biological test kit may include a reusable module and a disposable module. The disposable module may include one or more lancet devices such as that described above to collect a biological sample, one or more strip stations supporting biological strips and a disposable module connector. The reusable module may support measuring equipment to measure a property of the biological sample and a reusable module connector that engages removably with the disposable module connector. 1. A lancet device comprising:(a) a base that includes a support surface;(b) a lancet supported by the base and extending away from the support surface at an angle of approximately 90°;(c) a cover that includes (i) a peripheral edge along which the cover is connected to the base, (ii) a cover region configured to cover the lancet when the cover is in an un-depressed position, the cover region having a cover region geometry, (iii) a lancet aperture through which the lancet is configured to protrude when the cover is in a depressed position, and (iv) a peripheral hinge near the peripheral edge, the peripheral hinge having a peripheral hinge geometry that differs from the cover region geometry to facilitate controlled movement of the cover from the un-depressed position to the depressed position upon application of a predetermined depression force.226-. (canceled) This application claims priority to provisional application U.S. Ser. No. 61/817,172 filed Apr. 29, 2013, the disclosure of which is hereby incorporated by reference herein in its entirety.This disclosure relates to technology for collecting biological ...

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 1. An analyte monitoring system , the system comprising: a first wire comprising a working electrode configured to generate a signal indicative of an analyte concentration;', 'a second wire comprising a reference electrode; and', 'a third wire comprising a counter electrode; and, "an electrochemical sensor configured to measure a level of an analyte in a biological sample from a patient, wherein the biological sample is a tear, wherein the sensor is configured to be fastened to a portion of a patient's body, wherein the sensor is configured to be powered by inductive coupling, wherein the sensor comprises:"}sensor electronics configured to operatively connect to the sensor, wherein the sensor electronics are configured to process data obtained from the sensor.2. The system of claim 1 , wherein the first wire claim 1 , second wire claim 1 , and third wire are formed of metal.3. The system of claim 1 , wherein the first wire comprises platinum.4. The system of claim 1 , wherein the second wire comprises silver/silver chloride.5. The system of claim 1 , wherein the third wire comprises platinum.6. The system of claim 1 , wherein at least one of the first wire claim 1 , second wire claim 1 , or third wire is in a coiled configuration during sensor use.7. The system of claim 1 , wherein the sensor further comprises a membrane comprising an enzyme configured to react with the analyte claim 1 , wherein at least a portion of the working electrode is covered by the membrane.8. The system of claim 7 , wherein the enzyme is configured to react with glucose to produce hydrogen peroxide.9. The system of claim 8 , wherein the working electrode is configured to oxidize hydrogen peroxide to generate the signal indicative of the analyte concentration.10. The ...

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 1. An analyte monitoring system , the system comprising: a first wire comprising a working electrode configured to generate a signal indicative of an analyte concentration;', 'a second wire comprising a reference electrode; and', 'a third wire comprising a counter electrode; and, "an electrochemical sensor configured to measure a level of an analyte in a biological sample from a patient, wherein the biological sample is a tear, wherein the sensor is configured to be fastened to a portion of a patient's body, wherein the sensor is configured to be powered by inductive coupling, wherein the sensor comprises:"}sensor electronics configured to operatively connect to the sensor, wherein the sensor electronics are configured to process data obtained from the sensor.2. The system of claim 1 , wherein the first wire claim 1 , second wire claim 1 , and third wire are formed of metal.3. The system of claim 1 , wherein the first wire comprises platinum.4. The system of claim 1 , wherein the second wire comprises silver/silver chloride.5. The system of claim 1 , wherein the third wire comprises platinum.6. The system of claim 1 , wherein at least one of the first wire claim 1 , second wire claim 1 , or third wire is in a coiled configuration during sensor use.7. The system of claim 1 , wherein the sensor further comprises a membrane comprising an enzyme configured to react with the analyte claim 1 , wherein at least a portion of the working electrode is covered by the membrane.8. The system of claim 7 , wherein the enzyme is configured to react with glucose to produce hydrogen peroxide.9. The system of claim 8 , wherein the working electrode is configured to oxidize hydrogen peroxide to generate the signal indicative of the analyte concentration.10. The ...

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 112-. (canceled)13. A system for measuring an analyte concentration in a host , the system comprising:a transcutaneous analyte sensor; andsensor electronics configured to operatively connect to the transcutaneous analyte sensor.14. A method for processing data from a transcutaneous analyte sensor , the method comprising:receiving sensor data indicative of an analyte concentration in the host; andprocessing, using a processor, the sensor data. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 16/924,117, filed Jul. 8, 2020, which is a continuation of U.S. application Ser. No. 16/691,358, filed Nov. 21, 2019, now U.S. Pat. No. 10,709,362, which is a continuation of U.S. application Ser. No. 16/674,610, filed Nov. 5, 2019, now U.S. Pat. No. 10,722,152, which is a continuation of U.S. application Ser. No. 16/392,521, filed Apr. 23, 2019, which is a continuation of U.S. application Ser. No. 14/590,483, filed Jan. 6, 2015, now U.S. Pat. No. 10,314,525, which is a continuation of U.S. application Ser. No. 13/909,962, filed Jun. 4, 2013, now U.S. Pat. No. 9,247,900, which is a continuation of U.S. application Ser. No. 11/360,262, filed Feb. 22, 2006, now U.S. Pat. No. 8,615,282. Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a part of this specification. The aforementioned application is incorporated by reference herein in its entirety, and is hereby expressly made a part of this specification.The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, ...

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 112-. (canceled)13. A system for measuring an analyte concentration in a host , the system comprising:a transcutaneous analyte sensor; andsensor electronics configured to operatively connect to the transcutaneous analyte sensor.14. A method for processing data from a transcutaneous analyte sensor , the method comprising:receiving sensor data indicative of an analyte concentration in the host; andprocessing, using a processor, the sensor data. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 16/924,117, filed Jul. 8, 2020, which is a continuation of U.S. application Ser. No. 16/691,358, filed Nov. 21, 2019, now U.S. Pat. No. 10,709,362, which is a continuation of U.S. application Ser. No. 16/674,610, filed Nov. 5, 2019, now U.S. Pat. No. 10,722,152, which is a continuation of U.S. application Ser. No. 16/392,521, filed Apr. 23, 2019, which is a continuation of U.S. application Ser. No. 14/590,483, filed Jan. 6, 2015, now U.S. Pat. No. 10,314,525, which is a continuation of U.S. application Ser. No. 13/909,962, filed Jun. 4, 2013, now U.S. Pat. No. 9,247,900, which is a continuation of U.S. application Ser. No. 11/360,262, filed Feb. 22, 2006, now U.S. Pat. No. 8,615,282. Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a part of this specification. The aforementioned application is incorporated by reference herein in its entirety, and is hereby expressly made a part of this specification.The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, ...

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 112-. (canceled)13. A system for measuring an analyte concentration in a host , the system comprising:a transcutaneous analyte sensor; andsensor electronics configured to operatively connect to the transcutaneous analyte sensor.14. A method for processing data from a transcutaneous analyte sensor , the method comprising:receiving sensor data indicative of an analyte concentration in the host; andprocessing, using a processor, the sensor data. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 16/924,117, filed Jul. 8, 2020, which is a continuation of U.S. application Ser. No. 16/691,358, filed Nov. 21, 2019, now U.S. Pat. No. 10,709,362, which is a continuation of U.S. application Ser. No. 16/674,610, filed Nov. 5, 2019, now U.S. Pat. No. 10,722,152, which is a continuation of U.S. application Ser. No. 16/392,521, filed Apr. 23, 2019, which is a continuation of U.S. application Ser. No. 14/590,483, filed Jan. 6, 2015, now U.S. Pat. No. 10,314,525, which is a continuation of U.S. application Ser. No. 13/909,962, filed Jun. 4, 2013, now U.S. Pat. No. 9,247,900, which is a continuation of U.S. application Ser. No. 11/360,262, filed Feb. 22, 2006, now U.S. Pat. No. 8,615,282. Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a part of this specification. The aforementioned application is incorporated by reference herein in its entirety, and is hereby expressly made a part of this specification.The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, ...

Biological Fluid Collection Device and Biological Fluid Separation and Testing System

A biological fluid collection device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. After collecting the blood sample, the biological fluid collection device is able to transfer the blood sample to a point-of-care testing device or a biological fluid separation and testing device. After transferring the blood sample, the biological fluid separation and testing device is able to separate the plasma portion from the cellular portion and analyze the blood sample and obtain test results. 1. A biological fluid separation device , comprising:a rotatable body having a center of rotation, an outer periphery, and a body inlet, the body inlet adapted to receive a multi-component blood sample;a separation chamber defined within the rotatable body and in fluid communication with the body inlet and having a chamber outlet spaced apart from the body inlet, the separation chamber adapted to receive the multi-component blood sample; anda blood component chamber defined within the rotatable body and in fluid communication with the chamber outlet,wherein when the separation chamber contains the multi-component blood sample and a rotational force is applied to the rotatable body, a first blood component of the multi-component blood sample passes from the separation chamber into the blood component chamber and a second blood component of the multi-component blood sample is retained within the separation chamber,wherein the blood component chamber is disposed adjacent the center of rotation and the separation chamber is disposed adjacent the outer periphery of the rotatable body, andwherein the body inlet includes an engagement portion configured to receive a transfer device for closed transfer of a multi-component blood sample to the separation device.2. The biological fluid separation device of claim 1 , wherein the first blood component is a plasma component of the multi-component blood sample and the second blood component is a ...

LANCING DEVICE WITH VIBRATION ABSORPTION MECHANISM

A lancing device includes a main body and a replaceable lancet. A front cover is detachably mounted to a front end of the main body and formed by a shell and a positioning member connected inside the shell for receiving the lancet. A shock absorber is mounted in between the shell and the positioning member. When the lancet is fired by a built-in percussion unit of the main body to move forward, the front end of the lancet collides with a stop portion of the positioning member, and the lancet stops movement and instantaneously retracts. Meanwhile, most or all of the vibrational energy generated when the front end of the lancet collides with the positioning member can be absorbed by the shock absorber. In this way, the vibration in the process of the blood sampling can be reduced to further minimize the pain felt by the testee. 1. A lancing device comprising a main body and a front cover mounted to a front end of the main body , the front cover being formed of a shell and a positioning member connected inside the shell , a lancet being slidably mounted inside the positioning member , the lancing device being characterized in that a shock absorber mounted in-between the shell and the positioning member.2. The lancing device as defined in claim 1 , wherein the shock absorber surrounds the positioning member.3. The lancing device as defined in claim 2 , wherein the shock absorber is a hollow resilient member.4. The lancing device as defined in claim 3 , wherein the hollow resilient member is made of rubber or a thermoplastic flexible material.5. The lancing device as defined in claim 3 , wherein the shock absorber comprises at least one rubber ring mounted to an external periphery of a front section of the positioning member along the moving direction of the lancet.6. The lancing device as defined in claim 5 , wherein the at least one rubber ring is two in number and the two rubber rings are spaced from each other claim 5 , the other rubber ring being mounted to an ...

Methods, Systems, and Devices Relating to Open Microfluidic Channels

The various embodiments described herein relate to fabricating and using open microfluidic networks according to methods, systems, and devices that can be used in applications ranging from home-testing, diagnosis, and research laboratories. Open microfluidic networks allow the input, handling, and extraction of fluids or components of the fluid into or out of the open microfluidic network. Fluids can be inserted into an open microfluidic channel by using open sections of the open microfluidic network. Passive valves can be created in the microfluidic network, allowing the creation of logic circuits and conditional flow and volume valves. The fluid can be presented via the microfluidic network to diagnostic and analysis components. Fluids and components of the fluid can be extracted from the open microfluidic network via functional open sections that are easily interfaced with other microfluidic networks or common laboratory tools.

METHOD AND SYSTEM FOR PROVIDING AN INTEGRATED ANALYTE SENSOR INSERTION DEVICE AND DATA PROCESSING UNIT

Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is provided. 118-. (canceled)19. A method , comprising:piercing a body of a subject with a sharp distal end of an introducer, the introducer having a portion disposed within a housing;positioning a first portion of an analyte sensor in the body of the subject, wherein the first portion of the analyte sensor is at least partially disposed within the introducer prior to positioning the first portion of the analyte sensor, and wherein the analyte sensor includes a second portion coupled in electrical contact with a data processing unit disposed within the housing prior to positioning the first portion of the analyte sensor; andremoving the introducer from the housing after positioning the first portion of the analyte sensor such that the first portion of the analyte sensor remains positioned in the body of the subject.20. The method of claim 19 , further comprising attaching an adhesive layer provided on a lower surface of the housing to the body of the subject.21. The method of claim 20 , further comprising removing a protective layer from the adhesive layer prior to attaching the adhesive layer to the body of the subject.22. The method of claim 19 , wherein the first portion of the analyte sensor is in fluid contact with a biological fluid in the body after removing the introducer from the housing.23. The method of claim 19 , further comprising decoupling the introducer from the data processing unit after the first portion of the analyte sensor is positioned in the body of the subject.24. The method of claim 19 , further comprising receiving claim 19 , by a data communication unit of the data processing unit claim 19 , one or more signals associated with a monitored analyte level from the analyte sensor.25. The method of claim 24 , further comprising wirelessly communicating claim 24 , by the data communication unit claim 24 , data associated with the one or more signals ...

TRANSCUTANEOUS ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 1. A transcutaneous system for measuring an analyte concentration in a host , the system comprising:a sensor adapted for transcutaneous placement through a skin of a host, the sensor comprising a first end and a second end;a housing configured to support the sensor during a period of transcutaneous insertion; andan applicator comprising a needle configured for inserting the sensor into the skin of the host; wherein the needle is capable of inserting the first end of sensor into the host, sliding back over the second end of the sensor, and wherein the needle is configured to be released from the housing during the period of continuous transcutaneous insertion, wherein the first end and second end of the sensor are sized to fully reside within the needle.2. The system of claim 1 , further comprising sensor electronics configured to releasably attach to the housing during the period of transcutaneous insertion.3. The system of claim 1 , wherein the time period of transcutaneous insertion is at least about 3 days.4. A transcutaneous system for measuring an analyte concentration in a host claim 1 , the system comprising:a non-planar sensor adapted for transcutaneous placement through a skin of a host, the sensor comprising a first end and a second end; andan applicator comprising a needle configured for inserting the sensor into the skin of the host, wherein the system is configured such that the needle is capable of inserting the first end of sensor into the host, sliding back over the second end of the sensor, and thereby releasing the sensor from the needle, wherein a portion of the second end of the sensor is configured to provide connectivity between the sensor and sensor electronics.5. The system of claim 4 , wherein the non-planar sensor ...

Biological Fluid Separation Device and Biological Fluid Separation and Testing System

A biological fluid separation device that is adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid separation device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid separation device of the present disclosure also provides a closed separation and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid separation device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results. 1. A biological fluid separation device adapted to receive a multi-component blood sample , the biological fluid separation device comprising:a separation cartridge having an inlet port and a flow channel defined within the cartridge in fluid communication with the inlet port, the flow channel containing a separation element adapted to separate the multi-component blood sample into at least a first component and a second component, a first collection chamber defined within the cartridge in fluid communication with the flow channel and including a first outlet port, and a second collection chamber defined within the cartridge in fluid communication with the flow channel and including a second outlet port, the second collection chamber isolated from the first collection chamber.2. The biological fluid separation device of claim 1 , wherein the first component is a cellular portion of the multi-component blood sample and the second component is a plasma portion of the multi-component blood sample.3. The biological fluid separation ...

Biological Fluid Separation Device and Biological Fluid Separation and Testing System

A biological fluid separation device that is adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid separation device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid separation device of the present disclosure also provides a closed separation and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid separation device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results. 1. A biological fluid separation cartridge , comprising:a housing having an inlet port and a flow channel defined within the housing in fluid communication with the inlet port;a first collection chamber defined within the housing in fluid communication with the flow channel and including a first outlet port having a valve comprising a deformable wall member and a septum, wherein the septum covers the first outlet port; anda second collection chamber defined within the housing in fluid communication with the flow channel and including a second outlet port, the second collection chamber isolated from the first collection chamber, and the second outlet port spaced apart from the first outlet port.2. The biological fluid separation cartridge of claim 1 , wherein the flow channel has a spiral shape.3. The biological fluid separation cartridge of claim 1 , wherein at least a portion of the flow channel contains a sample stabilizer.4. The biological fluid separation cartridge of claim 1 , further comprising an inlet channel in fluid ...

Method and apparatus for penetrating tissue

A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface. 1. A tissue penetrating system , comprising:a housing member;a plurality of penetrating members positioned in the housing member, an electronic penetrating member driver positioned in the housing member for driving each of the plurality of penetrating members;a memory that includes a plurality of penetrating event velocity settings and penetrating event skin tenting profiles;a plurality of sensors, each of the plurality of sensors associated with a penetrating member positioned in the housing member, each of the plurality of sensors configured to receive a body fluid sample in response to a penetrating event of target tissue made with a penetrating member; anda processor positioned in the housing member and coupled to the electronic penetrating member and the memory, the processor accessing penetrating event velocity settings and penetrating event skin tenting profiles from the memory for setting penetration parameters of a penetrating member for a penetrating member penetration event in order to create a puncture wound in the target tissue for a successful penetration achieve a desired amount of blood.2. The system of claim 1 , further comprising:a tissue stabilizing member at an exterior and coupled to the housing and configured to enhance fluid flow from the target tissue to a sample chamber.3. The system of claim 2 , wherein a sample chamber has a volume no greater than 1 μL.4. The system of claim 1 , wherein the memory includes dwell times of the penetrating member in the target tissue.5. The system of claim 1 , wherein the memory includes penetration depths of ...

Piercing device with rotary element

The invention relates to a piercing device for taking blood for medical analyses, comprising a base body, comprising at least one needle which is arranged therein and a tip which can be extended, comprising a needle holding element which encloses the needle at least in part and a drive unit for driving a movement of the needle together with the needle holding element with respect to the base body. 1. A piercing device for taking blood for medical analyses , comprising a base body , comprising at least one needle which is arranged therein and a tip which can be extended , comprising a needle holding element which encloses the needle at least in part and comprising a drive unit for driving a movement of the needle together with the needle holding element with respect to the base body , wherein a rotary element for carrying out a rotary movement is arranged between the drive unit and the needle holding element as a connection element , and the rotary movement , both left and right , respectively brings about the movement of the needle holding element both forwards and backwards.2. The piercing device according to claim 1 , wherein the drive element can be moved linearly and has at least two engagement arms claim 1 , a respective one of which engages in one of at least two projections on the rotary element claim 1 , the other projection being deflectable by means of a curved path on the other engagement arm without said projection taking on an engagement position with the other engagement arm claim 1 , during each rotary movement.3. The piercing device according to claim 2 , wherein the first projection and the first engagement arm claim 2 , as seen in the piercing direction claim 2 , are arranged left of a longitudinal axis which extends through an axis of rotation of the rotary element claim 2 , and the second projection and second engagement arm are arranged right of the longitudinal axis.4. The piercing device according to claim 2 , wherein the rotary element is in ...

SYSTEMS AND METHODS FOR CONDUCTING ANIMAL STUDIES

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications. 1. A method for detecting a biological analyte , comprising:determining an identity of a fluidic device, the fluidic device configured for performing an assay to yield a signal indicative of the presence or concentration of the biological analyte in a sample;receiving a protocol from an external device, the protocol associated with the identity of the fluidic device and for controlling fluid movement caused by actuating elements interacting with the fluidic device to perform the assay;controlling the actuating elements in accordance with the protocol to perform the assay; and the signal indicative of the presence or concentration of the biological analyte in the sample; or', 'an absence of the biological analyte in the sample., 'detecting2. The method of claim 1 , wherein the protocol is a first protocol claim 1 , the assay is a first assay claim 1 , the signal is a first signal claim 1 , and the biological analyte is a first biological analyte claim 1 , the method further comprising:receiving a second protocol from the external device, the second protocol associated with the identity of the fluidic device and for controlling fluid movement caused by the actuating elements interacting with the fluidic device to perform a second assay to yield a second signal indicative of the presence or concentration of a second biological analyte, different from the first biological analyte, in the sample;controlling the actuating elements in accordance with the second protocol to perform the second assay; anddetecting the second signal indicative of the presence or concentration of the second biological analyte in the sample.3. The method of claim 1 , wherein the protocol ...

ANALYTE SENSOR DEVICES, CONNECTIONS, AND METHODS

Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together. 1a first assembly including a portion of an on-body device;a second assembly coupleable to the first assembly to form the on-body device and a sharp supporting a sensor of the on-body device;an applicator assembly releasably coupled to the first assembly; anda container releasably coupled to the second assembly,wherein in response to force applied to the applicator assembly along a longitudinal axis that drives the applicator assembly into the container, the applicator assembly releases and retrieves the second assembly from the container and couples the first assembly to the second assembly to form the on-body device releasably held within the applicator assembly, andwherein the on-body device once held within the applicator assembly is ready to be applied.. An apparatus comprising: The present application is a continuation of U.S. patent application Ser. No. 15/908,616, filed Feb. 28, 2018, which is a continuation of U.S. patent application Ser. No. 15/610,334, filed May 31, 2017, now U.S. Pat. No. 9,931,066, which is a continuation of U.S. patent application Ser. No. 15/193,499, filed Jun. 27, 2016, now U.S. Pat. No. 9,693,713, which is a continuation of U.S. patent application Ser. No. 13/710,460, filed Dec. 11, 2012, now U.S. Pat. No. 9,402,570, which claims priority to U.S. Provisional Application No. 61/569,287, filed Dec. 11, 2011, all of which are incorporated herein by reference in ...

DELIVERING AND/OR RECEIVING FLUIDS

The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. A deployment actuator may actuate the flow activator in a deployment direction, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, a device actuator may enable fluid communication between the opening and the vacuum source and the flow activator may be actuated after the enablement of fluid communication. 130-. (canceled)31. A device for receiving fluid from a subject , comprising:a device actuator;a housing including an opening to receive fluid into the housing;a flow activator comprising at least one needle;a vacuum source;a deployment actuator configured to move the flow activator in a deployment direction;an effector and an effector guide, wherein the effector is guided in motion via the effector guide in the deployment direction and a retraction direction, wherein the deployment actuator is held by the effector; anda retraction actuator configured to move the effector in the retraction direction.32. The device of claim 31 , wherein a portion of the deployment actuator is displaceable relative to the effector.33. The device of claim 31 , wherein the effector guide includes a slot that receives the effector claim 31 , wherein the effector moves along the slot in the deployment direction and in the retraction direction.34. The device of claim 31 , wherein the effector guide includes a first slot and a second slot claim 31 , wherein the effector moves along the first slot and the second slot in the deployment direction and the retraction direction.35. The device of claim ...

ADJUSTABLE LANCET AND TEST CARTRIDGE FOR AUTOMATED MEDICAL SAMPLE COLLECTION AND TESTING

A test cartridge includes an adjustable lancet. The adjustable lancet is controlled by a controller. The adjustable lancet automatically detects a subject's finger, adjusts the lancet's height, pricks the finger to draw blood, moves a tube to collect the blood, moves the tube away from the finger, and empties the blood from the tube into a vial or receptacle. The adjustable lancet may include safety features to prevent the lancet to trigger when the subject's fingernail is facing the lancet, to control the amount that the lancet pierces the subject's finger, and/or to prevent the reuse of a test cartridge for multiple persons or multiple times by the same person. The adjustable lancet may include a massager wheel and/or a pressure bar to rub the subject's finger after the finger is pierced to facilitate drawing of the blood from the finger. 1. A sample collection and testing device , comprisinga controller; a finger receptacle;', 'a lancet housing;', 'a lancet attached to an interior of the lancet housing; and', 'a force sensor connected to the finger receptacle for measuring a force applied by the finger receptacle;, 'an adjustable lancet assembly, the adjustable lancet assembly comprising receive a signal indicating a finger of a person is in the finger receptacle;', 'in response to receiving the signal, move the lancet housing to touch the finger;', 'receive a plurality of force measurements from the force sensor;', 'determine that the lancet housing has touched the finger based on an increase in the measured force; and', 'extend the lancet out of the lancet housing to prick the finger after determining that the lancet housing has touched the finger., 'wherein the controller is configured to2. The sample collection and testing device of further comprising:a massager wheel;a shaft connected to the massager wheel; move the lancet housing and the lancet away from the finger receptacle after the lancet is extended out of the lancet housing; and', 'swing the shaft ...

TRANSCUTANEOUS ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 120-. (canceled)21. A sensor system for measuring an analyte concentration in a host , the system comprising:a transcutaneous analyte sensor configured for insertion into a host's tissue, wherein the transcutaneous analyte sensor comprises an in vivo portion and an ex vivo portion, wherein the transcutaneous analyte sensor is configured to measure an analyte concentration in the host;a housing configured to be placed on a skin of the host, wherein the housing is configured to receive the ex vivo portion of the transcutaneous analyte sensor; andan electronics unit comprising a circuit board including a processor configured to process sensor data, wherein the sensor data is associated with the analyte concentration.22. The system of claim 21 , comprising a power source configured to power the electronics unit.23. The system of claim 21 , wherein the electronics unit is operatively connected to the transcutaneous analyte sensor.24. The system of claim 21 , comprising an antenna configured to radiate or receive a radio frequency transmission. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 15/586,134, filed May 3, 2017, which is a continuation of U.S. application Ser. No. 14/576,103, filed Dec. 18, 2014, now U.S. Pat. No. 9,668,682, which is a continuation of U.S. application Ser. No. 12/869,996, filed Aug. 27, 2010, now U.S. Pat. No. 9,451,910, which is a continuation of U.S. application Ser. No. 11/855,101, filed Sep. 13, 2007, now abandoned. Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a part of this ...

SENSOR MODULE WITH ENHANCED CAPILLARY FLOW

A sensor module is disclosed herein. The sensor module includes a main housing defining an analysis zone within the housing. The sensor module also includes a skin piercing member mounted within the main housing. The skin piercing member is movable relative to the main housing between a retracted position and an extended position. The main housing of the sensor module defines a fluid sample flow passage that extends from a sampling end of the main housing to the analysis zone. The fluid sample flow passage includes a funnel structure through which the skin piecing member extends when in the extended position. The fluid sample flow passage also includes capillary flow enhancing slots that extend outwardly from opposite sides of the funnel structure. 1. (canceled)2. A sensor module comprising:a main housing defining an analysis zone within the housing;a skin piercing member mounted within the main housing, the skin piercing member being movable relative to the main housing between a retracted position and an extended position;first and second electrodes positioned at the analysis zone, at least one of the electrodes including analyte sensing chemistry, the analysis zone being sealed to limit a degree to which the sensing chemistry is exposed to air.3. The sensor module of claim 2 , further comprising a fluid sample flow passage that extends from an exterior of the main housing to the analysis zone.4. The sensor module of claim 3 , where the skin piercing member passes through the fluid sample flow passage when in the extended position.5. The sensor module of claim 4 , further comprising a sealing member affixed to the exterior of the main housing which covers the fluid sample flow passage.6. The sensor module of claim 5 , wherein the skin piercing member pierces the sealing member when the skin piercing member is moved to the extended position.7. A sensor module comprising:a main housing defining an analysis zone within the housing, the main housing having a sampling ...

Transcutaneous analyte sensor

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Method and Apparatus for Providing Rolling Data in Communication Systems

Methods and systems for providing data communication in medical systems are disclosed. 1an in vivo glucose sensor that monitors glucose level; andsensor electronics operatively coupled to the glucose sensor to receive and process signals from the glucose sensor, the sensor electronics generating a plurality of data packets for communication to a remote location, each generated data packet including one of a plurality of glucose monitoring device data, each glucose monitoring device data assigned with a communication time slot such that the sensor electronics sequentially communicates the plurality of generated data packets based on the assigned communication time slot, wherein each generated data packet includes the glucose data and the corresponding glucose monitoring device data assigned with the respective communication time slot.. A glucose monitoring device, comprising: The present application is a continuation of U.S. patent application Ser. No. 14/814,236 filed Jul. 30, 2015, now U.S. Pat. No. 9,801,545, which is a continuation of U.S. patent application Ser. No. 13/406,528 filed Feb. 27, 2012, now U.S. Pat. No. 9,095,290, which is a continuation of U.S. patent application Ser. No. 11/681,133 filed Mar. 1, 2007, now U.S. Pat. No. 8,123,686, entitled “Method and Apparatus for Providing Rolling Data in Communication Systems,” the disclosure of which is incorporated herein by reference for all purposes.Analyte, e.g., glucose monitoring systems including continuous and discrete monitoring systems generally include a small, lightweight battery powered and microprocessor controlled system which is configured to detect signals proportional to the corresponding measured glucose levels using an electrometer. RF signals may be used to transmit the collected data. One aspect of certain analyte monitoring systems include a transcutaneous or subcutaneous analyte sensor configuration which is, for example, at least partially positioned through the skin layer of a subject ...

ANALYTE SENSOR DEVICES, CONNECTIONS, AND METHODS

Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together. 164-. (canceled)65. An on-body device , comprising: a proximal section comprising a connector support coupled with a proximal portion of a glucose sensor;', 'a distal tail section comprising a distal portion of the glucose sensor configured to be positioned under a skin surface and in contact with a bodily fluid of a subject;, '(1) a glucose sensor assembly comprising a top portion;', 'a base portion configured to be adhered to the skin surface of the subject by an adhesive patch; and', 'a first space defined by the top portion and the base portion; and, '(2) a housing comprising wherein the base portion of the housing comprises a recess in a bottom exterior surface, the recess comprising a distal-facing opening, wherein the recess defines a second space different from the first space,', 'wherein the connector support is received through the distal-facing opening and into the recess, and', 'wherein the glucose sensor is electrically coupled with the sensor electronics by the connector support when the connector support is received into the recess., '(3) sensor electronics positioned within the first space,'}66. The on-body device of claim 65 , wherein the housing comprises a single integral unit.67. The on-body device of claim 66 , wherein the top portion and the base portion form a single over-molded unit comprising a thermoplastic material claim 66 , and wherein the single over-molded unit ...

ANALYTE SENSOR DEVICES, CONNECTIONS, AND METHODS

Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together. 164-. (canceled)65. A method for assembling an on-body device comprising a glucose sensor assembly , a housing , and sensor electronics ,wherein the glucose sensor assembly comprises a proximal section comprising a connector support coupled with a proximal portion of a glucose sensor,wherein the housing comprises a top portion, a base portion, and a first space defined by the top portion and the base portion, wherein the base portion comprises a recess in a bottom exterior surface, wherein the recess comprises a distal-facing opening, and wherein the recess defines a second space different from the first space, positioning the sensor electronics within the first space of the on-body device, wherein the sensor electronics comprise a processor, a wireless communications facility, a battery, and a printed circuit board;', 'after positioning the sensor electronics within the first space, inserting the connector support through the distal-facing opening of the recess in the bottom exterior surface of the base portion and into the recess, causing the glucose sensor to electrically couple with the sensor electronics., 'the method comprising66. The method of claim 65 , wherein positioning the sensor electronics within the first space comprises injecting a thermoplastic material into a mold to form a single integral unit configured to seal the sensor electronics within the first space.67. The method of ...

Analyte sensor

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 112-. (canceled)13. A system for measuring an analyte concentration in a host , the system comprising:a transcutaneous analyte sensor; andsensor electronics configured to operatively connect to the transcutaneous analyte sensor.14. A method for processing data from a transcutaneous analyte sensor , the method comprising:receiving sensor data indicative of an analyte concentration in the host; andprocessing, using a processor, the sensor data. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 16/924,117, filed Jul. 8, 2020, which is a continuation of U.S. application Ser. No. 16/691,358, filed Nov. 21, 2019, now U.S. Pat. No. 10,709,362, which is a continuation of U.S. application Ser. No. 16/674,610, filed Nov. 5, 2019, now U.S. Pat. No. 10,722,152, which is a continuation of U.S. application Ser. No. 16/392,521, filed Apr. 23, 2019, which is a continuation of U.S. application Ser. No. 14/590,483, filed Jan. 6, 2015, now U.S. Pat. No. 10,314,525, which is a continuation of U.S. application Ser. No. 13/909,962, filed Jun. 4, 2013, now U.S. Pat. No. 9,247,900, which is a continuation of U.S. application Ser. No. 11/360,262, filed Feb. 22, 2006, now U.S. Pat. No. 8,615,282. Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a part of this specification. The aforementioned application is incorporated by reference herein in its entirety, and is hereby expressly made a part of this specification.The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, ...

Cam-Actuated Medical Puncturing Device and Method

The medical puncturing device includes a housing, a shield, and a skin puncturing assembly disposed within the housing. The shield is axially movable in the housing. The skin puncturing assembly includes a movable carrier and a skin puncturing element mounted to the carrier. A distal end of the skin puncturing element is adapted for puncturing the skin of a patient. The carrier is movable from a retracted position wherein the skin puncturing element is disposed within the shield to a puncturing position wherein the distal end of the skin puncturing element is exposed. The carrier is maintained in the retracted position by engagement of flexure members or a retaining tab with the carrier. A drive spring is provided to move the carrier from the retracted position to the puncturing position. A retraction spring is provided to return the carrier and skin puncturing element into the housing. 1. A lancet device , comprising:a housing having a proximal end and a distal end;a shield having a proximal end and a distal end, the shield proximal end disposed within the housing, and the shield being movable relative to the housing;a skin puncturing assembly disposed within the housing and comprising a movable carrier and a skin puncturing element, a distal end of the skin puncturing element adapted for puncturing the skin of a patient, the carrier movable between a first position where the distal end of the skin puncturing element is disposed within the shield, and a second position where the distal end extends out of the shield in a puncturing position;at least one flexure member in one of a first state in which the at least one flexure member engages the carrier to maintain the carrier in the first position, and a second state in which the at least one flexure member does not engage the carrier and the carrier is movable from the first position to the second position;a drive spring disposed within the housing for biasing the carrier from the first position to the second ...

Lancet Device

The lancet device includes a housing and a lancet having a puncturing element. The lancet is disposed within the housing and is adapted for axial movement between an initial or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward opening in the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet toward the puncturing position, and a retraction or return spring for returning the lancet to a position within the housing where the puncturing element is disposed within the housing. The retraction spring thereafter maintains engagement with the lancet to assist in preventing the puncturing element from again projecting outward from the forward opening in the housing. 1. A lancet device , comprising:a housing;a shield movably associated with the housing;a lancet disposed in the housing and comprising a tip, the lancet adapted for axial movement between a first position where the tip is disposed within the shield and a second position where the tip extends through a forward opening in the shield;a drive member disposed at a rearward end of the housing for biasing the lancet to the second position; andan actuator associated with the housing and engaged with the lancet to maintain the lancet in the first position,wherein movement of the shield into the housing causes disengagement of the actuator from the lancet and release of the at least partially compressed drive member thereby enabling the drive member to bias the lancet to the second position.2. The lancet device of claim 1 , wherein the drive member comprises a coil spring positioned between a surface of the housing and the lancet.3. The lancet device of claim 1 , wherein the actuator maintains the drive member in an at least partially compressed state.4. The lancet device of claim 1 , wherein the shield is at least partially disposed within the housing.5. ...

Medical device inserters and processes of inserting and using medical devices

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter.

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 118-. (canceled)19. A transcutaneous analyte sensor system , the system comprising:an analyte sensor configured for transcutaneous insertion through skin of a host;an on-skin device coupled to the sensor and comprising sensor electronics configured to process data obtained from the analyte sensor; anda display device remote from the on-skin device configured to request information from the on-skin device.20. The system of claim 19 , wherein the on-skin device is configured to provide sensor information indicative of a glucose value of the host.21. The system of claim 19 , wherein the on-skin device is configured to provide filtered sensor data.22. The system of claim 19 , wherein the on-skin device is configured to provide calibrated sensor data.23. The system of claim 19 , wherein the sensor electronics are configured to transmit sensor data responsive to the request from the display device.24. The system of claim 23 , wherein the display device comprises a user interface configured to display graphical information associated with the sensor data. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 15/891,201, filed Feb. 7, 2018, which is a continuation of U.S. application Ser. No. 14/293,298, filed Jun. 2, 2014, now abandoned, which is a continuation of U.S. application Ser. No. 13/361,820, filed Jan. 30, 2012, now U.S. Pat. No. 8,968,198, which is a continuation of U.S. application Ser. No. 11/360,250, filed Feb. 22, 2006, now U.S. Pat. No. 8,133,178. Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a ...

TRANSCUTANEOUS ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 1. A sensor system for measuring an analyte concentration in a host , the sensor system comprising:a sensor comprising at least one electrode; andsensor electronics configured to measure the analyte concentration in the host when the sensor is implanted therein, wherein the sensor electronics comprise a data sampling portion in data communication with the at least one electrode, wherein the data sampling portion comprises an analog portion configured to measure the current flowing at the at least one electrode and to convert the current measurement to digital values representative of the current, wherein the digital values are acquired at a predetermined time interval.2. The system of claim 1 , wherein the predetermined time interval is programmed.3. The system of claim 1 , wherein the predetermined time interval is programmable.4. The system of claim 1 , wherein the predetermined time interval is programmable at an interval from about 6 seconds to about 3600 seconds.5. The system of claim 1 , wherein the sensor electronics comprise a transmitter portion for transmitting a signal indicating a level of the analyte in the host at a programmable transmission interval.6. The system of claim 5 , wherein the programmable transmission interval is a multiple of the predetermined time interval.7. The system of claim 5 , wherein the transmission interval is programmable from about 30 seconds to about 60 minutes.8. The system of claim 1 , wherein the sensor electronics are configured to measure the current flow in at least a picoAmp range.9. The system of claim 1 , wherein the sensor electronics comprise an integrated circuit.10. The system of claim 9 , wherein the integrated circuit comprises the data sampling portion.11. The system of claim 1 , wherein ...

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter. 1. An apparatus for inserting a medical device through the skin of a subject , which comprises:a sheath defining a distal surface for placement on the skin of the subject;a device support movable between a proximal and distal position, and adapted to support the medical device, the device support comprising a first engagement member for releasably coupling the device support to the sharp support and a second engagement member for engaging the medical device;a sharp support movable between a proximal and a distal position and adapted to support a sharp for inserting the medical device into the skin of the subject and extending through a portion of said device support, a handle movable between a proximal position and a distal position relative to the sheath and adapted to urge the device support and the sharp support from a proximal to a distal position to insert the sharp into the skin of the subject; anda driver for advancing the sharp support towards the proximal position when the sharp support reaches the distal position.2. The apparatus of claim 1 , wherein the handle and sheath comprise an interlocking configuration which prevents relative movement of the handle with respect to the sheath which is overcome by a force applied to the handle.3. The apparatus of claim 1 , wherein the second engagement member comprises one or more movable arms for engaging the device.4. The apparatus of claim 3 , wherein the one or more movable arms are normally biased in a position spaced apart from the medical device.5. The apparatus of claim 4 , wherein the one or more movable arms are ...

ADJUSTABLE LANCET AND TEST CARTRIDGE FOR AUTOMATED MEDICAL SAMPLE COLLECTION AND TESTING

A test cartridge includes an adjustable lancet. The adjustable lancet is controlled by a controller. The adjustable lancet automatically detects a subject's finger, adjusts the lancet's height, pricks the finger to draw blood, moves a tube to collect the blood, moves the tube away from the finger, and empties the blood from the tube into a vial or receptacle. The adjustable lancet may include safety features to prevent the lancet to trigger when the subject's fingernail is facing the lancet, to control the amount that the lancet pierces the subject's finger, and/or to prevent the reuse of a test cartridge for multiple persons or multiple times by the same person. The adjustable lancet may include a massager wheel and/or a pressure bar to rub the subject's finger after the finger is pierced to facilitate drawing of the blood from the finger. 120.-. (canceled)21. A sample collection and testing device , comprising:a processor;a finger receptacle;a lancet housing;a lancet attached the lancet housing;a set of one or more light sources configured to direct light to the finger receptacle; anda set of one or more light sensors configured to measure light reflected from a person's finger positioned on the finger receptacle;{'claim-text': ['receive light measurements from the set of light sensors;', 'determine, from the light measurements, whether the finger is placed in the finger receptacle such that a fingernail is facing the lancet; and', 'extend the lancet to prick the finger only when the finger is placed in the finger receptacle such that no fingernail is facing the lancet.'], '#text': 'wherein the processor is configured to:'}22. The sample collection and testing device of claim 21 , wherein a portion of the finger receptacle that touches the finger is transparent claim 21 , wherein the set of light sources direct light to the finger receptacle through the transparent portion of the finger receptacle.23. The sample collection and testing device of claim 22 , wherein ...

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 112-. (canceled)13. A system for measuring an analyte concentration in a host , the system comprising: a first component comprising a sensor; and', 'a second component comprising sensor electronics configured to operatively connect to the sensor., 'a sensor system comprising Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 16/392,521, filed Apr. 23, 2019, which is a continuation of U.S. application Ser. No. 14/590,483, filed Jan. 6, 2015, now U.S. Pat. No. 10,314,525, which is a continuation of U.S. application Ser. No. 13/909,962, filed Jun. 4, 2013, now U.S. Pat. No. 9,247,900, which is a continuation of U.S. application Ser. No. 11/360,262, filed Feb. 22, 2006, now U.S. Pat. No. 8,615,282. Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a part of this specification.The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type or non-insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which can cause an array of physiological derangements associated with the deterioration of small blood vessels, for example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye. A hypoglycemic reaction (low blood sugar) can be induced by an inadvertent ...

Biological test kit

The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet.

Compact Fluid Analysis Device and Method to Fabricate

The present disclosure relates to a device for analyzing a fluid sample. In one aspect, the device includes a fluidic substrate that comprises a micro-fluidic component embedded in the fluidic substrate configured to propagate a fluid sample via capillary force through the device and a means for providing a fluid sample connected to the micro-fluidic component. The device also includes a lid attached to the fluidic substrate at least partly covering the fluidic substrate and at least partly closing the micro-fluidic component. The fluidic substrate may be a silicon fluidic substrate and the lid may be a CMOS chip. In another aspect, embodiments of the present disclosure relate to a method for fabricating such a device, and the method may include providing a fluidic substrate, providing a lid, and attaching, through a CMOS compatible bonding process, the fluidic substrate to the lid to close the fluidic substrate at least partly. 1. A device for analyzing a fluid sample , the device comprising: a micro-fluidic component embedded in the fluidic substrate and configured to propagate a fluid sample via capillary force through the micro-fluidic component, and', 'a means for providing a fluid sample connected to the micro-fluidic component; and, 'a fluidic substrate comprisinga lid attached to the fluidic substrate, at least partly covering the fluidic substrate, and at least partly closing the micro-fluidic component,wherein the fluidic substrate is a silicon fluidic substrate,and wherein the lid is a CMOS chip.2. The device according to claim 1 , wherein at least a part of the lid is in contact with the fluid sample when the fluid sample is present in the device.3. The device according to claim 2 , wherein the lid comprises a transistor layer electrically connected to at least one electrical component claim 2 , and wherein the electrical component being at least one of the following biosensing circuitry claim 2 , electrodes for sensing purposes claim 2 , electrodes for ...

Analyte sensor

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 112-. (canceled)13. A system for measuring an analyte concentration in a host , the system comprising:a transcutaneous analyte sensor; andsensor electronics configured to operatively connect to the transcutaneous analyte sensor.14. A method for processing data from a transcutaneous glucose sensor , the method comprising:receiving sensor data from the transcutaneous analyte sensor after the transcutaneous analyte sensor is implanted in a host, wherein the sensor data is indicative of an analyte concentration in the host; andprocessing, using a processor, the sensor data received from the transcutaneous analyte sensor. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 16/674,610, filed Nov. 5, 2019, which is a continuation of U.S. application Ser. No. 16/392,521, filed Apr. 23, 2019, which is a continuation of U.S. application Ser. No. 14/590,483, filed Jan. 6, 2015, now U.S. Pat. No. 10,314,525, which is a continuation of U.S. application Ser. No. 13/909,962, filed Jun. 4, 2013, now U.S. Pat. No. 9,247,900, which is a continuation of U.S. application Ser. No. 11/360,262, filed Feb. 22, 2006, now U.S. Pat. No. 8,615,282. Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a part of this specification. The aforementioned application is incorporated by reference herein in its entirety, and is hereby expressly made a part of this specification.The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods ...

ANALYTE SENSOR DEVICES, CONNECTIONS, AND METHODS

Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.

SYSTEMS AND INTERFACES FOR BLOOD SAMPLING

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood from subjects. In one aspect, the present invention is directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a substance transfer component (for example, one or more needles or microneedles) and a reduced pressure or vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some embodiments, the device may contain a “snap dome” or other deformable structure, which may be used, at least in part, to urge or move needles or other suitable substance transfer components into the skin of a subject. In some cases, for example, the device may contain a flexible concave member and a needle mechanically coupled to the flexible concave member such that the needle may be urged or moved into the skin using the flexible concave member. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter. 125-. (canceled)26. A glucose monitoring assembly , the assembly comprising:(1) an inserter comprising a sharp configured to insert a portion of a transcutaneous glucose sensor into a subject; and an on body electronics unit housing comprising a plurality of recesses disposed on a periphery of the on body electronics unit housing;', 'the transcutaneous glucose sensor; and', 'on body electronics coupled with the transcutaneous glucose sensor, wherein the on body electronics is disposed in the on body electronics unit housing,, '(2) an on body electronics unit, comprising advance the on body electronics unit and the sharp from a proximal position entirely within the inserter to a distal position such that the sharp pierces skin of the subject and the on body electronics unit housing is secured to the skin of the subject in the distal position,', 'automatically retract the sharp from the distal position to a retracted position entirely within the inserter,, 'wherein the inserter is configured towherein the plurality of recesses is detachably engaged with the inserter when the on body electronics unit and the sharp are in the proximal position,wherein the on body electronics unit housing further comprises a top surface and a bottom surface, wherein the top surface comprises an aperture of the top surface and the bottom surface comprises an aperture of the bottom surface, and wherein the sharp extends through the aperture of the bottom surface when the on body electronics unit and the sharp are in the proximal position, andwherein the inserter further comprises a distal end ...

Flash Activated Passive Shielding Needle Assembly

A safety needle device includes a housing including a passageway with a needle cannula extending therefrom. A shielding member is movable between a first position in which a puncture tip of the needle cannula is exposed therefrom and a second position in which the puncture tip of the needle cannula is encompassed therein. The shielding member is maintained in the first position against a biasing force which biases the shielding member toward the second position. A fluid and/or a temperature activation material is associated with the shielding member and is adapted to deform upon contact with a fluid medium and/or a certain temperature or temperature range. The fluid medium flowing through the needle cannula causes the fluid activation material to deform, such as through expansion, thereby releasing the shielding member from the first position and allowing a drive member to bias the shielding member toward the second position. 1. A needle assembly , comprising:a housing including a passageway extending therethrough and a needle cannula having a puncture tip extending from a forward end thereof;a shielding member movable with respect to the housing between a first position in which the puncture tip of the needle cannula is exposed and a second position in which the puncture tip of the needle cannula is shielded by the shielding member, the shielding member maintained in the first position against a biasing force provided by a drive member biasing the shielding member toward the second position;an activation material associated with the shielding member and adapted to deform upon direct contact with a fluid flowing through the passageway of the housing; anda movable actuator located within the passageway,wherein the fluid flowing through the passageway of the housing causes the activation material to deform and cause the actuator to move, thereby releasing the shielding member from the first position and causing the drive member to bias the shielding member toward the ...

BLOOD COLLECTING APPARATUS, LANCET AND LANCING DEVICE

The present invention provides a blood collecting apparatus including a lancet and a lancing device. The lancing device is used for inserting the lancet and triggering the lancet to collect blood. The lancing device includes a housing, a lancet holder, a triggering mechanism, a withdrawing mechanism, a distance adjusting mechanism and a cap. 1. A lancing device for inserting a lancet and triggering the lancet to collect blood , the lancing device comprising:a housing; a lancet fixing mechanism for fixing the lancet when the lancet holder has the lancet inserted therein and moves to the to-be-triggered position;', 'a to-be-triggered position locating device for positioning the lancet holder at the to-be-triggered position; and', 'an elastic element, wherein the elastic element is pressed by a ramp member of the housing to accumulate an elastic force when the lancet holder moves to the trigged position; the elastic element provides the elastic force to retract the lancet holder to the to-be-withdrawn position;', 'a retracting mechanism for retracting the lancet holder to a to-be-withdrawn position when the lancet holder had moved to the triggered position and collected blood, the retracting mechanism comprising], 'a lancet holder disposed in the housing, wherein the lancet holder can move from a to-be-triggered position to a triggered position for triggering the lancet to collect blood, the lancet holder comprises a triggering force providing device for providing a triggering force to move the lancet holder from the to-be-triggered position to the triggered position; and', 'a releasing device for releasing the lancet holder from the to-be-triggered position to let the triggering force move the lancet holder to the triggered position; and, 'a triggering mechanism for triggering the lancet holder to move from the to-be-triggered position to the triggered position to enable the lancet to collect blood, the triggering mechanism comprising a withdrawing rod for pushing the ...

Transcutaneous analyte sensor

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

METHOD AND SYSTEM FOR PROVIDING AN INTEGRATED ANALYTE SENSOR INSERTION DEVICE AND DATA PROCESSING UNIT

Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is provided. 1. An apparatus , comprising:a housing;a data processing unit disposed in the housing;an introducer disposed within the housing and including a portion having a sharp distal end configured for piercing through a skin layer, wherein the portion of the introducer is removed from the housing after piercing through the skin layer; and 'wherein the first portion of the analyte sensor is configured for transcutaneous positioning and in fluid contact with interstitial fluid under the skin layer, and the second portion of the analyte sensor is in electrical contact with the data processing unit prior to transcutaneous positioning of the first portion of the analyte sensor.', 'an analyte sensor including a first portion and a second portion, the first portion of the analyte sensor coupled to the portion of the introducer, and the second portion of the analyte sensor coupled to the data processing unit;'}2. The apparatus of claim 1 , further including an adhesive layer provided on a lower surface of the housing claim 1 , wherein the adhesive layer is configured to removably attach the housing to the skin layer.3. The apparatus of claim 2 , wherein the adhesive layer includes a removable protective layer.4. The apparatus of claim 1 , wherein the portion of the introducer includes a sharp tip for piercing through the skin layer claim 1 , wherein when the sharp tip is pierced through the skin layer claim 1 , the first portion of the analyte sensor is transcutaneously positioned under the skin layer and in fluid contact with the interstitial fluid.5. The apparatus of claim 1 , wherein the introducer is configured to decouple from the data processing unit after the first portion of the analyte sensor is transcutaneously positioned under the skin layer.6. The apparatus of claim 1 , wherein the data processing unit includes a data communication unit configured to receive ...

ANALYTE SENSOR

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. 112-. (canceled)13. A system for measuring an analyte concentration in a host , the system comprising:a transcutaneous analyte sensor; andsensor electronics configured to operatively connect to the transcutaneous analyte sensor.14. A method for processing data from a transcutaneous glucose sensor , the method comprising:receiving sensor data from the transcutaneous analyte sensor after the transcutaneous analyte sensor is implanted in a host, wherein the sensor data is indicative of an analyte concentration in the host; andprocessing, using a processor, the sensor data received from the transcutaneous analyte sensor. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation of U.S. application Ser. No. 16/674,610, filed Nov. 5, 2019, which is a continuation of U.S. application Ser. No. 16/392,521, filed Apr. 23, 2019, which is a continuation of U.S. application Ser. No. 14/590,483, filed Jan. 6, 2015, now U.S. Pat. No. 10,314,525, which is a continuation of U.S. application Ser. No. 13/909,962, filed Jun. 4, 2013, now U.S. Pat. No. 9,247,900, which is a continuation of U.S. application Ser. No. 11/360,262, filed Feb. 22, 2006, now U.S. Pat. No. 8,615,282. Each of the aforementioned applications is incorporated by reference herein in its entirety, and each is hereby expressly made a part of this specification. The aforementioned application is incorporated by reference herein in its entirety, and is hereby expressly made a part of this specification.The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods ...

Analyte sensor

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Blood Sampling Transfer Device

A blood sampling transfer device that includes a lancing tape having a flow channel and a transfer cartridge removably connected to the lancing tape is disclosed. The blood sampling transfer device provides a closed system that reduces the exposure of a blood sample to both skin and environment and provides fast mixing of a blood sample with a sample stabilizer. 1. A blood sampling transfer device , comprising:an adhesive lancing tape having a target, and a flow channel in fluid communication with a portion of the target;a transfer cartridge removably connected to the lancing tape, the transfer cartridge having a reservoir, anda frangible portion integrally formed between the transfer cartridge and the lancing tape such that the transfer cartridge and the lancing tape are detachably connected to one another via the frangible portion,wherein the flow channel is configured to permit a blood sample to flow from the target and through the frangible portion before entering the transfer cartridge,wherein, in a first position when the transfer cartridge is connected to the lancing tape, the reservoir is configured to be in fluid communication with the flow channel, andwherein, in a second position when the transfer cartridge is disconnected from the lancing tape, the transfer cartridge is configured to be separated from the lancing tape.2. The blood sampling transfer device of claim 1 , wherein the target of the lancing tape is aligned with the flow channel to promote flow of the blood sample via capillary action.3. The blood sampling transfer device of claim 1 , wherein the target of the lancing tape is a circular graphic indicator.4. The blood sampling transfer device of claim 1 , wherein the transfer cartridge includes a transfer cartridge flow channel in fluid communication with the reservoir.5. The blood sampling transfer device of claim 4 , wherein the transfer cartridge flow channel comprises a sample stabilizer and the transfer cartridge flow channel is configured ...

MAGNETIC LANCET DEVICE

Embodiments of the present invention provide magnetic lancet devices and methods for driving a lancet. For example, a magnetic lancet device may include a driving mechanism having a plurality of magnets and a lancet coupled to the driving mechanism. A magnetic interaction between the plurality of magnets is configured to drive the lancet from an engaged position to a penetrating position. 130-. (canceled)31. A driving mechanism for driving an object comprising:a plurality of magnets; anda guide tube,wherein at least one of the plurality of magnets is coupled to the guide tube, wherein at least one of the plurality of magnets comprises a carrier magnet coupled to an object and positioned within the guide tube, and wherein a magnetic interaction between the at least one magnet of the guide tube and the carrier magnet is configured to drive the object from the engaged position to the penetrating position.32. The driving mechanism according to claim 31 , wherein the magnetic interaction between the plurality of magnets is configured to be a magnetic repulse interaction for driving the object from the engaged position to the penetrating position. Embodiments of the present invention relate generally to lancet devices and, more particularly, to a lancet device utilizing a magnet driving mechanism.A major objective in educating patients on how to deal with the disease of diabetes is to have them recognize the importance of regularly checking their blood glucose levels. Currently, blood glucose testing meters have advanced to a level requiring a very small blood sample; however, obtaining even a small sample with a lancet device still inflicts unpredictable discomfort that many patients refuse to tolerate. In reality, the initial function of all reusable lancet devices begins to degrade from the first use and gradually tissue penetration depth varies even though the depth settings on the devices remain unchanged. Many lancet device designs involve some form of elastic ...

Cam-Actuated Medical Puncturing Device and Method

The medical puncturing device includes a housing, a shield, and a skin puncturing assembly disposed within the housing. The shield is axially movable in the housing. The skin puncturing assembly includes a movable carrier and a skin puncturing element mounted to the carrier. A distal end of the skin puncturing element is adapted for puncturing the skin of a patient. The carrier is movable from a retracted position wherein the skin puncturing element is disposed within the shield to a puncturing position wherein the distal end of the skin puncturing element is exposed. The carrier is maintained in the retracted position by engagement of flexure members or a retaining tab with the carrier. A drive spring is provided to move the carrier from the retracted position to the puncturing position. A retraction spring is provided to return the carrier and skin puncturing element into the housing. 1. A medical puncturing device , comprising:a housing having a proximal end and a distal end;a shield having a proximal end and a distal end, the shield proximal end disposed within the housing, and the shield axially movable relative to the housing; anda skin puncturing assembly disposed within the housing and comprising a movable carrier and a skin puncturing element integral with the carrier, a distal end of the skin puncturing element adapted for puncturing the skin of a patient, the carrier movable from a retracted position wherein the distal end of the skin puncturing element is disposed within the shield to a puncturing position wherein the distal end is exposed from the shield to puncture the skin of the patient, the carrier maintained in the retracted position by engagement of at least one retaining tab on the shield with the carrier and moved from the retracted position to the puncturing position upon release of the at least one retaining tab from the carrier.2. The medical puncturing device of claim 1 , further comprising a drive spring disposed within the housing claim 1 ...

BLOOD GLUCOSE METER

A blood glucose meter is provided. The blood glucose meter includes a body of the blood glucose meter, a lancing unit which is provided at one side of the body of the blood glucose meter and includes a lancet to puncture a skin in order to sample blood of a user, a sensor strip unit which is provided at another side of the body of the blood glucose meter which is different than the one side of the body at which the lancing unit is provided, the sensor strip unit being configured to sample the blood of the user, and a measurement unit which measures the blood sampled by the sensor strip unit. The blood glucose meter has the measurement unit which is integrally assembled with the body of the blood glucose meter and includes the lancing unit having the lancet and the sensor strip unit. 1. A blood glucose meter comprising:a measurement unit integrally assembled with a body of the blood glucose meter, and including a lancing unit having a lancet and a sensor strip unit.2. A blood glucose meter comprising:a body of the blood glucose meter;a lancing unit which is provided at one side of the body of the blood glucose meter and includes a lancet to puncture a skin in order to sample blood of a user;a sensor strip unit which is provided at another side of the body of the blood glucose meter which is different than the one side of the body at which the lancing unit is provided, the sensor strip unit being configured to sample the blood of the user; anda measurement unit which measures the blood sampled by the sensor strip unit.3. The blood glucose meter of claim 2 , wherein the body of the blood glucose meter is a pen type.4. The blood glucose meter of claim 2 , wherein the lancing unit comprises:a blood taking housing disposed at the one side of the body of the blood glucose meter;a holder housing which is disposed in the blood taking housing;a button which is provided to the holder housing and exposed to an external environment of the blood taking housing;a holder unit which ...

PUSH-TO-CHARGE LANCING DEVICE

A lancing device having improved charging features. In one example embodiment, the charging mechanism generally includes a user actuated portion or charging member and a cam feature for engagement therewith. The charging member includes a finger projection or boss and the cam feature includes a ramped surface. Actuating the charging member causes the finger projection to movably engage the ramp surface of the cam feature and charge the drive mechanism. 1. A lancing device comprising a housing , a lancet carrier translationally mounted at least partially within an interior of the housing , and a charging mechanism comprising an actuator operable by pushing toward the interior of the housing to retract the lancet carrier toward a charged position.2. The lancing device of claim 1 , wherein the actuator comprises a cam actuator that contacts a cam-follower surface of the lancet carrier to retract the lancet carrier toward a charged position.3. The lancing device of claim 2 , wherein the cam-follower surface of the lancet carrier comprises an arcuately curved surface.4. The lancing device of claim 1 , wherein the actuator comprises a rocker pivotal about a first axis and the lancet carrier is mounted to translate along a second axis generally transverse the first axis.5. The lancing device of claim 1 , wherein the actuator is mounted to translate along a first axis and the lancet carrier is mounted to translate along a second axis generally transverse the first axis.6. The lancing device of claim 1 , wherein the actuator operates upon a non-linear surface of the lancet carrier to retract the lancet carrier toward a charged position.7. The lancing device of claim 1 , wherein the actuator operates upon a linear surface of the lancet carrier to retract the lancet carrier toward a charged position.8. A charging mechanism for a lancing device claim 1 , the charging mechanism comprising an actuation member having a user interface portion projecting external of a housing of the ...

ADJUSTABLE TIP FOR A LANCET DEVICE AND METHOD

A lancet device and a lancet device tip for a lancet device. The tip includes a first sleeve and a second sleeve at least partially contained within the first sleeve. The second sleeve includes a stop surface. Rotation of the first sleeve relative to the second sleeve causes the second sleeve to move at least axially without changing an overall length of the lancet device tip. 1. A tip for a lancet device , comprising:a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;a slot disposed in one of the sidewall portion and the lancet stop element;at least one following element extending into the slot; andan actuator comprising a generally annular rotatable member that engages the at least one following element;wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element.2. The tip of claim 1 , wherein the slot is disposed on the sidewall portion.3. The tip of claim 2 , wherein the slot comprises a camming slot.4. The tip of claim 1 , further comprising an outer generally annular rotatable member.5. The tip of claim 1 , wherein the at least one following element is guided within the slot when the lancet stop element is moved axially or rotated.6. The tip of claim 1 , wherein the lancet stop element comprises a opening for allowing the needle to project therethrough.7. The tip of claim 1 , further comprising a rotatable nut disposed on the front assembly comprising one of a plurality of projections and grooves disposed on an outer surface.8. The tip of claim 7 , wherein the nut further comprises indicating marks and the front cap further comprises a reference mark.9. The tip of claim 7 , wherein the nut further comprises a distal wall which includes an opening for allowing the needle to project therethrough.10. A front cap mechanism for a lancet device wherein the front cap ...

MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter. 125-. (canceled)26. A glucose monitoring assembly , the assembly comprising: an inserter housing; and', 'a sharp carrier assembly disposed in the inserter housing, wherein the sharp carrier assembly comprises a sharp configured to insert a portion of a glucose sensor into a subject;, '(1) an inserter, comprising an on body electronics unit housing comprising a top surface and a bottom surface, wherein the top surface comprises a first aperture, the bottom surface comprises a second aperture, and wherein a passageway extends through the on body electronics unit between the first aperture and the second aperture;', 'the glucose sensor; and', 'on body electronics coupled with the glucose sensor, wherein the on body electronics are disposed within the on body electronics unit housing, and wherein the on body electronics comprise a processor, memory, a power supply, and wireless communication circuitry configured to wirelessly communicate data indicative of a glucose level,, '(2) an on body electronics unit, comprisingwherein the sharp carrier assembly is directly and removably engaged with the on body electronics unit housing at a location external to the passageway, advance the sharp carrier assembly and the on body electronics unit from a proximal position within the inserter housing to a distal position,', 'cause the sharp to insert the portion of the glucose sensor into the subject, and', 'retract the sharp carrier assembly from the distal position to a retracted position within the inserter housing, and, 'wherein the inserter is configured towherein the sharp extends through ...

METHOD OF REUSE PROTECTION FOR LANCET SYSTEM

A lancet magazine for use in a lancing aid is described comprising a plurality of lancets each having a lancet body at the proximal end of the lancet and a lancet tip at the distal end of the lancet, where the proximal end of the lancet points in the direction of the proximal end of the housing of the lancet magazine and the distal end of the lancet is aligned in the direction of the distal end of the housing and the lancets in the unused state are completely surrounded by the housing. Furthermore, an extension unit is movably connected to the housing in such a manner that the housing can be extended by movement of the extension unit in the direction of the distal end of the housing such that the lancet is prevented from emerging from the lancet magazine. 1. A method for avoiding re-use of a lancet magazine , comprising;(a) inserting a lancet magazine having a plurality of lancets into a lancing aid;(b) performing at least one lancing operation with at least one lancet of the plurality of lancets;(c) removing the lancet magazine from the lancing aid; and(d) moving an extension unit of the lancet magazine into an extended state which increases the length of the lancet magazine and thereby prevents the lancets from emerging from the lancet magazine.2. The method of claim 1 , wherein step (d) is executed automatically during step (c).3. The method of claim 1 , further comprising reinserting the lancet magazine into the lancing aid after step (d) without impairing the lancing aid.4. The method of claim 3 , wherein the extension unit remains in the extended state during the reinserting of the lancet magazine into the lancing aid.5. The method of claim 4 , further comprising claim 4 , after the lancet magazine has been reinserted into the lancing aid claim 4 , triggering a lancing mechanism of the lancing aid and thereby moving one of the lancets within the lancet magazine.6. The method of claim 1 , wherein step (d) comprises locking the extension unit in the extended ...