IP Library Granted Patent US 7,547,287
Granted Patent B2
US 7,547,287 · App. 10/335,212 · Granted Jun 16, 2009

Method and apparatus for penetrating tissue

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Quick Facts
Patent No.
US 7,547,287
App. No.
10/335,212
Granted
Jun 16, 2009
Kind
B2
Abstract

A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Claims (94)

1. A tissue penetrating system, comprising:

a housing member;

an electrically driven drive force generator;

a plurality of penetrating members positioned in the housing member, wherein each of the penetrating members is coupled to the drive force generator;

a tissue stabilizing member coupled to the housing and configured to stabilize tissue prior to a lancing event;

a penetrating member position sensor coupled to the plurality of penetrating members and measures actual depth of penetration by a penetrating member based on a penetrating member contact point that is measured prior to a lancing event,

a processor coupled to the penetrating member sensor and the drive force generator, operatively programmed with software that has control instructions for the electronically driven drive force generator to keep a wound tract created by a penetrating member open for a sufficient time to provide for spontaneous flow of blood for sample capture into an associated sample with a controlled blood volume of no more than 1 μL, wherein the control instructions are selected from at least one of, velocity of a penetrating member, velocity of a penetrating member in or out of target tissue and a dwell time of a penetrating member in the tissue site; and

wherein a time and position of tissue contact and depth of penetration is determined in response to the processor knowing, a distance of the penetrating member tip from a target tissue, acceleration and displacement of a penetrating member, and a start position of the penetrating member.

2. The system of claim 1 , wherein the tissue stabilizer member is configured to enhance fluid flow from a target tissue.

3. The system of claim 1 , wherein the tissue stabilizer member creates a stretching of a skin surface.

4. The system of claim 1 , wherein the tissue stabilizer member includes a plurality of protrusions.

5. The system of claim 1 , wherein the tissue stabilizer member applies a vacuum to a target tissue.

6. The system of claim 1 , wherein the tissue stabilizer member is configured to apply a force to a target tissue and cause the target tissue to press in an inward direction relative to the housing member.

7. The system of claim 1 , wherein the tissue stabilizing device applies a stimulation to a target tissue.

8. The system of claim 1 , wherein the depth of penetration is 100 to 2500 microns.

9. The system of claim 1 , wherein the depth of penetration is 500 to 750 microns.

10. The system of claim 1 , wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

11. The system of claim 1 , further comprising:

a second penetrating member sensor configured to provide an indication of velocity of a penetrating member.

12. The system of claim 1 , further comprising:

a feedback loop coupled to the penetrating member position sensor.

13. The system of claim 1 , wherein a penetrating member driver is a voice coil drive force generator.

14. The system of claim 1 , wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

15. The system of claim 1 , wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

16. The system of claim 1 , wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

17. The system of claim 1 , wherein the processor is utilized to adjust an application of force to a penetrating member when the penetrating member contacts a target tissue so that the penetrating member penetrates the target tissue within a desired range of speed.

18. The system of claim 1 , wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member.

19. The system of claim 1 , wherein the processor is utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from a target tissue.

20. The system of claim 1 , wherein in the first direction the penetrating member moves toward the target tissue at a speed that is different than a speed at which the penetrating member moves away from a target tissue.

21. The system of claim 1 , wherein in a first direction the penetrating member moves toward the target tissue at a speed that is greater than a speed at which the penetrating member moves away from a target tissue.

22. The system of claim 20 , wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

23. The system of claim 20 , wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

24. The system of claim 20 , wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

25. The system of claim 20 , wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

26. The system of claim 20 , wherein a dwell time of the penetrating member in a target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

27. The system of claim 1 , wherein a dwell time of the penetrating member in a target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second.

28. The system of claim 1 , wherein a dwell time of the penetrating member in a target tissue below a skin surface is in the range of 100 milliseconds to 1 second.

29. The system of claim 1 , further comprising:

a plurality of disposables integrated in a cassette.

30. The system of claim 29 , wherein each disposable has an exit port, and upon launch each penetrating member exists from the exit port.

31. The system of claim 1 , wherein the penetrating member position sensor includes a capacitive incremental encoder.

32. The system of claim 1 , wherein the penetrating member position sensor includes an incremental encoder.

33. The system of claim 1 , wherein the penetrating member position sensor includes an optical encoder.

34. The system of claim 1 , wherein the penetrating member position sensor includes an interference encoder.

35. The system of claim 1 , further comprising:

an analyte detecting member.

36. The system of claim 1 , further comprising:

a plurality of analyte detecting members each coupled to a penetrating member.

37. The system of claim 1 , wherein the sample chamber is sized to receive no more than 0.75 μL of the body fluid.

38. The system of claim 1 , wherein the sample chamber is sized to receive no more than 0.5 μL of the body fluid.

39. The system of claim 1 , wherein the sample chamber is sized to receive no more than 0.25 μL of the body fluid.

40. The system of claim 1 , wherein the sample chamber is sized to receive no more than 0.1 μL of the body fluid.

41. The system of claim 1 , further comprising:

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 1 μL of a body fluid disposed in the sample chamber.

42. The system of claim 1 , further comprising:

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.75 μL of a body fluid disposed in the sample chamber.

43. The system of claim 1 , further comprising:

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.5 μL of a body fluid disposed in the sample chamber.

44. The system of claim 1 , further comprising:

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.25 μL of a body fluid disposed in the sample chamber.

45. The system of claim 1 , further comprising:

an analyte detecting member coupled to a sample chamber, the analyte detecting member being configured to determine a concentration of an analyte in a body fluid using a sample that does not exceed a volume of 0.1 μL of a body fluid disposed in the sample chamber.

46. The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 1.0 cm 3 /penetrating member.

47. The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.75 cm 3 /penetrating member.

48. The system of claim 1 , wherein the each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.5 cm 3 /penetrating member.

49. The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.25 cm 3 /penetrating member.

50. The system of claim 1 , wherein each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.1 cm 3 /penetrating member.

51. The system of claim 1 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm 3 .

52. The system of claim 1 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm 3 .

53. The system of claim 1 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm 3 .

54. The system of claim 1 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm 3 .

55. The system of claim 1 , wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm 3 .

56. The system of claim 1 , further comprising:

a seal formed by a fracturable material between the penetrating member and a disposable, the seal being positioned at least one of a distal port or a proximal port of the disposable.

57. The system of claim 56 , further comprising

a second fracturable seal located at least one of the distal port or proximal port of disposable.

58. The system of claim 1 , wherein each penetrating member is an elongated member without molded attachments.

59. The system of claim 1 , further comprising:

a penetrating member transport device for moving each of a penetrating member into a position aligned with the penetrating member driver.

60. The system of claim 1 , further comprising,

a belt for holding the penetrating members in an array configuration.

61. The system of claim 1 , further comprising:

a tape device configured to hold the penetrating members in an array configuration.

62. The system of claim 1 , further comprising:

a support channel configured to hold the penetrating members in an array configuration.

63. The system of claim 1 , further comprising:

a cog configured to hold the penetrating members in an array configuration.

64. The system of claim 1 , further comprising:

a plurality of connectors between penetrating members for holding the penetrating members in an array configuration.

65. The system of claim 1 further comprising:

a support structure for receiving the penetrating members.

66. The system of claim 65 , wherein the support structure is a bandolier.

67. The system of claim 65 , wherein the support structure is a drum.

68. The system of claim 65 , wherein the support structure is a disc.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2012
From: PELIKAN TECHNOLOGIES, INC.
To: SANOFI-AVENTIS DEUTSCHLAND GMBH
Reel/Frame 028259/0634 →
RELEASE OF SECURITY INTEREST Recorded Mar 2, 2010
From: GENERAL ELECTRIC CAPITAL CORPORATION
To: PELIKAN TECHNOLOGIES, INC.
Reel/Frame 024016/0492 →
SECURITY AGREEMENT Recorded Dec 18, 2008
From: PELIKAN TECHNOLOGIES, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION
Reel/Frame 021998/0381 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2003
From: BOECKER, DIRK; ALDEN, DON; FREEMAN, DOMINIQUE M.
To: PELIKAN TECHNOLOGIES, INC.
Reel/Frame 013959/0749 →