Method and apparatus for penetrating tissue

• US 7,731,729 B2
• Filed: 02/13/2007
• Issued: 06/08/2010
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique
• Primary Examiner(s): Milano; Michael J
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US11/674,220
• Publication Number:
  US 20070167875A1
• Time in Patent Office: 1,211 Days
• Field of Search: 606/181, 606/182, 606/183, 606/167, 606/172, 606/173, 600/573, 600/583
• US Class Current: 606/181
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 2050/3008 having multiple compartments
• CPC Class Codes: A61B 2050/3009 having means for connecting similar adjacent containers
• 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 5/150022 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 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• 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 5/150435 Specific design of proximal end
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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 5/15087 : short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15123 : comprising magnets or solenoids
• 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 5/15163 : 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 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 50/20 : Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 50/22 : Racks
• CPC Class Codes: A61B 50/3001 : for sharps
• CPC Class Codes: A61M 2005/004 : Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0663 : Whole sensors
• CPC Class Codes: B01L 2300/18 : Means for temperature control
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 33/4905 : Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/557 : using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction

Abstract

A tissue penetrating system includes a plurality of penetrating members each having a tip. A penetrating member driver is coupled to the plurality of penetrating members. Each tip of a penetrating member is uncovered during launch of the penetrating member by the penetrating member driver. A support is provided with a plurality of openings. Each opening receives a penetrating member.

Claims

1. A tissue penetration device, comprising:

a penetrating member driver;

a cartridge;

a plurality of penetrating members integrated with the cartridge, each of a penetrating member coupled to the penetrating member driver when advanced along a path into a tissue target; and

a support with a plurality of openings, each opening receiving a penetrating member, each tip of a penetrating member being uncovered during launch of a penetrating member by the penetrating driver member; and

a penetrating member position sensor coupled to the plurality of penetrating members and to a processor, the penetrating member position sensor and the processor measuring a distance from an initialization point to a point of contact of a penetrating member to a target tissue surface, the penetrating member being retracted by the penetrating member driver to the initialization point with a distance to the target tissue being measured and a depth of penetration of the penetrating member determined.

2. The system of claim 1, further comprising:

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

3. The system of claim 2, wherein the depth of penetration is 100 to 2500 microns.

4. The system of claim 2, wherein the depth of penetration is 500 to 750 microns.

5. The system of claim 2, wherein the penetrating member sensor is further configured to provide an indication of velocity of a penetrating member.

6. The system of claim 2, further comprising:

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

7. The system of claim 2, further comprising:

a feedback loop coupled to the penetrating member sensor.

8. The system of claim 2, wherein the penetrating member driver is an electric drive force member.

9. The system of claim 2, wherein the penetrating member driver is a voice coil drive force generator.

10. The system of claim 2, wherein the penetrating member sensor is coupled to a processor with control instructions for the penetrating member driver.

11. The system of claim 10, wherein the processor includes a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.

12. The system of claim 10, wherein the processor is utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.

13. The system of claim 10, wherein the processor is utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.

14. The system of claim 10, 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.

15. The system of claim 10, 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.

16. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

17. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

18. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

19. The system of claim 15, wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

20. The system of claim 15, wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 1 microsecond to 2 seconds.

21. The system of claim 10, 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 the target tissue.

22. The system of claim 21, 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 the target tissue.

23. The system of claim 21, wherein in the 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 the target tissue.

24. The system of claim 2, wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 500 milliseconds to 1.5 second.

25. The system of claim 2, wherein a dwell time of the penetrating member in the target tissue below a skin surface is in the range of 100 milliseconds to 1 second.

26. The system of claim 2, wherein the penetrating member sensor includes a capacitive incremental encoder.

27. The system of claim 2, wherein the penetrating member sensor includes an incremental encoder.

28. The system of claim 2, wherein the penetrating member sensor includes an optical encoder.

29. The system of claim 2, wherein the penetrating member sensor includes an interference encoder.

30. The system of claim 1, further comprising:

an analyte detecting member.

31. The system of claim 1, further comprising:

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

32. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 1.0 μ

L of the body fluid.

33. The system of claim 32, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm³.

34. The system of claim 32, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm³.

35. The system of claim 32, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm³.

36. The system of claim 32, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm³.

37. The system of claim 32, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm³.

38. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.75 μ

L of the body fluid.

39. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.5 μ

L of the body fluid.

40. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.25 μ

L of the body fluid.

41. The system of claim 1, further comprising:

a sample chamber with an opening for transport of a body fluid into the sample chamber, the sample chamber being sized to receive no more than 0.1 μ

L of the body fluid.

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 1 μ

L 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 0.75 μ

L 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 0.5 μ

L 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 0.25 μ

L of a body fluid disposed in the sample chamber.

46. 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 μ

L of a body fluid disposed in the sample chamber.

47. The system of claim 1, wherein each of a penetrating of the plurality of penetrating members has a packing density of no more than 1.0 cm³/penetrating member.

48. 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 cm³/penetrating member.

49. 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 cm³/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 0.25 cm³/penetrating member.

51. 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 cm³/penetrating member.

52. The system of claim 1, further comprising:

a tissue stabilizer device coupled to the housing.

53. The system of claim 52, wherein the tissue stabilizer device is configured to enhance fluid flow from a target tissue.

54. The system of claim 52, wherein the tissue stabilizer device creates a stretching of a skin surface.

55. The system of claim 52, wherein the tissue stabilizer device includes a plurality of protrusions.

56. The system of claim 52, wherein the tissue stabilizer device applies a vacuum to a target tissue.

57. The system of claim 52, wherein the tissue stabilizer device 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.

58. The system of claim 52, wherein the tissue stabilizing member applies a stimulation to a target tissue.