Abstract: An annuloplasty repair segment for heart valve annulus repair. In one embodiment a multi-stranded cable replaces solid core wire for both the tricuspid and mitral valves. Cable allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. In addition, selective placement of point-welds or other such control points locally control other parameters such as the amount and direction of displacement as the ring undergoes external loading. Cable with well-placed control points result in a MIS annuloplasty ring with sufficient flexibility in the x-y plane to allow a surgeon to squeeze the ring into a small incision, such as for example 1 cm×1 cm, while maintaining structural rigidity under forces exerted on the implanted ring by the cardiac cycle and allowing for asymmetrical deflection to be designed into the product.

Abstract: A sewing ring for prosthetic heart valves that is connected and configured to pivot outward. A biocompatible fabric covering surrounds at least a portion of the sewing ring, and the ring may be exclusively connected to a stent with the fabric. The sewing ring may be generally planar and of uniform thickness, or may be of varying thickness. The fabric may be used to encompass both the stent and the sewing ring, and may be a single piece. A seam may be provided in the fabric as a discrete pivoting line. The sewing ring may be convertible between bi-stable positions. The ring may extend outward in a frusto-conical shape so as to enable inversion between a position facing the inflow end of the valve and a position facing the outflow end of the valve. A method of implantation, and a method of assembly of the heart valve is also provided.

Abstract: A device for measuring an expanded internal orifice of a patient includes an orifice-expanding device, a pressure measuring device, and a size-measuring device. The size-measuring device measures a dimension of the orifice after it has been expanded by the orifice-expanding device.

Abstract: Suture clip deployment devices for applying suture clips to sutures are described. Some embodiments can include a generally tubular main body and a vacuum port located at the distal end, a hollow inner body longitudinally slidable within the main body and extending from the main body at its distal end, and a suture recess located in the generally tubular main body. At least one suture clip configured to frictionally fit on an outer surface of the inner body is deployed during use. Clip deployment can occur after a vacuum source is applied to the device so as to draw the suture into the device. The suture lines can be retrieved through the suture recess, and the device can be actuated so as to deliver the suture clip off the delivery device and onto the suture, locking the suture in place.

Abstract: A 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: An apparatus for crimping a radially expandable stent includes a pressure vessel, shaping balloon, and mandrel. The mandrel is configured to slidingly receive a stent thereon, and to be slidingly advanced into the pressure vessel. The shaping balloon is inflated to radially compress the stent onto the form of the mandrel; such compression need not be uniform. Pressurization of the shaping balloon facilitates the expansion of the balloon to achieve compression of the stent, with depressurization of the shaping balloon causing the balloon to return to an unexpanded state.

Abstract: Devices for securing prostheses such as heart valves or annuloplasty rings with sutures and without using knots are disclosed. The devices are particularly well suited for traditional surgery or minimally invasive surgery, and improve the ease of implantation by eliminating surgical knots a clinician would normally tie in the limited space in and around the implant site. The devices have opposed the clamp halves surrounded by a coil spring. Sutures pass between the clamp halves and the coil spring has an inner coil diameter sufficient to compress the sutures between the clamp. A retention member positioned between the clamp halves maintains a minimum space and therebetween to enable the locking device to be slid along the sutures into position, and to adjust the tension of the sutures therethrough. A delivery tool may be used to deliver and deploy the locking devices.

Abstract: An exemplary system for crimping a prosthetic valve comprises a radially expandable and compressible prosthetic valve, a crimping device positioned around the valve and configured to reduce the diameter of the valve to a delivery configuration, and a sterile package enclosing the valve and the crimping device. The valve can be pre-assembled in a partially crimped configuration within the crimping device. After removing the sterile packaging, the crimping device can be used to crimp the valve from the partially crimped configuration to the delivery configuration, such as by twisting a knob on the crimping device. The system can further comprise at least a portion of a delivery catheter within the sterile package, wherein the valve is pre-mounted on or adjacent to an inflatable balloon of the delivery catheter, such that the valve can be crimped onto the delivery catheter using the crimping device.

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 valve sizer for determining an appropriate replacement valve size when performing a heart valve replacement procedure is provided. In one version the valve sizer has a hollow shaft with proximal and distal ends. A movable sizing element couples to the distal end of the shaft and is radially expandable between first, contracted and second, expanded positions. An actuator assembly on a handle includes an actuator coupled to a clutch member via a ball-spring-detent clutch. A rod extends through the shaft and maintains a fixed distance between the handle and a distal hub in the sizing element. Movement of the actuator causes axial movement of the shaft, thereby causing radial expansion of sizing petals relative to the hub. The clutch slips when a predetermined reaction force from the surrounding valve annulus is met by the petals.

Abstract: A device and method for deploying self-cinching surgical clips. The device accesses at least two layers of tissue or material from only one side of the tissue or material and punctures through the two layers of tissue or material. The various configurations of clips disclosed herein are 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 is disposed within the housing of the delivery device and held in a constrained state by a tube assembly until deployment wherein the clip assumes its relaxed state, where the ends of the clip are brought into close approximation, thereby securing the layers of tissue or material together.

Abstract: A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization.

Abstract: The present invention is directed to an apparatus and method for the stabilization and fastening of two pieces of tissue. A single device may be used to both stabilize and fasten the two pieces of tissue, or a separate stabilizing device may be used in conjunction with a fastening device. After the pieces of tissue are stabilized, they are fastened together using sutures or clips. One exemplary embodiment of a suture-based fastener comprises a needle connected to a suture. The needle enters the blind side of the tissue and exits the front side. The suture is then tied in a knot to secure the pieces of tissue. One example of a clip-based fastener comprises a spring-loaded clip having two arms with tapered distal ends and barbs. The probe includes a deployment mechanism which causes the clip to pierce and lockingly secure the two pieces of tissue.

Abstract: A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable coupling stent, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the coupling stent attached thereto. The coupling stent may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes a hollow two-piece handle through which a balloon catheter passes. A valve holder is stored with the heart valve and the handle easily attaches thereto to improve valve preparation steps.

Abstract: A method of implanting a collapsible prosthetic heart valve is disclosed. The prosthetic heart valve includes three biological leaflets mounted within a self-expanding tubular leaflet frame formed of nitinol. The method comprises loading a collapsed prosthetic heart valve into a distal end of a delivery tube. The distal end of the delivery tube is inserted into a vasculature of a patient and positioned proximal to an aortic valve. The prosthetic heart valve is expelled into an annulus of the aortic valve and allowed to self-expand to a first diameter. A balloon is then inflated within the prosthetic heart valve for expanding the prosthetic heart valve to a second diameter, wherein the second diameter is larger than the first diameter, thereby securely implanting the prosthetic heart valve within the annulus of the aortic valve.

Abstract: A method of implanting a collapsible prosthetic heart valve is disclosed. The prosthetic heart valve includes three biological leaflets mounted within a self-expanding tubular leaflet frame formed of nitinol. The method comprises loading a collapsed prosthetic heart valve into a distal end of a delivery tube. The distal end of the delivery tube is inserted into a vasculature of a patient and positioned proximal to an aortic valve. The prosthetic heart valve is expelled into an annulus of the aortic valve and expanded. The prosthetic heart valve includes cusp positioners that engage sinus cavities above the valve annulus and rotationally orient the prosthetic valve. Preferred embodiments of the cusp positioners do not occlude the coronary arteries.

Abstract: A method of treating a deficient mitral valve without open heart surgery is disclosed. A support band is advanced from a delivery catheter and positioned around native leaflets of the deficient mitral valve. The support band is preferably formed of a shape memory material and is configured to assume a curved shape upon advancement from the delivery catheter. While the support band is positioned around the native leaflets of the mitral valve, an expandable prosthetic heart valve is delivered through an apex of the left ventricle and into the mitral valve. The expandable prosthetic heart valve is then expanded within the mitral valve, thereby causing one or more of the native leaflets of the mitral valve to be frictionally secured between the support band and the prosthetic heart valve.

Abstract: A prosthetic valve assembly and method of implanting same is disclosed. The prosthetic valve assembly includes a prosthetic valve formed by support frame and valve leaflets, with one or more tethers each having a first end secured to the support frame and the second end attached to, or configured for attachment to, to papillary muscles or other ventricular tissue. The tether is configured and positioned so as to avoid contact or other interference with movement of the valve leaflets, while at the same time providing a tethering action between the support frame and the ventricular tissue. The valve leaflets may be flexible (e.g., so-called tissue or synthetic leaflets) or mechanical.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment.

Abstract: A prosthetic mitral valve assembly is disclosed. The assembly comprises a radially-expandable stent including a lower portion sized for deployment between leaflets of a native mitral valve and an upper portion having a flared end. The upper portion is sized for deployment within the annulus of the mitral valve and the flared end is configured to extend above the annulus. The stent is formed with a substantially D-shape cross-section for conforming to the native mitral valve. The D-shape cross-section includes a substantially straight portion for extending along an anterior side of the native mitral valve and a substantially curved portion for extending along a posterior side of the native mitral valve. The assembly further includes a valve portion formed of pericardial tissue and mounted within an interior portion of the stent for occluding blood flow in one direction.