Method and apparatus for a multi-use body fluid sampling device with analyte sensing

• US 7,198,606 B2
• Filed: 12/18/2002
• Issued: 04/03/2007
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Freeman, Dominique M.
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): TOWA, RENE T
• Application Number:
  US10/323,624
• Publication Number:
  US 20030199893A1
• Time in Patent Office: 1,567 Days
• Field of Search: 600/573, 600/583, 600575-579, 600/584, 606/167, 606/172, 606181-183
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150916 : by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/15123 : comprising magnets or solenoids
• CPC Class Codes: A61B 5/1513 : comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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 5/15151 : Each piercing element being stocked in a separate isolated compartment
• 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 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15169 : Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 : Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15178 : Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• 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 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• CPC Class Codes: A61B 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 37/0015 : by using microneedles

Abstract

A device for use with a penetrating member driver to penetrate tissue is provided. A plurality of penetrating members are coupled to a single cartridge and are operatively couplable to the penetrating member driver. The penetrating members are movable to extend radially outward from the cartridge to penetrate tissue. A plurality of analyte sensors are coupled to the single cartridge and are positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.

Claims

1. A device for use with a penetrating member driver to penetrate tissue, the device comprising:

a single cartridge;

a plurality of penetrating members coupled to said single cartridge and operatively couplable to a penetrating member driver, said penetrating members movable to extend radially outward from the cartridge to penetrate tissue;

a plurality of analyte sensors each in a sample chamber with the sample chambers being coupled to said single cartridge, each of a sample chamber being positioned on the cartridge to receive body fluid from a wound in the tissue created by each of said penetrating members and having a volume of no greater than 1 microliter; and

a position sensor coupled to the plurality of penetrating members, the position sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface, the position sensor further configured to provide an indication of velocity of a penetrating member.

2. The device of claim 1 wherein said penetrating members are slidably coupled to said cartridge.

3. The device of claim 1 wherein at least one analyte sensor is associated with at least one of said penetrating members.

4. The device of claim 1 wherein said cartridge is a flat radial disc.

5. The device of claim 1 wherein said cartridge has a diameter of less than 6 cm.

6. The device of claim 1 wherein said cartridge is a unitary body.

7. The device of claim 1 wherein said penetrating members are not attached by a resilient member to the cartridge.

8. The device of claim 1 wherein said analyte sensors are electrochemical sensors.

9. The device of claim 1 wherein said analyte sensors are potentiometric sensors.

10. The device of claim 1 wherein said sample chambers are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

11. The device of claim 1 wherein said analyte sensors are mounted on said cartridge.

12. The device of claim 1 wherein each of said analyte sensors comprises an array of sensors.

13. The device of claim 1 wherein each of said analyte sensors comprises an array of sensors wherein a plurality of said array sensors have different ranges of analyte sensitivity.

14. The device of claim 1 wherein each of said analyte sensors comprises an array of sensors formed from nanowires.

15. The device of claim 1 wherein each of said penetrating members are elongate members without molded attachments.

16. The device of claim 1 wherein each of said penetrating members are elongate wires of substantially constant diameter.

17. The device of claim 1 wherein each of said penetrating members is made of only one material selected from the following:

a metal or a metal alloy.

18. A device for use with a penetrating member driver to penetrate tissue, the device comprising:

a single cartridge having a plurality of openings;

a plurality of penetrating members having sharpened tips movable to penetrate tissue;

a plurality of analyte sensors coupled to said single cartridge, each of an analyte sensor being positioned in a sample chamber with a volume no greater than 1 microliter;

a sterility barrier covering said openings; and

a position sensor coupled to the plurality of penetrating members, the position sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface, the position sensor further configured to provide an indication of velocity of a penetrating member.

19. The device of claim 18 wherein said penetrating members are arranged in a radial pattern pointing each of said sharpened distal ends radially outward.

20. The device of claim 18 wherein said analyte sensors are positioned on the cartridge to receive body fluid from a wound in the tissue created by a penetrating member.

21. The device of claim 18 wherein said analyte sensors are electrochemical sensors.

22. The device of claim 18 wherein said analyte sensors are potentiometric sensors.

23. The device of claim 18 wherein said sample chambers are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

24. The device of claim 18 wherein said sterility barrier, prior to being breached, maintains a sterile environment inside said openings.

25. A device for use with a penetrating member driver to penetrate tissue, the device comprising:

a single cartridge having a plurality of cavities;

a plurality of penetrating members coupled to said single cartridge and couplable to a penetrating member driver, said penetrating members being movable to extend outward to penetrate tissue;

a plurality of analyte sensors each in a sample chamber with the sample chambers being coupled to said single cartridge, each of a sample chamber being positioned on the cartridge to receive body fluid from a wound in the tissue created by each of said penetrating members and having a volume of no greater than 1 microliter; and

a position sensor coupled to the plurality of penetrating members, the position sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface, the position sensor further configured to provide an indication of velocity of a penetrating member.

26. The device of claim 25 wherein said sample chambers define a portion of said cavities.

27. The device of claim 25 further comprising a sterility barrier covering said cavities.

28. The device of claim 25 wherein said analyte sensors are electrochemical sensors.

29. The device of claim 25 wherein said analyte sensors are potentiometric sensors.

30. The device of claim 25 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter.

31. The device of claim 25 wherein said analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

32. The device of claim 25 wherein at least some of said analyte sensors are positioned on a bottom surface of said cavities.

33. The device of claim 25 wherein at least some of said analyte sensors are positioned on a side surface of said cavities.

34. The device of claim 25 wherein at least some of said analyte sensors are positioned on a top surface of said cavities.

35. The device of claim 25 wherein at least some of said analyte sensors are positioned on a curved surface of said cavities.

36. A device for use with a penetrating member driver to penetrate tissue, the device comprising:

a single cartridge having a plurality of openings and a plurality of penetrating member cavities;

a plurality of penetrating members at least partially contained in said cavities;

a plurality of sensors each in a sample chamber with the sample chambers being attached to a substrate, said substrate couplable to said single cartridge in manner positioning at least one of said sensors with each of said plurality of cavities, each of a sample chamber being positioned on the cartridge to receive body fluid from a wound in the tissue created by each of said penetrating members and having a volume of no greater than 1 microliter; and

a position sensor coupled to the plurality of penetrating members, the position sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface, the position sensor further configured to provide an indication of velocity of a penetrating member.

37. The device of claim 36 wherein said substrate comprises a material selected from:

polymer, metallic foil, or paper.

38. The device of claim 36 wherein said substrate comprises a laminate made from combinations of any of the following:

polymer, metallic foil, or paper.

39. The device of claim 36 wherein said sample chambers define a portion of said cavities.

40. The device of claim 36 further comprising a sterility barrier covering a plurality of said openings.

41. The device of claim 36 wherein said sample chambers are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

42. A device for use with a penetrating member driver to penetrate tissue, the device comprising:

a single cartridge having a plurality of openings and a plurality of cavities that are sample chambers each with a volume no greater than 1 microliter;

a plurality of penetrating members with at least one penetrating members in at least one of said cavities;

a plurality of sensors each in a sample chamber and on a layer of material couplable to said single cartridge wherein at least two of said cavities each has at least one sensor in fluid communication with one of said cavities, said sensors positioned on the cartridge to receive body fluid from a wound in the tissue created by each of said penetrating members; and

a position sensor coupled to the plurality of penetrating members, the position sensor configured to provide information relative to a death of penetration of a penetrating member through a skin surface, the position sensor further configured to provide an indication of velocity of a penetrating member.

43. A device comprising:

a single cartridge;

at least 50 penetrating members coupled to and at least partially housed in said single cartridge wherein said cartridge has a diameter no greater than about 5 inches;

at least 50 analyte sensors each in a sample chamber that has a volume no greater than 1 microliter, each sensor associated with one of said penetrating members;

said penetrating members movable in an outward direction from the cartridge to penetrate tissue when actuated by a penetrating member driver; and

a position sensor coupled to the plurality of penetrating members, the position sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface, the position sensor further configured to provide an indication of velocity of a penetrating member.

44. The system of claim 43, wherein the diameter is no greater than about 5 cm.

45. The system of claim 43, wherein a volume of the cartridge does not exceed a packing density of about 0.5 cm3 per penetrating member and analyte sensor.

46. The system of claim 43, wherein a volume of the cartridge does not exceed a packing density of about 0.1 cm3 per penetrating member and analyte sensor.

47. A device comprising:

a single cartridge;

at least 100 penetrating members coupled to and at least partially housed in said single cartridge wherein said cartridge has a diameter no greater than 6 inches;

at least 100 analyte sensors each in a sample chamber that has a volume no greater than 1 microliter, each sensor being associated with one of said penetrating members;

said penetrating members movable in an outward direction from the cartridge to penetrate tissue when actuated by a penetrating member driver; and

a position sensor coupled to the plurality of penetrating members, the position sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface, the position sensor further configured to provide an indication of velocity of a penetrating member.

48. The system of claim 47, wherein the diameter is no great than about 5 cm.

49. The system of claim 47, wherein a volume of the cartridge does not exceed a packing density of about 0.5 cm3 per penetrating member and analyte sensor.

50. The system of claim 47, wherein a volume of the cartridge does not exceed a packing density of about 0.1 cm3 per penetrating member and analyte sensor.

51. A ranting system comprising:

a penetrating member driver;

a plurality of penetrating members in a disc-shaped housing;

a penetrating member release device releasing the penetrating member for a sterile environment prior to use and moving said penetrating member into position to be operatively coupled to said penetrating member driver;

a plurality of sampling modules that are sample chambers, each sample chamber having a volume no greater than 1 microliter, wherein each of said modules is coupled to one of said penetrating members and housed in said disc-shaped housing; and

a position sensor coupled to the plurality of penetrating members, the position sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface, the position sensor further configured to provide an indication of velocity of penetrating member.

52. The system of claim 51 wherein said penetrating member driver is an electric powered driver.

53. The system of claim 51 wherein said release device comprises a movable member sufficient to pierce a penetrating member enclosure.

54. The system of claim 51 further comprising a penetrating member coupler suitable for engaging one of the penetrating members and independently advancing one of the penetrating members along a path outward from the housing, into a target tissue, and back into the housing.

55. The system of claim 51 further comprising a penetrating member coupler configured for engaging one of the modules and advancing one of the modules and one of the penetrating members such that said one of the penetrating members advances along a path outward from the housing, into a target tissue, and back into the housing.

56. A lancing system for use with a penetrating member driver, said system comprising:

means for housing a plurality of penetrating members and analyte sensors each of an analyte sensor positioned in a sample chamber having a volume no greater than 1 microliter;

means for releasing one of said penetrating members from a sealed enclosure on said housing means;

means for operatively coupling one of said penetrating members to said penetrating member driver;

wherein one of said analyte sensors receives body fluid from a wound created in said tissue by one of said penetrating members,

position sensor means coupled to the plurality of penetrating members, the position sensor means configured to provide information relative to a depth of penetration of a penetrating member through a skin surface, the position sensor means further configured to provide an indication of velocity of a penetrating member.