Methods and devices for mitral valve chordae repair

Abstract

Methods and devices for transvascular prosthesis chordae implantation are disclosed. The catheter is advanced to the left atrium. The catheter may be anchored from the atrial side to the upper surface of the mitral leaflet and the leaflet anchor may be advanced into the mitral leaflet to secure the mitral leaflet to the leaflet suture. A ventricular anchor is secured to a wall of a ventricle to secure the ventricular wall to a ventricular suture. The leaflet suture and the ventricular suture may be tensioned and joined by a suture lock to form a prosthetic chordae.

Description

[0001] This application is a divisional application of application number 201980088765.6, filed July 12, 2021, entitled “Methods and Devices for Mitral Chordal Repair,” which claims priority to U.S. Provisional Application No. 62 / 778,662, filed December 12, 2018, U.S. Provisional Application No. 62 / 778,624, filed December 12, 2018, U.S. Provisional Application No. 62 / 875,265, filed July 17, 2019, U.S. Provisional Application No. 62 / 897,207, filed September 6, 2019, U.S. Provisional Application No. 62 / 897,809, filed September 9, 2019, and U.S. Provisional Application No. 62 / 905,267, filed September 24, 2019, the entire contents of each of which are incorporated herein by reference for all purposes.

[0002] Cross Reference to Related Applications

[0003] This application is a continuation-in-part of U.S. Patent Application No. 16 / 297,422, filed March 8, 2019, which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 62 / 641,612, filed March 12, 2018, and is a continuation-in-part of U.S. Provisional Application No. 15 / 858,671, filed December 29, 2017, which is a continuation-in-part of U.S. Application 15 / 638,176, filed June 29, 2017, now U.S. Patent No. 9,877,833, which claims priority to U.S. Provisional Application 62 / 441,031, filed December 30, 2016, the entire contents of each of which are incorporated herein by reference for all purposes.

[0004] This application also claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62 / 778,662, filed December 12, 2018, U.S. Provisional Application No. 62 / 778,624, filed December 12, 2018, U.S. Provisional Application No. 62 / 875,265, filed July 17, 2019, U.S. Provisional Application No. 62 / 897,207, filed September 6, 2019, U.S. Provisional Application No. 62 / 897,809, filed September 9, 2019, and U.S. Provisional Application No. 62 / 905,267, filed September 24, 2019, the entire contents of each of which are incorporated herein by reference for all purposes.

[0005] Any and all applications for which priority is claimed under 37 CFR 1.57 are BACKGROUND

[0006] The present disclosure relates to mitral valve repair or replacement, and more generally to methods and devices for mitral valve remodeling, repair, and / or replacement of mitral valve chordae tendinae to restore normal function of the mitral valve from a mitral regurgitation state.

[0007] Description of the Related Art

[0008] The heart consists of four valves that allow blood to flow in one direction through the heart's four chambers. The four valves are the tricuspid valve, mitral valve, pulmonary valve, and aortic valve. The four chambers are the left and right atria (upper ventricles) and the left and right ventricles (lower ventricles).

[0009] The mitral valve is formed by two leaflets, called the anterior and posterior leaflets, which open and close in response to the pressure exerted on them by the heart's pumping action. The mitral valve can develop or experience a variety of problems. Such problems include mitral regurgitation (MR), in which the mitral valve leaflets fail to close properly, leading to leakage from the mitral valve. Severe mitral regurgitation can adversely affect heart function and compromise a patient's quality of life and lifespan.

[0010] Several techniques have been developed to correct mitral regurgitation. These techniques include heart transplantation, valve replacement or repair, chordae tendineae shortening or replacement, and mitral annulus repair, also known as annulus plasty, depending on the stage and underlying cause.

[0011] Because this involves chordae tendineae replacement or repair, certain surgical and transapical approaches have been proposed. However, despite these efforts, a transvascular approach for chordae tendineae replacement or repair is still needed to reduce or eliminate MR (metastatic muscular atrophy). Summary of the Invention

[0012] One aspect of this disclosure includes an endovascular deployment catheter for deploying an implantable device, the endovascular deployment catheter comprising: an elongated, flexible tubular body having a proximal end, a distal end, and a central lumen; a sheath located at the distal end of the tubular body having sidewalls defining a chamber for removably receiving the implantable device; and at least one radially extending first engagement element located on the sidewall and exposed to the chamber for engaging a complementary second engagement element on the implantable device.

[0013] Another aspect of this disclosure includes a ventricular tissue anchor delivery system comprising: an elongated, flexible tubular body having a proximal end, a distal end, and a central lumen; a sheath located on the distal end of the tubular body having sidewalls defining a chamber; a ventricular tissue anchor removably positioned within the chamber, the tissue anchor including a hub and a helical tissue anchor; at least one radially extending first engagement element located on the sidewall and exposed to the chamber for engaging the helical tissue anchor; wherein rotation of the helical tissue anchor relative to the tubular body propels the helical tissue anchor distally outside the chamber.

[0014] According to another aspect of this disclosure, a method for deploying an implant from a deployment catheter via a delivery catheter, wherein the outer diameter of the implant is larger than the outer diameter of the delivery catheter, the method may include the steps of: deploying the implant from a retractable sheath at the distal end of the deployment catheter; retracting the deployment catheter proximally into the delivery catheter; and retracting the sheath in response to retracting the deployment catheter proximally into the delivery catheter.

[0015] Another aspect of this disclosure includes an intravascular suture cutter for cutting sutures, the cutter comprising: a cutter housing defining a suture path extending therethrough; and a cutter head rotatably positioned within the cutter housing, the cutter head including a cutting edge, wherein rotation of the cutter head within the cutter housing causes the cutting edge to pass through the suture path to cut the suture extending along the suture path.

[0016] Another aspect of this disclosure includes a method for cutting a suture, the method comprising the steps of: advancing the suture through a suture path extending through a cutter housing; and rotating a cutter head within the cutter housing such that a cutting edge on the cutter head passes through the suture path, thereby cutting the suture extending along the suture path.

[0017] Another aspect of this disclosure includes a leaflet anchor comprising: gauze having a first end, a second end, and a plurality of holes positioned between the first end and the second end; a suture having a distal end and a tail end; the distal end of the suture being connected to and extending from the second end of the gauze; and a radiopaque marker; wherein the tail end of the suture has extended through the plurality of holes such that the suture extends through the openings in the gauze, and when the gauze is pressed against the leaflet as the suture retracts through the leaflet, the leaflet anchor can be expanded from a reduced first cross-section for propulsion through the leaflet to an enlarged second cross-section for contact with the atrial side of the leaflet.

[0018] Another aspect of this disclosure includes a leaflet anchor deployment assembly comprising: a catheter; a hollow needle positioned within the catheter and configured to advance outside the catheter to puncture the leaflet of the mitral valve of the heart, the hollow needle having a leaflet anchor positioned within the needle, the hollow needle including a pointed end for puncturing the leaflet and a flexible portion near the tip of the pointed end; and a leaflet suture connected to the leaflet anchor extending proximally through the catheter.

[0019] Another aspect of this disclosure includes a system for deploying a leaflet anchor, the system comprising: a catheter; a needle positioned within the catheter and configured to advance outside the catheter to puncture the leaflet of the mitral valve of the heart; a leaflet anchor; a leaflet suture coupled to the leaflet anchor extending proximally through the catheter; and an energy storage device for advancing the needle with sufficient force to puncture the leaflet with the needle.

[0020] One aspect of this disclosure includes a method for transvascular prosthetic chordae tendineae implantation, the method comprising the steps of: advancing a catheter into the left atrium, through the mitral valve, and into the left ventricle; deploying a ventricular anchor from the catheter and into the wall of the left ventricle, such that a ventricular suture is attached to the ventricular anchor and extends proximally through the catheter; advancing a leaflet anchor from the atrial side through the upper surface of the mitral valve leaflet to position the leaflet anchor against the lower (ventricular) side of the leaflet, wherein the leaflet suture extends proximally through the leaflet, into and through the catheter; and securing the leaflet suture at the top of the leaflet engagement edge to the ventricular suture to limit the range of travel of the leaflet in the direction of the left atrium.

[0021] Another aspect of this disclosure is a leaflet anchor deployment system comprising: a catheter having a proximal end and a distal end; a leaflet anchor positioned on the distal end of the catheter; and a needle advanceable through the leaflet anchor, the needle releasably carrying a radially expandable leaflet anchor preloaded in the needle and having a suture extending proximally through the catheter.

[0022] According to another aspect of this disclosure, a method for transvascular prosthetic chordae tendineae implantation is provided. The method includes the following steps: advancing a catheter into the left atrium, through the mitral valve, and into the left ventricle; deploying a ventricular anchor from the catheter and into the wall of the left ventricle; attaching a ventricular suture to the ventricular anchor and extending proximally through the catheter; securing the leaflet anchor catheter to the mitral valve leaflet from the atrial side; with the leaflet anchor catheter secured to the leaflet, advancing the leaflet anchor from the catheter through the mitral valve leaflet to secure the mitral valve leaflet to the leaflet suture, wherein the leaflet suture extends proximally through the catheter; and securing the leaflet suture to the ventricular suture to limit the range of travel of the leaflet in the direction of the left atrium.

[0023] The step of advancing a leaflet anchor from a catheter through the mitral valve leaflet to secure the mitral valve leaflet to the leaflet suture may include advancing a needle preloaded with the leaflet anchor through the upper surface of the mitral valve leaflet. The step of securing the leaflet anchor catheter to the mitral valve leaflet may include using a leaflet connector. The leaflet connector may include a helical anchor or a tissue hook.

[0024] According to another aspect of this disclosure, a method for securing a leaflet anchor to a mitral valve leaflet is provided. The method includes the steps of: advancing a catheter into the left atrium; securing a leaflet connector coupled to the catheter from the atrial side to the mitral valve leaflet from the atrial side; and, after securing the leaflet connector to the mitral valve leaflet, advancing the leaflet anchor through the mitral valve leaflet to secure the mitral valve leaflet to the leaflet suture.

[0025] The step of advancing a leaflet anchor through the mitral valve leaflet to secure it to the leaflet suture may include advancing a needle preloaded with the leaflet anchor through the mitral valve leaflet from the atrial side. The needle may be advanced through the leaflet connector. The leaflet connector may include a helical anchor.

[0026] According to another aspect of this disclosure, a leaflet anchor deployment system is provided. The system includes: a catheter having a proximal end and a distal end; a leaflet connector located at the distal end of the catheter; and a needle advanceable through the leaflet connector, the needle including a radially expandable leaflet anchor pre-loaded therein and having a suture extending proximally through the catheter. The leaflet connector may include a helical anchor.

[0027] According to another aspect of this disclosure, a novel chordae tendineae deployment system is provided. The system includes: a catheter having a proximal end and a distal end; a helical ventricular anchor subassembly extending through the catheter, the helical ventricular anchor subassembly having a ventricular suture extending proximally through the catheter; and a leaflet anchor deployment subassembly extending through the catheter, the subassembly having a radially expandable leaflet anchor located within the subassembly and having a leaflet suture extending proximally through the catheter.

[0028] The radially expandable leaflet anchor may include gauze. The gauze can be transformed from an elongated strip configuration to a radially expanded, axially shortened configuration by proximal retraction of the suture. The radially expandable leaflet anchor may include a leaflet suture located between two pieces of material. The radially expandable leaflet anchor may be carried within a needle with a tip for piercing the leaflet. The leaflet anchor deployment subassembly may include an elongated tube having a distal and a central lumen, and a leaflet connector located at the distal end. The leaflet connector may include a helical leaflet anchor. The needle may be axially movable relative to the helical leaflet anchor. The system may also include a suture locking subassembly, which is advanceable through the catheter and configured to connect the ventricular suture to the leaflet suture.

[0029] According to another aspect of this disclosure, a leaflet anchor delivery subsystem is provided. The subsystem includes: an elongated, flexible tubular body having a proximal end, a distal end, and a central lumen; a deployment pin axially movable through the central lumen; a leaflet anchor carried within the deployment pin; and a leaflet connector carried by the distal end of the tubular body. The leaflet anchor may include a helical element. The deployment pin may extend axially through the helical element.

[0030] According to another aspect of this disclosure, a tissue anchor is provided. The tissue anchor includes: a hub; a suture extending proximally from the hub; a helical anchor extending distally from the hub; and a core wire concentrically extending through the helical anchor and beyond its distal end.

[0031] The tissue anchor may also include a suture anchoring guide extending proximally from the hub. The tissue anchor may also include a tubular sleeve, the length of which does not exceed about 10 cm and extends proximally from the hub. The tissue anchor may also include a radiopaque marker carried by the sleeve. The tissue anchor may also include a radiopaque marker carried by a core wire in an axially movable manner. The tissue anchor may also include a spring carried by the core wire. The tissue anchor may also include a tissue puncture point located at the distal end of the helical anchor, and barbs located on the helical anchor and configured to prevent the helical anchor from rotating out of engagement with the tissue.

[0032] According to another aspect of this disclosure, a tissue anchor with a dynamic depth indicator is provided. The tissue anchor includes: a hub; a tissue anchor extending distally from the hub; a core wire extending distally from the hub; a radiopaque marker movably carried by the hub; and a spring for biasing the radiopaque marker distally; wherein the radiopaque marker is proximal to the tissue anchor in response to the tissue anchor advancing into the tissue.

[0033] According to another aspect of this disclosure, an intravascular suture lock is provided. The suture lock includes: a body having a suture path extending therethrough; a movable wall located within a housing to reduce the cross-sectional size of the suture path; a rotatable coupling located on the housing; and a drive mechanism for advancing the movable wall in response to rotation of the coupling.

[0034] The suture lock may additionally include a friction-enhancing surface exposed to the suture path. The friction-enhancing surface may be on the movable wall. The suture lock may include a push wedge having an inclined surface and being axially movable within the housing. Rotation of the coupling may axially advance the push wedge, causing the movable wall to laterally advance to change the cross-sectional dimensions of the suture path. The movable wall may include a suture clamping surface on a first side and an inclined surface on a second side, the inclined surface being configured to slide in contact with the inclined surface of the push wedge.

[0035] According to another aspect of this disclosure, a stabilization system for transvascular cardiac repair may include: a base; a distal docking platform supported by the base in an axially movable manner; a proximal docking platform supported by the base in an axially movable manner; and an intermediate docking platform supported by the base in an axially movable manner.

[0036] According to another aspect of this disclosure, a suture management system for transvascular cardiac repair includes an anchoring tension member that may include a tension member that includes a clutch for limiting the tension of a suture that may be applied to a spool.

[0037] According to another aspect of this disclosure, the transvascular cardiac repair system may include: a base; a distal docking platform carried by the base; an entry sheath connected to the distal docking platform; a proximal docking platform carried by the base; a rotatable spool carried by the proximal docking platform; and a first suture extending from the entry sheath, through the entry sheath, and to the spool.

[0038] According to another aspect of this disclosure, the dynamic leaflet management system may include: a base; a distal docking platform carried by the base; an entry sheath connected to the distal docking platform; a proximal docking platform carried by the base; a first suture guide located on the proximal docking platform; a first leaflet suture extending proximally out of the entry sheath and passing through the first suture guide; and a weight connected proximally to the first suture guide to the first leaflet suture.

[0039] A method for synchronizing the deployment of a tissue anchoring needle with a cardiac cycle includes the steps of: monitoring physiological parameters of the cardiac cycle; creating a time signal correlated with the time of peak pressure in the left ventricle; issuing a control signal to an actuator in response to the time signal; and deploying the needle during the peak pressure in response to actuation of the actuator. Physiological parameters may include pulse, peripheral pulse, ECG signal, and especially QRS complex. Physiological parameters may include blood pressure. Physiological parameters may be acquired percutaneously or via an intravascular sensor. The sensor may include a pressure sensor.

[0040] The actuator may include a force-driven anchor driver. Alternatively, the actuator may include a locking device that prevents the pin from being deployed until the actuator is actuated to disengage the locking device.

[0041] According to another aspect of this disclosure, a cardiac synchronized leaflet anchor deployment system is provided. The system includes: a delivery catheter; a needle carried by the delivery catheter in an axially reciprocating manner; a needle driver configured to advance the needle from a first position within the catheter to a second position extending beyond the catheter; an actuator; a connector for electrical connection to a cardiac cycle data source; and control circuitry. The control circuitry can be configured to activate the actuator in response to detection of a predetermined point in the cardiac cycle.

[0042] In one embodiment, the actuator activates a needle driver to advance the needle distally. The system may also include a locking device that, when enabled, prevents the clinician from advancing the needle distally, wherein the actuator disables the locking device to allow the clinician to advance the needle distally.

[0043] The needle actuator can be spring-loaded, electromagnetically driven, hydraulically driven, pneumatically driven, or manually driven by a clinician. In one embodiment, the system is provided with a manual control device to allow the clinician to manually activate the needle actuator.

[0044] The needle may be provided with at least one retaining element to prevent the needle from retracting proximally from the target tissue. The retaining element may include a radially outwardly extending tissue engagement surface to prevent the needle from retracting proximally from the leaflet. One particular retaining element includes a helical line surrounding the needle. The helical line may include a wire spirally wound around the needle, which may be soldered to the outside of the needle.

[0045] According to another aspect of this disclosure, a leaflet anchor deployment system is provided. The system includes: a delivery catheter; a needle carried by the delivery catheter in an axially reciprocating manner; a tissue retention structure carried by the needle; and a tissue anchor carried within the needle. The tissue retention structure may include a radially outwardly extending flange, which may be a helical flange and may include a thread helically wound around the needle. The leaflet anchor deployment system may also include a deflection zone. The deflection zone may include a grooved sidewall of the needle. Gauze may be carried within the needle, for example, within the deflection zone. The deflection zone may be entirely located within 6 cm, 4 cm, or 2 cm distal to the needle.

[0046] One aspect of this disclosure may include a tissue anchor, comprising: a hub, a suture extending proximally from the hub, a helical anchor extending distally from the hub, and a secondary anchor, the secondary anchor being axially movable in the distal direction from a first configuration to an auxiliary anchor to a second deployment configuration to engage the tissue and inhibit loosening of the helical anchor.

[0047] Another aspect of this disclosure may include a novel chordae tendineae deployment system comprising a catheter having proximal and distal ends. A ventricular anchor subassembly may extend through the catheter and may have a ventricular suture extending proximally through the catheter. The ventricular anchor subassembly includes a helical tissue anchor and a secondary tissue anchor, the secondary tissue anchor being axially movable in a distal direction from a first configuration to a second deployment configuration to engage tissue and inhibit loosening of the helical tissue anchor. A leaflet anchor deployment subassembly may extend through the catheter and has a radially expandable leaflet anchor located within the subassembly and a leaflet suture extending proximally through the catheter.

[0048] Another aspect of this disclosure is a method for transvascular prosthetic chordae tendineae implantation, which may include the following steps: advancing a catheter into the left atrium, through the mitral valve, and into the left ventricle; deploying a ventricular anchor from the catheter and into the wall of the left ventricle by rotating a helical tissue anchor into the wall of the left ventricle; deploying a secondary tissue anchor into the wall of the left ventricle to inhibit loosening of the helical tissue anchor; attaching a ventricular suture to the ventricular anchor and extending proximally through the catheter; securing the leaflet anchor catheter to the mitral valve leaflet from the atrial side; with the leaflet anchor catheter secured to the leaflet, advancing the leaflet anchor from the catheter through the mitral valve leaflet to secure the mitral valve leaflet to the leaflet suture, wherein the leaflet suture extends proximally through the catheter; and securing the leaflet suture to the ventricular suture to limit the range of travel of the leaflet in the direction of the left atrium.

[0049] According to a first aspect of this disclosure, a system for transcatheter mitral valve chordae tendineae repair includes: an anchor configured to connect to ventricular tissue in the left ventricle of the heart; a suture configured to connect to the leaflets of the mitral valve of the heart; a suture lock having a distal aperture and a proximal aperture separated along a longitudinal axis, the suture lock being configured to allow the suture to pass through the suture lock between the distal aperture and the proximal aperture; and a port configured to connect to the anchor and receive the suture lock, the port being configured to retain the suture lock relative to the anchor, wherein a distal portion of the suture extends through the suture lock in a direction substantially parallel to the longitudinal axis of the suture lock, and a proximal portion of the suture extends between the port and the suture lock in a direction substantially parallel to the longitudinal axis of the suture lock. In some variations of the first embodiment, the port is configured to restrict movement of the suture relative to the suture lock.

[0050] In some variations of the first aspect, the inlet is configured to hold the suture lock relative to the anchor, enabling one-to-one or near-one-to-one movement of the suture. In some variations of the first aspect, the inlet and the suture lock hold the suture between the inner surface of the inlet and the outer surface of the suture lock, allowing the proximal portion of the suture outside the inlet to be cut without causing a movement of more than 5 / 1000 inch in the suture lock. In some variations of the first aspect, the inlet and the suture lock hold the suture between the inner surface of the inlet and the outer surface of the suture lock, maintaining tension on the distal portion of the suture near the leaflet when tension on the proximal portion of the suture outside the inlet is absent or reduced.

[0051] In some variations of the first aspect, the suture is a first suture attached to the first leaflet, and the system further includes at least a second suture attached to the first leaflet, wherein the tension of the first suture between the suture lock and the first leaflet is adjustable, and the tension of at least one second suture is also adjustable. In an alternative embodiment, at least one additional suture may be attached to the second leaflet of the mitral valve without substantially altering the tension of the first suture and the at least one second suture between the suture lock and the first leaflet.

[0052] In some variations of the first aspect, the inlet is configured to facilitate tissue encapsulation or inward growth. In some variations of the first aspect, the suture lock includes a tapered nose. In some variations of the first aspect, the inlet includes a bushing configured to contact the tapered nose when the suture lock is inserted into the inlet. In some variations of the first aspect, the inlet is formed of a material configured to reduce suture abrasion. In some variations of the first aspect, the proximal portion of the inlet has a tapered surface to facilitate suture lock entry into the inlet. In some variations of the first aspect, the inner surface of the inlet and the outer surface of the suture lock are configured to apply a retaining force against forces exerted on the suture by the leaflets.

[0053] In some variations of the first aspect, the suture lock is radiopaque, and the inlet includes a radiopaque element located near the proximal surface of the suture lock. Alternatively, the inlet may be at least partially or completely radiopaque. In some variations of the first aspect, the inlet includes a support coil. In some variations of the first aspect, the inlet is radially compliant to allow the suture lock to enter the inlet while providing restraint. In some variations of the first aspect, the suture is configured to produce a prosthetic chordae tendineae that retains function for at least 400 million cycles. In some variations of the first aspect, the suture is a first suture, and the system includes an anchoring suture configured to attach to an anchor and pass through the inlet and the suture lock and facilitate the guidance of the suture lock into the inlet.

[0054] In some variations of the first aspect, a portion of the insertion port is configured to retain the suture lock with a displacement force ranging from 0 N to approximately 10 N. In some variations of the first aspect, a portion of the insertion port is configured to retain the suture lock with a displacement force ranging from 0 N to approximately 6 N. In some variations of the first aspect, a portion of the insertion port is configured to retain the suture lock with a displacement force ranging from 0 N to approximately 4 N.

[0055] In some variations of the first aspect, the suture is configured to extend from the proximal opening of the suture lock and wrap around the nose of the suture lock when the suture lock is in the insertion port, and the nose has a generally circular profile to reduce suture abrasion.

[0056] In some variations of the first aspect, when the suture lock is located in the indentation, the indentation helps to maintain the longitudinal orientation of the suture lock within a range of approximately 15 degrees or less of the line drawn between the suture lock and the leaflet, or of the longitudinal orientation. In some variations of the first aspect, the suture lock can be inserted into and removed from the indentation.

[0057] In a second aspect, a system for forming a prosthetic chordae tendineae for transcatheter mitral valve repair includes: a suture lock configured to engage with a suture connected to a mitral valve leaflet; and an anchor configured to connect with ventricular tissue, the anchor including a retaining member configured to engage with the suture lock such that the suture lock maintains a positional relationship with the anchor.

[0058] In some variations of the second aspect, the retaining member is configured to engage with the suture lock to restrict movement of the suture lock relative to the anchor during the cardiac cycle. In some variations of the second aspect, the retaining member is configured to engage with the outer surface of the suture lock located between the proximal and distal ends of the suture lock. Alternatively, the retaining member may at least partially engage or engage with at least a portion of the inner surface of the suture lock. In some variations of the second aspect, the retaining member includes a socket configured to engage with the suture lock. The socket may be configured to be radially compliant to allow the suture lock to enter and engage with the socket.

[0059] In some variations of the second aspect, the retaining member is configured to selectively engage and disengage with the suture lock. In some variations of the second aspect, the retaining member is configured to maintain engagement with the suture lock by a displacement force of up to approximately 3 N. In some variations of the second aspect, the retaining member is configured to maintain engagement with the suture lock by a displacement force of at most approximately 1.5 N.

[0060] In some variations of the second aspect, the retaining member is configured to be at least partially connected to the suture lock via an interference fit.

[0061] In a third aspect, a system for a prosthetic chordae tendineae for transcatheter mitral valve repair includes: a suture configured to connect to the leaflets of the mitral valve of the heart; a suture lock configured to engage the suture; and an anchor configured to connect to tissue beneath the mitral valve, the anchor and the suture connected to the leaflets defining a generally longitudinal direction and including a limiting member configured to limit movement of the suture lock relative to the anchor in a direction orthogonal to the longitudinal direction.

[0062] In some variations of the third aspect, the limiting member is configured to restrict movement of the suture lock relative to the anchor in a plane perpendicular to the longitudinal direction. The limiting member can also be configured to restrict movement of the suture lock relative to the anchor along the longitudinal direction. In some variations of the third aspect, the suture lock defines the longitudinal direction, and the limiting member is configured such that the longitudinal direction defined by the anchor is substantially aligned with the longitudinal direction defined by the suture lock. In some variations of the third aspect, the limiting member is configured to contact the suture lock at at least two locations to restrict movement of the suture lock relative to the anchor. In some variations of the third aspect, the limiting member is configured to contact the outer surface of the suture lock at three or more points to restrict movement of the suture lock relative to the anchor.

[0063] In some variations of the third aspect, the limiting member is configured to contact the proximal surface of the suture lock to limit the movement of the suture lock relative to the anchor.

[0064] In a fourth aspect, a system for transcatheter chordae tendineae repair of the mitral valve includes: an anchor configured to connect to ventricular tissue beneath the mitral valve, the anchor including a retaining member; and a suture lock configured to realize a prosthetic chordae tendineae of the mitral valve by connecting the leaflets of the mitral valve to the anchor via a suture, the suture lock being configured to connect to the retaining member of the anchor, whereby at least some displacement force is transmitted from the suture lock to the anchor.

[0065] In some variations of the fourth aspect, the suture lock is configured to transmit displacement forces to the retaining member, with displacement forces ranging up to approximately 3 N. In some aspects of the fourth embodiment, the retaining member is configured to disengage from the suture lock in response to forces exceeding approximately 6 N. In some variations of the fourth aspect, the prosthetic chordae tendineae retain function for at least 400 million cycles.

[0066] In some variations of the fourth aspect, the suture lock extends in a longitudinal direction and includes a peripheral surface extending between a distal surface and a proximal surface, and the peripheral surface includes a longitudinally extending portion configured to connect with a retaining member.

[0067] In a fifth aspect, a system for transcatheter mitral valve chordae tendineae repair includes: a suture configured to connect with the leaflets of the mitral valve; an anchor configured to connect with ventricular tissue beneath the mitral valve; and a suture lock configured to engage with the suture and connect with a retaining member of the anchor to restrict angular movement of the suture relative to the suture lock.

[0068] In some variations of the fifth aspect, the suture lock is configured to engage with a retaining member of the anchor to limit angular movement of the suture relative to the longitudinal direction defined by the suture lock. In some variations of the fifth aspect, the suture is configured to slide relative to the suture lock after the retaining member is engaged with it. In some variations of the fifth embodiment, the suture lock includes an internal locking member configured to engage with the suture.

[0069] In some variations of the fifth aspect, the retaining member is configured to engage the suture in a manner that combines with a suture lock. The retaining member and the suture lock may also be configured to engage a portion of the suture adjacent to the interface between the retaining member and the suture lock. Anchors may define a longitudinal direction, and portions of the suture between adjacent interfaces of the retaining member and the suture lock may extend in a direction substantially parallel to the longitudinal direction.

[0070] In some variations of the fifth aspect, the anchor defines a longitudinal direction and the retaining member is configured to orient the suture lock such that a line extending parallel to the longitudinal direction from the suture lock intersects the leaflets of the mitral valve. In some variations of the fifth aspect, the suture is at least a first suture connected to the first leaflet of the mitral valve, and the system further includes at least a second suture configured to connect to the second leaflet of the mitral valve, and the suture lock is configured to engage the second suture and connect with the retaining member of the anchor to limit angular movement of the second suture relative to the suture lock. The suture lock may be configured to connect with the retaining member of the anchor to limit angular movement of the second suture relative to the longitudinal direction defined by the suture lock.

[0071] In a sixth aspect, a system for prosthetic chordae tendineae repair of a transcatheter mitral valve includes: a suture configured to connect with a mitral valve leaflet; a suture lock configured to engage the suture, the suture lock being oriented in a longitudinal direction; and an anchor configured to connect with ventricular tissue beneath the mitral valve and the suture lock via an anchoring suture, the anchor including a retaining member configured to connect with the suture lock to limit variations in the orientation angle of the suture lock relative to the longitudinal direction to less than 90°.

[0072] In some variations of the sixth aspect, the retaining member is configured to engage with the suture lock such that the angular change of the suture during movement within the cardiac cycle is less than approximately 10°. In some variations of the sixth aspect, the retaining member is configured to engage with the suture lock such that the angular change of the suture during movement within the cardiac cycle is less than approximately 5°. In some variations of the sixth aspect, the retaining member is a spigot.

[0073] In some variations of the sixth aspect, the suture is a first suture and the mitral valve leaflet is a first mitral valve leaflet. The system also includes a second suture configured to connect with the second mitral valve leaflet, and a retaining member is configured to engage with a suture lock to limit the variation of the angle formed between the second suture extending from the suture lock toward the second mitral valve leaflet and the longitudinal direction of the suture lock to less than 90°. The retaining member may be configured to engage with the suture lock such that the variation of the angle formed by the second suture extending from the suture lock toward the second mitral valve leaflet and the longitudinal direction of the suture lock during the movement of the second suture during the cardiac cycle is less than about 5°.

[0074] In a seventh aspect, a system for prosthetic chordae tendineae repair via transcatheter mitral valve repair includes: a suture configured to connect with the mitral valve leaflets; a suture lock configured to engage the suture, the suture lock extending in a longitudinal direction; and an anchor configured to connect with tissue beneath the mitral valve, the anchor including a retaining member configured to connect with the suture lock such that the suture extends from the suture lock toward the mitral valve leaflets at an angle of less than approximately 45° relative to the longitudinal direction of the suture lock.

[0075] In some variations of the seventh aspect, the suture extends from the suture lock toward the mitral valve leaflet at an angle of less than approximately 5° relative to the longitudinal direction of the suture lock. In some variations of the seventh embodiment, this angle is in the range of 0° to 45° during the movement of the suture during the cardiac cycle. In some variations of the seventh aspect, the suture is a first suture and the mitral valve leaflet is a first mitral valve leaflet; the system also includes a second suture configured to connect with a second mitral valve leaflet, and a retaining member is configured to connect with the suture lock such that the second suture extends from the suture lock toward the second mitral valve leaflet at an angle of less than approximately 45° relative to the longitudinal direction of the suture lock. The second suture may extend from the suture lock toward the second mitral valve leaflet at an angle of less than approximately 5° relative to the longitudinal direction of the suture lock. In some variations of the seventh aspect, the prosthetic chordae tendineae retains function for at least 400 million cycles.

[0076] In an eighth aspect, a prosthetic chordae tendineae for transcatheter mitral valve repair includes: a suture having a distal portion configured to engage with the leaflets of the mitral valve; a suture lock configured to engage with the suture; and a limiting member configured to engage with the suture lock and an anchoring member engaging with tissue beneath the mitral valve, the limiting member being configured to maintain the orientation of the suture lock relative to the limiting member during the application of force to the prosthetic chordae tendineae.

[0077] In some variations of the eighth aspect, the force applied to the prosthetic chordae tendineae ranges up to approximately 2.0 N. In some variations of the eighth aspect, the limiting member is configured to maintain the angle between the suture lock and the suture defined by the limiting member within a range of approximately 0° to 5°.

[0078] In some variations of the eighth aspect, the suture includes a proximal portion located near the suture lock, and the limiting member is configured to maintain the orientation of the suture lock relative to the limiting member during removal of the proximal portion of the suture lock. In some variations of the eighth aspect, the suture includes a proximal portion located near the suture lock, and the limiting member is configured to maintain the orientation of the suture lock relative to the limiting member during tension changes in the proximal portion of the suture lock. In some variations of the eighth aspect, the suture includes a proximal portion located near the suture lock, and the limiting member is configured to maintain the orientation of the suture lock relative to the limiting member when there is no tension in the proximal portion of the suture.

[0079] In some variations of the eighth aspect, the limiting member is configured to maintain the orientation of at least a portion of the suture relative to the limiting member. In some variations of the eighth aspect, the limiting member is configured to maintain an angle between a portion of the suture and the longitudinal line defined by the limiting member within a range of 0° to approximately 15°. This portion of the suture may be located proximal to the distal surface of the suture lock, and the angle may be approximately 0°. This portion of the suture may be located distal to the distal surface of the suture lock. In some variations of the eighth aspect, the limiting member is configured to maintain a substantially coaxial relationship between the suture lock and the limiting member.

[0080] In a ninth aspect, a system for transcatheter mitral valve chordae tendineae repair includes: a first suture configured to connect to a first leaflet of the mitral valve; a second suture configured to connect to either the first or second leaflet of the mitral valve; a suture lock configured to connect to the first and second sutures; and an anchor configured to connect to tissue beneath the mitral valve and restrict movement of the suture lock relative to the anchor.

[0081] In some variations of the ninth aspect, the anchor includes a limiting member configured to limit rotational and positional movement of the suture lock relative to the anchor. In some variations of the ninth embodiment, the anchor is configured to limit movement of the suture lock relative to the anchor by a force between approximately 0 N and 4 N. In some variations of the ninth aspect, the anchor is configured to limit rotational movement of the suture lock relative to the anchor by a force between approximately 0 N and 10 N. In some variations of the ninth aspect, the anchor is configured to limit movement of the suture lock relative to the anchor by a force between approximately 0 N and 6 N.

[0082] In some variations of the ninth aspect, the first suture includes a distal portion configured to connect with the first leaflet and a proximal portion located proximal to the suture lock, and an anchor is configured to restrict rotational movement of the suture lock relative to the anchor during removal of the proximal portion of the first suture. In some variations of the ninth aspect, the second suture includes a distal portion configured to connect with the second leaflet and a proximal portion located proximal to the suture lock, and an anchor is configured to restrict rotational movement of the suture lock relative to the anchor during removal of the proximal portion of the second suture.

[0083] In a tenth aspect, a prosthetic chordae tendineae for transcatheter mitral valve chordae tendineae repair includes: a suture configured to connect to the leaflets of the mitral valve; a suture lock configured to connect to the suture; and a limiting member configured to connect to the suture lock and an anchor that engages with tissue beneath the mitral valve, the limiting member being configured to limit the length of the prosthetic chordae tendineae from changing with the force applied to the prosthetic chordae tendineae. In some variations of the tenth embodiment, the limiting member is configured to limit the change in the length of the prosthetic chordae tendineae to less than about 0.5 mm by changing the force applied to the prosthetic chordae tendineae.

[0084] In some variations of the tenth aspect, the limiting member is configured to limit the change in the length of the prosthetic chordae tendineae as a result of changes in the force applied to the prosthetic chordae tendineae to less than about 0.1 mm. In some variations of the tenth aspect, the suture includes a distal portion configured to connect with the leaflet and a proximal portion configured to connect to a catheter to adjust the distal portion of the suture, and the limiting member is configured to limit the change in the length of the prosthetic chordae tendineae by a force applied via the catheter.

[0085] In the eleventh aspect, a system for transcatheter mitral valve chordae tendineae repair includes: a suture configured to connect with the leaflets of the mitral valve; a suture lock configured to advance along the suture and selectively engage the suture; and an anchor configured to connect with tissue beneath the mitral valve, the anchor including a retaining member configured to align the suture lock and the anchor.

[0086] In some variations of the eleventh aspect, the retaining member is configured to maintain the alignment of the suture lock relative to the anchor by a rotational force applied to the suture lock by the suture. In some variations of the eleventh aspect, the retaining member is configured to maintain the alignment of the suture lock relative to the anchor by a rotational force applied to the suture lock by the suture after the suture lock has selectively engaged the suture. In some variations of the eleventh embodiment, the anchor defines a longitudinal line and the suture lock defines a longitudinal line, and the retaining member is configured to align the suture lock with the anchor such that the longitudinal line of the anchor is substantially parallel to the longitudinal line of the suture lock.

[0087] In some variations of the eleventh aspect, the suture lock defines a longitudinal line and the retaining member is configured to align the suture lock with the anchor, such that the longitudinal line defined by the suture lock extends to the leaflet.

[0088] In a twelfth aspect, a system for transcatheter mitral valve chordae tendineae repair includes: a suture having a distal portion for engagement with the leaflets of the mitral valve and a proximal portion for adjusting the suture relative to the leaflets; a suture lock advancing along the suture; and an anchor configured to engage with tissue beneath the mitral valve, the anchor including a retaining member configured to selectively engage with the suture lock to restrict movement of the suture lock.

[0089] In some variations of the twelfth aspect, the retaining member is configured to be selectively coupled to the suture lock, wherein the suture lock provides a pivot point for the suture that remains substantially stationary relative to the anchor.

[0090] In some variations of the twelfth aspect, the suture is a first suture, and the system also includes a second suture having a distal portion for engagement with the leaflets of the mitral valve and a proximal portion for adjustment of the second suture; and a suture lock is configured to advance along the first and second sutures. The suture lock can provide a pivot point for the first and second sutures, which remains substantially stationary relative to the anchor. The distal portion of the first suture can be configured to engage with the first leaflet of the mitral valve, and the distal portion of the second suture can be configured to engage with the second leaflet of the mitral valve. In some aspects of the twelfth embodiment, the retaining member is a spigot.

[0091] In a thirteenth aspect, a system for establishing multiple prosthetic chordaes for transcatheter mitral valve chordae tendineae repair includes: a first suture having a distal portion for engagement with the leaflets of the mitral valve and a proximal portion for adjustment of the first suture; a second suture having a distal portion for engagement with the leaflets of the mitral valve and a proximal portion for adjustment of the second suture; a suture lock configured to advance along the first and second sutures; and an anchor configured to engage with tissue beneath the mitral valve, the anchor including a retaining member configured to selectively engage with the suture lock to retain tension on the distal portion of the first suture during adjustment of the second suture.

[0092] In some variations of the thirteenth aspect, adjusting the second suture includes using the proximal portion of the second suture to adjust the distal portion of the second suture. In some variations of the thirteenth aspect, a retaining member is configured to selectively engage with a suture lock to substantially maintain tension on the distal portion of the second suture during adjustment of the first suture. Adjustment of the first suture may include using the proximal portion of the first suture to adjust the distal portion of the first suture.

[0093] In some variations of the thirteenth aspect, the retaining member is a spigot. The spigot may be configured to engage a portion of the first suture near the outer surface of the suture lock. The spigot may also be configured to engage a portion of the second suture near the outer surface of the suture lock. The inner surface of the spigot and the outer surface of the suture lock may be configured to confine a portion of the first suture and a portion of the second suture. The inner surface of the spigot may include a material whose crystal structure is oriented in a direction corresponding to the orientation of the material of the first suture and the material of the second suture. In some variations of the thirteenth embodiment, the distal portions of the first and second sutures are configured to connect to the first leaflet of the mitral valve.

[0094] In a fourteenth aspect, a system for transcatheter mitral valve chordae tendineae repair includes: an anchor configured to connect with ventricular tissue; a suture configured to connect with mitral valve leaflets; a suture lock configured to selectively engage the suture; and a retaining element configured to engage the suture lock to the anchor, wherein at least one of the suture lock and the retaining element includes a tendon tapering surface to facilitate engagement of the suture lock to the anchor.

[0095] In some variations of the fourteenth aspect, the suture lock includes a proximal portion having a tapered surface, and the tapered surface is conical. In some variations of the fourteenth embodiment, the retaining element includes a distal portion having a tapered surface, and the tapered surface is funnel-shaped. In some variations of the fourteenth aspect, the suture lock includes a proximal portion having a tapered surface, and the retaining element includes a distal portion, the contour of the distal portion's surface corresponding to the contour of the tapered surface of the suture lock. In some variations of the fourteenth aspect, the retaining element is permanently attached to an anchor. In some variations of the fourteenth aspect, the retaining element is permanently attached to a suture lock. In some variations of the fourteenth aspect, the retaining element includes a distal portion comprising a radiopaque material. The retaining element may include a non-radiotransmissive portion proximal to the radiopaque material located on the distal portion. The suture lock may be radiopaque. In some variations of the fourteenth aspect, an anchoring suture is coupled to an anchor to guide the suture lock to the retaining member. The suture lock may be configured to selectively engage the anchoring suture.

[0096] In a fifteenth aspect, a system for transcatheter chordae tendineae repair of the mitral valve includes: an anchor configured to connect with ventricular tissue; a suture configured to connect with a mitral valve leaflet; a suture lock configured to selectively engage the suture, the suture lock extending along a longitudinal line; and a retaining member configured to secure the suture lock to the anchor, the retaining member being configured to apply a retaining force on the suture lock in a direction orthogonal to the longitudinal line of the suture lock.

[0097] In some variations of the fifteenth aspect, the retaining member is configured to facilitate tissue encapsulation or inward growth. In some variations of the fifteenth aspect, the retaining member includes a bushing configured to contact the suture lock when it is inserted into the retaining member. In some variations of the fifteenth aspect, the retaining member includes a coil configured to resist buckling of the retaining member during suture lock insertion. In some variations of the fifteenth aspect, the retaining member is formed of a material configured to reduce suture abrasion.

[0098] In some variations of the fifteenth aspect, the suture is configured to extend from the proximal opening of the suture lock and wrap around the nose of the suture lock when the suture lock is secured by the retaining member, and the nose has a generally circular outline. In some variations of the fifteenth aspect, the retaining member is a chuck. In some variations of the fifteenth aspect, the retaining member includes a pin. In some variations of the fifteenth aspect, the retaining member includes an anchoring suture configured to apply a retaining force to the suture lock in a direction generally parallel to the longitudinal line of the suture lock. Attached Figure Description

[0099] The foregoing and other features of this disclosure will become more apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. It is to be understood that these drawings depict only a few embodiments according to this disclosure and should not be considered as limiting the scope.

[0100] FIG. 1 The illustration shows the placement of ventricular anchors via the transatrial approach to the mitral valve.

[0101] FIG. 2A and FIG. 2B The diagram illustrates a ventricular anchor.

[0102] FIG. 2C This is a 3D view of the ventricular anchor on the distal end of the ventricular anchor deployment tool.

[0103] FIG. 2D This is a three-dimensional view of the proximal end of the ventricular anchor deployment tool.

[0104] FIG. 2E This is a partially exploded 3D view of the distal end of the ventricular anchor and the ventricular anchor deployment tool.

[0105] FIG. 2F The illustration shows a ventricular anchor with a secondary anchor in the first configuration.

[0106] FIG. 2G The diagram shows... FIG. 2F The ventricular anchor, wherein the secondary anchor is in the second deployment configuration.

[0107] FIG. 3 The illustration shows the deployment end of a catheter positioned to engage with the leaflets of the mitral valve.

[0108] FIG. 4 The illustration shows a leaflet captured by a spiral leaflet anchor, and a needle passing through the leaflet from the atrium to the ventricle.

[0109] FIG. 5 The illustration shows a gauze-type leaflet anchor that is deployed from a needle and enters the ventricle.

[0110] FIG. 6A The illustration shows proximal traction along the leaflet suture line to cause the gauze to contract against the ventricular side of the leaflet.

[0111] FIG. 6B to FIG. 6D The illustration shows the details of the gauze-type leaflet anchor.

[0112] FIG. 7 The illustration shows the leaflet anchors and sutures prepared for deployment of tensioning and attaching suture locks, as well as the deployed ventricular anchors and sutures.

[0113] FIG. 8 The illustration shows a three-dimensional view of the far end of the leaflet anchor delivery subsystem.

[0114] FIG. 9 The illustration shows a perspective view of the proximal end of the leaflet anchor delivery subsystem.

[0115] FIG. 10 The diagram shows an exploded view of the far end of the leaflet anchor delivery subsystem.

[0116] FIG. 11 The method described describes advancing sutures locked on leaflet anchor sutures and ventricular anchor sutures via a suture lock delivery subsystem to connect the leaflet anchor to the ventricular anchor.

[0117] FIG. 12 The image depicts a suture lock in the locked position after the tension has been adjusted and the end of the suture has been cut.

[0118] FIG. 13 A three-dimensional view of the distal end of the suture lock delivery subsystem is depicted.

[0119] FIG. 14 A three-dimensional view of the proximal end of the suture lock delivery subsystem is depicted.

[0120] FIG. 15 A partially exploded view of the distal end of the suture lock delivery subsystem is depicted.

[0121] FIG. 16 A three-dimensional view of the distal end of the suture cutting assembly is depicted.

[0122] FIG. 17 A side view of the cutting component portion of the suture lock delivery subsystem is depicted in a configuration where the cutting head has not yet been advanced to hold the suture before it is cut.

[0123] FIG. 18 A side view depicts the cutting component portion of a suture lock delivery subsystem in a configuration where the cutting head has been advanced to cut the suture.

[0124] FIG. 19 A side view depicts the suture lock and the distal end of a torque drive configured to engage with the suture lock.

[0125] FIG. 20 A proximal view of the suture lock is depicted.

[0126] FIG. 21 The distal view of the suture lock is depicted.

[0127] FIG. 22A This is a side view of the ventricular anchor delivery subsystem according to various aspects of this disclosure.

[0128] FIG. 22B yes FIG. 22A The side view of the proximal portion of the ventricular anchor delivery subsystem shown.

[0129] FIG. 22C yes FIG. 22A Side view of the middle section of the ventricular anchor delivery subsystem shown.

[0130] FIG. 22D yes FIG. 22A Side view of the distal portion of the ventricular anchor delivery subsystem shown.

[0131] FIG. 22E It is along FIG. 22D A longitudinal cross-sectional view of a portion of the image.

[0132] FIG. 22F This is a longitudinal cross-sectional view taken along a mandrel, which can be used to form... FIG. 22A The distal portion of the ventricular anchor delivery subsystem shown.

[0133] FIG. 23A This is a top view of an embodiment of a cutter conduit according to various aspects of this disclosure.

[0134] FIG. 23B yes FIG. 23A Side view and partial cross-sectional view of the cutter conduit.

[0135] FIG. 23C It is along FIG. 23A The cross-sectional view taken from line 23C-23C in the diagram.

[0136] FIG. 24A Based on all aspects of this disclosure FIG. 23A Front view of the cutter housing of the cutter conduit.

[0137] FIG. 24B yes FIG. 23A Side view of the cutter housing.

[0138] FIG. 24C yes FIG. 23B A cross-sectional side view of the cutter housing.

[0139] FIG. 24D It is along FIG. 24C The view of the cutter housing is taken from line 24D-24D.

[0140] FIG. 25A This is a front view of an embodiment of the cutter head.

[0141] FIG. 25B yes FIG. 25A Side view of the cutter head.

[0142] FIG. 26 This is a side perspective view of the cutter head positioned together with the cutter housing, where the cutter housing is shown in dashed lines.

[0143] FIG. 27 This is a cross-sectional side view of the handle of an embodiment of the cutter conduit.

[0144] FIG. 28 This is a top view of an embodiment of a suture and gauze that can form a leaflet anchor.

[0145] FIG. 29 It is along FIG. 28 The cross-sectional view taken from line BB in the diagram.

[0146] FIG. 30 This is a top view of an embodiment of a suture line and a perforated gauze that can form a leaflet anchor.

[0147] FIG. 31 The diagram shows... FIG. 30 In one embodiment of the leaflet anchor, the suture extends through the hole 31.

[0148] FIG. 32 It is a side perspective view of the needle according to certain aspects of this disclosure.

[0149] FIG. 33 This is a perspective view of a gauze delivery handle according to certain aspects of this disclosure.

[0150] FIG. 34A This is a top rear perspective view of a stabilization system and suture management system according to certain aspects of this disclosure.

[0151] FIG. 34B yes FIG. 34A Top-side three-dimensional view of the stabilization system and suture management system.

[0152] FIG. 35 yes FIG. 34A Side view of the stabilization system and suture management system.

[0153] FIG. 36 yes FIG. 34A A top view of the stabilization system and suture management system.

[0154] FIG. 37 yes FIG. 34A A closer top view of the rear section of the stabilization system and suture management system.

[0155] FIG. 38 yes FIG. 34A A closer, comprehensive view of the stabilization system and suture management system.

[0156] FIG. 39 This is a three-dimensional view of the distal end of the alternative leaflet anchor deployment pin.

[0157] FIG. 40 This is a schematic block diagram of a system that provides synchronization control signals based on the detection of pre-selected points in the cardiac cycle.

[0158] FIG. 41 This is a schematic block diagram of the trigger pulse generator used in the system shown in Figure 23.

[0159] FIG. 42 Is FIG. 40 The diagram shows a schematic block diagram of the actuator start-up circuit used in the system.

[0160] FIG. 43 Is FIG. 40 The diagram shows a schematic block diagram of the actuator unit used in the system.

[0161] FIG. 44 The illustration shows that in FIG. 40 The system depicts the ECG signal, marker pulse, trigger pulse, and ignition pulse waveforms.

[0162] FIG. 45 The diagram shows that it can be used FIG. 40 The touch-sensitive monitor used in the device depicted in the image.

[0163] FIG. 46 This is a schematic side-view perspective view of a heart having a transcatheter mitral valve chordae tendineae repair system according to various aspects of this disclosure.

[0164] FIG. 47 This is a cross-sectional side perspective view of the suture cutter mechanism according to various aspects of this disclosure.

[0165] FIG. 48 The movement of gauze sutures and suture locks in certain transcatheter chordae tendineae repair systems according to various aspects of this disclosure is depicted.

[0166] FIG. 49 and FIG. 50 The illustration shows the movement of the suture and suture lock according to various aspects of this disclosure.

[0167] FIG. 51 The illustration shows an anchor, retaining member, and suture lock of a transcatheter mitral valve chordae tendineae repair system according to various aspects of the present disclosure, wherein the upper portion of the anchor extends along a portion of the outer surface of the retaining member.

[0168] FIG. 52 The diagram shows... FIG. 51 A cross-sectional view of a transcatheter mitral valve chordae tendineae repair system, wherein the suture lock is located within the retaining member.

[0169] FIG. 53 The diagram illustrates the orientation of the suture lock, retaining member, and anchor according to various aspects of this disclosure.

[0170] FIG. 54 The diagram illustrates the orientation of the suture lock and the suture according to various embodiments of the present disclosure.

[0171] FIG. 55 The illustration shows an anchor, retaining member, and suture lock of a transcatheter mitral valve chordae tendineae repair system according to various embodiments of the present disclosure, wherein the anchor extends on the anchor hub.

[0172] FIG. 56 , FIG. 57 and FIG. 58 The illustration shows the anchor, retaining member, and suture lock of a transcatheter mitral valve chordae tendineae repair system, wherein the anchor is pushed out of the retaining member and into the adjacent tissue.

[0173] FIG. 59 and FIG. 60The illustration shows an anchor, retaining member, and suture lock of a transcatheter mitral valve chordae tendineae repair system according to various aspects of the present disclosure, wherein the anchoring gauze is located between the suture lock and the anchor hub.

[0174] FIG. 61 The illustration shows a side sectional view of a retaining member according to various aspects of this disclosure.

[0175] FIG. 62 The figure shows a side sectional view of the upper portion of the retaining member according to various aspects of the present disclosure.

[0176] FIG. 63 The illustration shows a retaining member including a dense portion of a fixed anchor hub, according to various embodiments of the present disclosure.

[0177] FIG. 64 The diagram shows... FIG. 63 A cross-sectional view of the socket.

[0178] FIG. 65A The illustration shows a side perspective view of the socket according to various aspects of this disclosure.

[0179] FIG. 65B The diagram shows... FIG. 65A Top sectional view of the socket.

[0180] FIG. 66 This is a schematic diagram of anchors, retaining members, and suture locks according to various aspects of this disclosure.

[0181] FIG. 67 The diagram illustrates the orientation of the prosthetic chordae tendineae according to various aspects of this disclosure.

[0182] FIG. 68 This is a side perspective view of a suture lock and lock actuator mechanism according to an embodiment of the present disclosure.

[0183] FIG. 69 This is a side perspective view of a stitched lock after the locking actuator mechanism and protective cover have been tightened and initially disengaged, according to various aspects of this disclosure.

[0184] FIG. 70 According to various aspects of this disclosure, when the lock actuator and protective cover are further disengaged... FIG. 69 A side view of the configuration. Detailed Implementation

[0185] U.S. Patent Application 15 / 858,671, filed December 29, 2017 (the entire contents of which are incorporated herein by reference), discloses a system and method for transvascular prosthetic chordae tendineae implantation. One aspect relates to: advancing a catheter into the left atrium, through the mitral valve, and into the left ventricle; deploying a ventricular anchor from the catheter and deploying the ventricular anchor into the left ventricular wall, attaching a ventricular suture to the ventricular anchor and extending proximally through the catheter; and advancing a leaflet anchor into the mitral valve leaflet to secure the mitral valve leaflet to the leaflet suture, wherein the leaflet suture extends proximally through the catheter and extends above the top of the engagement edge and secures the leaflet suture to the ventricular suture to limit the range of travel of the leaflet in the direction of the left atrium. Certain aspects are further improved herein.

[0186] Access to the mitral valve can be achieved via a standard transseptal approach to provide access to the left atrium. In this approach, the first step may include securing a leaflet capture catheter to the mitral valve leaflet at a location deemed optimal for correcting regurgitation. Probing the leaflet surface from the superior atrial surface can advantageously provide immediate feedback regarding the optimal location for adding additional mitral chordae tendineae. In another embodiment of this disclosure, a ventricular anchor is deployed first, followed by a leaflet anchor.

[0187] Reference FIG. 1 Ventricular anchors, such as helical anchor 32, have been deployed near the apex 20 of the left ventricle 24. Although the helical anchor 32 is shown positioned near the apex 20 in the following figures, the anchor 32 can be attached at a point offset from the thin tissue at the apex and can alternatively be implanted in the typically thicker adjacent wall of the ventricle, such as between the two papillary muscles. This allows the implanted new chordae tendineae construction (sutures, optional new papillary muscles, and / or helical anchors) to be aligned along a longitudinal axis substantially parallel or concentric with the original path of the autologous chordae tendineae. In some embodiments, the implanted new chordae tendineae construction is aligned along a longitudinal axis within 5, 10, or 15 degrees parallel to the original path of the autologous chordae tendineae and / or the path of adjacent autologous chordae tendineae. Furthermore, although a helical anchor is illustrated, the anchor can have different structures for engaging cardiac tissue, and therefore other tissue anchor structures can be used instead of the helical structure, including various puncture, hook, or radially expandable structures known for engaging tissue.

[0188] Reference FIG. 2A and FIG. 2BThe illustration depicts one embodiment of a tissue anchor suitable for use as a ventricular anchor according to one aspect of this disclosure. The anchoring component 50 will be primarily described in the context of this chordae tendineae repair application; however, the anchor can be used in any of a variety of other applications where soft tissue or bone anchors may be required.

[0189] Anchoring assembly 50 typically includes a coil 54, which may comprise any of a variety of materials, such as stainless steel or nitinol. The coil 54 extends helically between a proximal end 56 and a distal end 58. The distal end 58 is provided with a pointed tip 59 and also carries a retaining barb 61 configured to resist reverse rotation of the coil and detachment from the tissue. The proximal end 56 of the coil 54 is carried by a hub 57 (attached to or integrally formed with the hub 57), which is discussed in detail below.

[0190] Extending distally from the hub 57 and within the coil 54 is an elongated core wire 62 having a pointed, tissue-piercing distal end 64. The distal end 64 is positioned distal to the distal end 58 of the coil 54. This allows the pointed distal end 64 to pierce the tissue upon contact and before the coil 54 begins to rotate to embed itself into the target tissue. Engaging the tip 64 before the anchor rotates stabilizes the anchor against lateral movement, thereby allowing the anchor 50 to be placed onto the tissue in a single pass and allowing the coil 54 to rotate to engage the tissue without the anchor “walking” away from the desired target site, as those skilled in the art will understand. The proximal end of the core wire 62 can be attached to the hub in any of a variety of ways, such as by welding, brazing, adhesive, and / or by mechanical interference, for example, through an opening in the sidewall or other surface of the hub 57.

[0191] The radiopaque depth marker 66 is provided with an aperture 68 and is carried on the core wire 62 in a manner that allows axial movement. A distal stop 70, such as a radially outwardly extending protrusion or annular ridge, is carried by the core wire 62 and is spaced proximally from the distal end 64 of the tip to provide a core wire guide segment 72 on the distal side of the stop 70, so that the marker 66 does not interfere with the tissue anchoring function of the distal tip 64. The stop 70 is used to limit the distal travel of the marker 66. The marker 66 can be an annular structure, such as a circular disc having a central aperture for receiving the core wire 62.

[0192] A helical spring 71 is concentrically supported above the core wire 62, and this helical spring 71 biases the radiopaque mark 66 distally. Therefore, the radiopaque mark 66 is held in place against the proximal surface of the stop 70. In use, the mark 66 sits on the surface of the tissue at the target attachment site. As the helical coil anchor 54 rotates and advances distally into the tissue, the mark 66, together with the tissue surface, sits proximally on the core wire 62, thereby compressing the helical spring 71 until the mark 66 retracts proximally to the hub when the tissue anchor is fully embedded. This allows for fluorescence visualization of the progress of the coil into the tissue and the fully engaged endpoint of the coil 54 embedded in the target tissue by observing the changing distance between the mark 66 and a reference object such as the hub 57 or other radiopaque marks.

[0193] Hub 57 includes a proximal connector for engaging a rotary actuator as discussed elsewhere herein. In one embodiment, the connector includes an aperture, such as a hexagonal aperture, for removably engaging a complementary surface structure on the distal end of the actuator. A stitch 74 is secured to an anchoring assembly 50, such as hub 57, coil 54, or core wire 62. In the illustrated embodiment, stitch 74 is attached to a pin 76 that can be inserted through one or both apertures in the sidewall of the hub and across the central hub cavity. The stitch may additionally carry one or two or more radiopaque markers 82 spaced apart from hub 57 and may extend proximally through the proximal connector and the central cavity in the rotary actuator.

[0194] The suture locking guide, such as a tubular sleeve 78, extends proximally from the hub 57 by at least about 2 mm, 4 mm, or 8 mm, but typically not exceeding about 5 cm or 2 cm, depending on the desired performance. The guide sleeve 78 may comprise a flexible material such as ePTFE. Preferably, the proximal end of the sleeve 78 carries a radiopaque marking band 80, which is axially spaced from a marking 82 on the suture 74 to facilitate fluorescent visualization of the suture lock as the marking band 80 is advanced distally over the suture 74. The marking band 80 may be positioned between the inner and outer layers of the ePTFE sleeve, and may be created, for example, by placing a band over the sleeve and flipping the sleeve over itself to trap the ring.

[0195] The suture locking guide can include any of a variety of structures for maintaining the orientation of the suture lock after separation from the deployment catheter, such as the illustrated sleeve or an alignment pin extending proximally from the hub and received within the lumen of the suture lock. Since the tension on the suture is optimal when the suture lock is held in place by the deployment catheter, any change in the orientation of the suture lock after release from the catheter will affect the tension on the leaflet and may negatively impact the therapeutic value of the implantation. The suture locking guide helps maintain a constant maximum distance between the ventricular anchor and the leaflet anchor both before and after catheter deployment. In this way, the maximum tension on the leaflet suture (during systole) remains constant after the suture lock is locked, both before and after catheter separation.

[0196] The spiral anchoring assembly 50 can be delivered by the ventricular anchor delivery subsystem 300. FIG. 2C to FIG. 2E Various views of the ventricular anchor delivery subsystem 300 and its components are illustrated. FIG. 2C A three-dimensional view of the far end of subsystem 300 is depicted. FIG. 2D A three-dimensional view of the proximal end of subsystem 300 is depicted. FIG. 2E A partial exploded view of the far end of subsystem 300 is depicted.

[0197] Subsystem 300 can be delivered via delivery catheter 100. Delivery catheter 100 can be accessed in the left atrium using conventional techniques, such as transatrial septal puncture. Delivery catheter 100 can remain in a substantially constant position throughout the procedure, both when the various subsystems are placed in and removed from it. For example, the distal end of delivery catheter 100 can be positioned in the left atrium. In other embodiments, the distal end of delivery catheter 100 can be positioned in the left ventricle for the entire duration of the procedure.

[0198] As in FIG. 2C to FIG. 2E As shown, the ventricular anchor delivery subsystem 300 may include an outer sheath 304, an actuator (including a shaft 307 and a head 306), an anchor hub 308, and an anchor 302. The anchor 302 may be a helical anchor, and the actuator head 306 may be configured to rotate the helical anchor 302. The helical anchor 302 may include an inner diameter configured to be received above the outer diameter of the anchor hub 308. The helical anchor 302 may be securely attached to the anchor hub 308 by interference fit or other friction engagement, welding, or other known attachment techniques. The anchor hub 308 may be implanted on the left side together with the helical anchor 302.

[0199] Anchor hub 308 may include a suture 74 positioned generally along the central axis of anchor hub 308. FIG. 2AThe suture 74 is attached to the cavity of the helical anchor 302. In some embodiments, the suture 74 may include an attachment element (e.g., a knot or washer) having a diameter sized to prevent the suture 74 from being pulled proximally through the cavity of the anchor hub 308. For example, the suture 74 may be knotted on the distal side of the cavity. In some embodiments, the suture 74 may be attached to the anchor hub 308 (e.g., through the cavity, such as...). FIG. 2B As shown, it is wrapped around a structure such as the outer surface or pin 76 and attached to itself.

[0200] The helical anchor 302 may include a distal portion and a proximal portion of a winding. The proximal portion of the winding may be spaced closer to the distal portion and may be configured to secure the helical anchor 302 to the anchor hub 308. The distal portion of the winding may be spaced further apart than the proximal portion and may be configured for insertion into ventricular tissue. The anchor hub 308 may include an enlarged cross-section at its proximal end configured to abut the helical anchor 302 and / or prevent the helical anchor 302 from proximally advancing above the proximal end of the anchor hub 308. Other helical anchors, such as those described elsewhere herein, may also be configured for use with the ventricular anchor delivery subsystem 300 described herein.

[0201] The proximal side of the helical anchor 308 may include a recess for receiving an extension 306' of the driver head 306. The recess may be non-circular (e.g., elliptical or polygonal, such as hexagonal), such that the recess is configured to transmit torque from the driver to the anchor hub 308 as the driver rotates. The recess may be positioned about the central cavity of the anchor hub 308.

[0202] In other embodiments, the anchor hub 308 may include an extension, and the actuator 306 may have complementary recesses. The actuator head 306 may be generally cylindrical, having a distally facing post or orifice with a complementary configuration for rotatably engaging corresponding parts on the anchor. The actuator head 306 may be fixedly connected to the drive shaft 307. The actuator may include a central cavity through the actuator head 306 and the drive shaft 307 configured to receive the suture 74. The central cavity of the actuator may be configured to align with the central cavity of the anchor hub 308. The drive shaft 307 may be received within the guide shaft 305. The diameter of the actuator head 306 may be larger than the inner diameter of the guide shaft 305. The outer sheath 304 may be sized to receive the guide shaft 305, as well as the actuator head 306, the anchor hub 308, and the helical anchor 302.

[0203] The outer sheath 304 can be delivered into the left ventricle via the delivery catheter 100 and delivered close to the ventricular attachment site. In some embodiments, the outer sheath 304 can be delivered without a delivery catheter. In some embodiments, the helical anchor 302 can be concealed within the outer sheath 304 until the outer sheath 304 is positioned close to the ventricular attachment site, after which the helical anchor 302 is pushed distally through the outer sheath 304, or the outer sheath 304 is retracted proximally to expose the helical anchor 302. The helical anchor 302 can be positioned to contact the ventricular tissue. Rotation of the drive shaft 307 can cause rotation of the drive head 306, anchor hub 308, and helical anchor 302, thereby screwing the ventricular anchor 302 into the ventricular tissue. Rotation of the drive 309 can axially advance the drive 309, anchor hub 308, and helical screw 302 distally relative to the outer sheath 304.

[0204] The drive shaft 307 can be manually rotated by the user using the drive handle 312, such as FIG. 2D As shown in the diagram. The proximal end of the ventricular anchor delivery subsystem 300 may include a first hemostatic valve 314 and a second hemostatic valve 316, as shown in the diagram. FIG. 2D As shown in the diagram. A first hemostatic valve 314 can be positioned distal to the drive handle 312 and provides access to the guide shaft 305. A second hemostatic valve 316 can be positioned proximal to the drive handle 312 and provides access to the central chamber of the actuator. A ventricular anchoring suture (not shown) can extend through the second hemostatic valve 316.

[0205] In some embodiments, the insertion portion 306' of the actuator head 306 and the recess of the anchor hub 308 may have a frictional engagement that temporarily holds the two components together. Once the helical anchor 302 is inserted, the frictional engagement can be overcome as the actuator retracts proximally due to a reaction force from the ventricular tissue. In some embodiments, proximal tension on the suture 74 can provide engagement force between the proximal hub 308 and the actuator head 306, which can be released upon retraction of the actuator 309. The actuator head 306 can be retracted proximally into the outer sheath 304 before the outer sheath 304 is withdrawn into the delivery catheter 100.

[0206] The non-implantable component of the ventricular anchor delivery subsystem 300 can be removed from the delivery catheter 100, and a subsequent subsystem can be placed within the delivery catheter 100 to complete the implantation of the new chordae tendineae. In a modified embodiment, the ventricular anchor delivery subsystem 300 and a subsequent subsystem such as the leaflet anchor delivery subsystem 330 can be simultaneously positioned within the delivery catheter 100, and in some arrangements, both the tissue anchor and the leaflet anchor can be pre-loaded into the delivery catheter. In an alternative embodiment, the implantation of the ventricular anchor can be performed in a different order (e.g., after the implantation of the leaflet anchor). The ventricular anchor delivery component can be retracted proximally above the proximal end of the suture 74, which can remain extended through the delivery catheter 100 to reach the ventricular anchor 302.

[0207] In some embodiments of this disclosure, it may be necessary to provide auxiliary anchors to prevent the helical coil 54 of the ventricular anchor 32 from rotating in the reverse direction after implantation, which would cause the helical coil 54 to disengage from the attachment site. Generally, auxiliary anchors can be advanced from a first configuration, such as for transcavitary navigation and attachment of the main helical anchor, to a second deployment configuration for engaging tissue and preventing the helical anchor 54 from loosening from the attachment site.

[0208] In some embodiments, the auxiliary anchor can be automatically deployed into the second configuration in response to full engagement of the primary helical anchor. Alternatively, the auxiliary anchor can be deployed by the attending clinician via manual manipulation of a actuator or distal advance. The actuator can take the form of a tubular body carried on the anchor driver in an axially movable manner. Alternatively, the actuator can include the anchor driver. In such embodiments, the anchor driver can be provided with an engagement surface structure, such as a ratchet, that mates with a complementary surface structure on the radially inward-facing surface of the auxiliary anchoring assembly. The anchor driver can retract proximally without affecting the auxiliary anchor, but subsequent distal advance of the anchor driver deploys the auxiliary anchor. The actuator can alternatively include a suture locking catheter, as discussed further below.

[0209] The above and about FIG. 2F and FIG. 2G The described implementation of the auxiliary anchor can be used independently and / or in conjunction with those described herein and related to... FIG. 2A to FIG. 2E The features and aspects of the ventricular anchor 32 described in the embodiments are used in combination.

[0210] FIG. 2F and FIG. 2GThe illustration shows an embodiment of the ventricular anchor 32 that may include an auxiliary anchor 110. In the illustrated embodiment, the auxiliary anchor 110 includes at least one first fork 112 extending between a proximal end 114 and a distal tip 116. The fork 112 may be carried by a support 118, for example, by connection to the proximal end 114. The support 118 may facilitate axial advance of the fork 112. In the illustrated embodiment, the support 118 includes an annular structure, such as a ring 122, having an orifice 120. The orifice 120 is configured to receive an anchor actuator (not shown) or other tubular structures or components that may be part of an anchor deployment system in an axially movable manner.

[0211] Hub 57 is provided with at least one first fork guide 124, such as an orifice or cavity, for receiving a first fork 112 through which it is axially movable. The first fork guide 124 may include a deflecting surface for deflecting the fork 112 to a launch angle radially outward in a distal direction. The launch angle measured at the exit of the fork guide 124 may be in the range of approximately 30 degrees to approximately 45 degrees relative to the central longitudinal axis of the anchor, and in some embodiments, in the range of approximately 35 degrees to approximately 40 degrees.

[0212] As an alternative to or in addition to a deflecting surface, the fork can be pre-biased radially outward, causing it to extend outward as it is advanced beyond the fork guide 124. The distal advancement of the first fork 112 advances it through the first fork guide, the fork 112 extending radially outward in a distal direction to expose at least about 1 mm, 2 mm, 3 mm, or 4 mm or more of fork length, depending on the desired performance. Measured perpendicular to the longitudinal axis, the distal tip 116 of the fully deployed fork is at least about 1 mm, 2 mm, 3 mm, or 4 mm or more from the outer surface of the helical coil 54. The distal tip 116, when fully deployed, can be laterally spaced from the helical coil by at least about 50%, 75%, or 100% or more of the outer diameter of the helical coil.

[0213] The fork-shaped member 112 may comprise any of a variety of materials having sufficient structural integrity to resist rotation and preferably being able to maintain bias, such as stainless steel or nitinol. The fork-shaped member 112 may comprise a flat strip or a round wire, and in one embodiment, comprises a 0.016'' stainless steel round wire.

[0214] The distal advancement of the first fork 112 can be achieved by applying distal pressure to the support 118, for example, by an auxiliary anchor deployment pusher or conduit advanced on the suture 74 and / or an anchor driver discussed elsewhere herein. Alternatively, the auxiliary anchor 110 can be deployed such that a suture lock is advanced distally on the suture and advanced to contact the support 118, and the support 118 is further advanced distally to clamp the support 118 between the distal end of the suture lock and the hub 57. In this way, the suture lock can function as an auxiliary anchor lock that prevents or inhibits the auxiliary anchor from retracting from its deployment site.

[0215] A second fork 126 may be provided, extending through the second fork guide 128 and connecting to the support ring 122. Three, four, or more forks may be provided, depending on the desired performance of the auxiliary anchoring system. In the illustrated embodiment, two forks are shown, spaced approximately 180 degrees apart around the circumference of the helical anchor. In an embodiment with three forks, the forks may be equidistantly spaced at intervals of approximately 120 degrees.

[0216] As shown, the fork-shaped guides 124 and 128 can guide the fork-shaped members 112 and 126 through the fabric of the tubular suture anchor guide. The fabric may be provided with orifices aligned with the path of the fork-shaped members, or the fork-shaped members may pierce the fabric during deployment. The exit path of the fork-shaped members can be moved distally if needed, such that the fork-shaped members extend axially through the hub and into the helical coil, and exit laterally between two spaced adjacent windings of the coil. The fork-shaped members and / or support 118 may include radiopaque markings or materials to enable fluorescent confirmation of full deployment.

[0217] FIG. 3 Figure 6 illustrates the deployment of the leaflet anchor. (Refer to...) FIG. 3 The ventricular anchor 32 has been deployed and secured to the catheter 100 via the ventricular anchoring suture 74, and the ventricular anchor subsystem has been removed. The leaflet anchor is carried within a needle 338, shown as a target site on the atrial side of the leaflet. The needle 338 is carried within the catheter 100 in an axially reciprocating manner, for example, within a tubular sleeve 332 capable of being advanced through the catheter 100. Additional details regarding the needle and needle actuator are discussed below.

[0218] like FIG. 3 As shown in the illustration, in the arrangement depicted, a needle can pass from the atrium through the leaflet to the ventricle, and a pre-loaded suture can then be advanced into the ventricle. The suture can then be used to shrink the gauze onto the ventricular side of the leaflet to anchor the suture to the leaflet, as... FIG. 4As shown in the diagram. Therefore, the gauze forms a leaflet anchor capable of radial expansion. In some embodiments, other forms of radially expandable leaflet anchors may be used.

[0219] Then, leaflet anchors and leaflet sutures can be used in conjunction with ventricular anchors, ventricular sutures, and ventricular suture locks to effectively create new mitral valves, such as... FIG. 5 As shown in the figure. As described above, the leaflet anchor and leaflet suture can be used in conjunction with the systems and methods for transvascular prosthetic chordae tendineae implantation disclosed in U.S. Patent Application 15 / 858,671 (the entire contents of which are incorporated herein by reference) and various embodiments of the ventricular anchor, ventricular suture, and ventricular suture lock disclosed herein.

[0220] Preferably, the leaflet anchor deployment sub-assembly is provided with a temporary anchor for capturing and stabilizing the leaflet as the needle tip 338 advances through the target area. For example... FIG. 3 and FIG. 4 As illustrated, the distal end 400 of the delivery tube 332 or other system components carries a temporary tissue anchor, such as a helical tissue anchor 402. Anchor 402 may be similar to the ventricular anchor 54, except that the temporary anchor 402 does not have a distal barb, as the temporary anchor 402 is intended only for temporary engagement with the valve leaflet. Therefore, anchor 402 includes a helical element 406 terminating at a distal tip 408.

[0221] In use, the distal tip 408 is positioned at a target location on the surface of the leaflet, and the helical element 406 rotates about its axis to engage and penetrate the leaflet. The needle tip 338 may optionally engage with the leaflet before the helical element 406 rotates, and the needle tip 338 can be used to engage with ventricular anchors and... FIG. 2A and FIG. 2B The method discussed is similar to that used to stabilize anchors and prevent them from moving away from the target location in response to rotation.

[0222] After the helical element 406 engages to capture the leaflet from the atrial side and secure it to the catheter, the needle can be advanced distally through the central lumen defined by the helical element 406 and completely through the leaflet, such that the needle tip 338 exits the ventricular side of the leaflet, as... FIG. 4 As seen in the image, an actuator can be deployed using an anchor, such as a pusher that extends through the needle, to deploy the anchor from the needle and into the ventricle.

[0223] Reference FIG. 5The leaflet anchor can be gauze 340, similar to the gauze described elsewhere herein. Gauze 340 can be attached to or attached to the distal end of the leaflet anchor suture 344. The gauze can include soft and / or flexible materials, such as fabric. The suture 344 can extend through the needle 336. Gauze 340 can be folded or compressed to include a reduced radial cross-section, such that gauze 340 can be positioned within the needle 336 for delivery, as discussed below. FIG. 8 and FIG. 10 As shown. The gauze 340 can expand from a reduced cross-section to a larger radial cross-section when deployed from the distal end of the needle tip 338, as... FIG. 5 As shown in Figure 6. In some embodiments, the gauze 340 can be pushed through the needle 336 via a push line or release line (not shown). During delivery through the needle tip 338, the proximal retraction of the leaflet suture 344, as shown in Figure 6, can cause the leaflet anchor to have an axially contracted, radially expanded configuration. This prevents the leaflet anchor from retracting through the perforation in the leaflet and thereby anchors the leaflet suture 344 to the leaflet, as shown in Figure 6. FIG. 7 As shown in the image.

[0224] FIG. 6A to FIG. 6D A gauze 340 connected to the distal end of a leaflet suture 344 is schematically depicted. The gauze 340 may include two wings 341, 342 that can be rolled / folded around the longitudinal axis of the gauze 340 (e.g., in a clockwise or counterclockwise direction) to form a reduced cross-sectional configuration. In some embodiments, the leaflet suture 344 may be integrally formed with the gauze 340. To produce a foldable or retractable configuration, the suture 344 may extend distally through the gauze, forming a loop around the distal end of the gauze, and return proximally and threadedly through one or more openings formed in the gauze 340 (e.g., two openings, three openings, four openings, etc.). FIG. 6A As shown in the diagram. In some embodiments, the opening can be aligned along the center of the gauze 340.

[0225] An opening may extend through the gauze 340 and through the portion of the suture 344 embedded within the gauze 340. The embedded portion of the suture 344 may be at least partially flat within the gauze 340. In some embodiments, the opening may be positioned substantially near the center of the gauze (e.g., immediately adjacent to the left or right side of the embedded suture 344, or alternately between the left and right sides of the suture 344). The suture 344, when deployed, may be effectively connected to the distal end of the gauze 340 (e.g., the suture 344 may loop back to its position where it is inserted between the gauze pieces).

[0226] FIG. 6B to FIG. 6DAn example of gauze, as described elsewhere in this article, is illustrated schematically. FIG. 6B A gauze 340 is schematically depicted by attaching the distal end of the suture 344 (shown in dashed lines) between two flat sheets, such as sheets for the left wing 341 and the right wing 342. FIG. 6C The gauze 340 is shown along FIG. 6B The diagram illustrates a cross-section of the BB axis. In some embodiments, the suture 344 may (e.g., substantially below the center of the sheet) be inserted between two sheets and (e.g., under heat and / or pressure) pressed and / or laminated to join the three components together. At least one of these layers may be partially sintered. The suture 344 may be flattened and / or densed to improve resistance to suture tearing. The sheet may be a flat polytetrafluoroethylene (PTFE) sheet (e.g., a thin, uncured expanded PTFE (ePTFE) sheet) or any other suitable material. In some embodiments, the leaflet suture 344 may be arranged in an alternative configuration, such as a zigzag or S-shaped configuration, between the sheets. FIG. 6D It shows FIG. 6B The gauze 340 includes multiple openings 343, and the proximal tail end of the suture 344 can spirally pass through the multiple openings 343.

[0227] In some embodiments, one or more orifices 343 may be formed through the gauze in various configurations to form a shrinkable structure as described elsewhere herein, which is configured to anchor the suture 344 to the mitral valve leaflets. FIG. 6D Alternating openings 343 are shown around opposite sides of suture 344. In some embodiments, openings 343 may be formed on the same side of suture 344 (e.g., in wing 341 or wing 342). In some embodiments, openings 343 may be formed through suture 344. Openings 343 may be aligned along the center of gauze 340. Openings 343 may be aligned along the length of suture 344 (e.g., may form a straight line). Suture 344 may be at least partially flat between two opposing sheets, which may facilitate the placement of openings 343 through suture 344. Various combinations of the above-described positioning of openings 343 may be used.

[0228] The gauze 340 can be formed such that the wings 341 and 342 are approximately the same size, or the wings 341 and 342 can be formed into different sizes. When the leaflet suture 344 retracts proximally, the gauze 340 can be folded to present an accordion-like structure, such as... FIG. 6AAs depicted in the description, the gauze 340 may have a configuration including a proximal surface of a basic plane substantially perpendicular to the longitudinal axis of the leaflet suture 344. This configuration may facilitate anchoring the suture 344 within the leaflet. After the leaflet suture 344 has been anchored within the leaflet, the leaflet anchor delivery subsystem 340 may be withdrawn from the delivery catheter 100. The leaflet anchor delivery component may be retracted proximally at the proximal end of the suture 344, which may remain extended through the delivery catheter 100 together with the ventricular anchoring suture 74 to reach the leaflet anchor 340.

[0229] FIG. 8 to FIG. 10 Various views of the leaflet anchor delivery subsystem 330 and its components are illustrated. FIG. 8 A three-dimensional view of the far end of subsystem 330 is depicted. FIG. 9 A three-dimensional view of the proximal end of subsystem 330 is depicted. FIG. 10 An exploded view of the far end of subsystem 330 is depicted.

[0230] like FIG. 8 and FIG. 10 As shown, the leaflet anchor delivery subsystem 330 may include an external delivery tube 332. The tube 332 may optionally include a deflection zone, and the tube 332 may be configured to be steered by an operator, for example, by retracting one or two or more draw cables (not shown) proximally along the various sides of the flexible tube 332. The operator may control the deflection of the flexible tube via a knob 352 or lever or other actuation mechanism located on a handle 350 at the proximal end of the leaflet anchor delivery subsystem 330, such as... FIG. 9 As shown in the image.

[0231] An internal tubular shaft or needle 336 terminating at its distal end with a needle tip 338 may extend through the delivery tube 332. The internal needle 336 may include a hypotube, a squeeze tube, a braided tube, or a conduit with sufficient flexibility to conform to the shape of an optional flexible tube 332. The needle tip 338 may be coupled to the distal end of the internal flexible shaft 336. A flexible sheath 333 may surround the flexible tube 332 and the delivery shaft 334.

[0232] The proximal end of the internal tubular shaft 336 can be connected to the needle shank 354, such as... FIG. 9As shown in the diagram. The needle handle 354 may include a hemostatic valve 356. A leaflet suture 344 may be inserted through the valve 356. The valve 356 may be a tuohy-borst valve. The needle handle 354 may include an additional port 358 for access to the cavity of the internal flexible shaft 336. The needle handle 354 may be positioned proximal to the handle 350 such that the internal flexible shaft 336 extends through the handle 350 and into the cavity of the delivery shaft 334. The handle 350 may include a hemostatic valve for receiving the internal flexible shaft 336 and sealing the internal components of the handle (including the opening to the delivery shaft 334) from the surrounding environment.

[0233] The needle tip 338 can be extended and retracted by extending the needle shank 354 toward the handle 350 or by retracting the needle shank 354 from the handle 350. Distal advancement of the needle 336 can be achieved by manually advancing the handle 354. Alternatively, distal advancement of the needle can be assisted by a mechanical or electromechanical mechanism to produce a relatively high-speed, low-stroke distal advancement.

[0234] When the needle tip 338 extends distally beyond the tube 332, applying pressure to the leaflet can cause the needle tip 338 to pierce the leaflet, allowing it to extend through to the opposite side of the leaflet (e.g., the atrial side), as... FIG. 4 As shown in the diagram. This pressure can be applied by extending the needle tip 338 and / or retracting the entire delivery device 330 in the proximal direction while the needle tip 338 is in the extended position.

[0235] The ventricular anchoring suture 74 and the leaflet anchoring suture 344 can be joined together in a tensioned manner to form a new chordae tendineae implant or to combine two portions of the new chordae tendineae implant such that the new chordae tendineae extends across the atrial side of the leaflet engagement edge between the ventricular anchor 302 and the leaflet anchor 340. The total length of the new chordae tendineae can be adjusted by proximal traction of one or both sutures 74, 344 prior to the engagement suture lock 376, thereby applying appropriate tension to the leaflet, wherein the tension is subsequently maintained by the ventricular anchor 302. The sutures 74, 344 can be maintained in a position extending proximally through the delivery catheter 100 to reach the outside of the body. In some embodiments, the proximal ends of the sutures 74, 344 can be fed to the handle or proximal portion of the suture lock delivery system 370 to facilitate the placement of the suture lock and the cutting of the sutures 74, 344. In some embodiments, the proximal ends can be left free or otherwise connected or secured.

[0236] FIG. 11The advancement of suture lock 376 on ventricular anchor suture 74 and leaflet suture 344 is depicted. Suture lock delivery subsystem 370 can be advanced through delivery catheter 100, and tubular pusher catheter 372 can push suture lock 376 distally along sutures 74, 344. Once suture lock 376 has reached the ventricle, if further distal advancement to the ventricular anchor is required, suture lock 376 can continue to be pushed along ventricular suture 74 by proximal traction on suture 74, while simultaneously allowing leaflet suture 344 to be delivered distally through the catheter. As discussed further below, FIG. 12 The final configuration is illustrated, in which the leaflet anchor and ventricular anchor are fastened together to form an artificial chordae tendineae. The proximal tails of the two sutures have been severed, and the catheter has been retracted proximally from the ventricle through the mitral valve.

[0237] FIG. 13 to FIG. 14 Various views of the suture lock delivery subsystem 370 and its components are illustrated. FIG. 13 A three-dimensional view of the far end of subsystem 370 is depicted. FIG. 14 A three-dimensional view of the proximal end of subsystem 370 is depicted. FIG. 15 A partial exploded view of the far end of subsystem 370 is depicted. FIG. 16 A three-dimensional view of the distal end of the cutting component is depicted. FIG. 17 and FIG. 18 A side view of the cut component portion of subsystem 370 is depicted. FIG. 19 A side view depicting the suture lock 376 and the distal end of the torque drive 388 configured to engage the suture lock 376 is shown. FIG. 20 and FIG. 21 The proximal and distal views of the suture lock 376 are depicted respectively.

[0238] The suture lock delivery subsystem 370 can be configured to advance (e.g., slide) the suture lock 376 over two sutures 74, 344 (or even three, four, or additional sutures) to secure the two sutures 74, 344 (or even three, four, or additional sutures) together. The sutures 74, 344 can each retract proximally relative to the suture lock 376 to tension the sutures 74, 344 and adjust the length of each suture 74, 344 between the suture lock 376 and the corresponding tissue anchors 302, 340. Once the tension and length of the new chordae tendineae implant are optimal, the suture lock 376 can be locked to fix the length of the sutures 74, 344, so that the sutures 74, 344 can no longer move relative to the suture lock 376. The sutures 74, 344 can then be cut at a point near the suture lock 376. The sutures 74 and 344 can be cut by the same suture lock delivery subsystem 370 that delivers the suture lock 376. In other embodiments, a separate cutting device can be inserted into the delivery catheter 100 after the suture lock has been locked in place.

[0239] The suture lock allows one, two, or more sutures to be advanced and adjusted, and then locked with sufficient clamping efficiency to prevent the ePTFE sutures from slipping off the lock under normal use conditions (e.g., under tension of at least approximately 60% or 80% or more of the suture's breaking strength without slipping). The lock can be reopened to allow for readjustment and re-tightening of the tension on the mitral valve leaflets until the desired result has been achieved. The tightening tool can then be removed, leaving the suture lock in place.

[0240] The suture lock 376 can be advanced along the suture via the retainer catheter 373. The distal end of the retainer catheter 373 can be connected to the retainer element 377. FIG. 15 The retainer element may include a flange 371 or other mechanical features configured to engage the suture lock 376. For example, the flange 371 may be inserted into a recess at the proximal end of the suture lock 376. In some embodiments, rotation of the retainer conduit 373 and / or translation of the retainer conduit 373 substantially perpendicular to the axial direction may be used to disengage the retainer conduit 373 from the suture lock 376.

[0241] Sutures 74 and 344 can extend from their respective tissue anchors to pass through suture lock 376, thereby from FIG. 21 The distal opening 395, located on the distal side of the suture lock 376, is shown as an entry point, and... FIG. 20The sutures exit at a proximal opening 394 leading to the suture path, located on the proximal side of the suture lock 376. Sutures 74, 344 may extend through a channel in the cutter head 375 near the suture lock 376 and extend along the lateral side of the retainer catheter 373 and through the delivery catheter 100. The cutter head 375 may be coupled to the distal end of the cutter catheter 372. The retainer catheter 373 may extend through the lumen of the cutter catheter 372, allowing the two catheters 372, 373 to extend or retract relative to each other.

[0242] Once the sutures 74 and 344 are locked (securely secured) within the suture lock 376, the proximal ends of the sutures 74 and 344 can be cut adjacent to the proximal side of the suture lock. The sutures 74 and 344 can be cut by advancing the cutter conduit 372, which is connected to the cutter head 375, toward the proximal side of the suture lock 376. FIG. 17 to FIG. 18 As schematically illustrated, as the cutter head 375 advances along the retainer conduit 373 toward the retainer element 377, the cutter head brings the sutures 74, 344 very close to the cutting blade 379 positioned on the retainer element 377. The cutter head 375 is configured to advance on the retainer element 377 in such a way that the channel in the cutter head 375 for retaining the sutures 74, 344 is increasingly occupied spatially by the blade 379. As the blade 379 is forced into the channel of the cutter head 375, the blade 379 cuts the sutures 74, 344. Applying proximal tension to the sutures 74, 344 can facilitate the cutting of the sutures 74, 344. In other embodiments, different actuations (e.g., rotation of the cutting conduit) can be configured to cut the sutures 74, 344.

[0243] In some embodiments, more than two sutures may be used, and these sutures may be locked within the suture lock 376 in the same manner and cut via the suture lock delivery subsystem 370. In some embodiments, advance of the cutter head 375 onto the retainer element 377 may facilitate disengagement of the retainer conduit 373 from the suture lock 376. For example, the cutter head 375 may be advanced to a distal position configured to stabilize the suture lock 376, thereby allowing the retainer conduit 373 to be axially and / or rotationally disengaged from the suture lock 376.

[0244] FIG. 19A side view of an example of a suture lock 376 is illustrated (the suture lock 376 is shown with its housing / shell removed). As described elsewhere herein, a suture can pass through the suture lock 376 from the distal end to the proximal end. The suture lock 376 may include a screw 382 configured to advance a push wedge 384 distally or retract proximally depending on the direction of rotation of the screw. The screw 382 may be rotated via a torque shaft 388. The torque shaft 388 may include an actuator head configured to engage with a recess 381 located at the proximal end of the suture lock 376 (e.g., a polygonal recess or other non-circular recess, such as...). FIG. 20 As shown in the diagram, rotation of the torque shaft 388 causes rotation of the screw 382. The torque shaft 388 may extend through the lumen of the retainer catheter 373. The torque shaft 388 may be rotated at its proximal end by a knob 398 or other actuation mechanism located at the proximal end of the subsystem handle 396. The handle 396 may include a hemostatic valve 397. In some embodiments, sutures 311, 344 may pass through the hemostatic valve 397.

[0245] The advancement of the push wedge 384 via the torque shaft 388 causes the inclined or sloped surface 386 to progressively compress one or more springs, such as spring pins 388. The springs bias the clamp upwards to open the suture path until rotation via the torque shaft 388 causes forced closure. Compression of one or more springs 388 can press the clamp 390 downwards against the sutures 311, 344, thereby compressing the sutures 311, 344 between the two opposing surfaces. In some embodiments, the clamp 390 and the opposing surface 392 may have notched surfaces configured to match each other in discrete increments. The matching notched surfaces can provide enhanced friction, and in some embodiments, the matching notched surfaces can provide mechanical interference for retaining the sutures 311, 344 between the opposing surfaces, preventing the sutures 311, 344 from retracting from the suture lock 376 proximally or distally. In some embodiments, tightening can be reversed by rotating the torque shaft in opposite directions.

[0246] Once the suture lock is correctly positioned on and locked in place on sutures 74 and 344, sutures 74 and 344 can be cut as described elsewhere in this document. FIG. 12 The retraction of the suture lock delivery subsystem 370 after the sutures 74, 344 have been cut is depicted. Once the suture lock delivery subsystem 370 has been removed from the delivery catheter 100, the delivery catheter 100 can be withdrawn from the body.

[0247] Collapsible anchor delivery sheath

[0248] Depending on the configuration of the anchoring assembly 50, coil 54, and / or tubular sleeve 78, in some embodiments, the outer contour of the deployed anchoring assembly 50 may be larger than the inner diameter of the delivery catheter 100 and / or the introducer sheath. Therefore, in some embodiments, the aforementioned ventricular anchor delivery subsystem 300 can be as follows: FIG. 22A to FIG. 22E The ventricular anchor delivery subsystem 400 is modified such that it includes a retractable anchor delivery sheath 404 that can provide protection and support for the anchoring assembly 50, coil 54, and / or tubular sleeve 78 during delivery, while also being retractable to fit the inner diameter of the delivery conduit 100. In this way, the retractable anchor delivery sheath 404 can shrink to a smaller diameter when the sheath 404 is withdrawn into the delivery conduit 100. This retractable delivery sheath 404 can also be configured to secure the anchoring assembly 50 during delivery such that the anchoring assembly 50 will not detach from the delivery sheath 404 due to, for example, beating ventricles or movement or geometry encountered during insertion and placement. In some embodiments, the delivery sheath 404 may also have sufficient kink resistance to resist the movement of beating ventricles once the coil 54 of the anchoring assembly 50 is engaged with the heart wall. As described below, the sheath 404 may include a transmissive tip for detection. In some embodiments, the delivery sheath 404 may have an inner diameter sufficient to hold the coil 54 and the tubular sleeve 78, but an outer diameter small enough to fit within the delivery conduit 100 or the introducer sheath. In some embodiments, the anchor delivery sheath 404 is capable of contracting such that when the anchoring assembly 50 is delivered, the sheath 404 can be pulled through a narrower contraction of the delivery conduit 100 without excessive force and without tearing. In some embodiments, the anchor delivery sheath 404 is adapted to transition in diameter from the inner diameter of the delivery conduit 100 (e.g., about 9 Frenchies in some embodiments) to a second larger size (e.g., about 19 Frenchies in some embodiments) required to fit the anchoring assembly 50.

[0249] In one particular, non-limiting exemplary embodiment of the retractable anchor sheath 404, the sheath comprises approximately 0.005'' wall thermoplastic elastomer material (e.g., nylon elastomer) configured into three tubes of different diameters. For example, two relatively short pieces may be used to transition the diameter from a smaller diameter conduit (9 French in this embodiment) to a larger diameter (19 French in this embodiment) for receiving the anchor assembly 50. A third tube may form a retractable portion of the sheath itself. All three pieces may be formed on a tapered mandrel using thermal bonding or other suitable molding processes. In another embodiment, a radiopaque marker, such as a polymer radiopaque marker tape made of, for example, a thermoplastic elastomer having 60% by weight of tungsten, is bonded to the sheath and suitably bonded to it thermally or otherwise.

[0250] FIG. 22A to FIG. 22F A ventricular anchor delivery subsystem 400 with a retractable sheath 404 is illustrated. The ventricular anchor delivery subsystem 400 can be used in the methods and steps described above and includes a drive shaft 307, a drive head 306, and the other components described above for rotating and delivering the anchor assembly 50. The ventricular anchor delivery subsystem 400 may include a sheath 405 having a proximal portion 410, a middle portion 412, and a distal portion 414 that may include the retractable sheath 404. The proximal portion 410 may include a hemostatic valve 416 with a side port 418. In the illustrated embodiment, the proximal portion 410 and the middle portion 412 of the sheath 405 may be formed of a tube, such as a stainless steel thiocyanate tube, which may have a 9 French diameter outer diameter. The retractable sheath 404 may be formed of a separate material bonded or otherwise attached to a smaller diameter tube.

[0251] like FIG. 22D and FIG. 22E As shown, the distal end of the retractable sheath 404 may have a larger diameter than the diameter of the intermediate portion 412. FIG. 22E yes FIG. 22DA longitudinal cross-sectional view. Thread 422 may be formed on the inner surface of the distal end of the retractable sleeve 404 to retain the anchoring assembly 50 within the retractable sleeve 404. Thus, in one arrangement, the coil 54 of the anchoring assembly 50 may engage the thread 422 in the retractable sleeve 404, such that the anchoring assembly 50 is retained within the sleeve 404. Rotation of the anchoring assembly 50 may drive the anchoring assembly 50 forward through the sleeve 404. In this way, the sleeve 404 may support the anchoring assembly 50 during delivery, such that the anchoring assembly 50 will not detach from the delivery sleeve 404 during delivery. The distal, larger-diameter end of the sleeve 404 may also retract to fit through the inner diameter of the delivery conduit 100, such that the retractable anchoring delivery sleeve 404 can be retracted into the delivery conduit 100. In a modified arrangement, the sleeve 404 may include grooves, protrusions, or other elements for engaging the anchoring assembly 50.

[0252] Typically, the sheath 404 may be provided with any of the following interference elements: said interference element releasably engages an implantable device such as a helical tissue anchor and resists axial pull-out of the helical anchor once positioned within the sheath. Rotation of the anchor relative to the sheath in a first direction causes the anchor to move axially distally as the helix disconnects from the sheath's threaded connection. The interference element may be a helical (radially outward-extending) channel or a (radially inward-extending) ridge extending at least about one, two, or four or more complete revolutions around the inner circumference of the sheath.

[0253] Alternatively, at least one, two, six, or more radially inwardly extending tabs may be provided, each tab extending less than a full rotation around the circumference of the sheath. The engaging tabs around the inner surface of the sheath may have a length of no more than about 90 degrees in the circumferential direction, and in some embodiments may have a length of no more than about 45 degrees, 20 degrees, or 10 degrees or less in the circumferential direction. Depending on the desired performance, the implant can be disengaged from the catheter by multiple full rotations or by rotations less than a full rotation, such as less than about half a turn or a quarter turn relative to the catheter.

[0254] Either or both of the conduit sidewall and the rotary anchor actuator may be provided with torque transmission elements, such as helical or braided sidewalls, to facilitate the rotation of the actuator and inhibit the rotation of the deployed conduit.

[0255] The sheath extends between the distal open end and the proximal end attached to the catheter shaft. The proximal end may have angled engagement surfaces for slidably engaging the distal opening on the delivery catheter, allowing the sheath to change from a radially expanding configuration to a radially contracting configuration in response to retracting proximally into the delivery catheter.

[0256] The sheath may have an axial length corresponding to the intended implant, which is typically less than about 15 cm and in many embodiments no more than about 10 cm or 5 cm or 3 cm or less.

[0257] In embodiments where the device's OD is smaller than the ID of the lumen of the delivery catheter, the aforementioned rotational interlocking feature can be implemented on the inner surface of a flexible (retractable) sidewall as described above, or on a fixed (non-retractable) sidewall catheter. In embodiments with a retractable sheath, the sheath can retract proximally into the delivery catheter after device deployment, and the delivery catheter can have an ID smaller than the sheath's OD when in a radially enlarged configuration for accommodating the implantable device.

[0258] FIG. 22F The illustration shows a method for forming a shrinkable sheath 404. A mandrel 426 having a first diameter 430 and a second smaller diameter 432 may be provided. FIG. 22F It is similar to a spindle FIG. 2E A longitudinal cross-sectional view of the cross-section. The small-diameter portion 432 of the mandrel 426 may be positioned within the distal end of the intermediate portion 412. The mandrel 426 may include a transition region 427 located between the first portion 430 and the second portion 432 of the mandrel 426. A coil 450 may be positioned on the outer surface of the larger-diameter portion 430 of the mandrel 426. A sheath 452, which will form a retractable sheath 404, may be positioned at the distal end of the mandrel 426 and the intermediate portion 412. In an embodiment, the sheath 452 may include approximately 0.005'' wall thermoplastic elastomer (such as nylon elastomer). The sheath 452 may be heat-treated while positioned on the mandrel 426 such that the proximal end of the sheath 452 is reduced in diameter and bonded to the intermediate portion 412, and the distal end of the sheath 452 takes the form of a coil 450 to form internal threads on the sheath 404. As described above, the sheath 404 may include a radiopaque marker, such as a polymer radiopaque marker tape made of a thermoplastic elastomer having, for example, 60% by weight of tungsten, which is bonded to the sheath and suitably adhered to the sheath 404 by heat or otherwise. In an embodiment, the marker is positioned on the distal end of the sheath.

[0259] Rotary suture cutter

[0260] FIG. 23A to FIG. 23C , FIG. 24A to FIG. 24D , FIG. 25A to FIG. 25B and FIG. 26Another embodiment of the cutter conduit 500 is illustrated, which can be used to cut sutures 74, 344 in one or more of the procedures and systems described above. For example, once the sutures 74, 344 are locked (securely secured) within the suture lock 376, the proximal ends of the sutures 74, 344 can be cut adjacent to the proximal side of the suture lock 376 via an embodiment of the suture cutter conduit 500 described herein.

[0261] First refer to FIG. 23A and FIG. 23B The cutter catheter (also known as an intravascular suture cutter) 500 may include an outer sheath 504 extending through a delivery catheter 502 and an inner shaft 506 extending through the outer sheath 504. The proximal end of the outer sheath 504 may be coupled to a Luer lock 503. Referring to FIG24, the outer sheath 504 is coupled to a cutter housing 510 at its distal end. The cutter housing 510 may be barrel-shaped, forming a cylindrical chamber. The distal end of the cutter housing 510 may have an opening 512 through which a suture may extend and then through a window 514 formed on one side of the cutter housing 510 to define a suture path extending through the cutter housing 510. In this way, sutures 74, 344 can be advanced through the cutter housing 510, as... FIG. 23C As shown in the image.

[0262] Reference FIG. 25A , FIG. 25B and FIG. 26 The cutter head 520 is rotatably positioned within the cutter housing 510. The cutter head 520 may have a hollow, semi-barrel or partially barrel-shaped form including a cutting edge 522. The cutting edge 522 may have a spiral path or a curved shape as it extends from the distal end to the proximal end of the cutter head 520. The cutting edge 522 may extend along the side surface of the cutter head 520, such as... FIG. 26 As shown in the diagram, the suture extending through the distal opening 512 and the side window 514 can be cut by rotating the cutter head 520 within the cutter housing 510. Rotation causes the suture to be compressed between the cutting edge 522 and the inner surface of the cutter housing 510. Due to the contour of the cutting edge 522, the suture can be cut off, which can produce a more efficient and reliable cutting motion compared to compression or short-cutting movements.

[0263] Advantageously, when the intravascular suture cutter 500 is advanced into the heart, the cutting edge 522 of the cutter head 520 is not exposed and is covered by the surface of the cutter housing 510. For example, as FIG. 26As shown, the cutting edge 522 is covered by the inner surface of the cutter housing 510. In the illustrated embodiment, the cutter catheter 500 also includes a lock 540 located at the distal end of the intravascular suture cutter 500 to prevent rotation between the cutter head 520 and the cutter housing 510. In the illustrated embodiment, the lock 540 may include a protrusion 550 on the cutter head 520 that engages a corresponding recess 552 in the cutter housing 510. The protrusion 550 and the recess 552 prevent rotation between the cutter head 520 and the cutter housing 510 when engaged. In this way, the cutting edge 522 can be held in a position where it is not exposed and is covered by the inner surface of the cutter housing 510. The protrusion 520 and the recess 522 can be disengaged by axially advancing the rotating housing 520 relative to the cutter housing 510. In the disengaged position, the cutter head 520 can be rotated relative to the cutter housing 510 to cut the suture as described above. The protrusions 520 and recesses 522 may be reversed and / or positioned on other parts of the cutter housing 510 and the cutter head 520 in other arrangements.

[0264] FIG. 27 A proximal handle 570 can be formed around a Luer lock 503. The handle 570 can be used to control the movement of the cutter head 520 and the cutter housing 510. In this arrangement, the cutter head 510 can be fixed relative to the handle 570. The cutter head 520 can be rotatably connected and coupled to the suture cutter handle 572 such that rotation of the suture cutter handle 572 will cause the cutter head 520 to rotate relative to the cutter housing 510. As shown, the suture cutter handle 572 is positioned in a retracted position relative to the handle 570, in which the protrusion 550 and the recess 552 engage to prevent rotation between the cutter head 520 and the cutter housing 510. A lock 578 can be provided on the handle 570. Releasing the lock 578 allows the cutter head handle 572 to move axially (e.g., distally in the illustrated embodiment) relative to the handle 570. In this way, the protrusion 550 and the recess 552 can be disengaged and the suture cutter handle 572 can be rotated relative to the handle 570 to cut the suture.

[0265] Gauze with radiopaque markers

[0266] FIG. 28 to FIG. 31 An embodiment of a leaflet anchor 641 is illustrated, which may include gauze 640 and may be used with the systems and methods described herein. FIG. 28 and FIG. 29 An embodiment of a gauze 640 formed by fixing the distal end of a suture 644 between two flat sheets 645a, 645b is schematically depicted.FIG. 29 The gauze 640 is shown along FIG. 28 The diagram illustrates a cross-section of the BB axis. In some embodiments, the suture 644 may (e.g., substantially below the center of the sheet) be inserted between two sheets 645a, 645b and (e.g., under heat and / or pressure) pressed and / or laminated to join the three components together. At least one of these layers may be partially sintered. The suture 644 may be flat and / or dense to improve resistance to suture tearing. The sheet may be a flat polytetrafluoroethylene (PTFE) sheet (e.g., a thin, uncured expanded PTFE (ePTFE) sheet) or any other suitable material. In some embodiments, the leaflet suture 644 may be arranged in alternative configurations such as a zigzag or S-shaped configuration between the sheets. FIG. 30 It shows FIG. 28 The gauze 640 includes a plurality of openings 643 through which the proximal tail end 660 of the suture 644 can be spirally passed. In some embodiments, one or more openings 643 may be configured in various ways to pass through the gauze to form a shrinkable structure as described elsewhere herein, which is configured to anchor the suture 644 to the mitral valve leaflets. FIG. 30 An opening 643 extending through a suture 644 at the center of the gauze is shown. In some embodiments, the opening 643 may alternate around opposite sides of the suture 644. In some embodiments, the opening 643 may be formed on the same side of the suture 644 (e.g., in wing 641 or wing 642). In the illustrated arrangement, the opening 643 may be formed to pass through the suture 644. The opening 643 may be aligned along the center of the gauze 640. The opening 643 may be aligned along the length of the suture 644 (e.g., may form a straight line). The opening 643 may extend from a first or proximal end to a distal or second end of the gauze 640. The suture 644 may be at least partially flat between two opposing sheets, which may facilitate the placement of the opening 643 through the suture 644. Various combinations of the opening 643, including the positioning described above, may be used.

[0267] Transparent markings can be added to gauze 640. For example, in FIG. 28 to FIG. 31 In the illustrated embodiment, a marking tape 660a may be positioned near the second end or distal end of the gauze 640 around the suture. The marking tape 660a can be clamped to the suture 644 in this position. Then, the proximal end 660 of the suture 644 can be... FIG. 31The gauze 640 is spirally passed through the opening 643 formed in the gauze 640, starting from the opening 643 closest to the marking tape 660a, thereby positioning the marking tape 660a at the distal end of the gauze 640 during deployment. The gauze 640 can be transformed from an elongated strip configuration to a radially expanded and axially shortened configuration by the proximal retraction of the suture 644.

[0268] Flexible gauze delivery needle

[0269] As described above, in some embodiments, the radially expandable leaflet anchor can be carried within a hollow needle having a pointed end for piercing the leaflet. The radially expandable leaflet anchor can include gauze. The gauze can be transformed from an elongated strip configuration to a radially expanded, axially shortened configuration by the proximal retraction of the suture.

[0270] In some embodiments, the hollow needle includes an outer surface having one or more helical grooves. In other embodiments, the hollow needle may include one or more raised helical coils, such as thin coils attached to the outside of the hollow needle. FIG. 32 An embodiment of the hollow needle 1204 is shown, having a helical coil 1205 attached to the outer surface of the needle 1204. Because the leaflets can move before, during, and after the puncture procedure, the leaflets can have a sufficient range of motion to allow the hollow needle without a grooved or raised helical coil to potentially slip off the leaflets. A grooved surface or a raised helical coil offers several advantages. First, in cases where the hollow needle has not completely punctured the leaflets—i.e., gauze cannot be delivered to the distal portion of the hollow needle—or when the physician determines during the procedure that the hollow needle may slip off the leaflets prematurely, the physician can apply force to the catheter or a mechanism within the catheter that transmits rotational force to the needle, thereby further twisting the hollow needle towards the leaflet tissue and securing the leaflets so that they do not move away from the needle. Second, once gauze has been delivered, the physician can apply force to the catheter or a mechanism within the catheter that transmits rotational force to the hollow needle, thereby allowing the physician to remove the needle by unscrewing the hollow needle from the leaflets.

[0271] Depending on the catheter system used, the hollow needle can be guided to puncture from the left atrium to the left ventricle of the heart. In other embodiments, the hollow needle can be guided to puncture the leaflet from the left ventricle to the left atrium. Since the point of entry from outside the patient to the heart can vary, it is desirable that at least a portion of the hollow needle be flexible. Using a flexible hollow needle allows it to travel around all curvatures to approach the leaflet and allows the physician to fine-tune the needle placement before puncturing the leaflet. FIG. 32A cut portion 1203 of the hollow needle is shown, allowing the hollow needle to bend as needed. In some embodiments, the cut portion 1203 of the hollow needle may be laser-cut, machined, or may be made using other known methods.

[0272] The system may also include a hollow needle that punctures the leaflets via a source that releases stored energy. For example, the stored energy may be in the form of a spring, a pressurized liquid, a pressurized gas, an electrically activated piston, or other known methods. In some embodiments, the energy storage device is a spring. In a further embodiment, the spring is located... FIG. 33 The gauze delivery handle 1202 shown.

[0273] The amount of stored energy should provide sufficient force to the hollow needle to penetrate the leaflet a sufficient distance or depth. As used herein, “sufficient distance or depth” can mean one or more of the following: that the distal end of the hollow needle completely pierces the leaflet without causing the needle to contact or pierce any other structure within the heart; that the needle remains engaged with the leaflet as it moves; and that the physician can deliver gauze. If the needle does not penetrate the leaflet a sufficient distance or depth, the physician can rotate the hollow needle to drive it further through the leaflet tissue. If the needle does not pierce the leaflet in the correct position, the physician can rotate the hollow needle in the opposite direction to remove it from the leaflet tissue. The system can then be reconfigured—that is, re-energized, repositioned, and actuated using the stored energy—to properly position the hollow needle for gauze delivery. In some implementations, the system includes a control device in which a physician can position a catheter (including the retracted hollow needle) on or near the leaflet, check the catheter's positioning relative to the leaflet to ensure it is in the correct location, and actuate the release of stored energy to puncture the leaflet. At least a portion of the distal end of the catheter, at least a portion of the distal end of the hollow needle, or both may be radiopaque or include other visualization aids to allow the physician to check that the puncture site is correct before delivering gauze via the release of stored energy.

[0274] Component stabilization and suture management system

[0275] One aspect of this disclosure, which can be used alone or in combination with the aspects disclosed above, is a stabilization system for transvascular myocardial repair. This stabilization system can be used to stabilize and / or adjust the position of the proximal portion (e.g., the handle) of one or more of the described subcomponent components (e.g., the delivery catheter 100 and / or one or more subsystems that can be advanced into the delivery catheter). The stabilization system may also include a suture management system for adjusting the length and / or tension on one or both of the ventricular anchoring sutures and at least one leaflet suture.

[0276] In some respects, suture management systems for transvascular myocardial repair can help maintain a substantially fixed force or tension on the suture as the physician adjusts the suture length and sets the tension of the suture lock. Those skilled in the art will understand that the term "substantially fixed force" can include allowing for some small variations in tension. For example, in one aspect, the tension can vary by 10%.

[0277] The advantage of using this suture management system is that it allows the leaflets to continue moving in their "natural" state in response to the heartbeat during the repair surgery, while each gauze pad maintains basic contact with the leaflet by applying a substantially constant tension to the suture. Furthermore, suture tangling can be prevented or minimized by using this device. Another advantage is that the surgeon can individually adjust each suture to reduce or increase tension, thereby customizing the final movement of the leaflet. The suture management system can be located near the surgeon in the operating room during the procedure. After the anchors and leaflet sutures are deployed in the patient's body, the ends of the sutures passing through the delivery catheter can be attached to the suture management system and maintained under the aforementioned substantially constant tension.

[0278] In some aspects of this disclosure, aspects of the stabilization system can have advantages and can be used independently without requiring aspects of the suture management system or apparatus. Similarly, in some aspects of the suture management system, advantages can be found that allow for independent use without requiring aspects of the stabilization system. However, as described herein, systems utilizing combinations and sub-combinations of the stabilization system and aspects of the suture management system described herein can achieve certain advantages.

[0279] FIG. 34A and FIG. 34B An embodiment of a stabilization system (also referred to herein as "system") 1500 is illustrated. System 1500 may include a base or tray 1502, which may be mounted to a support or table (not shown) to prevent movement of the device during surgery. FIG. 35As shown, the base may include an upper plate or top plate 1504 and a lower plate or bottom plate 1506. The upper plate 1504 and the lower plate 1506 (also referred to herein as the top plate and bottom plate) are movably connected to each other via an adjustable positioning mechanism 1510 (also referred to herein as the "adjusting mechanism"), which, in the illustrated embodiment, may include a lower threaded boss 1512 coupled to the lower plate 1506 and an upper threaded boss 1514 coupled to the upper plate 1504. A screw 1516 may extend through the lower threaded boss 1512 and the upper threaded boss 1514. (See also: Screw 1516) FIG. 35 The axial movement of the upper plate 1504 relative to the lower plate 1506 can be restricted such that rotation of the screw handle 1518 causes the upper plate 1504 to move relative to the lower plate 1506. In this way, the adjusting mechanism 1510 can reposition the upper plate 1504 (and components connected to it) relative to the lower plate 1506 about the direction of arrow 1520, and the lower plate 1506 can be attached to a bracket or table as needed. The adjusting mechanism 1510 may include a lock to prevent movement between the upper plate 1504 and the lower plate 1506. In several embodiments, other mechanisms can be used to reciprocate the upper and lower plates relative to each other in an axial direction in a similar manner; other mechanisms include sliding plates, complementary guides and second channels, or rollers.

[0280] The stabilizing portion 1550 of system 1500 may include several components that can be used to hold or stabilize the aforementioned chordae tendineae repair device. In particular, as will be described in detail below, the device may be used to hold or stabilize the proximal portion of the introducer sheath (e.g., the handle), delivery catheter 100, ventricular anchor delivery subsystem 300, suture lock delivery subsystem 370, gauze delivery subsystem or handle 1202, and / or the proximal end or handle of the suture cutter catheter 500, and these components may be constructed according to the embodiments and aspects described herein.

[0281] For example, the system may include a first docking platform 1600, which may be positioned on the distal portion of system 1500 and may be referred to herein as "distal docking platform 1600". The distal docking platform 1600 may be configured to retain or stabilize the handle or proximal portion of the introducer catheter through which various components of the delivery subsystem described herein can be advanced. (See reference...) FIG. 35The distal docking platform 1600 may include a first stabilizing device 1602, which may be in the form of a clamping member 1602. The first stabilizing device 1602 may be configured to clamp around a tubular portion of a conduit, such as an inlet or an insert sheath. In the illustrated embodiment, the clamping member 1602 includes a pair of clamping plates 1604, 1606, which can be moved toward and away from each other via threaded posts 1608 coupled to a handle 1610. Thus, in the illustrated arrangement, manipulation of a control device, such as rotation of the handle 1610, can bring the plates 1604, 1606 together to clamp an inlet sheath (not shown) to the system 1500. In several embodiments, other mechanisms may be used in the first stabilizing device 1600 to stabilize the conduit or inlet sheath, such as friction-fitting devices, chucks, or engagement features that are form-fitted to a handle of the inlet sheath.

[0282] like FIG. 34A , FIG. 34B and FIG. 35 As shown, the clamping member can be connected to the upper plate 1504 of the base 1502 via an arm 1620. The arm 1620 may have an "L-shape" that positions the clamping member 1602 upward and forward along the axial direction of the upper plate 1504. The arm 1620 can be connected to the upper plate such that movement of the upper plate 1504 relative to the lower plate 1506 causes axial movement of the clamping member 1602.

[0283] like FIG. 36 As best seen in the illustration, the distal docking platform 1600 may include a second stabilizing device 1650. In the illustrated embodiment, the second stabilizing device 1650 may also be in the form of a clamping member and may be disposed on the arm 1620. In the illustrated embodiment, the second stabilizing device 1650 may be positioned on the elbow of the arm 1620. The second stabilizing device 1650 may be used to stabilize another component of the mitral valve repair system described herein. For example, the second stabilizing device 1650 may be used to stabilize the proximal end (or handle) of the suture lock delivery subsystem (see, for example...). FIG. 14 ).

[0284] The second stabilizing device 1650 illustrated may include a clamping member 1652 for holding the component. See also FIG. 34AIn the illustrated embodiment, clamping member 1652 includes a pair of plates that can be moved toward and away from each other in a manner similar to a first stabilizing device, controlled by a control device such as a screw. Thus, in the illustrated arrangement, rotation of the screw can bring the plates together to clamp a portion of the suture lock delivery subsystem (not shown) to system 1500. In several embodiments, other mechanisms may be used in the front mounting to stabilize the suture lock delivery subsystem, such as friction-fit devices or form-fitting engagement features connected to the suture lock delivery subsystem. FIG. 36 As shown, the arm may include a platform 1660, which may be used to support a portion or other part of the handle of the suture lock delivery subsystem. In one arrangement, a second stabilizing device 1650 may be used to secure the front portion of the suture lock delivery subsystem, while the rear or back portion of the handle suture lock delivery subsystem rests on the platform 1660.

[0285] Continue to refer to FIG. 35 and FIG. 36 System 1500 may include a second docking platform 1700, which, in the illustrated embodiment, may be positioned close to the first docking platform 1600, and may also be referred to herein as the proximal docking platform 1700. The proximal or second docking platform 1700 may be supported above the base 1502 by an arm 1702 extending from the top plate 1504. The proximal docking platform 1700 may be positioned at approximately the same height as the aforementioned stabilizing device. The proximal docking platform 1700 may include components of a suture management system, which will be described in more detail below. The proximal docking platform 1700 may include a third stabilizing device 1710. Device 1710 may include an elongated concave support surface, such as a U-shaped channel extending in the axial direction, which may be used to support components, such as the handle of the ventricular anchor delivery subsystem described herein according to an embodiment. The second docking platform 1700 can be connected to the top plate 1504 via the arm 1702, such that movement of the top plate 1504 causes movement of the platform 1700. Therefore, in the illustrated arrangement, both the proximal docking platform 1700 and the distal platform 1600 can be supported by the upper plate, and in some embodiments, can be fixedly supported by the upper plate.

[0286] Continue to refer to FIG. 35 and FIG. 36System 1500 may include a third docking platform 1800. The third docking platform 1800 may be positioned axially between a first docking platform 1600 and a second docking platform 1700, as described above, relative to each other in a distal and proximal manner. The third docking platform 1800 may also be referred to herein as an intermediate docking platform 1800. The intermediate docking platform 1800 may include a fourth stabilizing device 1802, which may be in the form of a vise or clamping member. The intermediate docking platform 1800 may be positioned between the first docking platform 1600 and the second docking platform 1700. The intermediate docking platform 1800 may include an adjustment mechanism 1810, which, in the illustrated embodiment, may include a threaded engagement between the stabilizing device 1802 and a lower guide rail 1812. The lower guide rail 1812 may be fixed relative to the upper plate 1505. The screw 1816 can be rotated to move the stabilizing device 1802 relative to the guide rail 1812 and the upper plate 1504. In this way, the adjusting mechanism 1810 can reposition the fourth stabilizing device (and the components connected to the fourth stabilizing device) relative to the lower plate 1506, which can be attached to a bracket or table as needed. The adjusting mechanism 1810 may include a lock to prevent movement. The intermediate docking platform may be carried by the upper plate 1504. The adjusting mechanism 1810 can also move the fourth stabilizing device (and the components connected to the fourth stabilizing device) relative to the upper plate 1504 and the components carried or fixedly supported by the upper plate, such as the distal docking platform and the proximal docking platform (and the components connected to the distal docking platform and the proximal docking platform).

[0287] In one embodiment, the fourth stabilizing device can be used to stabilize the delivery catheter, such as according to the delivery catheter 100 described above. In some embodiments, the first stabilizing device 1650 can be used to stabilize the introducer catheter, while the fourth stabilizing device 1802 can be used to stabilize the delivery catheter 100 inserted through the introducer catheter. In this way, rotation of the screw 1816 allows for fine movement of the delivery catheter relative to the introducer catheter. That is, movement of the intermediate docking platform can move the delivery catheter relative to the distal docking platform and the introducer catheter mounted to the distal docking platform.

[0288] Reference FIG. 37 and FIG. 38The suture management system 1700 may include at least one, two, three or more tensioning components that can be used to hold each suture and help keep the sutures taut at all times, thus avoiding the slack that could be caused by the force generated by each heartbeat, which could pull the gauze into the left atrium or left ventricle, or further avoiding the slack sutures from becoming entangled in the left atrium or left ventricle, or even the slack sutures from becoming entangled with other chordae tendineae in the left ventricle.

[0289] For example, in one embodiment, the anchoring suture may be attached to the anchoring tension member 1720. The anchoring tension member 1720 may include a rotatable spool 1712 equipped with a torque-limiting fastener, such as a clutch, to limit the amount of tension that can be applied to the suture wound around the spool (e.g., a suture attached to a ventricular anchor). If excessive tension is applied to the anchoring suture, the anchoring tension member 1720 can advantageously prevent or reduce the risk of the anchor being pulled out of the heart wall. In another embodiment, the anchoring tension member 1720 may include a spring-loaded post configuration to apply tension to the suture. In one embodiment, after the ventricular anchor is deployed, the proximal end of the suture of the ventricular anchor 302, attached to the ventricular anchor delivery subsystem 300, may be wound around the anchoring tension member 1720. In this way, a constant tension can be applied to the suture, and the torque clutch-limiting fastener can prevent or limit excessive tension applied to the ventricular anchor. In one implementation, the clutch torque limit is between approximately 2 N and approximately 5 N.

[0290] Continue to refer to FIG. 37 and FIG. 38The platform 1700 may be equipped with at least one, two, three, or more suture adjustment fingers 1770 to allow adjustment of the tension of the gauze sutures on the leaflets. In use, the sutures attached to the gauze may be attached with tension, such as a weight 1750, to provide the desired tension. In some embodiments, the weight may range from about 2 shells to about 8 grams. In the illustrated embodiment, the weight 1750 may be stored on the proximal platform 1700 by providing weight mounting elements, such as multiple holes, recesses, or slots that can receive the weight 1750. The sutures (e.g., leaflet sutures) may be housed in suture guides 1760, which may be recesses or grooves formed on the platform 1700. The guides 1760 may be configured to allow axial sliding of the sutures while providing some constraint on lateral movement. The proximal docking platform 1700 may include at least one, two, three, or more suture guides 1760. By suspending the end of the suture (e.g., a leaflet suture) attached to the weight 1750 over the edge of the platform 1700, a constant tension can be applied to the gauze suture, which can be useful in limiting or preventing suture tangling. As mentioned above, the platform 1700 may be provided with more than one guide 1760, such that more than one suture can be suspended over the edge of the platform 1700.

[0291] like FIG. 37 and FIG. 38 As shown, platform 1700 may further include suture adjustment features or fingers 1770, which may be positioned near or adjacent to a notch or groove 1760. The suture adjustment feature 1770 may include a rotatable spool. Each spool may include a groove 1774 through which a suture may extend. The rotatable spool 1770 may then be rotated to adjust the tension on the suture.

[0292] A suture management system can provide a dynamic leaflet management system. The advantage of using such a system is that it allows the leaflets to continue moving in their “natural” state in response to the heartbeat during repair surgery, while each gauze pad maintains basic contact with the leaflet by applying a substantially constant tension to the suture. Furthermore, using this system can prevent or minimize suture tangling. Another advantage can include allowing the surgeon to individually adjust each suture as needed to reduce or increase tension, thereby customizing the final movement of the leaflet. For example, in the embodiment in use, the tension on the suture can be adjusted while observing the valve’s capacity after the suture lock (described above) has been advanced into the patient and before locking and cutting the suture. This can be done by rotating the spool to increase or decrease the slack and corresponding tension in the suture. Once the desired tension is achieved, the suture lock can be activated as described above.

[0293] Multiple sutures, including, for example, up to four sutures, can be attached to the suture management device, and multiple suture management devices can be used as needed. Device components can include any suitable sterilizable material that meets the device's performance requirements, including non-limiting examples such as stainless steel, acetal resins such as polyoxymethylene and PTFE, aluminum, 3D printing resin materials, etc.

[0294] Valve leaflet tissue anchor deployment system

[0295] According to another aspect of this disclosure, an alternative leaflet tissue anchor deployment system is provided. (See also...) FIG. 39 The needle deployment catheter 332 carries the needle 336 in an axially reciprocating manner. A radiopaque marking strip 1900 is provided at the distal end of the needle deployment catheter 332 so that the positioning of the marking strip 1900 relative to the mitral valve leaflet can be visualized when the needle 336 is retracted proximally within the catheter 332.

[0296] exist FIG. 39 In the illustration, needle 336 is shown in a distally advancing configuration. Needle 336 includes a tubular body 1902 having sidewalls 1904 and at least one flexible reinforcement feature, such as a groove pattern. In the illustrated embodiment, at least one serpentine groove 1906 extends through the sidewall. The serpentine groove 1906 can be formed in any manner known in the art, such as by laser etching of a hypotube. The serpentine groove 1906 enhances the lateral flexibility of needle 336 along the deflection zone to aid in aiming at the appropriate position on the mitral valve leaflet. The length of the deflection zone is typically less than about 4 cm or less than about 2 cm, but long enough to encompass the entire length of the gauze.

[0297] The needle 336 terminates distally at a pointed tip 1908 separated from the tubular sidewall 1904 by an inclined surface 1910. The inclination angle of the surface 1910 is typically in the range of about 30 degrees to 85 degrees, preferably in the range of about 70 degrees to 80 degrees, and in one embodiment about 75 degrees.

[0298] At least one tissue retention element 1912 is provided to allow the needle 336 to be rapidly and forcefully advanced distally through the tissue, but resists the retraction of the needle 336 proximally from the target tissue. The retention element 1912 may comprise any of a variety of structures extending radially outward from the tubular sidewall 1904, such as at least one, two, five, ten, or more barbs, loops, or tabs. In the illustrated embodiment, the retention element includes an annular loop in the form of a continuous helix 1914, which may be formed from polymer strands or metal wire wound around the tubular body 1902 to form the helix. In one embodiment, the helix, such as 0.008-inch wire, is welded or otherwise secured to the tubular body 1902.

[0299] Needle 336 is advanced distally from diploma catheter 332 at a sufficient speed so that needle 336 can pierce the leaflet without requiring other methods. FIG. 3 The disclosed 406 type leaflet stabilizing anchor has a retaining element 1912 that provides sufficient retaining force to hold the leaflet on the needle until the gauze is deployed. Afterward, the needle can be retracted proximally without rotation, or it can be rotated to unscrew and remove the needle from the leaflet.

[0300] If additional leaflet stabilization is desired, it can be achieved through temporary leaflet anchors previously disclosed herein, or through alternative mechanical techniques of grasping or pinching the leaflets, or through aspiration or cryografting with a cold catheter. These techniques will include cold catheters of the type used in ablation procedures to freeze the target tissue. These cold ablation catheters for atrial fibrillation often accidentally attach themselves to the mitral valve leaflets and need to be deactivated to release the attached leaflets. The same cold attachment can be used to locate and isolate the leaflets in question for stabilization during the deployment of the leaflet anchor deployment needle. Cold catheters use gas exchange (nitric oxide or argon) to lower the temperature of the catheter tip and can reach temperatures as low as -75 degrees Celsius.

[0301] Actuator control system

[0302] The deployment of the mitral valve leaflet anchor described in this paper is achieved by puncturing the leaflet from the atrial side of the valve. This is to avoid the need for a gripping structure to capture and support the leaflet during leaflet puncture, and to facilitate the use of... FIG. 39 The needle shown, with its distal ejection of the leaflet anchor deployment needle, can be timed to correspond to the peak (systolic) pressure in the ventricle that appears near the QRS wave. This synchronizes the leaflet puncture with mitral valve closure, allowing the systolic pressure in the ventricle to provide the necessary backflow support during the puncture of the leaflet from the atrium.

[0303] The timing of leaflet needle firing in relation to the cardiac cycle can be performed manually by the clinician or can be partially or fully automated, depending on the desired implementation. For example, visual or audio signals or fluorescent images can alert the clinician to the timing of the QRS complex, allowing the clinician to press a firing trigger or other control device to deploy the needle. Because clinicians' reaction times can vary, it may be necessary to automate the needle firing procedure partially or fully.

[0304] For example, needle 338 can be equipped with an automatic needle actuator, such as a solenoid carried by the proximal end of the catheter. The solenoid is activated in response to an activation signal that causes the needle to protrude distally, the activation signal corresponding in time to a target time in the cardiac cycle, such as during the closure of the mitral valve.

[0305] Alternatively, the activation signal may be in the form of a visual, tactile, or auditory signal to a clinician, who, in response to the visual, tactile, or auditory signal, actuates a control device such as a button or slider to manually advance the needle, or actuates a control device to activate an electromechanical or mechanical needle actuator.

[0306] In another embodiment of this disclosure, needle deployment can be performed manually by a clinician, but only after the locking device has been disengaged. In this embodiment, a removable mechanical interference element may be created or attached to the proximal portion of the needle shaft. The distally facing interference surface may be supported by a radially outwardly extending tab or annular flange coupled to the needle, or a distal surface extending through the orifice of the needle. For this purpose, as will be understood by those skilled in the art, "needle" refers to the needle itself and any proximal extension structure (e.g., an extension tube or rod) mechanically connected to and moving with the needle.

[0307] The proximal interfering surface is configured to move between an engaging configuration and a disengaged configuration. In the engaging configuration, the proximal interfering surface engages with the distal interfering surface on the needle via an interference fit. In the disengaged configuration, the distal interfering surface and associated structure are freely advanced distally to eject the needle. The proximal interfering surface can be supported on a stop movably supported by a proximal handpiece, such as an axially movable pin or a pivotable or sliding rod. A stop actuator, such as a solenoid, is configured to move the stop between the engaging and disengaged configurations.

[0308] The stop can initially engage to prevent needle deployment. In response to an activation signal indicating a target time (e.g., during or near a QRS complex), the stop retracts into an open engagement configuration. This prevents premature needle deployment by the clinician but allows manual deployment at the desired target time. The stop can automatically return to the engagement configuration after a preset time window following the activation signal to prevent delayed needle deployment and create a narrow window allowing the clinician to fire the needle. If the clinician fails to deploy the needle within the window in time, the opportunity to fire the needle will reappear with the subsequent QRS complex.

[0309] Several techniques have been developed to directly detect the QRS complex or an indicator of that point in the cardiac cycle. Direct detection techniques include power spectral analysis, bandpass filtering, differentiation, template matching, and real-time techniques dependent on waveform characteristics. Indicators include, for example, blood pressure measured intravascularly on the arterial or venous side, or in the atria or ventricles of the heart, or blood pressure measured non-invasively, such as peripheral blood pressure. Venous measurements can be used as an indicator of the timing of the QRS complex because the aortic valve opens when the mitral valve closes, leaving a fingerprint on the circulatory venous pressure curve. Data from any of the aforementioned sources can be ideally tuned to account for any time delays from the actual QRS complex, according to desired time sensitivity. Preferably, the ECG signal will be obtained from a conventional ECG monitor, which is typically already present and operating in the operating room.

[0310] A typical ECG waveform consists of a P wave indicating atrial depolarization, a QRS complex indicating ventricular depolarization, a T wave indicating ventricular repolarization, and, in some cases, a possible U wave indicating extended repolarization. The primary activity of an ECG typically involves real-time identification of the QRS complex for various monitoring and diagnostic purposes. The QRS complex, or wave, typically lasts approximately 80 to 120 ms and corresponds to the onset of ventricular systole and the ejection of blood through the aortic valve. This also corresponds to the pressure-response closure of the mitral valve, which is important for the purposes of this disclosure.

[0311] FIG. 40 to FIG. 45 A system is described that provides control of the actuator in sync with the heart 10. As used herein, an actuator is anything that is activated in response to a control signal triggered by an event in the cardiac cycle, such as visual, auditory, or tactile feedback to a physician, an automatic needle initiation mechanism, or a locking mechanism in a manually operated needle deployment implementation that prevents the physician from deploying the needle until the actuator unlocks the initiation mechanism.

[0312] An overview of this system is in FIG. 40As shown, and as can be seen, it includes a component 212 for sensing the cardiac cycle, a component 218 for generating a trigger pulse for the actuator in response to the sensed cardiac cycle, a component 232 for positioning the leading edge of the trigger pulse at a specific time within the cardiac cycle, a component 234 for defining the width of the trigger pulse occurring during the cardiac cycle, and a component 222 for controlling the activation of the actuator in response to the trigger pulse and for a period of time that continues to respond to the defined width.

[0313] Specifically, the electrocardiogram (ECG) unit 212 is electrically connected to the patient's heart 10 to sense the cardiac cycle and provide an ECG signal 216. The ECG unit 212 can be connected to the heart in any known manner for sensing cardiac signals, including surface-mounted electrodes typically adhesively attached to the patient's chest, and internal or intracavitary electrodes. Alternatively, the sensing connection can also be integrally integrated with the catheter 332, for example by providing one or more electrical leads extending through the catheter 332 to conduct electrical signals or operate sensors (e.g., pressure sensors) or electrodes located distal to the catheter 332. The electrodes can have a monopolar or bipolar design; in the case of a monopolar design, surface contact can be used. The electrical leads can extend proximally through the catheter 332 and terminate in a standard electrical connector, which can then be removably connected to the ECG unit 212 and transmit the sensed signal 216 to the ECG unit 212.

[0314] Signal 216 is transmitted to trigger pulse generator 218. Trigger pulse generator 218 provides trigger pulse 220 to actuator activation circuit 222. Actuator activation circuit 222 actuates actuator 224 to, for example, initiate the needle or remove obstacles preventing the physician from initiating the needle prematurely, as already discussed.

[0315] The position of the trigger pulse 220 within the heartbeat cycle of the ECG signal 216 is determined by the pulse positioning circuit 232. The width of the pulse 220 and its duration during the heartbeat cycle are determined by the pulse width circuit 234. The trigger pulse generator 218, along with the pulse positioning circuit 232 and the pulse width circuit 234, can be included as an additional circuit board in the PC or microprocessor 236, in which case the system can be controlled via a computer keyboard and suitable software. The PC 236 and ECG 212 can have separate monitors, or they can have a single monitor 238 displaying both the ECG and information about the trigger pulse 220.

[0316] The trigger pulse generator 218 may include a tag pulse circuit 250 that provides a tag pulse 252 and a trigger pulse circuit 254 that generates a trigger pulse 220 in response to the tag pulse 252. Alternatively, in some cases, the tag pulse circuit 250 is included in the ECG itself.

[0317] This can be referenced. FIG. 44 To gain a better understanding, in FIG. 44 In this configuration, the ECG signal 216 can be considered as consisting of a series of heartbeat cycles 256a, 256b, and 256c, each including waveforms Q, R, S, and T. Waveform R crosses a preselected threshold 258, generating marker pulses 252a, 252b, and 252c. Trigger pulses 220a, 220b, and 220c are then generated by trigger pulse circuit 254. The position of the leading edge 260 and the total width 262 of each trigger pulse 220 are determined by pulse positioning circuit 232 and pulse width circuit 234, respectively. In response to the trigger pulses 220, initiation pulses 264, denoted as 264a, 264b, and 264c, are generated to excite actuator 224.

[0318] exist FIG. 42 In the diagram, the actuator activation circuit 222 is shown as including a gate 270, which normally prevents the trigger circuit 220 from transmitting power to the actuator laser power supply 272 in the actuator unit 224 (when relevant). The blocking effect of gate 270 can be overcome when the operator activates switch 274. However, the trigger pulse 220 is still blocked by the release circuit 276, which can be overcome by operating the release switch 278. This double-locking of the transmission of the trigger pulse 220 to the actuator power supply 272 ensures that the actuator activation is genuinely necessary and not accidental. Therefore, the operator must first release the system by operating the release switch 278 to activate the release circuit 276. Only in this way can the next occurring trigger pulse 220 be transmitted to the actuator power supply 272 through gate 270 via the actuator switch 274. Further details of a suitable design for synchronizing the trigger signal with the QRS wave can be found in U.S. Patent No. 5,674,217 to Wahlstrom et al., filed November 16, 1993, the disclosure of which is incorporated herein by reference in its entirety.

[0319] Fusible suture

[0320] In some embodiments, the disclosed system may utilize polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE) sutures because such sutures have ideal tensile strength and relatively low creep. However, PTFE and ePTFE sutures are not easily broken by cutting or melting.

[0321] To overcome this challenge, some embodiments of this disclosure involve sutures in which at least a portion is fusible. In some embodiments, the suture may be a two-component suture, wherein the distal end of the suture comprises a fusible suture material and the proximal end of the suture is a non-fusible suture material. In some embodiments, the distal portion of the suture comprises less than 50% of the total suture length. In other embodiments, the proximal end of the suture comprises greater than or equal to the total suture length. In another embodiment, the two-component suture may include a portion of a fusible suture, wherein the fusible portion is a relatively small fusible zone with non-fusible suture material on either side of the fusible zone. The fusible zone should be located on the suture at a location such that it does not affect the tensile strength or creep resistance of the implanted prosthetic chordae tendineae. When using a two-component suture, the junction between the fusible and non-fusible portions should be located near the suture lock or the point where the suture will be tied or knotted to avoid affecting the strength of the suture. After implantation of the prosthetic chordae tendineae, during normal cardiac function, no portion of the fusible suture should be under tension, or only a relatively small portion may be under tension. The bicomponent suture should have sufficient tensile strength along its entire length and especially at any interface between the fusible and nonfusible portions, so that the physician can apply sufficient tension to the suture during the tensioning step so that the suture does not break when tension is applied to correct mitral regurgitation.

[0322] FIG. 46 One embodiment of a schematic side view of the heart is shown, in which the left atrium 3301 and left ventricle 3302 are shown separated by a posterior mitral valve and an anterior mitral valve (not labeled). In this embodiment, gauze 3303 is secured to the ventricular side of the valve leaflets, wherein a portion of a non-fusible suture 3304 extends from the gauze into the left atrium 3301, entering the left ventricle 3302 between the two leaflets. In the left ventricle 3302, tissue anchors 3305 are secured to the cardiac tissue using helical anchors 3306. A non-fusible suture 3308 is connected to the non-fusible suture 3304 via a knot 3307. Only the cut portion of the fusible suture 3309 is shown, wherein the remaining distal end of the fusible suture has been retracted through a catheter (not shown). In this embodiment, all the tension of the beating heart is on sutures 3304 and 3308, while there is essentially no tension on the fusible suture 3309. The distal end of the suture should be as short as possible. Note that only one distal end of sutures 3304 and 3308 is shown.

[0323] The system may also include a suture cutter. Once tension is set in one or more sutures and mitral regurgitation is corrected or minimized, the suture cutter can be advanced through a catheter placed at the distal end of one or more sutures to melt the fusible suture, thereby cutting the suture. The distal end of the fusible suture can be retracted through the catheter to remove it from the patient. Each of the one or more sutures can be cut one at a time or two or more sutures can be melted at a time. The suture cutter includes a heat source, such as a coil, which can be energized to heat the coil, causing the temperature near the coil to rise above the melting temperature of the fusible suture.

[0324] FIG. 47 An embodiment is shown in which the suture cutter 3310 is advanced through a catheter (not shown) on the distal end 3311 of the suture and reaches the suture lock 3312. The sutures, already tensioned to minimize or correct mitral regurgitation and connected to the leaflet gauze 3303, and the sutures connected to the anchor 3306, are clamped in the suture lock 3312 such that the suture cannot move through the suture lock 3312 when tension is applied to the suture during normal cardiac function. The suture cutter 3310 may include a heating source, a short tube, a thiopanthus tube 3317, and an insulating conductor 3318. The heating source is, for example, a heater coil 3315. The short tube includes a heater housing 3316 coaxial with the heater coil 3315. The heater housing 3316 serves to insulate cardiac structures from heat and has an inner diameter larger than the outer diameter of the heater coil. The thiopanthus tube 3317 serves to prevent blood from entering the catheter. The insulating conductor 3318 provides electrical energy to the heater coil to provide a temperature above the melting point of the fusible suture. The transfer of electrical energy to the heater coil is activated by the doctor when the suture cutter has been moved into place and can be deactivated by the doctor after the suture is cut. FIG. 47 In this configuration, the non-fusible suture (unmarked) extends just through the suture lock (towards the suture cutter), and the fusible portion of the suture is coaxial with and located inside the inner diameter of the suture cutter's coil. In this way, once the distal portions of one or more sutures are removed, only the relatively short ends or tails of the sutures extend beyond the suture lock, while the remaining portions extending to the leaflets and ventricular anchors are non-fusible sutures and remain securely clamped within the suture lock.

[0325] The fusible suture components may include, but are not limited to, suitable melt compositions, including polyolefins, polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyester, polyamide, polyglycolic acid / L-lactide, polyethylene terephthalate, silicone resin, collagen, or other amino acid proteins and combinations thereof. In some embodiments, a portion of the suture is fusible, using any of the aforementioned polymers as the fusible portion or fusible region of the suture. The non-fusible portion of the suture may be PTFE or ePTFE.

[0326] Suture lock guide

[0327] The embodiments discussed above can provide an effective mechanism for transcatheter chordae tendineae repair, such as implantation and realization of prosthetic chordae tendineae. The embodiments discussed below build upon many of these concepts to provide additional advantages. For example, normal cardiac function causes the chordae tendineae repair system to undergo circulatory motion and load. In particular, due to the normal compressive circulation of the heart, the suture lock or other components (e.g., the suture) will oscillate or otherwise move within the ventricles. This motion generally occurs within... FIG. 48 As shown in the diagram, arrows 4180 and 4182 generally indicate the movement of the suture and the movement of the suture lock, respectively.

[0328] The oscillating motion of the suture and suture lock can cause excessive wear on the suture, especially at its junction with the suture lock. This wear can ultimately lead to premature degeneration and failure of the prosthetic chordae tendineae. Specifically, in some systems, the suture passes through the suture lock, for example, along its longitudinal direction. The suture connecting the mitral valve leaflet and the anchor extends from one end of the suture. The weight of the suture lock will pull the other end of the suture lock slightly downward relative to absolute orthogonality, and this angular motion will force the suture against the suture lock. If the suture lock includes relatively sharp angles, these angles can introduce shear forces that cause premature suture breakage. For example, FIG. 49 A suture lock 4206 is shown, its orientation causing suture 4211 to be positioned against a sharp corner on the suture lock 4206. During movement of suture 4211 and suture lock 4206, the sharp corner introduces shear forces on suture 4211. Suture 4244 is subjected to similar shear forces. These shear forces are amplified by the rotational movement of suture lock 4206, as indicated by arrow 4207.

[0329] Furthermore, increasing the tension on the suture tends to cause the suture lock to rotate in a direction substantially orthogonal to the suture, such as, for example... FIG. 50As shown in the diagram. Besides the mass of the suture lock and the resulting inertia during other movements, this movement can introduce high impact forces onto the suture, for example, as part of a “whipping” motion. In some cases, this can cause damage to the suture material due to its viscoelastic properties. Therefore, movement of the suture lock (e.g., relative to the anchor) can be another potential source of failure in mitral valve chordae tendineae repair systems.

[0330] Furthermore, varying tension along the sutures can alter the length of the prosthetic chordae tendineae, negatively impacting their effectiveness, for example, in resolving MR (metastatic muscular aortic) complications. For instance, and as... FIG. 49 and FIG. 50 As shown, when the tension on the suture is reduced or removed, the suture lock 4206 takes on a specific orientation relative to sutures 4211 and 4244. In this case, the prosthetic chordae tendineae has a specific length, which is measured, for example, between the leaflet (where suture 4244 is attached to the leaflet) and the ventricular tissue (where suture 4211 is fixed to the anchor 4202). In practice, a portion of the suture (e.g., suture 4211) wraps around the suture lock 4206 and does not contribute to the total length of the prosthetic chordae tendineae. However, when tension is applied to the suture, this tension will cause the suture lock 4206 to rotate, as... FIG. 50 As shown in the diagram, the portion of suture 4211 previously wrapped around suture lock 4206 is pulled away from suture lock 4206, resulting in a corresponding increase in the length of the prosthetic chordae tendineae. In some cases, this increase is approximately 0.10 mm to 0.30 mm, but in others, it can be as high as 0.50 mm. In some implementations, the amount of change will depend on the width of suture lock 4206 and the angle of rotation of suture lock 4206. In some cases, these length changes can reduce the effectiveness of the prosthetic chordae tendineae, requiring the surgeon to readjust the prosthetic chordae tendineae or necessitate reinstallation.

[0331] Embodiments of this disclosure are designed to mitigate some or all of these problems, and to provide the additional advantages of improved prosthetic chordae tendineae efficacy and / or increased ease of implementation. For example, some embodiments include transcatheter mitral valve chordae tendineae repair systems designed to reduce or eliminate suture movement relative to suture locks and other system components. Some embodiments also aim to reduce the amount of unrestrained sutures within the ventricles. Some embodiments provide prosthetic chordae tendineae with prosthetic papillary muscles that can reduce whiplash effects.

[0332] Some implementations are designed to limit or eliminate movement of the suture lock relative to the anchor. These implementations may also limit or eliminate movement of the suture relative to the anchor, at least in the vicinity of the anchor. As a result, these implementations reduce suture wear and promote a longer lifespan for mitral valve chordae tendineae repair systems.

[0333] In some embodiments, the transcatheter mitral valve chordae tendineae repair system utilizes a retaining member of the suture lock, also referred to herein as a suture lock guide (e.g., an inlet or sleeve), to generate a prosthetic papillary structure. (See above reference) FIG. 2A and FIG. 2B An example of such a suture lock guide is described, and this suture lock guide is in the form of a tubular sleeve 78. Movement of the suture relative to the suture lock can also be constrained near the suture lock, which reduces suture wear. In some embodiments, the transcatheter mitral valve chordae tendineae repair system includes a suture lock guide, also referred to herein as an anchor socket, which restricts movement of the suture lock relative to the anchor and movement of the suture relative to the suture lock.

[0334] The embodiments discussed herein can provide prosthetic systems designed to maintain integrity over approximately 800 million cycles or approximately 20 years. Disclosed are placements of prosthetic chordae tendineae capable of maintaining integrity for at least 400 million cycles or approximately 10 years. These prosthetic chordae tendineae will operate within typical conditions and environments without excessive structural and / or functional impairment after 400 million cycles, i.e., without porosity, tearing, severe delamination, transection, abrasion, incomplete leaflet engagement, excessive regurgitation, etc.

[0335] FIG. 51 and FIG. 52 Components of a transcatheter mitral valve chordae tendineae repair system 4300 according to some embodiments of the present disclosure are shown. The system 300 provides one or more prosthetic chordae tendineae using one or more sutures or tethers, which are deployed into the beating heart using a transcatheter delivery system without cardiopulmonary bypass. These embodiments can reduce wear over time on the anchoring sutures or tethers by using retaining or restraining members, in some embodiments of which the retaining or restraining members include a stent-type or stent graft-type port anchored to a fixation device or anchor located on the epicardium. Delivery systems and techniques discussed above and / or discussed by reference to PCT / US2017 / 069046 and PCT / US2019 / 021480, which are incorporated herein by reference, can be used in the components of the delivery system 4300.

[0336] FIG. 51 and FIG. 52 The diagram illustrates anchor 4302, retaining member 4304, and suture lock 4306. In several embodiments illustrated herein, retaining member 4304 may be similar to the above-described features in certain aspects of this disclosure. FIG. 2A and FIG. 2BThe sleeve or socket 78 described. In other embodiments, the retaining member may be a pin, hook, buckle, claw, clasp, buckle, stitching, etc. Anchor 4302 may be—partially or entirely—any anchor disclosed above and / or disclosed in PCT / US2017 / 069046 or PCT / US2019 / 021480. FIG. 51 and FIG. 52 The diagram also shows suture 4308 and anchoring suture 4310. Although FIG. 51 and FIG. 52 Two sutures 4308 are shown, but only one or more sutures may be used. Suture 4308 may be attached to one or more leaflets of the mitral valve, for example, using gauze attached to one or more leaflets of the mitral valve utilizing the systems or techniques described above and / or as described in PCT / US2017 / 069046 or PCT / US2019 / 021480. Therefore, suture 4308 may be referred to as a gauze suture. Anchor 4302 may engage ventricular tissue, and retaining member 4304 may receive and secure suture lock 4306 and sutures 4308, 4310.

[0337] In some embodiments, the suture lock guide or retaining member 4304 restricts movement of the suture 4308 and / or the suture lock 4306 while facilitating the installation, adjustment, and final operation of the suture 4308 as part of the prosthesis chordae tendineae. For example, in some embodiments, the retaining member (also referred to herein as the suture lock guide) 4304 is configured to selectively engage and disengage with the suture lock 4306. When engaged with the suture lock 4306, the retaining member 4304 can provide a force strong enough to prevent slippage during the cardiac cycle (e.g., having an unrestricted force ranging from approximately 1 N, 1.5 N, 2.0 N, 2.5 N, or 3 N) but still allows the physician to pull the suture 4308 to tighten or loosen the suture 4308 without displacing the suture lock 4306. In other embodiments, the retaining member 4304 is designed to hold the suture 4308 and the suture lock 4306 in place, such that any adjustment to the suture will require the physician to remove the suture lock 4306 from the retaining member 4304, adjust the suture 4308, and then reinsert the suture lock 4306 into the retaining member 4304. In some cases, removing the suture lock from the retaining member 4304 may require greater force, for example, a force of approximately 6 N to approximately 9 N or more, and in some embodiments, even a force exceeding 10 N. In other words, in some non-limiting embodiments, the retaining member 4304 is configured to apply a retaining force on the suture lock that resists forces between approximately 4 N and at least 10 N, including approximately 4.5 N, 5 N, 5.5 N, 6 N, 6.5 N, 7 N, 7.5 N, 8 N, 8.5 N, 9 N, 9.5 N, 10 N, 10.5 N, or 11 N.

[0338] Because of the retaining member 4304, the suture lock 4306 can maintain its positional relationship with the anchor 4302. For example, when cardiac tissue moves during the cardiac cycle, the retaining member 4304 will resist displacement forces (e.g., via the suture 4308) applied to the suture lock 4306. In some embodiments, the retaining member 4304 transmits the forces applied to the suture lock 4306 to the anchor 4302. The displacement forces can range from about 1 N, but in some cases, these forces can be about 1.5 N or up to about 3 N.

[0339] In some embodiments, the retaining member 4304 is formed by inverting the vascular graft catheter. The retaining member 4304 is designed to be radially compliant to allow the suture lock 4306 to enter the retaining member 4304 while providing restraint. The retaining member 4304 can also be axially rigid and abrasion-resistant. Axial rigidity allows the suture lock 4306 to enter the retaining member 4304 without buckling. Abrasion resistance can be minimized through PTFE-PTFE interactions.

[0340] For example, in FIG. 51 and FIG. 52 In the illustrated embodiment, the retaining member 4304 includes an inner surface 4330 defining a chamber that receives and secures the suture lock 4306 and / or the suture 4308. In some embodiments, the retaining member 4304 is made of a material that is flexible enough to accommodate the suture lock 4306 and even allow the suture 4308 to be adjusted relative to the suture lock 4306 after the suture lock 4306 has been inserted into the retaining member 4304. In some embodiments, the retaining member 4304 is radially compliant to allow the suture lock 4306 to enter into and engage with the retaining member 4304. The retaining member 4304 may engage with the suture lock 4306 using interference fits or the like.

[0341] In some embodiments, the retaining member 4304 is engaged with the outer surface of the suture lock 4306, for example, with a portion of the outer surface located between the proximal and distal ends of the suture lock 4306. For example, the retaining member 4304 contacts opposite sides of the suture lock 4306 to engage with it. In other embodiments, the retaining member 4304 contacts the suture lock 4306 at three or more points to restrain movement of the suture lock 4306 relative to the anchor 4302. FIG. 51 and FIG. 52 In this configuration, both the retaining member 4304 and the suture lock 4306 are cylindrically shaped, and the retaining member 4304 engages with the suture lock 4306 around its periphery. FIG. 51 and FIG. 52 In this embodiment, the engagement contact between member 4304 and suture lock 4304 extends longitudinally along the circumferential surface of the suture lock. In some embodiments, the engagement contact may extend over half of the longitudinal extent of the suture lock. In other embodiments, the engagement contact may extend over a percentage ranging from about 20% to about 98% of the longitudinal extent of the suture lock. In other embodiments, this range may be more limited, for example, from about 40% to about 80%, from about 50% to about 70%, or a combination of the ranges discussed herein (and any sub-ranges having the range explicitly mentioned by way of example).

[0342] FIG. 51 and FIG. 52A support member 4354 or support coil is also shown, which can reinforce the material of the retaining member 4304 when it secures the suture lock 4306 and the suture 4308. In some embodiments, the anchor 4302 and the support member 4354 are two separate structures that can be combined, while in other embodiments, the anchor 4302 and the support member 4354 are integrally formed from a single material. The support member 4354 may extend along the length of the retaining member 4304 to terminate at a position substantially aligned with the distal surface of the suture lock 4306 when the suture lock 4306 is fully inserted into the socket 4304. In other embodiments, the support member 4354 may extend along the length of the retaining member 4304 to terminate at a position substantially aligned with the upper portion of the suture lock 4306 but located below (or proximal to) the distal surface of the suture lock 4306. The support member 4354 contacts the outer surface of the retaining member 4304. The bonding material 4362 is placed along the exposed outer surfaces of the support member 4354 and the retaining member 4304. This bonding material 4362 may also contact the exposed outer surface of the anchor hub 4338.

[0343] In some embodiments, the support member 4354 provides axial stiffness to prevent folding when the suture lock 4306 enters the retaining member 4304. For example, in FIG. 51 and FIG. 52 In this embodiment, the support member 4354 is a support coil that resists longitudinal forces exerted on the retaining member 4304 by the suture lock 4306 when the suture lock 4306 is pressed into the retaining member 4304. This additional stiffness keeps the retaining member 4304 stable, thereby increasing ease of installation. In other embodiments, the retaining member 4304 may be formed of other materials and may be formed in other configurations. For example, the support member 4304 may be formed of a plurality of metal strips extending longitudinally along the outer surface of the retaining member 4304, or it may be one or more cylindrical hoops spaced longitudinally along another surface of the retaining member 4304. In some embodiments, the retaining member 4354 is formed of nitinol teeth or similar materials.

[0344] In some embodiments, the support member 4354 provides additional securing force to retain the suture lock 4306 and the suture 4308 within the retaining member 4304. For example, in FIG. 51 and FIG. 52In this embodiment, the support member 4354 is a support coil. In some embodiments, when the suture lock 4306 is pressed into the retaining member 4304, the support coil is linearly compressed, and its inner diameter increases to accommodate the suture lock 4306. The compressive force of the support coil (e.g., when it springs back toward its original configuration and smaller inner diameter) increases the frictional force between the retaining member 4304 and the suture lock 4306. Furthermore, in some embodiments, the support coil is configured to extend linearly in response to a force pulling the suture lock 4306 from the retaining member 4304. This further reduces the inner diameter of the support coil, thereby increasing the frictional force between the retaining member 4304 and the suture lock 4306.

[0345] In some embodiments, the support member 4354 terminates at a midpoint below the distal portion of the retaining member 4304. In this way, compared to the combination of the retaining member 4304 and the support member 4354, the distal portion of the retaining member 304 above the support member 4354 applies relatively less force to the suture lock 4306 and the suture 4308. With these relatively small forces, the physician can adjust the tension or length of the suture 4308 without displacing the suture lock 306 from the retaining member 4304.

[0346] In other words, in some embodiments, the retaining member 4304 (alone or in combination with the supporting member 4354) provides sufficient force to retain the suture lock 4306 during the cardiac cycle (e.g., a force from about 0 N to about 4 N). The force applied to the suture 4308 by the physician (e.g., pulling the proximal end of the suture 4308) and / or the leaflet (e.g., pulling the distal end of the suture 4308) allows the physician to adjust the suture 4308 relative to the suture lock 4306 while the suture lock 4306 remains fixed within the retaining member 4304 to adjust the length of the suture 4308 between the suture lock 4306 and the leaflet. In some embodiments, the magnitude of the force required to move the suture 4308 is in the range of 1 N to 2 N. Therefore, the retaining member 4304 (alone or in combination with the supporting member 4354) secures the suture lock 4306 relative to the anchor 4302 during adjustment of the suture 4308. Once the suture lock 4306 engages with the suture 4308 (as described below), the retaining member 4304 fixes the suture lock 4306, which in turn fixes the suture 4308 as part of the chordae tendineae of the prosthesis mitral valve.

[0347] Still refer to FIG. 51 and FIG. 52In the described embodiment, the retaining member 4304 is a generally cylindrical structure. The retaining member 4304 can be a scaffold or scaffold graft structure formed of ePTFE ( wholly or partially). The material forming the retaining member 4304 promotes inward tissue growth to further secure the anchor 4302 and / or the prosthetic chordae tendineae. The material forming the retaining member 4304 may include a thin-film microstructure in which the fibrils are oriented substantially parallel to the longitudinal axis of the retaining member 4304. In this way, any longitudinal movement of the suture 4308 (e.g., an ePTFE suture) will be aligned with the fibril orientation to further reduce suture friction and abrasion.

[0348] In other words, in some embodiments, the retaining member 4304 is made of ePTFE grafts, elastomers, other polymers, or combinations of these materials. For example, in some embodiments, the retaining member 4304 is constructed from ePTFE stretch grafts and may be densified to enhance column strength. In some embodiments, the retaining member 4304 is partially or fully bioresorbable or bioabsorbable and provides temporary fixation until, for example, biofibrillary adhesion occurs between tissue and other components. In some embodiments, the retaining member 4304 includes a mesh designed to enhance biocompatibility and fibrosis after implantation. All or part of the surface of the retaining member 4304 may be configured to promote tissue growth on and / or through its surface. In one example, such growth is achieved by providing a relatively rough and / or porous surface. Another example is drilling one or more holes in the material of the retaining member 4304 to allow scar tissue fibroblasts to grow through these holes, thereby increasing the strength of the fixation. Furthermore, biocoatings of types known in the art may be included on the surface of the retaining member 4304 to promote healing and tissue growth.

[0349] The suture lock 4306 can be secured within the retaining member 4304, where it is coaxially aligned with the anchor 4302. This configuration minimizes or eliminates relative movement of the suture lock 4306 relative to the suture 4308, at least within the retaining member 4304. This configuration also minimizes or eliminates movement of the suture 4308 relative to both the suture lock 4306 and the anchor 4302 within the retaining member 4304.

[0350] In some embodiments, the length of the support member 4354 ranges from approximately 0.5 mm to 3.0 mm. In other embodiments, the length of the support member 4354 varies from one-quarter of the length of the retaining member 4304 to the entire length of the retaining member 4304.

[0351] Other implementations (e.g., FIG. 2A ,FIG. 2B , FIG. 55 The embodiments shown do not include support member 4354. Some embodiments of these embodiments provide varying restraining forces through other mechanisms, including changing the material and / or surface treatment used to construct different portions of the socket or changing the size of the socket at different locations. Other embodiments utilize external tools to expand the upper portion of the socket or otherwise reduce the restraining force on the suture lock and suture at that upper portion.

[0352] like FIG. 52 As can be seen, the suture 4308 may be located between the outer surface of the suture lock 4306 and the inner surface of the retaining member 4304. In some embodiments, these surfaces (wholly or partially) are designed to facilitate the fixation of the suture 4308, for example, thereby providing a surface with a higher coefficient of friction. In other embodiments, these surfaces (wholly or partially) are designed to allow the suture 4308 to be easily adjusted, thereby providing a surface with a lower coefficient of friction. One or both of these surfaces may be resilient to help fix the suture 4308 while enabling adjustment.

[0353] Securing suture 4308 between suture lock 4306 and retaining member 4304 can provide additional advantages. For example, even when the tension on the proximal portion of the suture (e.g., the portion extending proximally from the inlet 4306 toward the physician or catheter) changes or is eliminated, suture lock 4304 and retaining member 4304 can maintain the tension on the distal portion of the suture (e.g., the portion extending from the suture lock 4306 toward the leaflet). As a result, once suture lock 4306 is placed within retaining member 4304, thereby securing suture 4308, any change in tension on the proximal portion of the suture (e.g., in the event of the physician accidentally bumping into the catheter) will have virtually no effect on the tension in the distal portion of suture 4308. Therefore, the physician does not need to keep each suture 4308 taut during the procedure. Furthermore, in some embodiments, suture lock 4306 and retaining member 4304 can be used to maintain the tension in the distal portion of another suture during adjustment of one suture.

[0354] like FIG. 52As shown, in some embodiments, the retaining member 4304 includes an upper enlargement 4376 and a lower enlargement 4378. These enlargements 4376, 4378 provide additional axial stiffness to prevent folding or buckling when the suture lock 4306 is pushed into the retaining member 4304. Furthermore, the enlarged upper portion 4376 may incorporate a band that increases stiffness and provides a radiopaque marking. In some embodiments, the upper enlargement 4376 includes an outer surface positioned further outward (e.g., radially) than the lower portion of the insertion port. The upper enlargement 4376 may include an inner surface positioned further outward (e.g., radially) than the lower portion of the retaining member 4304. For example, the upper enlargement 4376 may be tapered (e.g., funnel-shaped) to aid in receiving the suture lock 4306.

[0355] Sutures 4308 and 4310 can be formed from surgical-grade materials, such as biocompatible polymer suture materials. Examples of such materials include 2-0 ePTFE (polytetrafluoroethylene) or 2-0 polypropylene. In some embodiments, sutures 4308 and 4310 are non-elastic. In other embodiments, sutures 4308 and 4310 can be partially or fully elastic. In some embodiments, sutures 4308 and 4310 are partially or fully bioresorbable or bioabsorbable and provide temporary fixation until, for example, biofiber adhesion occurs between tissue and other components. Therefore, sutures 4308 and 4310 can be formed from biocompatible materials such as nitinol, ePTFE, PTFE, PET or polyester, nylon, silicone, collagen or other amino acid proteins, stainless steel, cobalt-chromium alloys, combinations thereof, etc.

[0356] FIG. 51 and FIG. 52 An anchor hub 4338 is shown, which can contact cardiac tissue 4352 and can serve as a stop point for anchor 4302 when anchor 4302 is screwed into cardiac tissue. Anchor hub 4338 may include an upper surface, which in some embodiments is coupled to bushing 4353 (discussed below). Anchor 4302 and anchor hub 4338 may be joined together mechanically, chemically, or otherwise, for example by friction engagement. Anchor hub 4338 can transmit forces applied to retaining member 4304 (e.g., via suture 4308) to cardiac tissue 4252 via anchor 4302. In this way, anchor hub 4338 works with retaining member 4304 to suppress oscillatory motion caused by movement of the heart.

[0357] In some embodiments, the proximal surface of the anchor hub 4338 contacts the suture lock 4306 (e.g., the nose of the suture lock 4306) and the suture 4308. The anchor hub 4338 (or at least its proximal surface) may be formed of a material designed to increase friction to secure the suture 4308 located between the anchor hub 4338 and the suture lock 4306, or it may be formed of a material that reduces friction to facilitate adjustment of the suture 4308 located between the anchor hub 4338 and the suture lock 4306. The anchor hub 4338 may be formed of PFA, silicone, PTFE, ePTFE, thermoplastic, etc. (or combinations thereof). In some embodiments, the anchor hub 4338 is partially or entirely formed of metal, stainless steel, or titanium, or may be formed of rigid plastics such as PEEK or other sufficiently rigid materials. The proximal surface of the bushing or anchor hub 4338 that interacts with the suture lock may be made of PFA, silicone, PTFE, ePTFE, thermoplastic, etc. (or combinations thereof).

[0358] In some embodiments, bushing 4353 is positioned adjacent to anchor hub 4338 to cushion suture lock 4306. This bushing may be formed of PFA or another polymer. The bushing provides a surface that contacts suture 4308 and engages with the nose of suture lock 4306 to help secure suture 4308. In some embodiments, the bushing facilitates suture adjustment due to the interaction between the PFA material of the bushing and the ePTFE material of suture 4308. The bushing may also provide a surface that reduces suture abrasion, particularly where anchor hub 4338 has a rougher surface adjacent to suture 4308 (e.g., due to the material and / or surface of anchor hub 4338). The proximal surface of bushing 4353 or anchor hub 4338 that interacts with suture lock may be made of PFA, silicone, PTFE, ePTFE, thermoplastic, etc.

[0359] In some embodiments, the diameter of the hub (e.g., hub 4338) corresponds to the smaller diameter or inner diameter of the support member 4354. Depending on how the hub 4338 is attached, the length of the hub 4338 is long enough to allow the support member 4354 to be attached to and driven into engagement with the hub 4338. The geometry of the retaining member 4304 attached to the hub 4338 is smaller than the smaller diameter of the support member 4354. In some embodiments, the outer diameter of the retaining member 4304 is smaller than the larger diameter of the support member 4354.

[0360] like FIG. 52As shown, the anchoring stitch 4310 can pass through the channel 4336 of the anchor hub 4338 and can be secured near the bottom surface 4340 of the anchor hub 4338. In some embodiments, the channel 4336 includes a bottleneck portion 4342 that secures the anchoring stitch 4310 (e.g., by capturing a knot formed at the end of the anchoring stitch 4310 below the bottleneck portion 4342). In other embodiments, the anchoring stitch 4310 and the anchor hub 4338 are joined together mechanically, chemically, or by other similar means, for example, by friction engagement.

[0361] The suture lock 4306 may incorporate features of suture locks disclosed herein and / or disclosed in PCT / US2017 / 069046 and PCT / US2019 / 021480. The suture lock 4306 may include a cylindrical outer surface corresponding to the cylindrical chamber of the retaining member 4304 to provide a frictional or interference fit. The suture lock 4306 may include a locking mechanism (e.g., an internal locking mechanism) for selectively securing the anchoring sutures 4310 and 4308. The illustrated suture lock 4306 includes a nose 4370 having a circular surface on which the suture is pressed when tensioned. In this way, the suture lock 4306 avoids sharp edges that could cause abrasion to the suture 4308. In some embodiments, the nose 4370 is formed of, for example, PFA or another material designed to reduce suture abrasion.

[0362] The suture lock 4306 can travel downwards along the anchor suture 4310 until it enters the cylindrical chamber of the retaining member 4304. The retaining member 4304 may provide some radial resistance to the suture lock 4306, but may be radially compliant to receive the suture lock 4306. In some embodiments, the suture 4308 can be adjusted even when the suture lock 4306 is bottomed out (i.e., downwards to the end of the insertion port 4304, which may include pressing against the bushing 4353). For example, the suture 4308 is most easily adjusted when the suture lock 4306 is outside the retaining member 4304. However, the suture 4308 can still be adjusted even after the suture lock 4306 has entered the retaining member 4304. In some embodiments, when the suture lock 4306 is bottomed out, the suture 4308 is clamped between the PFA bushing 4353 and the PFA nose 4370 of the suture lock 4306. At this stage, the suture 4308 can still be adjusted in some embodiments, albeit with greater resistance. For example, the material of the suture lockneck 4370 and the bushing 4353 can reduce friction for easier adjustment. In other embodiments, the bushing 4353 and the lockneck 4370 are designed to hold the suture in place and prevent further movement.

[0363] In some embodiments discussed above, the anchor 4302 and the retaining member 4304 are pre-assembled. In other words, the anchor 4302 and the retaining member 4304 are coupled together outside the patient's body. The suture lock 4306 is then coupled to the retaining member 4304 inside the patient's body (e.g., via an interference fit or a friction fit). In other embodiments, the retaining member 4304 and the suture lock 4306 are coupled together outside the patient's body. The retaining member 4304 and the anchor 4302 are then coupled together inside the patient's body (e.g., via an interference fit or a friction fit).

[0364] In some embodiments, the retaining member 4304 is configured to expand. For example, in some embodiments, the retaining member 4304 is formed of an elastic material that expands when the suture lock 4306 is pressed down into the retaining member 4304 and reseals around the suture lock 4306 to help secure it in place. In other embodiments, the retaining member 4304 has an expanded configuration and a retracted position. The retaining member 4304 can be delivered in its expanded configuration, and once the suture lock 4306 is in place, the retaining member 4304 retracts downward to its retracted position to secure the suture lock 4306 in place.

[0365] In some implementations, and as such FIG. 53 As shown, anchor 4402 defines a longitudinal line 4403, and retaining member 4404 or limiting member (e.g., a socket) constrains the movement of stitch lock 4406 relative to anchor 4402 in a direction orthogonal to the longitudinal line 4403 defined by anchor 4402. In some embodiments, retaining member 4404 constrains the movement of stitch lock 4406 relative to anchor 4402 in a plane orthogonal to longitudinal line 4403. In some embodiments, retaining member or limiting member (e.g., socket 4404) constrains the movement of stitch lock relative to anchor along longitudinal line 4403.

[0366] For example FIG. 53 As observed, the restraining member 4404 generally aligns the longitudinal line 4403 defined by the anchor 4402 and / or the longitudinal line 4405 defined by the restraining member 4404 with the longitudinal line 4407 defined by the suture lock 4406. In some embodiments, the retaining member 4404 secures the suture lock 4406 in a coaxial relationship with the anchor 4402 and / or the retaining member 4404. In some embodiments, the longitudinal lines defined by the anchor 4402, the retaining member 4404, and / or the suture lock 4406 extend to the leaflets of the mitral valve.

[0367] In some implementations, and as such FIG. 54As shown, retaining member 4504 constrains the angular movement of the suture (suture 4511) relative to the suture lock 4506. (As mentioned above regarding...) FIG. 49 and FIG. 50 In some embodiments discussed, the suture lock rotates in response to forces during the cardiac cycle, causing the angle formed by the portion of the suture extending from the suture lock toward the leaflet relative to the longitudinal line defined by the suture lock to vary over a wide range. The position of the suture lock above the anchor and closer to the leaflet also contributes to angular movement. However, as... FIG. 54 As shown, retaining member 4504 restricts angular movement of suture 4511 by securing suture lock 4506 in a specific orientation. For example, in some embodiments, the angle 4520 between the portion of suture 4511 extending from suture lock 4506 toward the leaflet and the longitudinal line 4522 of suture lock 4506 is less than 45°. In some embodiments, the angle 4520 can range from approximately -45° to +45°, which can also be understood as approximately 0° to 45° in two opposite directions. This angle 4520 can be formed in any plane including the aforementioned portion of suture 4511 and the longitudinal line 4522 of suture lock.

[0368] Although the suture 4511 will move during the cardiac cycle, the retaining member 4504 can constrain the angular movement (change in angle 4520) to less than 90°. In some embodiments, the angle change is less than 45°, while in other embodiments, the angle change may be less than about 40°, 35°, 30°, 25°, 20°, 15°, 10°, 8°, or even less than about 5°.

[0369] A method for measuring the angular change between the ventricular anchor and the suture lock.

[0370] The angular variation between the anchor and the suture lock can be determined, for example, by the following steps:

[0371] 1. Secure the ventricular anchor to one side of the tensile testing machine. This can be done by simulating ventricular anatomy, such as with a silicone pad, or by clamping it into the jaws of a standard tensile testing machine.

[0372] 2. Secure the prosthetic chordae tendineae to the other side of the tensile testing machine. This can be done by simulating valve anatomy, such as with a silicone pad, or by clamping it into the jaws of a standard tensile testing machine.

[0373] 3. Use a suture lock to connect the ventricular anchor and the prosthetic chordae tendineae together.

[0374] 4. Load the system with ventricular anchors, prosthetic tendineae, and suture locks in a tensioned manner to a minimum of 2 N.

[0375] 5. Measure the angle (angle 1) between the axis of the suture lock or any linear feature of the suture lock and the axis of the ventricular anchor or any linear feature of the ventricular anchor.

[0376] 6. Unload the system with ventricular anchors, prosthetic chordae tendineae, and suture locks to a load of less than 0 N or a load equal to the suspended static weight of the system on the load cell.

[0377] 7. Measure the angle (angle 2) between the axis of the suture lock or any linear feature of the suture lock and the axis of the ventricular anchor or any linear feature of the ventricular anchor.

[0378] 8. Calculate the difference between angle 1 and angle 2.

[0379] During the implantation of the prosthetic chordae tendineae, the anchor and retaining member can be delivered (e.g., via a catheter), and the anchor is implanted into the ventricular tissue. Anchoring sutures extend from the anchor. Sutures (e.g., gauze sutures) are then connected to one or more mitral valve leaflets. A suture lock advances along the anchoring sutures and the gauze sutures. In some implementations, the physician can adjust the position of the suture lock relative to the gauze sutures such that the length of the gauze suture between the suture lock and the leaflet ensures adequate manipulation of the prosthetic chordae tendineae (e.g., to reduce and / or eliminate MR). For example, the physician can pull the proximal portion of one of the sutures to reduce the amount of suture between the suture lock and the mitral valve leaflet.

[0380] However, in some implementations, the suture lock can be unrestricted. As a result, adjustments to the suture (e.g., pulling on the suture) can cause the suture lock to move upwards, affecting the tension of the suture in the portion between the suture lock and the mitral valve. This problem is exacerbated when multiple sutures are used with the suture lock. Adjusting one of the sutures can elevate the suture lock, thereby offsetting any previous adjustments to the other suture.

[0381] For example, the suture can be attached to the leaflet and pass through a suture lock, which acts as a movable pulley for the suture. Specifically, when the surgeon pulls on the end of the suture located outside the body, this will move the suture. However, pulling on the proximal portion of the suture will move the suture lock upward, so there is no one-to-one correspondence between the surgeon's movement of the suture outside the body and the movement of the suture between the suture lock and the leaflet.

[0382] This problem is exacerbated when multiple sutures pass through a single suture lock. For example, a surgeon might adjust the first suture to the correct length. However, once the surgeon begins adjusting the second suture, this movement will cause the suture lock to shift, which can negatively affect the first suture and require readjustment. This, in turn, can negatively affect the second suture, leading to additional necessary adjustments.

[0383] Additional complications can arise when a physician cuts the suture after engaging the suture lock. Before cutting the suture, the physician maintains tension on the suture, which keeps the suture lock in an elevated position. Cutting the suture (and / or disconnecting the suture lock from the catheter) releases this tension, and the suture lock can shift downwards, affecting the effectiveness of the suture as a prosthetic chordae tendineae. Maintaining tension on the suture (e.g., maintaining tension on the first suture while adjusting a second suture) can also lead to additional complications. For example, any unintentional movement of the catheter (e.g., accidental impact) can cause the suture lock to shift and change the suture length between the suture lock and the tissue (e.g., leaflet).

[0384] Several embodiments discussed herein address these problems by securing the suture lock within a retaining member, thereby creating a pivot point for the suture that is relatively fixed relative to the anchor. This is particularly beneficial during suture adjustments when the surgeon is creating the prosthetic chordae tendineae. Securing the suture lock to the anchor (e.g., by a retaining member) essentially eliminates upward movement of the suture lock during adjustments.

[0385] Furthermore, having a fixed pivot point allows for a more direct correlation between adjustments to the proximal portion of the suture (i.e., pulling on the portion of the suture near the surgeon) and the resulting adjustments to the distal portion of the suture (i.e., the portion of the suture between the suture lock and the mitral valve). In particular, many of the embodiments discussed herein enable precise bidirectional adjustment of the suture, where movement of the guide device (e.g., a catheter) directly translates into, for example, a change in the length of the suture between the valve leaflet and the suture lock. For example, if the guide device moves forward by one millimeter, the suture also moves forward by one millimeter. This is referred to as “one-to-one movement.” Those skilled in the art will readily understand from this disclosure that several embodiments discussed herein can achieve one-to-one movement or near-one-to-one movement under various conditions. In particular, mechanisms for making the suture “pushable” are disclosed by reference to PCT / US2017 / 069046 and PCT / US2019 / 021480, which are incorporated herein by reference, including placing a rigid tubular structure (i.e., a coil) on the suture. The stiffness provided by the coil allows the suture to be pushed in a manner similar to a cardiac guidewire. At this point, the movement of the improved suture follows the movement of the guiding device (e.g., a catheter or coil) in a "one-to-one" manner.

[0386] In other words, securing the suture lock within the retaining member creates a fixed pivot point for the suture, ensuring a one-to-one correspondence between the surgeon's movement of the suture outside the body and its movement between the suture lock and the leaflet. As will be readily understood by those skilled in the art, in some cases, the one-to-one movement will be close to one-to-one due to other variations (e.g., slight elongation of the suture or minor movement of the suture lock within the suture apex), differing significantly in nature and extent from the suture lock movement discussed in, for example, unrestricted embodiments. For instance, the movement ratio can vary from 1:1 to approximately 1:0.95, 1:0.90, 1:0.85, 1:0.80, and so on, down to 1:0.50.

[0387] Using suture locks to create a fixed pivot point offers additional advantages. For example, when multiple sutures pass through a suture lock, each suture can be adjusted independently without significantly affecting the others. Specifically, with the suture lock secured within the retaining member, the first suture can be adjusted to the correct length. The physician can then begin adjusting the second suture without interfering with the adjustment of the first suture, as the suture lock does not move with the second suture.

[0388] Furthermore, in some embodiments, a portion of the first suture lies between the outer surface of the suture lock and the inner surface of the insertion port. When the physician adjusts the second suture, the force provided by these surfaces holds this portion of the first suture in place. This configuration provides the additional advantage that the physician does not need to maintain external tension on the first suture. Reducing or eliminating tension on the suture can reduce any elongation of the suture or other adverse effects on the suture.

[0389] Furthermore, the first suture can be cut without altering the position of the suture lock or the length of the suture between the suture lock and the tissue. As those skilled in the art will understand, there may be some incremental movement (e.g., less than 5 / 1000 inch or less than 5 / 100 inch), which in this context can be considered a substantial change in position.

[0390] In addition, in some implementations, the suture lock is used as a fixed pivot point positioned close to the target tissue area (e.g., near the apex of the heart), which can increase the ease of installation.

[0391] In some embodiments, multiple sutures are attached to tissue (e.g., one or more leaflets) and pass through a suture lock. Each suture has a length extending between the suture lock and the tissue. When the suture lock is placed in a retaining member, the suture is held in place. If adjustment of the first suture is required (e.g., reducing the length of the first suture between the suture lock and the tissue), the suture lock can be removed from the retaining member, and the physician can pull the first suture to reduce its length. However, during this adjustment, the position of the suture lock remains relatively stationary (e.g., the suture lock moves no more than 1 mm). Therefore, the physician does not need to further adjust or readjust other sutures. In some embodiments, the suture can be adjusted while the suture lock is within the retaining member. The retaining member fixes the suture lock, thereby further reducing or eliminating movement of the suture lock during suture adjustment. For example, the movement of the suture lock can be less than or equal to approximately 0.5 mm.

[0392] In some embodiments, the suture lock engaged in the retaining member is relaxed enough that the force on the leaflet and the suture (e.g., ePTFE chordae tendineae) is sufficient to pull the suture across the interface between the suture lock and the retaining member, around the nose of the suture lock, through the open clamping mechanism of the suture lock, and back to the reinforced, drivable portion of the suture assembly. The operable force in this case can vary from 0 N to approximately 2 N. In some embodiments, the force ranges from 0.15 N to 1.50 N.

[0393] In some implementations, the physician pulls on the outer portion of the suture to reduce its length between the suture lock and the leaflet. If the physician wishes to increase the suture length between the suture lock and the leaflet, the physician can release tension on the outer portion of the suture, and the movement of the leaflet during the heart's natural cardiac cycle will pull on the suture. In some implementations, the suture lock is positioned in a first part of the retaining member, wherein the force acting on the suture is small enough that the physician and the leaflet can influence the change in the suture length between the suture lock and the leaflet, for example, a force between 0 N and 2 N. Simultaneously, the fastening force provided by the retaining member prevents the suture lock from moving during these adjustments or limits its movement to approximately 0.5 mm.

[0394] In some implementations, once the suture length between the suture lock and the corresponding tissue is correct (e.g., MR is clinically reduced or eliminated), the suture lock is pressed into a second part of the retaining member, which can apply a greater tightening force to the suture lock and the suture. Therefore, the force provided by the leaflet will not cause the suture to move within the suture lock (or only slightly, e.g., about 0.5 mm), so that the suture length between the suture lock and the tissue remains unchanged (or the amount of tension provided by the suture alone is moved, e.g., about 10%). At this point, the physician can measure and analyze the arrangement and tension provided by the prosthetic chordae tendineae. If satisfied, the physician can engage the suture lock to clamp the suture. In this configuration, the prosthetic chordae tendineae can be used for at least 400 million cycles, approximately 10 years, or even 800 million cycles, or approximately 20 years.

[0395] In some implementations, the suture is permanently secured solely by the restraining force provided by the retaining member, either alone or in conjunction with the outer surface of the suture lock. For example, the suture lock may not have any internal clamping or restraining mechanisms but instead provide an outer surface that, together with the inner surface of the retaining member, secures the suture against further movement caused by forces from the heart's natural circulation.

[0396] In some embodiments, the retaining member enables the suture lock to work with sutures of different sizes. For example, once the suture lock is inserted into the first part of the retaining member, sutures with larger sizes and / or thicknesses can be secured. Sutures with smaller sizes can also be secured, for example, by pressing the suture lock deeper into the retaining member.

[0397] The various embodiments of this disclosure can provide additional advantages by facilitating easy adjustment of the sutures. For example, friction can cause difficulties in adjusting the sutures, as well as in their lifespan and effectiveness. Some embodiments address this problem by using a suture lock with a tapered nose. For example, as... FIG. 52As shown, the distal end of the suture lock 4306 includes a tapered nose 4370. The outer surface of the suture lock 4306 has a cylindrical shape, and the outer surface of the nose 4370 also has a cylindrical shape, with its radius decreasing toward the distal end of the nose 4370.

[0398] The front surface of the nose 4370 presents an inner hole surrounded by a ring of tapering nose portion. In some embodiments, the diameter of the inner hole can range from 1 mm to 3 mm. The thickness of the ring can range from 0.5 mm to 2.0 mm.

[0399] The tapered nose 4370 facilitates the insertion of the suture lock 4306 into the retaining member 4304. In some embodiments, the nose 4370 tapers more steeply, while in other embodiments, it tapers less steeply. Additionally or alternatively, the retaining member 4304 may include a proximal portion whose profile tapers outward to guide the suture lock 4306 into the inner portion of the retaining member 4304. For example, the proximal end of the retaining member 4304 may have a larger radius than the middle portion of the retaining member 4304. As described above, the anchoring suture 4310 may also be used to guide the suture lock 4306 downward into the retaining member 4304.

[0400] like FIG. 52 As shown, the inner surface of the nose portion 4370 may include a proximal portion whose thickness increases along a longitudinal line from the anterior portion to the middle portion. After this middle portion, the thickness of the nose portion decreases toward the distal portion. In some embodiments, the proximal end of the nose portion may be configured to snap-fit ​​onto a suture lock body.

[0401] To facilitate bidirectional adjustment, some embodiments reduce friction on the sutures through suture locking and retaining members. For example, the nose contour provides a rounded surface, which facilitates movement of the sutures around the nose without abrading the sharp edges of the sutures. Furthermore, the nose may be composed of materials such as PFA or other materials that further reduce friction between the sutures and the nose.

[0402] The nose can be configured to accommodate multiple sutures simultaneously. Simultaneously, the tapered profile facilitates easier access to the retaining member. To utilize these two features, the size of the opening in the nose can correspond to the number of sutures to be used. For example, when using two sutures, the diameter of the nose opening can be 1 mm, while when using four sutures, the diameter of the nose opening can be 2 mm. Generally, the diameter-to-number-of-sutures ratio can be approximately 0.5 mm per suture. In some embodiments, different noses (e.g., noses with openings of different sizes) can be used interchangeably with a single suture lock body. In other embodiments, the size of the suture lock (e.g., the diameter of the suture lock) can be larger or smaller to accommodate different numbers of sutures.

[0403] In some embodiments, the retaining member is formed of ePTFE material, wherein the fibrils of the membrane microstructure are oriented in a direction generally parallel to the longitudinal axis of the retaining member. In this way, any longitudinal movement of the suture (e.g., ePTFE suture) will be aligned with the fibril orientation to further reduce friction and abrasion on the suture. For example, in some embodiments, the retaining member (whole or at least the inner surface) is formed of a generally integral ePTFE covering having nodes and fibril microstructures, wherein the nodes are oriented generally perpendicular to the longitudinal axis of the retaining member and the fibrils are oriented generally parallel to the longitudinal axis of the retaining member.

[0404] As discussed above, the retaining member engages the suture and / or the suture lock. In some embodiments, it is necessary to disengage the suture lock from the retaining member to allow relaxation into the suture. This simplifies tension maintenance of one suture relative to another because it eliminates length variations caused by the catheter. In these embodiments, the suture lock can be disengaged from the interference fit with the retaining member to increase suture relaxation. In other words, in some embodiments, multiple sutures pass through the suture lock, which is inserted into the retaining member. Thus, the suture is held in place between the outer surface of the suture lock and the inner surface of the retaining member. If the physician needs to adjust one of the sutures, the suture lock can be removed from the retaining member. At this stage, the suture in question can be adjusted without significant upward movement of the suture lock. Therefore, adjustment of this suture does not significantly alter the tension of the other sutures.

[0405] In some embodiments, the retaining member serves as a prosthetic papillary muscle that is part of the prosthetic chordae tendineae. Materials may be selected for, for example, the retaining member and sutures (as well as anchors and / or suture locks) to promote tissue encapsulation, tissue inward growth, and / or specific biological responses.

[0406] FIG. 55 The illustration shows another embodiment of the transcatheter mitral valve chordae tendineae repair system 4600. The system 4600 includes... FIG. 51 and FIG. 52 The features shown are similar to those in the previous embodiment. However, in this embodiment, the retaining member 4604 does not include a support member. Instead, the anchor 4602 terminates at the lower surface of the retaining member 4604 around the anchor hub 4638. A mechanical connection or joint 4601 secures the retaining member 4604 to the anchor hub 4638. The anchor 4602 and the anchor hub 4638 can be connected together in the manner described above. FIG. 55 In the middle, the wall of component 4604 can be compared to FIG. 51 and FIG. 52The wall thickness of the insertion port is 25% to 100%. A thicker wall can provide axial support to prevent buckling when the suture lock 4606 enters the retaining member 4604, while still being compliant enough to allow passage. A mechanical coupling or joint secures the anchor hub 4638 to the retaining member 4604, extending on the anchor hub 4638.

[0407] Some implementations relate to a method for transcatheter mitral valve chordae tendineae repair using a transcatheter mitral valve chordae tendineae repair system. In this process, the anchor and anchor insertion port are delivered, for example, via a delivery catheter. FIG. 56 to FIG. 58 The diagram illustrates the method of deploying anchor 4702, socket 4704, and stitch lock 4706. FIG. 56 In this configuration, anchor 4702 is located within port 4704. Both anchor 4702 and port 4704 can pass through the catheter and enter the left ventricle (e.g., via the left atrium). In some embodiments, anchor 4702 is fully retracted into port 4704 to prevent it from contacting or puncturing the catheter or other tissue. Once port 4704 is positioned against the ventricular wall, anchor 4702 is pushed out of port 4704 and into the tissue. As anchor 4702 emerges from port 4704, port attachment 4755 captures the coil thread until port attachment 4755 finally contacts anchor hub 4738 to lock anchor 4702 in place. In some embodiments, port attachment 4755 is a suture with a loop or series of loops through which the coil passes. In other embodiments, the socket attachment 4753 is an extension of the socket material at the distal end of the socket 4704, the extension having a hole or a series of holes through which the coil passes. In both examples, the coil is advanced by pressing the coil through the hole or ring until the socket attachment 4753 is secured against the hub 4738.

[0408] FIG. 57 The illustration shows anchor 4702 and socket 4704 once anchor 4702 is deployed into the ventricular tissue. Socket attachment device 4755 secures anchor hub 4738 (and anchor 4702) relative to socket 4704. Suture lock 4706 is then advanced along anchor suture 4710 into socket 4704 until suture lock 4706 contacts bushing 4753, as shown. FIG. 58 As shown. Once the suture 4708 is properly tensioned, the suture lock 4706 can be activated and lock the suture 4708 and anchor suture 4710 into place. The suture lock 4706 is coaxially aligned with the anchor 4702 and parallel to the suture 4708, which is fastened between the outer surface of the suture lock 4706 and the inner surface of the socket 4704. The suture 4708 is also fastened between the curved nose of the suture lock 4708 and the bushing 4753.

[0409] FIG. 59 and FIG. 60 The illustration shows another embodiment of the transcatheter mitral valve chordae tendineae repair system 4800. This system may include... FIG. 51 and FIG. 52 Similar features to those shown. In this embodiment, the anchoring gauze 4860 is incorporated into the anchoring suture 4810. When the suture lock 4806 is advanced into the insertion port 4804, the gauze 4860 contracts to form a bushing between the anchor hub 4838 and the suture lock 4806. The suture lock 4806 can selectively engage the remaining portion of the suture 4808 connected to the leaflet and the anchoring suture 4810.

[0410] FIG. 61 The illustration shows a spigot formed from dense ePTFE 4850. In some embodiments, the spigot is formed of ePTFE. The spigot can be formed by folding the tube itself back to create two layers. This strengthens the spigot to resist axial compression and folding when the suture locks into the spigot. In some embodiments, the retaining member is made of a thick-walled graft material. To increase axial stiffness, the thick-walled graft material can be densified. FIG. 61 The illustration shows an example of this, depicting transplanted material that has been rolled to achieve the appropriate thickness and density. Furthermore, the resulting two-layer structure adds dense flexibility.

[0411] FIG. 62 The illustration shows the "rolled" end 4852 of the PTFE socket. In some embodiments, the socket is formed of ePTFE. A marking tape 4854 is placed on the outer surface of the tube before it is rolled, positioned such that the tape is positioned between the two rolled layers at the top of the socket. This tape may be a non-transparent tape. In some embodiments, the retaining member includes an end whose radial stiffness differs from other portions. For example, the proximal portion of the retaining member may be formed to have increased radial stiffness. In some embodiments, the marking tape is placed between layers of the graft material as the graft material is rolled to form the retaining member, such as... FIG. 62 As shown. The marking strip increases radial stiffness and prevents this portion of the retaining member from transmitting light. In some embodiments, the marking strip is retained between two PTFE layers or two ePTFE layers and compacted into a PTFE or ePTFE structure.

[0412] FIG. 63 and FIG. 64The illustration shows a dense PTFE socket 5004 designed to intersect with an anchor hub 5016. In some embodiments, the socket 5004 is formed of ePTFE. The dense PTFE or ePTFE socket 5004 includes a lower extension 5070 designed to mate around a corresponding recess 5072 in the anchor hub 5016. The lower extension 5070 secures the socket 5004 to the hub 5072. A radiopaque strip 5074 is located near the top of the socket 5004. The dense PTFE or ePTFE can be used to maintain the retaining force of the anchor. FIG. 63 As shown, it will be held in place by pressing PTFE or ePTFE into the retaining ring on the anchor. FIG. 64 An exemplary retaining member is illustrated, wherein a marking strip has been incorporated into the proximal portion, while the distal portion includes a dense portion designed to retain the anchor. FIG. 64 (Not shown in the image).

[0413] FIG. 65A and FIG. 65B The illustration shows an insertion port formed by creating the outer and inner walls of an inverted vascular graft catheter. This port is created from a biocompatible material. This material can be the same as the suture material, thereby minimizing or reducing suture abrasion at the location where it exists at the insertion port. The orientation of the fibrils on the insertion port surface can be aligned with the orientation of the fibrils of the suture to further minimize abrasion.

[0414] The various prosthetic chordae tendineae deployment systems discussed above can be used in many different medical applications. These implementations can reduce or eliminate movement of the suture relative to the suture lock and movement of the suture lock relative to the anchor. For example, in some implementations, the anchor is delivered into cardiac tissue, such as near the apex of the left ventricle or near the papillary muscles. As described above, the anchor can be delivered via a transseptal catheter advanced into the left atrium and through the mitral valve. The anchor is a helical anchor and is coupled to the retaining member. In some implementations, the anchor is initially delivered into the retaining member and then pushed out of the retaining member and into the cardiac tissue. Anchoring sutures are attached to the anchor (e.g., via the anchor hub). Leaflet anchors (e.g., gauze) are then delivered and attached to the leaflets of the mitral valve. In some implementations, the gauze is located on the ventricular side of the leaflet, wherein the gauze sutures extend from the atrial side of the leaflet. In other implementations, the gauze is located on the atrial side of the leaflet and the gauze sutures extend from the ventricular side of the leaflet. Multiple gauzes and sutures can be placed in one or more leaflets.

[0415] To influence the prosthetic chordae tendineae, in some implementations, a suture lock can be advanced along with the anchoring suture and the suture itself. Specifically, the proximal end of the suture enters through a hole in the suture lock and passes through it. The suture lock is guided toward the retaining member by the suture anchor. Because the suture lock is radiopaque, and because the retaining member may include a radiopaque band near its proximal surface, the physician can use imaging techniques to confirm the position of the suture lock relative to the retaining member. Furthermore, the use of a radiopaque band in the retaining member allows the physician to confirm that the suture lock has been fully inserted into the retaining member.

[0416] In some implementations, once the suture lock reaches the retaining member, the surgeon can adjust the length of the suture between the suture lock and the leaflet to affect each new prosthetic chordae tendineae. In some implementations, some or all of this adjustment is made via the suture lock at or within the retaining member. In some implementations, because the suture lock is held in a relatively constant position at the retaining member, any movement of the suture may result in a one-to-one or near-one-to-one movement of the suture distal to the suture lock. For example, the ratio of proximal suture movement to distal suture movement can range from 0.5 to 1.0.

[0417] In some embodiments, this adjustment is made using a suture lock located just outside the retaining member, wherein the physician holds the suture lock in place and keeps the suture under tension. In other embodiments, the adjustment is made via a suture lock within the retaining member (either in the proximal portion of the retaining member or in the distal portion of the retaining member adjacent to the anchor hub). In these embodiments, the retaining member holds the suture lock in place but allows the suture to slide through it. The physician does not need to hold the suture lock in place.

[0418] Furthermore, in some embodiments, the restraining force of the retaining member is sufficient to hold the suture in place against the force exerted by the leaflets, and also allows the suture to slide in response to pull from the physician. In these embodiments, the physician does not need to hold the suture lock in place, nor does he need to keep each suture under tension. Instead, the retaining member holds the tension of the distal portion of the gauze suture (i.e., the portion of the gauze suture located distal to the retaining member and extending into the leaflets). This allows the physician to adjust each gauze suture individually, and any unintentional movement of the catheter (e.g., accidental impact) will not affect the suture. Of course, in this case, the physician's adjustment is in one direction (i.e., shortening the suture length between the suture lock and the gauze). If the physician needs to increase the suture length between the suture lock and the gauze, the physician can remove the suture lock from the suture so that movement of the leaflets will again pull the suture through the suture lock.

[0419] Once the suture is properly tightened, the physician can lock the suture in place, for example, using the techniques described herein and / or in PCT / US2017 / 069046 and PCT / US2019 / 021480, using a suture lock. In other embodiments, the retaining member locks the suture in place without the need for an additional locking mechanism within the suture lock. The physician can then cut any excess suture (e.g., sutures located proximal to the retaining member). Because the sutures proximal to the retaining member are not under tension, cutting these sutures will not cause significant movement of the suture lock and / or the sutures located between the suture lock and the leaflet.

[0420] In other embodiments, the retaining member and the suture lock are integrated and delivered as a unit. In some embodiments, the unit includes an anchor or is attached to an anchor during delivery. The surgeon can adjust the length of the suture extending between the suture lock and the leaflet, and the suture lock can be used to permanently lock the suture in place.

[0421] The prosthetic chordae obtained in these embodiments may be more durable than existing prosthetic chordae. First, suture movement relative to the suture lock is reduced or eliminated, thereby reducing suture wear. Second, suture lock movement relative to the anchor is reduced or eliminated, thereby further reducing suture wear. The orientation of the suture relative to the suture lock also reduces suture wear. The additional features discussed above (including, for example, the nose of the suture lock) increase the lifespan of the prosthetic chordae.

[0422] FIG. 66 The illustrations depict anchors, retaining members, and stitch locks according to various aspects of this disclosure. FIG. 67 The diagram illustrates the orientation of the prosthetic chordae tendineae according to various aspects of this disclosure.

[0423] Suture lock protector

[0424] In some aspects described herein, once the tension and length of the new chordae tendineae implant are optimized, the suture lock can be locked to fix the length of the suture so that the suture no longer moves relative to the suture lock.

[0425] In other aspects of this disclosure, after the physician tightens the suture to correct or minimize a mitral valve defect, the suture may be clamped, stapled, or otherwise engaged and locked in a suture lock, thereby maintaining the applied length adjustment and suture tension. Through this step and the resulting locking engagement, the mitral valve defect can be corrected or minimized and remain corrected throughout the functional life of the new chordae tendineae (i.e., prosthetic chordae tendineae). To advance the suture lock through the delivery catheter and clamp or staple the suture within it, the suture lock may be coupled to a lock actuator mechanism that allows the physician to apply the necessary force to clamp or otherwise lock the suture within the suture lock. The lock actuator mechanism is a lock actuator, and in an alternative embodiment, depending on the tightening requirements of the suture lock, it may be a locking screw driver, such as an energy storage mechanism.

[0426] In some aspects, the suture lock can also be coupled to a protective cover located on or with the lock actuator, wherein the protective cover includes a retaining mechanism configured to reversibly retain the suture lock to the protective cover to enhance engagement of the lock actuator. According to some embodiments and as exemplified by... FIG. 68 As shown, the system includes a delivery catheter 6905, a suture lock 6935, and a protective shield 6915. Also as... FIG. 68 As shown, the suture lock 6935 includes a screw 6925 that engages with a lock actuator 6910, wherein the lock actuator can be rotated to advance or retract the bevel (or push wedge) 6930, thereby clamping the suture 6945 against the opposing inner surface of the suture lock 6940. The suture lock 6935 cascades to a protective cover 6915. The lock actuator 6910 (shown in dashed lines) engages with the screw head of the screw 6925. The coaxial insertion of the lock actuator 6910 through the protective cover 6915 can force the suture locking retainer 6920 ( FIG. 68The diagram illustrates two retaining members 6920 (on opposite sides of the protective cover 6915) protruding from the outer surface of the protective cover 6915. The suture lock retaining members 6920 may provide a frictional engagement (not shown) with the suture lock 6935 or may engage with one or more recesses (shown in dashed perspective) within the suture lock 6935. In alternative embodiments, a frictional engagement between the lock actuator and the protective cover may be used alone, without the need for suture lock retaining members or recesses. If the lock actuator 6910 is positioned distal to the suture lock retaining member 6920, the suture lock retaining member 6920 of the protective cover 6915 will engage with the suture lock 6935 to restrict or eliminate movement of the suture lock 6935 relative to the protective cover 6910. Once the physician tightens the suture to correct mitral valve movement, the physician can rotate the lock actuator 6910 to clamp or staple the suture within the suture lock 6935. It will be apparent to those skilled in the art that alternative suture lock clamping or locking configurations fall within the scope of this disclosure, such as pushing or pulling components together to engage the locking of the suture lock.

[0427] Once the suture is clamped within the suture lock, the physician can use any known visualization technique to confirm that the mitral valve defect has been corrected or minimized. For example, if further adjustment is required, the lock actuator 6910 can be rotated to relieve the force on the suture 6945 and the tension adjusted as needed, and the process repeated to clamp the suture. After confirming that the mitral valve defect has been corrected or minimized, the lock actuator 6910 can be retracted, thereby disengaging from the screw head of the screw 6925.

[0428] FIG. 69 and FIG. 70 The removal of the lock actuator 6910 and protective shield 6915 from the suture lock 6935 is depicted. As the lock actuator 6910 retracts from the suture lock and passes the suture lock retainer, the suture lock retainer retracts into the protective shield, thereby disengaging the protective shield 6915 from the suture lock. The protective shield 6915 can also disengage from the suture lock when the suture lock retainer is retracted. Once the protective shield 6915 disengages the suture lock retainer 6920 (not shown) from the suture lock 6935, the physician can remove the lock actuator 6910 and protective shield 6915 from the catheter.

[0429] In some embodiments, the anchor may further include a retaining member configured to engage with the suture lock, such that the suture lock maintains its positional relationship with the anchor. In these embodiments, a physician may apply pressure to the lock actuator and protective shield to insert the suture lock into the retaining member. Once the suture lock has been inserted into the retaining member and the suture has been properly tensioned, the suture can be clamped in the suture lock, and the lock actuator and protective shield can be retracted from the suture lock and from the catheter, as discussed above.

[0430] The suture lock may also include an alternative mechanism configured to actuate the suture holding mechanism. In some embodiments, the suture holding mechanism may be a screw, wherein rotation of the screw can reversibly apply or remove pressure on the suture. FIG. 68 to FIG. 70 The following embodiment is illustrated, wherein the suture holding mechanism includes a screw 6925, one or more bevels 6930, and a suture lock 6940. The opposing surfaces of the bevels and / or the suture lock may include a plurality of notches, each notch having a height that is advanced by rotation of the screw to clamp the suture. The height of each notch may increase or decrease from the innermost notch to the outermost notch. Other suture holding mechanisms, such as springs or other energy storage mechanisms, may be used to provide the force to clamp the suture within the suture lock. The spring may be activated, for example, in any known manner, whereby the stored energy of the spring may be released during removal of the protective cover from the suture lock.

[0431] In some arrangements, the suture thread may include any thread, cable, wire, filament, strand, rope, yarn, gut, or similar structure, whether natural or synthetic, in the form of monofilament, composite filament, or multifilament (whether braided, woven, twisted, or otherwise held together).

[0432] Although this disclosure describes certain implementations and examples, many aspects of the systems and methods described above can be combined and / or modified in different ways to form yet another implementation or acceptable example. All such modifications and variations are intended to be included within the scope of this disclosure. In fact, a wide variety of designs and methods are possible and fall within the scope of this disclosure.

[0433] Furthermore, certain features described in this disclosure in the context of individual implementations may also be implemented in a combined manner in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented individually or in any suitable sub-combination in multiple implementations. Moreover, although features may be described above as functioning in certain combinations, in some cases, one or more features from the claimed combination may be removed from the combination, and the combination may be claimed as a sub-combination of sub-combinations or a variant thereof.

[0434] Any particular feature, aspect, method, characteristic, quality, property, element, etc., disclosed herein with respect to various embodiments may be used in all other embodiments set forth herein. Furthermore, any method described herein may be practiced using any device suitable for performing the described steps.

[0435] Furthermore, while components and operations may be depicted in the drawings or described in the specification in a specific arrangement or order, such components and operations need not be arranged and performed in the specific arrangement and order shown, nor need they be arranged in sequence, nor do they include all components and operations in order to achieve the desired result. Other components and operations not depicted or described may be incorporated into the implementation and examples. For example, one or more additional operations may be performed before, after, simultaneously with, or between any operation in the described operations. In addition, operations may be rearranged or reordered in other implementations. Furthermore, the separation of the various system components in the above embodiments should not be construed as requiring such separation in all embodiments; it should be understood that the described components and systems can generally be incorporated into a single product or packaged into multiple products.

[0436] In summary, this document describes various illustrative embodiments and examples. Although systems and methods have been disclosed in the context of those embodiments and examples, this disclosure extends the specific disclosed embodiments beyond other alternative embodiments and / or other uses of the embodiments, as well as certain modifications and equivalents thereof. It is expressly contemplated that various features and aspects of the disclosed embodiments can be combined with or substituted for each other. Therefore, the scope of this disclosure should not be limited to the specific disclosed embodiments described above, but should be determined only by a fair reading of the appended claims and their full scope of equivalents.

Claims

1. An intravascular deployment catheter for deploying an implantable device, the intravascular deployment catheter comprising: An elongated, flexible tubular body having a proximal end, a distal end, and a central lumen; A sheath located at the distal end of the tubular body, the sheath having sidewalls defining a chamber for removably receiving the implantable device; At least one radially extending first engagement element is located on the sidewall and exposed to the chamber, and the first engagement element is used to engage a complementary second engagement element located on the implantable device.

2. The intravascular catheter deployment according to claim 1, wherein, The sheath can switch between a radially enlarged configuration for accommodating the implantable device and a radially reduced configuration after the implantable device is deployed.

3. The intravascular catheter according to claim 1 or 2, wherein, The first coupling element includes a helical wire.

4. The intravascular deployment catheter according to claim 1, 2 or 3, further comprising the implantable device located within the sheath.

5. The intravascular catheter deployment according to claim 4, wherein, The implantable device is axially advanced in response to rotation of the implantable device relative to the sheath.

6. The intravascular catheter deployment according to claim 5, wherein, The implantable device includes a tissue anchor.

7. The intravascular catheter deployment according to claim 6, wherein, The tissue anchor includes a hub and a helical tissue engagement anchor, which are rotatably engaged with the first engagement element.

8. A ventricular tissue anchor delivery system, comprising: An elongated, flexible tubular body having a proximal end, a distal end, and a central lumen; A sheath located at the distal end of the tubular body, the sheath having sidewalls defining a chamber; A ventricular tissue anchor, wherein the ventricular tissue anchor is removably positioned within the cavity, the ventricular tissue anchor comprising a hub and a helical tissue anchor; as well as At least one radially extending first engaging element, located on the sidewall and exposed to the chamber, and the first engaging element is used to engage the helical tissue anchor. The rotation of the spiral tissue anchor relative to the tubular body propels the spiral tissue anchor distally out of the cavity.

9. The ventricular tissue anchor delivery system of claim 8, further comprising an anchor driver extending along the entire length of the tubular body.

10. The ventricular tissue anchor delivery system according to claim 8 or 9, wherein, The first engagement element includes a helical channel formed on the inner surface of the sheath.

11. The ventricular tissue anchor delivery system according to claim 8, 9, or 10, wherein, The sheath is capable of switching between a radially enlarging configuration for accommodating the helical structure anchor and a radially shrinking configuration after the deployment of the helical structure anchor.

12. The ventricular tissue anchor delivery system according to claim 11, wherein, The sheath is capable of switching from the radially expanding configuration to the radially contracting configuration in response to proximal retraction into the delivery catheter.

13. A method for deploying an implant from a deployment catheter via a delivery catheter, wherein, The implant has an outer diameter larger than the outer diameter of the delivery catheter, and the method includes the following steps: The implant is deployed from a retractable sheath on the distal end of the deployment catheter; The deployment catheter is retracted proximally into the delivery catheter; and The sheath retracts in response to the deployment catheter retracting proximally into the delivery catheter.

14. The method for deploying an implant according to claim 13, wherein, The implant includes a tissue anchor.

15. The method for deploying an implant according to claim 14, wherein, Deploying the implant includes rotating the tissue anchor relative to the sheath.

16. An intravascular suture cutter for cutting sutures, the intravascular suture cutter comprising: A cutter housing that defines a suture path extending through the cutter housing; A cutter head, rotatably positioned within the cutter housing, the cutter head including a cutting edge, wherein rotation of the cutter head within the cutter housing causes the cutting edge to pass through the suture path to cut the suture extending along the suture path.

17. The intravascular suture cutter according to claim 16, wherein, The suture path is positioned between an opening at the distal end of the cutter housing and a window formed on one side of the cutter housing.

18. The intravascular suture cutter according to claim 16 or 17, wherein, The cutter housing defines a barrel-shaped component forming a cylindrical inner surface.

19. The endovascular suture cutter according to claim 16, 17, or 18, further comprising an outer sheath and an inner shaft, the outer sheath being coupled to the cutter housing, the outer sheath extending along a longitudinal axis, and the inner shaft extending through the outer sheath and coupled to the cutter head, wherein... The rotation of the inner shaft relative to the outer sheath causes the cutting edge to rotate within the cutter housing.

20. The intravascular suture cutter of claim 19, further comprising a lock to prevent axial movement of the outer sheath relative to the inner shaft.

21. The intravascular suture cutter of claim 20, further comprising a handle connected to the proximal end of the outer sheath and a cutter handle connected to the proximal end of the inner shaft.

22. The intravascular suture cutter according to claim 21, wherein, The locking position is located within the handle.

23. The intravascular suture cutter according to any one of claims 16 to 22, wherein, The cut edge extends along a spiral path.

24. The intravascular suture cutter according to any one of claims 16 to 23, wherein, In the locked position, the cutting edge is covered by the cutter housing.

25. The intravascular suture cutter according to any one of claims 16 to 19, 23 or 24, wherein, A lock is provided in the cutter housing to prevent rotation between the cutter head and the cutter housing.

26. The intravascular suture cutter according to claim 20, 21, 22 or 25, wherein, The lock includes a protrusion located on the cutter head that engages the recess with the cutter housing.

27. The intravascular suture cutter according to claim 26, wherein, The lock, located within the cutter housing, is disengaged by axially moving the cutter head within the cutter housing.

28. A method for cutting sutures, comprising the following steps: Advance the suture along the suture path that extends through the cutter housing; as well as The cutter head is rotated within the cutter housing so that the cutting edge on the cutter head passes through the suture path and cuts the suture extending along the suture path.

29. The method of cutting a suture according to claim 28, wherein during the step of advancing the suture along a suture path extending through the cutter housing, the cutting edge is covered by the cutter housing.

30. The method of cutting sutures according to claim 28 or 29, further comprising releasing the cutter head from a lock within the cutter housing to allow the cutter head to rotate relative to the cutter housing.

31. The method for cutting sutures according to claim 30, wherein, Releasing the cutter head from the lock within the cutter housing includes axially moving the cutter head relative to the cutter housing.

32. A leaflet anchor, comprising: Gauze, the gauze having a first end, a second end, and a plurality of openings positioned between the first end and the second end of the gauze; A suture having a distal end and a distal end, the distal end of the suture being connected to and extending from a second end of the gauze; as well as Non-transparent markings Wherein, the tail end of the suture has extended through the plurality of orifices, such that the suture extends through the gauze opening, and when the gauze is pressed against the leaflet as the suture retracts through the leaflet, the leaflet anchor can be expanded from a reduced first cross section for advancing through the leaflet to an expanded second cross section for contacting the atrial side of the leaflet.

33. The leaflet anchor according to claim 32, wherein, The gauze consists of two pieces of material.

34. The leaflet anchor according to claim 33, wherein, A portion of the suture is positioned between the two pieces of material.

35. The leaflet anchor according to claim 34, wherein, The portion of the suture located between the two pieces of material has been flattened.

36. The leaflet anchor according to claim 34 or 35, wherein, The opening extends through the suture and is positioned between the two pieces of material.

37. The leaflet anchor according to any one of claims 32 to 36, wherein, The translucent marker is positioned on the suture line adjacent to the second end of the gauze.

38. The leaflet anchor according to any one of claims 32 to 37, wherein, The radiopaque markings include radiopaque strips positioned around the suture.

39. The leaflet anchor according to any one of claims 32 to 38, wherein, The translucent marking is positioned on the portion of the suture extending from the second end of the gauze.

40. A system for deploying leaflet anchors, the system comprising: catheter, A needle, positioned within the catheter and configured to be advanced outside the catheter to puncture the leaflets of the mitral valve of the heart; Leaflet anchors; Leaflet suture, the leaflet suture being connected to the leaflet anchor extending proximally through the catheter; as well as An energy storage device for propelling the needle with sufficient force to puncture the leaflet.

41. The system according to claim 40, wherein, The energy storage device is a spring, a pressurized liquid, or a pressurized gas.

42. The system according to claim 41 or 42, wherein, The system includes a trigger configured to release stored energy, thereby deploying the needle to puncture the leaflet.

43. The system according to claim 40, 41 or 42, wherein, The needle is hollow, allowing the leaflet anchor to be pushed out of the needle.

44. The system according to claim 40, 41, 42 or 43, wherein, The needle is hollow and the leaflet anchor is positioned inside the needle.

45. A stabilization system for transvascular cardiac repair, comprising: Base; A remote docking platform supported by the base in an axially movable manner; A proximal docking platform supported by the base in an axially movable manner; as well as An intermediate docking platform supported by the base in an axially movable manner.

46. ​​The stable system according to claim 45, wherein, The base includes a bottom plate, a top plate, and an adjustment mechanism for axially adjusting the position of the top plate relative to the bottom plate.

47. The stable system according to claim 46, wherein, Both the near-side docking platform and the far-side docking platform are supported by an upper plate.

48. The stable system according to claim 47, wherein, Both the near-side docking platform and the far-side docking platform are fixedly supported by the upper plate.

49. The stable system according to claim 48, wherein, The intermediate docking platform is supported by the upper plate in an axially movable manner.

50. The stable system according to claim 45, wherein, The proximal docking platform includes a suture management system.

51. The stable system according to claim 50, wherein, The suture management system includes an anchoring tension component.

52. The stable system according to claim 51, wherein, The anchoring tension component includes a rotatable spool.

53. The stabilization system of claim 52 further includes a clutch for limiting the amount of tension that can be applied to the suture wound around the rotatable spool.

54. The stable system according to claim 53, wherein, The clutch limits the amount of tension applied to the suture to a range from about 0.2 N to about 5 N.

55. The stable system according to claim 45, wherein, The proximal docking platform also includes a concave stabilizing surface for receiving the proximal handle of an intravascular device.

56. The stable system according to claim 45, wherein, The distal docking platform also includes a first stabilizing device configured to attach to the conduit.

57. The stable system according to claim 56, wherein, The first stabilizing device includes a clamping element for holding the material into the sheath.

58. A suture management system for transvascular cardiac repair, comprising an anchoring tension member, the anchoring tension member including a tension member, the tension member including a clutch for limiting the amount of tension that can be applied to a suture wound on a spool.

59. The suture management system according to claim 58, wherein, The clutch limits the amount of tension applied to the suture to a range from about 0.2 N to about 5 N.

60. The suture management system of claim 58 further includes a weight capable of being attached to the suture to provide tension to the suture.

61. The suture management system of claim 60 further includes one or more grooves formed on the edge of the platform, through which the sutures attached to the weight can be suspended.

62. A transvascular cardiac repair system, comprising: Base; The remote docking platform supported by the base; Access sleeve connected to the remote docking platform; The near-side docking platform supported by the base; A rotatable spool carried by the near-end docking station; as well as A first suture extends through the entry sheath and from the entry sheath to the rotatable spool.

63. The transvascular cardiac repair system of claim 62 further includes a tissue anchor attached to the distal end of the first suture.

64. The transvascular cardiac repair system according to claim 62, wherein, The rotatable spool is rotatably supported by the proximal docking platform, and the first suture is wound around the rotatable spool.

65. The transvascular cardiac repair system of claim 62 further includes a clutch for limiting the amount of tension that can be applied to the first suture wound around the spool.

66. The transvascular cardiac repair system according to claim 65, wherein, The clutch limits the amount of tension applied to the first suture to less than about 8 N.

67. The transvascular cardiac repair system according to claim 65, wherein, The clutch limits the amount of tension applied to the first suture to less than about 4 N.

68. The transvascular cardiac repair system according to claim 65, wherein, The clutch limits the amount of tension applied to the first suture to between about 0.5 N and about 3 N.

69. The transvascular cardiac repair system of claim 62 further includes a suture lock carried by the first suture in an axially slidable manner.

70. The transvascular cardiac repair system according to claim 69, wherein, The suture lock is clamped to the first suture.

71. The transvascular cardiac repair system according to claim 70, wherein, The suture lock is clamped to the first suture at a location adjacent to the tissue anchor.

72. The transvascular cardiac repair system of claim 69 further includes a leaflet suture that extends slidably through the suture lock.

73. The transvascular cardiac repair system according to claim 72, wherein, The suture lock is also clamped to the leaflet suture.

74. A dynamic leaflet management system, comprising: Base; The remote docking platform supported by the base; Access sleeve connected to the remote docking platform; The near-side docking platform supported by the base; The first suture guide is located on the proximal docking platform; The first leaflet suture extends proximally beyond the entry sheath and extends through the first suture guide. as well as A weight is attached to the first leaflet suture proximal to the first suture guide.

75. The dynamic leaflet management system of claim 74 further includes a leaflet anchor attached to the distal end of the first leaflet suture.

76. The dynamic leaflet management system according to claim 75, wherein, The first suture extends through the first guide in an axially slidable manner.

77. The dynamic leaflet management system of claim 75 further includes a second leaflet suture, the second leaflet suture extending proximally beyond the entry sheath and extending through the second suture guide.

78. A synchronization method for synchronizing the deployment of tissue anchor pins with the cardiac cycle, comprising the following steps: Monitor the physiological parameters of the cardiac cycle; Generates a time signal that is correlated with the time of peak pressure in the left ventricle; A control signal is sent to the actuator in response to the time signal; as well as A needle is deployed in response to actuation of the actuator during the pressure peak.

79. The synchronization method according to claim 78, wherein, The physiological parameters include pulse.

80. The synchronization method according to claim 78, wherein, The physiological parameters include peripheral pulse.

81. The synchronization method according to claim 78, wherein, The physiological parameters include ECG signals.

82. The synchronization method according to claim 78, wherein, The physiological parameters include the QRS wave.

83. The synchronization method according to claim 78, wherein, The physiological parameters include blood pressure.

84. The synchronization method according to claim 78, wherein, The physiological parameters were obtained percutaneously.

85. The synchronization method according to claim 78, wherein, The physiological parameters are obtained through intravascular sensors.

86. The synchronization method according to claim 85, wherein, The sensor includes a pressure sensor.

87. The synchronization method according to claim 78, wherein, The actuator includes an anchor driver.

88. The synchronization method according to claim 78, wherein, The actuator includes a lock that prevents the deployment of the needle until the actuator is actuated.

89. A cardiac synchronous leaflet anchor deployment system, comprising: Delivery catheter; The needle is axially reciprocated by the delivery conduit; A needle driver configured to advance the needle from a first position within the catheter to a second position extending beyond the catheter; Actuator; Connector for electrical connection to a cardiac cycle data source; as well as Control circuit, The control circuit is configured to activate the actuator in response to detecting a predetermined point in the cardiac cycle.

90. The system according to claim 89, wherein, The actuator activates the needle driver to advance the needle distally.

91. The system of claim 89, further comprising a locking device that prevents the physician from advancing the needle distally, wherein, The actuator disables the locking device to allow the doctor to advance the needle distally.

92. The system according to claim 89, wherein, The needle driver is spring-loaded.

93. The system of claim 89, comprising an electromagnetically driven driver.

94. The system of claim 89, comprising a hydraulically driven actuator.

95. The system of claim 89, comprising a pneumatically driven actuator.

96. The system of claim 89 further includes a manual controller for enabling a physician to manually activate the needle driver.

97. The system of claim 89 further includes at least one retaining element carried by the needle.

98. The system according to claim 97, wherein, The retaining element includes a radially outwardly extending tissue engagement surface to prevent the needle from retracting proximally from the leaflet.

99. The system according to claim 98, wherein, The retaining element includes a spiral line surrounding the needle.

100. The system according to claim 99, wherein, The spiral thread includes a thread that is spirally wound around the needle.

101. A leaflet anchor deployment system, comprising: Delivery catheter; A needle that is axially and reciprocatingly carried by the delivery catheter; The tissue retaining structure carried by the needle; as well as Tissue anchors carried within the needle.

102. The leaflet anchor deployment system according to claim 101, wherein, The tissue-retaining structure includes a radially outwardly extending flange.

103. The leaflet anchor deployment system according to claim 102, wherein, The tissue-retaining structure includes a helical flange.

104. The leaflet anchor deployment system according to claim 103, wherein, The flange includes a thread that is spirally wound around the needle.

105. The leaflet anchor deployment system of claim 101 further includes a deflection zone.

106. The leaflet anchor deployment system according to claim 105, wherein, The deflection zone includes the grooved sidewall of the needle.

107. The leaflet anchor deployment system of claim 101 further includes gauze carried within the needle.

108. The leaflet anchor deployment system of claim 107 further includes gauze carried within the deflection zone.

109. The leaflet anchor deployment system according to claim 105, wherein, The proximal end of the deflection zone is within approximately 6 cm of the distal end of the needle.

110. A tissue anchor, comprising: hub; A suture line extending proximally from the hub; A spiral anchor extending distally from the hub; as well as Secondary anchors, which are axially movable in the distal direction from the first configuration to the deployed second configuration to engage the structure and prevent loosening of the helical anchors.

111. The tissue anchor of claim 110, wherein, The secondary anchor includes a forked member extending between a proximal end and a distal tip.

112. The tissue anchor according to claim 111, wherein, The fork-shaped member is supported by a support member.

113. The tissue anchor according to claim 112, wherein, The support member includes a ring structure.

114. The tissue anchor according to claim 112 or 113, wherein, The support member can accommodate a tubular structure for a deployment system that propels the support member distally relative to the helical anchor.

115. The tissue anchor according to claim 110, wherein, The hub includes a fork guide for receiving the first fork in an axially movable manner.

116. The tissue anchor according to claim 115, wherein, The fork-shaped guide includes a deflection surface for deflecting the fork-shaped member to a launch angle that is radially outward along the distal direction.

117. The tissue anchor according to claim 116, wherein, The launch angle is in the range of approximately 30 to 45 degrees.

118. The tissue anchor of claim 110, wherein, The hub includes an aperture for receiving the secondary anchor in an axially movable manner.

119. The tissue anchor according to any one of claims 110 to 118, further comprising a core wire attached to the hub and extending concentrically through the helical anchor.

120. The tissue anchor according to any one of claims 110 to 119, further comprising a suture anchor guide extending proximally from the hub.

121. The tissue anchor according to claim 120, wherein, The second configuration of the secondary anchor deployment extends through the suture anchor guide.

122. The tissue anchor according to claim 121, wherein, The secondary anchor extends through the orifice in the suture anchor guide.

123. The tissue anchor according to claim 122, wherein, When the secondary anchor moves to the second configuration of deployment, the secondary anchor pierces the suture anchor guide.

124. The tissue anchor of claim 110, further comprising a radiopaque marker carried by the secondary anchor.

125. The tissue anchor according to any one of claims 110 to 124, further comprising a core wire attached to the hub and extending concentrically through the helical anchor.

126. The tissue anchor of claim 125, further comprising a radiopaque marker carried by the core wire in an axially movable manner.

127. The tissue anchor of claim 125, further comprising a spring carried by the core wire.

128. The tissue anchor according to claim 125, wherein, The core wire extends distally beyond the helical anchor.

129. The tissue anchor of claim 128, further comprising a distal stop on the core wire for limiting the distal travel of the transmissive marker.

130. The tissue anchor of claim 110, further comprising a tissue puncture point at the distal end of the helical anchor and barbs on the helical anchor, the barbs being proximal to the tissue puncture point and configured to prevent the helical anchor from rotating out of engagement with the tissue.

131. A novel chordae tendineae deployment system, comprising: The catheter has a proximal end and a distal end; A ventricular anchor sub-assembly capable of extending through the catheter, the ventricular anchor sub-assembly having a ventricular suture extending proximally through the catheter, the ventricular anchor sub-assembly including a helical tissue anchor and a secondary tissue anchor, the helical tissue anchor and the secondary tissue anchor being axially movable in a distal direction from a first configuration to a deployed second configuration to engage tissue and inhibit loosening of the helical tissue anchor; as well as A leaflet anchor deployment subassembly capable of extending through the catheter, the leaflet anchor deployment subassembly having a radially expandable leaflet anchor located within the leaflet anchor deployment subassembly and having a leaflet suture extending proximally through the catheter.

132. A method for transvascular prosthetic chordae tendineae implantation, comprising the following steps: The catheter is advanced into the left atrium, passes through the mitral valve, and enters the left ventricle; The ventricular anchor is deployed from the catheter into the left ventricular wall by rotating the spiral tissue anchor into the left ventricular wall. Sub-tissue anchors are deployed into the left ventricular wall to inhibit the loosening of the spiral tissue anchors; The ventricular suture is attached to the ventricular anchor and extends proximally through the catheter; Secure the leaflet anchor catheter to the mitral valve leaflet from the atrial side; With the leaflet anchoring conduit secured to the leaflet, the leaflet anchoring conduit is advanced from the conduit through the mitral valve leaflet to secure the mitral valve leaflet to the leaflet suture, wherein the leaflet suture extends proximally through the conduit; as well as The leaflet suture is fixed to the ventricular suture to limit the range of travel of the leaflet in the direction of the left atrium.

133. The method according to claim 132, wherein, Deploying the secondary anchor includes axially advancing the secondary anchor in the distal direction relative to the helical structure anchor.

134. A system for producing a prosthetic chordae tendineae for transcatheter mitral valve repair, the system comprising: A suture lock, the suture lock being configured to engage sutures connected to the leaflets of the mitral valve; as well as An anchor, the anchor being configured to connect with ventricular tissue, the anchor including a retaining member configured to connect with the suture lock such that the suture lock maintains its positional relationship with the anchor.

135. The system according to claim 134, wherein, The retaining member is configured to engage with the suture lock to restrict the movement of the suture lock relative to the anchor during the cardiac cycle.

136. The system according to claim 134, wherein, The retaining member is configured to engage with the outer surface of the suture lock located between the proximal and distal ends of the suture lock.

137. The system according to claim 134, wherein, The retaining member includes a socket configured to engage with the suture lock.

138. The system according to claim 137, wherein, The insertion port is configured to be radially compliant to allow the suture lock to enter and engage with the insertion port.

139. The system according to claim 134, wherein, The retaining member is configured to selectively connect and disconnect from the suture lock.

140. The system according to claim 134, wherein, The retaining member is configured to maintain its connection with the suture lock by a displacement force of up to approximately 3 N.

141. The system according to claim 134, wherein, The retaining member is configured to maintain its connection with the suture lock by a displacement force of up to approximately 1.5 N.

142. The system according to claim 134, wherein, The retaining member is configured to engage with the suture lock using an interference fit.

143. A system for prosthetic chordae tendineae repair via transcatheter mitral valve repair, the system comprising: A suture, the suture being configured to connect to the leaflets of the mitral valve of the heart; A suture lock, the suture lock being configured to engage the suture; as well as An anchor, configured to connect with tissue below the mitral valve, the anchor defining a longitudinal direction and including a restraining member configured to restrict movement of the suture lock relative to the anchor in a direction orthogonal to the longitudinal direction.

144. The system according to claim 143, wherein, The limiting member is configured to constrain the movement of the suture lock relative to the anchor in a plane orthogonal to the longitudinal direction.

145. The system according to claim 144, wherein, The limiting member is configured to constrain the movement of the suture lock relative to the anchor along the longitudinal direction.

146. The system according to claim 143, wherein, The suture lock defines a longitudinal direction, and wherein the limiting member is configured to substantially align the longitudinal direction defined by the anchor with the longitudinal direction defined by the suture lock.

147. The system according to claim 143, wherein, The limiting member is configured to contact opposite sides of the suture lock to constrain the movement of the suture lock relative to the anchor.

148. The system according to claim 143, wherein, The limiting member is configured to contact the outer surface of the suture lock at three or more points to constrain the movement of the suture lock relative to the anchor.

149. The system according to claim 143, wherein, The limiting member is configured to contact the proximal surface of the suture lock to constrain the movement of the suture lock relative to the anchor.

150. A system for transcatheter mitral valve chordae tendineae repair, the system comprising: An anchor, the anchor configured to connect with tissue below the mitral valve, the anchor including a retaining member; as well as A suture lock configured to realize a prosthetic chordae tendineae of the mitral valve by connecting the leaflets of the mitral valve to the anchor via sutures, the suture lock being configured to connect to the retaining member of the anchor to transmit displacement forces from the suture lock to the anchor.

151. The system according to claim 150, wherein, The suture lock is configured to transmit a displacement force to the retaining member, the displacement force extending upwards to approximately 3 N.

152. The system according to claim 150, wherein, The retaining member is configured to disconnect from the suture lock in response to a force exceeding approximately 6 N.

153. The system according to claim 150, wherein, The prosthetic tendon retains its function for at least 400 million cycles.

154. The system according to claim 150, wherein, The suture lock extends in a longitudinal direction, wherein the suture lock includes a peripheral surface extending between a distal surface and a proximal surface, and wherein the peripheral surface includes a longitudinally extending portion configured to connect with the retaining member.

155. A system for transcatheter chordae tendineae repair of the mitral valve, the system comprising a helical tissue anchor configured to connect with ventricular tissue in the left ventricle of the heart, a suture configured to connect with leaflets of the mitral valve of the heart, and a suture configured to connect to the helical tissue anchor, wherein, At least a portion of the suture is a meltable suture.

156. The system according to claim 155, wherein, The meltable portion of the suture is the distal end of the suture.

157. The system according to any one of claims 155 or 156, wherein, The system also includes a suture lock having a distal orifice and a proximal orifice separated along a longitudinal axis, the suture lock being configured such that the suture passes through the suture lock between the distal orifice and the proximal orifice, wherein the distal end of the suture is meltable.

158. The system according to any one of claims 155 to 157, wherein, The system also includes a suture cutter, wherein the suture cutter includes a heating source.

159. The system according to any one of claims 155 to 158, wherein, The suture is a two-component suture, wherein the proximal portion of the suture, which accounts for more than or equal to 50% of the total length of the suture, is a non-fusible suture, and the distal portion of the suture, which accounts for less than 50% of the total length of the suture, is a fusible suture.

160. The system according to any one of claims 155 to 159, wherein, The fusible suture is a polyolefin, polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyester, polyamide, polyglycolic acid / L-lactide, polyethylene terephthalate, silicone resin, collagen, or other amino acid proteins or combinations thereof.

161. The system according to any one of claims 159 or 160, wherein, The infusible portion of the suture is polytetrafluoroethylene or expanded polytetrafluoroethylene.

162. A system for transcatheter chordae tendineae repair of the mitral valve, the system comprising a helical tissue anchor configured to connect with ventricular tissue in the left ventricle of the heart, a suture configured to connect with leaflets of the mitral valve of the heart, a suture configured to connect to the helical tissue anchor, and a hollow needle configured to puncture the leaflets of the mitral valve of the heart, wherein, The outer surface of the hollow needle includes a helical groove located in the outer surface of the hollow needle, or the hollow needle includes a helical coil around the outer surface of the hollow needle.

163. The system according to claim 162, wherein, The system also includes an energy storage device for puncturing the leaflets with the hollow needle.

164. The system according to any one of claims 162 to 163, wherein, The energy storage device is a spring, a pressurized liquid, or a pressurized gas.

165. The system according to any one of claims 162 to 164, wherein, The hollow needle is configured to deliver gauze to the punctured leaflet.

166. The system according to any one of claims 162 to 165, wherein, The system also includes a lock to prevent accidental release of the stored energy.

167. The system according to any one of claims 162 to 166, wherein, The system is configured to deploy one or more additional gauze pads after the first gauze pad has been deployed.

168. The system according to any one of claims 162 to 167, wherein, The system includes a trigger configured to release stored energy, thereby deploying the needle to puncture the leaflet.

169. The system according to any one of claims 162 to 168, wherein, The deployed needle can be rotated to further drive the needle through the leaflet, or the needle can be rotated to remove the needle from the leaflet.

170. The system according to any one of claims 162 to 169, wherein, The leaflet is punctured from the atrial side or the ventricular side of the leaflet.

171. The system according to any one of claims 162 to 170, wherein, The length of the needle is adjustable.

172. The system according to any one of claims 162 to 171, wherein, The needle is configured to puncture the leaflet without any other leaflet-restricting mechanism.

173. The system according to any one of claims 162 to 172, wherein, The system includes a gauze holding mechanism for holding the gauze close to the distal portion of the hollow needle, wherein the gauze holding mechanism holds the gauze during the release of stored energy and subsequent puncture of the gauze.

174. A system for transcatheter chordae tendineae repair of the mitral valve, the system comprising: A helical tissue anchor configured to connect with ventricular tissue in the left ventricle of the heart, the helical tissue anchor further comprising a centering pin extending in a longitudinal direction coaxial with the helical tissue anchor. A suture formed to connect with the leaflets of the mitral valve of the heart; And a stitching line configured to connect with the anchor.

175. The system according to claim 174, wherein, The centering pin is positioned coaxially with the spiral-shaped anchor.

176. The system according to any one of claims 174 or 175, wherein, The centering pin also includes a washer, wherein the washer includes a hole (or opening) and the centering pin is inserted into the hole.

177. The system according to any one of claims 174 to 176, wherein, The system also includes a spring, which is coaxial with the centering pin and applies pressure to the washer to push the washer toward the distal end of the centering pin.

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