Personalizable system and method for anesthetizing the tympanic membrane

• US 10,195,369 B2
• Filed: 05/26/2016
• Issued: 02/05/2019
• Est. Priority Date: 07/25/2011
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Inventors: Andreas, Bernard H., Saleki, Mansour, Girotra, Rohit, Cantu, Alfredo, Bhat, Nikhil
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US15/165,660
• Publication Number:
  US 20160375204A1
• Time in Patent Office: 985 Days
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• 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: A61F 11/085 including an inner channel
• CPC Class Codes: A61F 11/12 External mounting means
• CPC Class Codes: A61F 11/20 Ear surgery
• CPC Class Codes: A61M 11/006 operated by applying mechanical pressure to the liquid to be sprayed or atomised
• 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

Abstract

Systems and methods are described for administering a solution to a tympanic membrane of an ear canal of a subject. In some embodiments, the system includes a fluid delivery channel with a proximal end, a distal end, and a lumen defined therebetween. The proximal end can include at least one of a valve and Luer connector for selectively establishing fluid communication between a solution source and the lumen of the fluid delivery channel. The distal end can include an atraumatic tip defining a plurality of spray holes for providing fluid communication between the lumen and the ear canal. The atraumatic tip can be capable of being inserted into the ear canal and positioned near the tympanic membrane with the plurality of spray holes substantially facing the tympanic membrane to fill the ear canal with the solution from a portion near the tympanic membrane out toward an outer ear portion.

Claims

1. A system for administering a solution to a tympanic membrane of an ear canal of a subject, the system comprising:

a fluid delivery channel with a proximal end, a distal end, and a lumen defined therebetween, the proximal end configured for selectively establishing fluid communication between a solution source and the lumen of the fluid delivery channel, the distal end including an atraumatic tip defining a plurality of spray holes for providing fluid communication between the lumen and the ear canal, the atraumatic tip having an outer diameter greater than an outer diameter of a portion of the fluid delivery channel proximal of the atraumatic tip, the atraumatic tip capable of being inserted into the ear canal and positioned near the tympanic membrane with the plurality of spray holes substantially facing the tympanic membrane to fill the ear canal with the solution from a portion near the tympanic membrane out toward an outer ear portion; and

an ear plug capable of conforming to at least one of a size and a shape of the ear canal to reduce leakage of the solution from the ear canal at least one of during and following administration of the solution, the ear plug including a vent system via which accumulated air from a portion of the ear canal distal to the ear plug can be evacuated through the ear plug to a portion of the ear canal proximal to the ear plug.

2. A system for administering a solution to a tympanic membrane of an ear canal of a subject, the system comprising:

an ear plug capable of conforming to at least one of a size and a shape of the ear canal to reduce leakage of the solution from the ear canal at least one of during and following administration of the solution, the ear plug including a vent system via which accumulated air from a portion of the ear canal distal to the ear plug can be evacuated through the ear plug to a portion of the ear canal proximal to the ear plug; and

a fluid delivery channel with a proximal end, a distal end, and a lumen defined therebetween, the proximal end configured for selectively establishing fluid communication between a solution source and the lumen of the fluid delivery channel, the distal end including an atraumatic tip defining a plurality of spray holes for providing fluid communication between the lumen and the ear canal, the atraumatic tip capable of being inserted into the ear canal and disposable distal to the ear plug such that the atraumatic tip can be positioned near the tympanic membrane with the plurality of spray holes substantially facing the tympanic membrane to fill the ear canal with the solution from a portion near the tympanic membrane out toward an outer ear portion.

3. The system of claim 2, wherein the plurality of spray holes includes three to twelve spray holes.

4. The system of claim 2, wherein the plurality of spray holes are evenly distributed on the atraumatic tip.

5. The system of claim 4, wherein the plurality of spray holes includes three spray holes spaced 120 degrees apart.

6. The system of claim 2, wherein the solution is at least one of an anesthetizing solution, an antibacterial solution, an antifungal solution, an anti-inflammatory solution, or a ceruminolytic solution.

7. The system of claim 6, wherein the anesthetizing solution includes at least one of lidocaine, epinephrine, or sodium bicarbonate.

8. The system of claim 2, wherein the vent system includes at least one of a vent hole, a vent slit, or a vent screen.

9. The system of claim 2, wherein the vent system includes a one-way air valve.

10. The system of claim 2, wherein the vent system is configured to maintain a maximum pressure in the ear canal of about 50 kilopascals or less.

11. The system of claim 10, wherein the vent system is configured to maintain the maximum pressure in the ear canal at about 25 kilopascals or less.

12. The system of claim 2, further comprising an iontophoresis electrode operably connected to a control unit and a return electrode.

13. The system of claim 2, further comprising a speculum capable of providing direct visualization of the tympanic membrane.

14. The system of claim 2, further comprising a headset including a headset frame capable of conforming to at least one of a size or a shape of a head of the subject.

15. The system of claim 2, wherein the atraumatic tip has an outer diameter greater than an outer diameter of a portion of the fluid delivery channel proximal of the atraumatic tip.

16. A method for administering a solution to a tympanic membrane in an ear canal of a subject, the method comprising:

introducing a distal end of a fluid delivery channel into the ear canal, the fluid delivery channel having a proximal end and a lumen defined between the proximal end and the distal end, the proximal end configured for selectively establishing fluid communication between a solution source and the lumen of the fluid delivery channel, the distal end including an atraumatic tip defining a plurality of spray holes;

positioning (i) an ear plug within the ear canal such that the ear plug conforms to at least one of a size and a shape of the ear canal and (ii) the atraumatic tip within the ear canal distal to the ear plug such that the atraumatic tip can be positioned near the tympanic membrane with the plurality of spray holes substantially facing the tympanic membrane;

filling the ear canal with the solution from a portion near the tympanic membrane out toward an outer ear portion by providing fluid communication between the solution source and the lumen of the fluid delivery channel, via the proximal end of the fluid delivery channel, and between the lumen of the fluid delivery channel and the ear canal, via the plurality of spray holes, the ear plug reducing leakage of the solution from the ear canal at least one of during and following the filling of the ear canal; and

evacuating accumulated air, using a vent system of the ear plug, from a portion of the ear canal distal to the ear plug through the ear plug to a portion of the ear canal proximal to the ear plug.

17. The method of claim 16, further comprising:

establishing an electrical connection between an iontophoresis electrode and the solution via a control unit connected to the iontophoresis electrode and a return electrode attached to the subject.