Systems and methods for anesthetizing ear tissue

• US 9,950,157 B2
• Filed: 08/21/2014
• Issued: 04/24/2018
• Est. Priority Date: 07/31/2008
• 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, Girotra, Rohit, Andreas, Bernard H., Baron, Scott J., Hayter, Paul G., Jenkins, Thomas R., Newhauser, Jr., Richard R., Walker, Jeffrey A.
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US14/464,884
• Publication Number:
  US 20150068539A1
• Time in Patent Office: 1,342 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 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 system for iontophoretic substance delivery to a tympanic membrane of an ear canal of a subject, the system comprising:

an earplug including;

an elongate tube defining a lumen, the elongate tube having a proximal end and a distal end; and

a flexible sealing element located at the distal end of the elongate tube, the flexible sealing element having a distal sealing surface, the flexible sealing element being capable of defining a space between the distal sealing surface, the ear canal, and the tympanic membrane, wherein

the lumen of the elongate tube is capable of delivering an iontophoretic substance to the space via an opening in the distal sealing surface;

and

an electrode device including an electrode tip located at a distal end of the electrode device, the electrode tip capable of being positioned within the lumen of the elongate tube of the earplug such that the electrode tip is entirely within the lumen of the elongate tube, the electrode device being capable of delivering the iontophoretic substance to the tympanic membrane.

2. The system of claim 1, wherein the elongate tube includes at least one electrode located distally within the lumen of the elongate tube and integrated with the lumen of the elongate tube, the at least one electrode being electrically coupleable with the electrode tip.

3. The system of claim 2 wherein the at least one electrode includes a wire shaped to form a cylindrical cage.

4. The system of claim 3, wherein the cylindrical cage includes a coil.

5. The system of claim 3, wherein the cylindrical cage includes a plurality of axially arranged loops.

6. The system of claim 3, wherein the cylindrical cage is capable of applying a compressive force onto the electrode tip.

7. The system of claim 1, wherein the distal sealing surface defines a plurality of microholes, the plurality of microholes being capable of venting fluid from the space when a fluid pressure in the space exceeds a threshold pressure.

8. The system of claim 7, wherein the plurality of microholes are-capable of venting the fluid only under a non-hydrostatic condition.

9. The system of claim 7, wherein the flexible sealing element defines an internal plenum, the internal plenum being capable of fluid communication with the space via the plurality of microholes.

10. The system of claim 9, wherein the elongate tube includes a venting channel in fluid communication with the internal plenum of the flexible sealing element.

11. The system of claim 10, wherein the elongate tube is an outer elongate tube, the system further comprising an inner elongate tube coaxially disposed within the lumen of the outer elongate tube, the venting channel being defined between an outer surface of the inner elongate tube and a luminal surface of the outer elongate tube.

12. The system of claim 1, wherein the flexible sealing element is umbrella shaped with an open end of the flexible sealing element facing toward the proximal end of the elongate tube.

13. The system of claim 1, wherein the earplug is a first earplug, the system further comprising a second earplug and a second electrode device for iontophoretic substance delivery to a second tympanic membrane of a second ear canal of the subject.

14. The system of claim 13, further comprising a headset which connects the first earplug and the second earplug.

15. The system of claim 14, wherein the headset includes a neckloop, a left ear hook capable of wrapping behind a conch of a left ear of the subject, and a right ear hook capable of wrapping behind a conch of a right ear of the subject, the neckloop connecting the left ear hook and the right ear hook.

16. The system of claim 15, wherein the left ear hook has a left contact zone capable of being placed over a left temporal bone of the subject, the right ear hook has a right contact zone capable of being placed over a right temporal bone of the subject, and the neckloop is capable of applying a compressive force to the left temporal bone via the left contact zone and the right temporal bone via the right contact zone.

17. The system of claim 15, wherein the headset further comprises at least one spring-loaded swing arm pivotally connecting at least one of the left ear hook and the right ear hook to at least one of the first earplug and the second earplug.

18. The system of claim 14, wherein the headset includes at least one low pressure fluid channel capable of fluid communication with at least one of the lumen of the elongate tube of the first earplug and a lumen of an elongate tube of the second earplug.

19. A system for iontophoretic substance delivery to a tympanic membrane of an ear canal of a subject, the system comprising:

an earplug including;

an elongate tube defining a lumen, the elongate tube having a proximal end and a distal end, the elongate tube including a venting channel within the lumen; and

a flexible sealing element located at the distal end of the elongate tube, the flexible sealing element defining an internal plenum, the flexible sealing element having a distal sealing surface, the flexible sealing element being capable of defining a space between the distal sealing surface, the ear canal, and the tympanic membrane, wherein

the lumen of the elongate tube is capable of delivering an iontophoretic substance to the space via an opening in the distal sealing surface;

and

an electrode device including an electrode tip located at a distal end of the electrode device, the electrode tip capable of being positioned within the lumen of the elongate tube such that the electrode tip is entirely within the lumen of the elongate tube, the electrode device being capable of delivering the iontophoretic substance to the tympanic membrane.

20. The system of claim 19, wherein the distal sealing surface defines a plurality of microholes, the venting channel being capable of fluid communication with the space via the plurality of microholes and the internal plenum.

21. The system of claim 20, wherein the internal plenum is capable of at least one of receiving excess iontophoretic substance from the space via the plurality of microholes, storing the excess iontophoretic substance, and returning the excess iontophoretic substance to the space via the plurality of microholes.

22. A system for iontophoretic substance delivery to a tympanic membrane of an ear canal of a subject, the system comprising:

an earplug including;

an elongate tube defining a lumen, the elongate tube having a proximal end and a distal end;

at least one electrode located distally within the lumen of the elongate tube and integrated with the lumen of the elongate tube; and

a flexible sealing element located at the distal end of the elongate tube, the flexible sealing element having a distal sealing surface, the flexible sealing element being capable of defining a space between the distal sealing surface, the ear canal, and the tympanic membrane, wherein

the lumen of the elongate tube is capable of delivering an iontophoretic substance to the space via an opening in the distal sealing surface; and

an electrode device including an electrode tip located at a distal end of the electrode device, the electrode tip capable of being positioned within the lumen of the elongate tube of the earplug such that the electrode tip is entirely within the lumen of the elongate tube, the electrode device being capable of delivering the iontophoretic substance to the tympanic membrane, the at least one electrode being electrically coupleable with the electrode tip.

23. A system for iontophoretic substance delivery to a tympanic membrane of an ear canal of a subject, the system comprising:

an earplug including;

an elongate tube defining a lumen, the elongate tube having a proximal end and a distal end, the elongate tube including at least one electrode located distally within the lumen of the elongate tube and integrated with the lumen of the elongate tube; and

a flexible sealing element located at the distal end of the elongate tube, the flexible sealing element having a distal sealing surface, the flexible sealing element being capable of defining a space between the distal sealing surface, the ear canal, and the tympanic membrane, wherein;

the lumen of the elongate tube is capable of delivering an iontophoretic substance to the space via an opening in the distal sealing surface; and

an electrode device including an electrode tip located at a distal end of the electrode device, the electrode tip capable of being positioned within the lumen of the elongate tube of the earplug such that the electrode tip is entirely within the lumen of the elongate tube, the electrode tip being electrically coupleable with the at least one electrode to deliver the iontophoretic substance to the tympanic membrane.