Heart chamber prosthetic valve implant with elevated valve section and single chamber anchoring for preservation, supplementation and/or replacement of native valve function
Inventors
Assignees
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Abstract
Various embodiments of the present invention comprise a single-chamber collapsible and expandable prosthetic valve implant device with an elevated valve section and comprising the following capabilities: (1) preservation of native valve functionality; (2) initial preservation of native valve functionality with subsequent full replacement of native valve functionality; (3) full replacement of native valve functionality; and/or (4) mitigation of the prolapsing distance of the dysfunctional leaflets by preventing the anterior excursion of the prolapsing leaflets above the upper annular surface and into the left atrial chamber in order to preserve native leaflet functionality for as long as possible. The expanded and implanted device does not extend beyond the boundaries of the subject heart chamber, e.g., the left atrium, thereby enabling the preservation of any remaining native valve functionality with subsequent full replacement of native valve functionality if and when needed.
Core Innovation
The invention relates to a device for expanded implantation within a heart chamber that is in fluid communication with an annulus comprising an annular plane and with a native valve having leaflets. The expanded and implanted device includes a base section with a lower surface configured to be at least partially disposed on the annular plane, and a raised portion spaced above the lower surface of the base section and the annular plane. A central cylinder valve support is operatively attached to the raised portion of the base section and comprises at least one prosthetic valve leaflet operatively attached therein.
The invention further includes an atrial dome section configured to be in pressured and frictional engagement with a roof of the heart chamber when the device is expanded and implanted. An intermediate section comprising an expandable mesh is operatively attached to the base section and the atrial dome section, and the lower surface of the central cylinder valve support is spaced above the lower surface of the base section.
The device operates in relation to a native valve having leaflets by preserving, supplementing, and eventually replacing native valve functionality as native function changes over time. It preserves remaining normal native functionality while initially supplementing a partially malfunctioning native valve and aims to mitigate retrograde flow and leaflet prolapse by preventing anterior excursion of prolapsing leaflets above an upper annular surface or annular plane into the chamber.
Claims Coverage
The provided excerpt includes two independent device claims, each specifying a heart-chamber-implanted prosthetic valve arrangement with a base section on an annular plane, a pressured and frictional engagement section contacting a chamber roof, an intermediate expandable mesh section, and a central cylinder valve support carrying prosthetic valve leaflet(s) positioned relative to the annular plane. Across the dependent claims in the excerpt, the coverage further includes anatomical limitations and constraints on structural presence or engagement with native valve structures and selected cardiac regions.
Raised base portion and central cylinder valve support spaced above the annular plane
A base section with a lower surface configured to be at least partially disposed on the annular plane, the lower surface comprising a raised portion configured to be spaced above the lower surface of the base section and the annular plane; and a central cylinder valve support operatively attached to the raised portion and comprising at least one prosthetic valve leaflet operatively attached therein, wherein the central cylinder valve support lower surface is spaced above the lower surface of the base section.
Pressured and frictional atrial dome engagement with the chamber roof
An atrial dome section configured to be in pressured and frictional engagement with a roof of the heart chamber when the device is expanded and implanted.
Expandable mesh intermediate section operatively attached between base and atrial dome
An intermediate section comprising an expandable mesh and operatively attached to the base section and the atrial dome section.
Annulus-surrounding aperture in the base and central cylinder valve support connected to the aperture
A base section comprising a lower surface configured to be at least partially disposed on the annular plane, the lower surface defining an aperture adapted to be located around the annulus; and a central cylinder valve support whose lower surface is operatively connected with a portion of the lower surface that defines the aperture.
Top section pressured and frictional engagement with the chamber roof
A top section configured to be in pressured and frictional engagement with a roof of the heart chamber when the device is expanded and implanted.
Central cylinder valve support not extending below the annular plane
A central cylinder valve support comprising at least one prosthetic valve leaflet operatively attached therein, wherein the lower surface of the central cylinder valve support is configured to not extend below the annular plane.
Across the two independent claims, the core coverage centers on an expanded implant located in a heart chamber in fluid communication with an annulus, using a base section on an annular plane, a pressured and frictional engagement section contacting the chamber roof, an intermediate expandable mesh section between those regions, and a central cylinder valve support carrying prosthetic valve leaflet(s) positioned so its lower surface is spaced above or configured not to extend below the annular plane.
Stated Advantages
Preserves remaining normal native functionality while supplementing a partially malfunctioning native valve.
Completely replaces native valve functionality when the native valve ceases to provide any normal native functionality.
Mitigates retrograde flow and leaflet prolapse by preventing anterior excursion of prolapsing leaflets above an upper annular surface or annular plane into the chamber.
Documented Applications
Expanded implantation of a prosthetic heart valve device within a single heart chamber that is in fluid communication with an annulus, including use in the left atrium with a mitral native valve.
A preservation-and-replacement progression for an at least partially malfunctioning native heart valve, in which remaining normal native functionality is preserved and supplemented initially and native functionality is completely replaced when it ceases.
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