Interstitial fluid collection and constituent measurement

• US 7,137,957 B2
• Filed: 03/06/2003
• Issued: 11/21/2006
• Est. Priority Date: 10/13/1993
• Status: Expired due to Term

• Current Assignee: Integ Incorporated (Johnson & Johnson)
• Original Assignee: Integ Incorporated (Johnson & Johnson)
• Inventors: Knudson, Mark B., Erickson, Brian J., Hilgers, Michael E., Shapland, J. Edward, Hendrickson, Tracy A., Solomon, Frank A.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/383,469
• Publication Number:
  US 20030149377A1
• Time in Patent Office: 1,356 Days
• Field of Search: 600573-584, 600/365, 600/309, 600/319, 606181-185, 606/188
• US Class Current: 600/573
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters

Abstract

An apparatus and method is disclosed for obtaining and measuring constituents in a sample of body fluid. The apparatus includes a member which is sized to penetrate into at least the dermal layer of skin to collect a sample of body fluid located within the dermal layer.

Claims

1. A method for collecting a sample of body fluid, comprising:

forming an artificial opening within a patient'"'"'s skin but not through a dermal layer of said skin;

accessing a constituent-containing fluid in said dermal layer;

exerting a capillary action on the accessed fluid; and

drawing a sample of said accessed fluid through said opening.

2. The method of claim 1 wherein said constituent is glucose.

3. The method of claim 1 further comprising testing said sample for said constituent.

4. The method of claim 1, wherein said step of forming said artificial opening comprises penetrating the skin with a hollow tube having an open end.

5. The method of claim 4, wherein said exerting a capillary action is performed by said hollow tube.

6. The method of claim 1, wherein said step of forming said artificial opening comprises penetrating the skin with a needle.

7. The method of claim 1, further comprising one or more of the group consisting of applying a negative pressure to said accessed fluid and compressing the skin adjacent said artificial opening.

8. The method of claim 1 wherein said fluid is substantially blood-free.

9. A method for collecting a sample of body fluid, comprising:

inserting a penetration member into but not through a dermal layer of skin to access body fluid therein, said penetration member having an open distal end; and

exerting a capillary action on the body fluid present at said open distal end of said penetration wherein said body fluid is drawn into said penetration member.

10. The method of claim 9, further comprising testing said body fluid for at least one constituent contained within the body fluid.

11. The method of claim 10, wherein said testing is performed while said body fluid is retained within said penetration member.

12. The method of claim 10, wherein said testing is performed at a location outside said penetration member.

13. The method of claim 9, further comprising at least one of the group consisting of applying a negative pressure at an open proximal end of said penetration member and compressing the skin surrounding said penetration member.

14. The method of claim 9, wherein said penetration member has an inner diameter sufficient to exert a capillary action on said fluid present at said open distal end.

15. The method of claim 9, further comprising penetrating said skin with a needle.

16. The method of claim 15, wherein said needle penetration and said penetration member insertion occur substantially simultaneously.

17. The method of claim 9, wherein said penetration member is inserted into an upper third portion of the dermal layer.

18. An apparatus for collecting a sample of body fluid, comprising:

a penetration member sized to penetrate into but not through the dermal layer of skin, said penetration member having an open distal end; and

means associated with said penetration member for exerting a capillary action on fluid present at said open distal end.

19. The apparatus of claim 18, wherein said capillary action means comprises a conduit comprising an open distal end and an inner diameter sufficient to exert a capillary action.

20. The apparatus for claim 19 further comprising a configuration wherein said conduit is insertable to a predetermined depth within the dermal layer.

21. The apparatus of claim 19, wherein said conduit is insertable only into an upper third portion of the dermal layer.

22. The apparatus of claim 19, further comprising means for controlling the depth of the penetration of said penetration member wherein said open distal end penetrates into the dermal layer of skin but not through the dermal layer of skin.

23. The apparatus of claim 19, wherein said penetration member is a hollow needle and said conduit is retained within said hollow needle.

24. The apparatus of claim 23, wherein said needle comprises opposing axially extending slots wherein a portion of said conduit is exposed for testing of fluid drawn within said conduit.

25. The apparatus of claim 18, wherein said penetration member comprises a lance.

26. The apparatus of claim 25, wherein said capillary action means comprises a slit within said lance.

27. The apparatus of claim 18, wherein said penetration member comprises a split sheet of metal and said capillary action means comprises a slit defined between opposing surfaces of said sheet of metal.

28. An apparatus for collecting a sample of body fluid, comprising:

a hollow needle comprising an insertion tip sized to penetrate into but not through the dermal layer of skin; and

a tube retained within said hollow needle, said tube comprising an open distal end and an inner diameter sufficient to exert a capillary action on fluid present at said open distal end so as to draw the fluid into said tube.

29. The apparatus of claim 28 wherein said distal end of said tube is disposed adjacent said insertion tip of said needle.