Expandable frames and paravalvular leak mitigation systems for implantable prosthetic heart valve devices
Inventors
Chambers, Jeffrey W. • Kruse, Steven D. • Kumar, Saravana B.
Assignees
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Publication Number
US-10874513-B2
Publication Date
2020-12-29
Expiration Date
Abstract
A collapsible and expandable prosthetic heart valve stent is provided and comprising an outer section, a valve support defining a flow channel therethrough, a transition section configured to smoothly transition the outer section to the valve support. The valve support is disposed within an interior defined by the outer section, with the inflow end of the valve support disposed inside the outer section's interior. In some cases, the outflow end of the valve support is at least partially defined by the transition section. The prosthetic leaflets are disposed on the inner surface of the valve support's flow channel and are located at or above the annulus of the heart chamber. A paravalvular leakage mitigation system is attached to the stent to mitigate retrograde blood flow and/or regurgitation.
Core Innovation
The disclosed invention relates to a collapsible and expandable prosthetic heart valve stent for implanting into at least one chamber of a patient's heart. The stent comprises an outer section having a stent cell pattern, an outer surface, an inner surface, and an interior. A valve support is defined as inverted entirely within the interior of the outer section and comprises a stent cell pattern with an inflow end and an outflow end extending radially upward.
The valve support includes an inner surface that defines a flow channel between the inflow and outflow ends, with prosthetic valve leaflets disposed within the flow channel. The prosthetic valve leaflets are configured to allow flow from the inflow end to the outflow end and prevent flow from the outflow end to the inflow end. A collapsible and expandable transition section is provided to transition the outer section to the valve support, and the outer section, the collapsible and expandable transition section, and the valve support comprise a unitary structure.
The invention further includes a paravalvular leakage mitigation system affixed to the stent. Multiple embodiments are described, including an implant skirt with continuous coverage on selected stent, transition, and valve-support surfaces, expandable or collapsible fabric or tissue seals supported by wire frames or wire loops, an interior cover with a collapsible mesh in a bounded space with optional wire frame support, a collapsible mesh concept using a self-expandable mesh frame or tube or laser-cut struts, and canopy structures that unfurl or unwind between closed and open canopy states in response to retrograde flow or pressure differential.
Claims Coverage
The provided content includes one independent claim with additional dependent claims refining the stent structure and the paravalvular leakage mitigation system. The inventive features center on an inverted valve support within an outer section, a collapsible and expandable transition section that forms a unitary structure, and an affixed paravalvular leakage mitigation system with multiple structural variants.
Unitary collapsible valve stent with inverted valve support and transition
The stent comprises an outer section and a valve support inverted entirely within the interior of the outer section, where the valve support extends radially upward and defines an inflow-to-outflow flow channel, and a collapsible and expandable transition section transitions the outer section to the valve support, with the outer section, the collapsible and expandable transition section and the valve support comprising a unitary structure and the outflow end of the valve support being at least partially defined by the transition section.
Prosthetic leaflets disposed in the valve support flow channel
A plurality of prosthetic valve leaflets are disposed within the flow channel defined by the valve support section, configured to allow flow from the inflow end to the outflow end of the flow channel and prevent flow from the outflow end of the flow channel to the inflow end of the flow channel.
Paravalvular leakage mitigation system affixed to the stent
A paravalvular leakage mitigation system is affixed to the stent.
Skirt continuous coverage across selected stent surfaces
The paravalvular leakage mitigation system includes a skirt affixed to at least a portion of the outer surface of the outer section, the outer surface of the transition section, and the inner surface of the valve support.
Fabric or tissue seals expanding when the stent expands
The paravalvular leakage mitigation system includes fabric or tissue attached to the outer section and at least partially surrounding the outer surface of the outer section, the fabric or tissue adapted to expand when the stent is expanded.
Mesh material in a bounded space within the stent
The stent includes mesh material positioned within a space bounded by the cover, the valve support, and the inner surface of the outer section.
Valve support outflow end constrained relative to the transition
The stent is defined such that the outflow end of the valve support does not extend outward beyond a transition section.
Canopy structures movable between closed and open states by retrograde flow or pressure differential
The paravalvular leakage mitigation system includes at least one canopy structure attached to an outer section, movable between open and closed states, and driven to the open state by retrograde fluid flow or a pressure differential.
Across the provided claim set, coverage focuses on a unitary collapsible and expandable stent architecture with an inverted radially upward-extending valve support defining an inflow-to-outflow flow channel and prosthetic leaflets, together with a paravalvular leakage mitigation system affixed to the stent. Dependent refinements specify particular skirt, cover, mesh, and canopy implementations and constrain geometry and leaflet-related functional behavior, including a constrained outflow end relative to the transition.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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