Sampling module for extracting interstitial fluid

• US 20070038148A1
• Filed: 08/11/2005
• Published: 02/15/2007
• Est. Priority Date: 08/11/2005
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Hilgers, Michael, Rademacher, Thomas, Stout, Phil, Mechelke, Joel
• Application Number:
  US11/203,022
• Publication Number:
  US 20070038148A1
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150022 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 5/150389 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 5/15107 Piercing being assisted by a triggering mechanism
• 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

Abstract

A sampling module for extracting interstitial fluid (ISF) from a user'"'"'s body includes a housing assembly and a pressure ring assembly operatively contained within the housing assembly. The pressure ring assembly includes a penetration member configured for penetrating a target site of the user'"'"'s body and, subsequently, residing in the target site and extracting ISF therefrom. The pressure ring assembly also includes a pressure ring configured for applying pressure to the user'"'"'s body in a first vicinity of the target site and a floating ring with an adhesive layer disposed on it'"'"'s distal end. The adhesive layer of the sampling module provides for adhesive attachment of the floating ring to the user'"'"'s body in a second vicinity of the target site, thereby influencing target site deformation during use of the sampling module.

Claims

1. A sampling module for extracting interstitial fluid (ISF) from a user'"'"'s body, the sampling module comprising:

a housing assembly; and

a pressure ring assembly operatively contained within the housing assembly, the pressure ring assembly including;

a penetration member configured for penetrating a target site of a user'"'"'s body and, subsequently, residing in the target site and extracting ISF therefrom;

at least one pressure ring configured for applying pressure to the user'"'"'s body in a first vicinity of the target site while said penetration member is residing the target site; and

at least one floating ring that includes;

a proximal end;

a distal end; and

an adhesive layer disposed on the distal end of the floating ring;

wherein the adhesive layer provides for adhesive attachment of the floating ring to the user'"'"'s body in a second vicinity of the target site, thereby influencing target site deformation during use of the sampling module.

2. The sampling module of claim 1, wherein the first vicinity where the pressure ring applies pressure closer to the target site than the second vicinity where the floating ring is adhesively attached to the user'"'"'s body.

3. The sampling module of claim 1, wherein the floating ring influences target site deformation by placing the target site under tension when the pressure ring is applying pressure in the first vicinity of the target site.

4. The sampling module of claim 1 further including a pressure ring retraction and deployment mechanism that serves to place the pressure ring in a retracted state wherein the pressure applied to the first vicinity by the pressure ring is related solely to the mass of the pressure ring assembly and housing assembly.

5. The sampling module of claim 4, wherein the pressure ring retraction and deployment mechanism includes a cam operatively engaged with the pressure ring.

6. The sampling module of claim 5, wherein the floating ring applies a pressure to the second vicinity, when the pressure ring is in a retracted state, that is solely related to the mass of the floating ring and pressure related to mass of the sampling module that is transferred to the second vicinity via the floating ring.

7. The sampling module of claim 1, wherein the pressure ring has an opening therethrough, an inner diameter in the range of from about 4 mm to about 12 mm and an outer diameter in the range of from about 5 mm to about 13 mm.

8. The sampling module of claim 1, wherein the floating ring has an opening therethrough, an inner diameter in the range of from about 7 mm to about 18 mm and an outer diameter in the range of from about 33 mm to about 50 mm.