Methods for accelerated release of material from a reservoir device

• US 20050055014A1
• Filed: 08/04/2004
• Published: 03/10/2005
• Est. Priority Date: 08/04/2003
• Status: Abandoned Application

• Current Assignee: MicroCHIPS Inc.
• Original Assignee: MicroCHIPS Inc.
• Inventors: Santini, John T. Jr., Sheppard, Norman F. Jr., Maloney, John M., Uhland, Scott A., Polito, Benjamin F., Coppeta, Jonathan R.
• Application Number:
  US10/911,175
• Publication Number:
  US 20050055014A1
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

Methods and devices are provided for selective release or exposure of reservoir contents, such as a drug formulation or diagnostic reagent, sealed in a reservoir, e.g., a microreservoir. The devices comprise a substrate; one or more reservoirs located in and defined by the substrate; reservoir contents located inside the reservoirs; a reservoir cap or rupturable layer sealing an outlet of the reservoir; and means for disintegrating the reservoir cap or rupturing the rupturable layer; and means for accelerating the release of the reservoir contents from the reservoir through the outlet, or for enhancing diffusional mass transport of a material into or out of the reservoir. The means for accelerating can, for example, include a shape memory material. In a preferred embodiment, the device is adapted for implantation into a human or animal body and comprises an array of several discrete reservoir, each one being individually openable at a desired time.

Claims

1. A device for the selective release or exposure of reservoir contents sealed in a reservoir comprising:

a substrate;

one or more reservoirs located in and defined by the substrate;

reservoir contents located inside the reservoirs;

a reservoir cap or rupturable layer sealing an outlet of the reservoir; and

means for disintegrating the reservoir cap or rupturing the rupturable layer; and

means for accelerating the release of the reservoir contents from the reservoir through the outlet, or for enhancing diffusional mass transport of a material into or out of the reservoir.

2. The device of claim 1, comprising means for accelerating the release of the reservoir contents, wherein the means for accelerating comprises a piston member driven by spring actuation or by volume expansion of an expansion agent.

3. The device of claim 2, wherein the piston member comprises a rigid plate or pin.

4. The device of claim 2, wherein the means for accelerating release comprises a shape memory material.

5. The device of claim 4, wherein the shape memory material comprises a shape memory alloy.

6. The device of claim 4, wherein the shape memory material comprises a shape memory polymer.

7. The device of claim 4, wherein the shape memory material is in the form of a spring positioned at the end of the reservoir distal the opening, and the means for accelerating further comprises a plate slidably positioned in the reservoir between the spring and the reservoir contents, the spring being actuatable to move the plate and reservoir contents towards the reservoir outlet to expel the reservoir contents from the reservoir.

8. The device of claim 2, wherein the expansion agent comprises a thermally expandable material disposed at the end of the reservoir distal the outlet.

9. The device of claim 1, wherein the means for accelerating comprises a propellant disposed at the end of the reservoir distal the outlet, the propellant being actuatable to move the reservoir contents towards the reservoir outlet to expel the reservoir contents from the reservoir.

10. The device of claim 9, wherein the propellant reacts to generate a gas, the expansion of which displaces the reservoir contents.

11. The device of claim 9, further comprising a flexible shell positioned in the reservoir between the propellant and the reservoir contents.

12. The device of claim 8, wherein the expansion agent and actuation means are, prior to expansion of the expandable material, separated from the reservoir contents by a layer of a hermetic material.

13. The device of claim 1, wherein the means for accelerating comprises electrodes and a voltage source which are capable of inducing the electroosmotic or iontophoretic transport of at least a portion of the reservoir contents.

14. The device of claim 1, comprising means for enhancing diffusional mass transport, wherein a surface of the substrate comprises electrodes which can be biased to induce flow of a fluid across the surface adjacent the outlet.

15. The device of claim 1, wherein the means for accelerating or means for enhancing diffusional mass transport comprises a flexible membrane disposed in the outlet of the reservoir and a vibration source element.

16. The device of claim 15, further comprising a resonating structure positioned outside of the reservoir.

17. The device of claim 1, wherein the means for accelerating comprises one or more resistive heating elements inside the reservoir or at the outlet, the resistive heating elements being operable to form bubbles in liquid reservoir contents.

18. The device of claim 1, wherein the means for accelerating comprises a magnetic field source and the reservoir contents comprises magnetic microparticles.

19. The device of claim 18, wherein the reservoir contents further comprises a gel which expands upon subjection to a magnetic flux.

20. The device of claim 2, wherein the means for accelerating is the means for rupturing the rupturable layer.

21. The device of claim 1, which comprises a plurality of reservoirs and corresponding discrete reservoir caps.

22. The device of claim 21, which comprises a means for disintegrating the reservoir caps, wherein the reservoir caps comprise a conductive material and the means for disintegrating comprising a source of electric current or potential and circuitry for disintegrating the reservoir caps.

23. The device of claim 21, wherein the reservoir cap disintegrates by electrothermal ablation.

24. The device of claim 21, wherein the reservoir caps disintegrate by electrochemical oxidation.

25. The device of claim 21, wherein the reservoir caps disintegrate by mechanical rupture.

26. The device of claim 21, wherein the reservoir caps disintegrate by a thermally induced phase change.

27. The device of claim 1, wherein the reservoir contents comprises a drug.

28. The device of claim 1, wherein the reservoir contents comprises a diagnostic agent or other reagent.

29. The device of claim 1, wherein the reservoir contents comprises an enzyme or other catalyst.

30. The device of claim 1, wherein the reservoirs are microreservoirs.

31. The device of claim 1, wherein the substrate comprises silicon, a ceramic, a metal, or a combination thereof.

32. The device of claim 1, wherein the reservoir cap comprises a metal film.

33. The device of claim 1, wherein the reservoir cap disintegrates before actuation of the means for accelerating release.

34. The device of claim 1, wherein the reservoir cap disintegration or rupture of the rupturable layer occurs partially or completely due to actuation of the acceleration means.

35. The device of claim 1, wherein the reservoir contents are hermetically sealed in the reservoir before release.

36. The device of claim 1, which is an implantable drug delivery device.

37. A method for delivering to a site reservoir contents from a reservoir comprising:

providing at a site for delivery the device of claim 1;

disintegrating the reservoir cap or rupturing the rupturable layer; and

actuating the means for accelerating or the means for enhancing diffusional mass transport.

38. A method for making an array of shape memory elements, comprising:

making a series of cuts into a sheet of a shape memory material to form a plurality of shape memory elements, each of which remains connected to said sheet following said making of series of cuts.

39. The method of claim 38, wherein the shape memory material comprises a shape memory alloy.

40. The method of claim 38, wherein each shape memory element comprises a spring.

41. The method of claim 38, wherein said series of cuts are made by etching, laser machining, stamping, wire electrodischarge machining, or a combination thereof.