Biological fluid constituent sampling and measurement devices and methods

• US 6,875,613 B2
• Filed: 06/12/2001
• Issued: 04/05/2005
• Est. Priority Date: 06/12/2001
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Leong, Koon-wah, Shartle, Robert, Kiser, Ernest J.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/879,188
• Publication Number:
  US 20020187556A1
• Time in Patent Office: 1,393 Days
• Field of Search: 422/58, 422/61, 422 7- 6, 422/68.1, 422/82.05, 436/63, 436/91, 436/95, 436/164, 436/165, 436/150, 604/317, 604/318, 604/403, 604/404, 604/411, 604/412
• US Class Current: 436/63
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A device for accessing biological fluid, sampling biological fluid constituents and determining the concentration of at least one target constituent within the accessed biological fluid is provided. The device has at least one micro-piercing member used to penetrate the skin to a selected depth and to access biological fluid, a constituent sampling means and a constituent measuring means. The constituent sampling means comprises a constituent transfer medium, such as a hydrophilic gel material, by which sampled constituents are transferred from the micro-piercing member to the measuring means. The measuring means includes an electrochemical cell having at least one porous electrode through which at least one sampled constituent is caused to enter into the electrochemical cell. Methods of sampling constituents within the skin and measuring the sampled constituents, as well as kits for practicing the invention are provided.

Claims

1. A biological fluid constituent sampling and concentration measurement device, said device comprising:

at least one skin-piercing member comprising a proximal end, a distal end, a channel extending from the proximal end to the distal end and a biological fluid access opening at the distal end;

an electrochemical cell for measuring the concentration of analyte within the biological fluid, wherein the cell comprises a first planar electrode positioned substantially transverse to the at least one skin piercing member and comprising a hole axially aligned with the channel of the at least one skin-piercing member; and

a constituent transfer medium comprising a hydrophilic material in fluid communication with the channel of the at least one skin-piercing member and with the at least one planar electrode.

2. The device of claim 1 wherein the hydrophilic material comprises a gel matrix.

3. The device of claim 2 wherein the gel matrix comprises a natural gel.

4. The device of claim 3 wherein the natural gel is selected from the group comprising agarose, gelatin, mucopolysaccharide, starch and the like.

5. The device of claim 2 wherein the gel matrix comprises a synthetic gel.

6. The device of claim 5 wherein the synthetic gel comprises a neutral water-soluble polymer.

7. The device of claim 2 wherein the synthetic gel comprises a polymer.

8. The device of claim 7 wherein the polymer is selected from the group consisting of polyvinyl pyrrolidone, polyethylene glycol, polyacrylic acid, polyvinyl alcohol, polyacrylamide, and copolymers thereof.

9. The device of claim 1 wherein the electrochemical cell further comprises a second planar electrodes spaced a from the first planar electrode wherein a reaction chamber is defined there between.

10. The device of claim 9 wherein the distance between the electrodes is from about 50 to 1000 Å

.

11. The device of claim 10 wherein the distance between the electrodes is from about 100 to 500 Å

.

12. The device of claim 9 further comprising at least one reagent material for chemically reacting with at least one biological fluid constituent, the at least one reagent material located on a surface of at least one electrode facing the reaction chamber, wherein the at least one reagent is selected based on the at least one constituent targeted for measurement.

13. The device of claim 9 wherein the second electrodes is porous and the pores of the second electrode are substantially smaller than the hole in the first electrode.

14. The device of claim 13 further comprising a housing halving at least one vent hole for venting air from within the electrochemical cell.

15. The device of claim 1 wherein the biological fluid interstitial fluid and the analyte is glucose.

16. A kit for sampling biological fluid constituents from the skin of a patient and for measuring the concentration of at least one analyte within the sampled biological fluid constituents, the kit comprising a plurality of devices according to claim 1.

17. The kit of claim 16 wherein the plurality of devices is disposable.

18. A system for sampling biological fluid constituents from the skin of a patient and measuring at least one target constituent within the sampled biological fluid constituents, the system comprising:

(a) at least one device according to claim 1; and

(b) a control means in electrical communication with the at least one device, the control means comprising;

(1) means for sending an electrical input signal to the device and for receiving an electrical output signal from the device, and

(2) a software algorithm which automatically calculates and determines the concentration of the target analyte in the accessed biological fluid upon receipt of the electrical output signal.

19. A method for sampling biological fluid constituents within the skin of a patient and for measuring the concentration of one or more target analytes contained therein, the method comprising the steps of:

providing a system according to claim 18;

operatively applying a first device to the patient'"'"'s skin wherein the system samples the patient'"'"'s biological fluid constituents and measures the concentration of the one or more target analytes therein;

removing the first device from the patient'"'"'s skin;

removing the first device from the, control means;

operatively coupling a second device to control means; and

repeating the above steps until the desired number of samplings and measurements have been performed.

20. The system of claim 18 further comprising a display means in electrical communication with the control means for displaying information in the form of electrical signals received from the control means related to the sampling of the at least one biological fluid constituents and the measuring of the at least one target constituent.

21. The system of claim 20 wherein the device is mounted to the housing by means of a lock-and-release mechanism.

22. A kit for sampling biological fluid constituents from the skin of a patient and for measuring the concentration of at least one analyte within the sampled biological fluid constituents, the kit comprising:

a system according to claim 18.

23. The kit of claim 22 wherein the control means is reusable.

24. The kit of claim 23 wherein the at least one device comprises two or more reagent materials for testing two or more targeted analytes.

25. The system of claim 18 further comprising a housing wherein the control means is located within the housing and the device is mounted to the housing.

26. The system of claim 25 further comprising user input buttons on the housing for providing user input to the control unit.

27. The system of claim 25 further comprising a display means on the housing for displaying information from the control means.

28. The system of claim 25 wherein the housing has a hand-held configuration.

29. A method for accessing a biological fluid within the skin of a patient the method comprising the steps of:

providing at least one micro-needle comprising an open distal end and a channel therethrough;

inserting the at least one micro-needle into the skin to a selected depth;

absorbing through the open distal end and into the micro-needle channel constituents present within biological fluid present at the open distal end; and

transferring the absorbed constituents through a hole in a conductive material into a measurement chamber, wherein the conductive material is substantially transverse to the at least one micro-needle and the hole is axially aligned with the micro-needle channel.

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

exerting a capillary force on the sampled biological fluid present in the measurement chamber; and

transferring the sampled constituents through a second conductive material comprising pores having a size substantially smaller than the hole.

31. The method according to claim 30 further comprising the step of venting air from the measurement chamber.

32. The method of claim 29 further comprising the steps of:

causing the sampled constituents to chemically react with a selected reagent within the measurement chamber;

providing a first signal to the measurement chamber; and

receiving a second signal from the measurement chamber, wherein the second electrical signal is representative of the concentration of the target analyte in the accessed biological fluid.

33. The method according to claim 32 wherein the accessed biological fluid is interstitial fluid and the at least one target analyte is glucose.

34. The method of 32 further comprising the step of deriving the concentration level of the at least one target analyte in the patient'"'"'s blood from the second signal.

35. The method of claim 34 further comprising the step of displaying a numerical value representative of the concentration of the at least one target analyte in the patient'"'"'s blood.

36. The method according to claim 35 wherein the step of deriving comprises using a software algorithm.