Abstract: Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.

Abstract: The present teachings provide systems, devices, and methods for reshaping the heart and reducing valve regurgitation. A device can be positioned proximate the heart and have a delivery profile and an inflated profile. The device can have a primary cavity and a secondary cavity, and an adhesive inside the secondary cavity. An injectable medium can be injected to the primary cavity of the device. As the primary cavity is filled, the adhesive is forced out of the secondary cavity to adhere the device. The inflated device can exert pressure on the heart, change the shape of a valve annulus, and allow a better coaptation of the valve leaflets.

Abstract: A distal end of a guide catheter is transvascularly advanced into a left ventricle of a heart of a subject. While the distal end of the guide catheter remains disposed in the left ventricle, a first tissue anchor of an implant is deployed from the distal end of the guide catheter. Subsequently, the guide catheter is retracted while progressively exposing the implant. Subsequently, a second tissue anchor of the implant is anchored to a posterior annulus of a mitral valve of the heart by deploying at least part of the second anchor within a left atrium of the heart, such that the implant extends from the first tissue anchor, over an atrial side of a posterior leaflet of the mitral valve, and to the second tissue anchor. Other embodiments are also described.

Abstract: A prosthetic heart valve includes a frame that is radially collapsible and expandable between a collapsed configuration and an expanded configuration, and defines a longitudinal axis. A leaflet structure situated within the frame, and a sealing member is disposed around the frame. The sealing member can include a first portion extending circumferentially around a portion of the frame, the first portion being configured to resiliently stretch in a direction along the longitudinal axis between a first state corresponding to the expanded configuration of the frame and a second state corresponding to the collapsed configuration of the frame. The sealing member can include a second portion extending circumferentially around a portion of the frame, the second portion being configured to resiliently stretch in a circumferential direction between a first state corresponding to the collapsed configuration of the frame and a second state corresponding to the expanded configuration of the frame.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander. An inflow stent frame is expandable for anchoring the valve in place, and may have an outflow end that is collapsible to a limited degree for delivery and expandable post-implant to facilitate valve-in-valve (ViV) procedures. The hybrid heart valves eliminate earlier structural bands, which both reduces manufacturing time and facilitates ViV procedures.

Abstract: A system for delivering medical implants has an expandable introducer sheath which can locally expand and lengthen to accommodate passage of a delivery catheter and implant, such as a prosthetic heart valve secured to a balloon catheter. The expandable sheath may be configured so that the local expansion is proportional to the local surface lengthening.

Abstract: A prosthetic valve delivery apparatus can comprise a handle, a gearbox, an input torque shaft and a plurality of output torque shafts. The input torque shaft can extend distally from the handle and can have a distal end portion operatively connected to the gearbox. The output torque shafts can be operatively connected to and extend distally from the gearbox. Rotation of the input torque shaft can cause rotation of the output torque shafts via the gear box.

Abstract: A valved conduit including a bioprosthetic aortic heart valve connected to a tubular conduit graft forming an ascending aorta. The conduit graft may attach to the heart valve in a manner that facilitates a redo operation in which the valve is replaced with another valve. A sewing ring may be pre-attached to the inflow end of the graft, and then the valve connected to a delivery holder advanced into the graft and secured to the sewing ring. Dry bioprosthetic valves coupled with conduit grafts sealed with a bioresorbable medium can be stored with the delivery holder.

Abstract: An implantable prosthetic valve includes a radially collapsible and expandable annular frame having three commissure attachment posts and four rows of circumferential struts. The rows include a first row, a second row downstream of the first row, a third row downstream of the second row, and a fourth row downstream of the third row and defining an outflow end of the frame. Each row of circumferential struts includes angled struts arranged in a zig-zag pattern. A leaflet structure includes three leaflets forming three commissures, each commissure being connected to one of the commissure attachment posts only at locations along the commissure attachment posts between a first plane that is perpendicular to a longitudinal axis of the frame and intersects crowns of the third row of struts and a second plane that is perpendicular to the longitudinal axis and intersects crowns of the fourth row of struts.

Abstract: A crimping system for a prosthetic heart valve comprises a split funnel comprising an elongated annular body having an enlarged insertion end, a narrower outlet end, and a central opening extending along a central longitudinal axis of the split funnel, between the insertion end and the outlet end. The body comprises first and second slots extending axially along opposite sides of the body from the outlet end toward the insertion end, the first and second slots defining first and second split portions of the body extending circumferentially between the first and second slots on opposite sides of the central opening. The crimping device is configured to crimp a prosthetic heart valve moving axially through the central opening from the insertion end to the outlet end while allowing portions of the prosthetic heart valve to protrude through the first and second slots and remain in an expanded configuration.

Abstract: Described herein are reusable surgical needles having a resiliently collapsible rear loop that captures a suture as it is passed through an object and resiliently expands upon exiting the object to release the suture. Also described are suture spool assemblies that include a rigid housing and a rotatable spool of suture material suspended within the housing so that a plurality of sutures can be dispensed from the assembly in succession during a surgery. Also described are annular pledgets having diametrical dimensions similar to an outer ring of a cardiac implant such that a single annular pledget can be used with a plurality of sutures that secure the cardiac implant to native tissue around the perimeter of the cardiac implant. Related methods of suturing cardiac implants are also disclosed.

Abstract: The active introducer sheath systems disclosed herein are expanded by activating a translation mechanism at the handle. The sheath has an inner cylindrical structure of comingled fixed and mobile elongate rods bound together by an attachment line. Activating the translation mechanism causes the mobile rods to move axially with respect to the fixed rods, changing the internal tension in the attachment line. Increased tension draws the fixed and mobile rods closer together, decreasing the diameter of the cylindrical structure. Decreased tension in the attachment line enables the fixed and mobile rods to move apart, increasing the diameter of the cylindrical structure. A prosthetic device, such as a prosthetic heart valve, can be routed through the expanded sheath and to the implantation site. During implantation, the sheath can be contracted back to its original outer diameter, and expanded again for retrieval of the delivery apparatus.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: Compressible heart valve annulus sizing templates suitable for minimally-invasive or otherwise reduced accessibility surgeries. The sizing templates may be folded, rolled, or otherwise compressed into a reduced configuration for passage through an access tube or other such access channel. Once expelled from the access tube the sizing templates expand to their original shape for use in sizing the annulus. The templates may be formed of an elastomeric polymer material such as silicone, a highly elastic metal such as NITINOL, or both. Grasping tabs or connectors for handles permit manipulation from outside the body. A NITINOL wireform may be compressed for passage through an access tube and expelled from the distal end thereof into a cloth cover to assume a sizer shape.

Abstract: An automated system that can be used for prosthetic heart valve manufacturing or suturing procedures. The system can include a first automated fixture that includes an articulating arm and a target device holder. The system can also include one or more additional automated fixtures, which can be configured as one or more suturing arms that include another articulating arm and a needle holder. The first automated fixture can be configured to rotate a target device held by the holder to allow the one or more additional automated fixtures to perform operations such as form sutures on the target device without intervention of a human operator. The system can include a targeting system configured to provide positioning feedback to the system.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a delivery catheter and a valve repair device. The valve repair device is disposed inside the delivery catheter. The valve repair device includes a pair of paddles and a pair of gripping members. The pair of paddles are movable between an open position and a closed position. The pair of paddles and the pair of gripping members are configured to secure the valve repair device to leaflets of the native valve. The pair of paddles are compressed inside the delivery catheter. Each paddle of the pair of paddles is configured to expand upon exiting the delivery catheter to increase the surface area of each paddle.

Abstract: In a representative embodiment, a method comprises implanting first and second inflatable bodies within an annulus of a native heart valve by securing the inflatable bodies to tissue of the native heart valve with sutures, and implanting a prosthetic heart valve between the inflatable bodies such that the prosthetic heart valve is retained within the annulus by the inflatable bodies.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes a coaption element, a pair of paddles, and barb portions. The barb portions extend directly from at least one of the coaption element and the pair of paddles.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a plurality of struts that define a repeating pattern of cells. The repeating pattern of cells comprises a column of exactly three generally diamond shaped cells positioned in end-to-end alignment, and a column of exactly two generally diamond shaped cells positioned in end-to-end alignment. The frame has a substantially hourglass shape with a narrow portion in between a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion are configured to expand radially outward to contact a right ventricular outflow tract.

Abstract: Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.