IP Library Granted Patent US 8,257,276
Granted Patent B2
US 8,257,276 · App. 12/708,105 · Granted Sep 4, 2012

Lancet device having capillary action

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Quick Facts
Patent No.
US 8,257,276
App. No.
12/708,105
Granted
Sep 4, 2012
Kind
B2
Abstract

A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical/reflectance testing measuring device, or a visual inspection.

Claims (53)

1. A method, comprising:

forming an incision in tissue by extending a lancet from a capillary member of an integrated unit, wherein the lancet is located inside the capillary member before said forming the incision;

partially withdrawing the lancet from the incision in which a portion of the lancet remains within the incision;

drawing body fluid from the incision into a capillary space defined between the capillary member and the lancet while the lancet is partially withdrawn within the incision, wherein the lancet acts as a focal point for drawing the body fluid into the capillary space; and

depositing the body fluid onto a test strip that is disposed in the capillary space.

2. The method of claim 1 , further comprising:

fully withdrawing the lancet from the incision after said drawing the body fluid so that the entire lancet is located inside the capillary member.

3. The method of claim 1 , further comprising:

wherein said drawing the body fluid includes collecting less than 1 μl of the body fluid with the capillary member.

4. The method of claim 1 , wherein the lancet is made in a solid piece that is sufficiently sharpened to form the incision.

5. The method of claim 1 , wherein the capillary space between the lancet and the capillary member is between 20 to 200 μm to improve fill time.

6. The method of claim 1 , further comprising:

maintaining sterility of the lancet with a sealing member placed over an end of the capillary member; and

removing the sealing member from the capillary member before said forming the incision.

7. The method of claim 1 , further comprising:

maintaining sterility of the lancet with a sealing member placed over an end of the capillary member; and

piercing the sealing member with the lancet during said forming the incision.

8. The method of claim 7 , wherein the sealing member includes a membrane.

9. The method of claim 1 , wherein said forming the incision includes penetrating the tissue to a depth of 0.5 to 1.2 mm with the lancet.

10. The method of claim 1 , wherein the test strip extends into the capillary space through a slot defined in the capillary member.

11. The method of claim 1 , wherein the test strip is received in a groove in the lancet.

12. The method of claim 1 , further comprising:

analyzing the body fluid with the test strip.

13. The method of claim 1 , wherein the capillary member includes a capillary tube.

14. The method of claim 1 , further comprising:

wherein the lancet is made in a solid piece that is sufficiently sharpened to form the incision;

wherein the capillary member includes a capillary tube;

maintaining sterility of the lancet with a sealing member placed over an end of the capillary member; and

piercing the sealing member with the lancet during said forming the incision;

wherein said forming the incision includes penetrating the tissue to a depth of 0.5 to 1.2 mm with the lancet;

fully withdrawing the lancet from the incision after said drawing the body fluid so that the entire lancet is located inside the capillary member;

wherein said drawing the body fluid includes collecting less than 1 μl of the body fluid with the capillary member; and

wherein the capillary space between the lancet and the capillary member is between 20 to 200 μm.

15. A method, comprising:

forming an incision in tissue with an integrated unit that includes a lancet received in a capillary member by moving the lancet longitudinally between a retracted position where the lancet is retracted inside the capillary member and an extended position where the lancet extends from the capillary member;

moving the lancet from the extended position to a partially withdrawn position where a portion of the lancet remains within the incision;

drawing body fluid from the incision into a capillary space defined between the capillary member and the lancet while the lancet is at the partially withdrawn position;

depositing the body fluid onto a test strip that is disposed in the capillary space; and

retracting the lancet to the retracted position after said drawing the body fluid.

16. The method of claim 15 , further comprising:

wherein said drawing the body fluid includes collecting less than 1 μl of the body fluid with the capillary member.

17. The method of claim 15 , wherein the capillary space between the lancet and the capillary member is between 20 to 200 μm to improve fill time.

18. The method of claim 15 , further comprising:

analyzing the body fluid with the test strip.

19. The method of claim 15 , wherein the test strip is received in a groove in the lancet.

20. The method of claim 15 , further comprising:

wherein the lancet is made in a solid piece that is sufficiently sharpened to form the incision;

wherein the capillary member includes a capillary tube;

maintaining sterility of the lancet with a sealing member placed over an end of the capillary member; and

piercing the sealing member with the lancet during said forming the incision;

wherein said forming the incision includes penetrating the tissue to a depth of 0.5 to 1.2 mm with the lancet;

wherein said drawing the body fluid includes collecting less than 1 μl of the body fluid with the capillary member; and

wherein the capillary space between the lancet and the capillary member is between 20 to 200 μm.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2015
From: ROCHE DIAGNOSTICS OPERATIONS, INC.
To: ROCHE DIABETES CARE, INC.
Reel/Frame 036008/0670 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 22, 2010
From: PEREZ, EDWARD P.; ROE, STEVEN N.
To: ROCHE DIAGNOSTICS CORPORATION
Reel/Frame 023967/0085 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 22, 2010
From: ROCHE DIAGNOSTICS CORPORATION
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 023967/0094 →