Methods and apparatus for expressing body fluid from an incision

• US 5,951,493 A
• Filed: 05/16/1997
• Issued: 09/14/1999
• Est. Priority Date: 05/16/1997
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Mercury Diagnostics, Inc.
• Inventors: Roe, Jeffrey N., Grage, Henry M., Douglas, Joel S.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/858,043
• Time in Patent Office: 851 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 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 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/15109 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 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 blood from a body, comprising the steps of:

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

B) removing the skin-lancing medium 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, causing the incision to bulge and the sides of the incision to open;

D) releasing the force of step C); and

E) repeating steps C) and D) a sufficient number of times to express a sample of blood from the incision.

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

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

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

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

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

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

8. A device for sampling blood 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 remove the skin-lancing medium from the incision; and

a stimulator member mounted to the housing at the open end thereof, the stimulator member extending about a longitudinal axis of the housing the axis and adapted to engage the skin surface to bulge and open the incision in response to a pressing of the end face against the skin surface, the stimulator member being longitudinally moveable relative to the housing such that by repeatedly pressing said stimulator member against the surface of the skin, a sample of blood is expressed from the incision.

9. The device according to claim 8 wherein the end face is inclined to generally face the axis.

10. The device according to claim 8 wherein the end face extends continuously about the axis.

11. The device according to claim 8 wherein the end face includes circumferentially spaced interruptions.

12. The device according to claim 8 wherein the stimulator member is movable relative to the housing along the axis.

13. The device according to claim 8 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.

14. The device according to claim 13 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.

15. The device according to claim 14 wherein the first and second stimulator members are interconnected by levers, each lever being pivoted intermediate its ends for rotation about an axis extending orthogonally relative to the longitudinal axis of the housing.

16. The device according to claim 8 wherein the stimulator member comprises a cylindrical ring.

17. The device according to claim 8 wherein the stimulator member comprises a helical spring.

18. The device according to claim 8 further including a heating mechanism for heating the stimulator member.

19. The device according to claim 8 wherein the heating mechanism comprises a battery mounted in the housing and electrically connected to the stimulator member.

20. The device according to claim 8 further including a vibrator mechanism for vibrating the stimulator member.

21. The device according to claim 20 wherein the vibrator mechanism applies an ultrasonic vibration to the stimulator member.

22. The device according to claim 20 wherein the stimulator member is a piezoelectric transducer.

23. The device according to claim 8 including a reciprocation mechanism for reciprocating the stimulator member along the axis.

24. The device according to claim 23 wherein the reciprocation mechanism comprises a motor, a cam sleeve connected to the motor to be driven thereby about the axis and including a cam surface, the stimulator member being operably connected to the cam surface to be displaced axially thereby against a spring bias.

25. The device according to claim 8 wherein the skin-lancing mechanism comprises a lancet.