Microdialysis needle assembly

• US 20050208648A1
• Filed: 03/16/2005
• Published: 09/22/2005
• Est. Priority Date: 03/17/2004
• Status: Abandoned Application

• Current Assignee: TheraFuse, Inc.
• Original Assignee: TheraFuse, Inc.
• Inventors: Gillett, David, Sage, Burton H. Jr.
• Application Number:
  US11/083,351
• Publication Number:
  US 20050208648A1
• Time in Patent Office: Days
• US Class Current: 435/287.200
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14528 invasively
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors

Abstract

A device for the measurement of analytes in a body fluid including a support with an upper surface, a layer adhered to the upper surface, the layer being of a hardenable material wherein at least one microfluidic channel has been etched after the layer is at least partially hardened, and a semipermeable membrane at least partially covering the layer.

Claims

1. A device for the measurement of analytes in a body fluid comprising:

a. a support with an upper surface,

b. a layer adhered to the upper surface, the layer including a hardenable material wherein at least one microfluidic channel has been etched after the layer is at least partially hardened, and

c. a semipermeable membrane at least partially covering the layer.

2. The device of claim 1 wherein the support is metal.

3. The device of claim 2 wherein the metal is stainless steel.

4. The device of claim 1 wherein the hardenable material is a photoresist.

5. The device of claim 4 wherein the photoresist is an epoxy.

6. The device of claim 5 wherein the epoxy is SU-8.

7. The device of claim 1 wherein the microfluidic channel is etched completely through the layer.

8. The device of claim 1 wherein the semipermeable membrane is a track-etched semipermeable membrane.

9. The device of claim 1 conformally coated with an insulating layer.

10. The device of claim 9 wherein the conformal coating is a vapor deposited coating.

11. The device of claim 10 wherein the conformal coating is parylene.

12. The device of claim 1, wherein the device includes a plurality of microfluidic channels etched after the layer is at least partially hardened, the plurality of microfluidic channels forming a microfluidic network, further comprising a manifold covering at least a portion of the semipermeable membrane.

13. The device of claim 12, wherein the manifold comprises:

a plurality of fluid access ports adapted to provide fluid access to the microfluidic network to permit a plurality of respective fluids to at least one of enter and exit the microfluidic network through the manifold.

14. The device of claim 13, wherein the manifold further comprises electrical leads adapted to provide electrical access to chambers of the microfluidic network.

15. A body analyte measurement system, comprising:

a. a first reservoir for containing a solution comprising a known concentration of the body analyte;

b. a second reservoir for containing an enzyme solution;

c. the device of claim 14, wherein the manifold includes an inlet in liquid communication with the first reservoir and an outlet, wherein the device is adapted to allow exchange of the body analyte between the solution and a body fluid when there is solution in the device and the device is in contact with the body fluid, wherein the device further includes a measurement path comprising a first chamber, a second chamber downstream from the first chamber, and a third chamber downstream from the second chamber such that the first chamber may receive liquid from the first reservoir and the outlet and the second chamber may receive liquid from the first chamber and the second reservoir; and

d. a valving system for controlling liquid flow along the measurement path such that the liquid flowing into the second chamber is either (i) liquid from the outlet that has passed through the first chamber and liquid from the second reservoir, or (ii) liquid from the first reservoir that has passed through the first chamber and liquid from the second reservoir.

16. The system of claim 15, wherein the valving system is contained inside the device.

40. The device of claim 1 further comprising a drug delivery system such that the amount or rate of delivery of the drug by the drug delivery system is based on a measurement made by the device.

17. A method of making a microdialysis sensor comprising:

a. providing a support with an upper surface,

b. creating a layer on the upper surface by adding a hardenable liquid to the upper surface and partially hardening the hardenable liquid such that the hardenable liquid adheres to the upper surface and forms a new upper surface,

c. creating a channel in the partially hardened layer,

d. adhering a semipermeable membrane to the new upper surface and hardening the layer to form an assembly including the support, the layer and the membrane, and

e. conformally coating the assembly with an insulating layer.

18. The method of claim 17 wherein the support is metal.

19. The method of claim 18 wherein the metal is stainless steel.

20. The method of claim 17 wherein the hardenable material is a photoresist.

21. The method of claim 20 wherein the photoresist is an epoxy.

22. The method of claim 21 wherein the epoxy is SU-8.

23. The method of claim 17 wherein the microfluidic channel has been etched completely through the layer.

24. The method of claim 17 wherein the semipermeable membrane is made by the track-etch method.

25. The method of claim 17 wherein the conformal coating is applied by vapor deposition.

26. The method of claim 25 wherein the conformal coating is parylene.

27. The method of claim 18, further comprising attaching a manifold to the assembly.

28. A method of making a microdialysis sensor comprising:

a. providing a metal support with an upper surface,

b. treating the upper surface using oxygen plasma,

c. creating a layer on the prepared upper surface by adding a hardenable liquid to the prepared upper surface and partially hardening the hardenable liquid such that the hardenable liquid adheres to the prepared upper surface and forms a new upper surface,

d. creating a channel in the partially hardened layer,

e. adhering a semipermeable membrane to the new upper surface by contacting the semipermeable membrane to the partially hardened layer and heating the assembly to further harden the layer to form an assembly including the support, the layer and the membrane, and

f. conformally coating the assembly with an insulating layer.

29. The method of claim 28 wherein the metal is stainless steel.

30. The method of claim 28 wherein the hardenable liquid is SU-8.

31. The method of claim 28 wherein the semipermeable membrane is made using the track-etch method.

32. The method of claim 28 wherein the insulating layer is parylene.

33. The method of claim 28 wherein the metal is stainless steel, the hardenable material is SU-8, the semipermeable membrane is made by the track-etch method, and the insulating layer is parylene.

34. The method of claim 28, further comprising attaching a manifold to the assembly.

35. A device comprising a plurality of body analyte monitoring system assemblies, the assemblies comprising:

a. a support with an upper surface, wherein the support with an upper surface is shared by the plurality of the assemblies;

b. a layer adhered to the upper surface, the layer including a hardenable material wherein a plurality of microfluidic channels are etched after the layer is at least partially hardened, the plurality of microfluidic channels forming a plurality of respective microfluidic networks of the assemblies, wherein the layer is shared by the plurality of assemblies;

c. a semipermeable membrane at least partially covering the layer, wherein the membrane is shared by the plurality of assemblies; and

d. manifolds associated with respective assemblies, the manifolds covering at least a portion of the semipermeable membranes of the respective assemblies, wherein the manifolds comprise a plurality fluid access ports adapted to provide fluid access to the microfluidic network of the respective assemblies to permit a plurality of respective fluids to at least one of enter and exit the respective microfluidic network through the respective manifold, and wherein the manifolds further comprises electrical leads adapted to provide electrical access to respective chambers of the respective microfluidic network.

36. The device of claim 35, wherein the device comprises at least about 100 assemblies.

37. The device of claim 35, wherein the device comprises at least about 500 assemblies.

41. The device of claim 35 further comprising a drug delivery system such that the amount or rate of delivery of the drug by the drug delivery system is based on a measurement made by the device.

38. A method of making a plurality of microdialysis assemblies, comprising the actions of:

a. providing a support with an upper surface;

b. creating a layer on the upper surface by adding a hardenable liquid to the upper surface and partially hardening the hardenable liquid such that the hardenable liquid adheres to the upper surface and forms a new upper surface;

c. creating a plurality of channels in the partially hardened layer to form a plurality of individual microfluidic networks;

d. adhering a semipermeable membrane to the new upper surface and hardening the layer to form an assembly including the support, the layer and the membrane;

e. creating a manifold layer, the manifold layer comprising a plurality fluid access ports adapted to provide fluid access to the individual microfluidic networks to permit a plurality of respective fluids to at least one of enter and exit the respective microfluidic networks through the manifold layer, and wherein the manifold layer further comprises electrical leads adapted to provide electrical access to chambers of the microfluidic networks; and

f. separating the device made by actions a-e into a plurality of assemblies, the plurality of assemblies including a plurality of assemblies each including a microfluidic network, and a plurality fluid access ports adapted to provide fluid access to the microfluidic network to permit a plurality of respective fluids to at least one of enter and exit the microfluidic network through the manifold.

39. The method of claim 38, further comprising separating the device into at least about 100 assemblies.