Method and apparatus for obtaining blood for diagnostic tests

• US 6,071,251 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: Henning, Timothy P., Lowery, Michael G., Shain, Eric B., Schapira, Thomas G., Young, Douglas F., Cunningham, David D.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/982,323
• Time in Patent Office: 917 Days
• Field of Search: 600/584, 600/573
• US Class Current: 600/584
• 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.

In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided. The article, which contains an appropriate detection element for determining the amount of analyte in the blood, can be used in conjunction with a meter that measures the signal generated by the detection element of the article. In one embodiment, the article is a multiple-layer element comprising:

(a) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking;

(b) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and

(c) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (a) capable of transporting blood to said layer (b).

Claims

1. A multiple-layer element comprising:

(a) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking;

(b) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and

(c) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (a) capable of transporting blood to said layer (b), wherein said meter-contactable layer has at least one opening therein.

2. The article of claim 1, wherein said blood-transporting layer comprises a mesh.

3. The article of claim 1, wherein said blood-transporting layer comprises a surfactant.

4. The article of claim 1, wherein said blood-transporting layer has at least one opening therein.

5. The article of claim 1, wherein said analyte-detecting layer detects analyte by means of an electrical measurement.

6. The article of claim 1, wherein said analyte-detecting layer detects analyte by means of an optical measurement.

7. The article of claim 1, wherein no more than two microliters of blood are required for analyte determination.

8. The article of claim 1, wherein no more than one microliter of blood is required for analyte determination.

9. The article of claim 1, wherein an overcoat layer is coated about the periphery of said blood-transporting layer.

10. The article of claim 1, wherein said blood-transporting layer is at least partially superimposed over said at least one opening.

11. The article of claim 10, wherein said blood-transporting layer is not superimposed over said at least one opening.

12. The article of claim 10, wherein said meter-contactable layer has at least two openings.

13. A multiple-layer article comprising:

(a) a covering layer having an opening therein;

(b) a layer, overlying the covering layer, capable of receiving blood through the opening in the covering layer and transporting blood by means of chemically aided wicking;

(c) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood transporting layer; and

(d) a layer capable of detecting the presence or analyte or measuring the amount of analyte in blood, which layer is disposed between the covering layer and the meter-contactable layer and is capable of receiving blood from the blood-transporting layer, wherein said meter-contactable layer has at least one opening therein.

14. The article of claim 13, wherein said blood-transporting layer is a mesh.

15. The article of claim 13, wherein said blood-transporting layer comprises a surfactant.

16. The article of claim 13, wherein said blood-transporting layer has at least one opening therein.

17. The article of claim 13, wherein said analyte-detecting layer detects analyte by means of an electrical measurement.

18. The article of claim 13, wherein said analyte-detecting layer detects analyte by means of an optical measurement.

19. The article of claim 13, wherein no more than two microliters of blood are required for analyte determination.

20. The article of claim 13, wherein no more than one microliter of blood is required for analyte determination.

21. The article of claim 13, wherein an overcoat layer is coated about the periphery of the blood-transporting layer.

22. The article of claim 13, wherein said blood-transporting layer is at least partially superimposed over said at least one opening.

23. The article of claim 13, wherein said blood-transporting layer is not superimposed over said at least one opening.

24. The article of claim 13, wherein said meter-contactable layer has at least two openings therein.

25. A multiple-layer article comprising:

(a) a covering layer;

(b) a layer, overlying said covering layer, that can be placed in contact with a meter; and

(c) a layer capable of detecting the presence of analyte or measures the amount of analyte in blood, which layer is disposed between said covering layer and said meter-contactable layer and is capable of receiving blood by means of capillary flow of blood between said covering layer and said meter-contactable layer, wherein said covering layer and said meter-contactable layer are spaced apart at a sufficient distance so that a capillary is formed between them, wherein said meter-contactable layer has at least one opening therein.

26. The article of claim 25, wherein an overcoat layer spaces said covering layer and said meter-contactable layer at a sufficient distance so that a capillary is formed between said covering layer and said meter-contactable layer.

27. The article of claim 25, wherein said analyte-detecting layer detects analyte by means of an electrical measurement.

28. The article of claim 25, wherein said analyte-detecting layer detects analyte by means of an optical measurement.

29. The article of claim 25, wherein no more than two microliters of blood are required for analyte determination.

30. The article of claim 25, wherein no more than one microliter of blood is required for analyte determination.

31. The article of claim 25, wherein said covering layer has an opening therein.