Iontophoresis methods

• US 9,392,229 B2
• Filed: 05/09/2012
• Issued: 07/12/2016
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Inventors: Morriss, John H., Liu, Greg, Hames, Kate
• Primary Examiner(s): HAYMAN, IMANI N
• Application Number:
  US13/467,851
• Publication Number:
  US 20120220923A1
• Time in Patent Office: 1,525 Days
• Field of Search: 604 20- 22, 604/500, 604/501, 604/512
• US Class Current: 1/1
• 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: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61M 2210/0662 Ears
• 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: 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 1/303 Constructional details electrodes for external use A61N1/0428
• 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
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: H04N 21/4722 for requesting additional data associated with the content
• CPC Class Codes: H04N 21/6581 Reference data, e.g. a movie identifier for ordering a movie or a product identifier in a home shopping application
• CPC Class Codes: H04N 21/8352 involving content or source identification data, e.g. Unique Material Identifier [UMID]
• CPC Class Codes: H04N 21/858 Linking data to content, e.g. by linking an URL to a video object, by creating a hotspot
• CPC Class Codes: H04N 7/17318 Direct or substantially direct transmission and handling of requests

Abstract

A method of anesthetizing a tympanic membrane of an ear of a patient using iontophoresis is disclosed. The method involves delivering an anesthetizing drug solution to an ear canal of the patient'"'"'s ear, wherein the drug solution includes an anesthetic and a buffer, and wherein the drug solution has a pH in the range of about 6.5 to about 7.5; and applying an amount of current to the drug solution, wherein the amount of applied current is increased at a rate of less than about 0.5 milliamp per minute until a maximum current is achieved.

Claims

1. An iontophoresis system for anesthetizing a tympanic membrane of an ear of a patient, the system comprising:

(a) an anesthetizing drug solution for applying to the tympanic membrane, the anesthetizing drug solution comprising an anesthetic and a buffer, wherein the buffer is configured to raise the pH of the drug solution to an increased pH in the range of 6.8 to 7.2, and wherein the anesthetizing drug solution further comprises;

i. a percent weight of Lidocaine greater than 2% by weight, wherein the percent weight of Lidocaine is proportional to the increased pH of the anesthetizing drug solution; and

ii. approximately 0.5% to 1.0% of sodium bicarbonate by weight;

(b) a current source;

(c) an electrode configured for placement within the ear of the patient in contact with the drug solution; and

(d) a controller coupled with the current source, the controller programmed to increase an amount of current applied through the electrode to the drug solution at a rate of less than 0.5 milliamp per minute until a maximum current of less than 1.0 milliamp is achieved.

2. The system of claim 1, wherein the anesthetizing drug solution comprises an anesthetic, and a vasoconstrictor.

3. The system of claim 2, wherein the vasoconstrictor comprises epinephrine.

4. The system of claim 1, wherein the controller is programmed to increase the amount of current applied to the drug solution at a rate of 0.2 milliamp per minute until a maximum current of 0.8 milliamp is achieved.

5. The system of claim 1, wherein the current source comprises at least one ear electrode configured for placement in an ear canal of the patient.

6. The system of claim 5, wherein the current source comprises two ear electrodes configured for placement in two ear canals of the patient, thus allowing for approximately simultaneous application of current to anesthetizing drug solution disposed in the two ear canals.

7. The system of claim 1, wherein the current applied to the drug solution is direct current.

8. The system of claim 1, wherein the maximum current is at least 0.5 milliamp.

9. An iontophoresis system for anesthetizing a tympanic membrane of an ear of a patient, the system comprising:

(a) an anesthetizing drug solution for applying to the tympanic membrane, the anesthetizing drug solution comprising an anesthetic and a buffer, wherein the buffer is configured to raise the pH of the drug solution to an increased pH in the range of 6.8 to 7.2, and wherein the anesthetizing drug solution further comprises;

i. a percent weight of Lidocaine, wherein the percent weight of Lidocaine is at least 3.5%; and

ii. approximately 0.5% to 1.0% of sodium bicarbonate by weight;

(b) a current source;

(c) an electrode configured for placement within the ear of the patient in contact with the drug solution; and

(d) a controller coupled with the current source, the controller programmed to increase an amount of current applied through the electrode to the drug solution at a rate of less than 0.5 milliamp per minute until a maximum current of less than 1.0 milliamp is achieved.