4c Medical Technologies, Inc.

St. Jude Medical, Cardiology Division, Inc.

Saravana B Kumar

Jason S Diedering

Sounthara Khouengboua

Thomas M Benson

Andrea N Para

Gaurav Satam

Peter Nicholas Braido

Bruce Moseman

Jeffrey W Chambers

Jeffrey R Stone

Joseph P Higgins

Kristen T Morin

Robert J Thatcher

Gregory G Brucker

Andrea L McCarthy

Kent J Smith

James E Flaherty

Jonathan Berndt

Karl A Kabarowski

Steven D Kruse

Alex Alden Peterson

Theodore Paul Dale

Ryan Kenneth Buesseler

Kristopher Henry Vietmeier

Ott Khouengboua

Sounthara (ott) Khouengboua

Jane M Korfe

Bruce A Moseman

Gaurav C Satam

Alex A Peterson

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.

Devices, systems and methods for improving recapture of prosthetic heart valve device with stent frame having valve support with inwardly stent cells

Loading systems for prosthetic heart valve devices are disclosed. A loading funnel is provided within a watertight interior space that is at least partially filled or fillable with biocompatible fluid. Funnel may have a cylindrical end to which is connected a delivery catheter having a lumen that will receive the collapsed prosthetic heart valve device. An expanded prosthetic heart valve device may be placed within the funnel and pushed or pulled into the funnel which provides a predictable, reliable and repeatable surface for collapsing the prosthetic heart valve device. Ultimately the prosthetic heart valve device is collapsed and translated into the lumen of the delivery catheter for further translation therealong and release into the heart chamber of interest.

Loading systems for collapsible prosthetic heart valve devices and methods thereof

The present invention provides a prosthetic heart valve device with improved fit and/or apposition between the device frame and left atrial tissue and/or the device base and the annular tissue of the left atrium to improve shifting of the implanted device and/or mitigate paravalvular leakage. The improved fit and/or apposition arises in various embodiments by providing or allowing an asymmetrical frame and/or frame base and/or providing a lower lip to aid in conforming to the asymmetrical shape of the atrium and/or ensure firm positioning therein. An additional benefit of these arrangement(s) is mitigation of paravalvular leakage as a result of improved fit and seal. In certain embodiments, the asymmetry of the frame assists with delivery of the device into the atrium.

Prosthetic mitral valve with improved atrial and/or annular apposition and paravalvular leakage mitigation

The invention relates to prosthetic heart valves comprising a stent frame with valve support disposed or inverted at least partially within the stent frame, wherein the valve support is at least partially within the interior of the stent frame. The inverted configuration comprises a maximum number of layers of material in cross section where the stent frame and valve support overlap. The maximum number of cross-sectional layers of material structure may be reduced to, e.g., two layers of material to reduce outer diameter during delivery by everting the valve portion to a position located outside of the stent portion, followed by inverted reconfiguration back to the inverted anchoring structure after delivery from the lumen of the delivery catheter to the heart chamber.

Delivery of heart chamber prosthetic valve implant

Devices and methods for supplementing and/or replacing native cardiac valve functionality, e.g., the mitral valve with a single prosthetic leaflet. An exemplary device is directed to dysfunctional mitral valves. In some cases, the entire device, including the single prosthetic leaflet, will be arranged entirely above the dysfunctional mitral valves and, therefore, disposed entirely within the left atrium. In other cases, the valve support and/or single prosthetic leaflet may extend a distance into the annulus between the left atrium and left ventricle. In some cases, the device will not physically interact with the native leaflets. In other cases, the device may physically interact with the native leaflets.

Systems, methods and devices for prosthetic heart valve with single valve leaflet

Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves

A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter to a region of constant inner diameter wherein the stent is in a collapsed configuration. The device and method may provide for an at least partially collapsed configuration of the stent that may be further collapsed as a part of the implantation procedure and may comprise a stent that is pre-loaded for future use.

Stent loading device

A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, the stent being formed of a plurality of struts forming cells. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets and a cuff. At least one runner is coupled to a cell and configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition.

Bowed runners for paravalvular leak protection

A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter alternating between two sections of decreasing diameter and two sections of constant diameter until reaching the inner diameter of the delivery sheath. A fluid-filled reservoir is provided at the proximal end of the loading device that is configured to provide moisture or wetting for materials associated with or attached to the stent that require moisture retention. Thus, as the stent is being collapsed with the loading device, at least a portion of the stent may be immersed in the fluid reservoir to preserve the subject material.

Stent loading device with fluid reservoir

A prosthetic heart valve may include a stent having an inflow end, an outflow end, a collapsed condition, and an expanded condition. The prosthetic valve may also include a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets. The prosthetic valve and/or stent may include features to anchor the prosthetic valve to a native valve annulus and to seal the prosthetic valve with respect to the native valve annulus, such as planar and/or nonplanar annular sealing members coupled to ends of the stent. The stent may include one or more circumferential rows of anchor members or hooks extending radially outwardly from the stent. These hooks may be configured to extend in a particular direction when the stent is in the collapsed condition to facilitate resheathing of the stent if, upon deployment, a user determines the prosthetic heart valve is not positioned optimally.

Transcatheter mitral valve stent frames

A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent extending between a proximal end and a distal end. The stent includes an annulus section adjacent the proximal end and having a first diameter, a plurality of first struts forming cells, and a plurality of second struts connected to the annulus section and forming a plurality of deflecting cells expandable to define a second diameter larger than the first diameter. A valve assembly is disposed within the stent and a cuff is coupled to the stent and covers the plurality of deflecting cells.

Subannular sealing for paravalvular leak protection

The invention provides methods, devices and systems for delivering, positioning and/or repositioning an expandable prosthetic heart valve in a patient's heart chamber. At least one non-looped wire and looped wire pair is operatively connected with an expanded prosthetic heart valve that is collapsed within a delivery catheter lumen having its distal end positioned in the subject heart chamber. The collapsed prosthetic heart valve is translated through the delivery catheter lumen to and out of its distal end where the prosthetic heart valve expands to a working configuration. The wire(s) of the non-looped and looped wire pair may be manipulated by pulling proximately or pushing distally to position or reposition the expanded prosthetic stent into position, then released from connection with the positioned stent and withdrawn from the patient.

Repositioning wires and methods for repositioning prosthetic heart valve devices within a heart chamber and related systems, devices and methods

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.

Growing community of inventors

Minnetonka, MN, United States of America

Saravana B Kumar