Method and apparatus for penetrating tissue

• US 8,062,231 B2
• Filed: 10/11/2006
• Issued: 11/22/2011
• 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): NGUYEN, VI X
• Application Number:
  US11/548,533
• Publication Number:
  US 20070142747A1
• Time in Patent Office: 1,868 Days
• Field of Search: 606/181, 606/182, 600/573, 600/575, 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 5/15107 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, C12Q1/56
• 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 electrically powered drive force generator, the electrically powered drive force generator moving the penetrating 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 following a predetermined velocity vs. position profile;

a penetrating member sensor configured to monitor depth of penetration and velocity of the penetrating member;

a processor coupled to the electrically powered drive force generator with program instructions that provide an input to the electrically powered drive force generator to control depth of penetration and velocity of the penetrating member to match the predetermined velocity vs. position profile via a feedback loop of the depth of penetration and velocity of the penetrating member from the penetrating member sensor; 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 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.

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

16. The system of claim 1, wherein the penetrating member has a packing density of no more than 0.75 cm3/penetrating member.

17. The system of claim 1, wherein the the penetrating member has a packing density of no more than 0.5 cm3/penetrating member.

18. The system of claim 1, wherein the penetrating member has a packing density of no more than 0.25 cm3/penetrating member.

19. The system of claim 1, wherein the penetrating member has a packing density of no more than 0.1 cm3/penetrating member.

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

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

27. The system of claim 1, wherein the tissue stabilizing member includes a plurality of protrusions.

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

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

30. The system of claim 1, further comprising:

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

31. The system of claim 30, further comprising

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

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

33. The system of claim 1, further comprising:

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

34. The system of claim 1, further comprising,

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

35. The system of claim 1, further comprising:

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

36. The system of claim 1, further comprising:

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

37. The system of claim 1, further comprising:

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

38. The system of claim 1, further comprising:

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

39. The system of claim 1, further comprising:

a support structure for receiving the penetrating member.

40. The system of claim 39, wherein the support structure is a bandolier.

41. The system of claim 39, wherein the support structure is a drum.

42. 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 electrically powered drive force generator, said electrically powered drive force generator moving said penetrating 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 following a predetermined velocity vs. position profile;

a penetrating member sensor configured to monitor depth of penetration and velocity of the penetrating member;

a processor coupled to the electrically powered drive force generator with program instructions that provide an input to the electrically powered drive force generator to control depth of penetration and velocity of the penetrating member to match the predetermined velocity vs. position profile via a feedback loop of the depth of penetration and velocity of the penetrating member from the penetrating member sensor; and

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