Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a waist portion that expands to a deployed size having a first diameter, first and second sealing portions extending in opposite directions from the waist portion and expanding radially outward of the waist portion. The first and second sealing portions are sized to seal against first and second portions of the inner surface of the right ventricular outflow tract at the deployed position over a range of sizes of expansion larger than the first diameter. A band is secured to the waist portion of the frame, restricting expansion of the waist portion substantially beyond the first diameter, such that the waist portion is configured to be spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which 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 other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Abstract: A covering layer for a transcatheter heart valve is in various embodiments configured to prevent or reduce damage to the native valve tissue around the site where the prosthetic valve is implanted. In some cases, prosthetic valves are manufactured with the covering layer attached. Other covering layers are stand-alone accessories that can be mounted onto pre-existing prosthetic valves by an end user. Covering layers that can be mounted by an end user are provided with various features that can facilitate easier attachment of the covering layer to the prosthetic valve, which further reduces the possibility of damage to the covering layer or to the valve. Another covering is provided with two layers in order to insulate and protect the native tissue surrounding the implant from damage due to friction or abrasion, and/or other movement driven wear.

Abstract: In a method of installing an expandable stent in a right ventricular outflow tract, a frame of the expandable stent is positioned at a deployed position in the right ventricular outflow tract, the frame including a waist portion, and first and second opposed sealing portions extending from the waist portion. The frame is expanded such that the waist portion expands to a first diameter, the first sealing portion expands to a second diameter larger than the first diameter and into contact with a first portion of an inner surface of the right ventricular outflow tract, and the second sealing portion expands to a third diameter larger than the first diameter and into contact with a second portion of the inner surface of the right ventricular outflow tract, wherein the waist portion is spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: Valve holders and introducers for delivering a prosthetic heart valve to an implant site are in various embodiments configured to facilitate insertion of prosthetic valves through small incisions or access sites on a patient's body. The valve holders can also be configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. A valve holder according to embodiments of the invention includes features that reduce or eliminate mistakes during implantation of the prosthetic valves, such as a removable activator dial and a removable handle that prevent implantation of the valve prior to proper deployment or adjustment of the holder. An introducer is provided which can facilitate passing of a prosthetic valve between adjacent ribs of a patient. Valve holders and introducers according to the various embodiments can be used in minimally invasive procedures, such as thoracotomy procedures.

Abstract: A method for replacing a stenotic native aortic valve of a patient can include inserting a delivery apparatus into a femoral artery of the patient, the delivery apparatus having a first shaft extending from the handle, a second shaft disposed around the first shaft, a third shaft extending through the second shaft, and a valve cover coupled to the first shaft. The valve cover can be in a first state housing an entirety of a prosthetic heart valve and retaining the prosthetic heart valve in a radially compressed state during the act of inserting. The method can further include advancing the delivery apparatus through the aorta of the patient to position the valve cover and the prosthetic heart valve within the native aortic valve, and moving the valve cover longitudinally from the first state to a second state in which the entirety of the prosthetic heart valve is uncovered.

Abstract: A method of implanting a prosthetic heart valve includes advancing a distal end portion of a catheter shaft through a patient's vasculature. The distal end portion of the catheter shaft includes an expansion device. A prosthetic heart valve is mounted on the expansion device with the expansion device and the prosthetic heart valve in a compressed configuration. The method further includes positioning the distal end portion of the catheter shaft and the prosthetic heart valve to an implantation location, and expanding the prosthetic heart valve and the expansion device from the compressed configuration to an expanded configuration. The expansion device includes an inner expandable member and a plurality of outer expandable members. The outer expandable members are distributed such that there are gaps providing perfusion passageways between the expansion device and the prosthetic heart valve when the expansion device is in the expanded configuration.

Abstract: A prosthetic heart valve assembly includes a self-expandable stent having an inlet end and an outlet end and a passageway extending therethrough. The stent includes a plurality of rows of prongs on the outer surface of the stent. A valve portion comprising a plurality of leaflets is positioned within the passageway for permitting blood to flow through the passageway from the inlet end to the outlet end while blocking flow in the opposite direction. The stent further includes a flared upper portion shaped for placement along a supra-annular surface of an annulus for preventing downward migration of the prosthetic valve assembly into a ventricle. Each of the prongs has a tip pointing toward the inlet end for penetrating surrounding tissue and preventing upward migration of the prosthetic heart valve assembly toward an atrium.

Abstract: Disclosed are devices and methods for delivering several sutures accurately and simultaneously around the perimeter of an annular prosthetic device (prosthetic heart valve, annuloplasty ring, etc.) to secure the prosthetic device within a native heart valve region. Devices can comprise a proximal handle portion including an actuator and a distal suturing portion including several curved and straight needles arrayed around the shaft axis. The straight needles and the curved needles are configured to simultaneously guide a plurality of sutures through the native tissue and through the annular prosthetic device. The actuator can cause the straight needles to move axially relative to the curved needles and can also cause the curved needles to rotate, such that the motions are coordinated to simultaneously place all the sutures.

Abstract: Devices and methods for deploying self-cinching surgical clips. A device can access at least two layers of tissue or material from only one side of the tissue or material and puncture through the two layers of tissue or material. The various configurations of clips disclosed herein can be made of a superelastic material such as Nitinol, and have a constrained and a relaxed state, and no sharp edges or tips so as to reduce tissue irritation following deployment. The clip can be disposed within the housing of the delivery device and held in a constrained state until deployment wherein the clip assumes its relaxed state, where the ends of the clip can be brought into close approximation, thereby securing the layers of tissue or material together.

Abstract: An expandable delivery sheath includes an elastic outer tubular layer and an inner tubular layer. The inner tubular layer include a thick wall portion integrally connected to a thin wall portion. The thin wall portion can include longitudinal reinforcing members/rods that facilitate unfolding during the passage of the implant, thus decreasing the push force and increasing the consistency of the push force. The inner tubular layer can have a non-expanded or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the non-expanded condition with the sheath reassuming its smaller profile.

Abstract: A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

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: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. In embodiments, a prosthetic heart valve assembly, including a self-expandable support structure and a self-expanding heart valve, are advanced through the aortic arch of a patient using a delivery system. The support structure, which includes a plurality leaflet retaining arms, is at least partially expanded and positioned on or adjacent to the outflow side of the aortic valve. The prosthetic heart valve is positioned in the aortic valve. The prosthetic heart valve is expanded while it is within an interior of the support structure and while the support structure is positioned on or adjacent to the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the arms of the support structure and the expanded prosthetic heart valve.

Abstract: Disclosed herein are suture clip delivery devices that can be loaded with several flat, disk-shaped suture clips and can deploy the suture clips one after another onto respective sutures without reloading the device with additional suture clips. An exemplary device includes a handle portion with an actuation mechanism that is coupled to a shaft portion that holds and deploys the suture clips. The shaft portion includes a mandrel on which the suture clips are mounted and a retainer that restricts the suture clips from moving proximally when the actuation mechanism pulls the mandrel proximally, which causes a distal-most suture clip to slide off the mandrel and be deployed onto one or more suture. The mandrel and remaining suture clips can then move distally to prepare to deploy the next suture clip.

Abstract: Valve repair systems and clips for attachment to one or more leaflets of a heart valve. The clip can include an elongated member configured to be positioned between two leaflets of the heart valve. The elongated member can have a first portion and a second portion that extends from the first portion. A width of the second portion can be greater than the width of the first portion. A pair of arms can be coupled to the first portion and extend toward the second portion. The pair of arms can extend radially away from the elongated member as the pair of arms extend away from the first portion toward the second portion when the arms are in an open position. And the pair of arms can be moveable from the open position to a closed position to pinch each leaflet between one of the arms and the elongated member.

Abstract: A method includes advancing a delivery assembly through a patient's vasculature toward a native heart valve of the patient, wherein the delivery assembly comprises a first catheter assembly and a second catheter assembly extending through a shaft of the first catheter assembly, and wherein a support member is in an uncoiled, elongated configuration within a sheath of the first catheter assembly. The support member is deployed from the sheath by pushing the second catheter assembly distally relative to the first catheter assembly so that the support member is uncovered by the sheath and the support member extends around native chordae tendineae and/or native leaflets of the native heart valve. A prosthetic valve is implanted within the native leaflets of the native heart valve such that the native chordae tendineae and/or native leaflets are frictionally engaged between the support member and the prosthetic valve.

Abstract: A delivery assembly includes a prosthetic device, a catheter shaft, a release wire, a first line, and a second line. The prosthetic device has a first arm and a second arm. The release wire extends through the catheter shaft. The first line includes a first loop. The first line extends from the catheter shaft, through the first arm of the prosthetic device, and to the release wire, where the release wire extends through the first loop. The second line includes a second loop. The second line extends from the catheter shaft, through the second arm of the prosthetic device, and to the release wire, where the release wire extends through the second loop.

Abstract: A method of implanting a prosthetic heart valve within a patient can comprise inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into the patient and advancing the prosthetic heart valve to a deployment location within the heart of the patient and inflating one or more of a plurality of differently-sized balloons in a balloon-assembly on the distal end portion of the delivery apparatus. The prosthetic heart valve can be mounted on the balloon assembly in a crimped state and the inflating of the one or more of the plurality of differently-sized balloons can expand the prosthetic heart valve from the crimped state to a radially expanded state having a non-cylindrical shape.