Percutaneous biological fluid sampling and analyte measurement devices and methods

• US 6,501,976 B1
• Filed: 06/12/2001
• Issued: 12/31/2002
• 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: Sohrab, Borzu
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/879,106
• Publication Number:
  US 20020188185A1
• Time in Patent Office: 567 Days
• Field of Search: 600/347, 600/345, 600/346, 600/348, 600/352, 600/353, 600/354, 600/355, 600/357, 600/358, 600/365, 600/366, 600/372, 600/373, 600/377, 600/393
• US Class Current: 600/347
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/150358 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 5/150984 Microneedles or microblades
• 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

Abstract

Devices and methods for sampling a biological fluid and measuring a target constituent within the biological fluid are provided. Generally, the subject devices include a sampling device configured to pierce a skin surface to provide access to biological fluid and concentrically-spaced working and reference electrodes positioned within the elongated sampling device that define an electrochemical cell for measuring the concentration of analyte within the biological fluid. The subject devices and methods are particularly suited for use in the sampling and concentration measuring of glucose in interstitial fluids. Also provided are kits that include the subject devices for use in practicing the subject methods.

Claims

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

(a) an elongated sampling means configured to pierce a skin surface to provide access to the biological fluid; and

(b) concentrically-spaced electrodes positioned within the elongated sampling means that define an electrochemical cell for measuring the concentration of analyte within the biological fluid.

2. The device of claim 1 further comprising an insulating material between the concentrically-spaced electrodes.

3. The device of claim 2 further comprising a redox reagent system.

4. The device of claim 2 wherein the insulating material comprises a plurality of pores configured to provide a capillary force sufficient to draw a sample of biological fluid into the pores.

5. The device of claim 1 further comprising a signal producing and receiving means in electrical communication with the electrodes.

6. The device of claim 1 wherein the sampling means comprises a lumen and an open distal end, wherein the open distal end provides a passageway into the lumen.

7. The device of claim 6 wherein the lumen is configured to provide a capillary force sufficient to draw a sample of biological fluid into the lumen.

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

9. A kit comprising at least one biological fluid sampling and analyte concentration measurement device according to claim 1.

10. A device for sampling biological fluid and measuring the concentration of a target constituent in the biological fluid, comprising:

a first electrode;

a second electrode concentrically positioned about and spaced apart from the first electrode; and

a porous material positioned in the space between the electrodes, wherein the device has a configuration for piercing the skin.

11. The device according to claim 10 having a penetration length no deeper than the dermis.

12. The device according to claim 11 having a penetration length no deeper than the epidermis.

13. The device according to claim 10 wherein the second electrode has a configuration for piercing the skin.

14. The device according to claim 13 wherein the second electrode has an open distal end and defines a space within the device, wherein the space has a configuration to provide a capillary force sufficient to draw biological fluid through the open distal end.

15. The device according to claim 10 further comprising a reagent in contact with the porous material or at least one of the electrodes.

16. The device according to claim 15 wherein the reagent is located on a surface of at least one of the electrodes facing the porous material.

17. A micro-needle for sampling a biological fluid and measuring a target constituent within the biological fluid, comprising:

a core having a length;

a first electrode coaxially conformed about the core length;

a porous material coaxially conformed about the first electrode;

a second electrode coaxially conformed about the porous material and having a length that extends beyond the core length and terminates at an open tip; and

a reagent contained within the micro-needle wherein the reagent is selected based on the target constituent.

18. The micro-needle according to claim 17 further comprises a plating formed circumferentially about the length of the second electrode.

19. A kit for sampling a biological fluid from the skin of a patient and for measuring the concentration of a constituent within the sampled biological fluid, the kit comprising:

at least one micro-needle according to claim 17.

20. The kit according to claim 19 further comprising a plurality of micro-needles and a support member wherein the plurality of micro-needles are arranged in an array on the support member.

21. The kit according to claim 20 wherein the micro-needles have varying lengths.

22. The kit according to claim 20 wherein the micro-needles comprise different reagents.

23. A system for sampling biological fluid from the skin of a patient and measuring a target constituent within the biological fluid, the system comprising:

(a) at least one micro-needle comprising sampling means, a reagent and an electrochemical cell housed within the micro-needle,

(1) wherein the electrochemical cell comprises a reference electrode, a working electrode and an insulating material there between, wherein the reagent is in contact with at least one or more of the reference electrode, the working electrode or the insulating material, and

(2) wherein the sampling means comprises a distal opening and at least one space within the micro-needle having a configuration capable of wicking biological fluid into the micro-needle; and

(b) a control unit in electrical communication with the at least one micro-needle, comprising;

(1) means for sending an electrical reference signal to the reference electrode and for receiving an electrical output signal from the working electrode, and

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

24. The system according to claim 23 further comprising a display unit in electrical communication with the control unit for displaying information in the form of electrical signals received from the control unit related to the sampling of the biological fluid and the measuring of the target constituent.

25. The system according to claim 23 further comprising a housing and a support means wherein the control unit is housed within the housing and the at least one micro-needle is mounted to the support means.

26. A method for testing a biological fluid within the skin of a patient and for determining the concentration of a target constituent contained therein, the method comprising the steps of:

providing at least one micro-needle comprising an open distal end and an electrochemical cell therein, the electrochemical cell comprising a reagent and a concentrically-layered electrode configuration;

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

wicking a sample of biological fluid present at the open distal end into the electrochemical cell;

allowing the sample to react with the reagent wherein a substance is formed within the electrochemical cell as a result of the reaction;

providing a first electrical signal to the substance; and

receiving a second electrical signal generated by the substance, wherein the second electrical signal is representative of the concentration the constituent in the sample.

27. The method according to claim 26 wherein the selected depth is no greater than the viable epidermis.

28. The method according to claim 27 wherein the selected depth is no greater than the stratum corneum.

29. The method according to claim 26 wherein the step of wicking comprises exerting a capillary force on the biological fluid present at the open distal end.

30. The method according to claim 26 wherein the steps of providing a first electrical signal and receiving a second electrical signal is performed by a control unit in electrical communication with the electrochemical cell.

31. The method according to claim 26 further comprising the step of deriving the concentration of the constituent in the patient'"'"'s blood from the second electrical signal.

32. The method according to claim 31 further comprising the step of displaying a numerical value representative of the concentration of the constituent in the patient'"'"'s blood.

33. The method according to claim 31 wherein the step of deriving comprises using a software algorithm.