A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Anchors for securing an implant within a body organ and/or reshaping a body organ are provided herein. Anchors are configured for deployment in a body lumen or vasculature of the patient that are curved or conformable to accommodate anatomy of the patient. Such anchors can include deformable or collapsible structures upon tensioning of a bridging element in a lateral direction, or segmented tubes that can be adjusted by tightening of one or more tethers extending therethrough. Such anchors can be used as a posterior anchor in a blood vessel in implant systems having a tensioned bridging element extending between the posterior anchor and an anterior anchor deployed at another location within or along the body organ. Methods of deploying such anchors, and use of multiple anchors or multiple bridging elements to a single anchor are also provided.

Described herein are methods and apparatus for approximating targeted tissue using locking sutures. The locking sutures can be configured to receive suture ends that are interweaved through portions of the locking sutures. In a pre-deployment configuration, a locking suture can slide along suture tails and can be positioned at a target location within a target region. Once a desired position and/or tension is achieved, the locking suture can be transitioned to a post-deployment configuration where the locking suture constricts around the suture tails to inhibit relative movement between the suture tails and the locking suture.

A method is provided for repairing the tricuspid valve of a patient using tension. A radially-expandable stent is implanted in a coronary sinus of the patient. A tissue anchor is implanted in tissue in the vicinity of the tricuspid valve. The tricuspid valve is repaired by applying tension between the radially-expandable stent and the tissue anchor using a flexible longitudinal member that connects the radially-expandable stent and the tissue anchor.

In one embodiment, a method of repairing a heart valve accesses an interior of a patient's beating heart minimally invasively and inserts one or more sutures into each of a plurality of heart valve leaflets with a suturing instrument. The suture ends of the sutures are divided into suture pairs, with each pair including one suture end from a suture inserted into a first valve leaflet and one suture end from a suture inserted into a second valve leaflet. One or more tourniquet tubes is advanced over the suture pairs to the leaflets to draw the sutures together to coapt the leaflets and then the sutures are secured in that position.

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the right atrium, which allow tricuspid valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant. The implants or systems of implants and methods may utilize a bridge stop to secure the implant.

An expandable tissue anchor is provided that includes an elongate tissue-coupling portion configured to be delivered through a cardiac tissue wall, and a flexible elongate tension member, which is coupled to a portion of the tissue-coupling portion such that a tensile force can be applied to the tissue-coupling portion after it has been expanded. A portion of the tension member is slidably disposed through a passage defined by the anchor. A sleeve encloses a portion of the tension member between the tissue-coupling portion and a distal opening of the passage. The sleeve and the passage are sized and shaped such that the size and shape of the passage prevent proximal movement of the sleeve past the passage upon application of the tensile force to the tension member, thereby limiting compression and deformation of the expanded tissue-coupling portion by the tension member. Other embodiments are also described.

This disclosure includes apparatuses and techniques to access the right ventricle via trans-femoral vein threading a catheter or catheters to the apex or bottom of the right ventricle. Piercing through the venous or right side of the heart in the interventricular septal wall to access the left ventricle a catheter can be passed to turn upward pointing to the mitral valve. From this access point in the left ventricle the flail mitral leaflet can be sutured and tethered pulling it back into position and reattached with a grounding anchor in the right ventricle or imbedding the anchor into the septal wall. The interventricular septal wall crossing technique could include the passing of a coaxial catheter through the first access catheter where the first access catheter could act as a guide to direct the internal or second coaxial catheter toward the flail mitral leaflet.

In one embodiment, a method of repairing a heart valve accesses an interior of a patient's beating heart minimally invasively and inserts one or more sutures into each of a plurality of heart valve leaflets with a suturing instrument. The suture ends of the sutures are divided into suture pairs, with each pair including one suture end from a suture inserted into a first valve leaflet and one suture end from a suture inserted into a second valve leaflet. One or more tourniquet tubes is advanced over the suture pairs to the leaflets to draw the sutures together to coapt the leaflets and then the sutures are secured in that position.

Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle. An outer surface of the valve body may accommodate tissue ingrowth or endothelialization, while a fluid-absorbing matrix can swell after introduction into the heart. The valve body shape may be selected after an anchor has been deployed, and catheter-based deployment systems may have a desirable low profile.