Integrated Analyte Devices and Processes

• US 20100249652A1
• Filed: 03/31/2010
• Published: 09/30/2010
• Est. Priority Date: 03/31/2009
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Doniger, Kenneth J., Rush, Benjamin
• Application Number:
  US12/752,097
• Publication Number:
  US 20100249652A1
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/15032 by heating
• 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 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15182 Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Devices and processes for the analysis of a body fluid are provided. Embodiments include integrated devices that include two or more analyte testing components. Also provided are processes of analyte testing devices.

Claims

1. An analyte testing device comprising:

a housing defining an interior space comprising an axis, the interior space including;

a disk configured to be held in place in a fixed position on the body of user, the disk stationary with respect to the axis and comprising;

at least one test strip having a sample chamber to receive biological sample of a user; and

at least one opening in the disk, the at least one opening in communication with a sample chamber of a test strip;

a skin piercing member holder rotatable about the axis and comprising at least one skin piercing member alignable with an opening of the disk to pierce through the opening of the disk to the skin of a user; and

a firing mechanism to advance the skin piercing member through the opening to pierce the skin of the user.

2. The analyte testing device of claim 1, wherein the axis is a substantially central axis.

3. The analyte testing device of claim 1, wherein the axis is a hub.

4. The analyte test device of claim 2, wherein the disk is stationarilly attached to the hub and the skin piercing member holder is rotatably attached to the hub.

5. The analyte test device of claim 4, further comprising an automated system to test for analyte automatically according to a schedule.

6. The analyte test device of claim 5, wherein the automated system comprises a timing mechanism and a microprocessor, wherein the microprocessor is programmed or is programmable to control the timing and firing mechanisms to execute the automatic analyte testing according to the schedule.

7. The analyte test device of claim 6, wherein the microprocessor is programmed or is programmable to determine analyte concentration from the biological sample received by a sample chamber of the device.

8. The analyte test device of claim 4, wherein the microprocessor is programmed or is programmable to align a skin piercing member with an opening of the disk.

9. The analyte test device of claim 8, wherein device comprises a plurality of test strips and a plurality of skin piercing members that are radially positioned about the hub.

10. The analyte test device of claim 9, wherein hub is fixed in place.

11. The analyte test device of claim 10, wherein the rotatable skin piercing member holder is rotatable about the fixed hub.

12. The analyte test device of claim 11, wherein the microprocessor comprising programming or is programmable to rotate the skin piercing member holder in discrete steps about the hub.

13. The analyte test device of claim 12, wherein the rotatable skin piercing member holder is rotated one step for each analyte test, and each step corresponds to the distance between adjacent disk openings.

14. The analyte test device of claim 13, wherein the device comprises a wound spring drive to drive coupled to the skin piercing member holder to drive the rotation of the rotatable skin piercing member holder.

15. The analyte test device of claim 14, wherein the wound spring drive energizes the skin piercing members to pierce the skin of the user.

16. The analyte test device of claim 15, wherein the wound spring drive provides power to the microprocessor.

17. The analyte test device of claim 4, wherein the device is about 5 inches or less in diameter and has a circumference of about 10 inches or less.

18. The analyte test device of claim 17, wherein the device is about 2 inches or less in diameter and has a circumference of about 6.25 inches or less.

19. The analyte test device of claim 18, wherein the device is able to contain about 100 test strips and about 100 skin piercing members at the same time.

20. An analyte testing device coupled to at least one microprocessor, the analyte test device comprising:

a housing defining an interior space comprising a hub, the interior space including;

a disk comprising two or more analyte test strips, each having a sample chamber to receive biological sample of a user, and the disk having at least the same number of openings in the disk as the number of test strips, so that each test strip is in communication with a sample chamber of a test strip;

a skin piercing member holder coupled to and moveable about the hub and comprising at least one skin piercing member, wherein the holder is advanceable by the one or more microprocessors to adjacent test strips so that a skin piercing member is alignable with an opening of the disk to pierce through the opening of the disk to the skin of a user; and

a sterilization system to sterilize at least one skin piercing member while it is contained within the interior space.

21. The analyte test device of claim 20, wherein the sterilization system comprises a source of electrical current and pathway to provide the current to a skin piercing member.

22. The analyte test device of claim 21, wherein the skin piercing member comprises a tip that comprises a conducting material, at least one contact pad to provide electrical contact between the tip and the source of electrical current, and at least one lead extending from the at least one lead to the tip.

23. The analyte test device of claim 22, wherein the sterilization system is configured to sterilize a skin piercing member after it has been used.

24. The analyte test device of claim 22, wherein the device is a no calibration device such that it is configured not to require a user to take any action to calibrate the device for the two or more test strips.

25. A computer-implemented process of glucose testing, the process comprising:

automatically actuating a skin piercing member of an on-body analyte testing device to pierce the body to obtain a sample of biological fluid according to a timing schedule;

testing the sample for glucose; and

repeating the automatic actuation and testing at least one more time according to the timing schedule to perform at least two glucose tests at two time periods.

26. The computer-implemented process of glucose testing of claim 25, wherein the repeating comprises advancing a skin piercing member from the first glucose test to at least a second test.

27. The computer-implemented process of glucose testing of claim 26, wherein the skin piercing member is sterilized between the first and second glucose tests.

28. The computer-implemented process of glucose testing of claim 27, further comprising securing a housing of a device that comprises a power supply, at least one microprocessor, at least one skin piercing member, and at least two glucose test strips, to a body part of a user so that the housing is fixed in position on the body of a user.

29. The computer-implemented process of glucose testing of claim 25, further comprising removing used or un-useable test strips from the housing and replacing useable test strips within the housing.

30. The computer-implemented process of glucose testing of claim 25, further comprising forwarding wirelessly or by a wired connection test data from the glucose tests to an insulin pump.

31. A device for piercing skin, the device comprising:

a housing defining an interior space;

an opening in the housing from the interior space to the exterior of the housing;

an assembly coupled to a frame and comprising a plurality of lancets linked together as a chain of lancets, the assembly coupled to the frame so that it is moveable about the frame as a single unit to position a lancet of the chain with respect to the opening; and

a moveable carriage coupled to the assembly to move a lancet that is positioned with respect to the opening along a stroke from position wherein the lancet is substantially entirely within the interior space to an extended position wherein at least a portion of the lancet extends a distance outwardly through the opening, and back to a position within the interior space.

32. The device of claim 31, wherein the chain of lancets comprises a roller chain.

33. The device of claim 32, wherein the device comprises at least one sprocket to which the roller chain is coupled.

34. The device of claim 33, wherein the device comprises two sprockets.

35. The device of claim 33, wherein the at least one sprocket is rotatably attached to the frame.

36. The device of claim 35, wherein the at least one sprocket rotates about its axis to move the roller chain.

37. The device of claim 36, wherein the movement of the roller chain is accomplished manually.

38. The device of claim 36, wherein the movement of the roller chain is accomplished at least semi-automatically.

39. The device of claim 31, wherein the device comprises a selector to selectively control the stroke range.

40. The device of claim 31, wherein the device comprises a lancet indicator to indicate a lancet of the chain.

41. The device of claim 40, wherein the indicator indicates the number of unused lancets remaining in the device or the number of used lancets in the device.

42. The device of claim 41, wherein the indicator is automatically re-settable each time the lancet chain is replaced with a different lancet chain.

43. The device of claim 41, wherein the indicator is manually re-settable each time the lancet chain is replaced with a different lancet chain.

44. The device of claim 31, wherein the chain of lancets is permanently attached to the device.

45. The device of claim 31, wherein the chain of lancets is removable from the device.

46. The device of claim 31, wherein the device comprises an analyte testing monitor within the interior space.

47. The device of claim 46, wherein the analyte testing monitor is a glucose testing monitor.

48. The device of claim 47, wherein the glucose testing monitor is a less than about 1 microliter of sample glucose testing monitor.

49. The device of claim 47, wherein a plurality of test strips are retained in the interior space.

50. A method of piercing skin, the method comprising:

moving a chain of lancets retained within an interior space of a device so that one of the lancets is positioned proximate to an opening of the device;

positioning the opening of a device proximate to a skin surface;

firing the device to move the positioned lancet at least partially out of the opening to pierce skin;

retracting the fired lancet into the interior space; and

moving the chain of lancets to position another lancet of the chain is positioned proximate to the opening.

51. The method of claim 50, wherein the moving is accomplished automatically.

52. The method of claim 50, wherein the moving is accomplished manually.

53. The method of claim 50, further comprising contacting an analyte test strip to biological fluid expressed at the pierced site.

54. The method of claim 53, wherein the contacting comprises moving a test strip from the interior space of the housing to the biological fluid exterior of the housing.

55. The method of claim 54, wherein the test strip is a less than about 1 microliter test strip.