Cardiac valve repair and pacing procedures, related devices and methods

Abstract

The present invention discloses devices and methods for treating or repairing regurgitant heart valves such as the mitral valve and / or the tricuspid valve. Exemplary valvuloplasty devices can be placed in the coronary sinus to re-shape the mitral valve and reduce mitral regurgitation as well as tricuspid regurgitation. The present disclosure also provides improved techniques for cardiac pacing.

Description

[0001] Cross - Reference to Related Applications

[0002] This patent application claims the benefit of priority to U.S. Provisional Application Serial No. 62 / 884,582, filed on August 8, 2019. This patent application is related to Patent Application Serial No. 15 / 796,344, filed on October 27, 2017 (now U.S. Patent No. 10,433,962), and U.S. Patent Application Serial No. 16 / 264,531, filed on January 31, 2019. The disclosure of each of the foregoing patent applications is hereby expressly incorporated by reference for any purpose. Technical Field

[0003] The present disclosure relates to techniques and devices in which an implant is disposed within the heart to alter the structure and / or function of the heart. Background Art

[0004] Traditional mitral valve plasty requires a sternotomy or thoracotomy and an open-heart surgery with cardiac arrest and cardiopulmonary bypass. For example, the valve plasty procedure is performed through a surgical incision, wherein the effective size of the valve annulus is reduced by attaching a prosthetic valve plasty ring to the left atrial aspect of the mitral valve annulus. Various rigid and flexible valve plasty rings have been developed for this purpose, such as those shown in U.S. Patent Serial Nos. 4,917,698; 5,041,130; 5,061,277; 5,064,431; 5,104,407; 5,201,880; and 5,350,420. Although highly effective, such open-heart procedures are associated with significant morbidity and an extended recovery period. As a result, the method is generally not available to patients whose symptoms do not justify the surgical risks and morbidity, or to patients with advanced disease, or to patients with significant comorbidity.

[0005] Methods of percutaneous mitral valve repair have been developed to reduce the clinical drawbacks of open-heart surgery. However, these methods have various drawbacks. International Application Serial No. PCT / US2017 / 031543, filed on May 8, 2017 and related to the present disclosure, represents a significant improvement over the state of the art. In some aspects, the present disclosure provides further improvements over the prior art.

[0006] In other aspects, the present disclosure provides improvements in the field of pacing. Since the first introduction of the pacemaker in 1958 by Furman and Rovinson, pacemakers have been used as important devices for treating patients with bradyarrhythmias. Pacemakers are commonly used in the treatment of arrhythmias, such as complete atrioventricular block, high-degree atrioventricular block, and sinoatrial node dysfunction, with accompanying symptoms. Treatment using a pacemaker is a method that artificially provides electrical stimulation when electrical stimulation is not transmitted normally to the heart and / or when incorrect stimulation is transmitted to the heart.

[0007] Figures 1A - 1C is a view of the conduction system of the human heart, where Figure 1A the flow in the conduction system is shown, and FIG. 1B shows the waveforms in an electrocardiogram, Figure 1C showing the relationship between the conduction process and the waveforms. As described in U.S. Patent Application No. 15 / 328,046, filed on June 6, 2015 (the entire content of which is incorporated herein by reference for any purpose), electrical stimulation is transmitted through the sinoatrial (SA) node in the atrium, the atrioventricular (AV) node in the atrium, and then through the His bundle and the bundle branches in the ventricles, and then through the conduction path to the entire ventricle.

[0008] In an electrocardiogram, the QRS-complex is generated by the depolarization process of the ventricular muscle. The first downward wave after the P wave is called the Q wave, the first upward wave is called the R wave, and the downward wave after the R wave is called the S wave. The width of the QRS represents the time required for electrical conduction through the entire ventricle. In a normal state, the width of the QRS is usually within about 0.12 seconds (about 90 ms), but when it is 0.12 seconds or longer, it indicates the presence of an interventricular conduction defect.

[0009] A pacemaker typically consists of a generator and leads. The generator provides power and includes a controller having a processing circuit and a detection circuit for detecting operational aspects of the heart. A pacemaker usually supplies power or suspends power supply according to the working state of the heart. Power is selectively applied to the heart through leads that terminate in electrodes. A pacemaker typically operates in a bipolar manner, meaning that the lead actually includes two electrodes - one for delivering electrons (anode) and one for absorbing electrons (cathode). However, for conventional purposes, the cathode is usually considered the hot lead. If the anode breaks or stops working, the pacemaker controller will detect this and then operate the device as a unipolar device, where the anode becomes the housing and the "hot" lead continues to act as the cathode.

[0010] According to the commonly used treatment method of current pacemakers, the tip of the pacemaker wire is inserted and fixed at the right ventricular apex (RV apex) of the ventricle, and then electrical stimulation is provided. This is called right ventricular apical pacing (RVAP). In RVAP, the electrical stimulation at the RV apex is not transmitted through the cardiac conduction system, which rapidly transmits electrical stimulation in the ventricle. Instead, it is transmitted through the myocardial cells of the ventricle, which transmit electrical stimulation relatively slowly. Therefore, it may take a relatively long time for the electrical stimulation to spread throughout the ventricle. This can be expected (and typically) to result in an increase in QRS width, which leads to ventricular dyssynchrony and reduces the pumping efficiency of the heart. Ideally, the ventricles contract simultaneously for better efficiency.

[0011] To address this problem, attempts have been made to position the electrodes of the pacemaker wire at the right ventricular basal septum and apply electrical stimulation around the nerve bundle to promote ventricular contraction. This is called right ventricular septal pacing (RVSP). RVSP is most commonly used in the interventricular septum of the right ventricular outflow tract (RVOT). RVSP theoretically compensates for the deficiencies of RVAP, but in actual operation, it is difficult to accurately position the pacemaker wire at the interventricular septum around the RVOT, and the wire can be detached or moved, so the operation itself is difficult and thus cannot be widely used. Another feature of RVSP is that the wire tip is positioned at the interventricular septum, but instead of stimulating the medial side of the interventricular septum, it stimulates the lateral side, and it is known that RVSP is less effective than methods that stimulate the endocardium or the center of the interventricular septum.

[0012] Another method of obtaining a narrower QRS is applied to the situation where heart failure patients with ventricular dysfunction have a wider QRS in the electrocardiogram. This method uses two wires, positions one wire at the RV apex and applies electrical stimulation, positions the other wire at the left vein, and applies electrical stimulation to one side of the left ventricle. This treatment seeks to obtain a narrower QRS by simultaneously applying electrical stimulation to the RV apex and the left ventricular side. This is called "cardiac resynchronization therapy (CRT)". When heart failure patients have LBBB (left bundle branch block), CRT is a very effective treatment. However, the shortcoming of CRT is that it requires the use of two wires to stimulate the ventricles to obtain a narrower QRS.

[0013] Sterile pacing that can apply direct electrical stimulation to the interventricular septum has been attempted. For example, methods of forcibly positioning the lead of a pacemaker from the right ventricle directly through the left ventricle into the interventricular septum have been disclosed in US2010 / 0298841 and US20123 / 0231728. These methods have a high invasion depth, which results in an artificial defect in the interventricular septum between the left and right ventricles, a high possibility of tearing the surrounding tissue during the operation, and a high possibility of embolism caused by air or blood clots. In addition, these methods have many risks and limitations. For example, it can be locally close to the middle or top of the ventricle, rather than preferably close to the bottom. US Patent 15 / 328,046 attempts to improve the prior art by another method aimed at solving the defects in the above methods. The present disclosure provides additional improvements to the prior art. Summary of the Invention

[0014] In certain embodiments, the present invention provides an embodiment of an implant that includes a tether formed in an annular shape, a locking member that slides on and engages with the tether to maintain tension in the tether, and a spacer that is connected to the locking member and extends from the implant, the spacer being configured to be disposed between the leaflets of a heart valve to allow the leaflets of the heart valve to engage against the spacer.

[0015] In some embodiments, the tether may include an elongate inner tether and an outer sheath material, wherein the tether includes a radiopaque material along its length. The radiopaque material within the elongate inner tether may include a radiopaque disposed within a section of heat-shrinkable polymer tubing that is located within the hollow of the elongate inner tether.

[0016] In some embodiments, the spacer may include an expandable member or a self-expanding volume that expands to a predetermined size to occupy a portion of the patient's native tricuspid annulus. The spacer may include a plurality of self-expanding filaments that have a first end and a second end at proximal and distal converging portions and expand radially outward from a compressed configuration to occupy a volume in the right ventricular outflow tract. The spacer may include an elongate expandable member that is configured to occupy a portion of the patient's RVOT in the patient's tricuspid region. The expandable member may include a core member connected to the first end and the second end of the expandable member.

[0017] In some embodiments, the spacer may be connected to the implant by a spacer tether. The spacer tether may be connected to the implant by a spacer locking member that is connected to the locking member of the implant. The spacer may include a membrane around its outer periphery. The implant locking member may define at least one distal opening therein, and the at least one distal opening may be connected to two distally extending tubular limbs disposed around the outer sheath material. The first of the tubular limbs may be configured to traverse the tricuspid valve and may include an atraumatic distal tip formed thereon for distributing axially applied stress on the surface of the native septum after traversing the tricuspid valve. The first tubular limb may be configured to allow the outer sheath material to pass therethrough. The second of the tubular limbs may be configured to traverse the coronary sinus and may be configured to allow the outer sheath material to pass therethrough.

[0018] The present invention also provides a method of implanting an implant as described above. The method may include one or more of the following steps: guiding the distal end of a guide wire at least partially through the coronary sinus of the heart and into the right ventricle or right atrium, withdrawing the distal end of the guide wire from the patient's body such that the proximal and distal ends of the guide wire are outside the patient's body, and passing the guide wire through the coronary sinus in a circumferential path around the native mitral valve, crimping a crimp of the implant to the proximal end of the guide wire, advancing the implant until both ends of the outer sheath material are exposed outside the patient's body, and securing the implant in place to maintain the length of the sheath by advancing a locking member along opposite ends of the outer sheath material, through the patient's vasculature and into the patient's heart, wherein the locking member is fastened within the patient's heart. The method may also include one or more of the following steps: advancing the spacer located above the end of the outer sheath material, positioning the spacer on the locking member, positioning the spacer in the RVOT in the tricuspid valve region, and expanding the spacer into the patient's tricuspid valve to reduce tricuspid regurgitation.

[0019] The present invention also provides an embodiment of an implant that includes an elongate tether formed in a loop shape, an implant locking member that slides on and engages the outer sheath to maintain tension in the outer sheath material, wherein the implant locking member defines at least one distal opening therein that is connected to two distally extending tubular limbs disposed around the outer sheath material, and a saddle connecting the distal regions of the tubular limbs adjacent the implant locking member, the saddle being configured to distribute stress on the heart tissue when the implant is under tension.

[0020] If desired, the saddle may be a strip of material that squeezes cardiac tissue when the implant is under tension. The saddle may be connected to the tubular limb at least in part by a suture pack. The saddle may be connected to the tubular limb at least in part by a constriction tube. The saddle may be connected to the tubular limb at least in part by at least partially melted material of the tubular limb.

[0021] The present invention also provides an embodiment of an implant that includes an elongate tether formed in a loop and an implant lock that slides on and engages the outer sheath tube to maintain tension in the outer sheath tube material. The implant lock may define at least one distal opening therein. The at least one distal opening may be connected to two distally extending tubular limbs disposed around the outer sheath tube material. A first tubular limb of the tubular limbs may be configured to traverse the coronary sinus and may be configured to allow the elongate tether to pass therethrough. A second tubular limb of the tubular limbs may be configured to traverse the tricuspid valve and may be configured to allow the elongate tether to pass therethrough. When the first and second tubular limbs exit the lock in a first direction, the first and second tubular limbs may be parallel to each other. The first tubular limb of the tubular limbs may be capable of bending away from the first direction, and the second tubular limb may be capable of continuing to extend in the first direction away from the bifurcation point of the first tubular limb. The second tubular limb may then bend along a path parallel to the first tubular limb such that the two tubular limbs point in the same direction generally orthogonal to the first direction.

[0022] The implant may further include a saddle that connects the tubular limbs near the bifurcation point. The saddle may be configured to distribute stress over cardiac tissue when the implant is under tension. The saddle may be connected to the tubular limb at least in part by a suture pack. The saddle may be connected to the tubular limb at least in part by a constriction tube. The saddle may be connected to the tubular limb at least in part by at least partially melted material of the tubular limb.

[0023] The present invention also provides an implantable pacing system that is configured and arranged to surround a loop in the heart. The system includes an implant for performing mitral annuloplasty as described herein, at least one electrical conductor, a cardiac pacing controller including a power source, a pulse generator, and a control circuit operably connected to the at least one electrical conductor, and at least one cardiac pacing electrode configured and arranged to be implanted in cardiac tissue, the at least one cardiac pacing electrode being electrically connected to the cardiac pacing controller by the at least one electrical conductor.

[0024] If desired, the locking member can be connected to the cardiac pacing controller. The at least one electrical conductor is at least partially disposed within the elongate inner tether or outer sheath material. The locking member can include a cardiac pacing lead passing therethrough. Electrical communication with the cardiac pacing lead can be established by engaging a portion of the locking member. Electrodes can be placed along one or more tubular limbs of the implant or at the saddle portion of the implant. If desired, the system can include a protective bridge for spanning the LCx artery when in the coronary sinus near the interventricular septum. The system can also include at least one sensor module at least partially disposed within the outer sheath, the at least one sensor module including at least one sensor for sensing at least one biological parameter. The at least one sensor module can include at least one pressure sensor for detecting blood pressure. The at least one sensor module can include at least one of the following: a chemical sensor, a distance sensor, a sensor having circuitry for detecting electrophysiological data, a motion sensor, and a position sensor.

[0025] If desired, the pacing system can further include at least one pacing lead. The at least one pacing lead can be configured and arranged to interface with the right atrium. The at least one pacing lead can be configured and arranged to interface with the right ventricle. The at least one pacing lead can be configured and arranged to interface with a cardiac vein. The at least one pacing lead can be configured and arranged to interface with tissue near the septal vein. The controller can be configured and arranged to provide at least one of pacing, defibrillation, measurement, and control. If an inner elongate tether is provided, the inner elongate tether can include a loop antenna for conducting signals to and from the controller. If desired, the pacing system can further include a reservoir for containing a beneficial agent, the reservoir being connected to a dispenser controlled by the controller. The beneficial agent can include a drug. The beneficial agent can include gene therapy material.

[0026] The present invention also provides an embodiment of an implant, the implant comprising an elongate tether formed in an annular shape, an implant locking member that slides on and engages with an outer sheath tube to maintain tension in the outer sheath tube material. The implant locking member may define at least one distal opening therein. The at least one distal opening may be connected to at least one distally extending tubular limb disposed around the outer sheath tube material. The at least one distally extending tubular limb may be configured to traverse the tricuspid valve and be configured to allow the elongate tether to pass therethrough. The implant may further comprise deployable leaflets connected to the at least one distally extending tubular limb. The deployable leaflets may comprise at least one deployable structural rib having a first end connected to the limb and a second free end, the at least one deployable structural rib being connected to a membrane, the leaflets being configured to self-deploy into the RVOT upon installation and engage against at least one tricuspid valve leaflet. If desired, the deployable leaflets may comprise a first deployable structural rib connected to and extending from a distal region of the at least one distally extending tubular limb, and a second deployable structural rib connected to and extending from a proximal region of the at least one distally extending tubular limb.

[0027] It should be understood that the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the embodiments disclosed herein.

[0028] The drawings, which are incorporated in and constitute a part of this specification, are included to illustrate and provide a further understanding of the methods and systems of the present disclosure. Together with the specification, the drawings serve to explain the principles of the disclosed embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The above and other objects, aspects, features, and advantages of the exemplary embodiments will become more apparent and can be better understood by reference to the following description in conjunction with the drawings, in which:

[0030] Figures 1A - 1C Aspects of cardiac pacing in accordance with the present disclosure are shown.

[0031] Figure 2 is a schematic diagram showing an exemplary coronary protection device in a proper position during circumferential valvuloplasty.

[0032] Figures 3A - 3D is a set of diagrams showing the cardiac region involved in trans-sinus coronary valvuloplasty and showing the use of the protection device to prevent coronary artery clamping when tension is applied to the circumferential valvuloplasty tensioning device.

[0033] Figure 3AIs an external perspective view of the left side of the heart, showing the circumflex artery branch, the lateral coronary artery branch, and the great cardiac vein branching from the ascending aorta.

[0034] Figure 3B Is an enlarged view of an arterial cross-section, showing the coronary sinus passing over the surface of the circumflex branch of the left coronary artery at the level of the great cardiac vein.

[0035] Figure 3C Is similar to Figure 3B but shows the placement of ligatures (such as, but not limited to, wires or sutures) during valvuloplasty without a protection device in place. When the ligatures are tightened during valvuloplasty, pressure is applied to the coronary artery branches, thereby restricting blood flow and myocardial perfusion.

[0036] Figure 3D Is an enlarged view of the same structure, showing the placement of the protection device over the ligature within the coronary sinus on the surface of the coronary artery.

[0037] Figure 4A Is a schematic view of a portion of an implant according to the present disclosure.

[0038] Figure 4B Is a side view of an exemplary protection element according to the present disclosure.

[0039] Figure 4C Is a schematic cross-sectional view of an exemplary implant according to the present disclosure.

[0040] Figure 4D Is suitable for use in Figure 4C an implant of the inner tether.

[0041] Figures 5A - 5E Shows various aspects of a crimping member according to the present disclosure, which is used to connect the distal end of an exemplary implant to the proximal end of a guide wire that has been guided through a patient's vasculature.

[0042] Figure 6 Is a schematic view of an embodiment of an extraction catheter according to the present disclosure.

[0043] Figure 7A Is a schematic top view of a human heart taken at the level of the atrioventricular valve, showing two alternative trajectories of the annuloplasty ligature around the mitral valve in dashed lines.

[0044] Figure 7B Is a front perspective view of the heart, with a portion of the myocardial wall cut away to show Figure 7A the annuloplasty trajectory of

[0045] Figure 8Is a posterior perspective view of the heart, showing the angled plane of the coronary sinus annuloplasty valve repair. The drawing schematically shows a smaller conventional surgical mitral valve repair ring in the mitral annulus plane and a larger coronary sinus annuloplasty in a plane angled to the mitral plane to surround the left ventricular outflow tract.

[0046] Figure 9 Is a schematic cross-sectional view of the mitral valve area of the heart, where a prosthetic heart valve is located within the mitral valve area and exerts an outward expansion force, an implant for mitral annuloplasty according to the present disclosure is located in the area around the mitral valve and exerts an inward force, and a coronary artery protection device according to the present disclosure is positioned along the mitral annuloplasty device to protect the coronary artery from being compressed.

[0047] Figure 10 Is a cross-sectional view of the heart with a mitral annuloplasty device that is delivered through the coronary sinus and around the mitral valve.

[0048] Figures 11A - 11E Shows an embodiment of a spacer that will be connected to the implant according to the present disclosure.

[0049] Figures 12A - 12C Shows a first embodiment of placing a spacer in the tricuspid valve position according to the present disclosure.

[0050] Figures 13A - 13C Shows a second embodiment of placing a spacer in the tricuspid valve position according to the present disclosure.

[0051] Figures 14A - 14B Shows various aspects of an embodiment of the implant according to the present disclosure.

[0052] Figure 14C Shows Figure 14B The implantation of an implant example of.

[0053] Figure 15 Shows aspects of the construction of the implant according to the present disclosure.

[0054] Figures 16A - 16B Shows a further embodiment of the implant according to the present disclosure.

[0055] Figures 17A - 17C Shows a placement view of the implant according to the present disclosure.

[0056] Figures 18A - 18D Shows a further aspect of the implant according to the present disclosure.

[0057] Figures 19A - 19E Shows a further aspect of the implant according to the present disclosure.

[0058] Figures 20A - 20EShows aspects of the leaflet structure that can be connected to the device according to the present disclosure.

[0059] Figures 21A - 21B Shows Figures 20A - 20E the arrangement of an embodiment of Detailed Description

[0060] Unless otherwise noted, technical terms are used in their conventional sense. To facilitate the review of various embodiments of the present disclosure, the following explanations of terms are provided:

[0061] "Valvuloplasty element" refers to a device that induces cardiac annulus remodeling to repair valvular insufficiency. Such devices include those placed in the coronary sinus and that exert their action by applying a compressive force on the annulus, for example, by dilation of an elastic valvuloplasty element or by placing the valvuloplasty element under tension, as in the case of annuloplasty by the method of encirclement.

[0062] The term "comprising" means "including but not limited to". Thus, "comprising a guiding catheter and a guide wire" means "including a guiding catheter and a guide wire"; without excluding other elements.

[0063] The term "guide wire" refers to a simple guide wire, a reinforced guide wire, or a steerable guide wire catheter that is capable of puncturing and / or penetrating tissue. A guide wire can also transmit energy to enhance its ability to penetrate tissue, for example, by puncturing, by transmitting radiofrequency ablation energy, or by transmitting laser ablation energy.

[0064] These are examples of "penetrating devices"; it is a device that is capable of penetrating cardiac tissue (such as the myocardium).

[0065] As used herein, the term "ligature" means including any suitable tensioning material and is not limited to only suture material. The term "tensioning material" or "ligature" includes sutures and valvuloplasty threads.

[0066] "Mitral annuloplasty by encirclement" involves a valvuloplasty procedure in which a tensioning element is placed through at least a portion (preferably all) of the coronary sinus such that circumferential tension is transmitted around the mitral annulus and such that the tensioning element can be placed under a selective degree of tension for valvuloplasty. However, the technique of mitral annuloplasty by encirclement also includes other encirclement trajectories, such as those disclosed herein, including trajectories through the proximal coronary septal perforator vein and the myocardium or fibrous ring between this vein and the right ventricle or right atrium to produce circumferential encirclement valvuloplasty tension.

[0067] "Tensioning material" is any material suitable for performing coronary sinus mitral annuloplasty, in which the circumferential material is placed under tension to reconstruct the mitral annulus. Examples of suitable tensioning materials are preferably the sheath materials described herein (e.g., made of woven polymeric materials).

[0068] Unless otherwise noted, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The singular terms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. The term "or" refers to a single element of the recited alternative elements or a combination of two or more elements unless the context clearly indicates otherwise. For example, the phrase "rtMRI or echocardiogram" refers to real-time MRI (rtMRI), electrocardiography, or both rtMRI and echocardiogram. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, suitable methods and materials will be described below. In case of conflict, the present specification, including the claims, will control. In addition, the materials, methods, and examples are illustrative only and not limiting.

[0069] Coronary sinus mitral annuloplasty is an example of a percutaneous mitral valve repair procedure, and the disclosed protection device can be used in this procedure. Although the devices and methods used therein can be widely applied to any prosthetic annuloplasty element placed in the coronary sinus, these methods will be described in connection with a specific example of annuloplasty. This particular embodiment should not be construed as limiting the procedure to annuloplasty, but only for illustrative purposes of its use in a specific embodiment.

[0070] Exemplary transcatheter-mitral-annuloplasty involves the use of a guiding catheter and an assist catheter, such as a steerable microcatheter of a guide coaxial wire or a tubed catheter, to introduce a tensioning material or device around the mitral annulus. Various percutaneous approaches can be used to gain access to the area around the mitral annulus, including access from and through the coronary sinus. In a particular embodiment, the tensioning material that forms part of the implant is applied around the mitral annulus along a path that, in some embodiments, includes an extra-anatomical bypass portion. For example (but not limited to), the tensioning material can traverse the area between the most anterior nasal portion of the coronary sinus and the coronary sinus ostium. As another non-limiting example, such tensioning material can be applied in the atrium of the mitral valve, from the posterolateral to the anterior of the coronary sinus, or from the septum to the lateral of the mitral annulus. This procedure reduces the cross-sectional area of the mitral annulus and the septal-lateral wall separation, thereby restoring the line of coaptation of the mitral valve.

[0071] Because it has been found that mitral valvuloplasty via the coronary sinus inadvertently transmits pressures sufficient to constrict or occlude underlying coronary arteries, some of the devices disclosed herein have been developed to increase the safety and effectiveness of the procedure, for illustrative purposes. Figure 2 The use of implant 400 with protection device 420 during mitral annuloplasty valvuloplasty is schematically shown. Figure 2 Shown is sheath material 450 (in the preferred embodiment, braided suture material) used as a tensioning element extending over left circumflex coronary artery 252 through a portion of coronary sinus 250. Figure 2 Shown is implant 400 located within coronary sinus 250, where protection element 420 extends over coronary artery 252 and proximal and distal portions 428, 429 are located on either side of coronary artery 252. When tension is applied to tether portion 450 of implant 400, proximal and distal portions 428, 429 remain in place on either side of coronary artery 252 and transmit a compressive force to the wall of coronary sinus 250 rather than to the underlying coronary artery (LCx) 252.

[0072] Figure 3A , Figure 3B , Figure 3C and Figure 3D Alternative views of the function of annuloplasty protection device 400 are provided. Figure 3A Shown is the external anatomy of the heart, where coronary sinus 250 extends over the circumflex branch 252 of left coronary artery 254. Figure 3B An enlarged view of the overlapping relationship between coronary sinus 250 and coronary artery 252 is shown. Figure 3C Shown is hollow tether 450 placed under tension during annuloplasty valvuloplasty, which constricts underlying coronary artery 252 and interferes with myocardial perfusion. Figure 3D Shown is hollow tether 450 extending through protection device 420, which inhibits the application of compressive force to coronary artery 252, and thus coronary artery 252 remains patent and able to normally perfuse myocardial tissue.

[0073] Figures 4A - 4B Shown is an embodiment of implant 400 including protection bridge 420. The distal end of implant 400 is connected to crimp 570 to facilitate its delivery as described below. Distal delivery tube 440 slides over the distal portion of sheath 450 that houses the various components of implant 400. Crimp 570 is crimped around the distal end of the sheath at its proximal end and components within the sheath at the distal end of implant 400 are crimped. As Figures 4A - 4BAs shown, the implant 400 includes an arched protection element 420. A hollow tether 410, such as a small-diameter braided polyester suture, is laid on top of the protection arch 420 and is fixed in place, for example, by suture loops (not shown) or one or more shrink tubes (not shown). In one embodiment, a shrink tube slides over the tether 410 and above the protection arch 420 and shrinks in place to fix the tether 410 in place from one end to the other on the upper surface of the arch 420. If desired, the shrink tube can extend beyond the ends of the protection element 400 to act as a strain relief, providing a more gradual stiffness transition at the ends of the element 420. Also, if desired, additional or alternative strain reliefs 430 can be provided at the ends of the protection element 420 and also around the tether 410. A sheath 450, such as a larger-diameter braided suture, is then assembled over the components such as elements 410, 420, and 430. The sheath 450 narrows in the area without the protection element 420. A distal delivery tube 440 slides over the distal region of the sheath 450, while a proximal delivery tube 470 slides over the distal region of the sheath 450 and is crimped in place at the distal and proximal ends of the implant, respectively, if desired.

[0074] As Figure 4B shown, the inner tether 410 can consist of multiple sub-components. The illustrated embodiment of the inner tether 410 can consist of an innermost metallic, radiopaque wire 410a (such as platinum) surrounded by a heat-shrinkable tube 410b (such as PTFE, PET). These nested components can then be correspondingly accommodated within a braided suture 410c. Preferably, the lengths of the components 410a, 410b, 410c coextend with the sheath 450 and are crimped to the sheath 450 at the proximal and distal ends of the implant 400.

[0075] Preferably, the inner tether 410 is radiopaque along its entire length to enhance its visualization during and after implantation. While the radiopacity of the inner tether 410 can be enhanced by the presence of metallic (such as platinum) wires, wires, or filaments, it can be formed by a tungsten-loaded polymer, a tantalum-loaded polymer, and / or the braided suture material 410c, which is impregnated with one or more of bismuth, tungsten, tantalum, barium sulfate, etc. in one way or another (such as by incorporation into the underlying polymer or into the braided material).

[0076] Delivery tubes 440, 470 are provided on the sheath 450 and can be adjacent to or near the proximal and distal ends of the protection bridge 420. Removable delivery tubes are assembled on the continuous outer tether 450 on each side, extending from the protection bridge to the exchange crimps, as Figure 4Aas shown), to help exchange the guide wire for the cerclage implant. Alternatively, they can be routed under the outer sheath tube 450. As needed, the detachable delivery tube can be made of a polymeric material such as PEEK, HDPE, etc. When the implant is in place, the detachable delivery tube can be removed by pulling them out. The sheath tube 450 surrounding this structure can in turn include a lubricious coating, such as a hydrophobic coating (e.g., PTFE, PVDF) or a hydrophilic coating (e.g., PVP), along at least a portion or all of its length. This can be provided, for example, in the form of one or more additional layers, or in the form of adjacent and / or overlapping tubes of PTFE shrink tubing. The overlapping regions can serve as strain reliefs to help provide regions of transition stiffness. The shrink tubing can be a multi-layer co-extrusion as described elsewhere herein, which can include an intermediate braided layer formed of a polymeric or metallic material and can include a radiopaque material.

[0077] In some embodiments, the sheath tube 450 can be made of 1-2 mm ultra-high molecular weight polyethylene (“UHMWPE”) coreless circular braid from DSM, Dyneema, or Teleflex. In some embodiments, the tether / sheath tube 450 can be loaded with at least 20 wt% of bismuth to improve radiopacity. For example, the sheath tube can be loaded with about 20 to about 70% of bismuth or barium sulfate, or loaded in any amount in increments of about 1 wt% between them. Additionally or alternatively, additional or alternative radiopaque materials can be incorporated into the sheath tube material, such as tungsten, tantalum, and barium sulfate. For example, these materials can be incorporated as drawn metal (e.g., platinum or other radiopaque material) wires into the braid, such as by weaving, or by guiding the drawn wire along a central channel defined within the tether.

[0078] Figure 4C and Figure 4D Another implementation of the implant 400’ according to the present disclosure is shown. Figure 4CShows the distal and central portions of the implant 400'. The implant 400' includes an innermost core wire (e.g., platinum) 410a', which is preferably housed within an elongate Pebax tube 410b'. The assembly of components 410a', 410b' is then introduced into a tubular (e.g., 5 mm) braided suture 410c'. The collection of components is then introduced into a shorter tube 480', preferably also Pebax or other suitable thermoplastic material. Tube 480' is preferably only a few inches long and is sufficient to span the full length of the protection bridge 420'. The components 410a', 410b', 410c' and 480' are then heat shrunk in a heating operation. The heating operation causes the Pebax material to melt between the fibers of the braided suture 410', thereby enhancing its stiffness in the area of the protection bridge 420'. The heat-fused assembly of components 410a', 410b', 410c' and 480' is then placed above the upper surface of the bridge 420', and then another (e.g., 1 mm diameter) braided polymer suture 450' is introduced. Suture 450 holds the assembly of components 410a', 410b', 410c' and 480' in place on the upper surface of the bridge 420'. Next, an outer tubular layer 490' made of Pebax or other suitable thermoplastic material is installed on the portion of the cross-over bridge 420' of the outer sheath tube 450'. The collection of components is then heat shrunk again to fuse the polymeric materials of components 480' and 490' into the fibers of the braided sheath tube 450', further enhancing stiffness and also providing a smooth surface with excellent stress transition along the length of the implant 400'. The inner radiopaque wire 410a' preferably does not extend through the entire length of the implant, but preferably occupies a central region that is approximately 100 cm to 200 cm long (e.g., approximately 170 cm long), with approximately equal lengths on either side of the bridge 420'.

[0079] As Figure 4D Further shown, a distal delivery tube 440' is also provided and is also preferably made of a thermoplastic polymer such as Pebax (preferably thermoplastic elastomer "TPE"). As shown, the delivery tube 440' includes a distally-expanded proximal end adapted to abut or even partially overlap the distal end of the bridge 420'. A proximal delivery tube 470' (not specifically shown) may similarly be provided with a distally-expanded end that similarly abuts or overlaps the proximal end of the bridge 420'.

[0080] Figure 4D Shows a cross-section of the distal region of the implant 400', showing how it is fixed to the distal crimp 570'. The distal crimp 570' includes a distal channel for receiving a guide wire (not shown) and a proximal channel for receiving a plurality of nested tubular components. Figure 4DThe innermost component shown in [description] includes a Pebax tube 410b' nested within a braided suture 410c'. In this embodiment, the core wire 410a' does not extend all the way to the crimp, although it could if desired. The component 410c' is disposed within an outer sheath tube or braided suture 450'. The distal end of the suture 450' is in turn disposed within a short (e.g., 2 - 3 cm) portion 572' of a polymer tube (e.g., Pebax). The distal end of the tube 572' is fitted into a cylindrical opening in the proximal face of the crimp 570'. The outer delivery tube 440 is then slid over the outer proximal portion of the crimp 570', which may be recessed. The proximal portion of the crimp 570' includes a plurality of holes or windows 574' formed therethrough. Once the component is assembled, the component is heat - shrunk so that the polymer in the distal end of the delivery tube 440' fuses with the tube 572' through the windows 574', thereby securing the crimp 570' to the implant 400'. The distal end of the tube 440' may initially be flared outward to assist in initially fitting the component into or onto the crimp 570'. Although not shown, the proximal end of the implant 400' may be similarly constructed and fused without a crimp, e.g., by heat - shrinking the proximal end of the proximal delivery tube 470' to the internal components.

[0081] The present disclosure also provides a version of the implant 400' that does not include a protective bridge. The construction of this embodiment is the same as the implant 400' except that in the central region where the bridge 420' would have been present, there is no bridge 420' and the tube 480' is not included. Instead, the assembly of components 410a', 410b', and 410c' is heat - fused and introduced into the outer sheath tube 450'. To indicate the central position of the implant 400', a marker strip is slid into position over the sheath tube 450' and held in place by sliding another polymer tube (preferably Pebax) over the marker and heat - shrinking it into place. If desired, another heat - shrink tube may be shrunk over the marker, which may also be at least partially radio - opaque to enhance radio - opacity while increasing the thickness at the center of the implant to prevent it from being pulled out of the locking member as a safety feature during implantation.

[0082] Figures 5A - 5EShows various views of a crimping member 570 that provides a transition region from the proximal end 502 of a guide wire to the distal end of an implant 400. If provided, a second crimping member at the proximal end of the implant 400 can provide an alternative or additional structural connection location for securing the proximal end of the sheath 450 to the proximal end of the inner tether 410. As shown, the crimping member 570 includes an outer proximal generally tapered conical surface, an outer distal generally tapered conical surface, and two intermediate tapered outer conical surfaces. The diameter of the distal end of the crimping member is less than the diameter of the proximal end of the crimping member 570 to define a relatively large proximal hole and a relatively narrow, intersecting distal hole, the relatively large proximal hole for receiving the distal end of the implant 400, the distal end of the implant 400 being within the sheath 450 and including the distal end of the sheath 450, the distal hole sized to receive the proximal end 502 of the guide wire. The crimping member 570 is preferably made of a deformable metallic material that is initially secured to the distal end of the implant 400. Once the guide wire is introduced and properly guided through the heart and out of the body (discussed further below), the crimping member 570 of the implant 400 is then crimped onto the guide wire (e.g., with a hand crimper), and the implant 400, including proximal and distal delivery tubes, the protection element 420, and the sheath 450 are advanced through the vasculature until the protection element straddles the LCx artery. It will be appreciated that the protection element 420 can be omitted from the implant, and, for example, for patients where an arch protection element is not required for the anatomy, can be replaced with a relatively straight structural element (or no rigid element at all).

[0083] Regurgitation (leakage) of the mitral or tricuspid valve can be caused by many different reasons, such as ischemic heart disease, myocardial infarction, acquired or hereditary cardiomyopathy, congenital defects, trauma, infectious diseases, and various forms of heart disease. Primary cardiomyopathy can cause valvular regurgitation through dilation, leading to annulus dilation, through overstretching, degeneration, or rupture of the papillary muscles, or through papillary muscle dysfunction or malposition, resulting in poor leaflet coaptation. This regurgitation can lead to arrhythmias, such as atrial fibrillation, and atrial fibrillation itself can lead to an inevitable deterioration of myocardial function. This deterioration may be associated with dysfunction, congestive heart failure, and significant pain, suffering, decreased quality of life, and even premature death.

[0084] A less risky, minimally invasive method, such as percutaneous valvuloplasty, allows more patients to receive mechanical treatment for valvular regurgitation. Due to the reduced risk and complications of the surgery (compared to open heart surgery), catheter-based cardiac valve surgery is applicable to a wider patient population. Improved devices and methods for catheter-based valve repair are disclosed herein, which can be used to repair damaged or malfunctioning heart valves, for example, by percutaneous annuloplasty (reconstruction or enlargement of the annulus or ring of a defective heart valve) to reposition the leaflets.

[0085] Typically, a system for performing a valvuloplasty procedure may include a guiding catheter (GC), such as a preformed transjugular balloon-tipped guiding catheter introduced into the coronary (venous) sinus. Retrograde coronary venography pressurizes and visualizes the great cardiac vein and the septal perforator veins. A high-performance guidewire designed for coronary recanalization can be maneuvered using a deflectable microcatheter, e.g., into the great cardiac vein and then into the basal septal perforator vein.

[0086] Typically, a valvuloplasty procedure may also include imaging the internal body tissues, organs, structures, cavities, and spaces of a subject using an imaging system. For example, transmitter or receiver coils can be used to facilitate the navigation of active devices using the imaging system, such as magnetic resonance imaging (MRI). Such imaging can generally be performed along any or a predetermined plane using various imaging methods based on X-ray technology, fluoroscopy, MRI, electromagnetic positron navigation, video techniques (e.g., endoscopy, arthroscopy, etc.), ultrasound, and other such techniques. In some embodiments, real-time MRI (rtMRI), intracardiac ultrasound, or electromagnetic guidance is employed. A particularly useful adjunct in circumferential valvuloplasty is XFM, where X-ray is used in conjunction with MRI to target myocardial structures, e.g., to help guide a valvuloplasty guidewire through cardiac structures in its trajectory. For example, the XFM technique is disclosed in deSilva et al., "Circulation" 114:2342-2350 (2006). The guiding catheter is capable of percutaneous entry into a subject's body via an arm, neck, or leg vein, e.g., into a chamber of the heart. In some embodiments, the guiding catheter is designed to enter a ventricle and / or an atrium of the heart. The guiding catheter allows the introduction of one or more adjunct catheters, which include, for example, a valve manipulation catheter, a microcatheter, or a catheter needle catheter. The adjunct catheter(s) are used to treat, affect, or manipulate an organ, tissue, or structure of interest within the subject, e.g., the heart or a specific structure within the heart. If the guiding catheter is used for percutaneous (or other) entry into the heart, the guiding catheter allows the introduction of one or more adjunct catheters (e.g., a valve manipulation catheter) into the heart while maintaining hemostasis. The adjunct catheters can be coaxial or adjacent to each other, or can be introduced from multiple entry points outside the body.

[0087] Guiding catheters have different shapes to accommodate the appropriate components of a mitral valve repair procedure. For example, guiding catheter shapes can be provided to fit different coronary sinuses with different radii of curvature, different coronary veins, transaortic and transseptal accesses, or different-sized atria and ventricles. All of these shapes can be adapted to appropriate first, second, and third curves. Examples of catheter configurations suitable for performing percutaneous transvascular mitral valvuloplasty are known in the art and are described in detail in U.S. Patent Publication No. 2002 / 0216039, the entire disclosure of which is incorporated herein by reference for any purpose.

[0088] Although any approach available for the coronary sinus can be used, the venous approach is preferred, such as via the jugular vein. As yet another example, a guiding catheter can be introduced into a vein, such as the femoral vein or the jugular vein, and guided through the inferior vena cava or the superior vena cava into the right ventricle of the heart. Two examples of trajectories for annuloplasty are shown in Figure 7A and Figure 7B . The first trajectory (labeled "simple" or "RV" trajectory) is the trajectory in which the annuloplasty wire enters the right atrium through the superior vena cava and then is introduced into the coronary sinus through the coronary ostium. The wire passes through the great cardiac vein of the heart into the basal vessel, such as the basal septal perforator vein. Then, the wire leaves the septal perforator vein through the myocardial interstitium and enters the right ventricle, and re-enters the right atrium along the septal tricuspid commissure (at the intersection of the anterior and septal leaflets).

[0089] Then, a guide wire is retrieved using, for example, a wire snare. Any suitable instrument can be used to capture the distal end of the guide wire and withdraw it through the vasculature until it is exposed outside the body. An exemplary preferred and improved snare system for facilitating wire removal is further described in Figure 6 .

[0090] For purposes of illustration and not limitation, Figure 6 an exemplary snare catheter 600 for capturing a guide wire according to the present disclosure is shown. As Figure 6 shown, the snare catheter 600 is defined by an elongate outer tubular member or sheath 601 that slidably receives therein an intermediate tubular member 602 along its length. The intermediate tubular member 602 in turn includes another elongate inner tubular member 604, such as a hypotube, slidably disposed therein along its length. Relative axial displacement of the tubular members 602, 604 causes the wire snare basket 606 (e.g., a contractable body) to expand or contract. The snare basket 606 is defined by a plurality of preformed wires and has a proximal end 610 connected to the distal end of the intermediate tubular member 602 and a distal end 612 connected to the distal end of the inner tubular member 604. Thus, when the ends 612, 610 are pulled apart from each other by sliding the tubular member 602 distally relative to the tubular member 604, the preformed wires of the basket 606 are stretched and folded radially inwardly, allowing the basket 606 to be pulled proximally relative to the outer tubular member or sheath 601. The inner tubular member 604 is preferably a metallic member, such as a stainless steel or nitinol hypotube, that defines another lumen along its length that can accommodate a guide wire passing therethrough. An atraumatic tapered atraumatic distal tip 605 is preferably formed on the distal end of the inner tubular member 604 and the distal portion 612 of the snare basket 606.

[0091] After snaring the guide wire and removing its distal end from the patient, the implant (e.g., 400) is replaced with the guide wire by crimping the implant onto the proximal end of the guide wire via a crimping member (e.g., 570). Then, as the guide wire is withdrawn from the patient's body, the implant (e.g., 400) can advance along the path of the guide wire until the distal end (e.g., 249) of the protection device or bridge (if provided, e.g., 420) approaches the interventricular septum and the bridge crosses the LCx artery. For example, the position of the damaged coronary artery is confirmed by radiography. In another method, the coronary vein enters the branches of the coronary sinus from the right atrium or right ventricle in the opposite direction under imaging guidance.

[0092] Figure 7A and Figure 7B Another or "complex" right atrial circumferential track as shown further extends posteriorly through the basal septal myocardium into the right atrium near the coronary sinus. The lead passes through the deep tissues of the septum, moves posteriorly and exits above the coronary sinus ostium. The plane of the circumferential annuloplasty is as Figure 8 shown, related to the plane of the coronary sinus 860, so that even if the coronary sinus is far from the mitral valvuloplasty, the valvuloplasty still has unique feasibility. As shown, the plane of the circumferential band 860 enhances mitral valve engagement, even when the coronary sinus is geometrically far from the mitral annulus, because it is "tilted" toward the left ventricular outflow tract. Thus, the angle α between the plane of the circumferential annuloplasty 860 and the plane of the mitral annulus 862 as shown is advantageous. In addition, the track of the circumferential valvuloplasty as shown induces mutual mitral valve closure and left ventricular outflow tract relaxation during ventricular systole.

[0093] The size of the guide wire is set to operate with the guiding catheter and is generally longer than the guiding catheter. For example, a guide wire with a length of about 100 to about 250 cm and a diameter of about 0.1 to about 2 mm can be used with the above catheter. If an auxiliary catheter, such as a tension delivery catheter, is intended to be used with the guiding catheter, then the size of the auxiliary catheter is also designed to operate with the guiding catheter and is generally longer than the guiding catheter.

[0094] The guiding catheter can be made of any suitable material or combination of materials that provides the strength and flexibility suitable for resisting collapse caused by external forces such as those applied during bending or twisting. Exemplary materials include, but are not limited to: polymers such as polyethylene or polyurethane; carbon fiber; ceramics; or metals such as nitinol, platinum, titanium, tantalum, tungsten, stainless steel, copper, gold, cobalt-chromium alloy or nickel. The guiding catheter can optionally be composed of or reinforced with fibers of metal, carbon fiber, glass, fiberglass, rigid polymer or other high-strength materials. In a particular embodiment, the guiding catheter material is MRI-compatible, such as braided nitinol, platinum, tungsten, gold or carbon fiber. Additionally, the outer surface of the guiding catheter can be coated with a hydrophobic material or substance, such as or other lubricating materials, such as hydrophilic materials (e.g., PVP), which assist in guiding the catheter into the subject's body and / or assist in guiding the movement of the catheter through the subject's body.

[0095] In addition, the guiding catheter may include a deflectable tip, such as a simple deflectable tip having a single axial degree of freedom. Exemplary (non-limiting) fixed-fulcrum and movable-fulcrum-deflectable-tip catheters are commercially available, such as the deflectable-tip catheters described in U.S. Patent Nos. 5,397,321, 5,487,757, 5,944,689, 5,928,191, 6,074,351, 6,198,974, and 6,346,099, which are hereby incorporated by reference in their entirety for any purpose. Thus, any suitable fixed-fulcrum or movable-fulcrum deflectable-tip catheter may be suitable for use as the guiding catheter disclosed herein. The guiding catheter may also include a structure or mechanism for assisting the rotation of the catheter about its longitudinal axis.

[0096] The guiding catheter may include a guide sheath, a handle, a grip, and other structures or devices that assist in guiding the catheter operation at its proximal end. Various control mechanisms, including electrical, optical, or mechanical control mechanisms, may be connected to the catheter through the guide sheath. For example, a guide wire may be included as a mechanical control mechanism. The guide sheath may include additional operating features, such as a grip for assisting in the manual control of the guiding catheter, markings indicating the orientation of the lumen or sub-lumen of the guiding catheter, markings for measuring the advancement depth of the guiding catheter, instruments for measuring the operating or physiological characteristics of the guiding catheter or the subject (e.g., a thermometer or a pressure monitor), or a syringe control mechanism connected to the lumen of the guiding catheter for delivering small, precise volumes of injectates. In some embodiments, the guide sheath contains an instrument electrically connected to the metal braid within the guiding catheter, thereby allowing the guiding catheter to be used simultaneously as a receiver coil for MRI.

[0097] A guide wire for use with a system for guiding a guiding catheter into and through a subject's body can be constructed of any suitable material or combination of materials, including the materials described above with respect to the guiding catheter. Exemplary (non-limiting) guide wires are composed of materials having a strength and flexibility suitable for use with the device, such as metal (e.g., surgical stainless steel, nitinol, platinum, titanium, tungsten, copper, or nickel) strands, carbon fiber, or polymers such as braided nylon. Specific (non-limiting) wires are composed of strands of nitinol or other flexible, kink-resistant materials. The guiding catheter or guide wire can include image enhancement features, structures, materials, or devices, such as radiopaque markers adjacent its distal end (e.g., platinum or tantalum bands around the perimeter of the guide wire). As another example, the guide wire can include an etched pattern or notch, or be coated with an acoustic reflective material to enhance images obtained by intravascular, intracardiac, transesophageal, or other ultrasound imaging methods. As another example, the guide wire can be coated with a T1 shortening agent or a T2 shortening agent to facilitate passive visualization using MRI. As yet another example, an optical fiber-assisted catheter can be inserted and passed through an auxiliary catheter lumen of the guiding catheter to assist in visualizing the position of the guide wire within the subject when the guide wire is deployed through the distal guide wire lumen port. In some embodiments, the guide wire and / or guiding catheter include at their distal tips structures, devices, or equipment for penetrating tissue, such as myocardium, skeletal muscle, or connective tissue. For example, the distal tip of the guide wire can be sharpened to a point for piercing through tissue, or an auxiliary catheter having a coring mechanism or forceps at its distal tip can be used in conjunction with the guide wire. In alternative embodiments, the guide wire can transmit radiofrequency or laser ablation energy to assist in traversing tissue. However, in alternative embodiments, the distal end of the guide wire is curved to provide a J-shaped or pigtail tip to prevent the guide wire from piercing tissue during manipulation. In other alternative embodiments, the guide wire itself has a deflectable tip to enable it to pass through tissue regardless of the influence of natural tissue planes. One or more auxiliary catheters can be deployed within the lumen of the guiding catheter. Like the guiding catheter, each auxiliary catheter has a proximal end and a distal end; however, not all auxiliary catheters have a single lumen. For example, non-lumen auxiliary catheters can include various probes, such as temperature probes, radiofrequency or cryoablation probes, or solid needles.

[0098] An exemplary non-limiting auxiliary catheter is a cannulated needle catheter that can be deployed through the guiding catheter and into a chamber of the heart to place a circumferential valvuloplasty ligature via the coronary sinus around the mitral valve. The cannulated needle catheter is an auxiliary catheter that can be used to apply sutures to body tissues, organs, or structures of interest.

[0099] Tension is applied via a sheath material (e.g., 450) by valvuloplasty circumferential ligation, the sheath material preferably being a hollow braided suture material as described above. Tension can be applied to both ends of the sheath (e.g., 450) which, when externalized / exposed at the vessel entry point, is consistent with the locking member delivery catheter described in further detail below, which guides the ends of the suture through a locking member mounted at the end of the locking member delivery catheter. Then, the tension in the sheath (e.g., 450) can be fixed by locking the locking member of the locking member delivery catheter, as described, for example, in U.S. Patent No. 10,433,962. As needed, the locking member or knot can be located in the right atrium or right ventricle where the two circumferential ligation tracks intersect, or at the vessel entry point, or between the two. Thus, if desired, tension can be delivered by, for example, backpressure applied to the fixation device through a delivery catheter. Before fixation, the tension can be released or reduced, for example, to reposition the protection device or achieve a lower degree of mitral annulus circumferential reduction. When tension is applied, valvular regurgitation is preferably repeatedly and non-invasively evaluated by appropriate imaging techniques. Such imaging techniques include X-ray angiography, electromagnetic position detection, MRI, external or intracavitary or intravascular ultrasound, X-ray computed tomography, pressure sensors in affected chambers such as the left atrium or pulmonary veins or pulmonary artery, or "fusion" or combination of any of the above. After valvular regurgitation has been reduced (or even eliminated) and the desired tension has been achieved, the tension is fixed using the locking member or knot delivery system as described above, and any excess sheath material proximal to the locking member or knot can be cut and removed in any desired manner. According to one aspect of the present disclosure, a cutting tool can be used as described in U.S. Patent No. 10,433,962. The use of an implant having a protection device (e.g., 420) in a circumferential ligation valvuloplasty technique has been disclosed. However, depending on its unique anatomy, a protection device is not needed for all patients.

[0100] Figure 9 FIG. 4 is a schematic cross-sectional view of the mitral valve region of the heart, showing an exemplary implant system 900 that includes an implanted TMV 912 disposed within the heart wall 902 and within a mitral valvuloplasty device 910 disposed around the heart wall. Device 910 includes an arched protection device 420 that spans the coronary artery 252 to protect the artery from compression applied externally by device 910 and the outward expansion force 914 applied to the inner side of the heart wall 902 by the TMV 912. Exemplary protection device 420 includes an arched portion that extends between two flat, generally coplanar proximal and distal segments 428, 429. The bridge or protection device 420 can have any combination of features and dimensions described herein with respect to other exemplary protection devices.

[0101] Figure 10Illustrated is a tension suture (e.g., 450) extending partially around the mitral valve through the coronary sinus 250 without including the disclosed protective device. Thus, when the coronary sinus overlaps the artery, the circumflex coronary artery 252 is trapped under the tension suture, thereby applying an undesired compression on the artery. When the TMV is also implanted within the mitral valve, it can apply additional internal and external compressive forces on the artery 252. Without the protective device, the artery 252 would collapse and / or be pinched by the reaction force.

[0102] Figures 11A - 11E Illustrated is an embodiment of a spacer according to the present disclosure to be connected to an implant to be at least partially located within a heart valve such as the tricuspid valve. The spacer is preferably connected to a circumferential implant as described in the present disclosure, but the spacer can also be anchored in place by other devices such as an expandable frame located within the patient's vasculature.

[0103] Figure 11A Illustrated is an aspect of a spacer 1100 without a covering according to the present disclosure to show internal components. As shown, the spacer 1100 is formed by a plurality of elongated members 1106. Each elongated member 1106 or filament can be a wire made of a shape memory material such as a NiTi alloy material. However, it should be recognized that other materials can also be used. Each elongated member 1106 is connected to other filaments in the structure at a proximal or collection portion 1102 and a distal or collection portion 1104. Each collection portion can be formed by, for example, a crimp or a tubular portion to which the filaments 1106 are connected. The proximal collection portion 1102 is connected to a locking member or a locking member housing 1108 by a tether or cable 1110.

[0104] In Figure 11A the illustrated embodiment, by Wire made (e.g., from Fort Wayne Metals, Fort Wayne, Indiana), which includes a NiTi tube filled with platinum wire to provide a combination of shape memory properties from the NiTi material and radiopacity from the platinum material. The NiTi material is configured to self-expand from a collapsed linear configuration to the expanded configuration, where the filaments 1106 are all radially compressed inwardly, e.g., inside a delivery catheter. When the device is deployed from the end of a tubular catheter, it assumes the described shape. The tether or centering arm 1110 can also be made of NiTi material and is used to project outwardly into the vasculature to allow the spacer to be centered in the lumen, thereby positioning it generally at the center of the tricuspid valve. In this embodiment, to allow the leaflets of the tricuspid valve to engage (coapt) against the surface of the spacer 1100. The locking member 1108 and the spacer are introduced by passing the locking member 1108 carrying the spacer through a tether formed by the sheath 450 of the annuloplasty implant. As shown, the locking member 1108 is configured to slide around and attach to the locking member of the annuloplasty implant, and the tubular limb of the annuloplasty implant is attached to the locking member of the annuloplasty implant. The relative orientation of the locking member 1108 and the locking member and limb of the annuloplasty implant is shown in Figure 11E is shown.

[0105] Figure 11B is again described in connection with Figure 11C and Figure 11D embodiments side by side with Figure 11A embodiments. Figure 11A Embodiments of Figure 11C preferably are provided with a membrane covering over the filaments 1106 to enclose the volume defined by the filaments. Figure 11D shows a relatively large diameter balloon, Figure 11C and Figure 11D shows a relatively small diameter balloon that can be used in place of the embodiment of FIG. 1IB. The balloon can be configured to self-expand via filaments (e.g., 1106), as in the embodiment of FIG. 1IB or other expansion structural elements. Similarly, the balloon can be filled with a fluid, such as saline, etc. Figure 11E shows an embodiment of Figure 11D disposed on the forked locking member of the annuloplasty implant.

[0106] Figures 12A - 12CIllustrates a first embodiment of placing a spacer in the tricuspid valve position according to the present disclosure. Specifically, for illustrative purposes, a polymer replica of the heart is used to demonstrate the placement of the annuloplasty implant as described elsewhere herein and in U.S. Patent No. 10,433,962. Specifically, after the body of the implant including the sheath 450 is guided through the limbs of the locking assembly and the locking member is locked in place to place the mitral annulus in tension, one or more ends of the accessible sheath 450 are used as guides, where the locking member 1108 passes through one or both ends of the sheath 450 and is conveyed thereon such that the spacer 1100 projects into the region of the tricuspid valve. Once the desired position is obtained, the locking member is locked in place by adjusting the axial and rotational positions of the locking member 1108. The locking member can be locked in place by an interference fit and / or it can be locked onto the locking member of the annuloplasty implant. As another example, the locking member 1100 can be advanced parallel to another tether at one of the two ends of the sheath 450, and a knot can be pushed down along the two tether ends 450 onto the locking member 1108 to hold the spacer implant 1100 in place in the tricuspid valve. During implantation, the adjustment of the spacer 1100 can be performed in real time under visualization and contrast fluid to ensure that the spacer 1100 is properly placed in the tricuspid valve, thereby ensuring optimal leaflet engagement. The spacer 1100 can be connected to the distal end of a delivery catheter (not shown) by a releasable connection (e.g., threaded to the assembly 1108), and the delivery catheter can be threaded along one or more tethers 450 in an over-the-wire (OTW) or rapid exchange (RX) configuration. Then, the locking member 1108 can slide on the locking member of the annuloplasty implant and the locking member is locked in place. Figures 13A - 13C Illustrates a second embodiment of placing a spacer in the tricuspid valve position according to the present disclosure. Figure 13A Illustrates an inflated spacer disposed above the uncut implant tether 450. Figure 13B Illustrates the relative placement of the forked locking structure of the annuloplasty implant and the lateral positioning of the spacer 1100, while Figure 13C Shows the relative position in the tricuspid valve region from an axial perspective.

[0107] Figures 14A - 14B Illustrates aspects of an embodiment of an implant according to the present disclosure. Specifically, Figures 14A - 14B Illustrates aspects of the mitral annuloplasty implant locking member and limbs configured for neck access. Figure 14A Illustrates a neck access forked annulus and locking member without a "saddle" attachment, while Figure 14BAn implant with a "saddle" attachment is shown. The saddle attachment is connected to each limb extending outward from the locking member at either end. The saddle attachment facilitates the manipulation of the locking member and the limbs by helping to limit the separation of the limbs of the device when placed under tension through the sheath 450. Additionally, compared to not using a saddle, the saddle helps to spread mechanical stress along its length, thereby distributing stress more evenly over the cardiac tissue. This also results in a more uniform surface along the coronary sinus and RVOT limbs. Figure 14C shows an implantation of an implant embodiment Figure 14B showing placement of the right ventricular outflow tract (RVOT) limb through the tricuspid valve. Figure 14C Also shown is the arrangement of the saddle portion along the interventricular septum, showing how the saddle portion spreads stress over the surface of the interventricular septum.

[0108] Figure 15 shows the structural aspects of one form of the saddle attachment according to the present disclosure. The saddle attachment is constructed of a pledglet material, which includes a layer of radiopaque material to aid in visualization thereon. The radiopaque layer includes a pledglet material cover disposed thereon to sandwich the radiopaque material within the saddle. The pledget is configured to be in continuous contact with the tissue. The radiopaque material can take various forms, including radiopaque polymer beads, flat bands containing radiopaque material, polymer bands containing radiopaque material, radiopaque ink disposed on the pledglet material, sutures containing radiopaque material, metallic marker bands surrounding the saddle, etc. In Figure 15 the illustrated embodiment, a section of pledglet material is sewn onto a continuous pledget band over the radiopaque material to encapsulate it. Then, the band forming the saddle can be connected to the CS and RVOT limbs of the locking member in various ways. For example, the saddle can be connected to the forked limbs by refluxing a polymer over the assembly and / or by wrapping the ends of the saddle around the limbs with suture material. It will be appreciated that various techniques can be used to incorporate the saddle into the limbs and the techniques described are merely exemplary.

[0109] Figures 16A - 16B shows a further embodiment of a forked and locking implant for femoral access according to the present disclosure. Figure 16A An implant without the saddle attachment is shown, Figure 16B and an implant with the saddle attachment is shown. As with Figures 14A - 14B the forked locking member in Figures 16A - 16BEach of the wishbone lockings shown includes a locking body having a coronary sinus (CS) limb and a right ventricular outflow tract (RVOT) limb extending from the distal end of the locking member, wherein the locking body defines at least one lumen (not shown) therethrough to allow a tether 450 to pass through, and the tether 450 also passes through the CS and RVOT limbs. The locking member is locked in place using a locking catheter as described above, e.g., in U.S. Patent No. 10,433,962, wherein an internal locking body is pushed or pulled into place relative to the outer body of the locking member to squeeze or otherwise hold the tether 450 in place within the locking member to maintain tension on the mitral annulus. As with Figure 14B the embodiment of Figure 16B the wishbone lockings shown include a saddle attachment that spans the two limbs at the bifurcation and restricts separation of the legs when under tension. Each limb may terminate in a bumper as described in U.S. Patent No. 10,433,962. The saddle helps to spread stress along the tissue surface along the interatrial septum in the right atrium when the implant is placed under tension. Figures 16A - 16B The wishbone lockings shown are particularly configured to perform mitral annuloplasty as described in U.S. Patent No. 10,433,962, except through a femoral access. Thus, the shape of the locking member and the wishbone are configured to access from that direction. In particular, a portion of the assembly includes a locking member, herein referred to as a locking tower, which descends into the inferior vena cava due to the direction obtained through femoral access. Specifically, the two limbs extend outwardly in a parallel direction. Then the first limb bends laterally to be introduced into the coronary sinus, and then the second RVOT limb also bends laterally, wherein when using the femoral approach, both limbs are rotated substantially in a vertical direction to approach the CS and RVOT. As will be appreciated, the saddle may be configured to deploy in a generally planar configuration and have an effective width wider than the limbs to more effectively spread tension-induced stress along the heart tissue. Figures 17A - 17C A placement view of an implant according to the present disclosure is shown. Figures 16A - 16B Figure 17A Depicts the locking tower of the locking assembly being placed relatively downward into the IVC during implantation. Figure 17B Shows Figures 16A - 16B the saddle of the implant set to span the coronary sinus ostium and the interatrial septum and shows the positioning of the coronary sinus limb relative to the coronary sinus and the relative positioning of the RVOT limb through the tricuspid valve. Figure 17C Is a depiction of Figures 16A - 16BImages of in-situ implantation of the device in a porcine model showing the relative position of the wishbone and the saddle between the limbs descending into the IVC. Also shown is the remainder of the implant including the sheath 450 surrounding the arch 420. Also shown are marker bands 422 spaced apart from each other and crimped around the tether 450 to assist in completing measurements and the amount of tether 450 that has been withdrawn through the limb and the locking member. Figures 19C - 19E Shows Figure 16B In-situ placement of the implant in a simulated heart structure. Figure 19C Shows in Figure 16B In an embodiment of, how the saddle band connecting the CS and RVOT limbs unfolds and provides a large surface area under the locking tower to spread the load on the tissue under tension.

[0110] Further in accordance with the present disclosure, the implants of FIGS. 14 and 16 can be used as structures to support pacing electrodes and pacemaker hardware to allow cardiac pacing.

[0111] For purposes of illustration only and not limitation, Figures 18A - 18D Shows in accordance with the present disclosure Figure 16B Other aspects of the implant to show the relative positions of the sensors and electrodes when the device is adapted for pacing. Figures 19A - 19B Also shown is for Figure 14B Schematic arrangement of the sensors and other components of the implant.

[0112] In some embodiments, an implantable pacing system can be provided that is configured and arranged to surround a loop path in the heart. For example, U.S. Patent No. 15 / 328,046 presents a technique for implanting a pacemaker lead through a septal vein using a method through the coronary sinus, in a manner similar to setting a path for an implant device in accordance with the present disclosure.

[0113] Accordingly, an initial lead (preferably a bipolar lead) is anchored at a location in the myocardium where signals originating from the myocardium can provide a minimum signal. Once properly anchored, if desired, the proximal end of the lead or an extension thereof can be externalized from the patient, and the cardiac lead can be used at least in part as a delivery track to deliver implants of special configurations structurally similar to those disclosed herein on the lead. Optionally, the cardiac lead can be externalized, and the implant can be delivered after being crimped to the proximal end of the externalized guidewire disclosed herein, and the implant can be installed. When the time comes to engage the mounting lock, the lock can pass through the implant (e.g., 400) and the cardiac lead, and when the lock is locked in place, the lock can be configured to complete electrical contact with the lead. For example, the lock can include a controller having a power source and a signal generator. An internal elongate tether can also be formed into a circuit with the lock, and appropriate control circuitry can be provided in the lock to cause a loop of platinum or other wire in the internal tether to be used as an antenna for transmitting or receiving signals, or for receiving charging pulses to charge a battery in the lock to power the pacemaker.

[0114] However, Figures 18A - 18D and Figures 19A - 19B Embodiments of can also be configured, as shown, to include all of their sensors and electrodes as an integrated unit on a board. Accordingly, the implant can be delivered and assembled in place and programmed to stimulate cardiac tissue and / or sense biological conditions within the heart (e.g., electromechanical and chemical conditions).

[0115] Accordingly, the pacing system can include an elongate internal tether as described herein having a proximal end and a distal end, an outer sheath material surrounding the elongate internal tether having a proximal end and a distal end, at least one electrical conductor disposed along at least one of the elongate internal tether and the outer sheath or within at least one of the elongate internal tether and the outer sheath, a cardiac pacing controller, as shown, which can be integrated into the mounting lock of the implant and can include a power source such as a battery, a pulse generator, and control circuitry operably connected to the at least one electrical conductor, and at least one cardiac pacing electrode configured and arranged to be implanted in or on top of cardiac tissue, the at least one cardiac pacing electrode being electrically connected to the cardiac pacing controller through the at least one electrical conductor and the mounting lock securing the proximal and distal ends of the outer sheath material.

[0116] In some embodiments, the locking member may be connected to a cardiac pacing controller. The at least one electrical conductor is at least partially disposed within the elongate inner tether housed within the sheath 450 of the implant. If desired, the locking member / controller may include one or more cardiac pacing leads that pass through the locking member / controller and terminate at electrodes at a predetermined location shown in the figure, or at any other desired location. Electrical communication with the cardiac pacing lead may be established by engaging a portion of the locking member. Alternatively, the locking member / controller may be pre-connected to cardiac leads and electrodes integrally formed in the Figures 18A - 19B curved tubular limb of the implant shown, the curved tubular limb being connected to the locking member / controller. If desired, the portion of the implant received by the locking member limb may also be provided with sensors. If desired, power may be delivered directly to the implant via the coiled platinum wire described elsewhere herein. Components integrated into the sheath portion located between the ends of the locking member limb, such as sensors and electrodes, may then draw power from the core wire (e.g., 410a') for operation. The electrical connection between the power source / locking member and the pacing electrode or other sensors may be a direct conduction path where the conductor is placed between an inner tubular polymer layer and an outer tubular polymer layer of a limb connected to the locking member / controller, or nested within a layer of the implant. If desired, the sensor or electrode may be formed above the surface of the implant locking member / limb and sheath 450, with or without a bridge provided, and then covered with an additional layer of heat-shrinkable polymer tubing. If desired, the outer layer of the tubing may include a window formed therein for exposing the sensor or electrode.

[0117] In some embodiments, the pacing system may further include at least one lumen along the length of the outer sheath for receiving a pacing lead, wherein the pacing system may be slid along the pacing lead into the coronary sinus. The at least one lumen may be configured to direct the pacing lead toward the cardiac pacing controller. In some embodiments, the system may include a protective bridge for spanning the LCx artery when in the coronary sinus near the interventricular septum, as described elsewhere herein. In some embodiments, at least a portion of the cardiac pacing controller may be disposed within the outer sheath.

[0118] The pacing system may further include a battery disposed within the components of the locking member, within the limb, or within the outer sheath 450. The pacing system may further include a circuit board, which is, for example, at least partially disposed within the outer sheath 450 or within the locking member body. The pacing system may further include a communication circuit at least partially disposed within the outer sheath. The communication circuit may be hardwired and / or wireless (e.g., via Bluetooth communication).

[0119] If desired, the pacing system may also include at least one sensor circuit disposed at least partially within the outer sheath, and at least one sensor module includes at least one sensor (e.g., a sensing circuit) for sensing at least one biological parameter. For example, the at least one sensor circuit / module may include at least one pressure sensor for detecting blood pressure, or at least one of a chemical sensor, a distance sensor, a sensor having a circuit for detecting electrophysiological data, a motion sensor, and a position sensor.

[0120] In some embodiments, at least one electrical conductor may terminate at a locking member / controller. If desired, the system may also include at least one pacing lead (and / or an electrical sensor for sensing cardiac electrical signals) formed in the surface of the outer sheath. The at least one pacing lead may be configured and arranged to interface with the right atrium. If desired, another pacing lead may be configured and arranged to interface with the right ventricle, or a cardiac vein (e.g., the septal vein), and be located, for example Figure 18B in the region represented by circles spaced apart from each other along the CS limb and / or the RVOT limb or 18C along the saddle. Similarly, Figure 19B a schematic arrangement of sensors and electrodes along the RVOT and CS limbs and along the saddle is shown. In both embodiments, the triangular region defined by the saddle and the CS and RVOT limbs may be used to locate a housing including a battery, a controller, and / or communication circuitry. The loop of the implant may include a conductive member along its length, which may form a loop antenna for remote charging and / or communicating with an external controller. If desired, the controller may be configured and arranged to provide at least one of pacing, defibrillation, measurement, and control.

[0121] Thus, in some embodiments of the pacing system, the inner elongate tether may include a loop antenna for conducting signals to and from the controller. In further embodiments, the pacing system (or other system) may also include a reservoir for containing a beneficial agent, which is connected to a dispenser controlled by the controller. For example, the beneficial agent may include a drug, gene therapy material, and / or live cells for seeding at least one location of the damaged heart.

[0122] The intrinsic electrical activity of the heart (i.e., the P wave or QRS complex) transmits a small current (a few millivolts) to the pulse generator via the pacemaker lead. This current may be recorded or detected by the pacemaker circuitry. Pacemaker sensing can be used to formulate the pacemaker's response to intrinsic heartbeats. The P wave or atrial activity is transmitted to the atrial channel of the pacemaker via the atrial lead (if present) and is sensed as atrial activity. Ventricular activity (QRS complex) can be transmitted to the ventricular channel of the pacemaker via the ventricular lead (if present, e.g., via the septal vein), and this is sensed as ventricular activity.

[0123] For the electrical activity to be transmitted from the heart to the pacemaker, a closed circuit must exist, just as for the electrical pulses transmitted from the pacemaker to the heart. Thus, like pacing, sensing can be unipolar or bipolar. Bipolar sensing detects the intrinsic electrical activity that occurs between the tip electrode and the ring electrode of the lead. Unipolar sensing detects the electrical activity that occurs between the tip of the lead and the metal housing of the pulse generator. Since this is a much larger area, it is more likely to detect other electrical signals, such as those that may be generated by the muscles of the diaphragm or an external source (and thus be misinterpreted by the pacemaker as a heartbeat). It is important to note that the only way for the pacemaker to determine which chamber the signal originated from is through which wire transmitted the signal to the pacemaker. For example, the pacemaker can interpret any electrical signal transmitted through the atrial lead to the atrial channel as a P wave, even if the signal is actually a QRS complex with an amplitude large enough to be sensed by the atrial channel. It is also noted that the time at which the pacemaker detects an atrial or ventricular signal is not necessarily the start of the P wave or QRS. The pacemaker cannot sense the activity in the chamber until the electrical activity actually reaches the pacemaker lead.

[0124] The present disclosure also provides embodiments of a cardiac implant that includes at least one valve leaflet disposed thereon. For purposes of illustration and not limitation, Figures 20A - 20E Aspects of a leaflet structure that can be coupled to the device according to the present disclosure are shown. Figures 21A - 21B Shown is Figures 20A - 20E an arrangement of an embodiment of. As shown, the leaflet 2900 is preferably configured to help reduce the effects of tricuspid regurgitation by occupying the space between the septal tricuspid leaflet and the anterior leaflet, where the RVOT limb of the implant is located at the junction between the leaflets. It will be understood that more than one sail or leaflet can be provided as needed.

[0125] As shown, the RVOT limb of the locking assembly of the disclosed mitral annuloplasty implant can be provided with one or more deployable leaflets 2900 to supplement or at least partially replace one or more native leaflets of the tricuspid valve. The leaflet 2900 can have a generally sail-like shape that includes a membrane or fabric attached to the RVOT limb of the mitral annuloplasty implant at one or more points and also includes a deployable frame. Figure 20A Shown is such a leaflet or sail connected to the RVOT limb of the mitral annuloplasty implant. As shown, the leaflet has a longitudinal edge connected to the RVOT limb. For example, the membrane or fabric can form a tubular sleeve along one edge to accommodate the RVOT limb passing therethrough. The leaflet or sail also includes at least one free edge that is capable of extending outwardly from the RVOT limb into the blood flow path in the tricuspid valve region. As Figures 20D - 20EAs shown, one or more deployable structural elements or ribs may be integrated with the RVOT limb, for example, by connecting to the RVOT limb with a heat shrink band or other connector. Figure 20D Two curved flat rings of shape memory material (e.g., NiTi alloy) are shown. The distal end of the distal rib is connected near the bumper at the distal end of the RVOT limb, and the proximal end of the proximal rib is connected to the proximal end or region of the RVOT limb. The sail or leaflets are preferably sutured to the structural ribs to assist in the deployment of the leaflets when the leaflets become unconstrained. The sail or leaflets preferably comprise an inert fabric such as ePTFE, polyester, or other suitable fabric.

[0126] During delivery, the leaflets may be held in a constrained position wrapped around the RVOT limb and held in place with a tie such as a suture (not shown) that allows the leaflets to deploy upon release of the tie, e.g., by a slipknot or other suitable means, during delivery. Optionally, the sail may be folded with respect to the RVOT limb with the CS limb and / or the RVOT limb may be wrapped with the CS limb and withdrawn proximally into the tubular distal end of the delivery catheter, and the sail or leaflets may self-deploy in situ upon sheath withdrawal. Figures 21A - 21B is a schematic view showing the in situ placement of the sail or leaflets 2900 in the RVOT near the tricuspid valve.

[0127] The devices and methods disclosed herein may be used for other processes under the same conditions or may be modified as needed to suit a particular process. Given the many possible embodiments to which the principles of this disclosure may be applied, it should be recognized that the illustrated embodiments are only preferred embodiments of this disclosure and should not be considered a limitation on the scope of this disclosure. Each patent and patent application cited herein is hereby expressly incorporated by reference in its entirety for any purpose.

Claims

1. An implant, comprising: a) an elongate tether formed as a loop; b) an implant lock that slides on the elongate tether and engages the elongate tether to maintain tension in the elongate tether, wherein the implant lock defines at least one distal opening therein, and the at least one distal opening is connected to two distally extending tubular limbs disposed around the elongate tether; Wherein: a first tubular limb of the tubular limbs is configured to traverse the coronary sinus and is configured to allow the elongate tether to pass therethrough; a second tubular limb of the tubular limbs is configured to traverse the tricuspid valve and is configured to allow the elongate tether to pass therethrough; and when the first tubular limb and the second tubular limb leave the lock in a first direction, the first tubular limb and the second tubular limb are parallel to each other, the first tubular limb bends away from the first direction, and the second tubular limb continues to extend in the first direction away from the bifurcation point with the first tubular limb, and then the second tubular limb bends along a path parallel to the first tubular limb such that the two tubular limbs point in the same direction substantially orthogonal to the first direction, wherein the implant further includes a saddle connecting the tubular limbs near the bifurcation point, and the saddle is configured to distribute stress on the heart tissue when the implant is under tension.

2. The implant according to claim 1, wherein, The saddle is connected to the tubular limbs at least in part by suture winding.

3. The implant according to claim 1, wherein, The saddle is connected to the tubular limbs at least in part by a shrink tube.

4. The implant according to claim 1, wherein, The saddle is connected to the tubular limbs at least in part by at least partially melted material of the tubular limbs.

5. The implant according to claim 1, further comprising: a deployable leaflet coupled to the second tubular limb, the deployable leaflet including at least one deployable structural rib having a first end coupled to the limb and a second free end, the at least one deployable structural rib being coupled to a membrane, and the leaflet being configured to self-deploy into the RVOT upon installation and engage against at least one tricuspid valve leaflet.

6. The implant according to claim 5, wherein, The deployable leaflet includes: a first deployable structural rib coupled to a distal region of the at least one distally extending tubular limb and extending from the distal region of the at least one distally extending tubular limb; and a second deployable structural rib coupled to a proximal region of the at least one distally extending tubular limb and extending from the proximal region of the at least one distally extending tubular limb.

7. The implant according to claim 1, comprising: a spacer coupled to the lock and extending from the implant, the spacer being configured to be disposed between the leaflets of a heart valve to allow the leaflets of the heart valve to engage against the spacer.

8. The implant according to claim 7, wherein, The spacer includes an inflatable member or a self-expanding volume that expands to a predetermined size to occupy a portion of the patient's native tricuspid annulus.

9. The implant according to claim 7, wherein, The spacer includes a plurality of self-expanding filaments having a first end and a second end at a proximal collection portion and a distal collection portion, and radially expanding outward from a compressed configuration to occupy a volume in the right ventricular outflow tract.

10. The implant according to claim 7, wherein, The spacer includes an elongate expandable member configured to occupy a portion of the patient's RVOT in the patient's tricuspid region.

11. The implant according to claim 10, wherein, The expandable member includes a core member coupled to a first end and a second end of the expandable member.

12. The implant according to claim 7, wherein, The spacer is coupled to the implant via a spacer tether.

13. The implant according to claim 12, wherein, The spacer tether is coupled to the implant via a spacer lock coupled to a lock of the implant.

14. The implant according to claim 7, wherein, The spacer includes a membrane around its outer periphery.

15. An implantable pacing system configured and arranged to loop around the heart, comprising: a) an implant according to any one of claims 1 to 14; b) at least one electrical conductor; d) a cardiac pacing controller including a power source, a pulse generator, and control circuitry operably coupled to the at least one electrical conductor; and e) at least one cardiac pacing electrode configured and arranged to be implanted in cardiac tissue, the at least one cardiac pacing electrode being electrically coupled to the cardiac pacing controller via the at least one electrical conductor.

16. The pacing system according to claim 15, wherein, The lock is coupled to the cardiac pacing controller.

17. The pacing system according to claim 15, wherein, The elongate tether includes an elongate inner tether and outer sheath material, and the at least one electrical conductor is at least partially disposed within the elongate inner tether or the outer sheath material.

18. The pacing system according to claim 15, wherein, The lock includes a cardiac pacing lead passing therethrough along a path.

19. The pacing system according to claim 18, wherein, Electrical communication with the cardiac pacing lead is established by engaging a portion of the lock.

20. The pacing system according to claim 15, wherein, The electrodes are placed along one or more of the tubular limbs of the implant or the saddle portion of the implant.

21. The pacing system according to claim 15, wherein, The system includes a protection bridge for spanning the LCx artery when in the coronary sinus near the interventricular septum.

22. The pacing system of claim 15, further comprising at least one sensor module at least partially disposed within the outer sheath, the at least one sensor module including at least one sensor for sensing at least one biological parameter.

23. The pacing system according to claim 22, wherein, The at least one sensor module includes at least one pressure sensor for detecting blood pressure.

24. The pacing system according to claim 22, wherein, The at least one sensor module includes at least one of the following: a chemical sensor, a distance sensor, a sensor having circuitry for detecting electrophysiological data, a motion sensor, and a position sensor.

25. The pacing system of claim 15, further comprising at least one pacing lead.

26. The pacing system according to claim 25, wherein, The at least one pacing lead is configured and arranged to interface with the right atrium.

27. The pacing system according to claim 25, wherein, The at least one pacing lead is configured and arranged to interface with the right ventricle.

28. The pacing system according to claim 25, wherein, The at least one pacing lead is configured and arranged to interface with a cardiac vein.

29. The pacing system according to claim 25, wherein, The at least one pacing lead is configured and arranged to interface with tissue near the septal vein.

30. The pacing system according to claim 15, wherein, The controller is configured and arranged to provide at least one of pacing, defibrillation, measurement, and control.

31. The pacing system according to claim 15, wherein, The elongate tether includes an elongate inner tether including a loop antenna for conducting signals to and from the controller.

32. The pacing system according to claim 15, wherein, A reservoir for containing a beneficial agent is also included, coupled to a dispenser controlled by the controller.

33. The pacing system according to claim 32, wherein, The beneficial agent includes a drug.

34. The pacing system according to claim 32, wherein, The beneficial agent includes gene therapy material.

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