Method for extracting interstitial fluid

• US 20070038147A1
• 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:
  US11/203,020
• Publication Number:
  US 20070038147A1
• 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 method for extracting interstitial fluid from a target site of a user includes adhesively attaching a floating ring of a sampling module for extracting interstitial fluid to the user in the vicinity of a target site and then mounting the sampling module to the floating ring and attaching the sampling module to the user. Subsequently, the target site is penetrated with a penetration member of the sampling module. Pressure is then applied in another vicinity of the target site by a pressure ring of the sampling module and, thereafter, ISF extracted from the target site via a penetration member of the sampling module.

Claims

1. A method for extracting interstitial fluid from a user, the method comprising:

adhesively attaching at least one floating ring of a sampling module for extracting interstitial fluid from a user'"'"'s body to the user'"'"'s body;

mounting the sampling module to the floating ring and attaching the sampling module to the user;

wherein the sampling module includes;

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

the at least one floating ring, the at least one floating ring including;

a proximal end;

a distal end; and

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

wherein the adhesive layer provided for the 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;

penetrating a target site of the user'"'"'s body with the penetration member of the sampling module;

applying pressure to the first vicinity of the target site with the pressure ring;

extracting interstitial fluid from the target site via the penetration member.

2. The method of claim 1, wherein the floating ring creates tension in the target site during the applying pressure step, thereby influencing target site deformation.

3. The method of claim 1, wherein the applying pressure step is accomplished by placing the sampling module in a deployed state wherein the penetration member is residing in the target site and the pressure ring is applying pressure to the first vicinity of the target site.

4. The method of claim 3 further including the step of placing the sampling module in a retracted state wherein the penetration member is residing in the target site and the pressure ring is applying a pressure to the first vicinity of the target site related solely to the mass of the pressure ring assembly and housing assembly.

5. The method of claim 4 further including the step of cycling between the deployed state and the retracted state.

6. The method of claim 5, wherein the deployed state has a duration of about 5 minutes and the retracted state has a duration of about 10 minutes.

7. The method of claim 5, wherein the cycling has a duration of at least 8 hours.

8. The method of claim 1, wherein the step of mounting the sampling module to the floating ring includes slidingly securing the sampling module to the floating ring.

9. The method of claim 1, wherein the step of mounting the sampling module to the floating ring includes mounting the sample module such that it is concentrically disposed about the floating ring.