Systems, methods and devices for two-step delivery and implantation of prosthetic heart valve
Inventors
Assignees
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Publication Number
US-11944537-B2
Publication Date
2024-04-02
Expiration Date
Abstract
A two-step delivery method, system and device is disclosed comprising, in various embodiments, a self-expanding frame. A self-expanding frame is delivered and expanded within a heart chamber followed by delivery of a prosthetic valve comprising prosthetic valves thereon into the expanded self-expanding frame, which is in turn connected to a valve connection region defined on and by the delivered and expanded frame.
Core Innovation
The invention relates to a two-step method of delivering a prosthetic mitral valve device to an implantation site within a left atrium using transseptal access with a delivery catheter. A self-expanding prosthetic mitral valve frame is loaded in a collapsed configuration into the delivery catheter lumen and delivered out of the distal end into the left atrium at a location proximate the implantation site, where it expands so that at least a portion of the expanded frame engages at least a portion of an upper annular surface.
After the frame is expanded and engaged with the upper annular surface, a prosthetic mitral valve comprising prosthetic mitral valve leaflets is loaded into the delivery catheter lumen and delivered out of the distal end into the expanded prosthetic mitral valve frame. The prosthetic mitral valve is positioned and connected to the prosthetic mitral valve connection region of the expanded self-expanding prosthetic mitral valve frame.
The connected prosthetic valve is positioned above the native mitral valve leaflets such that native mitral valve functionality is not interfered with by the connected prosthetic valve. The left ventricle and the native mitral valve leaflets are not touched at any point by the prosthetic mitral valve device or the delivery catheter, while native mitral valve functionality is at least partially supplemented by the prosthetic mitral valve leaflets.
Claims Coverage
The patent content provided contains one independent claim covering the full two-step transseptal delivery and connection sequence. The independent claim is further refined by multiple dependent claims that add spatial relationship and non-contact constraints and optionally include tether wire support elements.
Two-step transseptal delivery of a self-expanding frame
Accessing the left atrium by transseptal access with a delivery catheter; loading the self-expanding prosthetic mitral valve frame in a collapsed configuration into the lumen; delivering the collapsed frame into the left atrium proximate the implantation site; allowing the frame to expand so that at least a portion of the expanded frame engages at least a portion of an upper annular surface.
Delivering and connecting a leaflet-bearing prosthetic valve to the expanded frame
Loading the prosthetic mitral valve comprising prosthetic mitral valve leaflets into the delivery catheter lumen and delivering it into the expanded self-expanding prosthetic mitral valve frame; positioning and connecting the prosthetic mitral valve to the prosthetic mitral valve connection region of the expanded frame.
Avoiding contact with the left ventricle and native leaflets while positioning above the native leaflets
The left ventricle and the native mitral valve leaflets are not touched at any point by the prosthetic mitral valve device or the delivery catheter; the connected prosthetic valve is positioned above the native mitral valve leaflets such that native mitral valve leaflet functionality is not interfered with and is at least partially supplemented by the prosthetic mitral valve leaflets.
Overall, the claim coverage is centered on transseptal, two-stage placement of a self-expanding frame that engages an upper annular surface, followed by delivery and connection of a prosthetic mitral valve with prosthetic leaflets to a connection region on the expanded frame, while ensuring no touching of the left ventricle or native mitral valve leaflets and positioning the prosthetic valve above the native leaflets to supplement functionality without interference.
Stated Advantages
Native mitral valve leaflet functionality is not interfered with by the connected prosthetic valve.
Native mitral valve leaflet functionality is at least partially supplemented by the prosthetic mitral valve leaflets.
The left ventricle and the native mitral valve leaflets are not touched at any point by the prosthetic mitral valve device or the delivery catheter.
Annular tissue below the upper annular surface is not touched.
Documented Applications
No documented applications found
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