Iontophoretic intra-tympanic drug delivery system

• US 7,840,260 B2
• Filed: 01/30/2008
• Issued: 11/23/2010
• Est. Priority Date: 01/20/2004
• Status: Expired due to Fees

• Current Assignee: Yainax Medical LLC
• Original Assignee: Yainax Medical LLC
• Inventors: Epley, John M.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Gilbert; Andrew M
• Application Number:
  US12/012,109
• Publication Number:
  US 20080132824A1
• Time in Patent Office: 1,028 Days
• Field of Search: 604/21, 604/35, 604/239, 604/275, 604/514, 606/109
• US Class Current: 604/21
• 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 11/20 Ear surgery
• CPC Class Codes: A61M 2205/07 having air pumping means
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2210/0668 Middle ear
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1428 with manual pumping action
• CPC Class Codes: A61M 5/1582 Double lumen needles
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

A system, method, and apparatus for iontophoretically delivering medically-active ions beyond the tympanic membrane, into a middle ear portion of a patient, and to an area or structure of the middle or inner ear that is targeted for treatment. The system and apparatus can include a needle configured partially for insertion through a tympanic membrane and having a longitudinal bore, a flexible lumen coupled with the needle, and typically a fluid source coupled with the lumen such that a fluid in the fluid source can be delivered from the fluid source, through the lumen and the needle, and into the middle ear. A positioning tab can be coupled with the needle to assist determining a proper insertion extent of the needle through the membrane. The system and method can also include a power source having oppositely charged electrodes, electrically-conductive materials coupled with an electrode and disposed within the fluid source, lumen, and/or needle, and electrically-conductive materials coupled with an oppositely-charged electrode and further coupled with the patient'"'"'s skin. Medically-active ions are iontophoretically delivered by the apparatus, when the fluid is delivered to a patients middle ear and an electrical charge is imparted to the ions by the apparatus.

Claims

1. An iontophoretic system for delivering medically-active ions in solution to a middle ear of a patient, comprising:

a needle, wherein the needle is configured to enable one or both of delivering a fluid to and removing fluid from a middle ear of a patient, the needle comprising;

a sharpened end configured to pierce a tympanic membrane and for insertion through the tympanic membrane of the ear;

wherein the sharpened end of the needle includes multiple sharpened knife-like edges radiating outward from a common central sharpened point, the edges presented outwardly from a longitudinal axis of the needle and configured when inserted through the tympanic membrane to form multiple membrane flaps;

an opposite end,

at least one longitudinal bore configured to extend between the opposite end and the sharpened end, and

a fluid outlet proximate to the sharpened end and in fluid communication with the at least one longitudinal bore;

a flexible lumen in fluid communication with the at least one longitudinal bore and having a first end configured to operatively couple with the opposite end of the needle and having a second end configured to operatively couple with a fluid source; and

iontophoretic means configured with at least an anode and a cathode to deliver medically-active ions through the needle to the middle ear.

2. The system of claim 1, wherein substantial portions of an exterior surface of the needle are formed of an electrically nonconductive material, are covered by an electrically nonconductive material, or comprise a combination thereof.

3. The system of claim 1, wherein the iontophoretic means comprises:

one or more electrical power sources configured to supply an electrical current;

at least a first electrically-conductive material operatively coupled with a first electrode of the one or more electrical power sources and provided either within or as a part of the longitudinal bore; and

at least a second electrically-conductive material configured to attach to the patient'"'"'s skin and operatively coupled with a second electrode of the one or more power sources, wherein the second electrode is configured for an opposite electrical charge relative to the first electrode.

4. The system of claim 1, wherein the iontophoretic means includes electrically-conductive means for supplying an ionizing electrical charge to a fluid residing within the longitudinal bore, the flexible lumen, or both, and means for applying an opposite electrical charge to a patient'"'"'s body such that iontophoresis of medically active ions is induced from the fluid provided through the needle to a round window membrane of the patient'"'"'s middle ear.

5. The system of claim 4, wherein the means for supplying an ionizing electrical charge comprises multiple electrodes residing within any one of or collectively within a combination selected from the group consisting of the longitudinal bore, the flexible lumen, and a fluid reservoir in fluid communication with the flexible lumen.

6. The system of claim 5, wherein the electrodes are configured to provide an ionizing electrical charge in two or more stages and to provide a contiguous electromotive force gradient as a voltage drop sequentially toward the middle ear.

7. The system of claim 2, wherein the needle further comprises a positioning tab operatively coupled with the exterior of the needle and configured to contact a surface of the tympanic membrane external to the middle ear and to establish a maximum insertion extent of the sharpened end of the needle through the tympanic membrane, and wherein substantial portions of an exterior surface of the positioning tab are formed of an electrically nonconductive material, are covered by an electrically nonconductive material, or comprise a combination thereof.

8. An iontophoretic method for delivering medically-active ions in solution to a middle ear of a patient, comprising:

imparting a positive electrical charge to medically-active ions of a fluid by operatively coupling an anode of a power source with the fluid;

imparting a negative electrical charge to a round window membrane of a middle ear of a patient by operatively coupling a cathode of the power source to the patient;

inserting a portion of a needle through a tympanic membrane of the patient so that a sharpened end of the needle and a fluid outlet proximate to the sharpened end are presented within the middle ear;

wherein the sharpened end of the needle includes multiple sharpened knife-like edges radiating outward from a common central sharpened point, the edges presented outwardly from a longitudinal axis of the needle and configured when inserted through the tympanic membrane to form multiple membrane flaps;

providing the fluid to the middle ear through the fluid outlet via a longitudinal bore of the needle in fluid communication with the fluid outlet; and

iontophoretically delivering the medically-active ions to one or both of the round window membrane and a portion of an inner ear separated from the middle ear by the round window membrane.

9. The method of claim 8, wherein delivering the medically-active ions comprises maintaining an elevated concentration of positively-charged, medically-active ions within the middle ear by sequentially providing fresh fluid via the needle and evacuating spent fluid via a Eustachian tube of the patient.

10. The method of claim 8, wherein substantial portions of an exterior surface of the needle are formed of an electrically nonconductive material, are covered by an electrically nonconductive material, or are formed and covered according to a combination thereof.

11. The method of claim 8, further comprising one of:

providing the anode within a structure or within two or more of a contiguous combination of structures selected from the group consisting of the longitudinal bore, a fluid reservoir in fluid communication with the longitudinal bore, and a flexible lumen in fluid communication with the longitudinal bore;

or

providing the anode as one of a plurality of anodes within one of or any combination of structures selected from the group consisting of the longitudinal bore, a fluid reservoir in fluid communication with the longitudinal bore, and a flexible lumen in fluid communication with the longitudinal bore.

12. The method of claim 10, further comprising:

providing a positioning tab operatively coupled with the exterior surface of the needle and configured to contact a surface of the tympanic membrane external to the middle ear when the needle is inserted through the tympanic membrane, and further configured to delimit the portion of the needle to be inserted through the tympanic membrane, wherein substantial portions of an exterior surface of the positioning tab are formed of an electrically nonconductive material, are covered by an electrically nonconductive material, or comprise a combination thereof.

13. An iontophoretic intra-tympanic drug delivery apparatus, comprising:

a fluid delivery portion comprising,

a needle having a sharpened end, an opposite end, a longitudinal bore extending from the sharpened end to the opposite end, and a fluid outlet from the longitudinal bore disposed proximate the sharpened end, wherein the sharpened end of the needle includes multiple sharpened knife-like edges radiating outward from a common central sharpened point, the edges presented outwardly from a longitudinal axis of the needle and configured when inserted through the tympanic membrane to form multiple membrane flaps;

a positioning tab coupled with an exterior portion of the needle between the sharpened end and the opposite end and configured to contact a surface of a tympanic membrane of a patient when the sharpened end of the needle is inserted therethrough, and

a flexible lumen operatively coupled with the opposite end and in fluid communication with the longitudinal bore; and

an iontophoretic portion, comprising,

one or more power sources,

a first current-carrying means operatively coupled with a first electrode of the one or more power sources, and

a first electrically-conductive material operatively coupled with the first current-carrying means;

the first electrically-conductive material being configured during use to be located within, and to be in electrically-conductive contact with a fluid within, one or more selected from the group consisting of the flexible lumen, the longitudinal bore, or a fluid reservoir operatively coupled with and in fluid communication with the flexible lumen.

14. The apparatus of claim 13, wherein the iontophoretic portion further comprises:

a second current-carrying means operatively coupled with a second electrode of the one or more power sources, and

a second electrically-conductive material operatively coupled with the second current-carrying means and configured to operatively couple with skin of the patient.

15. The apparatus of claim 13, wherein a substantial exterior portion of the needle, the positioning tab, or both is/are formed of an electrically-nonconductive material, is covered with an electrically-nonconductive material, or is a combination of so covered and so formed.

16. The apparatus of claim 14, wherein one of the first or the second electrode is an anode, and the other of the first or the second electrode is a cathode, and the apparatus is configured to form a current-carrying electrical circuit when operatively coupled with a patient and when a fluid comprising medically-active ions is operatively disposed through the fluid delivery means into a middle ear of the patient.

17. The apparatus of claim 13, wherein the sharpened end of the needle includes multiple sharpened knife-like edges radiating outward from a common central sharpened point, the edges presented outwardly from a longitudinal axis of the needle and configured when inserted through the tympanic membrane to form multiple membrane flaps with cleanly incised reciprocal margins.

18. The apparatus of claim 13, further comprising:

one or more controllers operatively coupled with the current-carrying means and configured to modulate an electrical current supplied to the current-carrying means from the one or more power sources.