Method and apparatus for obtaining blood for diagnostic tests

• US 20020169393A1
• Filed: 10/05/2001
• Published: 11/14/2002
• Est. Priority Date: 12/06/1996
• Status: Active Grant

• Current Assignee: David D. Cunningham, Douglas F. Young, Eric B. Shain, Timothy P. Henning
• Original Assignee: David D. Cunningham, Douglas F. Young, Eric B. Shain, Timothy P. Henning
• Inventors: Henning, Timothy P., Shain, Eric B., Young, Douglas F., Cunningham, David D.
• Granted Patent: US 6,837,858 B2
• Time in Patent Office: Days
• US Class Current: 600/573
• 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) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained,

(b) forming a seal between said blood collection device and said surface of the skin,

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

(d) triggering a lancing assembly and causing a lancet to penetrate said skin,

(e) retracting said lancet,

(f) withdrawing blood toward and onto a fluid collector, and

(g) releasing the vacuum.

In another 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 said sealable chamber,

(b) a power source,

(c) a vacuum pump operably connected to said power source, said vacuum pump in communication with said sealable chamber,

(d) a lancing assembly positioned within said housing, said lancing assembly capable of moving a lancet towards said sealable opening, and

(e) a fluid collector positioned in said sealable chamber, said fluid collector in fluid communication with said sealable opening.

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 power source,

(c) a vacuum pump operably connected to said power source, said vacuum pump in communication with said sealable chamber,

(d) a lancing assembly positioned in said housing, said lancing assembly capable of moving a lancet towards said sealable opening, and

(e) a fluid collector positioned in said sealable chamber, said fluid collector in fluid communication with said sealable opening.

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

(a) a body portion, and

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

3. The apparatus of claim 2, wherein said fluid collector is positioned in a slot in said door portion.

4. The apparatus of claim 3, wherein said slot locates said fluid collector adjacent said sealable opening when said door portion is positioned over said body portion.

5. The apparatus of claim 2, wherein said body portion contains at least one slot for inserting said fluid collector.

6. The apparatus of claim 2, wherein said body portion includes at least one electrical connection.

7. The apparatus of claim 2, wherein said door portion includes at least one electrical connection.

8. The apparatus of claim 2, wherein said body portion comprises a movable projection containing a slot, said fluid collector positioned in said slot.

9. The apparatus of claim 8, wherein said movable projection includes at least one electrical connection.

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

(a) a body portion,

(b) an interior cover portion positionable over said lancing assembly, and

(c) a door portion positionable over said interior cover portion and including said sealable opening.

11. The apparatus of claim 10, wherein said interior cover portion contains at least one alignment channel to position said fluid collector.

12. The apparatus of claim 10, wherein said door portion contains at least one alignment fixture to position said fluid collector.

13. The apparatus of claim 10, wherein the housing further comprises a projection.

14. The apparatus of claim 13, wherein said fluid collector is positioned in at least one slot in said projection.

15. The apparatus of claim 14, wherein said at least one slot is parallel to the upper surface of said interior cover.

16. The apparatus of claim 14, wherein said at least one slot is not parallel to the upper surface of said interior cover.

17. The apparatus of claim 14, wherein said projection includes at least one electrical connection.

18. The apparatus of claim 1, further comprising a heating element.

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

20. The apparatus of claim 19, wherein said biosensor comprises a glucose detector.

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

22. The apparatus of claim 21, wherein said reflectance strip comprises a glucose detector.

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

24. The apparatus of claim 1, further comprising a display operably connected to said power source and said fluid collector.

25. The apparatus of claim 1, further comprising a switch operably connected to said vacuum pump and said lancing assembly through said power source.

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

27. The apparatus of claim 26, wherein the electronics control power to said vacuum pump.

28. The apparatus of claim 26, wherein the electronics control power to a heating element.

29. The apparatus of claim 26, wherein the electronics control power to the lancing assembly.

30. The apparatus of claim 1, further comprising more than one of said fluid collector.

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

(a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained,

(b) forming a seal between said blood collection device and said surface of the skin,

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

(d) triggering a lancing assembly and causing a lancet to penetrate said skin,

(e) retracting said lancet,

(f) withdrawing blood toward and onto a fluid collector, and

(g) releasing the vacuum.

32. The method of claim 31, further comprising the step of generating a signal indicative of glucose level.

33. The method of claim 31, further comprising the step of causing said fluid collector to move to a position near the position where said lancet penetrated said skin.

34. The method of claim 33, wherein said movement of the fluid collector is created by the release of a latch.

35. The method of claim 33, wherein said movement of the fluid collector is created by a four-bar linkage.

36. The method of claim 33, wherein said movement of the fluid collector is created by a pivoting projection.