Tympanic membrane pressure equalization tube delivery system
First Claim
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1. A method, comprising:
- positioning a shaft assembly proximate to a tympanic membrane, the shaft assembly including;
(i) a piercing element configured to form an incision in the tympanic membrane, and (ii) a shaft including an expandable feature;
triggering, after positioning the shaft assembly proximate to the tympanic membrane, an actuation assembly including a cam such that the cam moves to advance a portion of the shaft assembly toward the tympanic membrane;
forming, in response to advancing the portion of the shaft assembly, the incision in the tympanic membrane using the piercing element; and
expanding the expandable feature of the shaft to dilate the incision.
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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.
237 Citations
16 Claims
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1. A method, comprising:
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positioning a shaft assembly proximate to a tympanic membrane, the shaft assembly including;
(i) a piercing element configured to form an incision in the tympanic membrane, and (ii) a shaft including an expandable feature;triggering, after positioning the shaft assembly proximate to the tympanic membrane, an actuation assembly including a cam such that the cam moves to advance a portion of the shaft assembly toward the tympanic membrane; forming, in response to advancing the portion of the shaft assembly, the incision in the tympanic membrane using the piercing element; and expanding the expandable feature of the shaft to dilate the incision. - View Dependent Claims (2, 3, 4, 5, 6)
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7. An apparatus, comprising:
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a body; and a shaft assembly extending distally from the body, the shaft assembly including a shaft including; a tubular portion defining a longitudinal axis; and an expandable portion including a plurality of fingers, at least one of the fingers of the plurality of fingers including a piercing element configured to form an incision in a tympanic membrane, each finger of the plurality of fingers configured to move outwardly relative to the longitudinal axis to transition the expandable portion from a first state to a second state to dilate the incision. - View Dependent Claims (8, 9, 10)
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11. An apparatus, comprising:
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a body; a shaft assembly extending distally from the body and including a plurality of coaxially-arranged shafts; an actuation assembly configured to move the plurality of coaxially-arranged shafts to deploy a tympanostomy tube in a tympanic membrane; and a trigger assembly including; a link configured to pivot between a first position in which the link is engaged with the actuation assembly and prevents movement of the actuation assembly and a second position in which the link is disengaged from the actuation assembly and enables movement of the actuation assembly; and a release mechanism configured to pivot the link from the first position to the second position. - View Dependent Claims (12, 13, 14, 15)
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16. A method, comprising:
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positioning a shaft assembly proximate to a tympanic membrane, the shaft assembly including;
(i) a plurality of fingers disposed at the distal end of the shaft assembly arranged as a cone and expandable from a closed configuration to a dilated configuration, (ii) a piercing element including a sharpened tip of at least one of the fingers configured to form an incision in the tympanic membrane;advancing a portion of the shaft assembly toward the tympanic membrane; forming, in response to advancing the portion of the shaft assembly, the incision in the tympanic membrane using the piercing element to pierce the tympanic membrane with the sharpened tip; and expanding the plurality of flexible fingers from the closed configuration to the expanded configuration to dilate the incision.
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Specification