Devices and methods for the expression of bodily fluids from an incision

• US 20020188223A1
• Filed: 06/07/2002
• Published: 12/12/2002
• Est. Priority Date: 06/08/2001
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Raney, Charles C., Patel, Paul, Perez, Edward
• Application Number:
  US10/165,102
• Publication Number:
  US 20020188223A1
• Time in Patent Office: Days
• US Class Current: 600/573
• 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. One system utilizes a constricting member which engages the skin at initial, outer positions, and moves to draw the skin into an inner position forming a bulged, pinch of skin containing the incision site. The constricting member comprises flexible or non-flexible components, and is formed as a single, continuous member or as a plurality of discrete elements. A second system includes a bi-stable expression member including a skin-engaging portion having a first, outwardly bulged condition, and a second, inverted condition the skin is drawn into and retained within the member. The exterior surface of the expression member is optionally configured or treated to enhance the grasping of the skin. A third system involves a pressing member including deformable portions defining opposed, skin-engaging surfaces which are displaced upon pressing the member against the skin a sufficient amount. The deformable portions comprise flexible or non-flexible components, and are formed as a single, continuous member or as a plurality of discrete elements. The present invention further encompasses the combination 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 device for expressing bodily fluid from an incision in the skin, the incision being formed at an incision site, the device comprising:

a body; and

a member connected with said body and defining opposed, skin-engaging surfaces, said member having a first condition with the skin-engaging surfaces contacting the skin and located at initial, outer positions, said 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.

2. The device of claim 1 in which said member comprises a member deformable between the first and second conditions.

3. The device of claim 2 in which said member is flexible and reversibly flexes between the first and second conditions.

4. The device of claim 3 in which said member is comprised of a material selected from the group consisting of silicone, urethane, polyvinyl chloride, and delrin.

5. The device of claim 2 in which said member is deformable in a manner that is at least partially irreversible.

6. The device of claim 2 in which said member is configured to deform to move the skin-engaging surfaces from the first positions to the second positions upon pressing the member against the skin.

7. The device of claim 2 in which said member comprises a single, continuous member defining at least two opposed, skin-engaging surfaces.

8. The device of claim 7 in which said member comprises a continuous, perimetric surface defining the opposed, skin-engaging surfaces.

9. The device of claim 8 in which said member comprises a circular surface defining the skin-engaging surfaces.

10. The device of claim 8 in which said member comprises a plurality of separate, contiguous elements defining the continuous, perimetric skin-engaging surfaces.

11. The device of claim 7 in which said member is flexible and reversibly flexes between the first and second positions.

12. The device of claim 11 in which said member is comprised of a material selected from the group consisting of silicone, urethane, polyvinyl chloride, and delrin.

13. The device of claim 11 in which said member is configured to deform to move the skin-engaging surfaces from the first positions to the second positions upon pressing the member against the skin.

14. The device of claim 2 in which said member comprises a plurality of separate elements, each element defining a skin-engaging surface.

15. The device of claim 14 in which the separate elements are spaced apart.

16. The device of claim 1 in which said member comprises a plurality of separate, rigid elements, each element defining a skin-engaging surface and being movable between the first and second conditions.

17. The device of claim 16 in which the separate elements are spaced apart.

18. The device of claim 17 in which the separate elements are movable to move the skin-engaging surfaces in a radially-inward direction from the first positions to the second positions.

19. The device of claim 18 in which the separate elements are arranged to have the skin-engaging surfaces fall within a circular pattern in the first positions.

20. The device of claim 16 in which the separate elements pivot to move the skin-engaging surfaces from the first positions to the second positions.

21. The device of claim 20 in which the separate elements are arranged to have the skin-engaging surfaces fall within a circular pattern in the first positions, and in which the separate elements are pivotable to move the skin-engaging surfaces in a radially-inward direction from the first positions to the second positions.

22. The device of claim 1 and which further includes a second expression member positioned to express the bodily fluid from the incision.

23. The device of claim 1 and which further includes a sealing ring attached to said body and positioned interior of said member, the sealing ring being positioned to be in contact with the skin when the skin is drawn inward with the skin-engaging surfaces in the inner positions.

24. The device of claim 1 and which further includes an incising mechanism connected to said body and positioned to incise a person'"'"'s skin at a location interior of said member.

25. The device of claim 24 in which said incising mechanism comprises a lancing device positioned to lance the person'"'"'s skin.

26. The device of claim 25 in which said lancing device comprises an annular capillary lancet, the annular capillary lancet including a capillary tube and a lancet received within the capillary tube.

27. The device of claim 25 in which said body comprises a test strip.

28. The device of claim 1 and which further includes a sampling device connected to said body.

29. The device of claim 28 in which said sampling device includes an inlet, said sampling device having a fluid-receiving position for receiving the bodily fluid expressed from the incision.

30. The device of claim 29 in which said sampling device is retained in the fluid-receiving position when the skin-engaging surfaces move from the outer positions to the inner positions.

31. The device of claim 29 in which said sampling device further includes a second position displaced from the fluid-receiving position, said sampling device being movable from the second position to the fluid-receiving position with the skin-engaging surfaces in the inner positions.

32. The device of claim 28 in which said sampling device includes a capillary tube defining a passageway communicating with the inlet opening.

33. The device of claim 28 in which said sampling device includes a test strip.

34. The device of claim 28 and which further includes a test system connected with said body and in fluid communication with said sampling device.

35. The device of claim 28 and which further includes an incising mechanism connected to said body and positioned to incise a person'"'"'s skin at a location interior of said member.

36. The device of claim 35 in which said incising mechanism comprises a lancing device positioned to lance the person'"'"'s skin.

37. The device of claim 35 and which further includes a test system connected with said body and in fluid communication with said sampling device.

39. The device of claim 38 in which said member is configured to automatically invert from the first condition to the second condition upon pressing said member against the skin.

40. The device of claim 38 in which said body comprises a cylindrical portion including a ring-shaped end surface, and in which said member comprises a semi-spherical member including a circular rim secured to the cylindrical end portion.

41. The device of claim 38 in which the exterior skin-engaging surface of said member includes a plurality of projections for engaging the skin as said member inverts from the first condition to the second condition.

42. The device of claim 38 in which the aperture has a minimum dimension of at least about 2 mm.

43. The device of claim 42 in which the aperture is round and has a diameter of at least about 7 mm.

44. The device of claim 38 and which further includes an incising mechanism connected to said body and positioned to incise a person'"'"'s skin at a location interior of said member.

45. The device of claim 44 in which said incising mechanism comprises a lancing device positioned to lance the person'"'"'s skin.

46. The device of claim 45 in which said lancing device comprises a lancet positioned and operable to incise the skin through the aperture in said member.

47. The device of claim 38 and which further includes a sampling device connected to said body.

48. The device of claim 38 and which further includes a test system connected to said body and in fluid communication with said sampling device.

49. The device of claim 38 and which further includes an incising mechanism connected to said body and positioned to incise a person'"'"'s skin at a location interior of said member.

50. The device of claim 49 in which said incising mechanism comprises a lancing device positioned to lance the person'"'"'s skin.

51. The device of claim 50 and which further includes a test system connected to said body and in fluid communication with said sampling device.

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

a body defining a cavity; and

a bi-stable expression member connected with said body adjacent to the interior cavity and including a portion having first and second stable conditions, said portion in the first stable condition being outwardly bulged relative to said body, said portion in the second stable condition being inverted and received within the cavity of said body, said portion including an exterior skin-engaging surface and defining an aperture communicating between the exterior skin-engaging surface and the cavity of said body, the skin-engaging surface engaging the skin and drawing the skin into said member as said portion inverts from the first condition to the second condition.

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

a body; and

a member connected with said body and including deformable portions defining opposed, skin-engaging surfaces, said member having a first condition with the skin-engaging surfaces contacting the skin and located at first positions, said member having a second condition with the skin-engaging surfaces engaging the skin and at second positions displaced from the first positions, the deformable portions being configured to deform from the first positions to the second positions upon pressing of said member against the skin, the first condition of said member corresponding to said member being in contact with the skin and the second condition of said member corresponding to said member being pressed against the skin a sufficient amount to deform the portions from the first positions to the second positions.

53. The device of claim 52 in which the deformable portions are flexible and reversibly flex between the first positions and the second positions.

54. The device of claim 52 in which said member comprises a single, continuous member defining the opposed skin-engaging surfaces.

55. The device of claim 52 in which said member comprises a plurality of separate, contiguous elements defining the opposed, skin-engaging surfaces.

56. The device of claim 52 in which said member comprises a plurality of separate, spaced-apart elements defining the opposed, skin-engaging surfaces.

57. The device of claim 56 in which the separate elements are arranged to have the skin-engaging surfaces fall within a circular pattern in the first and second positions.

58. The device of claim 52 in which the skin-engaging surfaces include outer contact areas and inner contact areas, the deformable portions being configured to provide resistance to deformation which is greater at the outer contact areas than at the inner contact areas, said device thereby applying greater pressure to the skin at the outer areas as compared to the inner areas when said device is pressed against the skin.

59. The device of claim 52 in which the skin-engaging surfaces include outer contact areas and inner contact areas, the inner contact areas being recessed inwardly of the outer contact areas, said device thereby applying pressure to the skin first at the outer areas and second at the inner areas when said device is pressed against the skin.

60. The device of claim 52 and which further includes an incising mechanism connected to said body and positioned to incise a person'"'"'s skin at a location interior of said member.

61. The device of claim 60 in which said incising mechanism comprises a lancing device positioned to lance the person'"'"'s skin.

62. The device of claim 61 in which said lancing device comprises a lancet positioned and operable to incise the skin through the aperture in said member.

63. The device of claim 52 and which further includes a sampling device connected to said body.

64. The device of claim 52 and which further includes a test system connected to said body and in fluid communication with said sampling device.

65. The device of claim 52 and which further includes an incising mechanism connected to said body and positioned to incise a person'"'"'s skin at a location interior of said member.

66. The device of claim 65 in which said incising mechanism comprises a lancing device positioned to lance the person'"'"'s skin.

67. The device of claim 66 and which further includes a test system connected to said body and in fluid communication with said sampling device.

69. The method of claim 68 in which the member is deformable between the first and second conditions, and said moving comprises deforming the member.

70. The method of claim 68 in which the member is flexible and reversibly flexes between the first and second conditions, and said moving comprises flexing the member.

71. The method of claim 68 in which the member comprises a single, continuous member defining at least two opposed, skin-engaging surfaces.

72. The method of claim 68 in which the member comprises a plurality of separate elements, each element defining a skin-engaging surface, and said moving comprises moving each of the plurality of elements.

73. The method of claim 68 and which further includes incising the skin.

74. The method of claim 68 and which further includes collecting the bodily fluid.

75. The method of claim 74 and which further includes incising the skin.

76. The method of claim 74 and which further includes testing the bodily fluid.

77. The method of claim 76 and which further includes incising the skin.

79. The method of claim 78 and which further includes incising the skin.

80. The method of claim 78 and which further includes collecting the bodily fluid.

81. The method of claim 80 and which further includes incising the skin.

82. The method of claim 80 and which further includes testing the bodily fluid.

83. The method of claim 82 and which further includes incising the skin.

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

providing an expression device including a body and a member connected with the body and defining opposed, skin-engaging surfaces, the member having a first condition with the skin-engaging surfaces contacting the skin and located at initial, outer positions, the 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;

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

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

providing an expression device including a body defining a cavity and a bi-stable expression member connected with the body adjacent to the interior cavity and including a portion having first and second stable conditions, the portion in the first stable condition being outwardly bulged relative to the body, the portion in the second stable condition being inverted and received within the cavity of the body, the portion including an exterior skin-engaging surface and defining an aperture communicating between the exterior skin-engaging surface and the cavity of the body, the skin-engaging surface engaging the skin and drawing the skin into the member as the portion inverts from the first condition to the second condition;

contacting the skin with the skin-engaging surface at the first, outwardly bulged condition; and

inverting the portion with the skin-engaging surface in contact with the skin to draw the skin into the member.

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

providing an expression device including a body and a member connected with the body and including deformable portions defining opposed, skin-engaging surfaces, the member having a first condition with the skin-engaging surfaces contacting the skin and located at first positions, the member having a second condition with the skin-engaging surfaces engaging the skin and at second positions displaced from the first positions, the deformable portions being configured to deform from the first positions to the second positions upon pressing of the member against the skin, the first condition of the member corresponding to the member being in contact with the skin and the second condition of the member corresponding to the member being pressed against the skin a sufficient amount to deform the portions from the first positions to the second positions;

contacting the skin with the skin-engaging surfaces with the skin-engaging surfaces in the first positions; and

pressing the expression device against the skin and deforming the member to move the skin-engaging surfaces from the first positions to the second positions.

85. The method of claim 84 in which the deformable portions are flexible, and said deforming comprises flexing the deformable portions.

86. The method of claim 84 in which the skin-engaging surfaces include outer contact areas and inner contact areas, the deformable portions being configured to provide resistance to deformation which is greater at the outer contact areas than at the inner contact areas, the device thereby applying greater pressure to the skin at the outer areas as compared to the inner areas when the device is pressed against the skin.

87. The method of claim 84 in which the skin-engaging surfaces include outer contact areas and inner contact areas, the inner contact areas being recessed inwardly of the outer contact areas, the device thereby applying pressure to the skin first at the outer areas and second at the inner areas when the device is pressed against the skin.

88. The method of claim 84 and which further includes incising the skin.

89. The method of claim 84 and which further includes collecting the bodily fluid.

90. The method of claim 89 and which further includes incising the skin.

91. The method of claim 89 and which further includes testing the bodily fluid.

92. The method of claim 91 and which further includes incising the skin.