Enhanced interstitial fluid collection

• US 20010011157A1
• Filed: 03/19/2001
• Published: 08/02/2001
• Est. Priority Date: 09/08/1995
• Status: Active Grant

• Current Assignee: Integ Incorporated (Johnson & Johnson)
• Original Assignee: Integ Incorporated (Johnson & Johnson)
• Inventors: Hoegh, Thomas B., Erickson, Brian J., Hilgers, Michael E., Latterell, Scott T., Brinda, Paul D., Shoup, Michael J.
• Granted Patent: US 6,712,776 B2
• Time in Patent Office: Days
• 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 sampler for collecting interstitial fluid from a skin layer, said sampler comprising:

a sampling needle having an axis and a distal end;

a first pressure surface at least partially surrounding said needle in spaced relation thereto;

said needle and said first pressure surface movable relative to one another along a path of travel generally parallel to said axis with said needle and said first pressure surface having an extended position and a retracted position;

said extended position characterized by said distal end of said needle extending beyond said first pressure surface;

said retracted position characterized by said distal end of said needle recessed behind said first pressure surface;

first biasing means for biasing said needle and said first pressure surface to said retracted position.

2. A sampler according to

claim 1

further comprising a second pressure surface at least partially surrounding said needle and movable therewith, said second pressure surface axially spaced from said distal end of said needle by a distance approximating a desired penetration of said needle into said skin layer.

3. A sampler according to

claim 2

comprising second biasing means for urging said needle and said second pressure surface in a direction outwardly of said first pressure surface.

4. A sampler according to

claim 2

wherein said second pressure surface and said first pressure surface define a substantially continuous surface when said second pressure surface and said first pressure surface are in generally planar alignment.

5. A sampler according to

claim 1

wherein said first biasing means is selected for said first pressure surface to be urged against said skin layer with a force sufficient to define a pressurized zone of interstitial fluid opposing said needle prior to penetration of said needle into said skin layer.

6. A sampler according to

claim 2

wherein said second pressure surface is concave.

7. A sampler according to

claim 1

wherein said first pressure surface is a distal end of a ring surrounding said needle in spaced relation thereto.

8. A sampler according to

claim 7

further comprising a piston surrounding said needle and movable therewith, said piston axially spaced from said distal end of said needle by a distance approximating a desired penetration of said needle into said skin layer.

9. A sampler according to

claim 8

wherein said piston and said ring are in close sliding tolerance.

10. A sampler according to

claim 9

comprising second biasing means for urging said needle and said piston in a direction outwardly of said ring.