Integrated fluid analyte meter system

Patent metadata

Field	Value
Publication number	US-9380963-B2
Application number	US-201213554631-A
Country	US
Kind code	B2
Filing date	Jul 20, 2012
Priority date	Dec 10, 2007
Publication date	Jul 5, 2016
Grant date	Jul 5, 2016

Abstract

An integrated meter system for determining information related to an analyte of a fluid sample includes a meter including a housing and a plurality of test sensors. Each of the plurality of test sensors includes a penetrating member, a testing portion, and a channel. The channel is adapted to receive the fluid sample. The test sensors are removably located within the housing. At least one of the test sensors is removably connected to an adjacent test sensor. The integrated meter system also includes a test-sensor advancement mechanism that is configured to advance the test sensors.

First claim

What is claimed is:

1. A test sensor, comprising:
a lid;
a base, the base and the lid assisting in forming a channel;
a testing portion positioned in the channel, the testing portion including reagent material;
a penetrating member coupled to the channel such that the penetrating member is in fluid communication with the testing portion;
a deformable sealing member surrounding at least a portion of the penetrating member to assist in inhibiting communication between the reagent material and the atmosphere, the penetrating member being configured to pierce the deformable sealing member in response to the deformable sealing member deforming under a load applied directly to the deformable sealing member by a user of the test sensor.

2. The test sensor of claim 1 , wherein the deformable sealing member is formed by a portion of the lid, a portion of the base, or both.

3. The test sensor of claim 1 , wherein the deformable sealing member is attached to the lid, the base, or both.

4. The test sensor of claim 1 , wherein the deformable sealing member surrounds the at least a portion of the penetrating member to further assist in protecting the reagent material from humidity, oxygen, and contaminates.

5. The test sensor of claim 1 , wherein the deformable sealing member comprises polymeric material.

6. The test sensor of claim 1 , wherein the penetrating member is a hollow point needle.

7. A method of using a meter, the method comprising:
loading a test sensor into the meter, the test sensor including a deformable sealing member, a penetrating member, a channel, and a testing portion, the channel being adapted to receive a fluid sample and being in fluid communication with the testing portion;
advancing the test sensor with a test sensor-advancement mechanism such that:
(i) the deformable sealing member engages a portion of a user's skin;
(ii) the deformable sealing member deforms under a load applied directly to the deformable sealing member by the user;
(iii) the penetrating member pierces the deformed deformable sealing member; and
(iv) the penetrating member pierces the portion of the user's skin.

8. The method of claim 7 , wherein the penetrating member pierces the deformed deformable sealing member prior to the penetrating member piercing the portion of the user's skin.

9. The method of claim 8 , further comprising collecting the fluid sample through the penetrating member.

10. The method of claim 9 , further comprising delivering the collected fluid sample through the channel to the testing portion.

11. The method of claim 7 , further comprising determining the concentration of the analyte of the fluid sample.

12. The method of claim 7 , wherein the meter includes a release button and a spring-loaded plunger and wherein the advancing includes pressing the release button to disengage the spring-loaded plunger resulting in advancing the test sensor.

13. The method of claim 7 , wherein the loading the test sensor into the meter includes loading a plurality of test sensors into the meter, each of the plurality of test sensors being removably connected to respective adjacent ones of the plurality of test sensors.

14. The method of claim 7 , wherein the test sensor loaded into the meter further includes a lid and a base, the lid and the base assisting in forming the channel, the deformable sealing member being formed by a portion of the lid, a portion of the base, or both.

15. An integrated meter system for determining an analyte concentration of a fluid sample, the integrated meter system comprising:
a meter housing;
a plurality of test sensors removably located within the meter housing, each of the plurality of test sensors including a lid, a base, a penetrating member, a testing portion, a channel, and a deformable sealing member, the lid and the base assisting in forming the channel, the channel being adapted to receive the fluid sample, the deformable sealing member surrounding at least a portion of the penetrating member;
a test-sensor advancement mechanism coupled to the meter housing and being configured to advance the plurality of test sensors, in response to the test-sensor advancement mechanism advancing a first one of the test sensors into a portion of a user's skin, the deformable sealing member of the first one of the test sensors is configured to deform under a load applied directly to the deformable sealing member by the user such that the penetrating member of the first one of the test sensors pierces the deformable sealing member and the portion of the user's skin.

16. The system of claim 15 , wherein, for each of the test sensors, the deformable sealing member is formed by a portion of the lid, a portion of the base, or both.

17. The system of claim 15 , wherein the first one of the plurality of test sensors is removably connected to an adjacent second one of the plurality of test sensors.

18. The system of claim 15 , further comprising a cartridge enclosing the plurality of test sensors, the cartridge being removably located within the meter housing.

19. The system of claim 15 , wherein the test-sensor advancement mechanism includes a spring-loaded plunger and a release button, the spring-loaded plunger being coupled to the meter housing and being configured to engage at least one of the plurality of test sensors therein.

20. The system of claim 15 , wherein, for each of the test sensors, the deformable sealing member assists in preventing or inhibiting communication between the testing portion and the atmosphere.

Assignees

• Gofman Igor
• Stein Mitchel
• Ascensia Diabetes Care Holdings Ag

Inventors

• Gofman Igor
• Stein Mitchel

Classifications

• Y10T436/114165

  with step of insertion or removal from test line · CPC title

• A61B5/1486

  using enzyme electrodes, e.g. with immobilised oxidase · CPC title

• Y10T436/112499

  with sample on test slide · CPC title

• A61B2562/0295

  Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 · CPC title

• A61B5/15146

  Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. (multiple simultaneous cutting or piercing A61B5/150977) · CPC title