Non-invasive transudate extraction

• US 20040162467A1
• Filed: 04/13/2004
• Published: 08/19/2004
• Est. Priority Date: 06/14/2001
• Status: Abandoned Application

• Current Assignee: The Horticulture And Food Research Institute Of New Zealand Limited
• Original Assignee: The Horticulture And Food Research Institute Of New Zealand Limited
• Inventors: Cook, Christian John
• Application Number:
  US10/480,234
• Publication Number:
  US 20040162467A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14525 using microdialysis
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• 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 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 8/00 Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

A transudate extraction device (1) for non-invasive extraction of transudate through a target area of a skin barrier of an organism subjected to sufficient ultrasonic energy from a generator (2) to induce transudation therethrough, the device including at least: a contacting means (3) for contacting said target area to receive transudate therefrom, a transudate collection chamber (6) in open communication with said contacting means to receive transudate therefrom, circulating means for circulating transudate within said collection chamber by, for example having a fluid flow (12) through an inlet port (8) and out an outlet port (9) to thereby create and maintain a concentration gradient through the skin of a said test subject, said collection chamber having a discharge opening (9) through which exudate collected therein can be discharged.

Claims

1. A transudate extraction device for non-invasive extraction of transudate through a target area of a skin barrier of an organism subjected to sufficient ultrasonic energy to induce transudation therethrough, the device including at least:

a contacting means for contacting said target area to receive transudate therefrom,

a transudate collection chamber in open communication with said contacting means to receive transudate therefrom,

circulating means for circulating transudate within said collection chamber to thereby create and maintain a concentration gradient through the skin of a said test subject, said collection chamber having a discharge opening through which exudate collected therein can be discharged.

2. A device according to claim 1 wherein said contacting means and said collection chamber are incorporated into a common housing.

3. A device according to claim 1 or claim 2 wherein said contacting means is a transudate permeable or semi-permeable membrane.

4. A device according to claim 1 or claim 2 wherein said contacting means is an O-ring.

5. A device according to any one of the preceding claims wherein said collection chamber is of a regular geometric shape in cross-section.

6. A device according to claim 5 wherein said collection chamber is circular in cross section.

7. A device according to any one of the preceding claims wherein said circulating means comprises a flow of liquid into and out of said collection chamber.

8. A device according to claim 7 wherein there are provided an inlet conduit and an outlet conduit through which said flow of liquid is maintained, a source of liquid communicating with said inlet conduit and a collecting means communicating with said outlet conduit.

9. A device according to claim 8 wherein said collecting means is a collecting vessel.

10. A device according to claim 9 wherein said collecting vessel is a test-tube.

11. A device according to any one of the preceding claims which includes an analysing means for analysing the composition of said transudate.

12. A device according to claim 11 wherein said analysing means is in said collection chamber.

13. A device according to claim 12 wherein said analysing means is in said outlet conduit.

14. A device according to any one of claims 11 to 13 wherein said analysing means is capable of detecting an analytes in said transudate.

15. A device according to any one of the preceding claims including means for providing an electric charge across said target area, associated with said contacting means.

16. A device according to any one of the preceding claims having an ultrasonic generator attaching means, said attaching means being adapted to orient a said ultrasonic generator therein to direct ultrasonic energy onto said target area.

35. A replaceable member adapted for attachment to the test area of a device of any one of claims 1 to 16.

17. A method for non-invasively extracting transudate through a skin barrier of an organism, which includes at least the steps of:

treating a target area of a said skin barrier with a sufficient concentration of ultrasonic energy to induce transudation therethrough;

collecting said transudate thereby produced in a dynamic flow of fluid, said dynamic flow being controlled so as to provide a concentration gradient in a direction which induces continuing transudation through said skin barrier, and recovering transudate from said dynamic flow.

18. A method according to claim 17 wherein the frequency of said ultrasound energy is in the range 1-3 MHz.

19. A method according to claim 17 wherein the frequency of said ultrasound energy is in the range 10-30 kHz.

20. A method according to any one of claims 17 to 19 wherein the output of said ultrasound energy is in the range 0.1 to 3 W/cm².

21. A method according to any one of claims 17 to 19 wherein the output of said ultrasound energy is in the range 5-15 W/cm².

22. A method according to any one of claims 17 to 21 wherein said fluid is saline.

23. A method according to any one of claims 17 to 22 wherein said ultrasound energy is pulsed on and off.

24. A method according to claim 23 wherein said ultrasound energy is pulsed for about 5 seconds on and 5 seconds off.

25. A method according to any one of claims 17 to 24 wherein said transudate is passed through a permeable or semi permeable membrane interposed between said skin barrier and said dynamic flow of liquid.

26. A method according to any one of claims 17 to 25 wherein the method further includes the step of collecting and storing transudate in a collection vessel.

27. A method according to any one of claims 17 to 26 which includes the additional step of analysing said transudate.

28. A method according to claim 27 wherein said analysing step comprises detecting one or more analytes in the transudate.

29. A method according to claim 27 or claim 28 wherein said analysing step is carried out substantially contemporaneously with the extraction of transudate.

30. A method according to any one of claims 17 to 29 wherein turbulence in the fluid stream is minimised.

31. A method according to any one of claims 17 to 30 wherein flow rate of said dynamic flow of fluid is in the range of 50 to 600 μ

l/min.

32. A method according to any one of claims 17 to 31 that additionally includes enhancing extraction of an analyte through the skin before or contemporaneously with extracting transudate.

33. A method according to claim 32 wherein enhancing extraction of the analyte is achieved by subjecting said skin barrier to an electromagnetic field.

34. A method according to any one of claims 17 to 33 that additionally includes the step of sanitising the fluid stream.