Multi-functional inner ear treatment and diagnostic system

• US 5,476,446 A
• Filed: 04/21/1995
• Issued: 12/19/1995
• Est. Priority Date: 10/18/1993
• Status: Expired due to Term

• Current Assignee: DURECT Corporation
• Original Assignee: Inner Ear Medical Delivery Systems, Inc.
• Inventors: Arenburg, Irving K.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/426,190
• Time in Patent Office: 242 Days
• Field of Search: 604/20-21, 604/892.1, 604/96-103, 604/52-53, 128/DIG 12, 128/24 AA
• US Class Current: 604/21
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 11/006 Ear cleaners, e.g. curettes cotton tips A61F13/38; cleaning by suction A61M1/71, by irrigation A61M3/02
• 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

Abstract

A therapeutic treatment apparatus for use in the middle and inner ear. The apparatus includes a tubular stem portion attached to a medicine-retaining reservoir with an internal cavity. The reservoir includes multiple pores therethrough or an opening having a semipermeable membrane therein which enables medicine delivery from the reservoir. Such delivery occurs when the reservoir comes in contact with selected middle-inner ear interface tissues. A conductive member for receiving electrical potentials from ear tissues is affixed to the apparatus. Alternatively, the apparatus may include tubular first and second stem portions secured on opposite sides of a reservoir along with a conductive member attached thereto of the type indicated above. This apparatus is surgically inserted so that the first stem portion is placed within the inner ear. At least part of the apparatus (the second stem portion) resides within the external auditory canal. A further alternative embodiment involves an apparatus with a stem portion, a reservoir, and an inflatable insert member therein. The insert member is operatively connected to a temperature-controlled fluid supply designed to deliver fluids (e.g. gases or liquids) to the insert causing expansion thereof. Such expansion can therapeutically modify the pressure characteristics of inner ear fluids and fluid chambers.

Claims

1. A treatment apparatus for delivering therapeutic agents into the inner ear of a human subject comprising:

a reservoir portion comprising an exterior wall and an internal cavity therein surrounded by said wall;

a tubular first stem portion comprising an open first end, a second end, and a passageway extending continuously through said first stem portion, said second end of said first stem portion being connected to said reservoir portion so that said passageway through said first stem portion is in fluid communication with said internal cavity in said reservoir portion; and

a tubular second stem portion comprising an open first end, a second end, and a passageway extending continuously through said second stem portion, said second end of said second stem portion being connected to said reservoir portion so that said passageway through said second stem portion is in fluid communication with said internal cavity in said reservoir portion.

2. The treatment apparatus of claim 1 wherein said first stem portion is positioned on a first side of said reservoir portion and said second stem portion is positioned on a second side of said reservoir portion, said first side being directly opposite said second side so that said first stem portion and said second stem portion form a 180°

angle relative to each other.

3. The treatment apparatus of claim 1 wherein at least one of said first stem portion and said second stem portion comprises a valve positioned therein.

4. The treatment apparatus of claim 1 wherein at least a portion of said apparatus is radiopaque so that said portion will be visible during application of X-rays thereto.

5. A treatment apparatus for delivering therapeutic agents into the inner ear of a human subject comprising:

a reservoir portion comprising an exterior wall and an internal cavity therein surrounded by said wall;

a tubular first stem portion comprising an open first end, a second end, and a passageway extending continuously through said first stem portion, said second end of said first stem portion being connected to said reservoir portion so that said passageway through said first stem portion is in fluid communication with said internal cavity in said reservoir portion;

a tubular second stem portion comprising an open first end, a second end, and a passageway extending continuously through said second stem portion, said second end of said second stem portion being connected to said reservoir portion so that said passageway through said second stem portion is in fluid communication with said internal cavity in said reservoir portion; and

electrical potential transmission means fixedly secured to said apparatus for transmitting electrical potentials into and out of said inner ear.

6. The treatment apparatus of claim 5 wherein said electrical potential transmission means comprises an elongate conductive member, said conductive member comprising a proximal end and a distal end.

7. The treatment apparatus of claim 6 wherein said proximal end of said conductive member comprises a conductive spherical member fixedly secured thereto.

8. The treatment apparatus of claim 5 wherein said first stem portion is positioned on a first side of said reservoir portion and said second stem portion is positioned on a second side of said reservoir portion, said first side being directly opposite said second side so that said first stem portion and said second stem portion form a 180°

angle relative to each other.

9. A method for delivering therapeutic agents to the inner ear of a human subject through the external auditory canal and middle ear thereof comprising the steps of:

providing a treatment apparatus comprising;

a reservoir portion comprising an exterior wall and an internal cavity therein surrounded by said wall, said internal cavity comprising a supply of liquid therapeutic agents therein;

a tubular first stem portion comprising an open first end, a second end, and a passageway extending continuously through said first stem portion, said second end of said first stem portion being connected to said reservoir portion so that said passageway through said first stem portion is in fluid communication with said internal cavity in said reservoir portion; and

a tubular second stem portion comprising an open first end, a second end, and a passageway extending continuously through said second stem portion, said second end of said second stem portion being connected to said reservoir portion so that said passageway through said second stem portion is in fluid communication with said internal cavity in said reservoir portion;

forming an access port in said ear between said middle ear and said inner ear so that access to said inner ear from said middle ear may be achieved;

inserting said reservoir portion of said apparatus into said middle ear;

positioning said first end of said second stem portion within said external auditory canal at a position remotely spaced from said middle ear; and

placing said first end of said first stem portion through said access port and within said inner ear so that said first end of said first stem portion is against and in direct contact with tissues of said inner ear to be treated by said apparatus, said liquid therapeutic agents within said reservoir portion being delivered from said internal cavity through said first stem portion to said tissues of said inner ear during said direct contact between said first end of said first stem portion and said tissues of said inner ear.

10. The method of claim 9 further comprising the step of delivering an additional supply of liquid therapeutic agents through said external auditory canal and into said first end of said second stem portion of said apparatus while said reservoir portion is maintained within said middle ear and said first end of said first stem portion is maintained within said inner ear.

11. A method for delivering therapeutic agents to the inner ear of a human subject through the external auditory canal and middle ear thereof comprising the steps of:

providing a treatment apparatus comprising;

a reservoir portion comprising an exterior wall and an internal cavity therein surrounded by said wall, said internal cavity comprising a supply of liquid therapeutic agents therein;

a tubular first stem portion comprising an open first end, a second end, and a passageway extending continuously through said first stem portion, said second end of said first stem portion being connected to said reservoir portion so that said passageway through said first stem portion is in fluid communication with said internal cavity in said reservoir portion;

a tubular second stem portion comprising an open first end, a second end, and a passageway extending continuously through said second stem portion, said second end of said second[stem portion being connected to said reservoir portion so that said passageway through said second stem portion is in fluid communication with said internal cavity in said reservoir portion; and

electrical potential transmission means fixedly secured to said apparatus for transmitting electrical potentials into and out of said inner ear, said electrical potential transmission means comprising an elongate conductive member, said conductive member comprising a proximal end and a distal end;

forming an access port in said ear between said middle ear and said inner ear so that access to said inner ear from said middle ear may be achieved;

inserting said reservoir portion of said apparatus into said middle ear;

positioning said first end of said second stem portion within said external auditory canal at a position remotely spaced from said middle ear;

.

placing said first end of said first stem portion through said access port and within said inner ear so that said first end of said first stem portion is against and in direct contact with tissues of said inner ear to be treated by said apparatus, said liquid therapeutic agents within said reservoir portion being delivered from said internal cavity through said first stem portion to said tissues of said inner ear during said direct contact between said first end of said first stem portion and said tissues of said inner ear; and

placing said proximal end of said conductive member in direct contact with tissues from at least one of said middle ear and said inner ear.

12. The method of claim 11 further comprising the step of delivering an additional supply of liquid therapeutic agents through said external auditory canal and into said first end of said second stem portion of said apparatus while said reservoir portion is maintained within said middle ear and said first end of said first stem portion is maintained within said inner ear.