Drug-eluting stapes prosthesis

Patent metadata

Field	Value
Publication number	US-9662201-B2
Application number	US-201514801649-A
Country	US
Kind code	B2
Filing date	Jul 16, 2015
Priority date	Jul 3, 2007
Publication date	May 30, 2017
Grant date	May 30, 2017

Abstract

A medical implant device includes a prosthesis adapted to replace at least a portion of a bone. The prosthesis includes a drug-eluting polymer adapted to deliver a drug to at least a portion of an area surrounding the prosthesis.

First claim

What is claimed is:

1. A method of selectively administering a drug to an inner ear of a patient without administering the drug to the middle ear, the method comprising:
removing at least a portion of a stapes bone of the patient and creating an opening in the patient's stapes footplate;
obtaining a stapes prosthesis comprising
(i) a wire portion adapted for anchoring to an incus bone;
(ii) a piston portion having a proximal end coupled to the wire portion and a distal end configured to fit into the opening created in the stapes footplate, wherein the piston portion comprises a solid side wall surrounding a hollow section that opens at the distal end of the piston portion; and
(iii) a drug-eluting core comprising a drug arranged within the hollow section, wherein the solid side wall of the piston portion is constructed to limit the release of the drug only through the distal end;

inserting the distal end of the stapes prosthesis into the opening in the stapes footplate such that the distal end is in direct fluid communication with fluid in the inner ear; and
connecting the wire portion of the stapes prosthesis to the incus bone;
wherein the stapes prosthesis carries vibrations from the incus bone to the inner ear and the drug-eluting core delivers the drug directly to the fluid in the inner ear through the opening into the patient's stapes footplate without releasing the drug into the middle ear.

2. The method of claim 1 , wherein the piston portion comprises a drug-eluting polymer.

3. The method of claim 2 , wherein the piston portion comprises a monolithic polymer matrix having drug molecules distributed therethrough surrounded by the solid side wall.

4. The method of claim 1 , wherein the distal end of the piston portion comprises a semi-permeable membrane through which the drug is released to the fluid in the inner ear.

5. The method of claim 1 , wherein the drug-eluting core comprises a drug-eluting material that releases the drug over time.

6. The method of claim 5 , wherein the drug-eluting material comprises a polymer matrix, a gel, or a liquid that includes the drug.

7. The method of claim 6 , wherein the polymer matrix comprises a non-degradable polymer matrix.

8. The method of claim 6 , wherein the gel comprises a hydrogel.

9. The method of claim 1 , wherein the drug comprises one or more of a bisphosphonate, antioxidant, platinum-based chemotherapeutic agent, steroid, antibiotic, and an anti-apoptotic agent.

10. The method of claim 9 , wherein the drug comprises a bisphosphonate comprising alendronate sodium.

11. The method of claim 1 , wherein the drug comprises one or more of dexamethasone, gentamicin, and a caspase inhibitor.

12. The method of claim 1 , wherein the patient has been diagnosed with having otosclerosis or being susceptible to otosclerosis and the drug comprises a bisphosphonate.

13. The method of claim 12 , wherein the bisphosphonate comprises alendronate sodium.

14. The method of claim 1 , wherein the patient has been diagnosed with having Meniere's disease or being susceptible to Meniere's disease and the drug comprises one or more of a steroid and an antibiotic.

15. The method of claim 14 , wherein the antibiotic comprises gentamicin.

16. The method of claim 1 , wherein the patient has been diagnosed with having noise-induced hearing loss (NIHL) or being susceptible to NIHL and the drug comprises an anti-apoptotic agent.

17. The method of claim 16 , wherein the anti-apoptotic agent comprises a caspase inhibitor.

18. The method of claim 1 , wherein the solid side wall comprises a non-permeable coating or impermeable sheath.

19. The method of claim 18 , wherein the non-permeable coating or impermeable sheath comprises a metal film.

Assignees

• Massachusetts Eye & Ear Infirmary
• Charles Stark Draper Laboratory Inc

Inventors

• Keegan Mark E
• Mckenna Michael J

Classifications

• A61F2250/0024

  made from both porous and non-porous parts, e.g. adjacent parts · CPC title

• A61L27/14

  Macromolecular materials · CPC title

• A61L27/54

  Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} · CPC title

• A61F2002/183

  Ear parts · CPC title

• A61F2230/0004

  Rounded shapes, e.g. with rounded corners · CPC title