Method and device for sampling and analyzing interstitial fluid and whole blood samples

• US 6,612,111 B1
• Filed: 03/27/2000
• Issued: 09/02/2003
• Est. Priority Date: 03/27/2000
• Status: Expired due to Fees

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Sponsoring Entity: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Hodges, Alastair, Chambers, Garry, Chatelier, Ron
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Time in USPTO: 1254 Days
• Field of Search: 600/309, 600/322, 600/345, 600/347, 600/365, 600/576, 600/578, 600/580, 600/582, 600/584, 606/181, 435/4, 435/7.1, 435/14, 435/69.6, 422/50, 422/55, 422/68.1, 422/101, 422/102, 436/68, 204/403, 738/67, 738/640.1, 738/640.2, 738/645.1, 738/646.2
• US Class Current: 60/583
• CPC Class Codes: A61B 2010/008 : Interstitial fluid
• 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 5/14514 : using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 : for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 : for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14865 : invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/150022 : for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 : Venting means
• 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 5/150389 : Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150755 : Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15105 : Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• 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 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15142 : Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

The invention disclosed in this application is a method and device for combining the sampling and analyzing of sub-dermal fluid samples, e.g., interstitial fluid or whole blood, in a device suitable for hospital bedside and home use. It is applicable to any analyte that exists in a usefully representative concentration in the fluid, and is especially suited to the monitoring of glucose.

Claims

1. A fluid sampling device comprising a body, the body comprising a dermal layer penetration probe having a penetrating end and a communicating end, and an analysis chamber having a proximal and distal end, the analysis chamber having a volume, the sampling device further comprising a pre-chamber having a volume and a first and second end, wherein the pre-chamber is interposed between the penetration probe and the analysis chamber such that the first end of the pre-chamber is adjacent the communicating end of the penetration probe and the second end of the pre-chamber is adjacent the proximal end of the analysis chamber, wherein the volume of the pre-chamber is greater than the volume of the analysis chamber, and wherein the penetration probe is in fluid communication with the analysis chamber such that fluid can flow from the penetration probe toward the analysis chamber.

2. The device of claim 1, wherein the analysis chamber has at least one flexible wall and wherein upon compression of the chamber at the flexible wall the volume of the analysis chamber is reduced.

3. The device of claim 1, wherein the pre-chamber has at least one flexible wall and wherein upon compression of the chamber at the flexible wall the volume of the pre-chamber is reduced.

4. The device of claim 1, wherein the pre-chamber comprises a valve at the first end capable of substantially sealing the pre-chamber from the penetration probe.

5. The device of claim 1, wherein the pre-chamber is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force and wherein a differential exists between the first and the second capillary forces.

6. The device of claim 5, wherein the capillary force exerted by the analysis chamber is greater than the capillary force exerted by the pre-chamber.

7. The device of claim 6, wherein an interior surface of the pre-chamber comprises at least first and second pre-chamber walls spaced apart at a first distance to define a pre-chamber height, and wherein an interior surface of the analysis chamber comprises at least first and second analysis chamber walls spaced apart at a second distance to define an analysis chamber height, wherein the height of the analysis chamber is less than the height of the pre-chamber, and wherein the differential capillary force derives at least in part from a difference between the pre-chamber height and the analysis chamber height.

8. The device of claim 5, wherein at least one of the pre-chamber and analysis chamber comprises a substance capable of enhancing or diminishing a capillary force.

9. The device of claim 8, wherein the substance is selected from the group consisting of a polymer, a resin, a powder, a mesh, a fibrous material, a crystalline material, a porous material, or a combination thereof.

10. The device of claim 8, wherein the substance is selected from the group consisting of polyethylene glycol, polyvinylpyrrolidone, a surfactant, a hydrophilic block copolymer, and polyvinylacetate.

11. The device of claim 1, wherein the pre-chamber comprises a first pre-chamber wall and a second pre-chamber wall and wherein the analysis chamber comprises a first analysis chamber wall and a second analysis chamber wall, and wherein the distance between the pre-chamber walls is greater than the distance between the analysis chamber walls.

12. The device of claim 1, further comprising a compressible bladder in communication with the analysis chamber, the compressible bladder being capable of applying a positive or a negative pressure to the analysis chamber.

13. The device of claim 12, wherein the compressible bladder opens into the distal end of the analysis chamber.

14. The device of claim 1, wherein the penetration probe is selected from the group consisting of a needle, a lancet, a tube, a channel, and a solid protrusion.

15. The device of claim 1, wherein the penetration probe comprises a material selected from the group consisting of carbon fiber, boron fiber, plastic, metal, glass, ceramic, a composite material, mixtures thereof, and combinations thereof.

16. The device of claim 1, wherein the penetration probe comprises two sheets of material in substantial registration, having a protrusion on each sheet, wherein the sheets are spaced apart such that liquid can be drawn between the sheets by capillary action.

17. The device of claim 16, wherein the two sheets of material extend into the device so as to form a pre-chamber adjacent the analysis chamber and in fluid communication therewith.

18. The device of claim 1, wherein the device has a proximal edge, the edge comprising a recess, wherein the penetration probe is positioned within the recess.

19. The device of claim 18, wherein the recess is configured to substantially align with a shape of a selected dermal surface.

20. The device of claim 1, further comprising a releasable actuator, wherein the actuator is capable of supplying a force sufficient to cause the penetration probe to penetrate a dermal layer.

21. The device of claim 20, wherein the actuator is external to the body, and wherein upon release the actuator propels the body toward the dermal layer.

22. The device of claim 20, wherein the actuator is integral with the body.

23. The device of claim 22, wherein upon release the actuator propels the penetration probe toward the dermal layer.

24. The device of claim 1, wherein the analysis chamber comprises an electrochemical cell, the cell comprising a working electrode and a counter/reference electrode.

25. The device of claim 1, further comprising an interface for communication with a meter.

26. The device of claim 25, wherein the interface communicates a voltage or a current.

27. A method for determining a presence or an absence of an analyte in a fluid sample comprising the steps of:

providing a fluid sampling device comprising a dermal layer penetration probe having a penetrating end and a communicating end, and an analysis chamber having a proximal and distal end, the analysis chamber having a volume, the fluid sampling device further comprising a pre-chamber having a volume and a first and second end, wherein the pre-chamber is interposed between the penetration probe and the analysis chamber such that the first end of the pre-chamber is adjacent the communicating end of the penetration probe and the second end of the pre-chamber is adjacent the proximal end of the analysis chamber, wherein the volume of the pre-chamber is greater than the volume of the analysis chamber, and wherein the penetration probe is in fluid communication with the analysis chamber such that fluid can flow from the penetration probe toward the analysis chamber;

penetrating a dermal layer with the penetration probe;

substantially filling the analysis chamber with a fluid sample by allowing the sample to flow from the penetration probe toward the analysis chamber; and

detecting a presence or an absence of the analyte within the analysis chamber.

28. The method of claim 27, wherein the sample is selected from the group consisting of interstitial fluid and whole blood.

29. The method of claim 28, the fluid sampling device further comprising a compressible bladder in communication with the analysis chamber, the compressible bladder being capable of applying a positive or a negative pressure to the analysis chamber.

30. The method of claim 29, further comprising the steps of:

applying a compressing force to the compressible bladder, to reduce the volume of the compressible bladder; and

releasing the compressing force, to form a partial vacuum in the compressible bladder and analysis chamber.

31. The method of claim 30, wherein the penetrating step is preceded by the applying step and followed by the releasing step.

32. The method of claim 27, wherein the detecting step comprises a qualitative or quantitative measurement of a characteristic of the sample.

33. The method of claim 32 wherein the characteristic of the sample comprises a reaction product of the analyte.

34. The method of claim 33, wherein the reaction product is selected from the group consisting of a color indicator, an electric current, an electric potential, an acid, a base, a precipitate, and a gas.

35. The method of claim 27, wherein the analyte is selected from the group consisting of an ion, an element, a sugar, an alcohol, a hormone, a protein, an enzyme, a cofactor, a nucleic acid sequence, a lipid, a pharmaceutical, and a drug.

36. The method of claim 27, wherein the analyte is selected from the group consisting of potassium ion, ethanol, cholesterol, and lactate.

37. The method of claim 27, wherein the flow of sample toward the analysis chamber is driven by a driving force, wherein the driving force comprises a force selected from the group consisting of a capillary force and a pressure differential.

38. The method of claim 37, wherein the pre-chamber is capable of exerting a first capillary force and the analysis chamber is capable of exerting a second capillary force and wherein a differential exists between the first and the second capillary forces.

39. The method of claim 38, wherein the capillary force exerted by the analysis chamber is greater than the capillary force exerted by the pre-chamber.

40. The method of claim 39, wherein an interior surface of the pre-chamber comprises at least first and second pre-chamber walls spaced apart at a first distance to define a pre-chamber height, and wherein an interior surface of the analysis chamber comprises at least first and second analysis chamber walls spaced apart at a second distance to define an analysis chamber height, wherein the height of the analysis chamber is less than the height of the pre-chamber, and wherein the differential capillary force derives at least in part from a difference between the pre-chamber height and the analysis chamber height.

41. The method of claim 39, wherein at least one of the pre-chamber and analysis chamber comprises a substance capable of enhancing or diminishing a capillary force.

42. The method of claim 41, wherein the substance is selected from the group consisting of a polymer, a resin, a powder, a mesh, a fibrous material, a crystalline material, a porous material, or a combination thereof.

43. The method of claim 41, wherein the substance is selected from the group consisting of polyethylene glycol, polyvinylpyrrolidone, a surfactant, a hydrophilic block copolymer, and polyacrylic acid.

44. The method of claim 37, wherein the pressure differential comprises a positive pressure applied toward the analysis chamber.

45. The method of claim 37, wherein the pressure differential comprises a negative pressure applied from the analysis chamber.

46. The method of claim 37, the pre-chamber further comprising at least one flexible wall and wherein upon compression of the chamber at the flexible wall the volume of the pre-chamber is reduced.

47. The method of claim 46, the pre-chamber further comprising a valve at the first end capable of substantially sealing the pre-chamber from the penetration probe.

48. The method of claim 47, wherein the step of substantially filling the analysis chamber with sample comprises losing the valve and compressing the pre-chamber.

49. The method of claim 27, the analysis chamber further comprising at least one flexible wall and wherein upon compression of the analysis chamber at the flexible wall the volume of the analysis chamber is reduced.

50. The method of claim 49, further comprising the steps of:

applying a compressing force to the flexible wall of the analysis chamber to reduce the volume of the analysis chamber; and

releasing the compressing force, to form a partial vacuum in the analysis chamber.

51. The method of claim 50, wherein the penetrating step is preceded by the applying step and followed by the releasing step.