Method and apparatus for improving fluidic flow and sample capture

• US 8,668,656 B2
• Filed: 12/31/2004
• Issued: 03/11/2014
• Est. Priority Date: 12/31/2003
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Lum, Paul, Mauze, Ganapati, Poplonski, Tomasz, Shatsky, Rebecca
• Primary Examiner(s): Dougherty, Sean
• Assistant Examiner(s): HENSON, DEVIN B
• Application Number:
  US12/744,514
• Publication Number:
  US 20100292611A1
• Time in Patent Office: 3,357 Days
• Field of Search: 600/583, 600/584, 606181-183, 204/403.01
• 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, comprising:

a cartridge;

at least one penetrating member positioned in the cartridge;

a controllable penetrating member driver configured to be coupled to the at least one penetrating member;

a processor coupled to the controllable penetrating member and providing a controllable velocity of the at least one penetrating member;

a sample port for receiving a body fluid in response to a puncturing event by the at least one penetrating member;

a sample chamber;

a channel coupled to the sample port and the sample chamber, at least a portion of the channel being a capillary channel with a hydrophilic surface positioned adjacent to the sample chamber;

at least one electrode positioned in the sample chamber and configured to determine an amount of an analyte in the body fluid; and

a mesh membrane positioned in the channel and at the sample port or adjacent to the sample port to guide a flow of the body fluid through at least a portion of the capillary channel with the mesh providing that the body fluid contacts the channel regardless of an orientation of body fluid sampling device, the mesh membrane and channel configured to provide a transport of the body fluid to the sample chamber and a measurement in less than 10 seconds.

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

3. The device of claim 1 wherein a sensory material is mounted on a plurality of electrodes.

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

5. The device of claim 1 wherein the mesh membrane has a lollipop configuration.

6. The device of claim 1 wherein the mesh membrane is oriented perpendicular to a path of the penetrating member.

7. The device of claim 1 wherein the mesh membrane is oriented to intersect a path of the penetrating member.

8. The device of claim 1 wherein topside sections of the capillary portion of the channel include a PET film hydrophobic on an outer most layer and hydrophilic on an inner layer abutting against a hydrophobic double-sided adhesive layer.

9. The device of claim 1 wherein bottom side sections of the capillary section include a PET film hydrophilic on the inner layer abutting against a 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 PET surfaces abutting the mesh structures are hydrophilic.

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

11. The device of claim 1 wherein mesh membrane is also positioned in a ring configuration around the cartridge.

12. A method of sampling a body fluid, comprising:

providing a fluid sampling device that includes a cartridge, at least one penetrating member positioned in the cartridge, a controllable penetrating driver, a processor, a sample port, a sample chamber coupled to a channel coupled to the sample port, at least a portion of the channel having a hydrophilic surface, at least a portion of the channel being a capillary channel positioned adjacent to the sample chamber, at least one electrode positioned in the sample chamber, and configured to determine an amount of an analyte in the body fluid and a mesh membrane positioned in the channel;

using the processor to provide a controllable velocity of the at least one penetrating member;

receiving a body fluid at the sample port in response to a puncturing event by the at least one penetrating member; and

using the mesh membrane to guide a flow of the body fluid through at least a portion of the capillary channel, with the mesh membrane and channel configured to provide a transport of the body fluid to the sample chamber in less than 10 seconds, wherein the mesh provides that the body fluid contacts the channel regardless of an orientation of body fluid sampling device.

13. The method of claim 12 wherein the mesh membrane includes a hydrophilic portion and a hydrophobic portion.

14. The method of claim 12 wherein a plurality of mesh membranes are used, each mesh membrane associated with at least one penetrating member.

15. The method of claim 12 wherein the mesh membrane is positioned to extend over at least a portion of a penetrating member exit chamber on said cartridge.

16. The method of claim 12 further comprising:

a sensory material positioned on a plurality of electrodes.

17. The method of claim 12 further comprising a plurality of electrodes each having a sensory material.

18. The method of claim 12, wherein a plurality of sets of electrodes are associated with each penetrating member.

19. The method of claim 12 wherein the mesh membrane is oriented perpendicular to a path of the penetrating member.

20. The method of claim 12 wherein the mesh membrane is oriented to intersect a path of the penetrating member.

21. The method of claim 12 wherein a plurality of mesh membranes are positioned in a ring configuration around the cartridge.

22. The method of claim 12 wherein a plurality of mesh membranes are positioned in a ring configuration around the cartridge, with at least one mesh membrane for each penetrating member in the cartridge.