Method and apparatus for obtaining blood for diagnostic tests

• US 6,071,249 A
• Filed: 12/02/1997
• Issued: 06/06/2000
• Est. Priority Date: 12/06/1996
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Graham, Hugh W., Henning, Timothy P., Lowery, Michael G., Shain, Eric B., Young, Douglas F., Cunningham, David D.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/982,324
• Time in Patent Office: 917 Days
• Field of Search: 600/584, 600/583, 600/578, 606/181
• US Class Current: 600/578
• 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 5/14532 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 5/150076 by heating
• 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 5/150358 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 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• 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 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• 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: 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.

It has also been discovered that an improved design and construction of the nosepiece can provide enhanced collection of blood from the unobstructed opening in the skin. It has been discovered that by controlling the construction of the interior cavity of the nosepiece, collection of blood can be improved.

Claims

1. A nosepiece suitable for use with a vacuum aided blood vacuum aided collection apparatus, said nosepiece comprising:

(a) a lower base having an opening therein;

(b) an upper base having an opening therein;

(c) an interior wall joining said upper base and said lower base, the area of said opening in said upper base being less than the area of said opening in said lower base; and

(d) a seal attached to said lower base of said nosepiece, the distance between the lowermost point of said seal and the lowermost point of said upper base be such that skin, when stretched into said nosepiece, comes as close as possible to said upper base or contacts said upper base.

2. The nosepiece of claim 1, further including at least one passageway for vacuum.

3. The nosepiece of claim 1, wherein said opening in said upper base is circular in shape.

4. The nosepiece of claim 1, wherein said opening in said upper base is oval in shape.

5. The nosepiece of claim 1, wherein said interior wall is tapered.

6. The nosepiece of claim 1, wherein said interior wall is comprised of stepwise cylindrical sections.

8. The nosepiece of claim 1, further including a seal attached to said lower base of said nosepiece.

9. The nosepiece of claim 8, wherein said seal is in the form of an annular ring.

11. The nosepiece of claim 8, wherein said seal is formed from rubber or an elastomeric material.

12. The nosepiece of claim 8, wherein said seal is formed from an adhesive.

13. The nosepiece of claim 1, wherein the ratio of the diameter of the opening in the lower base to the diameter of the opening in the upper base is at least about 3 to 1.

14. The nosepiece of claim 1, wherein the distance between the lowermost point of said seal and the lowermost point of said upper base ranges from about 1.5 mm to about 8.0 mm.

7. A nosepiece suitable for use with a vacuum aided blood collection apparatus, said nosepiece comprising:

(a) a lower base having an opening therein;

(b) an upper base having an opening therein;

(c) an interior wall joining said upper base and said lower base, the area of said opening in said upper base being less than the area of said opening in said lower base, wherein said opening in said upper base is surrounded by a rim; and

(d) a seal attached to said lower base of said nosepiece, the distance between the lowermost point of said seal and the lowermost point of said rim be such that skin, when stretched into said nosepiece, comes as close as possible to said rim or contacts said rim.

15. The nosepiece of claim 7, further including at least one passageway for vacuum.

16. The nosepiece of claim 7, wherein said opening in said upper base is circular in shape.

17. The nosepiece of claim 7, wherein said opening in said upper base is oval in shape.

18. The nosepiece of claim 7, wherein said interior wall is tapered.

19. The nosepiece of claim 7, wherein said interior wall is comprised of stepwise cylindrical sections.

20. The nosepiece of claim 7, wherein said seal is in the form of an annular ring.

21. The nosepiece of claim 7, wherein said seal is formed from rubber or an elastomeric material.

22. The nosepiece of claim 7, wherein said seal is formed from an adhesive.

23. The nosepiece of claim 7, wherein the ratio of the diameter of the opening in the lower base to the diameter of the opening in the upper base is at least about 3 to 1.

24. The nosepiece of claim 7, wherein the distance between the lowermost point of said seal and the lowermost point of said rim ranges from about 1.5 mm to about 8.0 mm.

10. A nosepiece suitable for use with a vacuum aided blood collection apparatus, said nosepiece comprising:

(a) a lower base having an opening therein;

(b) an upper base having an opening therein; and

(c) an interior wall joining said upper base and said lower base, the area of said opening in said upper base being less than the area of said opening in said lower base, further including a seal attached to said lower base of said nosepiece, wherein said seal is capable of moving between a first position and a second position.

25. The nosepiece of claim 10, further including at least one passageway for vacuum.

26. The nosepiece of claim 10, wherein said opening in said upper base is circular in shape.

27. The nosepiece of claim 10, wherein said opening in said upper base is oval in shape.

28. The nosepiece of claim 10, wherein said interior wall is tapered.

29. The nosepiece of claim 10, wherein said interior wall is comprised of stepwise cylindrical sections.

30. The nosepiece of claim 10, wherein said seal is formed from rubber or an elastomeric material.

31. The nosepiece of claim 10, wherein said seal is formed from an adhesive.

32. The nosepiece of claim 10, wherein the ratio of the diameter of the opening in the lower base to the diameter of the opening in the upper base is at least about 3 to 1.