Method and apparatus for obtaining blood for diagnostic tests

• US 20010031931A1
• Filed: 03/22/2000
• Published: 10/18/2001
• Est. Priority Date: 12/06/1996
• Status: Active Grant

• Current Assignee: David D. Cunningham, Douglas F. Young, Eric B. Shan, Timothy P. Henning
• Original Assignee: David D. Cunningham, Douglas F. Young, Eric B. Shan, Timothy P. Henning
• Inventors: CUNNINGHAM, DAVID D., Shan, Eric B., Henning, Timothy P., Young, Douglas F.
• Granted Patent: US 6,283,926 B1
• Time in Patent Office: Days
• 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 vacuum and stretching of the skin.

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

, 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.

4. The method of

claim 3

, 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.

5. The method of

claim 4

, 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.

6. The method of

claim 3

, 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 6

, 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.

8. 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.

9. The method of

claim 8

, wherein said lancet is cocked by means of a vacuum.

10. The method of

claim 8

, wherein said lancet is triggered by means of a vacuum.

11. The method of

claim 1

, wherein said extracted sample is analyzed by means of a glucose detector.

12. The method of

claim 11

, wherein said glucose detector employs a reflectometer.

13. The method of

claim 11

, wherein said glucose detector employs a biosensor.

14. The method of

claim 8

, wherein said lancet penetrates said skin to a depth of no more than 1.6 mm.

15. 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.

16. 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.

17. The method of

claim 1

, wherein said blood is obtained from a forearm.

18. 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.

19. An apparatus for suitable for obtaining a sample of body fluid for analysis in a diagnostic test, said apparatus comprising:

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

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

20. The apparatus of

claim 19

, further including a housing.

21. The apparatus of

claim 19

, wherein said device for forming said unobstructed opening comprises a lancet disposed in a lancing assembly.

22. The apparatus of

claim 21

, wherein said lancing assembly comprises a nosepiece having a seal, whereby a vacuum can be formed through the lancing assembly by said vacuum pump.

23. The apparatus of

claim 19

wherein said lancet is capable of being retracted after it forms said unobstructed opening in said skin.

24. The apparatus of

claim 19

, wherein said device for forming said unobstructed opening is a laser.

25. The apparatus of

claim 19

wherein said device for forming said unobstructed opening is a fluid jet.

26. The apparatus of

claim 19

, further comprising a heating element.

27. The apparatus of

claim 19

, 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. The apparatus of

claim 22

, wherein said vacuum is applied by a fixture having a major dimension ranging from about 2 mm to about 10 mm.