Integrated Lancet and Analyte Testing Apparatus

• US 20100087754A1
• Filed: 10/02/2009
• Published: 04/08/2010
• Est. Priority Date: 10/03/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Feldman, Benjamin J., Rush, Benjamin M.
• Granted Patent: US 8,282,578 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/15146 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 Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 : fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood

Abstract

Integrated lancing and analyte measurement systems are provided which minimize the number of actions required to operate the systems, accomplished in part by combining two or more user steps into one.

Claims

1. An integrated analyte measurement system, comprising:

a housing;

a lancet positionable within the housing for advancement through a first aperture in the housing to lance the skin of a user;

electronics within the housing for measuring an analyte level within body fluid; and

a feed-through path configured for retaining a test strip within a second aperture in the housing wherein the test strip is exposed for application of body fluid thereto, and for simultaneously electronically coupling the test strip with the electronics;

wherein the system is configured to arm the lancet for advancement with a single user action.

2. The system of claim 1, wherein the analyte test strip is sealably contained within the housing, and wherein the system is further configured to advance the test strip to within the feed-through path with the single user action.

3. The system of claim 2, further comprising a cartridge contained within the housing and configured for containing a plurality of analyte test strips therein, wherein the system is configured to advance a single test strip at a time from within the cartridge to within the feed-through path with the single user action.

4. The system of claim 3, wherein the cartridge comprises first and second openings, wherein the first opening is aligned with the second aperture within the housing, the system further comprising a pusher mechanism for entering the first opening and pushing a single test strip through the second opening.

5. The system of claim 4, wherein the pusher mechanism comprises a flexible strip.

6. The system of claim 5, wherein the pusher mechanism comprises a shaft.

7. The system of claim 4, wherein the first and second openings are sealable, and wherein the single user action unseals the openings.

8. The system of claim 3, wherein the plurality of test strips is biased against a wall of the cartridge.

9. The system of claim 8, wherein the test strips are biased by a spring mechanism contained within the cartridge.

10. The system of claim 4, wherein the cartridge is biased by a spring mechanism within the housing to seal the first and second openings.

11. The system of claim 10, wherein the single use action releases the bias on the cartridge thereby unsealing the first and second openings.

12. The system of claim 1, further comprising a lever wherein the single user action comprises translating the lever in a single axis of motion relative to the housing.

13. The system of claim 12, wherein the single user action comprises extending the lever away from the housing.

14. The system of claim 1, wherein a second single user action advances the lancet through the first aperture.

15. The system of claim 14, wherein the second single user action comprises pushing a button framed within the housing.

16. The system of claim 1, wherein the feed-through is integrated within the housing or is coupled to the housing.

17. The system of claim 1, wherein the feedthrough path comprises multiple electrodes for electronically coupling to corresponding electrodes on the test strip.

18. The system of claim 1, wherein the electronics are configured to turn on when a test strip is within the feed-through path.

19. The system of claim 1, wherein system is configured to receive the analyte test strip within the feed-through path from outside the housing through the second aperture.

20. The system of claim 1, wherein the electronics are configured to optically measure an analyte level.

21. The system of claim 1, further comprising a lancing mechanism within the housing configured for arming and advancing the lancet, wherein the lancing mechanism comprises a firing spring and a return spring, wherein the firing spring has a greater spring constant than the return spring.

22. The system of claim 1, further comprising a manually activated lever, wherein the single user action comprises pulling the lever in a first direction.

23. The system of claim 22, wherein pulling the lever advances the test strip into the feed-through path.

24. The system of claim 22, further comprising a lancet firing button for moving the lever in an opposite direction and advancing the lancet through the first aperture.

25. The system of claim 22, wherein the single user action further comprises pushing the lever in an opposite direction.

26. The system of claim 25, wherein the lever is coupled to and drives a lance arming shaft and a strip advance shaft.

27. The system of claim 26, wherein the lance arming shaft and the strip advance shaft extend approximately in parallel from a bottom surface of the lever.

28. The system of claim 1, further comprising an expression cap coupled to the housing at the first aperture.

29. The system of claim 28, wherein the housing is configured to couple with one or more expression caps having various heights for varying a lancing depth.

30. The system of claim 28, wherein the height of the expression cap is adjustable to vary a lancing depth.

31. The system of claim 30, wherein the expression cap comprises indicia on an external surface indicative of the lancing depth.

32. The system of claim 22, further comprising a mechanism within the housing configured for preventing movement of the lever in a second direction until the lever has been fully extended in the first direction.

33. The system of claim 32, wherein the mechanism is further configured for preventing movement in the first direction upon commencement of movement in the second direction.

34. The system of claim 2, further comprising a mechanism for rearming the lancet without advancing a test strip.

35. A method of using an integrated analyte measurement system, the method comprising:

pulling a lever to advance a test strip through a first aperture in a housing and to arm a lancet positioned within the housing for firing through a second aperture in the housing; and

pressing a button within the housing to fire the lancet through the second aperture into the skin.

36. The method of claim 35, further comprising contacting an exposed end of the test strip with body fluid extracted from the skin and measuring an analyte level within the body fluid by means of electronics within the housing.

37. The method of claim 35, further comprising moving a switch within the housing to rearm the lancet without advancing a test strip.

38. The method of claim 35, further comprising containing a plurality of test strips within the housing in a hermetically sealable condition, wherein pulling the lever momentarily unseals the test strips.

39. The method of claim 35, further comprising selectively adjusting the height of a skin-contacting structure extending from the housing at the first aperture.

40. The method of claim 35, further comprising, prior to pushing the button, pushing the lever in the opposite direction.