Integrated lancet and bodily fluid sensor

• US 20040064068A1
• Filed: 09/30/2002
• Published: 04/01/2004
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Karl, Frederick, Chelak, Todd M., West, Robert E., DeNuzzio, John D., Allen, William, Stewart, Bill, Palmer, Phyllis, Keith, Steven, Monahan, Lawrence A., Griswold, Lee
• Granted Patent: US 7,192,405 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150725 removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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
• CPC Class Codes: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A lancing device integrated with a sensing strip and method of making and using the same are provided. A lance and analyte sensing strip are combined in a single, preferably disposable, device. In a preferred embodiment, a slot is provided in a support member so the lance can be engaged by a lance driver and driven into the skin producing a bodily fluid sample from a wound. The sensing area of the sensing strip is adjacent to the wound location reducing dexterity requirements for patients.

Claims

1. A bodily fluid sample acquisition and testing device comprising:

a lancet adapted to be engaged by a lancing device;

a bodily fluid chemistry sensing strip comprising a sensing area; and

a primary support member adapted to fixedly engage said sensing strip, and to slidably engage said lance, said primary support member adapted to allow said lance to slide between an unexposed position and an exposed position.

2. The bodily fluid sample acquisition and testing device of claim 1, wherein said sensing area is in electrical contact with two electrodes.

3. The bodily fluid sample acquisition and testing device of claim 1, wherein said primary support member comprises a slot, said slot adapted to allow contact between said lance and said lancing device, said lancing device being adapted to slide said lance in the direction of said slot.

4. The bodily fluid sample acquisition and testing device of claim 1, wherein said sensing area is adjacent to said exposed position of said lance.

5. A bodily fluid sample acquisition and testing device as in claim 1, wherein said sensing strip comprises a wick.

6. A bodily fluid sample acquisition and testing device as in claim 1, wherein said sensing strip comprises a notch.

7. A bodily fluid sample acquisition and testing device as in claim 1, wherein said primary support member comprises a notch.

8. A bodily fluid sample acquisition and testing device as in claim 1, wherein said sensing strip is adapted to sense bodily fluid having a volume less than one microliter.

9. A bodily fluid sample acquisition and testing device as in claim 1, wherein said sensing strip is adapted to sense bodily fluid having a volume less than one half micro liter.

10. A cartridge comprising a plurality of bodily fluid sample acquisition and testing devices, each of said acquisition and testing devices comprising:

a lancet adapted to be engaged by a lancing device;

a bodily fluid chemistry sensing strip comprising a sensing area; and

a primary support member adapted to fixedly engage said sensing strip, and to slidably engage said lance, said primary support member adapted to allow said lance to slide between an unexposed position and an exposed position.

11. The cartridge of claim 10, wherein said sensing area is in electrical contact with two electrodes.

12. The cartridge of claim 10, wherein said primary support member comprises a slot, said slot being adapted to allow contact between said lance and said lancing device, said lancing device adapted to slide said lance in the direction of said slot.

13. A cartridge as in claim 10, wherein said sensing area is adjacent to said exposed position of said lance.

14. A cartridge as in claim 10, wherein said sensing strip comprises a wick.

15. A cartridge as in claim 10, wherein said sensing strip comprises a notch.

16. A cartridge as in claim 10, wherein said primary support member comprises a notch.

17. A cartridge as in claim 10, wherein said sensing strip is adapted to sense bodily fluid having a volume less than one microliter.

18. A cartridge as in claim 10, wherein said sensing strip is adapted to sense bodily fluid having a volume less than one half microliter.

19. A cartridge as in claim 10, further comprising a spring adapted to retain said plurality of acquisition and testing devices against a proximal end of said cartridge.

20. A cartridge as in claim 19, further comprising a first slot aligned with a proximal one of said plurality of acquisition and testing devices.

21. A cartridge as in claim 20, further comprising a second slot aligned with a proximal one of said plurality of acquisition and testing devices, wherein said first slot is further aligned with said slot is said proximal one of said plurality of acquisition and testing devices, and said second slot is adapted to permit said proximal one of said plurality of acquisition and testing devices to be ejected from said cartridge.

22. A bodily fluid sample acquisition and testing device comprising:

a lancet adapted to be engaged by a lancing device; and

a primary support member adapted to fixedly engage a bodily fluid chemisry sensing strip, and to slidably engage said lance, said primary support member adapted to allow said lance to slide between an unexposed position and an exposed position.

23. The bodily fluid sample acquisition and testing device of claim 22, wherein said primary support member further comprises a slot adapted to allow contact between said lance and said lancing device, said lancing device adapted to slide said lance in the direction of said slot

24. A method of manufacturing a bodily fluid sample acquisition and testing device, comprising the steps of:

inserting a lance into a primary support member having a slot for accessing said lance, sterilizing said primary support member and lance; and

after sterilizing said primary support member and lance, inserting a bodily fluid chemistry sensing strip comprising a sensing area into said primary support member such that said sensing area is adjacent to said lance.

25. The method of claim 24, wherein said sensing area is in electrical contact with two electrodes.

26. The method of claim 24, wherein said sterilization step comprises radiating said primary support member and lance with an electron beam.

27. The method of claim 24, wherein said sterilization step comprises radiating said primary support member and lance with gamma radiation.

28. A bodily fluid sample acquisition and testing device comprising:

a primary support member having a bodily fluid chemistry sensing strip attached thereto, said sensing strip comprising a sensing area in proximity to a sensing end of said primary support member;

a cantilever member comprising a first end hinged to said support member;

a lancing member comprising a lancet support member and a lancet having a pointed end attached to said lancet support member, said lancet support member being hinged to a second end of said cantilever member;

said primary support member, cantilever member, and lancing member adapted to adopt a first orientation being substantially coplanar, and to adopt a second orientation with said lancing member defining an angle with said primary support member such that said pointed end of said lance is adjacent to said sensing area of said sensing strip.

29. The bodily fluid sample acquisition and testing device of claim 28, wherein said sensing area is in electrical communication with two electrodes.

30. The bodily fluid sample acquisition and testing device of claim 28, wherein said primary support member has a substantially flat orientation.

31. The bodily fluid sample acquisition and testing device of claim 28, wherein said lancet is slidably attached to said lancet support member such that said lancet is adapted to be inserted into and withdrawn from a patient'"'"'s skin.

32. The bodily fluid sample acquisition and testing device of claim 28, wherein said angle is a right angle.

33. The bodily fluid sample acquisition and testing device of claim 28, wherein said angle is an acute angle.

34. The bodily fluid sample acquisition and testing device of claim 28, wherein said primary support member has a first surface defining a plane, and wherein said device further comprises a lancer adapted to engage said lancet in said second orientation, and to drive said lancet past said plane into a patient'"'"'s skin.

35. A cartridge comprising a plurality of bodily fluid sample acquisition and testing devices, each of said devices comprising:

a primary support member having a bodily fluid chemistry sensing strip attached thereto, said sensing strip comprising a sensing area in proximity to a sensing end of said primary support member;

a cantilever member comprising a first end hinged to said support member;

a lancing member comprising a lancet support member and a lancet having a pointed end attached to said lancet support member, said lancet support member being hinged to a second end of said cantilever member;

said primary support member, cantilever member, and lancing member adapted to adopt a first orientation being substantially coplanar, and to adopt a second orientation with said lancing member defining an angle with said primary support member such that said pointed end of said lance is adjacent to said sensing area of said sensing strip.

36. The cartridge of claim 35, wherein said sensing area is in electrical communication with two electrodes.

37. The cartridge of claim 35, wherein said primary support member has a substantially flat orientation.

38. The cartridge of claim 35, wherein said lancet is slidably attached to said lancet support member such that said lancet is adapted to be inserted into and withdrawn from a patient'"'"'s skin.

39. The cartridge of claim 35, wherein said angle is a right angle.

40. The cartridge of claim 35, wherein said angle is an acute angle.

41. The cartridge of claim 35, wherein said primary support member has a first surface defining a plane, and wherein said device further comprises a lancer adapted to engage said lancet in said second orientation, and to drive said lancet past said plane into a patient'"'"'s skin.

42. A cartridge as in claim 35, further comprising a spring adapted to retain said plurality of acquisition and testing devices against a proximal end of said cartridge.

43. A cartridge as in claim 35, further comprising a slot aligned with a proximal one of said plurality of acquisition and testing devices, and adapted to permit said proximal one of said plurality of acquisition and testing devices to be ejected from said cartridge.

44. A bodily fluid sample acquisition and testing device comprising:

a primary support member adapted to engage a bodily fluid chemistry sensing strip, said sensing strip comprising a sensing area in proximity to a sensing end of said primary support member;

a cantilever member comprising a first end hinged to said support member;

a lancing member comprising a lancet support member and a lancet having a pointed end attached to said lancet support member, said lancet support member being hinged to a second end of said cantilever member;

said primary support member, cantilever member, and lancing member adapted to adopt a first orientation being substantially coplanar, and to adopt a second orientation with said lancing member defining an angle with said primary support member such that said pointed end of said lance is adjacent to said sensing area of said sensing strip.

45. The bodily fluid sample acquisition and testing device of claim 44, wherein said sensing area is in electrical communication with two electrodes.

46. A bodily fluid sample acquisition and testing device comprising:

a primary support member enclosing a lancet and a bodily fluid chemistry sensing strip, said primary support member having a first port adapted to allow a point of said lancet to extend out of said primary support member and a second port adjacent to said first port in fluid communication with a sensing end of said sensing strip; and

a primary support member holding mechanism adapted to drive said lancet point out of said first port, retract said lancet, and move said primary support member to align said second port with a wound created by said lancet.

47. The bodily fluid sample acquisition and testing device of claim 46, further comprising:

a first spring adapted to drive said lancet into the skin of a patient;

a pushbutton adapted to release said lancet; and

a second spring adapted to realign said primary support member after said lancet is withdrawn from said patient.

48. The bodily fluid sample acquisition and testing device of claim 46, further comprising a wick in fluid communication with said sensing strip.

49. The bodily fluid sample acquisition and testing device of claim 46, wherein said primary support member holding mechanism is further adapted to move said primary support member after a fluid droplet has formed at said wound, said fluid droplet having attained a minimum volume of 0.25 μ

l.

50. A bodily fluid sample acquisition and testing device comprising:

a primary support member enclosing a lancet and adapted to engage a bodily fluid chemistry sensing strip, said primary support member having a first port adapted to allow a point of said lancet to extend out of said primary support member and a second port adjacent to said first port in fluid communication with a sensing end of said sensing strip; and

a primary support member holding mechanism adapted to drive said lancet point out of said first port, retract said lancet, and move said primary support member to align said second port with a wound created by said lancet.

51. A cartridge comprising a plurality of bodily fluid sample acquisition and testing devices, each of said devices comprising:

a primary support member enclosing a lancet and a bodily fluid chemistry sensing strip, said primary support member having a first port adapted to allow a point of said lancet to extend out of said primary support member and a second port adjacent to said first port in fluid communication with a sensing end of said sensing strip; and

a primary support member holding mechanism adapted to drive said lancet point out of said first port, retract said lancet, and move said primary support member to align said second port with a wound created by said lancet.

52. The cartridge of claim 51, further comprising:

a first spring adapted to drive said lancet into the skin of a patient;

a pushbutton adapted to release said lancet; and

a second spring adapted to realign said primary support member after said lancet is withdrawn from said patient.

53. The cartridge of claim 51, further comprising a wick in fluid communication with said sensing strip.

54. The cartridge of claim 51, further comprising a spring adapted to retain said plurality of acquisition and testing devices against a proximal end of said cartridge.

55. The cartridge of claim 51, further comprising a first slot aligned with a proximal one of said plurality of acquisition and testing devices.

56. The cartridge of claim 55, further comprising a second slot aligned with a proximal one of said plurality of acquisition and testing devices, wherein said first slot is further aligned with said slot is said proximal one of said plurality of acquisition and testing devices, and said second slot is adapted to permit said proximal one of said plurality of acquisition and testing devices to be ejected from said cartridge.

57. The cartridge of claim 51, further comprising a wick in fluid communication with said sensing strip.

58. A method of obtaining and testing a bodily fluid sample comprising the steps of:

inserting a testing cartridge into a testing device, said testing cartridge comprising at least one sensing strip adjacent to a lancet;

driving said lancet into the skin of a patient to cause a wound;

retracting said lancet from said patient; and

moving said cartridge so that said sensing strip is aligned with said wound.

59. The method of claim 58, further comprising the steps of:

drawing bodily fluid from said wound into said sensing strip;

applying a voltage across said sensing strip; and

measuring a current through said sensing strip.

60. The method of claim 59, wherein said bodily fluid comprises less than one microliter.

61. The method of claim 59, wherein said bodily fluid comprises less than one-half micro liter.

62. The method of claim 58, further comprising the steps of:

drawing bodily fluid from said wound into said sensing strip;

applying a current through said sensing strip; and

measuring a voltage across said sensing strip.

63. A bodily fluid sample acquisition and testing device comprising:

a lance; and

a primary support member comprising a first slot adapted to engage a bodily fluid chemistry sensing strip, said strip comprising a sensing area;

said primary support member further comprising a second slot, said second slot being substantially parallel to said first slot, said second slot adapted to allow contact between said lance and a lance driver adapted to engage said lance to provide slidable translation of said lance between an unexposed position and an exposed position;

wherein said bodily fluid chemistry sensing strip is adjacent to said exposed position of said lance.

64. The bodily fluid sample acquisition and testing device of claim 63, wherein said sensing area is in electrical contact with at least two electrodes.

65. The device of claim 63, wherein said primary support member has a substantially flat orientation.

66. A bodily fluid sample acquisition and testing device comprising:

a lance; and

a primary support member comprising a first slot adapted to engage a bodily fluid chemistry sensing strip, said sensing strip comprising a sensing area;

said primary support member further comprising a second slot, said second slot being substantially parallel to said first slot, said second slot adapted to allow contact between said lance and a lance driver adapted to engage said lance to provide slidable translation of said lance between an unexposed position and an exposed position;

wherein said bodily fluid chemistry sensing strip is adjacent to a wound produced by said lance in said exposed position.

67. The device of claim 66, wherein said sensing area is in electrical contact with at least two electrodes.

68. The device of claim 66, wherein said primary support member has a substantially flat orientation.

69. A method of obtaining a bodily fluid sample for testing, comprising the steps of:

inserting at least one bodily fluid chemistry sensing strip into a primary support member having a first slot adapted to receive said bodily fluid chemistry sensing strip;

said strip comprising a sensing area;

said primary support member further comprising a second slot adapted to receive at least one lance;

said lance adapted to be engaged by a lance driver;

placing said primary support member against skin; and

activating said lance driver to traverse said lance into said skin to provide a bodily fluid sample.

70. The method of claim 69, wherein said sensing area is in electrical contact with at least two electrodes.

71. The method of claim 69 further comprising the step of positioning said bodily fluid chemistry sensing strip adjacent said bodily fluid sample to cause said sample to flow to said sensing area.