Method and apparatus for penetrating tissue

• US 7,717,863 B2
• Filed: 12/31/2002
• Issued: 05/18/2010
• 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 M.
• Primary Examiner(s): Milano; Michael J
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/335,240
• Publication Number:
  US 20030199907A1
• Time in Patent Office: 2,695 Days
• Field of Search: 606/167, 606/172, 606181-183, 600/573, 600/576, 600577-579, 600/583, 600/584
• US Class Current: 600/583
• CPC Class Codes: A61B 17/32093 for skin incisions
• 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 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/15146 : 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 5/15163 : 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 5/15186 : 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 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 penetration device includes a penetrating member driver and a cartridge. A plurality of penetrating members are integrated with the cartridge. Each penetrating member is coupled to the penetrating member driver when advanced along a path into a tissue target. 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

1. A tissue penetration device, comprising:

a penetrating member driver;

a cartridge;

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

a penetrating member position sensor coupled to a processor, the processor including a memory that includes stored information of (i) a distance of a penetrating member tip from a target tissue, (ii) acceleration and displacement of the penetrating member; and

(iii) a start position of the penetrating member, the processor using the stored information to calculate depth of penetration of the penetrating member and

a feedback loop coupled to the penetrating member position sensor.

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

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

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

5. The system of claim 1, further comprising:

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

6. The system of claim 1, wherein the penetrating member driver is an electric drive force member.

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

8. 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.

9. The system of claim 8, 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.

10. The system of claim 9, wherein in a 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.

11. The system of claim 10, 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.

12. The system of claim 10, wherein a speed of a penetrating member in the first direction is the range of 0.05 to 60 m/sec.

13. The system of claim 10, wherein a speed of a penetrating member in the first direction is the range of 0.1 to 20.0 m/sec.

14. The system of claim 10, wherein a speed of a penetrating member in the first direction is the range of 1.0 to 10.0 m/sec.

15. The system of claim 10, wherein a speed of a penetrating member in the first direction is the range of 3.0 to 8.0 m/sec.

16. The system of claim 10, 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.

17. The system of claim 1, 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.

18. The system of claim 1, 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.

19. The system of claim 1, further comprising:

a plurality of cartridges integrated in a cassette.

20. The system of claim 19, wherein each cartridge has an exit port, and upon launch each penetrating member exists from the exit port.

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

22. The system of claim 1, further comprising:

an analyte detecting member.

23. The system of claim 1, further comprising:

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

24. 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.

25. The system of claim 24, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 1.0 cm³.

26. The system of claim 24, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.75 cm³.

27. The system of claim 24, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.5 cm³.

28. The system of claim 24, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.25 cm³.

29. The system of claim 24, wherein each of a penetrating member and an associated sample chamber have a combined packing density of no more than 0.1 cm³.

30. 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.

31. 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.

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 0.25 μ

L of the body fluid.

33. 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.

34. 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.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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 0.5 cm³/penetrating member.

41. 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.

42. 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.

43. The system of claim 1, where in each of a penetrating member of the plurality of penetrating members has a packing density of no more than 0.1 cm³/penetrating member.

44. The system of claim 1, further comprising:

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

45. The system of claim 44, further comprising

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

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

47. 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.

48. The system of claim 1, further comprising,

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

49. The system of claim 1, further comprising:

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

50. The system of claim 1, further comprising:

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

51. The system of claim 1, further comprising:

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

52. The system of claim 1, further comprising:

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

53. The system of claim 1, further comprising:

a support structure for receiving the penetrating members.