Method and apparatus for antegrade transcatheter valve repair or implantation
Inventors
Fischell, Tim A. • Saltiel, Frank
Assignees
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Publication Number
US-11766328-B1
Publication Date
2023-09-26
Expiration Date
Abstract
Methods, apparatuses, and systems for performing a valve replacement or repair. Apparatuses may include systems and may include an outer catheter, one or more interchangeable inner catheters, a guidewire and an expandable chordae tendinae deflector. Also described herein are rapid pacing sheaths that may be used with any of these apparatuses and methods.
Core Innovation
The disclosed invention relates to percutaneous antegrade delivery and implantation of a valve in a patient using a transseptal puncture to deliver a tapered inner catheter into a left atrium and then into a left ventricle. The distal region of the inner catheter is flush with an outer catheter at a distal end region of the outer catheter, including configurations where an annularly engaged, flush outer surface between the inner and outer catheters is achieved without a gap. The method uses advancing an outer catheter and either the first inner catheter or a second inner catheter exchanged for the first inner catheter to place the inner catheter in the left ventricle while performing catheter-based positioning.
A key functional element is an expandable deflector that is expanded to deflect away from the chordae tendinae of the left ventricle. The expandable deflector is used while advancing the inner/outer catheter system so that the distal end region of the inner catheter assumes bends and faces toward the left ventricular outflow tract. In one embodiment, the inner catheter is deflected within the left atrium to assume a first bend, and then deflected within the left ventricle to assume a second bend that faces the patient's left ventricular outflow tract.
After deflection and positioning, a guidewire is advanced out of the distal end of the first or second inner catheter and across a valve of the patient's heart, and the inner catheter is removed while leaving the guidewire in place. A replacement valve is then implanted through the outer catheter, including implantation of a replacement aortic valve. The deflector expansion and valve crossing are incorporated into an antegrade workflow that uses monorail-style inner/outer catheter relationships to facilitate crossing of the mitral valve orifice and advancing to an aortic valve for replacement valve implantation.
Claims Coverage
The independent claims cover six inventive features.
Flush coupling between inner and outer catheters
A first inner catheter distally tapered through a transseptal puncture, wherein a distal region of the first inner catheter is flush with an outer catheter at a distal end region of the outer catheter; or a region proximal to the distal end annularly engaged such that the outer surface of the first inner catheter is flush with the outer surface of the outer catheter without a gap.
Expandable deflector for chordae tendinae avoidance
Expanding an expandable deflector to deflect away from the chordae tendinae of the left ventricle.
Antegrade catheter advancement to position in the left ventricle
Advancing the outer catheter and either the first inner catheter or a second inner catheter exchanged for the first inner catheter so that the first or second inner catheter is in a left ventricle while deflecting away from the chordae tendinae.
Guidewire crossing of a heart valve
Advancing a guidewire out of the distal end of the first or second inner catheter and across a valve of the patient's heart; or across an aortic valve of the patient's heart.
Leaving guidewire in place and implanting replacement valve through outer catheter
Removing the first or second inner catheter, leaving the guidewire in place, and implanting a replacement valve in the patient's heart through the outer catheter; including implanting a replacement aortic valve through the outer catheter.
Inner catheter bending geometry toward left ventricular outflow tract
Deflecting the first inner catheter within the left atrium so that a distal end region of the inner catheter assumes a first bend, and deflecting the first or second inner catheter within the left ventricle so that the distal end region of the first or second inner catheter assumes a second bend and faces the patient's left ventricular outflow tract.
The claim coverage centers on a percutaneous antegrade catheter system through a transseptal puncture with flush inner/outer coupling, an expandable deflector expanded to deflect away from left ventricular chordae tendinae, catheter advancement with inner-catheter bending geometry toward the left ventricular outflow tract, guidewire crossing of a valve, removal of the inner catheter while leaving the guidewire in place, and implantation of a replacement valve through the outer catheter.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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