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System and method for transaortic delivery of a prosthetic heart valve

  • US 10,149,757 B2
  • Filed: 03/17/2014
  • Issued: 12/11/2018
  • Est. Priority Date: 03/15/2013
  • Status: Active Grant
First Claim
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1. A method of implanting a prosthetic heart valve to an aortic valve annulus of a patient, comprising:

  • providing a balloon catheter that includes a balloon catheter shaft, a balloon on a distal end of the catheter shaft and a tapered distal tip that is distal of the balloon, wherein the tapered distal tip tapers from a maximum diameter proximally of a distal end of the tapered distal tip to a minimum diameter at the distal end of the tapered distal tip, the tapered distal tip further tapering proximally from its maximum diameter to a lesser diameter at a proximal end of the tapered distal tip, the maximum diameter being at least substantially equal to a valve delivery diameter of the prosthetic heart valve, and wherein the tapered distal tip is substantially flexible with increased flexibility toward the distal end of the tapered distal tip and reduced flexibility proximal of the distal end of the tapered distal tip;

    wherein the tapered distal tip further includes an inner portion for engaging the balloon catheter shaft, the inner portion having a narrower diameter at a distal end and a wider diameter at its proximal end to create an angled balloon-engaging space when the tapered distal tip is mounted on the balloon catheter shaft;

    wherein the balloon extends distally into the angled balloon-engaging space of a proximal portion of the tapered distal tip such that a distal portion of the balloon is sandwiched within the balloon-engaging space between the proximal portion of the tapered distal tip and the balloon catheter shaft,wherein the angled balloon-engaging space tapers distally from the proximal end of the tapered distal tip and through a section of the tapered distal tip that tapers proximally from the maximum diameter of the tapered distal tip to the lesser diameter at the proximal end of the tapered distal tip;

    wherein the angled balloon-engaging space stops at a section of the tapered distal tip having the maximum diameter; and

    wherein a seal forms when the distal portion of the balloon material is sandwiched between the proximal portion of the tapered distal tip and the balloon catheter shaft;

    providing a balloon-expandable prosthetic heart valve mounted over the balloon on the distal end of the balloon catheter;

    creating a puncture in an aortic wall at or near an aortic arch of the patient;

    inserting an introducer sheath through the puncture;

    passing the balloon catheter through the introducer sheath into an aorta;

    advancing the balloon catheter through the aortic annulus and thereby engaging the tapered distal tip distally against one or more leaflets of a resident aortic valve, wherein the balloon catheter is advanced until the balloon-expandable prosthetic heart valve is positioned within the aortic annulus; and

    inflating the balloon to expand the balloon-expandable prosthetic heart valve from the valve delivery diameter to an expanded diameter at the aortic annulus;

    wherein all portions of this method are performed while the patient'"'"'s heart remains beating.

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