Methods and apparatus for expressing body fluid from an incision

• US 7,841,991 B2
• Filed: 06/26/2003
• Issued: 11/30/2010
• Est. Priority Date: 05/17/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Grage, Henry M., Douglas, Joel S.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Danega; Renee
• Application Number:
  US10/607,347
• Publication Number:
  US 20040073140A1
• Time in Patent Office: 2,714 Days
• Field of Search: 600/583, 606/181, 606/170
• 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 device for expressing bodily fluid from an incision in the skin, the incision being formed at an incision site in the skin surface, the device comprising:

a skin stimulating member including at least three pins and at least three spaced-apart skin-engaging surfaces arranged around the incision site, said skin stimulating member having

a first position with the skin-engaging surfaces contacting the skin and located at initial, outer positions, and

a second position with the skin-engaging surfaces engaging the skin and located at constricting, inner positions, said inner position of each skin-engaging surface being in a radially-inward direction toward the incision site from the corresponding outer position,

wherein each skin-engaging surface pivots around one of the pins when moving between the first and second positions; and

a skin penetrating member connected to said skin stimulating member and positioned between the skin-engaging surfaces; and

wherein said skin stimulating member includes at least three levers, each lever being pivotally mounted to said skin-stimulating member and each lever having a lower end with a roller, each said roller defining one of said spaced-apart skin-engaging surfaces and each said roller adapted to rotate about an axis extending approximately parallel to the skin surface at the incision site.

2. The device of claim 1, wherein said skin stimulating member includes at least three elongated elements spaced-apart from one another, wherein each elongated element includes a skin-engaging surface.

3. The device of claim 2, wherein each elongated element is rigid.

4. The device of claim 3, wherein each elongated element pivots to move between the inner and outer positions.

5. The device of claim 1, wherein said skin-engaging surfaces are adapted to move across the skin surface as said skin-engaging surfaces move from said outer positions to said inner positions while said skin stimulating member is held against the skin.

6. The device of claim 1, wherein said skin stimulating member is adapted to repeatedly move said skin-engaging surfaces from said outer positions to said inner positions while said skin stimulating member is held against the skin.

7. The device of claim 1, wherein the skin-engaging surfaces are adapted to draw the skin 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.

8. The device of claim 1, wherein said skin penetrating member is oriented orthogonally to the skin surface when said skin stimulating member is pressed against the skin and in said first and second positions.

9. The device of claim 1, wherein the skin-engaging surfaces are adapted to bulge the skin as the skin-engaging surfaces move from the outer positions to the inner positions.

10. The device of claim 1, wherein the skin stimulating member forms a pressurized pinch of skin when the skin stimulating member contacts the skin and moves from the first position to the second position.

11. The device of claim 1, wherein said skin stimulating member includes at least three discrete, spaced-apart skin-engaging surfaces,

wherein at least two of said at least three skin-engaging surfaces are diametrically-opposed across the incision site.

12. The device of claim 11 wherein the skin stimulating member is adapted to have the skin-engaging surfaces arranged in a circular pattern in the first positions.

13. The device of claim 1, wherein said skin-engaging surfaces move from the outer positions to the inner positions by application of a force oriented in a downward direction toward the skin.

14. The device of claim 1, wherein said skin-engaging surfaces move from the outer positions to the inner positions by application of a manual force.

15. The device of claim 1, wherein the skin penetrating member includes a sharpened tip that extends beyond the skin-engaging surfaces and penetrates the skin surface while the skin-engaging surfaces are in contact with the skin.

16. The device of claim 1, wherein said skin penetrating member includes an extended position wherein the skin penetrating member penetrates the skin surface while the skin-engaging surfaces are engaged with the skin and located in said second position.

17. A device for expressing bodily fluid from an incision in the skin, the incision being formed at an incision site in the skin surface, the device comprising:

a skin stimulating member including at least three pins and at least three spaced-apart skin-engaging surfaces arranged around the incision site, said skin stimulating member having

a first position with the skin-engaging surfaces contacting the skin and located at initial, outer positions, and

a second position with the skin-engaging surfaces engaging the skin and located at constricting, inner positions, said inner position of each skin-engaging surface being in a radially-inward direction toward the incision site from the corresponding outer position,

wherein each skin-engaging surface pivots around one of the pins when moving between the first and second positions, and

wherein said skin-engaging surfaces include the surface of at least one roller.

18. The device of claim 17, wherein said skin stimulating member includes at least three elongated elements spaced-apart from one another, wherein each elongated element includes a skin-engaging surface.

19. The device of claim 18, wherein each elongated element is rigid.

20. The device of claim 19, wherein each elongated element pivots to move between the inner and outer positions.

21. The device of claim 17, wherein said skin-engaging surfaces are adapted to move across the skin surface as said skin-engaging surfaces move from said outer positions to said inner positions while said skin stimulating member is held against the skin.

22. The device of claim 17, wherein said skin stimulating member is adapted to repeatedly move said skin-engaging surfaces from said outer positions to said inner positions while said skin stimulating member is held against the skin.

23. The device of claim 17, wherein the skin-engaging surfaces are adapted to draw the skin 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.

24. The device of claim 17, further comprising a skin penetrating member adapted to penetrate the skin and oriented orthogonally to the skin surface when said skin stimulating member is pressed against the skin and in said first and second positions.

25. The device of claim 17, further comprising a skin penetrating member with a sharpened tip that extends beyond the skin-engaging surfaces and penetrates the skin surface while the skin-engaging surfaces are in contact with the skin.

26. The device of claim 17, further comprising a skin penetrating member with an extended position wherein the skin penetrating member penetrates the skin surface while the skin-engaging surfaces are engaged with the skin and located in said second position.

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

positioning at least three spaced-apart skin-engaging surfaces around the incision site and in contact with the skin;

pivoting each skin-engaging surface around a pin;

moving the at least three spaced-apart skin-engaging surfaces in radially-inward directions toward the incision site from outer to inner positions;

constricting the skin with the skin-engaging surfaces in the inner positions;

extending a lancet connected to the at least three spaced-apart skin-engaging surfaces between the skin-engaging surfaces; and

penetrating the skin with the lancet.

28. The method of claim 27, further comprising drawing the skin inward with the skin-engaging surfaces.

29. The method of claim 27, further comprising drawing the skin inward exclusively by said moving.

30. The method of claim 27, further comprising forming a pressurized pinch of skin with the skin-engaging surfaces.

31. The method of claim 27, further comprising creating a bulged skin area by said moving.