Percutaneous tricuspid valve repair devices and methods

Abstract

The first ventricular surface anchor can be positioned against the first right ventricular surface, the first ventricular surface anchor connected to a first tension member. The first tension anchor against the tension anchor surface of the heart, the first tension anchor connected to a second tension member. The first tension member connected to the first ventricular surface anchor can extend toward the second tension member connected to the first tension anchor, and the first tension member and the second tension member can draw the first right ventricular surface to the first tension anchor. The surface anchor can include a nitinol frame and holes forming an outer periphery. The nitinol frame can have an austenitic state that is in a deployed configuration when the temperature of the nitinol frame is body temperature. The surface anchor can also include a grommet with a distal tubular portion connected to the proximal finger portion.

Description

[Technical field]

[0001] Incorporation by reference to any priority application This application claims priority to U.S. Provisional Patent Application No. 63 / 379,404, filed October 13, 2022, and U.S. Provisional Patent Application No. 63 / 336,850, filed April 29, 2022, the entireties of each of which are incorporated herein by reference for all purposes.

[0002] The present disclosure relates generally to percutaneous repair of heart valves, and in particular embodiments, to percutaneous repair of tricuspid valves. [Background technology]

[0003] Functional tricuspid regurgitation (FTR) is the result of one or several pathophysiological abnormalities of the heart, which may include tricuspid annular dilation, annular geometry, right or left ventricular dysfunction, right or left ventricular geometry, right or left heart failure, pulmonary hypertension (primary or secondary mitral regurgitation), and retained cusps. Currently, it is estimated that 1.6 million people in the United States have moderate to severe tricuspid regurgitation, and of these people, only 8,000 undergo tricuspid valve surgery annually. Historical treatment options for patients with tricuspid regurgitation have been medical management and tricuspid valve surgery. Most tricuspid valve surgeries are accompanied by left heart valve surgery, for example, mitral valve surgery. Tricuspid valve surgery is rarely performed alone, and those that are performed are associated with a high operative mortality rate (8-10%). FTR, especially moderate to severe FTR, has been shown to be a strong independent determinant of mortality and is associated with more signs and symptoms of heart failure, reduced cardiac output, and decreased renal function.Therefore, there is a clear need for less invasive techniques to treat functional tricuspid regurgitation. Summary of the Invention

[0004] Certain embodiments of the present disclosure include drawing the anterior portion of the tricuspid annulus to the posterior septal portion of the tricuspid annulus at the coronary sinus opening, thereby reducing annulus size in the region of the valve where tricuspid regurgitation is most prevalent. The force transfer vector in certain embodiments may be substantially across the valve opening and very close to the annulus plane, making the force transfer very efficient and effective for optimal reduction of the tricuspid valve diameter. Utilizing the space created by the right ventricular outflow tract (RVOT), with the anchor abutting the right ventricular surface anterior to the tricuspid annulus, can provide a large, robust area for safely placing tissue anchors, also referred to herein as surface anchors, to distribute the force over a large surface area and minimize stress in the tissue. Utilizing multiple tissue anchors, each of which may be attached to a tensioning element and may span one to three centimeters of the tricuspid annulus, or a single tissue anchor spanning such distances with two or more tensioning members individually attached, can further reduce tissue stress by distributing the applied force over a larger surface area and dividing the required tension over multiple tensioning elements. The ability to individually control the tension in each tensioning element allows the implanting user to modulate the reduction of tricuspid annulus diameter to achieve optimal leaflet coaptation and minimize any distortion of the right coronary artery (RCA). Placing one or more anchor elements across the lower atrial septum with the anchor elements abutting the left atrial wall above the mitral valve provides a very secure location for anchor fixation and force transmission that has not been previously utilized in tricuspid valve repair. The muscle tissue in this region of the atrial septum is thick and closely adherent to the left ventricular myocardium, providing a relatively immobile location through which forces can be transmitted. This location is also substantially away from the annulus anterior and near the tricuspid annular plane (so that a line drawn between the annulus anterior and the septal anchor location passes through or near or adjacent to the center of the tricuspid valve opening), resulting in an optimal force vector for reducing tricuspid annulus dimensions.

[0005] Other embodiments disclosed herein include implanting septal anchor elements substantially in or against the left ventricular myocardial tissue below the coronary sinus and / or its opening, or across the left ventricular myocardium from the coronary sinus to the left ventricular cavity, with the anchor element against the left ventricular wall. These areas have also not been previously utilized and share the same advantages as the location on the left atrial wall where the tensioning member passes through the lower atrial septum: optimal force vectoring, robust and stable tissue, relatively immobile tissue, and large surface area for anchor apposition. Additionally, embodiments disclosed herein describe methods and designs for implanting tissue anchors with large surface area. These anchor elements are unique in that they can be compressed or folded to fit a small lumen for catheter delivery, but can expand into a much larger surface area element upon exiting the catheter. Some of the anchor elements disclosed herein abut the surface of the heart tissue where the tensioning element passes through the heart tissue to another heart chamber. The result is an anchor element that distributes forces over a large surface area to minimize tissue stress and exerts such forces across the exterior of the heart chamber wall, including against the endocardial surface, which is tougher than the myocardial tissue layer, thereby minimizing the risk of tissue tearing or tissue anchor detachment.

[0006] In certain embodiments, the promotion of less invasive techniques for treating FTR may require the need to pass through the tissue of the heart from one heart chamber to another while the heart is beating in order to pass an implanted instrument or implant from one chamber to another. In certain embodiments, the first step in passing a device across the tissue may include passing a guidewire across the tissue, which may then be used as a rail for passing a catheter, instrument, or implant. This may prove difficult because the tissue of the heart is constantly moving, and the guidewire and tissue may easily deflect relative to each other when attempting to push the guidewire through the tissue, even when the guidewire is excited by radio frequency current. Conventional guiding catheters with free distal ends are unable to provide sufficient stabilization to prevent deflection of the guidewire or tissue and facilitate passage of the guidewire. Thus, there is a need for catheters and methods that can better stabilize the guidewire when crossing tissue in the heart.

[0007] Certain embodiments of the present disclosure include first attaching a stabilizing catheter to the myocardium of the heart valve annulus or tissue near (within 15 millimeters) the annulus, and secondly passing a guidewire through the inner diameter of the stabilizing catheter, through the myocardial tissue of the heart valve annulus, and into the heart chamber adjacent to the chamber adjacent to which the stabilizing catheter resides, such that the distal end of the guidewire extends from the distal end of the stabilizing catheter. The stabilizing catheter can be firmly adhered or attached to the heart tissue to guide the precise location where the guidewire first contacts and penetrates the tissue, so that the stabilizing catheter prevents the guidewire from bending, flexing or buckling under compressive forces applied to the guidewire as it is pushed through the tissue, and so that the stabilizing catheter counteracts the forces exerted by the guidewire on the tissue while it is being pushed through the tissue. These advantages prevent the guidewire from scraping the tissue, deflecting against the tissue, or pushing the tissue away from the guidewire.

[0008] In some embodiments disclosed herein, the distal end of the stabilizing catheter forms a helical coil with a sharp distal tip. The tip of the stabilizing catheter is pushed into and contacts tissue, and the stabilizing catheter is then rotated, allowing a force applied to the tip of the stabilizing catheter coil to pierce the tissue. Continued rotation of the stabilizing catheter threads and embeds the coil into the tissue. Once threaded into the tissue, the distal coil can resist forces in any direction from the tissue or apply forces in any direction against the tissue. The distal coil can be removed from the tissue by rotating the stabilizing catheter in a direction opposite to the direction used to penetrate the tissue.

[0009] In some embodiments disclosed herein, the stabilizing catheter is threaded into the right atrial side of the anterior tricuspid annulus, either partially into the annulus such that the tip of the stabilizing catheter does not exit the annulus tissue into the right ventricular space, or completely through the annulus such that the tip of the stabilizing catheter exits into the right ventricle.

[0010] Other embodiments disclosed herein include sharpening the tip and wrapping the distal end of the guidewire into a helical coil so that the guidewire can be threaded through the heart tissue by applying torque to the wire with minimal compressive force. Yet another embodiment disclosed herein includes constructing a helical thread in the distal tapered section of the dilator so that the dilator can be advanced through the heart tissue with minimal compressive force by rotating the dilator while in contact with the heart tissue.

[0011] In some embodiments, techniques described herein relate to a method of tricuspid valve repair comprising: securing a first ventricular surface anchor to a first right ventricular surface, the first ventricular surface anchor connected to a first tension member; securing the first tension anchor to a tension anchor surface of the heart, the first tension anchor connected to a second tension member; stretching the first tension member connected to the first ventricular surface anchor towards the second tension member connected to the first tension anchor; and pulling the first right ventricular surface to the first tension anchor with the first tension member and the second tension member.

[0012] In some embodiments, the techniques described herein relate to methods that further include securing a second tension anchor to another tension anchor surface of the heart, the second tension anchor being connected to a third tension member, the third tension member being connected to the first tension member and the second tension member via a tension member lock.

[0013] In some embodiments, the techniques described herein relate to methods in which a tension anchor surface opposes the left atrial surface of the interatrial septum inferior to the fossa ovalis.

[0014] In some embodiments, the techniques described herein relate to methods in which a tension anchor surface opposes the left atrial surface of the interatrial septum inferior and posterior to the fossa ovalis.

[0015] In some embodiments, the techniques described herein relate to methods in which the tension anchor surface is on the right ventricular surface of the interventricular septum.

[0016] In some embodiments, the techniques described herein relate to methods in which the tension anchor surface is on the left ventricular surface of the interventricular septum.

[0017] In some embodiments, the techniques described herein relate to methods in which the tension anchor surface is in the coronary sinus close to the right atrium.

[0018] In some embodiments, the techniques described herein relate to a method further comprising: securing a second ventricular surface anchor to a right ventricular surface near the anterior of the tricuspid annulus, the second ventricular surface anchor being connected to a third tension member, and a center of the first ventricular surface anchor being spaced 0.5 to 4 centimeters from a center of the second ventricular surface anchor; stretching a first tension member connected to the first ventricular surface anchor and a second tension member connected to the second ventricular surface anchor toward the first tension anchor; and pulling the first right ventricular surface and the right ventricular surface near the anterior of the tricuspid annulus to the first tension anchor with the first tension member, the second tension member, and the third tension member.

[0019] In some embodiments, the techniques described herein include securing a third ventricular surface anchor to a right ventricular surface near the posterior of the tricuspid annulus, the third ventricular surface anchor being connected to a fourth tension member, the center of the third ventricular surface anchor being spaced 0.5-4 centimeters from the center of the second ventricular surface anchor, and the center of the third ventricular surface anchor being spaced 0.5-4 centimeters from the center of the first ventricular surface anchor; and securing the third ventricular surface anchor to the first tension member. and pulling the first right ventricular surface, the right ventricular surface near the anterior of the tricuspid annulus, and the right ventricular surface near the posterior of the tricuspid annulus toward the first tension anchor with the first tension member, the second tension member, the third tension member, and the fourth tension member.

[0020] In some embodiments, the techniques described herein relate to methods where the first right ventricular surface is near the anterior of the tricuspid annulus.

[0021] In some embodiments, the techniques described herein relate to methods where the first right ventricular surface is within the right ventricular outflow tract.

[0022] In some embodiments, the techniques described herein relate to methods where the first right ventricular surface is within the pulmonary artery proximal to the pulmonary valve.

[0023] In some embodiments, the techniques described herein further include securing a second tension anchor to a second tension anchor surface of the heart with a third tension member, the third tension member connecting the second tension anchor to the first tension anchor.

[0024] In some embodiments, the techniques described herein further include securing a third tension anchor to a third tension anchor surface of the heart with a fourth tension member, the fourth tension member connecting the third tension anchor to the first tension anchor.

[0025] In some embodiments, the techniques described herein further include securing a fourth tension anchor to a fourth tension anchor surface of the heart with a fifth tension member, the fifth tension member connecting the fourth tension anchor to the first tension anchor.

[0026] In some embodiments, the techniques described herein relate to methods where drawing the first right ventricular surface to the first tension anchor further includes advancing a tension lock over the first tension member and the second tension member to a location proximal to the first tension anchor to draw the first right ventricular surface to the first tension anchor, locking the tension lock to maintain tension on the first tension member and the second tension member, and trimming excess material of the first tension member and the second tension member.

[0027] In some embodiments, the techniques described herein relate to methods in which locking the tension lock includes adjusting the tension lock from a first configuration that may allow the tension member to move freely relative to the tension lock, to a second configuration that prevents the tension member from moving freely relative to the tension lock.

[0028] In some embodiments, the techniques described herein relate to methods that further include advancing a grommet over a first tensioning member that is connected to the first ventricular surface anchor, such that the grommet is positioned against an atrial surface of the heart opposite the ventricular surface anchor that is attached to the first tensioning member.

[0029] In some embodiments, the techniques described herein further include advancing a grommet over a second tension member connected to the first tension anchor, wherein the grommet is positioned against a tissue surface opposite the first tension anchor, which is attached to the second tension member.

[0030] In some embodiments, the techniques described herein relate to methods in which the first tensioning member and the second tensioning member are parts of a single tensioning element.

[0031] In some embodiments, the techniques described herein include a method of tricuspid annulus repair comprising: securing a first ventricular surface anchor near an anterior portion of the tricuspid annulus, the first ventricular surface anchor being connected to a first tension member; securing a second ventricular surface anchor near a posterior portion of the tricuspid annulus near the right ventricular surface, the second ventricular surface anchor being connected to a second tension member; and securing the first tension anchor to a left atrial surface of the atrial septum, the second ventricular surface anchor being connected to a second tension member. the first tension anchor is connected to a third tension member; extending a first tension member connected to the first ventricular surface anchor and a second tension member connected to the second ventricular surface anchor toward the third tension member connected to the first tension anchor; and drawing an anterior portion of the tricuspid annulus and a posterior portion of the tricuspid annulus to the first tension anchor using the first tension member, the second tension member, and the third tension member.

[0032] In some embodiments, the techniques described herein relate to methods in which a second ventricular surface anchor is positioned below the fossa ovalis.

[0033] In some embodiments, the techniques described herein relate to methods that further include trimming excess material from the first tension member, the second tension member, and the third tension member.

[0034] In some embodiments, the techniques described herein relate to methods further comprising drawing the right ventricular surface to the first tension anchor, wherein drawing the right ventricular surface to the first tension anchor further comprises advancing a tension lock over the first tension member, the second tension member, and the third tension member to a location proximal to the first tension anchor to draw the first ventricular surface anchor and the second ventricular surface anchor to the first tension anchor, locking the tension lock to maintain tension on the first tension member, the second tension member, and the third tension member, and trimming excess material from the first tension member, the second tension member, and the third tension member.

[0035] In some embodiments, the techniques described herein relate to a tricuspid valve repair system comprising two or more surface anchor systems, each surface anchor system comprising a nitinol wire frame defined at its periphery by nitinol wire, comprising a surface anchor comprising a nitinol wire internal feature within an area defined by the periphery formed by the nitinol wire frame, the nitinol wire frame comprising an austenitic state in a deployed configuration when the temperature of the nitinol wire frame is body temperature, a tether assembly connecting the two or more surface anchor systems at tether connection points, and a tether lock.

[0036] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which two or more surface anchor systems and tether locks are positioned along a tether assembly.

[0037] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which the surface anchors can rotate laterally relative to the tether assembly.

[0038] In some embodiments, the techniques described herein relate to a tricuspid valve repair system, further comprising a grommet and a grommet lock.

[0039] In some embodiments, the techniques described herein relate to a tricuspid valve repair system, wherein the grommet is a flat grommet comprising an expandable nitinol frame, the flat grommet being placed onto the tether assembly through holes in the flat grommet, and the expandable nitinol frame of the grommet comprises an austenitic state in a deployed configuration when the temperature of the expandable nitinol frame is at the temperature of the human body.

[0040] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which the flat grommet further comprises a covering material that provides a flat surface for the expandable nitinol frame.

[0041] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which the grommet is a T-bar grommet comprising a single rigid member having a length along its major axis that is greater than its width along its minor axis, the width of the T-bar grommet is configured to accommodate the T-bar grommet within an inner diameter of a delivery catheter, the T-bar grommet is placed onto a tether assembly through a hole at or near the center of the T-bar grommet, the T-bar grommet can be pivoted about the tether assembly for insertion into a delivery catheter for deployment such that the major axis of the T-bar grommet is approximately parallel to the axis of the tether assembly, and after deployment from the delivery catheter, the T-bar grommet can be pivoted about the tether assembly such that the major axis of the T-bar grommet is tilted relative to the axis of the tether assembly.

[0042] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which the grommets are self-expanding grommets that can expand after deployment to interact with a grommet lock.

[0043] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which the grommet lock includes a tether hole extending through a distal surface of the grommet lock, a plurality of grommet lock spring arms connected to the distal surface of the grommet lock, a plurality of grommet lock alignment walls, and a grommet lock tether contact surface, wherein the grommet lock contacts the tether assembly by the tether hole and the grommet lock tether contact surface, and applying a force to the distal surface of the grommet lock toward the proximal end engages the plurality of grommet lock spring arms by deflecting the plurality of grommet lock spring arms at the grommet lock deflection node, thereby generating a clamping force at the grommet lock tether contact surface and preventing the grommet from moving outwardly from the surface anchor along the tether assembly, and wherein the grommet and grommet lock are also disposed along the tether assembly.

[0044] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which the grommet lock includes a first unlocked state that is slidable along the tether assembly and a second locked state that is not slidable along the tether assembly, the second locked state preventing distal translation of the grommet along the tether assembly.

[0045] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which the grommet lock is a knot formed at a tether connection point, where the tether assembly is passed through the grommet before reconnecting the tether assembly at the tether connection point so that the knot is proximal to the grommet, and where the knot is slidable distally by pushing the knot with a pushing catheter, where the knot prevents the grommet from sliding proximally along the tether assembly, whereby the knot prevents separation of the grommet and the surface anchor.

[0046] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which a tether assembly is connected to a surface anchor by encircling an internal feature of a nitinol frame to form a tether loop before reconnecting the tether assembly at the tether attachment point.

[0047] In some aspects, the techniques described herein relate to tricuspid valve repair systems in which the surface anchors are covered by a surface anchor sheath.

[0048] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which the Nitinol wire frame of the surface anchors is formed by laser cutting a Nitinol sheet or strip.

[0049] In some embodiments, the techniques described herein relate to tricuspid valve repair systems in which a surface anchor can be mechanically compressed into a first, non-deployed state to a size and dimensions that fit into a catheter having an inner diameter smaller than the width of the surface anchor in the second, deployed state of the surface anchor.

[0050] In some embodiments, the techniques described herein relate to tricuspid valve repair systems in which the surface anchors are substantially flat, such that the surface anchor length and surface anchor width are at least 5 times the surface anchor thickness.

[0051] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which a surface anchor transitions from its first, undeployed state to its second, deployed state upon release from a surface anchor delivery catheter.

[0052] In some embodiments, the techniques described herein relate to a tricuspid valve repair system comprising an anchor system, the anchor system comprising a nitinol frame forming a circumferential edge and a surface anchor comprising holes, the nitinol frame comprising an austenitic state in a deployed configuration when the temperature of the nitinol frame is at body temperature, a grommet comprising a distal tubular portion connected to a proximal finger portion, the proximal finger portion being comprised of a plurality of flexible beams extending radially from the distal tubular portion, a tether for connecting the anchor system, and a surface anchor hub, the anchor system, the grommet, and the surface anchor hub being disposed along the tether.

[0053] In some aspects, the techniques described herein relate to a tricuspid valve repair system in which a distal tubular portion of a grommet includes a central flexible beam that is directed radially inward toward the inner surface of the grommet tube.

[0054] In some aspects, the techniques described herein relate to tricuspid valve repair systems in which the grommet comprises nitinol having an austenitic state that is in a deployed configuration when the temperature of the grommet is approximately the temperature of the human body.

[0055] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which a surface anchor hub includes a distal flange having an outer diameter larger than the inner diameter of the hole in the surface anchor, a midshaft having an outer cross-sectional dimension smaller than the inner diameter of the hole in the surface anchor, a proximal nose having an outer diameter smaller than the inner diameter of the hole in the surface anchor and smaller than the inner diameter of the grommet and larger than the outer cross-sectional dimension of the midshaft, and a hole through the center of the distal flange, the inner diameter of the hole through the center being larger than the outer diameter of the tether.

[0056] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which a central flexible beam within the distal tubular portion of the grommet is positioned over the mid-shaft of the surface anchor hub, such that when the central flexible beam of the distal tubular portion of the grommet contacts the proximal nose, the grommet is positionable from a first position in which the grommet is not attached to the surface anchor hub to a second position in which the grommet is attached to the surface anchor hub, thereby limiting proximal translation of the grommet relative to the surface anchor hub.

[0057] In some aspects, the techniques described herein relate to a tricuspid valve repair system in which multiple flexible beams of the proximal fingers of the grommet can be mechanically deflected proximally and radially inward for insertion into a catheter having an inner diameter smaller than the location of the proximal fingers of the grommet in the deployed configuration.

[0058] In some aspects, the techniques described herein relate to a tricuspid valve repair system in which deployment of a grommet allows the proximal fingers of the grommet to transition from their undeployed configuration to their deployed configuration.

[0059] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which the distal end of the tether is larger than the inner diameter of the hole passing through the surface anchor hub, such that the tether cannot be pulled proximally through the surface anchor hub.

[0060] In some embodiments, the techniques described herein relate to a tricuspid valve repair system in which the surface anchors and grommets can rotate laterally relative to the tether.

[0061] In some embodiments, the techniques described herein relate to tricuspid valve repair systems in which a surface anchor can be mechanically compressed into a first, non-deployed state to a size and dimensions that fit into a catheter having an inner diameter smaller than the width of the surface anchor in the second, deployed state of the surface anchor.

[0062] In some embodiments, the techniques described herein include a method of implanting a tricuspid valve repair system to repair a heart, the tricuspid valve repair system including a tether and two or more surface anchor systems, each surface anchor system including a surface anchor, a grommet, and a grommet lock, the method including advancing the tricuspid valve repair system toward the heart, positioning a distal end of a catheter containing the surface anchor systems adjacent to an implantation surface of the heart, penetrating the implantation surface of the heart with the catheter, and removing the tricuspid valve repair system from the catheter using a pushing catheter positioned within the catheter. and partially retracting the catheter such that the catheter no longer penetrates the implantation surface of the heart; pushing a grommet and a grommet lock of the tricuspid valve repair system out of the catheter with a pushing catheter, allowing the grommet to transition from the undeployed configuration to the deployed configuration; and advancing the grommet lock distally a desired distance along the tether of the tricuspid valve repair system such that the distance between the surface anchor and the grommet is substantially occupied by a thickness of the implantation surface of the heart.

[0063] In some aspects, the techniques described herein relate to methods in which allowing the surface anchors to transition from a non-deployed configuration to a deployed configuration includes allowing the surface anchors to transition to an austenitic state configured to be in the deployed configuration.

[0064] In some aspects, techniques described herein relate to methods, where allowing the grommet to transition from a non-deployed configuration to a deployed configuration includes allowing the grommet to transition to an austenitic state in which it is configured to be in the deployed configuration.

[0065] In some aspects, the techniques described herein relate to methods that further include resecting excess tether from the tricuspid valve repair system.

[0066] In some embodiments, techniques described herein include a method of implanting a tricuspid valve repair system to repair a heart, the tricuspid valve repair system including a tether and two or more surface anchor systems, each surface anchor system including a surface anchor, a lockable grommet, and a surface anchor hub, the method including positioning a catheter adjacent to an implantation surface of the heart, penetrating the implantation surface of the heart with the catheter, pushing the surface anchors and the surface anchor hubs of the tricuspid valve repair system out of the catheter with a pushing catheter located within the catheter, allowing the surface anchors to transition from a non-deployed configuration to a deployed configuration, and inserting the catheter into the implantation surface of the heart. partially retracting the catheter so that it no longer penetrates the implantation surface; pushing a lockable grommet of the tricuspid valve repair system from the catheter with a pushing catheter; allowing the lockable grommet to transition from a non-deployed configuration to a deployed configuration; and advancing the lockable grommet distally a desired distance along a tether of the tricuspid valve repair system and beyond the surface anchor hub such that the distance between the surface anchor and the lockable grommet is substantially occupied by a thickness of the implantation surface of the heart and the lockable grommet interacts with the surface anchor hub such that the lockable grommet is locked against proximal translation relative to the surface anchor hub.

[0067] In some aspects, the techniques described herein relate to methods in which allowing the surface anchors to transition from a non-deployed configuration to a deployed configuration includes allowing the surface anchors to transition to an austenitic state configured to be in the deployed configuration.

[0068] In some aspects, techniques described herein relate to methods where allowing a lockable grommet to transition from a non-deployed configuration to a deployed configuration includes allowing the lockable grommet to transition to an austenitic state configured to be in the deployed configuration.

[0069] In some embodiments, the techniques described herein include a foldable flat implant system for tricuspid valve repair configured to attach to a septal surface anchor, the system comprising a flexible anterior bar anchor non-fixably attached to a delivery catheter, at least one guidewire having a distal tip, the at least one guidewire passing through a hole in the flexible anterior bar anchor at a rotatable guidewire connection, and a front bar tether including at least one tether snare configured to pass through a lumen of a snare catheter, the at least one guidewire the at least one guidewire is attached to the tether at a proximal end thereof, and by pulling the at least one guidewire through the flexible anterior bar anchor by using the at least one tether snare, a tether attached to the proximal end of the at least one guidewire is pulled through a hole in the flexible anterior bar anchor, and the anterior bar tether connects the septal surface anchor with the flexible anterior bar anchor.

[0070] In some embodiments, the techniques described herein include a method for implanting a tricuspid valve repair system to repair a patient's heart, comprising: advancing into the patient a tricuspid valve repair system including a septal surface anchor attached to a septal surface anchor tether, a flexible anterior bar anchor, at least one guidewire connected at its proximal end to the anterior anchor tether with a plug end, and a foldable flat implant system having at least one tether snare within a steerable anterior anchor delivery catheter; placing the septal surface anchor in the left atrium of the heart via the guidewire and the septal surface anchor delivery catheter; inserting the steerable anterior anchor delivery catheter attached to the flexible anterior bar anchor in a non-deployed configuration into the guiding catheter and advancing the flexible anterior bar anchor to a distal end of the guiding catheter; orienting the guiding catheter over the tricuspid valve of the heart; extending the steerable anterior anchor delivery catheter to deliver the tricuspid valve repair system to the patient; and deploying the flexible front bar anchor into a deployed configuration; positioning the flexible front bar anchor adjacent to the anterior anchor implantation region with a distal end of at least one guidewire; penetrating the anterior anchor implantation region to an opposite side of the anterior anchor implantation region with the distal end of the at least one guidewire; connecting at least one tether snare to a proximal end of the at least one guidewire; advancing the at least one guidewire through the anterior anchor implantation region and the flexible front bar anchor such that the proximal end of the at least one guidewire passes through the flexible front bar anchor and a plug end of the anterior anchor tether further from the anterior anchor implantation region contacts a distal surface of the flexible front bar anchor; detaching the flexible front bar anchor from the steerable front anchor delivery catheter; and removing the steerable front anchor delivery catheter from the patient.

[0071] In some embodiments, the techniques described herein relate to methods further comprising positioning a steerable anterior anchor delivery catheter at a secondary location near the anterior anchor implantation region such that the tether passed through the secondary location can still functionally interact with the flexible anterior bar anchor; penetrating the secondary location with a distal end of a second guidewire to an opposite side of the secondary location, the second guidewire being connected at its proximal end with a plug end to a second anterior anchor tether; connecting a second tether snare to the proximal end of the second guidewire; and advancing the second guidewire through the secondary location and the flexible anterior bar anchor such that the proximal end of the second guidewire passes through the flexible anterior bar anchor and the plug end of the second anterior anchor tether contacts a distal surface of the flexible anterior bar anchor further from the anterior anchor implantation region.

[0072] In some embodiments, the techniques described herein relate to methods further including passing a tether lock through the locking catheter and past the anterior anchor tether and the septal surface anchor tether, applying tension to the anterior anchor tether within the right atrium to pull the tricuspid annulus along the right ventricular wall toward the atrial septum and / or coronary sinus, locking the tether lock to maintain tension on the anterior anchor tether and the septal surface anchor tether, cutting excess tether from the anterior anchor tether and the septal surface anchor tether, and removing all catheters from the patient.

[0073] In some embodiments, the techniques described herein relate to methods in which the anterior anchor implantation region is on the right ventricular surface near the anterior tricuspid annulus, and the flexible anterior bar anchor spans 1-4 centimeters of the surface near the anterior tricuspid annulus.

[0074] In some embodiments, the techniques described herein relate to methods in which a flexible anterior bar anchor includes an elongated nitinol frame having rigid eyelets attached near each end, a cover, and an anchor bar delivery connection near the center of the elongated nitinol frame.

[0075] In some embodiments, the techniques described herein relate to methods whereby the covering may be tapered from near the center of the elongated nitinol frame to the ends of the elongated nitinol frame.

[0076] In some embodiments, the techniques described herein relate to methods in which the tricuspid valve repair system includes two guidewires and two snare tethers.

[0077] In some embodiments, the techniques described herein relate to a guidewire delivery system including a flexible guide catheter having a guide catheter lumen, a stabilizing catheter having a distal tip, a stabilizing catheter lumen, and a flexible region, the stabilizing catheter being dimensioned to enable passage of the stabilizing catheter through the guide catheter lumen, and a spiral tip located at the distal tip of the stabilizing catheter and a guidewire being dimensioned to enable passage through the stabilizing catheter lumen.

[0078] In some aspects, the techniques described herein relate to a guidewire delivery system in which the helical tip is a laser-cut helix having a generally trapezoidal cross-section.

[0079] In some aspects, the techniques described herein relate to a guidewire delivery system in which the helical tip is a wound wire helix having a circular cross-section.

[0080] In some embodiments, the techniques described herein relate to a guidewire delivery system in which the helical tip is a two turn helix.

[0081] In some aspects, the techniques described herein relate to a guidewire delivery system in which the helical tip is a tapered wound helix, and the radius of curvature of the distal-most end of the helical tip is greater than the radius of curvature of the proximal-most end of the tapered wound helix.

[0082] In some aspects, the techniques described herein relate to a guidewire delivery system in which the helical tip is a tapered wound helix, and the radius of curvature of the distal-most end of the helical tip is smaller than the radius of curvature of the proximal-most end of the tapered wound helix.

[0083] In some embodiments, techniques described herein relate to a method for passing a guidewire over a surface of the heart, the method comprising: advancing a guidewire delivery system toward the heart, the guidewire delivery system including a flexible guide catheter having a guide catheter lumen, a stabilizing catheter having a distal end, a stabilizing catheter lumen, and a flexible region, the stabilizing catheter configured to pass through the guide catheter lumen, a helical tip located at a distal end of the stabilizing catheter, and a guidewire configured to pass through the stabilizing catheter lumen; positioning the flexible guide catheter within the right atrium of the heart at the surface of the heart; advancing the stabilizing catheter through the flexible guide catheter, positioning the helical tip at the distal end of the stabilizing catheter against the surface of the heart, rotating the helical tip such that the helical tip engages the surface of the heart, and advancing the guidewire through the stabilizing catheter and the surface of the heart.

[0084] In some aspects, the techniques described herein relate to methods in which the surface of the heart through which the guidewire is passed is near the anterior tricuspid annulus.

[0085] In some aspects, the techniques described herein relate to methods in which the surface of the heart through which the guidewire is passed is such that the guidewire passes from the right atrium into the right ventricular outflow tract of the heart.

[0086] In some aspects, the techniques described herein relate to methods that further include further rotating the helical tip while the stabilizing catheter is advanced toward the surface of the heart such that the distal end of the stabilizing catheter can completely clear the surface of the heart.

[0087] In some embodiments, techniques described herein include a method of tricuspid valve repair comprising advancing a guidewire delivery system toward the heart, the guidewire delivery system including a flexible guide catheter having a guide catheter lumen, a stabilizing catheter having a distal tip located at a distal end of the stabilizing catheter, a stabilizing catheter lumen, and a flexible region, the stabilizing catheter configured to pass through the guide catheter lumen, and a helical tip located at a distal tip of the stabilizing catheter and a guidewire configured to pass through the stabilizing catheter lumen; and preparing at least three surface anchors for deployment, the at least three surface anchors including a nitinol wire frame covered by a surface anchor exterior and defined at a periphery by the nitinol wire, and a nitinol wire internal feature within a region defined by the periphery formed by the nitinol wire frame, the nitinol wire frame being configured to extend beyond the nitinol wire frame. The method includes preparing an austenitic state in a deployed configuration when the temperature of the frame is body temperature; positioning a flexible guide catheter within the right atrium of the heart near the anterior tricuspid annulus; advancing a stabilizing catheter through the flexible guide catheter; positioning a helical tip on a distal end of the stabilizing catheter against a right atrial surface of the heart near the anterior tricuspid annulus; rotating the helical tip such that the helical tip engages the right atrial surface of the heart near the anterior tricuspid annulus; and interfacing the stabilizing catheter and the right ventricle between the right atrium and the right ventricle. advancing a guidewire through a surface of the heart, advancing an anchor delivery catheter over the guidewire from the right atrium to the right ventricle, retracting the guidewire through the anchor delivery catheter, securing a first anchor connected to the first tether through the anchor delivery catheter against the right ventricular surface near the anterior of the tricuspid valve annulus, retracting the anchor delivery catheter through the flexible guide catheter, and positioning the flexible guide catheter within the right atrium of the heart near the anterior of the tricuspid valve annulus, generally adjacent to the first anchor.advancing a stabilizing catheter through the flexible guide catheter; positioning a helical tip on a distal end of the stabilizing catheter adjacent to the first anchor and against a surface of the right ventricular heart near the anterior tricuspid annulus; rotating the helical tip such that the helical tip engages a surface of the right atrial heart near the anterior tricuspid annulus; advancing a guidewire through the stabilizing catheter and the heart between the right atrium and the right ventricle; advancing an anchor delivery catheter over the guidewire from the right atrium into the right ventricle; retracting the guidewire through the anchor delivery catheter; securing a second anchor connected to a second tether through the anchor delivery catheter against the surface of the right ventricular heart near the anterior tricuspid annulus a distance of 1-4 centimeters from the first anchor; retracting the anchor delivery catheter through the flexible guide catheter; positioning the flexible guide catheter within the right atrium of the heart near the atrial septum; and advancing the anchor delivery catheter through the flexible guide catheter. positioning a distal tip of the anchor delivery catheter against the atrial septum below the fossa ovalis; advancing a guidewire through the anchor delivery catheter and the atrial septum of the heart; advancing the anchor delivery catheter over the guidewire from the right atrium into the left atrium of the heart; retracting the guidewire through the anchor delivery catheter; securing a third anchor connected to the third tether through the atrial septum of the heart; and retracting the anchor delivery catheter through the atrial septum of the heart. passing a tether lock over the first tether, the second tether, and the third tether; advancing the tether lock to a location near the third anchor; drawing the anterior portion of the tricuspid annulus to the posterior septal portion of the tricuspid annulus with the first tether, the second tether, and the third tether; and actuating the tether lock to clamp the first tether, the second tether, and the third tether and fix the distance of the first anchor, the second anchor, and the third anchor relative to one another.

[0088] In some embodiments, the techniques described herein relate to methods further including advancing a grommet distally along a selected tether selected from a first tether, a second tether, or a third tether of a guidewire delivery system, and advancing a grommet lock distally along the selected tether, where the grommet passes through the guidewire delivery system a desired distance, such that the distance between the anchor connected to the selected tether and the grommet is substantially accounted for by the thickness of the implant surface of the heart.

[0089] In some embodiments, the techniques described herein include attaching a fourth surface anchor to a delivery catheter, the fourth surface anchor including a nitinol wire frame covered by a surface anchor sheath and defined by nitinol wire at a periphery and an internal nitinol wire feature within an area defined by the periphery formed by the nitinol wire frame, the nitinol wire frame including an austenitic state in a deployed configuration when a temperature of the nitinol wire frame is at body temperature; positioning a flexible guide catheter within the right atrium of the heart near the anterior tricuspid annulus generally adjacent to the second anchor; advancing a stabilizing catheter through the flexible guide catheter; positioning a helical tip on a distal end of the stabilizing catheter against a surface of the right ventricular heart near the anterior tricuspid annulus adjacent to the first anchor; and advancing the helical tip to the right atrium of the heart near the anterior tricuspid annulus. rotating the helical tip to engage the atrial surface; advancing a guidewire through the stabilizing catheter and the heart between the right atrium and the right ventricle; advancing an anchor delivery catheter over the guidewire from the right atrium into the right ventricle; retracting the guidewire through the anchor delivery catheter; securing a fourth anchor connected to the fourth tether through the anchor delivery catheter against the right ventricular surface near the anterior of the tricuspid annulus a distance of 1 to 4 centimeters from the second anchor; retracting the anchor delivery catheter through the flexible guide catheter, wherein the tether lock further passes past the fourth tether to draw the anterior of the tricuspid annulus to the posterior septal portion of the tricuspid annulus, and wherein actuating the tether lock further includes a fourth tether to fix a distance between the first anchor, the second anchor, the third anchor, and the fourth anchor relative to one another.

[0090] In some aspects, the techniques described herein relate to methods in which a distal tip of a guidewire is configured to deliver high frequency current to the distal tip, where the high frequency current reduces the force required to pass through a portion of the heart.

[0091] In some embodiments, techniques described herein include a method of tricuspid valve repair comprising advancing a guidewire delivery system toward the heart, the guidewire delivery system including a flexible guide catheter having a guide catheter lumen, a stabilizing catheter having a distal tip located at a distal end of the stabilizing catheter, a stabilizing catheter lumen, and a flexible region, the stabilizing catheter configured to pass through the guide catheter lumen, and a helical tip located at a distal tip of the stabilizing catheter and a guidewire configured to pass through the stabilizing catheter lumen; and preparing at least two surface anchors for deployment, the at least two surface anchors including a nitinol wire frame covered by a surface anchor exterior and defined at a periphery by nitinol wire, and a nitinol wire internal feature within a region defined by the periphery formed by the nitinol wire frame, the nitinol wire frame being configured to extend beyond the nitinol wire lumen. the wire frame being in an austenitic state in a deployed configuration when the temperature of the wire frame is at body temperature; positioning a flexible guide catheter within the right atrium of the heart near the anterior tricuspid annulus; advancing a stabilizing catheter through the flexible guide catheter; positioning a helical tip on a distal end of the stabilizing catheter against a surface of the right atrial heart near the anterior tricuspid annulus; rotating the helical tip such that the helical tip engages the surface of the right atrial heart near the anterior tricuspid annulus; advancing a guidewire through the stabilization catheter and the surface of the heart; advancing an anchor delivery catheter over the guidewire from the right atrium to the right ventricle; retracting the guidewire through the anchor delivery catheter; securing a first anchor connected to the first tether through the anchor delivery catheter against the right ventricular surface near the anterior of the tricuspid annulus; retracting the anchor delivery catheter through the flexible guide catheter; and positioning the flexible guide catheter within the right atrium of the heart near the interatrial septum.positioning a distal tip of an anchor delivery catheter against the atrial septum below the fossa ovalis, advancing a guidewire through the anchor delivery catheter and the atrial septum of the heart, advancing the anchor delivery catheter over the guidewire from the right atrium into the left atrium of the heart, retracting the guidewire through the anchor delivery catheter, securing a second anchor connected to a second tether through the atrial septum of the heart, retracting the anchor delivery catheter through the atrial septum of the heart, passing a tether lock through the first and second tethers, advancing the tether lock to a location near the second anchor, drawing an anterior portion of the tricuspid annulus to a posterior septal portion of the tricuspid annulus with the first and second tethers, and actuating the tether lock to clamp the first and second tethers and fix a distance between the first and second anchors relative to one another.

[0092] In some aspects, the techniques described herein relate to a guidewire delivery system that includes a dilator having a lumen and a lumen shoulder, and a helical guidewire residing within the lumen, where the helical guidewire abuts the lumen shoulder which prevents axial movement of the helical guidewire through the dilator, where the helical guidewire is capable of rotating within the lumen, and where the helical guidewire has a helical guidewire portion at a guidewire distal end that is fixably attached to the helical guidewire.

[0093] In some aspects, the techniques described herein relate to a method for passing a guidewire over a surface of the heart, the method including advancing a guidewire delivery system within the heart, the guidewire delivery system including a stabilizing catheter having a lumen with a lumen shoulder and a helical guidewire abutting the lumen shoulder and capable of rotating within the lumen of the stabilizing catheter, the helical guidewire having a helical guidewire portion at a guidewire distal end that is fixably attached to the helical guidewire, positioning the guidewire delivery system within the right atrium of the heart, positioning the helical guidewire against the surface of the heart, rotating the helical guidewire such that the helical guidewire engages the surface of the heart, and advancing the guidewire and the stabilizing catheter through the surface of the heart.

[0094] In some embodiments, the techniques described herein relate to a lock for use within a tricuspid valve repair system, the lock housing including a lock housing having a throughbore configured to accommodate at least two tensioning members passing through the lock housing, and an adjustable lock tensioner configured to move within the lock housing, the adjustable lock tensioner capable of tightening the at least two tensioning members as they pass through the lock housing, the lock capable of transitioning from a first configuration that allows the tensioning members to move freely relative to the lock, to a second configuration that prevents the tensioning members from moving freely relative to the lock.

[0095] In some embodiments, techniques described herein relate to a method of manufacturing a surface anchor, comprising: activating a laser configured to cut a Nitinol sheet, the Nitinol sheet having a thickness and area configured to match at least a final size of the surface anchor; and displacing the Nitinol sheet relative to the laser along a profile in the Nitinol sheet, the profile cut from the Nitinol sheet substantially similar to the final shape of the surface anchor.

[0096] In some embodiments, the techniques described herein relate to a method of tricuspid annulus repair that includes securing a first anchor against a right ventricular surface near an anterior portion of the tricuspid annulus, extending a tension member from the first anchor toward the right atrial surface of the atrial septum, and drawing the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus with the tension member.

[0097] In some aspects, the techniques described herein relate to methods in which drawing the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus includes advancing a lock coupled to a tensioning member toward the right atrial surface of the atrial septum.

[0098] In some embodiments, the techniques described herein relate to methods that include positioning a left atrial anchor element against a left atrial surface of the atrial septum and coupling the first anchor and the left atrial anchor element to one another with a tension member.

[0099] In some embodiments, the techniques described herein relate to methods that further include securing a second anchor against the right ventricular surface of the anterior portion of the tricuspid annulus, extending a second tensioning member from the second anchor toward the right atrial surface of the atrial septum, and drawing the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus with the second tensioning member.

[0100] In some embodiments, the techniques described herein relate to a tricuspid valve repair system that includes one or more features described above.

[0101] In some embodiments, the techniques described herein relate to methods of tricuspid valve repair comprising implanting one or more features of the tricuspid valve repair system described above into a patient's heart.

[0102] In some aspects, the techniques described herein relate to a method for traversing tissue in a body with a guidewire, the method including threading a stabilizing catheter having a helical wire at its distal end into the tissue, passing the guidewire through the stabilizing catheter, and using the stabilizing catheter to support the guidewire while traversing completely through the tissue with the guidewire.

[0103] These and other features, aspects, and advantages of the present application will be described with reference to drawings of specific embodiments that are intended to illustrate, but not to limit, the invention. It is understood that the drawings are for purposes of illustrating the various concepts disclosed herein and may not be to scale. [Brief description of the drawings]

[0104] [Figure 1] FIG. 2 is a four-chamber cross-sectional view of the heart with a regurgitant jet between the anterior and septal leaflets of the tricuspid valve.

[0105] [Diagram 2] FIG. 1C is a four-chamber cross-sectional view of a heart with an embodiment of a treatment including an anchor element implanted below the fossa ovalis against the left atrial surface of the interatrial septum and connected via a tension band to an anchor element implanted anterior to the tricuspid annulus against the right ventricular surface by a lock near the right atrial surface of the interatrial septum.

[0106] [Diagram 3]FIG. 1C is a four-chamber cross-sectional view of a heart with an embodiment of a treatment including an anchor element implanted against the right ventricular surface of the interventricular septum below the tricuspid leaflet hinge and connected via a tension band to an anchor element implanted against the right ventricular surface anterior to the tricuspid annulus by a lock near the right atrial surface of the interatrial septum.

[0107] [Figure 4] FIG. 1C is a four-chamber cross-sectional view of a heart with an embodiment of a treatment including an anchor element implanted against the left ventricular surface of the interventricular septum below the mitral leaflet hinge and connected via a tension band to an anchor element implanted against the right ventricular surface anterior to the tricuspid annulus by a lock near the right atrial surface of the interatrial septum.

[0108] [Diagram 5] FIG. 5 is a four-chamber cross-sectional view of the heart with one embodiment of a treatment including anchor elements implanted in each of the locations shown in FIGS. 2-4 and connected via tension bands to anchor elements implanted against the right ventricular surface anterior to the tricuspid annulus with a lock near the right atrial surface of the atrial septum.

[0109] [Figure 6] FIG. 3 is a top-down (surgeon) view of the heart with one embodiment of the treatment according to FIG. 2, including an anchor element implanted below the fossa ovalis against the left atrial surface of the atrial septum, and connected via a tension band to an anchor element implanted anterior to the tricuspid annulus against the right ventricular surface by a lock near the right atrial surface of the atrial septum.

[0110] [Figure 7] FIG. 13 is a top-down (surgeon) view of the heart with one embodiment of a treatment including an anchor element implanted below the fossa ovalis against the left atrial surface of the interatrial septum and connected via a tension band to anchor elements implanted against the right ventricular surface anterior and posterior to the tricuspid annulus with a lock near the right atrial surface of the interatrial septum.

[0111] [Figure 8] FIG. 1 is a top-down (surgeon) view of the heart with one embodiment of a treatment including an anchor element and a bar that spans from the atrial septum to the right atrium, below the fossa ovalis to the RVOT. The anchor elements, which are implanted in the right ventricular surface of the anterior and posterior tricuspid annulus, are attached to the bar via tensioning bands via locks near the center of the bar, and the tension of the bands pulls the portion of the tricuspid annulus in contact with the anchor element toward the bar.

[0112] [Figure 9] FIG. 13 is a top-down (surgeon) view of the heart with one embodiment of a treatment including an anchor element implanted against the underside of the coronary sinus near its opening and connected via a tension band to anchor elements implanted against the right ventricular surfaces anterior and posterior to the tricuspid annulus with a lock near the right atrial surface of the atrial septum.

[0113] [Figure 10] 1 is a cross-sectional view of a heart with one embodiment of treatment with a tension band that includes an anchor element implanted on the underside of the coronary sinus near the opening of the coronary sinus and loops from within the coronary sinus through the left ventricular myocardium below the coronary sinus toward the tricuspid annulus. Another anchor element is implanted on the right ventricular surface anterior to the tricuspid annulus, with the tension band traversing through the annulus into the right atrium. The tension bands are tensioned and connected together in a lock located near the opening of the coronary sinus to pull the anterior tricuspid annulus toward the coronary sinus.

[0114] [Figure 11]FIG. 1 is a cross-sectional view of a heart with one embodiment of treatment with a tension band that includes an anchor element implanted on the undersurface of the coronary sinus near the ostium of the coronary sinus and loops from near the tricuspid annulus through the left ventricular myocardium below the coronary sinus and into the coronary sinus. Another anchor element is implanted on the right ventricular surface anterior to the tricuspid annulus, with the tension band traversing through the annulus into the right atrium. The tension bands are tensioned and connected together in a lock located near the ostium of the coronary sinus to pull the anterior tricuspid annulus toward the coronary sinus.

[0115] [Figure 12] FIG. 11 is a cross-sectional view of a heart according to one embodiment of a treatment including anchor elements implanted similarly to that of FIG. 10, except that a pad is additionally embedded in the underside of the coronary sinus, where a tension band allows myocardial tissue to be tucked between the pad and the anchor and exits to prevent the tension band from cutting the myocardial tissue.

[0116] [Figure 13] FIG. 1 is a cross-sectional view of a heart with one embodiment of treatment with a tension band that includes an anchor element implanted against the right ventricular surface of the tricuspid annulus below the coronary sinus ostium (near the septum / posterior tricuspid commissure) and loops from near the tricuspid annulus through the left ventricular myocardium below the coronary sinus and into the coronary sinus. Another anchor element is implanted on the right ventricular surface anterior to the tricuspid annulus, and the tension band traverses through the annulus into the right atrium. The tension bands are tensioned and connected together in a lock located near the coronary sinus ostium to pull the anterior tricuspid annulus toward the coronary sinus.

[0117] [Figure 14] FIG. 1 shows catheter entry through the venous circulation via the femoral vein and inferior vena cava (IVC) into the right atrium, with the distal tip of the catheter positioned below the fossa ovalis and adjacent to the coronary sinus ostium.

[0118] [Figure 15]FIG. 13 shows a wire crossing the interatrial septum from the right atrium to the left atrium.

[0119] [Figure 16] FIG. 13 shows a dilator and sheath following a wire across the atrial septum into the left atrium.

[0120] [Figure 17] FIG. 13 shows the septal anchor element being deployed from a sheath within the left atrium.

[0121] [Figure 18] FIG. 13 shows the septal anchor element abutting the left atrial wall, with the anchor deployment catheter or sheath removed and the tension band connected to the anchor element passing through the guiding catheter.

[0122] [Figure 19] FIG. 1 shows a guiding catheter with a sheath and dilator oriented toward the anterior tricuspid annulus, with the septal anchor abutting the left atrial wall and a tension band connected to the septal anchor extending through the guiding catheter.

[0123] [Figure 20] Four-chamber view of the heart with the guiding catheter, sheath, and dilator oriented toward the anterior tricuspid annulus and the wire passing from the right atrial to the right ventricular side of the anterior tricuspid annulus. The septal anchor rests against the left atrial wall and a tension band connected to the septal anchor extends through the guiding catheter.

[0124] [Figure 21] FIG. 13 shows a sheath and dilator following a wire from the right atrium across the anterior tricuspid annulus into the right ventricle.

[0125] [Figure 22]FIG. 13 shows the anterior anchor element being deployed from the sheath into the right ventricle.

[0126] [Figure 23] FIG. 1 shows the anterior anchor element abutting the right ventricular surface anterior to the tricuspid annulus with an attached tension band passing from the right ventricle to the right atrium and into the guiding catheter. The septal anchor abuts the left atrial wall with an attached tension band passing from the left atrium through the atrial septum to the right atrium and into the guiding catheter.

[0127] [Figure 24] FIG. 13 shows the locking of tension bands connected to the anterior and septal anchor elements by a locking catheter passing through a locking and guiding catheter positioned near the atrial septum.

[0128] [Diagram 25] Figure 1 shows a guiding catheter in the right atrium above the tricuspid valve, with an anterior anchor delivery catheter passing through the tricuspid valve and hooked under the anterior tricuspid leaflet in the right ventricle. The anterior anchor is shown mounted on the distal end of the catheter in a collapsed configuration. The septal anchor abuts the left atrial wall and an attached tension band passes through the atrial septum into the guiding catheter.

[0129] [Figure 26] FIG. 13 shows the anterior anchor in an expanded or deployed configuration in the right ventricle behind the anterior tricuspid leaflet, with wires passing through each end of the anterior anchor crossing the anterior tricuspid annulus from the right ventricle to the right atrium.

[0130] [Figure 27] FIG. 1 shows the snare catheter exiting the guide catheter and entering the right atrium, positioned to capture one of the wires spanning the anterior tricuspid annulus.

[0131] [Figure 28]FIG. 13 shows the first tensioning member of the anterior anchor captured through the guiding catheter, with the plug at the end of the tensioning band abutting the anterior anchor.

[0132] [Figure 29] FIG. 1 shows the snare catheter exiting the guiding catheter and entering the right atrium and positioned to capture the second wire spanning the anterior tricuspid annulus.

[0133] [Diagram 30] FIG. 13 shows both tension bands connected to an anterior anchor captured through the guiding catheter, the plugs at the ends of the tension bands abutting the anterior anchors, and the anterior anchor delivery catheter being removed.

[0134] [Diagram 31] An anterior anchor resting against the ventricular surface anterior to the tricuspid annulus with an attached tension band being routed to a lock near the atrial septum. The septal anchor is shown resting against the left atrial wall with an attached tension band being routed to the lock. A lock catheter extends from the guide catheter and is connected to the lock.

[0135] [Diagram 32] FIG. 13 shows a view of the tricuspid valve from the right atrium looking down on the tricuspid valve, showing a tension band passing through the anterior tricuspid annulus and connected to the atrial septum and a lock near the coronary sinus ostium.

[0136] [Diagram 33] FIG. 13 is a right ventricular perspective looking up at the tricuspid valve of two expandable t-bar anchor elements positioned on opposing right ventricular surfaces anterior to the tricuspid annulus in and near the RVOT.

[0137] [Diagram 34]FIG. 1 shows a braided nitinol anchor in the left atrium abutting the left atrial wall at the interatrial septum, above the mitral valve.

[0138] [Diagram 35] FIG. 1 illustrates an anchor element embodiment in which the anchor is constructed from a Nitinol wire form that is heat set into an elliptical perimeter with triangular ends and a cross in the center. The perimeter is constructed from two layers of Nitinol wire that are spirally wound around each other to lock the wires together and distribute forces from the central crossing to the perimeter and vice versa. A stainless steel sleeve connects the free ends of the wires.

[0139] [Diagram 36] FIG. 36 illustrates an alternative configuration of the wire form of FIG. 35, in which the wire form has been heat set to a more rounded perimeter profile.

[0140] [Figure 37] FIG. 36 shows the anchor element of FIG. 35 having a polymer or fabric sheath covering the wire form and a tension band attached to the central intersection by a knot.

[0141] [Figure 38] FIG. 38 shows the anchor element of FIG. 37 compressed into an elongated form within a deployment catheter or sheath.

[0142] [Figure 39] FIG. 1 shows a braided nitinol septal anchor abutting the left atrial wall of the heart, with a grommet secured to the tension band where it exits the right atrium, such that the septum is sandwiched between the anchor and grommet and the anchor cannot move from its location.

[0143] [Figure 40A]FIG. 1 shows an embodiment of a front anchor "bar" and delivery catheter where the anchor is attached in the center to the delivery catheter and the end of the anchor is attached to a hollow flexible tube with a threaded swivel joint on the distal end. The wire passes through the hollow tube through the anchor and a loop in a snare catheter positioned near the wire exit point. [Figure 40B] FIG. 40B is an alternative view of the embodiment of FIG. 40A.

[0144] [Diagram 41] FIG. 41 shows the anterior anchor shown in FIG. 40 in a collapsed configuration in which the anchor has been collapsed by applying tension to flexible hollow tubes connected to each end of the anchor.

[0145] [Figure 42A] FIG. 42 is an isometric view of the anterior anchor "bar" shown in FIGS. 40 and 41 with a clear polymer sheath. An internal metal frame made from Nitinol can be seen with two threaded stainless steel hubs with through holes that are interference fit on each end of the frame. A central hole is shown for attachment to a delivery catheter. The hub is threaded to attach to the swivel of the delivery catheter and the through holes are sized to allow the wires and tension bands to pass but prevent the plugs at the ends of the tension bands from passing through. The sheath may be injection or compression molded over the frame and hubs with a flexible and resilient material such as silicone elastomer, Pellethane® or other suitable material, or it may be a sewn or heat bonded fabric sheath of PET, PTFE felt or other suitable material.

[0146] [Figure 42B]42B showing the frame and hub sealed within the sheath. The sheath tapers to a thinner profile towards the center to reduce bending stiffness at the center and allow the anchor to preferentially fold around the center when the hub end is pulled due to the center being secured to the catheter.

[0147] [Diagram 43] FIG. 43 shows the front anchor "bar" of FIGS. 40-42 attached to a delivery catheter in an articulated configuration. A swivel can be seen attached to the hub of the anchor and connected to a flexible hollow tube of laser cut metal or twisted metal strand construction. The swivel allows the anchor to transition from a first, folded configuration where the axis of the hub is substantially perpendicular to the catheter tip axis to a second, deployed configuration where the axis of the anchor hub is substantially parallel to the axis of the catheter tip. Wires can be seen extending from the anchor hub. The swivel can be removed from the anchor by rotation of the flexible hollow tube.

[0148] [Figure 44A] FIG. 1 illustrates one embodiment of an anchor element where the anchor is constructed from braided nitinol wire that is shape-set into a disk configuration. An end view of the anchor is shown, depicting the anchor as substantially circular. The anchor can be elongated, whereby the disk is collapsed into an elongated tube for delivery through a catheter. A tension band is centrally attached to the distal end of the anchor via an interference knot, whereby the anchor is flattened when the tension band is tensioned.

[0149] [Figure 44B]FIG. 1 illustrates an embodiment of an anchor element where the anchor is constructed from braided nitinol wire that is shape-set into a series of disks. Although two disks are depicted, any number of disks can be constructed. The anchor is shown abutting a cross section of tissue with small holes for tensioning bands. Having multiple disks increases the amount of material abutting the tissue, making the anchor more resistant to pulling through the tissue without increasing the stiffness of the anchor to collapse into the delivery catheter.

[0150] [Figure 44C] FIG. 13 illustrates an embodiment of an anchor element constructed from braided nitinol wire in which the anchor is shaped into two discs such that when the tension band is tensioned, the distal disc abuts against the tissue and resists pulling, and when the tension band is slack or if it is cut or broken, the proximal disc is configured to slide over the tension band and hold the anchor in place.

[0151] [Fig.44D] FIG. 44C illustrates an embodiment of an anchor element similar to FIG. 44C, except that the anchor is held in place on the proximal end by shaped Nitinol fingers. The fingers can be laser cut from a tube or can be individual wire elements that are attached to the proximal hub of the anchor and straightened for advancement through the delivery catheter. Although four fingers are depicted in a cross configuration, any number of fingers can be used in this configuration.

[0152] [Diagram 45]FIG. 1 illustrates an anchor embodiment in which the anchor is constructed from a laser cut nitinol sheet or strip with a diamond pattern. This laser cut pattern allows the anchor to be compressed and elongated into a slim profile for delivery through a catheter, and then passively return to the deployed configuration shown upon exiting the catheter. The central hole does not allow the knot in the tension band to pass through, so that when the tension band is tensioned, it pulls the anchor from the center, allowing the anchor to lie flat and intimate against any surface it comes into contact with.

[0153] [Figure 46A] FIG. 51 shows an anchor element such as those in FIGS. 35-38, 45, and 50 abutting tissue with a tension band passing therethrough.

[0154] [Figure 46B] FIG. 46B shows the anchor shown in FIG. 46A being inserted into a catheter.

[0155] [Figure 46C] FIG. 46C illustrates the anchor shown in FIG. 46B being deployed from a catheter, with the tension band tensioned and the anchor assuming a "t-bar" configuration when in contact with any structure.

[0156] [Figure 47A]FIG. 45 illustrates an anchor such as that shown in FIG. 50a-c, in which a proximal grommet constructed from a laser cut nitinol tube is snapped into the central hole of the anchor. The grommet includes multiple laser cut nitinol fingers that are curved and shaped into a configuration that radiates away from the tube axis so that the fingers can hold the anchor in place on the tissue while the tension band is loose or if the tension band breaks or is severed. The distal end of the nitinol tube is constructed with a raised step and taper, and a slot is cut to form a cantilever beam section. When the anchor is tensioned against the tube, the taper at the distal end of the tube deflects the beam toward the centerline, allowing the raised step to pass through the hole in the anchor. Once the raised step passes through the hole, potential energy stored in the beam straightens the raised step and locks the raised end of the tube to the anchor.

[0157] [Figure 47B] FIG. 47B is an isometric view of the grommet element shown in FIG. 47A.

[0158] [Figure 48A] 13 shows an alternative configuration for holding the anchor in place when there is no tension on the tension band, where tissue is compressed between an anchor on the distal end and a flat grommet on the proximal end that slides over the tension band. A lock is crimped onto the tension band to lock the distance between the anchor and the grommet. The grommet can be of a similar configuration to any of the anchor elements disclosed herein.

[0159] [Figure 48B] FIG. 48B shows a configuration similar to FIG. 48A, except that the grommet is locked to the anchor using a locking mechanism that utilizes a screw that, when rotated, clamps the tension band between the central hole and the side exit hole.

[0160] [Figure 49A]FIG. 1 shows one of various alternative anchor concepts depicting a braided nitinol anchor functionally similar to the Amplatzer device. [Figure 49B] FIG. 1 illustrates one of various alternative anchoring concepts depicting an S-hook anchor. [Figure 49C] FIG. 1 depicts a T-bar anchor, one of various alternative anchoring concepts. [Figure 49D] FIG. 1 illustrates a ship anchor and one of a variety of alternative anchor concepts. [Figure 49E] FIG. 13 illustrates various alternative anchoring concepts depicting a suture contained within a bar anchor. [Fig.49F] FIG. 13 illustrates one of a variety of alternative anchor concepts depicting a rigid hook that enters a bar and may include additional barbs.

[0161] [Figure 50A] FIG. 13 illustrates an anchor embodiment in which the anchor is constructed from a laser cut Nitinol sheet or strip with a diamond pattern that allows the anchor to be compressed and elongated into a slim profile for delivery through a catheter, followed by a passive return to the deployed configuration shown upon exiting the catheter. The central hole does not allow the knot in the tension band to pass through, so that when the tension band is tensioned, it pulls the anchor from the center, allowing the anchor to lie flat and intimate against any surface it comes into contact with.

[0162] [Figure 50B] FIG. 50B illustrates an alternative cutting configuration 5020 of the anchor of FIG. 50A.

[0163] [Figure 50C] FIG. 50C illustrates an alternative cutting configuration 5040 of the anchor of FIGS. 50A and 50B.

[0164] [Figure 51A]FIG. 1 illustrates one embodiment of an anchor element in which the anchor is constructed from a nitinol wire that is shaped to form a series of lobes. The wire is wound into tight loops between each lobe such that a central hole is approximated through the anchor. A tension band passes through the central hole, which constrains the lobes from radially displacing relative to one another. The tension band has a knot formed at its distal end such that the knot cannot pass through the central hole such that when the tension band is pulled, the knot contacts the center of the anchor and pulls the anchor from the center. The anchor can be elongated to facilitate delivery through the catheter, and upon exiting the catheter, returns to the shaped-set configuration due to potential energy stored in the wire from the straightening process.

[0165] [Figure 51B] FIG. 51B shows another embodiment similar to FIG. 51A, except that in addition to the lobes, the wire is also formed into a peripheral circle.

[0166] [Figure 51C] FIG. 51C is an alternative perspective view of the anchor shown in FIG. The anchor can be straightened to facilitate delivery through the catheter. The anchor can be pulled into the catheter by simply pulling the distal end, and pushed back out of the catheter by pushing either the distal or proximal end. Pushing the distal end causes the anchor to elongate as it is pushed due to counteracting frictional forces against the catheter wall proximal to the force application point, which reduces the deployment force compared to pushing from the proximal end.

[0167] [Figure 52]FIG. 1 shows a stabilization catheter with a distal helix with a sharp tip that is laser cut from a solid tube. Immediately proximal to the helix is ​​a flexible region created by laser cutting an interrupted slot into the tube. The most proximal region of the catheter is shown with a handle for applying torque and / or translation, and a hub for accepting a hemostasis valve or other accessory.

[0168] [Figure 53] FIG. 2 is a cross-sectional view of the stabilizing catheter shown in FIG. 1 showing a guidewire passing through the ID of the stabilizing catheter.

[0169] [Figure 54] FIG. 13 shows the distal end of a stabilizing catheter having a helical wire with a sharp tip that is welded to a catheter body of tubular construction with interrupted laser cut slots to provide flexibility while maintaining torsional stiffness.

[0170] [Figure 55] FIG. 55 shows the stabilizing catheter shown in Figure 54 being passed through the guiding catheter.

[0171] [Figure 56] FIG. 56 shows the stabilizing catheter and guide catheter shown in FIG. 55, with a guidewire extending from the distal end.

[0172] [Figure 57] This figure shows the stabilizing catheter and guide catheter shown in Figure 56 in the right atrium of a human heart model. The spiral part of the stabilizing catheter is screwed into the model from the right atrium near the anterior tricuspid annulus.

[0173] [Figure 58] A four-chamber cross-sectional view of the heart, with the guide catheter entering the right atrium from the IVC. The guide catheter is directed toward the anterior tricuspid annulus.

[0174] [Figure 59] A four-chamber cross-sectional view of the heart with a guide catheter in the right atrium and a stabilizing catheter with a distal helix directed by the guide catheter to a location near the anterior tricuspid annulus. The helix is ​​screwed into tissue by applying torque to the stabilizing catheter.

[0175] [Figure 60] FIG. 59 is a four-chamber cross-sectional view of the heart with the guide catheter and stabilizing catheter shown in FIG. 59 and the guidewire passing through the stabilizing catheter and tissue into the right ventricle.

[0176] [Figure 61] A four-chamber cross-sectional view of the heart with the guide catheter in the right atrium and the guidewire passing from the right atrium to the right ventricle through tissue at or near the anterior tricuspid annulus. The stabilizing catheter shown in Figures 59 and 60 has been withdrawn.

[0177] [Figure 62] Four-chamber cross-sectional view of the heart with a guide catheter in the right atrium directing a stabilizing catheter to a location at or near the anterior tricuspid annulus. The distal spiral of the stabilizing catheter is threaded through tissue so that it exits into the right ventricle, and a guidewire is shown passing through the stabilizing catheter and into the right ventricle.

[0178] [Figure 63] A four-chamber cross-sectional view of the heart with the guide catheter, stabilizing catheter, and guidewire as shown in Figure 62, except that the distal helix of the stabilizing catheter has been threaded completely through the tissue, so that the main shaft of the stabilizing catheter exits into the right ventricle.

[0179] [Figure 64]FIG. 1 shows a stabilization catheter having a distal helix constructed from two helically wound wires 180 degrees apart.

[0180] [Figure 65] FIG. 1 shows a stabilized catheter having a distal helix that tapers outward from smaller outer and inner diameters at the junction to the catheter body to larger inner and outer diameters near the tip.

[0181] [Figure 66] FIG. 1 illustrates a guidewire that is helically wound and has a distal end that transitions into a straight wire.

[0182] [Figure 67] FIG. 1 is a cross-sectional view of a guidewire inside a dilator having a distal end that is helically wound, a dilator having a smaller distal inner diameter and a larger proximal inner diameter, with a section immediately proximal to the distal end of a smaller diameter, and a more proximal section of a larger diameter, such that the guidewire is trapped within the dilator.

[0183] [Figure 68] FIG. 13 shows a dilator having threads formed in the distal tapered section.

[0184] [Figure 69A] FIG. 1 illustrates a surface anchor element used as an anchor element in a tricuspid valve repair system.

[0185] [Figure 69B] FIG. 69B shows the surface anchor element from FIG. 69A in a collapsed state within a delivery catheter.

[0186] [Figure 69C] FIG. 69C shows the surface anchor element from FIG. 69B after it has been deployed from its delivery catheter.

[0187] [Figure 70A]FIG. 1 shows an implant system with two anterior surface anchors and one septal surface anchor used as a tricuspid valve repair system.

[0188] [Figure 70B] FIG. 70B illustrates the surface anchor from FIG. 70A used in a tricuspid valve repair system.

[0189] [Figure 70C] FIG. 1 is a side cross-sectional view of a surface anchor including a grommet and anchor hub for holding the surface anchor to a patient.

[0190] [Fig. 70D] FIG. 70B shows one section of the implant system of FIG. 70A demonstrating the order of elements when the system is deployed.

[0191] [Figure 70E] FIG. 70B shows one section of the implant system of FIG. 70A while in a pre-deployed state within a delivery catheter.

[0192] [Fig. 70F] FIG. 70B illustrates one section of the implant system of FIG. 70A during the installation process into a patient.

[0193] [Fig. 70G] A diagram showing one section of the implant system of FIG. 70A during the installation process into a patient, after the step shown in FIG. 70F.

[0194] [Fig. 70H] A diagram showing one section of the implant system of FIG. 70A during the installation process into a patient, after the step shown in FIG. 70G.

[0195] [Figure 71] FIG. 1 illustrates an implant system with a flat grommet used within a tricuspid valve repair system.

[0196] [Figure 72A] FIG. 1 illustrates an implant system with a T-bar grommet used within a tricuspid valve repair system.

[0197] [Fig. 72B] FIG. 72B is a front view of the T-bar grommet shown in FIG.

[0198] [Fig. 72C] FIG. 72B illustrates the implant system of FIG. 72A while in a pre-deployed state.

[0199] [Figure 73] FIG. 1 illustrates an implant system having a flat grommet with a slidable tether connection point for use within a tricuspid valve repair system.

[0200] [Fig. 74A] FIG. 1 illustrates a self-expanding grommet used in a tricuspid valve repair system.

[0201] [Fig. 74B] FIG. 74B illustrates an implant system having a self-expanding grommet of FIG. 74A used within a tricuspid valve repair system.

[0202] [Fig. 75A] FIG. 1 illustrates the grommet lock in the locked configuration used within the tricuspid valve repair system.

[0203] [Fig. 75B] FIG. 75B illustrates the tether lock of FIG. 75A in an unlocked configuration for use within a tricuspid valve repair system.

[0204] [Fig. 75C] FIG. 75B is an alternative view of the tether lock of FIG. 75A in a locked configuration for use within a tricuspid valve repair system.

[0205] [Fig. 75D] FIG. 75B is a side cross-sectional view of the tether lock of FIG.

[0206] [Figure 76A] FIG. 13 illustrates an alternative embodiment of a tether lock in a locked configuration for use within a tricuspid valve repair system.

[0207] [Figure 76B] FIG. 76B illustrates the tether lock of FIG. 76A in an unlocked configuration for use within a tricuspid valve repair system.

[0208] [Figure 76C] FIG. 76B is a cross-sectional view of the tether lock of FIG. 76A in a locked configuration for use within a tricuspid valve repair system.

[0209] [Fig. 76D] FIG. 76B is a cross-sectional view of the tether lock of FIG. 76A in an unlocked configuration for use within a tricuspid valve repair system.

[0210] [Figure 76E] FIG. 76A is a front view of the tether lock of FIG. 76A used within a tricuspid valve repair system.

[0211] [Fig. 76F] FIG. 76A is a rear view of the tether lock of FIG. 76A used within a tricuspid valve repair system.

[0212] [Figure 77A] FIG. 13 is a cross-sectional view of an alternative embodiment of a tether lock used within a tricuspid valve repair system in a locked configuration.

[0213] [Fig. 77B] FIG. 77B is a cross-sectional view of the tether lock of FIG. 77A in an unlocked configuration.

[0214] [Fig. 77C] FIG. 77B is an exploded view of the tether lock of FIG.

[0215] [Fig. 78A] FIG. 13 is a cross-sectional view of an alternative embodiment of a tether lock used within a tricuspid valve repair system in a locked configuration.

[0216] [Fig. 78B] FIG. 78B is a cross-sectional view of the tether lock of FIG. 78A in an unlocked configuration.

[0217] [Fig. 78C] FIG. 78B is an exploded view of the tether lock of FIG.

[0218] [Figure 79A] FIG. 13 is a perspective view of an alternative embodiment of a tether lock used within the tricuspid valve repair system.

[0219] [Figure 79B] FIG. 79B is a cross-sectional view of the tether lock of FIG. 79A in a locked configuration.

[0220] [Figure 79C] FIG. 79B is a cross-sectional view of the tether lock of FIG. 79A in an unlocked configuration.

[0221] [Fig. 79D] FIG. 79B is an exploded view of the tether lock of FIG.

[0222] [Figure 80A] FIG. 13 is a cross-sectional view of an alternative embodiment of a tether lock used within a tricuspid valve repair system in an unlocked configuration.

[0223] [Figure 80B] FIG. 80B is a perspective cross-sectional view of the tether lock of FIG. 80A in a locked configuration.

[0224] [Fig. 80C] FIG. 80B is a perspective cross-sectional view of the tether lock of FIG. 80A in an unlocked configuration.

[0225] [Fig. 80D] FIG. 80B is an exploded view of the tether lock of FIG.

[0226] [Figure 81] FIG. 1 is a four-chamber cross-sectional view of the heart with one embodiment of a treatment including an implant system used as a tricuspid valve repair system, with two anterior surface anchors implanted against the right ventricular surface anterior to the tricuspid annulus that are connected via tension bands to one septal surface anchor implanted against the left atrial surface of the interatrial septum, below the fossa ovalis, held by a lock near the right atrial surface of the interatrial septum.

[0227] [Figure 82] 70A-70H are top-down (surgeon) views of the heart according to one embodiment of the treatment with two anterior surface anchors implanted facing the right ventricular surface anterior to the tricuspid annulus connected via tension bands to one septal surface anchor implanted facing the left atrial surface of the atrial septum below the fossa ovalis, held by a lock near the right atrial surface of the atrial septum used as a tricuspid valve repair system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0228] The embodiments of the present disclosure will now be described with reference to the accompanying drawings. The terms used in the description presented herein are simply utilized in connection with the detailed description of the embodiments of the present disclosure and are not intended to be interpreted in any restrictive or limiting manner. Furthermore, the embodiments of the present disclosure may include several novel features, no single one of which is solely responsible for its desirable attributes or is essential to practice the embodiments disclosed herein described. For purposes of this disclosure, certain aspects, advantages and novel features of various embodiments are described herein. It should be understood that not all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, one skilled in the art will recognize that an embodiment may be implemented to achieve one advantage or a group of advantages taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0229] FIG. 1 shows a four-chamber cross-section of the heart with a regurgitant jet between the anterior and septal leaflets of the tricuspid valve. The heart 1 is divided into four chambers that are responsible for circulating and reoxygenating the patient's blood. Blood enters the heart at the right atrium 2 and is pumped into the right ventricle 3, which is separated from the right atrium 2 by the tricuspid valve 10, which includes the septal leaflet 11, the anterior leaflet 12, and the posterior leaflet 13 (shown in FIG. 15). The fluid then flows to the lungs to be reoxygenated and returns to the heart at the left atrium 4, which connects to the left ventricle 5, before being distributed throughout the body. Critical to the healthy operation of the heart are the heart valves between the right atrium 2 and the right ventricle 3, as well as between the left atrium 4 and the left ventricle 5. The heart 1 shown in FIG. 1 shows a tricuspid valve 10 that is leaking and allowing a regurgitant jet 6 of blood to flow from the right ventricle 3 into the right atrium 2, described herein as functional tricuspid regurgitation (FTR).

[0230] In some applications of the present disclosure, techniques are described for repairing a leaking tricuspid valve by pulling the anterior of the tricuspid annulus toward the septal portion of the tricuspid annulus or the portion of the tricuspid annulus near the coronary sinus via two or more tension bands attached via surface anchors near the anterior tricuspid annulus, which are connected to tension bands attached via surface anchors to the lower atrial septum. When reference is made herein to the tricuspid annulus or the anterior tricuspid annulus, such references may also include tissue of the heart near the tricuspid annulus. For example, a location on or near the tricuspid annulus may be defined as within 15 mm of the tricuspid annulus or an area of ​​the heart where application of a force to the area will at least partially transfer the force to the tricuspid annulus. The surface anchors or tissue anchors disclosed in certain embodiments may resist forces tending to withdraw the attached tension member by providing a surface that abuts the endocardial layer of the heart. When the surface anchor is placed in a ventricle, the surface anchor may be referred to herein as a ventricular surface anchor. In certain embodiments, the surface anchors can also abut other surfaces of the cardiac tissue and / or be embedded in the cardiac tissue. Certain aspects and advantages of the embodiments described herein can also be used with one or more of the anchors that are anchors embedded in tissue. While in many embodiments, more than one tensioning band is described, in certain embodiments, a single tensioning band can be utilized. The tensioning band (which can also be referred to as a tension band or tensioning element or tensioning element or tensioning member or tether) can be part of a tensioning assembly, which can include one or more tensioning bands / elements. The tensioning assembly can have multiple individual tensioning elements / bands that can form a tensioning member (also referred to as a tensioning member), or a single tensioning element / band that has a portion (e.g., an end portion) that forms a tensioning member.For example, a single tension element (or band) can be looped through multiple surface anchors such that the total number of tension elements present in the tether assembly is one, with each surface anchor associated with a portion of the tension element to form a tension member. Additionally, in certain embodiments, surface anchors can be used in place of tissue anchors as disclosed in the embodiments herein, or tissue anchors can be used in place of surface anchors as disclosed in the embodiments herein. In some embodiments, the anterior anchor element can be 5 millimeters to 30 millimeters long, but in certain embodiments can be 14 millimeters to 18 millimeters long, in certain embodiments can be 2 millimeters to 20 millimeters wide, but in certain embodiments can be 5 millimeters to 10 millimeters wide, and in certain embodiments can be 0.1 millimeters to 5 millimeters thick, which are positioned in contact with the right ventricular wall behind the anterior leaflet 12 of the tricuspid valve 52, such as the anchors shown in Figures 2-5, 33, 37-38, 45, 50, and 69-74. Although many embodiments are disclosed in the context of the tricuspid valve, certain aspects of the methods, systems and devices disclosed herein may find utility in other areas of the body, including treatment of other valves of the heart.

[0231] 2-5 show several possible embodiments of a technique for repairing a leaking tricuspid valve. In FIG. 2, one embodiment of the system comprises three anchor elements, namely, a first anterior anchor and a second anterior anchor 202 (the second anterior anchor is shown in FIG. 6) implanted in the right ventricle 3 proximal to the tricuspid valve 10 against the anterior tricuspid annulus 52 or the right ventricular surface of the annulus, and a septal left atrial anchor 204 implanted in the left atrium 4 against the left atrial surface below the fossa ovalis 53. A surface anchor may be referred to with reference to its implantation location. Thus, a surface anchor implanted near the right ventricular surface of the anterior tricuspid annulus 52 may be referred to as a ventricular surface anchor. A surface anchor, such as the septal left atrial anchor 204, implanted in the left atrium 4 against the left atrial surface below the fossa ovalis 53 may be referred to as a tension anchor. It is also possible to implant multiple tension anchors in or around the same region. When implanting multiple tension anchors in or around the same region, the center of the second tension anchor should be spaced 0.5-4 centimeters from the center of the first tension anchor to increase efficiency and reduce the chance of overlapping anchors on the surface of the heart. The three anchor elements are joined by one or more tensioning members 240, or tensioning bands, sutures or tethers, which are positioned closer together to achieve closure of the tricuspid valve 10 via lock 230 or a tether lock as detailed in other embodiments disclosed herein.

[0232] In FIG. 3, one embodiment of the system includes three anchor elements, namely, first and second anterior anchors 202, which are implanted in the right ventricle 3 proximal to the tricuspid valve 10 against the right ventricular surface of the anterior tricuspid annulus 52, and a septal right ventricular anchor 206, which is located in the right ventricle 3 on the septal side of the tricuspid valve 10 along the ventricular septum. Although the septal right ventricular anchor 206 is not located in the same position as the septal left atrial anchor 204 in FIG. 2, both the septal right ventricular anchor 206 and the septal left atrial anchor 204 act as tension anchors because they connect to a ventricular surface anchor, which is a surface anchor implanted near the right ventricular surface of the anterior tricuspid annulus 52. The three anchor elements are similarly joined by one or more tension bands that are coupled or attached together with a lock 230 (or tension member lock). In the embodiment of FIG. 3, the lock 230 is located in the right atrium 2. However, in other embodiments, lock 230 can be located elsewhere in the heart, such as in the right ventricle 3, left atrium 4, or left ventricle 5. In other embodiments, lock 230 can be located outside the heart. In other embodiments, lock 230 can additionally be incorporated into any of the surface or tissue anchors used in the embodiments to facilitate fixed attachment thereto, or optionally may be permanently incorporated into the surface or tissue anchors.

[0233] In FIG. 4, one embodiment of the system comprises three anchor elements, namely, a first anterior anchor and a second anterior anchor 202, which are embedded in the right ventricle 3 close to the tricuspid valve 10, facing the right ventricular surface of the anterior tricuspid annulus 52, and a septal left ventricular anchor 208 located in the left ventricle 5. Although the septal left ventricular anchor 208 is not located in the same position as the septal left atrial anchor 204 in FIG. 2, both the septal left ventricular anchor 208 and the septal left atrial anchor 204 act as tension anchors, since they connect to a ventricular surface anchor, which is a surface anchor embedded near the right ventricular surface of the anterior tricuspid annulus 52. This principle can be referred to other surface anchors disclosed herein. The three anchor elements are similarly joined by one or more tension bands using a lock 230.

[0234] In FIG. 5, one embodiment of the system includes five anchor elements, namely, a first anterior anchor and a second anterior anchor 202 implanted in the right ventricle 3 proximal to the tricuspid valve 10 against the right ventricular surface of the anterior tricuspid annulus 52, a third septal left atrial anchor 204 located in the left atrium 4, a fourth septal ventricular anchor 206 located in the right ventricle 3 on the septal side of the tricuspid valve 10 along the interventricular septum, and a fifth septal left ventricular anchor 208 located in the left ventricle 5. The three anchor elements are similarly joined by one or more tension bands using locks 230. FIGS. 6-9 show a top-down, or short axis, or surgeon's view of the implantation site for treatment. The figures generally show a top-down view of the heart, showing the anterior leaflets 12 of the tricuspid valve 10, mitral valve 15, aortic valve 20, and pulmonary valve 25, as well as the coronary sinus 54 and right coronary artery 55.

[0235] FIG. 6 shows a top-down (surgeon) view of heart 1 with one embodiment of a treatment including anchor element 204 implanted below the fossa ovalis 53 (as shown in FIG. 2 ) against the left atrial surface of the atrial septum 51 and connected via tension band 240 to anchor element 202 implanted against the right ventricular surface of the anterior tricuspid annulus 52 by lock 230 near the right atrial surface of the atrial septum, the anterior anchor 202 being connected to tension band 240 through annulus entry point 212.

[0236] FIG. 7 shows a top-down (surgeon) view of heart 1 with one embodiment of a treatment including anchor element 204 implanted below the fossa ovalis 53 (as shown in FIG. 2 ) against the left atrial surface of the atrial septum 51 and connected via tension band 240 to anchor elements 202 implanted against the right ventricular surfaces of the anterior and posterior tricuspid annulus 52 by locks 230 near the right atrial surface of the atrial septum 51, the anterior anchor 202 being connected to tension band 240 through annulus entry point 212.

[0237] 8 shows a top-down (surgeon) view of the heart with one embodiment of a treatment including anchor elements 202 and 204 and a bar 213 that extends from the interatrial septum 51 connected by the septal left atrial anchor 204 below the fossa ovalis 53 (as shown in FIG. 2) to the right ventricular outflow tract (RVOT) 57 (as shown in FIG. 33). Anchor element 202, which is embedded in the right ventricular surface of the anterior and posterior tricuspid annulus 52, is attached to bar 213 via a lock 230 near the center of bar 213 and a tensioning band 240 that passes through annulus entry point 212, and the tension of band 240 draws the portion of the tricuspid annulus in contact with anchor element 202 toward bar 213.

[0238] FIG. 9 shows a top-down (surgeon's) view of the heart with one embodiment of a treatment including anchor element 214 implanted against the underside of the coronary sinus 52, near its opening, and connected via tension band 240 to anchor element 202 implanted against the right ventricular surface of the anterior and posterior tricuspid annulus 52 by lock 230 near the right atrial surface of the atrial septum 53.

[0239] 10-13 show alternative views of a further embodiment of the treatment. The figures generally show the right atrium 2 and right ventricle 3 of the heart, with the anterior annulus 52 and coronary sinus 54.

[0240] 10 shows a cross-section of a heart with one embodiment of a treatment using a tension band 240 that includes an anchor element 214 implanted on the underside of the coronary sinus 54 near the opening of the coronary sinus and loops from within the coronary sinus through the left ventricular myocardium below the coronary sinus 54 (shown in FIG. 32 ) toward the tricuspid annulus 52. Another anchor element 202 is implanted on the right ventricular surface of the anterior tricuspid annulus 52, with the tension band 240 traversing through the annulus into the right atrium 2. The tension bands are tensioned and connected together in a lock 230 located near the opening of the coronary sinus 54 to pull the anterior tricuspid annulus 52 toward the coronary sinus 54.

[0241] 11 shows a cross-section of a heart with one embodiment of a treatment using a tension band 240 that includes an anchor element 214 that is implanted on the underside of the coronary sinus 54 near the opening of the coronary sinus, and loops from near the tricuspid annulus 52, through the left ventricular myocardium 56 below the coronary sinus 54 (shown in FIG. 32), and into the coronary sinus 54. Another anchor element 202 is implanted on the right ventricular surface of the anterior tricuspid annulus 52, with the tension band 240 traversing through the annulus 52 and into the right atrium 2. The tension bands 240 are tensioned and connected together in a lock 230 located near the opening of the coronary sinus 54 to pull the anterior tricuspid annulus 52 towards the coronary sinus 54.

[0242] FIG. 12 shows a cross-section of a heart according to one embodiment of a treatment including an anchor element 214 embedded similarly to that of FIG. 10, except that a grommet 215 is additionally embedded in the underside of the coronary sinus 54, where the tension band allows myocardial tissue to be tucked between the grommet 215 and the coronary sinus anchor 214, and where the tension band 240 exits to prevent the myocardial tissue from being cut.

[0243] 13 shows a cross-section of a heart with one embodiment of a treatment with a tension band 240 that includes an anchor element 206 implanted against the right ventricular surface of the tricuspid annulus below the opening of the coronary sinus 54 (near the septum / posterior tricuspid commissure) and loops from near the tricuspid annulus 52 through the left ventricular myocardium below the coronary sinus and into the coronary sinus 54. Another anchor element 202 is implanted on the right ventricular surface of the anterior tricuspid annulus 52, with the tension band 240 traversing through the annulus into the right atrium 2. The tension bands 240 are tensioned and connected together in a lock 230 located near the opening of the coronary sinus to pull the anterior tricuspid annulus towards the coronary sinus.

[0244] The anchor elements (202, 204, 206, 208, 214) can be connected to one or more flexible tension bands 240 by a variety of mechanisms, including knots, crimp joints, or other suitable mechanisms, and the tension bands 240 can pass from the anchor elements (202, 204, 206, 208, 214) through one or more tissues within the heart and into the right atrium 2. The tension bands 240 can pass through various tissues within the heart, such as tissue of the right ventricle 3, the tricuspid annulus 52, or the atrial septum 51, as desired or necessary. For example, in the embodiment shown in Figures 2, 3, 4, and 5, the tension bands 240 can pass through the tricuspid annulus or tissue near the tricuspid annulus at a distance of 0 to 15 millimeters from the hinge point of the tricuspid valve leaflets 10. The annulus entry point 212 where the tension band 240 passes through tissue is preferably as small as possible so that when the tension band is pulled taut, the anchor elements (202, 204, 206, 208) are pulled against the ventricular surface of the tricuspid annulus and are unable to pass through the foramen that the tension band 240 passes by. Thus, pulling the tension band 240 exerts a force against the tricuspid annulus that is distributed across the surface area of ​​the anchor elements (202, 204, 206, 208, 214) and acts in the direction of the longitudinal axis of the tension band 240. As many anchor elements as desired by the implanting user may be implanted near the tricuspid annulus 52 (within 15 millimeters) behind the anterior leaflet 12 or posterior leaflet 13 and / or within the RVOT 57, with at least one, and in certain embodiments at least two, anchor elements spanning a distance of 1 to 3 centimeters between the anchor elements. In some embodiments, the septal anchor element 204, or any anchor element, can be between 8 millimeters and 20 millimeters long in certain embodiments, between 8 millimeters and 20 millimeters wide in certain embodiments, and between 0.1 millimeters and 5 millimeters thick in certain embodiments, and can include a disk that can be positioned along the posterior atrial septum 51 against the left atrial wall above the mitral valve 15 and below the fossa ovalis 53.The positioning of the septal anchor 204 can be such that it is near the underside of the atrial septum 51 where the myocardial tissue is thicker compared to the atrial septum or the fossa ovalis, and close to the upper surface of the ventricular septum (within about 20 millimeters in certain embodiments), such as the left septal atrial anchor 204 shown in FIG. 2. This location can minimize stretching and distortion under tensile loads. This location is also far from the atrioventricular node (AV node) so as to avoid or reduce the associated risk of conduction disturbances and the need to implant a pacemaker as a result of the procedure. The septal anchor element 204 can be substantially round, oval, rectangular, square, or any other shape suitable for distributing forces over a substantial surface area and minimizing interference with the mitral valve 15 and the fossa ovalis 53. The location of the anchor 204 below the fossa ovalis 53 can leave an area of ​​the septum accessible for other left-sided heart repair or valve replacement procedures. The septal anchor in certain embodiments can be designed to extend flush against the left atrial wall so as not to interfere with mitral valve 15 repair or replacement devices. The septal anchor element can be connected to the flexible tension band 240 by a knot, crimp joint, or other suitable device, and the tension band can pass through the muscle of the atrial septum 51 and into the right atrium 1 (see, e.g., FIG. 2). The hole through which the tension band passes through the tissue is preferably as small as possible so that when the tension band is pulled taut, the anchor element is pulled against the left atrial muscle surface and cannot pass through the hole by which it passes. Thus, pulling on the tension band 240 exerts a force against the muscle of the atrial septum 51, which force is distributed over the surface area of ​​the anchor element 204 and acts in the direction of the longitudinal axis of the tension band. When tension bands 240 connected to anterior anchor element 202 and septal anchor element 204 are fed through a common opening in locking mechanism 230 and simultaneously tensioned, the anterior tricuspid annulus 52 is pulled toward the septal anchor 204 on the atrial septum 51, reducing the distance between the anterior leaflet hinge point 12 and the septal leaflet hinge point 11 and increasing the overlap of the tricuspid leaflets at their junction.

[0245] The anchor elements (202, 204, 206, 208, 214) in certain embodiments are constructed from an expanded form such that the anchor elements (202, 204, 206, 208, 214) can be compressed, flattened, elongated, or forced into a catheter or sheath 220 with an inner diameter of 1 to 3 millimeters, and can expand to their embedded configuration when they exit the catheter. Expansion can be accomplished via a passive mechanism, such as through potential energy of the anchor element material that accumulates as a result of being stretched into the catheter 220, or via an active mechanism in which the anchor elements (202, 204, 206, 208, 214) are expanded by an externally controlled instrument light, such as a screw, that uses a set of linkages between the proximal and distal elements to translate the proximal element relative to the distal element such that the anchor expands when the proximal and distal elements are approximated together. Additionally, expansion can be accomplished by longitudinally rotating the anchor elements relative to the tension band to which they are attached such that the long axis of the anchor elements is aligned with the longitudinal axis of the tension band 240 for passage through the catheter 220, and the anchor elements (202, 204, 206, 208, 214) are allowed to rotate relative to the tension band such that the plane approximated by the anchor elements (202, 204, 206, 208, 214) is perpendicular to the longitudinal axis of the tension band 240 when they exit the catheter 220. The construction of the anchor elements is made of implantable grade materials and may use metallic materials such as stainless steel, cobalt-chromium or nitinol, or polymeric materials such as PEEK or nylon, or composites of polymeric and metallic materials. Preferred materials in certain embodiments have a high degree of recoverable strain (>1%) so that the anchors do not plastically deform when compressed into the delivery catheter.Some embodiments disclosed herein include anchor elements (202, 204, 206, 208, 214) having a metal frame or scaffold (such as anchor element 3500 as shown in FIG. 35) that is coated with a thin material (such as sheath 3708 of coated anchor element 3700 in FIG. 37) of biological origin, such as bovine or porcine pericardium, or synthetic origin, such as polyethylene terephthalate (PET) or expanded polytetrafluoroethylene (ePTFE). The frame provides the anchor element with increased bending stiffness and passive or self-expanding properties to distribute forces from the tension band over a larger surface area. The anchor element can be substantially flat such that its length and width are at least five times its thickness in some embodiments. In some embodiments, the anchor element can be at least ten times its thickness in length and width. The sheath 3708 promotes tissue healing and ingrowth, sealing of holes by which the tension band 240 passes, and can also transfer loads between unconnected portions of the metal frame. If constructed from Nitinol or other shape memory material, the frame can be heat set into a preferred deployed configuration so that when heated to body temperature and deployed inside the body from a catheter, the frame assumes its heat set shape.

[0246] The tension band 240 can be a suture, cable, wire, twine, filament, or similar device that is secure in bending and compression while retaining a high degree of tensile strength and stiffness. The tension band 240 can also be a rod, bracket, post, support, or similar device that resists bending and compressive forces as well as tension. The construction of the tension band 240 can be made of implantable grade materials and can use polymeric materials such as PET, polyethylene, ultra-high molecular weight polyethylene (UHMWPE), ePTFE, PTFE, or other suitable polymers, or can use metallic materials such as stainless steel, nitinol, or cobalt-chromium, or can use combinations of such materials. The construction of the tension band can be monofilament or multifilament, with the filaments being axially arranged, twisted, woven, or braided. The cross-sectional dimensions of the tension band may be in the range of 0.075 mm to 0.76 mm, but in certain embodiments may be in the range of 0.13 mm to 0.38 mm to provide an optimal balance of tensile strength, flexibility, profile and abrasion resistance. The cross-section of the tension band may be substantially circular, elliptical, or flat, and the material may include a radiopaque coating or be composited with a radiopaque material to facilitate viewing under fluoroscopy, or may have filaments of radiopaque material woven or extruded through the cross-section. Examples of radiopaque materials may include platinum, platinum iridium, bismuth, barium sulfate, or tungsten. In some embodiments, the ultimate tensile strength of the tension band or tether may be greater than 2 pounds force, but in certain embodiments, may be greater than 8 pounds force. In some embodiments, the tensile stiffness may be greater than 0.045 mm / mm / N. In some embodiments, the maximum tensile stiffness of the tension band or tether can be greater than 0.045 mm / mm / N.The tensioning band 240, in some embodiments, can be a rigid or semi-rigid member capable of resisting compressive forces. In some embodiments, the tensioning band 240 can be a flexible or semi-flexible member. A flexible or semi-flexible member can have a much lower compressive strength than a rigid or semi-rigid member, such that the flexible or semi-flexible member will bend or deform under any prevailing compressive force. For example, the flexible member may bend or flex at a force that is less than 10% or less than 1% of the force that the flexible member resists when tensioned.

[0247] The locking element 230 may be constructed with holes parallel to the long axis of the lock through which all tensioning members 240 may pass freely and may be used to connect or attach tensioning members of a tensioning assembly. The lock 230 used within the treatment may be any embodiment of the tether lock disclosed in Figures 75-80, other locks disclosed herein such as lock 4850, or other suitable locks, as desired or required. When the tensioning band 240 is pulled within the lock, the portion of the tensioning members 240 between the lock 230 and the anchor members (202, 204, 206, 208, 214) is forced to shorten relative to the lock 230, thus pulling the anchor elements (202, 204, 206, 208, 214) together. FIG. 48B discloses an embodiment of a lock 4850 having a second hole 4856 exiting the side of the lock such that the tension member 240 can enter the hole extending through the lock from the distal end 4854 and exit the lock through the side hole 4856. A screw 4852 can be threaded into the proximal end of the hole extending through the lock, as shown in FIG. 48b. When the screw 4852 is threaded into the lock 4850, the lock 4850 transitions from its non-clamping configuration to its clamping configuration, clamping the tension band 240 between the hole extending parallel to the axis of the lock 4854 and the hole exiting the side of the lock 4856, locking the tension band 240 in place. Alternatively, the screw may be incorporated into the locking mechanism, such as in the tether locks 7600 and 7900 disclosed herein. The lock may be made of a metal construction, such as stainless steel or titanium, or a rigid polymer construction, such as PEEK. Another way to construct the lock is to make it from a thin-walled metal tubular structure with a central hole through which the tension band can pass freely. Once the tension band is under tension, the lock can be crimped against the tension band 240 by flattening and bending the lock with an externally controlled sliding pin or by compressing a set of opposing pins or anvils within the lock catheter. Suitable implantable materials may include stainless steel or titanium.

[0248] 14-24 illustrate an exemplary method for implanting an embodiment of the treatment into a patient's heart. In certain embodiments, the steps for implanting can include one or more of the following steps: first preparing an implant system 200 to include two or more anchors (anterior anchor 202 and left septal atrial anchor 204 as shown in FIGS. 14-24), two or more tension bands 240, and a lock 230, a guide catheter system, an implant catheter system, and a lock catheter system, to enter the venous system at the groin.

[0249] Next, the guide catheter 200 is advanced through the IVC 50 into the right atrium 2.

[0250] Next, the atrial septum 51 is lifted using the sheath 226 and dilator 224 assembly through the catheter 220.

[0251] Then, crossing the interatrial septum 51 into the left atrium 4 using the wire 222 , followed by the dilator 224 and sheath 226 .

[0252] The dilator 224 and wire 222 are then removed, leaving the sheath 226 in the left atrium 4 .

[0253] Next, advancing the septal anchor 204 through the sheath 226 and into the left atrium 4.

[0254] Next, a step of releasing the septal anchor 204 into the left atrium 4.

[0255] Next, the sheath 226 is removed from the guiding catheter 220 , leaving the septal anchor 204 in the left atrium 4 , and the tension member 240 of the septal anchor 204 is externalized through the guiding catheter 220 .

[0256] Next, a step of inserting a dilator 224 and a sheath 226 through the guiding catheter 220 next to the septal anchor suture 240.

[0257] Next, directing the guide catheter into the anterior annulus 52.

[0258] Next, the atrial septum 52 is lifted using the sheath 226 and the dilator 224 through the guiding catheter 220.

[0259] Then, the wire 222, followed by the dilator 224 and sheath 226, is used to cross the atrial septum 52 into the right ventricle 3 and / or RVOT.

[0260] The dilator 226 and wire 222 are then removed, leaving the sheath 226 in the right ventricle and / or RVOT.

[0261] Next, advancing the anterior anchor 202 through the sheath 226 and into the right ventricle 3 and / or RVOT.

[0262] Then, releasing the anterior anchor 202 into the right ventricle 3 and / or RVOT.

[0263] Next, the sheath 226 is removed from the guiding catheter 220, leaving the anterior anchor 202 facing the right ventricular surface of the tricuspid annulus, such that the tension member 240 of the anterior anchor 202 is exteriorized through the guiding catheter.

[0264] Then, an additional anterior anchor 202 is implanted in the same manner as the first anterior anchor 202.

[0265] Then, advancing the lock 230 via the lock catheter 232, within the guiding catheter 220, and over the exteriorized sutures 240 that are connected to the implant.

[0266] Next, tension is applied to the suture 240 within the right atrium 2 to draw the tricuspid annulus 52 along the right ventricular free wall to the atrial septum 51 and / or coronary sinus 54.

[0267] Then, locking the lock 230 to maintain tension on the suture 240 and cutting the free end of the suture 240 adjacent the lock.

[0268] Then finally, remove all catheters from the body.

[0269] In another embodiment, a method similar to that described above for implanting an embodiment of a treatment in a patient's heart can be performed using a substantially similar system, except that anterior anchor 202 is implanted before septal anchor 204.

[0270] The method may also further include advancing a grommet 219 along tension member 240 over the surface adjacent any embodiment of the surface anchor and opposite the surface of the heart adjacent the surface anchor. The grommet 219 acts to hold the embodiment of the surface anchor against the skin such that the section of the heart adjacent the surface anchor is sandwiched between the anchor and the grommet and the anchor cannot move from its location.

[0271] The procedure may be performed under ultrasound imaging guidance, e.g., transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE), and fluoroscopic imaging guidance. The steps for implantation may be performed in a different order than described, e.g., anterior anchor 202 may be implanted before septal anchor 204. The number of anchors implanted may be at the discretion of the implanting user. The guiding catheter 220 may be of a steerable configuration through the use of a pull cable that is fixed at one or more points 5 centimeters distal to the guiding catheter 220 that is controlled from outside the body, e.g., by turning a knob or pulling a lever on the guide catheter handle that applies tension to the pull cable and shortens it relative to the catheter shaft. The pull cable may be biased to one side of the catheter shaft such that shortening the pull cable shortens the catheter shaft on the side where the pull cable is biased, resulting in the catheter shaft bending in the direction of the pull cable. Alternatively, the central slidable lumen can be pulled against a fixed outer lumen of the structure, where the material of the outer lumen is such that the flexural modulus is higher on one side of the outer lumen relative to the other side of the outer lumen in one or more regions of the outer lumen within the distal 5 centimeters. Pulling the lumen exerts a compressive force on the outer lumen, which causes the catheter to bend in the direction in which the flexural modulus of the outer lumen is lower. An advantage to this structure is that the tensile member is substantially along the neutral axis of the catheter, where the flexural modulus of the outer lumen is uniform around the circumference, and where bending or curving may be undesirable, the catheter does not bend or curve along the proximal region. The guiding catheter 220 can be steerable in one, two, three or four directions, and if there are two or more steering planes, the articulation points can be at the same location or separated by a distance of 0.5 centimeters to 4 centimeters along the length of the catheter, resulting in the catheter bending in different directions in two or more separate regions.

[0272] The wire 222 used to cross the septum 51 and tricuspid annulus 52 can optionally be powered by alternating current in the radio frequency range so that the wire forms an electrode such that a sudden change in impedance at the distal end of the wire results in an arc, heating the tip of the wire and allowing it to cross tissue more easily. Alternatively, the tip of the wire 222 can be sharpened to increase the stress concentration on the tissue as the wire is pressed against it, allowing the wire to pierce and cross tissue more easily. The distal end of the wire 222 can be straight so that as it extends from the dilator 224 it travels in substantially the same direction as the tip of the dilator is pointing, or the distal end of the wire 222 can be curved so that it takes a more favorable path through tissue or travels a curved path relative to the dilator to avoid various structures as the wire exits the heart chamber. The curvature of the wire 222 can be variable and can be straight or configured in a helical or pigtail configuration proximal to the less tightly curved section so that the wire curls into one or more loops as it exits the dilator and is less traumatic when it contacts cardiac tissue distal to the tissue being traversed. Additionally, the curvature of the wire can be configured so that the distal tip curves in a different (or the same) direction as the more proximal section so that the curvature of the more proximal section matches the curvature of the guide catheter (due to the wire taking a path that results in the lowest strain energy in the wire) and the distal section curves in a predictable and controllable direction as it exits the dilator.

[0273] When reference is made to the anterior annulus 52 or anterior implant or anchor 202, this refers to a location substantially spanning the atrial septum 51 across the tricuspid valve 10 and may include the area from the septal commissure of the anterior leaflet 12 to approximately the center of the posterior tricuspid leaflet. Reference to the right ventricle 3 or the right ventricular surface of the anterior tricuspid annulus 52 may also include the portion of the RVOT 57 in close proximity (within 10 mm or within 15 mm or within 20 mm) to the tricuspid annulus. Utilizing it, the portion of the RVOT behind the anterior tricuspid leaflet 12 and / or anterior tricuspid annulus offers the inherent advantage of a large space to safely pass a wire thereto (or therefrom) and place a surface anchor, while also having a relatively large tissue thickness between the right ventricle and right atrium that can contribute to a robust anchor location. Optionally, after delivery of each anchor element (202, 204, 206, 208, 214), a grommet such as 215, 219, 4710, 4802, 7030, 7102, 7220, 7302 or 7402 having a lock 230 attached to or separate from the grommet may be advanced over the suture attached to the anchor element and abut tissue on the heart chamber adjacent to that chamber, causing the anchor element to abut (e.g., against the right atrial septum for a left atrial anchor element, or against the right atrial annular surface for an anterior anchor element). The lock is then used to clamp the suture so that the tissue is between the anchor element and the grommet, and the grommet and lock hold the anchor element against or in close proximity to the tissue during the remainder of the procedure or if the suture is cut or broken. Thus, the anchor element cannot move or embolize in the absence of tension on the tether to which it is attached. A grommet as used herein can be a grommet disclosed herein and shown in Figures 71, 72A, 73, or 74, or any other grommet available, as desired or required.

[0274] Tensioning of tension members 240 secured to the septal and anterior anchor elements (202, 204, 206, 208, 214) can be performed under ultrasound and fluoroscopic guidance at the user's discretion to reduce or eliminate tricuspid regurgitation 6 and increase coaptation between the tricuspid valve leaflets.

[0275] An alternative embodiment disclosed herein includes an anchor element (such as left ventricular septum anchor 208 of FIG. 5 ) positioned against the left ventricular wall below mitral valve 15 on the interventricular septum with attached suture 240 passing from left ventricular cavity 5 to right atrium 2. Yet another embodiment disclosed herein includes an anchor element (such as right ventricular septum anchor 206 of FIG. 5 ) positioned against the right ventricular surface below tricuspid valve 10 near the interventricular septum with attached tether 240 passing through tricuspid annulus 52 and / or ventricular myocardium to right atrium 2 and / or coronary sinus 54. Yet another embodiment disclosed herein includes an anchor element (such as coronary sinus anchor 214 of FIGS. 10, 11 and 12 ) abutting the inferior surface of coronary sinus 54 with attached tension member 240 traversing left ventricular myocardium 56 below coronary sinus 54. As the tether passes through the left ventricular myocardium 56, it can form a loop as in Figures 10 and 12, or it can form a curved path with the anchor at the distal end as in Figure 11. The steps for implantation of any of the alternative embodiments are substantially the same as those previously described, except that the guiding catheter is oriented to facilitate implantation of the anchor element in the alternative anatomical location. Any of the embodiments disclosed herein can be utilized alone or in combination with any of the other embodiments. Any of the anchor embodiments disclosed herein can be used in any one or all of the anatomical locations disclosed herein.

[0276] 25-31 show steps for implantation of another embodiment disclosed herein. The figures generally depict one embodiment of a foldable flat implant system 4000 comprising a guiding catheter 4001, a flexible steerable delivery catheter 4002 non-fixedly connected to an anchor bar 4040, a septal anchor 4020, and a snare catheter 4070. The anchor bar 4040 can incorporate holes or slots for passage of one or more guidewires 4060 that can penetrate into an anatomical location within the heart substantially similar to the guidewire 222 disclosed herein. The snare catheter 4070 can be comprised of one or more snare guide catheters 4072 that guide one or more snare wires 4074 used during the method of implanting another embodiment disclosed herein. The septal anchor 4020 disclosed herein can be substantially similar to the anchor 204 as disclosed in FIGS. 17-24.

[0277] Steps for implanting an embodiment of the foldable flat implant system 4000 as disclosed in Figures 25-31 may include one or more of the following steps: First, guide the catheter 4001 into the venous system at the groin.

[0278] The catheter is then advanced through the IVC 50 into the right atrium 2.

[0279] Next, lifting the atrial septum 51 through the catheter with a sheath and dilator assembly, such as the sheath 226 and dilator 224 disclosed herein.

[0280] Next, crossing the interatrial septum 51 into the left atrium 4 using a guidewire, such as the guidewire 222 disclosed herein, followed by a dilator and sheath.

[0281] The dilator and wire are then removed, leaving the sheath in the left atrium.

[0282] Next, a septal anchor 4020 is advanced through the sheath into the left atrium.

[0283] Next, releasing the septal anchor 4020 into the left atrium.

[0284] The sheath is then removed from the guiding catheter, leaving the septal anchor in the left atrium, and the septal anchor suture is exteriorized through the guiding catheter.

[0285] Then, with the attached anterior anchor 4040 in a folded or compressed configuration, the steerable anterior anchor delivery catheter 4002 is inserted into the guiding catheter 4001 and the anchor is advanced to the distal end of the guiding catheter.

[0286] Next, the guide catheter 4002 is directed above the tricuspid valve 10.

[0287] The anterior anchor delivery catheter 4002 is then extended to direct the anterior anchor 4040 through the tricuspid valve and into the right ventricle 3 and / or RVOT.

[0288] Next, bend the anterior anchor delivery catheter 4002 to form a "J" shape in the right ventricular outflow tract 57 such that the anterior anchor 4040 is hooked behind the anterior tricuspid leaflet 12 in the right ventricle 3, as in Figure 25. Figure 25 shows the guiding catheter 4001 in the right atrium 2 above the tricuspid valve 10 with the anterior anchor delivery catheter 4002 passing through the tricuspid valve 10 and hooked below the anterior tricuspid leaflet 12 in the right ventricle 3. The anterior anchor 4040 is shown mounted on the distal end of the catheter 4002 in a folded configuration. The septal anchor 4020 abuts against the left atrial wall and the attached tension band 4074 passes through the atrial septum 51 into the guiding catheter 4001.

[0289] The anterior anchor 4040 is then unfolded or expanded into a deployed configuration that is generally flat and has a length of between 1 and 4 centimeters, although in certain embodiments, between 1.5 and 2.5 centimeters.

[0290] The anterior delivery catheter 4002 is then pulled so that the anterior anchor abuts the right ventricular surface of the anterior tricuspid annulus 52 and the anterior anchor spans a distance of 1 centimeter to 4 centimeters of the anterior tricuspid annulus 52.

[0291] Then, two or more guidewires 4060 are passed through the anterior anchor and across the annulus, with the outermost wires spaced 1-4 centimeters apart, so that the wires exit into the right atrium, as shown in Figure 26. Figure 26 shows the anterior anchor 4040 in an expanded or deployed configuration in the right ventricle 3 behind the anterior tricuspid leaflet 12, with wires 4060 passing through each end of the anterior anchor crossing the anterior tricuspid annulus 52 from the right ventricle 3 to the right atrium 2.

[0292] Then, capturing two or more guidewires 4060 in the right atrium with an equal number of snare catheters 4070 , the snare catheters 4070 being advanced through the snare guide catheters 4072 .

[0293] Next, the wire 4060 attached to the suture 4074 with the plug 4076 at its end is pulled externally to the patient through the guiding catheter 4001 until the plug 4076 end of the suture abuts the anterior anchor, as shown in Figures 27-29. Figure 27 shows the snare catheter 4072 exiting the guide catheter 4001 into the right atrium 2 and positioned to capture one of the wires 4060 spanning the anterior tricuspid annulus 52. Figure 28 shows the first tension member 4074 of the anterior anchor 4040 captured through the guiding catheter 4001 with the plug 4076 at the end of the tension band 4074 abutting the anterior anchor 4040. FIG. 29 shows a second snare catheter 4072 exiting the guiding catheter and entering the right atrium 2 and positioned to capture a second wire 4060 spanning the anterior tricuspid annulus 52.

[0294] Next, detach the anterior anchor 4040 from the anterior anchor delivery catheter 4002 and remove the anterior anchor delivery catheter 4002, as shown in Figure 30. Figure 30 shows both tension bands 4074 connected to the anterior anchor 4040 captured through the guiding catheter 4001, with the plug 4076 at the end of the tension band 4074 abutting the anterior anchor 4040 and the anterior anchor delivery catheter 4002 being removed.

[0295] Then, advance a suture lock 4080 through the locking catheter 4082 and over the exteriorized suture 4074 connected to the implant within the guiding catheter, as shown in Figure 31. In this view, the anterior anchor is shown abutting the ventricular surface of the anterior tricuspid annulus 52, with the attached tension band 4074 routed to the lock 4080 near the atrial septum 51. The septal anchor 4020 is shown abutting the left atrial wall, with the attached tension band 4074 routed to the lock 4080. A locking catheter 4082 extends from the guiding catheter and is connected to the lock 4080.

[0296] Next, tension is applied to the suture 4074 within the right atrium 3 to draw the tricuspid annulus 52 along the right ventricular free wall to the atrial septum 51 and / or coronary sinus 54.

[0297] Then, locking the suture lock 4080 to maintain tension on the suture and severing the free end of the suture adjacent the lock.

[0298] Then finally, remove all catheters from the body.

[0299] A foldable flat implant system 4000 for use in the above method is further shown in Figures 40A-43. The anterior anchor 4040 may be constructed using a superelastic frame made from Nitinol wire or laser cut Nitinol sheet or strip having a length of about 10-35 mm and a width of about 3-7 mm, such as the anchor bar structure 4044 of Figure 42A. The frame may be attached to a stainless steel, titanium, or polymer hub 4050 (such as polyetheretherketone (PEEK) or polyphenylsulfone) by providing a snap fit, where the frame extends over the hub and fits into a groove 4056 on the hub 4050. The hub may be threaded and may have a hole 4054 extending through its center such that it can be threaded to a guidewire-catheter connection 4010 that can swivel during deployment, the guidewire-catheter connection 4010 being connected to a guidewire catheter 4064 on the delivery catheter 4002 such that the hole 4054 allows for the passage of the wire 4062 and suture 4074. Advantageously, the hole 4054 through the hub 4050 is sized such that it fits tightly to allow the wire 4062 and suture 4074 to pass freely, but that a plug, sleeve or knot attached to the end of the suture will be trapped such that, when trapped, the suture will transmit tension to the anchor. The hub 4050 may alternatively take the form of a rigid eyelet or similar rigid feature with a through hole to allow the guidewire 4062 to pass through the anterior anchor 4040. The anchor may be coated with a flexible material 4042, such as, for example, a silicone elastomer, a thermoplastic elastomer such as Pellethane®, PTFE felt, or other suitable implantable grade material to minimize stress concentrations on the tissue and seal holes through the tissue through which the suture 4074 passes. The coating may be molded (injection or compression molded) over the frame, or sewn to the frame with thread or sutures, or heat bonded to the frame.The sheath and / or frame may be tapered in cross section, as shown by 4052 in FIG. 42B, resulting in a thinner center and therefore less bending stiffness at the center, so that when tension is applied to the ends of the anchor (through the hub 4050) and the center of the anchor 4040 is held stationary, the anchor will preferentially fold around its center to facilitate progression through the guide catheter 4001 and movement behind the anterior tricuspid leaflet 12 into the RVOT without entangling with the chordae. When tension applied to the hub 4050 is released, the superelastic properties of the frame allow it to return to a flat deployed configuration without plastically deforming. The center of the anchor may be a threaded hole or molded into an L-shaped latch for attachment to a delivery catheter. The delivery catheter 4002 may include a flexible guidewire catheter 4064 secured to a guidewire-catheter connection 4010 that is threaded on its distal end for attachment to the anchor hub, as shown in FIG. 41. The guidewire catheter connection 4010 has a hole through the center to allow the wire 4060 and tension band 4074 to pass through and can swivel between 0 and 90 degrees between the distal and proximal ends such that in a first collapsed configuration, the axis of the anchor hub can be substantially perpendicular to the axis of the delivery catheter and in a second deployed configuration, the axis of the anchor hub can be substantially parallel to the axis of the delivery catheter. The flexible guidewire catheter 4064 can be of laser cut stainless steel construction with discontinuous slots cut around the circumference of the tube to provide flexibility while maintaining torsional stiffness, or can be of multi-filar helical twisted stainless steel cable construction. The guidewire catheter 4064 can be coated with a polymer such as Pebax or fluorinated ethylene propylene (FEP) to enhance lubricity. Alternatively, the guidewire catheter 4064 can be of braid-enhanced polymer construction such as Pebax, nylon or polyimide. The anterior anchor delivery catheter 4002 can be steerable similar to the guiding catheters disclosed herein.

[0300] FIG. 32 shows one embodiment of the device as viewed from the right atrium 2, with two flexible bands 240 traversing from a location in the right ventricle 3 in or around the right ventricular surface of the anterior tricuspid annulus 52 (the portion of the tricuspid annulus that is attached to the anterior tricuspid leaflet), through the annulus tissue, into the right atrium 2, and to a locking hub or lock 230 located on the right atrial side, near the inferior and posterior surface of the atrial septum 51. Each tensioning member 240 is connected to a right ventricular surface anchor 202 (such as the anchor shown in FIGS. 2-13) located at the anterior annulus 52 of the tricuspid valve 10 through a knot, crimp connector, or cam lock mechanism. Applying tension to the flexible bands 240 pulls the surface anchor 202 against the right ventricular surface of the anterior tricuspid annulus 52, thereby pulling the anterior tricuspid annulus 52 towards the suture lock and reducing the distance between the anterior tricuspid annulus 52 and the atrial septum 51. Unique aspects of the location of the right ventricular anchor 202 shown in FIG. 32 are that 1) the anchor is substantially in or near the space forming the right ventricular outflow tract 57, safely crossing the tricuspid annulus (without risk of puncturing the right coronary artery or damaging the tricuspid valve leaflets) and providing a large surface area on the ventricular side of the tricuspid annulus to counteract tension on the tricuspid annulus and position the large area anchor 202 (distributing force over a large surface area, thus reducing stress on the tissue), and 2) the force line created by two or more tension members spanning the anterior tricuspid annulus 52 substantially reduces tricuspid annulus dimension in the region of the tricuspid valve 10 that most frequently exhibits regurgitant jets 6 in functional tricuspid regurgitation.

[0301] FIG. 34 shows the septal portion of the Nitinol mesh anchor 218 shown in FIG. 32. The septal portion of the device is located in the left atrium 4, below the fossa ovalis 53 and above the mitral valve 15. The septal device can be constructed from a septal anchor 218 that sits substantially flat against the left atrium (to prevent interference with common mitral valve 15 interventions and minimize risk of thrombosis), traverses through the atrial septum 51, and is connected to a flexible band 240 that is connected to a lock 230. This location is significant in that it is thick, muscular, and in close proximity to the superior surface of the left ventricular myocardium, making it relatively immobile compared to the anterior tricuspid annulus 52. When the tensioning member 240 connected to the anterior tissue anchor 202 and the band connected to the septal tissue anchor 218 are tensioned within the lock 230 by a catheter 232 inserted in the left or right femoral vein, a force vector is generated that pulls the anterior tricuspid annulus 52 toward the atrial septum 51. The lock 230 can be actuated via the catheter 232 to clamp the flexible tension member 240 and maintain tension on the band. The catheter 232 can then be used to cut the tension member 240 proximal to the suture lock, so that any excess material can be removed or cut away, with only minimal material permanently remaining in the patient. Cutting away excess material from the tension member is beneficial in limiting unwanted interference in the operation of the heart or unwanted thrombogenic responses. An alternative angle of this placement can be shown in FIG. 33, which shows a right ventricular perspective looking up at the tricuspid valve 10 of two expandable anchor elements 202 positioned in and near the RVOT 57 and facing the right ventricular surface of the anterior tricuspid annulus 52.

[0302] Several embodiments of tissue anchors are disclosed herein. In one embodiment shown in Figures 33 and 35-38, the anchor element 3500 is constructed from a nitinol wire that forms a periphery 3502 and an interior region where the wire creates one or more intersections 3506. The wire can be spirally wound around itself around the periphery in two or more layers such that the layers are locked together, so that a force applied to one layer or the central intersection 3506 is transmitted to all layers simultaneously. The nitinol wire can be heat set to maintain its shape when in the austenitic state, and the free ends of the wire can be connected by a sleeve that can be crimped or otherwise joined to the nitinol wire, such as sleeve 3504 shown in Figure 35, or the ends of the wire can be fused together by welding. The austenite finish temperature (Af) of nitinol can be the temperature at which the nitinol material becomes austenitic structure when heated to body temperature (at or about 37°C). The body temperature can typically range from 97°F (36.1°C) to 99°F (37.2°C), but can be slightly above or below this range depending on various factors, and in certain embodiments the austenite finish temperature (Af) can be 97°F (36.1°C) to 99°F or about 97°F (36.1°C) to about 99°F. The anchor periphery can be constructed to be substantially oval, as in the anchor element shown in FIG. 35, substantially circular, such as the embodiment shown in FIG. 36, or any other shape, as desired or required. The anchor can be a bare wire, as in FIG. 35, or can be covered with an optional sheath 3708, such as synthetic (PET, ePTFE, etc.) or biological (pericardial tissue) derived sheath 3708, as shown in FIG. 37. The sheath 3708 can be tightly attached to the wire form or can be loose (allowing relative movement between the sheath and the wire form).The sheath forms an interactive layer between the anchor and tissue, promotes tissue healing and incorporation (ingrowth) of the anchor into the tissue, provides sealing of holes through which the flexible tension band passes through the tissue, and serves to lock the wire forms together across their surface area. Suitable techniques for attaching the sheath to the frame may include suturing or stitching the sheath to the frame, heat bonding the sheath to the frame, molding the sheath around the frame, or other suitable attachment processes, as appropriate. A flexible tension band 3710, substantially similar to other tension bands disclosed herein, such as tension band 240, may be connected at or near the center of the wire form (as demonstrated in FIG. 37, the flexible band 3710 is connected to the wire intersection 3506 of the covered anchor element 3700 with optional sheath 3708), such that when the flexible band 3710 is pulled, it transfers tension substantially to the center of the wire form at its connection to the covered anchor element 3700 at the knot 3712. In this manner, when the flexible band 3710 is pulled through the hole and the anchor contacts the opening to the hole, the entire periphery 3502 of the anchor faces the entrance to the hole, similar to other anchors disclosed herein, such as a T-bar. The wireform construction of the anchor element 3500 and the superelastic properties of its material, Nitinol, allow the anchor to be compressed along its length, thereby substantially elongating and narrowing its shape, facilitating its passage through and through a catheter 3800 having an inner diameter substantially smaller than the length or width of the unconstrained anchor, as demonstrated in FIG. 38, which shows the anchor element 3700 of FIG. 37 compressed and elongated within a transparent tube that mimics a deployment catheter 3800. When the anchor is released from the constraint of the catheter 3800, such as by exiting the catheter, the anchor expands back to its pre-configured form, creating a large surface area over which forces can be transmitted to tissue.The anchor 3700 is rotatable relative to the flexible band 3710 such that when the anchor 3700 is compressed and elongated as shown in FIG. 38 in its first, undeployed configuration, it can also be rotated relative to the flexible band 3710 to a first pre-deployed state, where the axis of the flexible band 3710 and the plane formed by the anchor 3700 in the pre-deployed state are relatively parallel to one another to facilitate translation into and through the catheter. Once the anchor 3700 is deployed from the catheter and is no longer constrained by the catheter, any force applied to the anchor 3700 along an axis from an attachment location on the anchor 3700 to the flexible band 3710 will cause the anchor 3700 to rotate relative to the band to the point where the plane formed by the anchor 3700 is perpendicular rather than parallel to the axis of the flexible band 3710. When the flexible band 3710 is pulled through an opening, such as a passageway through tissue, with the anchor 3700 on one side of the opening and the free end of the flexible band 3710 on the other side of the opening, the anchor 3700 comes into contact with a material, such as cardiac tissue, through which the opening rotates the anchor relative to the flexible band until the side of the anchor opposite the side originally in contact with the material also comes into contact with the material. Once the anchor comes into contact with the material, the anchor achieves its second deployed configuration in which the moment on the anchor relative to the attachment point of the flexible band 3710 is balanced and the plane of the anchor is either perpendicular rather than parallel to the axis of the flexible band, or at some angle to the axis of the flexible band other than parallel that causes the anchor to achieve rotational equilibrium. Thus, in the second deployed configuration, the anchor lies flat against the material through which the opening passes and resists entering the opening.

[0303] FIG. 39 shows a braided nitinol septal anchor 204 abutting the left atrial wall of the heart with a grommet 219 (similar in function to the coronary sinus grommet or pad 215 of FIG. 12) secured to the tension band 240 where the tension band exits the right atrium such that the septum 51 is sandwiched between the anchor and grommet and the anchor cannot move from its location.

[0304] In other embodiments of the tissue anchor, the anchor frame can be laser cut from a nitinol sheet material with a central hole, or intersections, and various diamond elements, such as the anchor frames shown in Figures 45, 50 and the frame 7020 of the anterior surface anchor 7002 shown in Figures 69 and 70. The diamond elements allow the anchor to be compressed and elongated so that it can reduce its cross-sectional area for delivery through a catheter and expand to its deployed configuration upon exiting the catheter. The anchor can be coated with a polymeric or biological sheath, as disclosed above. The central hole is sized to allow the tension band to pass freely, but not allow the knot at the distal end of the tension band to pass, so that when the tension band is pulled, the knot transmits force to the anchor.

[0305] In other embodiments of tissue anchors, such as that shown in FIG. 44, the anchor is constructed from braided nitinol wire with the proximal and distal ends fused to a hollow tube that allows the tension band to pass freely through. The anchor may be heat set into a circular, elliptical, or oblong disk, or multiple disks (e.g., anchor 4450 in FIG. 44b), to provide a large flat surface area for transmitting force to the tissue. The tension band may be free to pass through the center of the anchor and secured to the distal hub, or it may have a knot on the distal end that interferes with a hole through the distal hub of the anchor, so that when the tension band is pulled, a force is applied to the distal hub of the anchor, which causes the anchor to flatten against any surface it abuts, as shown in FIGS. 44A-D. The anchor may be pulled from the proximal end, or the distal and proximal ends of the anchor may be pulled outwardly relative to one another, causing the anchor to elongate and reduce in diameter when in its undeployed configuration 4408, such as catheter 4408, so that it can be loaded into and deployed from the catheter. By constructing the anchor from multiple disks, the amount of material in contact with the tissue is increased, thereby increasing the force required to pull the anchor through tissue without increasing the force required to elongate the anchor for delivery through the catheter.

[0306] One, two, three or more tissue anchors, each connected to a flexible band, can be placed on the right ventricular surface of the anterior tricuspid annulus 52. Additional anchors (as many as the practitioner selects), each connected to a flexible band, can be implanted around the tricuspid annulus at any location along the anterior or posterior annulus. All flexible bands can be routed to a central lock located near the atrial septum or anywhere above the tricuspid valve opening, and the bands can be tensioned simultaneously, individually, or in any combination in between to pull each tissue anchor toward the atrial septum.

[0307] In another embodiment, two or more bands can be connected to a single tissue anchor that spans the ventricular surface of the anterior tricuspid annulus 52, such as with a foldable flat implant system 4000 as disclosed in Figures 40-43. When two or more flexible bands are attached to a single anchor, at least two of the flexible bands 4072 are located near either end of the anchor 4040 such that the portion of the anchor between the flexible bands spans one to four centimeters of the anterior tricuspid annulus 52 and the bands traverse from the right ventricle 3 through the annular muscle 52 to the right atrium 2 at a location on the anterior annulus 52 spaced one to three centimeters or more apart. In the case of a single anchor 4040 with multiple flexible bands 4072 attached, the anchor may be collapsible by providing a flexible internal frame 4044 as in FIG. 41 or by providing a linkage mechanism such that it can be introduced into the RVOT and collapsed into a slim profile to minimize any interaction with the native chordae tendineae, and then expanded once in the RVOT at or near the ventricular surface of the tricuspid annulus.

[0308] An embodiment of a system for placing multiple bands on a single anchor as shown in Figures 40-43 includes a foldable flat implant system 4000 having a flexible delivery catheter 4002 for delivering an anchor bar 4040 that is non-fixably attached to a delivery catheter anchor interface 4008, the anchor bar 4040 having a guidewire hub 4050 with tether holes 4048 that allow passage of at least two anchor bar guidewires 4060 that interact with a snare wire 4074 that is guided by a snare guide catheter 4072 housed within a snare catheter 4070. A process demonstrating the placement is shown in Figures 25-31.

[0309] The anchor bar 4040 can be made of a flexible biocompatible material and is shown in dashed lines in FIGS. 40A-43 to show the internal components. The anchor bar 4040 includes an anchor bar structural member 4044 that can be constructed of Nitinol or some other semi-rigid material to provide structure to the anchor bar 4040. Connected to the anchor bar structural member 4044 is an anchor bar guidewire hub 4050 that can be connected to a guidewire catheter 4064 that supports the anchor bar guidewire 4060 during use via a guidewire hub screw 4054 that is connected to a guidewire catheter connection 4010. The anchor bar 4040 has an anchor bar delivery connection 4046 for non-fixed connection to a flexible delivery catheter 4002 at a delivery catheter anchor interface 4008. The anchor bar 4040 is covered by an anchor bar sheath 4042 that is made of a biocompatible material. The anchor bar 4040 is flexible so that it can be bent for ease of use while inserting the foldable flat implant system 4000 into a patient, as shown in FIG.

[0310] The anchor bar guidewire 4060 passes through the anchor bar 4040, which is connected to a guidewire-catheter connection 4010 that accommodates the guidewire, and which is a flexible hinge to accommodate the flexibility of the anchor bar 4040. The guidewire-catheter connection 4010 is constructed from a distal element 4012 having threads on a distal end that are configured to attach to the guidewire hub threads 4054, and a proximal element 4016 having a rotation slot point passing through its distal end, through which the proximal element 4016 interfaces with the distal element 4012 via a pin 4014 that passes through a pore in the proximal element 4016 and the distal element 4012. The pin allows the proximal element 4016 to pivot from parallel to perpendicular to the distal element 4012 while transmitting torsional, tension and compression forces between the distal and proximal elements. This hinged connection helps reduce angular strain on the anchor bar guidewire 4060. The anchor bar guidewire 4060 passes through the anchor bar guidewire lumen 4048, which is surrounded by the anchor bar guidewire hub 4050, and terminates in an anchor bar guidewire distal tip 4062 that is sharpened to facilitate entry into cardiac tissue.

[0311] During deployment, the anchor bar guidewire distal tip 4062 passes through the patient's tissue to interact with a snare wire 4074 provided by a snare guide catheter 4072 delivered through a snare catheter 4070 connected to the foldable flat implant system 4000. The anchor bar guidewire 4060 can be connected to the snare guide catheter 4072 and can be retracted through the tissue and snare catheter until it is exteriorized from the patient. The anchor bar guidewires 4060 can have flexible tethers (such as sutures) attached to their distal ends such that when the anchor bar guidewire is fully pulled through the snare catheter, it is pulled through the guidewire hub 4050 of the anchor bar 4040 until a knot or other suitable termination on the tether interferes with the hole 4048 in the guidewire hub 4050.

[0312] 44A-51C show alternative embodiments of tissue anchors.

[0313] In other embodiments of tissue anchors, the anchors can be laser cut from a Nitinol sheet material with a central hole or intersections as well as various diamond elements such as anchor 4400 shown in FIG. 44A. Anchor 4400 is shaped into a disk configuration. An end view of the anchor is shown depicting the anchor as substantially circular. The anchor can be elongated so that the disk is collapsed into an elongated tube for delivery through a catheter. Tension band 240 is centrally attached to the distal end of the anchor via an interference knot 4404, which allows the anchor to flatten when tension band is applied. Diamond elements 4402 allow the anchor to be compressed and elongated so that it can reduce its cross-sectional area for delivery through a catheter and expand to its deployed configuration upon exiting the catheter. The anchor can be coated with a polymeric or biological sheath as disclosed above. The central hole 4406 is sized to allow the tension band to pass freely but not allow the knot at the distal end of the tension band to pass through so that when the tension band is pulled, the knot transmits force to the anchor.

[0314] 44B shows an embodiment of an anchor element where the anchor 4450 is constructed from braided nitinol wire that is shape-set into a series of disks. Although two disks are depicted, any number of disks can be constructed. The anchor is shown abutting a cross section of tissue with small holes for tension bands 240. Having multiple disks increases the amount of material abutting the tissue, making the anchor more resistant to pulling through the tissue without increasing the stiffness of the anchor to collapse into the delivery catheter.

[0315] FIG. 44C shows one embodiment of an anchor element 4460 constructed from braided nitinol wire in which the anchor is shaped into two discs such that when the tension band 240 is tensioned, the distal disc 4462 abuts against the tissue and resists pulling, and when the tension band is slack or if it is cut or broken, the proximal disc 4464 slides over the tension band and holds the anchor in place.

[0316] FIG. 44D illustrates one embodiment of an anchor element 4470 similar to the embodiment shown in FIG. 44C, except that the anchor 4470 is held in place on the proximal end by shaped Nitinol fingers 4474. The anchor 4470 has a distal disk 4472 substantially similar to the distal disk 4462 of FIG. 44C. The fingers can be laser cut from a tube or can be individual wire elements that are attached to the proximal hub of the anchor and can be straightened for advancement through a delivery catheter. Although four fingers are depicted in a cross configuration, any number of fingers can be used in this configuration.

[0317] 45 shows an anchor embodiment 4500 in which the anchor is constructed from a laser cut nitinol sheet with a diamond pattern 4502. This laser cut pattern allows the anchor to be compressed and elongated into a slim profile for delivery through a catheter, and then passively return to the deployed configuration shown upon exiting the catheter. The central hole 4504 does not allow the knot 4506 in the tension band 240 to pass through, so that when the tension band is tensioned, it pulls the anchor from the center, allowing the anchor to lie flat and intimate against any surface it comes into contact with.

[0318] 46A-C show how embodiments of the anchors disclosed herein, such as the anchors from FIGS. 35-38, 45, 50, and 69-74, can be deployed within a patient. FIG. 46A shows a side cross-sectional view of an exemplary anchor element with tension band 240 abutting tissue through which it is passing. FIG. 46B shows the anchor shown in FIG. 46A being inserted into a catheter 4600, which can be substantially similar to other delivery catheters disclosed herein, such as catheter 220. FIG. 46C shows the anchor shown in FIG. 46B being deployed from catheter 4600, which assumes a deployed configuration when the tension band is tensioned and the anchor contacts any surface.

[0319] FIG. 47A shows an anchor such as that shown in FIG. 45 and FIG. 50A-C with a proximal grommet 4710 constructed from a laser cut nitinol tube snapped into the central bore of the anchor. FIG. 47B shows an isometric view of the grommet element shown in FIG. 47A. The grommet 4710 includes a plurality of laser cut nitinol fingers 4712 that are curved and shaped into a configuration that radiates away from the tube axis so that the fingers can hold the anchor 4702 in place on the tissue while the tension band is loose or if the tension band 240 breaks or is severed. The distal end 4720 of the nitinol tube 4714 is constructed with a raised step 4722 and a taper 4723, with a slot 4724 cut into it to form a cantilever section. When the anchor 4702 is tensioned against the tube 4714, the taper 4723 at the distal end of the tube causes the beam to deflect toward the centerline, allowing the raised step 4722 to pass through a hole in the anchor 4702. Once the raised step 4722 passes through the hole, the potential energy stored in the beam straightens the raised step and locks the raised distal end 4720 of the tube to the anchor.

[0320] 48A shows an alternative configuration for holding the anchor 4800 in place when there is no tension on the tension band, where tissue is compressed between an anchor 4800 on the distal end and a flat grommet 4802 on the proximal end that slides over the tension band 240. A lock 230 is crimped onto the tension band 240 to lock the distance between the anchor 4800 and the grommet 4802. The grommet can be of a similar configuration to any of the anchor or grommet elements disclosed herein.

[0321] FIG. 48B shows a similar configuration to FIG. 48A , except that the grommet 4802 is locked to the anchor 4800 using a locking mechanism 4850 that utilizes a screw 4852 that, when rotated, clamps the tension band between a central hole 4854 and a side exit hole 4856.

[0322] Figures 49A-F show various alternative anchor concepts, where Figure 49A shows a braided nitinol anchor similar in function to the Amplatzer device, Figure 49B shows an S-hook anchor, Figure 49C shows a T-bar anchor, Figure 49D shows a Ship anchor, Figure 49E shows a suture contained within a bar anchor, and Figure 49F shows a rigid hook contained within a bar, which may include additional barbs.

[0323] 50A shows an anchor embodiment 5000 in which the anchor is constructed from a laser cut nitinol sheet with a diamond pattern 5002 that allows the anchor to be compressed and elongated into a slim profile for delivery through a catheter, followed by passively returning to the deployed configuration shown upon exiting the catheter. The central hole 5004 does not allow the knot 5006 in the tension band 240 to pass through, so that when the tension band 240 is tensioned, it pulls the anchor from the center, allowing the anchor to lie flat and intimate against any surface it comes into contact with.

[0324] FIG. 50B illustrates an alternative cutting configuration of an anchor 5020 that is substantially similar to the anchor 5000 of FIG. 50A.

[0325] FIG. 50C illustrates an alternative cutting configuration of an anchor 5040 that is substantially similar to the anchor 5000 of FIG. 50A and the anchor 5020 of FIG. 50B.

[0326] FIG. 51A shows an anchor embodiment 5100 constructed from a Nitinol wire that is shaped to form a series of lobes 5102. The wire is wound into tight loops 5104 between each lobe, resulting in a central hole being formed through the anchor. A tension band 240 passes through the central hole, which constrains the lobes from radially displacing relative to one another. The tension band 240 has a knot 5106 formed at its distal end that cannot pass through the central hole formed by the tight loops 5104, such that when the tension band 240 is pulled, the knot 5106 contacts the center of the anchor 5100 and pulls the anchor 5100 from the center. The anchor 5100 can be elongated to facilitate delivery through the catheter, and upon exiting the catheter, returns to its shaped configuration due to potential energy stored in the wire from the straightening process.

[0327] FIG. 51B shows an anchor embodiment 5120 that is substantially similar to the anchor 5100 of FIG. 51A, except that in addition to the lobes 5102, the wire is also formed into a peripheral circle 5122.

[0328] FIG 51C illustrates an alternative embodiment of the anchor 5120 shown in FIG 51B. The anchor can be straightened to facilitate delivery through the catheter. The anchor can be pulled into the catheter simply by pulling on the distal end of the arched wire that forms the anchor 5120, and pushed back out of the catheter by pushing on either the distal or proximal end of the arched wire. Pushing on the distal end causes the anchor to elongate as it is pushed due to counteracting frictional forces against the catheter wall proximal to the force application point, which reduces the deployment force compared to pushing from the proximal end.

[0329] Any of the anchor embodiments disclosed herein may also include a grommet on the wall of the tissue opposite where the anchor abuts. The grommet holds the anchor in place when there is no tension on the tension band or if the tension band is cut or broken. The grommet may also be permanently fixed to the anchor, may be fixed to the anchor after deployment by providing a snap-fit ​​connection, or may be a separate component that is slid over the tension band and locked in place to the anchor with a separate lock that presses the grommet against the tissue wall and clamps the tension band. The grommet may be of braided Nitinol or laser cut Nitinol tube construction with fingers shaped radially outward from a central axis to grip the tissue. The grommet may be of a similar configuration to any of the anchor elements disclosed herein, such as grommet 7030 in FIG. 70, frame 7104 in FIG. 71, grommet 7220 in FIG. 72, and extension grommet 7402 in FIG. 74, may be another applicable grommet, or any other grommet, as desired or required.

[0330] In some applications of the present disclosure, a technique is described for crossing tissue at or near the tricuspid annulus (within 15 mm) from the right atrium to the right ventricle by first attaching or embedding the distal end of a stabilizing catheter into tissue at or near the tricuspid annulus from the right atrial side, and secondly passing a guidewire through the stabilizing catheter, the guidewire exiting the distal end of the stabilizing catheter and passing through tissue at or near the tricuspid annulus from the right atrium to the right ventricle, as shown in, for example, FIG. 59 and FIG. 60. The guidewire can then be left in place across the tissue at or near the tricuspid annulus, while the stabilizing catheter is retracted or removed from the tissue, leaving the guidewire in place across the tissue. See the example shown in FIG. 61. The guidewire can then be used as a rail for passing additional catheters or devices across the tissue from the right atrium to the right ventricle, such as for deploying a surface anchor embodiment as disclosed herein. This method and apparatus for crossing tissue with a guidewire can be incorporated into the procedures shown in Figures 14-24 to more easily facilitate crossing the tricuspid annulus or atrial septum with the anchor delivery catheter 226 and dilator 224.

[0331] In some applications, the stabilizing catheter features a helical wire coil on the distal end of the stabilizing catheter to facilitate threading the distal end of the stabilizing catheter into tissue, examples of which are shown in Figures 52-57, 59-60, and 62-65. The stabilizing catheter may provide the following unique advantages, but is not limited to: 1) By using a rotational motion to torque the stabilizing catheter to penetrate tissue at the target location, a large force (the force is approximately proportional to the torque applied divided by the radius of the distal helix of the catheter) may be generated at the sharp tip of the stabilizing catheter to rapidly penetrate tissue; 2) By rotating the helical wire coil into tissue, the resulting force vector at the tip of the stabilizing catheter is at an acute angle to the axis of the stabilizing catheter, which minimizes the compressive force applied along the axis of the stabilizing catheter, thereby minimizing the deflection of the tissue and the stabilizing catheter relative to each other as they penetrate the tissue. 3) Once the distal helical coil of the stabilizing catheter has penetrated the tissue, continued rotation of the stabilizing catheter creates a normal force on the surface of the helical coil with a force component in the direction of the stabilizing catheter that drives the helix deeper into the tissue. 4) Once the distal helix of the stabilizing catheter is embedded in tissue, its location relative to the tissue is fixed and it is able to resist translational and shear forces in any direction. 5) Once the distal helix of the stabilizing catheter is embedded in tissue, the stabilizing catheter provides a conduit that can direct the guidewire to the distal tip of the stabilizing catheter and support the guidewire without bending, buckling, shearing, or deflecting off-course as it passes through tissue. 6) The stabilizing catheter can be easily removed by rotating in the opposite direction to the above rotation. 7) The use of a helical wound wire at the distal end of the stabilizing catheter minimizes trauma to the tissue leaving only a small diameter puncture of the wire.These advantages, either directly or in combination with one another, make it easier to pass a guidewire to a precise location within the moving anatomy of a beating heart.

[0332] The present disclosure is not limited to crossing the tricuspid annulus 52 from the right atrium 2 to the right ventricle 3, but can be used as a technique for crossing between any two adjacent heart chambers, which may include right atrium 2 to left atrium 3, right ventricle 3 to left ventricle 5, right ventricle 3 to right atrium 2, left atrium 4 to right atrium 2, left ventricle 5 to right ventricle 3, left atrium 4 to left ventricle 3 (near or across the mitral annulus 15), left ventricle 5 to right ventricle 3 (near or across the mitral annulus 15), or from a ventricle or atrium to the pericardial space. The present disclosure can also be incorporated as a technique for crossing other tissues in the body outside of the heart.

[0333] In certain embodiments, the steps of passing the guidewire through the treatment area may include one or more of the following steps.

[0334] First, guiding a guide catheter 5500 into the venous system at the groin.

[0335] Next, the guiding catheter 5500 is advanced through the IVC 50 into the right atrium 2.

[0336] Next, positioning the distal end of the guiding catheter 5500 at or near the tricuspid annulus 52, orienting it toward the intended treatment area as shown in FIG. 58. The position of the guiding catheter 5500 can be within 30 mm of the tricuspid annulus 52.

[0337] The stabilizing catheter 5200 is then passed through the guiding catheter 5500, or a stabilizing element is extended from the distal end of the guiding catheter 5500, until the spiral distal end 5202 of the stabilizing catheter 5200 exits the guiding catheter 5500 and contacts tissue at or near (within 20 millimeters of) the tricuspid annulus 52 in the treatment area.

[0338] Then, applying forward pressure while rotating the stabilizing catheter to screw the distal end 5202 of the stabilizing catheter 5200 into the tissue of the treatment area, as shown in Figure 59. Figure 59 shows a four-chamber cross-section of the heart 1 with the guide catheter 5500 in the right atrium 2 and the stabilizing catheter 5200 having a distal helix 5202 being directed by the guide catheter 5500 to a location near the anterior tricuspid annulus 52, and the helix 5202 being screwed into the tissue by applying a torque to the stabilizing catheter 5200.

[0339] Then, once the stabilizing catheter 5200 is securely attached to the tissue, the stabilizing catheter 5200 is passed over the guidewire 5212 until the distal tip of the guidewire 5212 contacts the tissue in which the stabilizing catheter 5200 is embedded.

[0340] Next, push the guidewire 5212 through the tissue until it exits the tissue and enters the right ventricle 3, as shown in Figure 60. Figure 60 shows a four-chamber cross-section of the heart 1 with the guide catheter 5200 and stabilizing catheter 5500 shown in Figure 59, and the guidewire 5212 passing through tissue near the anterior tricuspid annulus 52 and into the right ventricle 3. In some embodiments, an alternating current is passed through the guidewire 5212 in this step to heat the distal tip and reduce the force required to pass the guidewire through tissue.

[0341] Then, removing the stabilizing catheter 5200 from the tissue by rotating the stabilizing catheter 5200 in a direction opposite to the direction used to insert it into the tissue.

[0342] Then, finally, removing or retracting the stabilizing catheter 5200 while leaving the guidewire in place across the tissue from the right atrium 2 to the right ventricle 3 as shown in Figure 61. Figure 61 shows a four-chamber cross-section of the heart 1 with the guide catheter 5500 in the right atrium 2 and the guidewire 5212 passing through tissue at or near the anterior tricuspid annulus 52 from the right atrium 2 to the right ventricle 3. The stabilizing catheter shown in Figures 59 and 60 has been withdrawn.

[0343] In some embodiments of the present disclosure, the stabilizing catheter includes a catheter having a distal tip constructed from a helical shaped wire attached to or transitioning into a substantially tubular catheter having an inner diameter and an outer diameter, such as the embodiment shown in FIGS. 52-56. As shown in FIGS. 52 and 53, a handle 5208 may be attached near the proximal end of the stabilizing catheter 5200 to provide an area for a user to grasp the catheter and apply torque or translation to the catheter. The distal helical wire 5202 may be 2-10 millimeters long, but may be any length suitable for threading into the desired tissue. The pitch of the helical portion 5202 may be 10-40 turns per inch, and the wire diameter may be 0.010-0.030 inches. The outer diameter of the helical portion may be 0.040-0.156 inches. The distal tip 5204 of the helical wire 5202 can be sharpened to a point to penetrate tissue more easily due to the increased contact stress exerted by the reduced surface area of ​​the tip when the tip is pressed against tissue. When the tip 5204 of the distal helix 5202 of the catheter is pressed against tissue and a torque is applied to the catheter, a force is applied between the helix 5202 tip 5204 and the tissue that is approximately proportional to the torque applied divided by the radius of the helix. This force causes the helix to penetrate the surface of the tissue (the endocardial layer) and continue to penetrate the tissue (through the myocardium) in front of the helix tip. Continuing to rotate the catheter as the helix tip penetrates the tissue applies a force along the axis of the helix that draws the helix further into the tissue. Thus, the helical end of the catheter is screwed into the tissue.

[0344] The spiral wire 5202 forming the distal end of the stabilizing catheter may be constructed from a metal suitable for direct contact with the bloodstream in the human body. Examples include stainless steel, titanium, nitinol, and tungsten. The inner diameter of the spiral is sufficient for a guidewire to pass through. The spiral wire may be substantially round, circular, square, rectangular, or any cross-sectional shape suitable for fabricating a large-diameter structure or spiral. Alternatively, the spiral wire may be constructed from a rigid plastic such as PEEK, a composite material such as carbon fiber, or a ceramic material. The wound wire spiral 5214 may be constructed as a separate component that is attached to the distal end of the stabilizing catheter by welding (as shown in FIG. 54), soldering, crimping, a mechanical interlocking connection, adhesive, or other process, as desired or required. Alternatively, the spiral wire may be laser cut from the stabilizing catheter tube, as shown in FIG. 52. The helix 5202 can be formed with an outer diameter approximately equal to the outer diameter of the stabilizing catheter shaft, as shown, for example, in Figs. 52 and 53, or it can be formed with an outer diameter that is larger (see example shown in Fig. 54) or smaller than the stabilizing catheter shaft. Constructing a stabilizing catheter with a helical coil larger than the diameter of the main catheter shaft can help reduce the torque for the stabilizing catheter main shaft to completely pass through tissue, as shown, for example, in Fig. 63. In some embodiments disclosed in, the helix can include two or more helically wound wires, such as the double helix 6400 in Fig. 64, to increase the lead of the helix without changing the surface area of ​​the wire relative to a single wire helix of uniform pitch. In other embodiments disclosed in, the helix can be tapered outwardly or inwardly, such as the tapered helix 6500 in Fig. 65, to create a pushing effect that can enhance tissue retention as the helix is ​​threaded into tissue. In some embodiments, all or a portion of the guidewire or helix may have a circular cross-section, while in other embodiments the cross-section may be rectangular or trapezoidal.The outwardly tapered helix can provide more clearance for the guidewire as it advances through tissue within the center of the helix.

[0345] 57 shows a stabilizing catheter, such as the stabilizing catheter 5200 and guide catheter 5500 disclosed herein, in the right atrium 3 of a human heart 1. The helical portion 5202 of the stabilizing catheter 5200 is threaded into the heart near the anterior tricuspid annulus 52 from the right atrial side.

[0346] The shaft of the stabilizing catheter 5200 can be constructed to be flexible in bending with relatively high torsional stiffness. Examples of suitable constructions are laser cut metal tubes, multifilar hollow helical stranded wire or cable, and braided wire reinforced polymers. This type of construction allows the stabilizing catheter to travel tortuous paths and transmit torque through curved or tortuous paths. The inner diameter of the stabilizing catheter is such that it is slightly larger than the outer diameter of the intended guidewire to allow the guidewire to move unrestrictedly through the stabilizing catheter. When the shaft of the stabilizing catheter is constructed from metal, the outer diameter of the stabilizing catheter can be coated with a polymer such as polyether block amide (PEBA), polyamide (nylon), polyimide, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP) or any other polymer suitable for direct contact with the bloodstream. The polymer sheath can be implemented to reduce friction, provide a hemostatic seal between the inner and outer diameters of the catheter, or provide electrical insulation. When the shaft of the stabilizing catheter is constructed from metal, the inner diameter can also be constructed from a polymer layer to reduce friction, provide a hemostatic seal between the inner and outer diameters, or provide electrical insulation.

[0347] In some embodiments of the present disclosure, the stabilizing catheter 5200 can be designed as a permanent component of the guiding catheter 5500 that telescopes in and out of the distal tip of the guiding catheter. In other embodiments, the stabilizing catheter 5200 is a separate component that can be inserted through the guiding catheter and then completely removed from the guiding catheter, as in Figures 55-57.

[0348] In some embodiments of the present disclosure, the spiral portion 5202 of the stabilizing catheter can be threaded completely through the tissue being traversed such that the stabilizing catheter enters one side of the tissue and exits the other side of the tissue, and the guidewire can then be passed unimpeded through the stabilizing catheter from one side of the tissue to the other, as in FIG. 63. This step can be performed after the step performed in FIG. 59, as disclosed herein. For example, when crossing the tricuspid annulus, the spiral portion 5202 can be threaded from the right atrium 2 through tissue at or near the tricuspid annulus 52 into the right ventricle 3. In other embodiments, as in FIG. 60, the spiral portion 5202 is threaded only partially through the tissue, and the guidewire 5212 must be pushed through the remaining tissue to traverse the tissue. In such cases, the stabilizing catheter 5200 provides a conduit through which the guidewire 5212 passes that can counteract the force exerted by the tissue on the wire and prevent the tissue from being pushed away from the wire. The stabilizing catheter 5500 also prevents the guidewire 5212 from bending, flexing, sagging, or shearing under the compressive forces required to cross tissue due to a combination of the additional bending stiffness provided by the stabilizing catheter and because the stabilizing catheter 5200 can be pulled under tension to shift the compressive load on the guidewire.

[0349] In some embodiments of the present disclosure, the guidewire 5212 can be constructed from a conductive material such as stainless steel, titanium, nitinol, or tungsten, and can be insulated by an electrically insulating polymer such as PTFE, FEP, polyimide, or PEBA. The distal tip of the guidewire can be uninsulated and thus form an electrode. When high frequency current is applied to the guidewire 5212 from a signal generator with a return path through the patient's body, a discharge is generated at the uninsulated tip, which causes the tip of the guidewire to heat up quickly and pass through tissue with less force. A voltage is typically applied to the wire in the radio frequency range. Commercially available guidewires, such as those manufactured by Baylis Medical Inc., are available for such applications. Alternatively, the distal tip of the guidewire 5212 can be sharpened to aid in mechanically penetrating tissue under force alone. The tip of the guidewire can be sharpened to a point to reduce the force required to traverse tissue.

[0350] In another embodiment of the present disclosure, the guidewire itself can be constructed with a spirally wound wire at the distal tip, as shown in FIG. 66. This guidewire 6600 can be threaded into tissue in the same manner as the previously described stabilizing catheter 5200 with a spirally wound distal end, providing the same benefits for engaging tissue in a beating heart. The spiral end of the wire 6600 can be formed by mechanically winding the wire itself, or by attaching a separate spirally wound wire to the guidewire, for example, by welding, soldering, mechanical interlocking, or adhesive bonding. A guidewire with a spirally wound tip 6600 can be threaded completely through tissue, and once the spiral exits the tissue and into a cavity adjacent to its origin, it can be freely pushed into such cavity and act as a rail for threading additional devices. Suitable materials of construction are metals suitable for contacting the bloodstream. Examples include stainless steel, titanium, nitinol, and tungsten. An advantage of forming a helix on the guidewire is that the extra step of introducing and removing a stabilizing catheter, such as stabilizing catheter 5200, is eliminated.

[0351] FIG 67 shows a cross-sectional view of a dilator system 6700 including a dilator 6702 and a helical guidewire 6710 similar to the helical guidewire 6600 of FIG 66. The guidewire 6710 can have a relatively smaller diameter 6712 followed by a straight section of a relatively larger diameter 6708. Such a guidewire can be assembled into a dilator 6702 having a tapered distal end 6706 with a smaller inner diameter 6704 transitioning to a larger inner diameter 6708 proximal to the distal tip such that the smaller diameter straight section of the guidewire is captured within the smaller inner diameter of the dilator by a dilator shoulder 6709 as shown in FIG 67. As the guidewire 6710 is threaded into tissue, a shoulder 6719 formed at the transition from the smaller diameter 6712 to the larger diameter 6714 of the guidewire presses against a corresponding shoulder 6709 between the smaller inner diameter 6704 and the larger inner diameter 6708 of the dilator, thereby pushing the dilator 6702 through the tissue behind the guidewire 6710. In an alternative configuration, the dilator can be permanently bonded or secured to the guidewire such that the dilator and guidewire act as a single component, and rotating the dilator rotates the guidewire and thus can be threaded through tissue by rotating the dilator.

[0352] In another embodiment of the present disclosure, a dilator 6800 is constructed with a helical thread 6802 cut into the distal taper of the dilator as shown in FIG. 68. When passing the dilator through tissue, rotation of the dilator creates a force applied against the lead of the thread acting in the direction of the dilator shaft, which causes the dilator to be pulled through tissue and therefore easier to pass through than simply being pushed. The dilator may be constructed from a polymeric material such as PEBA, high or low density polyethylene, nylon or other suitable polymers, and may be augmented with metal or polymer braids, laser cut metal tubing, or other suitable materials to increase torsional stiffness.

[0353] In some applications of the present disclosure, a system is described for facilitating implantation of an anchor in tissue at or near (within 15 mm) the tricuspid annulus from the right atrium to the right ventricle by first attaching or embedding a distal end of a stabilizing catheter into tissue at or near the tricuspid annulus from the right atrial side, and second passing a guidewire through the stabilizing catheter, the guidewire exiting the distal end of the stabilizing catheter and passing through tissue at or near the tricuspid annulus from the right atrium to the right ventricle. The system may vary as desired or needed and may include multiple anchors, multiple tethers, and multiple tether locks.

[0354] 69A-69C show one embodiment of a surface anchor system 6900 that can be used in a method for tricuspid valve repair. With reference to FIG. 69A, the surface anchor system 6900 is comprised of a nitinol wire frame 6904 forming a periphery and having a nitinol frame internal feature 6916 on the inside of the periphery, a surface anchor sheath 6906, and a tether 6902 attached to the nitinol wire frame 6904 at the nitinol frame internal feature 6916 via a tether loop 6912 of the tether 6902 secured by a tether knot 6914. The nitinol frame internal feature 6916 can be near the center of the area formed by the periphery, but may be at any location within the periphery. The nitinol frame internal feature 6916 as depicted in FIG. 69A-69C is shown as a cross shape. The nitinol wire frame 6904 is wound around itself in a helical section 6910 along the periphery of the frame formed by the nitinol wire so that when a force is applied to the nitinol frame or a portion of the frame, the force is distributed throughout the entire frame. The surface anchor 6901 can be substantially similar to the anchor 3700 as described herein. The surface anchor 6901 can be flexible such that it can assume an undeployed configuration and thus be elongated and compressed for insertion into a catheter 6920 with an inner diameter much smaller than the width of the unconstrained anchor, as shown in FIG. 69B. When the surface anchor is pulled away from the catheter and is no longer constrained, the strain energy of the nitinol frame is released and the surface anchor 6901 is transformed from its undeployed configuration as shown in FIG. 69B to its deployed configuration as shown in FIGS. 69A and 69C. When tether 6902 connects to surface anchor 6901, tether 6902 can pivot because tether loop 6912 is connected to surface anchor 6901 by tether knot 6914.This allows the surface anchor 6901 to transition from its undeployed configuration as shown in FIG. 69B, where the tether axis is substantially parallel to the plane of the anchor, to its deployed configuration as shown in FIG. 69A and FIG. 69C, where the tether axis is substantially perpendicular to the plane of the surface anchor or at some angle other than parallel. If the surface anchor 6901 is threaded through an opening, such as a passageway or hole through body tissue while attached to the tether 6902, pulling on the free end of the tether on the other side of the opening will pull the surface anchor 6901 against the opening of the opening. The Nitinol wire frame 6904 of the surface anchor 6901 can be heat treated in its deployed state so that it maintains its shape when in the austenitic state. The austenite finish temperature (Af) of Nitinol can be the temperature at which the Nitinol material transitions to an austenitic crystal structure and returns to its deployed state when heated to body temperature (approximately 37° C.). It can be heat treated into a deployed configuration as shown in Figures 69A and 69C, so that when heated above its austenite finish temperature, it will naturally assume the peripheral shape described above unless constrained. The free ends of the Nitinol wire frame 6904 can be joined with a surface anchor wire connector 6908 (e.g., a crimp connector). Alternatively, the free ends can be joined by other means, such as welding. The surface anchor 6901 can be deployed from the catheter 6920 via a pushing catheter 122 that fits inside the catheter 6920 and contacts the surface anchor and pushes it out of the catheter 6920 when translated toward the distal end of the catheter 6920.

[0355] 70A-H show an implant system 7000 comprising a plurality of anterior surface anchors 7002 (two shown) connected to a septal surface anchor 7004 via a tether 7006 that engages each surface anchor with an attached surface anchor hub 7014. The tether 7006 can be tensioned through a tether lock 7012, which draws the anterior surface anchor 7002 towards the septal surface anchor 7004. When the surface anchors engage tissue on either side of the heart valve annulus, such as the anterior surface anchor 7002 engaged with the right ventricular surface anterior to the tricuspid annulus and the septal surface anchor 7004 engaged with the left atrial septum, tensioning the tether reduces the distance between the anterior surface anchor 7002 and the septal surface anchor 7004, thereby reducing the distance across the heart valve annulus and improving coaptation of the heart valve leaflets. 70A shows a lockable tissue grommet 7030 that can be positioned on a surface of tissue opposite the surface against which the anterior and septal surface anchors 7002, 7004 abut, effectively locking the surface anchors 7002 and 7004 in place such that the anchors cannot move in the absence of tension in the tether. Thus, tissue can be sandwiched between the surface anchors 7002 or 7004 and the lockable tissue grommet 7030, as shown in FIG. 70H and described in detail herein.

[0356] FIG. 70B shows a front view of the surface anchors, anterior surface anchor 7002 and septal surface anchor 7004. The surface anchors 7002 and 7004 are comprised of a nitinol frame 7020, which may be laser cut into a series of flexible struts that allow the surface anchors to be elongated and compressed as described herein and shown in FIG. 70E and FIG. 72C. The nitinol frame 7020 may be covered by a surface anchor sheath 7022, which may include a fabric or solid elastomeric sheath to promote sealing, healing and tissue ingrowth into the surface anchor. The anterior surface anchor 7002 and septal surface anchor 7004 further comprise holes 7024 located within the periphery defined by the nitinol frame 7020, as shown in FIG. 70D.

[0357] 70C and 70D, the lockable tissue grommet 7030 non-lockably attaches to or locks to the surface anchor hub 7014 to hold the anterior surface anchor 7002 or septal surface anchor 7004 against the surface of the heart. As shown in FIG. 70C, the tether 7006 can pass through a central lumen that passes through the tissue grommet 7030, the anterior surface anchor 7002 or septal surface anchor 7004, and the central distal tubular portion of the surface anchor hub 7014, and then tied to form a tether knot 7010. Alternatively, the tether 7006 can have a mechanical fastener placed on the end of the tether 7006 after passing through those members, such that when the tether is tensioned, the tether knot 7010 or the attached fastener cannot pass through the lumen of the surface anchor hub 7014. The surface anchor hub 7014 can be constructed such that its distal end forms a surface anchor hub bell 7016 having a large diameter such that the surface anchor hub 7014 cannot fit through the hole 7024 in the surface anchor 7002 or 7004. The surface anchor hub 7014 has a surface anchor hub nose or distal flange 7017 at its proximal end that is smaller than the surface anchor hub bell 7016 but larger than the surface anchor hub midshaft 7018. As described in detail herein, the surface anchor hub nose or flange 7017 is sized such that when the surface anchor hub 7014 interacts with the tissue grommet 7030, the radially inwardly oriented tissue grommet flexible retaining fingers or central flexible beam 7036 centrally located on the tissue grommet 7030 and the surface anchor hub nose or flange 7017 interfere and substantially prevent the tissue grommet 7030 from moving proximally in the longitudinal direction.The surface anchor hub midshaft 7018 has a smaller diameter than the surface anchor hub bell 7016 or the surface anchor hub nose 7017 such that the central flexible beam 7036 can interact with a face of the surface anchor hub nose 7017 at a surface formed due to the diameter difference between the dimensions of the surface anchor hub nose 7017 and the dimensions of the surface anchor hub midshaft 7018, thus retaining the tissue grommet 7030 and preventing proximal translation of the tissue grommet 7030 relative to the surface anchor hub 7014. The surface anchor tissue grommet 7030 can incorporate a tissue grommet central flexible beam 7036 that is pre-positioned into the inner diameter of the grommet. The tissue grommet flexible retaining fingers or central flexible beam 7036 are dimensioned such that the tips of the tissue grommet flexible retaining fingers 7036 naturally sit behind the latitudinal surface of the surface anchor hub nose 7017 and can be deflected outward to allow the grommet to pass the hub, such that the nose will interfere with the fingers if forces acting on the implant system 7000 separate the surface anchor hub 7014 and tissue grommet 7030 after they interface. Thus, the grommet is locked to the hub and the distance between the grommet and the surface anchor is fixed. In some embodiments of the present disclosure, the tissue grommet 7030 is shown having one tissue grommet central flexible beam 7036, however, in other embodiments, the tissue grommet can be constructed with multiple central flexible beams 7036 that together provide the same functionality as the single central flexible beam 7036 described herein.

[0358] The surface anchor tissue grommet 7030 can be constructed with a proximal finger portion with multiple flexible tissue grommet flexible arms or beams 7032 extending radially from a distal tubular portion that can be deflected into a pre-deployed configuration to allow insertion into a catheter 7050, as shown in FIGS. 70E and 70F. Upon release from the catheter 7050, strain energy stored within the tissue grommet flexible arms or beams 7032 can move the arms back to the deployed configuration. Materials suitable for constructing the tissue grommet flexible arms can have a high degree of recoverable strain, such as being able to recover more than 1%, more than 5%, or other percentages, as desired or required. Thus, materials such as Nitinol or other materials as detailed herein or known to those skilled in the art are suitable for use.

[0359] 70E-70H show an exemplary method for implanting an embodiment of the treatment system 7000 into a patient's heart. In certain embodiments, the steps for implantation may include one or more of the following steps:

[0360] First, the surface anchor tissue grommet 7030 and surface anchor 7002 or 7004 are crimped into their respective pre-deployed configurations, and the tissue grommet 7030, anterior surface anchor 7002 or septal surface anchor 7004, tether 7006 and surface anchor hub 7014 are constrained within a catheter 7050 that houses an outer pushing catheter 7052 and an inner pushing catheter 7054. The grommet, surface anchor and hub are spaced axially outward from one another. This is illustrated in FIG. 70E.

[0361] The catheter assembly with the implant assembly is then advanced through the cardiac tissue 7040 until the catheter exits on the opposite side of the tissue from which it entered.

[0362] The inner pushing catheter 7054 is then translated distally to slidably displace the surface anchor 7002 or 7004 and the surface anchor hub 7014 distally until they exit the distal end of the catheter. Upon exiting the catheter, the surface anchor expands to its deployed configuration. This step is shown in FIG.

[0363] The inner pusher is then retracted distally into the catheter.

[0364] The catheter is then withdrawn distally from the tissue.

[0365] An outer pushing catheter 7052 is then used to push the tissue grommet 7030 out of the distal end of the catheter. The grommet assumes its deployed configuration upon exiting the catheter. This step is shown in FIG.

[0366] The outer pushing catheter 7052 is then used to push the tissue grommet 7030 over the surface anchor hub 7014 as described above, while tensioning the tether 7006 until the grommet is locked onto the hub.

[0367] Then, as the grommet is pressed against the distal surface of the tissue (in the process of pushing over the hub), the tissue grommet flexible arms 7032 deflect distally. As the grommet is locked onto the hub, the tissue grommet flexible arms 7032 exert compression on the cardiac tissue 7040, sandwiching it between the tissue grommet 7030 and the surface anchor 7002 or 7004. Thus, the space between the grommet and the surface anchor is substantially occupied by the thickness of the surface to which the implant is secured. This secures the surface anchor in place. This step is shown in FIG. 70H.

[0368] FIG. 71 illustrates an alternative embodiment of an implant system 7100 featuring a surface anchor 6901 as previously described attached to a tether 6902 as previously described, and another embodiment of a grommet referred to below as a flat grommet 7102 secured against proximal translation by a tether lock 7500 as described herein. In one embodiment of the present disclosure, the flat grommet 7102 can be constructed similarly to the surface anchors 6901, 7002, and 7004 as shown and described in FIGS. 69A and 70B, with an expandable metal frame 7104 and optionally a covering material 7106. The flat grommet 7102 features holes through which the tether can pass and translate along the tether. The flat grommet 7102 can be elongated, compressed, and pivoted about the axis of the tether 6902, similar to the surface anchors 6901, 7002, and 7004 previously described. The tether lock 7500 can be constructed as shown in FIGS. 75A-75D such that it is slidable along the tether 6902 when pushed distally, but grips the tether 6902 and prevents sliding when pushed with a proximal force. The implant system 7100 can use any other embodiment of a tether lock described herein, or any other tether lock suitable for implantation, as desired or required. The function of the flat grommet 7102 with the tether lock 7500 to pinch tissue between the grommet and the surface anchor and prevent migration of the surface anchor is substantially the same as the function of the tissue grommet 7030 and the surface anchor hub 7014.

[0369] 72A-72C illustrate an alternative embodiment of an implant system 7200. The implant system 7200 is substantially similar to the implant system 7100 as shown in FIG. 7100, except that the implant system 7200 utilizes a T-bar grommet 7220 instead of a flat grommet 7102. The T-bar grommet 7220 is in a rigid, unexpanded form and has a length that is significantly greater than its width. The T-bar grommet 7220 may comprise a single rigid member. The T-bar grommet 7220 has a hole or T-bar slot 7222 at or near its center through which the tether 6902 can pass, and the grommet can slidably translate along the axis of the tether. The width of the T-bar grommet is less than the inner diameter of the catheter 7050, and the T-bar grommet can pivot about the tether such that the long axis of the T-bar grommet is approximately parallel to the axis of the tether for insertion into the catheter for deployment, as shown in FIG. 72C. When the T-bar grommet 7220 is unconstrained by the catheter and subject to a load applied to its surface at any distance outward from the tether 6902, such as when in contact with tissue, the T-bar grommet 7220 pivots relative to the tether 6902 such that its long axis is approximately perpendicular to the axis of the tether, as shown in FIG. 72A. The T-bar grommet 7220 can be restrained from translating proximally along the tether 6902 by a tether lock 7500 as previously described. Any of the locks disclosed herein can be used as the tether lock.

[0370] 73 illustrates an alternative embodiment of an implant system 7300 for securing a grommet as previously described, such as a flat grommet 7102. In this embodiment, the tether 7310 is formed into a loop that passes through the flat grommet 7302 a first time, passes through the surface anchor 6901 a first time, passes back through the surface anchor 6901 a second time, and then loops around the surface anchor 6901, passes through the flat grommet 7302 a second time, and terminates by rejoining the tether at a sliding connection point 7312 that is in a position prior to the tether 7310's first pass through the flat grommet 7302, such that pulling on the tether 7310 draws the surface anchor 6901 towards the flat grommet 7302 by advancing the connection point 7312 distally along the tether. The grommet used in the implant system 7300 can be a flat grommet 7302, a T-bar grommet 7220, or any other grommet compatible with the system of tethers 7310, as desired or required. As shown in FIG. 73, a flat grommet 7302 is used. The tether connection point 7312 can be a slidable knot or other similar connection point such that the tether connection point 7312 can slide along a first portion of the tether 7310 before first being threaded through the flat grommet 7302. The function of the grommet is similar to that previously described, except that rather than being secured against proximal translation along the tether by a tether lock 7500, it is secured against proximal translation by the tether connection point 7312, which can be a slidable knot. The implant system 7300 can be deployed in a manner substantially similar to the implant system 7200 previously described. The gap between the flat grommet 7302 and the surface anchor 6901 is initially set to be larger than the thickness of the tissue sandwiched between the grommet and the anchor.Once the surface anchor 6901 is deployed on one side of the tissue and the flat grommet 7302 is deployed on the other side of the tissue, the slidable knot 7312 can be moved distally by a pushing catheter, such as 7050, while applying tension to the free end of the tether 6902, causing the tether connection point 7312 to slide distally, decreasing the distance between the flat grommet 7302 and the surface anchor system 6900, until the tissue is sufficiently compressed between the flat grommet 7302 and the surface anchor system 6900. The tether connection point 7312 resists proximal sliding, maintaining compression of the tissue.

[0371] 74A and 74B show an alternative embodiment of an implant system 7400 for securing a grommet as previously described, such as a flat grommet 7102. In this embodiment, the grommet used to hold the surface anchor 6901 in the treatment area is a self-expanding grommet 7402. FIG. 74A shows the self-expanding grommet 7402 in a deployed state after the grommet has expanded. FIG. 74B shows the self-expanding grommet 7402 of the implant system 7400 utilizing a surface anchor 6901, a tether lock 7500, a tether 6902, and a catheter 7050. The self-expanding grommet 7402 can be deployed in a manner similar to other grommets disclosed herein. While in the delivery catheter, the self-expanding grommet 7402 is in a collapsed state with its arms not yet expanded. Upon being expelled from the deployment catheter 7050, the arms of the self-expanding grommet 7402 are configured to return to their expanded state, as shown in Figures 74A and 74B. The flat grommet 7402 can be constructed from Nitinol or other similar material that has shape memory and highly recoverable strain properties that allow the flat grommet 7402 to be heat set into a first expanded or deployed configuration, as shown in Figures 74A and 74B, and then constrained into a second collapsed configuration for translation through the catheter such that after deployment, the flat grommet 7402 can recover to the expanded configuration when released from the catheter.

[0372] 75A-75D show one embodiment of a tether lock 7500. FIG. 75A shows the tether lock 7500 in a closed configuration in which the tether lock spring arms 7502 are resiliently bent at the tether lock biasing nodes 7504 to close the tether lock 7500 onto the tether 6902 and prevent it from sliding laterally. The tether lock 7500 can have one or more tether lock biasing nodes 7504 for one or more tether lock spring arms 7502. FIG. 75B shows the tether lock 7500 in an open configuration that allows the tether lock 7500 to slide laterally along the tether 6902. FIG. 75C shows the tether lock 7500 in a closed position from another angle. The tether lock 7500 further includes a tether lock tether hole 7512 at a distal end 7510 of the tether lock through which the tether 6902 can pass. The tether lock 7500 further includes at least one tether lock alignment wall 7506 located at a proximal end of the tether lock 7500 that can maintain the tether 6902 in alignment with the closure member of the tether lock 7500. The tether 6902 continues to pass between the tether lock tether contact surfaces 7508 and is thereby sandwiched between the spring arms. When the tether lock is forced to move from the proximal side of the tether lock to the distal end 7510 of the tether lock, the frictional force between the tether 6902 and the tether lock tether contact surface 7508 induces a moment on the spring arms that causes the spring arms to pinch the tether together, effectively clamping the tether, as shown in FIG 75 A. When the tether lock is forced to move from the distal side of the tether lock to the proximal side of the tether lock, the friction between the tether 6902 and the tether lock tether contact surface 7508 induces a moment on the spring arms that causes the spring arms to spread apart, allowing the tether lock to slide along the tether.Thus, the tether lock can be pushed distally and will slide along the tether with minimal force, but if the tether lock experiences a proximal force, such as the resistance of compressing tissue between the surface anchor and the grommet, the tether lock will automatically clamp the tether and prevent movement. The greater the proximal force on the tether lock, the greater the clamping force on the tether. The tether lock can be comprised of a metallic construction, such as stainless steel, titanium or nitinol, or a polymeric construction, such as PEEK or nylon. The tether lock tether contact surface 7508 of the spring arm can have a toothed shape as shown to increase friction against the tether.

[0373] 76A-80D illustrate several alternative embodiments of tether locks for use with various tethers (e.g., tether 6902, tether 7006, etc.) that can be used in place of the illustrated tether locks disclosed herein, such as lock 230 of FIGS. 2-13, lock 4080 of FIG. 31, lock 7012 of FIG. 70A, lock 7500 of FIGS. 71-72 and 74-75, or other embodiments of the implant system as disclosed herein. The various lock embodiments disclosed herein can accommodate an adjustable lock tensioner located within the body of the lock such that the adjustable lock tensioner can tighten one or more tensioning members that pass at least partially through the lock housing.

[0374] 76A-76F illustrate one embodiment of a tether lock 7600 having a slidable wedge 7604 driven by a lead screw 7606 that clamps one or more tethers 6902, hereafter referred to as a slidable wedge tether lock 7600. In FIGS. 76A and 76C, which show cross-sectional views of the slidable wedge tether lock 7600, the lock is shown in a locked configuration. In FIGS. 76B and 76D, which show cross-sectional views of the slidable wedge tether lock 7600, the lock is shown in an unlocked configuration. The screw can have a flange 7608 that is captive within a slot 7610 in the slidable wedge 7604, such that as the lead screw 7606 is translated in either direction along its axis, a force is exerted on the wedge causing it to translate in the direction of the lead screw 7606. The lock is established by a tether lock housing 7602 having a housing slot 7612 at an angle relative to the axis of the housing. The housing slot 7612 can engage a pin 7614 passing through a slidable wedge 7604 such that as the wedge is translated proximally, the housing slot 7612 exerts an upward force on the pin 7614, thereby raising the wedge into the housing (to an unlocked configuration). Translating the wedge distally has the opposite effect, causing the slot to drive the wedge downwardly within the housing, ultimately clamping the tether into the locked configuration. Optionally or in addition to the lock calibration system described above, the slidable wedge 7604 can interact with a housing tip 7616 along a housing tip angled surface 7618 relative to the axis of the tether lock housing 7602 such that distal translation of the wedge creates a downward force on the wedge due to a reaction force at the housing tip angled surface 7618. Thus, in this embodiment, threading the lead screw 7606 into the tether lock housing 7602 causes the slidable wedge 7604 to clamp the tether.The more acute the angle between the slot 7610 and / or housing tip bevel 7618 and the tether axis, the greater the downward clamping force. Tension on the tether directed distally to the lock creates a frictional force between the tether 7006 and the slidable wedge 7604, which causes the wedge to translate distally, and the resulting reaction force between the housing slot 7612 and pin 7614 or the slidable wedge 7604 and housing tip 7616 further clamps the tether, and thus increasing tension on the suture creates an increased clamping force on the tether, even if the screw loosens over time. Thus, this mechanism is self-locking in the presence of tension on the tether, reducing the likelihood of loosening over time. FIG. 76E shows the passage of the tether into a housing tip opening 7620 at the distal end of the lock, and FIG. 76F shows a tether lock housing opening 7622 where the tether exits the proximal end of the lock.

[0375] 77A-77C illustrate one embodiment of a tether lock having a rotatable pawl that clamps one or more tethers, hereafter referred to as a rotatable pawl tether lock 7700. A cross section of the lock is shown in a closed configuration in FIG. 77A and an open configuration in FIG. 77B. FIG. 77C is an exploded view of the components. When a tether 6902 contacts the pawl contact surface 7706 and the tether 6902 is pulled distally under tension, a frictional force is exerted on the pawl in the direction the tether is being pulled, which creates a moment about the rounded end of the pawl where the tether is captured in a matching rounded groove in the tether lock housing 7702. The moment causes the pawl contact surface 7706 to rotate in the direction the tether 6902 is being pulled. When the tether is pulled distally, such as due to tension on the tether as it reduces the heart valve annulus, the arcuate path of the pawl drives the suture downward and clamps against the end of the pawl. Thus, the lock is self-locking as tension is applied distally to the tether, with increased tension resulting in increased clamping force. The lock may house a spring clip 7708, which exerts a moment on the pawl contact surface 7706, forcing it into a closed position. A pull pin 7710 may be inserted through the pawl through hole 7712 to counter the force of the spring clip 7708 and hold the pawl open, to smoothly advance the lock over the tether to its intended position through the patient anatomy, and to hold the pawl contact surface 7706 in a desired open position to fine-tune the tension on the tether as it reduces the heart valve annulus without occlusion. The end of the pull pin may reside in the pawl recess hole 7714 to provide additional support for the pull pin. Removal of the pull pin causes the rotatable pawl 7704 to spring into its locked configuration. During assembly, the pawl and spring can be inserted into the housing from that side, and the two tether lock side holes 7703 can be welded or otherwise attached to the housing to hold everything in place.78A-C show an alternative embodiment of a spring clip 7808 that may be used to place the pawl 7804 in the primary locking configuration. A pawl ball 7816 may be positioned between the spring clip 7808 and the pawl 7804 to ensure a smooth contact surface and prevent binding between the pawl and the spring. The spring may be manufactured as a typical coil spring in this embodiment.

[0376] 79A-79D show one embodiment of a tether lock 7900 having a threaded rotatable pawl 7904 that engages and clamps to one or more tethers, similar to the rotatable pawl tether lock 7700 disclosed herein. The threaded rotatable pawl 7904 features a pawl pin 7906 that resides within a tether lock housing opening 7903, such that the threaded rotatable pawl 7904 is rotatable about the pawl pin 7906. A cylindrical nut 7908 resides within a pawl groove 7910 in the pawl 7904, which allows the nut to translate up and down within the pawl. The cylindrical nut 7908 features a nut pin 7912 on each end that engages a pawl slot 7914 in the threaded rotatable pawl 7904 so that the nut is captive within the pawl and translation of the nut along the axis of the housing exerts a moment on the pawl, causing it to rotate. A pawl screw 7916 may be captively held between the cylindrical nut 7908 and a tether lock housing proximal cover 7918, which are attached to the housing via welding, for example. The pawl screw 7916 threads through the cylindrical nut 7908 and rotation of the thread causes translation of the nut which rotates the pawl. The pawl may be constructed from two pieces as shown in FIG. 79D to allow assembly of the nut and once inserted into the housing, the nut is captively held within the pawl. The two halves of the pawl may also be joined via welding or other mechanical means.

[0377] 80A-80D show one embodiment of a tether lock having a spring clip 8006 that directly engages and clamps one or more tethers 6902. The spring clip tether lock 8000 is shown in an open or unlocked configuration in FIG. 80A and FIG. 80C and in a closed or locked configuration in FIG. 80B. The spring clip 8006 is captively held within the tether lock housing 8002 under a preload, where the spring clip is deflected from its natural state such that the spring clip clamping surface 8008 of the spring clip naturally contacts the bottom surface of the housing and is therefore naturally in a closed position exerting a clamping force on the tether. The spring clip 8006 is constrained from translation within the tether lock housing 8002 by the proximal face of the housing tip 8004 and the housing back surface 8020, which are affixed to the housing after insertion of the spring clip, e.g., via welding. The spring clip arm 8010 is deflectable about a spring clip deflection node 8012 in the spring clip geometry such that as the spring clip arm is deflected, the spring clip clamping surface 8008 rotates within the housing to either an unlocked or locked configuration depending on the direction of the force applied. When the tether 6902 is pulled distally, frictional forces between the tether and the spring clip clamping surface 8008 of the spring clip create a moment about the spring clip deflection node 8012 that rotates the spring clip spring clip arm 8010 in a direction that drives the spring clip clamping surface 8008 onto the tether 6902, thus clamping the tether between the spring arm and the housing. The more tension applied to the tether, the tighter the spring arm clamps the tether. A spring clip pin 8014 may be inserted through spring clip hole 8016 in spring clip 8006 and supported in housing tip hole 8005 in housing tip 8004 of the lock. The pin may hold the spring clip in an open configuration as shown in Figures 80A and 80C, which is desirable to smoothly advance the lock over the tether to its intended location through the patient anatomy and fine tune the tension on the tether as it reduces the heart valve annulus without occlusion.Removal of the spring clip pin 8014 allows the spring clip 8006 to spring into a closed configuration. The spring clip pin 8014 can be threaded and rotatably actuated through the catheter or can be a component of the catheter itself. The threads can serve as an attachment mechanism between the lock and the catheter, where unscrewing the pin deploys the spring clip into the locked configuration and releases the lock from the catheter.

[0378] Although specific embodiments of the present invention have been described, these embodiments are presented by way of example only and are not intended to limit the scope of the present disclosure. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and modifications of the systems and methods described herein may be made without departing from the spirit of the present invention.

[0379] It should be understood that features, materials, properties, or groups described in connection with a particular aspect, embodiment, or example are applicable to any other aspect, embodiment, or example described in this section or elsewhere in this specification, unless incompatible therewith. All of the features disclosed in this specification (including the accompanying claims, abstract, and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of any of the above embodiments. Protection extends to any novel one or any novel combination of features disclosed in this specification (including the accompanying claims, abstract, and drawings), or any novel one or any novel combination of steps of any method or process so disclosed.

[0380] Moreover, certain specific features described in this disclosure in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described above as acting in a specific combination, one or more features from the claimed combination can, in some cases, be deleted from the combination, and the combination can be claimed as a subcombination or a variation of the subcombination.

[0381] Moreover, although operations may be depicted in the figures or described herein in a particular order, such operations need not be performed in the particular order depicted or sequential order, or all operations need not be performed, to achieve desirable results. Other operations not depicted or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Furthermore, operations may be rearranged or reordered in other embodiments. Those skilled in the art will appreciate that in some embodiments, the actual steps performed in the illustrated and / or disclosed processes may differ from those shown in the figures. In embodiments, some of the steps described above may be removed and other steps may be added. Furthermore, the features and attributes of certain embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure. Also, it will be understood that the separation of various system components in the above-described embodiments should not be understood as requiring such separation in all embodiments, and that the described components and systems may generally be integrated together in a single product or packaged in multiple products.

[0382] For the purpose of this disclosure, certain aspects, advantages and novel features are described herein. Not all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the present disclosure may be embodied or performed to achieve one advantage or a group of advantages without necessarily achieving other advantages as may be taught or suggested herein.

[0383] Conditional language such as "can," "could," "might," or "may," unless specifically stated otherwise or understood otherwise within the context in which it is used, is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to imply that a feature, element, and / or step is somehow required by one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or instruction, whether or not said feature, element, and / or step is included in or will be performed in any particular embodiment.

[0384] Conjunctive language such as "at least one of X, Y, and Z," unless specifically stated otherwise, should be understood otherwise by the context as it is commonly used to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is generally not intended to imply that an embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0385] As used herein, degree words used herein, such as the terms "approximately", "about", "generally" and "substantially", refer to values, amounts, or characteristics close to the stated value, amount, or characteristic that still performs the desired function or achieves the desired result. For example, the terms "approximately", "about", "generally" and "substantially" may refer to amounts that are within 10%, within 5%, within 1%, within 0.1%, and within 0.01% of the stated amount. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to values, amounts, or characteristics that deviate from exact parallelism by 15 degrees or less, 10 degrees or less, 5 degrees or less, 3 degrees or less, 1 degree or less, or 0.1 degrees or less. Numbers and values ​​used herein preceded by terms such as "about" or "approximately" include the stated number. For example, "approximately 7 mm" includes "7 mm," and numbers and ranges preceded by terms such as "about" or "approximately" should be construed as disclosing numbers and ranges with or without such terms preceding the number or value, such that this application supports the claiming of numbers, values, and ranges disclosed in the specification and / or claims with or without terms such as "about" or "approximately" preceding such numbers, values, or ranges, such that, for example, "approximately 2 times to approximately 5 times" also includes the disclosure of a range of "2 times to 5 times."

[0386] The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere herein, but may be defined by the claims, as presented in this section or elsewhere herein, or as presented in the future. The language of the claims should be interpreted broadly based on the language used in the claims, and not limited to the examples described herein or during the prosecution of this application, which examples should be interpreted as non-exclusive.

Claims

1. A tricuspid valve repair system, It is a system of three or more surface anchors, where each surface anchor system is It includes a nitinol wire frame that forms the periphery, and includes a surface anchor within the periphery that includes an internal feature portion. The nitinol wire frame includes three or more surface anchoring systems, including an austenite state in which it is deployed when the temperature of the nitinol wire frame is body temperature. A tether assembly that connects the three or more surface anchor systems at the tether connection point, A tricuspid valve repair system equipped with a tether lock.

2. A tricuspid valve repair system, It is a system of three or more surface anchors, where each surface anchor system is A surface anchor system comprising three or more surface anchors, each including a frame that forms a periphery and a surface anchor containing an internal feature portion within the periphery, A tether assembly comprising multiple tethers, each tether extending from each of the three or more surface anchor systems to the internal feature portion, A tricuspid valve repair system comprising a tether lock positioned on top of the tether assembly.

3. The tricuspid valve repair system according to claim 1, wherein the tether lock is configured to restrict relative movement between the three or more surface anchor systems.

4. The tricuspid valve repair system according to any one of claims 1 to 3, wherein the surface anchor can rotate laterally with respect to the tether assembly.

5. A tricuspid valve repair system according to any one of claims 1 to 3, further comprising a grommet and a grommet lock, wherein the grommet lock is configured to prevent the grommet from moving along the tether assembly.

6. The grommet is a flat grommet containing an expandable nitinol frame, The flat grommet is positioned on the tether assembly through a hole in the flat grommet. The tricuspid valve repair system according to claim 5, wherein the expandable nitinol frame of the grommet includes an austenite state in which it is deployed when the temperature of the expandable nitinol frame is the temperature of the human body.

7. The tricuspid valve repair system according to claim 6, wherein the flat grommet further comprises a covering material that provides a flat surface to the expandable nitinol frame.

8. The grommet is a T-bar grommet that includes a single rigid member having a length along its major axis that is longer than its width along its minor axis. The width of the T-bar grommet is configured to accommodate the T-bar grommet within the inner diameter of the delivery catheter. The T-bar grommet is positioned on the tether assembly through a hole located in or near the center of the T-bar grommet. The T-bar grommet can be pivoted around the tether assembly so that its long axis is substantially parallel to the axis of the tether assembly, for insertion into the delivery catheter for deployment. The tricuspid valve repair system according to claim 5, wherein, after being deployed from the delivery catheter, the T-bar grommet can be pivoted around the tether assembly such that the long axis of the T-bar grommet is inclined with respect to the axis of the tether assembly.

9. The tricuspid valve repair system according to claim 5, wherein the grommet is a self-expanding grommet that can expand after deployment to interact with the grommet lock.

10. The grommet lock comprises a tether hole penetrating the distal surface of the grommet lock, a plurality of grommet lock spring arms connected to the distal surface of the grommet lock, a plurality of grommet lock position alignment walls, and a grommet lock tether contact surface. The grommet lock contacts the tether assembly through the tether hole and the grommet lock tether contact surface. By applying force toward the proximal end to the distal surface of the grommet lock, the grommet lock spring arms are engaged by deflecting them at the grommet lock deflection node, thereby generating a clamping force at the grommet lock tether contact surface, preventing the grommet from moving outward from the surface anchor along the tether assembly. The tricuspid valve repair system according to claim 5, wherein the grommet and the grommet lock are also arranged along the tether assembly.

11. The grommet lock includes a first unlocked state in which it is slidable along the tether assembly, and a second locked state in which it is not slidable along the tether assembly. The tricuspid valve repair system according to claim 5, wherein the second locked state prevents proximal translation of the grommet along the tether assembly.

12. The grommet lock is a knot formed at the tether connection point. Before the tether assembly is rejoined at the tether connection point, the tether assembly passes through the grommet, and as a result the knot is near the grommet. The knot can slide distally by pushing it with a pushing catheter. The tricuspid valve repair system according to claim 5, wherein the knot prevents the grommet from sliding proximal along the tether assembly, and as a result, the knot prevents the grommet and the surface anchor from separating.

13. The tricuspid valve repair system according to any one of claims 1 to 3, wherein the tether assembly is connected to the surface anchor by surrounding the internal feature portion and forming a tether loop before rejoining the tether assembly at the tether connection point.

14. The tricuspid valve repair system according to any one of claims 1 to 3, wherein the surface anchor is covered by a surface anchor exterior.

15. The tricuspid valve repair system according to claim 1 or 3, wherein the nitinol wire frame of the surface anchor is formed by laser cutting a nitinol sheet or strip.

16. The tricuspid valve repair system according to any one of claims 1 to 3, wherein the surface anchor can be mechanically compressed to a size and dimensions that fit a catheter having an inner diameter smaller than the width of the surface anchor in the second deployed state of the surface anchor, thereby returning it to a first undeployed state.

17. The tricuspid valve repair system according to claim 16, wherein when released from a surface anchor delivery catheter, the surface anchor transitions from a first undeployed state to a second deployed state.

18. The tricuspid valve repair system according to claim 1 or 3, wherein the surface anchor is substantially flat, and as a result, the surface anchor length and surface anchor width are at least five times the surface anchor thickness.

19. The aforementioned periphery is equipped with a wire configured to be wound spirally around itself in two or more layers, with the layers being fixed to each other. The free end of the wire is connected by a sleeve or by welding, as described in claim 1 or 3 of the tricuspid valve repair system.

20. The tricuspid valve repair system according to claim 19, wherein the free end of the nitinol wire is connected by a sleeve.

21. The tricuspid valve repair system according to claim 1 or 3, wherein the internal feature portion has a cross shape.

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