In-situ adapter for a testing device

• US 20040267229A1
• Filed: 05/17/2004
• Published: 12/30/2004
• Est. Priority Date: 08/16/2001
• Status: Abandoned Application

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Griffith, Alun, Moerman, Piet
• Application Number:
  US10/398,984
• Publication Number:
  US 20040267229A1
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An adapter for a standard glucose meter to convert the glucose meter into an integrated testing device is provided. The adapter comprises lancing device, a test strip port for holding a test strip in close proximity to a puncture site, a strip connector for providing an electrical connection between the test strip and the electronics in the glucose meter and a connector for connecting the adapter to the glucose meter. The adapter further includes an adapter cap, including a pressure ring for facilitating the expression of blood from a puncture site. The adapter includes a cocking mechanism for cocking the lancing device, a depth control mechanism for varying the penetration depth of the lancet and a trigger for actuating the lancet.

Claims

1. An adapter for a testing device for testing analytes in bodily fluids comprising:

a housing;

a lancet assembly comprising a lancet drive train for holding and driving a lancet into the skin of a user;

a test port for holding a test strip; and

a housing connector for connecting the adapter housing to the testing device.

2. The adapter of claim 1, further comprising:

a strip connector for establishing electrical contact between a test strip in the test port of the adapter and the testing device.

3. The adapter of or claim 2, further comprising a removable lancet cap including a pressure ring to assist extraction of the blood sample.

4. The adapter of claim 3, further comprising a dedicated storage compartment.

5. The adapter of claim 4, further comprising a cocking button for cocking the lancet drive train.

6. The adapter of claim 5, further comprising a trigger button for actuating the lancet drive train.

7. The adapter of claim 6, further comprising a depth adjustment button for adjusting a penetration depth of the lancet.

8. The adapter of claim 7, wherein the angular position of the depth adjustment button defines a cocked position and a final extended position of the lancet.

9. The adapter of claim 8, wherein the depth adjustment button includes a first slanted protrusion for defining the cocked position and a second slanted protrusion that is parallel to the first slanted protrusion for defining the final extended position.

10. The adapter of claim 9, wherein the first slanted protrusion contacts a stop on the lancet drive train to define a cocked position.

11. The adapter of claim 10, further comprising a cocking button for cocking the lancet drive train, wherein the second slanted protrusion contacts a fixed cocking rib on the cocking button.

12. The adapter of claim 11, wherein the cocking button includes a stop for the lancet drive train, such that the position of the cocking button defines the final extended position of the lancet.

13. The adapter of claim 12, wherein the testing device is a glucose meter and the analyte being tested is glucose in a sample of blood.

14. A depth adjustment mechanism for a lancet device comprising:

a substrate movably mounted in a slot of a housing of the lancet device and having an interior surface;

a first projection on the interior surface of the substrate and defining an interface with a lancet drive train; and

a second projection on the interior surface of the substrate substantially parallel to the first projection and defining an interface with a cocking button.

15. The depth adjustment mechanism of claim 14, wherein the position of the substrate in the slot defines a cocked position of the lancet drive train and a stopping position of the lancet drive train.

16. The depth adjustment mechanism of claim 15, wherein the first projection interfaces with a catch on the lancet drive train to define the cocked position.

17. The depth adjustment mechanism of claim 16, wherein the second projection interfaces with a stop for the lancet drive train to define the stopping position.

18. The depth adjustment mechanism of claim 17, wherein the stop for the lancet drive train comprises a cocking button for the lancet drive train.

19. The depth adjustment mechanism of claim 18, further comprising a rim disposed on the interior side, wherein the rim interfaces with a groove on the housing to allow movement of the substrate.

20. The depth adjustment mechanism of claim 19, further comprising a knob disposed on an external surface of the substrate to allow a user of the lancet device to move the substrate in the slot.

21. The depth adjustment mechanism of claim 20, further comprising a cocking button for cocking the lancet drive train and including a cocking rib for interfacing with the second projection and an interior rib defining a stop for lancet drive train.

22. The depth adjustment mechanism of claim 21, further comprising a catch on the lancet drive train for interfacing with the first projection to define a cocked position of the lancet drive train.

23. An integrated testing device for testing analytes in bodily fluids comprising the depth adjustment mechanism according to claim 22.

24. An integrated testing device for testing analytes in bodily fluids comprising:

a housing;

a lancet assembly comprising a lancet drive train for holding and driving a lancet into the skin of a user;

a test port for holding a test strip;

a testing device for testing analytes in bodily fluids applied to the test strip; and

a housing connector for connecting the housing to the testing device.

25. A connector for connecting an adapter containing a lancing device to a testing device for testing analytes in bodily fluids comprising:

a housing surface adapted to be removably mounted on the testing device; and

a projection on the housing surface,

wherein the projection is configured for connection with a housing feature on the testing device, such that the connector connects the adapter to the testing device.

26. A connector according to claim 25, wherein the housing surface is a battery door and the housing feature is an opening on the testing device.

27. A method of providing an integrated testing device, comprising:

providing a testing device for testing analytes in bodily fluids;

providing an adapter containing a housing, a lancet assembly, a test port for holding a test strip, a strip connector for establishing electrical contact between a test strip in the test port of the adapter and the testing device, and a housing connector for connecting the adapter housing to the testing device; and

attaching said adapter to said testing device using the housing connector.

28. A method of sampling and testing a sample of bodily fluid comprising:

providing a testing device for testing analytes in bodily fluids;

providing an adapter containing a housing, a lancet assembly including a lancet, a test port for holding a test strip, a test strip disposed in the test port, a strip connector for establishing electrical contact between a test strip in the test port of the adapter and the testing device, and a housing connector for connecting the adapter housing to the testing device;

attaching the adapter to the testing device using the housing connector to form an integrated device;

cocking the lancet assembly; and

actuating the lancet assembly to drive the lancet into the skin a predetermined depth to produce a sample of bodily fluid, wherein the test strip absorbs the sample and produces a signal indicative of an analyte level and wherein the strip connector automatically transmits the signal indicative of the analyte level to the testing device.