Systems and methods for anesthetizing ear tissue

• US 8,452,392 B2
• Filed: 07/27/2009
• Issued: 05/28/2013
• 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, Girotra, Rohit, Andreas, Bernard H., Baron, Scott J., Hayter, Paul G., Jenkins, Thomas, Walker, Jeffrey A., Newhauser, Richard R. Jr.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Bosworth, Kami A
• Application Number:
  US12/510,217
• Publication Number:
  US 20100030131A1
• Time in Patent Office: 1,401 Days
• Field of Search: 604/20, 604/21, 604/164.01, 604/164.02, 604/167.01, 604/167.06, 604/170.01, 604/170.02, 604/289, 604/290, 604/310, 604/311, 604/501
• 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: A61M 1/96 Suction control thereof
• CPC Class Codes: A61M 1/964 having venting means on or near the dressing
• 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 2205/3341 stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2210/0662 Ears
• CPC Class Codes: A61N 1/044 Shape of the electrode
• 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 1/36021 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 method involves using the system on a human or animal subject.

Claims

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

an earplug, comprising;

a distal portion;

a proximal portion;

a tube extending from the distal portion to the proximal portion, wherein the tube has a stiffness less than a stiffness of the proximal and distal portions of the earplug;

at least one flexible sealing element extending from an outer surface of the tube and disposed closer to the distal end than the proximal end; and

an electrode device, comprising;

an elongate shaft; and

an electrode tip having a diameter greater than that of the elongate shaft, wherein the electrode device is movable within the tube of the earplug from a retracted position, in which fluid can pass around the electrode through the tube, to an advanced position, in which the electrode tip contacts an inner surface of the tube to prevent fluid from flowing through the tube.

2. The system of claim 1, wherein the earplug further comprises a side vent in fluid communication with the tube for allowing venting of air and/or fluid from the tube.

3. The system of claim 1, wherein the distal portion is rigid relative to the tube.

4. The system of claim 1, wherein the distal portion includes an o-ring which seals against the electrode tip of the electrode device in the advanced position.

5. The system of claim 4, wherein an outer diameter of the electrode tip is greater than an internal diameter of the o-ring, and wherein the o-ring is flexible to allow the electrode tip to pass into it to form a seal.

6. The system of claim 1, wherein the proximal portion is rigid.

7. The system of claim 6, wherein the proximal portion includes a luer fitting.

8. The system of claim 1, wherein the at least one flexible sealing element is umbrella shaped, with an open end of the sealing element facing the proximal end of the earplug.

9. The system of claim 1, wherein the at least one flexible sealing element comprises a distal sealing element and a proximal sealing element, and wherein a diameter of the proximal sealing element is larger than a diameter of the distal sealing element.

10. The system of claim 9, wherein each of the flexible sealing elements is umbrella shaped, with an open end of each sealing element facing the proximal end of the earplug.

11. The system of claim 1, wherein the electrode device is malleable.

12. The system of claim 1, wherein the electrode device includes a lumen.

13. The system of claim 1, additionally comprising an ear hook connected with the proximal portion of the earplug, the ear hook including a curved member for engaging a portion of the ear and preventing dislodgement of the earplug after placement in the ear.

14. The system of claim 1, further comprising an additional earplug and an additional electrode for use in iontophoretic substance delivery to the tympanic membrane of the other ear of the human or animal subject.

15. The system of claim 14, further comprising a headset for coupling the earplug and the additional earplug while they are in the subject'"'"'s ears.

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

an elongate, flexible tube with a proximal portion and a distal portion, including a main lumen extending therethrough, the distal portion including an inner lip at the distal end of the distal portion and a sealing member proximal to the inner lip, wherein the elongate tube has sufficient flexibility to bend to conform to the shape of an ear canal;

a first flexible sealing element shaped like an umbrella to form a seal within the ear canal, the first flexible sealing element being integral to and disposed on an exterior of the elongate tube and being offset a distance from a distal most portion of the elongate tube;

a second flexible sealing element shaped like an umbrella to form a seal within the ear canal, the second flexible sealing element being integral to and disposed on the exterior of the elongate tube and proximal to the first sealing element;

a distal stiffening tube located within the distal portion of the elongate tube distal to the sealing member, the distal stiffening tube preventing the distal portion of the elongate tube from bending;

a luer fitting coupled with the proximal portion of the tube and including a side vent in fluid communication with the main lumen of the tube; and

an electrode device comprising;

an elongate shaft; and

an electrode tip having a diameter greater than that of the elongate shaft, wherein the electrode device is movable within the tube lumen of the earplug from a retracted position, in which fluid can pass around the electrode through the tube, to an advanced position, in which the electrode tip fits within the distal portion of the elongate tube between the inner lip and the sealing member to form a fluid tight seal.

17. A kit for anesthetizing a tympanic membrane of an ear of a human or animal subject using iontophoresis, the kit comprising:

an earplug, comprising;

a distal portion;

a proximal portion;

a tube extending from the distal portion to the proximal portion, wherein the tube has a stiffness less than a stiffness of the proximal and distal portions of the earplug;

at least one flexible sealing element extending from an outer surface of the tube and disposed closer to the distal end than the proximal end; and

an electrode device, comprising;

an elongate shaft; and

an electrode tip having a diameter greater than that of the elongate shaft, wherein the electrode device is movable within the tube of the earplug from a retracted position, in which fluid can pass around the electrode through the tube, to an advanced position, in which the electrode tip contacts an inner surface of the tube to prevent fluid from flowing through the tube; and

a controller electrically connectable to the electrode device.

18. The kit of claim 17, further comprising:

an additional earplug for the other ear of the subject; and

an additional electrode device for the additional earplug, wherein the controller connects to the electrode device and the additional electrode device.

19. The kit of claim 17, further comprising a headset for placing on the subject'"'"'s head and holding the electrode and earplug.

20. The kit of claim 17, further comprising a drug solution to provide iontophoretic anesthesia to the tympanic membranes of both ears of the subject.

21. The kit of claim 20, further comprising a drug delivery device for delivering the drug solution into the ear canals of the subject.