DEVICES AND METHODS FOR EXPRESSION OF BODILY FLUIDS FROM AN INCISION

• US 20100249653A1
• Filed: 06/10/2010
• Published: 09/30/2010
• Est. Priority Date: 06/08/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Raney, Charles C., Perez, Edward, Patel, Paul
• Granted Patent: US 9,538,941 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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 5/15113 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• 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

Systems and methods for the expression of bodily fluid from an incision in the skin include devices which bear against the skin in a manner to retain the fluid adjacent the incision site and urge the fluid inwardly toward the incision. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

Claims

1. A method for expressing and testing bodily fluid obtained from an incision in the skin, the method comprising:

attaching a first disposable test strip to a lancing device with a lancet, the first disposable test strip including a test strip integrally formed with a first constricting member, a first fluid passageway, and a first test area;

bulging the skin toward an opening to the first fluid passageway and expressing bodily fluid from the incision by pressing skin-engaging surfaces of the first constricting member against the skin and moving the skin-engaging surfaces toward one another, wherein the opening to the first fluid passageway is located on the surface of the first test strip adjacent the first constricting member;

lancing the bulged skin with the lancet to create an incision;

drawing the bodily fluid by capillary action from the skin through the opening and along the first fluid passageway to the first test area, the first test area being in fluid communication with the first fluid passageway;

testing the bodily fluid in the first test area;

removing the first test strip from the lancing device and disposing of the first test strip; and

attaching a second disposable test strip to the lancing device, the second disposable test strip including a second constricting member, a second fluid passageway, and a second test area.

2. The method of claim 1, wherein the opening on the surface of the first test strip defines an aperture extending through the test strip, and wherein said lancing includes the lancet extending through the aperture in the test strip.

3. The method of claim 1, wherein the constricting member includes a plurality of flexible elements surrounding said opening, each flexible element including a skin-engaging surface, wherein said moving includes flexing the plurality of flexible elements with the skin-engaging surfaces moving radially inward from outer to inner positions.

4. The method of claim 1, further comprising orienting the lancet approximately orthogonal to the skin surface at the incision site before said bulging and during said lancing.

5. A method for expressing and testing bodily fluid obtained from an incision in the skin, the method comprising:

attaching a first disposable test strip to a lancing device with a lancet, the first disposable test strip including a test strip integrally formed with a first constricting member, a first capillary tube, and a first test area;

bulging the skin toward an opening to the first capillary tube and expressing bodily fluid from the incision by pressing skin-engaging surfaces of the first constricting member against the skin;

moving the skin-engaging surfaces from initial, outer positions to constricting, inner positions, wherein the opening to the first capillary tube is located on the surface of the first test strip adjacent the first constricting member;

lancing the bulged skin with the lancet to create an incision;

drawing the bodily fluid by capillary action from the skin through the opening and along the first capillary tube to the first test area, the first test area being in fluid communication with the first capillary tube;

testing the bodily fluid in the first test area;

removing the first test strip from the lancing device and disposing of the first test strip; and

attaching a second disposable test strip to the lancing device, the second disposable test strip including a second constricting member, a second capillary tube, and a second test area.

6. The method of claim 5, further comprising:

flexing the first constricting member by pressing the skin-engaging surfaces of the first constricting member against the skin.

7. The method of claim 6, wherein the constricting member includes a plurality of deformable elements surrounding said opening, each deformable element including a skin-engaging surface, wherein said moving includes moving the plurality of skin-engaging surfaces radially inward from the outer to the inner positions.

8. The method of claim 5, wherein the opening to the first capillary tube defines an aperture extending through the test strip, and wherein said lancing includes extending the lancet through the aperture in the test strip.

9. The method of claim 5 further comprising:

orienting the lancet perpendicular to the skin surface at the incision site during said bulging.

10. The method of claim 9, further comprising:

orienting the lancet perpendicular to the skin surface at the incision site during said lancing.

11. An apparatus for expressing and testing bodily fluid obtained from an incision in the skin, the apparatus comprising:

a lancing device for forming an incision in the skin; and

an integrated test strip with a bottom surface;

said test strip attached to said lancing device during sampling with said test strip bottom surface facing the skin, said integrated test strip including;

a constricting member for constricting the skin, said constricting member integrally formed with said test strip and extending from said test strip bottom surface to at least two skin-engaging surfaces,

a fluid passageway for collecting bodily fluid, said fluid passageway integrally formed with said test strip and including an opening on the surface of said test strip adjacent said constricting member, wherein said skin-engaging surfaces move closer together and draw the skin inward toward said opening as said at least one skin-engaging surface contacts and is pressed against the skin,

a test area including a test reagent for testing bodily fluid, said test area integrally formed with said test strip and in fluid communication with said fluid passageway; and

wherein said integrated test strip, said constricting member, said fluid passageway and said test area are removable from said lancing device as a single unit and are disposable as a single unit.

12. The apparatus of claim 11, wherein said opening defines an aperture sized to receive a lancet extending through the test strip, said opening extending through said test strip, and wherein said housing attachment portion is configured to align said test strip aperture and said lancet with said lancet extending downwardly through said opening to lance the skin.

13. The apparatus of claim 11, wherein said constricting member includes a plurality of deformable elements, each deformable element including a skin-engaging surface.

14. The apparatus of claim 13, wherein said plurality of deformable elements surrounds said opening.

15. The apparatus of claim 13, wherein said deformable elements are elongated, arm-like structures.

16. The apparatus of claim 11, wherein said test strip includes a sealing ring surrounding said opening, wherein said deformable elements draw the skin inward to contact said sealing ring and form a fluid tight seal between the skin and the sealing ring.

17. The apparatus of claim 11, wherein said passageway includes a capillary channel that draws fluid from said passageway opening by capillary action.

18. The apparatus of claim 11, wherein said test strip is flat and narrow and said constricting member extends from the bottom surface of said flat and narrow test strip that faces the skin.

19. A method for expressing and testing bodily fluid obtained from an incision in the skin, the method comprising:

attaching a first disposable test strip to a lancing device with a lancet, the first disposable test strip including a test strip integrally formed with a first constricting member, a first fluid passageway, and a first test area;

bulging the skin toward an opening to the first fluid passageway and expressing bodily fluid from the incision by pressing skin-engaging surfaces of the first constricting member against the skin and moving the skin-engaging surfaces toward one another, wherein the opening to the first fluid passageway is located on the surface of the first test strip adjacent the first constricting member;

lancing the bulged skin with the lancet to create an incision;

drawing the bodily fluid by capillary action from the skin through the opening and along the first fluid passageway to the first test area, the first test area being in fluid communication with the first fluid passageway;

testing the bodily fluid in the first test area;

removing the first test strip from the lancing device and disposing of the first test strip; and

attaching a second disposable test strip to the lancing device, the second disposable test strip including a second constricting member, a second fluid passageway, and a second test area.

20. The method of claim 19, wherein the opening on the surface of the first test strip defines an aperture extending through the test strip, and wherein said lancing includes the lancet extending through the aperture in the test strip.

21. The method of claim 19, wherein the constricting member includes a plurality of flexible elements surrounding said opening, each flexible element including a skin-engaging surface, wherein said moving includes flexing the plurality of flexible elements with the skin-engaging surfaces moving radially inward from outer to inner positions.

22. The method of claim 19, further comprising orienting the lancet approximately orthogonal to the skin surface at the incision site before said bulging and during said lancing.