Systems and methods for anesthetizing ear tissue

• US 9,713,710 B2
• Filed: 03/13/2013
• Issued: 07/25/2017
• 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: Walker, Jeffrey A., Newhauser, Jr., Richard R., Morriss, John H., Girotra, Rohit, Andreas, Bernard H., Baron, Scott J., Hayter, Paul G., Jenkins, Thomas, Liu, Greg
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US13/798,635
• Publication Number:
  US 20130197426A1
• Time in Patent Office: 1,595 Days
• Field of Search: 600379, 604 20, 604 21, 60416402, 60416404, 60416706, 606109, 606162
• 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 a tympanic membrane of an ear of a human or animal subject, the system comprising:

(a) an earplug including;

(i) a distal portion;

(ii) a proximal portion;

(iii) a tube extending from the distal portion to the proximal portion, the tube defining a lumen; and

(iv) at least one flexible sealing element extending from an outer surface of the tube, wherein a first flexible sealing element of the at least one flexible sealing element includes;

(A) an external facing; and

(B) an adhesive layer configured on the external facing; and

(b) an electrode device including;

(i) an elongate shaft, and

(ii) an electrode tip having a diameter greater than that of the elongate shaft, the elongate shaft of the electrode device at least partially disposed within the lumen of the tube of the earplug, the electrode device being movable within the lumen of the tube of the earplug between a retracted position, in which fluid can pass around the electrode device through the lumen, and an advanced position, in which the electrode tip contacts an inner surface of the tube to prevent fluid from flowing through the lumen.

2. The system of claim 1,

wherein the tube has a stiffness less than a stiffness of the proximal and distal portions of the earplug and wherein the flexible sealing element is disposed closer to the distal portion than to the proximal portion.

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

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

5. The system of claim 1, wherein the distal portion includes an o-ring, the o-ring configured to form a seal with the electrode tip of the electrode device when the electrode device is in the advanced position.

6. The system of claim 5, 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 such that the electrode tip can pass into the o-ring to form the seal.

7. The system of claim 1, wherein the first flexible sealing element is umbrella shaped, with an open end of the first flexible sealing element facing the proximal portion of the earplug.

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

9. The system of claim 8, wherein each of the first flexible sealing element and the second flexible sealing element is umbrella shaped, with an open end of each flexible sealing element facing the proximal portion of the earplug.

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

11. 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.

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

13. The system of claim 12, further comprising a headset for coupling the earplug and the additional earplug while they are in the subject'"'"'s ears.

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

(a) an earplug including;

(i) an elongate, flexible tube with a proximal portion, a distal portion, and a main lumen extending therethrough;

(ii) a first flexible sealing element shaped like an umbrella to form a seal within an ear canal, wherein the first flexible sealing element comprises an external facing with an adhesive layer, the first flexible sealing element being integral to and disposed on an exterior of the elongate, flexible tube and being offset a distance from a most distal end of the distal portion of the elongate, flexible tube;

(iii) a fitting coupled with the proximal portion of the elongate, flexible tube and including a side vent in fluid communication with the main lumen; and

(iv) a stiffening tube located within the distal portion of the elongate, flexible tube distal to the first flexible sealing element, the stiffening tube preventing the distal portion of the elongate, flexible tube from bending; and

(b) an electrode device including;

(i) an elongate shaft; and

(ii) an electrode tip having a diameter greater than that of the elongate shaft.

15. The system of claim 14, the earplug further comprising:

(v) 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, flexible tube and being proximal to the first sealing element.

16. The system of claim 14, further comprising a kit, the kit comprising:

(i) a controller connected to the electrode device;

(ii) an additional earplug for another ear of the subject; and

(iii) an additional electrode device for the additional earplug,

wherein the controller connects to the electrode device and the additional electrode device.

17. The system of claim 14, further comprising a headset for placing on the subject'"'"'s head and holding the electrode device and the earplug.

18. The system of claim 14, further comprising a drug solution to provide iontophoretic anesthesia to the tympanic membrane of the ear of the subject.

19. The system of claim 18, further comprising a drug delivery device for delivering the drug solution into the ear canal of the subject.

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

(a) an earplug including;

(i) a distal portion;

(ii) a proximal portion;

(iii) a tube extending from the distal portion to the proximal portion, the tube defining a lumen; and

(iv) at least one flexible sealing element extending from an outer surface of the tube, wherein a first flexible sealing element of the at least one flexible sealing element includes;

(A) an external facing; and

(B) an adhesive layer configured on the external facing; and

(b) an electrode device including;

(i) an elongate shaft, and

(ii) an electrode tip having a diameter greater than that of the elongate shaft, the elongate shaft of the electrode device being at least partially disposed within the lumen of the tube of the earplug, the electrode device being configured to selectively allow fluid communication through the lumen of the tube between the distal portion and the proximal portion of the earplug, an inner surface of the tube and an outer surface of the electrode tip being configured to provide feedback when the electrode device transitions between an advanced position and a retracted position.