Apparatus and method for obtaining blood for diagnostic tests

• US 6,506,168 B1
• Filed: 05/26/2000
• Issued: 01/14/2003
• Est. Priority Date: 05/26/2000
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Fathallah, Marwan A., Chambers, Geoffrey R.
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/579,906
• Time in Patent Office: 963 Days
• Field of Search: 600/573, 600/574, 600/575, 600/576, 600/577, 600/578, 600/579, 600/580, 600/581-84, 606/180, 606/181, 606/182
• US Class Current: 600/578
• 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 5/150076 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 5/150358 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 5/150801 Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
• 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 5/1519 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

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, an apparatus for carrying out the method described previously is provided. The apparatus comprises:

(a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with the sealable chamber;

(b) a vacuum pump in communication with the sealable chamber;

(c) a device for forming an unobstructed opening in an area of skin from which a sample is to be collected, preferably a lancing assembly, the device positioned within the sealable chamber;

(d) a movable support for supporting and positioning a port for a fluid collector in the sealable chamber, the movable support capable of moving the port within the sealable chamber between a first position and a second position; and

(e) a stop for aligning the fluid collector.

In another aspect of the invention, the method comprises a method for utilizing the aforementioned apparatus.

Claims

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

(a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with said sealable chamber;

(b) a vacuum pump in communication with said sealable chamber;

(c) a device for forming an unobstructed opening in an area of skin from which a sample is to be collected, said device positioned within said sealable chamber;

(d) a movable support for supporting and positioning a port for a fluid collector in said sealable chamber, said movable support capable of moving said port within said sealable chamber between a first position and a second position; and

(e) a stop for aligning said fluid collector.

2. The apparatus of claim 1, wherein said housing comprises:

(a) a body, and

(b) a cover, said cover positionable over said body and including said sealable opening.

3. The apparatus of claim 1, wherein said fluid collector is a test strip.

4. The apparatus of claim 3, wherein said test strip has an opening therein.

5. The apparatus of claim 1, wherein said stop (e) projects from said cover of said housing.

6. The apparatus of claim 1, wherein said movable support (d) supports a test strip port.

7. The apparatus of claim 6, wherein said test strip port is enclosed by a port shroud.

8. The apparatus of claim 6, wherein said test strip port includes a switch.

9. The apparatus of claim 8, wherein said switch comprises a “

no touch”

contact and a “

pull up”

contact.

10. The apparatus of claim 1, further including a means for preventing said sample from reaching and contaminating said port for said fluid collector.

11. The apparatus of claim 1, wherein said port for said fluid collector includes at least one electrical connection.

12. The apparatus of claim 1, wherein said housing contains at least one latitudinal registration feature to position said fluid collector latitudinally.

13. The apparatus of claim 1, wherein said fluid collector comprises a biosensor.

14. The apparatus of claim 13, wherein said biosensor comprises a glucose detector.

15. The apparatus of claim 1, wherein said fluid collector comprises a reflectance strip.

16. The apparatus of claim 15, wherein said reflectance strip comprises a glucose detector.

17. The apparatus of claim 1, further comprising a reflectometer.

18. The apparatus of claim 1, further comprising electronics.

19. The apparatus of claim 18, wherein the electronics control power to said vacuum pump.

20. The apparatus of claim 18, wherein the electronics control power to the lancing assembly.

21. The apparatus of claim 1, wherein movement of said movable support is effected by a diaphragm.

22. The apparatus of claim 21 wherein said diaphragm is capable of being expanded by a pressure gradient.

23. The apparatus of claim 1, further including a power source.

24. The apparatus of claim 23, wherein said vacuum pump is operably connected to said power source.

25. The apparatus of claim 23, further comprising a display operably connected to said power source and said fluid collector.

26. The apparatus of claim 23, further comprising a switch operably connected to said vacuum pump and said lancing assembly through said power source.

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

(a) providing the apparatus of claim 1;

(b) inserting a fluid collector into said support;

(c) aligning said fluid collector latitudinally;

(d) aligning said fluid collector longitudinally;

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

(f) collecting said sample of blood from said unobstructed opening in said skin, with the aid of vacuum and stretching of the skin.

28. The method of claim 27, further comprising the step of generating a signal indicative of glucose level.

29. The method of claim 27, further including the step of aligning said fluid collector longitudinally after step (e) and before step (f).

30. The method of claim 29, wherein said movement of said fluid collector is effected by a pressure gradient operating upon said movable support.

31. The method of claim 27, wherein steps (c) through (f) include the steps of:

(i) placing said apparatus over a region on the surface of the skin from which said sample is to be obtained;

(ii) forming a seal between said apparatus and said surface of the skin;

(iii) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood;

(iv) triggering a lancing assembly and causing a lancet to penetrate said skin;

(v) retracting said lancet;

(vi) withdrawing blood toward and onto a fluid collector; and

(vii) releasing said vacuum.