Personalizable system and method for anesthetizing the tympanic membrane

Abstract

Systems and methods are provided for anesthetizing a tympanic membrane of an ear. The systems are personalizable to ensure proper anesthetizing solution administration. The systems and methods may also be useful for administering a solution to the ear canal of a human patient and for maintaining the solution therein.

What is claimed is: 
     
         1 . A method for administering a therapeutic solution to the ear canal of a patient, said method comprising:
 selecting or adjusting a headset based on a size and shape of the patient's head;   positioning the headset about the patient's head; and   filling the ear canal with the therapeutic solution;   wherein an ear plug is inserted into the ear canal either prior to or following filling the ear canal.   
     
     
         2 . The method of  claim 1  further comprising selecting an ear plug based on a size and shape of the ear canal and positioning the selected ear plug onto the headset. 
     
     
         3 . The method of  claim 1  further comprising inserting the ear plug into the patients ears prior to filling the ear canal with the therapeutic solution. 
     
     
         4 . The method of  claim 1  further comprising inserting the ear plug into the patients ears following filling the ear canal with the therapeutic solution. 
     
     
         5 . The method of  claim 1  wherein the therapeutic solution may be administered to a second ear canal either simultaneously or sequentially. 
     
     
         6 . The method of  claim 1  wherein the headset comprises a first fill system valve through which the solution is administered to a first ear canal. 
     
     
         7 . The method of  claim 6  wherein the headset comprises a second fill system valve through which solution is administered to a second ear canal. 
     
     
         8 . The method of  claim 1  wherein the solution is administered using a manual fill nozzle. 
     
     
         9 . The method of  claim 1  wherein the therapeutic solution is retained in the ear canal throughout a predetermined treatment period. 
     
     
         10 . The method of  claim 9  further comprising removing the solution from the ear canal following the predetermined treatment period. 
     
     
         11 . A device for administering a therapeutic solution to the ear canal of a patient, said device comprising:
 a headset comprising a headset frame that is designed to conform to the size and shape of the patient's head; and   an ear plug that is designed to conform to the size and shape of the patient's ear canal.   
     
     
         12 . The device of  claim 11  wherein the headset further comprises a fill system for filling the ear canal with the therapeutic solution. 
     
     
         13 . The device of  claim 12  wherein the fill system comprises:
 a valve for attachment to a therapeutic solution delivery device, said valve being fluidly connected to a spray tip through a fluid delivery channel. 
 
     
     
         14 . The device of  claim 13  wherein the fill system comprises a second valve, said second valve being fluidly connected to a second spray tip through a second fluid delivery channel. 
     
     
         15 . The device of  claim 12  wherein the headset comprises locking arms, the locking arms having a first position and a second position;
 wherein the first position permits visualization of the ear canal, and 
 wherein the second position provides for sealing of the ear canal by the ear plug. 
 
     
     
         16 . The device of  claim 12  wherein the ear plugs further comprise a venting system selected from the group consisting of vent holes, vent slits and vent screens. 
     
     
         17 . A method for administering a therapeutic solution to the ear canal of a patient and delivering the solution to the tympanic membrane using iontophoresis, said method comprising:
 selecting or adjusting a headset based on a size and shape of the patient's head, said headset including an iontophoresis electrode connected to a control unit and a return electrode;   positioning the headset about the patient's head;   filling the ear canal with the therapeutic solution;   attaching the return electrode to the patient; and   activating a control unit to initiate an iontophoresis procedure;   wherein an ear plug is inserted into the ear canal either prior to or following filling the ear canal.   
     
     
         18 . The method of  claim 17  further comprising selecting an ear plug based on a size and shape of the ear canal and positioning the selected ear plug onto the headset. 
     
     
         19 . The method of  claim 17  further comprising inserting the ear plug into the patients ears prior to filling the ear canal with the therapeutic solution, and wherein the iontophoresis electrode establishes electrical connection with the therapeutic solution during filling of the ear canal. 
     
     
         20 . The method of  claim 17  further comprising inserting the ear plug into the patients ears following filling the ear canal with the therapeutic solution. 
     
     
         21 . The method of  claim 17  wherein the therapeutic solution may be administered to a second ear canal either simultaneously or sequentially. 
     
     
         22 . The method of  claim 17  wherein the headset comprises a first fill system valve through which the solution is administered to a first ear canal. 
     
     
         23 . The method of  claim 17  wherein the headset comprises a second fill system valve through which substance is administered to a second ear canal. 
     
     
         24 . The method of  claim 17  wherein the solution is administered using a manual fill nozzle. 
     
     
         25 . The method of  claim 17  wherein the therapeutic solution is retained in the ear canal throughout a predetermined treatment period. 
     
     
         26 . The method of  claim 25  further comprising removing the solution from the ear canal following the predetermined treatment period. 
     
     
         27 . A device for administering a therapeutic solution to the ear canal of a patient and for iontophoresis delivery to the tympanic membrane, said device comprising:
 a headset comprising a headset frame that is designed to conform to the size and shape of the patient's head and an iontophoresis electrode that is connected to a control unit and a return electrode for delivering the solution into the tympanic membrane; and   an ear plug that is designed to conform to the size and shape of the patient's ear canal.   
     
     
         28 . The device of  claim 27  wherein the headset further comprises a fill system for filling the ear canal with the therapeutic solution. 
     
     
         29 . The device of  claim 27  wherein the fill system comprises:
 a valve for attachment to a therapeutic solution delivery device, said valve being fluidly connected to a spray tip. 
 
     
     
         30 . The device of  claim 29  wherein the fill system comprises a second valve, said second valve being fluidly connected to a second spray tip. 
     
     
         31 . The device of  claim 27  wherein the headset comprises locking arms, the locking arms having a first position and a second position;
 wherein the first position permits visualization of the ear canal, and 
 wherein the second position provides for sealing of the ear canal by the ear plug. 
 
     
     
         32 . The device of  claim 27  wherein the ear plugs further comprise a venting system selected from the group consisting of vent holes, vent slits and vent screens. 
     
     
         33 . A method for anesthetizing a tympanic membrane of a human patient, the method comprising:
 inserting an ear plug sizer into a patient's ear canal to determine the appropriate ear plug size;   selecting an ear plug based on the determined appropriate ear plug size;   positioning the selected ear plug onto a headset;   positioning the headset about a patients head;   filling the ear canal with an anesthetizing solution;   inserting the ear plug of the headset into the patient's ear; and   activating a control unit to begin the iontophoresis procedure.   
     
     
         34 . The method of  claim 33  further comprising preparing the anesthetizing solution and warming it to body temperature. 
     
     
         35 . The method of  claim 34  further comprising filling the headset by injection the solution into a fluid delivery channel of the headset until the solution exits the ear plugs. 
     
     
         36 . The method of  claim 35  further comprising removal of air in the fluid delivery channel. 
     
     
         37 . The method of  claim 36  wherein the removal of air using a dual chamber instillation port. 
     
     
         38 . The method of  claim 36  wherein fluid delivery channel comprises a semiporous material. 
     
     
         39 . A method for filling and retaining fluid in the ear canal of a human patient, the method comprising:
 inserting an ear plug sizer into a patient's ear canal to determine the appropriate ear plug size;   selecting an ear plug based on the determined appropriate ear plug size;   positioning the selected ear plug onto a headset;   positioning the headset about a patients head;   and inserting the ear plug of the headset into the patient's ear for retaining said fluid in the patient's ear canal;   wherein the ear canal is filled with the fluid during the method for filling and retaining fluid in the patient's ear canal.   
     
     
         40 . A system for anesthetizing a tympanic membrane of a human patient, the system comprising:
 ear plug sizers;   iontophoresis electrodes;   ear plugs sized by said ear plug sizers for fluidly sealing an ear canal of the patient and positioned about the iontophoresis electrodes;   a control unit; and   a headset comprising a headset frame, wherein said headset frame fluidly connects said iontophoresis electrodes to a source of anesthetizing solution, and wherein said headset frame electrically connects said two electrodes to the control unit.   
     
     
         41 . The system of  claim 40  further comprising temporal pads attached at the ends of the headset frame. 
     
     
         42 . The system of  claim 40  further comprising a wire support frame for support of the ear plug in the x, y and z directions. 
     
     
         43 . The system of  claim 40  wherein the headset frame is sized according to the size of the patient's head. 
     
     
         44 . The system of  claim 40  wherein the headset frame further comprises accessories useful for watching, and/or listening to movies, music or video games. 
     
     
         45 . The system of  claim 40  wherein the headset frame further comprises attachments selected from the group consisting of horns, antlers, antennas and elephant ears. 
     
     
         46 . The system of  claim 40  wherein the anesthetizing solution is selected from the group consisting of lidocaine, the combination of lidocaine and epinephrine, and the combination of lidocaine, epinephrine and sodium bicarbonate. 
     
     
         47 . A headset for use in anesthetizing a tympanic membrane of a human patient, the headset comprising:
 a headset frame comprising a first headset arm and a second headset arm;   the first headset arm comprising a first iontophoresis electrode and a first fill system tip;   the second headset arm comprising a second iontophoresis electrode and a second fill system tip;   wherein said headset frame fluidly connects said iontophoresis electrodes and said fill system tips to a source of anesthetizing solution, and   wherein said fill system tip comprises an atraumatic tip and at least one spray hole for delivering said anesthetizing solution to the tympanic membrane.   
     
     
         48 . The headset of  claim 47  wherein the fill system tips comprise three spray holes spaced  120  degrees apart. 
     
     
         49 . A headset for use in administering a solution into the ear canal of a human patient and retaining the solution therein, the headset comprising:
 a headset frame comprising a first headset arm and a second headset arm;
 the first headset arm comprising a first fill system tip and a first earplug; 
   the second headset arm comprising a second fill system tip and a second earplug;   wherein said headset frame fluidly connects said fill system tips to a source of solution,   wherein said fill system tip comprises an atraumatic tip and at least one spray hole for administering said solution to the ear canal; and   wherein said ear plugs retain the solution in the ear canal.   
     
     
         50 . The headset of  claim 49  wherein the solution is selected from the group consisting of an anesthetizing solution, an antibacterial solution, an antifungal solution, an anti-inflammatory solution or a ceruminolytic solution. 
     
     
         51 . A device for administering a solution into the ear canal of a human patient, said device comprising:
 a distal end comprising an atraumatic tip and at least one spray hole;   a proximal end comprising a luer connector for attachment to a source of the solution;   a lumen between said proximal end and said distal end;   wherein said lumen comprises a bend angle of between about 0 and 140 degrees.   
     
     
         52 . The device of  claim 51  wherein the lumen comprises a bend angle of between about 120 and 140 degrees. 
     
     
         53 . The device of  claim 51  further comprising a speculum fixedly attached to said device. 
     
     
         54 . The device of  claim 51  wherein the solution is selected from the group consisting of an anesthetizing solution, an antibacterial solution, an antifungal solution, an anti-inflammatory solution or a ceruminolytic solution. 
     
     
         55 . An ear plug sizer kit for determining the appropriate ear plug for use in a human patient, the kit comprising:
 a first ear plug sizer comprising a first lug fixedly with a first outer diameter and a first ear plug with a first sealing diameter said first lug being fixedly connected to a first end of a first shaft and said first ear plug being detachably connected to a second end of said first shaft;   a second ear plug sizer comprising a second lug with a second outer diameter and a second ear plug with a second sealing diameter, said second lug being fixedly connected to a first end of a second shaft and said second ear plug being detachably connected to a second end of said second shaft;   wherein the first outer diameter is equivalent to the first sealing diameter and the second outer diameter is equivalent to the second sealing diameter.   
     
     
         56 . A method for filling a patient's ear canal with a therapeutic solution while minimizing air bubbles in the ear canal, said method comprising:
 sealing the ear canal with an ear plug such that there is minimal leakage of the therapeutic solution from the ear canal;   providing ear canal vents for venting air from within the ear canal; and   turbulently filling the ear canal by administering the therapeutic solution through one or more spray holes in a fill system while venting the ear canal as a result of a low pressure escape of air through the ear canal vents.   
     
     
         57 . The method of  claim 56  wherein the ear canal vents comprise ear plug vent holes. 
     
     
         58 . The method of  claim 56  wherein venting the ear canal maintains a maximum pressure in the ear canal of 25 kilopascals. 
     
     
         59 . A device for filling a patient's ear canal with a therapeutic solution while minimizing air bubbles in the ear canal, said device comprising:
 an ear plug that is designed to conform to the size and shape of the patient's ear canal to seal the ear canal from leakage of the therapeutic solution;   a fill system comprising an atraumatic tip portion and one or more spray holes to turbulently fill the ear canal with the therapeutic solution; and   a vent system that is designed to maintain a maximum pressure in the ear canal at or below 25 kilopascals.   
     
     
         60 . The device of  claim 59  wherein the vent system comprise ear plug vent holes. 
     
     
         61 . The device of  claim 59  wherein the fill system comprises three or more spray holes.