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 sealing member includes microholes which vent fluid above a certain pressure threshold. A headset may connect the earplug to a second earplug. The method involves using the system on a human or animal subject.

Abstract: Systems, apparatus, and methods described herein relate to a tympanic membrane pressure equalization tube. The tympanic membrane pressure equalization tube can include a tubular body defining a lumen and having a proximal end and a distal end, where the tubular body is configured to be deployed in a tympanic membrane; and a fluid transport element disposed within the lumen and extending at least a length of the tubular body. The tubular body can be configured to transition from a first state in which the tubular body can be disposed within an introducer and a second state in which the tubular body can be retained in an incision formed the tympanic membrane after deployment, and the fluid transport element can enable transport of a fluid across the tympanic membrane.

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 sealing member includes microholes which vent fluid above a certain pressure threshold. A headset may connect the earplug to a second earplug. The method involves using the system on a human or animal subject.

Abstract: A tympanostomy tube delivery device comprises a shaft assembly and a handpiece. All or a portion of the shaft assembly is selectively coupleable and removable from the handpiece. The handpiece includes a housing defining an opening that can receive a portion of the shaft assembly. The shaft assembly comprises a cannula, a piercer/dilator tube, a shield tube, and a pusher tube operable to translate relative to the cannula. The pressure equalization tube is positioned within the shield tube of the shaft assembly. The piercer/dilator tube and the shield tube are operable to pierce the tympanic membrane and dilate an opening formed therein. The pusher tube is operable to drive the pressure equalization tube out of the shield tube of the shaft assembly and into the opening formed in the tympanic membrane. Upon completion of the procedure, all or a portion of the shaft assembly may then be removed and replaced.

Abstract: The invention is a tympanic membrane pressure equalization tube. The tube has a distal end and a proximal end and a tube lumen. A medial flange is located at the distal end of the tube and has 2 or more retention elements and a space between each retention element. A lateral flange is located at the proximal end of the tube. The outside diameter of the medial flange is greater than the outside diameter of the lateral flange and the diameter of the medial flange is between about 2.0 and 5.0 mm and the diameter of the lateral flange is between about 1.75 mm and 4.0 mm.

Abstract: Systems and methods are provided for automatically forming an incision in a tympanic membrane of an ear and placing a tympanic membrane pressure equalization tube into the incision. The systems include a housing with a shaft extending therefrom. A mechanism is disposed within the housing. A distal end of the shaft is placed against a tympanic membrane, and the mechanism is triggered to causes the tympanic membrane to be automatically incised and dilated and a tympanic membrane pressure equalization tube to be placed in the dilated incision.

Abstract: A tympanostomy tube delivery device comprises a shaft assembly, a pressure equalization tube, and a handpiece. All or a portion of the shaft assembly is selectively coupleable and removable from the handpiece. The shaft assembly comprises a cannula, a piercer/dilator tube, a shield tube, and a pusher tube operable to translate relative to the cannula. The pressure equalization tube is positioned within the shield tube of the shaft assembly. The piercer/dilator tube and the shield tube are operable to pierce the tympanic membrane and dilate an opening formed therein. The pusher tube is operable to drive the pressure equalization tube out of the shield tube of the shaft assembly and into the opening formed in the tympanic membrane. Upon completion of the procedure, all or a portion of the shaft assembly may then be removed and replaced.

Abstract: A tympanostomy tube delivery device comprises a body, a cannula extending distally from the body, and a cylindraceous member disposed within the cannula. The cylindraceous member comprises a tubular portion and a plurality of leaves positioned at the distal end of the tubular portion. The leaves are movable between a collapsed position and an expanded position. The cylindraceous member is slidable relative to the cannula to selectively expose the leaves relative to the open distal end of the cannula. A first leaf of the plurality of leaves has a sharp distal point configured to pierce a tympanic membrane and a longitudinally extending sharp edge. The cylindraceous member may be used to create and dilate a myringotomy incision in a tympanic membrane. The tympanostomy tube delivery device may then be used to deploy a tympanostomy tube through the myringotomy incision.

Abstract: Systems and methods are provided for automatically forming an incision in a tympanic membrane of an ear and placing a tympanic membrane pressure equalization tube into the incision. The systems include a housing with a shaft extending therefrom. A mechanism is disposed within the housing. A distal end of the shaft is placed against a tympanic membrane, and the mechanism is triggered to causes the tympanic membrane to be automatically incised and dilated and a tympanic membrane pressure equalization tube to be placed in the dilated incision.

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.

Abstract: A tympanostomy tube delivery device comprises a body, a cannula extending distally from the body, and a cylindraceous member disposed within the cannula. The cylindraceous member comprises a tubular portion and a plurality of leaves positioned at the distal end of the tubular portion. The leaves are movable between a collapsed position and an expanded position. The cylindraceous member is slidable relative to the cannula to selectively expose the leaves relative to the open distal end of the cannula. A first leaf of the plurality of leaves has a sharp distal point configured to pierce a tympanic membrane and a longitudinally extending sharp edge. The cylindraceous member may be used to create and dilate a myringotomy incision in a tympanic membrane. The tympanostomy tube delivery device may then be used to deploy a tympanostomy tube through the myringotomy incision.

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.

Abstract: Systems and methods are provided for sealing an ear canal for retaining a solution in the ear canal. Adhesive earplugs are provided through which the solution can be delivered, and which, following delivery, retain the fluid in the ear canal. The systems and methods may also be useful for delivering an anesthetizing solution to the ear canal of a human patient and for maintaining the solution therein for use with an iontophoresis system for anesthetizing the tympanic membrane.

Abstract: A tympanostomy tube delivery device comprises a shaft assembly, a pressure equalization tube, and a sensor. The shaft assembly comprises a cannula and a pusher operable to translate relative to the cannula. The pressure equalization tube is positioned within the shaft assembly. The pusher is operable to drive the pressure equalization tube out of the shaft assembly. The sensor is operable to detect a physical parameter associated with engagement between the distal end of the shaft assembly and a tympanic membrane. A controller may activate a feedback device to inform an operator that the distal end of the shaft assembly has achieved suitable apposition with the tympanic membrane, based on information from the sensor.

Abstract: Systems and methods are provided for sealing an ear canal for retaining a solution in the ear canal. Adhesive earplugs are provided through which the solution can be delivered, and which, following delivery, retain the fluid in the ear canal. The systems and methods may also be useful for delivering an anesthetizing solution to the ear canal of a human patient and for maintaining the solution therein for use with an iontophoresis system for anesthetizing the tympanic membrane.

Abstract: A tympanostomy tube delivery device comprises a shaft assembly, a pressure equalization tube, and a sensor. The shaft assembly comprises a cannula and a pusher operable to translate relative to the cannula. The pressure equalization tube is positioned within the shaft assembly. The pusher is operable to drive the pressure equalization tube out of the shaft assembly. The sensor is operable to detect a physical parameter associated with engagement between the distal end of the shaft assembly and a tympanic membrane. A controller may activate a feedback device to inform an operator that the distal end of the shaft assembly has achieved suitable apposition with the tympanic membrane, based on information from the sensor.

Abstract: A tympanostomy tube delivery device comprises a shaft assembly, a pressure equalization tube, and a handpiece. All or a portion of the shaft assembly is selectively coupleable and removable from the handpiece. The shaft assembly comprises a cannula, a piercer/dilator tube, a shield tube, and a pusher tube operable to translate relative to the cannula. The pressure equalization tube is positioned within the shield tube of the shaft assembly. The piercer/dilator tube and the shield tube are operable to pierce the tympanic membrane and dilate an opening formed therein. The pusher tube is operable to drive the pressure equalization tube out of the shield tube of the shaft assembly and into the opening formed in the tympanic membrane. Upon completion of the procedure, all or a portion of the shaft assembly may then be removed and replaced.

Abstract: Apparatus for delivering stents to body lumens include one or more tubular prostheses carried at the distal end of a catheter shaft, a sheath slidably disposed over the prostheses, and a guidewire tube extending from within the sheath to the exterior of the sheath through an exit port in a sidewall thereof. A guidewire extends slidably through the guidewire tube. The sheath can be moved relative to the catheter shaft and the guidewire tube to expose the prostheses for deployment. Methods of delivering stents are also provided.

Abstract: The invention is a tympanic membrane pressure equalization tube. The tube has a distal end and a proximal end and a tube lumen. A medial flange is located at the distal end of the tube and has 2 or more retention elements and a space between each retention element. A lateral flange is located at the proximal end of the tube. The outside diameter of the medial flange is greater than the outside diameter of the lateral flange and the diameter of the medial flange is between about 2.0 and 5.0 mm and the diameter of the lateral flange is between about 1.75 mm and 4.0 mm.

Abstract: Systems and methods are provided for automatically forming an incision in a tympanic membrane of an ear and placing a tympanic membrane pressure equalization tube into the incision. The systems include a housing with a shaft extending therefrom. A mechanism is disposed within the housing. A distal end of the shaft is placed against a tympanic membrane, and the mechanism is triggered to causes the tympanic membrane to be automatically incised and dilated and a tympanic membrane pressure equalization tube to be placed in the dilated incision.