Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein

• US 20060036187A1
• Filed: 06/30/2004
• Published: 02/16/2006
• Est. Priority Date: 06/30/2004
• Status: Abandoned Application

• Current Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Hilgers, Michael, Hanson, Cass A., Stout, Phil, Mechelke, Joel, Racchini, Joel, Rademacher, Thomas, Kaar, Simon G., Wehrheim, Frank, Vos, Hester
• Application Number:
  US10/882,994
• Publication Number:
  US 20060036187A1
• Time in Patent Office: Days
• US Class Current: 600/576
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150083 by vibration, e.g. ultrasound
• 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 5/150412 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 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• 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

Abstract

Systems and methods are provided for extracting a bodily fluid sample (e.g., an interstitial fluid sample) and monitoring an analyte therein. Certain of the systems include a a penetration member configured for penetrating and residing in a target site of a user'"'"'s skin layer and, subsequently, extracting a fluid sample therefrom. The system also includes a pressure ring(s) adapted for applying pressure to the user'"'"'s skin layer in the vicinity of the target site. The system is configured such that the pressure ring(s) is capable of applying pressure in an oscillating manner. Certain methods include penetrating the skin and applying pressure to the skin in an oscillating manner.

Claims

1. A system for extracting bodily fluid from the skin, the system comprising:

a penetration member configured for penetrating a target site in the skin and accessing bodily fluid therein; and

means for applying pressure to the skin in an oscillating manner, the pressure application means extending substantially concentrically about the penetration member.

2. The system of claim 1 wherein an oscillation frequency of the pressure ring comprises applying a greater amount of pressure for a first time period and subsequently applying a lesser amount of pressure for a second time period.

3. The system of claim 2 wherein the first period of time is the same as the second period of time.

4. The system of claim 2 wherein the first period of time is different than the second period of time.

5. The system of claim 4 wherein the first period of time is longer than the second period of time.

6. The system of claim 4 wherein the first period of time is shorter than the second period of time.

7. The system of claim 2 wherein the lesser amount of pressure is the complete removal of pressure.

8. The system of claim 1 wherein the pressure application means comprises one or more concentrically positioned pressure rings.

9. The system of claim 1 wherein the pressure application means is configured to apply a pressure in the range from about 0.1 to about 150 pounds per square inch to the skin.

10. The system of claim 2 wherein the first period of time is in the range from about 3 seconds to about 3 hours and the second period of time is in the range from about 3 seconds to about 3 hours.

11. The system of claim 1 wherein the penetration member is configured to reside in the user'"'"'s skin layer for a period of at least about 1 hour.

12. The system of claim 1 wherein the bodily fluid is interstitial fluid.

13. A method for extracting bodily fluid from the skin, the method comprising;

penetrating a target site in the skin and accessing bodily fluid therein; and

applying pressure to the skin in an oscillating manner substantially concentrically about the target site wherein extraction of fluid from the skin is facilitated.

14. The method of claim 13 wherein the pressure is applied at an oscillation frequency comprising applying a greater amount of pressure for a first time period and subsequently applying a lesser amount of pressure for a second time period.

15. The system of claim 14 wherein the first time period is the same as the second time period.

16. The system of claim 14 wherein the first time period is different than the second time period.

17. The system of claim 16 wherein the first time period is longer than the second time period.

18. The system of claim 16 wherein the first time period is shorter than the second time period.

19. The system of claim 14 wherein the applying the lesser amount of pressure comprises applying no pressure.

20. The system of claim 13 wherein the applying pressure application comprises applying one or more concentrically positioned pressure rings to the skin.

21. The system of claim 13 wherein the pressure applied is in the range from about 0.1 to about 150 pounds per square inch to the skin.

22. The system of claim 14 wherein the first period of time is in the range from about 3 seconds to about 3 hours and the second period of time is in the range from about 3 seconds to about 3 hours.

23. The system of claim 13 wherein the skin is penetrated for a period of at least about 1 hour.

24. The system of claim 13 wherein the bodily fluid is interstitial fluid.

25. A system for extracting bodily fluid from skin and monitoring at least one analyte therein, the system comprising:

a penetration member configured for penetrating a target site within the skin and extracting fluid therefrom;

at least one pressure ring adapted for applying pressure in an oscillating manner to the skin layer in the vicinity of the target site about the penetration member;

means for measuring the at least one analyte in bodily fluid extracted by the penetration member; and

means for controlling the oscillation frequency of the at least one pressure ring.

26. The system of claim 25 wherein the bodily fluid is interstitial fluid.

27. The system of claim 26 wherein the at least one analyte is glucose.

28. The system of claim 25 wherein the oscillation frequency is predetermined.

29. The system of claim 25 wherein the oscillation frequency is responsive to the fluid flow rate or volume being extracted.

30. A method for extracting bodily fluid from skin and monitoring at least one analyte therein, the method comprising:

penetrating a target site within the skin;

applying pressure in an oscillating manner to the skin in the vicinity of the target site;

extracting fluid from the skin; and

measuring the at least one analyte in the extracted fluid.

31. The method of claim 30 wherein pressure is applied at a frequency responsive to the flow rate or volume of the fluid extracted.

32. The system of claim 30 wherein pressure is applied at a predetermined frequency.

33. The system of claim 30 wherein the bodily fluid is interstitial fluid.

34. The system of claim 33 wherein the at least one analyte is glucose.

35. An interstitial fluid extraction device comprising:

a penetration member configured for penetrating a target site of a user'"'"'s skin layer and, subsequently, residing in the user'"'"'s skin layer and extracting an ISF sample therefrom;

a rotatable gear wheel; and

at least one pressure ring adapted for applying pressure to the user'"'"'s skin layer in the vicinity of the target site while the penetration member is residing in the user'"'"'s skin layer,

wherein the gear wheel is adapted to interact with the pressure ring such that rotation of the gear wheel in a first direction imparts translational motion to the pressure ring progressively towards the user'"'"'s skin layer allowing pressure to be applied to the user'"'"'s skin layer and rotation of the gear wheel in a second direction, opposite to the first direction, imparts translational motion to the pressure ring progressively away from the user'"'"'s skin layer.

36. The interstitial fluid extraction device of claim 35, wherein the gear wheel has at least one protrusion and the pressure ring has a helical groove thereon which is keyed to interface with the protrusion, whereby rotating the gear wheel imparts a linear motion onto the pressure ring.

37. The interstitial fluid extraction device of claim 35, wherein the pressure ring has at least one protrusion and the gear wheel has a helical groove thereon which is adapted to interface with the protrusion, whereby rotating the gear wheel imparts a linear motion onto the one pressure ring

38. The interstitial fluid extraction device of claim 36, wherein the protrusion is a pin fixedly mounted to the gear wheel.

39. The interstitial fluid extraction device of claim 37, wherein the protrusion is a pin fixedly mounted to the pressure ring.

40. The interstitial fluid extraction device of claim 35, wherein the gear wheel is a worm gear.

41. The interstitial fluid extraction device of claim 36, further comprises a worm wheel which is adapted to mechanically interface with the worm gear.

42. The interstitial fluid extraction device of claim 35, wherein the at least one pressure ring is slidingly adapted to the gear wheel.

43. The interstitial fluid extraction device of claim 35, further comprises a motor which is adapted to rotate the gear wheel.

44. The interstitial fluid extraction device of claim 35, further comprises an analysis module which is adapted to receive the ISF sample extracted.

45. The interstitial fluid extraction device of claim 35, wherein the extraction device is configured to be worn on the body.

46. The interstitial fluid extraction device of claim 35, wherein the interstitial fluid extraction device is configured such that the pressure ring is capable of applying the pressure in an oscillating manner wherein the pressure is applied for a time period in the range of three seconds to three hours, the pressure is subsequently removed for a time period in the range of three seconds to three hours and then the pressure is re-applied for a period in the range three seconds to three hours.

47. The interstitial fluid extraction device of claim 35, wherein the penetration member is configured to reside in the user'"'"'s skin layer for a period of at least 1 hour.

48. The interstitial fluid extraction device of claim 35, wherein the at least one pressure ring is a plurality of pressure rings.

49. The interstitial fluid extraction device of claim 35, wherein the pressure rings are arranged concentrically.

50. The interstitial fluid extraction device of claim 35, wherein the pressure ring is configured to apply a pressure in the range of 0.1 to 150 pounds per square inch to a user'"'"'s skin layer.

51. The interstitial fluid extraction device of claim 35, wherein an external lancing device interfaces with the ISF extraction device to launch the penetration member towards the user'"'"'s skin layer.

52. The interstitial fluid extraction device of claim 35, wherein a launching mechanism is in the extraction device.

53. The interstitial fluid extraction device of claim 35, wherein an analysis module is fluidically attached to the extraction device via a flexible conduit, whereby the analysis module does not oscillate between a retracted and a deployed state with the pressure ring.

54. The interstitial fluid extraction device of claim 35, wherein an analysis module is fluidically and rigidly attached to the extraction device, whereby the analysis module does oscillate between a retracted and a deployed state.

55. A method for extracting interstitial fluid from skin and monitoring at least one analyte therein, the method comprising:

providing the interstitial fluid extraction device of claim 35 comprising;

penetrating the skin with the penetration member;

translating the pressure ring towards the skin and maintaining contact with the skin for a first period of time; and

translating the pressure ring away from the skin and removing the pressure ring from contact with the skin for a second period of time; and

translating the pressure ring towards the skin and maintaining contact with the skin for a third period of time.