SYSTEMS AND METHODS FOR ANESTHETIZING EAR TISSUE

• US 20100198135A1
• Filed: 12/30/2009
• Published: 08/05/2010
• Est. Priority Date: 07/31/2008
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Morriss, John H., Liu, Greg, Andreas, Bernard H., Jenkins, Thomas, Walker, Jeffrey A., Girotra, Rohit, Hayter, Paul G., Baron, Scott J., Newhauser, Richard R. JR.
• Granted Patent: US 8,840,602 B2
• Time in Patent Office: Days
• 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: 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: A61K 9/0046 Ear
• 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 2202/048 Anaesthetics see also A61M19/00
• CPC Class Codes: A61M 2205/3341 stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2210/0662 Ears
• CPC Class Codes: A61M 2210/0668 Middle ear
• CPC Class Codes: A61M 3/0279 Cannula; Nozzles; Tips; their connection means
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• 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

Abstract

A system and method for use in iontophoretic anesthesia of a tympanic membrane are disclosed. The system generally includes an earplug and an electrode device. The earplug includes at least one sealing member for sealing the earplug in an ear canal. The sealing member includes microholes which vent fluid above a certain pressure threshold. A headset may connect the earplug to a second earplug. The method involves using the system on a human or animal subject.

Claims

1. A method to deliver an iontophoretic substance to the tympanic membrane of an ear of a human or animal subject, the method comprising:

inserting an earplug into an ear canal of a patient;

fluidly sealing a portion of a flexible sealing element of the earplug in the ear canal to create a space between the earplug and the tympanic membrane; and

injecting a iontophoretic substance into the earplug to fill the space between the earplug and the tympanic membrane;

wherein the space becomes pressurized with the iontophoretic substance during injecting, and wherein fluid within the space is vented through microholes in the flexible sealing element to relieve the pressure.

2. The method of claim 1, wherein the microholes are configured to vent the fluid above a pressure threshold.

3. The method of claim 2, wherein the microholes are configured to not vent the fluid under hydrostatic condition.

4. The method of claim 1, wherein the fluid is vented into a plenum of the earplug.

5. The method of claim 1, further comprising:

inserting an electrode device into the earplug to bring a electrode tip of the electrode device into contact with the iontophoretic substance; and

energizing the electrode device to anesthetize the tympanic membrane using the iontophoretic substance.

6. The method of claim 5, wherein the electrode tip electrically couples with an electrode of the earplug, and wherein the electrode of the earplug is energized with the electrode device.

7. The method of claim 1, wherein inserting an earplug comprises placing a headset connected to the earplug behind a neck of the patient.

8. The method of claim 7, wherein the headset includes left and right ear hooks, and wherein placing the headset comprises placing respective portions of the left and right ear hooks over left and right temporal bones of the patient.

9. The method of claim 7, wherein the headset is connected to a second earplug, the second earplug being configured identically to the earplug, and wherein the headset applies an independent force to the earplugs to maintain them in their respective ear canals.

10. The method of claim 9, wherein the headset includes fluid channels respectively fluidly connected to the earplug and the second earplug, and wherein injecting the iontophoretic substance comprises filling the fluid channel of the headset under low pressure.

11. The method of claim 1, further comprising:

observing the fluid venting out of the earplug and wherein injecting the iontophoretic substance is stopped after the fluid is observed venting out of the earplug.

12. A system for iontophoretic substance delivery to the tympanic membrane of an ear of a human or animal subject, the system comprising:

an earplug, comprising;

a flexible sealing element including an elongate tube extending proximally therefrom, the flexible sealing element having a distal sealing surface with a plurality of microholes, the microholes being configured to vent fluid above a pressure threshold; and

an electrode device moveable within the inner tube, the electrode device including an elongate shaft connected to an electrode tip.

13. The system of claim 12, wherein the microholes are configured to not vent the fluid under a hydrostatic condition.

14. The system of claim 12, wherein the flexible sealing element includes an internal plenum, the microholes being fluidly connected to the internal plenum.

15. The system of claim 14, wherein the internal plenum is fluidly connected to a venting channel of the elongate tube.

16. The system of claim 15, wherein the elongate tube comprises an elongate outer tube over an elongate inner tube, with the venting channel positioned therebetween.

17. The system of claim 12, wherein the elongate tube includes at least one electrode integrated into the elongate tube, the at least one electrode being electrically connectable with the electrode tip.

18. The system of claim 17, wherein the electrode comprises a wire shaped as a cylindrical cage.

19. The system of claim 18, wherein the cylindrical cage comprises a coil.

20. The system of claim 18, wherein the cylindrical cage comprises a plurality of axially arranged loops.

21. The system of claim 18, wherein the cylindrical cage is configured to compress the electrode tip.

22. The system of claim 12, wherein the flexible sealing element is umbrella shaped.

23. The system of claim 12, further comprising a second earplug and a second electrode device, both respectively configured identically to the earplug and the electrode device.

24. The system of claim 23, further comprising a headset which connects the earplug and the second earplug.

25. The system of claim 24, wherein the headset comprises a neckloop connected to left and right ear hooks, the left and right ear hooks respectively configured to wrap behind the conchs of ears.

26. The system of claim 25, wherein the left and right ear hooks are each configured to apply compressive force from the neckloop over left and right temporal bones of the patient, respectively.

27. The system of claim 25, wherein the headset further comprises left and right low pressure fluid channels, each fluidly connected to the inner tubes of the earplug and the second earplug, respectively.

28. The system of claim 25, wherein the headset further comprises a left and right spring-loaded swing arm, each pivotally connected to the left and right ear hooks, respectively, and each connected to the earplug and the second earplug, respectively.