Methods and apparatus for expressing body fluid from an incision

• US 6,071,250 A
• Filed: 01/28/1999
• Issued: 06/06/2000
• Est. Priority Date: 05/16/1997
• 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., Grage, Henry M., Douglas, Joel S.
• Primary Examiner(s): O'Connor, Cary E.
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/238,140
• Time in Patent Office: 495 Days
• Field of Search: 600/573, 600/576, 600/583, 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 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 device for expressing whole capillary blood from a lanced skin surface comprising:

A) a housing;

B) a stimulating member mounted at least partially within the housing, the stimulator member comprising a stimulating end adapted to surround an incision to manipulate the skin surface by opening the incision so as to fill the incision with blood when the stimulating end is pressed against the skin surface, the stimulating member being longitudinally slidable relative to the housing such that by repeatedly pressing the stimulator member against the surface of the skin, a sample of blood is expressed from the incision.

2. The device in accordance to claim 1, wherein the stimulating member comprises concentric inner and outer separate stimulating sleeves, where the outer sleeve engages the skin surface first and the inner sleeve second to manipulate the skin and force blood into the incision as the incision is opened and force the blood to the surface of the skin as the incision closes.

3. The device in accordance to claim 1, wherein the stimulating member comprises concentric inner and outer separate stimulating sleeves, where the inner sleeve engages the skin surface first and the outer sleeve second to manipulate the skin and force blood into the incision as the incision is opened and force the blood to the surface of the skin as the incision closes.

4. A method of obtaining a sample of capillary whole blood from the 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) applying a force by depressing the skin in a manner to form a depressed ring of body tissue in surrounding relationship to the incision to manipulate the incision open;

C) releasing the force of step B; and

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

5. A device for expressing body fluid from a lanced skin surface, comprising:

a housing; and

a stimulator mechanism mounted to the housing at an end thereof, the stimulator mechanism extending from the end of the housing for contacting the skin including a generally circular array of stimulator elements each mounted to the housing for movement toward and away from a longitudinal axis of the housing.

6. The device according to claim 5, wherein the stimulator elements comprise rollers mounted to the housing by pivoted levers.

7. The device according to claim 5, further including a lancet carrier mounted in the housing and adapted to support a disposable lancet;

and a drive mechanism in the housing for driving the lancet carrier along a longitudinal axis of the housing to lance a skin surface and form an incision therein.

8. A device for expressing body fluid from a lanced skin surface comprising:

a housing;

a stimulator member mounted on the housing at an end thereof, the stimulator member comprising a coil spring compressible toward the housing in response to being pushed against the skin in surrounding relationship to a lanced portion thereof.

9. A device for expressing body fluid from a lanced skin surface comprising:

a housing;

a hollow stimulator member mounted at an end of the housing and adapted to engage the skin surface in surrounding relationship to a lanced portion thereof;

and heating means for heating the stimulator member.

10. The device according to claim 9, wherein the heating means comprises a battery mounted in the housing and electrically connected to the stimulator member.

11. A device for expressing blood or interstitial fluid from a lanced skin surface, comprising:

a housing;

a retractable skin lancing mechanism mounted in the housing;

a hollow stimulator member mounted on the housing at an end thereof and adapted to engage the skin surface in surrounding relationship to a lanced portion thereof, the stimulator member operable to apply an ultrasonic frequency to the skin surface.

12. The device according to claim 11, wherein the stimulator member comprises a piezoelectric transducer.

13. The device according to claim 12, wherein the transducer is ring-shaped and includes a frusto-conical inner surface.

14. A device for expressing body fluid from a lanced skin surface comprising:

a housing;

a skin lancing mechanism mounted in the housing;

a hollow stimulator member mounted at an end of housing for longitudinal movement relative to the housing and adapted to contact the skin surface in surrounding relationship to a lanced portion thereof;

a motor mounted in the housing; and

a reciprocatory mechanism connected to the motor to be driven thereby and operably connected to the stimulator member for reciprocating the stimulator member along a longitudinal axis of the stimulator member.