Body fluid sampling device and methods of use

• US 6,056,701 A
• Filed: 12/03/1998
• Issued: 05/02/2000
• Est. Priority Date: 05/17/1996
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Drexler, Andrew M., Roe, Jeffrey N., Radwanski, Ryszard, Duchon, Brent G., Douglas, Joel S.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/204,909
• Time in Patent Office: 516 Days
• Field of Search: 600/573, 600/576, 600/583, 600/584, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• 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 device for sampling body fluid includes a housing having a sleeve at a forward end thereof which is displaceable in response to being pressed against a user'"'"'s skin to trigger the firing of a lancet. After the lancet is removed from the incision, the sleeve is repeatedly pressed against the skin to depress a ring of body tissue in surrounding relationship to the incision to express body fluid outwardly through the incision. A pusher member is then actuated to push a capillary tube through a front end of the housing for drawing-in body fluid. The lancet is a disposable lancet which includes a body supporting a skin-lancing member and the capillary tube. The disposable lancet passes through an upper end of a lancet carrier when being installed or removed. The device cannot be armed until the disposable lancet is installed in the housing, because the capillary tube functions to push a safety device to a non-safety position.

Claims

1. An incision-forming member carrier comprising:

an adapter sleeve, the adapter sleeve having means for releasably securing the adapter sleeve within a housing member;

an incision-forming member carrier sleeve means coaxially received within the adapter sleeve for releasably securing a disposable incision-forming member therein; and

a stimulator means coaxially received within the adapter sleeve for depressing a ring of body tissue surrounding an incision formed by the incision-forming member such that by repeatedly applying and releasing a downward force to the stimulator means a sample of body fluid is expressed from the incision.

2. The carrier of claim 1, wherein the means for releasably securing the adapter sleeve comprises a plurality of spring fingers.

3. The carrier of claim 1, wherein the incision-forming member carrier sleeve means comprises a vertical through-passage adapted to receive the disposable incision forming member therein, and an upwardly-facing seat including means for supporting the disposable incision-forming member.

4. The carrier of claim 3, wherein the upwardly facing seat comprises a plurality of guide ramps and an upwardly open recess.

5. The carrier of claim 1, wherein the stimulator means comprises a longitudinally-extending sleeve having an end face configured to depress a ring of body tissue.

6. The carrier of claim 5, wherein the end face has a shape chosen from the group consisting of:

annular, oval, and polygonal.

7. In combination, the carrier of claim 1 and a disposable incision-forming member releasably secured within the carrier, the disposable incision-forming member comprises:

a body having an upper end and a lower end;

an incision forming means mounted in the body; and

a body-fluid sample drawing means mounted in the body, the sample drawing means being longitudinally moveable relative to the body means.

8. The combination of claim 7, wherein the incision forming means comprises a lancet.

9. The combination of claim 7, wherein the sample drawing means comprises a capillary tube.

10. A body fluid sampling device comprising:

a housing; and

the combination of the carrier and the disposable incision forming member of claim 7, wherein the carrier is releasably secured to the housing.

11. An incision-forming member carrier comprising:

an adapter sleeve, the adapter sleeve having formations adapted to releasably securing the adapter sleeve within a housing member;

an incision-forming member carrier sleeve coaxially received within the adapter sleeve adapted to releasably secure a disposable incision-forming member therein; and

a stimulator sleeve coaxially received within the adapter sleeve, the stimulator sleeve adapted to depress a ring of body tissue surrounding an incision such that by repeatedly applying and releasing a downward force to the stimulator sleeve a sample of body fluid is expressed from the incision.

12. The carrier of claim 11, wherein the formations adapted to releasably securing the adapter sleeve comprises a plurality of spring fingers.

13. The carrier of claim 11, wherein the incision-forming member carrier sleeve comprises a vertical through-passage adapted to receive the disposable incision forming member therein, and an upwardly-facing seat adapted to support the disposable incision-forming member.

14. The carrier of claim 13, wherein the upwardly facing seat comprises a plurality of guide ramps and an upwardly open recess.

15. The carrier of claim 11, wherein the stimulator sleeve comprises a longitudinally extending sleeve having an end face configured to depress a ring of body tissue.

16. The carrier of claim 15, wherein the end face has a shape chosen from the group consisting of:

annular, oval, and polygonal.

17. In combination, the carrier of claim 11 and a disposable incision-forming member releasably secured within the carrier, the disposable incision-forming member comprises:

a body having an upper end and a lower end;

an incision forming member mounted in the body; and

a body-fluid sample drawing member mounted in the body, the sample drawing member being longitudinally moveable relative to the body.

18. The combination of claim 17, wherein the incision forming member comprises a lancet.

19. The combination of claim 17, wherein the sample drawing member comprises a capillary tube.

20. A body fluid sampling device comprising:

a housing; and

the combination of a carrier and a disposable incision forming member of claim 17, wherein the carrier is releasably secured to the housing.

21. A method of obtaining a sample of body fluid comprising:

(i) providing a body fluid sampling device, the body fluid sampling device comprising a housing, an incision-forming member carrier releasably retained within the housing, the incision-forming member carrier including a stimulator member, and a disposable incision-forming member, the disposable incision forming member including a sample-drawing member;

(ii) forcing the incision-forming member out of the housing such that an incision is formed on a skin surface;

(iii) forming a ring of depressed body tissue about the incision by engaging a skin surface with an end of the stimulator member, then repeatedly applying and releasing a downward force to the stimulator member such that a sample of body fluid is expressed from the incision;

(iv) bringing the sample-drawing member into communication with the body fluid sample, and transporting the body fluid sample away form the skin surface with the sample drawing member;

(v) removing the carrier from the housing;

(vi) removing the disposable incision-forming member from the carrier;

(vii) replacing the disposable incision-forming member by releasably mounting a new disposable incision-forming member in the carrier; and

(viii) releasably securing the carrier within the housing.

22. The method of claim 21, wherein the incision forming member comprises a lancet.

23. The method of claim 21, wherein the body fluid sample has a volume of approximately 3 μ

L-8 μ

L.

24. The method of claim 21, wherein the sample-drawing member comprises a capillary tube.