SYSTEMS AND METHODS FOR ANESTHETIZING EAR TISSUE
First Claim
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1. A system for use in iontophoretic substance delivery to the tympanic membrane of an ear of a human or animal subject, the system comprising:
- an earplug, comprising;
a distal portion;
a proximal portion;
a tube extending from the distal portion to the proximal portion, wherein the tube has a stiffness less than a stiffness of the proximal and distal portions of the earplug;
at least one flexible sealing element extending from an outer surface of the tube and disposed closer to the distal end than the proximal end; and
an electrode device, comprising;
an elongate shaft; and
an electrode tip having a diameter greater than that of the elongate shaft,wherein the electrode device is movable within the tube of the earplug from a retracted position, in which fluid can pass around the electrode through the tube, to an advanced position, in which the electrode tip contacts an inner surface of the tube to prevent fluid from flowing through the tube.
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Accused Products
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.
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Citations
31 Claims
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1. A system for use in iontophoretic substance delivery to the tympanic membrane of an ear of a human or animal subject, the system comprising:
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an earplug, comprising; a distal portion; a proximal portion; a tube extending from the distal portion to the proximal portion, wherein the tube has a stiffness less than a stiffness of the proximal and distal portions of the earplug; at least one flexible sealing element extending from an outer surface of the tube and disposed closer to the distal end than the proximal end; and an electrode device, comprising; an elongate shaft; and an electrode tip having a diameter greater than that of the elongate shaft, wherein the electrode device is movable within the tube of the earplug from a retracted position, in which fluid can pass around the electrode through the tube, to an advanced position, in which the electrode tip contacts an inner surface of the tube to prevent fluid from flowing through the tube. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A system for use in iontophoretic substance delivery to the tympanic membrane of an ear of a human or animal subject, the system comprising:
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an elongate, flexible tube with a proximal portion and a distal portion, including a main lumen extending therethrough, the distal portion including an inner lip at the distal end of the distal portion and a sealing member proximal to the inner lip, wherein the elongate tube has sufficient flexibility to bend to conform to the shape of an ear canal; a first flexible sealing element shaped like an umbrella to form a seal within the ear canal, the first flexible sealing element being integral to and disposed on an exterior of the elongate tube and being offset a distance from a distal most portion of the elongate tube; a second flexible sealing element shaped like an umbrella to form a seal within the ear canal, the second flexible sealing element being integral to and disposed on the exterior of the elongate tube and proximal to the first sealing element; a distal stiffening tube located within the distal portion of the elongate tube distal to the sealing member, the distal stiffening tube preventing the distal portion of the elongate tube from bending; a luer fitting coupled with the proximal portion of the tube and including a side vent in fluid communication with the main lumen of the tube; and an electrode device comprising; an elongate shaft; and an electrode tip having a diameter greater than that of the elongate shaft, wherein the electrode device is movable within the tube lumen of the earplug from a retracted position, in which fluid can pass around the electrode through the tube, to an advanced position, in which the electrode tip fits within the distal portion of the elongate tube between the inner lip and the sealing member to form a fluid tight seal.
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17. A method of anesthetizing a tympanic membrane of an ear of a human or animal subject using iontophoresis, the method comprising:
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delivering an anesthetizing drug solution to an ear canal of the subject; inserting an iontophoresis earplug coupled with an electrode into the ear canal with the electrode disposed in a first position in the earplug, wherein a lumen of the earplug is open from a distal opening to a proximal opening for venting fluid when the electrode is disposed in the first position; allowing excess anesthetizing drug solution to vent through the earplug lumen; moving the electrode from the first position to a second position in the earplug to form a seal between the electrode and an inner wall of the earplug lumen; and activating the electrode to deliver current to the drug solution in the ear canal. - View Dependent Claims (18, 19, 20, 21, 22)
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23. A method of anesthetizing a tympanic membrane of an ear of a human or animal subject using iontophoresis, the method comprising:
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delivering an anesthetizing drug solution to an ear canal of the subject; inserting a iontophoresis device into an ear canal of the subject, the iontophoresis device including an earplug having a lumen and an electrode disposed inside the lumen, wherein inserting the device forms a seal between the device and the ear canal to hold the drug solution in the ear canal and simultaneously vents excess drug solution past the electrode and through the earplug lumen; and activating the electrode to deliver current to the drug solution. - View Dependent Claims (24, 25, 26)
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27. A kit for anesthetizing a tympanic membrane of an ear of a human or animal subject using iontophoresis, the kit comprising:
an earplug, comprising; a distal portion; a proximal portion; a tube extending from the distal portion to the proximal portion, wherein the tube has a stiffness less than a stiffness of the proximal and distal portions of the earplug; at least one flexible sealing element extending from an outer surface of the tube and disposed closer to the distal end than the proximal end; and an electrode device, comprising; an elongate shaft; and an electrode tip having a diameter greater than that of the elongate shaft, wherein the electrode device is movable within the tube of the earplug from a retracted position, in which fluid can pass around the electrode through the tube, to an advanced position, in which the electrode tip contacts an inner surface of the tube to prevent fluid from flowing through the tube; and a controller electrically connectable to the electrode device. - View Dependent Claims (28, 29, 30, 31)
Specification