Body fluid sampling constructions and techniques

• US 20050070819A1
• Filed: 03/31/2003
• Published: 03/31/2005
• Est. Priority Date: 03/31/2003
• Status: Abandoned Application

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Rosedale Medical Inc. (Intuity Medical, Inc.)
• Inventors: Margicin, John M., Mahoney, Derek D., Aceti, John G., Fletcher, Gary D., Zanzucchi, Peter J., Poux, Christopher J., McBride, Sterling E., Parsay, Syrous
• Application Number:
  US10/401,683
• Publication Number:
  US 20050070819A1
• Time in Patent Office: Days
• US Class Current: 600/576
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150122 by heating
• CPC Class Codes: A61B 5/150145 by negative pressure, e.g. suction, vacuum
• CPC Class Codes: A61B 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

A device operable to extract a sample of body fluid, the device including at least one skin-penetration member, an actuator, a controller, and a housing mounting the at least one skin-penetration member for extension from the device. Another device for extracting body fluid includes at least one skin-penetration member having an inner bore and an outer diameter, and at least one axially moveable hollow tubular member disposed in the inner bore. Yet another device includes at least one skin-penetration member, an actuator, a controller, a housing mounting the at least one skin-penetration member, and a skin sensor measuring electrical parameters transmitted through the at least one skin-penetration member. Associated methods are also disclosed.

Claims

1. A device operable to extract a sample of body fluid, the device comprising:

at least one skin-penetration member;

an actuator for extending and/or retracting the at least one skin-penetration member;

a controller for controlling the actuator; and

a housing for mounting the at least skin-penetration member and the actuator.

2. The device of claim 1, further comprising an attachment mechanism for attaching the device to a wearer.

3. The device of claim 2, wherein the attachment mechanism comprises a strap.

4. The device of claim 2, wherein the attachment means comprises an adhesive.

5. The device of claim 1, wherein the body fluid comprises whole blood.

6. The device of claim 1, wherein the device is wearable by a human.

7. The device of claim 1, wherein the skin-penetration member comprises a lancet.

8. The device of claim 1, wherein the at least one skin-penetration member comprises at least one microneedle having an outside diameter of approximately 40-200 micrometers.

9. The device of claim 1, wherein the at least one skin-penetration member comprises one microneedle having an inside diameter of approximately 25-160 micrometers.

10. The device of claim 1, wherein the device is operable to extend the at least one microneedle to a maximum penetration depth of approximately 2.5 mm.

11. The device of claim 1, wherein the device is operable to extend the at least one skin-penetration member a maximum length of approximately 8.0 mm.

12. The device of claim 1, wherein the at least one skin-penetration member is metal.

13. The device of claim 1, wherein the at least one skin-penetration member is no larger than a 34 gage needle.

14. The device of claim 1, wherein the at least one skin-penetration member is no larger than a 36 gage needle.

15. The device of claim 1, wherein the at least one skin-penetration member has a tip sharpened to an angle of approximately 9-19 degrees.

16. The device of claim 1, wherein the at least one skin-penetration member has a corrugated tip.

17. The device of claim 1, wherein the at least one skin-penetration member has a sharpened tip comprising a plurality of facets.

18. The device of claim 1, wherein the at least one skin-penetration member has a hollow cylindrical body comprising an outer cylindrical surface and an inner bore, the at least one skin-penetration member further comprising at least one hole in the cylindrical body defining a passage through the outer surface into the inner bore.

19. The device of claim 18, wherein the at least one hole is round.

20. The device of claim 18, wherein the at least one hole is polygonal.

21. The device of claim 1, wherein the at least one skin-penetration member has a hollow cylindrical body comprising a cylindrical outer surface and an inner bore, the at least one skin-penetration member further comprising at least one axial slot or groove formed in the outer surface.

22. The device of claim 1, wherein the at least one skin-penetration member has at least one convolution.

23. The device of claim 1, wherein the at least one skin-penetration member has an inner bore, the device further comprising at least one axially moveable hollow tubular member concentrically housed within the inner bore of the at least one skin-penetration member.

24. The device of claim 1, wherein the at least one skin-penetration member has an inner bore, the device further comprising at least one additional axially moveable skin-penetration member disposed within the inner bore.

25. The device of claim 1, wherein the at least one skin-penetration member has an inner bore, the device further comprising at least one axially moveable lance disposed within the inner bore.

26. The device of claim 1, wherein the at least one skin-penetration member comprises an expanding needle.

27. The device of claim 1, wherein the at least one skin-penetration member comprises a flat needle.

28. The device of claim 1, wherein the at least one skin-penetration member comprises a coating disposed on the outer surface thereof.

29. The device of claim 28, wherein the coating comprises a friction reducing agent.

30. The device of claim 28, wherein the coating comprises silicone.

31. The device of claim 28, wherein the coating comprises a non-reactive hydrophilic/hydrophobic matrix.

32. The device of claim 29, wherein the coating comprises a pain-reducing agent.

33. The device of claim 1, wherein the at least one skin-penetration member comprises a coating disposed in the inner bore thereof, the coating comprising a capillary action-enhancing agent.

34. The device of claim 33, wherein the coating comprises an anti-coagulant.

36. The device of claim 1, wherein the at least one skin-penetration member comprises an outer cylindrical surface, a first end region having a distal sharpened tip, and a second axially opposite end region, a hollow tubular member fitted over the outer cylindrical surface at the second end region.

37. The device of claim 1, further comprising a hub member secured to the outer cylindrical surface at the first end region.

38. The device of claim 37, further comprising a syringe body attached to the hub.

39. The device of claim 38, wherein the syringe body is operably attached to the actuation means.

40. The device of claim 38, wherein the hollow tubular member comprises a first end region fitted over the outer cylindrical surface of the at least one skin-penetration member, and an axially opposite second end, the device further comprising a fluid coupling member attached to the second end of tubular member.

41. The device of claim 1, wherein the controller and/or actuator comprises means for limiting the depth of penetration of the at least one skin-penetration member to approximately 2.5 mm.

42. The device of claim 1, wherein the controller and/or actuator is operable to rotate the at least one skin-penetration member.

43. The device of claim 1, wherein the controller and/or actuator is operable to at least partially withdrawing the at least one skin-penetration member after penetrating the skin of the wearer, while remaining inserted into the skin of the wearer.

44. The device of claim 1, wherein the controller and/or actuator is operable to actuate the needle at a speed of approximately 1.0-1.5 mm/sec.

45. The device of claim 1, wherein the controller and/or actuator is operable to repeatedly extend and retract the at least one skin-penetration member during a single sampling event.

46. The device of claim 1, wherein the actuator comprises an electromechanical device.

47. The device of claim 1, wherein the actuator comprises a direct current stepper motor.

48. The device of claim 1, wherein the actuator comprises a spring.

49. The device of claim 1, wherein the device further comprises a thermal stimulation member for stimulating the skin of the wearer.

50. The device of claim 49, wherein the thermal stimulation member comprises at least one infrared heating element.

51. The device of claim 1, further comprising a mechanical stimulation member for stimulating the skin of the wearer.

52. The device of claim 51, wherein the mechanical stimulation member comprises a mechanism for pinching the skin of the wearer.

53. The device of claim 52, wherein the mechanical stimulation member comprises a mechanism for mechanically stimulating the skin of the wearer comprises means for applying a vacuum to the skin of the wearer.

54. The device of claim 1, further comprising a mechanism for pricking the surface of the skin, followed by insertion of the at least one skin-penetration member into the wearer in the vicinity of the pricked skin surface.

55. The device of claim 1, wherein the device further comprises a mechanism for applying pressure to the skin of the wearer subsequent to insertion of the at least one skin-penetration member.

56. The device of claim 1, wherein the at least one skin-penetration member comprises an inner bore, the device further comprising a vacuum device for applying a vacuum to the inner bore while the at least one skin-penetration member is extended into the skin of the wearer.

57. The device of claim 56, wherein the vacuum device is applying a reversible so that a positive pressure may be applied to the inner bore while the at least one skin-penetration member is extended into the skin of the wearer.

58. The device of claim 56, wherein the vacuum device is capable of applying a variable vacuum so as to produce a pulsation in vacuum pressure applied to the inner bore.

59. The device of claim 56, wherein the vacuum device is capable of applying a vacuum of approximately 0.18-0.25 psi.

60. The device of claim 56, wherein the means for applying a vacuum comprises an electroacoustic device.

61. The device of claim 56, further comprising a mechanism for desensitizing wearer prior to inserting the at least one skin-penetration member.

62. The device of claim 1, further comprising a skin sensor.

63. The device of claim 62, wherein the skin sensor measures electrical parameters of the needle.

64. The device of claim 63, wherein the skin sensor comprises an electronic circuit operable to detect when the at least one skin-penetration member contacts the surface of the skin.

65. The device of claim 1, wherein the housing allows the at least one skin-penetration member to be extended from the device of a non-orthogonal angle relative to a surface of the skin into which it is inserted.

66. The device of claim 65, wherein the non-orthogonal angle is approximately 10-40°

.

35. A device for extracting body fluid, the device comprising:

at least one skin-penetration member having an inner bore and an outer diameter; and

at least one axially moveable hollow tubular member disposed in the inner bore.

67. A body fluid sampling device comprising:

at least one skin-penetration member;

an actuator for extending and/or retracting the at least one skin-penetration member;

a controller for controlling the actuator;

a housing for mounting the at least one skin-penetration member and the actuator; and

a skin sensor measuring electrical parameters transmitted through the at least one skin-penetration member.

70. The device of claim 67, wherein the housing allows the at least one skin-penetration member to be extended from the device of a non-orthogonal angle relative to a surface of the skin into which it is inserted.

71. The device of claim 70, wherein the non-orthogonal angle is approximately 10-40°

.

68. The device of clam 67, further comprising:

a base; and

a frame, the actuation means mounted to the frame, and the frame pivotably connected to the base.

69. The device of claim 68, wherein the base comprises a guide member operable to guide the at least one skin-penetration member as it is extended therethrough by the actuation means.

72. A method of extracting a sample of body fluid, the method comprising:

(i) inserting at least one skin-penetration member a predetermined distance into the skin at a sampling site;

(ii) at least partially retracting the at least one skin-penetration member back from the predetermined distance; and

(iii) withdrawing a sample of body fluid form the sampling site.

73. The method of claim 72, wherein the sample comprises at least one of blood and interstitial fluid.

74. The method of claim 72, wherein the at least one skin-penetration member comprises a lancet.

75. The method of claim 72, wherein the at least one skin-penetration member comprises a microneedle.

76. The method of claim 72, wherein step (i) comprises inserting the at least one skin-penetration member at an angle of 10°

-40°

relative to the surface of the skin.

77. The method of claim 72, wherein step (ii) comprises retracting the at least one skin-penetration member to an extent such that the member is still located beneath the surface of the skin.

78. The method of claim 72, wherein step (ii) comprises retracting the at least one skin-penetration member to an extent such that the member is completely withdrawn from the skin.

79. The method of claim 77, wherein step (iii) comprises withdrawing the sample from beneath the surface of the skin.

80. The method of claim 78, wherein step (iii) comprises withdrawing the sample off the surface of the skin.

81. The method of claim 72, wherein the at least one skin-penetration member comprises at least one microneedle.

82. The method of claim 72, wherein step (iii) comprises withdrawing the sample through an inner bore of the skin-penetration member.

83. The method of claim 72, wherein step (iii) comprises withdrawing the sample, at least in part, by capillary action.

84. The method of claim 72, wherein step (iii) comprises withdrawing the sample, at least in part, by vacuum pressure.

85. The method of claim 72, wherein at least one of steps (i) and (ii) further comprise:

rotating;

reciprocating; and

/or angularly articulating the at least one skin-penetration member.

86. The method of claim 72, wherein the at least one skin-penetration member comprises a needle having an inner bore, and step (iii) further comprises axially extending a hollow tubular member from the inner bore of the needle, and withdrawing the sample through the hollow tubular member.

87. The method of claim 72, wherein at least one of steps (i) and (ii) comprises sensing the depth of penetration and/or distance of retraction of the at least one skin-penetration member.