Tympanostomy tube delivery device with cutting dilator

The method of claim 1, further comprising:

• retracting the first and second tubular members relative to a third tubular member in a proximal direction, the third tubular member disposed within a lumen of the second tubular member and configured to deploy a tympanostomy tube;
• and
• deploying, in response to retracting the first and second tubular members, the tympanostomy tube in the incision using the third tubular member.

The method of claim 2, wherein the tympanostomy tube is disposed within the lumen of the second tubular member distal to the third tubular member;

• wherein deploying the tympanostomy tube includes pushing the tympanostomy tube out of the lumen of the second tubular member using the third tubular member.

The method of claim 1, wherein the first tubular member has a cylindrical shape with an outer diameter,

• wherein moving the plurality of leaves from the collapsed position to the expanded position includes moving the distal edge of the at least one of the plurality of leaves to a position outside of the outer diameter.

The method of claim 1, wherein the plurality of leaves includes four leaves,

• wherein each of two leaves of the four leaves includes a sharp distal tip configured to create an incision in the tympanic membrane and a distal edge configured to cut the tympanic membrane, the two leaves disposed on diametrically opposed sides of the distal end of the first tubular member.

The method of claim 1, wherein the at least one of the plurality of leaves includes a curved surface and a radially extending surface, and wherein the distal edge is defined at a convergence of the curved surface and the radially extending surface.

The method of claim 1, wherein the distal edge of the at least one of the plurality of leaves projects in a direction parallel to a longitudinal axis of the first tubular member when the plurality of leaves is in the expanded position.

The method of claim 9, wherein the bellows is collapsed in the first state and expanded in the second state.

The method of claim 9, wherein expanding the bellows from the first state to the second state includes connecting an interior of the bellows to atmospheric air exterior to the shaft assembly.

The apparatus of claim 12, wherein the connection between the tubular member and the plurality of leaves includes a living hinge.

The apparatus of claim 12, wherein the sharp distal point is configured to create a straight-line incision when the plurality of leaves move between the collapsed position and the expanded position.

The apparatus of claim 12, wherein the plurality of leaves comprises two leaves, the first leaf including the sharp distal point and the second leaf including a blunt distal point,

• wherein the tubular member has a cylindrical shape with an outer circumference,
• wherein the first leaf extends around a greater portion of the outer circumference than the second leaf,
• wherein the first leaf has a longitudinal length greater than a longitudinal length of the second leaf.

The apparatus of claim 16, further comprising a valve assembly including a vent port in fluid communication with atmospheric air,

• wherein the valve assembly is in fluid communication with the vacuum and the interior of the bellows,
• wherein the valve assembly is configured to selectively couple the interior of the bellows to one of the vacuum and the vent port,
• wherein the bellows is configured to move the pivoting member from the first position to the second position when the interior of the bellows is coupled to the vent port via the valve assembly.

The apparatus of claim 17, wherein the bellows is configured to expand from a collapsed state to an expanded state,

• wherein the bellows moves the pivoting member from the first position to the second position when the bellows expands from the collapsed state to the expanded state.

The apparatus of claim 18, wherein the bellows expands from the collapsed state to the expanded state when the distal end of the shaft assembly engages with the tympanic membrane and the interior of the bellows is coupled to the vent port.

The apparatus of claim 19, wherein the vacuum source generates a negative pressure when the distal end of the shaft assembly engages with the tympanic membrane, and wherein the bellows expands from the collapsed state to the expanded state in response to the negative pressure.