Iontophoresis methods

• US 10,576,277 B2
• Filed: 06/01/2016
• Issued: 03/03/2020
• 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:
  US15/170,366
• Publication Number:
  US 20170028193A1
• Time in Patent Office: 1,371 Days
• 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 second until a maximum current is achieved.

Claims

1. A method of anesthetizing a tympanic membrane of an ear of a patient using iontophoresis, the method comprising:

delivering a solution to an ear canal of the ear, the solution including a therapeutic agent;

applying a current to the solution in stepped increments via a circuit, such that the current transports the therapeutic agent into the tympanic membrane;

monitoring an output value associated with the applying, the output value being at least one of an output current of the circuit, an output voltage of the circuit, and a setpoint current of the circuit;

measuring the current applied to the solution; and

determining, based on the stepped increments and the current measured, an amount of charge delivered by the current.

2. The method of claim 1, wherein the solution includes lidocaine of greater than 2% by weight.

3. The method of claim 2, wherein the solution includes approximately 0.5%-1.0% sodium bicarbonate by weight.

4. The method of claim 1, wherein the solution has a pH range of about 6.8-7.2.

5. The method of claim 1, wherein applying the current in stepped increments includes:

increasing a level of the current to a first level;

maintaining the level of current at the first level for a predefined period of time; and

,

following the predefined period of time, increasing the level of current to a second level.

6. The method of claim 1, wherein applying the current includes increasing a level of the current to a predefined level of approximately 1.0 milliamp or less.

7. A method of anesthetizing a tympanic membrane of an ear of a patient using iontophoresis, the method comprising:

increasing a concentration of ionized molecules of a therapeutic agent in an iontophoresis solution;

adding a buffer to the iontophoresis solution to reduce the acidity level of the iontophoresis solution such that the iontophoresis solution with the buffer has a pH in a range of about 6.5 to about 7.5;

delivering, after the increasing and the adding, the iontophoresis solution to an ear canal of the ear; and

applying a current to the drug solution to transport the ionized molecules of the therapeutic agent into the tympanic membrane adjacent to the ear canal.

8. The method of claim 7, wherein the pH of the iontophoresis solution with the buffer is in the range of about 6.8 to about 7.2.

9. The method of claim 7, wherein applying the current includes increasing a level of the current at a rate of about 0.2 milliamps per second.

10. The method of claim 7, wherein applying the current includes increasing a level of the current to a predefined level of approximately 0.8 milliamps or less.

11. The method of claim 7, wherein the increasing the concentration of ionized molecules of the therapeutic agent is based on the adding the buffer solution.

12. The method of claim 7, wherein the therapeutic agent in the iontophoresis solution includes 3.3%-4% lidocaine by weight.

13. A method of treating a patient, the patient having an ear canal, the method comprising:

positioning a fluid in the ear canal, the fluid including a therapeutic agent;

inserting an electrode of an iontophoresis device in the ear canal;

attaching a ground electrode of the iontophoresis device to the patient, the electrode and the ground electrode forming a circuit configured to deliver a current to the fluid,

energizing the circuit to deliver the current at a first level to the fluid;

receiving a signal using an input device indicating a level of discomfort experienced by the patient; and

in response to the receiving, changing the current delivered by the circuit to a second level based on the signal indicating the level of discomfort experienced by the patient.

14. The method of claim 13, wherein the therapeutic agent includes an anesthetic.

15. The method of claim 13, wherein the therapeutic agent includes at least one of lidocaine, epinephrine, sodium bicarbonate, other anesthetics, other buffers, or combinations thereof.

16. The method of claim 13, wherein the therapeutic agent includes at least one of an antibiotic, an anti-inflammatory, a mucolytic, an anesthetic, a steroid, an anti-viral, a surfactant or combinations thereof.

17. The method of claim 13, wherein the energizing includes energizing the circuit to deliver the current in stepped increments over a time period until a level of the current is at the first level.

18. The method of claim 17, wherein the first level is less than 1.0 milliamp.

19. The method of claim 13, wherein the changing the current includes increasing the current to the second level based on the signal indicating the level of discomfort experienced by the patient.

20. The method of claim 13, wherein the changing the current includes decreasing the current to the second level based on the signal indicating the level of discomfort experienced by the patient.