Abstract: A tissue anchor delivery includes comprises a needle including a hollow shaft portion, a tip portion, and an outlet opening. The tissue anchor delivery device further includes a plurality of tissue anchors disposed within the shaft portion of the needle and a suture coupled to each of the plurality of tissue anchors and disposed at least partially within the shaft portion of the needle.

Abstract: A valve holder for delivering a prosthetic heart valve to an implant site is in various embodiments configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. The valve holder can be configured to deploy or actuate automatically when performing preparatory steps that are already familiar to practitioners, such as attaching a delivery handle to the valve holder, so that the valve holders will not require additional steps or training to use. Therefore, operation of the valve holders is kept simple, and occurrences of mistakes caused by user error can be minimized or reduced. Valve holders according to different embodiments can be designed to accommodate implantation of prosthetic heart valves from either the inflow end or the outflow end of the native valve annulus.

Abstract: Valve holders and introducers for delivering a prosthetic heart valve to an implant site are 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 handle that prevents implantation of the valve prior to proper deployment or adjustment of the holder. An introducer is provided which can facilitate temporary deformation of a nitinol prosthetic valve to pass between adjacent ribs of a patient without rib spreading. Valves are provided having a wireform and stiffener band made of materials that exhibit superelastic properties.

Abstract: A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient's native valve annulus. Methods of making and using prosthetic heart valves are also disclosed.

Abstract: A method for repairing a native valve of a patient during a non-open-heart procedure includes attaching two or more attachment members to the native valve. The method also includes applying a force to the two or more attachment members such that the two or more attachment members cause a cinching effect on at least a portion of the native valve. The method further includes securing the two or more attachment members with one or more anchor members such that the two or more attachment members maintain the cinching effect.

Abstract: A heart valve sizer and sizer cover are provided for determining the size of a heart valve annulus. The valve sizer can include a handle, a shaft extending distally from the handle, a sizing element coupled to the distal end of the shaft, the sizing element being movable between a first retracted position and a second expanded position, and a sizer cover. The sizer cover can be formed from a continuous sheet of material configured to surround at least a portion of the sizing element of the heart valve sizer so as to guard against entanglement of the sizing element with structures of a human heart.

Abstract: A prosthetic heart valve configured to replace a native heart valve and for post-implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post-implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in-valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.

Abstract: A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient's native valve annulus. Methods of making and using prosthetic heart valves are also disclosed.

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: A heart valve sizer and sizer cover are provided for determining the size of a heart valve annulus. The valve sizer can include a handle, a shaft extending distally from the handle, a sizing element coupled to the distal end of the shaft, the sizing element being movable between a first retracted position and a second expanded position, and a sizer cover. The sizer cover can be formed from a continuous sheet of material configured to surround at least a portion of the sizing element of the heart valve sizer so as to guard against entanglement of the sizing element with structures of a human heart.

Abstract: A prosthetic heart valve configured to replace a native heart valve and for post-implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post-implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in-valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.

Abstract: An articulating implant holder system for heart valve repair or replacement has an implant configured to be secured to a heart valve annulus, an implant holder secured to the implant, an articulating handle assembly comprising a handle, a swivel pivotably secured to the handle at a first location and a connector pivotably secured to the swivel at a second location, an actuating cable secured between the handle and the connector to cause the swivel to move from a first position to a second position, and a latch removably secured to the implant holder. A plurality of sizer heads are configured to correspond to different sizes of heart valve annuluses and each of the plurality of sizer heads has a latching feature. A latching feature of the swivel is configured to removably snap on to the latching feature of each of the plurality of sizer heads and is configured to permanently snap on to the latch.

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 annuloplasty ring assembly with detachable handle includes an annuloplasty ring configured to be secured to an annulus of a heart valve and an annuloplasty ring. The annuloplasty ring is attached to the ring holder such that the annuloplasty ring is in conformal contact along a lower surface of a peripheral edge portion of the ring holder. The assembly includes a handle adapter extending proximally from an upper proximal face of the ring holder. The handle adapter is also attached or attachable to a distal attachment end of the handle on one side and removably attached to the annuloplasty ring holder on another side.

Abstract: A minimally-invasive annuloplasty ring for implant at a mitral annulus. The annuloplasty ring has an inner core member with a C-shaped plan view that generally defines an oval with a major axis and a minor axis, and is symmetric about the minor axis. A posterior portion of the core member bisected by the minor axis has a thicker radial dimension than a pair of free end regions terminating on an anterior side of the core member. The radial thickness smoothly transitions between the posterior portion and the end regions. The inner core member may be covered with a fabric, and is a superelastic metal so that it can be straightened out and delivered through an access tube. The curvatures and thicknesses around the core member are selected so that the strain experienced when straightened does not exceed 7-8%.

Abstract: A method and device for anchoring a prosthetic heart valve or annuloplasty ring to a valve annulus in a heart and a method of implanting same is disclosed. The device can include a prosthetic valve or annuloplasty ring with one or more anchors configured to be threaded or otherwise passed underneath a native leaflet and/or subvalvular tissue to secure the device at the native annulus.

Abstract: A prosthetic heart valve holder system includes a prosthetic heart valve having a base at an inflow end, a plurality of commissure posts extending from the base toward an outflow end, and valve leaflets secured to the commissure posts to permit flow through the heart valve. A deflector is provided at the outflow end having a central hub and a plurality of arms extending from the central hub secured to and covering the tips of respective commissure posts. A valve support body is secured to the base and a post connects the valve support body to the hub of the deflector.