Devices and methods for body fluid sampling and analysis

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member.

Calibration material delivery devices and methods

A device includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. Methods for verifying the accuracy of an analyte monitoring device include receiving control information from a test cartridge, transporting control material to an analysis site, determining the presence of the control material, analyzing the control material, and providing a pass or fail signal.

DEVICES AND METHODS FOR BODY FLUID SAMPLING AND ANALYSIS

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member. 1. An integrated body fluid sampling meter comprising:a meter housing comprising a light source and a first detector; anda disposable cartridge insertable into the meter housing and comprising a plurality of cells, wherein each cell has a first wall comprising a viewing window and a second wall comprising a light-blocking covering,wherein one of the plurality of cells is positionable between the light source and the first detector.2. The meter of wherein the disposable cartridge is rotatable within the meter housing.3. The meter of wherein the meter is configured to initiate an indexing protocol upon insertion of the disposable cartridge into the meter housing claim 2 , wherein the integrity of each cell is checked.4. The meter of further comprising a processor claim 3 , and wherein the processor is configured to index each cell as either available or used during the indexing protocol.5. The meter of wherein the meter housing comprises a contact pad and wherein the disposable cartridge is movable between a testing position claim 4 , where an available cell is aligned with the contact pad claim 4 , and a standby position claim 4 , where each of the plurality of cells is out of alignment with the contact pad.6. The meter of wherein the light-blocking covering is a foil seal.7. The meter of wherein the meter housing comprises a punch for puncturing the foil seal.8. The meter of wherein the ...

DEVICES AND METHODS FOR BODY FLUID SAMPLING AND ANALYSIS

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member. 114-. (canceled)15: A body fluid sampling arrangement comprising:a hub comprising a patterned surface, wherein the patterned surface defines a volume;a skin penetration member configured to pierce skin and comprising a bore therethrough, wherein the bore is in fluid communication with the patterned surface; anda quantification member configured to react with a body fluid sample,wherein the hub is configured to collect the body fluid sample in the volume, and when the volume is filled, deliver the body fluid sample to the quantification member.16: The arrangement of claim 15 , wherein the volume is a volume sufficient to provide a measurable result indicative of a property of the body fluid sample.17: The arrangement of claim 16 , wherein the body fluid sample is blood and the property of the body fluid sample is a concentration of glucose.18: The arrangement of claim 15 , wherein the patterned surface is configured to spread the body fluid sample so that it is positioned across a surface of the quantification member prior to contacting the quantification member.19: The arrangement of claim 15 , wherein the bore is centrally positioned relative to the patterned surface and the patterned surface is configured to promote spread of the body fluid sample radially across the patterned surface.20: The arrangement of claim 15 , wherein the patterned surface comprises a groove or a channel configured ...

Calibration material delivery devices and methods

A device includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. A method of verifying the accuracy of an analyte monitoring device includes receiving control information, receiving a fluid sample, identifying the fluid sample as a control solution, and analyzing the control solution.

DEVICES AND METHODS FOR BODY FLUID SAMPLING AND ANALYSIS

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member. 114-. (canceled)15. An integrated body fluid sampling meter comprising:a meter housing;a cartridge insertable into the meter housing and comprising a plurality of sampling arrangements, wherein the plurality of sampling arrangements includes a first sampling arrangement moveable between a pre-fired position and a rest position; andan imaging assembly in the meter housing, the imaging assembly configured to image different portions of the first sampling arrangement as the first sampling arrangement moves between the pre-fired position and the rest position.16. The meter of claim 15 , wherein the first sampling arrangement comprises a reagent pad and the imaging assembly is configured to image a viewing area including at least a portion of the reagent pad.17. The meter of claim 16 , wherein the reagent pad has a midline and the viewing area is on a first side of the midline when the first sampling arrangement is in the rest position.18. The meter of claim 17 , wherein the viewing area is configured to move toward the midline of the reagent pad when the first sampling arrangement moves from the rest position toward the pre-fired position.19. The meter of claim 16 , wherein the viewing area is configured to move from a first side of the midline of the reagent pad to a second side of the reagent pad as the sampling arrangement moves.20. The meter of claim 16 , wherein the first sampling ...

CALIBRATION MATERIAL DELIVERY DEVICES AND METHODS

A device includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. 147-. (canceled)48. A method of verifying the accuracy of an analyte monitoring device , the method comprising:receiving control information from a test cartridge with an analyte monitoring device, wherein the control information comprises a range of analyte concentration values for a control material;transporting the control material to an analysis site in the test cartridge, wherein the control material has a known and/or predetermined concentration of at least one analyte;determining the presence of the control material using the analyte monitoring device;analyzing the control material to measure the concentration of the at least one analyte contained therein;comparing the measured concentration of the at least one analyte with the control information to determine if the measured concentration corresponds to the range of concentration values obtained from the control information; andproviding a pass or fail signal to indicate whether the measured concentration falls within the range of analyte concentration values.49. The method of further comprising detecting the presence of a control material device with the analyte monitoring device.50. The method of further comprising lancing a control material device with the analyte monitoring device to extract the control material therein.51. The method of wherein determining the presence of the control material comprises determining whether the control material is a body fluid or a control material.52. The method of wherein determining the presence of the control material comprises analyzing the control material using a colorimetric technique.53. The method of wherein determining the presence of the control material comprises analyzing the rate of reaction of the control ...

ANALYTE MONITORING SYSTEM WITH AUDIBLE FEEDBACK

Described here are devices, systems, and methods for analyte measurement. The analyte measurement devices and systems may be configured to produce a prompt that may convey information, instructions and/or encouragement to a user. In some variations, analyte measurement devices may be configured to change a prompt based on the replacement or addition of components of/to the device. In some instances, a prompt may be an auditory prompt and/or a visual prompt. In some variations, a system may comprise an analyte measurement device comprising a housing, a speaker, and a control unit. The housing may comprise a releasable housing portion comprising an identifier that is associated with a prompt. In some variations, a system may comprise an analyte measurement device and a skin that may releasably attach to the analyte measurement device and may comprise an identifier that is associated with a prompt. 1. A system comprising: a housing, wherein the housing comprises a releasable housing portion and wherein the releasable housing portion comprises an auditory identifier that is associated with an auditory prompt set;', 'a speaker;', 'a control unit, wherein the control unit is configured to detect the auditory identifier, set the auditory prompt set associated with the detected auditory identifier as an active prompt set, and instruct the speaker to output at least one auditory prompt from the active prompt set., 'an analyte measurement device comprising2. The system of wherein the system further comprises a plurality of releasable housing portions.3. The system of wherein each of the releasable housing portions is associated with an auditory prompt set comprising at least one auditory prompt that differs from at least one auditory prompt associated with the other releasable housing portions of the plurality of releasable housing portions.4. The system of wherein the control unit comprises a processor.5. The system of wherein the control unit comprises a memory unit.6. The ...

MEDICAL DIAGNOSTIC DEVICES AND METHODS

A medical diagnostic device includes a wirelessly transmitted time data receiver and processor. Associated devices, methods and functionality are also described. 124-. (canceled)25: A method of operating a blood glucose meter comprising:generating a plurality of glucose concentration measurement values from a plurality of tests performed with the blood glucose meter;correlating, using the blood glucose meter, the plurality of glucose concentration measurement values with the particular points in time during the day when the glucose concentration measurement values were taken to establish a set of time-correlated glucose measurement values;deriving a trend based on the set of time-correlated glucose concentration measurement values; andsuggesting a potential treatment based at least in part on the trend.26: The method of further comprising alerting a user to perform another test with the blood glucose meter within a set period of time to verify the trend.27: The method of claim 25 , wherein the suggested potential treatment is carbohydrate intake.28: The method of claim 25 , wherein the derived trend is a falling glucose concentration level.29: The method of further comprising downloading the glucose concentration measurement values and associated time data from the blood glucose meter.30: The method of claim 25 , wherein the blood glucose meter automatically sets and maintains an internal clock.31: The method of further comprising receiving time data wirelessly to set an internal clock of the blood glucose meter.32: The method of claim 25 , wherein the blood glucose meter comprises a memory comprising stored time data and the method further comprises receiving claim 25 , with the blood glucose meter claim 25 , time data wirelessly and comparing claim 25 , with the blood glucose meter claim 25 , the received time data with the stored time data.33: The method of further comprising overwriting the stored time data with the received time data upon detection of a ...

ANALYTE MONITORING SYSTEM WITH AUDIBLE FEEDBACK

Described here are devices, systems, and methods for analyte measurement. The analyte measurement devices and systems may be configured to produce a prompt that may convey information, instructions and/or encouragement to a user. In some variations, analyte measurement devices may be configured to change a prompt based on the replacement or addition of components of/to the device. In some instances, a prompt may be an auditory prompt and/or a visual prompt. In some variations, a system may comprise an analyte measurement device comprising a housing, a speaker, and a control unit. The housing may comprise a releasable housing portion comprising an identifier that is associated with a prompt. In some variations, a system may comprise an analyte measurement device and a skin that may releasably attach to the analyte measurement device and may comprise an identifier that is associated with a prompt. 1. A system comprising: a housing, wherein the housing comprises a releasable housing portion and wherein the releasable housing portion comprises an auditory identifier that is associated with an auditory prompt set;', 'a speaker;', 'a control unit, wherein the control unit is configured to detect the auditory identifier, set the auditory prompt set associated with the detected auditory identifier as an active prompt set, and instruct the speaker to output at least one auditory prompt from the active prompt set., 'an analyte measurement device comprising2. The system of wherein the system further comprises a plurality of releasable housing portions.3. The system of wherein each of the releasable housing portions is associated with an auditory prompt set comprising at least one auditory prompt that differs from at least one auditory prompt associated with the other releasable housing portions of the plurality of releasable housing portions.4. The system of wherein the control unit comprises a processor.5. The system of wherein the control unit comprises a memory unit.6. The ...

SYSTEMS AND METHODS FOR MANAGING CHRONIC DISEASE USING ANALYTE AND PATIENT DATA

Devices, systems, and methods herein relate to managing a chronic condition such as diabetes. These systems and methods may obtain patient data from a plurality of devices, integrate the data for analysis of trends that may be presented to the patient and/or health care professional along with an actionable suggestion. In some variations, a method may include the steps of receiving analyte data generated by an analyte measurement device and patient data generated by a patient measurement device. One or more data trends may be generated by analyzing the analyte data against the patient data using a computing device. The device settings of one or more of the analyte measurement device and the computing device may be modified in response to one or more of the data trends. 1. A method of monitoring a chronic condition of a patient , comprising:receiving analyte data generated by an analyte measurement device and patient data generated by a patient measurement device;generating one or more data trends by analyzing the analyte data against the patient data using a computing device comprising a processor and memory; andmodifying device settings of one or more of the analyte measurement device and the computing device in response to one or more of the data trends.2. The method of claim 1 , further comprising outputting at least one prompt to modify patient behavior in response to one or more of the data trends.3. The method of claim 2 , wherein the prompt may comprise encouragement to comply with one or more of a testing claim 2 , diet claim 2 , and exercise regimen.4. The method of claim 1 , further comprising outputting at least one prompt to modify the device settings in response to one or more of the data trends.5. The method of claim 4 , further comprising outputting a set of prompts to modify the device settings at predetermined intervals.6. The method of claim 1 , wherein modifying the device settings comprises modifying one or more of frequency claim 1 , timing ...

Medical measurement method

Calibration material delivery devices and methods

Devices and methods for body fluid sampling and analysis

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect .. a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member.

Analyte monitoring system with audible feedback

Calibration material delivery devices and methods

These are devices and methods of delivering calibration or control information to a device, such as an analyte monitor. The devices may include a first portion configured to be grasped by the hand of the user, and a second portion including a reservoir and a flexible neck. The reservoir may contain a control material that contains a target analyte in a known or predetermined concentration.

Medical diagnostic devices and methods

A medical diagnostic device includes a wirelessly transmitted time data receiver and processor. Associated devices, methods and functionality are also described.

Analyte monitoring system with audible feedback

Described here are devices, systems, and methods for analyte measurement. The analyte measurement devices and systems may be configured to produce a prompt that may convey information, instructions and/or encouragement to a user. In some variations, analyte measurement devices may be configured to change a prompt based on the replacement or addition of components of/to the device. In some instances, a prompt may be an auditory prompt and/or a visual prompt. In some variations, a system may comprise an analyte measurement device comprising a housing, a speaker, and a control unit. The housing may comprise a releasable housing portion comprising an identifier that is associated with a prompt. In some variations, a system may comprise an analyte measurement device and a skin that may releasably attach to the analyte measurement device and may comprise an identifier that is associated with a prompt.

Calibration material delivery devices and methods

A device includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. A method of verifying the accuracy of an analyte monitoring device includes receiving control information, receiving a fluid sample, identifying the fluid sample as a control solution, and analyzing the control solution.

Devices and methods for body fluid sampling and analysis

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member.

Devices and methods for body fluid sampling and analysis

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member.

Blood glucose monitoring device

A medical diagnostic device includes a wirelessly transmitted time data receiver and processor. Associated devices, methods and functionality are also described.

A method of verifying the accuracy of the operation of an analyte monitoring device

Devices and methods for body fluid sampling and analysis

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member.

Calibration material delivery devices and methods

A device is described that includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. Related arrangements and methods are also described.

Medical diagnostic devices and methods

A medical diagnostic device includes a wirelessly transmitted time data receiver and processor. Associated devices, methods and functionality are also described.

Medical diagnostic devices and methods

A medical diagnostic device includes a wirelessly transmitted time data receiver and processor. Associated devices, methods and functionality are also described.

Calibration material delivery devices and methods

A device is described that includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. Related arrangements and methods are also described.

Calibration material delivery devices and methods

A device includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. A method of verifying the accuracy of an analyte monitoring device includes receiving a fluid sample, identifying the fluid sample as a control solution, and analyzing the fluid sample.

Blood glucose monitoring device

A blood glucose meter and associated method is disclosed. The meter and associated method correlates glucose concentration measurement values with a particular point in time during a day and predicts whether the values are associated with either a pre-prandial test or post-prandial test based at least in part on the correlated time associated with the value. A user is then prompted to confirm the prediction. This enables a meter to accurately and automatically mark values as either pre- or post-prandial.

分析物モニタリングシステムおよび分析物のモニタリング方法

【課題】流体試料の抽出、移送及び分析の何れか又はこれらの任意の組合せを実施する測定器及び方法を提供する。 【解決手段】測定器は、測定器ハウジング及びカートリッジを有するようにしうる。ある例では、カートリッジの１つ以上の部分に係合しうるタワーを測定器に設けることができる。測定器ハウジングには撮像システムを設けることができ、この撮像システムはタワー内に設けてもタワー内に設けないでもよい。カートリッジには、流体試料を抽出個所から収集するように構成しうる１つ以上の抽出装置を設けることができる。抽出装置には、皮膚穿通部材、ハブ及び定量化部材を設けることができる。 【選択図】図１Ａ

Medical diagnostic devices and methods

A medical diagnostic device includes a wirelessly transmitted time data receiver and processor. Associated devices, methods and functionality are also described.

Systems and methods for managing chronic disease using analyte and patient data

Devices, systems, and methods herein relate to managing a chronic condition such as diabetes. These systems and methods may obtain patient data from a plurality of devices, integrate the data for analysis of trends that may be presented to the patient and/or health care professional along with an actionable suggestion. In some variations, a method may include the steps of receiving analyte data generated by an analyte measurement device and patient data generated by a patient measurement device. One or more data trends may be generated by analyzing the analyte data against the patient data using a computing device. The device settings of one or more of the analyte measurement device and the computing device may be modified in response to one or more of the data trends.