Method of controlled drug delivery from implant device

• US 7,892,221 B2
• Filed: 01/21/2005
• Issued: 02/22/2011
• Est. Priority Date: 07/02/1996
• Status: Expired due to Fees

• Current Assignee: Massachusetts Institute of Technology
• Original Assignee: Massachusetts Institute of Technology
• Inventors: Santini, John T. Jr., Göpferich, Achim, Cima, Michael J., Langer, Robert S.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US11/041,161
• Publication Number:
  US 20050149000A1
• Time in Patent Office: 2,223 Days
• Field of Search: 604/891, 604/891.1, 604/20, 604/93.01, 604/288.01, 128/899
• US Class Current: 604/890.1
• 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 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: C25F 5/00 Electrolytic stripping of metallic layers or coatings
• CPC Class Codes: C25F 7/00 Constructional parts, or assemblies thereof, of cells for electrolytic removal of material from objects for both electrolytic coating and removal C25D; Servicing or operating
• CPC Class Codes: Y10T 137/8242 Electrical

Abstract

Reservoir-based medical devices are provided. In one embodiment, the medical device comprises a substrate; at least two discrete, microfabricated reservoirs provided in spaced positions across at least one surface of the substrate; discrete reservoir caps covering the at least two reservoirs; and control circuitry for selectively disintegrating the reservoir caps to open the reservoirs. The reservoirs of the device can include a diagnostic reagent or other molecules useful in medical diagnostics. In one embodiment, the reservoir cap comprises an anode and the control circuitry comprises a cathode and a power source for creating an electric potential between the cathode and the anode. Application of the electric potential causes the reservoir cap to disintegrate, thereby opening the reservoir.

Claims

1. A method for local delivery of drug molecules in a patient, the method comprising:

implanting at a site in a patient a drug delivery device which comprises a support structure, at least two discrete reservoirs provided in spaced positions across at least one surface of the support structure, and a release system loaded in each of the reservoirs, the release system including drug molecules dispersed in a degradable matrix material; and

allowing the matrix material to disintegrate in vivo to release the drug molecules from the reservoirs to the site in a controlled manner.

2. The method of claim 1, wherein the drug delivery device is implanted via a catheter.

3. The method of claim 1, wherein the drug molecules are released from the device in a pulsatile manner.

4. The method of claim 1, wherein the drug molecules are released from the device over a period of time of at least three months.

5. The method of claim 1, wherein one of the at least two reservoirs comprises two or more layers of the release system.

6. The method of claim 1, wherein the kinetics of release of the drug molecules from one of the at least two reservoirs is different than the kinetics of release of the drug molecules from the other of the at least two reservoirs.

7. The method of claim 1, wherein the drug delivery device further comprises at least two discrete degradable reservoir caps, each reservoir cap covering one of the at least two reservoirs and delaying onset of release of the drug molecules therefrom.

8. The method of claim 1, wherein the matrix material comprises a biodegradable or bioerodible polymeric material.

9. The method of claim 1, wherein the drug molecules comprise anesthetics, vaccines, chemotherapeutic agents, metabolites, immunomodulators, antioxidants, antibiotics, and ion channel regulators, or hormones.

10. The method of claim 1, wherein the substrate comprises silicon or metal.

11. The method of claim 1, wherein the substrate comprises a polymer.

12. The method of claim 1, wherein the reservoirs are microfabricated.

13. A method for local delivery drug molecules in a patient, the method comprising:

implanting at a site in a patient a drug delivery device which comprises a support structure, at least two discrete reservoirs provided in spaced positions across at least one surface of the support structure, and a release system loaded in each of the reservoirs, the release system including drug molecules dispersed in a non-degradable matrix material; and

allowing the drug molecules to diffuse from the matrix material in vivo to release the drug molecules from the reservoirs to the site in a controlled manner.

14. The method of claim 13, wherein the drug delivery device is implanted via a catheter.

15. The method of claim 13, wherein the drug molecules are released from the device over a period of time of at least three months.

16. The method of claim 13, wherein the kinetics of release of the drug molecules from one of the at least two reservoirs is different than the kinetics of release of the drug molecules from the other of the at least two reservoirs.

17. The method of claim 13, wherein the drug delivery device further comprises at least two discrete reservoir caps, each reservoir cap covering one of the at least two reservoirs and delaying the onset of release of the drug molecules therefrom.

18. The method of claim 17, wherein the reservoirs caps comprise a polymer.

19. The method of claim 13, wherein the matrix material comprises a polymeric material.

20. The method of claim 13, wherein the drug molecules comprise anesthetics, vaccines, chemotherapeutic agents, metabolites, immunomodulators, antioxidants, antibiotics, and ion channel regulators, or hormones.

21. The method of claim 13, wherein the substrate comprises silicon or metal.

22. The method of claim 13, wherein the substrate comprises a polymer.

23. The method of claim 13, wherein the reservoirs are microfabricated.