ELECTRICAL STIMULATION IN THE MIDDLE EAR FOR TREATMENT OF HEARING RELATED DISORDERS

• US 20100198302A1
• Filed: 08/31/2008
• Published: 08/05/2010
• Est. Priority Date: 09/20/2007
• Status: Active Grant

• Current Assignee: Estimme Ltd.
• Original Assignee: Estimme Ltd.
• Inventors: Shalev, Alon
• Granted Patent: US 8,718,786 B2
• Time in Patent Office: Days
• US Class Current: 607/57
• 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: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: A61N 1/36036 of the outer, middle or inner ear

Abstract

An auditory implant system for treating a hearing disorder is disclosed. Methods are also disclosed for the use thereof. The system comprises an implantable array of electrodes and a pulse generator (PG), wherein at least one electrode is a cochlear effecting electrode adapted for disposition in the associated Eustachian tube in the proximity of the associated fenestra rotunda.

Claims

1. A minimally-invasive auditory implant system for treating a hearing disorder, said system comprising:

i) an implantable array of electrodes;

ii) a pulse generator (PG);

iii) a support structure in which at least a portion of said array is mounted;

wherein at least one electrode in said array is a cochlear effecting electrode (CEE) adapted for affecting the cochlea of one first ear of a patient, said CEE further adapted for disposition in the associated first Eustachian tube in the proximity of the associated first fenestra rotunda; and

wherein said support structure is adopted for transitioning between a radially collapsed (conveying) configuration and a radially expanded (anchoring) configuration, said configuration respectively facilitating conveying said support structure through said portion of Eustachian tube and anchoring said support structure at said portion of Eustachian tube, enabling disposing at least a portion of said array in proximity of said associated fenestra rotunda.

2. A system according to claim 1 wherein said electrode array further comprises at least one second effecting electrode (SEE) adapted for effecting the associated cochlea of one second ear of said patient, said SEE further adapted for disposition in the associated second Eustachian tube in the proximity of the associated second fenestra rotunda and further wherein said pulse generator is adapted to deliver an electrical signal to said second cochlea via said SEE.

3. A system according to claim 1 wherein said support structure comprises a generally tubular engagement portion adapted to fit longitudinally in said Eustachian tube, comprising a proximal end, a distal end and a body connecting therebetween, said engagement portion having a length between about 4 millimeters to about 14 millimeters;

wherein said at least one effecting electrode is disposed near said distal end of said engagement portion, and wherein said distal end is adapted to internally engage a portion of said Eustachian tube such that said effecting electrode is anchored in said proximity to said fenestra;

wherein said system additionally comprises a delivery apparatus for releasably deploying said support structure within said Eustachian tube thereby actuating transitioning of said engagement portion from said first radially collapsed configuration to said second radially expanded configuration, said delivery apparatus optionally comprising an endoscopic visualization channel.

4. A system according to claim 1, further comprising a pulse generator adopted for generating an electrical signal to said cochlea via said effecting electrode, and provided with coupling means to said electrode, said coupling means being selected from the group consisting of a radio frequency link, an acoustic energy link, a magnetic induction link and an electric lead, said pulse generator being optionally implanted in the body of said subject and provided with means of wireless control thereby enabling its control from outside the body.

5. A system according to claim 1 wherein said support structure comprises a return electrode positioned in a body site of said subject selected from the group consisting of middle ear, pharynx, larynx, oral cavity, nasal cavity, and Eustachian tube.

7. A system according to claim 1 wherein said hearing disorder is selected from the group consisting of hearing loss, sensoryneural hearing loss, conduction hearing loss, mixed hearing loss, tinnitus, Meniere'"'"'s disease, and vertigo.

8. A minimally-invasive method for treating a hearing disorder said method comprising the steps of

i) obtaining the auditory implant system of claim 1;

ii) conveying said support structure through the Eustachean tube and anchoring it in said Eustachean tube, thereby disposing said cochlear effecting electrode in the proximity of said fenestra rotunda;

iii) generating in said PG an electrical signal and transmitting said signal to said cochlea via said effecting electrode.

9. A method according to claim 8 wherein said method comprises steps of inserting said support structure with at least a portion of said electrode array through the nosopharyngeal end of said Eustachian tube into the bony portion of said Eustachian tube and adjusting said support structure, thereby achieving a minimally invasive implantation.

10. A method according to claim 8 comprising a step of obtaining at least one second effecting electrode for effecting the associated cochlea of the second ear of said patient, and disposing said second effecting electrode in the proximity of the associated second fenestra rotunda, wherein said pulse generator is adapted to transmit an electrical signal to said second cochlea via said second effecting electrode.

11. A method according to claim 8 further comprising at least one of the following steps:

i) conveying an electrode from at least a portion of the Eustachian tube to said proximity of the fenestra rotunda; and

ii) transitioning the configuration of said support structure between a radially collapsed configuration and a radially expanded configuration.

12. A method according to claim 8 further comprising the steps of

i) releasably deploying said support structure within said Eustachian tube, thereby actuating transitioning of said engagement portion from said first radially collapsed configuration to said second radially expanded configuration;

ii) delivering an endoscopic visualization channel;

iii) adjusting, in a post-implant manner, said support structure provided with an extension arm and adapted for post implant adjustment by the physician, so as to fitting said auditory implant system in place; and

iv) positioning said effecting electrode in said middle ear of said subject.

13. A method according to claim 8 further comprising at least one additional step selected from

i) implanting said pulse generator in the body of said subject

ii) implanting said pulse generator in pharynx of said subject;

iii) implanting said pulse generator in nasopharynx of said subject;

iv) implanting at least one electrode submucosally; and

v) implanting at least one electrode subperiostally.

14. A method according to claim 8 further comprising positioning a return electrode in a body site of said subject selected from middle ear, pharynx, larynx, oral cavity, nasal cavity, and Eustachian tube.

15. A method according to claim 8 wherein said disorder is selected from the group consisting of hearing loss, sensoryneural hearing loss, conduction hearing loss, mixed hearing loss, tinnitus, Meniere'"'"'s disease, and vertigo

6. A system according to claim i wherein said system comprises at least one submucosally or subperiostally implantable electrode.