Systems for anesthetizing ear tissue

ES 2 393 697 T3

DESCRIPTION

Systems for anesthetizing ear tissue

Field of the invention

The present invention relates to iontophoretic drug delivery systems. In particular, the present invention relates to novel and advantageous iontophoretic drug delivery systems for anesthetizing ear tissue.

Background of the invention

Iontophoresis is a procedure to deliver a drug through a biological membrane, such as the skin or, in the case of certain ear surgery procedures, the tympanic membrane (MT). By applying a low-level electrical current to a similarly charged drug solution, iontophoresis repels drug ions, thereby transporting them across the skin or other membrane. In ear procedures, attempts have been made in the past to use iontophoresis to anesthetize (or "numb") a TM before placing a tube into the ear through it to treat chronic ear infections. For TM iontophoresis, a drug solution is placed in an ear canal and current is applied to the solution via an electrode, thereby transporting the anesthetizing drug through the TM.

Previous iontophoresis devices and systems have had limited success and often cannot be used in all patients. The above devices generally do not seal the drug solution in an ear canal, thus requiring a patient to recline and tilt their head during an iontophoresis procedure. Using currently available iontophoresis procedures, the patient must remain relatively still in this reclined position, with the head tilted for 5-15 minutes while the iontophoresis procedure provides adequate anesthesia to the TM, which can be especially difficult for children. . Furthermore, using currently available systems, it is only possible to anesthetize one ear at a time, thus making iontophoretic anesthesia of both MTs in one patient a relatively lengthy and uncomfortable procedure.

Attempts have been made to deliver iontophoretic fluid to a TM through an earplug designed to keep the fluid in the ear canal. For example, see US Patent No. 5,674,196, issued to Donaldson et al. Earplugs such as that described in the Donaldson document and other currently available earplugs, however, have a number of drawbacks. For example, most earplugs are designed to keep fluid out of the ear canal, rather than in the ear canal. The currently available earplugs described above generally do not adequately conform to the curved anatomy of the ear canal and therefore do not form a good seal in the ear canals of at least some (and in some cases all ) the patients. Thus, current earplugs typically allow fluid to leak out of the ear, making administration of iontophoretic anesthesia difficult if not impossible with the patient in an upright position. Furthermore, the earplug devices described above for use in iontophoresis have not addressed problems such as the formation of bubbles in the iontophoretic drug solution, which bubbles can interfere with contact between an iontophoretic electrode and the solution.

Therefore, it would be advantageous to have improved devices and systems for delivering iontophoresis to a tympanic membrane. Ideally, such devices and systems would allow iontophoretic anesthesia to be administered to a patient in an upright position. Also ideally, such devices and systems would facilitate bilateral simultaneous MT iontophoresis. At least some of these objectives will be met by embodiments of the present invention.

WO-A-2008/030485 discloses a drug-compatible, biocompatible drug delivery catheter which may include a multi-lumen tube attached to an end fitting, with the end fitting having an internal fluid chamber and a fluid outlet region.

Brief summary of the invention

A system for use in the iontophoretic delivery of a substance to the tympanic membrane of an ear of a human or animal subject, the system comprising; an ear plug, comprising; a distal part; a proximal part; a tube extending from the distal part to the proximal part, wherein the tube has a stiffness less than a stiffness of the proximal and distal parts of the earplug; at least one flexible sealing element extending from an external surface of the tube and disposed closer to the distal end than the proximal end; and an electrode device, comprising: an elongated shaft; and an electrode tip having a diameter greater than that of the elongated shaft, characterized in that the electrode device is movable within the earplug tube from a retracted position, in which fluid can pass around the electrode through of the tube, to a forward position, in which the tip of the electrode contacts an internal surface of the tube to prevent fluid from flowing through the tube.

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In one embodiment, the earplug may include a side vent in fluid communication with the tube to allow evacuation of air and / or fluid from the tube. In one embodiment, the distal portion can be rigid with respect to the tube. In one embodiment, the distal portion may include an O-ring that is sealed against the electrode tip of the electrode device in the forward position. In one embodiment, an outer diameter of the electrode tip can be greater than an inner diameter of the O-ring, and the O-ring can be flexible to allow the tip of the electrode to pass into it to form a seal. In one embodiment, the proximal portion can be rigid. In one embodiment, the proximal portion may include a Luer connector fitting. In one embodiment, the at least one flexible sealing element may be in the shape of an umbrella, with an open end of the sealing element facing the proximal end of the earplug. In one embodiment, the at least one flexible seal member may include a distal seal member and a proximal seal member, and a diameter of the proximal seal member may be greater than a diameter of the distal seal member. In one embodiment, each of the flexible sealing elements may be umbrella-shaped, with an open end of each sealing element facing the proximal end of the earplug. In one embodiment, the electrode device can be malleable. In one embodiment, the electrode device can include a light. In one embodiment the system may include an earhook connected to the proximal portion of the earplug, the earhook including a curved member to engage a portion of the ear and prevent detachment of the earplug after placement in the ear. ear. In one embodiment, the system may include an additional earplug and an additional electrode for use in iontophoretic delivery of a substance to the tympanic membrane of the other ear of the human or animal subject. In one embodiment the system may include earplugs to couple the earplug and the additional earplug while they are on the subject's ears.

In one aspect of the invention, a system for use in the iontophoretic delivery of a substance to the tympanic membrane of an ear of a human or animal subject may include an elongated flexible tube with a proximal part and a distal part, a first element flexible sealing element shaped like an umbrella to form a seal inside the ear canal, a second flexible sealing element shaped like an umbrella to form a seal inside the ear canal, a distal stiffening tube located in the distal portion of the elongated tube distal with respect to the sealing member, a Luer connector fitting engaged with the proximal portion of the tube and including a side vent in fluid communication with the main lumen of the tube, and a device electrode. The flexible tube may include a main lumen extending through it. The distal portion may include an inner edge at the distal end of the distal portion and a sealing member proximal to the inner edge. The elongated tube may have sufficient flexibility to bend to conform to the shape of an ear canal. The first flexible sealing element may be integral with and disposed on an exterior of the elongated tube and offset a distance from a more distal portion of the elongated tube. The second flexible sealing element may be integral with and disposed outside of the elongated tube and proximal to the first sealing element. The distal stiffening tube can prevent the distal portion of the elongated tube from bending. The electrode device can include an elongated shaft. The tip of the electrode may have a diameter greater than that of the elongated shaft. The electrode device may be movable within the lumen of the earplug tube from a retracted position, in which fluid can pass around the electrode through the tube, to a forward position, in which the tip of the electrode it can fit within the distal portion of the elongated tube between the inner edge and the sealing member to form a fluid tight seal.

Also described herein is a procedure of anesthesia of a tympanic membrane of a patient's ear using iontophoresis which may involve administering an anesthetizing drug solution to a patient's ear canal, inserting an iontophoresis device into the filled ear canal. with anesthetic drug solution, evacuate excess anesthetic drug solution through the lumen while inserting and while the electrode is in the first position, moving the electrode from the first position to the second position and activating the electrode in the second position. The iontophoresis device can include an electrode movable from a first position to a second position within a lumen. The first position of the iontophoresis device can evacuate the ear canal. The second position of the iontophoresis device can the ear canal.

In one example, the method may further include verifying the movement of the electrode from the first position to the second position using auditory and / or tactile feedback. In one embodiment, the procedure may include repeating the procedure for a second ear of the subject. In one embodiment, a subject's head may be placed in a reclined, tilted position when the drug solution is delivered to the ear canal, and an upright position when the electrode is activated. In one embodiment, the method may include repeating the procedure for a second ear of the subject, mating the earplugs with earplugs attached to the subject's head before or during activation. In one embodiment, the method may include deforming the electrode to conform to a shape of the ear canal.

In one aspect, the procedure of anesthetizing a tympanic membrane of a patient's ear using iontophoresis described herein may include administering an anesthetizing drug solution to a patient's ear canal, inserting an iontophoresis device into an ear canal. the patient and activate the electrode. The iontophoresis device can include an electrode within a lumen. The iontophoresis device can seal the anesthetic drug solution and simultaneously evacuate excess anesthetic drug solution past the electrode and through a seal within the lumen.

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In one example, the procedure may include repeating the procedure for a second ear of the patient. In one embodiment the patient may be in a tilted position to the side when administered and an upright position when activated. In one embodiment, the method may include deforming the electrode to conform to the shape of the ear canal.

A kit for anesthetizing a tympanic membrane of an ear of a human or animal subject using iontophoresis, the kit comprising; the system for use in the iontophoretic delivery of a substance to the tympanic membrane of an ear of a human or animal subject of the invention; and a controller electrically connectable to the electrode device of the system.

In one embodiment, the kit may include an additional earplug for the subject's other ear, and an additional electrode device for the additional earplug. In one embodiment, the controller can be connected to the electrode device and the additional electrode device. In one embodiment, the kit may include helmets to be placed on the subject's head and to attach the electrodes and earplugs. 31. In one embodiment, the kit may include a sufficient amount of drug solution to provide iontophoretic anesthesia to the tympanic membranes of both ears of the subject. In one embodiment, the kit may include a drug delivery device to deliver the drug solution into the ear canals of the subject.

For a further understanding of the nature and advantages of the various aspects and embodiments, reference should be made to the following description and accompanying drawing figures. Each of the figures is provided for purposes of illustration and description only and is not intended to limit the scope of embodiments of the present invention.

Brief description of the drawings

Figure 1A shows a front view of an outer ear.

Figure 1B shows a partial cross-sectional view of an outer, middle, and inner ear.

Figures 2A-2C show cross-sectional views of a system for anesthetizing a tympanic membrane, in accordance with various embodiments of the invention.

Figure 2D shows a perspective view of a distal end of an earplug, according to one embodiment of the invention.

Figure 2E shows a side view of an earplug, according to one embodiment of the invention.

Figures 2F and 2H show side views of systems for anesthetizing a tympanic membrane, in accordance with various embodiments of the invention.

Figure 2H shows a system in use, according to one embodiment of the invention.

Figures 3A-3C show partial cross-sectional views of a system for anesthetizing a tympanic membrane in use, in accordance with various embodiments of the invention.

Figure 4 shows a kit for anesthetizing a tympanic membrane, according to an embodiment of the invention.

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<td>Figure 5B</td><td>sample</td><td>a</td><td>view</td><td>side</td><td>of</td><td>a</td><td>element</td><td>of</td><td>sealed</td><td>flexible,</td><td>of</td><td>agreement</td><td>with</td><td>a</td><td>realization</td><td>of</td><td>the</td>

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<td>Figure 5C</td><td>sample</td><td>a</td><td>view</td><td>frontal</td><td>of</td><td>a</td><td>element</td><td>of</td><td>sealed</td><td>flexible,</td><td>of</td><td>agreement</td><td>with</td><td>a</td><td>realization</td><td>of</td><td>the</td>

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invention.

Figure 5E shows a perspective view of a flexible sealing element, according to an embodiment of the invention.

Figure 5F shows a front view of a flexible sealing element, according to an embodiment of the invention.

Figure 6A shows a front view of an earplug including an ear hook, in accordance with one embodiment of the invention.

Figure 6B shows a front view of an earplug including an ear hook, in accordance with one embodiment of the invention.

ES 2 393 697 T3

Figure 6C shows a front view of an earplug including an ear hook in use, in accordance with one embodiment of the invention.

Figure 6D shows a side view of an integrated headset, according to an embodiment of the invention

Figures 6E and 6G show front views of integrated headphones in use, in accordance with various embodiments of the invention.

Figure 7A shows a perspective view of an earplug, according to one embodiment of the invention.

Figure 7B shows a perspective view of an extended portion for use in an earplug, in accordance with one embodiment of the invention.

Figure 7C shows a cross-sectional view of an extended portion for use in an earplug, in accordance with one embodiment of the invention.

Figures 7D-7I show perspective views of extended parts for use in an earplug, in accordance with various embodiments of the invention.

Figure 7J shows an exploded view of an extended portion for use in an earplug, in accordance with one embodiment of the invention.

Figure 8A shows a side view of an expandable earplug, in accordance with one embodiment of the invention.

Figure 8B shows a side view of an expandable earplug in use, in accordance with one embodiment of the invention.

Figure 9A shows a cross-sectional view of a foam plug device, according to one embodiment of the invention.

Figure 9B shows a cross-sectional view of a foam balloon device, according to one embodiment of the invention.

Figure 10A shows a cross-sectional view of a speculum-type orifice, according to one embodiment of the invention.

Figure 10B shows a cross-sectional view of an alternative distal hole, in accordance with one embodiment of the invention.

Figure 10C shows a perspective view of an alternative distal hole, in accordance with one embodiment of the invention.

Figures 10D and 10E show a speculum-like orifice in use, in accordance with one embodiment of the invention.

Figures 10F to 10H show a speculum-like orifice in use, in accordance with one embodiment of the invention.

Figures 11 and 12 illustrate simplified support structures that are worn on a patient's head and support an iontophoresis system, in accordance with various embodiments of the invention.

Detailed description of the invention

Figure 1A shows a view of an external ear. The outer ear includes a major element known as the auricle or pinna 100. The outer ear serves as a funnel to direct sounds into the inner parts of the ear. The main physical elements of the ear include the lobe 102, shell 104, antihelix 106, helix 108, scapha 110, triangular fossa 112, external acoustic meatus 114, tragus 116 and antitragus 118.

Figure 1B shows a cross section of the inner and outer parts of the ear. The pinna 100 is shown connected to the external auditory meatus 118, or ear canal. The ear canal 118 shows up as a relatively straight passage, but it is often a more curved and tortuous passage. Ear canal 118 is connected to middle ear 120, which includes eardrum 122. Middle ear 120, in turn, is connected to inner ear 124. The eardrum 122 normally has an air pocket behind an outer part called the tympanic membrane. When the middle ear 120 becomes infected, the fluid swells within the eardrum 122. The expansion of the fluid causes extreme pain to a person with a middle ear infection. Middle ear infections are common in young children. Suffering can be relieved by piercing the tympanic membrane to evacuate fluid, a treatment known as tympanocentesis. The patient may undergo general anesthesia prior to a tympanocentesis procedure, but this is not preferred due to costs and health risks. As a preferable alternative, the tympanic membrane can be locally anesthetized using iontophoretic drug delivery. In this way, the patient can be treated while awake. Devices and

ES 2 393 697 T3 methods for locally anesthetizing the tympanic membrane are disclosed in co-assigned patent applications US 11 / 962,063 and US 11 / 749,729, the entirety of which is incorporated herein by reference.

Figure 2A shows an iontophoresis system 200 for anesthetizing a tympanic membrane, in accordance with one embodiment of the invention. The system 200 includes an earplug 202 and an electrode device 206. The earplug 202 may include a flexible sealing element 204, a distal portion 208, a proximal portion 210, and a tube 212 connecting both. Tube 212 is relatively more flexible, in terms of flexural strength, than distal portion 208 and proximal portion 210. This is particularly advantageous since the open ear canal is a tortuous passage, requiring that distal portion 208 and proximal portion 210 are positioned at opposite ends of the tortuous passageway. Earplug 202 will preferably bend and match the shape of the tortuous passage without blocking tube 212. Alternatively, the earplug 202 may be pre-bent or preformed into a preferred shape to match a tortuous passage of an ear canal. To achieve a desired flexibility, earplug 202 can be formed from a flexible polymeric material, such as silicone.

The distal portion 208 may include a rigid member 214. The rigid member 214 may be generally cylindrical or tube-shaped and include an inner edge 216 that prevents the electrode device from exiting the distal portion 208. The rigid member 214 may be Constructed from a metal or polymer that adds structural integrity to distal portion 208. Rigid member 214 provides distal portion 208 to be more rigid than tube 212 so that distal portion 208 will retain shape when passing through a tortuous passageway. Rigid member 214 may be bent or molded into distal portion 208 Alternatively, rigid member 214 is integral to distal portion 208 as a portion of the wall thickness that is greater than the wall thickness of tube 212.

The distal portion 208 may also include an O-ring 218. The O-ring 218 seals the electrode device 206 from fluid within the distal portion 208. The O-ring may be bent or molded into the distal portion 208, or alternatively be formed of a piece between distal portion 208 and tube 212. The O-ring 218 may be designed to allow fluid to pass through when it experiences a pressure load greater than atmospheric, for example the pressure that occurs when the system 200 is inserted into a fluid-filled ear. For example, the O-ring 218 can be designed as a duckbill seal that opens in the proximal direction. 2.2 cm H2O has been found in testing to be a good threshold value for O-ring pressure relief.

Proximal portion 210 may be stiffer than tube 212 so that the shape of proximal portion 210 will be maintained when inserted into a tortuous passageway. Proximal portion 210 may include a side vent 220. Side vent 220 functions to evacuate excess fluid out of the ear, which is evacuated from proximal portion 208 and through tube 212. Alternatively, side vent 220 may be located around tube 212. Proximal portion 210 may include a Luer connector fitting with a fluid-tight fitting 222 to interface with electrode device 206, as shown. The proximal portion may include a serrated portion 222 to interface with tube 212. Alternatively, proximal portion 210 may be integrally formed on tube 212, and retain rigidity by molded stiffening inserts or through the use of thick sections. wall.

Flexible sealing elements 204 are used to form a fluid tight seal between system 200 and the ear canal. Flexible sealing elements 204 are generally flexible and deform and conform to the shape of an ear canal to form a fluid tight seal. Two flexible sealing elements 204 are shown, however only one is required and more than two may be used. The first sealing element 204a may be oval-umbrella-shaped and integrally formed on tube 212 and distal portion 208, as shown. Alternatively, the flexible sealing elements 204 may be pyramidal (three-sided) or triangular in shape. It has been found that the ear canal often has an oval or triangular cross section. A shoulder 226 between the first flexible sealing element 204a and the most distal portion of the system 200 is preferred. The shoulder 226 provides extra volume within the ear for air bubbles to reside, thereby preventing air bubbles from blocking the distal portion 208. The second sealing element 204b can be larger than the first sealing element and forming in one piece on tube 212, as shown.

In an alternative embodiment, the flexible sealing elements 204 may include adhesive elements to promote a fluid-tight seal between the surface of the sealing elements 204 and the ear canal. For example, an adhesive layer can be used on the outer surfaces (ie, facing the channel) of the first sealing element 204a and / or the second sealing element 204b. The adhesive layer can be covered by a backing tape, which can be removed prior to insertion into the ear canal. Various adhesives can be used, for example, a temperature-dependent adhesive that is only slightly tacky at room temperature and becomes extremely tacky after insertion through heating through the ear canal. A temperature-dependent adhesive can allow placement and replacement in the complex anatomy of the ear to minimize patient discomfort. The earplug 202 can be cooled by a cold pack to reduce stickiness and allow removal of the earplug 202. Examples of adhesive elements include the Eakin Cohesive® seal manufactured by CovaTec, Inc., and Pre-Gauze. Po® manufactured by Landec Labs, Inc. Alternatively, a temperature dependent adhesive can be used which is extremely tacky at body temperature and becomes slightly tacky when heated to a temperature above body temperature. In this embodiment, the heat can be applied by means of a hot compress

ES 2 393 697 T3 to reduce stickiness and allow removal of the ear plug 202.

Electrode device 206 includes an electrode tip 228, elongated shaft 230, and proximal connector 232. Electrode tip 228 may be cylindrical in shape to mate with the inside of distal portion 208. Electrode tip 228 has generally a shape to form a seal within distal portion 208 between inner edge 216 and O-ring 218. Electrode tip 228 is also sized to be slidable within tube 212. Electrode tip 228 is preferably constructed from silver (99.9% pure). A pure silver electrode tip 228, which may include an oxidized layer on the tip of the electrode 228, has been found to aid the iontophoresis procedure. Previous devices used stainless steel or gold electrodes that have a tendency to cause electrolysis of an iontophoresis fluid, for example lidocaine, which in turn lowers the pH value and causes discomfort. The silver electrode relatively reduces electrolysis and thus prevents discomfort. Alternatively the electrode tip 228 may include a silver coating on a different metal such as stainless steel.

Electrode tip 228 is shown as a cylindrical shaped mass of metal, however in alternative embodiments the electrode tip 228 may have different configurations to increase surface area and to promote iontophoresis. For example, a plurality of silver wires configured similar to a brush can be used. In another embodiment, a plurality of concentric hypotubes with stepped diameters can be used. In another embodiment, a mass of silver mesh shaped similar to steel wool can be used. In another embodiment, a molded polymer matrix plug with a relatively large surface area (eg, sponge-like) and a gold or silver plating or deposition may be used. In another embodiment, a metal-coated woven fabric can be used, with or without an external insulator depending on the size. In another embodiment, a cylindrical body with an internal and distally exposed "honeycomb" may be used. In another embodiment, a "silver foil" spool can be used. In another embodiment, a recessed plug may be used sized (ie, smaller diameter) such that the plug has exposed sides. In another embodiment, elongated shaft 230 can be used as an electrode, as a tube or wire, and using a proximal seal on tube 212. In another embodiment, a dough with a plurality of petals or branches (eg, flower-shaped) that are integrated into the surface of a flexible sealing element 204 may be used. In another embodiment, a soft, flexible bag may be used, with an insulating outer surface and a silver coated inner surface, extending distally from distal portion 208. In another embodiment, one or more cavities, including metal-coated surfaces, may be used in distal portion 208. In another embodiment, the electrode tip 228 may include holes and / or a textured surface (eg, countersunk, etched, sandblasting) to increase surface area. In another embodiment, the electrode tip 228 can include multiple types of metal with one metal being a sacrificial anode (eg, zinc). In another embodiment, a conveyor system (eg, a flexible metal coated belt) can be used that can be actuated to supply a fresh electrode surface throughout the process. In another embodiment, tube 212 may include cleaning elements that clean the surface of an electrode as they rotate, to provide a fresh elector surface throughout the procedure. In another embodiment, the electrode tip 228 may include a protective coating to help prevent corrosion.

Electrode tip 228 may be attached to elongated shaft 230 by soldering or welding. Elongated shaft 230 may be constructed from the same materials as electrode tip 228. Elongated shaft 230 may also include a lumen to allow fluid passage. The elongated shaft 230 is preferably malleable to allow a user to pre-bend the elongated shaft before inserting the system 200 into an ear canal. Earplug 202 can also be placed before electrode device 206, and thus electrode device 206 can be shaped to fit pre-inserted and deformed earplug 202. Proximal connector 232 has a shaped to be fluidly sealed with proximal portion 210. Proximal connector 232 is further electrically connected to lead 234 to provide power to electrode device 206.

Figure 2B shows iontophoresis system 200 in a first position, in accordance with one embodiment of the invention. Electrode device 206 is shown with electrode tip 228 in a proximal position within tube 212. In the first position distal portion 208 is in fluid communication with tube 212. In the first position, fluid can pass through distal portion 208 and exit through vent 220, as shown by the directional arrow.

Figure 2C shows iontophoresis system 200 in a second position, in accordance with one embodiment of the invention. Electrode device 206 is shown with the electrode tip in a distal position at distal portion 208. Electrode device 206 can be forced past O-ring 218 which can cause an audible "snap". In this way, the electrode device 206 can be moved from the first position to the second position with an audible confirmation. In the second position, the open distal position 208 is closed and is no longer in fluid communication with tube 212. In an alternative embodiment, O-ring 218 may allow fluid to pass through when fluid pressure within the channel the ear exceeds a threshold.

Figure 2D shows an alternate embodiment of iontophoresis system 200. In this embodiment, offset portion 226 and distal portion 208 each include a plurality of aligned holes 236 that are located approximately behind inner edge 216. Four are shown Holes 236, however, more or fewer holes may be used in alternative embodiments. Holes 236 may have any of a series

ES 2 393 697 T3 of suitable sizes, for example in one embodiment may have diameters of about 0.025 inches (0.0635 cm) each. Holes 236 can reduce the trapped volume of the drug solution and allow more surface area of ​​the electrode tip 228 to be exposed, which in turn can reduce the voltage requirement for an iontophoresis procedure. An iontophoresis procedure gradually causes the electrode tip 228 to corrode, thereby drawing more voltage from an iontophoresis system as the electrical efficiency of the electrode tip decreases. It has been shown experimentally, in cadaver tests, that holes 236 can reduce voltage requirements by approximately two-thirds over a 10 minute period, compared to a system 200 without holes 236. In this way, the use of holes 236 can avoid system checks and voltage spikes. System checks are cases where the iontophoresis system cannot meet the voltage demands of the corroded electrode tip 228 and thus the iontophoresis procedure may be stopped unintentionally. Voltage spikes can cause discomfort to the patient.

Figure 2E shows an alternate embodiment of iontophoresis system 200. In this embodiment, system 200 remains largely as described above, however, a bag 238 is attached to the distal end of system 200. Bag 238 may be constructed from a collapsible substance such as a polymer or fine woven material. The bag 238 may have an external adhesive substance, such as the adhesive members described herein. Organic debris, such as skin flakes or earwax, can be dislodged during insertion and / or the iontophoresis procedure. Debris can stick to the System 200 electrode and reduce the active surface area of ​​the electrode. During use, the system can be inserted into the ear and the bag 238 can adhere to the surfaces of the ear canal leading to the eardrum 122. Bag 238 can be expanded against the ear canal by physical probing with a probe such as a cotton swab, or inflated using expanding foam or a balloon. In some embodiments, bag 238 can be a double-walled balloon. Bag 238 can prevent debris from sticking to the electrode by presenting a physical barrier between the ear canal and the electrode. The bag can also reduce the loss of drug solution, since the walls of the ear canal will be blocked from absorption of drug solution.

Figures 2F through 2H show alternative embodiments of iontophoresis system 200. In these embodiments, system 200 remains largely as described above, however, a flexible electrode 240 extends from the distal end of system 200. Flexible electrode 240 may include an insulating side 242, and a conductive side 244 with a metal (eg, silver) portion exposed. Flexible electrode 240 can be constructed from a flexible polymeric material, such as polyimide, and coextruded with a metal strip. Flexible electrode 240 may be configured as a single looped band with the metal portion exposed on the inside of the loop. Alternatively, more than one band can be used, as shown by flexible electrode 246 of FIG. 2G. The extension length of the flexible electrode 240 can be adjusted according to the anatomy of a specific patient. During use, the flexible electrode 240 can come into contact with the ear canal, as shown in FIG. 2H, without causing shocks, since the conductive side 244 does not come into contact with the ear canal. Flexible electrode 204 can be deflected from the ear canal due to its flexible nature. Flexible electrode 240 provides a greater electrode surface area for a more efficient iontophoresis procedure. The large surface area of ​​the electrode can also reduce the formation of bubbles in the drug solution.

Figures 3A to 3C show a method of using the iontophoresis system 200 to anesthetize the tympanic membrane of a patient's ear. A cross section of an ear 300 from a patient is shown. The patient may initially be positioned on their side with the treatment ear facing upward. Iontophoresis fluid 302 is then injected into the ear canal, as shown. An ear plug 304 is then inserted into the filled ear canal to seal the iontophoresis fluid within the ear canal. Earplug 304 is generally as described in embodiments herein. Earplug 304 may be initially primed with iontophoresis fluid 302 prior to insertion into the ear canal.

In Figure 3B, an electrode device 306 is inserted into the inserted earplug 304. The electrode device 306 may be malleable and optionally pre-bent prior to insertion. Electrode device 306 may make an audible noise when fully inserted into earplug 304, thereby giving the user an audible signal to verify that the electrode device is properly positioned. As the electrode device 306 is fully inserted, the pressure will increase within the ear canal and the excess fluid 308 will be evacuated out of the back of the plug and immediately balance the pressure of the fluid with the atmosphere, as shown . This is extremely advantageous, since even a slight increase in pressure can cause great pain to an infected ear. After the electrode device 306 has been fully inserted, it can be supplied with energy to treat the patient. The other ear can also be treated as described in this document.

In an alternative example, the electrode device 306 may be partially inserted into the earplug 304 at a first position, for example the tip of the electrode 228 in the tube 212, during initial insertion into the ear canal. After the earplug 304 has been placed, the electrode device 306 can be moved from the first position to a second position (eg, working position) of full insertion in the earplug 304.

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In yet another alternative example, electrode device 306 may be fully inserted into earplug 304 prior to insertion into the ear canal. As the earplug 304 is inserted into the ear canal, the pressure will increase within the ear and, simultaneously, the pressure will be relieved through the seal within the earplug 304 which evacuates excess fluid when the pressure exceeds a certain threshold. This example is advantageous in that it does not require a user to move the electrode while the earplug is in place within the ear.

Figure 3C shows the ear, and therefore the patient, in an upright position. Device 304 includes a shoulder 310 from the electrode that causes air bubble 312 to move to the position shown. The shoulder 310 prevents air bubbles from resting directly or partially on the electrode, which could cause partial or ineffective treatment. The shoulder 310 is advantageous in that it allows the system 200 to be worn in an upright position and therefore both ears can be treated simultaneously.

In an alternate example, the patient may be in an upright position prior to insertion of iontophoresis fluid 302 or earplug 304. Earplug 304 is first inserted into the ear canal with the earplug device. electrode 306 fully inserted. In this embodiment, the electrode device 306 includes a different light to fill the ear canal. Iontophoresis fluid 302 is injected through electrode device 306 to fill the ear canal. When the ear canal is filled with iontophoresis fluid 302, the pressure will increase within the ear and, simultaneously, the pressure will be relieved through a seal within the earplug 304. In this way, excess fluid is evacuated when the pressure exceeds a certain threshold. This example is advantageous because one or both ears can be filled simultaneously if required, and also when the patient is in an upright position.

In an alternate example, a proximal sealing material can be applied after device 304 has been positioned as shown in Figure 3C. The sealing material can be made of soft putty-like material, for example, a bone wax (eg, beeswax, paraffin, or isopropyl palmitate) can be used. The sealing material can be used separately, or as a fixed member, so that it can be sealed to the device 304, for example, as a proximally located disc (for example, between the sealing member 204b and the side vent 220 of FIG. 2A). The sealing material can be moldable when heated to body temperature. During use, the sealing material can be pushed and formed into the outer ear shell and anatomy after device 304 is positioned as shown in FIG. 3C. The sealing material can be adapted to the complex anatomy of the external ear and ensures a secure fixation. The sealing material can also provide a fluid-tight seal that allows the use of a slightly undersized 304 device, which in turn allows for a more rapid and atraumatic insertion of the device into the ear canal, since the sealing material it is providing the primary seal in place of device 304.

Alternatively, a cloth patch can be used in place of or in conjunction with the sealing material. The fabric patch may be disc-shaped and sealable attached to device 304, such as a proximally located disc (eg, between sealing member 204b and side vent 220 of FIG. 2A). The cloth patch may include an adhesive, such as the temperature-dependent adhesive described herein. The fabric patch can alternatively use a conventional adhesive, for example, as used in Nexcare ™ Tegaderm ™ Clear Vedaja manufactured by 3M, Inc. During use, the fabric patch can be pushed into the shell. and the anatomy of the outer ear after device 304 is positioned as shown in Figure 3C. The cloth patch can provide both a fluid seal and ensure secure attachment. Thus, the cloth patch can also be used with a device smaller than the standard 304 device.

Figure 4 shows a kit 400 for anesthetizing a tympanic membrane of a patient's ear using iontophoresis, according to one embodiment of the invention. The kit includes a 402 system, which is substantially similar to the devices described herein. Each system 402 includes an earplug 404 and an electrode device 406. As shown, various sizes of earplugs are possible. Kit 400 also includes a controller 408, which includes a return electrode 410, and is electrically compatible with system 402. Controller 412 provides electrical power to system 402 for an iontophoresis procedure. Examples of compatible controllers are shown in previously incorporated and co-assigned US application No. 11 / 962,063.

Figures 5A and 5B show front and side views, respectively, of a flexible sealing element 500 in an umbrella-like configuration, in accordance with one embodiment of the invention. Flexible sealing element 500 includes integral ribs 502 or spokes. The integral ribs 502 allow the remaining parts 504 of the flexible sealing element 500 to be thinner than the ribbed parts, and thus the flexible sealing element 500 is very easily deformed. Thus, a device incorporating the flexible sealing element 500, for example the system 200, can achieve a seal within an ear canal with less force than a sealing element lacking the integral ribs 502. Alternatively, the integral ribs 502 may be located on the inside of the flexible sealing device 500.

ES 2 393 697 T3

Figures 5C and 5D show front and side views respectively, of a flexible sealing element 506, according to one embodiment of the invention. Flexible sealing member 506 includes cutouts 508. Cutouts 508 have a thin band of material. The cutout portions 508 are thinner than the remaining portion 510 of the flexible sealing element 506, and thus the flexible sealing element 506 is very easily deformed. Thus, a device incorporating the flexible sealing element 506, for example the system 200, can achieve a seal within an ear canal with less force than a sealing element that lacks the cutouts 508. Alternatively, the cutouts 508 may be located on the inside of the flexible sealing device 506.

Figures 5E and 5F show perspective and front views respectively, of a flexible sealing element 510, in accordance with one embodiment of the invention. Flexible sealing element 506 is pyramidal or triangular in shape, as shown. Flexible sealing element 506 includes three sides to seal an ear canal. The ear canals do not have circular cross sections and are often triangular in shape. In this way, the flexible sealing element 510 can fit into and seal an ear canal very effectively.

Figures 6A and 6B show rear and side views, respectively, of an earplug 600, in accordance with one embodiment of the invention. The earplug 600 includes a main body 602, which may include a tubular member and at least one flexible sealing member as generally described herein. The earplug also includes a 604 ear hook. Previous devices have used retention mechanisms such as earmuff or helmet style configurations to help retain earplugs. These prior devices tend to cause discomfort and discomfort to the user (eg, young children) and result in patient-induced disturbances to iontophoresis treatment. Earhook 604 may be formed of a flexible polymer such as silicone, and may also be integral with earplug 600. Earhook 604 may also include a skeleton-like construction of a flexible polymer wound around a core (for example a wire). The core can be malleable so that the earhook 604 can be molded to fit the profile of a specific ear. Alternatively, the core can be resilient and help apply a constant force from the outer ear to the earplug 600.

Figure 6C shows the earplug 600 in use, in accordance with one embodiment of the invention. The 604 ear hook is designed to wrap around the cross of a 606 helix of one ear. Earhook 604 is advantageous over other prior devices in that it has a relatively low mass and thus does not appear too intrusive to a patient.

Figure 6D shows an integrated headset 608, in accordance with one embodiment of the invention. The handset includes a main body 610, which includes a power source and a control unit. The control unit may have the functionality of the control unit 412 of Figure 4. The main body 610 may include control buttons for starting or stopping an iontophoresis procedure. Main body 610 can include one or more adhesive patches. The receiver 608 also includes a malleable bridge 612 that has a curved profile. The malleable bridge 612 can be constructed from a flexible polymer, such as rubber, and can have a malleable metal core. An earplug 614 may be pivotally connected to the malleable bridge 612. The earplug 614 may generally share the construction of the earplugs disclosed herein. A cable 616 leads from the main body 610 and connects to a return electrode 618. The return electrode 618 may include a snap element to allow connection to other return electrodes.

Figure 6E shows the integrated headset 608 in use, in accordance with one embodiment of the invention. The main body 610 can be positioned behind the helix as shown, and can be temporarily adhered to the skin of the patient. The malleable bridge 612 is wrapped around the helix and the earplug 614 is inserted into the ear canal. Integrated earpiece 608 supports earplug 614 to prevent unwanted movement and also to provide a constant mounting force to help ensure a fluid-tight seal. The malleable bridge 612 can be adjusted to provide more or less mounting force. The earplug 614 can be rotated so that the integrated earpiece 608 can be used in either ear. Return electrode 618 may adhere to a portion of the patient's skin to provide an electrical return path for the control unit. Since the integrated handset 608 includes an integrated control unit, the patient can be free to move during the procedure.

Figure 6F shows an integrated headset 620 in use, in accordance with one embodiment of the invention. Integrated handset 620 is configured similarly to handset 608 of FIG. 6D, however, a control unit 622 is separately housed with a return electrode patch. The integrated earpiece 620 also includes a malleable body 624 that completely surrounds the helix of the ear. The malleable body 624 can be constructed from a flexible polymer, such as rubber, and can have a malleable metal core. The malleable body 624 can be adjusted to fit various ear anatomies to prevent unwanted movement and also to provide a constant mounting force to help ensure a fluid tight seal.

Figure 7A shows an earplug 700, in accordance with one embodiment of the invention. Different regions of the ear anatomy have different levels of electrical resistance. Electric current flows preferentially

ES 2 393 697 T3 through areas of lower resistance. For example, the tympanic membrane has less resistance than cartilage areas in the ear canal. It is desirable to prevent unwanted electrical contact with areas of increased resistance, and also desirable to limit the amount of current delivered for the comfort of the patient. Placing the electrode as close to the tympanic membrane as possible helps achieve a positive result by helping to reduce the overall current supply. However, the ear canal is known to be tortuous and thus placing an electrode close to the tympanic membrane is difficult without coming into contact with other areas of the ear. The earplug 700 solves these difficulties.

The earplug 700 includes a sealing body 702 for sealing the earplug 700 in an ear canal. The sealing body 702 may include the construction of other similar earplugs disclosed herein. The sealing body 702 may or may not include lights and vents to fill the ear canal. Earplug 700 includes an isolation body 704 that runs through sealing body 702. The extended portion 706 of the isolation body 704 houses an electrode 708. The extended portion 706 is advantageous in that it extends the electrode 708 well beyond the seal body and closer in use to the tympanic membrane. The distal portion 706 can also contact parts of the ear canal while still providing insulation for the electrode 708.

Figures 7B and 7C show perspective and cross-sectional views respectively, of an alternative extended portion 710, which may be used for example with the earplug 700 shown in Figure 7A. The extended portion 710 has multiple slits 712 that provide fluid access to the inner electrode 714. The extended portion 710 may be formed from a hypotube that has been cut and covered with an outer insulating barrier. The extended part is advantageous in that it reduces the number of parts needed, and also lowers the current density by using a relatively large surface area for the electrode 714. The lower current density has been found to increase patient comfort. Alternatively, the domed portion 710 can be removed and more or fewer slits 712 than shown can also be used.

Figure 7D shows a perspective view, of an alternative extended portion 710, which can be used for example with the earplug 700 shown in Figure 7A. The extended portion 710 includes insulation portions 716a, 716b, and the electrode 718. The electrode 718 can be constructed from a superelastic alloy, such as nickel titanium. And thus, when electrode 716a comes into contact with parts of the ear canal, electrode 718 will easily deflect as needed. Electrode 718 may be longer than shown, and includes multiple insulating portions 716b, to further extend electrode 718 near the tympanic membrane.

Figure 7E shows a perspective view, of an alternative extended portion 720, which can be used for example with the earplug 700 shown in Figure 7A. The extended portion 720 is of a hypotube construction similar to that shown in Figures 7B and 7C. The extended portion 720 includes multiple perforations 722 that allow fluid communication with an inner electrode portion 724, shown by the darkest areas. The extended portion 720 may be formed from a hypotube that has been cut and drilled, and covered with an external insulating barrier.

Figure 7F shows a perspective view, of an alternative extended portion 726, which can be used for example with the earplug 700 shown in Figure 7A. The extended portion 726 can be configured as an easily deformable but resilient basket. When the extended portion 726 comes into contact with parts of an ear canal, it will easily deflect. The extended part 728 is constructed from an external insulation material 728 and an internal conductive part 730. The extended part 726 can be constructed from a superelastic material such as nickel titanium, and of fine proportions, for example less than 0 , 13 mm (0.005 inch) thick.

Figure 7G shows a perspective view, of an alternative extended portion 732, which can be used for example with the earplug 700 shown in Figure 7A. The extended portion 732 includes an outer isolation member 734 and a plurality of electrodes 736. The plurality of electrodes 736 extend into the isolation member 734. This configuration is advantageous in that it greatly increases the conductive surface area and thus helps to reduce the current density. This configuration also directs current flow in a distal direction toward the tympanic membrane when in use.

Figure 7H shows a perspective view, of an alternative extended portion 738, which can be used for example with the earplug 700 shown in Figure 7A. The extended portion 738 is similar to the extended portion shown in FIG. 7F. However, the electrodes 742 are insulated to a more distal point as shown. This configuration also directs current flow in a distal direction toward the tympanic membrane when in use.

Figures 7I and 7J show perspective and exploded views respectively, of an alternative extended portion 744, which may be used for example with the earplug 700 shown in Figure 7A. The extended portion 744 includes a spiral configuration as shown, further including a laminated construction. The laminated construction includes an outer insulation member 746, a conductive member 748, and an inner insulation member 750. Internal insulation member 750 includes openings 752 that leave

ES 2 393 697 T3 exposed to conductive member 750. Extended portion 744 may be constructed from initially coated flat wire, which is subsequently cut on one side to form openings 752, and further spirally.

Figures 8A and 8B show side and operational views, respectively, of an expandable earplug, in accordance with one embodiment of the invention. The earplug 800 includes an outer expandable portion 802 and an expander 804. The outer expandable portion 802 and the expander may be internally connected near the distal end of the earplug, as shown. The expander 804 is slidable within the expandable portion, and can be withdrawn proximally to force the outer expandable portion to expand into a second configuration, as shown in Figure 8B. The external expandable portion 802 can be constructed from a soft polymer, for example silicone. This configuration is advantageous as it allows a precise fit within the anatomy of a specific ear and also allows for deeper positioning.

Figure 9A shows a foam plug device 900, in accordance with one embodiment of the invention. The foam plug device 900 includes an electrode 902 and a perforated tube 904 attached to the electrode 902. A foam plug 906 surrounds the electrode 902. The foam plug 906 may be cylindrical or conical in shape, and may be constructed from open cell foam. Electrode 902 may be constructed from a solid or stranded wire of malleable metal (eg, silver), or a solid or perforated tube, and include insulation 908 leading from the proximal end of perforated tube 904. An electrical connector ( not shown) may connect to the proximal end of electrode 902. Perforated tube 904 may be constructed from a flexible, insulating or conductive material, and generally includes perforations throughout. The foam plug device 900 may also include additional sealing elements (not shown) and / or adhesives, as described herein. During use, the foam plug 906 can be compressed, inserted into an ear canal, and then allowed to expand to seal the ear canal. The drug solution may be introduced into the ear canal prior to insertion of the foam plug device 900, or afterwards due to the open cell nature of the foam plug 902. The porosity of the foam plug may allow the solution of Drug contacts along the entire length of perforated tube 904, thereby increasing the surface area of ​​the electrode through perforations in perforated tube 904. The porosity of the foam plug can also prevent pressure build-up during an iontophoresis procedure.

Figure 9B shows a foam balloon device 910, in accordance with one embodiment of the invention. The foam balloon device 910 includes an electrode 912. The electrode 912 can be constructed from a solid or stranded wire of malleable metal (eg, silver), or solid or perforated tube. In one embodiment, electrode 912 may include an outer lumen (not shown) that can be manufactured from a block polyetheramide (eg, Pebax® 55D) with an internal diameter of approximately 1.52mm (0.060) and a outer diameter of approximately 1.83mm (0.072). An electrical connector (not shown) can connect to the proximal end of the electrode. Electrode 912 may also include a distal end with an expanded insulator surrounding a plurality of wire strands. A foam plug 914 surrounds the electrode 912. The foam plug 914 may be constructed from open cell foam. It has been found that a polyether foam (EC85HDE) with a density of 80.1 kg / m³ (5 pound / ft³) and manufactured by Foamex Innovations, Inc., is suitable. The foam plug can have a cylindrical shape with an external diameter of 5-15mm, and an internal diameter of

2.5 mm. 8.3mm and 11mm outside diameters have been used. The foam plug can have other shapes, such as conical. The foam plug is enveloped by a double-walled balloon 916. The double-walled balloon 916 may be constructed from a compliant, semi-compliant, or non-compliant material. In one embodiment, the double-walled balloon 916 may be formed by dip coating a molded mandrel with a silicone, such as MED 106400 manufactured by NuSil Technology LLC. The double-walled balloon 916 can then be attached to a portion of the electrode 912 and then partially inverted to create a double wall. The foam plug 914 can then be inserted into the space between the walls. The distal portion of balloon 916 may be connected to a suction coupler 918, such as a T-connector 88207 available from Qosina Corp.

During use, a vacuum may be applied to the suction coupler 918, causing the foam plug 914 to retract. The foam balloon device 910 can then be inserted into an ear canal. Once in place, the vacuum can be interrupted, causing the foam 914 to expand. The expansion of the foam 914 presses the double-walled balloon 916 into contact with the walls of the ear canal to fluidly seal the drug solution within the ear canal. Since positive air pressure is not used to inflate the double-walled balloon, the danger of balloon rupture is negated. The vacuum can be reapplied to re-retract the foam 914 to aid removal.

Figure 10A shows a speculum-like orifice 1000, in accordance with one embodiment of the invention. The speculum-like orifice 1000 may have a generally conical shape. The speculum-like orifice 1000 may be constructed from a polymer or metal alloy. The speculum-like orifice 1000 can be relatively flexible or rigid. The speculum-like hole 1000 may include a proximal hole 1002 that is removably coupled to a distal hole 1004. The proximal hole 1002 can be coupled to the distal hole 1004 by a slight interference fit or by a threaded connection. An internal plug 1006 may be removably and sealable coupled to the distal hole 1004. The inner plug 1006 includes an electrode 1008, which is configured as a loop electrode as shown in Figure 2F. However, electrode 1008 can generally assume the shape of any of the electrodes disclosed herein.

ES 2 393 697 T3 document. Inner plug 1006 may include sealing members (not shown) configured similarly to other sealing members disclosed herein. Distal hole 1004 may include an adhesive layer

1010 which can take the form of any of the adhesives disclosed in this document. The adhesive layer

1010 It can also be a layer of collapsible silicone putty, ostomy bag adhesive gasket material, expanding foam, impression material, gel, bone wax, balloon adhesive, or a silicone gasket.

Figure 10B shows an alternative distal hole 1012, in accordance with one embodiment of the invention. The distal hole 1012 is configured similarly to the distal hole 1004, however, the distal hole 1012 includes a surface of the electrode 1014. The surface of the electrode 1014 may be a layer of metal, such as silver, attached to the interior surface of the electrode. distal hole 1004. An inner plug 1016 may be removably and sealable to the distal hole 1012. The inner plug 1016 may include a contact surface 1018 that can make electrical contact with the electrode surface when the inner plug 1016 engages the hole. distal 1004.

Figure 10C shows an alternative distal hole 1020, in accordance with one embodiment of the invention. Distal hole 1012 is configured similarly to distal hole 1004, however, distal hole 1012 engages a plug with a plurality of tentacular electrodes 1022. Tentacular electrodes 1022 are highly flexible and provide a greater surface area. Tentacular electrodes 1022 can include insulating and conductive areas of exposed metal.

Figures 10D and 10E show speculum-like orifice 1000 in use, in accordance with one embodiment of the invention. The speculum hole 1000 can be operated via the proximal hole 1002. The increased diameter of the proximal hole 1002 allows finger manipulation and insertion of the speculum hole 1000. The speculum hole can be adjusted to provide visualization of the membrane tympanic. The adhesive layer 1010 on the distal hole 1004 provides a fluid tight seal and fixation between the distal hole 1004 and the ear canal. Once the speculum-like hole 1000 has been placed in an optimal position, the proximal hole 1002 can be disengaged from the distal hole 1004. The distal hole 1004 can then be filled with a drug solution and the inner plug 1006 can be inserted into the distal hole 1004. The internal plug 1006 can then be supplied with electrical current to complete the iontophoresis procedure.

Figures 10F to 10H show speculum-like orifice 1000 in use, in accordance with one embodiment of the invention. The speculum-like hole 1000 includes an alternate distal hole 1012 with the surface of the electrode 1014. The distal hole 1012 has already been placed in the ear canal and the proximal hole 1002 has been removed, in accordance with Figures 10D and 10E. Distal port 1012 can be filled with a drug solution, and inner plug 1016 can be inserted into distal port 1012. Inner plug 1016 can then be supplied with electrical current to complete the iontophoresis procedure.

Figure 11 shows a simplified support structure 1100 that is worn on the patient's head, in accordance with one embodiment of the invention. The simplified support structure 1100 is worn on the patient's head while the patient is awake and upright. Support structure 1100 is configured to hold the one or more systems described herein in alignment with the ears of patient E. As can be seen in Figure 11, the support structure 1100 may have an alignment structure with a first body 1110 that engages the first ear, a second body 1110 that engages the second ear, and a member that engages extends around the patient's head between the first and second bodies. Any of the earplugs of the present invention can be attached to the head by means of helmets such as in Figure 11.

Figure 12 shows a simplified support structure 1200 worn on the patient's head, in accordance with one embodiment of the invention. Support structure 1200 is configured similar to glasses and can be worn similarly. Earplugs 1210 are hingedly connected to support structure 1200 and can be levered into the ear canals by support structure 1200. Earplugs 1210 may be configured similarly to any of the earplugs disclosed herein. Support structure 1200 can prevent unwanted movement and provide sealing force against earplugs 1210. Support structure 1200 can include adjustable elements to adjust width and length for patients of various sizes. Support structure 1200 can include visual panels, such as LCD panels that can provide video viewing for the patient. The earplugs 1210 may also include speakers to provide audio to the patient.

The present invention can be carried out in other specific ways without departing from its essential characteristics. These other embodiments are intended to be included within the scope of the present invention, which is defined by the following claims.