Lancet device having capillary action

• US 8,257,276 B2
• Filed: 02/18/2010
• Issued: 09/04/2012
• Est. Priority Date: 01/22/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Perez, Edward P., Roe, Steven N.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/708,105
• Publication Number:
  US 20100145229A1
• Time in Patent Office: 929 Days
• Field of Search: 600573-583, 606181-182
• US Class Current: 600/583
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 35/1079 with means for piercing stoppers or septums

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

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 μ

l 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 μ

m 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 μ

l 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 μ

m.

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 μ

l 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 μ

m 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 μ

l 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 μ

m.