Heart chamber prosthetic valve implant with base, mesh and dome sections with single chamber anchoring for preservation, supplementation and/or replacement of native valve function
Inventors
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Abstract
Various embodiments of the present invention comprise a single-chamber collapsible and expandable prosthetic valve implant device 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 in fluid communication with an annulus comprising an annular plane, an inner annulus and an upper annular surface located between the annular plane and the flexing point of the native leaflets, where the lower boundary of the heart chamber extends to the upper annular surface. The device is fully contained within the heart chamber, so it does not engage with the native mitral valve leaflets, the left ventricle, or the pulmonary artery, and is positioned relative to the flexing point to preserve native leaflet function.
A core aspect is defining an upper annular surface above the native leaflet flexing point, together with a spatial relationship that locates the lower surface of a central valve support on or above the upper annular surface. This arrangement mitigates leaflet prolapse into the atrial chamber by preventing prolapse beyond the upper annular surface region while maintaining antegrade blood flow through prosthetic leaflet(s).
The expandable device includes an expandable anchoring structure comprising a base, a dome section, and an intermediate structure between the base and the dome section. A central valve support is open to blood flow therethrough, is aligned with the annulus, and includes at least one prosthetic leaflet; the central valve support’s geometry is arranged to allow antegrade blood flow through the prosthetic leaflet(s) and prevent retrograde blood flow through the prosthetic leaflet(s).
Claims Coverage
The provided independent claim describes 1 inventive device concept with multiple structural and positional limitations, centered on an expandable anchoring structure and a central valve support carrying prosthetic leaflet(s) with explicit antegrade-versus-retrograde flow behavior and explicit positioning relative to the upper annular surface and the native leaflet flexing point.
Expanded implantation geometry with upper annular surface relative to native flexing point
A device for expanded implantation within a heart chamber in fluid communication with an annulus comprising an annular plane, an inner annulus and an upper annular surface located between the annular plane and the flexing point of the native leaflets, where the lower boundary of the heart chamber extends to the upper annular surface.
Expandable anchoring structure with base, intermediate structure, and dome section
An expandable anchoring structure comprising a base with an upper surface and a lower surface at least partially disposed on the annular plane, a dome section, and an intermediate structure operatively disposed between the upper surface of the base section and the dome section.
Central valve support aligned with annulus and carrying prosthetic leaflet(s)
A central valve support open to blood flow therethrough and connected with, and positioned at least partially within, the base and aligned with the annulus, the central valve support comprising at least one prosthetic leaflet attached within the valve support and a lower surface.
Antegrade flow through prosthetic leaflet(s) and prevention of retrograde flow
The central valve support allows antegrade blood flow through the at least one prosthetic leaflet and prevents retrograde blood flow through the at least one prosthetic leaflet.
Lower surface of central valve support positioned relative to upper annular surface
The lower surface of the central valve support is located on or above the upper annular surface.
Across the provided independent claim, the inventive concept is a heart-chamber implant defined by annular plane/inner annulus/upper annular surface relationships to the native leaflet flexing point, paired with an expandable anchoring structure (base, intermediate structure, dome section) and a central, annulus-aligned valve support carrying prosthetic leaflet(s) that permits antegrade flow and prevents retrograde flow, with the valve support lower surface positioned on or above the upper annular surface.
Stated Advantages
Allows antegrade blood flow through the at least one prosthetic leaflet.
Prevents retrograde blood flow through the at least one prosthetic leaflet.
Mitigates leaflet prolapse into the atrial chamber by positioning relative to the native leaflet flexing point/upper annular surface.
Preserves native leaflet function by avoiding engagement with native leaflets and related heart structures.
Documented Applications
Treatment of mitral valve function using a single-chamber, collapsible/expandable prosthetic valve implant fully contained within a heart chamber (e.g., left atrium).
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