Method and apparatus for antegrade transcatheter valve repair or implantation
Inventors
Fischell, Tim A. • Saltiel, Frank
Assignees
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Publication Number
US-12186189-B2
Publication Date
2025-01-07
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 described invention is a system for antegrade delivery of a replacement valve that uses an outer catheter configured as a sheath and an inner catheter that is detachably coupled within the outer catheter lumen. The outer catheter has an engagement region within the lumen at a distal end region, and the inner catheter has a tapered distal end region and an engagement surface proximal to the tapered distal end. The engagement surface detachably couples to the engagement region so that an outer surface of the inner catheter is flush with an outer surface of the outer catheter without a gap.
The inner catheter further includes a deflector on an outer surface distal to the tapered distal end region, where the deflector is configured to radially expand to deflect away from chordae tendinae of the left ventricle. Between the engagement surface and a distal end of the inner catheter, the inner catheter has a steering region configured to bend, and the system includes a guidewire lumen for advancing and delivering the replacement valve antegrade.
The disclosure additionally emphasizes interchangeable or detachable inner catheter concepts with outer sheath coupling designed for gapless flush surfaces, and steering or bending behavior that can be directed toward the LVOT or aortic or toward the mitral outflow. A chordae tendinae deflection feature is expandable to prevent chordal entanglement during valve delivery.
Claims Coverage
The provided independent claim covers a replacement-valve antegrade delivery system with a detachable inner catheter in a sheath-like outer catheter, including a gapless flush engagement coupling, a chordae tendinae deflecting radially expandable deflector, a bending steering region, and a guidewire lumen. The provided dependent claim excerpts indicate refinements that impose quantitative limits and specific structural configurations on taper, steering bend amount, axial location, coupling dimensions, and a rapid exchange monorail guidewire connection.
Detachable gapless flush coupling of tapered inner catheter
The system has an outer catheter engagement region at a distal end region and an inner catheter with a tapered distal end region and an engagement surface proximal to the tapered distal end, wherein the engagement surface detachably couples to the engagement region so that an outer surface of the inner catheter is flush with an outer surface of the outer catheter without a gap.
Radially expandable chordae tendinae deflector
The inner catheter includes a deflector on an outer surface distal to the tapered distal end region, wherein the deflector is configured to radially expand to deflect away from chordae tendinae of the left ventricle.
Bendable steering region for directing delivery
The inner catheter includes a steering region between the engagement surface and a distal end of the inner catheter that is configured to bend.
Guidewire lumen
The system includes a guidewire lumen.
Quantified steering bend and location refinements
In dependent refinements, the steering region is configured to have a bend greater than 120 degrees, and the steering region is positioned 3–6 mm from the distal tip of the inner catheter.
Quantified inner-catheter taper and engagement-region diameter step
In dependent refinements, the tapered distal end region tapers from 3 Fr or smaller to 14 Fr or larger, and an engagement region has an inner diameter at least 1 French smaller than the lumen’s inner diameter in a proximally adjacent region.
Rapid exchange monorail guidewire lumen configuration
In dependent refinements, the guidewire lumen includes a rapid exchange monorail connection.
Overall, the claim coverage centers on an antegrade delivery system that detachably couples a tapered inner catheter to an outer sheath with a gapless flush engagement, incorporates a radially expandable deflector configured to deflect away from chordae tendinae, and provides a bendable steering region plus a guidewire lumen, with dependent refinements specifying quantitative taper, steering, coupling dimensions, and a rapid exchange monorail guidewire configuration.
Stated Advantages
Deflects away from chordae tendinae of the left ventricle to prevent chordal entanglement during valve delivery.
Documented Applications
Antegrade delivery of a replacement valve, including aortic and mitral valve repair or implantation.
Transseptal antegrade delivery and valve implantation or replacement.
Application of pacing signals during deployment using a pacing sheath and pacing controller.
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