Enhanced interstitial fluid collection

• US 5,879,367 A
• Filed: 09/08/1995
• Issued: 03/09/1999
• Est. Priority Date: 09/08/1995
• Status: Expired due to Term

• 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.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/525,942
• Time in Patent Office: 1,278 Days
• Field of Search: 128/760, 128/771, 128/770, 606/181, 606/182
• US Class Current: 606/181
• 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

first biasing means for biasing said first pressure surface to a position wherein said distal end of said needle is recessed behind said first pressure surface,

said first biasing means being 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.

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 2 wherein said second pressure surface is concave.

6. 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.

7. A sampler according to claim 6 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.

8. A sampler according to claim 7 wherein said piston and said ring are in close sliding tolerance.

9. A sampler according to claim 8 comprising second biasing means for urging said needle and said piston in a direction outwardly of said ring.