Devices, systems and methods for improving recapture of prosthetic heart valve device with stent frame having valve support with inwardly stent cells
Inventors
Berndt, Jonathan • Khouengboua, Sounthara • Kumar, Saravana B.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12453630-B2
Publication Date
2025-10-28
Expiration Date
Abstract
A collapsible and expandable prosthetic mitral valve stent is provided with improved recapture into a distal lumen of a delivery sheath. Various embodiments comprise a valve support within the interior of a stent frame and defining a flow channel therethrough, wherein the top or upstream of the valve support comprises a row, or a plurality, of stent cells that are bent radially inward at least partially over the flow channel. Some embodiments may comprise a recapture assist mechanism, such as an open paddle, attached to one or more of the inwardly bent stent cells and adapted to receive and/or engage a wire to aid in positioning, expansion, recapture and/or implanting the device in a patient's heart chamber.
Core Innovation
The invention is a prosthetic heart valve device adapted for expansion and implantation into a heart chamber of a patient. It includes a collapsible and expandable stent having an outer section defining an interior, and a valve support extending upward into the interior, wherein the valve support is inverted entirely within the interior and a blood flow channel is defined between an inflow end and an outflow end. Prosthetic valve leaflets are disposed within the blood flow channel to allow flow from the inflow end to the outflow end and prevent flow from the outflow end to the inflow end.
The inflow end of the valve support comprises a plurality of top-most stent cells that are bent inwardly over the blood flow channel. This inwardly bent top-most stent cell structure is described as improving collapsibility and recapture into a distal delivery-sheath lumen. Variations additionally include transition cells that turn the outer stent inward to contribute to the collapsibility and recapture behavior of the stent structure.
In some embodiments, the device adds a recapture assist mechanism on inwardly bent cells or struts, configured to receive or engage a push and/or pull wire. The recapture assist mechanism includes an open paddle or a slot for engaging the wire to assist directional positioning during delivery, expansion, recapture/resheathing, and reimplantation. Additional structural variations include an elongated upstream valve-support section with a stent cap for wire engagement and connector struts between the valve support and the outer stent to assist maintaining placement and enabling more efficient collapsing/recapture.
Claims Coverage
The claim set covers a prosthetic heart valve device with an inverted valve support inside a collapsible and expandable stent, prosthetic valve leaflets in an inflow-to-outflow blood flow channel, and an inflow-end inwardly bent set of top-most stent cells over the blood flow channel. Dependent refinements add transition cells turning the outer stent inward, unitary stent configurations, and recapture assist mechanisms using a wire and an open paddle or slot.
Inverted valve support within a collapsible and expandable stent
A collapsible and expandable stent has an outer section defining an interior, and a valve support extending upward into the interior, wherein the valve support is inverted entirely within the interior and a blood flow channel is defined between an inflow end and an outflow end.
Leaflets in an inflow-to-outflow blood flow channel
A plurality of prosthetic valve leaflets are disposed within the blood flow channel to allow flow from the inflow end to the outflow end and prevent flow from the outflow end to the inflow end.
Inwardly bent top-most stent cells over the blood flow channel
The inflow end of the valve support comprises a plurality of top-most stent cells that are bent inwardly over the blood flow channel.
Valve support defined as part of the collapsible and expandable stent
The device includes a valve support defined by the collapsible and expandable stent.
Transition cells turning the outer stent inward
A plurality of transition cells arranged between an outer section of a collapsible and expandable stent and a valve support turn the outer section inwardly.
Unitary stent integrating valve support and outer section
The valve support and the outer section of a collapsible and expandable stent together form a single unitary stent.
Recapture assist mechanism engaging a wire
A recapture assist mechanism is configured to engage a wire to help position the device in a heart chamber.
Open paddle recapture assist mechanism for wire engagement
The recapture assist mechanism includes an open paddle configured to engage the wire.
Overall, the claim set centers on an inverted valve support inside a collapsible and expandable stent, with prosthetic valve leaflets in a defined inflow-to-outflow blood flow channel and inwardly bent top-most stent cells at the inflow end. Dependent refinements specify structural variants such as transition cells turning the outer stent inward and optional unitary stent construction, and they add recapture assist mechanisms that engage a wire using an open paddle or slot to assist positioning and recapture-related handling.
Stated Advantages
Improves collapsibility and recapture into a distal delivery-sheath lumen.
Helps with directional positioning during delivery, expansion, recapture/resheathing, and reimplantation.
Helps maintain placement.
Enables more efficient collapsing/recapture.
Reduces paravalvular leakage (PVL) using skirt/prolapse prevention features.
Documented Applications
Transseptal placement into the left atrium for implantation into a heart chamber.
Supplementation and/or eventual replacement of native valve leaflet functionality.
Percutaneous delivery routes.
Surgical delivery routes.
Interested in licensing this patent?