Split tip expression device

• US 7,377,903 B2
• Filed: 03/05/2004
• Issued: 05/27/2008
• Est. Priority Date: 03/05/2004
• 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.
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): Foreman; Jonathan M
• Application Number:
  US10/794,957
• Publication Number:
  US 20050197666A1
• Time in Patent Office: 1,544 Days
• Field of Search: 600/573, 600/576, 600/583, 606/181, 606/182, 606/183
• US Class Current: 600/583
• 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 5/150175 Adjustment of penetration depth
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• 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 5/15121 comprising piezos
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

An expression device for a lancing device of the type that directs a skin-lancing medium against a skin site to make an incision for testing bodily fluids. The expression device has a pair of skin-engaging tabs curved and oriented to make the skin taut adjacent a lancet used with the device. This increases the incision width and enhances the quantity of blood removed for subsequent testing.

Claims

1. Apparatus for sampling bodily fluid, said apparatus comprising:

a housing,

a skin-lancing device mounted in said housing for directing a skin-lancing medium against a skin surface to form an incision therein, and then remove the skin-lancing medium from the incision,

a device mounted in said housing, said device having a pair of elongated skin-engaging flexible tabs, each tab having a length and defining a centerline extending through the center of said tab along said length, said tabs oriented to urge the skin taut adjacent the incision site on said skin to at least open the incision, said tabs extending from a base to adjacent the incision, each said tab having an intermediate section wherein said centerline extends toward the skin surface and toward said skin-lancing medium, and each said tab having a section adjacent the skin surface wherein said centerline extends toward the skin surface and away from said skin-lancing medium.

2. Apparatus as claimed in claim 1 wherein the pair of skin-engaging flexible tabs act to express bodily fluid after incision.

3. Apparatus as claimed in claim 1 wherein the pair of skin-engaging flexible tabs hold the skin taut before incision.

4. Apparatus as claimed in claim 1 wherein said tabs have friction enhancing surfaces on their tips for engaging the skin.

5. Apparatus as claimed in claim 1 wherein said tabs extend beyond the lancing medium in its condition prior to lancing said skin.

6. Apparatus as claimed in claim 1 further comprising a removable cap over said skin lancing device and said skin engaging flexible tabs.

7. Apparatus as claimed in claim 1 further comprising a cap attached to said housing for contacting the skin on opposing sides of the incision.

8. Apparatus as claimed in claim 1 wherein each said skin-engaging flexible tab has an elongated tip, said pair of elongated tips having parallel line contacts with the skin.

9. Apparatus as claimed in claim 1 wherein said centerline in said intermediate section extends toward said skin-lancing medium when said tab is pressed against the skin, and wherein said centerline in said section adjacent the skin surface extends away from said skin-lancing medium when said tab is pressed against the skin.

10. Apparatus as claimed in claim 1 wherein said centerline in said intermediate section curves toward said skin-lancing medium and said centerline in said section.

11. Apparatus as claimed in claim 1 wherein said base is removable from said housing.

12. Apparatus as claimed in claim 11 further comprising clips mounted on said housing and having slots into which said base extends, said base having a slot surrounding the site for said lancing medium to permit sideways removal from said base.

13. Apparatus as claimed in claim 1 wherein said pair of skin-engaging flexible tabs are opposed from one another and have line contact with the skin, said lancing medium being a blade-like lancet extending parallel to said opposed line contacts.

14. Apparatus as claimed in claim 13 wherein said lancing medium further comprises a capillary passage adjacent said blade-like lancet to carry bodily fluid from said incision.

15. Apparatus as claimed in claim 14 wherein said capillary passage is parallel to said lancing medium.

16. Apparatus as claimed in claim 14 wherein said capillary passage is bounded on one side by said lancing medium.

17. A method of sampling bodily fluid from an incision m a skin site comprising:

providing a skin lancing device having a pair of flexible tabs extending alongside said skin lancing device to elongated skin-engaging edges, said tabs having an intermediate section extending toward the skin surface and toward said skin lancing device, and a section adjacent the elongated skin-engaging edges extending toward the skin surface and away from said skin lancing devices;

making an incision;

engaging the skin along straight lines with said elongated skin-engaging edges;

pressing said elongated skin-engaging edges against said skin to stretch the skin taut at said site to at least open the incision; and

urging said elongated skin-engaging edges away from said skin lancing device.

18. A method as claimed in claim 17 further comprising carrying bodily fluid from the incision by a capillary passage adjacent the skin lancing device.

19. A method as claimed in claim 17 wherein the pair of flexible tabs are elongated.

20. A method as claimed in claim 17 wherein said engaging the skin is along parallel straight lines.

21. A method as claimed in claim 17 wherein said elongated skin-engaging edges move in opposite directions away from one another.

22. A method as claimed in claim 17 further comprising the further step of stretching the skin taut prior to making an incision.

23. A method as claimed in claim 22 comprising the further step of expressing bodily fluid from the incision.

24. Apparatus for sampling bodily fluid, said apparatus comprising:

a housing,

a skin-lancing device mounted to said housing for directing a skin-lancing medium against a skin surface to form an incision therein, and for removing the skin-lancing medium from the incision,

a cap attached to said housing, said cap defining an interior and including a skin-engaging portion for contacting the skin, and

at least two flexible tabs, each tab attached to said housing and extending at least partially within said interior to a free end, each said free end including a skin-engaging edge, wherein said at least two skin-engaging edges are parallel, and said at least two flexible tabs are oriented to urge said skin-engaging edges in opposite directions away from one another when pressed against the skin.

25. Apparatus as claimed in claim 24 wherein each said flexible tab is elongated and includes an intermediate portion and an end portion, said end portion being adjacent said free end, wherein said at least two intermediate portions extend toward one another and said at least two end portions extend away from one another.

26. Apparatus as claimed in claim 24 wherein each said skin-engaging edge is elongated and engages the skin along a straight line, and wherein said at least two flexible tabs are oriented to urge said skin-engaging edges away from said skin-lancing medium to at least open the incision.

27. Apparatus as claimed in claim 24 wherein said cap contacts the skin surface after said skin-engaging edges when said cap is pressed against the skin surface.

28. Apparatus as claimed in claim 24 wherein said cap limits the urging of said two skin-engaging edges.

29. Apparatus as claimed in claim 24 wherein said cap is removable from said housing.

30. Apparatus as claimed in claim 24 wherein said skin-lancing medium comprises a blade-like lancet, said apparatus further comprising a capillary passage adjacent said blade-like lancet to carry bodily fluid from said incision.

31. Apparatus as claimed in claim 30 wherein said capillary passage is defined at least in part by said blade-like lancet.

32. Apparatus for sampling bodily fluid, said apparatus comprising:

a housing,

a skin-lancing device mounted in said housing for directing a skin-lancing medium against a skin surface defining a plane to form an incision therein, and for removing the skin-lancing medium from the incision,

at least two flexible tabs attached to said housing with said skin-lancing device positioned between said at least two flexible tabs, each tab extending from a base portion to a free end and including an intermediate portion between said base portion and said free end, each said free end including a skin-engaging edge, wherein said at least two flexible tabs are oriented to urge said skin-engaging edges in opposite directions away from one another when pressed against the skin,

wherein said at least two base portions, intermediate portions and free ends each include an inner surface facing said skin-lancing device, an outer surface facing away from said skin-lancing device, and a thickness separating said inner surface and said outer surface, wherein said base portion thickness, said intermediate portion thickness and said free end thickness are approximately equal,

wherein a distance separating said at least two intermediate portion inner surfaces and parallel to said skin surface plane is less than a distance separating said at least two base portion inner surfaces and parallel to said skin surface plane, and

wherein a distance separating said at least two intermediate portion inner surfaces and parallel to said skin surface plane is less than a distance separating said at least two free end inner surfaces and parallel to said skin surface plane.

33. Apparatus as claimed in claim 32 wherein each said skin-engaging edge has a straight line contact with the skin surface and said at least two skin-engaging edges are parallel.

34. Apparatus as claimed in claim 32 wherein said at least two flexible tabs are elongated and opposed from one another with each having line contact with the skin, said skin-lancing medium being a blade-like lancet with the orientation of the blade being parallel to said line contacts.

35. Apparatus for sampling bodily fluid, said apparatus comprising:

a housing,

a skin-lancing device with a central axis mounted to said housing for directing a skin-lancing medium against a skin surface to form an incision therein,

at least two flexible tabs mounted to said housing and extending from an upper base portion to a lower portion with a middle portion between said upper and lower portions, said lower portion including a skin-engaging end, said skin-engaging ends adapted to engage and stretch the skin surface between said skin-engaging ends,

wherein each said at least two flexible tabs has an inner surface facing said skin-lancing device, an outer surface facing away from said skin-lancing device, and a thickness separating said inner surface and said outer surface, wherein said thickness is constant from said base to said skin-engaging end, and

wherein each said inner surface is convex with said middle portion being nearer said skin-lancing device central axis than either said upper portion or said lower portion.

36. Apparatus as claimed in claim 35 wherein said at least two flexible tabs are adapted to urge said skin-engaging edges away from one another when pressed against the skin.

37. Apparatus as claimed in claim 35 wherein said at least two flexible tabs are elongated and opposed from one another with each having line contact with the skin, and wherein said skin-lancing device is a blade-like lancet with the orientation of the blade being parallel to said line contacts.

38. Apparatus for sampling bodily fluid, said apparatus comprising:

a housing,

a skin-lancing device mounted in said housing for directing a skin-lancing medium against a skin surface to form an incision therein, and for removing the skin-lancing medium from the incision,

at least two flexible tabs, each tab attached to said housing and extending to a free end, each said free end including a skin-engaging edge, wherein said at least two skin-engaging edges are parallel, and said at least two flexible tabs are oriented to urge said skin-engaging edges in opposite directions away from one another when pressed against the skin, and

at least two flexible replacement tabs, wherein said flexible replacement tabs are interchangeably attachable to said housing with said at least two flexible tabs.

39. Apparatus for sampling bodily fluid, said apparatus comprising:

a housing,

a skin-lancing device mounted in said housing for directing a skin-lancing medium against a skin surface to form an incision therein, and then remove the skin-lancing medium from the incision,

a device mounted in said housing, said device having a pair of elongated skin-engaging flexible tabs, each tab having a length and defining a centerline extending through the center of said tab along said length, said tabs oriented to urge the skin taut adjacent the incision site on said skin to at least open the incision, said tabs extending from a base to adjacent the incision, each said tab having an intermediate section wherein said centerline extends toward said skin-lancing medium and a section adjacent the skin surface wherein said centerline extends away from said skin-lancing medium, wherein said base is removable from said housing, and

clips mounted on said housing and having slots into which said base extends, said base having a slot surrounding the site for said lancing medium to permit sideways removal from said base.

40. Apparatus for sampling bodily fluid, said apparatus comprising:

a housing,

a skin-lancing device mounted in said housing for directing a skin-lancing medium against a skin surface to form an incision therein, and then remove the skin-lancing medium from the incision,

a device mounted in said housing, said device having a pair of elongated skin-engaging flexible tabs, each tab having a length and defining a centerline extending through the center of said tab along said length, said tabs oriented to urge the skin taut adjacent the incision site on said skin to at least open the incision, said tabs extending from a base to adjacent the incision, each said tab having an intermediate section wherein said centerline extends toward said skin-lancing medium and a section adjacent the skin surface wherein said centerline extends away from said skin-lancing medium, and

a cap attached to said housing for contacting the skin on opposing sides of the incision.