Implantable, tissue conforming drug delivery device

• US 7,582,080 B2
• Filed: 12/01/2005
• Issued: 09/01/2009
• Est. Priority Date: 01/09/2001
• Status: Expired due to Fees

• Current Assignee: Microchips Biotech, Inc. (Keratin Biosciences, Inc.)
• Original Assignee: MicroCHIPS Inc.
• Inventors: Cima, Michael J., Santini, John T. Jr., Sheppard, Norman F. Jr., Herman, Stephen J.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Mehta; Bhisma
• Application Number:
  US11/291,973
• Publication Number:
  US 20060178655A1
• Time in Patent Office: 1,370 Days
• Field of Search: 604/65, 604/66, 604/131, 604/890.1, 604/891.1, 604/93.01, 604/19
• US Class Current: 604/891.1
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• 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 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• 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: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: H01L 24/96 the devices being encapsulated in a common layer, e.g. neo-wafer or pseudo-wafer, said common layer being separable into individual assemblies after connecting
• CPC Class Codes: H01L 2924/00 Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/01004 Beryllium [Be]
• CPC Class Codes: H01L 2924/01005 Boron [B]
• CPC Class Codes: H01L 2924/01006 Carbon [C]
• CPC Class Codes: H01L 2924/01011 Sodium [Na]
• CPC Class Codes: H01L 2924/01013 Aluminum [Al]
• CPC Class Codes: H01L 2924/01015 Phosphorus [P]
• CPC Class Codes: H01L 2924/0102 Calcium [Ca]
• CPC Class Codes: H01L 2924/01027 Cobalt [Co]
• CPC Class Codes: H01L 2924/01033 Arsenic [As]
• CPC Class Codes: H01L 2924/01074 Tungsten [W]
• CPC Class Codes: H01L 2924/01075 Rhenium [Re]
• CPC Class Codes: H01L 2924/01079 Gold [Au]
• CPC Class Codes: H01L 2924/014 : Solder alloys
• CPC Class Codes: H01L 2924/12041 : LED
• CPC Class Codes: H01L 2924/12042 : LASER
• CPC Class Codes: H01L 2924/12043 : Photo diode
• CPC Class Codes: H01L 2924/14 : Integrated circuits
• CPC Class Codes: H01L 2924/1461 : MEMS
• CPC Class Codes: H01L 2924/19041 : being a capacitor
• CPC Class Codes: H01L 2924/19043 : being a resistor

Abstract

A drug delivery device for implantation into a patient is provided that includes at least one device element that includes a substrate having a plurality of discrete reservoirs disposed therein, the reservoirs containing drug molecules and a degradable matrix material which controls in vivo release of the drug molecules from the reservoirs, wherein the drug delivery device is adapted to conform to a curved bone tissue surface. In one embodiment, the substrate is flexible and conforms to a bone tissue surface. In another embodiment, the device has two or more device elements attached to or integral with a flexible supporting layer.

Claims

1. A drug delivery device for implantation into a patient comprising:

a first device element which comprises a first substrate having a first plurality of discrete reservoirs disposed therein and at least a second device element which comprises a second substrate having a second plurality of discrete reservoirs disposed therein, said reservoirs containing drug molecules and a degradable matrix material which controls in vivo release of the drug molecules from the reservoirs, and

a flexible supporting layer,

wherein the first and second device elements are attached to or integral with the flexible supporting layer such that drug molecules are releasable from each of the first and second pluralities of discrete reservoirs independent of drug molecules release from the other of the first and second pluralities of discrete reservoirs,

whereby the drug delivery device is conformable to a curved body tissue surface.

2. The device of claim 1, wherein the flexible supporting layer comprises a biocompatible polymer.

3. The device of claim 2, wherein the biocompatible polymer comprises a polyimide, polyester, parylene, hydrogel, polyethylene, polypropylene or silicone.

4. The device of claim 1, wherein the supporting layer is porous or provided with apertures therethrough.

5. The device of claim 1, wherein the drug molecules are dispersed in a polymeric matrix material.

6. The device of claim 5, wherein the polymeric matrix material comprises a synthetic biodegradable polymer.

7. The device of claim 5, wherein the polymeric matrix material comprises a poly(lactic acid), a poly(glycolic acid), a poly(lactic-co-glycolic acid), a poly(caprolactone), or a poly(anhydride).

8. The device of claim 1, further comprising a plurality of discrete reservoir caps, each reservoir cap covering an opening in one of the reservoirs, wherein release of the drug molecules from the reservoirs is further controlled by disintegration of the reservoir caps.

9. The device of claim 8, wherein the reservoir caps comprise a polymer which degrades in vivo to release the drug molecules.

10. The device of claim 8, wherein disintegration of the reservoir caps is actively controlled.

11. The device of claim 10, wherein the reservoir caps comprise a metal film and the device further comprises a power source and active electronics.

12. The device of claim 1, wherein the drug molecules comprise a therapeutic or prophylactic molecules.

13. The device of claim 12, wherein the therapeutic or prophylactic molecules comprise an antibiotic agent.

14. The device of claim 12, wherein the therapeutic or prophylactic molecules comprise a growth factor.

15. The device of claim 12, wherein the therapeutic or prophylactic molecules comprise fibronectin.

16. The device of claim 12, wherein the therapeutic or prophylactic molecules comprise a chemotherapeutic agent.

17. The device of claim 1, wherein the first and second device elements are flexibly connected together by tethers or hinges.

18. The device of claim 1, wherein the drug delivery device is conformable across a thickness of said drug delivery device to the curved body tissue surface.

19. The device of claim 1, wherein the drug delivery device is conformable to bone tissue.

20. A drug delivery device for implantation into a patient comprising:

two or more device elements which each comprise a substrate having a plurality of discrete reservoirs disposed therein, said reservoirs containing therapeutic or prophylactic molecules and a degradable matrix material which controls in vivo release of the therapeutic or prophylactic molecules from the reservoirs,

wherein the reservoirs of the plurality of discrete reservoirs in a first of said two or more device elements are discrete from the reservoirs of the plurality of discrete reservoirs in a second of said two or more device elements, and

wherein the two or more device elements are flexibly connected together by tethers or hinges.

21. The device of claim 20, which is adapted to conform to a bone tissue surface.

22. The device of claim 20, wherein the therapeutic or prophylactic molecules comprise an antibiotic agent or growth factor.

23. A method for delivering a drug to a site comprising:

implanting at a site in a patient at least one drug delivery device which comprises at least two device elements, each comprising a substrate which has a plurality of discrete reservoirs containing a drug, each said reservoir having a release opening formed in a release side of said substrate, the at least two device elements being attached to or formed integral with a flexible supporting layer such that said release sides of said at least two device elements are positionable facing in confronting relationship to a body tissue surface,

conforming the drug delivery device to a tissue surface at the site; and

controllably releasing the drug from the discrete reservoirs.

24. The method of claim 23, wherein the at least two device elements are attached together by tethers or hinges.

25. The method of claim 23, wherein the reservoirs further comprise a degradable matrix material which controls in vivo release of the drug from the reservoirs.

26. The method of claim 23, wherein in the step of conforming, the drug delivery device conforms across a thickness of the device to curved tissue at the site.

27. A drug delivery device for implantation into a patient comprising:

at least two device elements, each of which comprises a substrate having a plurality of discrete reservoirs disposed therein, each said reservoir having a release opening formed in a release side of said substrate, said reservoirs containing drug molecules and a degradable matrix material which controls in vivo release of the drug molecules from the reservoirs,

the at least two device elements being attached to or integral with a flexible supporting layer such that both said release sides are positionable facing in confronting relationship to a body tissue surface,

wherein the drug delivery device is conformable to a curved body tissue surface.

28. A drug delivery device (50) for implantation into a patient comprising:

two or more drug delivery device elements (54, 54), each device element comprising a substrate (60) having a plurality of discrete reservoirs (62) disposed therein, said reservoirs containing drug molecules and a degradable matrix material which controls in vivo release of the drug molecules from the reservoirs, and

a flexible supporting layer (52), and

each said two or more drug delivery device elements (54, 54) being attached to or integral with said flexible supporting layer (52),

wherein the drug delivery device is conformable to a curved body tissue surface.

29. A drug delivery device for implantation into a patient comprising:

at least two device elements, each of which comprises a substrate formed of a flexible polymeric material and having a plurality of discrete reservoirs disposed therein, each said reservoir having a release opening formed in a release side of said substrate, said reservoirs containing drug molecules and a degradable matrix material which controls in vivo release of the drug molecules from the reservoirs, and

wherein the at least two device elements are attached to or integral with a flexible supporting layer such that both said release sides are positionable facing in confronting relationship to a body tissue surface.