Method and apparatus for obtaining blood for diagnostic tests

• US 6,063,039 A
• Filed: 12/06/1996
• Issued: 05/16/2000
• Est. Priority Date: 12/06/1996
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Henning, Timothy P., Shain, Eric B., Young, Douglas F., Cunningham, David D.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/759,698
• Time in Patent Office: 1,257 Days
• Field of Search: 600/562, 600/573, 600/583, 600/584, 600/578, 600/579, 604/317, 604/318
• US Class Current: 600/573
• 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 5/150099 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 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Abstract

Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:

(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and

(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.

In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:

(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and

(b) a vacuum pump.

Preferably, the apparatus also includes a housing.

Claims

1. A method for obtaining a sample of blood for a diagnostic test, said method comprising the steps of:

(a) forming an unobstructed opening in an area of skin from which said sample is to be extracted;

(b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of (1) a vacuum generated by a pump capable of being switched on and off to maintain a desired level of vacuum and (2) stretching of the skin, whereby sufficient blood is collected for said diagnostic test, further comprising the step of increasing the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

2. The method of claim 1, wherein said diagnostic test is a test to determine the concentration of glucose in blood.

3. The method of claim 1, wherein a vacuum is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

4. The method of claim 3, wherein stretching is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

5. The method of claim 1, wherein heat is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

6. The method of claim 5, wherein heat is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

7. The method of claim 1, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a lancet.

8. The method of claim 7, wherein said lancet penetrates said skin to a depth of no more than 1.6 mm.

9. The method of claim 1, wherein said extracted sample is analyzed by means of a glucose detector.

10. The method of claim 9, wherein said glucose detector employs a reflectometer.

11. The method of claim 9, wherein said glucose detector employs a biosensor.

12. The method of claim 1, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a laser.

13. The method of claim 1, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a fluid jet.

14. The method of claim 1, wherein said blood is obtained from a forearm.

16. The method of claim 1, wherein said blood is obtained at a pain level lower than that experienced when a finger is pierced by a standard finger lancet.

15. A method for obtaining a sample of blood for a diagnostic test, said method comprising the steps of:

(a) forming an unobstructed opening in an area of skin from which said sample is to be extracted;

(b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of (1) a vacuum generated by a pump capable of being switched on and off to maintain a desired level of vacuum and (2) stretching of the skin, whereby sufficient blood is collected for said diagnostic test, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a lancet, wherein said lancet is cocked by means of a vacuum.

17. A method for obtaining a sample of blood for a diagnostic test, said method comprising the steps of:

(a) forming an unobstructed opening in an area of skin from which said sample is to be extracted;

(b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of (1) a vacuum generated by a pump capable of being switched on and off to maintain a desired level of vacuum and (2) stretching of the skin, whereby sufficient blood is collected for said diagnostic test, wherein said lancet is triggered by means of a vacuum.

18. An apparatus suitable for obtaining a sample of blood for analysis in a diagnostic test, said apparatus comprising:

(a) a housing;

(b) a device for forming an unobstructed opening in an area of skin from which the sample is to be extracted; and

(c) a vacuum generated by a pump for extracting said sample from said unobstructed opening in said area of said skin, said housing further containing electronics having programmed instructions to switch the pump on and off to maintain a desired level of vacuum.

19. The apparatus of claim 18, further including a housing.

20. The apparatus of claim 18, wherein said device for forming said unobstructed opening comprises a lancet disposed in a lancing assembly.

21. The apparatus of claim 20, wherein said lancing assembly comprises a nosepiece having a seal, whereby a vacuum can be formed through the lancing assembly by said vacuum pump.

22. The apparatus of claim 21, wherein said vacuum is applied by a fixture having a major dimension ranging from about 2 mm to about 10 mm.

23. The apparatus of claim 18, wherein said lancet is capable of being retracted after it forms said unobstructed opening in said skin.

24. The apparatus of claim 18, wherein said device for forming said unobstructed opening is a laser.

25. The apparatus of claim 18, wherein said device for forming said unobstructed opening is a fluid jet.

26. The apparatus of claim 18, further comprising a heating element.

27. The apparatus of claim 18, further comprising a glucose detector.

28. The apparatus of claim 27, wherein said glucose detector is a biosensor.

29. The apparatus of claim 27, wherein said glucose detector is a reflectometer.

30. A method for obtaining a sample of blood for a diagnostic test, said method comprising the steps of:

(a) forming an unobstructed opening in an area of skin from which said sample is to be extracted;

(b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of (1) a vacuum generated by a pump operated to maintain a desired level of vacuum and (2) stretching of the skin, whereby sufficient blood is collected for said diagnostic test, further comprising the step of increasing the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

31. The method of claim 30, wherein said diagnostic test is a test to determine the concentration of glucose in blood.

32. The method of claim 30, wherein a vacuum is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

33. The method of claim 32, wherein stretching is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

34. The method of claim 30, wherein heat is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

35. The method of claim 34, wherein heat is used to increase the availability of blood to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

36. The method of claim 30, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a lancet.

37. The method of claim 36, wherein said lancet penetrates said skin to a depth of no more than 1.6 mm.

38. The method of claim 30, wherein said extracted sample is analyzed by means of a glucose detector.

39. The method of claim 38, wherein said glucose detector employs a reflectometer.

40. The method of claim 38, wherein said glucose detector employs a biosensor.

41. The method of claim 30, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a laser.

42. The method of claim 30, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a fluid jet.

43. The method of claim 30, wherein said blood is obtained from a forearm.

44. The method of claim 30, wherein said blood is obtained at a pain level lower than that experienced when a finger is pierced by a standard finger lancet.

45. A method for obtaining a sample of blood for a diagnostic test, said method comprising the steps of:

(a) forming an unobstructed opening in an area of skin from which said sample is to be extracted;

(b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of (1) a vacuum generated by a pump operated to maintain a desired level of vacuum and (2) stretching of the skin, whereby sufficient blood is collected for said diagnostic test, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a lancet, wherein said lancet is cocked by means of a vacuum.

46. A method for obtaining a sample of blood for a diagnostic test, said method comprising the steps of:

(a) forming an unobstructed opening in an area of skin from which said sample is to be extracted;

(b) extracting said sample from said unobstructed opening in said area of said skin, with the aid of (1) a vacuum generated by a pump operated to maintain a desired level of vacuum and (2) stretching of the skin, whereby sufficient blood is collected for said diagnostic test, wherein said lancet is triggered by means of a vacuum.

47. An apparatus suitable for obtaining a sample of blood through an area of skin for analysis in a diagnostic test, said apparatus comprising:

(a) a device for forming an unobstructed opening in said area of said skin through which the sample is to be extracted;

(b) a pump for generating a vacuum for extracting said sample from said unobstructed opening in said area of said skin, and

(c) means for controlling said pump, wherein said means for controlling said pump operates said pump to maintain said vacuum at a specified level.

48. The apparatus of claim 47, further including a housing.

49. The apparatus of claim 47, wherein said device for forming said unobstructed opening comprises a lancet disposed in a lancing assembly.

50. The apparatus of claim 49, wherein said lancing assembly comprises a nosepiece having a seal, whereby a vacuum can be formed through the lancing assembly by said vacuum pump.

51. The apparatus of claim 50, wherein said vacuum is applied by a fixture having a major dimension ranging from about 2 mm to about 10 mm.

52. The apparatus of claim 47, wherein said lancet is capable of being retracted after it forms said unobstructed opening in said skin.

53. The apparatus of claim 47, wherein said device for forming said unobstructed opening is a laser.

54. The apparatus of claim 47, wherein said device for forming said unobstructed opening is a fluid jet.

55. The apparatus of claim 47, further comprising a heating element.

56. The apparatus of claim 47, further comprising a glucose detector.

57. The apparatus of claim 56, wherein said glucose detector is a biosensor.

58. The apparatus of claim 56, wherein said glucose detector is a reflectometer.