Wicking methods and structures for use in sampling bodily fluids

• US 7,264,627 B2
• Filed: 08/29/2002
• Issued: 09/04/2007
• Est. Priority Date: 08/29/2001
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Perez, Edward
• Primary Examiner(s): Nguyen; Anhtuan T.
• Assistant Examiner(s): Erezo; Darwin P.
• Application Number:
  US10/230,494
• Publication Number:
  US 20030060730A1
• Time in Patent Office: 1,832 Days
• Field of Search: 606/181, 606/182, 606/185
• US Class Current: 606/181
• 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 5/150213 Venting means
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• 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

Abstract

A sampling member defines a passageway including an inlet opening for reception of a bodily fluid therein, and a wicking member having a first portion coupled with the sampling member adjacent to the inlet opening. The wicking member further includes a second portion displaced from the first portion for initially contacting the bodily fluid. In use the sampling member is placed adjacent to an incision site with the second portion of the wicking member positioned to have the bodily fluid first contact the wicking member and thereby draw the fluid from the incision site to the inlet opening. In related embodiments there is provided a sampling system and method which further includes a lancing device to create the incision and optionally expression members to urge the bodily fluid from the incision, preferably in an integrated unit.

Claims

1. A device, comprising:

an incision forming device configured to form an incision;

an analysis area configured to analyze bodily fluid from the incision;

a sampling device defining a capillary passageway that extends from the analysis area for drawing the bodily fluid via capillary action to the analysis area;

a wicking member extending from the sampling device proximal the capillary passageway to draw the bodily fluid from the incision to the sampling passageway, wherein the wicking member is an elongate member that is hydrophilic to draw the bodily fluid; and

wherein the wicking member includes a folded section configured to fold against the sampling device until deployment.

2. The device of claim 1, wherein the wicking member has a uniform size and shape.

3. The sampling device of claim 1, wherein:

the sampling device has a top surface, a bottom surface and an aperture extending from the top surface to the bottom surface, the aperture being configured to surround the incision;

the capillary passageway opens into the aperture; and

the wicking member extends within the aperture.

4. The sampling device of claim 3, further comprising a sealing member surrounding the aperture at the bottom surface of the sampling device to minimize fluid leakage.

5. The sampling device of claim 4, wherein the sealing member includes a hydrophobic surface to resist passage of the bodily fluid.

6. The sampling device of claim 4, further comprising a constricting system extending from the bottom surface to create a bulge of skin around the incision.

7. The sampling device of claim 3, further comprising a constricting system provided around the aperture to create a bulge of skin around the incision.

8. The sampling device of claim 7, wherein the constricting system includes at least two deformable elements positioned on opposite sides of the aperture for engaging and constricting the skin.

9. The sampling device of claim 3, wherein the sampling device has a recessed surface between the capillary passageway and the bottom surface to promote fluid flow into the capillary passageway.

10. The sampling device of claim 1, wherein the sampling device has a constricting system extending therefrom to create a bulge of skin around the incision.

11. The sampling device of claim 1, wherein the analysis area includes a test reagent covering absorbent material.

12. The sampling device of claim 1, wherein:

the sampling device has a top surface, a bottom surface and an end edge; and

the capillary passageway communicates with the end edge at a location displaced from the bottom surface.

13. The sampling device of claim 12, wherein the sampling device has a recessed surface connecting between the capillary passageway and the bottom surface.

14. The sampling device of claim 12, further comprising a sealing member located on the bottom surface to block passage of the bodily fluid.

15. The sampling device of claim 1, further comprising:

wherein the sampling device defines an aperture, the wicking member extending within the aperture; and

wherein the incision forming member includes a lancet for lancing skin, the aperture of the sampling device being positioned in alignment with the lancet in order for the lancet to lance the skin through the aperture.