Method and apparatus for improving fluidic flow and sample capture

• US 20100292611A1
• Filed: 12/31/2004
• Published: 11/18/2010
• Est. Priority Date: 12/31/2003
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Shatsky, Rebecca, Poplonski, Tomasz, Lum, Paul, Mauze, Ganapati
• Granted Patent: US 8,668,656 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2017/3437 with means for removing or absorbing fluid, e.g. wicks or absorbent pads
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/15045 comprising means for capillary action
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15101 Details
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A system and method is provided for the capture of bodily fluid upon lancing of a patient. In one embodiment, the fluid sample capture aperture mesh (320) ring is placed in the pathway of a finger penetrating member (340). The aperture mesh ring has a center clearance area that allows the penetrating member to pierce the skin unobstructed. The aperture mesh ring may contain a series of fluid sampling meshes as to allow the release bodily fluid to “wick” into the fluid sampling meshes for transport to the respective sensor. The invention may also relate to a method of improving the fluidic flow through a membrane mesh structure for the transportation of bodily fluids from a point of sampling to a point of measurement.

Claims

1. A body fluid sampling device for use on a patient, the device comprising:

a cartridge;

at least one penetrating member mounted on the cartridge; and

a wicking material positioned to substantially surround at least one penetrating member exit on the cartridge so as to acquire body fluid flowing from a wound on the patient created by actuating the penetrating member.

3. The device of claim 1 further comprising a capillary structure coupled to the wicking material, said capillary structure bring said fluid to the sensory material.

4. The device of claim 1 further comprising a capillary structure coupled to the wicking material, said capillary structure bring said fluid to the sensory material positioned on a plurality of electrodes located in the capillary structure.

5. The device of claim 1 further comprising a capillary structure coupled to the wicking material, said capillary structure bring said fluid to the sensory material positioned on a plurality of electrodes and are in fluid communication with the capillary structure.

6. The device of claim 1 further comprising a plurality of electrodes each having said sensory material.

7. The device of claim 1 wherein the sensory material is mounted on a plurality of electrode.

8. The device of claim 1 a plurality of sets of electrodes are associated with each penetrating member.

9. The device of claim 1 wherein the wicking material has a lollipop configuration.

10. The device of claim 1 wherein the wicking material is oriented perpendicular to a path of the penetrating member.

11. The device of claim 1 wherein the wicking material is oriented to intersect a path of the penetrating member.

12. The device of claim 1 wherein topside connecting sections of the wicking member comprises a PET film hydrophobic on an outer most layer and hydrophilic on an inner layer abutting against the hydrophobic double-sided adhesive layer.

13. The device of claim 1 wherein bottom side sections of the wicking member comprises a PET film hydrophilic on the inner layer abutting against the hydrophobic adhesive and hydrophobic on the outside, wherein an inner fluidic channel region is a sandwich structure of top PET film/fluidic mesh structures/and bottom PET film, wherein the PET surfaces abutting the mesh structures are hydrophilic.

14. The device of claim 1 wherein a plurality of wicking members are positioned in a ring configuration around the cartridge.

15. The device of claim 1 wherein a plurality of wicking members are positioned in a ring configuration around the cartridge, with at least one wicking member for each penetrating member in the cartridge.

2. A body fluid sampling device for use on a patient, the device comprising:

a cartridge having a radial-disc shape;

a plurality of penetrating members mounted on said cartridge;

a sensory material on a first side of said cartridge, said sensory material sufficient for detecting at least one analyte; and

a wicking material positioned to substantially surround a penetrating member exit so as to acquire body fluid flowing from a wound created by the penetrating member and draw the body fluid to the sensory material.

16. A body fluid sampling system for measuring analyte levels in the body fluid, said system comprising:

a housing having a transparent window;

a cartridge in said housing;

a plurality of penetrating member in said cartridge;

a sensory material on a first side of said cartridge, said sensory material sufficient for detecting at least one analyte;

a wicking material positioned to substantially surround a penetrating member exit so as to acquire body fluid flowing from a wound created by the penetrating member.

17. The system of claim 16 wherein a wicking member is coupled to each of said analyte detecting member and positioned to extend over at least a portion of a penetrating member exit chamber on said cartridge.

18. A device comprising:

a mesh membrane;

an adhesive integrated onto and within the mesh membrane for defining a fluid channel within the mesh membrane structure, wherein the adhesive is hydrophobic and upon integration into the mesh, will prohibit fluidic flow where flow is not desirable by design;

wherein the adhesive integrate onto and within a mesh membrane for defining a fluid channel within the mesh membrane structure.

19. A device comprising:

a mesh membrane;

hydrophobic and hydrophilic adhesives within the mesh membrane for the enhancement of fluidic capture and transport flow, wherein the developed surface energy properties of specific adhesive formulations has allowed the availability of extreme hydrophobic and hydrophilic properties and various viscosities as to promote absorption into the pores of the mesh membranes, creating pressure sensitive adhesives along with fluid attractive properties to direct optimal fluid capture, transport, and flow.

20. An actuation device comprising:

a combined lancing and blood sample analysis device in a single disposable cartridge, said cartridge does not have conducive leads and includes a wicking material surrounding a penetrating member exit.

21. A method comprising:

providing a fluid sampling device comprising a cartridge, at least one penetrating member mounted on the cartridge, and a wicking material positioned to substantially surround at least one penetrating member exit on said cartridge so as to acquire body fluid flowing from a wound on the patient created by actuating the penetrating member;

positioning the cartridge so that launching the penetrating member creates a wound on the patient which expresses body fluid;

using the wicking member to capture fluid expressed from the wound.

22. The method of claim 21 wherein the wicking member comprises of a hydrophilic portion and a hydrophobic portion.

23. The method of claim 21 wherein a plurality of wicking members are used, each associated with at least one penetrating member and each of the wicking members having a lollipop configuration.

24. The method of claim 21 wherein the wicking member is coupled to each of said analyte detecting member and positioned to extend over at least a portion of a penetrating member exit chamber on said cartridge.

25. The method of claim 21 further comprising a capillary structure coupled to the wicking material, said capillary structure bring said fluid to the sensory material.

26. The method of claim 21 further comprising a capillary structure coupled to the wicking material, said capillary structure bring said fluid to the sensory material positioned on a plurality of electrodes located in the capillary structure.

27. The method of claim 21 further comprising a capillary structure coupled to the wicking material, said capillary structure bring said fluid to the sensory material positioned on a plurality of electrodes and are in fluid communication with the capillary structure.

28. The method of claim 21 further comprising a plurality of electrodes each having a sensory material.

29. The method of claim 21 a plurality of sets of electrodes are associated with each penetrating member.

30. The method of claim 21 wherein the wicking material has a lollipop configuration.

31. The method of claim 21 wherein the wicking material is oriented perpendicular to a path of the penetrating member.

32. The method of claim 21 wherein the wicking material is oriented to intersect a path of the penetrating member.

33. The method of claim 21 wherein topside connecting sections of the wicking member comprises a PET film hydrophobic on an outer most layer and hydrophilic on an inner layer abutting against the hydrophobic double-sided adhesive layer.

34. The method of claim 21 wherein bottom side g sections of the wicking member comprises a PET film hydrophilic on the inner layer abutting against the hydrophobic adhesive and hydrophobic on the outside, wherein an inner fluidic channel region is a sandwich structure of top PET film/fluidic mesh structures/and bottom PET film, wherein the PET surfaces abutting the mesh structures are hydrophilic.

35. The method of claim 21 wherein a plurality of wicking members are positioned in a ring configuration around the cartridge.

36. The method of claim 21 wherein a plurality of wicking members are positioned in a ring configuration around the cartridge, with at least one wicking member for each penetrating member in the cartridge.