Method and apparatus for penetrating tissue

• US 20070142747A1
• Filed: 10/11/2006
• Published: 06/21/2007
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique
• Granted Patent: US 8,062,231 B2
• Time in Patent Office: Days
• 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 5/15107 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: 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

These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes a drive force generator and a penetrating member operatively coupled to the force generator. The force generator moves the member along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. The drive force generator is configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of the tissue. A tissue stabilizing member is associated with the device and at least partially surrounds an impact location of the penetrating member on the tissue site.

Claims

1. A body fluid sampling system for use on a tissue site, the system comprising:

a housing;

an electrically powered drive force generator

a penetrating member operatively coupled to the force generator, the force generator moving the member along a path out of the housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site;

a processor coupled to the drive force generator with program instructions that provide an input to the drive force generator of at least one of, a penetrating member depth of penetration, velocity, braking, or retraction; and

a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.

2. The system of claim 1, wherein a penetrating member sensor includes an interference encoder.

3. The system of claim 1, further comprising an analyte detecting member.

4. The system of claim 1, further comprising a plurality of analyte detecting members positioned to receive body fluid.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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 cm3.

21. 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 cm3.

22. 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 cm3.

23. 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 cm3.

24. 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 cm3.

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

26. The system of claim 1 wherein the tissue stabilizer device creates a stretching of a skin surface.

27. The system of claim 1, wherein the tissue stabilizer device includes a plurality of protrusions.

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

29. The system of claim 1, 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.

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

31. The system of claim 1, further comprising:

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

32. The system of claim 31, further comprising

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

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

34. 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.

35. The system of claim 1, further comprising,

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

36. The system of claim 1, further comprising:

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

37. The system of claim 1, further comprising:

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

38. The system of claim 1, further comprising:

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

39. The system of claim 1, further comprising:

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

40. The system of claim 1, further comprising:

a support structure for receiving the penetrating members.

41. The system of claim 40, wherein the support structure is a bandolier.

42. The system of claim 40, wherein the support structure is a drum.

43. A body fluid sampling system for use on a tissue site, the system comprising:

a housing;

an electrically powered drive force generator

a penetrating member operatively coupled to the force generator, the force generator moving the member along a path out of the housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site;

a processor coupled to the drive force generator with program instructions that provide an input to the drive force generator of at least one of, a penetrating member depth of penetration, velocity, braking, or retraction; and

a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.

44. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a position sensor used to determine a position of the penetrating member during actuation;

a processor coupled to the drive force generator and the position sensor with program instructions that provide an input to the drive force generator of at least one of, a penetrating member depth of penetration, velocity, braking, or retraction; and

a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.

45. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

wherein said penetrating member is an elongate member without a molded attachment;

a processor coupled to the drive force generator with program instructions that provide an input to the drive force generator of at least one of, a penetrating member depth of penetration, velocity, braking, or retraction;

a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site; and

a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site

46. A body fluid sampling system for use on a tissue site, the system comprising:

a voice coil drive force generator;

a plurality of modules each containing a penetrating member, each of said modules coupled together to define a flexible array;

a transport device for moving each of said modules into a launch position operatively coupling said penetrating member to the force generator;

a processor coupled to the drive force generator with program instructions that provide an input to the drive force generator of at least one of, a penetrating member depth of penetration, velocity, braking, or retraction; and

a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.

47. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;

a processor coupled to the drive force generator with program instructions that provide an input to the drive force generator of at least one of, a penetrating member depth of penetration, velocity, braking, or retraction;

a sterility enclosure covering at least a tip of said penetrating member, said sterility enclosure removed from said penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact said enclosure during actuation; and

a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.

48. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a penetrating member having an elongate portion without a molded attachment and operatively coupled to said force generator;

a processor coupled to the drive force generator with program instructions that provide an input to the drive force generator of at least one of, a penetrating member depth of penetration, velocity, braking, or retraction;

a sterility enclosure creating a sterile environment around at least a tip of said penetrating member, said penetrating member breaching said sterile environment during actuation; and

a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.

49. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a processor coupled to the drive force generator with program instructions that provide an input to the drive force generator of at least one of, a penetrating member depth of penetration, velocity, braking, or retraction;

an analyte detection member positioned to receive fluid from a wound created by said penetrating member, said detection member configured to determine a concentration of an analyte in the fluid using a sample of less than 1 μ

L of the fluid; and

a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.

50. A body fluid sampling system for use on a tissue site, the system comprising:

an electrically powered drive force generator

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a processor coupled to the drive force generator with program instructions that provide an input to the drive force generator of at least one of, a penetrating member depth of penetration, velocity, braking, or retraction; and

a vacuum source associated with said device for creating a lower atmosphere environment to draw fluid from a wound created by said penetrating member.

51. A body fluid sampling system for use on a tissue site, the system comprising:

an electrically powered drive force generator

a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a processor coupled to the drive force generator with program instructions that provide an input to the drive force generator of at least one of, a penetrating member depth of penetration, velocity, braking, or retraction; and

a movable capillary tube advancable between a first position and a second position.