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Publication numberWO2003020134 B1
Publication typeApplication
Application numberPCT/US2002/027465
Publication date7 Aug 2003
Filing date29 Aug 2002
Priority date29 Aug 2001
Also published asCA2458208A1, EP1423049A2, US7264627, US20030060730, WO2003020134A2, WO2003020134A3
Publication numberPCT/2002/27465, PCT/US/2/027465, PCT/US/2/27465, PCT/US/2002/027465, PCT/US/2002/27465, PCT/US2/027465, PCT/US2/27465, PCT/US2002/027465, PCT/US2002/27465, PCT/US2002027465, PCT/US200227465, PCT/US2027465, PCT/US227465, WO 03020134 B1, WO 03020134B1, WO 2003/020134 B1, WO 2003020134 B1, WO 2003020134B1, WO-B1-03020134, WO-B1-2003020134, WO03020134 B1, WO03020134B1, WO2003/020134B1, WO2003020134 B1, WO2003020134B1
InventorsEdward P Perez
ApplicantAmira Medical, Edward P Perez
Export CitationBiBTeX, EndNote, RefMan
External Links: Patentscope, Espacenet
Wicking methods and structures for use in sampling bodily fluids
WO 2003020134 B1
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.
Amended Claims  (OCR text may contain errors)
AMENDED CLAIMS
[received by the International Bureau on 09 June 2003 (09.06.03); claims 1 and 2 amended, new claims 3-34 added (6 pages)]
L A sampling device for bodily fluids comprising: a sampling member defining a passageway including an inlet opening, the passageway configured for reception of the bodily fluid therein, said sampling member being positionable adjacent an incision site; and a wicking member having a first portion coupled with said sampling member at a location adjacent to the inlet opening, said wicking member further including a second portion displaced from the first portion, the second portion being closer to the incision site than the first portion when said sampling member is positioned adjacent to the incision site.
1. A method for collecting a bodily fluid from an incision site comprising: providing a sampling device including a sampling member defining a passageway including an inlet opening, the passageway configured for reception of the bodily fluid therein, the sampling device further including a wicking member having a first portion coupled with the sampling member at a location adjacent to the inlet opening, the wicking member further including a second portion displaced from the first portion; and positioning the sampling device adjacent to the incision site to have the second portion of the wicking member closer to the incision site than the first portion, whereby fluid at the incision site first contacts the wicking member and is thereby drawn from the incision site to the inlet opening of the sampling member.
3. The sampling device of claim 1, wherein: the sampling member 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 site; the inlet opening opens into the aperture; and the wicking member extends within the anerrnrfi
4. The sampling device of claim 3, further comprising a sealing member surrounding the aperture at the bottom surface of the sampling member 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 site.
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 site.
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 member has a recessed surface between the inlet opening and the bottom surface to promote fluid flow into the inlet opening.
10. The sampling device of claim 1 , wherein the sampling member has a constricting system extending therefrom to create a bulge of skin around the incision site.
11. The sampling device of claim 1 , further comprising a test area in fluid communication with the passageway for testing the bodily fluid. 12, The sampling device of claim 11 , wherein the test area includes a test reagent covering absorbent material.
13. The sampling device of claim 1, wherein: the sampling member has a top surface, a bottom surface and an end edge; and the inlet opening communicates with the end edge at a location displaced from the bottom surface.
14. The sampling device of claim 13, wherein the sampling member has a recessed surface connecting between the inlet opening and the bottom surface.
15. The sampling device of claim 13, further comprising a sealing member located on the bottom surface to block passage of the bodily fluid.
16. The sampling device of claim 1 , further comprising: wherein the sampling member defines an aperture, the wicking member extending within the aperture; and a lancing device including a lancet for lancing skin, the lancing device defining a slot in which the sampling member is received, the aperture of the sampling member being positioned in alignment with the lancet in order for the lancet to lance the skin through the aperture,
17. The method of claim 2, further comprising lancing an incision into skin at the incision site with a lancet by extending the lancet through an aperture in the sampling member.
18, The method of claim 2, further comprising pressing a constricting system that extends from the sampling member to create a bulge of skin around the incision site.
1 . The method of claim 2, further comprising: drawing the fluid from the inlet opening, into the passageway and into a test area defined in the sampling member; and 5 testing the fluid in the test area.
20. A fluid sampling device, comprising: a test strip defining a passageway including an inlet opening, the test strip being positionable adjacent an incision, the passageway configured for reception of o bodily fluid from the incision; and means for wicking the fluid from the incision into the inlet opening positioned proximal the inlet opening.
21. The device of claim 20, wherein the means for wicking the fluid 5 includes a wicking member extending from the test strip adjacent the inlet opening.
22. The device of claim 20, wherein the means for wicking the fluid includes a lancet positioned adjacent the inlet opening and the incision, the lancet is provided with a hydrophilic outer surface to wick the fluid into the inlet opening. 0
23. A fluid sampling device, comprising: a sampling member defining a passageway including an inlet opening; a deformable expression member positioned proximal the inlet opening to form a bulge of skin upon pressing the expression member against the skin; and 5 a lancet configured to form an incision in the skin, the lancet extending proximal the inlet opening to draw fluid into the inlet opening.
24. The device of claim 23, wherein the lancet is slidably positioned inside the passageway. 0
25. The device of claim 24, wherein the sampling member includes a capillary tube.
26. The device of claim 24, further comprising a pressing member positioned inside the deformable expression member proximal the inlet opening to pull apart and maintain the incision open upon formation of the incision.
27. The device of claim 24, further comprising a test strip positioned within the passageway to test the fluid.
28. The device of claim 23, wherein the sampling member includes a capillary tube.
29. The device of claim 23, further comprising a pressing member positioned inside the deformable expression member proximal the inlet opening to pull apart and maintain the incision open upon formation of the incision.
30. The device of claim 23, further comprising a test strip positioned within the passageway to test the fluid.
31. The device of claim 23, wherein the expression member has a cylindrical shape.
32. A method of sampling bodily fluid from an incision, comprising: forming a bulge of skin by pressing a deformable expression member of a sampling device against the s in; lancing the bulge of the skin with a lancet of the sampling device to form the incision; and positioning the lancet proximal the incision to draw the fluid from the incision into an inlet opening of a passageway defined in a sampling member of the sampling device.
33. The method of claim 32, further comprising pressing a pressing member of the sampling device against the skin to spread apart the incision.
34. The method of claim 32, wherein: the sampling member includes a capillary tube; the lancet is longitudinally moveable inside the passageway in the capillary tube; and said lancing includes extending the lancet from the capillary tube.
Classifications
International ClassificationA61B5/151, A61B5/1459, A61B5/157, A61B5/1473, A61B5/15, A61B5/00, A61B5/145
Cooperative ClassificationA61B5/150022, A61B5/14514, A61B5/150068, A61B5/15105, A61B5/150358, A61B5/15117, A61B5/150412, A61B5/15194, A61B5/15113, A61B5/150503, A61B5/1519, A61B5/150213, A61B5/15128, A61B5/14532
European ClassificationA61B5/145D2B, A61B5/14B2
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