Abstract: Disclosed herein are embodiments of stabilizers for use in delivering a replacement heart valve. The stabilizers can receive a portion of a delivery system, such as a handle, to prevent unwanted motion of the delivery system. The stabilizer can include a linear actuator for adjusting a position of the delivery system once held within the stabilizer.

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 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: 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: Disclosed herein are devices for mechanically removing clot and/or other material from implants implanted in the vasculature of a patient, and associated systems and methods. In some embodiments, a system for removing clot material from an implant—such as a stent—includes a clot treatment device configured to be deployed within the stent, a handle, and a first elongate member and a second elongate member coupling the clot treatment device to the handle. The first elongate member couples a first end portion of the clot treatment device to the handle, and the second elongate member couples a second end portion of the clot treatment device to an actuator of the handle. Actuation of the actuator is configured to move the second elongate member relative to the first elongate member to move the first and second end portions toward one another to radially expand the clot treatment device.

Abstract: Disclosed herein are embodiments of methods of using stabilizers for use in delivering a replacement heart valve. The stabilizers can receive a portion of a delivery system, such as a handle, to prevent unwanted motion of the delivery system. The stabilizer can include a linear actuator for adjusting a position of the delivery system once held within the stabilizer.

Abstract: Disclosed herein are embodiments of stabilizers for use in delivering a replacement heart valve. The stabilizers can receive a portion of a delivery system, such as a handle, to prevent unwanted motion of the delivery system. The stabilizer can include a linear actuator for adjusting a position of the delivery system once held within the stabilizer.

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: 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 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: 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: Embodiments of the present disclosure are directed to delivery systems, devices and/or methods of use to deliver and/or controllably deploy an implant in the form of a prosthesis, such as but not limited to a replacement heart valve, to a desired location within the body. In some embodiments, a replacement heart valve and methods for delivering a replacement heart valve to a native heart valve, such as a mitral valve, are provided. Features of delivery systems are disclosed, as well as echogenic markers for delivery systems.

Abstract: Disclosed herein are embodiments of adapters that can be used to translate and/or rotate the position of a delivery system, such as for use with a replacement mitral valve. The adapters can allow for three-dimensional motion of the delivery system, thus allow for precise positioning and movement of the delivery system during use by an operator.

Abstract: A method for replacing a native heart valve includes advancing a delivery catheter having a valve prosthesis disposed along a distal end portion thereof, wherein the valve includes an inner frame having an hourglass shape and an outer sealing frame connected to and surrounding the inner frame. A valve body is mounted within the inner frame and includes a plurality of leaflets. The leaflets have longitudinal curvatures when in an open position, wherein the curvatures are shaped for conforming to the curved interior surface of the inner frame. This combination of features reduces the possibility of blood stagnating between the leaflets and inner frame, which reduces the possibility of thrombus formation.

Abstract: Disclosed herein are embodiments of an expandable replacement heart valve prosthesis. The expandable replacement heart valve prosthesis can include a number of different features, such as an hourglass (or generally hourglass) shape in the fully expanded position, anchor stiffening features, and improved retraction/retention configurations. For example, certain struts on the prosthesis can have different thicknesses/widths than other struts to improve compressibility.

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. Disclosed are a number of features that can improve steerability or release of the prosthesis into the body location.

Abstract: A mitral valve prosthesis includes an hourglass shaped inner frame and a bulbous outer frame. A valve body having a plurality of leaflets is positioned within an interior region of the inner frame. The leaflets are shaped to substantially conform to an interior surface of the inner frame when the leaflets are in an open position. As a result, the gap between the leaflets and the inner frame is decreased, thereby reducing the likelihood of thrombus formation. Ventricular anchors are preferably provided along a distal end of the inner frame. The anchors extend proximally for placement behind native mitral valve leaflets. A fabric skirt may extend along an inner or outer surface of the outer frame. In preferred embodiments, the fabric skirt extends distally beyond a distal end of the outer frame and is adapted for forming a seal along the mitral valve annulus.