Sample element with barrier material

• US 20050038357A1
• Filed: 04/15/2004
• Published: 02/17/2005
• Est. Priority Date: 04/15/2003
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Braig, James R., Hartstein, Philip C.
• Application Number:
  US10/825,223
• Publication Number:
  US 20050038357A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• 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
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 21/0303 Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence

Abstract

Disclosed is a sample element for holding a volume of bodily fluid drawn from the skin of a patient at a withdrawal site. The sample element comprises a housing defining a sample chamber therein, and a barrier. The barrier has a first side configured to contact the skin of the patient at the withdrawal site, and a second side in fluid communication with the sample chamber. The barrier is configured to be pierced by a lance, to permit the bodily fluid to pass from the first side to the second side. Also disclosed is a method of drawing a bodily fluid from the skin of a patient at a withdrawal site. The method comprises placing a first side of a barrier against the skin of the patient at the withdrawal site. The method further comprises forming a first opening through the barrier and a second opening in the skin of the patient at the withdrawal site. The first opening and the second opening are in fluid communication. The method further comprises placing a sample chamber in fluid communication with a second side of the barrier.

Claims

1. A sample element for holding a volume of bodily fluid drawn from the skin of a patient at a withdrawal site, said sample element comprising:

a housing defining a sample chamber therein; and

a barrier having a first side configured to contact the skin of the patient at said withdrawal site, and a second side in fluid communication with said sample chamber, said barrier being configured to be pierced by a lance, to permit said bodily fluid to pass from said first side to said second side.

2. The sample element of claim 1, wherein said barrier is formed from a substantially nonporous material.

3. The sample element of claim 2, wherein said barrier, in the absence of an opening pierced therein, is configured to permit substantially none of said bodily fluid to pass from said first side to said second side.

4. The sample element of claim 1, wherein said barrier, when placed against the skin of a patient and pierced, is configured to permit substantially none of said bodily fluid to pass from said second side to said first side.

5. The sample element of claim 1, further comprising an adhesive disposed on said first side of said barrier.

6. The sample element of claim 1, wherein said sample chamber is reagentless.

7. The sample element of claim 1, wherein said sample chamber is at least partially defined by a window.

8. The sample element of claim 7, wherein said window is transmissive of infrared radiation.

9. The sample element of claim 7, wherein said barrier is more easily pierced by a lance than is said window.

10. The sample element of claim 1, wherein said barrier is more easily pierced by a lance than is an adjacent portion of said housing.

11. The sample element of claim 1, further comprising a supply passage extending from said sample chamber, said supply passage having a first sidewall adjacent said barrier, said barrier being more easily pierced by a lance than is said first sidewall.

12. The sample element of claim 1, further comprising a separator located between said second side of said barrier and said sample chamber.

13. A method of drawing a bodily fluid from the skin of a patient at a withdrawal site, said method comprising:

placing a first side of a barrier against the skin of the patient at said withdrawal site;

forming a first opening through said barrier and a second opening in the skin of the patient at said withdrawal site, said first opening and said second opening being in fluid communication; and

placing a sample chamber in fluid communication with a second side of said barrier.

14. The method of claim 13, wherein placing said sample chamber in fluid communication with said second side of said barrier, comprises placing said sample chamber in fluid communication with said first opening.

15. The method of claim 13, further comprising causing said bodily fluid to flow into said sample chamber.

16. The method of claim 15, further comprising causing said bodily fluid to flow through a separator before flowing into said sample chamber.

17. The method of claim 13, further comprising affixing said first side of said barrier to the skin of the patient with an adhesive.

18. The method of claim 13, further comprising removing said barrier from the skin of the patient.

19. The method of claim 18, further comprising removing residual bodily fluid from said withdrawal site with said barrier.

20. The method of claim 13, further comprising analyzing the bodily fluid.

21. The method of claim 13, further comprising minimizing after-bleed.

22. The method of claim 13, further comprising reducing, with said barrier, the degree to which contaminants from the surface of the skin of the patient enter said bodily fluid.

23. A sample element for holding a volume of bodily fluid, said sample element comprising:

a housing having a sample chamber therein, and a flow path extending from said sample chamber; and

a barrier disposed across said flow path, said barrier having a first side configured to contact the skin of a patient at a lancing site;

said flow path being enclosed on all sides except where said flow path joins said sample chamber such that, upon formation of an opening in said barrier, fluid may flow from said first side, through said flow path and into said sample chamber.

24. The sample element of claim 23, wherein said barrier has a second side in fluid communication with said sample chamber.

25. The sample element of claim 23, wherein said barrier is pierceable to permit bodily fluid to pass through said barrier.

26. The sample element of claim 23, wherein said sample chamber is reagentless.

27. The sample element of claim 23, wherein said sample chamber is at least partially defined by a window.

28. The sample element of claim 27, wherein said window is transmissive of infrared radiation.

29. The sample element of claim 27, wherein said barrier is more easily pierced by a lance than is said window.

30. The sample element of claim 23, wherein said barrier is more easily pierced by a lance than is an adjacent portion of said housing.

31. The sample element of claim 23, further comprising a supply passage extending from said sample chamber, said supply passage having a first sidewall adjacent said barrier, said barrier being more easily pierced by a lance than is said first sidewall.

32. The sample element of claim 23, wherein said flow path comprises a supply passage.

33. The sample element of claim 32, wherein said flow path comprises a supply passage and an entry chamber in fluid communication with said supply passage.

34. The sample element of claim 23, further comprising a separator located in said flow path.