Iontophoresis methods

• US 8,192,420 B2
• Filed: 12/20/2007
• Issued: 06/05/2012
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Morriss, John, Liu, Greg, Hames, Kate
• Primary Examiner(s): Ho, Jackie
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US11/962,063
• Publication Number:
  US 20090163848A1
• Time in Patent Office: 1,629 Days
• Field of Search: 604/20, 604/500, 604/501, 604/512
• US Class Current: 604/501
• 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 tympanic membranes in a patient, the patient having a first and a second ear canal, the method comprising:

delivering an amount of an anesthetizing drug solution to the first ear canal, 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;

delivering an additional amount of the anesthetizing drug solution to the second ear canal;

inserting a first electrode of an iontophoresis device in the first ear canal to contact the anesthetizing drug solution;

inserting a second electrode of the iontophoresis device in the second ear canal to contact the anesthetizing drug solution;

attaching a ground electrode of the iontophoresis device to the patient, the first electrode and the ground electrode forming a first circuit, the second electrode and the ground electrode forming a second circuit;

energizing the first circuit to deliver a current to the anesthetizing drug solution in the first ear canal via the first electrode to cause at least some of the drug solution to pass into a first tympanic membrane;

energizing the second circuit to deliver a current to the anesthetizing drug solution in the second ear canal via the second electrode to cause at least some of the drug solution to pass into a second tympanic membrane, independently of energizing the first circuit and while energizing the first circuit;

independently increasing the current delivered to the first and second electrodes at a ramp-up rate of about 0.2 milliamp per second until a maximum delivered current is achieved in each electrode; and

displaying a progress meter for each of a left and right ear indicating delivery of the current to the anesthetizing drug solution for each of the left and right ear.

2. The method of claim 1, wherein the anesthetic comprises lidocaine and the buffer comprises sodium bicarbonate, and wherein the solution further comprises epinephrine.

3. The method of claim 2, wherein the drug solution includes approximately 2%-4% lidocaine by weight.

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

5. The method of claim 1, wherein the anesthetizing drug solution comprises at least one of lidocaine, epinephrine, sodium bicarbonate, other anesthetics, other buffers, and combinations thereof.

6. The method of claim 1, wherein the anesthetizing drug solution comprises at least one of an antibiotic, an anti-inflammatory, a mucolytic, a steroid, an anti-viral, a surfactant or combinations thereof.

7. The method of claim 1, wherein said energizing and increasing comprise applying the current to the anesthetizing drug solution over a time period, said current having an initial value, the ramp-up rate from said initial value to said maximum value and a ramp-down rate from said maximum value to said initial value.

8. The method of claim 7, wherein said ramp-up rate comprises a stepped and positive slope.

9. The method of claim 8, wherein said current having a final value, said final value is less than about 1.0 milliamp.

10. The method of claim 9, wherein said final value is approximately 0.8 milliamp or less.

11. The method of claim 7, wherein said period of time is between about 30 and 240 seconds.

12. The method of claim 1, further comprising pausing at least one of the energizing steps.

13. The method of claim 1, wherein said anesthetizing drug solution is an iontophoretic solution of lidocaine and epinephrine that is buffered to have a pH of about 6.8-7.2.

14. The method of claim 13, wherein said iontophoretic solution has a lidocaine HC1 concentration between approximately 2%-4% by weight.

15. The method of claim 1, further comprising monitoring the first or the second circuit'"'"'s output current.

16. The method of claim 15, wherein said monitoring comprises comparing the output current with a threshold value.

17. The method of claim 15, wherein said monitoring is performed at a rate of at least once per second.

18. A method of anesthetizing tympanic membranes in a patient, the patient having a first and a second ear canal, the method comprising:

delivering an amount of an anesthetizing drug solution to the first ear canal, 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;

delivering an additional amount of the anesthetizing drug solution to the second ear canal;

inserting a first electrode of an iontophoresis device in the first ear canal to contact the anesthetizing drug solution;

inserting a second electrode of the iontophoresis device in the second ear canal to contact the anesthetizing drug solution;

attaching a ground electrode of the iontophoresis device to the patient, the first electrode and the ground electrode forming a first circuit, the second electrode and the ground electrode forming a second circuit;

energizing the first circuit to deliver a current to the anesthetizing drug solution in the first ear canal via the first electrode to cause at least some of the drug solution to pass into a first tympanic membrane;

energizing the second circuit to deliver a current to the anesthetizing drug solution in the second ear canal via the first electrode to cause at least some of the drug solution to pass into a second tympanic membrane, independently of energizing the first circuit and while energizing the first circuit;

independently increasing the current delivered to the first and second electrodes at a ramp-up rate of about 0.2 milliamp per second until a maximum delivered current is achieved in each electrode; and

receiving a signal correlated within pain level and modifying the current delivered to the first and second electrodes in response, the signal being controlled by the patient.

19. The method of claim 18, wherein the anesthetic comprises lidocaine and the buffer comprises sodium bicarbonate, and wherein the solution further comprises epinephrine.

20. The method of claim 19, wherein the drug solution includes approximately 2%-4% lidocaine by weight.

21. The method of claim 20, wherein the drug solution includes approximately 0.5%-1.0% sodium bicarbonate by weight.

22. The method of claim 18, wherein the anesthetizing drug solution comprises at least one of lidocaine, epinephrine, sodium bicarbonate, other anesthetics, other buffers, and combinations thereof.

23. The method of claim 18, wherein the anesthetizing drug solution comprises at least one of an antibiotic, an anti-inflammatory, a mucolytic, a steroid, an anti-viral, a surfactant or combinations thereof.

24. The method of claim 18, wherein said energizing and increasing comprise applying the current to the anesthetizing drug solution over a time period, said current having an initial value, the ramp-up rate from said initial value to said maximum value and a ramp-down rate from said maximum value to said initial value.

25. The method of claim 24, wherein said ramp-up rate comprises a stepped and positive slope.

26. The method of claim 25, wherein said current having a final value, said final value is less than about 1.0 milliamp.

27. The method of claim 26, wherein said final value is approximately 0.8 milliamp or less.

28. The method of claim 24, wherein said period of time is between about 30 and 240 seconds.

29. The method of claim 18, further comprising pausing at least one of the energizing steps.

30. The method of claim 18, wherein said anesthetizing drug solution is an iontophoretic solution of lidocaine and epinephrine that is buffered to have a pH of about 6.8-7.2.

31. The method of claim 30, wherein said iontophoretic solution has a lidocaine HC1 concentration between approximately 2%-4% by weight.

32. The method of claim 18, further comprising monitoring the first or the second circuit'"'"'s output current.

33. The method of claim 32, wherein said monitoring comprises comparing the output current with a threshold value.

34. The method of claim 32, wherein said monitoring is performed at a rate of at least once per second.