System and method for the simultaneous automated bilateral delivery of pressure equalization tubes
First Claim
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1. A system for deploying a tympanostomy tube in a tympanic membrane in an ear of a patient, the system comprising:
- (a) a cutting tool having a proximal end and a distal end, the distal end capable of penetrating the tympanic membrane;
(b) a sheath having a proximal end and a distal end, wherein the sheath can selectively cover the distal end of the cutting tool;
(c) an actuation assembly movably supporting the cutting tool, the sheath, and the tympanostomy tube, the actuation assembly being operable to cause relative movement between;
(i) the cutting tool and the sheath to at least one of expose the distal end of the cutting tool for penetrating the tympanic membrane and cover the distal end of the cutting tool for removing the system from the ear; and
(ii) the tympanostomy tube and at least one of the cutting tool and the sheath to deploy the tympanostomy tube in the penetrated tympanic membrane; and
(d) a first locking mechanism including at least one leg biased toward a radially expanded configuration, the at least one leg being radially compressed in an unlocked state and radially expanded in a locked state, wherein the at least one leg can restrict proximal movement of the tympanostomy tube after deployment in the locked state.
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Abstract
Systems and methods for treating a patient having a head with a first ear and a second ear, function by aligning a first device with a tympanic membrane of the first ear; inputting a command to an input device operatively coupled to the first device to generate a signal; and actuating the first device in response to the signal so as to drive a penetrator of the device through the tympanic membrane.
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Citations
20 Claims
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1. A system for deploying a tympanostomy tube in a tympanic membrane in an ear of a patient, the system comprising:
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(a) a cutting tool having a proximal end and a distal end, the distal end capable of penetrating the tympanic membrane; (b) a sheath having a proximal end and a distal end, wherein the sheath can selectively cover the distal end of the cutting tool; (c) an actuation assembly movably supporting the cutting tool, the sheath, and the tympanostomy tube, the actuation assembly being operable to cause relative movement between; (i) the cutting tool and the sheath to at least one of expose the distal end of the cutting tool for penetrating the tympanic membrane and cover the distal end of the cutting tool for removing the system from the ear; and (ii) the tympanostomy tube and at least one of the cutting tool and the sheath to deploy the tympanostomy tube in the penetrated tympanic membrane; and (d) a first locking mechanism including at least one leg biased toward a radially expanded configuration, the at least one leg being radially compressed in an unlocked state and radially expanded in a locked state, wherein the at least one leg can restrict proximal movement of the tympanostomy tube after deployment in the locked state. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A disposable actuator system for deploying a tympanostomy tube in a tympanic membrane of a patient, the system comprising:
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(a) a tube assembly including; (i) a cutting tool for penetrating the tympanic membrane; (ii) a sheath for selectively covering the cutting tool; and (iii) the tympanostomy tube predisposed inside the sheath, wherein the tube assembly is operable to transition between a first state and a second state, the cutting tool being covered by the sheath in the first state and at least a portion of the cutting tool being exposed for penetrating the tympanic membrane and deploying the tympanostomy tube in the second state; (b) an actuation mechanism for coupling the actuator system to a drive system operable to transition the tube assembly from the first state to the second state; and (c) a first locking mechanism including at least one leg biased toward a radially expanded configuration, the at least one leg being radially compressed in an unlocked state and radially expanded in a locked state, wherein the at least one leg can restrict proximal movement of the tympanostomy tube after deployment in the locked state. - View Dependent Claims (18)
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19. A method for deploying a tympanostomy tube in a tympanic membrane in an ear canal of a patient, the method comprising:
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(a) inserting a distal portion of an actuation assembly into the ear canal of the patient, the actuation assembly movably supporting a cutting tool, a sheath, and the tympanostomy tube, the sheath covering a distal end of the cutting tool during the insertion; (b) operating the actuation assembly to advance the cutting tool relative to the sheath to penetrate the tympanic membrane with the distal end of the cutting tool; (c) operating the actuation assembly to advance the tympanostomy tube relative to the sheath for deployment in the penetrated tympanic membrane and to actuate a locked state of a first locking mechanism, the first locking mechanism including at least one leg biased toward a radially expanded configuration, the at least one leg being radially compressed in an unlocked state and radially expanded in the locked state, for restriction of proximal movement by the tympanostomy tube after the deployment; and (d) withdrawing the distal portion of the actuation assembly from the ear canal of the patient, the sheath covering the distal end of the cutting tool during the withdrawal. - View Dependent Claims (20)
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Specification