Methods and apparatus for expressing body fluid from an incision

• US 6,706,000 B2
• Filed: 06/14/2001
• Issued: 03/16/2004
• Est. Priority Date: 11/21/1997
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Raney, Charles C., Perez, Edward P.
• Primary Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/879,991
• Publication Number:
  US 20020022789A1
• Time in Patent Office: 1,006 Days
• Field of Search: 600/573, 600/576, 600/583, 606/181-183
• 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 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 5/15111 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 5/15186 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 5/1519 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

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 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 constricting member mounted to the housing at the open end thereof for movement relative to the housing, the constricting member radially disposed about a longitudinal axis of the housing and pivotally attached thereto, wherein the constricting member causes 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 the 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.

2. The device according to claim 1 wherein the end face is inclined to generally face the axis.

3. The device according to claim 1 wherein the stimulator member extends continuously about the axis.

4. The device according to claim 1 wherein the stimulator member includes circumferentially spaced interruptions.

5. The device according to claim 1 wherein the stimulator member is movable relative to the housing along the axis.

6. The device according to claim 5, wherein the stimulator member and the constricting member are movable relative to the housing and are interconnected to move axially in mutually opposite directions.

7. The device according to claim 1 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 relatively movable along the axis.

8. The device according to claim 7 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.

9. The device according to claim 6 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.

10. The device according to claim 1 wherein the stimulator member comprises a helical spring.

11. The device according to claim 1 further including a second stimulator chosen from the group consisting of a heating mechanism for heating the stimulator member or constricting member;

and a vibrator mechanism for vibrating the stimulator member or constricting member.

12. 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 constricting member mounted to the housing at the open end thereof for movement relative to the housing, the constricting member radially disposed about a longitudinal axis of the housing and pivotally attached thereto, wherein the constricting member causes the skin surface to form a bulge in response to a pressing on the housing;

a stimulator member mounted to the housing at the open end thereof for movement relative to the housing, the stimulator member extending about the 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; and

wherein the constricting member comprises at least two legs pivotally mounted to the housing, and biasing members for biasing the legs in response to a force applied to the housing.

13. A body fluid sampling device, comprising:

a housing;

a skin-lancing mechanism coupled to the housing and adapted to form an incision in skin; and

a stimulator member coupled to the housing, the stimulator member including a flexible membrane with a skin contacting surface for frictionally engaging the skin to stretch open the incision upon pressing the stimulator member against the skin.

14. The device of claim 13, wherein the skin contacting surface has a plurality of rings radially disposed about an aperture in the flexible membrane.

15. The device of claim 13, wherein the stimulator member includes a raised member disposed upon the skin contacting surface in a spiraling manner for directing fluid into the incision.

16. A body fluid sampling device, comprising:

a housing;

a skin-lancing mechanism coupled to the housing and adapted to form an incision in skin;

a stimulator member coupled to the housing, the stimulator member including a flexible membrane with a skin contacting surface for frictionally engaging the skin to stretch open the incision upon pressing the stimulator member against the skin; and

a constricting member coupled to the stimulator member for puckering the skin against the stimulator member upon pressing the constricting member against the skin.

17. The device of claim 16, wherein the constricting member is constructed of pliable material for flexing the constricting member to pucker the skin upon pressing the constricting member against the skin.

18. The device of claim 16, wherein the constricting member includes a plurality of arms pivotally coupled to the stimulator member to pucker the skin.

19. The device of claim 18, wherein each of the arms has a biasing member for biasing each of the arms against the skin.

20. The device of claim 16, wherein the skin contacting surface has a plurality of rings radially disposed about an aperture in the flexible membrane.

21. The device of claim 16, wherein the stimulator member includes a raised member disposed upon the skin contacting surface in a spiraling manner for directing fluid into the incision.

22. A body fluid sampling device, comprising:

a housing;

a skin-lancing mechanism coupled to the housing and adapted to form an incision in skin;

a constricting member coupled to the housing to pucker the skin upon pressing the constricting member against the skin; and

wherein the constricting member includes a plurality of arms pivotally coupled to the housing to pucker the skin.

23. The device of claim 22, wherein each of the arms has a biasing member for biasing each of the arms against the skin.

24. The device of claim 22, further comprising a stimulator member coupled between the housing and the constricting member, the stimulator member including a skin contacting surface for frictionally engaging the skin to stretch open the incision upon pressing the stimulator member against the skin.

25. 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 stretches the incision open, whereby body fluid is expressed from the opening of the incision; and

wherein step C comprises applying the force progressively closer to the incision.

26. The method according to claim 25, wherein a force between the stimulating member and the skin causes the stimulating member to retain the skin in a stretched position.

27. The method according to claim 25, wherein step C includes applying the force in a direction inclined generally toward the incision.

28. The method according to claim 25, wherein step C includes applying heat in a region of the incision.

29. The method according to claim 25, wherein step C includes applying ultrasonic frequency to a region of the incision.

30. The method according to claim 25, wherein step A comprises lancing a region of the body of the user other than a finger tip.

31. The method according to claim 25, wherein step A comprises applying a lancet against the skin.