Vacuum sample expression device

• US 20050277849A1
• Filed: 06/10/2004
• Published: 12/15/2005
• Est. Priority Date: 06/10/2004
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Wong, Daniel, Kennedy, John, Raney, Charles C., Chan, Frank A., Schuettenhelm, Shilpa
• Application Number:
  US10/865,633
• Publication Number:
  US 20050277849A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150229 Pumps for assisting the blood sampling
• 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 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• 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

Abstract

A body fluid sampling device is used to sample a bodily fluid from an incision in skin. The device includes a housing that defines a sample cavity with one open end that contacts skin. The device also includes a lancing mechanism that forms an incision in the skin. A vacuum mechanism is used to create a vacuum inside the sample cavity to express fluid from the incision site. To release the vacuum, a valve is connected with the sample cavity to exchange atmospheric air and further works to minimize fluid splatter. The fluid sample can then be tested or analyzed as desired.

Claims

1. A body fluid sampling device, comprising:

a housing defining a cavity with an open end adapted to contact skin;

a lancing mechanism disposed in said cavity to form an incision in the skin;

a vacuum mechanism to form a vacuum inside said cavity to express body fluid from the incision; and

a valve disposed on said housing for releasing the vacuum in said cavity to minimize splatter of the body fluid when the vacuum is released.

2. The device of claim 1, wherein the vacuum mechanism includes an accordion section to create the vacuum.

3. The device of claim 1, further comprising a piston disposed in said cavity to apply mechanical force to the skin.

4. The device of claim 1, further comprising a lancing cap disposed around said lancing mechanism to control the depth of the incision created by said lancing mechanism.

5. The device of claim 4, wherein said lancing mechanism includes a lancet, said lancing cap being disposed around said lancet to flatten the skin during formation of the incision.

6. The device of claim 1, further comprising an expression cap coupled to said housing to press around the incision to express the body fluid.

7. The device of claim 6, wherein said expression cap has a stair stepped shaped expression surface.

8. A method, comprising:

contacting an open end of a body fluid sampling device against skin, wherein the sampling device includes a vacuum mechanism, an incision forming device and a vacuum release valve;

forming an incision in the skin with the incision forming device;

creating a vacuum at the open end of the sampling device with the vacuum mechanism; and

minimizing splattering of body fluid from the incision by releasing the vacuum with the vacuum release valve.

9. The method of claim 8, wherein said forming the incision occurs before said contacting.

10. The method of claim 8, wherein said creating the vacuum occurs before said forming the incision.

11. The method of claim 8, wherein said creating the vacuum occurs after said forming the incision.

12. The method of claim 8, further comprising applying mechanical force with the sampling device to the skin to express the body fluid from the incision.

13. The method of claim 12, wherein said applying mechanical force includes pressing the sampling device against the skin to express the body fluid from the incision.

14. The method of claim 12, wherein said applying mechanical force includes pressing a piston inside the sampling device against the skin.

15. A body fluid sampling device, comprising:

a housing defining a cavity with an open end adapted to contact skin;

a vacuum mechanism connected with said cavity to form a vacuum inside said cavity; and

a piston disposed in said cavity to apply mechanical force to skin.

16. The device of claim 15, further comprising a lancing mechanism with a lancet disposed in said cavity to form an incision in the skin.

17. The device of claim 16, further comprising a lancing cap disposed around said lancet to control penetration depth of said lancet into the skin.

18. The device of claim 16, further comprising an accordion section forming a seal between said lancing mechanism and said housing to maintain the vacuum.

19. A method, comprising:

placing a body fluid sampling device against skin, wherein the body fluid sampling device includes a vacuum mechanism;

creating a vacuum with the vacuum mechanism;

forming an incision in skin; and

applying mechanical force against the skin with the sampling device to express body fluid from the incision.

20. The method of claim 19, wherein said applying mechanical force includes pressing a piston of the sampling device against the skin.

21. The method of claim 19, wherein said creating the vacuum occurs before said forming the incision.

22. The method of claim 19, wherein said creating the vacuum occurs after said forming the incision.

23. The method of claim 19, wherein said forming the incision occurs before said placing the body fluid sampling device against the skin.

24. The method of claim 19, wherein said forming the incision include forming the incision with a lancing mechanism of the sampling device.

25. The method of claim 19, further comprising testing the body fluid with the sampling device.