Abstract: Disclosed herein are embodiments of delivery capsules for delivering prosthetic implants around the relatively tight bends of a catheter. In particular, disclosed herein are delivery capsules including a tubular layer for holding the heart valve, a frame enclosing the tubular layer and an elongate element coupled to the frame for allowing the tubular layer and frame to expand. For example, the frame may be biased to expand and withdrawal of the elongate element from openings in the frame can release the frame to expand into a larger diameter. Another embodiment includes a helical wire wrapped around the capsule for easy delivery through bends and a second helical wire that is advanced between windings of the first helical wire to selectively stiffen the capsule for withdrawal. Other embodiments include sock-like capsules that can be crumpled into shorter lengths by pulling a pull line attached to the capsule.

Abstract: A prosthetic heart valve includes a frame having an inflow end and an outflow end, and defining a longitudinal axis. The prosthetic heart valve further includes a leaflet structure situated at least partially within the frame, and a covering disposed around the frame. The covering includes a first woven portion extending circumferentially around the frame and including a plurality of texturized strands or yarns extending along the longitudinal axis of the frame. The covering further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. The texturized strands extend along the longitudinal axis of the frame from the first woven portion to the second woven portion and form a floating portion between the first woven portion and the second woven portion.

Abstract: In one embodiment, a prosthetic valve can comprise a radially expandable and compressible frame, which can include a plurality of struts which are pivotally joined together without requiring individual rivets. In some embodiments, the struts are interwoven, and can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In another embodiment, the frame comprises a plurality of inner struts and outer struts which are connected by a plurality of chains of interconnected rivets, avoiding the need to provide individual rivets at each junction between struts. In still another embodiment, separate hinges or flanged rivets are provided to interconnect the struts.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of strut members that is radially collapsible and expandable. A leaflet structure is situated within the frame, and includes a plurality of leaflets having opposing commissure tab portions on opposite sides of the leaflet. Each commissure tab portion is paired with an adjacent commissure tab portion of an adjacent leaflet to form one or more commissures. A commissure support element is positioned at each of the commissures, and comprise a first member and a second member that are separable from each other and configured to receive leaflets therebetween. The first and second members are detached from the frame and spaced radially inwardly from the frame such that the members contact the leaflets radially inward from the frame and limit movement of the leaflets so that they articulate at a location that is spaced radially inwardly from the frame.

Abstract: A method for improving leaflet prolapse and/or valve regurgitation associated with a heart valve involves delivering a catheter into a ventricle of a heart, attaching a cord to a first papillary muscle disposed in the ventricle, the first papillary muscle being connected to a first leaflet of an atrioventricular heart valve, attaching the cord to a second papillary muscle, the second papillary muscle being connected to a second leaflet of the heart valve, secure first and second portions of the cord in a fixed relative position to form a loop attached to both the first and second papillary muscles, and releasing the cord from the catheter.

Abstract: A delivery catheter is in various embodiments configured to deliver an anchoring device to a native valve annulus of a patient's heart, where the anchoring device can better secure a prosthesis at the native annulus. The delivery catheter can includes a distal section that includes one or more spines or is laser cut to assume a particular shape for better facilitating delivery of the anchoring device at the implant site and can include a flexible tube, a first pull wire, and a second pull wire. The flexible tube can comprise a bore extending between the first end and the second end sized for passing the anchoring device therethrough. The distal portion can comprise a first flexing section and a second flexing section. Actuation of the first pull wire and the second pull wire can cause the flexible tube to move from a first configuration to a second configuration.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: Systems and methods usable in delivering a docking device to a native valve of a patient's heart. A distal region of a delivery catheter can be positioned in an atrium of the heart and a distal tip can be positioned at or near a commissure of the native valve. The docking device can be located within the delivery catheter. A pusher, such as a pusher wire or tube, of a pusher tool can be advanced distally through the delivery catheter, wherein the pusher can push the docking device along within the delivery catheter. The docking device can be connected to the pusher tool by a line, such as a suture. A member of the pusher tool can be rotatable to change the amount of the suture extending from the pusher tool.

Abstract: A prosthetic heart valve includes a frame having a plurality of strut members, an inflow end, and an outflow end. The prosthetic heart valve further includes a leaflet structure situated at least partially within the frame, and a covering disposed around the frame. The covering has a first layer and a second layer, wherein the second layer has a plush surface. The first layer is folded over a circumferential edge portion of the second layer to form a protective portion that extends beyond the strut members in a direction along a longitudinal axis of the prosthetic heart valve.

Abstract: Docking devices for docking a prosthetic valve at a native valve of a heart can include a coiled docking anchor and a retrieval suture. The docking device and retrieval suture can be configured for improved retention and retrieval of the docking device after deployment. The docking devices can have an end portion with a central axis. The retrieval suture can be connected to the end portion such that a line of force applied by applying tension to the retrieval suture is substantially aligned with the central axis.

Abstract: An assembly can comprise a radially expandable and compressible annular frame, at least one linear actuator assembly coupled to the frame and at least one locking mechanism coupled to the frame. The linear actuator can be configured to apply a distally directed force and/or a proximally directed force to the frame to radially expand or compress the frame. The locking mechanism can comprise a first sleeve member connected to the frame at a first location, a second sleeve member having internal threads and being connected to the frame at a second location, and a first screw configured to engage the internal threads of the second sleeve member to retain the frame in a radially expanded state.

Abstract: Anchoring or docking devices configured to be positioned at a native valve of a human heart and to provide structural support for docking a prosthetic valve therein. The docking devices can have coiled structures that define an inner space in which the prosthetic valve can be held. The docking devices can have enlarged end regions with circular or non-circular shapes, for example, to facilitate implantation of the docking device or to better hold the docking device in position once deployed. The docking devices can be laser-cut tubes with locking wires to assist in better maintaining a shape of the docking device. The docking devices can include various features to promote friction, such as frictional cover layers. Such docking devices can have ends configured to more securely attach the cover layers to cores of the docking devices.

Abstract: Docking devices can be configured to be positioned at a native valve of a human heart to provide structural support for docking a prosthetic valve. The docking devices generally have coiled structures that define an inner space in which the prosthetic valve can be held. Some docking devices can be adjusted from a first wider configuration which facilitates easier advancement of the docking device around the valve anatomy, to a second narrower configuration after the docking device has been delivered to more securely hold the prosthetic valve. The docking device may also be better held in position at the native valve after adjustment to the narrower configuration. Some docking devices include a stabilization segment or double coil configuration, where a main coil region is configured to securely hold a prosthetic valve, while a stabilization coil region is configured to more stably hold the docking device at the native valve.

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 delivery system can include a number of advantageous steering and delivery features, in particular for the transseptal delivery approach.

Abstract: Exemplary embodiments of devices and method for affecting at least one anatomical tissue can be provided. A configuration can be provided that includes a structure which is expandable (i) having and/or (ii) forming at least one opening or a working space through which the anatomical tissue(s) is placed in the structure. For example, the structure, prior to being expanding, can have at least one partially rigid portion. In addition, or as an alternative, upon a partial or complete expansion thereof, the structure can be controllable to have a plurality of shapes. Further, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes.

Abstract: Ultrasound probe systems and methods for using an ultrasound probe to assist during treatment of conditions of the human heart are provided. The method may comprise loading a medical instrument into a guide fastened to the ultrasound probe. The ultrasound probe may be inserted into a patient by way of an incision. The distal end of the ultrasound probe may be navigated to a location adjacent to an exterior surface of the heart. A treatment site may be identified on the exterior surface of the heart based on images obtained from an ultrasound transducer disposed within a distal end of the ultrasound probe. The medical instrument may be advanced within the guide to the treatment site and the medical instrument used for treatment. After treatment, the medical instrument may be withdrawn from the treatment site.

Abstract: An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

Abstract: Embodiments of prosthetic valves for implantation within a native mitral valve are provided. A prosthetic valve may comprise a radially compressible main body and a one-way valve portion. The prosthetic valve may further comprise one or more ventricular anchors coupled to the main body and disposed outside of the main body. The ventricular anchors may be configured such that a reduced profile of the prosthetic valve is possible. A space may be provided between an outer surface of the main body and the ventricular anchors for receiving native mitral valve leaflets. The prosthetic valve may include an atrial sealing member adapted for placement above the annulus of the mitral valve. Methods and devices for receiving the native mitral valve leaflets between the ventricular anchors and the main body are described.

Abstract: Disclosed herein are embodiments of delivery capsules for delivering prosthetic implants around the relatively tight bends of a catheter. In particular, disclosed herein are delivery capsules including a tubular layer for holding the heart valve, a frame enclosing the tubular layer and an elongate element coupled to the frame for allowing the tubular layer and frame to expand. For example, the frame may be biased to expand and withdrawal of the elongate element from openings in the frame can release the frame to expand into a larger diameter. Another embodiment includes a helical wire wrapped around the capsule for easy delivery through bends and a second helical wire that is advanced between windings of the first helical wire to selectively stiffen the capsule for withdrawal. Other embodiments include sock-like capsules that can be crumpled into shorter lengths by pulling a pull line attached to the capsule.