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: According to one representative embodiment, a method of treating aortic insufficiency comprises delivering a support structure to a position around the leaflets of a native heart valve. An expandable prosthetic heart valve can be advanced into the native heart valve and into the interior of the annular body. The prosthetic heart valve can be expanded into contact with the leaflets of the native valve, thereby causing the leaflets of the native valve to be frictionally secured between an inner surface of the annular body and an outer surface of the prosthetic heart valve. A delivery apparatus for delivering the support structure can include a first shaft that is allowed to move in a proximal direction relative to a second shaft, when the second shaft foreshortens as a result of an adjustment mechanism being actuated to increase the curvature of the second shaft.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery devices for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components which are moveable relative to each other. The delivery system can include a nose cone which can cover at least a first end of the prosthesis, an outer elongate member which can cover at least a second end of the prosthesis, and a tether which can at least partially restrain the prosthesis from deployment.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery devices for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components which are moveable relative to each other. The delivery system can include a nose cone which can cover at least a first end of the prosthesis, an outer elongate member which can cover at least a second end of the prosthesis, and a tether which can at least partially restrain the prosthesis from deployment.

Abstract: Methods are described herein for delivering a replacement mitral valve to a native mitral valve location. In one method, ventricular anchors of the replacement mitral valve are released and allowed to reverse orientation while positioned in the left atrium of a human heart. After reversing orientation, the ventricular anchors extend in a generally proximal direction. The ventricular anchors can then be advanced through the mitral annulus into the left ventricle and then moved back toward the left atrium to capture native mitral valve leaflets between the main body and the ventricular anchors of the replacement mitral valve. In one modification, the ventricular anchors are allowed to reverse orientation at a level adjacent the mitral annulus. The implantation methods described herein are preferably performed via a transseptal delivery approach or a transapical delivery approach.

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 are 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: 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: Implementations of the tissue illumination systems, devices, and methods disclosed herein take advantage of the translucent nature of tissue to reveal properties by light transmission, for example, tissue type, tissue transition locations, underlying structures, and the like, that are not easily distinguished by reflected light. Illuminating a back-side of a translucent tissue permits a user to distinguish between different types of tissue, tissue transition locations, and/or structures that are difficult or impossible to discern under overhead or front-side illumination. Implementations include a light source that is positionable behind a tissue or disposable within a body cavity or duct, for example, within a heart ventricle.

Abstract: Devices, systems and methods are described herein for sealing openings in an anatomical wall. A sealing system includes an elongate tubular support for delivery to an anatomical opening to be sealed, a cover of bio-compatible material covering a distal portion of the tubular support, and an anchor assembly, the anchor assembly being designed to secure the cover material to the opening. The anchor assembly can include a plurality of distal anchors and a plurality of proximal anchors, a button, ring or donut, and/or a C-clip. In some embodiments, the system further comprises a closure member for closing off an end of the cover material after removal of the tubular support.

Abstract: A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity, and an annular flap positioned around an exterior of the expandable frame. In some embodiments, the annular flap can extend outward from the frame and have a collapsed configuration and an expanded configuration.

Abstract: Disclosed herein are embodiments of a prosthesis and delivery device, as well as methods of use. The delivery device can be composed of an inner retention assembly configured to carry an expandable prosthesis to an in situ target location. The inner retention assembly can slide within an outer elongate hollow member which can cover the expandable prosthesis. The outer elongate hollow member can further be longitudinally collapsed into a receiving member located at the distal end of the outer elongate hollow member.

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. A delivery component can have a plurality of slots that provide for desired bending of the delivery component, particularly compound bending of the delivery component that can facilitate steering of the delivery component in three dimensions.

Abstract: Devices, systems and methods are described for implantation of a prosthesis within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a tether connected to a single directional handle knob for release of the prosthesis within the lumen or body cavity and retraction of the tether towards the handle.

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: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support structure and an expandable prosthetic valve are advanced through the aortic arch of a patient using a delivery system. The support structure is delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior). The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

Abstract: A medical device for treating aortic insufficiency (and associated aneurysms or defects of any other vessel associated with a valve) includes a support structure, a stent, a prosthetic valve and a deflector. Generally, the support structure is configured to cooperate with the prosthetic valve to pinch the native valve therebetween and provide an anchor for the stent which extends into the aorta and supports the deflector which is positioned to abate blood flow against the aneurysm.

Abstract: According to one representative embodiment, a method of treating aortic insufficiency comprises delivering a support structure to a position around the leaflets of a native heart valve. The support structure comprises an annular body defining an interior and at least one projection extending radially inwardly from the annular body. An expandable prosthetic heart valve can be advanced into the native heart valve and into the interior of the annular body. The prosthetic heart valve can be expanded into contact with the leaflets of the native valve, thereby causing the leaflets of the native valve to be frictionally secured between an inner surface of the annular body and an outer surface of the prosthetic heart valve and causing the at least one projection and a portion of one of the leaflets contacted by the at least one projection to extend into an opening of the frame of the prosthetic valve.

Abstract: Implementations of the tissue illumination systems, devices, and methods disclosed herein take advantage of the translucent nature of tissue to reveal properties by light transmission, for example, tissue type, tissue transition locations, underlying structures, and the like, that are not easily distinguished by reflected light. Illuminating a back-side of a translucent tissue permits a user to distinguish between different types of tissue, tissue transition locations, and/or structures that are difficult or impossible to discern under overhead or front-side illumination. Implementations include a light source that is positionable behind a tissue or disposable within a body cavity or duct, for example, within a heart ventricle.

Abstract: A medical device for treating aortic insufficiency (and associated aneurysms or defects of any other vessel associated with a valve) includes a support structure, a stent, a prosthetic valve and a deflector. Generally, the support structure is configured to cooperate with the prosthetic valve to pinch the native valve therebetween and provide an anchor for the stent which extends into the aorta and supports the deflector which is positioned to abate blood flow against the aneurysm.