Abstract: A steerable delivery system is provided for delivering a replacement heart valve to a native heart valve location. The steerable delivery system includes an outer sheath assembly having a capsule along a distal end portion for retaining the replacement heart valve in a compressed configuration. The capsule is constructed to provide both compression resistance and flexibility. The capsule may be formed with an outer polymer layer, a metal middle layer located on a radially inner surface of the outer polymer layer, and an inner liner located on a radially inner surface of the metal middle layer. A fluoroelastomer layer is provided for bonding the inner liner to the metal middle layer. The metal middle layer is preferably a metal hypotube.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. The steerable delivery system can contain a steerable rail configured for multi-plane bending to direct a distal end of the delivery system.

Abstract: A fabric having a honeycomb weave pattern is provided for use with medical implants. The fabric may be heat treated to increase a thickness and texture of the fabric. The fabric may be compliant and compressible for providing cushioning within a patient's body. For example, the fabric may be applied to a prosthetic valve to cushion a portion of the prosthetic heart valve. The fabric may also be textured to provide enhanced friction between the prosthetic heart valve and the surrounding native tissue. Enhanced friction may be achieved by weave patterns or by the inclusion of protrusions or barbs in the fabric.

Abstract: A delivery system includes a suture attachment mechanism for maintaining a connection to a heart valve after initial deployment, thereby allowing recapture of the heart valve if desired. A plurality of suture portions is provided along a distal end portion of the delivery system, each suture portion having a first end fixed to the delivery system and a second end releasably coupled to a retention member on the delivery system. A knob on a handle of the delivery system is actuated for causing the second end of each suture portion to be released from its respective retention member, thereby allowing the suture portions to be decoupled from the heart valve. The suture portions are located only along a distal end portion of the delivery system for improving reliability and consistency.

Abstract: Embodiments of a crimping device for crimping a radially expandable and compressible prosthetic valve are disclosed. A crimping device can comprise a housing configured to receive a prosthetic valve in a radially expanded state. The housing member can include a funnel segment and an outlet in communication with the funnel segment. The crimping device can further comprise an actuator rotatably coupled to the housing, wherein rotation of the actuator relative to the housing causes the prosthetic valve to move axially through the funnel segment such that at least a portion of the prosthetic valve compresses radially by engagement with the funnel segment and exits the crimping device via the outlet.

Abstract: Disclosed herein are embodiments of a delivery system which can be used to recapture and/or reposition a replacement valve, such as a replacement mitral valve, after initial deployment of the valve. Embodiments of the delivery system can involve a torqueing manifold that interacts with multiple tethers that are releasably coupled to eyelets of a replacement heart valve. Engagement pins may be configured to releasably retain one end of the tethers.

Abstract: A transfemoral delivery system for implanting a replacement heart valve is provided. The replacement heart valve includes an expandable frame and a plurality of distal anchors. The delivery device includes an outer sheath assembly, a mid-shaft assembly, and an inner assembly, wherein the outer sheath assembly and the mid shaft assembly retain the replacement heart valve in a radially compacted state. The outer sheath assembly is retracted relative to the mid-shaft assembly to release the distal anchors while a portion of the replacement heart valve remains retained by the mid shaft assembly. After the distal anchors engage leaflets of the native heart valve, the retained portion of the replacement heart valve is released from the mid-shaft assembly and is allowed to fully expand.

Abstract: A prosthetic heart valve for deployment in a native heart valve. The prosthetic heart valve includes an inner frame and a plurality of anchors extending from a distal portion of the inner frame. An outer sealing frame is positioned radially outward of the inner frame. The distal end portion of the outer frame is attached to a distal portion of the inner frame by a flexible cloth material such that the outer frame can move axially or tilt with respect to the inner frame. The anchors are shaped to capture native leaflets between the anchors and the outer frame to secure the prosthetic valve in the native heart valve. Prosthetic valve leaflets are provided in a lumen of the inner frame for allowing one way flow through the prosthetic valve, thereby replacing the function of the native heart valve.

Abstract: Apparatuses, systems, and methods for prosthetic valves. Embodiments of prosthetic valves may include sealing bodies configured for an anchor to at least partially pass through. The pass through may allow for the sealing body to seal to a portion of a patient's heart in the event of a miscapture of a leaflet by the anchor. Embodiments may include modular valve systems and prosthetic valves including anchors for coupling to chordae, trabeculae, or papillary structures of a patient's heart. Embodiments may include prosthetic valves including anchors for engaging calcification of a patient's native valve.

Abstract: Disclosed herein are embodiments of a delivery system which can be used to recapture and/or reposition a replacement valve, such as a replacement mitral valve, after initial deployment of the valve. Embodiments of the disclosure can use the crimping/tensioning of sutures in order to re-crimp the replacement valve after release, though longitudinal or rotational forces.

Abstract: A replacement mitral valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native mitral valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors is coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

Abstract: Methods for delivering a replacement heart valve include advancing a delivery system through a femoral vein and into the atrium of a heart, wherein the delivery system includes an outer sheath assembly, a mid shaft assembly and an inner assembly. The outer sheath assembly and the mid shaft assembly are adapted to retain the replacement heart valve in a radially compacted state over the inner assembly. The outer sheath assembly is retracted to allow a plurality of distal anchors to self-expand while a portion of the replacement heart valve remains retained in a compacted state by the mid shaft assembly. The distal anchors are positioned to engage one or more native leaflets and the retained portion of the replacement heart valve is then released and allowed to fully expand for implanting the replacement heart valve within the native valve.

Abstract: A replacement mitral valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native mitral valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors is coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

Abstract: Disclosed are embodiments of delivery systems for delivery of replacement heart valves. This can include mitral, aortic, tricuspid, and pulmonary valves. The delivery systems can include one or more different components and configurations that advantageously improve placement of the replacement heart valves during the operation of the delivery system.

Abstract: A replacement mitral valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native mitral valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors is coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

Abstract: Apparatuses and methods for loading and deploying implants from delivery apparatuses. The apparatuses in certain embodiments may comprise crimping devices for compressing an implant for insertion into a portion of a delivery apparatus. The apparatuses in certain embodiments may comprise features of delivery apparatuses allowing for improved loading and deployment of an implant from the delivery apparatuses.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components, including a flexible nose cone, multi-layer sheath, and pre-compressed shaft, which can be moveable relative to each other.

Abstract: Devices, systems and methods are described herein to provide improved treatment of a tricuspid valve. Such treatment may include tricuspid valve replacement, which may include providing a prosthetic tricuspid valve within the tricuspid valve annulus. Delivery systems for delivering the prosthetic tricuspid valve to the tricuspid valve annulus are disclosed herein. Treatment may also include repair of the tricuspid valve.

Abstract: Embodiments of a crimping device for crimping a radially expandable and compressible prosthetic valve are disclosed. A crimping device can comprise a housing configured to receive a prosthetic valve in a radially expanded state. The housing member can include a funnel segment and an outlet in communication with the funnel segment. The crimping device can further comprise an actuator rotatably coupled to the housing, wherein rotation of the actuator relative to the housing causes the prosthetic valve to move axially through the funnel segment such that at least a portion of the prosthetic valve compresses radially by engagement with the funnel segment and exits the crimping device via the outlet.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components, including a flexible nose cone, multi-layer sheath, and pre-compressed shaft, which can be moveable relative to each other.