Percutaneous biological fluid constituent sampling and measurement devices and methods

• US 20050261606A1
• Filed: 09/23/2003
• Published: 11/24/2005
• Est. Priority Date: 06/12/2001
• Status: Abandoned Application

• Current Assignee: Sony Ericsson Mobile Communications USA Incorporated (Sony Group Corp.)
• Original Assignee: Sony Ericsson Mobile Communications USA Incorporated (Sony Group Corp.)
• Inventors: Sohrab, Borzu
• Application Number:
  US10/669,397
• Publication Number:
  US 20050261606A1
• Time in Patent Office: Days
• US Class Current: 600/573
• 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 5/150282 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 5/150389 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 5/150984 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
• CPC Class Codes: A61B 5/685 Microneedles

Abstract

A device for sampling at least one biological fluid constituent and measuring at least one target constituent within the biological fluid. The device has at least one micro-needle having an open distal end used to penetrate the skin to a depth where pain and bleeding are minimized. The device further includes a hydrophilic gel within the micro-needle for sampling the biological fluid constituents and an electrochemical cell for measuring the concentration of targeted constituents within the sampled biological fluid constituents. In certain embodiments, the electrochemical cell is integrated within the micro-needle whereby the steps of sampling and measuring are performed completely in-situ. In other embodiments, the electrochemical cell is located external to the micro-needle at its proximal end. Constituent sampling and measurement systems, methods and kits are also provided.

Claims

1-12. -12. (canceled)

14-39. -39. (canceled)

40. A method for determining the concentration of at least one target constituent contained within biological fluid, the method comprising the steps of:

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

providing an electrochemical cell within the lumen, the electrochemical cell comprising a concentrically-layered electrode configuration;

inserting the open distal end of the micro-needle into the skin to a selected depth;

transferring a sample of at least one target constituent within the biological fluid present at the open distal end through the lumen and into the electrochemical cell;

providing a first electrical signal to the electrochemical cell; and

receiving a second electrical signal generated by the electrochemical cell, wherein the second electrical signal is representative of the concentration the constituent in the biological fluid.

43. A method according to claim 40 or 41 wherein the selected depth is no greater than the viable epidermis.

44. The method according to claim 43 wherein the selected depth is no greater than the stratum corneum.

45. A method according to claim 40 or 41 wherein the step of transferring comprises providing a hydrophilic gel material within the micro-needle lumen and in contact with the electrochemical cell, wherein the hydrophilic gel material absorbs at least one target constituent within biological fluid present at the open distal end of the micro-needle.

46. A method according to claim 40 or 41 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.

47. A method according to claim 40 or 41 further comprising the step of deriving the concentration of the constituent in the patient'"'"'s biological fluid from the second electrical signal.

48. The method according to claim 47 further comprising the step of displaying a numerical value representative of the concentration of the constituent in the patient'"'"'s biological fluid.

49. The method according to claim 47 wherein the step of deriving comprises using a software algorithm.

50. The method of claim 45 further comprising the step of allowing the concentration of the at least one targeted constituent in the hydrophilic gel material to equilibrate with the concentration of the at least one targeted constituent within biological fluid in the patient'"'"'s skin prior to the step of providing a first electrical signal to the electrochemical cell.

51. The method of claim 45 wherein the step of providing a first electrical signal to the electrochemical cell is performed prior to the time it takes for the concentration of the at least one targeted constituent in the hydrophilic gel material to equilibrate with the concentration of the least one targeted constituent within biological fluid in the patient'"'"'s skin.

42. A method for determining the concentration of at least one target constituent contained within biological fluid, the method comprising the steps of:

providing at least one hollow micro-needle comprising an open distal end, an open proximal end and a lumen extending there between;

providing an electrochemical cell in fluid communication with the hollow micro-needle, the cell comprising a parallely-spaced electrode configuration, wherein the electrode configuration is positioned at the open proximal end of the hollow micro-needle substantially transverse to the micro-needle;

inserting the open distal end of the hollow micro-needle into the skin to a selected depth;

transferring a sample of the at least one targeted biological fluid constituent present at the open distal end of the hollow micro-needle into the electrochemical cell;

providing a first electrical signal to the electrochemical cell; and

receiving a second electrical signal generated by the electrochemical cell, wherein the second electrical signal is representative of the concentration the constituent in the biological fluid.

52-57. -57. (canceled)