Percutaneous tricuspid valve repair devices and methods

Abstract

A first ventricular surface anchor may be placed against the first right ventricular surface, where the first ventricular surface anchor is connected to a first tension member. A first tension anchor against a tension anchor surface of the heart wherein the first tension anchor is connected to a second tension member. The first tension member connected to the first ventricular surface anchor may extend toward the second tension member connected to the first tension anchor; and the first tension member and the second tension member may drag the first right ventricular surface toward the first tension anchor. The surface anchor may include a nitinol frame and an aperture forming an outer perimeter. When the temperature of the nitinol frame is a body temperature, the nitinol frame may have an austenitic state in a deployed configuration. The surface anchor may also include a grommet including a distal tubular portion connected to a proximal finger portion.

Description

[0001] Incorporation by reference to any priority application

[0002] This application claims priority to U.S. Provisional Application No. 63 / 379,404, filed on October 13, 2022, and priority to U.S. Provisional Application No. 63 / 336,850, filed on April 29, 2022, each of which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] The present disclosure relates generally to percutaneous repair of heart valves and, in certain embodiments, to percutaneous repair of the tricuspid valve. Background Art

[0004] Functional tricuspid regurgitation (FTR) is the result of one or more pathophysiological abnormalities of the heart, which may include tricuspid valve annular dilatation, annular shape, right or left ventricular dysfunction, right or left ventricular shape, right or left heart failure, pulmonary hypertension (primary or secondary mitral valve regurgitation), and valve leaflet tethering. It is currently estimated that 1.6 million people in the United States suffer from moderate to severe tricuspid valve regurgitation, and only 8,000 of these people undergo tricuspid valve surgery each year. The historical treatment options for patients suffering from tricuspid valve regurgitation are medical management and tricuspid valve surgery. Most tricuspid valve surgeries are combined with left heart valve surgery, such as mitral valve surgery. Less isolated tricuspid valve surgery is performed, and those that are performed are associated with a high surgical mortality rate (8-10%). FTR, particularly 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 impaired renal function. Therefore, there is a clear need for less invasive methods to treat functional tricuspid regurgitation. Summary of the invention

[0005] Certain embodiments of the present disclosure include drawing the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus near the coronary sinus ostium, thereby reducing the annular dimension in the area of ​​the valve where tricuspid regurgitation is most prevalent. In certain embodiments, the vector of force transfer can be generally through the orifice of the valve and very close to the annular plane, which makes the force transfer very efficient and effective for optimal reduction in tricuspid valve diameter. Utilizing the space created by the right ventricular outflow tract (RVOT) where the anchor abuts the right ventricular surface against the anterior tricuspid annulus can provide a large and robust area for secure placement of tissue anchors (also referred to herein as surface anchors) and distribute the force over a large surface area, thereby minimizing stress in the tissue. Utilizing multiple tissue anchors, each of which may be attached to a tensioning element and span 1-3 or more centimeters of the tricuspid annulus, or a single tissue anchor spanning such a distance with 2 or more separately attached tension members, tissue stress can be further reduced by distributing force application over a greater surface area and dispersing the desired tension across multiple tensioning elements. The ability to control the tension on each tensioning element individually allows the implant user to customize the reduction in tricuspid annular diameter to achieve optimal leaflet coaptation and minimize any twisting of the right coronary artery (RCA). Placing one or more anchoring elements across the inferior interatrial septum, where the anchoring element abuts against the left atrial wall above the mitral valve, provides a very secure location for anchor fixation and force transmission that has not previously been utilized in tricuspid valve repair. The muscle tissue in this region of the atrial septum is thick and tightly adhered to the left ventricular myocardium, providing a relatively fixed location through which forces can be transmitted. This location is also near the plane of the tricuspid annulus and generally opposite the anterior annulus (such that a line drawn between the anterior annulus and the septal anchor location passes through, near, or close to the center of the tricuspid valve orifice), which results in an optimal force vector for reducing the tricuspid valve annulus size.

[0006] Other embodiments disclosed therein include implanting a septal anchoring element substantially within or adjacent to the left ventricular myocardial tissue below the coronary sinus and / or its ostium or through the left ventricular myocardium from the coronary sinus to the left ventricular chamber, wherein the anchoring element is adjacent to the left ventricular wall. These areas have also not been previously utilized and share the same advantages as the location of the tensioning member on the left atrial wall that passes through the inferior atrial septum: optimal force vectorization, robust and stable tissue, relatively fixed tissue, and a large surface area for anchoring apposition. In addition, the embodiments disclosed herein describe methods and designs for implanting large surface area tissue anchors. These anchoring elements are unique in that they can be compressed or folded into a small lumen for catheter delivery, but expand into a much larger surface area element after exiting the catheter. Some of the anchoring elements disclosed herein are adjacent to the surface of the heart tissue, wherein the tensioning element passes through the heart tissue to another chamber of the heart. The result is an anchoring element that distributes force over a large surface area to minimize tissue stress and that applies such force to substantially the outer surface of the heart chamber wall (including against the endocardial surface) which is tougher than the myocardial tissue layer, minimizing the risk of tearing tissue or splitting of the tissue anchor.

[0007] In some embodiments, the promotion of less invasive methods for treating FTR may require the following needs: in order to transfer an implanted device or implant from one chamber to an adjacent chamber, pass through the tissue of the heart from one chamber to another chamber while the heart is beating. In some embodiments, the first step in passing the device through the tissue may include passing a guide wire through the tissue, which can then be used as a rail for delivering a catheter, instrument or implant. This can prove to be challenging because the tissue of the heart is in constant motion, and when trying to push the guide wire through the tissue, even when the guide wire is excited with radiofrequency current, the guide wire and the tissue can easily deflect relative to each other. Traditional guide catheters with free distal ends cannot provide sufficient stability to prevent deflection of the guide wire or tissue and promote the passage of the guide wire. Therefore, there is a need for catheters and methods that can better stabilize the guide wire when passing through tissue within the heart.

[0008] Certain embodiments of the present disclosure include first attaching a stabilizing catheter to the myocardium of a heart valve annulus or tissue near the annulus (within 15 mm), and secondly passing a guide wire through the inner diameter of the stabilizing catheter so that the distal end of the guide wire extends out from the distal end of the stabilizing catheter and passes through the myocardial tissue of the heart valve annulus to a chamber of the heart adjacent to the chamber where the stabilizing catheter is present. The stabilizing catheter can be firmly adhered or attached to the tissue of the heart so that its guide guide wire will first contact and penetrate the precise location of the tissue, so that the stabilizing catheter prevents the guide wire from buckling, bowing or bending under the compressive force imposed on the guide wire when it is pushed through the tissue, and so that the stabilizing catheter counteracts the force applied by the guide wire on the tissue when the guide wire is pushed through the tissue. These benefits prevent the guide wire from skiving against the tissue, deflecting relative to the tissue, or pushing the tissue away from the guide wire.

[0009] In some embodiments disclosed therein, the distal end of the stabilizing catheter forms a spiral coil with a sharpened distal tip. When the end of the stabilizing catheter is pressed into contact with the tissue and the stabilizing catheter is subsequently rotated, the force imparted at the end of the stabilizing catheter coil can pierce the tissue. Continued rotation of the stabilizing catheter causes the coil to screw into the tissue and embed into the tissue. Once screwed into the tissue, the distal coil can resist forces in any direction from the tissue or impart forces in any direction that resist 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.

[0010] In some embodiments disclosed therein, the stabilizing catheter is tightened into the right atrial side of the anterior tricuspid annulus. The stabilizing catheter may be tightened partially into the annulus so that the tip of the stabilizing catheter does not exit the annular tissue into the right ventricular space, or the stabilizing catheter may be tightened completely through the annulus so that the tip of the stabilizing catheter exits into the right ventricle.

[0011] Other embodiments disclosed therein include winding the distal end of the guide wire into a helical coil with a sharpened tip so that the guide wire can be tightened into and through the tissue of the heart by applying torque to the wire with minimal compressive force. Yet another embodiment disclosed therein includes configuring a helical thread in a distal tapered section of the dilator so that rotating the dilator when in contact with the tissue of the heart causes the dilator to be advanced through the tissue of the heart with minimal compressive force.

[0012] In some aspects, the technology described herein relates to a method of tricuspid valve repair, the method comprising: anchoring a first ventricular surface anchor against a first right ventricular surface, wherein the first ventricular surface anchor is connected to a first tension member; anchoring the first tension anchor against a tension anchor surface of the heart, wherein the first tension anchor is connected to a second tension member; extending the first tension member connected to the first ventricular surface anchor toward the second tension member connected to the first tension anchor; and dragging the first right ventricular surface toward the first tension anchor using the first tension member and the second tension member.

[0013] In some aspects, the technology described herein relates to a method that also includes: anchoring a second tension anchor to another tension anchor surface of the heart, wherein the second tension anchor is connected to a third tension member; wherein the third tension member is connected to the first tension member and the second tension member via a tension member lock.

[0014] In some aspects, the technology described herein relates to a method wherein the tension anchor surface is placed against a left atrial surface of the interatrial septum below the foramen ovale.

[0015] In some aspects, the technology described herein relates to a method wherein the tension anchor surface is placed against a left atrial surface of the atrial septum below and behind the foramen ovale.

[0016] In some aspects, the technology described herein relates to a method wherein the tension anchor surface is at a right ventricular surface of the ventricular septum.

[0017] In some aspects, the technology described herein relates to a method wherein the tension anchor surface is at a left ventricular surface of the ventricular septum.

[0018] In some aspects, the technology described herein relates to a method wherein the tension anchor is surfaced at the coronary sinus proximal to the right atrium.

[0019] In some aspects, the technology described herein relates to a method that also includes: anchoring a second ventricular surface anchor against a right ventricular surface near the anterior portion of the tricuspid annulus; wherein the second ventricular surface anchor is connected to a third tension member; wherein the center of the first ventricular surface anchor is spaced 0.5 cm to 4 cm from the center of the second ventricular surface anchor; and extending the first tension member connected to the first ventricular surface anchor and the second tension member connected to the second ventricular surface anchor toward the first tension anchor; and using the first tension member, the second tension member and the third tension member to drag the first right ventricular surface and the right ventricular surface near the anterior portion of the tricuspid annulus toward the first tension anchor.

[0020] In some aspects, the technology described herein relates to a method, further comprising: anchoring a third ventricular surface anchor against a right ventricular surface near the posterior portion of the tricuspid annulus; wherein the third ventricular surface anchor is connected to a fourth tension member; wherein the center of the third ventricular surface anchor is spaced 0.5 cm to 4 cm from the center of the second ventricular surface anchor, and the center of the third ventricular surface anchor is spaced 0.5 cm to 4 cm from the center of the first ventricular surface anchor; and extending the first tension member connected to the first ventricular surface anchor, the second tension member connected to the second ventricular surface anchor, and the third tension member connected to the third ventricular surface anchor toward the first tension anchor; and dragging the first right ventricular surface, the right ventricular surface near the anterior portion of the tricuspid annulus, and the right ventricular surface near the posterior portion of the tricuspid annulus toward the first tension anchor using the first tension member, the second tension member, the third tension member, and the fourth tension member.

[0021] In some aspects, the technology described herein relates to a method wherein the first right ventricular surface is adjacent an anterior portion of the tricuspid annulus.

[0022] In some aspects, the technology described herein relates to a method wherein the first right ventricular surface is within the right ventricular outflow tract.

[0023] In some aspects, the technology described herein relates to a method wherein the first right ventricular surface is within the pulmonary artery proximal to the pulmonary valve.

[0024] In some aspects, the technology described herein relates to a method further comprising anchoring a second tension anchor against a surface of the second tension anchor of the heart with a third tension member; wherein the third tension member connects the second tension anchor to the first tension anchor.

[0025] In some aspects, the technology described herein is directed to a method further comprising anchoring a third tension anchor against a surface of the third tension anchor of the heart with a fourth tension member; wherein the fourth tension member connects the third tension anchor to the first tension anchor.

[0026] In some aspects, the technology described herein is directed to a method further comprising anchoring a fourth tension anchor against a surface of the fourth tension anchor of the heart with a fifth tension member; wherein the fifth tension member connects the fourth tension anchor to the first tension anchor.

[0027] In some aspects, the technology described herein relates to a method wherein pulling the first right ventricular surface toward the first tension anchor further comprises: advancing a tension lock over the first tension member and the second tension member to a position proximal to the first tension anchor to pull the first right ventricular surface toward 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.

[0028] In some aspects, the technology described herein relates to a method wherein locking the tensioning lock comprises adjusting the tensioning lock from a first configuration that allows a tension member to move freely relative to the tensioning lock to a second configuration that prevents the tension member from moving freely relative to the tensioning lock.

[0029] In some aspects, the technology described herein relates to a method that also includes advancing a grommet over the first tension member connected to the first ventricular surface anchor; wherein the grommet is positioned against an atrial surface of the heart opposite the ventricular surface anchor attached to the first tension member.

[0030] In some aspects, the technology described herein relates to a method further comprising advancing a grommet over the second tension member connected to the first tension anchor; wherein the grommet is positioned against a tissue surface opposite the first tension anchor attached to the second tension member.

[0031] In some aspects, the technology described herein relates to a method wherein the first tension member and the second tension member are parts of a single tension element.

[0032] In some aspects, the technology described herein relates to a method for tricuspid valve repair, the method comprising: anchoring a first ventricular surface anchor near an anterior portion of a tricuspid annulus, wherein the first ventricular surface anchor is connected to a first tension member; anchoring a second ventricular surface anchor near a right ventricular surface at a posterior portion of the tricuspid annulus, wherein the second ventricular surface anchor is connected to a second tension member; anchoring the first tension anchor against a left atrial surface of an atrial septum, wherein the first tension anchor is connected to a third tension member; extending the first tension member connected to the first ventricular surface anchor and the second tension member connected to the second ventricular surface anchor toward the third tension member connected to the first tension anchor; and using the first tension member, the second tension member, and the third tension member to drag the anterior portion of the tricuspid annulus and the posterior portion of the tricuspid annulus toward the first tension anchor.

[0033] In some aspects, the technology described herein relates to a method wherein the second ventricular surface anchor is located below the foramen ovale.

[0034] In some aspects, the technology described herein is directed to a method further comprising trimming excess material from the first tension member, the second tension member, and the third tension member.

[0035] In some aspects, the technology described herein relates to a method further comprising: pulling the right ventricular surface toward the first tension anchor further comprising: advancing a tension lock to a position proximal to the first tension anchor over the first tension member, the second tension member, and the third tension member to pull the first ventricular surface anchor and the second ventricular surface anchor toward 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.

[0036] In some aspects, the technology described herein relates to a tricuspid valve repair system, the tricuspid valve repair system comprising: two or more surface anchor systems, each surface anchor system comprising: a surface anchor, the surface anchor comprising a nitinol wire frame defined by nitinol wire at its perimeter, and the surface anchor comprising an internal nitinol wire feature within an area defined by the perimeter formed by the nitinol wire frame; wherein, when the temperature of the nitinol wire frame is body temperature, the nitinol wire frame comprises an austenitic state in a deployed configuration; a tether assembly, the tether assembly connecting two or more surface anchor systems at a tether connection point; and a tether lock.

[0037] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the two or more surface anchor systems and the tether lock are disposed along the tether assembly.

[0038] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the surface anchor is capable of rotatable laterally relative to the tether assembly.

[0039] In some aspects, the technology described herein relates to a tricuspid valve repair system, further comprising a grommet and a grommet lock.

[0040] In some aspects, the technology described herein relates to a tricuspid valve repair system, wherein the grommet is a flat grommet comprising an expandable nitinol frame; wherein the flat grommet is disposed on the tether assembly through a hole in the flat grommet; and wherein, when the temperature of the expandable nitinol frame is human body temperature, the expandable nitinol frame of the grommet comprises an austenitic state in a deployed configuration.

[0041] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the planar grommet additionally includes a cover material that provides a planar surface to the expandable nitinol frame.

[0042] In some aspects, the technology described herein relates to a tricuspid valve repair system, wherein the grommet is a T-bar grommet, the T-bar grommet comprising a singular rigid member having a length along a major axis, the length along the major axis being longer than a width along a minor axis, wherein the width of the T-bar grommet is configured to accommodate the T-bar grommet within an inner diameter of a delivery catheter; wherein the T-bar grommet is disposed on the tether assembly through a hole at or near the center of the T-bar grommet; and wherein the T-bar grommet is capable of pivoting about the tether assembly such that the long axis of the T-bar grommet is substantially parallel to the axis of the tether assembly for insertion into the delivery catheter for deployment; and wherein, after deployment from the delivery catheter, the T-bar grommet is capable of pivoting about the tether assembly such that the longer axis of the T-bar grommet is angled relative to the axis of the tether assembly.

[0043] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the grommet is a self-expanding grommet capable of expanding after deployment to interact with the grommet lock.

[0044] In some aspects, the technology described herein relates to a tricuspid valve repair system, wherein the grommet lock includes a tether hole passing 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 through the tether hole and the grommet lock tether contact surface; wherein applying a force on 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 a grommet lock deflection node, thereby generating a clamping force at the grommet lock tether contact surface and preventing the grommet from moving along the tether assembly away from the surface anchor; and wherein the grommet and the grommet lock are also disposed along the tether assembly.

[0045] In some aspects, the technology described herein relates to a tricuspid valve repair system, wherein the grommet lock includes a first unlocked state capable of sliding along the tether assembly and a second locked state capable of not sliding along the tether assembly; wherein the second locked state prevents the grommet from translating distally along the tether assembly.

[0046] In some aspects, the technology described herein relates to a tricuspid valve repair system, wherein the grommet lock is a knot formed at the tether connection point; wherein the tether assembly is passed through the grommet and then the tether assembly is reattached at the tether connection point so that the knot is proximal to the grommet; and wherein the knot is capable of sliding distally by pushing the knot with a push catheter; and wherein the knot prevents the grommet from sliding proximally along the tether assembly so that the knot prevents the grommet from separating from the surface anchor.

[0047] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the tether assembly is connected to the surface anchor by wrapping around an internal feature of a nitinol frame to form a tether loop prior to reattaching the tether assembly at the tether connection point.

[0048] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the surface anchor is covered by a surface anchor outer covering.

[0049] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the nitinol wire frame of the surface anchor is formed by laser cutting a nitinol sheet or strip.

[0050] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the surface anchor is capable of being mechanically compressed to a first, non-deployed state to a size and dimension compatible with a catheter having an inner diameter that is less than the width of the surface anchor in its second, deployed state.

[0051] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the surface anchor is substantially flat such that the surface anchor length and the surface anchor width are at least 5 times the surface anchor thickness.

[0052] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein a surface anchor transitions from its first, non-deployed state to its second, deployed state upon release from a surface anchor delivery catheter.

[0053] In some aspects, the technology described herein relates to a tricuspid valve repair system, comprising: an anchor system, the anchor system comprising a surface anchor, the surface anchor comprising a nitinol frame and a hole forming an outer perimeter; wherein, when the temperature of the nitinol frame is body temperature, the nitinol frame comprises an austenitic state in a deployed configuration; a grommet, the grommet comprising a distal tubular portion connected to a proximal finger portion; wherein the proximal finger portion is composed 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; wherein the anchor system, the grommet and the surface anchor hub are arranged along the tether.

[0054] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the distal tubular portion of the grommet includes a central flexible beam oriented radially inwardly toward an inner surface of the tube of the grommet.

[0055] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the grommet comprises nitinol having an austenitic state in a deployed configuration when the temperature of the grommet is approximately human body temperature.

[0056] In some aspects, the technology described herein relates to a tricuspid valve repair system, wherein the surface anchor hub comprises: a distal flange, the outer diameter of the distal flange is larger than the inner diameter of the hole in the surface anchor; a central axis, the outer cross-sectional dimension of the central axis is smaller than the inner diameter of the hole in the surface anchor; a proximal nose, the outer diameter of the proximal nose is 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 central axis; and a hole passing through the center of the distal flange, and wherein the inner diameter of the hole passing through the center is larger than the outer diameter of the tether.

[0057] In some aspects, the technology described herein relates to a tricuspid valve repair system, wherein the grommet can be configured to move 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, wherein the central flexible beam within the distal tubular portion of the grommet is positioned above the mid-axis of the surface anchor hub and the central flexible beam of the distal tubular portion of the grommet contacts the proximal nose such that proximal translation of the grommet relative to the surface anchor hub is limited.

[0058] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the plurality of flexible beams of the proximal finger portion of the grommet are capable of being mechanically deflected proximally and radially inward for insertion into a catheter having an inner diameter that is smaller than the position of the proximal finger portion of the grommet in the deployed configuration.

[0059] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein deployment of the grommet allows the proximal finger portion of the grommet to transition from its non-deployed configuration to its deployed configuration.

[0060] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the distal end of the tether is larger than the inner diameter of the hole through the surface anchor hub such that the tether cannot be pulled in a proximal direction through the surface anchor hub.

[0061] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the surface anchor and the grommet are capable of rotatable laterally relative to the tether.

[0062] In some aspects, the technology described herein relates to a tricuspid valve repair system wherein the surface anchor is capable of being mechanically compressed to a first, non-deployed state to a size and dimension compatible with a catheter having an inner diameter that is less than the width of the surface anchor in its second, deployed state.

[0063] In some aspects, the technology described herein relates to a method of implanting a tricuspid valve repair system to repair a heart, the tricuspid valve repair system comprising a tether and two or more surface anchor systems, each surface anchor system comprising a surface anchor, a grommet, and a grommet lock, the method comprising: advancing the tricuspid valve repair system toward the heart, positioning the distal end of a catheter housing the surface anchor system adjacent to an implantation surface of the heart; piercing the implantation surface of the heart with the catheter; pushing the tricuspid valve repair system from the catheter with a pushing catheter located within the catheter The surface anchor of the system; allowing the surface anchor to transition from a non-deployed configuration to a deployed configuration; partially retracting the catheter so that the catheter no longer pierces the implant surface of the heart; pushing the grommet and the grommet lock of the tricuspid valve repair system from the catheter with the pushing catheter; allowing the grommet to transition from a non-deployed configuration to a deployed configuration; and advancing the grommet lock distally along the tether of the tricuspid valve repair system to a desired distance so that the distance between the surface anchor and the grommet is substantially occupied by the thickness of the implant surface of the heart.

[0064] In some aspects, the technology described herein relates to a method wherein allowing the surface anchor to transition from the non-deployed configuration to the deployed configuration includes allowing the surface anchor to transition to an austenitic state configured to the deployed configuration.

[0065] In some aspects, the technology described herein relates to a method wherein allowing the grommet to transition from the non-deployed configuration to the deployed configuration includes allowing the grommet to transition to an austenitic state configured to the deployed configuration.

[0066] In some aspects, the technology described herein relates to a method further comprising trimming excess tether from the tricuspid valve repair system.

[0067] In some aspects, the technology described herein relates to a method of implanting a tricuspid valve repair system to repair a heart, the tricuspid valve repair system comprising a tether and two or more surface anchor systems, each surface anchor system comprising a surface anchor, a lockable grommet, and a surface anchor hub, the method comprising: positioning a catheter adjacent to an implantation surface of the heart; piercing the implantation surface of the heart with the catheter; pushing the surface anchor and the surface anchor hub of the tricuspid valve repair system from the catheter with a pushing catheter located within the catheter; allowing the surface anchor to transition from a non-deployed configuration to a deployed configuration; partially retracting the catheter so that The catheter no longer pierces the implantation surface of the heart; the lockable bezel of the tricuspid valve repair system is pushed from the catheter with the push catheter; the lockable bezel is allowed to transition from a non-deployed configuration to a deployed configuration; and the lockable bezel is advanced distally along the tether of the tricuspid valve repair system to a desired distance above the surface anchor hub, so that the distance between the surface anchor and the lockable bezel is substantially occupied by the thickness of the implantation surface of the heart, and the lockable bezel interacts with the surface anchor hub so that the lockable bezel is locked to prevent proximal translation relative to the surface anchor hub.

[0068] In some aspects, the technology described herein relates to a method wherein allowing the surface anchor to transition from the non-deployed configuration to the deployed configuration includes allowing the surface anchor to transition to an austenitic state configured to the deployed configuration.

[0069] In some aspects, the technology described herein relates to a method wherein allowing the lockable grommet to transition from the non-deployed configuration to the deployed configuration includes allowing the lockable grommet to transition to an austenitic state configured to the deployed configuration.

[0070] In some aspects, the technology described herein relates to a foldable flat implant system for tricuspid valve repair, the foldable flat implant system being configured to be attached to a septal surface anchor, the foldable flat implant system comprising: a flexible anterior rod anchor, the flexible anterior rod anchor being non-fixably attached to a delivery catheter; at least one guide wire, the at least one guide wire having a distal end, the at least one guide wire passing through a hole in the flexible anterior rod anchor at a rotatable guide wire connector; an anterior rod tether, the anterior rod tether comprising at least one tether snare, the at least one tether snare being configured to pass through the lumen of a snare catheter; wherein the at least one guide wire is capable of being loosely connected to the at least one tether snare after passing through treatment tissue and being advanced through the flexible front rod anchor; wherein the at least one guide wire is attached to a tether at a proximal end; wherein pulling the at least one guide wire through the flexible front rod anchor by the at least one tether snare causes the tether attached to the proximal end of the at least one guide wire to be pulled through the hole in the flexible front rod anchor; and wherein the front rod tether connects the spacing surface anchor to the flexible front rod anchor.

[0071] In some aspects, the technology described herein relates to a method for implanting a tricuspid valve repair system to repair a patient's heart, the method comprising: advancing the tricuspid valve repair system into the patient, the tricuspid valve repair system comprising a septal surface anchor attached to a septal surface anchor tether and a foldable flat implant system having a flexible anterior rod anchor, at least one guide wire connected at its proximal end to the anterior anchor tether having a plug end, and at least one tether snare within a manipulable anterior anchor delivery catheter, installing the septal surface anchor into the left atrium of the heart via the guide wire and the septal surface anchor delivery catheter; inserting the manipulable anterior anchor delivery catheter attached to the flexible anterior rod anchor into a guide catheter in a non-deployed configuration, and tracking the flexible anterior rod anchor to the distal end of the guide catheter; guiding the guide catheter above the tricuspid valve of the heart; extending the manipulable anterior anchor delivery catheter and guiding the flexible anterior rod anchor through the tricuspid valve into the right ventricle; deploying the flexible anterior rod anchor into a deployed configuration; positioning the flexible anterior rod anchor and the distal end of the at least one guide wire adjacent to the anterior anchor implantation area; piercing the anterior anchor implantation area with the distal end of the at least one guide wire to the opposite side of the anterior anchor implantation area; connecting the at least one tether snare to the proximal end of the at least one guide wire; advancing the at least one guide wire through the anterior anchor implantation area and through the flexible anterior rod anchor so that the proximal end of the at least one guide wire passes through the flexible anterior rod anchor and so that the plug end of the anterior anchor tether contacts the distal surface of the flexible anterior rod anchor away from the anterior anchor implantation area; detaching the flexible anterior rod anchor from the steerable anterior anchor delivery catheter; and removing the steerable anterior anchor delivery catheter from the patient.

[0072] In some aspects, the technology described herein relates to a method, additionally comprising: positioning the maneuverable anterior anchor delivery catheter to a secondary location near the anterior anchor implantation area so that a tether passing through the secondary location is still able to functionally interact with the flexible anterior rod anchor; piercing the secondary location to an opposite side of the secondary location with a distal end of a second guide wire, wherein the second guide wire is connected at its proximal end to a second anterior anchor tether having a plug end; connecting a second tether snare to the proximal end of the second guide wire; and advancing the second guide wire through the secondary location and through the flexible anterior rod anchor so that the proximal end of the second guide wire passes through the flexible anterior rod anchor and so that the plug end of the second anterior anchor tether contacts a distal surface of the flexible anterior rod anchor away from the anterior anchor implantation area.

[0073] In some aspects, the technology described herein relates to a method, additionally comprising: passing a tether lock over the anterior anchor tether and the septal surface anchor tether via a locking catheter; tensioning the anterior anchor tether within the right atrium to drag 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; trimming excess tether from the anterior anchor tether and the septal surface anchor tether; and removing all catheters from the patient.

[0074] In some aspects, the technology described herein relates to a method wherein the anterior anchor implantation region is at the right ventricle surface near the anterior tricuspid annulus; wherein the flexible anterior rod anchor spans one to four centimeters of the surface near the anterior tricuspid annulus.

[0075] In some aspects, the technology described herein relates to a method wherein the flexible anterior rod anchor comprises an elongated nitinol frame having rigid eyelets attached near each end, a covering, and an anchor rod delivery connector near the center of the elongated nitinol frame.

[0076] In some aspects, the technology described herein relates to a method wherein the covering can be tapered from near the center of the elongated Nitinol frame to an end of the elongated Nitinol frame.

[0077] In some aspects, the technology described herein relates to a method wherein the tricuspid valve repair system includes two guide wires and two snare tethers.

[0078] In some aspects, the technology described herein relates to a guide wire delivery system, comprising: 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 sized to enable the stabilizing catheter to pass through the guide catheter lumen; a helical tip at the distal tip of the stabilizing catheter; and a guide wire sized to enable it to pass through the stabilizing catheter lumen.

[0079] In some aspects, the technology described herein relates to a guide wire delivery system wherein the helical tip is a laser cut helix having a generally trapezoidal cross-section.

[0080] In some aspects, the technology described herein relates to a guide wire delivery system wherein the helical tip is a wound wire helix having a circular cross-section.

[0081] In some aspects, the technology described herein relates to a guide wire delivery system wherein the helical tip is two wrapped helices.

[0082] In some aspects, the technology described herein relates to a guide wire delivery system wherein the helical tip is a tapered winding helix wherein a radius of curvature of a distal-most end of the helical tip is greater than a radius of curvature of a proximal-most end of the tapered winding helix.

[0083] In some aspects, the technology described herein relates to a guide wire delivery system wherein the helical tip is a tapered winding helix wherein a radius of curvature of a distal-most end of the helical tip is smaller than a radius of curvature of a proximal-most end of the tapered winding helix.

[0084] In some aspects, the technology described herein relates to a method for passing a guide wire through the surface of a heart, the method comprising: advancing a guide wire delivery system toward the heart, the guide wire delivery system comprising: 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 being configured to enable the stabilizing catheter to pass through the guide catheter lumen; a helical tip located at the distal end of the stabilizing catheter; and a guide wire configured to enable it to pass through the stabilizing catheter lumen; positioning the flexible guide catheter at the surface of the heart within the right atrium of the heart; advancing the stabilizing catheter through the flexible guide catheter; positioning the helical tip against the surface of the heart at the distal end of the stabilizing catheter; rotating the helical tip so that the helical tip engages with the surface of the heart; and advancing the guide wire through the stabilizing catheter and through the surface of the heart.

[0085] In some aspects, the technology described herein relates to a method wherein the surface of the heart through which the guide wire passes is near the anterior tricuspid annulus.

[0086] In some aspects, the technology described herein relates to a method wherein the surface of the heart through which the guide wire is passed is such that the guide wire passes from the right atrium to within the right ventricular outflow tract of the heart.

[0087] In some aspects, the technology described herein relates to a method further comprising: while advancing the stabilizing catheter toward the surface of the heart, further rotating the helical tip so that the distal end of the stabilizing catheter can completely pass through the surface of the heart.

[0088] In some aspects, the technology described herein relates to a method of tricuspid valve repair, the method comprising: advancing a guide wire delivery system toward the heart, the guide wire delivery system comprising: a flexible guide catheter having a guide catheter lumen; a stabilizing catheter having a distal tip located on a distal end of the stabilizing catheter, a stabilizing catheter lumen, and a flexible region, the stabilizing catheter being configured to enable the stabilizing catheter to pass through the guide catheter lumen; a helical tip located at the distal tip of the stabilizing catheter; and a guide wire configured to enable it to pass through the stabilizing catheter lumen; at least three guide wires prepared for deployment a surface anchor, wherein at least three surface anchors are covered by a surface anchor outer covering and include a nitinol wire frame defined by nitinol wire at its perimeter, an internal nitinol wire feature within an area defined by the perimeter formed by the nitinol wire frame, wherein when the temperature of the nitinol wire frame is body temperature, the nitinol wire frame includes an austenitic state in a deployed configuration; positioning the flexible guide catheter within the right atrium of the heart, near the anterior tricuspid annulus; advancing the stabilizing catheter through the flexible guide catheter; positioning the spiral tip at the distal end of the stabilizing catheter against the right atrium surface of the heart, near the anterior tricuspid annulus; causing the The spiral tip is rotated so that the spiral tip engages with the right atrium surface of the heart near the anterior tricuspid annulus; the guide wire is advanced through the stabilization catheter and through the surface of the heart between the right atrium and the right ventricle; an anchor delivery catheter is advanced over the guide wire from the right atrium into the right ventricle; the guide wire is retracted through the anchor delivery catheter; a first anchor connected to a first tether is anchored through the anchor delivery catheter against the right ventricle surface near the anterior portion of the tricuspid annulus; the anchor delivery catheter is retracted through the flexible guide catheter; the flexible guide catheter is positioned in the right atrium of the heart, near the anterior tricuspid annulus wherein the guide wire is positioned adjacent the right atrium and the right ventricle; ...Anchoring a second anchor connected to a second tether by passing the anchor delivery catheter against the surface of the right ventricle near the anterior portion of the tricuspid annulus at a distance of 1 cm to 4 cm away from the first anchor; retracting the anchor delivery catheter through the flexible guide catheter; positioning the flexible guide catheter in the right atrium of the heart, near the atrial septum; advancing the anchor delivery catheter through the flexible guide catheter; positioning the distal end of the anchor delivery catheter against the atrial septum below the fossa ovalis; advancing the guide wire through the anchor delivery catheter and through the atrial septum of the heart; advancing the anchor delivery catheter over the guide wire from the right atrium to the left atrium of the heart retracting the guide wire through the anchor delivery catheter; anchoring a third anchor connected to a third tether through the atrial septum of the heart; retracting the anchor delivery catheter through the atrial septum of the heart; passing the first, second, and third tethers through a tether lock; advancing the tether lock to a position adjacent to the third anchor; using the first, second, and third tethers, pulling the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus; and actuating the tether lock to clamp the first, second, and third tethers and fix the distances between the first, second, and third anchors relative to each other. ;

[0089] In some aspects, the technology described herein relates to a method further comprising: advancing a grommet distally along a selected tether selected from the first tether, the second tether, or the third tether of the guide wire delivery system; and advancing a grommet lock distally along the selected tether through which the grommet of the guide wire delivery system is passing to a desired distance so that the distance between an anchor connected to the selected tether and the grommet is substantially occupied by the thickness of the implantation surface of the heart.

[0090] In some aspects, the technology described herein relates to a method further comprising: attaching a fourth surface anchor to a delivery catheter, the fourth surface anchor being covered by a surface anchor outer covering and comprising a nitinol wire frame defined by nitinol wire at its perimeter, an internal nitinol wire feature within an area defined by the perimeter formed by the nitinol wire frame, wherein when the temperature of the nitinol wire frame is body temperature, the nitinol wire frame comprises an austenitic state in a deployed configuration; positioning the flexible guide catheter within the right atrium of the heart, near the anterior tricuspid annulus, and substantially adjacent to the second anchor; advancing the stabilizing catheter through the flexible guide catheter; positioning the spiral tip at the distal end of the stabilizing catheter against the right atrium surface of the heart, near the anterior tricuspid annulus, and adjacent to the first anchor; rotating the spiral tip so that the spiral tip is aligned with the anterior tricuspid annulus of the heart; engaging the right atrium surface; advancing the guide wire through the stabilizing catheter and through the heart between the right atrium and the right ventricle; advancing the anchor delivery catheter over the guide wire from the right atrium into the right ventricle; retracting the guide wire through the anchor delivery catheter; anchoring a fourth anchor connected to a fourth tether through the anchor delivery catheter against the right ventricle surface near the anterior portion of the tricuspid annulus at a distance of 1 cm to 4 cm away from the second anchor; retracting the anchor delivery catheter through the flexible guide catheter; wherein the tether lock is additionally passed over the fourth tether; wherein pulling the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus also includes the fourth tether; and wherein actuating the tether lock also includes the fourth tether to fix the distances between the first anchor, the second anchor, the third anchor, and the fourth anchor relative to each other.

[0091] In some aspects, the technology described herein relates to a method wherein a distal tip of the guide wire is configured to transmit a high-frequency current to the distal tip, wherein the high-frequency current reduces the force required to pass through a portion of the heart.

[0092] In some aspects, the technology described herein relates to a method of tricuspid valve repair, comprising: advancing a guide wire delivery system toward the heart, the guide wire delivery system comprising: a flexible guide catheter having a guide catheter lumen; a stabilizing catheter having a distal tip located on a distal end of the stabilizing catheter, a stabilizing catheter lumen, and a flexible region, the stabilizing catheter being configured to enable the stabilizing catheter to pass through the guide catheter lumen; a helical tip located at the distal tip of the stabilizing catheter; and a guide wire configured to enable it to pass through the stabilizing catheter lumen; at least two surface anchors prepared for deployment, the at least two The surface anchor is covered by a surface anchor outer covering and includes a nitinol wire frame defined by nitinol wire at its perimeter, an internal nitinol wire feature within an area defined by the perimeter formed by the nitinol wire frame, wherein when the temperature of the nitinol wire frame is body temperature, the nitinol wire frame includes an austenitic state in a deployed configuration; positioning the flexible guide catheter within the right atrium of the heart, near the anterior tricuspid annulus; advancing the stabilizing catheter through the flexible guide catheter; positioning the spiral tip at the distal end of the stabilizing catheter against the right atrium surface of the heart, near the anterior tricuspid annulus; rotating the spiral tip so that the spiral tip is in the deployed configuration; The invention relates to a method for achieving a good heart rate and a good heart rate. The method comprises the steps of: engaging the right atrium surface of the heart near the anterior tricuspid annulus; advancing the guide wire through the stabilizing catheter and through the surface of the heart between the right atrium and the right ventricle; advancing the anchor delivery catheter from the right atrium into the right ventricle over the guide wire; retracting the guide wire through the anchor delivery catheter; anchoring the first anchor connected to the first tether through the anchor delivery catheter against the right ventricle surface near the anterior portion of the tricuspid annulus; retracting the anchor delivery catheter through the flexible guide catheter; positioning the flexible guide catheter in the right atrium of the heart near the atrial septum; placing the distal end of the anchor delivery catheter against the septum below the fossa ovalis the first tether and the second tether being passed through a tether lock; the tether lock being advanced to a position adjacent to the second anchor; and the anterior portion of the tricuspid annulus being pulled toward the posterior septal portion of the tricuspid annulus using the first tether and the second tether;and actuating the tether lock to clamp the first tether and the second tether and fix the distance between the first anchor and the second anchor relative to each other. ;

[0093] In some aspects, the technology described herein relates to a guide wire delivery system, comprising: a dilator having an inner lumen and an inner lumen shoulder; and a helical guide wire positioned within the inner lumen, wherein the helical guide wire abuts the inner lumen shoulder, the inner lumen shoulder preventing the helical guide wire from axially moving through the dilator, wherein the helical guide wire is capable of rotating within the inner lumen; and wherein the helical guide wire has a helical guide wire portion at a distal guide wire end that is fixably attached to the helical guide wire.

[0094] In some aspects, the technology described herein relates to a method for passing a guide wire through the surface of a heart, the method comprising: advancing a guide wire delivery system within the heart, the guide wire delivery system comprising: a stabilizing catheter having an inner lumen, the inner lumen having an inner lumen shoulder; and a helical guide wire, the helical guide wire adjacent to the inner lumen shoulder and capable of rotating within the inner lumen of the stabilizing catheter, wherein the helical guide wire has a helical guide wire portion at a distal guide wire end that can be fixedly attached to the helical guide wire; positioning the guide wire delivery system within the right atrium of the heart; positioning the helical guide wire against the surface of the heart; rotating the helical guide wire so that the helical guide wire engages the surface of the heart; and advancing the guide wire and the stabilizing catheter through the surface of the heart.

[0095] In some aspects, the technology described herein relates to a lock for use in a tricuspid valve repair system, the lock comprising: a lock housing having a pass through hole configured to accommodate at least two tension members passing through the lock housing; and an adjustable lock tensioner configured to move within the lock housing; wherein the adjustable lock tensioner is capable of retracting the at least two tension members as the at least two tension members pass through the lock housing; and wherein the lock is capable of transitioning from a first configuration capable of allowing the tension members to move freely relative to the lock to a second configuration that prevents the tension members from moving freely relative to the lock.

[0096] In some aspects, the technology described herein relates to a method of manufacturing a surface anchor, the method comprising: activating a laser configured to cut through a Nitinol sheet, wherein the Nitinol sheet has an area and thickness configured to accommodate at least a final size of the surface anchor; and displacing the Nitinol sheet relative to the laser along a contour within the Nitinol sheet; wherein the contour cut from the Nitinol sheet is substantially similar to the final shape of the surface anchor.

[0097] In some aspects, the technology described herein relates to a method of tricuspid valve repair, the method comprising: anchoring a first anchor against a right ventricular surface near an anterior portion of a tricuspid annulus; extending a tension member from the first anchor toward the right atrial surface of the atrial septum; and using the tension member to drag the anterior portion of the tricuspid annulus toward a posterior septal portion of the tricuspid annulus.

[0098] In some aspects, the technology described herein relates to a method wherein drawing the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus includes advancing a lock coupled to the tension member toward the right atrial surface of the atrial septum.

[0099] In some aspects, the technology described herein relates to a method that includes placing a left atrial anchoring element against a left atrial surface of the atrial septum, and coupling the first anchor and the left atrial anchoring element to each other with the tension member.

[0100] In some aspects, the technology described herein relates to a method that also includes: anchoring a second anchor against the right ventricular surface of the anterior portion of the tricuspid ring; extending a second tension member from the second anchor toward the right atrial surface of the atrial septum; and using the second tension member to drag the anterior portion of the tricuspid ring toward the posterior septal portion of the tricuspid ring.

[0101] In some aspects, the technology described herein relates to a tricuspid valve repair system that includes one or more of the features described above.

[0102] In some aspects, the technology described herein relates to a method of tricuspid valve repair, the method comprising implanting one or more features of the aforementioned tricuspid valve repair system into the heart of a patient.

[0103] In some aspects, the technology described herein relates to a method of passing a guide wire through tissue within a body, the method comprising: tightening a stabilizing catheter having a spiral wire on a distal end into the tissue; passing the guide wire through the stabilizing catheter; and using the stabilizing catheter to support the guide wire while completely passing the guide wire through the tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0104] These and other features, aspects and advantages of the present application are described with reference to the accompanying drawings of certain embodiments, which are intended to illustrate but not limit the present invention. It should be understood that these drawings are for the purpose of illustrating the various concepts disclosed herein and may not be to scale.

[0105] Figure 1 A 4-chamber cross-section of a heart is illustrated with the regurgitant jet between the anterior and septal leaflets of the tricuspid valve.

[0106] Figure 2 A 4-chamber cross-section of a heart is illustrated having a treatment embodiment comprising an anchoring element implanted on the left atrial surface against the atrial septum beneath the fossa ovalis and connected via a tension band via a lock on the right atrial surface near the atrial septum to an anchoring element implanted on the right ventricular surface against the anterior tricuspid annulus.

[0107] Figure 3 A 4-chamber cross-section of a heart is illustrated having a treatment embodiment comprising an anchoring element implanted on the right ventricular surface against the ventricular septum below the hinge of the tricuspid valve leaflets and connected via a tension band via a lock near the right atrial surface of the atrial septum to an anchoring element implanted on the right ventricular surface against the anterior tricuspid annulus.

[0108] Figure 4 A 4-chamber cross-section of a heart is illustrated having a treatment embodiment comprising an anchoring element implanted on the left ventricular surface against the ventricular septum below the hinge of the mitral valve leaflets and connected via a tension band via a lock on the right atrial surface near the atrial septum to an anchoring element implanted against the anterior tricuspid annulus.

[0109] Figure 5 A 4-chamber cross-section of a heart is illustrated with a treatment embodiment comprising an anchoring element implanted in a Figures 2 to 4 In each of the positions illustrated in , and connected via a tension band to an anchoring element implanted against the right ventricular surface of the anterior tricuspid annulus through a lock near the right atrial surface of the atrial septum.

[0110] Figure 6 Illustrated based on Figure 2A top (surgeon's) view of the heart of a treatment embodiment of the present invention comprising an anchoring element implanted on the left atrial surface against the atrial septum beneath the fossa ovalis and connected via a tensioning band via a lock near the right atrial surface of the atrial septum to an anchoring element implanted on the right ventricular surface against the anterior tricuspid annulus.

[0111] Figure 7 Illustrated is a top (surgeon's) view of a heart having a treatment embodiment comprising an anchoring element implanted on the left atrial surface against the atrial septum beneath the fossa ovalis and connected via a tension band via a lock on the right atrial surface near the atrial septum to an anchoring element implanted on the right ventricular surface against the anterior and posterior tricuspid annuli.

[0112] Figure 8 A top (surgeon's) view of a heart with a treatment embodiment is illustrated, the embodiment comprising anchoring elements and a rod spanning the right atrium from the atrial septum to the RVOT below the fossa ovalis. Anchoring elements implanted on the right ventricular surface of the anterior and posterior tricuspid annulus are attached to the rod via a tension band via a lock near the center of the rod, and tensioning of the band draws those portions of the tricuspid annulus in contact with the anchoring elements toward the rod.

[0113] Fig. 9 Illustrated is a top (surgeon's) view of a heart having a treatment embodiment comprising an anchoring element implanted against the inferior surface of the coronary sinus near the ostium and connected via a tension band via a lock near the right atrial surface of the atrial septum to anchoring elements implanted against the anterior and posterior tricuspid annuli.

[0114] Fig.10 A cross section of a heart with one treatment embodiment is illustrated, the embodiment comprising an anchoring element implanted on the lower surface of the coronary sinus near the ostium of the coronary sinus, wherein a tension band is looped through the left ventricular myocardium below the coronary sinus from within the coronary sinus toward the tricuspid annulus. Another anchoring element is implanted on the right ventricular surface of the anterior tricuspid annulus, wherein the tension band crosses 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] Fig.11A cross section of a heart with one treatment embodiment is illustrated, the embodiment comprising implanting an anchoring element implanted on the lower surface of the coronary sinus near the ostium of the coronary sinus, wherein a tension band is looped through the left ventricular myocardium below the coronary sinus from near the tricuspid annulus to within the coronary sinus. Another anchoring element is implanted on the right ventricular surface of the anterior tricuspid annulus, wherein a tension band is looped across the annulus to within the right atrium. The tension bands are tensioned and connected together within a lock located near the ostium of the coronary sinus to pull the anterior tricuspid annulus toward the coronary sinus.

[0116] Fig.12 A cross-section of a heart with a treatment embodiment is illustrated, the embodiment comprising Fig.10 The anchoring elements are implanted similarly to those in , except that a pad is additionally implanted on the inferior surface of the coronary sinus where the tensioner band withdraws to allow myocardial tissue to be compressed between the pad and the anchor and prevent the tensioner band from cutting through the myocardial tissue.

[0117] Fig.13 A cross section of a heart with one treatment embodiment is illustrated, the embodiment comprising an anchoring element implanted against the right ventricular surface of the tricuspid annulus below the coronary sinus ostium (near the septal / posterior tricuspid valve commissure) with a tension band looped through the left ventricular myocardium below the coronary sinus from near the tricuspid annulus into the coronary sinus. Another anchoring element is implanted on the right ventricular surface of the anterior tricuspid annulus with a tension band traversing 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.

[0118] Fig.14 Catheter access through the venous circulatory system via the femoral vein and inferior vena cava (IVC) into the right atrium is illustrated, with the distal tip of the catheter positioned below the fossa ovalis and proximal to the ostium of the coronary sinus.

[0119] Fig.15 A wire is illustrated passing through the atrial septum from the right atrium to the left atrium.

[0120] Fig.16 The dilator and sheath are illustrated along the wire through the atrial septum into the left atrium.

[0121] Fig.17 A septal anchoring element is illustrated deployed outside of a sheath within the left atrium.

[0122] Fig.18 The septal anchor element is illustrated abutting against the left atrium wall, with the anchor deployment catheter or sheath removed and a tension band connected to the anchor element passed through a guide catheter.

[0123] Fig.19A guide catheter having a sheath and dilator directed toward the anterior tricuspid annulus is illustrated with a septal anchor abutting the left atrial wall and a tensioning band connected to the septal anchor extending through the guide catheter.

[0124] Fig. 20 A 4-chamber cross section of the heart is illustrated with a guide catheter, sheath, and dilator being directed toward the anterior tricuspid annulus and a wire being passed from the right atrial side of the anterior tricuspid annulus to the right ventricular side. A septal anchor is abutted to the left atrial wall with a tension band connected to the septal anchor extending through the guide catheter.

[0125] Fig.21 The sheath and dilator are illustrated along the wire through the anterior tricuspid annulus from the right atrium to the right ventricle.

[0126] Fig. 22 Deployment of the anterior anchoring element from the sheath into the right ventricle is illustrated.

[0127] Fig.23 An anterior anchoring element is illustrated adjacent to the right ventricular surface of the anterior tricuspid annulus, with an attached tension band passing from the right ventricle to the right atrium and into a guide catheter. A septal anchor is adjacent to the left atrial wall, with an attached tension band passing from the left atrium through the atrial septum to the right atrium and into a guide catheter.

[0128] Fig.24 Locking of a tension band connected to the anterior and septal anchoring elements with a lock placed near the atrial septum and a locking guide catheter passed through a guide catheter is illustrated.

[0129] Fig.25 A guide catheter is illustrated 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 valve leaflets in the right ventricle. The anterior anchor is illustrated mounted to the distal end of the catheter in a folded configuration. The septal anchor abuts against the left atrial wall, with an attached tension band passing through the atrial septum into the guide catheter.

[0130] Fig.26 The anterior anchor is illustrated in its expanded or deployed configuration behind the anterior tricuspid valve leaflets within the right ventricle, with a wire passing through each end of the anterior anchor traversing the anterior tricuspid valve annulus from the right ventricle to the right atrium.

[0131] Fig. 27 A snare catheter is illustrated exiting the guide catheter into the right atrium and positioned to capture one of the wires passing through the anterior tricuspid valve annulus.

[0132] Fig.28 A first tensioning member passing through the anterior anchor of a guiding catheter snare is illustrated, wherein a plug at the end of the tensioning band abuts against the anterior anchor.

[0133] Fig.29 The snare catheter is illustrated exiting the guide catheter into the right atrium and positioned to capture a second wire passing through the anterior tricuspid valve annulus.

[0134] Fig.30 Two tensioning bands connected to the anterior anchor are illustrated through a guiding catheter snare, with the plugs at the ends of the tensioning bands abutting against the anterior anchor, and the anterior anchor delivery catheter removed.

[0135] Fig.31 The anterior anchor is illustrated abutting the ventricular surface of the anterior tricuspid valve annulus with an attached tension band routed to the lock near the atrial septum. The septal anchor is illustrated abutting against the left atrial wall with an attached tension band routed to the lock. The lock catheter 4082 extends from the guide catheter and is connected to the lock.

[0136] Fig.32 Illustrated is a view from the right atrium looking down on the tricuspid valve of a tension band passing through the anterior tricuspid annulus and connected to a lock near the atrial septum and the coronary sinus ostium.

[0137] Fig.33 A right ventricular view of two expandable stem anchoring elements positioned within and adjacent to the RVOT 57 against the right ventricular surface of the anterior tricuspid annulus is illustrated looking up at the tricuspid valve 10 .

[0138] Fig.34 A braided Nitinol anchor is illustrated within the left atrium, abutting the left atrial wall against the atrial septum above the mitral valve.

[0139] Fig.35 An anchor element embodiment is illustrated where the anchor is constructed from a Nitinol wire form that is heat set into an oval perimeter with triangular ends and a cross in the center. The perimeter is constructed from 2 layers of Nitinol wire that are spirally wound around each other to lock the wires together and distribute the forces from the center cross to the perimeter and vice versa. A stainless steel sleeve connects the free ends of the wires.

[0140] Fig.36 Example from Fig.35 An alternative configuration of wire forms in which the wire form is heat set into a more circular perimeter profile.

[0141] Fig.37 Illustrated Fig.35 An anchoring element in which a polymer covering or a fabric covering is over the wire form and a tensioning strap is attached to the center cross by a knot.

[0142] Fig.38 The invention illustrates a device that is stretched and compressed into a deployment catheter or sheath. Fig.37 anchoring element.

[0143] Fig.39 A braided nitinol septal anchor is illustrated abutting against the left atrial wall of the heart with a grommet attached to the tension band at its right atrial outlet such that the septum is sandwiched between the anchor and the grommet and the anchor cannot move from its position.

[0144] Fig.40A One embodiment of a front anchor "rod" and delivery catheter is illustrated, where the anchor is centrally attached 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 is passed through the hollow tube, through the anchor and through a loop of the snare catheter positioned near the wire exit point. Fig.40B Shows Fig.40A Alternative views of embodiments of the present invention.

[0145] Fig.41 The front anchor illustrated in FIG. 40 is illustrated in a collapsed configuration, wherein the anchor is collapsed by tensioning a flexible hollow tube connected to each end of the anchor.

[0146] Fig.42A 40 and 41 illustrate a transparent polymer cover. Fig.41 An isometric view of the anterior anchor "rod" illustrated in . The inner metal frame made of Nitinol can be seen to have two threaded stainless steel hubs with through holes that are interference fit into each end of the frame. The central hole for attachment to the delivery catheter is shown. The hub is threaded for attachment to the swivel of the delivery catheter, and the through hole is sized to allow the passage of wires and tensioning bands, but to block the passage of plugs at the ends of the tensioning bands. The covering can be made of a flexible material and an elastic material such as a silicone elastomer, ) or other suitable material injection molded or compression molded over the frame and hub, or can be a stitched or heat-bonded fabric covering of PET, PTFE felt or other suitable material.

[0147] Fig.42B Illustrated Fig.42B A side view of the front anchor "rod" shown in Figure 1, showing the frame and hub enclosed within the covering. The covering tapers to a thinner profile toward the center to reduce bending stiffness at the center and cause the anchor to preferentially fold about the center when the hub end is pulled with the center secured to the catheter.

[0148] Fig.43The front anchor "rod" shown in Figures 40-42 is illustrated attached to a delivery catheter in a hinged configuration. A swivel can be seen attached to the hub of the anchor and connected to a flexible hollow tube constructed of laser cut metal or twisted metal strands. The swivel allows the anchor to transition from a first folded configuration, in which the axis of the hub is generally perpendicular to the axis of the catheter tip, to a second deployed configuration, in which the axis of the anchor hub is generally parallel to the axis of the catheter tip. Wires can be seen extending from the anchor hub. The swivel can be disengaged from the anchor by rotation of the flexible hollow tube.

[0149] Fig.44A An embodiment of an anchoring element is illustrated in which the anchor is constructed of a braided nitinol wire shaped into a disc configuration. An end view of the anchor is shown, in which the anchor is depicted as being generally circular. The anchor can be elongated, which causes the disc to collapse into a long narrow tube for delivery through a catheter. A tensioning band is centrally attached to the distal end of the anchor via an interference knot, which causes the anchor to flatten when the tensioning band is tensioned.

[0150] Fig.44B One embodiment of an anchoring element is illustrated in which the anchor is constructed of a braided nitinol wire shaped as a series of discs. Two discs are depicted; however, any number of discs may be constructed. The anchor is shown abutting against a cross section of tissue, with small holes for tensioning bands. Having multiple discs increases the amount of material abutting the tissue, which makes the anchor more resistant to being pulled through the tissue, without increasing the stiffness of the anchor in order to collapse into a delivery catheter.

[0151] Fig.44C An embodiment of an anchor element is illustrated in which the anchor is constructed of a braided nitinol wire shaped into two discs such that the distal disc abuts tissue and resists being pulled through when the tensioning band is tensioned, and the proximal disc is configured to slide over the tensioning band and hold the anchor in place when the tensioning band is relaxed or if the tensioning band is cut or broken.

[0152] Fig.44D An example similar to Fig.44C An embodiment of an anchor element of the invention, except that the anchor is held in place on the proximal end by shaped nitinol fingers. The fingers may be laser cut from the tube, or may be separate wire elements attached to the proximal hub of the anchor and may be straightened for tracking through a delivery catheter. The four fingers are depicted in a cross configuration; however, any number of fingers may be used in this configuration.

[0153] Fig.45An anchor embodiment is illustrated where the anchor is constructed from a laser cut Nitinol sheet or strip with a diamond pattern. The laser cut pattern allows the anchor to be compressed and elongated into a narrow profile for delivery through a catheter, and then allows it to passively return to the deployed configuration shown when exiting the catheter. The center hole does not allow the knot in the tension band to pass through so that when the tension band is pulled it will pull the anchor from the center and cause it to lie flat against any surface the anchor contacts.

[0154] Fig.46A An example of an anchoring element abutting against tissue with a tensioning band passed through is shown. Figure 35-Figure 38 , Fig.45 and those anchoring elements in FIG. 50 .

[0155] Fig.46B The example of the catheter inserted into the Fig.46A The anchor member illustrated in .

[0156] Fig.46C Illustrated is a catheter deployed Fig.46B An anchor is illustrated in , where when the tensioning strap is pulled and the anchor is in contact with any structure, it assumes a "t-bar" configuration.

[0157] Fig.47A Examples include Fig.45 and Figure 50A-50C An anchor such as those illustrated in , wherein a proximal grommet constructed from a laser cut Nitinol tube snap fits into a central hole in the anchor. The grommet includes a plurality of laser cut Nitinol fingers shaped into a configuration in which the fingers are curved and radially dispersed from the tube axis so that the fingers can hold the anchor in place on the tissue when the tensioning band is relaxed or if the tensioning band is broken or cut. The distal end of the Nitinol tube is constructed with a raised step and a taper in which 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 causes the beam to deflect toward the centerline, thereby allowing the raised step to pass through the hole in the anchor. Once the raised step passes through the hole, the potential energy stored in the beam causes them to straighten and the raised distal end of the tube is locked to the anchor.

[0158] Fig.47B Illustrated Fig.47A An isometric rendering of the grommet element illustrated in FIG.

[0159] Fig.48AAn alternative configuration for holding the anchor in place in the absence of tension on the tensioning band is illustrated, whereby tissue is compressed between the anchor on the distal end and a flat grommet on the proximal end that slides over the tensioning band. A lock is crimped to the tensioning band to lock the distance between the anchor and the grommet. The grommet can have a similar construction to any of the anchoring elements disclosed herein.

[0160] Fig.48B Illustrated with Fig.48A A similar arrangement except that the grommet is locked relative to the anchor with a locking mechanism utilizing a screw that, when rotated, clamps the tensioning band between the central hole and the side exit hole.

[0161] Figure 49A-49F Various alternative anchor concepts are illustrated; Fig.49A depicts a braided nitinol anchor similar in function to an Amplatzer device; Fig.49B An S-hook anchor is depicted; Fig.49C A T-bar anchor is depicted; Fig.49D A boat-shaped anchor is depicted; Fig.49E Sutures into the rod anchor are depicted; Fig.49F A rigid hook into the stem is depicted and may include additional barbs.

[0162] Fig.50A An anchor embodiment is illustrated where the anchor is constructed from a laser cut Nitinol sheet or strip with a diamond pattern that allows the anchor to compress and elongate into a narrow profile for delivery through a catheter and then passively return to the deployed configuration shown when exiting the catheter. The center hole does not allow the knot in the tension band to pass through so that when the tension band is pulled it will pull the anchor from the center and cause it to lie flat against any surface the anchor contacts.

[0163] Fig.50B Illustrated Fig.50A Alternative cutting configurations for anchors in.

[0164] Fig.50C Illustrated Fig.50A and Fig.50B Alternative cutting configurations for anchors in.

[0165] Fig.51AAn anchor embodiment is illustrated in which the anchor is constructed of a shape-set nitinol wire to form a series of lobes. The wire is wound into a tight loop between each lobe so that the center hole approximately passes through the anchor. A tensioning band passes through the center hole, which constrains the lobes to radially shift relative to each other. The tensioning band has a knot formed at the distal end that cannot pass through the center hole so that when the tensioning band is pulled, the knot contacts the center of the anchor and pulls the anchor from the center. The anchor can be elongated for delivery through a catheter and returns to the shape-set configuration after exiting the catheter due to the potential energy stored in the wire from the straightening process.

[0166] Fig.51B An example similar to Fig.51A An anchor embodiment of the invention, except that in addition to the lobes, the wire is also formed into a perimeter circle.

[0167] Fig.51C Illustrated Fig.51B An alternative perspective of the anchor illustrated in FIG. The anchor can be straightened to facilitate delivery through a catheter. The anchor can be pulled into the catheter by simply pulling on the distal end, and can be pushed out of the catheter by pushing on the distal end or the proximal end. Pushing on the distal end causes the anchor to lengthen as it is pushed due to counteracting friction against the catheter wall proximal to the point of force application, which reduces deployment force compared to pushing from the proximal end.

[0168] Fig.52 A stable catheter is illustrated with a distal helix having a pointed tip laser cut from a solid tube. Immediately proximal to the helix is ​​a flexible region created by laser cutting intermittent slots into the helix. The most proximal region of the catheter is shown with a handle for applying torque and / or translation and a hub for accepting a hemostatic valve or other accessories.

[0169] Fig.53 Illustrated Figure 1 A cross-sectional view of a stabilizing catheter is shown showing a guide wire passing through the ID of the stabilizing catheter.

[0170] Fig.54 The distal end of a stabilized catheter having a helical wire with a sharpened tip welded to a tubularly constructed catheter body having intermittent laser cut slots to provide flexibility while maintaining torsional stiffness is illustrated.

[0171] Fig.55 Illustration of a guide catheter Fig.54 A stable catheter is illustrated in FIG.

[0172] Fig.56 Illustrated Fig.55A stabilizing catheter and a guide catheter are illustrated in which a guide wire extends from the distal end.

[0173] Fig.57 An example of the right atrium of a human heart model is shown. Fig.56 The stabilizing catheter and the guiding catheter are illustrated in FIG. The helix of the stabilizing catheter is screwed into the model near the anterior tricuspid annulus from the right atrial side.

[0174] Fig.58 A 4-chamber cross section of the heart is illustrated with a guide catheter entering the right atrium from the IVC. The guide catheter is directed toward the anterior tricuspid annulus.

[0175] Fig.59 A 4-chamber cross section of a heart is illustrated with a guide catheter in the right atrium and a stabilizing catheter with a distal helix being guided by the guide catheter to a position near the anterior tricuspid annulus. The helix is ​​tightened into the tissue by applying torque to the stabilizing catheter.

[0176] Fig.60 A 4-chamber cross section for a heart is illustrated having Fig.59 A guide catheter and a stabilizing catheter are illustrated in FIG. , and a guide wire is passed through the stabilizing catheter and through tissue into the right ventricle.

[0177] Fig.61 A 4-chamber cross-section of a heart is illustrated with a guide catheter in the right atrium and a guide wire passing through tissue at or near the anterior tricuspid valve annulus from the right atrium to the right ventricle. Fig.59 and Fig.60 The stabilizing catheter illustrated in FIG has been withdrawn.

[0178] Fig.62 A 4-chamber cross-section of the heart is illustrated, wherein a guide catheter in the right atrium guides a stabilizing catheter to a position at or near the anterior tricuspid valve annulus. The distal helix of the stabilizing catheter has passed through tissue such that it exits into the right ventricle, and a guide wire is illustrated as being passed through the stabilizing catheter into the right ventricle.

[0179] Fig.63 A 4-chamber cross section of a heart is illustrated, with Fig.62 The guide catheter, stabilizing catheter, and guide wire are illustrated in FIG. 1 , except that the distal helix of the stabilizing catheter has been completely tightened through the tissue such that the main shaft of the stabilizing catheter is withdrawn into the right ventricle.

[0180] Fig.64 A stable catheter having a distal helix constructed from 2 helically wound wires 180 degrees apart is illustrated.

[0181] Fig.65A stable catheter is illustrated having a distal helix that tapers outwardly from smaller outer and inner diameters at the junction with the catheter body to larger inner and outer diameters near the tip.

[0182] Fig.66 A guide wire having a distal end that is wound into a helix and transitions into a straight line is illustrated.

[0183] Fig.67 A cross section of a dilator having a smaller distal inner diameter and a larger proximal inner diameter is illustrated, wherein the guide wire inside the dilator has a distal end wound into a spiral, a smaller diameter section just proximal to the distal end, and a larger diameter more proximal section. The guide wire is thus captured within the dilator.

[0184] Fig.68 An expander having threads formed in a distal tapered section is illustrated.

[0185] Fig.69A A surface anchor element to be used as an anchoring element for a tricuspid valve repair system is illustrated.

[0186] Fig.69B Illustrated is a diagram of a delivery catheter in its collapsed state. Fig.69A surface anchor element.

[0187] Fig.69C Example from Fig.69B The surface anchor element after it has been deployed from its delivery catheter.

[0188] Fig.70A An implant system including two anterior surface anchors and one septal surface anchor to be used as a tricuspid valve repair system is illustrated.

[0189] Fig.70B An example of a valve from which a tricuspid valve repair system may be used is shown. Fig.70A surface anchor.

[0190] Fig.70C Illustrated is a side cross-sectional view of a surface anchor including a grommet and an anchoring hub to retain the surface anchor to a patient.

[0191] Fig.70D Illustrated Fig.70A A section of an implant system showing the sequence of components as the system is being deployed.

[0192] Fig.70E An example is shown in its pre-deployed state within a delivery catheter. Fig.70A A section of an implant system.

[0193] Fig.70F Illustrated Fig.70A A section of an implant system during its installation process into a patient.

[0194] Figure 70G Example Fig.70F After the steps described in Fig.70A A section of an implant system during its installation process into a patient.

[0195] Figure 70H Example Figure 70G After the steps described in Fig.70A A section of an implant system during its installation process into a patient.

[0196] Fig.71 An implant system having a flat grommet to be used in a tricuspid valve repair system is illustrated.

[0197] Fig.72A An implant system having a T-bar grommet to be used in a tricuspid valve repair system is illustrated.

[0198] Fig.72B Illustrated Fig.72A A front view of the T-bar grommet depicted in FIG.

[0199] Fig.72C illustrates the Fig.72A implant system.

[0200] Fig.73 An implant system having a flat grommet with a slidable tether attachment point to be used in a tricuspid valve repair system is illustrated.

[0201] Fig.74A A self-expanding grommet to be used within a tricuspid valve repair system is illustrated.

[0202] Fig.74B An example of a device having a tricuspid valve repair system to be used Fig.74A Implant system with self-expanding grommet.

[0203] Fig.75A The grommet lock is illustrated in its locked configuration to be used within a tricuspid valve repair system.

[0204] Fig.75B Illustrated is a diagram of a tricuspid valve repair system in its unlocked configuration to be used within the tricuspid valve repair system. Fig.75A Tether lock in.

[0205] Fig.75C Illustrated is a diagram of a tricuspid valve repair system in its locked configuration to be used within the tricuspid valve repair system. Fig.75A An alternative view of the tether lock in .

[0206] Fig.75D Illustrated Fig.75A Cross-sectional side view of a tether lock in FIG.

[0207] Fig.76A An alternative embodiment of a tether lock in its locked configuration to be used within a tricuspid valve repair system is illustrated.

[0208] Fig.76B Illustrated is a diagram of a tricuspid valve repair system in its unlocked configuration to be used within the tricuspid valve repair system. Fig.76A Tether lock.

[0209] Fig.76C Illustrated is a diagram of a tricuspid valve repair system in its locked configuration to be used within the tricuspid valve repair system. Fig.76A Cross-sectional view of a tether lock.

[0210] Fig.76D Illustrated is a diagram of a tricuspid valve repair system in its unlocked configuration to be used within the tricuspid valve repair system. Fig.76A Cross-sectional view of a tether lock.

[0211] Fig.76E An example of a tricuspid valve repair system to be used Fig.76A Front view of the tether lock.

[0212] Fig.76F An example of a tricuspid valve repair system to be used Fig.76A Rear view of a tether lock.

[0213] Fig.77A Illustrated is a cross-sectional view of an alternative embodiment of a tether lock in its locked configuration to be used in a tricuspid valve repair system.

[0214] Fig.77B illustrates the Fig.77A Cross-sectional view of a tether lock.

[0215] Fig.77C Illustrated Fig.77A Exploded view of a tether lock.

[0216] Fig.78A Illustrated is a cross-sectional view of an alternative embodiment of a tether lock in its locked configuration to be used in a tricuspid valve repair system.

[0217] Fig.78B illustrates the Fig.78A Cross-sectional view of a tether lock.

[0218] Fig.78C Illustrated Fig.78A Exploded view of a tether lock.

[0219] Fig.79A A perspective view of an alternative embodiment of a tether lock to be used within a tricuspid valve repair system is illustrated.

[0220] Fig.79B illustrates the Fig.79A Cross-sectional view of a tether lock.

[0221] Fig.79C illustrates the Fig.79A Cross-sectional view of a tether lock.

[0222] Fig.79D Illustrated Fig.79A Exploded view of a tether lock.

[0223] Fig.80A Illustrated is a cross-sectional view of an alternative embodiment of a tether lock in its unlocked configuration to be used in a tricuspid valve repair system.

[0224] Fig.80B illustrates the Fig.80A A perspective cross-sectional view of a tether lock.

[0225] Fig.80C illustrates the Fig.80A A perspective cross-sectional view of a tether lock.

[0226] Fig.80D Illustrated Fig.80A Exploded view of a tether lock.

[0227] Fig.81 A 4-chamber cross-section of a heart is illustrated with a therapeutic embodiment comprising an implant system including two anterior surface anchors implanted against the right ventricular surface of the anterior tricuspid annulus connected via tensioning bands to a septal surface anchor implanted against the left atrial surface of the atrial septum beneath the fossa ovalis, the septal surface anchor being retained by a lock near the right atrial surface of the atrial septum to function as a tricuspid valve repair system.

[0228] Fig.82 Illustrated based on FIG. 70A to FIG. 70HA top (surgeon's) view of the heart of a treatment embodiment of the present invention comprising two anterior surface anchors implanted against the right ventricular surface of the anterior tricuspid valve annulus connected via tensioning bands to a septal surface anchor implanted against the left atrial surface of the atrial septum beneath the fossa ovalis, the septal surface anchor being retained by a lock near the right atrial surface of the atrial septum to function as a tricuspid valve repair system. DETAILED DESCRIPTION

[0229] Embodiments of the present disclosure will now be described with reference to the accompanying drawings. The terms used in the description presented herein are not intended to be interpreted in any limited or restrictive manner, only because they are used in conjunction with the detailed description of the embodiments of the present disclosure. In addition, embodiments of the present disclosure may include several novel features, none of which is individually responsible for its desired properties or is necessary for practicing the embodiments of the present disclosure described herein. For the purposes of the present disclosure, certain aspects, advantages and novel features of multiple embodiments are described herein. It should be understood that, according to any specific embodiment, not all such advantages may be achieved. Therefore, for example, those skilled in the art will recognize that an embodiment can be performed in a manner that realizes an advantage or a group of advantages as taught herein, without having to realize other advantages as may be taught or implied herein.

[0230] Figure 1 A 4-chamber cross section of a heart is illustrated, with the regurgitant jet between the anterior and septal leaflets of the tricuspid valve. The heart 1 is divided into four chambers, which are responsible for the patient's blood circulation and reoxygenation. Blood enters the heart in the right atrium 2 and is pumped to 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 (as shown in FIG. Fig.15 The fluid then flows to the lungs to be reoxygenated and returns to the heart at the left atrium 4 connected to the left ventricle 5 and is then distributed throughout the body. Important in the healthy functioning of the heart are the heart valves between the right atrium 2 and the right ventricle 3 and between the left atrium 4 and the left ventricle 5. Figure 1 The heart 1 depicted in shows a tricuspid valve 10 which is leaking, thereby allowing a regurgitant jet 6 of blood to flow from the right ventricle 3 to the right atrium 2, which is described herein as functional tricuspid regurgitation (FTR).

[0231] In some applications of the present disclosure, a technique is described for repairing a leaking tricuspid valve by pulling an anterior portion of the tricuspid annulus toward a septal portion of the tricuspid annulus or that portion of the tricuspid annulus near the coronary sinus via two or more tension bands, the tension bands being attached near the anterior tricuspid annulus via surface anchors, the surface anchors being connected to the tension bands, which are attached to the inferior atrial septum via surface anchors. Where reference is made herein to the tricuspid annulus or the anterior tricuspid annulus, such reference 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 being within 15 mm of the tricuspid annulus or a region of the heart, whereby applying a force to such a region transmits the force at least partially to the tricuspid annulus. The surface anchors or tissue anchors disclosed in certain embodiments may resist forces attempting to withdraw an attached tension member by providing a surface adjacent to the endocardial layer of the heart. When the surface anchor is placed within the ventricle, the surface anchor may be referred to herein as a ventricular surface anchor. In certain embodiments, the surface anchor may also be adjacent to other surfaces of the tissue of the heart and / or also embedded in the tissue of the heart. Certain aspects and advantages of the embodiments described herein may also be used with one or more of the anchors being anchors embedded within the tissue. Although two or more tension bands are described in many embodiments, in certain embodiments, a singular tension band may be utilized. The tension band (which may also be referred to as a tension band or tension element or tension element or tension member or tether) may be part of a tension assembly, wherein the assembly may include one or more tension bands / elements. The tension assembly may have a plurality of individual tension elements / bands that may form a tension member (also referred to as a tension member), or a singular tension element / band that has a portion (e.g., an end portion) that forms a tension member. For example, a singular tension element (or band) may be looped through a plurality of surface anchors such that the total number of tension elements present in the tether assembly is one (1), wherein each surface anchor is associated with a portion of a tension element to form a tension member. Additionally, in some embodiments, a surface anchor may be used in place of or in place of a tissue anchor as disclosed in the embodiments herein. In some embodiments, the anterior anchoring element comprises an anchor that may be 5 mm to 30 mm long, but in some embodiments may be 14 mm to 18 mm long, and in some embodiments may be 2 mm to 20 mm wide, but in some embodiments may be 5 mm to 10 mm wide, and in some embodiments may be 0.1 mm to 5 mm thick, positioned to contact the right ventricular wall behind the anterior leaflet 12 of the tricuspid valve 52, such as Figures 2 to 5 , Fig.33 , Figure 37 to Figure 38 , Fig.45, FIG. 50 , and the anchors depicted in FIGS. 69-74 . Although many embodiments are disclosed in the context of the tricuspid valve, it should be understood that 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.

[0232] Figures 2 to 5 Several possible embodiments of techniques for repairing a leaky tricuspid valve are described. Figure 2 In one embodiment of the system, three anchoring elements are included: a first anterior anchor 202 and a second anterior anchor 202, which are implanted in the right ventricle 3 against the right ventricular surface of the anterior tricuspid annulus 52 or the anterior annulus near the tricuspid valve 10 (the second one is shown in FIG. Figure 6 ); and a septal left atrial anchor 204, which is implanted in the left atrium 4 against the left atrium surface below the fossa ovalis 53. Surface anchors may be referred to with reference to the location at which the surface anchors are implanted. 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. Surface anchors (such as the septal left atrial anchor 204) implanted in the left atrium 4 against the left atrium surface below the fossa ovalis 53 may be referred to as tension anchors. It is also possible to implant multiple tension anchors in or around the same area. When multiple tension anchors are implanted in or around the same area, the center of the second tension anchor should be spaced 0.5 cm to 4 cm from the center of the first tension anchor in order to increase efficacy and reduce possible overlap of the anchors on the surface of the heart. The three anchoring elements are connected by one or more tensioning members 240 or tensioning bands, sutures or tethers, which are positioned closer together to implement closure of the tricuspid valve 10 via a lock 230 or tether lock as detailed in other embodiments disclosed herein.

[0233] exist Figure 3 In one embodiment of the system, three anchoring elements are included: a first anterior anchor 202 and a second anterior anchor 202, which are implanted in the right ventricle 3 near the tricuspid valve 10 against the right ventricular surface of the anterior tricuspid annulus 52; and a septal right ventricular anchor 206, which is positioned 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 positioned in the right ventricle 3, the septal right ventricular anchor 206 is not positioned in the right ventricle 3. Figure 2 The three anchoring elements are similarly connected by one or more tension bands that are coupled or attached together with a lock 230 (or tension member lock). Figure 3In the embodiment of the present invention, the lock 230 is positioned within the right atrium 2. However, in other embodiments, the lock 230 may be positioned elsewhere in the heart, such as within the right ventricle 3, the left atrium 4, or the left ventricle 5. In other embodiments, the lock 230 may be positioned outside the heart. In other embodiments, the lock 230 may be additionally incorporated into any of the surface anchors or tissue anchors used in this embodiment, such that it can be fixedly attached to the surface anchor or tissue anchor, or optionally permanently incorporated into the surface anchor or tissue anchor.

[0234] exist Figure 4 In one embodiment of the system, three anchoring elements are included: a first anterior anchor 202 and a second anterior anchor 202, which are implanted in the right ventricle 3 near the tricuspid valve 10 against the right ventricular surface of the anterior tricuspid annulus 52; and a septal left ventricular anchor 208, which is positioned in the left ventricle 5. Although the septal left ventricular anchor 208 is not positioned in the same Figure 2 The septal left atrium anchor 204 is located at the same position as the septal left atrium anchor 208, but both the septal left ventricular anchor 208 and the septal left atrium anchor 204 act as tension anchors when they are connected to the ventricular surface anchor, which is a surface anchor implanted near the right ventricular surface of the anterior tricuspid annulus 52. This principle can be applied to other surface anchors disclosed herein. The three anchor elements are similarly connected to the lock 230 by one or more tension bands.

[0235] exist Figure 5 , one embodiment of the system includes five anchoring elements: a first anterior anchor 202 and a second anterior anchor 204, which are implanted in the right ventricle 3 near the tricuspid valve 10 against the right ventricular surface of the anterior tricuspid annulus 52; a third septal left atrial anchor 204, which is positioned in the left atrium 4; a fourth septal ventricular anchor 206, which is positioned in the right ventricle 3 on the septal side of the tricuspid valve 10 along the ventricular septum; and a fifth septal left ventricular anchor 208, which is positioned in the left ventricle 5. The three anchoring elements are similarly connected to the lock 230 by one or more tension bands. Figures 6 to 9 A top view, or short axis view, or surgeon's view of the implant site for treatment is depicted. These figures generally depict a top view of the heart, depicting the anterior leaflet 12 of the tricuspid valve 10, the mitral valve 15, the aortic valve 20 and the pulmonary valve 25, as well as the coronary sinus 54 and the right coronary artery 55.

[0236] Figure 6 A top (surgeon) view of a heart 1 is illustrated with a treatment embodiment including an anchoring element 204 positioned in the fossa ovalis 53 (eg, Figure 2The anterior anchor 202 is implanted against the left atrial surface of the atrial septum 51 below the atrial septum (shown in the figure), and is connected to an anchor element 202 implanted against the right ventricular surface of the anterior tricuspid ring 52 via a lock 230 near the right atrial surface of the atrial septum via a tension band 240, and the anterior anchor 202 is connected to the tension band 240 via a ring entry point 212.

[0237] Figure 7 A top (surgeon) view of a heart 1 is illustrated with a treatment embodiment including an anchoring element 204 positioned in the fossa ovalis 53 (eg, Figure 2 The anterior anchor 202 is implanted in the left atrium surface against the atrial septum 51 below the atrial septum 51 and is connected to an anchor element 202 implanted in the right ventricle surface against the anterior tricuspid annulus and the posterior tricuspid annulus 52 via a lock 230 near the right atrial surface of the atrial septum 51 via a tension band 240, and the anterior anchor 202 is connected to the tension band 240 via a ring entry point 212.

[0238] Figure 8 A top (surgeon's) view of a heart with a treatment embodiment is illustrated, the embodiment including anchoring element 202 and anchoring element 204 and rod 213, the rod 213 being positioned in the fossa ovalis 53 (eg, Figure 2 ) from the atrial septum 51 connected by the septal left atrial anchor 204 to the right ventricular outflow tract (RVOT) 57 (as shown in Fig.33 Anchoring elements 202 implanted on the right ventricular surface of the anterior and posterior tricuspid annuli 52 are attached to rods 213 via locks 230 near the center of the rods via tensioning bands 240 passing through the annular entry points 212, and tensioning of bands 240 pulls those portions of the tricuspid annulus in contact with the anchoring elements 202 toward the rods 213.

[0239] Fig. 9 A top (surgeon's) view of a heart having a treatment embodiment is illustrated, the embodiment including an anchoring element 214 implanted against the inferior surface of the coronary sinus 52 near the ostium and connected via a lock 230 near the right atrial surface of the atrial septum 53 via a tensioning band 240 to an anchoring element 202 implanted against the right ventricular surface of the anterior and posterior tricuspid annuli 52.

[0240] Figures 10 to 13 Alternative views of further treatment embodiments are illustrated.These figures generally show the right atrium 2 and right ventricle 3 of the heart, as well as the anterior annulus 52 and coronary sinus 54.

[0241] Fig.10A cross-section of a heart is illustrated with a treatment embodiment comprising an anchoring element 214 implanted on the inferior surface of the coronary sinus 54 near the ostium of the coronary sinus, wherein a tension band 240 is passed through the coronary sinus 54 (eg, Fig.32 ) is looped from the coronary sinus toward the tricuspid annulus 52. Another anchoring element 202 is implanted on the right ventricular surface of the anterior tricuspid annulus 52, with a tension band 240 crossing the annulus into the right atrium 2. The tension bands are tensioned and connected together in a lock 230 positioned near the ostium of the coronary sinus 54 to pull the anterior tricuspid annulus 52 toward the coronary sinus 54.

[0242] Fig.11 A cross-section of a heart is illustrated with a treatment embodiment comprising an anchoring element 214 implanted on the lower surface of the coronary sinus 54 near the ostium of the coronary sinus, wherein a tension band 240 is passed through the coronary sinus 54 (eg, Fig.32 54) is looped from the vicinity of the tricuspid annulus 52 to the coronary sinus 54. Another anchoring element 202 is implanted on the right ventricular surface of the anterior tricuspid annulus 52, with a tension band 240 traversing the annulus 52 to the right atrium 2. The tension bands 240 are tensioned and connected together in a lock 230 positioned near the ostium of the coronary sinus 54 to pull the anterior tricuspid annulus 52 toward the coronary sinus 54.

[0243] Fig.12 A cross-section of a heart with a treatment embodiment is illustrated, the embodiment comprising Fig.10 Anchor element 214 is similarly implanted, except that a grommet 215 is additionally implanted on the inferior surface of coronary sinus 54 where the tensioner band is withdrawn to allow myocardial tissue to be compressed between grommet 215 and coronary sinus anchor 214 and prevent tensioner band 240 from cutting through myocardial tissue.

[0244] Fig.13 A cross section of a heart is illustrated with one treatment embodiment including an anchoring element 206 implanted against the right ventricular surface of the tricuspid annulus (near the septal / posterior tricuspid valve commissure) beneath the ostium of the coronary sinus 54 with a tension band 240 looped through the left ventricular myocardium beneath the coronary sinus from near the tricuspid annulus 52 into the coronary sinus 54. Another anchoring element 202 is implanted on the right ventricular surface of the anterior tricuspid annulus 52 with a tension band 240 traversing the annulus into the right atrium 2. The tension bands 240 are tensioned and connected together within a lock 230 positioned near the ostium of the coronary sinus to pull the anterior tricuspid annulus toward the coronary sinus.

[0245] The anchoring elements (202, 204, 206, 208, 214) can be connected to one or more flexible tensioning bands 240 by various mechanisms including knots, crimped joints, or other suitable mechanisms, and the tensioning bands 240 can be passed from the anchoring elements (202, 204, 206, 208, 214) through one or more tissues within the heart and into the right atrium 2. The tensioning band 240 can be passed through various tissues within the heart as desired or required, such as through tissue of the right ventricle 3, the tricuspid annulus 52, or the atrial septum 51. In, for example, Figure 2 , Figure 3 , Figure 4 and Figure 5 In the embodiment illustrated in , the tensioning band 240 can pass through the tricuspid annulus or tissue near the tricuspid annulus at a distance of 0 mm to 15 mm from the hinge point of the tricuspid valve leaflets 10. The annular entry point 212 through which the tensioning band 240 passes through the tissue is preferably as small as possible so that when the tensioning band is pulled in tension, the anchoring elements (202, 204, 206, 208) are pulled against the ventricular surface of the tricuspid annulus and cannot pass through the hole through which the tensioning band 240 passes. Therefore, pulling the tensioning band 240 exerts a force on the tricuspid annulus that is distributed across the surface area of ​​the anchoring elements (202, 204, 206, 208, 214) and acts in the direction of the longitudinal axis of the tensioning band 240. As many anchoring elements as desired by the implant user, preferably at least 1 and in some embodiments at least 2 anchoring elements, may be implanted proximate the tricuspid annulus 52 (within 15 mm), behind the anterior leaflet 12 or the posterior leaflet 13, and / or within the RVOT 57, with the anchoring elements spanning a distance of 1 cm to 3 cm between the anchoring elements. In some embodiments, the septal anchor element 204 or any of the anchoring elements may include a disc that may be 8 mm to 20 mm long in some embodiments, and 8 mm to 20 mm wide in some embodiments, and 0.1 mm to 5 mm thick in some embodiments, and the disc may be positioned against the left atrial wall along the posterior atrial septum 51 above the mitral valve 15 and below the fossa ovalis 53. The septal anchor 204 may be positioned so that it is proximate the inferior surface of the atrial septum 51, where the muscle tissue is thicker than the atrial septum or fossa ovalis and close to the superior surface of the ventricular septum (within about 20 mm thereof in some embodiments), such as Figure 2. The left septal atrial anchor 204 depicted in . This location can minimize stretching and twisting under tensile loads. The location is also away from the atrial and ventricular node (AV node) to avoid or reduce the associated risks of conduction disturbances and the need for implantation of a pacemaker due to surgery. The septal anchoring element 204 can be generally circular, oblong, rectangular, square or any other shape suitable for distributing forces over a considerable surface area and minimizing interference with the mitral valve 15 and the oval fossa 53. The location of the anchor 204 below the oval fossa 53 can make this area of ​​the septum available for other left-sided heart repair or valve replacement surgeries. In some embodiments, the septal anchor can be designed to lie flat against the left atrial wall so as not to interfere with the mitral valve 15 repair or replacement device. The septal anchoring element can be connected to a flexible tensioning band 240 by a knot, a crimping joint or other suitable means, and the tensioning band can pass through the muscle of the atrial septum 51 to the right atrium 1 (see, for example Figure 2 ). The hole through which the tensioning band passes through the tissue is preferably as small as possible so that when the tensioning band is pulled in tension, the anchoring element is pulled against the surface of the left atrial muscle and cannot pass through the hole through which the tensioning band passes. Therefore, pulling the tensioning band 240 exerts a force on the muscle of the atrial septum 51 that is distributed across the surface area of ​​the anchoring element 204 and acts in the direction of the longitudinal axis of the tensioning band. When the tensioning band 240 connected to the anterior anchoring element 202 and the tensioning band 240 connected to the septal anchoring element 204 are routed through a common orifice in the locking mechanism 230 and are tensioned simultaneously, the anterior tricuspid annulus 52 is pulled toward the septal anchor 204 on the atrial septum 51, thereby reducing the distance between the anterior leaflet hinge point 12 and the septal leaflet hinge point 11 and increasing the overlap of the tricuspid valve leaflets at their apposition points.

[0246] In certain embodiments, the anchoring elements (202, 204, 206, 208, 214) are constructed in an expanded form such that the anchoring elements (202, 204, 206, 208, 214) can be compressed, flattened, stretched, or squeezed into a catheter or sheath 220 having an inner diameter between 1 mm and 3 mm, and then expanded into their implanted configuration after exiting the catheter. The expansion can be achieved via a passive mechanism, such as via potential energy stored in the anchoring element material due to being stretched tight into the catheter 220, or the expansion can be achieved via an active mechanism, whereby the anchoring elements (202, 204, 206, 208, 214) are expanded by an external control mechanism (such as by a screw) that utilizes a set of links between the proximal and distal elements to translate the proximal element relative to the distal element, so that when the proximal and distal elements are brought closer together, the anchor expands. Additionally, expansion can be achieved by longitudinally rotating the anchor element relative to the attached tensioning band such that the long axis of the anchor element is aligned with the longitudinal axis of the tensioning band 240 for passage through the catheter 220, and allowing the anchor element to rotate relative to the tensioning band as the anchor element (202, 204, 206, 208, 214) exits the catheter 220 such that the plane approximated by the anchor element (202, 204, 206, 208, 214) is normal to the longitudinal axis of the tensioning band 240. The construction of the anchor element utilizes implantable grade materials, and may utilize metallic materials such as stainless steel, cobalt chromium or nitinol or polymeric materials such as polyetheretherketone or nylon or composites of polymeric and metallic materials. In certain embodiments, the preferred material will have a high degree of recoverable strain (>1%) such that the anchor is not plastically deformed when compressed into the delivery catheter. Some embodiments disclosed herein include anchoring elements (202, 204, 206, 208, 214) having a metal frame or scaffold (such as Fig.35 ), the metal frame or stent is covered with a thin material (such as a polyethylene terephthalate (PET) or expanded polytetrafluoroethylene (ePTFE)) of biological (such as bovine or porcine pericardium) or synthetic (such as polyethylene terephthalate (PET) or expanded polytetrafluoroethylene (ePTFE)) origin. Fig.37The frame provides the anchoring element 3700 with a covering 3708 covering the anchoring element 3700. The frame imparts increased bending stiffness to the anchoring element to distribute the force from the tensioning band over a larger surface area, as well as passive expansion or self-expansion properties. In some embodiments, the anchoring element can be substantially flat such that its length and width are at least 5 times its thickness. In some embodiments, the length and width of the anchoring element can be at least 10 times its thickness. The covering 3708 promotes tissue healing and ingrowth, thereby sealing the hole through which the tensioning band 240 passes, and can also transfer loads between disconnected portions of the metal frame. When constructed of nitinol or other shape memory materials, the frame can be heat-set into a preferred deployment configuration so that when heated to body temperature and deployed from a catheter inside the body, the frame assumes the heat-set shape.

[0247] The tension band 240 can be a suture, cable, wire, thread, filament or similar device that is flexible when bent and compressed while maintaining a high degree of tensile strength and stiffness. The tension band 240 can also be a rod, stent, support, support or similar device that resists bending and compression forces and tensile forces. The tension band 240 structure can be made of implant-grade materials, and polymer materials (such as PET, polyethylene, ultra-high molecular weight polyethylene (UHMWPE), ePTFE, PTFE or other suitable polymers) can be used or metal materials (such as stainless steel, nitinol or cobalt chromium) can be used, or a combination of such materials can be used. The construction of the tension band can be a monofilament or multifilament with axially arranged, twisted, woven or braided filaments. The cross-sectional size of the tension band can be in the range of 0.075 mm to 0.76 mm, but and in some embodiments in the range of 0.13 mm to 0.38 mm, to provide the best balance of tensile strength, flexibility, profile and wear resistance. The cross-section of the tension band can be generally circular, oval or flat, and the material can include a radiopaque coating, or be composited with a radiopaque material, or have filaments of radiopaque material woven or extruded through the cross-section to facilitate viewing under fluoroscopy. Examples of radiopaque materials can include platinum, platinum iridium, bismuth, barium sulfate, or tungsten. In some embodiments, the ultimate tensile strength of the tension band or tether can be greater than 2 pounds force, but in some embodiments, it can be greater than 8 pounds force. In some embodiments, the tensile stiffness can be greater than 0.045mm / mm / N. In some embodiments, the ultimate tensile stiffness of the tension band or tether can be greater than 0.45mm / mm / N. In some embodiments, the tension band 240 can be a rigid or semi-rigid member that can resist compressive forces. In some embodiments, the tension band 240 can be a flexible or semi-flexible member. The flexible or semi-flexible member can have a much smaller compressive strength than the rigid or semi-rigid member, so that the flexible or semi-flexible member will buckle or deform under any significant compressive force. For example, the flexible member may flex or bend with a force that is less than 10% or 1% of the force that the flexible member resists when in tension.

[0248] The locking element 230 can be configured with a hole parallel to the long axis of the lock through which all tensioning members 240 can freely pass and can be used to connect or attach the tensioning members of the tensioning assembly. The lock 230 used in the treatment can be any one of the embodiments of the tether lock disclosed in Figures 75 to 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, it causes the portion of the tensioning member 240 between the lock 230 and the anchoring member (202, 204, 206, 208, 214) to shorten relative to the lock 230, which thus pulls the anchoring elements (202, 204, 206, 208, 214) together. Fig.48BAn embodiment of a lock 4850 is disclosed that has a second hole 4856 that exits one side of the lock so that the tensioning 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 screwed into the proximal end of the hole extending through the lock, as depicted in FIG. 48b. When the screw 4852 is screwed into the lock 4850, the lock 4850 transitions from its non-clamping configuration to its clamping configuration to clamp the tensioning band 240 between the hole extending parallel to the axis of the lock 4854 and the hole that exits one side of the lock 4856, thereby locking the tensioning band 240 in place. Alternatively, the screw can be incorporated into a locking mechanism such as the tether locks 7600 and 7900 disclosed herein. The lock can be constructed of a metal such as stainless steel or titanium or can be constructed of a rigid polymer such as polyetheretherketone. Another way to construct the lock is to make it of a thin wall metal tubular construction with a central hole through which the tensioning band can freely pass. Once the tensioning band has been stretched, the lock can be crimped against the tensioning band 240 by flattening and bending the lock with externally controlled sliding pins, or by compressing a set of opposing pins or anvils within the lock catheter. Suitable implantable materials may include stainless steel or titanium.

[0249] Figures 14 to 24 An exemplary method for implanting a therapeutic embodiment in a patient's heart is depicted. In some embodiments, the steps for implanting may include one or more of the following steps: first preparing an implant system 200 including two or more anchors (e.g., Figures 14 to 24 As depicted in , anterior anchor 202 and left septal atrial anchor 204), two or more tensioning bands 240, and lock 230, a guide catheter system, an implant catheter system, and a lock catheter system for accessing the venous system at the groin.

[0250] The guide catheter 200 is then tracked through the IVC 50 to the right atrium 2 .

[0251] The atrial septum 51 is then inflated using the sheath 226 and dilator 224 assembly passed through the catheter 220 .

[0252] Then, the wire 222 , followed by the dilator 224 and the sheath 226 , are passed through the atrial septum 51 into the left atrium 4 .

[0253] Then, the dilator 224 and the wire 222 are removed, leaving the sheath 226 in the left atrium 4 .

[0254] The tracking septal anchor 204 is then passed through the sheath 226 into the left atrium 4 .

[0255] Then, septal anchor 204 within left atrium 4 is released.

[0256] Sheath 226 is then removed from guide catheter 220 , leaving septal anchor 204 within left atrium 4 and septal anchor 204 tensioning member 240 exteriorized through guide catheter 220 .

[0257] Dilator 224 and sheath 226 are then inserted through guide catheter 220 alongside spacer anchor suture 240 .

[0258] Then, the guide catheter is introduced to the front ring 52.

[0259] The tricuspid annulus 52 is then expanded using the sheath 226 and dilator 224 passed through the guide catheter 220 .

[0260] The annulus 52 is then passed through the wire 222, followed by the dilator 224 and sheath 226 into the right ventricle 3 and / or RVOT.

[0261] The dilator 226 and wire 222 are then removed, leaving the sheath 226 in the right ventricle and / or RVOT.

[0262] The anterior anchor 202 is then tracked through the sheath 226 into the right ventricle 3 and / or RVOT.

[0263] Then, the anterior anchor 202 within the right ventricle 3 and / or RVOT is released.

[0264] The sheath 226 is then removed from the guide catheter 220, leaving the anterior anchor 202 against the right ventricular surface of the tricuspid annulus and the anterior anchor 202 tensioning member 240 exteriorized by the guide catheter.

[0265] The additional anterior anchor 202 is then implanted in the same manner as the first anterior anchor 202 .

[0266] The lock 230 is then tracked within the guide catheter 220 via the lock catheter 232 over the externalized sutures 240 connected to the implant.

[0267] Then, the suture 240 in the right atrium 2 is tensioned to draw the tricuspid annulus 52 along the right ventricular free wall toward the atrial septum 51 and / or the coronary sinus 54 .

[0268] The lock 230 is then locked to maintain tension on the suture 240 and the free end of the suture 240 adjacent the lock is cut.

[0269] Then finally, all catheters are removed from the body.

[0270] In another embodiment, a substantially similar system may be used to perform a method similar to that described above for implanting a therapeutic embodiment into a patient's heart, except that the anterior anchor 202 is implanted before the septal anchor 204 .

[0271] The above method may further include advancing a grommet 219 on the surface of any one embodiment of the adjacent surface anchor and on the opposite side of the surface of the heart adjacent the surface anchor along the tensioning member 240. The grommet 219 acts to hold the embodiment of the surface anchor against the skin such that the segment of the heart adjacent the surface anchor is sandwiched between the anchor and the grommet and the anchor cannot move from its position.

[0272] The procedure can be performed under ultrasound imaging guidance (e.g., transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE)) and fluoroscopic imaging guidance. The steps for implantation can be performed in a different order than described, for example, the front anchor 202 can be implanted before the septal anchor 204. The number of anchors implanted can be determined by the implantation user. The guide catheter 220 can be a steerable structure, for example, using a pull cable attached to one or more points within 5 cm of the distal side of the guide catheter 220, and the pull cable is controlled outside the body by rotating a knob or pulling a lever on the guide catheter handle, and the knob or lever causes the pull cable to be tensioned and shortened relative to the catheter shaft. The pull cable can be biased to one side of the catheter shaft, so that shortening the pull cable causes the catheter shaft to shorten on the side toward which the pull cable is biased, thereby causing the catheter shaft to articulate in the direction of the pull cable. Alternatively, the central slidable lumen can be pulled relative to a fixed outer lumen of the construction, whereby 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 within 5 cm distal to the outer lumen. Pulling the inner lumen applies a compressive force on the outer lumen, which causes the catheter to articulate in the direction where the flexural modulus of the outer lumen is lower. An advantage of this construction is that the pulling member is generally along the neutral axis of the catheter, which does not cause the catheter to bend or bow along the proximal region, where the flexural modulus of the outer lumen is uniform around the circumference and where bending or bowing may be undesirable. The guide catheter 220 can be 1, 2, 3 or 4-way steerable, and in the case of more than 1 steering plane, the hinge points can be at the same location or separated by a distance of 0.5 cm to 4 cm along the length of the catheter, so that the catheter articulates in different directions at 2 or more different regions.

[0273] The wire 222 used to pass through the septum 51 and the tricuspid annulus 52 can optionally be powered by an alternating current in the radio frequency range so that the wire forms an electrode, whereby a sudden change in impedance at the distal end of the wire causes an arc, thereby causing the end of the wire to heat and pass through the tissue more easily. Alternatively, the end of the wire 222 can be sharpened to increase the stress concentration on the tissue when the wire is pushed against the tissue, thereby causing the wire to pierce and pass through the tissue more easily. The distal end of the wire 222 can be straight so that when the expander 224 is extended, the wire travels in a direction substantially the same as the direction in which the end of the expander is pointing, or the distal end of the wire 222 can be curved so that the wire will travel on a curved path relative to the expander to select a more favorable path through the tissue or avoid various structures when the wire exits into the chamber of the heart. The curvature of the wire 222 can be variable and can be configured in a spiral or pigtail configuration proximal to a straight or less tightly curved segment so that as the wire extends from the dilator, the wire curls into one or more loops that prevent damage to the wire when it contacts cardiac tissue distal to those tissues being passed through. Additionally, the curvature of the wire can be configured so that the distal end bends in a different (or the same) direction as the more proximal segment so that the curvature of the more proximal segment will be consistent with the curvature of the guide catheter (due to the wire picking selecting the path that results in the lowest strain energy within the wire) and the distal segment will bend in a predictable and controllable direction when exiting the dilator.

[0274] Where reference is made to the anterior ring 52 or anterior implant or anterior anchor 202, it refers to a location that generally passes through the tricuspid valve 10 from the atrial septum 51, and may include an 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 right ventricular surface of the anterior tricuspid ring 52 may also include those portions of the RVOT 57 that are in close proximity to the tricuspid annulus (within 10 mm or within 15 mm or within 20 mm). Utilizing the portion of the RVOT behind the anterior tricuspid valve leaflet 12 and / or the anterior tricuspid valve ring provides unique advantages: a large space to safely pass wires into (or from) and place surface anchors, while also having a relatively large tissue thickness between the right ventricle and right atrium, which may contribute to a robust anchoring location. Optionally, after delivery of each anchoring element (202, 204, 206, 208, 214), a grommet with a lock 230 (such as 215, 219, 4710, 4802, 7030, 7102, 7220, 7302, or 7402, with the lock 230 attached to or separate from the grommet) can be tracked over the suture attached to the anchoring element and the grommet can be pressed against tissue on the heart chamber adjacent to the chamber to which the anchoring element is adjacent (e.g., against the right atrial septum for a left atrial anchoring element or against the right atrial annular surface for an anterior anchoring element). The lock will then be used to clamp the suture so that the tissue is between the anchoring element and the grommet, wherein the grommet and lock hold the anchoring element against the tissue or in close proximity to the tissue during the remainder of the procedure or if the suture is cut or broken. Thus, the anchoring element will not be able to migrate or embolize in the absence of tension on the tether to which it is attached. As desired or required, the grommets used herein may be those disclosed herein and in Fig.71 , Fig.72A , Fig.73 Or the grommet depicted in Figure 74, or other available grommet.

[0275] Tensioning of the tension members 240 attached to the septal and anterior anchoring elements (202, 204, 206, 208, 214) may be performed at the user's discretion under ultrasound and fluoroscopic guidance to reduce or eliminate tricuspid regurgitation 6 and increase coaptation between the tricuspid leaflets.

[0276] An alternative embodiment disclosed herein includes an anchoring element (such as a mitral valve) placed on the ventricular septum against the left ventricular wall beneath the mitral valve 15. Figure 5 208) wherein the attached suture 240 passes from the left ventricular chamber 5 to the right atrium 2. Yet another embodiment disclosed herein includes an anchoring element (such as a suture 240) placed near the ventricular septum against the right ventricular surface beneath the tricuspid valve 10. Figure 5The invention also provides a right ventricular septal anchor 206, wherein the attached tether 240 passes through the tricuspid annulus 52 and / or the ventricular myocardium to the right atrium 2 and / or the coronary sinus 54. Another embodiment disclosed herein includes an anchoring element (such as a right ventricular septal anchor 206) that is adjacent to the lower surface of the coronary sinus 54. Fig.10 , Fig.11 and Fig.12 The tether may be provided with a coronary sinus anchor 214, wherein the attached tension member 240 traverses the left ventricular myocardium 56 below the coronary sinus 54. When the tether is passed through the left ventricular myocardium 56, it may form a loop, such as in Fig.10 and Fig.12 or forming a curved path with the anchor at the distal end, such as in Fig.11 The steps for implantation for any of the alternative embodiments are substantially the same as those already described, except that a guide catheter will be guided to facilitate implantation of the anchoring element to the alternative anatomical location. Any of the embodiments disclosed herein may be used alone or in combination with any of the other embodiments. Any of the anchor embodiments disclosed herein may be used in any or all of the anatomical locations disclosed herein.

[0277] Figures 25 to 31 Depicted are steps for implanting another embodiment disclosed herein. These figures generally represent an embodiment of a foldable flat implant system 4000 that includes a guide catheter 4001, a flexible, steerable delivery catheter 4002 non-fixedly connected to an anchor rod 4040, a spacing anchor 4020, and a snare catheter 4070. The anchor rod 4040 may include a hole or slot for passage of one or more guide wires 4060 that may pierce an anatomical location within the heart in a manner generally similar to the guide wire 222 disclosed herein. The snare catheter 4070 may include one or more snare guide catheters 4072 that guide one or more snare wires 4074 for use during a method of implanting another embodiment disclosed herein. The spacing anchor 4020 disclosed herein may be generally similar to the embodiment of the present invention. Figures 17 to 24 The anchor 204 disclosed in .

[0278] For implantation Figures 25 to 31 The steps of an embodiment of the foldable flat implant system 4000 disclosed in the may include one or more of the following steps: First, the guide catheter 4001 is entered into the venous system at the groin.

[0279] The tracking catheter is then passed through the IVC 50 to the right atrium 2 .

[0280] The atrial septum 51 is then inflated using a sheath and dilator assembly passed through the catheter, such as the sheath 226 and dilator 224 disclosed herein.

[0281] Then, a guide wire (such as the guide wire 222 disclosed herein) is passed through the atrial septum 51 into the left atrium 4, followed by a dilator and a sheath.

[0282] The dilator and wire are then removed, leaving the sheath in the left atrium.

[0283] The tracking septal anchor 4020 is then passed through the sheath into the left atrium.

[0284] The septal anchor 4020 within the left atrium is then released.

[0285] The sheath is then removed from the guiding catheter, leaving the septal anchor within the left atrium and the septal anchor suture exteriorized through the guiding catheter.

[0286] The steerable anterior anchor delivery catheter 4002 is then inserted into the guide catheter 4001 with the attached anterior anchor 4040 in a folded or compressed configuration and followed to the distal end of the guide catheter.

[0287] The guide catheter 4002 is then guided over the tricuspid valve 10 .

[0288] The anterior anchor delivery catheter 4002 is then extended and the anterior anchor 4040 is guided through the tricuspid valve, into the right ventricle 3 and or the RVOT.

[0289] The anterior anchor delivery catheter 4002 is then articulated to form a "J" shape within the right ventricular outflow tract 57 so that the anterior anchor 4040 hooks behind the anterior tricuspid valve leaflet 12 within the right ventricle 3, such as at Fig.25 middle. Fig.25 A guide catheter 4001 is illustrated above the tricuspid valve 10 within the right atrium 2 with an anterior anchor delivery catheter 4002 passing through the tricuspid valve 10 and hooked under the anterior tricuspid valve leaflets 12 within the right ventricle 3. The anterior anchor 4040 is illustrated mounted in a folded configuration to the distal end of the catheter 4002. The septal anchor 4020 abuts against the left atrial wall with an attached tension band 4074 passing through the atrial septum 51 into the guide catheter 4001.

[0290] The front anchor 4040 is then unfolded or expanded into a deployed configuration that is generally planar and has a length of 1-4 centimeters, but in certain embodiments has a length of 1.5-2.5 centimeters.

[0291] The anterior delivery catheter 4002 is then pulled so that the anterior anchor abuts against the right ventricular surface of the anterior tricuspid annulus 52 , with the anterior anchor spanning a distance of 1 cm to 4 cm of the anterior tricuspid annulus 52 .

[0292] Then, two or more guide wires 4060 are passed through the annulus and through the front anchor, with the outermost wires separated by 1 cm to 4 cm, so that the wires exit into the right atrium, as shown in FIG. Fig.26 As shown in . Fig.26 The anterior anchor 4040 is illustrated in its expanded or deployed configuration within the right ventricle 3 behind the anterior tricuspid valve leaflets 12 , with a wire 4060 passing through each end of the anterior anchor traversing the anterior tricuspid valve annulus 52 from the right ventricle 3 to the right atrium 2 .

[0293] Then, the two or more guide wires 4060 in the right atrium are snared with the same number of snare catheters 4070 , which are advanced through the snare guide catheter 4072 .

[0294] Then, the wire 4060 attached to the suture 4074 having the plug 4076 at the end is pulled through the guide catheter 4001 and in a direction toward the outside of the patient until the plug 4076 end of the suture abuts against the anterior anchor, as shown. Figure 27 to Figure 29 As depicted in . Fig. 27 A snare catheter 4072 is illustrated exiting the guide catheter 4001 into the right atrium 2 and positioned to capture one of the wires 4060 passing through the anterior tricuspid annulus 52 . Fig.28 A first tensioning member 4074 of the anterior anchor 4040 is illustrated being snared by the guide catheter 4001 , with a plug 4076 at the end of the tensioning band 4074 abutting the anterior anchor 4040 . Fig.29 The second snare catheter 4072 is illustrated exiting the guide catheter into the right atrium 2 and positioned to capture the second wire 4060 passing through the anterior tricuspid valve annulus 52 .

[0295] The front anchor 4040 is then detached from the front anchor delivery catheter 4002 and the front anchor delivery catheter 4002 is removed, as in Fig.30 middle. Fig.30 Two tensioning bands 4074 connected to the front anchor 4040 are illustrated, snared by the guide catheter 4001, with plugs 4076 at the ends of the tensioning bands 4074 abutting the front anchor 4040, with the front anchor delivery catheter 4002 removed.

[0296] Then, within the guide catheter, via the lock catheter 4082, the suture lock 4080 is tracked over the external suture 4074 connected to the implant, as shown in FIG. Fig.31In this figure, the anterior anchor is illustrated abutting the ventricular surface of the anterior tricuspid valve annulus 52, with an attached tension band 4074 routed to a lock 4080 near the atrial septum 51. The septal anchor 4020 is illustrated abutting against the left atrial wall, with an attached tension band 4074 routed to the lock 4080. A lock catheter 4082 extends from the guide catheter and is connected to the lock 4080.

[0297] The sutures 4074 in the right atrium 3 are then tensioned to draw the tricuspid annulus 52 along the right ventricular free wall toward the atrial septum 51 and / or the coronary sinus 54 .

[0298] The suture lock 4080 is then locked to maintain tension on the suture and the free end of the suture adjacent the lock is cut.

[0299] Then finally, all catheters are removed from the body.

[0300] exist FIG. 40A to FIG. 43 A foldable flat implant system 4000 used in the above method is further depicted in FIG. A superelastic frame made of nitinol wire or laser cut nitinol sheet or strip having a length of about 10 mm to 35 mm and a width of about 3 mm to 7 mm, such as anchor rod structural member 4044 in FIG. 42 can be used to construct an anterior anchor 4040. The frame can be attached to a stainless steel, titanium, or polymer hub 4050 (such as polyetheretherketone (PEEK) or polyphenylsulfone) by providing a snap fit, wherein the frame is extended over the hub and snapped into a groove 4056 on the hub 4050. The hub can be threaded and have a hole 4054 extending through the center so that the thread can be attached to a guide wire catheter connector 4010 that can be rotated during deployment, the guide wire catheter connector 4010 is connected to the guide wire catheter 4064 on the delivery catheter 4002, and the hole 4054 allows the wire 4062 and the suture 4074 to pass through. Advantageously, the size of the hole 4054 through the hub 4050 is set so that the wire 4062 and the suture 4074 fit tightly so that they can pass freely, but the plug, sleeve or knot attached to the end of the suture will be caught so that when caught, the suture will transmit tensile force to the anchor. The hub 4050 can alternatively take the form of a rigid eyelet or similar rigid feature with a through hole to allow the guide wire 4062 to pass through the front anchor 4040. The anchor may be covered in a compliant material 4042 (e.g., silicone elastomer, thermoplastic elastomer (e.g., PTFE felt or other suitable implantable grade material) to minimize stress concentrations on the tissue and seal the holes through the tissue through which the sutures 4074 pass. The covering can be molded over the frame (injection or compression molding), or sutured to the frame with threads or sutures, or heat bonded to the frame. The cross-section of the covering and / or frame can be tapered, such as by Fig.42B 4052 in the figure, making it thinner in the center, resulting in less bending stiffness in the center, so that when the ends of the anchor are tensioned (via the hub 4050) and the center of the anchor 4040 is held fixed, the anchor preferentially folds about its center to facilitate tracking and navigation through the guide catheter 4001 into the RVOT and behind the anterior tricuspid valve leaflets 12 without entanglement with the chordae tendineae. When the tension applied to the hub 4050 is released, the superelastic properties of the frame allow the frame to return to a flat deployment configuration without plastic deformation of the frame. The center of the anchor can have a threaded hole or a latch molded into an L shape for attachment to a delivery catheter. The delivery catheter 4002 can include a flexible guide wire catheter 4064 attached to a guide wire catheter connector 4010, the guide wire catheter connector 4010 being threaded at the distal end for attachment to the anchor hub, such as Fig.41 . The guide wire catheter connector 4010 will have a hole through the center to allow the wire 4060 and the tensioning band 4074 to pass through, and can be rotated between 0 degrees and 90 degrees between the distal end and the proximal end so that in the first folded configuration, the axis of the anchor hub can be substantially perpendicular to the axis of the delivery catheter, and in the second deployment configuration, the axis of the anchor hub can be substantially parallel to the axis of the delivery catheter. The flexible guide wire catheter 4064 can be a laser-cut stainless steel structure, wherein discontinuous slots are cut around the circumference of the tube to provide flexibility while maintaining torsional rigidity, or the flexible guide wire catheter 4064 can be a multi-filament (multi-fillar) spirally twisted stainless steel cable structure. The guide wire catheter 4064 can be jacketed with a polymer (such as Pebax or fluorinated ethylene propylene (FEP)) to enhance lubricity. Alternatively, the guide wire catheter 4064 can be a braided reinforced polymer structure, such as Pebax, nylon or polyimide. The front anchor delivery catheter 4002 may be steerable in a similar manner as the guide catheters disclosed herein.

[0301] Fig.32One embodiment of the device is depicted as viewed from the right atrium 2, whereby two flexible bands 240 traverse from within the right ventricle 3 at a location in or around the right ventricular surface of the anterior tricuspid annulus 52 (that portion of the tricuspid annulus that is attached to the anterior tricuspid valve leaflets), through the annular tissue into the right atrium 2 and to a locking hub or lock 230 positioned near the inferior and posterior surface of the atrial septum 51 on the right atrial side. Each tension member 240 is connected to a right ventricular surface anchor 202 (such as a cam lock) positioned on the anterior annulus 52 of the tricuspid valve 10 by a knot, crimp connector, or cam lock mechanism. Figures 2 to 13 Applying tension to the flexible band 240 pulls the surface anchor 202 against the right ventricular surface of the anterior tricuspid annulus 52, which thereby pulls the anterior tricuspid annulus 52 toward the suture lock, thereby reducing the distance between the anterior tricuspid annulus 52 and the atrial septum 51. Fig.32 Unique aspects of the location of the right ventricular anchor 202 illustrated in the drawings are: 1) the anchor is generally in or near the space forming the right ventricular outflow tract 57, which provides a large surface area on the ventricular side of the tricuspid annulus for safely traversing the tricuspid annulus (without risk of puncturing the right coronary artery and damaging the tricuspid leaflets), for counteracting tensioning forces on the tricuspid annulus, and for placing a large surface area anchor 202 (which distributes force over a larger surface area and thereby reduces stress on the tissue); and 2) the line of force application created by spanning the anterior tricuspid annulus 52 with two or more tensioning members significantly reduces the tricuspid annular size of the tricuspid valve 10 in the area where the regurgitant jet 6 is most often shown in functional tricuspid regurgitation.

[0302] Fig.34 Shows Fig.322. The septal portion of the nitinol mesh anchor 218 depicted in FIG. The septal portion of the device is positioned within the left atrium 4, below the fossa ovalis 53 and above the mitral valve 15. The septal device can be constructed of a septal anchor 218 that lies generally flat against the left atrium (to prevent interference with common mitral valve 15 intervention and minimize the risk of thrombosis) and is connected to a flexible band 240 that traverses the interatrial septum 51 and is connected to a lock 230. This placement is important because it is thick and muscular and is in close proximity to the superior surface of the left ventricular myocardium, which makes it relatively fixed 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 via a catheter 232 inserted in the left or right femoral vein, a force vector is created that pulls the anterior tricuspid annulus 52 toward the interatrial septum 51. The lock 230 can be actuated via the catheter 232 to clamp the flexible tension member 240 and maintain the tension on the band. The catheter 232 can then be used to trim the tension member 240 proximal to the suture lock so that any excess material can be removed or trimmed and only minimal material is permanently left in the patient. Trimming excess material from the tension member will be beneficial in limiting unwanted interference in the operation of the heart or unwanted thrombotic response. Alternative angles for this installation can be shown in FIG. Fig.33 middle, Fig.33 A right ventricular view of two expandable anchoring elements 202 positioned against the right ventricular surface of the anterior tricuspid annulus 52 within and adjacent to the RVOT 57 is illustrated looking up at the tricuspid valve 10 .

[0303] Several embodiments of tissue anchors are disclosed herein. Fig.33 as well as Figures 35 to 38 In one embodiment of the invention, the anchoring element 3500 is constructed of a nitinol wire that forms a perimeter 3502 and an interior region of the wire that forms one or more crosses 3506. The wire can be helically wound around itself around the perimeter in 2 or more layers so that the layers lock together so that a force applied to one layer or the center cross 3506 is transmitted to all layers simultaneously. The nitinol wire can be heat set so that it maintains its form while in the austenitic state, and the free end of the wire can be connected by a sleeve that can be crimped or otherwise bonded to the nitinol wire, such as with a Fig.35, or the ends of the wires can be fused together via welding, as depicted in the sleeve 3504. The austenite finish temperature (Af) of the nitinol can be such that when heated to body temperature (37°C or approximately 37°C), the nitinol material has an austenitic structure. Body temperature is typically in the range of 97°F (36.1°C) to 99°F (37.2°C), but it can also be slightly above or slightly below that range, depending on a variety of factors, and in some embodiments, the austenite finish temperature (Af) can be from 97°F (36.1°C) to 99°F, or from approximately 97°F (36.1°C) to approximately 99°F. As desired or required, the anchor perimeter can be configured to be generally rectangular, such as Fig.35 The anchoring element depicted in , can be configured as a generally circular shape, such as Fig.36 The embodiment depicted in FIG. 1 may be configured in any other shape. The anchor may be a bare wire such as in Fig.35 or may be covered with a covering 3708 of synthetic (PET, ePTFE or similar) or biological (pericardial tissue) origin, such as Fig.37 . The covering 3708 may be tightly adhered to the wire form, or it may be loose (allowing relative movement between the covering and the wire). The covering serves to form an interaction layer between the anchor and the tissue, promote tissue healing and bonding (ingrowth) of the anchor into the tissue, provide a seal for the holes through which the flexible tensioner passes through the tissue, and lock the wire form together across its surface area. Suitable techniques for attaching the covering to the frame may include suturing or spreading the covering to the frame, heat bonding the covering to the frame, molding the covering around the frame, or other suitable attachment processes, as desired. The flexible tensioner 3710 (which is generally similar to other tensioners disclosed herein (such as tensioner 240)) may be connected at or near the center of the wire form (e.g., Fig.37 3708) such that when the flexible band 3710 is pulled, tensile forces are substantially transferred to the center of the wire via 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 orifice to the hole, the entire perimeter 3502 of the anchor resists entry into the hole in a manner similar to other anchors disclosed herein, such as a T-bar. The construction of the wire form of the anchor element 3500 and the superelastic properties of the nitinol used to make the anchor element 3500 allow the anchor to be compressed along its length, which significantly elongates and narrows the form of the anchor, thereby facilitating entry into and through the following catheter 3800, which has a substantially smaller diameter than the catheter 3800 disclosed herein. Fig.38 The inner diameter of the length or width of the unconstrained anchor shown in Fig.38 The illustration is of a transparent tube stretched and compressed into a simulated deployment catheter 3800. Fig.37 When the constraint of the catheter 3800 is released, such as by the anchor member exiting the catheter, the anchor member expands back to its pre-configured form, thereby creating a large surface area through which forces can be transmitted to the tissue. The anchor member 3700 is capable of rotating relative to the flexible band 3710 so that when the anchor member 3700 is rotated as shown in FIG. Fig.38 When compressed and elongated in its first, non-deployed configuration as depicted, it can also be caused to rotate relative to the flexible band 3710 to a first pre-deployed state in which the axis of the flexible band 3710 and the plane formed by the anchor 3700 in the pre-deployed state of the anchor 3700 are relatively parallel to each other 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 the axis from the attachment location on the anchor 3700 to the flexible band 3710 causes the anchor 3700 to rotate relative to the band to a position in which the plane formed by the anchor 3700 is more perpendicular to, rather than parallel to, the axis of the flexible band 3710. When the flexible band 3710 is pulled through an orifice, such as through a passage through tissue, with the anchor 3700 on one side of the orifice and the free end of the flexible band 3710 on the opposite side of the orifice, contact between the anchor 3700 and the material through which the orifice passes (such as cardiac tissue) causes the anchor to rotate relative to the flexible band until the side of the anchor opposite to the side that initially contacted the material also contacts the material. Once the anchor contacts the material, the anchor will achieve its second deployment configuration in which the moments on the anchor relative to the attachment point of the flexible band 3710 are in balance and the plane of the anchor is more perpendicular to the axis of the flexible band than parallel, or at an angle relative to the axis of the flexible band than parallel, which causes the anchor to achieve rotational balance. Therefore, in this second deployment configuration, the anchor lies flat against the material through which the orifice passes and prevents entry into the orifice.

[0304] Fig.39 A braided nitinol septal anchor 204 is illustrated abutting against the left atrium wall of the heart, wherein a grommet 219 (similar in function to Fig.12 A coronary sinus grommet or pad 215) is attached to the tensioning band 240 at the right atrial outlet of the tensioning band so that the septum 51 is sandwiched between the anchor and the grommet and the anchor cannot move from its position.

[0305] In other embodiments of tissue anchors, the anchor frame can be laser cut from a Nitinol sheet material with a central hole or cross and various diamond-shaped elements, such as Fig.45 , the anchor frame illustrated in FIG50 , and the frame 7020 of the front surface anchor 7002 illustrated in FIGS. 69 and 70 . The diamond-shaped elements allow for compression and elongation of the anchor so that its cross-sectional area can be reduced for delivery through a catheter and can be expanded into its deployed configuration after exiting the catheter. The anchor can be covered with a polymeric covering or a biological covering as previously discussed. The size of the central hole will be set to allow the tensioning band to pass freely, but not allow the knot at the distal end of the tensioning band to pass so that when the tensioning band is pulled, the knot will transfer force to the anchor.

[0306] In other embodiments of tissue anchors, such as those illustrated in FIG. 44 , the anchor is constructed of braided nitinol wire with the proximal and distal ends fused to a hollow hub that allows the tensioning band to pass freely. The anchor can be heat set into a circular, oval, or rectangular disk or multiple disks (e.g., anchor 4450 in FIG. 44b ) to give a large flat surface area for force transmission to the tissue. The tensioning band can pass freely through the center of the anchor and attach to the distal hub, or can have a knot on the distal end that interferes with the hole through the distal hub of the anchor so that when the tensioning band is pulled, it causes a force to be applied to the distal hub of the anchor, which causes the anchor to flatten against any surface it abuts, such as FIG. 44A to FIG. 44D The anchor can be pulled from the proximal end, or the distal and proximal ends of the anchor can be pulled apart relative to each other, which causes the anchor to elongate and contract in diameter, such as catheter 4408 when in its non-deployed configuration 4408, so that it can be loaded into and deployed from a catheter. Constructing the anchor from multiple discs increases the amount of material in contact with the tissue, which increases the force required to pull the anchor through the tissue without increasing the force required to elongate the anchor for delivery through the catheter.

[0307] 1, 2, 3 or more tissue anchors, each connected to a flexible band, can be placed at the right ventricular surface of the anterior tricuspid annulus 52. Additional anchors (as many as the operator chooses) - each connected to a flexible band - can be implanted around the tricuspid annulus anywhere along the anterior or posterior annulus. All flexible bands can be routed to a central lock positioned near the atrial septum, or anywhere above the tricuspid valve orifice, and the bands can be tensioned simultaneously, individually, or any combination in between to pull each tissue anchor toward the atrial septum.

[0308] In another embodiment, two or more bands may be connected to a single tissue anchor across the ventricular surface of the anterior tricuspid annulus 52, such as with FIGS. 40 to 41. Fig.43In the case of a single anchor 4040 having two or more attached flexible bands, at least two of the flexible bands 4072 will be positioned near either end of the anchor 4040 so that the portion of the anchor between the flexible bands spans 1-4 cm of the anterior tricuspid annulus 52, with the bands traversing from the right ventricle 3, passing through the annular muscle 52, and separating 1 cm to 3 cm or more on the anterior annulus 52 into the right atrium 2. In the case of a single anchor 4040 having multiple attached flexible bands 4072, the anchor may be foldable by providing a flexible internal frame 4044 or by providing a connecting rod, such as in Fig.41 In one embodiment, the anchor can be folded into a thin profile for introduction into the RVOT and for minimizing any interaction with native chordae tendineae, and then expanded once within the RVOT at or near the ventricular surface of the tricuspid annulus.

[0309] As shown in Figure 40 to Fig.43 An embodiment of a system for mounting multiple bands to a single tissue anchor depicted in includes a foldable flat implant system 4000 having a flexible delivery catheter 4002 to deliver an anchor rod 4040 non-fixably attached to a delivery catheter anchor interface 4008, the anchor rod 4040 having a guide wire hub 4050 having a tether hole 4048 that allows passage of at least two anchor rod guide wires 4060 that interact with snare wires 4074 guided by a snare guide catheter 4072 housed within a snare catheter 4070. The process of demonstrating its installation is depicted in . Figures 25 to 31 middle.

[0310] The anchor rod 4040 can be made of a flexible biocompatible material and is depicted in phantom at FIG. 40A to FIG. 43 4008. The anchor rod 4040 includes an anchor rod structural member 4044, which may be composed of nitinol or some other semi-rigid material to provide structure to the anchor rod 4040. Attached to the anchor rod structural member 4044 is an anchor rod guide wire hub 4050, which may be connected to a guide wire catheter 4064 supporting an anchor rod guide wire 4060 via guide wire hub threads 4054 connected to the guide wire catheter connector 4010 during use. The anchor rod 4040 has an anchor rod delivery connector 4046 to non-fixably connect to the flexible delivery catheter 4002 at the delivery catheter anchor interface 4008. The anchor rod 4040 is covered by an anchor rod covering 4042 made of a biocompatible material. The anchor rod 4040 is flexible, such as Fig.41as shown in the figure so that it can be bent for ease of use when inserting the foldable flat implant system 4000 into a patient.

[0311] The anchor rod guide wire 4060 passes through the anchor rod 4040, which is connected to the guide wire catheter connector 4010 that houses the guide wire, and the guide wire catheter connector 4010 is a flexible hinge to accommodate the flexible nature of the anchor rod 4040. The guide wire catheter connector 4010 is constructed of a distal element 4012, a proximal element 4016, and the distal element 4012 has a thread on the distal end, which is configured for attachment to the guide wire hub thread 4054, and a proximal element 4016 has a rotation slot point through its distal end, and the proximal element 4016 is connected to the distal element 4012 via a pin 4014, and the pin 4014 passes through the proximal element 4016 and the distal element 4012 via a slot. The pin allows the proximal element 4016 to pivot from parallel to perpendicular relative to the distal element 4012 while transmitting torsional, tensile and compressive forces between the distal and proximal elements. This articulated connection helps reduce angular strain on the anchor rod guide wire 4060. The anchor rod guide wire 4060 passes through the anchor rod guide wire lumen 4048 surrounded by the anchor rod guide wire hub 4050 and terminates at the anchor rod guide wire distal end 4062, which is pointed to facilitate entry into the heart tissue.

[0312] During deployment, the anchor rod guide wire distal end 4062 passes through the patient's tissue to interact with the snare wire 4074 provided by the snare guide catheter 4072, which is delivered via the snare catheter 4070 connected to the foldable flat implant system 4000. The anchor rod guide wire 4060 can be connected to the snare guide catheter 4072 and receded through the tissue and through the snare catheter until it is placed outside the patient's body. The anchor rod guide wire 4060 can have a flexible tether (such as a suture) attached to its distal end so that when the anchor rod guide wire is fully pulled through the snare catheter, the tether is pulled through the guide wire hub 4050 of the anchor rod 4040 until the knot on the tether or other suitable end termination interferes with the hole 4048 of the guide wire hub 4050.

[0313] Figures 44A to 51C Alternative embodiments of tissue anchors are depicted.

[0314] In other embodiments of tissue anchors, the anchors can be laser cut from Nitinol sheet material with a central hole or cross and various diamond-shaped elements, such as Fig.44AAnchor 4400 as depicted in . Anchor 4400 is shaped as a disc configuration. An end view of the anchor is shown, wherein the anchor is depicted as being generally circular. The anchor can be elongated, which causes the disc to collapse into a long narrow tube for delivery through a catheter. The tensioning band 240 is centrally attached to the distal end of the anchor via an interference knot 4404, which causes the anchor to flatten when the tensioning band is tensioned. The diamond-shaped element 4402 allows compression and elongation of the anchor so that its cross-sectional area can be reduced for delivery through a catheter and can expand to its deployed configuration when exiting the catheter. The anchor can be covered with a polymeric covering or a biological covering as previously discussed. The size of the central hole 4406 will be set to allow the tensioning band to pass freely, but not allow the knot at the distal end of the tensioning band to pass, so that when the tensioning band is pulled, the knot will transfer force to the anchor.

[0315] Fig.44B One embodiment of an anchoring element is illustrated in which the anchor 4450 is constructed of a braided nitinol wire shaped as a series of discs. Two discs are depicted; however, any number of discs may be constructed. The anchor is shown against a cross section of tissue with small holes for tensioning band 240. Having multiple discs increases the amount of material adjacent to the tissue, which makes the anchor more resistant to being pulled through the tissue without increasing the stiffness of the anchor in order to collapse into the delivery catheter.

[0316] Fig.44C One embodiment of an anchor element 4460 is illustrated in which the anchor is constructed of a braided nitinol wire shaped as two discs such that a distal disc 4462 abuts tissue and resists being pulled through when the tensioning band 240 is tensioned, and a proximal disc 4464 is configured to slide over the tensioning band and hold the anchor in place when the tensioning band is relaxed or if the tensioning band is cut or broken.

[0317] Fig.44D An example similar to Fig.44C An embodiment of an anchoring element 4470 of the embodiment depicted in FIG. 1, except that the anchor 4470 is held in place on the proximal end by a shaped nitinol finger 4474. The anchor 4470 has a shape generally similar to Fig.44C The distal disc 4462 of the distal disc 4472 of the ...

[0318] Fig.45An anchor embodiment 4500 is illustrated in which the anchor is constructed from a laser cut Nitinol sheet with a diamond pattern 4502. The laser cut pattern allows the anchor to be compressed and elongated into a narrow profile for delivery through a catheter, and then allows it to passively return to the deployed configuration shown when exiting the catheter. The central hole 4504 does not allow the knot 4506 in the tensioning band 240 to pass through so that when the tensioning band is pulled, it will pull the anchor from the center and cause it to lie flat against any surface the anchor contacts.

[0319] FIG. 46A to FIG. 46C An example of an anchor disclosed herein (such as from Figures 35 to 38 , Fig.45 , Figure 50, and how embodiments of the anchor members of Figures 69 to 74 can be deployed into a patient. Fig.46A A side bisected view of an example anchoring element abutting against tissue with a tensioning band 240 passed therethrough is illustrated. Fig.46B The example of the catheter 4600 is inserted into the Fig.46A , the catheter can be substantially similar to other delivery catheters disclosed herein, such as catheter 220. Fig.46C Illustrated is a diagram of a catheter 4600 deployed from Fig.46B An anchor is illustrated in , where when the tensioning band is pulled and the anchor comes into contact with any structure, it assumes a deployed configuration.

[0320] Fig.47A Examples include Fig.45 and Figure 50A-50C An anchor similar to those illustrated in , wherein a proximal grommet 4710 constructed from a laser cut nitinol tube snaps into the central hole of the anchor. Fig.47B Illustrated Fig.47A . An isometric rendering of the grommet element illustrated in . The grommet 4710 includes a plurality of laser cut nitinol fingers 4712 that are shaped into a configuration in which the fingers are curved and radially dispersed from the tube axis so that the fingers can hold the anchor 4702 in place on the tissue when the tensioning band is relaxed or if the tensioning band 240 is broken or cut. The distal end 4720 of the nitinol tube 4714 is constructed with a raised step 4722 and a taper 4723 in which a slot 4724 is cut to form a cantilever beam 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, thereby allowing the raised step 4722 to pass through the hole in the anchor 4702. Once the raised steps 4722 pass through the hole, the potential energy stored in the beams causes them to straighten and the raised distal end 4720 of the tube is locked to the anchor.

[0321] Fig.48AAn alternative configuration for holding the anchor 4800 in place in the absence of tension on the tensioning band is illustrated, whereby tissue is compressed between the anchor 4800 on the distal end and a flat grommet 4802 on the proximal end that slides over the tensioning band 240. The lock 230 is crimped to the tensioning band 240 to lock the distance between the anchor 4800 and the grommet 4802. The grommet may have a similar construction to any of the anchor elements or grommet elements disclosed herein.

[0322] Fig.48B Illustrated with Fig.48A A similar construction, except that the grommet 4802 is locked relative to the anchor 4800 by a locking mechanism 4850 which utilizes a screw 4852 which, when rotated, clamps the tensioning band between the center hole 4854 and the side exit hole 4856.

[0323] Figure 49A-49F Various alternative anchor concepts are illustrated; Fig.49A depicts a braided nitinol anchor that is similar in function to an occluder device; Fig.49B An S-hook anchor is depicted; Fig.49C A T-bar anchor is depicted; Fig.49D A boat-shaped anchor is depicted; Fig.49E Sutures into the rod anchor are depicted; Fig.49F A rigid hook into the stem is depicted and may include additional barbs.

[0324] Fig.50A An anchor 5000 embodiment is illustrated where the anchor is constructed from a laser cut Nitinol sheet with a diamond pattern 5002 that allows the anchor to compress and elongate into a narrow profile for delivery through a catheter and then passively return to the deployed configuration shown when 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 pulled it will pull the anchor from the center and cause it to lie flat against any surface the anchor contacts.

[0325] Fig.50B An alternative cutting configuration for an anchor 5020 is illustrated, which is generally similar to Fig.50A Anchor 5000 in.

[0326] Fig.50C An alternative cutting configuration for an anchor 5040 is illustrated, which is generally similar to Fig.50A The anchor 5000 and Fig.50B Anchor 5020 in.

[0327] Fig.51AAn anchor embodiment 5100 is illustrated in which the anchor is constructed of a shape-set nitinol wire to form a series of lobes 5102. The wire is wound into a tight loop 5104 between each lobe so that a central hole is formed through the anchor. A tensioning band 240 passes through the central hole, which constrains the lobes from radial displacement relative to each other. The tensioning band 240 has a knot 5106 formed at the distal end that cannot pass through the central hole formed by the tight loop 5104 so that when the tensioning band 240 is pulled, the knot 5106 contacts the center of the anchor 5100 and pulls the anchor 5100 at its center. The anchor 5100 can be elongated for delivery through a catheter and returns to the shape-set configuration after exiting the catheter due to the potential energy stored in the wire from the straightening process.

[0328] Fig.51B Illustrate a method that is generally similar to Fig.51A An anchor embodiment 5120 of the anchor 5100 is shown, except that in addition to the lobes 5102, the wire is also formed into a perimeter circle 5122.

[0329] Fig.51C Illustrated Fig.51B An alternative embodiment of the anchor 5120 illustrated in . The anchor can be straightened to facilitate delivery through a catheter. The anchor can be pulled into the catheter by simply pulling on the distal end of the arcuate wire forming the anchor 5120, and the anchor can be pushed out of the catheter by pushing on the distal end or the proximal end of the arcuate wire. Pushing on the distal end causes the anchor to lengthen as it is pushed due to the counteracting friction against the catheter wall proximal to the point of force application, which reduces the deployment force compared to pushing from the proximal end.

[0330] Any of the anchor embodiments disclosed herein may also include a grommet on the wall of the tissue opposite the location adjacent to the anchor. The grommet holds the anchor in place in the absence of tension on the tension band or if the tension band is cut or broken. The grommet may be permanently attached to the anchor, attached to the anchor after deployment by providing a snap-fit ​​connection, or be a separate component that slides over the tension band and is locked in place relative to the anchor with a separate lock that pushes the grommet against the tissue wall and clamps the tension band. The grommet may be a braided Nitinol construction or a laser cut Nitinol tube construction with fingers that are shaped to grip the tissue radially outward from the central axis. The grommet may have a plurality of grommets that are similar in shape to any of the anchor elements disclosed herein (such as grommet 7030 of FIG. 70, Fig.71 72, and the extended grommet 7402 of FIG. 74), may be another applicable grommet, or any other grommet.

[0331] In some applications of the present disclosure, a technique is described for passing tissue at or near (within 15 mm) the tricuspid valve annulus from the right atrium to the right ventricle by first attaching or embedding the distal end of a stabilizing catheter from the right atrium side into tissue at or near the tricuspid valve annulus, and secondly passing a guide wire through the stabilizing catheter, which will exit the distal end of the stabilizing catheter and will pass through tissue at or near the tricuspid valve annulus from the right atrium to the right ventricle, such as, for example, in Fig.59 and Fig.60 The guide wire can then be placed in position and passed through tissue at or near the tricuspid valve annulus while the stabilizing catheter is retracted or removed from the tissue, leaving the guide wire in position through the tissue. Fig.61 The guide wire can then be used as a guide for passing an additional catheter or device through tissue from the right atrium to within the right ventricle, such as for deploying the surface anchor embodiments disclosed herein. Such methods and apparatus for passing a guide wire through tissue can be incorporated into Figures 14 to 24 In the procedure illustrated in FIG. 1 , it is easier to facilitate passing the anchor delivery catheter 226 and dilator 224 through the tricuspid annulus or the atrial septum.

[0332] In some applications, the stabilizing catheter features a helical wire coil on the distal end of the stabilizing catheter to facilitate tightening the distal end of the stabilizing catheter into the tissue, an example of which is illustrated in Figure 52 to Figure 57 , Figure 59 to Figure 60 as well as Figure 62 to Figure 65The stabilizing catheter may provide, but is not limited to providing, the following unique advantages: 1) by using a rotational motion and applying torque to the stabilizing catheter to pierce tissue at a target location, a significant force (the force is approximately proportional to the applied torque divided by the radius of the distal helix of the catheter) may be generated at the sharpened tip of the stabilizing catheter to quickly penetrate the tissue, 2) by rotating the helical wire coil into the tissue, the resultant force vector at the tip of the stabilizing catheter is at an acute angle relative to the axis of the stabilizing catheter, which may minimize deflection of the tissue and the stabilizing catheter relative to each other when penetrating the tissue because there is a minimal compressive force applied along the axis of the stabilizing catheter, 3) once the distal helical wire coil of the stabilizing catheter penetrates the tissue, continued rotation of the stabilizing catheter generates a normal force on the surface of the helical coil that is directed toward the stabilizing catheter. The force has a force component in the direction of the axis of the stabilizing catheter that drives the helix deeper into the tissue, 4) once the distal helix of the stabilizing catheter is embedded in the tissue, its position 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 the tissue, the stabilizing catheter provides a conduit that can guide the guide wire to the distal tip of the stabilizing catheter and support the guide wire from bending, buckling, scraping or deflecting off course while passing through the tissue, 6) the stabilizing catheter can be easily removed by rotating in the direction opposite to the direction used for rotation, 7) the use of a helically wound wire at the distal end of the stabilizing catheter minimizes trauma to the tissue, leaving only a small puncture of the wire diameter. These advantages, either discretely or in combination with one another, make it easier to pass a guide wire through a precise location in the moving tissue of a beating heart.

[0333] The present disclosure is not limited to passing through the tricuspid valve annulus 52 from the right atrium 2 to the right ventricle 3, but can be used as a technique for passing between any two adjacent chambers of the heart, which can include from the right atrium 2 to the left atrium 3, the right ventricle 3 to the left ventricle 5, the right ventricle 3 to the right atrium 2, the left atrium 4 to the right atrium 2, the left ventricle 5 to the right ventricle 3, the left atrium 4 to the left ventricle 3 (near or through the mitral valve annulus 15), the left ventricle 5 to the right ventricle 3 (near or through the mitral valve annulus 15), or the heart ventricle or atrium to the pericardial space. In addition, the present disclosure can be included as a technique for passing through other tissues outside the heart within the body.

[0334] In some embodiments, the step of passing the guide wire through the treatment area may include one or more of the following steps:

[0335] First, a guide catheter 5500 is introduced into the venous system at the groin.

[0336] The guide catheter 5500 is then tracked through the IVC 50 to the right atrium 2.

[0337] Then, the distal end of the guide catheter 5500 is positioned at or near the tricuspid valve annulus 52, directed toward the intended treatment area, such as Fig.58 The guide catheter 5500 may be positioned within 30 mm of the tricuspid valve annulus 52 .

[0338] The stabilizing catheter 5200 is then passed through the guide catheter 5500, or the stabilizing element is extended from the distal end of the guide catheter 5500, until the helical distal end 5202 of the stabilizing catheter 5200 exits the guide catheter 5500 and contacts tissue at or near the tricuspid valve annulus 52 (within 20 mm) at the treatment area.

[0339] Then, forward pressure is applied while rotating the stabilizing catheter to tighten the distal end 5202 of the stabilizing catheter 5200 into the tissue at the treatment area, such as Fig.59 exemplified in . Fig.59 A 4-chamber cross-section of a heart 1 is illustrated with a guide catheter 5500 within the right atrium 2 and a stabilizing catheter 5200 having a distal helix 5202 being guided by the guide catheter 5500 to a position near the anterior tricuspid valve annulus 52 where the helix 5202 is tightened into the tissue by applying torque to the stabilizing catheter 5200.

[0340] Then, once the stabilizing catheter 5200 is securely attached to the tissue, the guide wire 5212 is passed through the stabilizing catheter 5200 until the distal tip of the guide wire 5212 contacts the tissue at the location where the stabilizing catheter 5200 is embedded.

[0341] Then, the guide wire 5212 is pushed through the tissue until it exits the tissue into the right ventricle 3, as shown in FIG. Fig.60 exemplified in . Fig.60 A 4-chamber cross section of a heart 1 is illustrated, with Fig.59 , and a guide wire 5212 that passes through the stabilizing catheter 5500 and through the tissue near the anterior tricuspid valve annulus 52 to the right ventricle 3. In some embodiments, at this step, alternating current is passed through the guide wire 5212 to heat the distal tip and reduce the force that causes the guide wire to pass through the tissue.

[0342] The stabilizing catheter 5200 is then removed from the tissue by rotating the stabilizing catheter 5200 in a direction opposite to the direction used for insertion into the tissue.

[0343] Then finally, the stabilizing catheter 5200 is removed or retracted, leaving the guide wire in place through the tissue from the right atrium 2 to the right ventricle 3, as shown in FIG. Fig.61 exemplified in . Fig.61 A 4-chamber cross-section of the heart 1 is illustrated with the guide catheter 5500 within the right atrium 2 and the guide wire 5212 passing through tissue at or near the anterior tricuspid annulus 52 from the right atrium 2 to the right ventricle 3 . Fig.59 and Fig.60 The stabilizing catheter illustrated in FIG has been withdrawn.

[0344] In some embodiments of the present disclosure, a stabilizing catheter includes a catheter having a distal tip constructed of a helical wire that is attached to or transitions to a generally tubular catheter having an inner diameter and an outer diameter, such as Figure 52 to Figure 56 A handle 5208 may be attached near the proximal end of the stabilizing catheter 5200 to provide an area for the user to grasp the catheter and apply torque or translation to the catheter, such as Fig.52 and Fig.53 exemplified in . The length of the distal helical wire 5202 can be between 2 mm and 10 mm, but can also be any length suitable for tightening into the desired tissue. The pitch of the spiral 5202 can be between 10 turns per inch to 40 turns, and the wire diameter can be from 10 thousandths to 30 thousandths of an inch. The outer diameter of the spiral can be from 40 thousandths to 156 thousandths of an inch. The distal end 5204 of the spiral wire 5202 can be sharpened to a point to penetrate the tissue more easily due to the increased contact stress applied from the reduced surface area of ​​the end when the end is pressed against the tissue. When the end 5204 of the distal spiral 5202 of the catheter is pressed against the tissue and torque is applied to the catheter, a force is given between the end 5204 of the spiral 5202 and the tissue, which is approximately proportional to the torque applied divided by the radius of the spiral. This force causes the spiral to penetrate the surface of the tissue (endocardial layer) and continue to penetrate the tissue in front of the spiral tip (through the myocardium). Once the spiral tip has penetrated the tissue, continued rotation of the catheter imparts a force along the axis of the spiral that pulls the spiral further into the tissue. Thus, the spiral end of the catheter is tightened into the tissue.

[0345] The spiral wire 5202 forming the distal end of the stable catheter can be constructed of a metal suitable for direct contact with the blood flow in the human body. Examples include stainless steel, titanium, nitinol, and tungsten. The inner diameter of the spiral is sufficient to allow a guide wire to pass through. The spiral wire can be of a generally circular, round, square, rectangular, or trapezoidal configuration or any cross-sectional shape suitable for making a spiral. Alternatively, the spiral wire can be constructed of a rigid plastic (such as polyetheretherketone), a composite material (such as carbon fiber), or a ceramic material. The wound wire spiral 5214 can be constructed as a separate component that is welded (such as by welding) as desired or required. Fig.54), soldered, crimped, mechanically interlocked, adhesively or other processes attached to the distal end of the stabilizing catheter. Alternatively, the spiral wire can be laser cut from the stabilizing catheter tubing, such as Fig.52 The spiral 5202 can be formed to have an outer diameter approximately equal to the outer diameter of the stable catheter shaft, as shown by Fig.52 and Fig.53 As shown in the example, or it can form a larger than (see Fig.54 ) or less than the outer diameter of the shaft of the stabilizing catheter. Constructing the stabilizing catheter with a helical coil that is larger than the diameter of the main catheter shaft can help reduce the torque required to fully penetrate the stabilizing catheter main shaft through the tissue, such as by Fig.63 In some disclosed embodiments, the helix may include 2 or more helically wound wires, such as Fig.64 The double helix 6400 in the embodiment of the present invention can be used to increase the lead of the helix without changing the surface area of ​​the wire relative to a single wire helix of equal pitch. In other embodiments disclosed herein, the helix can be tapered outward, such as Fig.65 The tapered spiral 6500 in the middle may be tapered inwardly to create a squeezing effect when the spiral is tightened into the tissue, which may enhance the retention of the tissue. In some embodiments, all or part of the guide wire or spiral may have a circular cross-section; in other embodiments, the cross-section may be rectangular or trapezoidal. The spiral tapered outwardly may provide more clearance for the guide wire as it is advanced through the tissue at the center of the spiral.

[0346] Fig.57 A stabilizing catheter, such as the stabilizing catheter 5200 and the guiding catheter 5500 disclosed herein, is illustrated within the right atrium 3 of a human heart 1. The helix 5202 of the stabilizing catheter 5200 is tightened into the heart from the right atrium side near the anterior tricuspid annulus.

[0347] The shaft of the stable catheter 5200 can be configured to be flexible when bent, with relatively high torsional stiffness. Examples of suitable structures are laser-cut metal tubing, multifilament hollow spiral twisted wire or cable, and braided wire reinforced polymer. This type of construction allows the stable catheter to navigate a tortuous path and transmit torque through a curved or tortuous path. The inner diameter of the stable catheter is such that it is slightly larger than the outer diameter of the expected guide wire to allow the guide wire to move through the stable catheter without restriction. When the shaft of the stable catheter is constructed of metal, the outer diameter of the stable catheter can be covered 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 blood flow. The polymer outer covering can be implemented to reduce friction, provide a hemostatic seal between the inner diameter and the outer diameter of the catheter, or provide electrical isolation. When the shaft of the stable catheter is constructed of metal, the inner diameter can also be constructed of a polymer layer to reduce friction, provide a hemostatic seal between the inner diameter and the outer diameter, or provide electrical insulation.

[0348] In some embodiments of the present disclosure, the stabilizing catheter 5200 can be designed as a permanent component of the guide catheter 5500 that telescopes in and out of the distal end of the guide catheter. In other embodiments, the stabilizing catheter 5200 is a separate component that can be inserted through the guide catheter and completely removed from the guide catheter, such as in Figure 55 to Figure 57 middle.

[0349] In some embodiments of the present disclosure, the helix 5202 of the stabilizing catheter can be tightened completely through the tissue being passed through, so that the stabilizing catheter enters one side of the tissue and exits the opposite side of the tissue, and the guide wire can thereafter pass through the stabilizing catheter from one side of the tissue to the other side without obstruction, such as in Fig.63 As disclosed herein, Fig.59 For example, when passing through the tricuspid valve annulus, the spiral 5202 can be tightened from the right atrium 2, through the tissue at or near the tricuspid valve annulus 52, and into the right ventricle 3. In other embodiments, the spiral 5202 is only tightened partially through the tissue, and the guide wire 5212 must be pushed through the remaining tissue to pass through the tissue, such as in Fig.60 In such a case, the stabilizing catheter 5200 provides a conduit through which the guide wire 5212 passes that can counteract the forces exerted on the wire by the tissue and prevent the tissue from pushing away from the wire. Due to the combination of the additional bending stiffness provided by the stabilizing catheter and due to the ability of the stabilizing catheter 5200 to be pulled in tension to counteract the compressive load on the guide wire, the stabilizing catheter 5500 also prevents the guide wire 5212 from buckling, bending, bowing, or scraping under the compressive forces required to pass through the tissue.

[0350] In some embodiments of the present disclosure, the guide wire 5212 can be constructed of a conductive material (such as stainless steel, titanium, nitinol or tungsten) and insulated with an electrically insulating polymer (such as PTFE, FEP, polyimide or PEBA). The distal end of the guide wire may be uninsulated, thus forming an electrode. When a high-frequency current is applied to the guide wire 5212 from a signal generator in a return path through the patient's body, an electrical discharge is generated at the uninsulated end, which causes the end of the guide wire to heat quickly and pass through the tissue with less force. The voltage is usually applied to the wire in the radio frequency range. Commercially available guide wires (such as guide wires manufactured by Baylis Medical Inc.) can be used for such purposes. Alternatively, the distal end of the guide wire 5212 can be shaped to help mechanically penetrate the tissue only under force. The end of the guide wire can be sharpened to a point to reduce the force required to pass through the tissue.

[0351] In another embodiment of the present disclosure, the guide wire itself can be configured to have a helically wound wire at the distal tip, such as Fig.66 . This guide wire 6600 can be tightened into the tissue in the same manner as the stabilized catheter 5200 with a spiral distal end already described, and provides the same advantages for engaging the tissue in the 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 guide wire via, for example, welding, soldering, mechanical interlocking or adhesive bonding. The guide wire 6600 with a spirally wound end can be completely tightened through the tissue, and once the spiral exits the tissue into a chamber adjacent to the position from which it originates, it can be freely pushed into such a chamber and act as a guide rail for passing an additional device. Suitable construction materials are metals suitable for contact with blood flow. Examples include stainless steel, titanium, nitinol and tungsten. The advantage of forming a spiral on the guide wire is that the extra steps for introducing and removing a stabilized catheter (such as a stabilized catheter 5200) are eliminated.

[0352] Fig.67 Depicts a cross-sectional view of an expansion system 6700 comprising an expander 6702 and a device similar to Fig.666708. The guide wire 6710 may have a relatively small diameter 6712 followed by a straight section of relatively large diameter 6708. Such a guide wire may be assembled into a dilator 6702 having a tapered distal end 6706 having a smaller inner diameter 6704 that transitions to a larger inner diameter 6708 proximal to the distal end such that the smaller diameter straight section of the guide wire is captured within the smaller inner diameter of the dilator by the dilator shoulder 6709, as shown. Fig.67 As the guide wire 6710 is tightened into tissue, a shoulder 6719 formed at the transition of the guide wire from the smaller diameter 6712 to the larger diameter 6714 will push against a corresponding shoulder 6709 between the smaller inner diameter 6704 and the larger inner diameter 6708 of the expander, which in turn will push the expander 6702 to follow the guide wire 6710 through the tissue. In an alternative construction, the expander can be permanently bonded or fixed to the guide wire so that the expander and guide wire act as a single component and rotation of the expander causes rotation of the guide wire so that by rotating the expander it can be tightened through tissue.

[0353] In another embodiment of the present disclosure, the expander 6800 is constructed with helical threads 6802 cut into the distal taper of the expander, such as Fig.68 As illustrated in . When the expander is passed through tissue, rotation of the expander generates a force acting in the direction of the expander axis, against the lead of the threads, which pulls the expander through the tissue, thus making passage through the tissue easier than pushing alone. The expander can be constructed of a polymer material such as PEBA, high-density or low-density polyethylene, nylon or other suitable polymers, and can be reinforced with metal braid or polymer braid, laser-cut metal tubing or other suitable materials to increase torsional stiffness.

[0354] In some applications of the present disclosure, a system is described for facilitating implantation of an anchor in tissue at or near the tricuspid valve annulus from the right atrium to the right ventricle by first attaching or embedding the distal end of a stabilizing catheter in tissue at or near the tricuspid valve annulus from the right atrium side, and secondly passing a guide wire through the stabilizing catheter, which will exit the distal end of the stabilizing catheter and will pass through tissue at or near the tricuspid valve annulus from the right atrium to the right ventricle. The system varies as desired or required, and may include multiple anchors, multiple tethers, and multiple tether locks.

[0355] Figures 69A to 69COne embodiment of a surface anchor system 6900 that may be used in a method for tricuspid valve repair is illustrated. Fig.69A , the surface anchor system 6900 is comprised of a nitinol wire frame 6904 forming a perimeter and having a nitinol frame interior feature 6916 within the perimeter, the tether 6902 being attached to the nitinol wire frame 6904 at the nitinol frame interior feature 6916 via a tether loop 6912 of the tether 6902 secured with a tether knot 6914. The nitinol frame interior feature 6916 may be near the center of the area formed by the perimeter, but may also be anywhere within the perimeter. Figure 69A-Figure 69C The nitinol frame internal feature 6916 depicted in FIG. 6 is shown as a cross. The nitinol wire frame 6904 is wrapped around itself at the helical section 6910 along the perimeter 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 frame. The surface anchor 6901 can be substantially similar to the anchor 3700 as described herein. The surface anchor 6901 is flexible so that it can assume a non-deployed configuration whereby it can be stretched and compressed for insertion into a device having a substantially smaller size than that of the nitinol wire. Fig.69B The unconstrained anchor is shown within the catheter 6920 with an inner diameter of 1.000 mm. When the surface anchor is pushed out of the catheter and is no longer constrained, the strain energy of the nitinol frame is released and the surface anchor 6901 moves from the catheter 6920 to the inner diameter of the catheter 6920. Fig.69B Its non-deployment configuration shown in is converted to Fig.69A and Fig.69C 6902 is connected to the surface anchor 6901, the tether 6902 can pivot when the tether loop 6912 is connected to the surface anchor 6901 by the tether knot 6914. This allows the surface anchor 6901 to be moved from Fig.69B The non-deployed configuration shown in Fig.69A and Fig.69C, wherein in the non-deployed configuration the tether axis is generally parallel to the plane of the anchor and in the deployed configuration the tether axis is generally perpendicular to or at an angle other than parallel to the plane of the surface anchor. If the surface anchor 6901 is passed through an orifice, such as a passage or hole through body tissue, while attached to the tether 6902, pulling the free end of the tether on the other side of the orifice will cause the surface anchor 6901 to be pulled against the opening of the orifice. The nitinol wire frame 6904 of the surface anchor 6901 can be heat set in its deployed state so that it will maintain its form while in the austenitic state. The austenite finish temperature (Af) of the nitinol can be such that when heated to body temperature (approximately 37°C), the nitinol material transforms to an austenitic crystal structure and returns to its deployed state. This can be heat set as Fig.69A and Fig.69C The deployment configuration shown in , so that when heated to above its austenite finish temperature, it naturally assumes a perimeter shape unless constrained. The free end of the nitinol wire frame 6904 can be connected to a surface anchor wire connector 6908 (e.g., a crimp connector). Alternatively, the free end can be connected by other means (such as by welding). The surface anchor 6901 can be deployed from the catheter 6920 via a push 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.

[0356] Figure 70A-70H An implant system 7000 is illustrated that includes a plurality (2 shown) of anterior surface anchors 7002 connected to a septal surface anchor 7004 via tethers 7006 that engage each surface anchor with an attached surface anchor hub 7014. The tethers 7006 can be tensioned by tether locks 7012 that pull the anterior surface anchors 7002 toward the septal surface anchors 7004. When the surface anchors engage tissue on either side of the annulus of a heart valve, such as the anterior surface anchor 7002 engaging the right ventricular surface of the anterior tricuspid annulus and the septal surface anchor 7004 engaging the left atrial septum, the tethers can be tensioned to reduce the distance between the anterior surface anchor 7002 and the septal surface anchor 7004, which reduces the distance across the heart valve annulus and improves coaptation of the heart valve leaflets. Fig.70AA lockable tissue grommet 7030 is illustrated which can be positioned on a surface of tissue opposite to the surface to which the anterior surface anchor 7002 and the septal surface anchor 7004 are abutted and effectively locks the surface anchors 7002 and 7004 in place such that they cannot migrate in the absence of tension on the tether. Thus, tissue can be sandwiched between the surface anchor 7002 or the surface anchor 7004 and the lockable tissue grommet 7030, as shown in FIG. Figure 70H As illustrated in and described in detail herein.

[0357] Fig.70B A front view of a surface anchor of an anterior surface anchor 7002 and a septal surface anchor 7004 is illustrated. The surface anchors 7002 and 7004 are composed of a nitinol frame 7020 that can be laser cut into a series of flexible struts that allow the surface anchors to be elongated and compressed as described herein and in Fig.70E and Fig.72C The nitinol frame 7020 is covered with a surface anchor outer covering 7022, which may include a fabric or solid elastic covering to promote sealing, healing, and tissue ingrowth into the surface anchor. The anterior surface anchor 7002 and the septal surface anchor 7004 additionally include holes 7024 positioned within the perimeter defined by the nitinol frame 7020, as shown in FIG. Fig.70D exemplified in .

[0358] refer to Fig.70C and Fig.70D The lockable tissue grommet 7030 is non-fixably attached or locked to the surface anchor hub 7014 to hold the anterior surface anchor 7002 or the septal surface anchor 7004 against the surface of the heart. Fig.70C, the tether 7006 can be passed through a central lumen that passes through the central distal tubular portion of the tissue grommet 7030), the anterior surface anchor 7002 or the septal surface anchor 7004, and the surface anchor hub 7014, and then tied to form a tether knot 7010. Alternatively, the tether 7006 can be passed through those components and then have a mechanical fastener placed at the end of the tether 7006 so that when the tether is tensioned, the tether knot 7010 or the attached fastener cannot be pulled through the lumen of the surface anchor hub 7014. The surface anchor hub 7014 can be configured so that the distal end forms a surface anchor hub bell 7016 having a major diameter so that the surface anchor hub 7014 cannot pass through the hole 7024 in the surface anchor 7002 or the surface anchor 7004. The surface anchor hub 7014 has a surface anchor hub nose or distal flange 7017 at its proximal end having a diameter smaller than the surface anchor hub bell 7016 but larger than the surface anchor hub central axis 7018. 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 tissue grommet flexible retaining fingers or central flexible beam 7036 are centrally positioned on the radially inwardly oriented tissue grommet 7030 and the surface anchor hub nose or flange 7017 interferes with and substantially prevents longitudinal movement of the tissue grommet 7030 in the proximal direction as described in detail herein. The surface anchor hub midshaft 7018 has a smaller diameter than the surface anchor hub bell 7016 or the surface anchor hub nose 7017 so that the central flexible beam 7036 can interact with the surface of the surface anchor hub nose 7017 at a surface formed by the diameter difference between the size of the surface anchor hub nose 7017 and the size of the surface anchor hub midshaft 7018, thereby retaining the tissue grommet 7030 and preventing the tissue grommet 7030 from translating proximally relative to the surface anchor hub 7014. The surface anchor tissue grommet 7030 can include a tissue grommet central flexible beam 7036 pre-set to the inner diameter of the grommet. The tissue grommet flexible retention fingers or central flexible beam 7036 are sized so that the tips of the tissue grommet flexible retention fingers 7036 naturally rest behind the latitudinal surface of the surface anchor hub nose 7017 and can be deflected outwardly, allowing the grommet to pass over the hub so that the nose will interfere with the fingers if forces impacting the implant system 7000 would separate the surface anchor hub 7014 and tissue grommet 7030 after they are connected. 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 depicted as having one tissue grommet center flexible beam 7036, however, in other embodiments, the tissue grommet may be constructed with multiple center flexible beams 7036 that together provide the same functionality as the single center flexible beam 7036 described therein.

[0359] The surface anchor tissue grommet 7030 can be constructed with a proximal finger portion that includes a plurality of 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, such as Fig.70E and Fig.70F . When released from the catheter 7050, the stored strain energy in the tissue grommet flexible arms or beams 7032 can cause the arms to move back to the deployed configuration. Suitable materials of construction for the tissue grommet flexible arms can have a high degree of recoverable strain, such as being able to recover greater than 1%, greater than 5%, or other percentages as desired or required. Thus, materials such as Nitinol are suitable for use, or other materials as described in detail herein or known to those skilled in the relevant art.

[0360] FIG. 70E to FIG. 70H An example method for implanting an embodiment of a therapeutic system 7000 into a patient's heart is depicted. In some embodiments, the steps for implanting may include one or more of the following steps:

[0361] First, the surface anchor tissue grommet 7030 and surface anchor 7002 or surface anchor 7004 are crimped into their respective pre-deployment configurations, and the tissue grommet 7030, the anterior surface anchor 7002 or the spacer surface anchor 7004, the tether 7006 and the surface anchor hub 7014 are constrained within the catheter 7050 housing the outer push catheter 7052 and the inner push catheter 7054. The grommet, surface anchor and hub are axially spaced from each other. This is depicted in Fig.70E middle.

[0362] The catheter assembly with the implant assembly is then advanced through the cardiac tissue 7040 until the catheter exits the opposite side of the tissue from which it entered.

[0363] Then, the inner push catheter 7054 is translated distally to slideably displace the surface anchor 7002 or the surface anchor 7004 and the surface anchor hub 7014 distally until they exit the distal end of the catheter. The surface anchor expands to its deployed configuration after exiting the catheter. This step is depicted at Fig.70F middle.

[0364] The inner pusher is then withdrawn distally into the catheter.

[0365] The catheter is then retracted distally from the tissue.

[0366] Then, the outer push catheter 7052 is used to push the tissue grommet 7030 out of the distal end of the catheter. Once the grommet exits the catheter, the grommet assumes its deployed configuration. This step is depicted in FIG. Figure 70G middle.

[0367] Then, while tension is placed on the pulling tether 7006, the outer push catheter 7052 is used to push the tissue grommet 7030 over the surface anchor hub 7014, as previously described, until the grommet is locked to the hub.

[0368] Then, as the grommet is pushed against the distal surface of the tissue (in the process of pushing the hub), the tissue grommet flexible arms 7032 deflect distally. Once the grommet is locked to the hub, the tissue grommet flexible arms 7032 apply compression to the cardiac tissue 7040, thereby clamping the cardiac tissue 7040 between the tissue grommet 7030 and the surface anchor 7002 or surface anchor 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 attached. This secures the surface anchor in place. This step is depicted at Figure 70H middle.

[0369] Fig.71 An alternative embodiment of an implant system 7100 is illustrated, which features a surface anchor 6901 as previously described attached to a tether 6902 as previously described, and features another embodiment of a grommet, hereinafter referred to as a flat grommet 7102, which is secured against proximal translation by a tether lock 7500, as described herein. In one embodiment of the present disclosure, the implant system 7100 may be used with a tether lock 7500 as previously described. Fig.69A and Fig.70B The flat grommet 7102 is constructed similarly to the surface anchors 6901, 7002, and 7004 shown and described in the drawings, having an expandable metal frame 7104 and optionally having a covering material 7106. The flat grommet 7102 features a hole through which the tether passes and can translate along the tether. The flat grommet 7102 can be stretched, compressed, and pivoted about the axis of the tether 6902, similar to the surface anchors 6901, 7002, and 7004 described previously. The tether lock 7500 can be as shown. Figure 75A-Figure 75DThe implant system 7100 is constructed as illustrated so that it can slide along the tether 6902 when pushed distally, but grasps the tether 6902 and prevents sliding when pushed by a force in the proximal direction. As desired or required, the implant system 7100 can use any other embodiment of the tether lock described herein, or any other tether lock suitable for implantation. The function of the flat grommet 7102 and the tether lock 7500 - whereby it clamps the tissue between the grommet and the surface anchor and prevents migration of the surface anchor - is substantially the same as the function of the tissue grommet 7030 and the surface anchor hub 7014.

[0370] Figure 72A-72C An alternative embodiment of an implant system 7200 is illustrated. Implant system 7200 is substantially similar to implant system 7100 as depicted in FIG. 7100, except that instead of a flat grommet 7102, implant system 7200 utilizes a T-bar grommet 7220. T-bar grommet 7220 is a rigid, non-expandable form and has a length that is significantly greater than its width. T-bar grommet 7220 may include a singular rigid member. T-bar grommet 7220 has a hole or T-bar slot 7222 at or near the center through which tether 6902 may pass and which allows the grommet to 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 allows the T-bar grommet to pivot about the tether so 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, such as Fig.72C When the T-bar grommet 7220 is unconstrained by the catheter and experiences a load applied to its surface at any distance away from the tether 6902, such as when contacting tissue, the T-bar grommet 7220 pivots relative to the tether 6902 so that its long axis is approximately perpendicular to the axis of the tether, as shown in FIG. Fig.72A . The T-bar grommet 7220 may be restricted from proximal translation along the tether 6902 by a tether lock 7500 as previously discussed. Any of the locks disclosed herein may be used as a tether lock.

[0371] Fig.73An alternative embodiment of an implant system 7300 for securing a grommet as previously described, such as a flat grommet 7102, is illustrated. In this embodiment, a tether 7310 is formed as a loop that passes through the flat grommet 7302 a first time, passes through the surface anchor 6901 a first time, passes through the surface anchor 6901 a second time thereby encircling the surface anchor 6901, passes through the flat grommet 7302 a second time, and terminates by reconnecting with the tether at a sliding connection point 7312 at a location prior to the tether 7310 first passing through the flat grommet 7302 such that pulling the tether 7310 draws the surface anchor 6901 toward the flat grommet 7302 by advancing the connection point 7312 distally along the tether. As desired or required, the grommet used within the implant system 7300 may be the flat grommet 7302, the T-bar grommet 7220, or any other grommet that is compatible with the tether 7310 system. Fig.73 , a flat grommet 7302 is used. The tether connection point 7312 can be a slidable knot or other similar connection point so that the tether connection point 7312 can be slid along the first portion of the tether 7310 before the tether 7310 is first passed through the flat grommet 7302. The function of the grommet is similar to those previously described, however, instead of securing the grommet against proximal translation along the tether by the tether lock 7500, the grommet 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 substantially similar manner to the previous implant system 7200. The gap between the flat grommet 7302 and the surface anchor 6901 is initially set to be greater than the thickness of the tissue that will be 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 opposite side of the tissue, the slidable knot 7312 can be moved distally using a push catheter such as 7050 while applying tension to the free end of the tether 6902, which causes the tether connection point 7312 to slide distally and reduce 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 sliding proximally, maintaining compression of the tissue.

[0372] Fig.74A and Fig.74B An alternative embodiment of an implant system 7400 for securing a grommet as previously described, such as a flat grommet 7102, is illustrated. In this embodiment, the grommet used to hold the surface anchor 6901 to the treatment area is a self-expanding grommet 7402. Fig.74A The self-expanding grommet 7402 is shown in an expanded state after the grommet has been expanded. Fig.74BA self-expanding grommet 7402 is shown in an implant system 7400 that utilizes 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 similar manner to other grommets disclosed herein. When within the delivery catheter, the self-expanding grommet 7402 is in a collapsed state in which its arms have not yet expanded. After being forced out of the deployment catheter 7050, the arms of the self-expanding grommet 7402 are configured to return to their deployed state, as shown in FIG. Fig.74A and Fig.74B The flat grommet 7402 may be constructed of Nitinol or other similar material having shape memory and high recoverable strain properties that allow the flat grommet 7402 to be heat set into a first expanded or deployed configuration, such as Fig.74A and Fig.74B , and then constrained into a second collapsed configuration for translation through the catheter so that after deployment, the flat grommet 7402 can return to the expanded configuration when released from the catheter.

[0373] FIG. 75A to FIG. 75D One embodiment of a tether lock 7500 is illustrated. Fig.75A The tether lock 7500 is depicted in a closed configuration, wherein the tether lock spring arm 7502 is resiliently bent at the tether lock deflection node 7504 to close the tether lock 7500 on the tether 6902 and prevent it from sliding in a lateral direction. The tether lock 7500 can have one or more tether lock deflection nodes 7504 for one or more tether lock spring arms 7502. Fig.75B The tether lock 7500 is depicted in an open configuration, which allows the tether lock 7500 to slide laterally along the tether 6902. Fig.75C The tether lock 7500 is depicted in a closed position from another angle. The tether lock 7500 additionally has a tether lock tether hole 7512 on the distal end 7510 of the tether lock through which the tether 6902 can be passed. The tether lock 7500 additionally includes at least one tether lock alignment wall 7506 positioned on the proximal end of the tether lock 7500, which can maintain the tether 6902 aligned with the closing member of the tether lock 7500. The tether 6902 continues to pass between the tether lock tether contact surfaces 7508 so that it is clamped between the spring arms. When a force is applied to the tether lock moving from the proximal side of the tether lock toward the tether lock distal end 7510, the friction between the tether 6902 and the tether lock tether contact surface 7508 induces a moment on the spring arms that causes them to clamp together, effectively clamping onto the tether, such as Fig.75A. If a force is applied to the tether lock that moves 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 causes a moment on the spring arm that causes them to disperse, thereby allowing the tether lock to slide along the tether. Therefore, the tether lock can be pushed distally and will slide along the tether with very little force, but when the tether lock encounters a proximally directed force (such as resistance to compressing tissue between the surface anchor and the grommet), the tether lock automatically clamps down onto the tether and prevents movement. The greater the proximally directed force on the tether lock, the greater the clamping force on the tether. The tether lock can be a metal construction such as stainless steel, titanium or nitinol or a polymer construction such as polyetheretherketone or nylon. The tether lock tether contact surface 7508 of the spring arm can have a toothed geometry as shown to increase friction on the tether.

[0374] FIG. 76A to FIG. 80D Several alternative embodiments of tether locks to be used with various tethers (e.g., tether 6902, tether 7006, etc.) are depicted that may be used in place of the depicted tether locks disclosed herein, such as from Figures 2 to 13 Lock 230, from Fig.31 Lock 4080, from Fig.70A Lock 7012, from Figure 71 to Figure 7 2 and other embodiments of the lock 7500 of Figures 74 to 75 or implant systems as disclosed herein. Various lock embodiments disclosed herein can accommodate an adjustable lock tensioner disposed within the body of the lock such that the adjustable lock tensioner can retract one or more tension members at least partially through the lock housing.

[0375] Figures 76A to 76F One embodiment of a tether lock 7600 having a slidable wedge 7604 driven by a lead screw 7606 clamped to one or more tethers 6902 is illustrated, hereinafter referred to as a slidable wedge tether lock 7600. Fig.76A and Fig.76C The lock is illustrated in a locked configuration in FIG, which shows a cross-sectional view of a slidable wedge tether lock 7600. Fig.76B and Fig.76D, which shows a cross-sectional view of a slidable wedge tether lock 7600. The screw can have a flange 7608 that is captured in a slot 7610 of a slidable wedge 7604 such that translation of the lead screw 7606 in either direction along its axis exerts a force on the wedge, causing it to translate in the direction of the lead screw 7606. The lock can be configured with a tether lock housing 7602 having a housing slot 7612 that is angled relative to the axis of the housing. The housing slot 7612 can engage a pin 7614 that passes through the slidable wedge 7604 such that when the wedge translates proximally, the housing slot 7612 exerts an upward force on the pin 7614, causing the wedge to rise within the housing (to an unlocked configuration). Distal translation of the wedge has the opposite effect, wherein the slot will cause the wedge to be driven downward within the housing, ultimately clamping the tether into a locked configuration. Alternatively or in addition to the above locking configuration system, the slidable wedge 7604 can interact with the housing end 7616 along the housing end angled surface 7618 relative to the axis of the tether lock housing 7602, such that distal translation of the wedge causes a downward force on the wedge due to the reaction force at the housing end angled surface 7618. Thus, tightening the lead screw 7606 into the tether lock housing 7602 in this embodiment causes the slidable wedge 7604 to clamp the tether. The more acute the angle between the slot 7610 and / or the housing end angled surface 7618 and the tether axis, the greater the downward clamping force. Tension on the tether pointing distally relative to the lock causes friction 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 the pin 7614 or the slidable wedge 7604 and the housing end 7616 further causes the wedge to clamp on the tether, thereby increasing the tension on the suture line resulting in an increased clamping force on the tether, even if the screw loosens over time. Therefore, the mechanism is self-locking in the presence of tension on the tether, thereby mitigating the possibility of loosening over time. Fig.76E The passage of the tether into the housing end opening 7620 at the distal end of the lock is illustrated, and Fig.76F Tether lock housing opening 7622 is illustrated with the tether exiting the proximal end of the lock.

[0376] Figures 77A to 77C An embodiment of a tether lock having a rotatable pawl for gripping one or more tethers is illustrated, hereinafter referred to as a rotatable pawl tether lock 7700. The lock has a cross-section in Fig.77A is shown in a closed configuration and in Fig.77B is shown in its open configuration. Fig.77Cis an exploded view of the components. When the tether 6902 contacts the pawl contact surface 7706 and the tether 6902 is pulled distally under tension, a friction force is applied to the pawl in the direction in which the tether is pulled, which results in a moment about the rounded end of the pawl, which is constrained in a matching rounded groove in the tether lock housing 7702. This moment causes the pawl contact surface 7706 to rotate in the direction in which the tether 6902 is pulled. If the tether is pulled distally, such as due to a tensile force on the tether when the heart valve annulus is reduced, the arcuate path of the pawl causes the end of the pawl to drive downward and clamp the suture. Thus, when tension is applied to the tether in the distal direction, the lock is self-locking, and increasing tension results in increasing clamping force. The lock can accommodate a spring clip 7708 that applies a moment on the pawl contact surface 7706, causing it to be in a closed position. In order to maintain the pawl contact surface 7706 in the open position, which is desirable for smoothly advancing the lock on the tether through the patient's anatomy to its intended position and for fine-tuning the tension on the tether when reducing the heart valve annulus without obstruction, a pull pin 7710 can be inserted through the pawl through hole 7712 to counteract the spring clip 7708 force and keep the pawl open. One end of the pull pin can reside in the pawl recess hole 7714 to provide additional support on the pull pin. Removing the pull pin will cause the rotatable pawl 7704 to spring into its locked configuration. During assembly, the pawl and spring can be inserted into the housing from one side, and the two tether lock side housings 7703 can be welded or otherwise attached to the housing to keep all the components in place. Figures 78A to 78C An alternative embodiment of a spring clip 7808 is illustrated that can be used to arrange the pawl 7804 in a primary locking configuration. A pawl ball 7816 can 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. In this embodiment, the spring can be manufactured as a typical coil spring.

[0377] FIG. 79A to FIG. 79DOne embodiment of a tether lock 7900 having a threaded rotatable pawl 7904 that engages and clamps one or more tethers, similar to the rotatable pawl tether lock 7700 disclosed herein, is illustrated. The threaded rotatable pawl 7904 features a pawl pin 7906 that is disposed in a tether lock housing opening 7903, wherein the threaded rotatable pawl 7904 is capable of rotating about the pawl pin 7906. A cylindrical nut 7908 resides in a pawl recess 7910 within the pawl 7904 that allows the nut to translate up and down within the pawl. The cylindrical nut 7908 features a nut pin 7912 at each end that engages a pawl slot 7914 in the threaded rotatable pawl 7904, such that the nut is captured in the pawl, and translation of the nut along the axis of the housing will exert a torque on the pawl, thereby rotating the pawl. The pawl screw 7916 may be held captive between the cylindrical nut 7908 and the tether lock housing proximal cover 7918, which are attached to the housing, for example, via welding. The pawl screw 7916 is threaded through the cylindrical nut 7908, and rotation of the screw causes translation of the nut, which causes the pawl to rotate. The pawl may be formed by Fig.79D The two pieces shown in the embodiment of the present invention are constructed to allow the assembly of the nut, and once inserted into the housing, the nut is kept captured in the pawl. The two halves of the pawl can also be connected via welding or other mechanical means.

[0378] FIG. 80A to FIG. 80D One embodiment of a tether lock having a spring clip 8006 is illustrated that directly engages and clamps onto one or more tethers 6902. The spring clip tether lock 8006 is Fig.80A and Fig.80C is shown in an open or unlocked configuration and in Fig.80B8006 is shown in a closed or locked configuration. The spring clip 8006 is held captured within the tether lock housing 8002 under preload, wherein the spring clip is deflected from its natural state so that the spring clip clamping surface 8008 of the spring clip naturally contacts the bottom surface of the housing, thereby naturally being in a closed position and applying a clamping force on the tether. The spring clip 8006 is constrained for translation within the tether lock housing 8002 by the proximal surface of the housing end 8004 and the housing rear surface 8020, which are attached to the housing, such as via welding, after insertion into the spring clip. The spring clip arm 8010 is capable of deflecting about a spring clip deflection node 8012 in the geometry of the spring clip, such that when the arms of the spring clip are deflected, the spring clip clamping surface 8008 rotates within the housing into an unlocked configuration or a locked configuration, depending on the direction in which the force is applied. As the tether 6902 is pulled distally, the friction between the tether and the spring clamp clamping surface 8008 of the spring clamp creates a moment about the spring clamp deflection node 8012 that causes the spring clamp spring clamp arm 8010 to rotate in a direction that drives the spring clamp clamping surface 8008 into the tether 6902, thereby clamping the tether between the spring arm and the housing. The greater the tension applied to the tether, the greater the force with which the spring arm clamps onto the tether. The spring clamp pin 8014 can be inserted into the spring clamp hole 8016 in the spring clamp 8006 and supported in the housing end hole 8005 in the housing end 8004 of the lock. The pin can hold the spring clamp in place as shown. Fig.80A and Fig.80C , which is desirable for smoothly advancing the lock on the tether through the patient's anatomy to its intended position and for fine-tuning the tension on the tether as the heart valve annulus is reduced without obstruction. Removing the spring clip pin 8014 allows the spring clip 8006 to spring into the closed configuration. The spring clip pin 8014 can be threaded and rotatably actuated via the catheter, or can be a component of the catheter itself. The threads can be used as an attachment mechanism between the lock and the catheter, wherein unscrewing the pin both deploys the spring clip into the locked configuration and releases the lock from the catheter.

[0379] Although certain embodiments of the present invention have been described, these embodiments are presented only by way of example and are not intended to limit the scope of the present disclosure. In fact, the novel methods and systems described herein can be embodied in a variety of other forms. In addition, various omissions, substitutions, and changes may be made to the systems and methods described herein without departing from the spirit of the present disclosure.

[0380] Features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment or example will be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract and drawings) and / or all steps of any method or process so disclosed may be combined in any combination, excluding at least some mutually exclusive combinations of such features and / or steps. Protection is not limited to the details of any foregoing embodiments. Protection extends to any novel feature or any novel combination of features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel step or any novel combination of steps of any method or process so disclosed.

[0381] In addition, certain features described in the present disclosure in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented in multiple embodiments individually or in any suitable sub-combination. In addition, although features may be described above as working in certain combinations, one or more features from a claimed combination may be removed from the combination in some cases, and the combination may be claimed as a sub-combination or a variation of a sub-combination.

[0382] In addition, although the operations may be depicted in the drawings or described in the specification in a particular order, it is not necessary to perform such operations in the particular order shown or in a sequential order, or it is not necessary to perform all operations to achieve the desired result. Other operations not depicted or described may be included in the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously or between any of the described operations. In addition, in other embodiments, the operations may be rearranged or reordered. It will be appreciated by those skilled in the art that in some embodiments, the actual steps taken in the illustrated and / or disclosed processes may be different from those steps shown in the drawings. According to an embodiment, some of the steps described above may be removed, and other steps may be added. In addition, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, and all additional embodiments fall within the scope of the present disclosure. Moreover, the separation of the various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems may generally be integrated together in a single product or packaged into multiple products.

[0383] For purposes of the present disclosure, certain aspects, advantages, and novel features are described herein. Not all such advantages may be achieved according to any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure may be embodied or performed in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0384] Unless expressly stated otherwise or otherwise understood in the context as used, conditional language such as "can," "may," "might," or "may" 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 one or more embodiments require features, elements, and / or steps in any way, or that one or more embodiments must include logic for determining, with or without user input or prompting, whether such features, elements, and / or steps are included in or are to be performed in any particular embodiment.

[0385] Unless specifically stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" is understood with the context as commonly used to convey that an item, term, etc. can be X, Y, or Z. Thus, such linking language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0386] As used herein, language of degree, such as the terms "about," "approximately," "roughly," and "substantially" as used herein, refers to a value, amount, or characteristic that is close to a stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "about," "approximately," "roughly," and "substantially" may refer to an amount that is less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount. As another example, in certain embodiments, the terms "roughly parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees. As used herein, numbers and values ​​preceded by terms such as "about" or "approximately" include the numbers that are recorded. For example, "about 7 mm" includes "7 mm", and numbers and ranges preceded by terms such as "approximately" or "about" should be interpreted as disclosing numbers and ranges with or without such terms preceding the numbers or values, so that this application supports claiming protection for numbers, values ​​and ranges disclosed in the specification and / or claims, regardless of whether such numbers, values ​​or ranges are preceded by terms such as "about" or "approximately", such that, for example, "about two times to about five times" also includes disclosure of a range of "two times to five times".

[0387] The scope of the disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere in this specification, and may be limited by the claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims should be interpreted broadly based on the language employed in the claims, and not limited to the examples described in this specification or during the prosecution of the application, which examples should be interpreted as non-exclusive.

Claims

1. A method for tricuspid valve repair, comprising: anchoring a first ventricular surface anchor against a first right ventricular surface, wherein the first ventricular surface anchor is connected to a first tension member; anchoring a first tension anchor against a tension anchor surface of the heart, wherein the first tension anchor is connected to a second tension member; extending the first tension member connected to the first ventricular surface anchor toward the second tension member connected to the first tension anchor; and The first right ventricular surface is drawn toward the first tension anchor using the first tension member and the second tension member.

2. The method according to claim 1, further comprising: anchoring a second tension anchor to another tension anchor surface of the heart, wherein the second tension anchor is connected to a third tension member; Wherein, the third tension member is connected to the first tension member and the second tension member via a tension member lock.

3. The method according to claim 1, wherein: The tension anchor surface abuts the left atrial surface of the interatrial septum below the foramen ovale.

4. The method according to claim 1, wherein: The tension anchor surface abuts the left atrial surface of the atrial septum below and behind the foramen ovale.

5. The method according to claim 1, wherein: The tension anchor surface is at the right ventricular surface of the ventricular septum.

6. The method according to claim 1, wherein: The tension anchor surface is at the left ventricular surface of the ventricular septum.

7. The method according to claim 1, wherein: The tension anchor surface is at the coronary sinus proximal to the right atrium.

8. The method of claim 1, further comprising anchoring a second ventricular surface anchor against a right ventricular surface proximate an anterior portion of a tricuspid annulus; in, the second ventricular surface anchor being connected to a third tension member; wherein the center of the first ventricular surface anchor is spaced 0.5 cm to 4 cm from the center of the second ventricular surface anchor; and extending the first tension member connected to the first ventricular surface anchor and the second tension member connected to the second ventricular surface anchor toward the first tension anchor; and The first right ventricular surface and a right ventricular surface proximate an anterior portion of the tricuspid annulus are drawn toward the first tension anchor using the first tension member, the second tension member, and the third tension member.

9. The method of claim 8, further comprising anchoring a third ventricular surface anchor against a right ventricular surface proximate a posterior portion of the tricuspid annulus; in, the third ventricular surface anchor being connected to a fourth tension member; wherein the center of the third ventricular surface anchor is spaced 0.5 cm to 4 cm from the center of the second ventricular surface anchor, and the center of the third ventricular surface anchor is spaced 0.5 cm to 4 cm from the center of the first ventricular surface anchor; and extending the first tension member connected to the first ventricular surface anchor, the second tension member connected to the second ventricular surface anchor, and the third tension member connected to the third ventricular surface anchor toward the first tension anchor; and The first right ventricular surface, the right ventricular surface near the anterior portion of the tricuspid annulus, and the right ventricular surface near the posterior portion of the tricuspid annulus are pulled toward the first tension anchor using the first tension member, the second tension member, the third tension member, and the fourth tension member.

10. The method according to claim 1, wherein: The first right ventricular surface is adjacent to an anterior portion of the tricuspid annulus.

11. The method according to claim 1, wherein: The first right ventricular surface is within the right ventricular outflow tract.

12. The method according to claim 1, wherein: The first right ventricular surface is within the pulmonary artery proximal to the pulmonary valve.

13. The method of claim 1, further comprising anchoring the second tension anchor against a surface of the second tension anchor in the heart with a third tension member; in, The third tension member connects the second tension anchor to the first tension anchor.

14. The method of claim 13, further comprising anchoring the third tension anchor against a surface of the third tension anchor in the heart with a fourth tension member; in, The fourth tension member connects the third tension anchor to the first tension anchor.

15. The method of claim 14, further comprising anchoring the fourth tension anchor against a surface of the fourth tension anchor in the heart with a fifth tension member; in, The fifth tension member connects the fourth tension anchor to the first tension anchor.

16. The method according to claim 1, wherein: Drawing the first right ventricular surface toward the first tension anchor further comprises: advancing a tension lock over the first tension member and the second tension member to a position proximal to the first tension anchor to draw the first right ventricular surface toward the first tension anchor; locking the tension lock to maintain tension on the first tension member and the second tension member; and Excess material of the first tension member and the second tension member is trimmed.

17. The method according to claim 16, wherein: Locking the tensioning lock comprises: The tension lock is adjusted from a first configuration that allows free movement of the tension member relative to the tension lock to a second configuration that prevents free movement of the tension member relative to the tension lock.

18. The method of claim 1, further comprising advancing a grommet over the first tension member connected to the first ventricular surface anchor; in, The grommet is positioned against an atrial surface of the heart opposite the ventricular surface anchor attached to the first tension member.

19. The method of claim 1, further comprising advancing a grommet over the second tension member connected to the first tension anchor; in, The grommet is positioned against a tissue surface opposite the first tension anchor attached to the second tension member.

20. The method according to claim 1, wherein: The first tension member and the second tension member are parts of a single tension element.

21. A method for tricuspid valve repair, comprising: anchoring a first ventricular surface anchor proximate an anterior portion of the tricuspid annulus, wherein the first ventricular surface anchor is connected to a first tension member; anchoring a second ventricular surface anchor proximate the right ventricular surface of the posterior portion of the tricuspid annulus, wherein the second ventricular surface anchor is connected to a second tension member; anchoring a first tension anchor against a left atrial surface of the interatrial septum, wherein the first tension anchor is connected to a third tension member; extending the first tension member connected to the first ventricular surface anchor and the second tension member connected to the second ventricular surface anchor toward the third tension member connected to the first tension anchor; and The anterior portion of the tricuspid annulus and the posterior portion of the tricuspid annulus are drawn toward the first tension anchor using the first tension member, the second tension member, and the third tension member.

22. The method according to claim 21, wherein: The second ventricular surface anchor is located below the foramen ovale.

23. The method of claim 21, further comprising trimming excess material from the first, second, and third tension members.

24. The method of claim 21, further comprising: Drawing the right ventricular surface toward 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 position proximal to the first tension anchor to draw the first ventricular surface anchor and the second ventricular surface anchor toward 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 Excess material is trimmed from the first tension member, the second tension member, and the third tension member.

25. A tricuspid valve repair system, comprising: Two or more surface anchor systems, each surface anchor system comprising: a surface anchor comprising a Nitinol wire frame defined at a perimeter thereof by Nitinol wire, and comprising an internal Nitinol wire feature within an area defined by the perimeter formed by the Nitinol wire frame; wherein when the temperature of the nitinol wire frame is body temperature, the nitinol wire frame comprises an austenitic state in a deployed configuration; a tether assembly connecting two or more surface anchor systems at a tether connection point; and Tether lock.

26. The tricuspid valve repair system according to claim 25, wherein: The two or more surface anchor systems and the tether lock are disposed along the tether assembly.

27. The tricuspid valve repair system according to claim 25, wherein: The surface anchor is capable of rotatable laterally relative to the tether assembly.

28. The tricuspid valve repair system of claim 25, further comprising a grommet and a grommet lock.

29. The tricuspid valve repair system according to claim 28, wherein: The grommet is a flat grommet comprising an expandable nitinol frame; wherein the flat grommet is disposed on the tether assembly through a hole in the flat grommet; and Wherein, when the temperature of the expandable nitinol frame is human body temperature, the expandable nitinol frame of the grommet comprises an austenitic state in a deployed configuration.

30. The tricuspid valve repair system according to claim 29, wherein: The flat grommet additionally includes a covering material that provides a flat surface to the expandable nitinol frame.

31. The tricuspid valve repair system according to claim 28, wherein: The grommet is a T-bar grommet comprising a singular rigid member having a length along a major axis that is longer than a width along a minor axis, wherein the width of the T-bar grommet is configured to accommodate the T-bar grommet within the inner diameter of the delivery catheter; wherein the T-bar grommet is disposed on the tether assembly through a hole at or near the center of the T-bar grommet; and wherein the T-bar grommet is capable of being pivoted about the tether assembly such that the long axis of the T-bar grommet is substantially parallel to the axis of the tether assembly for insertion into the delivery catheter for deployment; and Wherein, after deployment from the delivery catheter, the T-bar grommet is enabled to pivot about the tether assembly such that a longer axis of the T-bar grommet is angled relative to an axis of the tether assembly.

32. The tricuspid valve repair system according to claim 28, wherein: The grommet is a self-expanding grommet that is capable of expanding after deployment to interact with the grommet lock.

33. The tricuspid valve repair system according to claim 28, wherein: the grommet lock comprising a tether hole 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 through the tether hole and the grommet lock tether contact surface; wherein applying a force on 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 a grommet lock deflection node such that a clamping force is generated at the grommet lock tether contact surface and movement of the grommet along the tether assembly away from the surface anchor is prevented; and Wherein, the grommet and the grommet lock are also arranged along the tether assembly.

34. The tricuspid valve repair system according to claim 28, wherein: The grommet lock includes a first unlocked state capable of sliding along the tether assembly and a second locked state capable of not sliding along the tether assembly; Wherein, the second locked state prevents the grommet from translating distally along the tether assembly.

35. The tricuspid valve repair system according to claim 28, wherein: The grommet lock is a knot formed at the tether connection point; wherein the tether assembly is passed through the grommet and then the tether assembly is reattached at the tether connection point such that the knot is proximal to the grommet; and wherein the knot is capable of sliding distally by pushing the knot with a pushing catheter; and Wherein the knot prevents the grommet from sliding proximally along the tether assembly such that the knot prevents the grommet from separating from the surface anchor.

36. The tricuspid valve repair system according to claim 25, wherein: The tether assembly is connected to the surface anchor by looping around an internal feature of a nitinol frame to form a tether loop before reattaching the tether assembly at the tether connection point.

37. The tricuspid valve repair system according to claim 25, wherein: The surface anchor is covered by a surface anchor outer cover.

38. The tricuspid valve repair system according to claim 25, wherein: The Nitinol wire frame of the surface anchor is formed by laser cutting a Nitinol sheet or strip.

39. The tricuspid valve repair system according to claim 25, wherein: The surface anchor is capable of being mechanically compressed to a first, non-deployed state to a size and dimension compatible with a catheter having an inner diameter that is less than a width of the surface anchor in its second, deployed state.

40. The tricuspid valve repair system according to claim 25, wherein: The surface anchor is substantially planar such that the surface anchor length and the surface anchor width are at least 5 times the surface anchor thickness.

41. The tricuspid valve repair system according to claim 39, wherein: Upon release from the surface anchor delivery catheter, the surface anchor transitions from its first, non-deployed state to its second, deployed state.

42. A tricuspid valve repair system, comprising: an anchor system comprising a surface anchor including a nitinol frame and a hole forming an outer perimeter; wherein when the temperature of the nitinol frame is body temperature, the nitinol frame comprises an austenitic state in the deployed configuration; a grommet including a distal tubular portion connected to a proximal finger portion; wherein the proximal finger portion is comprised of a plurality of flexible beams extending radially from the distal tubular portion; a tether for connecting the anchor system, and surface anchor hub; Wherein, the anchor system, the grommet and the surface anchor hub are arranged along the tether.

43. The tricuspid valve repair system according to claim 42, wherein: The distal tubular portion of the grommet includes a central flexible beam oriented radially inwardly toward an inner surface of the grommet's tube.

44. The tricuspid valve repair system according to claim 42, wherein: The grommet includes Nitinol having an Austenitic state in a deployed configuration when the temperature of the grommet is approximately human body temperature.

45. The tricuspid valve repair system according to claim 43, wherein: The surface anchor hub includes: a distal flange, the outer diameter of which is larger than the inner diameter of the hole in the surface anchor; a central shaft, the outer cross-sectional dimension of which is smaller than the inner diameter of the hole in the surface anchor; a proximal nose, the outer diameter of which is 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 central shaft; and a hole passing through the center of the distal flange, and wherein the inner diameter of the hole passing through the center is larger than the outer diameter of the tether.

46. ​​The tricuspid valve repair system according to claim 45, wherein: The grommet can be configured to move 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, wherein the central flexible beam within the distal tubular portion of the grommet is positioned above the mid-axis of the surface anchor hub and the central flexible beam of the distal tubular portion of the grommet contacts the proximal nose such that proximal translation of the grommet relative to the surface anchor hub is limited.

47. The tricuspid valve repair system according to claim 46, wherein: The plurality of flexible beams of the proximal finger portion of the grommet are capable of being mechanically deflected proximally and radially inwardly for insertion into a catheter having an inner diameter that is smaller than the position of the proximal finger portion of the grommet in the deployed configuration.

48. The tricuspid valve repair system according to claim 46, wherein: Deployment of the grommet allows the proximal finger portion of the grommet to transition from its non-deployed configuration to its deployed configuration.

49. The tricuspid valve repair system according to claim 45, wherein: The distal end of the tether is larger than an inner diameter of the hole through the surface anchor hub such that the tether cannot be pulled in a proximal direction through the surface anchor hub.

50. The tricuspid valve repair system according to claim 42, wherein: The surface anchor and the grommet are capable of rotatable laterally relative to the tether.

51. The tricuspid valve repair system according to claim 42, wherein: The surface anchor is capable of being mechanically compressed to a first, non-deployed state to a size and dimension compatible with a catheter having an inner diameter that is less than a width of the surface anchor in its second, deployed state.

52. A method of implanting a tricuspid valve repair system to repair a heart, the tricuspid valve repair system comprising a tether and two or more surface anchor systems, each surface anchor system comprising a surface anchor, a grommet, and a grommet lock, the method comprising: advancing the tricuspid valve repair system toward the heart, positioning a distal end of a catheter containing a surface anchor system adjacent to an implantation surface of the heart; piercing the implantation surface of the heart with the catheter; pushing the surface anchor of the tricuspid valve repair system from the catheter using a pushing catheter located within the catheter; allowing the surface anchor to transition from a non-deployed configuration to a deployed configuration; partially retracting the catheter so that the catheter no longer pierces the implantation surface of the heart; pushing the grommet and the grommet lock of the tricuspid valve repair system from the catheter with the pushing catheter; allowing said grommet to transition from a non-deployed configuration to a deployed configuration; as well as The grommet lock is advanced distally along the tether of the tricuspid valve repair system to a desired distance such that the distance between the surface anchor and the grommet is substantially occupied by the thickness of the implantation surface of the heart.

53. The method of claim 52, wherein: Allowing the surface anchor to transition from the non-deployed configuration to the deployed configuration includes allowing the surface anchor to transition to an austenitic state configured in the deployed configuration.

54. The method of claim 52, wherein: Allowing the grommet to transition from the non-deployed configuration to the deployed configuration includes allowing the grommet to transition to an austenitic state configured in the deployed configuration.

55. The method of claim 52, further comprising trimming excess tethers from the tricuspid valve repair system.

56. A method of implanting a tricuspid valve repair system to repair a heart, the tricuspid valve repair system comprising a tether and two or more surface anchor systems, each surface anchor system comprising a surface anchor, a lockable grommet, and a surface anchor hub, the method comprising: positioning a catheter adjacent to an implantation surface of the heart; piercing the implantation surface of the heart with the catheter; pushing the surface anchor and the surface anchor hub of the tricuspid valve repair system from the catheter using a pushing catheter located within the catheter; allowing the surface anchor to transition from a non-deployed configuration to a deployed configuration; partially retracting the catheter so that the catheter no longer pierces the implantation surface of the heart; pushing the lockable grommet of the tricuspid valve repair system from the catheter with the pushing catheter; allowing said lockable grommet to transition from a non-deployed configuration to a deployed configuration; as well as The lockable bezel is advanced distally along the tether of the tricuspid valve repair system to a desired distance above the surface anchor hub such that the distance between the surface anchor and the lockable bezel is substantially occupied by the thickness of the implantation surface of the heart, and such that the lockable bezel interacts with the surface anchor hub such that the lockable bezel is locked to prevent proximal translation relative to the surface anchor hub.

57. The method of claim 56, wherein: Allowing the surface anchor to transition from the non-deployed configuration to the deployed configuration includes allowing the surface anchor to transition to an austenitic state configured in the deployed configuration.

58. The method of claim 56, wherein: Allowing the lockable grommet to transition from the non-deployed configuration to the deployed configuration includes allowing the lockable grommet to transition to an austenitic state configured in the deployed configuration.

59. A foldable flat implant system for tricuspid valve repair, the foldable flat implant system configured to attach to a septal surface anchor, the foldable flat implant system comprising: a flexible front rod anchor that is non-fixably attached to the delivery catheter; at least one guide wire having a distal tip, the at least one guide wire passing through a hole in the flexible front rod anchor at a rotatable guide wire connection; a front rod tether, the front rod tether comprising at least one tether snare configured to pass through a lumen of a snare catheter; wherein the at least one guide wire is capable of being loosely connected to the at least one tether snare after passing through treatment tissue and being advanced through the flexible front rod anchor; wherein the at least one guide wire is attached to the tether at a proximal end; wherein pulling the at least one guide wire through the flexible front rod anchor via the at least one tether snare causes the tether attached to the proximal end of the at least one guide wire to be pulled through the hole in the flexible front rod anchor; and Wherein, the front rod tether connects the spacing surface anchor and the flexible front rod anchor.

60. A method for implanting a tricuspid valve repair system to repair a patient's heart, the method comprising: advancing a tricuspid valve repair system into a patient, the tricuspid valve repair system comprising a septal surface anchor attached to a septal surface anchor tether and a foldable flat implant system having a flexible anterior stem anchor, at least one guide wire connected at its proximal end to the anterior anchor tether having a plug end, and at least one tether snare within a steerable anterior anchor delivery catheter, installing the septal surface anchor into the left atrium of the heart via a guide wire and a septal surface anchor delivery catheter; inserting the steerable anterior anchor delivery catheter attached to the flexible anterior rod anchor into a guide catheter in a non-deployed configuration and tracking the flexible anterior rod anchor to a distal end of the guide catheter; guiding the guide catheter above the tricuspid valve of the heart; extending the steerable anterior anchor delivery catheter and directing the flexible anterior stem anchor through the tricuspid valve into the right ventricle; deploying the flexible front rod anchor into a deployed configuration; positioning the flexible anterior rod anchor and the distal end of the at least one guide wire adjacent to an anterior anchor implantation region; piercing the anterior anchor implantation region to an opposite side of the anterior anchor implantation region with the distal end of the at least one guide wire; connecting the at least one tether snare to the proximal end of the at least one guide wire; advancing the at least one guide wire through the anterior anchor implantation region and through the flexible anterior rod anchor such that the proximal end of the at least one guide wire passes through the flexible anterior rod anchor and such that the plug end of the anterior anchor tether contacts a distal surface of the flexible anterior rod anchor away from the anterior anchor implantation region; disengaging the flexible front shaft anchor from the steerable front anchor delivery catheter; and The steerable anterior anchor delivery catheter is removed from the patient.

61. The method of claim 60, additionally comprising: positioning the steerable anterior anchor delivery catheter to a secondary location proximate the anterior anchor implantation region such that a tether passing through the secondary location is still able to functionally interact with the flexible anterior shaft anchor; piercing the secondary location with a distal end of a second guide wire to an opposite side of the secondary location, wherein the second guide wire is connected at a proximal end thereof to a second front anchor tether having a plug end; connecting a second tether snare to the proximal end of the second guide wire; and The second guide wire is advanced through the secondary location and through the flexible anterior rod anchor so that the proximal end of the second guide wire passes through the flexible anterior rod anchor and so that the plug end of the second anterior anchor tether contacts a distal surface of the flexible anterior rod anchor away from the anterior anchor implantation area.

62. The method of claim 60, additionally comprising: passing a tether lock over the anterior anchor tether and the spacing surface anchor tether via a lock catheter; tensioning the anterior anchor tether within the right atrium to draw the tricuspid annulus along the right ventricular wall toward the atrial septum and / or the coronary sinus; locking the tether lock to maintain tension on the front anchor tether and the spacing surface anchor tether; trimming excess tether from the front anchor tether and the spacing surface anchor tether; as well as All catheters were removed from the patient.

63. The method of claim 60, wherein: The anterior anchor implantation region is at the right ventricle surface near the anterior tricuspid valve ring; Wherein, the flexible anterior rod anchor spans one centimeter to four centimeters of the surface near the anterior tricuspid annulus.

64. The method of claim 60, wherein: The flexible anterior rod anchor includes an elongated nitinol frame having rigid eyelets attached near each end, a covering, and an anchor rod delivery connector near the center of the elongated nitinol frame.

65. The method of claim 64, wherein: The covering can taper from near the center of the elongated Nitinol frame to an end of the elongated Nitinol frame.

66. The method of claim 60, wherein: The tricuspid valve repair system includes two guide wires and two snare tethers.

67. A guide wire delivery system comprising: 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 sized to enable the stabilizing catheter to pass through the guide catheter lumen; a helical tip at a distal tip of the stabilizing catheter; and A guide wire is sized to pass through the stabilizing catheter lumen.

68. The guide wire delivery system of claim 67, wherein: The helical tip is a laser cut helix having a generally trapezoidal cross-section.

69. The guide wire delivery system of claim 67, wherein: The helical tip is a wound wire helix having a circular cross-section.

70. The guide wire delivery system of claim 67, wherein: The helical shape ends in two intertwined helices.

71. The guide wire delivery system of claim 67, wherein: The helical tip is a tapered winding helix, wherein a radius of curvature of a distal-most end of the helical tip is greater than a radius of curvature of a proximal-most end of the tapered winding helix.

72. The guide wire delivery system of claim 67, wherein: The helical tip is a tapered winding helix, wherein a radius of curvature of a distal-most end of the helical tip is smaller than a radius of curvature of a proximal-most end of the tapered winding helix.

73. A method for passing a guide wire through the surface of a heart, comprising: Advancing a guide wire delivery system toward the heart, the guide wire delivery system comprising: 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 being configured to enable the stabilizing catheter to pass through the guide catheter lumen; a helical tip located at the distal end of the stabilizing catheter; and a guide wire configured to enable it to pass through the stabilizing catheter lumen; positioning the flexible guide catheter at the surface of the heart within the right atrium of the heart; advancing the stabilizing catheter through the flexible guide catheter; positioning the helical tip against the surface of the heart at the distal end of the stabilizing catheter; rotating the helical tip so that the helical tip engages the surface of the heart; and The guide wire is advanced through the stabilization catheter and through the surface of the heart.

74. The method of claim 73, wherein: The surface of the heart through which the guide wire passes is near the anterior tricuspid annulus.

75. The method of claim 73, wherein: The surface of the heart through which the guide wire passes is such that the guide wire passes from the right atrium into the right ventricular outflow tract of the heart.

76. The method of claim 73, further comprising: As the stabilizing catheter is advanced toward the surface of the heart, the helical tip is further rotated so that the distal end of the stabilizing catheter can completely pass through the surface of the heart.

77. A method for tricuspid valve repair, comprising: Advancing a guide wire delivery system toward the heart, the guide wire delivery system comprising: a flexible guide catheter having a guide catheter lumen; a stabilizing catheter having a distal tip located on a distal end of the stabilizing catheter, a stabilizing catheter lumen, and a flexible region, the stabilizing catheter being configured to enable the stabilizing catheter to pass through the guide catheter lumen; a helical tip located at the distal tip of the stabilizing catheter; and a guide wire configured to enable it to pass through the stabilizing catheter lumen; at least three surface anchors prepared for deployment, the at least three surface anchors being covered by a surface anchor outer covering and comprising a Nitinol wire frame defined at its perimeter by Nitinol wire, interior Nitinol wire features within an area defined by the perimeter formed by the Nitinol wire frame, wherein the Nitinol wire frame comprises an austenitic state in a deployed configuration when the temperature of the Nitinol wire frame is body temperature; positioning the flexible guide catheter within the right atrium of the heart, proximal to the anterior tricuspid annulus; advancing the stabilizing catheter through the flexible guide catheter; positioning the helical tip at the distal end of the stabilization catheter against a right atrial surface of the heart, proximal to the anterior tricuspid annulus; rotating the helical tip so that the helical tip engages the right atrial surface of the heart proximate the anterior tricuspid annulus; advancing the guide wire through the stabilization catheter and across the surface of the heart between the right atrium and right ventricle; advancing an anchor delivery catheter over the guide wire from the right atrium into the right ventricle; retracting the guide wire through the anchor delivery catheter; anchoring a first anchor connected to a first tether through the anchor delivery catheter against a surface of the right ventricle near an anterior portion of the tricuspid annulus; retracting the anchor delivery catheter through the flexible guide catheter; positioning the flexible guide catheter within the right atrium of the heart, proximal to the anterior tricuspid annulus, substantially adjacent to the first anchor; advancing the stabilizing catheter through the flexible guide catheter; positioning the helical tip at the distal end of the stabilization catheter against a right atrial surface of the heart, near the anterior tricuspid annulus, adjacent the first anchor; rotating the helical tip so that the helical tip engages the right atrial surface of the heart proximate the anterior tricuspid annulus; advancing the guide wire through the stabilization catheter and through the heart between the right atrium and the right ventricle; advancing the anchor delivery catheter over the guide wire from the right atrium into the right ventricle; retracting the guide wire through the anchor delivery catheter; anchoring a second anchor connected to a second tether through the anchor delivery catheter against a right ventricular surface near an anterior portion of the tricuspid annulus at a distance of 1 cm to 4 cm away 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, proximate the atrial septum; advancing the anchor delivery catheter through the flexible guide catheter; positioning the distal tip of the anchor delivery catheter against the atrial septum beneath the fossa ovalis; advancing the guide wire through the anchor delivery catheter and through the atrial septum of the heart; advancing the anchor delivery catheter over the guide wire from the right atrium into the left atrium of the heart; retracting the guide wire through the anchor delivery catheter; anchoring a third anchor connected to a third tether through the atrial septum of the heart; retracting the anchor delivery catheter through the atrial septum of the heart; passing the first tether, the second tether, and the third tether through a tether lock; advancing the tether lock to a position adjacent the third anchor; pulling the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus using the first tether, the second tether, and the third tether; and The tether lock is actuated to clamp the first, second, and third tethers and fix a distance between the first, second, and third anchors relative to each other.

78. The method of claim 77, further comprising: advancing a grommet distally along a selected tether selected from the first tether, the second tether, or the third tether of the guide wire delivery system; as well as A grommet lock is advanced distally along the selected tether through which the grommet of the guide wire delivery system is passing to a desired distance such that a distance between an anchor connected to the selected tether and the grommet is substantially occupied by a thickness of an implantation surface of the heart.

79. The method of claim 77, further comprising: attaching a fourth surface anchor to the delivery catheter, the fourth surface anchor being covered by a surface anchor outer covering and comprising a Nitinol wire frame defined at its perimeter by Nitinol wire, interior Nitinol wire features within an area defined by the perimeter formed by the Nitinol wire frame, wherein the Nitinol wire frame comprises an austenitic state in a deployed configuration when the temperature of the Nitinol wire frame is body temperature; positioning the flexible guide catheter within the right atrium of the heart, proximal to the anterior tricuspid annulus, substantially adjacent to the second anchor; advancing the stabilizing catheter through the flexible guide catheter; positioning the helical tip at the distal end of the stabilization catheter against a right atrial surface of the heart, near the anterior tricuspid annulus, adjacent the first anchor; rotating the helical tip so that the helical tip engages the right atrial surface of the heart proximate the anterior tricuspid annulus; advancing the guide wire through the stabilization catheter and through the heart between the right atrium and the right ventricle; advancing the anchor delivery catheter over the guide wire from the right atrium into the right ventricle; retracting the guide wire through the anchor delivery catheter; anchoring a fourth anchor connected to a fourth tether through the anchor delivery catheter against a right ventricular surface near an anterior portion of the tricuspid annulus at a distance of 1 cm to 4 cm away from the second anchor; retracting the anchor delivery catheter through the flexible guide catheter; wherein the tether lock is additionally passed over the fourth tether; wherein pulling the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus further comprises the fourth tether; and Wherein, actuating the tether lock further comprises the fourth tether to fix the distances between the first anchor, the second anchor, the third anchor, and the fourth anchor relative to each other.

80. The method of claim 77, wherein: The distal tip of the guide wire is configured to transmit a high frequency current to the distal tip. Therein, the high frequency current reduces the force required to pass through a portion of the heart.

81. A method for tricuspid valve repair, comprising: Advancing a guide wire delivery system toward the heart, the guide wire delivery system comprising: a flexible guide catheter having a guide catheter lumen; a stabilizing catheter having a distal tip located on a distal end of the stabilizing catheter, a stabilizing catheter lumen, and a flexible region, the stabilizing catheter being configured to enable the stabilizing catheter to pass through the guide catheter lumen; a helical tip located at the distal tip of the stabilizing catheter; and a guide wire configured to enable it to pass through the stabilizing catheter lumen; at least two surface anchors prepared for deployment, the at least two surface anchors being covered by a surface anchor outer covering and comprising a nitinol wire frame defined at its perimeter by nitinol wire, interior nitinol wire features within an area defined by the perimeter formed by the nitinol wire frame, wherein the nitinol wire frame comprises an austenitic state in a deployed configuration when the temperature of the nitinol wire frame is body temperature; positioning the flexible guide catheter within the right atrium of the heart, proximal to the anterior tricuspid annulus; advancing the stabilizing catheter through the flexible guide catheter; positioning the helical tip at the distal end of the stabilization catheter against a right atrial surface of the heart, proximal to the anterior tricuspid annulus; rotating the helical tip so that the helical tip engages the right atrial surface of the heart proximate the anterior tricuspid annulus; advancing the guide wire through the stabilization catheter and across the surface of the heart between the right atrium and right ventricle; advancing an anchor delivery catheter over the guide wire from the right atrium into the right ventricle; retracting the guide wire through the anchor delivery catheter; anchoring a first anchor connected to a first tether through the anchor delivery catheter against a surface of the right ventricle near an anterior portion of the tricuspid annulus; retracting the anchor delivery catheter through the flexible guide catheter; positioning the flexible guide catheter within the right atrium of the heart, proximate the atrial septum; positioning the distal tip of the anchor delivery catheter against the atrial septum beneath the fossa ovalis; advancing the guide wire through the anchor delivery catheter and through the atrial septum of the heart; advancing the anchor delivery catheter over the guide wire from the right atrium into the left atrium of the heart; retracting the guide wire through the anchor delivery catheter; anchoring 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 the first tether and the second tether through a tether lock; advancing the tether lock to a position adjacent the second anchor; pulling the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus using the first tether and the second tether; and The tether lock is actuated to clamp the first tether and the second tether and fix a distance between the first anchor and the second anchor relative to each other.

82. A guide wire delivery system, comprising: a dilator having an inner lumen and an inner lumen shoulder; and a helical guide wire positioned within the inner lumen, wherein the helical guide wire abuts the inner lumen shoulder, the inner lumen shoulder preventing the helical guide wire from axially moving through the dilator, wherein the spiral guide wire is capable of rotating within the inner lumen; and Wherein, the helical guide wire has a helical guide wire portion at a distal guide wire end that can be fixedly attached to the helical guide wire.

83. A method for passing a guide wire through the surface of a heart, comprising: advancing a guide wire delivery system within the heart, the guide wire delivery system comprising: a stabilizing catheter having an inner lumen having an inner lumen shoulder; and a helical guide wire abutting the inner lumen shoulder and rotatable within the inner lumen of the stabilizing catheter, wherein the helical guide wire has a helical guide wire portion at a distal guide wire end that is fixably attached to the helical guide wire; positioning the guide wire delivery system within the right atrium of the heart; positioning the helical guide wire against the surface of the heart; rotating the helical guide wire so that the helical guide wire engages the surface of the heart; and The guide wire and the stabilizing catheter are advanced through the surface of the heart.

84. A lock for use in a tricuspid valve repair system, comprising: a lock housing having a through hole configured to receive at least two tension members passing through the lock housing; as well as an adjustable lock tensioner configured to move within the lock housing; wherein the adjustable lock tensioner is capable of contracting the at least two tension members when the at least two tension members pass through the lock housing; and The lock is adapted to be adapted to move from a first configuration that allows the tension member to move freely relative to the lock to a second configuration that prevents the tension member from moving freely relative to the lock.

85. A method of manufacturing a surface anchor, comprising: activating a laser configured to cut through a sheet of nitinol having an area and a thickness configured to accommodate at least a final size of the surface anchor; and displacing the Nitinol sheet relative to the laser along a contour within the Nitinol sheet; wherein the contour cut from the Nitinol sheet is substantially similar to the final shape of the surface anchor.

86. A method for tricuspid valve repair, comprising: anchoring a first anchor against a surface of the right ventricle proximal to an anterior portion of the tricuspid annulus; extending a tension member from the first anchor toward a right atrial surface of the atrial septum; as well as The anterior portion of the tricuspid annulus is drawn toward the posterior septal portion of the tricuspid annulus using the tension member.

87. The method of claim 86, wherein: Drawing the anterior portion of the tricuspid annulus toward the posterior septal portion of the tricuspid annulus includes advancing a lock coupled to the tension member toward the right atrial surface of the interatrial septum.

88. The method of claim 86, comprising placing a left atrial anchoring element against a left atrial surface of the atrial septum, and coupling the first anchor and the left atrial anchoring element to each other with the tension member.

89. The method of claim 86, further comprising: anchoring a second anchor against a right ventricular surface of the anterior portion of the tricuspid annulus; extending a second tension member from the second anchor toward the right atrial surface of the atrial septum; as well as The anterior portion of the tricuspid annulus is drawn toward the posterior septal portion of the tricuspid annulus using the second tension member.

90. A tricuspid valve repair system comprising one or more of the features described above.

91. A method of tricuspid valve repair comprising implanting one or more features of the tricuspid valve repair system described above into the heart of a patient.

92. A method of passing a guide wire through tissue in a body, comprising: tightening a stabilizing catheter having a spiral wire on the distal end into the tissue; passing the guide wire through the stabilizing catheter; as well as The stabilizing catheter is used to support the guide wire while fully threading the guide wire through the tissue.

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