METHODS AND APPARATUS FOR EXPRESSING BODY FLUID FROM AN INCISION

• US 20110046515A1
• Filed: 11/03/2010
• Published: 02/24/2011
• Est. Priority Date: 05/17/1996
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Grage, Henry M., Roe, Jeffrey N., Douglas, Joel S.
• Application Number:
  US12/938,784
• Publication Number:
  US 20110046515A1
• 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 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 5/150503 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 acts 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 act C includes applying the force in a direction inclined generally toward the bulged incision.

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

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

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

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

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

9. A method, comprising the acts of:

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.

10. The method of claim 9, 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.

11. The method of claim 10, 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.

12. A method of obtaining a sample of capillary whole blood from a target tissue, comprising the acts of:

providing a penetrating system that includes a tissue stabilizing member;

applying skin stimulation to a skin surface site with the tissue stabilizing member;

introducing a penetrating member through the skin surface site to form an incision; and

collecting blood from the incision in the penetrating system.

13. The method of claim 12, wherein the skin stimulation is a vibratory motion applied to the skin surface.

14. The method of claim 13, wherein the skin stimulation is an ultrasonic vibratory motion applied to the skin surface.

15. The method of claim 12, wherein the skin stimulation increases blood circulation at the skin surface.

16. The method of claim 12, wherein the skin stimulation applies heat in a region of the incision.

17. A method, comprising the acts of:

forming an incision in tissue with a device; and

expressing body fluid from the incision by depressing the tissue surrounding the incision progressively closer to the incision with the device.

18. The method of claim 17, wherein:

the device includes an outer stimulator ring surrounding an inner stimulator ring; and

said expressing includes

pressing the outer stimulator ring against the tissue, and

pressing the inner stimulator ring against the tissue after said pressing the outer stimulator ring against the tissue.

19. The method of claim 17, wherein:

the device includes a helical spring; and

said expressing includes pressing the helical spring against the tissue.