Sample element with barrier material and vacuum

• US 20060030790A1
• Filed: 08/06/2004
• Published: 02/09/2006
• Est. Priority Date: 08/06/2004
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Braig, James R., Hartstein, Philip C., Rule, Peter, Smith, Heidi S.
• Application Number:
  US10/913,666
• Publication Number:
  US 20060030790A1
• Time in Patent Office: Days
• US Class Current: 600/584
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/1514 by use of gaseous agents, e.g. using suction aspiration or pressurized gas

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 sample element also comprises a vacuum source. 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. Additionally, the vacuum source can be actuated to draw the bodily fluid through the barrier and into the sample chamber. Also disclosed is a method of drawing a bodily fluid form 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 and second openings are in fluid communication. The method further comprises applying suction at the first opening of the barrier to draw a bodily fluid from the patient.

Claims

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

a sample chamber;

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; and

a vacuum source in fluid communication with said sample chamber and said second side of said barrier.

2. The apparatus of claim 1, wherein the vacuum source comprises a deformable chamber, the chamber selectively actuatable to provide a suction force on said sample chamber and said second side of said barrier.

3. The apparatus of claim 1, wherein the vacuum source comprises a suction port removably connectable to an analyte measuring device, the device actuatable to provide a suction force on said sample chamber and said second side of said barrier through said suction port.

4. The apparatus of claim 3, wherein the vacuum source is disposed in the analyte measuring device.

5. The apparatus of claim 1, wherein the sample chamber is reagentless.

6. The apparatus of claim 1, wherein the sample chamber is at least partially defined by at least one window.

7. The apparatus of claim 6, wherein the at least one window is substantially transmissive of infrared radiation.

8. The apparatus of claim 6, wherein the at least one window is made of polyethylene.

9. The apparatus of claim 6, wherein the at least one window is made of polypropylene.

10. The apparatus of claim 1, wherein the sample chamber is positioned between two windows.

11. The apparatus of claim 1, wherein the barrier is formed of a substantially nonporous material.

12. The apparatus of claim 11, wherein the 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.

13. The apparatus of claim 1, wherein the barrier is hydrophobic.

14. The apparatus of claim 1, wherein the barrier is hydrophilic.

15. The apparatus of claim 1, wherein the barrier comprises an antibacterial coating.

16. The apparatus of claim 1, further comprising an adhesive disposed on said first side of said barrier.

17. The apparatus of claim 1, further comprising a one-way valve in fluid communication with the vacuum source and the sample chamber.

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

a sample chamber;

a supply passage extending from said sample chamber;

a barrier positioned across said supply passage, said barrier having an outer side and an inner side in fluid communication with said sample chamber, said barrier being configured to be pierced by a lance; and

a vacuum source in fluid communication with said sample chamber and said inner side of said barrier.

19. The sample element of claim 18, wherein the sample chamber is reagentless.

20. The sample element of claim 18, wherein the sample chamber is at least partially defined by at least one window.

21. The sample element of claim 20, wherein the at least one window is substantially transmissive of infrared radiation.

22. The sample element of claim 20, wherein the at least one window is made of polyethylene.

23. The sample element of claim 20, wherein the at least one window is made of polypropylene.

24. The sample element of claim 18, wherein the sample chamber is positioned between two windows.

25. The sample element of claim 18, wherein the barrier is formed of a substantially nonporous material.

26. The sample element of claim 25, wherein the barrier, in the absence of an opening pierced therein, is configured to permit substantially none of said bodily fluid to pass from said outer side to said inner side.

27. The sample element of claim 18, wherein the barrier is hydrophobic.

28. The sample element of claim 18, wherein the barrier is hydrophilic.

29. The sample element of claim 18, wherein the barrier comprises an antibacterial coating.

30. The sample element of claim 18, further comprising an adhesive disposed on said outer side of said barrier.

31. The sample element of claim 18, further comprising a one-way valve in fluid communication with the vacuum source and the sample chamber.

32. A method comprising:

placing a first side of a barrier against the skin of a patient at a 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

applying suction to said barrier so that a bodily fluid is drawn through said first opening when said first opening is present.

33. The method of claim 32, wherein said suction is applied before forming said first opening.

34. The method of claim 32, wherein said suction is applied after forming said first opening.

35. The method of claim 32, further comprising the step of measuring a concentration of an analyte in said bodily fluid.

36. The method of claim 32, wherein a second side of said barrier is attached to a sample element, and wherein applying said suction comprises selectively actuating a deformable chamber disposed on said sample element.

37. The method of claim 32, wherein a second side of said barrier is attached to a sample element, and wherein applying said suction comprises selectively actuating a vacuum source disposed on an analyte detection device, the detection device removably connected to said sample element.

38. The method of claim 32, wherein applying said suction comprises disposing an opening of a sample element proximal said first opening through said barrier and selectively actuating a deformable chamber disposed on said sample element.

39. The method of claim 32, wherein applying said suction comprises disposing an opening of a sample element proximal said first opening through said barrier and selectively actuating a vacuum source disposed on an analyte detection system, the detection system removably connected to said sample element.