DEVICES AND METHODS FOR EXPRESSION OF BODILY FLUIDS FROM AN INCISION

• US 20090118752A1
• Filed: 01/14/2009
• Published: 05/07/2009
• Est. Priority Date: 06/08/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Raney, Charles C., Patel, Paul, Perez, Edward
• Granted Patent: US 7,758,518 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• 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 bodily fluid from an incision in the skin surface, the incision being formed at an incision site, the method comprising:

providing an expression device including a body and a constricting member connected with the body and defining skin-engaging surfaces, the constricting member having a first condition with the skin-engaging surfaces contacting the skin and located at initial, outer positions, the constricting member having a second condition with the skin-engaging surfaces engaging the skin and located at constricting, inner positions, the skin being drawn inward as the skin-engaging surfaces move from the outer positions to the inner positions, the skin being constricted by the skin-engaging surfaces in the inner positions, wherein the constricting member is flexible between the first and second conditions and the skin-engaging surfaces include at least first and second discrete and spaced apart skin-engaging surfaces, and wherein the first and second skin-engaging surfaces are positioned on opposite sides of the incision site;

contacting the skin with the skin-engaging surfaces at the initial, outer positions; and

flexing the constricting member from the first condition to the second condition with a downward force exerted against the skin, said downward force being perpendicular to the skin surface at the incision site before said contacting; and

moving the skin-engaging surfaces to the constricting, inner positions to draw the skin inward and to constrict the skin with the skin-engaging surfaces, wherein said moving of the first skin-engaging surface is in a substantially nonparallel direction to said moving of the second skin-engaging surface.

2. The method of claim 1 in which the constricting member is flexible and reversibly flexes between the first and second conditions, and said moving comprises flexing the member the method further comprising:

removing the skin-engaging surfaces from the skin; and

moving the skin-engaging surfaces from the inner positions to the outer positions.

3. The method of claim 1 in which the constricting member comprises a plurality of separate elements, each element defining a skin-engaging surface, and said flexing comprises flexing each of the plurality of elements to move the first and second skin-engaging surfaces in substantially nonparallel directions.

4. The method of claim 1 and which further includes incising the skin.

5. The method of claim 4, wherein the expression device body further includes a test strip with an aperture extending through the test strip, and wherein said incising includes extending a lancet through the aperture in the test strip.

6. The method of claim 5, further comprising:

orienting the lancet perpendicular to the skin surface at the incision site during said flexing; and

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

7. The method of claim 1 and which further includes:

providing a testing device connected to the expression device;

transferring a droplet of bodily fluid from the expression device to the testing device, and

testing the bodily fluid with said testing device.

8. The method of claim 7 and which further includes:

providing an incision device; and

incising the skin with the incision device.

9. The method of claim 8, wherein the incision device is reusable and adapted to be individually connected with each of a plurality of expression devices, and wherein the expression device body and the constricting member are integrally formed, disposable and adapted to be discarded after the concentration of an analyte in at most one sample of bodily fluid is determined, and the method further comprising:

disconnecting the expression device body and the constricting member as an integrally formed unit from the incision device after said testing and prior to further collecting of bodily fluid; and

discarding the expression device and the constricting member.

10. The method of claim 9, further comprising:

connecting a replacement expression device including a replacement body and a replacement constricting member connected with the replacement body and defining replacement skin-engaging surfaces, the replacement constricting member having a first condition with the replacement skin-engaging surfaces contacting the skin and located at initial, outer positions, the replacement constricting member having a second condition with the replacement skin-engaging surfaces engaging the skin and located at constricting, inner positions, the skin being drawn inward as the replacement skin-engaging surfaces move from the outer positions to the inner positions, the skin being constricted by the replacement skin-engaging surfaces in the inner positions, wherein the replacement constricting member is flexible between the first and second conditions and the replacement skin-engaging surfaces include at least first and second discrete and spaced apart replacement skin-engaging surfaces, and wherein the first and second replacement skin-engaging surfaces are positioned on opposite sides of the incision site.

11. The method of claim 1, wherein the skin is drawn inward exclusively by said flexing.

12. The method of claim 1, further comprising:

forming a pressurized pinch of skin with the skin-engaging surfaces.

13. The method of claim 1, further comprising:

creating a bulged skin area by said moving flexing.

14. The method of claim 1, wherein the expression device includes a length and width, and the expression device further includes a fluid passageway along the length, the fluid passageway including a width less than the expression device width, the method further comprising:

drawing the bodily fluid by capillary action from the skin and along the fluid passageway.

15. The method of claim 14, wherein said drawing transports the bodily fluid along the fluid passageway in a direction perpendicular to the lancet.

16. The method of claim 14, wherein said drawing transports the bodily fluid along the fluid passageway in a direction parallel to the skin surface at the incision site.

17. The method of claim 14, wherein the expression device further includes a test area in fluid communication with the fluid passageway and said drawing includes drawing the bodily fluid along the fluid passageway to the test area, said method further comprising:

testing the bodily fluid in the test area.

18. The method of claim 1, wherein the constricting member includes a plurality of discrete and spaced apart skin-engaging surfaces surrounding an opening, and wherein said flexing includes moving the plurality of skin-engaging surfaces radially inward from the outer positions to the inner positions.

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.

23. 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.

24. The method of claim 23, further comprising:

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

25. The method of claim 24, 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.

26. The method of claim 23, 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.

27. The method of claim 23 further comprising:

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

28. The method of claim 27, further comprising:

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

29. A method for expressing bodily fluid from an incision in the skin surface at an incision site, the incision being formed at an incision site, the method comprising the acts of:

contacting the skin with at least two skin-engaging surfaces of an expression device, the expression device including at least two discrete and spaced apart deformable elements, each deformable element extending to a skin-engaging surface;

pressing the skin-engaging surfaces against the skin with a first force in a first direction;

flexing the deformable elements with the first force in the first direction;

moving the skin-engaging surfaces radially inward from outer to inner positions with the first force in the first direction; and

constricting the skin with the first force in the first direction.

30. The method of claim 29, wherein the deformable elements are curved, each said deformable element defining a first radius of curvature before said flexing and a second radius of curvature after said flexing, wherein the first radius of curvature is greater than the second radius of curvature.

31. The method of claim 29, wherein said contacting includes contacting the skin with at least four skin-engaging surfaces of the expression device, the expression device including at least four discrete and spaced apart deformable elements, each deformable element extending to a skin-engaging surface.

32. The method of claim 29, further comprising:

lancing the skin surface at the incision site with a lancing device connected to the deformable elements.

33. The method of claim 29, wherein the expression device includes a capillary passageway, said method further comprising:

transferring a droplet of bodily fluid formed at the incision site from the incision site along the capillary passageway; and

moving the droplet of bodily fluid along the capillary passageway by capillary action.

34. The method of claim 29, wherein the deformable elements are integrally formed with a test strip, the test strip including a test site, said method further comprising:

transferring a droplet of bodily fluid formed at the incision site from the incision site to the test site; and

testing the droplet of bodily fluid at the test site.