Enhanced interstitial fluid collection

• US 6,997,886 B2
• Filed: 11/17/2003
• Issued: 02/14/2006
• Est. Priority Date: 09/08/1995
• Status: Expired due to Fees

• Current Assignee: Integ Incorporated (Johnson & Johnson)
• Original Assignee: Integ Incorporated (Johnson & Johnson)
• Inventors: Erickson, Brian J., Hilgers, Michael E., Latterell, Scott T., Hoegh, Thomas B., Brinda, Paul D., Shoup, Michael J.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/715,975
• Publication Number:
  US 20040102715A1
• Time in Patent Office: 820 Days
• Field of Search: 600/573, 600/576, 600/578, 600/581, 600/583, 600/584, 600/365, 606/181, 606/182
• US Class Current: 600/576
• 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 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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
• 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 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A sampling apparatus for interstitial fluid includes a pressure ring surrounding a collection needle. The pressure ring and needle are movable relative to one another for the ring to first engage a patient'"'"'s skin surface prior to insertion of the needle.

Claims

1. A method of collecting a sample of body fluid from a skin layer the method comprising:

providing a sampling tool comprising a needle and a skin stretching member having opposing surfaces at least partially surrounding said needle, wherein said needle and said skin stretching member are independently movable relative to one another along a path substantially parallel to an axis of said needle;

placing said skin stretching member against the skin of a patient with said opposing surfaces at least partially surrounding and defining a fluid collection area;

moving said skin stretching member relative to said needle to stretch a skin layer in the fluid collection area;

moving said needle relative to said skin stretching member thereby inserting said needle into the fluid collection area of the stretched skin layer; and

collecting said sample of body fluid.

2. The method of claim 1 wherein said skin stretching member is circular.

3. The method of claim 2 further comprising causing body fluid to flow into the fluid collection area.

4. The method of claim 1 wherein said skin stretching member comprises a pressure ring.

8. The method of claim 1 further comprising placing an absorbent membrane in fluid communication with said needle wherein said collected body fluid is deposited on said absorbent membrane.

9. The method of claim 8 further comprising testing said body fluid deposited on said absorbent membrane with light.

10. The method of claim 1 further comprising testing said collected body fluid for determining the concentration of at least one constituent.

12. The method of claim 1 wherein said moving said skin stretching member comprises employing a first spring and said moving said needle comprises employing a second spring.

5. A method of collecting a sample of body fluid from skin, the method comprising:

providing a fluid collection device comprising a piston having a distal surface, a needle operatively connected to said piston and having a distal end extending a distance from said distal piston surface, and a pressure surface adjacent said needle, said piston and said pressure surface being independently movable relative to one another along a path substantially parallel to the axis of said needle;

placing said pressure surface against the skin of a patient to define a fluid collection area

moving said pressure surface relative to said piston thereby stretching skin within the fluid collection area;

moving said piston relative to said pressure surface thereby inserting said needle into the fluid collection area of the skin; and

collecting body fluid.

6. The method of claim 5 wherein stretching the skin comprises drawing tight the skin.

7. The method of claim 5 further comprising further moving said piston relative to said pressure surface wherein said distal piston surface extends distally beyond said pressure surface.

11. The method of claim 5 further comprising testing said collected body fluid for determining the concentration of at least one constituent.

13. The method of claim 5 wherein said moving said pressure surface comprises employing a first spring and said moving said piston comprises employing a second spring.

14. A sampling tool for accessing a sample of body fluid from a skin layer, said sampling tool comprising:

a needle; and

a skin stretching member having opposing surfaces at least partially surrounding said needle, wherein said needle and said skin stretching member are independently movable relative to one another along a path substantially parallel to an axis of said needle.

15. The sampling tool of claim 14 wherein said opposing surfaces are configured to at least partially surround the skin layer and to define a fluid collection area when said skin stretching member is operatively placed against the skin of a patient.

16. The sampling tool of claim 14 wherein said skin stretching member is circular.

17. The sampling tool of claim 14 wherein said skin stretching member comprises a pressure ring.

18. The sampling tool of claim 14 further comprising:

a first spring for moving said skin stretching member; and

a second spring for moving said needle.

19. A device for accessing a sample of body fluid from skin, the fluid collection device comprising:

a piston having a distal surface;

a needle operatively connected to said piston and having a distal end extending a distance from said distal piston surface; and

a pressure surface adjacent said needle, said piston and said pressure surface being independently movable relative to one another along a path substantially parallel to the axis of said needle.

20. The fluid collection device of claim 19 further comprising an absorbent membrane in fluid communication with said needle.

21. The fluid collection device of claim 19 further comprising:

a first spring for moving said pressure surface; and

a second spring for moving said needle.