Commissural alignment balloon for transcatheter procedures

A balloon catheter for delivering a prosthetic heart valve to a targeted site at a native valve of a patient, the balloon catheter comprising:

• a delivery shaft;
• and
• a balloon fixedly attached to the delivery shaft, wherein when the balloon is in a deflated state, a membrane material of the balloon defines a plurality of folded portions extending along a longitudinal axis of the delivery shaft,
• wherein when the balloon is disposed within a prosthetic heart valve when the balloon is in the deflated state and the prosthetic heart valve is in a collapsed state, a first set of folded portions of the plurality of folded portions extend clockwise about the longitudinal axis of the delivery shaft and a second set of folded portions of the plurality of folded portions extend counterclockwise about the longitudinal axis of the delivery shaft.

A method of pleating a balloon attached to a delivery shaft comprises:

• inflating the balloon such that a cross-section of the balloon is substantially circular;
• moving a set of pleating heads radially inward, each pleating head of the set of pleating heads pushing a membrane material of the balloon inwards to define a recess of a set of recesses, wherein each pleating head comprises a pleating tooth located at a distal end of the respective pleating head;
• placing a pleating nut to secure the pleating tooth of each pleating head, preserving the set of recesses;
• retracting the set of pleating heads radially outward, leaving the pleating tooth corresponding to each pleating head secured to the pleating nut;
• moving a set of folding heads radially inwards, each folding head of the set of folding heads pushing a membrane material of the balloon inwards to define a plurality of folded portions;
• and
• arranging the plurality of folded portions so that a first set of folded portions of the plurality of folded portions extend clockwise about a longitudinal axis of the delivery shaft and a second set of folded portions of the plurality of folded portions extend counterclockwise about the longitudinal axis of the delivery shaft.