Methods and apparatus for expressing body fluid from an incision

• US 20040073140A1
• Filed: 06/26/2003
• Published: 04/15/2004
• Est. Priority Date: 05/17/1996
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Grage, Henry M., Douglas, Joel S.
• Granted Patent: US 7,841,991 B2
• Time in Patent Office: Days
• 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 5/150076 by heating
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• 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 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• 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 5/1519 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 sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user'"'"'s skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Claims

1. A method of obtaining a sample of body fluid from a body, comprising the steps of:

A) applying a skin-lancing device against the skin of a user to form an incision in the skin;

B) removing the skin-lancing device from the incision; and

thereafter

C) applying a force to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision wherein a stimulating member and a plurality of levers act to bulge and stretch the incision open, whereby body fluid is expressed from the opening of the incision.

2. The method according to claim 1, wherein forces between the stimulating member and the skin cause the stimulating member to retain the skin in a stretched position.

3. The method according to claim 1 wherein step C includes applying the force in a direction inclined generally toward the bulged incision.

4. The method according to claim 1 wherein step C comprises applying the force progressively closer to the incision.

5. The method according to claim 1 wherein step C includes applying heat in a region of the incision.

6. The method according to claim 1 wherein step C includes applying ultrasonic frequency to a region of the incision.

7. The method according to claim 1 wherein step A comprises lancing a region of the body of the user other than a finger tip.

8. The method according to claim 1 wherein step A comprises applying a lancet against the skin.

9. A device for sampling body fluid comprising:

a housing having an open end;

a skin-lancing mechanism mounted in the housing for applying a skin-lancing medium against a skin surface to form an incision therein, and then removing the skin-lancing medium from the incision;

a plurality of levers mounted to the housing at the open end thereof for movement relative to the housing, the plurality of levers pivotally attached thereto, wherein the levers cause the skin surface to form a bulge in response to a pressing on the housing; and

a stimulator member mounted to the housing at the open end thereof for movement relative to the housing, the stimulator member extending about a longitudinal axis of the housing and having an end face adapted to engage the skin surface of the bulge and to stretch open the incision in response to a pressing of the end face against the skin surface.

10. The device according to claim 9 wherein the end face is inclined to generally face the axis.

11. The device according to claim 9 wherein the stimulator member extends continuously about the axis.

12. The device according to claim 9 wherein the stimulator member includes circumferentially spaced interruptions.

13. The device according to claim 9 wherein the stimulator member is movable relative to the housing along the axis.

14. The device according to claim 13, wherein the stimulator member and the plurality of levers are movable relative to the housing and are interconnected to move axially in mutually opposite directions.

15. The device according to claim 9 wherein the stimulator member comprises a first stimulator member, and further including at least one additional stimulator member arranged in telescoping relationship to the first stimulator member, the stimulator members being movable relative to one another along the axis.

16. The device according to claim 15 wherein the stimulator members include first and second stimulator members which are movable relative to the housing and are interconnected to move axially in mutually opposite directions.

17. The device according to claim 16 wherein the first and second stimulator members are interconnected by levers, each lever having opposite ends, each lever being pivoted intermediate the ends of each lever for rotation about an axis extending orthogonally relative to the longitudinal axis of the housing.

18. The device according to claim 9 wherein the stimulator member comprises a helical spring.

19. The device according to claim 9 further including a second stimulator chosen from the group consisting of, a heating mechanism for heating the stimulator member or levers, and a vibrator mechanism for vibrating the stimulator member or levers.

20. The device according to claim 9, wherein the plurality of levers are circumferentially disposed about a distal end of the housing, wherein each lever pivots independently.

21. A method, comprising:

forming an incision in skin with an incision forming mechanism of a sampling device; and

squeezing the skin around the incision with a stimulation mechanism of the sampling device after said forming the incision to express body fluid from the incision.

22. The method of claim 21, wherein:

the stimulation mechanism includes a plurality of levers pivotally mounted on the sampling device, each of the levers has an end for squeezing the skin; and

said squeezing includes pivoting the levers so that the ends of the levers move in a radially inward direction.

23. The method of claim 22, wherein:

the stimulation mechanism includes an inner member slidably disposed in the sampling device, the inner member has a cam face that engages the levers; and

said squeezing includes pressing the sampling device against the skin so that cam face of the inner member pivots the levers.

24. A body fluid sampling device, comprising:

a housing;

an incision forming mechanism coupled to the housing to form an incision in skin; and

means for squeezing body fluid from the incision after the incision is formed that is coupled to the housing.

25. The device of claim 24, wherein the means for squeezing includes an inner member slidably disposed in the housing and a plurality of levers pivotally mounted to the housing, each of the levers has a first end engageable with the inner member and a second end engageable with the skin, the inner member is slidable in the housing to pivot the levers.

26. The device of claim 25, wherein each of the levers has a roller at the second.

27. The device of claim 24, wherein the means for squeezing includes a helical spring coupled to the housing.