Inner Ear Drug Delivery Device and Method

• US 20100106134A1
• Filed: 10/15/2009
• Published: 04/29/2010
• Est. Priority Date: 10/15/2008
• Status: Abandoned Application

• Current Assignee: MED-EL Elektromedizinische Gerate GmbH (MED-EL Corporation)
• Original Assignee: MED-EL Elektromedizinische Gerate GmbH (MED-EL Corporation)
• Inventors: Jolly, Claude, Martini, Alessandro
• Application Number:
  US12/579,778
• Publication Number:
  US 20100106134A1
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61F 11/00 Methods or devices for treatment of the ears or hearing sense implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A drug delivery device for the inner ear is described. A drug delivery member for the inner ear without any stimulation electrodes has an intra-cochlear portion that penetrates into the inner ear of the patient and contains a drug eluting polymer material having at least one therapeutic drug which is released over time in a therapeutically effective amount into fluid in the inner ear of the patient.

Claims

1. A drug delivery device for the inner ear, comprising:

a drug delivery member without stimulation electrodes and including an intra-cochlear portion for penetrating into the inner ear of the patient, the member containing a drug eluting polymer material having at least one therapeutic drug for release over time in a therapeutically effective amount into fluid in the inner ear of the patient.

2. A device according to claim 1, wherein the intra-cochlear portion is a cylindrical rod.

3. A device according to claim 1, wherein the intra-cochlear portion has a conical shape.

4. A device according to claim 1, further comprising:

a support wire within at least a portion of the drug delivery device to provide supporting stability to the drug delivery member.

5. A device according to claim 8, wherein the support wire includes a puncturing point towards an apical end of the intra-cochlear portion for puncturing the round window membrane to insert the intra-cochlear portion into the inner ear.

6. A device according to claim 1, further comprising:

an extra-cochlear portion that resides in the middle ear of a patient.

7. A device according to claim 6, wherein the extra-cochlear portion completely occludes where the intra-cochlear portion penetrates into the inner ear.

8. A device according to claim 6, further comprising:

an anchor rod within the intra-cochlear portion of the drug delivery member and adapted to extend out into the middle ear, ending in a retrieval knob for pulling the drug delivery member out of the cochlea.

9. A device according to claim 8, wherein the anchor rod is adapted to penetrate through the round window membrane.

10. A device according to claim 8, wherein the intra-cochlear portion of the drug delivery member has opposing conical ends.

11. A method of delivering at least one therapeutic drug into the inner ear of a patient, the method comprising:

inserting through an opening into the inner ear an intra-cochlear portion of a drug delivery member without stimulation electrodes and including a drug eluting polymer material having at least one therapeutic drug; and

releasing from the drug eluting material over time a therapeutically effective amount of the drug into fluid in the inner ear of the patient.

12. A method according to claim 11, wherein the intra-cochlear portion is a cylindrical rod.

13. A method according to claim 11, wherein the intra-cochlear portion has a conical shape.

14. A method according to claim 11, wherein at least a portion of the drug delivery member contains a support wire to provide supporting stability to the drug delivery member.

15. A method according to claim 14, wherein the support wire includes a puncturing point towards an apical end of the intra-cochlear portion to puncture the round window membrane for inserting the intra-cochlear portion into the inner ear.

16. A method according to claim 11, wherein the drug delivery member further includes an extra-cochlear portion that resides in the middle ear of a patient.

17. A method according to claim 16, wherein the intra-cochlear portion of the drug delivery member includes an anchor rod adapted to extend out into the middle ear, ending in a retrieval knob for pulling the drug delivery member out of the cochlea.

18. A method according to claim 17, wherein the intra-cochlear portion of the drug delivery member has opposing conical ends.

19. A method according to claim 11, wherein inserting the intra-cochlear portion uses robotic surgery based on a key hole approach.

20. A method according to claim 11, wherein inserting the intra-cochlear portion uses at least one of a supra-metal approach, an atticotomy approach, a trans-canal approach, a mastoidectomy and posterior tympanotomy approach, a tympano-meatal flap approach, and a myringothomy approach.

21. A drug delivery system for delivering a therapeutic drug, the system comprising:

a drug delivery source containing the therapeutic drug and located adjacent to a mastoid cortex surface;

an elongated delivery member defining a passage through the mastoid cortex surface into the middle ear for carrying the therapeutic drug.

22. A drug delivery system according to claim 21, wherein the delivery member includes at least one delivery opening for delivering the therapeutic drug into the middle ear.

23. A drug delivery system according to claim 21, wherein the delivery member includes at least one opening for delivering the therapeutic drug into the cochlea scala.

24. A drug delivery system according to claim 21, wherein the delivery member includes an outer tube support that provides structural stiffening.

25. A drug delivery system according to claim 21, wherein the delivery member includes an inner core support that provides structural stiffening.