Mitral valve leaflet restraint

Abstract

The present invention provides a method and apparatus for transvascular implantation of newly formed chordae tendineae. [Solution] A method and apparatus for transvascular implantation of artificial chordae tendineae are disclosed. A catheter advances through the mitral valve into the left atrium and left ventricle. A ventricular anchor is deployed from the catheter into the wall of the left ventricle, extending proximal through the catheter, leaving a ventricular suture attached to the anchor. A leaflet anchor is deployed with the leaflet suture extending proximal through the catheter to fix the mitral valve leaflet to the leaflet suture. The leaflet suture is fixed to the ventricular suture to limit the range of movement of the leaflet toward the left atrium. Also disclosed is a mitral valve leaflet restraint assembly that is assembled in its original location, having neopapillary muscle and neochordae tendineae.

Description

Technical Field

[0001] This application is a continuation-in-part of U.S. Application No. 15 / 638,176, filed on June 29, 2017, claiming priority to U.S. Provisional Application No. 62 / 441,031, filed on December 30, 2016, the disclosures of which are hereby incorporated by reference in their entireties.

[0002] This disclosure generally relates to mitral valve repair devices and techniques, and more particularly to transvascular methods and devices for chordal replacement to reduce mitral valve regurgitation.

Background Art

[0003] The heart includes four heart valves. These valves allow blood to pass through the four chambers of the heart in one direction. The four valves are the tricuspid valve, the mitral valve, the pulmonary valve, and the aortic valve. The four chambers are the left atrium and right atrium (upper chambers) and the left ventricle and right ventricle (lower chambers).

[0004] The mitral valve is formed from two valve leaflets called the anterior leaflet and the posterior leaflet. These leaflets open and close in response to the pressure applied to the leaflets during heart contraction. Several problems can occur with the mitral valve. One problem is mitral valve regurgitation (MR). Mitral valve regurgitation has the symptom that the mitral valve leaflets do not close properly, and thus leakage from the mitral valve may occur. Severe mitral valve regurgitation can potentially have an adverse effect on cardiac function and may reduce the quality of life and lifespan of the patient.

[0005] Techniques for treating mitral valve regurgitation have been developed. These techniques include heart transplantation, valve replacement or repair, chord shortening or replacement, and repair of the mitral valve annulus, also known as annuloplasty. The above techniques are selected according to the stage and etiology.

Summary of the Invention

Problems to be Solved by the Invention

[0006] Certain surgical and transapical approaches have been proposed for the replacement or repair of chordae tendineae. However, despite these proposals, transvascular approaches for chordae tendineae replacement or repair remain necessary to reduce or eliminate MR. [Means for solving the problem]

[0007] According to one aspect of the present disclosure, a method for implanting a transvascular prosthetic chordae tendineae is provided. The method includes the steps of advancing a catheter through the mitral valve into the left atrium and left ventricle, and deploying a ventricular anchor from the catheter to the wall of the left ventricle, the ventricular anchor being extended proximal through the catheter, leaving a ventricular suture attached to the ventricular anchor. With the leaflet suture extending proximal through the catheter, the leaflet anchor is deployed to fix the mitral valve leaflet to the leaflet suture. The leaflet suture is fixed to the ventricular suture to limit the range of movement of the leaflet toward the left atrium.

[0008] The step of advancing the leaflet anchor includes securing the leaflet anchor to the leaflet within a range of approximately 3 mm to 10 mm from the leaflet junction. The step of deploying the ventricular anchor preferably includes attaching the anchor to the ventricular septum or ventricular wall, away from the apex. The step of deploying the ventricular anchor includes advancing the anchor driver through the mitral valve, rotating the driver to secure the ventricular anchor, and retracting the anchor driver proximal to expose the ventricular suture carried by the ventricular anchor.

[0009] The step of deploying the leaflet anchor includes positioning the needle guide in contact with the leaflet and advancing the needle from the needle guide through the leaflet. The method further includes deflecting the distal end of the needle guide by an angle of at least about 160° in order to position the distal end of the needle guide toward the ventricular side of the leaflet. The needle guide includes a slotted tube, and the deflection of the needle guide is performed by retracting the pull wire proximal.

[0010] The fixation step includes applying a suture lock to the ventricular suture and the leaflet suture. The method further includes a step of applying tension to the leaflet suture before the fixation step in order to improve the function of the leaflet. The method further includes a step of applying sufficient tension to the leaflet suture to raise the limit of systolic leaflet movement to the same level as that of the annulus. The fixation step includes engaging a knot to fix the leaflet suture and the ventricular suture. Furthermore, the method includes a step of cutting the leaflet suture and the ventricular suture proximal to the suture lock or knot so that they can function as native chordaes.

[0011] The method further includes an initial step of identifying patients having at least three characteristics selected from the group consisting of: the patient being diagnosed with primary or degenerative mitral regurgitation; the patient being diagnosed with secondary or functional mitral regurgitation; the patient being diagnosed with myxomatous mitral regurgitation; the patient being diagnosed with flail leaflet, chordal tear, or leaflet prolapse; the patient having a grade of mitral regurgitation of 1 or higher; the patient having an A2 leaflet to P2 leaflet diameter at least 5 mm smaller than the total length of the P2 leaflet + A2 leaflet; the patient having an A2 leaflet to P2 leaflet diameter of at least 10 mm; and the patient having an access vessel diameter of at least 2 mm.

[0012] The patient further has at least one of the following characteristics, selected from the group consisting of: the patient has been evaluated by a cardiac team including at least one cardiac surgeon and determined not to be a suitable candidate for conventional open-heart surgery repair; the patient has an STS predicted mortality score of 2 or higher; the patient has been offered and refused open-heart surgery repair; the patient is between 18 and 90 years old; the patient has not received a blood transfusion; the patient has previously undergone open-heart surgery; or the patient has an ejection fraction of at least 10 percent.

[0013] A further aspect of the present disclosure provides a method for increasing the mitral valve leaflet junction area during systole. The method includes the steps of fixing at least a first ventricular tension element to the ventricular wall and fixing at least a first leaflet tension element to the mitral valve leaflet. The leaflet tension element is retracted proximal to move the limit of leaflet movement toward the ventricle during systole, thereby increasing the mitral valve leaflet junction area during systole. The leaflet tension element is then fixed to the ventricular tension element.

[0014] The ventricular tension element includes a neopapillary muscle having a distal end facing the ventricular anchor and a proximal end substantially at the level of the apex of the original papillary muscle. The fixation step includes fixing the leaflet tension element to the ventricular tension element at the proximal end of the neopapillary muscle. The neopapillary muscle has an elongated, non-traumatic body and contains ePTFE.

[0015] The step of fixing the leaflet tension element includes advancing a needle guide having a distal end through the mitral valve into the left ventricle, and deflecting the needle guide at an angle of at least 160° to position the distal end in contact with the leaflet during diastole. The method further includes advancing a leaflet anchor deployment needle from the distal end of the needle guide through the leaflet, and deploying the anchor from the needle. The step of deploying the anchor includes deploying the anchor from a first reduced cross section within the deployment needle to a second enlarged cross section for seating toward the atrial side of the leaflet. The step of deploying the anchor includes deploying a cotton spool.

[0016] The step of retracting the leaflet tension element proximal includes positioning the opening in the left ventricle with at least the leaflet tension element extending through the opening, and retracting the leaflet tension element proximal with the opening acting as a fulcrum so that the tension element pulls the leaflet toward the ventricle. The fulcrum is the distal opening of the catheter, and the step of retracting proximal includes retracting the leaflet tension element proximal through the catheter. The method further includes fixing a second leaflet tension element to the leaflet and ventricular tension elements.

[0017] A further aspect of this disclosure provides an assembled-in-situ mitral valve leaflet restraint. The restraint comprises an elongated, flexible neo-papillary muscle having a proximal and distal end, and a helical tissue anchor attached to the distal end of the neo-papillary muscle. The elongated, flexible neo-chordae extend proximal to the neo-papillary muscle, and the leaflet anchor is attached to the proximal end of the neo-chordae. The leaflet anchor is expandable from a first reduced section for advancing through the leaflet to a second enlarged section for contacting the atrial side of the leaflet. The neo-chordae are attached to a suture that extends distally through the neo-papillary muscle to the helical tissue anchor.

[0018] The spiral anchor includes a laser-cut hypotube. The spiral anchor includes one, two, or more coiled circular wires. The neonatal chordae tendineae include a suture extending from the proximal end of the neonatal papillary muscle to the valve leaflet anchor. The suture extends through the neonatal papillary muscle to the spiral tissue anchor.

[0019] The newly formed chordae tendineae include a first element extending proximal to the newly formed papillary muscle and a second element extending distally to the valve leaflet anchor. The proximal portion of the first element and the distal portion of the second element are connected to each other by a locking device. The locking device has a locked state and an unlocked state. In the unlocked state, the locking device advances across the first and second elements, and in the locked state, it is configured to fixatively clamp the first and second elements.

[0020] The leaflet anchor includes a cotton spool. The cotton spool is configured to fold when a suture connected to the cotton spool is pulled, resulting in a second enlarged cross-section when folded. The suture passes through at least two, at least three, or four or more openings in the cotton spool. The openings are substantially collinear. The leaflet anchor includes a T-tag bar. The T-tag bar includes a bar rotatably connected to the suture such that the rotation of the bar expands the leaflet anchor from a first reduced cross-section to a second enlarged cross-section. The leaflet anchor includes a hub. The hub has a plurality of radially extending, flexible spokes. The plurality of spokes are configured to bend into aligned positions along the longitudinal axis and are constrained within the feeding needle. The plurality of spokes are biased to expand radially outward when unconstrained, expanding the leaflet anchor from a first reduced cross-section to a second enlarged cross-section.

[0021] The spiral anchor includes a hub configured to receive and secure the suture by friction. The spiral anchor includes a loop for securing the neopapillary muscle to the spiral anchor. The neopapillary muscle includes a soft ribbon.

[0022] According to further aspects of the present disclosure, the neonatal chordae tendineae deployment system has an elongated, flexible tubular body having a proximal and distal end, and a helical ventricular anchor is located within the tubular body and has a rotating driver extending proximal through the tubular body. A radially expandable valve leaflet anchor is located within the tubular body and has a suture extending proximal through the tubular body.

[0023] A further aspect of the present disclosure provides a neonatal chordae tendineae deployment system. The deployment system comprises a catheter having a proximal and distal end, a helical anchor located within the catheter, and a leaflet anchor that is radially expandable within the catheter. The helical anchor has a driver configured to rotate a helical anchor extending proximal through the catheter. The leaflet anchor has a suture that extends proximal through the catheter.

[0024] The radially expandable valve leaflet anchor includes a cotton suture. The cotton suture is deformable from an elongated strip-like configuration to a configuration that is radially expanded and axially contracted by retraction of the suture proximally. The radially expandable valve leaflet anchor includes a suture inserted between two sheet-like materials. The radially expandable valve leaflet anchor has a deflectable deployment tube held within the catheter.

[0025] The distal deflection region of the deployment tube is deflectable by at least approximately 160° in response to the operation of the proximal deflection control. The distal deflection region is located within approximately 1.5 cm from the distal end of the deployment tube. The distal deflection region is deflectable to form a curve with an optimal radius of approximately 1.5 cm or less. A deflectable deployment tube includes a slotted deflection tube.

[0026] The novel chord deployment system is configured to deploy the helical anchor in the distal direction and to deploy the radially expandable anchor in the proximal direction. The expandable leaflet anchor is continuously inserted into the catheter after the helical anchor and the driver are removed from the catheter. The expandable leaflet anchor, the helical anchor, and the driver are pre - arranged within the catheter.

[0027] According to a further aspect of the present disclosure, a leaflet anchor delivery system is provided. The leaflet anchor delivery system includes a delivery shaft and a tissue - penetrating element. The delivery shaft has a distal portion and a proximal portion and has a deflection region disposed at the distal portion of the delivery shaft. The tissue - penetrating element is configured to advance through the distal end of the delivery shaft. The deflection region is configured to position the distal end of the delivery shaft on the ventricular side of the leaflet when the proximal portion of the delivery shaft extends into the left atrium. The deflection region includes a flexible tube. The flexible tube has an optimal radius of curvature of less than about 2 cm when deflected.

[0028] According to a further aspect of the present disclosure, a cotton suture for fixing to the leaflet of the heart is provided. The cotton suture has two flat sheets including a substantially overlapping region, a suture disposed between the two flat sheets, and one or more openings extending through the two flat sheets. The suture has a proximal end and a distal end. The proximal end extends from the first side of the two flat sheets. The one or more openings extending through the two flat sheets are sized to receive the suture. The two flat sheets are joined to each other across a portion of the overlapping region on both sides of the suture.

[0029] The suture is at least partially flattened between two sheets. One or more openings extend through the flattened suture. The distal end of the suture extends to the second side of two flat sheets on the opposite side of the first side. The suture extends along a substantially straight line between two flat sheets. The suture extends along a zigzag or wavy direction between two flat sheets. The two flat sheets include expanded polytetrafluoroethylene. At least one of the two flat sheets is at least partially sintered.

[0030] The proximal end of the suture extending from the first side of the two flat sheets passes through one or more openings. The cotton suture has a folded structure in which the two flat sheets are folded at least once so as to form a radially expanded cross section. The radially expanded cross section extends around the suture when the suture passes through one or more openings.

Brief Description of the Drawings

[0031] [Figure 1] Figure 1 shows a mitral annulus with a suture fed through a catheter attached thereto. [Figure 2] Figure 2 shows a distal anchor attached to a suture connected to a mitral annulus and fed through a catheter. [Figure 3] Figure 3 shows a distal anchor including a suture that will later be attached to the mitral valve leaflet or mitral annulus and rotating toward the apex of the heart. [Figure 4] Figure 4 shows a distal anchor rotating toward the apex of the heart with the suture attached to the mitral valve leaflet or mitral annulus. [Figure 5] Figure 5 shows a distal anchor attached above the apex of the heart at approximately the same height as the top of the papillary muscle and protruding. [Figure 6] Figure 6 shows a distal anchor attached above the apex of the heart at approximately the same height as the top of the papillary muscle and protruding, and attached to the mitral annulus and / or mitral valve leaflet. [Figure 7] Figure 7 shows a distal anchor attached to a loop-shaped suture that protrudes above the apex of the heart, at approximately the same height as the top of the papillary muscle, and moves through the catheter. [Figure 8] Figure 8 shows a catheter-fed suture loop that penetrates the mitral valve leaflet, including strain relief on the ventricular side of the mitral valve leaflet, and a distal anchor located at the bottom of the left ventricle, held by a suture lock that extends along the tail of the suture and is ultimately suture tension regulated. [Figure 9] Figure 9 shows a catheter-fed suture line that penetrates the mitral valve leaflet, including strain relief on the ventricular side of the mitral valve leaflet, and a suture lock portion that advances toward the atrial side of the mitral valve leaflet and is fixed to the tail of the suture before the suture is cut. [Figure 10] Figure 10 shows a catheter-fed suture line that penetrates the mitral valve leaflet, including strain relief on the ventricular side of the mitral valve leaflet, and a suture lock that advances toward the atrial side of the mitral valve leaflet to secure the suture tail. The other end of the suture tail extends from the catheter handle through the catheter and passes through a distal anchor positioned at the bottom of the left ventricle to pull the suture. As the user adjusts the tension of the suture, a second suture lock advances across the final suture tail. [Figure 11] Figure 11 shows a suture loop supplied from a catheter and penetrating the mitral valve leaflet, which loops around the strain relief located on the ventricular side of the mitral valve leaflet, and a distal anchor positioned at the bottom of the left ventricle, with the final tension adjustment of the suture held by a suture lock that advances along the tail of the suture. It also shows a cryotherapy catheter attached to the mitral valve leaflet that firmly holds the valve leaflet and resists the penetrating force of the strain relief. [Figure 12]Figure 12 shows a suture loop supplied from a catheter and penetrating the mitral valve leaflet, which loops around the strain relief supplied to the ventricular side of the mitral valve leaflet, and a distal anchor positioned at the bottom of the left ventricle, with the final tension adjustment of the suture held by a suture lock that advances along the tail of the suture. It also shows a cryotherapy catheter attached to the mitral valve leaflet that firmly holds the valve leaflet and resists the penetrating force of the strain relief. [Figure 13] Figure 13 shows the position of the mitral valve annulus penetration and the position of the distal anchor relative to the congenital papillary muscle, as viewed from the atrial side. [Figure 14] Figure 14 shows the position of the mitral valve annulus penetration and the position of the distal anchor relative to the congenital papillary muscle, as viewed from the atrial side. [Figure 15] Figure 15 shows various anchors for attachment to the left ventricle apex, including laser-cut hypotube and coiled circular wire, with vertical risers that adjust the connection point closer to the level of the papillary muscle in order to more accurately simulate the correct angle and adapt the newly formed cord connection. [Figure 16] Figure 16 shows a transseptal catheter that delivers an anchor to the apex of the left ventricle, including multiple replacement cords extending outside the catheter handle. [Figure 17] Figure 17 shows a transseptal catheter feeding a penetration tool through the mitral valve leaflet to deliver a strain relief anchor connected to a suture loop. [Figure 18] Figure 18 shows a transseptal catheter that feeds the suture loop through the mitral valve leaflet, and the suture loop that penetrates the valve leaflet. [Figure 19] Figure 19 shows a transseptal catheter supplying strain relief to the ventricular side of the mitral valve leaflet, and exposed strain relief supplied through or by a penetration tool. [Figure 20] Figure 20 shows a transseptal catheter supplying strain relief and a penetration tool withdrawn from the mitral valve leaflet. [Figure 21]Figure 21 shows a transseptal catheter that delivers strain relief, having a suture loop extending posteriorly from the catheter handle and a connection to a distal anchor. [Figure 22] Figure 22 shows a transseptal catheter that feeds a suture lock portion, which advances from the proximal end of the suture to the tail of the suture while tension is applied, to the distal anchor via a catheter handle, in order to adjust the position and tension of the final implanted suture connected to the mitral valve leaflet and distal apical anchor. [Figure 23] Figure 23 shows the final suture loop that secures the distal apical anchor to the mitral valve leaflet, with the mitral anchor being a single-sided flange or single-sided as shown in the non-exploded view. [Figure 24] Figure 24 shows the strain relief element on the mitral valve leaflet, the distal apical anchor, and the continuous loop anchor delivered to the final position. [Figure 25] Figure 25 shows an example of a distal apical anchor consisting of a stainless steel tube and a silicone anchor plug to restrict the movement of the suture before feeding the suture lock for final positioning. The materials may be varied and changed to enhance the size and function of the material. [Figure 26] Figure 26 shows the catheter penetrating the septum from the right atrium and the left atrium. [Figure 27] Figure 27 shows the anchor rotating toward the left ventricle. [Figure 28] Figure 28 shows a distal apical anchor in place with a suture line extending through the catheter, and an extended arm exposed to capture the mitral valve leaflet with a needle that is fired when properly positioned on the valve leaflet. [Figure 29] Figure 29 shows an extension arm in contact with the mitral valve leaflet and a needle connected to a suture loop that penetrates the leaflet so as to expose the suture loop on the atrial side of the mitral valve leaflet. [Figure 30]Figure 30 shows the suture loop penetrating the mitral valve leaflet and exposed on the atrial side of the leaflet, so as to receive a loop snare for capturing the suture loop and retrieving it through a catheter. [Figure 31] Figure 31 shows the suture loop closing around the suture loop and the suture being pulled proximal through the catheter. [Figure 32] Figure 32 shows a catheter that delivers suture lock to the posterior side of the mitral valve leaflet when the suture loops along a pathway including the distal apical anchor. [Figure 33] Figure 33 shows a second catheter that receives the suture ends to feed a suture lock across the valve leaflets, after applying appropriate tension to the two ends, thereby locking the suture. [Figure 34] Figure 34 shows the suture locks in their final positions above and below the mitral valve leaflets, and the cut suture ends that hold the final implantation of the distal apical anchor connected to the mitral valve leaflets. [Figure 35A] Figure 35A shows the newly formed papillary muscle attached in the left ventricle. [Figure 35B] Figure 35B shows a maneuverable valve leaflet puncture catheter advancing through the mitral valve. [Figure 35C] Figure 35C shows a maneuverable valve leaflet puncture catheter deflected at an angle of at least approximately 180°. [Figure 35D] Figure 35D shows the puncture of the valve leaflet and the deployment of the foldable cotton-spun valve leaflet anchor. [Figure 35E] Figure 35E shows the puncture of the valve leaflet and the deployment of the foldable cotton-spun valve leaflet anchor. [Figure 35F] Figure 35F shows the puncture of the valve leaflet and the deployment of the foldable cotton-spun valve leaflet anchor. [Figure 35G] Figure 35G shows the puncture of the valve leaflet and the deployment of the foldable cotton-spun valve leaflet anchor. [Figure 35H]Figure 35H shows the valve leaflet suture and ventricular suture extending proximal through the dispensing catheter. [Figure 35I1] Figure 35I1 shows the deployed state of a T-tag type valve leaflet anchor. [Figure 35I2] Figure 35I2 shows the deployed state of a T-tag type valve leaflet anchor. [Figure 35I3] Figure 35I3 shows the deployed state of a T-tag type valve leaflet anchor. [Figure 35I4] Figure 35I4 shows the deployed state of a T-tag type valve leaflet anchor. [Figure 35J1] Figure 35J1 shows the expanded state of a radially expandable tissue anchor. [Figure 35J2] Figure 35J2 shows the deployed state of a radially expandable tissue anchor. [Figure 35J3] Figure 35J3 shows the expanded state of a radially expandable tissue anchor. [Figure 35K] Figure 35K schematically shows the fulcrum located near the proximal end of the newly formed papillary muscle. [Figure 35L] Figure 35L shows the verification of mitral valve function before removal of the deployment system. [Figure 35M] Figure 35M shows the attachment of the valve leaflet suture to the ventricular suture after the desired tension has been applied. [Figure 35N] Figure 35N shows the cut state of the valve leaflet suture and ventricular suture so that the newly formed cord is left in the predetermined position. [Figure 35O] Figure 35O shows the operable distal portion of a valve leaflet puncture catheter with a complex deflection structure. [Figure 36A] Figure 36A shows the papillary muscle initially bound and captured with a loop. [Figure 36B] Figure 36B shows the papillary muscle, which has been looped and pulled up to a cord in the region where the cutting step is preferably performed. [Figure 37] Figure 37 shows an example of a chordae tendineae cutting tool. [Figure 38A]Figure 38A shows a spiral anchor placed near the apex of the left ventricle via the ventricular anchor delivery subsystem. [Figure 38B] Figure 38B shows the configuration of the valve leaflet anchoring subsystem to the ventricular side of the valve leaflet using a distal flexible tube. [Figure 38C] Figure 38C shows the state of valve leaflet penetration using a needle positioned at the distal end of the ventricular valve leaflet delivery subsystem. [Figure 38D] Figure 38D shows the advanced state of the needle-threaded cotton spool valve tip anchor, with a reduced radial cross-section. [Figure 38E] Figure 38E shows a cotton-spun yarn valve tip anchor with an enlarged radial cross-section. [Figure 38F] Figure 38F shows a folded cotton suture tip anchor used to secure the suture to the atrial side of the valve leaflet. [Figure 38G] Figure 38G shows the state in which the suture lock has been advanced via the suture lock supply subsystem across the suture of the valve leaflet anchor and the suture of the ventricular anchor in order to connect the valve leaflet anchor to the ventricular anchor. [Figure 38H] Figure 38H shows the suture lock in the locked position after tension has been adjusted with the suture tail cut. [Figure 39A] Figure 39A is a perspective view showing the distal end of the ventricular anchor delivery subsystem. [Figure 39B] Figure 39B is a perspective view showing the proximal end of the ventricular anchor delivery subsystem. [Figure 39C] Figure 39C is a partially exploded view of the distal end of the ventricular anchor delivery subsystem. [Figure 40A] Figure 40A is a perspective view showing the distal end of the valve leaflet anchor feeding subsystem. [Figure 40B] Figure 40B is a perspective view showing the proximal end of the valve leaflet anchor feeding subsystem. [Figure 40C] Figure 40C is an exploded view of the distal end of the valve leaflet anchor feeding subsystem. [Figure 40D]Figure 40D is a perspective view showing the flexible tube of the valve leaflet anchor feeding subsystem. [Figure 40E] Figure 40E is a side view of the transition region of the flexible tube in the valve leaflet anchor feeding subsystem. [Figure 40F] Figure 40F is a side view of the figure shown in Figure 40E, and shows the transition region of the flexible tube of the valve leaflet anchor feeding subsystem. [Figure 41A] Figure 41A is a perspective view showing the distal end of the suture lock feeding subsystem. [Figure 41B] Figure 41B is a perspective view showing the proximal end of the suture lock feeding subsystem. [Figure 41C] Figure 41C is an exploded view of the distal end of the suture lock feeding subsystem. [Figure 41D] Figure 41D is a perspective view showing the distal end of the cutting assembly. [Figure 41E] Figure 41E is a side view of the cutting assembly of the suture lock feeding subsystem when the cutting head is not advanced to hold the suture before cutting. [Figure 41F] Figure 41F is a side view of the cutting assembly of the suture lock feeding subsystem with the cutting head advanced for cutting the suture. [Figure 41G] Figure 41G is a side view of the distal end of a suture lock and a torque driver configured to engage with the suture lock. [Figure 41H] Figure 41H shows the proximal end of the suture lock. [Figure 41I] Figure 41I shows the distal end of the suture lock. [Figure 42] Figure 42 shows newly formed chordae tendineae embedded between two papillary muscles, aligned substantially parallel to the original chordae tendineae. [Figure 43A] Figure 43A schematically shows a cotton-wrapped suture formed by integrating the distal end of the suture between two flat sheets of cotton-wrapped suture. [Figure 43B]Figure 43B is a schematic cross-sectional view of the cotton yarn shown in Figure 43A. [Figure 43C] Figure 43C is a schematic diagram of a cotton spool having an opening, as shown in Figure 43C, in which the suture tail extends through the opening to form a foldable anchor. [Modes for carrying out the invention]

[0032] Embodiments for attaching a lacerated or dislodged cord (string) include a catheter, which is fed through the femoral vein, crosses the inferior vena cava (IVC) and the septum to the left middle atrium, where attachment to the mitral annulus is performed. This attachment may be performed by an anchor inserted into the mitral valve or a single suture loop through the mitral annular tissue, which rotates, penetrates, or passes through local tissue where the mitral valve leaflets are in contact with atrial tissue at or near the mitral annulus. The anchor may consist of a coiled wire anchor that rotates into the tissue, including a suture receiving portion for the replacement of the cord or a pre-attached cord fixed to the anchor.

[0033] The connection to the mitral valve annulus provides a secure and reliable attachment point as a stable anchor via a piercing, hook, or corkscrew-type fixing device. To this attachment point, the cord is connected to cover the mitral valve leaflets and further attached to or fixed to the apex of the left ventricle. It may also pierce the anterior or posterior mitral valve leaflets at any position. The cord may be formed from round, flat PTFE, PE, or nylon, as conventionally used in cord repair surgery.

[0034] In one embodiment, the cord functions as a new or artificial cord. In a particular embodiment, the cord may be a standard suture. In one embodiment, one or more additional artificial elements are fixed across the cord. For example, a tubular structure advances (e.g., slides) across the cord through a feeding device. The structure may be configured to appropriately self-position along the length of the cord, or the structure may be fixed to the cord in a suitable position (e.g., by positioning locking members in the proximal and / or distal directions of the structure). Any suitable locking member may be used to position the structure in place. The locking member may be crimpable, have a mechanical locking mechanism, and / or frictionally engage with the cord such that it requires a threshold amount of force to advance across the cord. Any suitable form of locking member may be used. The locking member may be similar to the suture locks described herein. In one embodiment, the locking member may be configured to advance distally and proximally across the cord. In one embodiment, the locking member may be configured to advance in only one direction (e.g., distally across the cord). In one embodiment, additional prosthetic structures may be fixed intermittently at the proximal or distal end, or along the length of the cord. The cord may be attached to the proximal or distal end of the prosthetic structure. For example, two cords may be used, one cord attached to the proximal end of the structure and the other cord attached to the distal end of the structure. In one embodiment, the cord may be connected to the structure, for example, at the proximal and / or distal end (e.g., inserted into or wrapped around the loop of the structure), or it may extend parallel to the length of the structure. The prosthetic structure may be configured to contact one or more physiological tissues (e.g., interacting with valve leaflets) and / or to replicate the mechanical / structural properties of a physiological structure (e.g., papillary muscle).

[0035] Fixation to the mitral annulus provides a secure and immovable attachment point to the mitral valve leaflets, which are difficult to capture with a torn cord due to movement caused by the heartbeat. The movement can be stopped by grasping the moving leaflets with a mechanical capture tool, a suction tube, or a cryocatheter for free grasping the leaflets, as will be described in more detail below with respect to specific exemplary embodiments. Once the upper anchor is securely attached to the mitral annulus, it covers the space between the existing cords across the mitral valve leaflets to restrict their lateral position relative to the leaflets. Positioning the leaflets between the existing cords provides the artificial cord (artificial string) with an upper anchor point, a fixed angular position through the existing cords, and a positive anchor in another positive position at the apex of the left ventricle. The replacement cord may be a single suture strand and / or multiple cords supporting the load by traversing the pathway vertically as described above.

[0036] An inferior apical anchor, which may be positioned in the left ventricle, can be secured via a rotary screw or plug to reliably hold the cord. The anchor may be low in height and located near the base of the apex, or it may have a length that extends to better conform to the innate papillary muscle about 20–22 mm above the apex of the left ventricle. In one embodiment, the anchor extends above the apex over a range of less than about 5 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm or more, and / or between the above values. A single or multiple cords are attached to one or more anchors at the base of the left ventricle. The anchor may be made of stainless steel, nitinol or other metallic material visible by fluoroscopy, or a polymer material such as PEEK, PTFE or other implantable material. These polymers may include radiopaque markers for visibility, if necessary.

[0037] The fixation system in the embodiment includes an apical tissue anchor connected to or attached to the left ventricle and a riser that causes the attachment to protrude from the apical tissue anchor, and may be formed from a monolithic material or a combination of materials including polymer and metal. The structure may be rigid as a whole or have flexible joints that allow movement or elastic regions (or multiple elastic regions) for controlled movement and flexibility. The fixation system may consist of a circular cross-sectional shape or other external shapes including shapes that vary in the longitudinal direction. The diameter is approximately 6 to 24 French (2 to 8 mm) and the length is approximately 20 to 40 mm, and is generally supplied via a catheter that can be operated with or without a guidewire along the central axis. Once the superior leaflet anchor is attached to the mitral annulus or leaflet, covering the mitral leaflet, and further connected to the inferior anchor, tension adjustment is possible via real-time imaging / monitoring (e.g., under live echo) while monitoring leaflet movement and reduction of regurgitation. The final step includes applying tension to the cord, locking the cord, and detaching the cord from the supply system. The tension in the cord applies tension to the connected mitral valve leaflet strain relief, causing a locking device such as LSI Solutions' Cor-Knot to advance along the cord, ultimately leading to the cutting of the suture tail.

[0038] According to one embodiment (see Figures 1-7), the delivery of the substitution code includes the following steps: 1. Transvenous and transfemoral insertion of the supply catheter 100. 2. Advance of catheter 100 into right atrium 10. 3. Transseptal advancement of catheter 100 to left atrium 14 12 4. Advance the catheter 100 to the mitral valve annulus 16 for positioning and feeding of the strain relief anchor 18. 5. Positioning of the mitral valve leaflet grasping tool 6. Installation of strain relief anchor 18 on mitral valve ring 16 7. Advancement of replacement code 22 across mitral valve 25 between existing codes 17 8. Advancement of cord 22 to the apex 20 of the left ventricle and distal attachment to the apex 20. 9. Apply tension to cord 22 while monitoring the movement of the mitral valve leaflets.

[0039] As an alternative, in certain embodiments (see, for example, Figures 26-34), the feeding order may be somewhat reversed: 1. Transfemoral entry of the feeding catheter 100 2. Advance of catheter 100 into right atrium 10. 3. Transseptal advancement of catheter 100 to left atrium 14 12 4. Advancement of the supply catheter 100 to the apex 20 of the left ventricle through the mitral valve 24. 5. Delivery of distal ventricular anchor (e.g., rotating anchor 32) to the apex 20. 6. Withdraw the supply catheter 100 so that the lower apical anchor 30 is exposed. 7. Pull the supply catheter 100 proximal to expose a new cord suture line 22 or multiple lines 22. 8. Across each new code 22, mitral valve leaflet strain relief can be supplied through the mitral valve leaflets to the ventricular side of the leaflets. 9. Advancement of the suture lock 26 extending over the suture tail 28 to lock the position of the suture to the position of the strain relief anchor. 10. Cutting of the suture tail at the mitral valve leaflet anchor. 11. Advancement of the suture lock 26 from the catheter handle to the suture tail of the mitral valve leaflet anchor. 12. Advancement of the suture lock 26, which extends from the catheter handle to the distal apical anchor, locking the tension applied from the outermost distal suture tail of the catheter handle. 13. Resection of the tail of the suture in the distal apical anchor. Some of the steps in the above method may be optional. Additional steps may be included where appropriate. Furthermore, the steps may be rearranged in any feasible order.

[0040] The embodiments shown in Figures 1-7 will be described in more detail. Figure 1 shows the suture 22 and mitral annulus 16 supplied and attached via a catheter 100. Figure 2 shows the distal anchor 32 supplied via catheter 100 and attached to the suture 22 connected to the mitral annulus 16. Figure 3 shows the distal anchor 32, which includes a suture line 22 attached for later attachment to the mitral valve leaflet 24 or mitral annulus 16, and is rotating toward the apex 20 of the heart. Figure 4 shows the distal anchor 32 rotating toward the apex 20 with the suture line 22 attached to the mitral valve leaflet 24 or mitral annulus 17. Figure 5 shows the distal anchor 32 attached protruding above the apex 20 at approximately the same height as the top of the papillary muscle. The anchor 32 has a riser 70 connected to a connection point 72. In one embodiment, the length of the riser 70 is approximately 20-40 mm. The riser 70 has the same or different material, diameter, rigidity, etc., as the rest of the anchor 32. The riser 70 may be aligned longitudinally with the rest of the anchor 32, or it may be positioned at a predetermined angle to the rest of the anchor 32. The riser 70 may be firmly fixed or integrated with the rest of the anchor 32, articulated (e.g., joint / socket), or flexibly connected (e.g., interconnection loop). The tension applied to the anchor 32 during the placement of the new chordae tendineae determines or alters the orientation of the riser 70 relative to the heart and / or the rest of the anchor 32. Figure 6 shows a distal anchor 32 mounted projecting above the apex 20 at approximately the same height as the top of the papillary muscle. The distal anchor 32 may be attached to the mitral valve annulus 16 and / or mitral valve leaflet 24 via one or more sutures. Figure 7 shows a distal anchor 32 that is attached to a loop-shaped suture that moves through the catheter 100, protruding above the apex 20 at approximately the same height as the top of the papillary muscle.

[0041] Figure 8 shows one embodiment in which a suture 50, supplied by a loop-shaped catheter, penetrates the mitral valve leaflet 24, a strain relief 52 is located on the ventricular side of the mitral valve leaflet 24, and a distal anchor 32 is located at the bottom of the left ventricle under final suture tension adjustment, held by a suture lock 54 that advances across the tail of the suture 56. A single suture loop 50 connects the distal anchor 32 to the strain relief 52, directly to the distal anchor, and / or to other leaflet anchors. Multiple loops may be used. In one embodiment, the suture 50 may pass through the loop structure in the strain relief 52 and / or distal anchor 32 so as to effectively fold back. In one embodiment, the suture 50 may pass through a channel in the strain relief 52 and / or distal anchor 32 such that the proximal end of the suture 50 enters one opening and the distal end of the suture 50 exits another opening. The opening can be located on the same side of the distal anchor 32 and / or strain relief 52. The opening may also be located on the opposite side of the distal anchor 32 and / or strain relief 52. The relative length of the suture tail 56 extending from the distal anchor 32 and strain relief 52 determines the effective final position of the suture lock 56. For example, by minimizing the length of the suture tail 56 extending from the strain relief 52, the suture lock 54 can be effectively positioned on the atrial side of the mitral valve leaflet 24, for example, directly across the strain relief 52. By minimizing the length of the suture tail 56 extending from the proximal end of the distal anchor 32, the suture lock 54 can be effectively positioned directly above the distal anchor 32. The suture lock 54 may be any suitable type of suture lock mechanism, including those described herein. The strain relief 52 may have an expandable structure so that it is inserted into the valve leaflet 24 in a folded state (e.g., a reduced cross-sectional structure) and expands on the ventricular side of the valve leaflet 24 (e.g., to an enlarged cross-sectional structure). The strain relief 52 may be self-expanding. In one embodiment, the strain relief 52 may be a cotton spool as described herein.The strain relief 52 may be inserted via a needle or other suitable instrument for penetrating the tissue of the valve leaflet 24, as described herein. The strain relief 52 is housed in and advances through the internal lumen of the needle. The needle may restrain the strain relief 52 in a foldable structure. The strain relief 52 may be inserted through the valve leaflet 24 with the suture 50 pre-loaded (e.g., in a loop through the strain relief) such that when the strain relief 52 is installed, the proximal and distal ends of the suture 50 extending from the strain relief remain extended through the puncture port through the valve leaflet 24. The suture lock 54 prevents the suture tail 56 from advancing or retracting through the suture lock 54, thereby holding the suture cord taut after engagement of the suture lock 54 and allowing the suture tail 56 to be cut near the suture lock 54. The tail 56 of the suture 50 may be cut directly adjacent to or proximal to the suture lock 54, thereby allowing the length of the suture tail 56 to extend freely from the suture lock 54. The strain relief 52 and distal anchor can be loaded into the suture loop 50 and then sequentially placed through the catheter 100 in any order.

[0042] Figure 9 shows one embodiment in which a suture or loop 60 supplied from the catheter penetrates the mitral valve leaflet 24 with the strain relief 52 positioned on the ventricular side of the mitral valve leaflet 24. The strain relief 52 is inserted as described with reference to Figure 8. In this embodiment, the suture lock 62 advances toward the atrial side of the mitral valve leaflet 24 to secure the suture tail before cutting the suture 60. The suture lock 62 advances along only one tail of the suture 60 to secure only the suture tail extending from the strain relief 52, and not the suture tail extending from the distal anchor 32. The suture lock 62 may be configured (e.g., in size and / or shape) to prevent the suture lock from being pulled through the puncture site in the mitral valve leaflet 24. The suture tail extending from the distal anchor 32 can be fixed as described with reference to Figure 10.

[0043] Figure 10 shows one embodiment in which a suture wire 60 supplied from the catheter penetrates the mitral valve leaflet 25, with a strain relief 52 positioned on the ventricular side of the mitral valve leaflet 25 and a suture lock 62 advanced on the atrial side of the mitral valve leaflet to secure the suture tail, as described with reference to Figure 9. The other end of the suture tail extends from the catheter handle through a catheter 100 that traverses around a distal anchor 32 positioned at the bottom of the left ventricle to apply tension to the suture. When the tension of the suture is adjusted by the user, a second suture lock 63 advances across the final suture tail and locks in place at the final suture tail. The second suture lock 62 (e.g., size and / or shape) may be configured to prevent the suture lock 62 from being pulled through the distal anchor 32 under tension.

[0044] Figure 11 shows one embodiment in which a suture loop 60 supplied from a catheter penetrates the mitral valve leaflet 24 with a penetrating element 27 (e.g., a needle), with the strain relief 52 forming a loop and positioned on the ventricular side of the mitral valve leaflet 24, the distal anchor 32 positioned at the bottom of the left ventricle, and the final tension adjustment of the suture held by a suture lock that has advanced across the tail of the suture. The configuration of this embodiment may be the same as that of the embodiments shown in Figures 8-10. By using a cryocatheter 70 attached to the mitral valve leaflet 24, the leaflet can be held stably and resisted by the penetrating force of the strain relief. The cryocatheter 70 is supplied through the same catheter 100 or a separate catheter. The cryocatheter provides a temporary cooling effect to the mitral valve leaflet 24 and temporarily causes the tissue of the leaflet 24 to adhere to the catheter. Other holding devices, including suction devices, tissue grasping devices, and additional penetrating devices, may be used alone or in combination. The application of a retaining force to the valve leaflet 24 is advantageous in that it assists in the application of a counteracting force to the valve leaflet during the insertion of the penetrating element 27.

[0045] Figure 12 shows a suture loop 60 supplied from a catheter penetrating the mitral valve leaflet 24, with the strain relief forming a loop and located on the ventricular side of the mitral valve leaflet, the distal anchor 32 located at the bottom of the left ventricle, and the final tension adjustment of the suture held by a suture lock that has advanced along the tail of the suture. A cryocatheter 70 attached to the mitral valve leaflet is shown to stably hold the valve leaflet and counteract the penetrating force of the strain relief. The embodiment shown in Figure 12 is similar to the embodiment shown in Figure 11, except that the penetrating element 27 is retracted from the tissue.

[0046] Figures 13 and 14 show, from the atrial side, the location of the penetration of the mitral annulus 16 and the position of the distal anchor 32 relative to the innate papillary muscle, according to a specific embodiment. In one embodiment, the anterior or posterior leaflet, or the annular tissue adjacent thereto, may be penetrated. The location of the penetration and the placement of the strain relief or leaflet anchor are used to influence the amount of tension applied to the leaflets.

[0047] Figure 15 shows various anchors 32a, 32b, 32c, and 32d for attachment to the apex of the left ventricle. The anchors have coiled circular wires 32a, 32b, and 32c and laser-cut hypotube 32d, with vertical risers 70 that adjust the connection point 72 closer to the level of the papillary muscle to more accurately simulate the correct angle and match the new cord connection. Anchor 32a includes a single helical coil extending around the outer circumference of a longitudinally extending pointed shaft. In one embodiment, the shaft may be omitted. Anchor 32b includes two helical coils extending in opposite directions at substantially the same pitch. In one embodiment, a pointed shaft like that of 32a may extend between the coils. Anchor 32c includes a single helical coil whose outer diameter decreases from the proximal end of the coil to the distal end of the coil. Anchor 32d includes a single coil formed from laser-cut hypotube. In one embodiment, the connection point 72 may be a single closed loop. The suture portion may be tied to or attached to a loop. In one embodiment, other forms of connection or other forms of cord may be used for the suture portion. The anchor 32c includes a riser 70 in the form of a support and a connection point 72 that receives the suture portion 60. The suture portion 60 can be fixed within the connection point 72 by a silicone plug 74. The plug may be made of a suitable material. The connection point 72 may have a channel configured (e.g., in size and shape) to receive the plug 74. The connector may have one or more openings extending through the side wall of the channel that allow the passage of the suture portion. The plug 74 may frictionally engage with the channel. One or more suture portions extend through the openings in the side wall and the channel as shown in Figure 15. The suture portion slides freely through the opening when the plug 74 is not present during installation, thereby allowing adjustment of the length of the suture portion and the tension in the suture portion. The plug 74 may be inserted into the channel and form a tight frictional fit with the channel. The plug 74 frictionally secures one or more sutures between its outer surface and the inner surface of the side wall, thereby effectively locking the sutures in place relative to the anchor 32c. The plug 74 may be installed after adjusting the length and tension of one or more sutures.In other embodiments, the suture extends through the loop to the distal end of the channel, thereby allowing the suture to slide. The proximal and distal ends of the suture may extend through the proximal opening of the channel. The plug 74 frictionally secures the suture as described above, preventing further sliding of the suture relative to the anchor 32d. The various features of the anchors 32a to 32d disclosed herein can be applied in any suitable combination.

[0048] Figures 16-22 illustrate other methods relating to specific embodiments. Figure 16 shows a transseptal catheter for feeding an anchor 32 to the apex 20 of the left ventricle, including a plurality of replacement cords 22 extending from the handle of the catheter 100. Figure 17 shows the transseptal catheter 100 of Figure 16 for feeding a penetration tool 80 through the mitral valve leaflet 24 to feed a strain relief anchor connected to a suture loop 60. Figure 18 shows the transseptal catheter 100 for feeding the penetration tool 80 through the mitral valve leaflet 24 together with the suture loop 60. Figure 19 shows the transseptal catheter 100 for feeding a strain relief 52 to the ventricular side of the mitral valve leaflet 24, with the strain relief exposed for feeding through or by the penetration tool 80. In one embodiment, the strain relief 52 may self-expand when exposed, as described herein. Figure 20 shows a transseptal catheter supplying strain relief 52, with the penetration tool 80 withdrawn from the mitral valve leaflet 24. In the embodiment shown in Figure 20, each of the two strain reliefs is positioned on each side of the mitral valve leaflet 24. The leaflet may be sandwiched between the atrial strain relief and the ventricular strain relief. After the ventricular strain relief 52 is positioned and tension is applied to the suture so that the ventricular strain relief 52 is in flush contact with the leaflet 24, the atrial strain relief may be advanced across the suture. The atrial strain relief may be configured to lock or fix in place at the suture to prevent contact between the strain relief and the tissue of the leaflet 24 and to prevent slack from developing between the strain reliefs that would relieve pressure on the strain relief. In one embodiment, the suture lock may advance behind the atrial strain relief, bringing the atrial strain relief into flush contact with the tissue of the valve leaflet 24. In some examples, using two strain reliefs can reduce strain at the puncture point through the valve leaflet 24, thereby reducing damage to the tissue of the valve leaflet 24.Figure 21 shows a transseptal catheter 100 supplying strain relief 52, with a suture loop 60 extending from the catheter handle and a connection to the distal anchor 32. Figure 22 shows a transseptal catheter supplying suture lock 62 to the distal anchor 32. The suture lock 22 advances along the suture tail to adjust the position and tension of the final implanted suture connected to the mitral valve leaflet 24 and the distal apical anchor 32 while tension is applied from the proximal end of the suture via the catheter handle.

[0049] Figure 23 shows one embodiment in which the continuous suture loop is fixed to the strain relief element 52 on the mitral valve leaflet 24 in its final position. In one embodiment, the continuous loop may be formed by applying a suture lock to the tail of the loop-shaped suture. Alternatively, any other suitable means may be used to form the continuous suture loop. In one embodiment, the mitral valve leaflet anchor or strain relief element 52 may have two sides (e.g., including a double-sided flange 52b) as shown, or it may have a single-sided flange 52a, not shown. The double-sided flange 52b may have expandable elements (e.g., expandable flanges) configured to be positioned on both sides of the mitral valve leaflet tissue. In one embodiment, the two opposing flanges are fixedly joined to each other via an intermediate element that crosses the puncture opening of the valve leaflet 24. The flanges may have multiple strain relief elements (e.g., flexible / deformable loops) configured to distribute strain over a larger surface area of ​​the valve leaflet 24.

[0050] Figure 24 shows one embodiment in which the continuous loop 90 is fed to its final position and the strain relief element 52 and distal apical anchor 32 are positioned relative to the mitral valve leaflet 24. This embodiment may be similar to the embodiment shown in Figure 23.

[0051] Figure 25 shows an example of a distal apical anchor 32. This distal apical anchor 32 has a silicone anchor plug 72 and a stainless steel tube 73 configured to restrict the movement of the suture before feeding the suture lock 62 for final positioning. In one embodiment, the plug 72 is used as a temporary suture lock. In other embodiments, the plug may function as a temporary suture lock that advances across the suture, in addition to or in place of the suture lock 62. If the plug 72 is used temporarily, the plug 72 may be removed before implantation is complete. The material may be changed to accommodate size and / or material reinforcement. In one implementation example, the anchor 32 is the same as or similar to the anchor 32c shown in Figure 15.

[0052] Figures 26-34 show an embodiment in which the arrangement order of the distal apical anchors 32 can be changed. Figure 26 shows the catheter 100 passing through the right atrium and penetrating the septum 12, and the left atrium 14.

[0053] Figure 27 shows the anchor 32 rotating toward the apex of the left ventricle. Depending on the configuration of the anchor, the anchor 32 rotates clockwise or counterclockwise. As described herein, the anchor 32 may be rotated by a feeding device (e.g., a rotary screwdriver) that can be inserted through the catheter 100. Furthermore, although the anchor 32 is rotated toward the apex of the left ventricle in the illustrated embodiment, in modified examples the anchor 32 may be fixed at other locations in the left ventricle. For example, as will be described in more detail below, the methods and apparatus in the embodiments described herein may be used in a configuration in which the anchor 32 is located in the left ventricle between the papillary muscles. In such a configuration, the sutures extending through the anchor 32 and the mitral valve leaflet 24 are advantageously aligned with one or more chordae tendineae extending from the fixed mitral valve leaflet 24.

[0054] Figure 28 shows a distal apical anchor 32 in a predetermined position, with the suture line 22 extending through the catheter 100 to the proximal end of the extracorporeal delivery device. As described herein, the suture line forms a loop through the anchor 32. The extension arm 94 of the catheter 100 is exposed laterally to the catheter slightly proximal to the distal end of the catheter 100. The extension arm 94 may be angled to extend proximal from the side of the catheter 100. The extension arm may be configured, for example, to capture the mitral valve leaflet 24 on the ventricular side of the valve leaflet 24. The extension arm 94 may have a pointed tip. Alternatively, the extension arm 94 may have a needle, allowing the needle to pass through the catheter 100 and the extension arm 94. The valve leaflet 24 may engage with the needle when it is properly positioned relative to the valve leaflet 24. In one embodiment, the extension arm may be formed on a separate catheter configured to be independently advancing distally and retracting proximally through the catheter 100.

[0055] Figure 29 shows an extension arm 94 in contact with the mitral valve leaflet 24 and a needle 96 connected to a suture loop 60 and penetrating the leaflet 24, with the suture loop 60 exposed on the atrial side of the mitral valve leaflet 24. In one embodiment, the suture loop may be formed from one tail of the suture extending through the distal anchor 32. The other end may extend proximal through the delivery catheter to the proximal end of the delivery catheter 100 and outside the body. In one embodiment, the suture loop 60 is a ring, and the suture is looped through this ring. In one embodiment, the suture loop 60 may be a loop in the suture that engages with the needle 96, and the needle 96 may be configured to hold the suture loop 60 and prevent the suture loop from retracting proximal through the needle 96. In one embodiment, a continuous suture may extend through the distal anchor 32 such that four strands extend from the distal anchor 32, two of which extend to the proximal end of the catheter 100, and the other two strands extend to form a suture loop 60.

[0056] Figure 30 shows the suture loop 60 penetrating the mitral valve leaflet and exposed on the atrial side of the leaflet to receive a loop snare 99 that captures the suture loop 60 and retracts through the catheter 100. The loop snare is fed through another opening of the catheter 100 located proximal to the extension arm 94. The extension arm 94 and the loop snare opening may be located on the same side of the catheter 100. The loop snare 99 may be configured to contract around the suture loop 60 so that it holds the suture loop 60 and retracts proximal into the catheter 100 through the loop snare opening (advancing the suture loop distally through the extension arm 94).

[0057] Figure 31 shows a suture loop snare 99 closing around the suture loop 60 and the suture being withdrawn proximal through the catheter 100. Figure 32 shows the catheter 100 feeding the suture lock 62 to the posterior side of the mitral valve leaflet as the suture loops along a path including the distal apical anchor 32. The suture lock 62 and the distal anchor 32 may be configured so that the suture lock 62 can freely pass through the connection point of the distal anchor 32 to reach the ventricular side of the valve leaflet 24. For example, the suture lock 62 may be configured to pass through the loop of the distal anchor 32. The extension arm 94 may retract before or during the above steps so that the valve leaflet 24 is not captured by the extension arm 94. In one embodiment, as described herein, the extension arm may be formed as part of an internal catheter that advances through the catheter 100 and is withdrawn through the catheter 100.

[0058] Figure 33 shows a second catheter 101 that receives the suture end, applies appropriate tension to the two ends, and then delivers a suture lock that locks the suture across the valve leaflet. The catheter 100 is withdrawn to carry the suture loop 60 out of the body, where it aligns with the other end of the suture. The second suture lock is applied to the suture end and then delivered into the body using the second catheter 101. Figure 34 shows suture locks 62 positioned at predetermined final positions above and below the mitral valve leaflet 35, and the suture end that has been cut, leaving the final implantation of the distal apical anchor connected to the mitral valve leaflet 24. The second suture lock 62 may be positioned at an alternative position relative to the valve leaflet 24, depending on the length of the suture between the two suture locks. By positioning the two suture locks on both sides of the valve leaflet 24, the suture locks can function as strain relief. In one embodiment, the first suture lock 62 located on the ventricular side of the valve leaflet 24 may be omitted.

[0059] Chordae tendineae termination and suture locking structures and devices include one or more knots, cotton spools, or other termination techniques to reduce focal stress at the attachment point. Penetration of annular tissue and valve leaflets can be achieved by inserting a sharp needle. The penetration is controlled via an operable catheter and core shaft to push, position, and drive the needle through the mitral valve leaflets. The procedure can be guided under fluoroscopy, echocardiography, or any other appropriate visualization or monitoring. Leaflet retrieval and identification can be achieved by mechanical techniques to grasp or pinch the leaflets, or by aspiration or cryocapture using a cryocatheter. These techniques include, for example, cryocatheters used for ablation to freeze focal tissue, as described with reference to Figure 12. Cryoablation catheters used for atrial fibrillation may inadvertently adhere to the mitral valve leaflets, requiring the procedure to be stopped to release the attached leaflet. The same cryo-attachment can be used to locate and identify the problematic leaflet for repositioning and repair. Cryogenic catheters use gas displacement (nitrogen oxide or argon) to reduce the temperature of the catheter tip, resulting in a temperature of approximately -75°C.

[0060] The inferior apical anchor structure consists of a coiled distal portion that rotates toward the apex of the left ventricle, having a flat or rounded wire structure, or a laser-cut tube that mimics a wine cork-like corkscrew, similar to those described in the examples of Figures 6 and 15. A variable screw pitch allows for a more secure attachment to the surrounding tissue. Other devices for fixation to the tissue include crimping or ellipsizing of the screw anchor to achieve similar fixation. Attachment to the anchorizer is performed by pinning, welding, or joining via other mechanical devices. In alternative examples, the anchor is formed from the same material as the tube, which is made of stainless steel, Nitinol®, or other implantable material, and is laser-cut. The nearest end may be provided with a loop or tube for receiving replacement cords, as shown in connection 72 of Figure 15, or multiple replacement cords may be pre-provided for feeding and extending from the catheter handle.

[0061] In other embodiments, the distal anchor may be delivered to the left ventricular apex along with multiple replacement cords that are looped around the anchor and extend to the most proximal handle portion of the catheter. This allows for delivery of multiple anchors extending vertically from the left ventricular apex to a single origin, with the free ends of the replacement cords extending from the delivery catheter for access and advancement of other tools for locking or cutting. A delivery penetration element or tube advances and penetrates across the free end to the mitral valve leaflet, delivering a cotton spool or restraint element through the leaflet to the ventricular side of the leaflet. This secures the loop and restraint element to hold the loop from tension through the leaflet, functioning as a strain relief element. A locking element is delivered across the same free end of the replacement cord, ensuring the position of the cord and cotton spool relative to the position of the leaflet. The free end may be cut after delivery. Locate and retain the valve leaflets, which may be achieved by a cryocardial catheter that holds the leaflets from the atrial side, or by using a gripping device that grasps the leaflets from the free edge. Once the first penetration is performed and the cotton suture is fed, tension is applied to the other free end around the distal apical anchor, and a second locking element is fed to hold its position relative to the end of the apical anchor. The cord or suture anchor may be secured by interference fit to another cord line extending to the distal apical anchor and / or to the mitral valve leaflets. The figure shows the feeding and placement of a mitral valve leaflet anchor to the posterior leaflet, but the anchor and replacement cord may be fed to the anterior leaflet, or to any position on the mitral valve leaflet including the free edge, junction area, or mitral annulus.

[0062] Alternatively, a distal rotating anchor connected to a continuous loop of suture, such as a rubber band, is positioned in the left ventricle. One end is fixed to the distal anchor. The other end penetrates the mitral valve leaflet and connects to a strain relief element, distributing force to the ventricular side of the mitral valve leaflet. This prevents the replacement cord from being pulled through the leaflet or the leaflet from being torn. The strain relief element may be a laser-cut tube that expands from a small shape to a large shape via a compressive axial force as it passes through the leaflet. Alternatively, the strain relief element may be made of a shape-memory metal such as nitinol and may be pre-set to have a small feed diameter that expands significantly. The feed diameter is approximately 0.5 mm and expands to approximately 2-3 mm. The feed length is approximately 2-5 mm and can be shortened to approximately 1-2 mm. Furthermore, the strain relief element may be made of shape-memory metal and set in a circular configuration, such as in an Amplatz device, or it may be a simple or complex suture knot positioned on the ventricular side of the valve leaflet. Another configuration is a nitinol-coated loop wire, such as a daisy, including a nitinol wire pedal. This device may also be used to adjust the final length of the loop cord by winding the loop end that has passed through the valve leaflet. For example, the free length of the suture or cord may be gradually reduced by the number of times the suture or cord is wound around the device. This winding mechanism may also be positioned in a distal coil anchor located in the left ventricle. This adjustment may be made during delivery to adjust the length of the cord and / or shorten or lengthen it after the procedure. A rotary ratchet drive connected to the drive shaft or wire may be rotated outside the body by engaging and disengaging when adjustment is needed. The drive shaft may be a round wire made of stainless steel or nitinol, and the two elements can be engaged or disengaged using a hexagonal coupling interface between the drive shaft and the winding mechanism. The two elements are fed in an interlocked state for operation, and are later coupled using a loop snare to grip the winding mechanism, connecting to the drive shaft which engages with the hexagonal drive unit.The winding mechanism may use a simple rotating spool with a toothed stopper to prevent rotation, or it may utilize frictional resistance to maintain the tensioned position. As an alternative, the distal coil anchor can be designed to receive an internally aligned pitch adjustment screw coupled to the cord so that the outer body of the distal anchor is driven into the apical tissue, and tension can be applied to the cord by shortening the relative distance between the two screw elements by rotating the internally aligned pitch screw. The simplest configuration is to place one coil inside another, in which both coils have right-hand or left-hand threads and are coupled to each other to add rotational motion to translational or axial motion. By locking the two coils together after processing, a secure position of the cord length can be provided between the valve leaflet and the distal anchor system.

[0063] Patient selection

[0064] In one embodiment, the method for treating a patient begins with selecting a suitable patient. However, the methods, apparatus, and systems described herein are not limited to application to preferred or suitable patients. Preferably, the patient has at least one, three, or five of the following characteristics from the first group: • Diagnosed with primary or degenerative mitral valve regurgitation. • Diagnosed with secondary or functional mitral regurgitation. • A diagnosis of myxomatous mitral regurgitation. • Diagnosis of flail leaflet, chordal tear, or leaflet prolapse. • Mitral valve regurgitation is grade 1 or higher, grade 2 or higher, grade 3 or higher, or grade 4 or higher. The diameter of the A2 leaflet to the P2 leaflet must be at least 5, 10, 15, 20, 30, or 50 mm smaller than the total length of the P2 + A2 leaflets. Furthermore, similar mathematical relationships may be used to ensure a suitable redundant joint after repair, in order to perform a durable repair. The diameter of the A2-P2 valve leaflets is 10-50 mm, preferably 24-36 mm, or most preferably 26-33 mm. • The access vessel diameter must be at least 2-10 mm. Preferably, the patient has at least one, three, or five of the following characteristics from the second group: • The patient has been evaluated by a cardiac team, including at least one, preferably two, cardiac surgeons, and has been determined not to be a suitable candidate for repair via conventional open-heart surgery. • The surgical mortality rate predicted by STS (Society of Thoracic Surgery score, STS score) must be between 2 and 20 or higher. The patient was offered a repair procedure via open-heart surgery but refused. • The age must be between 18 and 90 years, preferably between 35 and 85 years, and more preferably between 40 and 85 years. • The patient will not receive a blood transfusion. • The patient has previously undergone open-chest surgery. • The ejection fraction must be at least 10-60 percent. Regarding the embodiment of the device, it is preferable that the patient substantially does not have the following requirements (third group): • Moderate or severe COPD ·Hypercoagulable diseases • Systemic degenerative collagen disease (i.e., Marfan syndrome) • Previous septal infarction affecting the anchor area • Ventricular septal defect • Known allergies to contrast agents • Previous mitral valve replacement

[0065] In one embodiment, the selected patient meets at least one, two, or three criteria of Group 1 and at least one, two, or three criteria of Group 2. In another embodiment, the selected patient meets at least one, two, or three criteria of Group 1 and at least one, two, or three criteria of Group 2, and does not meet at least one, two, or three requirements of Group 3.

[0066] Patients may be evaluated using echocardiographic imaging and / or CT imaging. MRI imaging may also be used. It is preferable to set up a contrast-gated cardiac CT with at least 32, 64, or 128 slices before the procedure and use it for patient selection and / or case planning. Using imaging software, the diameter from the A2 hinge point to the P2 leaflet hinge point can be measured, and the free length of the leaflets can be measured. By comparing these measurements, it is possible to ensure the presence of a sufficiently redundant joint that will result in a durable repair after the procedure is completed. In one embodiment, the annular dimensions can be reduced using other devices or methods, such as a transcatheter valve repair device, to form a sufficiently small diameter.

[0067] Image creation

[0068] This disclosure has the potential to enable superior real-time evaluation and adjustment of suture placement and tension during procedures. The embodiment relating to the imaging method offers significant advantages in visualization compared to methods available during cardiac incision surgery.

[0069] Tension optimization

[0070] During open-heart surgical mitral valve repair, the heart stops, relaxes, and contracts, so the surgeon must estimate the dynamic movement of the structure based on experience. The surgeon's initial assessment stage includes filling the ventricle with saline solution to push the mitral valve leaflets into a closed position, as well as visually assessing areas of leakage, prolapse, and / or improper joining.

[0071] The above evaluation is limited because it cannot be performed on a beating heart. However, the suture is tied and secured based on the above evaluation, and then the atrium is closed and the heart is resuscitated, and a final echocardiographic evaluation or other monitoring is performed on the beating heart. If a problem is identified, the surgeon needs to stop the heart again, reopen the atrium, and correct the already completed repair. Since the suture is tied and trimmed, it cannot simply be tensioned again. Therefore, the suture is generally replaced or an additional artificial cord is added. In one embodiment of this disclosure, real-time echocardiographic evaluation is possible because the tension of the suture is individually adjusted.

[0072] In one embodiment, a method for implanting artificial cords includes, firstly, the step of fixing one end of a plurality of artificial cords to the mitral valve leaflet or the annulus of the surrounding tissue and fixing the other end to an anchor point mechanically connected to the left ventricle, and secondly, the step of adjusting the tension of the artificial cords while viewing echocardiographic images and other images of the mitral valve.

[0073] In one embodiment of the method, the echocardiographic image includes a color Doppler assessment of velocity and / or flow. In one embodiment, the echocardiographic image includes a real-time 3D or 4D echo. In one embodiment, the color flow Doppler image and the 3D image are fused or combined. In one embodiment, the echo probe is positioned along the patient's esophagus. In one embodiment, the echo probe is a surface probe positioned on the patient's chest. In other embodiments, the echo probe is positioned in the patient's vascular system.

[0074] In one embodiment, at least one, two, three, four, or five of the following functions are confirmed under echocardiography while tension is applied to the artificial cord. In other embodiments, the following functions are confirmed after tension has been applied to the artificial cord and before the cord is permanently disconnected from the supply system. It is possible to easily reapply tension if necessary. • Absence of pre-systolic clipping that causes obstruction or limitation of the left ventricular outflow tract. • Mitral valve gradient • Appearance of reverse jet • Speed ​​of reverse flow • Length of the reverse jet MR grade • A minimum valve leaflet joining distance of at least 3, 5, 9, 12, or 15 mm must be achieved across the joining line. • The degree of leaflet prolapse or the height to which a portion of the mitral valve leaflets move above the mitral valve plane. • Areas of "smoke" or congestion (stasis) within the atria, ventricles, or atrial appendages. • Closure between the left and right ventricles, particularly at the location of the ancho or other septal sections.

[0075] Furthermore, while the tension of the suture is easily adjustable, at least one, two, three, four, or five of the following are evaluated during the evaluation period after the initial tension is applied to the suture and before the suture is cut from the feeding system or before any excess suture is removed: ·blood pressure ·Cardiac output Actual Coagulation Time (ACT) • EKG electrocardiogram • Cardiac enzymes CKMB and troponin • Patency of the coronary arteries Fluoroscopic evaluation of potential ventricular shunts from anchors or transventricular access. Fluoroscopy of the ventricular anchor • Transparent position of the feed / transport system • Atrial pressure or wedge pressure • Oxygen content in the patient's blood

[0076] After the evaluation step is completed based on the information obtained from the measurements, the physician or medical team decides whether to perpetuate the results, readjust the tension, add additional repair elements, or discontinue the procedure. In one embodiment, the physician has the option of removing the entire implant. In other embodiments, the physician has the option of removing the artificial cord from the implant while leaving the ventricular anchor implanted. In one embodiment, the evaluation step is further enhanced by including a stress echocardiogram element. In the stress echocardiogram element, the patient is given drugs such as pressure regulators to adjust heart rate, cardiac output, and ventricular pressure, and the repair is further evaluated to assess how it functions under different hemodynamic conditions.

[0077] monitoring

[0078] During the procedure, it is preferable that the patient be under conscious sedation. This makes transesophageal echocardiography difficult, but minimizes the risks of anesthesia and allows for earlier discharge of the patient. During general anesthesia or conscious sedation, standard catheterization lab monitoring, including arterial pressure, EkG, ACT, and blood gases, is necessary. Furthermore, wedge pressure or left atrial pressure is useful for this procedure. Careful monitoring of arterial pressure for the above procedure provides early indicators of damage to the mitral valve apparatus, entanglement of the apparatus in the chordae tendineae, and / or damage to the septum. Measuring left atrial pressure can provide a simple and quantifiable assessment criterion for improvement in mitral valve function without the challenges associated with obtaining appropriate echocardiography.

[0079] access

[0080] The vessel is accessed by conventional methods that are standard in interventional cardiology. Preferably, the vessel is a vein. In one embodiment, the vessel is the femoral vein. In other embodiments, the vessel is the radiohumeral or subclavian vein. Access may be by cut-down or percutaneous needle insertion. In one embodiment, the vessel is prepared for closure by pre-insertion of a vascular closure device such as Percolse or Prostar (Abbott Vascular).

[0081] The guidewire is advanced through the valve into the right ventricle, optionally using a guide catheter. The device of this disclosure can advance along the guidewire to a position near the apex of the ventricle.

[0082] The tip of the device may be sharply curved. The curve may be oriented so that the exit lumen faces the septum of the heart. The radius of curvature of a fully curved system is preferably less than about 3 to 30 mm, and the curvature is preferably located less than about 5 to 50 mm from the tip of the system.

[0083] In one embodiment, the curvature described above is formed using a manipulable catheter. Certain embodiments of the manipulable catheter include a pull wire that forms the inner radius of the catheter when pulled. Some embodiments also include coils, blades, and / or axial reinforcements.

[0084] In the embodiment, the curve is formed using coaxial sheaths having different shapes. For example, an outer sheath that is substantially straight or has a large radius of curvature near the tip may be used in combination with an inner sheath that has a small radius of curvature at the distal tip. By advancing the inner sheath from the outer sheath, the desired curve is formed at the tip of the catheter. A larger curvature angle can be obtained by advancing a more curved sheath.

[0085] In one embodiment, the two sheaths have different relative stiffnesses at different points in length. In a particular embodiment, the outer sheath is curved to access the apex of the ventricle and to remain stable through the superior vena cava. To enable this, the shape may extend back 7–50 cm from the distal tip of the sheath. The inner sheath is substantially more flexible than the outer sheath in the range of about 7–55 cm from the distal tip (e.g., less than about 30, 50, 70, or 90% of the bending stiffness by the ASTM three-point bending test). This allows the inner sheath to move relative to the outer sheath without substantially changing the orientation of the outer sheath in the heart and superior vena cava. The distal portion of the inner sheath is preferably stiffer than the aforementioned portion and has sufficient strength despite the approximate shape portion being in contact with the structural portion of the heart when the inner sheath extends from the outer sheath.

[0086] The device may be oriented so that the catheter exit is located near the apex of the right ventricle, pointing towards the septum, and preferably upward toward the mitral valve. The position of the sheath can be confirmed by imaging. In one embodiment, a four-ventricular echocardiogram is used. In other embodiments, a short-axis mitral image is used. In one embodiment, fluoroscopy is used. Depending on the location of the area requiring repair, a desired puncture site is selected, and an appropriate angle is selected based on the direction of the planned replacement code.

[0087] In one embodiment, a higher puncture site, closer to the papillary muscle attachment point, and further away from the ventricular apex is preferred. This position offers the advantage of less change in cord tension compared to apical placement, as the heart remodels and ventricular volume decreases to a more normal physiological level.

[0088] The needle and / or dilator may advance through one or more sheaths and the septum of the heart. In one embodiment, the needle and dilator are used together. Both the needle and dilator may be pre-formed with a curve near the distal tip so that the needle remains in the left ventricle and avoids the mitral valve apparatus. The presence of the needle in the left ventricle can be confirmed by echocardiography, fluoroscopy, and / or the presence of red (oxygenated) pulsating blood at the proximal end of the needle.

[0089] After access to the ventricle is achieved, the guidewire can be advanced across the septum. In one embodiment, the guidewire is advanced further across the mitral valve into the atrium, and in other embodiments, the guidewire is advanced further into the pulmonary veins. Echocardiography and / or wire manipulation can be used to confirm that the wire is not entangled in the mitral apparatus. In one embodiment, devices such as balloons or sheaths can be advanced across the wire to confirm that the wire does not pass through any cord structures.

[0090] Ventricular anchor

[0091] This disclosure includes several embodiments relating to ventricular anchors.

[0092] In one embodiment, the ventricular anchor is similar to the Amplatz septal occluder (ST Jude Medical), which consists of blade portions that expand on both sides of the septum.

[0093] In other embodiments, the anchor is a spiked, stent-like structure intended to deploy within the ventricular wall. The stent structure may be self-expanding or mechanically expandable (i.e., balloon-expandable) and may include a spiked anchor similar to those found in stent grafts such as Endurant (Medtronic).

[0094] In other embodiments, the anchor is a flanged and covered stent, with the right ventricular side open to a substantially flat structure oriented to a plane substantially perpendicular to the stent axis.

[0095] In other embodiments, the flange consists of a ring extending around the flange, and the flange itself is a layer of fabric. The flange is folded into an elliptical shape and fed through a lumen. The ring may be made of nitinol-titanium stainless steel or a cobalt-chromium alloy. The fabric lumen may extend through the center of the flange into the transseptal puncture. In one embodiment, after the cord is implanted, tension is applied through the cord to press the flange against the septum. During the procedure, part of the feeding system can be used to press the flange against the septum. In other embodiments, the fabric sleeve is fixed with a stent or barb or the like to stabilize it within the septum.

[0096] The ventricular anchor deploys along the guidewire. After the anchor is deployed, the cord delivery anchor and its delivery system can be delivered along the guidewire via the ventricular anchor.

[0097] positioning

[0098] To place the new code, echocardiography is used to determine the correct location. Areas of regurgitation jets or leaflet prolapse or instability can be identified using 2D or 3D echocardiography and / or color flow Doppler. Preferably, a combination of these imaging modes is used.

[0099] The device for feeding the cord may advance through the septal puncture. In one embodiment, the same operable or moldable system used to form the septal puncture advances through the puncture. In other embodiments, the device may be a separate device capable of passing through other sheaths.

[0100] The distal tip of the device may be oriented relative to the mitral valve structure as follows: The device may be deflected anteriorly by increasing the curvature of the system entering the left ventricle through the septum. The device may be deflected posteriorly by decreasing the curvature of the system entering the left ventricle through the septum. The device may be deflected from commissure to commissure by rotating the curved portion that passes through the sheath. The device may be deflected longitudinally by extending the distal portion of the device, or ventricularly by retracting it.

[0101] Primary

[0102] To replace the main cord and the cord located near the free end of the valve leaflet, several methods are possible for engaging with the mitral valve leaflet. In one embodiment, the large knot system from Harpoon Medical may be used. In another embodiment, the loop suture from Neochord Inc. may be used. Both of these methods appear to work well in early clinical experience. A preferred embodiment is intended to replicate a clinically proven suture tissue interface developed based on experience in open thoracotomy.

[0103] In other embodiments, a branched catheter is used. One end of the catheter engages below the valve leaflet and is pressed to help identify the area of ​​the leaflet through which the suture passes. The other end passes toward the atrium. One needle or a pair of needles puncture the valve leaflet from the first end of the catheter, and a snare captures the needle or suture from the needle from the second end of the catheter. In one embodiment, the loop end of the suture passes across the snare so as to form a circumferential hitch when the needle end of the suture is retracted. In other embodiments, the loop end of the suture is twisted to become doubled twice, and the prusik forms a knot known as a double circumferential hitch.

[0104] Secondary

[0105] To replace the second cord, which is located further posterior to the free edge of the valve leaflet, the apparatus and method described for replacing the main cord must be applied. The fastening method using a large knot is suitable for replacing the second cord, which does not require modification.

[0106] The branching catheterization method is suitable for the replacement of a second cord with minor adaptations to allow the snare side to puncture the valve leaflet.

[0107] excision

[0108] During mitral valve repair, surgeons may excise a portion of the valve leaflet tissue. A similar effect can be achieved using the aforementioned branching catheter system. This is accomplished by positioning the suture through the valve leaflet and then tightening the suture to bring the tissue together. Note that the suture may be located near the excised leaflet or extended to serve as a new cord.

[0109] partial annuloplasty

[0110] In some cases, it is desirable to use a double puncture technique on the annulus near the hinge point of the valve leaflet to achieve an effect similar to surgical annuloplasty. In one embodiment, a series of suture loops are formed surrounding the entire annulus. In another embodiment, suture loops are formed only in safe areas of the aortic valve, coronary arteries, and conduction pathways. In yet another embodiment, suture loops are formed in the area of ​​the heart most likely to dilate (i.e., the area of ​​the previous infarction) or near the mitral commissure.

[0111] evaluation

[0112] After placing one or more repair sutures in the mitral structure, the results are evaluated. Tension is selectively applied to each artificial cord until the desired valve leaflet movement is obtained. Preferably, the target joint height is determined by echocardiography. In one embodiment, the sutures are subjected to excessive tension so that remodeling may occur when excessive and insufficient tension are balanced.

[0113] Knotting

[0114] In one embodiment, the suture is tied on the right ventricle side of the anchor using a crimpable knot that is large enough to prevent the crimped knot from passing through the opening of the anchor.

[0115] In other embodiments, the artificial cord is crimped directly onto an anchor that is sewn or tied to the suture.

[0116] Suture adjustment

[0117] In one embodiment, the tension of the artificial cord can be adjusted by a similar method. In one embodiment, this can be achieved entirely from the right ventricle without crossing the septum again. In one embodiment, a crimpable knot is captured, pulled away from its base, and twisted. The twisting action of one of the pair of sutures forming the artificial cord effectively shortens the artificial cord. In another embodiment, a crimpable knot is captured and pulled, and an additional crimpable knot is positioned.

[0118] Multiple systems

[0119] In one embodiment, 1 to about 10 artificial cords can be attached to a single septal anchor. In one embodiment, one or more ventricular anchors are used to optimize the direction of cord tension or to minimize the load on the septal anchor.

[0120] Alternative method

[0121] For some patients' biological structures, it is necessary or desirable to secure the cord to a different region of the left ventricle rather than the septum. In one embodiment, the site of fixation is the papillary muscle. Preferably, the attachment of the suture to the papillary muscle or ventricular wall is performed by creating a figure-eight suture, as is commonly done by surgeons during open cord replacement. This type of anchor can be placed via a transcatheter method through the transseptal ventricular puncture described above, or via the more common transatrial transseptal puncture. One embodiment of a system suitable for suturing to the papillary muscle is a simple modification of a bifurcation leaflet suture system in which the ends of the needle and snare curve inward toward each other, so that when in operation, the ends of the needle and snare position the suture through the papillary muscle. In another embodiment, the ventricular anchor is a cork-screw shaped anchor similar to either an Aptos Endovascular staple (Medtronic) or any configuration used to secure pacemaker leads.

[0122] Withdrawal

[0123] In one embodiment, the ventricular anchor is retrievable. Examples include devices such as a retrievable, self-expanding stent or Amplatz.

[0124] In one embodiment, the artificial cord is retrievalable throughout the hemodynamic evaluation period. In one embodiment, this is achieved by pulling both ends of the suture for evaluation before engaging a periphery hitch for permanent implantation.

[0125] The accompanying Alfieri method for repair rings.

[0126] In one embodiment, the above procedure is performed in combination with other mitral valve repair procedures. This simulates several techniques commonly used by surgeons. Several clinically-use devices exist that simulate annuloplasty rings, including cardiac dimension coronary sinus-based approaches and suture-based approaches from Mitralign and Valtech. Furthermore, the MitraClip (Abbott) simulates the Alfieri stitch, a less commonly used surgical technique that forms two orifices.

[0127] Device

[0128] The apparatus of a particular embodiment includes an outer sheath curved to engage with the shapes of the vena cava and right ventricle. The proximal end of the outer sheath is connected to a handle of the delivery system. A conventional dilator for accessing the vessel is located within the outer sheath. Upon accessing the right ventricle, the dilator transforms into a special transventricular dilator having a relatively flexible proximal portion and a rigid, sharp, curved distal portion with a short, tapering, wirelessly opaque tip. The handle includes a member for locking onto the dilator, thereby preventing movement in the axial and rotational directions. The inner diameter (ID) of the dilator allows clearance for a long, flexible, preferably hollow needle. In one embodiment, the needle is curved. The needle is configured so that the tip of the needle advances through the distal tip of the dilator to precisely position the puncture. In one embodiment, the needle is sized to accommodate a guidewire having a diameter of 0.009, 0.014, 0.018, or 0.035 inches. In other embodiments, the dilator advances through the puncture site and across the needle until the needle is withdrawn. In one embodiment, the needle is integrated with the dilator and either retracts within the dilator or extends to a limited length beyond the tip of the dilator. In one embodiment, the length is approximately 2–20 mm. In other embodiments, the length is approximately 4–40 mm. In one embodiment, the length may be less than approximately 2 mm or more than approximately 40 mm.

[0129] One exemplary application described above will be explained below with reference to Figures 35A to 35O. Referring to Figure 35A, the catheter 100 (also referred to herein as an elongated flexible tubular body) has a distal end and a proximal end. The distal end of the catheter 100 enters the left atrium 102 in the prior art. The catheter 100 passes through the mitral valve 104 and advances to the vicinity of the apex 112 of the left ventricle 106. A tissue anchor 108, such as a helical tissue anchor 110, is rotated toward the muscle wall by an anchor driver (not shown) in the form of a rotary driver (not shown) and advances distally through the catheter 100. In certain embodiments, the anchor driver or rotary driver extends proximal through the catheter 100. After fixing the tissue anchor 108, the catheter 100 and / or anchor driver retract proximal, leaving the anchor 110 fixed to the wall and attached to the anchor suture 114. The anchor suture 114 extends proximal to the entire length of the catheter 100. The distal portion of the anchor suture 114 carries a neopapillary muscle 116, which may optionally include a soft ribbon or body 118 that approximates the size of the trapezius papillary muscle. The neopapillary muscle 116 has a substantially larger diameter than the suture 114. The suture 114 may be configured to extend through the neopapillary muscle 116 (e.g., through a central channel) or to be attached to the proximal end of the neopapillary muscle as described herein. In certain embodiments, the neopapillary muscle replacement component 118 may be formed from a soft PTFE material.

[0130] Preferably, the anchor 108 is attached to a point offset from the thin tissue of the apex 112 and is generally embedded in the thicker adjacent ventricular wall. Preferably, the anchor is positioned such that the longitudinal axis of the embedded neocord is substantially parallel to or concentric with the original path of the original cord. In such an arrangement, the tissue anchor 108 may be positioned in the left ventricle between the papillary muscles. As described herein, the tissue anchor takes the form of a helical ventricular anchor.

[0131] Referring to Figure 35B, the operable leaflet capture catheter 120 may advance distally beyond the catheter 100 through the mitral valve 104 to the left ventricle 106. The operable catheter 120 is advanced through the catheter 100. In an alternative example, the operable catheter 120 is advanced along the catheter 100. In a particular embodiment, the operable leaflet capture catheter 120 may be positioned within the catheter 100 along a driver (e.g., a rotary driver) connected to a tissue anchor (e.g., a helical ventricular anchor). In a particular embodiment, the driver (e.g., a rotary driver) connected to a tissue anchor (e.g., a helical ventricular anchor) is inserted through the catheter 100 and, after deployment, is removed or partially removed from the catheter 100. The operable leaflet capture catheter 120 then advances through the catheter 100 toward the desired location.

[0132] The distal portion of the leaflet capture catheter 120 includes a deflection region 122. The deflection region 122 may include various deflection mechanisms. For example, a plurality of spaced transverse slots 124 may be provided along the first side of the catheter 120. The opposite second side 126 of the catheter may have an axially incompressible dorsal portion. When one or more pull wires (not shown) are retracted proximal, the slots 124 collapse axially, thereby deflecting the catheter as shown in Figure 35C, for example. The slots 124 may be configured to allow a type and range of movement suitable for the insertion of a leaflet anchor.

[0133] Preferably, the deflection region 122 may be deflectable over an angle of at least about 160°, preferably at least about 180° or about 190° or more, in a simple or compound curve. The optimal radius of curvature of the deflection region 122 is less than about 2 cm, less than 1.5 cm in one embodiment, and preferably less than about 1 cm in other embodiments. In one embodiment, in order to position the leaflet anchor at a desired retracted position from the leaflet junction edge, the shortest straight-line distance D between the distal tip 128 and the catheter shaft is in the range of about 0.5 cm to about 1.5 cm, and optionally about 1 cm.

[0134] The operable valve leaflet capture catheter 120 advances through the mitral valve 104 to position its distal tip 128 in contact with the ventricular side 130 of the loose valve leaflet 132, and then deflects as shown in Figure 35C.

[0135] As shown in Figure 35D, the control device of the proximal manifold can be operated to advance the needle 134 through the loose valve leaflet 132 from the distal end 128. Puncture of the valve leaflet 132 with the needle 134 is performed when the valve leaflet 132 is displaced toward the left ventricle 106 during cardiac diastole.

[0136] The catheter 120 and / or needle 134 are used to deploy various tissue anchors to secure the suture to the valve leaflet 132. In certain embodiments, as described herein, the tissue anchor is a radially expandable leaflet anchor connected to a suture that extends proximal through the catheter 100. In the illustrated embodiment, a cotton spool 136 carried by the leaflet anchor suture 138 is deployed from the needle 134 toward the atrial side of the leaflet 132. The cotton spool takes the form of an elongated ribbon having a proximal end and a distal end. The distal end is secured to the leaflet anchor suture 138. The leaflet anchor suture 138 may be passed through one, two, four or more openings in the elongated ribbon. As shown in Figures 35E to 35G, the proximal retraction of the leaflet anchor suture 138 causes the ribbon to fold axially, forming a mass with sufficient cross-sectional area, resulting in insufficient proximal tension on the leaflet suture to pull the resulting cotton spool through the leaflet. Therefore, in certain configurations, the proximal retraction of the suture 138 allows the cotton spool 136 to be transformed from an elongated strip configuration into a configuration that expands radially and contracts axially.

[0137] Subsequently, the valve leaflet capture catheter 120 retracts proximal, leaving behind the structure shown in Figure 35H.

[0138] Any of the various leaflet anchors can be used, and they share the characteristic of being able to expand laterally from a low crossing profile that crosses the leaflets to a larger transverse profile that resists retraction through the leaflets. Lateral expansion is achieved by tilting the T-anchor or by active deformation by a control wire or elastic deformation after release from constraint.

[0139] Figures 35I1 to 35I4 show the deployed state of a T-tag anchor through a loose valve leaflet 132. An anchor element, such as a single T-tag bar 140 fixed to the suture 138, can be advanced distally through the needle 134 by a push wire 142. The push wire 142 is provided with a distal push platform 144, which has a notch 146 for accommodating the suture 138. As the bar 140 exits the needle 134, the bar rotates around the suture attachment point and seats on the atrial side of the valve leaflet 132 when the valve leaflet suture 138 is pulled proximal. Depending on the desired performance characteristics, the bar 140 may have a single element as shown, or an "X" shaped or multi-pillar structure.

[0140] Alternative leaflet anchors are shown in Figures 35J1-35J3. The tissue anchor has a hub 150 fixed to the suture 138. The hub 150 has a number of spokes 152. The spokes are laterally expandable from a low-profile linear structure when constrained within the needle 134 to an expanded structure shown in Figure 35J3 to resist proximal retraction through the leaflet 132. At least two, preferably four, six, or more spokes or struts 152 are provided, extending radially outward from the hub 150 when deployed to provide a contact area with respect to the leaflet. The struts are inclined radially outward in the proximal direction, providing dampers of forces that temporarily move the hub 150 closer to the leaflet 132 in response to tension spikes, such as when the leaflet 132 reaches its limit of movement due to the implanted neocord during cardiac systole. The spokes 152 and hub 150 may be laser-cut from a NiTi tube and attached to the valve leaflet suture 138 by adhesive bonding, crimping, or other means.

[0141] Referring to Figure 35K, the fulcrum 154 may be located near the distal end of the neonatal cord and the proximal end of the neonatal papillary muscle. The fulcrum 154 provides a point through which the length and / or tension between the leaflet anchor 136 and the distal anchor 110 can be adjusted. At least the leaflet suture 138 passes across the fulcrum, so that the proximal retraction of the leaflet suture 138 pulls the limit of the ventricular movement of the leaflet toward the atrial direction. The fulcrum 154 may also be the edge of the distal opening of the lumen of the adjustment catheter, which advances distally across the leaflet suture and potentially the ventricular anchor suture. In an alternative example, the fulcrum may include an eye or loop at the distal end of a fulcrum indicator such as a hypotube or support wire. Alternatively, the fulcrum 154 may be located at the suture lock, through which both the anchor suture and the leaflet suture can pass.

[0142] Before engaging the suture lock, the leaflet suture may be slowly retracted proximally to gradually restrict the prolapse of the loose leaflet into the left atrium. Mitral regurgitation can be observed on fluoroscopy, and the leaflet suture may be retracted until the mitral regurgitation (MR) is eliminated or sufficiently minimized.

[0143] Referring to Figure 35L, the catheter 100 advances distally to induce flexion of the anchor suture and leaflet suture, thereby minimizing the effect of the catheter 100 on leaflet function. This allows the physician to assess the effect on mitral regurgitation at the current tension level of the leaflet suture. If necessary, the leaflet suture may be retracted or advanced to further adjust the range of leaflet movement.

[0144] Once the desired cardiac function is achieved, the suture lock engages using known techniques or techniques described herein to fix the maximum distance between the tissue anchor 108 and the valve leaflet anchor, as shown in Figure 35M. In an alternative example, if an adjustment catheter is used as a fulcrum, the suture lock or knot advances distally through the catheter to a position near the proximal end of the neonatal papillary muscle and the distal end of the neonatal cord, and is fixed before the adjustment catheter retracts.

[0145] Referring to Figure 35N, the leaflet suture 138 and anchor suture 114 are cut proximal to the suture lock using well-known techniques or techniques described herein, and the catheter 100 is withdrawn from the patient. This leaves the neocord and neopapillary muscle in their designated positions within the left ventricle.

[0146] Referring to Figure 35O, the distal deflection region 122 of the modified valve leaflet capture catheter 120 is illustrated. Similar to the deflection region shown in Figure 35C, the implementation example in Figure 35O includes multiple axially compressible slots 124 on the opposite side of the non-foldable dorsal portion 126. This structure forms a first recess 150 when the pull wire retracts proximally. As previously mentioned, the minimum distance D at maximum bending of the deflection region 122 is generally in the range of approximately 0.5 to approximately 1.5 cm.

[0147] Depending on the desired performance, a second recess 152 may be provided that is operable by folding a second set of slots 154 axially. The bending of the second recess 152 may be achieved by retracting a second pull wire proximally. In an alternative example, the first recess 150 and the second recess 152 can be bent simultaneously by pulling a single pull wire.

[0148] In the illustrated embodiment, the second recess 152 is recessed in the opposite direction to the first recess 150 in the same plane. In an alternative example, the second recess 152 is recessed in the same direction as the first recess 150. In either configuration, the first recess is located in the first plane, and the second recess 152 is located in the second plane, which is rotationally offset from the first plane depending on the desired performance. Additional details of the composite curved catheter shaft are disclosed in U.S. Patent Publication No. 2014 / 0243877, which is incorporated herein by reference in whole.

[0149] Referring to Figures 36A-37, in one embodiment, rather than treating pure degenerative mitral regurgitation, the methods and apparatus according to the embodiments described herein may be used to treat a small group of patients with functional mitral regurgitation. Here, the patients have a tethered leaflet type defect. In this biostructure, there are mitral leaflets of adequate length to close and seal against leakage, but the chordae tendineae are too short for the leaflets to move into the plane of the mitral annulus. This type of biostructure usually occurs because the annulus expands and / or the ventricle expands while the chordae tendineae remain substantially the same length. Treatment of these patients is performed by cutting all or part of the congenital chordae as a step in the procedure.

[0150] In one embodiment, the cord cutting step is performed as the first step, prior to the device injection step. This prevents the possibility of accidental damage to the implantation site, but may cause a severe backflow condition during the procedure. In an alternative embodiment, the natural cord may be cut at any point during or after the implantation of the artificial cord. Cutting as the final step may result in the disadvantage that accurate evaluation of the results cannot be achieved until after the cord has been implanted. The injected device may be identical or similar to one of the embodiments described herein.

[0151] In certain embodiments, the innate chordae tendineae may be cut after the initial leaflet and ventricular anchors have been positioned and before the final tension is applied. In certain embodiments, this is achieved by first separating the innate chordae by passing a guidewire around each papillary muscle, capturing the end of the wire, and advancing a sheath over the wire to form snug loops around the papillary muscles before the chordae are implanted. These loops remain intact during the normal implantation of the ventricular and leaflet anchors. When the ventricular and leaflet anchors are in place, the innate chordae are cut, preferably with partial tension, using one of the apparatuses and methods described herein. This is achieved by manipulating the loops around the papillary muscles so that they move beyond the papillary head to the base of the chordae tendineae, and then cutting the loops. In one embodiment, the guidewire is simply pulled into the guide to produce the cutting action. In other embodiments, a blade-shaped tool is provided that fits into the guide and has a lumen for the guidewire. By pulling both ends of the guidewire, the chordae tendineae are pulled against the blade and cut. Many other tissue cutting devices have been described in the art, but the device and method described herein may be applied to such a device. After the natural chordae tendineae are cut, the tension of the implantation is adjusted. If the results are satisfactory, the implantation can be made permanent by locking the suture lock and cutting the suture tail, as described herein or in a similar manner. If the results are unsatisfactory, additional chordae tendineae may be added, or other mitral valve repair procedures may be performed in conjunction.

[0152] Instead of directly tying the chordae tendineae with a loop, tying the papillary muscle with a loop ensures that all chordae tendineae are securely captured. This is because all normal chordae tendineae are attached to the heads of the papillary muscles. Cutting with a looped guidewire is one method of cutting the natural chordae tendineae, but other methods and devices such as various types of transvascular suture cutters may also be used.

[0153] Next, referring to Figures 36A-37, Figure 36A shows the looped papillary muscle 200 in the initially captured configuration. Figure 36B shows the looped papillary muscle 200 pulled up onto the cord 202 in the area where the cutting step is preferably performed. Figure 37 illustrates one embodiment of the chordae tendineae cutting tool 210. The illustrated embodiment includes a cutting edge 218 and an element 220, with a total of two lumens 212, 214, one at each end of the looped guidewire 216, to protect the cutting edge 218 from contact with the sheath 210 and other parts of the patient and device that are not intended to be cut. After the papillary muscle is looped, the guidewire is fed through the first lumen 212 and the snare is fed through the second lumen 214 to capture the guidewire. The snare pulls the guidewire into the second lumen 214. As mentioned above, cutting using a looped guidewire is one method for cutting the natural chordae tendineae, but other devices and methods such as various types of transvascular suture cutters may also be used.

[0154] In one embodiment, the procedures described herein may be performed by specialized delivery systems and devices. The delivery system may include a plurality of subcomponents configured to perform various steps of the above procedures. In one implementation, a neochordae dehiscence system having an elongated, flexible tubular body, such as a catheter 100, may be used to access the patient's heart (e.g., the left atrium). Multiple subsystems may be introduced into the heart via the delivery catheter 100. The subsystems may include catheters having a diameter smaller than the internal lumen of the delivery catheter 100 and are configured to be inserted through the delivery catheter 100. In one implementation, some or all of the various subsystems may simultaneously occupy the delivery catheter 100 to perform the operations described herein. In one implementation, some or all of the various subsystems may subsequently occupy the delivery catheter 100 to perform the operations described herein. For example, the delivery system may include a ventricular anchor delivery system 300, a valve leaflet anchor delivery system 330, and / or a suture lock delivery system 370, as described herein. Figures 38A–38H schematically illustrate a method for implanting neochordae tendineae via a delivery system that includes subsystems for delivering ventricular anchors, valve leaflet anchors, and suture locks. The procedures shown in Figures 38A–38H may be identical or substantially identical to those shown in Figures 35A–35O. In one embodiment, the neochordae tendineae (or artificial chordae tendineae) includes a suture, as shown in Figures 38A–38H. In other embodiments, the neochordae tendineae are other flexible elements. The flexible elements are attached to the suture at their proximal and / or distal ends to connect to the ventricular anchors and / or valve leaflet anchors.

[0155] Figure 38A shows the placement of a helical anchor 302 near the apex 112 of the left ventricle 196. Although the helical anchor 302 is shown positioned near the apex 112 in the following figures, the anchor 302 can be attached at a point offset from the thin tissue of the apex and embedded in the generally thicker adjacent ventricular wall, such as between two papillary muscles. It is preferable to position the anchor such that the longitudinal axis of the embedded neocord is substantially parallel to or concentric with the original path of the innate cord. For example, as shown in Figure 42, in such a position, the tissue anchor 302 may be located in the left ventricle between the papillary muscles. Furthermore, although a helical anchor has been illustrated, the anchor may have a different structure to engage with cardiac tissue as described above, and other structures may have various through or hook structures for engaging with tissue instead of a helical structure.

[0156] The spiral anchor 302 can be delivered by the ventricular anchor delivery subsystem 300. Figures 39A-39C show the ventricular anchor delivery subsystem 300 and its components, respectively. Figure 39A is a perspective view of the distal end of subsystem 300. Figure 39B is a perspective view of the proximal end of subsystem 300. Figure 39C is an exploded view of the distal end of subsystem 300. Subsystem 300 can be delivered through a delivery catheter 100. The delivery catheter 100 may be accessed by conventional techniques such as atrial septal puncture. Once the various subsystems are positioned and removed from the delivery catheter 100, the delivery catheter 100 may be maintained in a substantially constant position throughout the procedure. For example, the distal end of the delivery catheter 100 may be located in the left atrium. In other implementations, the distal end of the delivery catheter 100 is located in the left ventricle throughout the procedure.

[0157] As shown in Figures 39A and 39C, the ventricular anchor delivery subsystem 300 includes an outer sheath 304, a guide shaft 305, a driver 309 (including a shaft 307 and a head 306), an anchor hub 308, and an anchor. The anchor is a helical anchor 302, and the driver 309 may be configured to rotate the helical anchor 302, such that the driver 309 is configured to rotate the helical anchor 302. The helical anchor 302 may have an inner diameter configured to be positioned on the outer diameter of the anchor hub 308. The helical anchor 302 may be fixed to the anchor hub 308 by interference fit or friction engagement. The anchor hub 308 may remain embedded together with the helical anchor 302. The anchor hub 308 may have a lumen substantially aligned along the central axis of the anchor hub 308 for receiving a suture portion 311 (not shown) and for attaching the suture portion 311 to the helical anchor 302. In one embodiment, the suture portion 311 may include an attachment element (e.g., a knot or washer) having a diameter such that the suture portion 311 is not pulled proximal through the lumen of the anchor hub 308. For example, the suture portion 311 is tied distal to the lumen. In one embodiment, the suture portion 311 may be tied to the anchor hub 308 (e.g., passing through the lumen and tying over the outer surface). The helical anchor 302 includes a distal section and a proximal section of the fins. The proximal sections of the fins may be spaced closer together than the distal sections of the fins and may be configured to fix the helical anchor 302 to the anchor hub 308. The distal section of the vane may be further spaced apart than the proximal section of the vane and may be configured to be inserted into the ventricular tissue. The anchor hub 308 may have an enlarged cross-section at its proximal end, configured to abut against the helical anchor 302 and / or to prevent the helical anchor 302 from advancing proximally across the proximal end of the anchor hub 308. Other helical anchors, such as those described herein, are configured to be used with the ventricular anchor delivery subsystem 300 described herein.

[0158] The proximal surface of the helical anchor 308 may have a recess that receives the extension 306' of the driver head 306. The recess is non-circular (e.g., oblong or polygonal) and is configured to transmit torque from the driver 309 to the anchor hub 308 when the driver 309 rotates. The recess may be positioned around the central lumen of the anchor hub 308. In other embodiments, the anchor hub 308 includes an extension, and the driver head 306 has a recess. The driver head 306 is generally cylindrical. The driver head 306 may be fixedly coupled to the drive shaft 307. The driver 309 has a central lumen that passes through the driver head 306 and a drive shaft 307 configured to receive the suture 311. The central lumen of the driver 309 is configured to align with the central lumen of the anchor hub 308. The drive shaft 307 is received within the guide shaft 305. The diameter of the driver head 306 is larger than the inner diameter of the guide shaft 305. The outer sheath 304 may be sized to accommodate the guide shaft 305, the driver head 306, the anchor hub 308, and the helical anchor 302.

[0159] The outer sheath 304 is delivered via the delivery catheter 100 to the left ventricle and near the ventricular attachment site. In one embodiment, the outer sheath 304 is delivered without the use of a delivery catheter. In one implementation, the helical anchor 308 is hidden within the outer sheath 304 until the outer sheath 304 is positioned proximal to the ventricular attachment site and then pushed distally through the outer sheath 304 to expose the helical anchor 302. The helical anchor 302 is positioned to be in contact with the ventricular tissue. Rotation of the drive shaft 307 rotates the driver head 306, anchor hub 308 and helical anchor 302, thereby screwing the ventricular anchor 302 into the ventricular tissue. Rotation of the driver 309 advances the driver 309, anchor hub 308 and helical screw 302 axially distally relative to the outer sheath 304. As shown in Figure 39B, the drive shaft 307 can be manually rotated by the user using the drive handle 312. The proximal end of the ventricular anchor delivery subsystem 300 has first and second hemostatic valves 314, 316, as shown in Figure 39B. The first hemostatic valve 314 is located distal to the drive handle 312 and provides access to the guide shaft 305. The second hemostatic valve 316 is located proximal to the drive handle 312 and provides access to the central lumen of the driver. The ventricular anchor suture 311 may extend through the second hemostatic valve 316.

[0160] In one embodiment, the ventricular delivery subsystem 300 has a shield or guard portion 303 (shown in Figure 38A) positioned around the distal end of the outer sheath 304. The guard portion 303 has an open distal end and may include a tubular wall portion that can be attached to the tubular sheath 304 or retract from the sheath 304 and advance. The guard portion 303 may be expandable from a reduced first cross-section for transluminal navigation to an enlarged second cross-section that allows for anchor rotation.

[0161] The guard portion 303 may have a diameter that expands distally such that the inner diameter of the guard portion 303 is larger at the distal end of the guard portion 303 than the outer diameter at the distal end of the outer sheath 304. The expanded diameter of the guard portion 303 provides sufficient space for the helical anchor 302 to rotate without contacting the inner surface of the guard portion 303. When the helical anchor 302 is installed, the guard portion 303 may be positioned in contact with or close to the ventricular tissue. Advantageously, during the rotational insertion of the helical anchor 302, the guard portion 303 prevents chordae tendineae or other tissue adjacent to the helical anchor 302 from becoming entangled in the fins of the helical anchor 302. Once the helical anchor 302 has been inserted into the ventricular tissue to an appropriate depth, the driver 309 may be removed from the anchor hub 308 so that the helical anchor 302 is disengaged from the rest of the ventricular anchor delivery subsystem 300.

[0162] In one implementation configuration, the insertion portion 306' of the driver head 306 and the recess of the anchor hub 308 have a frictional engagement that temporarily holds the two elements together. When the helical anchor 302 is inserted, the reaction force from the ventricular tissue can overcome the frictional engagement when the driver retracts proximally. In one implementation configuration, the proximal tension of the suture portion 311 creates an engagement force between the proximal hub 308 and the driver head 306, which is released when the driver 309 is replaced. The driver head 306 may be retracted proximally into the outer sheath 304 before the outer sheath 304 is retracted into the delivery catheter 100.

[0163] The non-implantable elements of the ventricular anchor delivery subsystem 300 may be removed from the delivery catheter 100, and the subsystem may be positioned in the delivery catheter 100 to complete the implantation of the neochordae tendineae. In a modified example, the ventricular anchor delivery subsystem 300 and subsystems such as the leaflet anchor delivery subsystem 330 may be positioned simultaneously within the delivery catheter 100, and in a particular configuration, both the tissue and the leaflet anchor may be pre-assembled in the delivery catheter. In other embodiments, the implantation of the ventricular anchor may be performed in a different order (e.g., after the implantation of the leaflet anchor). The ventricular anchor delivery elements may retract proximally across the proximal end of the suture 311, or they may remain extended through the delivery catheter 100 to the ventricular anchor 302. Figures 38A-38H show the placement of neochordae tendineae but do not show the neopapillary muscle 116, for example, shown in Figure 35A. However, the procedure may be performed in combination with the neopapillary muscle 116. The newly formed papillary muscle 116 may, for example, advance across the suture 311 after the placement of the ventricular anchor 302. In one embodiment, the newly formed papillary muscle is connected to the anchor hub 308.

[0164] Figures 38B–38F illustrate various steps, including the placement of the leaflet anchor via the leaflet anchor delivery subsystem 330. The leaflet anchor is delivered after the placement of the ventricular anchor. The leaflet anchor delivery subsystem 330 is delivered through the delivery catheter 100 along the ventricular anchor suture 311, which remains connected to the ventricular anchor 302. In one embodiment, the leaflet anchor is delivered before the placement of the ventricular anchor 302. In an alternative example, the leaflet anchor delivery subsystem 330 may be delivered, for example, transapically to the left ventricle or transseptally from the right ventricle to the left ventricle through the ventricular wall.

[0165] Figures 40A to 40F show the valve leaflet anchor feeding subsystem 330 and its components. Figure 40A shows a perspective view of the distal end of subsystem 330. Figure 40B shows a perspective view of the proximal end of subsystem 330. Figure 40C shows an exploded view of the distal end of subsystem 330. Figure 40D is a perspective view of the flexible tube 332. Figures 40E and 40F show different side views of the transition region of the flexible tube 332.

[0166] As shown in Figures 40A and 40C, the leaflet anchor feeding subsystem 330 has a feeding shaft 334. A deflectable flexible tube 332 may be connected to the distal end of the feeding shaft 334. Figure 40D shows one implementation example of the flexible tube 332. The deflectable flexible tube 332 forms a deflection region 122 as described herein. As described herein, the deflectable flexible tube 332 may be configured to be operable by an operator, for example, by retracting proximal one or more pull wires (not shown) along various sides of the flexible tube 332. As shown in Figure 40B, the operator can control the bending of the flexible tube via a knob 352 or via other operating mechanisms or levers located on a handle portion 350 at the proximal end of the leaflet anchor feeding subsystem 330.

[0167] As shown in Figure 40D, the flexible tube has transverse slots. One side of the flexible tube 332 is free of openings or slots, forming a relatively rigid or axially incompressible back. The transverse slots are located at various length positions of the flexible tube 332 on the side substantially opposite to the aforementioned side. The axial spacing of the transverse slots, the axial width of the transverse slots, the shape of the transverse slots, the circumferential orientation of the transverse slots, and / or the circumferential length of the transverse slots affect the degree of flexibility and / or the orientation of the flexible tube 332, making it more flexible in local areas or substantially along the entire length of the flexible tube 332.

[0168] The flexible tube 332 may have two or more sections along its length that have different patterns of transverse slots and / or different bending characteristics. For example, in the flexible tube 332 shown in Figure 40D, the patterns of transverse slots are different in the distal and proximal sections, respectively. Figures 40E and 40F are enlarged side views showing the flexible tube 332 near the transition between the distal and proximal sections. In the example shown in Figures 40E and 40F, the sections are offset from each other by approximately 90° in the rotational direction with respect to the longitudinal axis of the flexible tube 332.

[0169] A flexible tube 332 may be used to direct or guide the distal end of the leaflet anchor delivery subsystem 330 toward the leaflet. The flexible tube 332 is particularly advantageous when the distal end is positioned toward the ventricular side of the leaflet as the subsystem is delivered from the right atrium to the heart. As shown in Figure 38B, the distal end of the leaflet anchor delivery subsystem 330 may be deflected (e.g., at least about 180°) so that pressure is applied to the ventricular surface of the leaflet as the subsystem retracts proximally. The radius of curvature of the deflected flexible tube 332 or the optimal radius of curvature is generally less than about 2 cm, preferably less than about 1.5 cm or 1.0 cm.

[0170] A flexible jacket 333 may be used to cover the flexible tube 332 and the delivery shaft 334. An inner flexible shaft 336, having a needle tip and terminating at its distal end, may extend through the delivery shaft 334 and the flexible tube 333. The inner flexible shaft 336 may have a braided tube or a catheter flexible enough to conform to the shape of the flexible tube 332. The needle tip 338 may be connected to the distal end of the inner flexible shaft 336. As shown in Figure 40B, the proximal end of the inner flexible shaft 336 is connected to a needle handle 354. The needle handle 354 may include a hemostatic valve 356. The valve leaflet suture 344 is inserted through the valve 356. The valve 356 may be of the epidural type. The needle handle 354 may have an additional port 358 for accessing the lumen of the inner flexible shaft 336. The needle handle portion 354 may be positioned proximal to the handle portion 350 so that the inner flexible shaft 336 extends through the lumen of the handle portion 350 and the feed shaft 334. The handle portion 350 may have a hemostatic valve to receive the inner flexible shaft 336 and to seal the internal elements of the handle portion from the surrounding environment. The hemostatic valve has an opening toward the feed shaft 334. The needle 338 may be expandable and retractable by extending the needle handle portion 354 toward the handle portion 350, or by retracting the needle handle portion 354 toward the handle portion 350.

[0171] As shown in Figure 38C, the pressure applied to the valve leaflet when the needle tip 338 extends distally beyond the flexible tube 332 and flexible jacket 333 causes the needle tip 338 to puncture the valve leaflet so that it extends through the opposite side of the valve leaflet (e.g., the atrial side). This pressure is applied by extending the needle tip 338 and / or by retracting the entire feeding device 330 proximal while the needle tip 338 is in the expanded position.

[0172] Figures 38D–38F show the deployment of the valve leaflet anchor. The valve leaflet anchor may be a cotton thread 340 as described herein. The cotton thread 340 may be connected to or attached to the distal end of the suture portion 344. The cotton thread may be formed from a soft and / or flexible material such as a fabric. The suture portion 344 extends through an inner flexible shaft 336. As shown in Figures 38D, 40A, the cotton thread 340 may be folded or compressed into a form including a reduced radial cross-section so that it can be positioned within the inner flexible shaft 336 for feeding. As shown in Figure 38E, the cotton thread 340 expands to have a larger radial cross-section when deployed from the distal end of the needle tip 338. In one embodiment, the cotton thread 340 is similar to that shown in Figure 35E and is pushed through the inner flexible shaft 336 via a push wire or release wire (not shown). As shown in Figure 38F, when the needle is fed through the needle tip 338, the valve leaflet anchor folds axially and expands radially due to the proximal retraction of the valve leaflet suture portion 344, preventing the valve leaflet anchor from retracting through the puncture opening in the valve leaflet, thereby fixing the valve leaflet suture portion 344 to the valve leaflet.

[0173] Figure 40C schematically shows a cotton spool 340 connected to the distal end of the valve leaflet suture 344. The cotton spool 340 may have two flaps 341, 342 which are folded / wound (e.g., clockwise or counterclockwise) around the longitudinal axis of the cotton spool 340 to form a reduced cross-sectional shape. In one embodiment, the valve leaflet suture 344 is formed integrally with the cotton spool 340 as described herein (Figures 43A-43C). To form a foldable or assembleable structure, the proximal end of the suture 344 extending from the cotton spool 340 may pass through one or more openings formed in the cotton spool 340 (e.g., two openings, three openings, four openings, etc.). In one embodiment, the openings are arranged along the center of the cotton spool 340. The opening penetrates the cotton suture 340 and passes through the embedded portion of the suture 344, which is integral to the cotton suture 340. The embedded portion of the suture 344 is flattened at least partially within the cotton suture 340. In one embodiment, the opening is located substantially near the center of the cotton suture (e.g., immediately to the left or right of the embedded suture 344, or alternately between the left and right sides of the suture 344). When unfolded, the suture 344 effectively connects to the distal end of the cotton suture 340 (e.g., the suture 344 returns to its insertion point between the cotton suture sheets). The cotton suture 340 may be formed such that the wing portions 341, 342 are approximately the same size or different in size. As shown in Figure 38F, when the valve leaflet suture 344 retracts proximally, the cotton suture 340 may fold into an accordion-like shape. The cotton suture 340 may have a substantially flat plane that is substantially perpendicular to the longitudinal axis of the leaflet suture 344. This configuration facilitates the fixation of the suture 344 to the leaflet. When the leaflet suture 344 is fixed to the leaflet, the leaflet anchor delivery subsystem 340 may be withdrawn from the delivery catheter 100. The leaflet anchor delivery element may retract proximal across the proximal end of the suture 344, and the suture 344 may still extend along the ventricular anchor suture 311 through the delivery catheter 100 to the leaflet anchor 340.

[0174] The ventricular anchor suture 311 and the valve leaflet anchor suture 344 may be joined together with tension applied to form an implantation portion of the new chordae tendineae or to connect two sections of the implantation portion of the new chordae tendineae to each other. This allows the new chordae tendineae to extend between the ventricular anchor 302 and the valve leaflet anchor 340. With tension maintained by the ventricular anchor 302, the total length of the new chordae tendineae may be adjusted so that appropriate tension is applied to the valve leaflets. The sutures 311 and 344 may remain extended to a predetermined position outside the body through the delivery catheter 100. In one embodiment, during the placement of the suture lock and the cutting of the sutures 311 and 344, the proximal ends of the sutures 311 and 344 may be supplied to the handle portion or the proximal portion of the suture lock delivery system 370. In one embodiment, the proximal ends may remain free ends or may be joined or fixed by other means.

[0175] Figures 41A to 41I show various diagrams of the suture lock feeding subsystem 370 and its components. Figure 41A is a perspective view of the distal end of subsystem 370. Figure 41B is a perspective view of the proximal end of subsystem 370. Figure 41C is an exploded view of the distal end of subsystem 370. Figure 41D is a perspective view of the distal end of the cutting assembly. Figures 41E and 41F are side views of the cutting assembly portion of subsystem 370. Figure 41G is a side view of the distal end of the suture lock 376 and the torque driver 388 configured to engage with the suture lock 376. Figures 41H and 41I show the proximal and distal ends of the suture lock 376, respectively.

[0176] The suture lock feeding subsystem 370 may be configured to advance (e.g., slide) the suture lock 376, which secures the sutures 311, 344 to each other, across both sutures 311, 344 (or additional sutures). Each of the sutures 311, 344 may retract proximal to apply tension to the sutures 311, 344 and adjust the length of each suture between the suture lock 376 and the respective tissue anchors 302, 340. Once the length and tension of the implanted portion of the neonatal chordae tendineae are optimized, the suture lock 376 is locked to fix the length of the sutures 311, 344 so that the sutures 311, 344 do not move relative to the suture lock 376. The sutures 311, 344 may be cut at a point close to the suture lock 376. The sutures 311 and 344 may be cut by the same suture lock supply subsystem 370 that supplied the suture lock 376. In other embodiments, a separate cutting device may be inserted into the supply catheter 100 after the suture lock is locked in place.

[0177] Figure 38G shows the advancement of the suture lock 376 over the ventricular anchor suture 311 and the valve leaflet suture 344. The suture lock delivery subsystem 370 may advance through the delivery catheter 100, or it may push the suture lock 376 along the distal direction of the sutures 311 and 344 to bring the proximal portions of the sutures 311 and 344 close to the distal end of the suture lock 376. The suture lock 376 advances along the suture by the retaining catheter 373. The distal end of the retaining catheter 373 may be connected to a retaining element 377 (Figure 41C). The retaining element may include a flange 371 or other mechanical features configured to engage with 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 one embodiment, the retaining catheter 373 may be disengaged from the suture lock 376 by rotation of the retaining catheter 373 and / or movement substantially perpendicular to the axial direction of the retaining catheter 373. The sutures 311 and 344 extend from their respective tissue anchors so as to pass through the suture lock 376, entering through the distal channel 395 on the distal surface of the suture lock 376 as shown in Figure 41I and exiting through the proximal channel 394 on the proximal surface of the suture lock 376 as shown in Figure 41H. The sutures 311 and 344 may also extend through the channel in the proximal cutter head 375 of the suture lock 376, along the outside of the retaining catheter 373, and through the dispensing catheter 100. The cutter head 375 may be connected to the distal end of the cutter catheter 372. The retaining catheter 373 may extend through the internal lumen of the cutter catheter 372 so that the two catheters 372 and 373 are extendable or retractable from one another.

[0178] When the sutures 311 and 344 are locked (fixed) within the suture lock 376, the proximal ends of the sutures 311 and 344 can be cut adjacent to the proximal surface of the suture lock. The sutures 311 and 344 may also be cut by advancing a cutter catheter 372 connected to the cutter head 375 toward the proximal surface of the suture lock 376. As schematically shown in Figures 41E to 41F, when the cutter head 375 advances along the retaining catheter 373 toward the retaining element 377, the cutter head brings the sutures 311 and 344 close to a cutting blade 379 positioned in the retaining element 377. The cutter head 375 is configured to advance across the retaining element 377 such that the channel in the cutter head 375 holding the sutures 311 and 344 is gradually spatially occupied by the blade 379. As the blade 379 is pushed into the channel of the cutter head 375, the blade 379 shears the sutures 311,344. The application of proximal tension to the sutures 311,344 facilitates the cutting of the sutures 311,344. In other embodiments, different actions (e.g., rotation of the cutting catheter) may be configured to cut the sutures 311,344. In one implementation example, more than two sutures may be employed, locked within the suture lock 376, and cut in the same manner by the suture lock feeding subsystem 370. In one embodiment, the advancement of the cutter head 375 across the retaining element 377 facilitates the disengagement of the retaining catheter 373 from the suture lock 376. For example, the cutter head 375 may advance to a distal position configured to stabilize the suture lock 376, thereby allowing the retaining catheter 373 to disengage from the suture lock 376 axially and / or rotationally.

[0179] Figure 41G is a side view of an example of a suture lock 376 (shown with the outer casing / shell removed). As described herein, the suture may extend through the suture lock 376 from the distal end to the proximal end. The suture lock 376 may have a screw 382 configured to advance a push wedge 384 distally or retract it proximal depending on the direction of rotation of the screw. The screw 382 may be rotated by a torque shaft 388. The torque shaft 388 may have a driver head. This driver head fits into a recess 381 (for example, a polygonal recess or other non-circular recess, as shown in Figure 41H) located at the proximal end of the suture lock 376, such that the screw 382 rotates as the torque shaft 388 rotates. The torque shaft 388 may extend through the internal lumen of the retaining catheter 373. The torque shaft 388 can be rotated at its proximal end by a knob 398 or another actuation mechanism located at the proximal end of the subsystem handle 396. The handle 396 may have a hemostatic valve 397. In one implementation example, the sutures 311,344 pass through the hemostatic valve 397.

[0180] The advancement of the push wedge 384 by the torque shaft 388 causes the ramp or inclined surface 386 to gradually compress one or more springs, such as a spring pin 388. The compression of one or more springs 388 pushes the clamp 390 down against the sutures 311, 344, compressing the sutures 311, 344 between two opposing surfaces. In one embodiment, the clamp 390 and the opposing surface 392 may have notched surfaces configured to interlock with each other in discrete increments. The interlocked notched surfaces may enhance the retention of the sutures 311, 344 between the opposing surfaces so as not to be pulled proximal or distal from the suture lock 376. In one embodiment, the tightening can be released by rotating the torque shaft in the opposite direction.

[0181] When the suture lock is properly positioned and locked in place across the sutures 311 and 344, the sutures 311 and 344 may be cut as described herein. Figure 38H shows the retraction of the suture lock feeding subsystem 370 after the sutures 311 and 344 have been cut. Once the suture lock feeding subsystem 370 is removed from the feeding catheter 100, the feeding catheter 100 is withdrawn from the body.

[0182] Figure 42 schematically shows a helical anchor 110 embedded in a portion of the ventricle having relatively thicker tissue between two papillary muscles. As described herein, the embedded neocord structure, optional neocord muscle and / or helical anchor may be positioned along a longitudinal axis substantially parallel or concentric with the surrounding innate chordal pathway and / or the initial pathway of the innate cord. In certain embodiments, the embedded neocord structure, optional neocord muscle and / or helical anchor is positioned along a longitudinal axis within 5°, 10°, or 15° of a position parallel to the initial pathway of the innate cord and / or the surrounding innate chordal pathway.

[0183] Figures 43A–43C schematically illustrate examples of cotton-spun yarn as described herein, particularly with reference to Figures 38E and 38F. Figure 43A schematically illustrates a cotton-spun yarn 340 formed by attaching the distal end (shown by a dashed line) of a suture 344 between two flat sheets, such as the right-wing wing sections 341 and 342. Figure 43B shows a cross-section of the cotton-spun yarn 340 along axis BB shown in Figure 43A. In one embodiment, the suture 344 may be inserted between two sheets (e.g., substantially downward from the center of the sheets), pressed, and / or laminated to bond the three components together (e.g., under heat and / or pressure). At least one layer may be partially sintered. The suture 344 may be flattened and / or densified to improve the resistance of the suture to tearing. The sheet may be a flat polytetrafluoroethylene (PTFE) sheet (e.g., a thin, uncured foamed PTFE (ePTFE) sheet) or may be formed from other suitable materials. In one implementation, the leaflet suture 344 may be arranged between sheets of alternative structures, such as a zigzag or S-shaped structure. Figure 43C shows the cotton suture 340 of Figure 43A, having a plurality of openings 343 through which the proximal caudal end of the suture 344 passes. In one embodiment, one or more openings 343 may be formed through the cotton suture in various configurations to form a foldable structure configured to fix the suture 344 to the mitral valve leaflet, as described herein. Figure 43C shows openings 343 arranged alternately on both sides of the suture 344. In one embodiment, the openings 343 are formed on the same side as the suture 344 (e.g., a wing portion 341 or a wing portion 342). In one embodiment, the openings 343 are formed through the suture 344. The opening 343 may be positioned along the center of the cotton spool 340. The opening 343 may be positioned along the length of the seam 344 (for example, forming a straight line). The seam 344 is at least partially flattened between two opposing sheets, thereby facilitating the positioning of the opening 343 through the seam 344. Various combinations of the opening 343, including the positions described above, may be used.

[0184] While this disclosure describes specific embodiments and examples, various aspects of the above-described systems and methods may be combined in different ways and / or modified to form further embodiments or acceptable embodiments. All such modifications and variations are included within the scope of this disclosure. In fact, a wide variety of designs and methods are possible and are included within the scope of this disclosure.

[0185] Furthermore, there may be multiple embodiments included within the scope of this disclosure that are not expressly listed above or elsewhere in this specification, but this disclosure includes all embodiments included within the scope described herein. In addition, this disclosure includes embodiments which are any combination of any structure, material, step or other feature disclosed elsewhere in this specification with any other structure, material, step or other feature disclosed elsewhere in this specification.

[0186] Furthermore, certain features described in this disclosure in the context of separate embodiments may be implemented in combination in a single embodiment. Alternatively, various features described in the context of a single embodiment may be implemented in multiple embodiments separately or in any suitable combination. Furthermore, although it is stated that a feature acts in a particular combination, one or more features of a claimed combination may be made independent of the combination as needed, and the combination may be asserted as a subordinate combination or a variation of a subordinate combination.

[0187] For the purposes of this disclosure, certain embodiments, advantages, and features are described herein. Not all such embodiments, advantages, and features are necessarily realized according to any particular embodiment. Those skilled in the art will understand that this disclosure can be implemented in a manner that realizes one or a group of advantages taught herein, without necessarily realizing other advantages taught or suggested herein.

[0188] Any specific features, aspects, methods, characteristics, qualities, attributes, elements, etc., disclosed herein in relation to various embodiments may be used in all other embodiments described herein. Furthermore, any methods described herein may be carried out using any apparatus suitable for performing the listed steps.

[0189] Furthermore, while components and operations are illustrated or described in a specific arrangement or sequence, such components and operations do not need to be arranged or performed in the specific arrangement and sequence illustrated or described to obtain the desired results, nor do not all components and operations need to be included. Other components and operations not illustrated or described may be incorporated into the embodiments and examples. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the operations described. Furthermore, in other embodiments, operations may be rearranged or rearranged. Also, the separation of various system components in the above embodiments should not be understood as requiring such separation in all embodiments, and the described components and systems can generally be integrated into a single product or packaged into multiple products.

[0190] In other words, various exemplary embodiments and examples are described herein. Systems and methods are disclosed in relation to the above embodiments and examples, but this disclosure extends to other alternative embodiments and / or other uses, modifications and equivalents of embodiments other than those specifically disclosed. This disclosure is expressly intended to allow various features and aspects in the disclosed embodiments to be combined or substituted for each other. Accordingly, the scope of this disclosure is not limited to the specific embodiments disclosed and should be determined only by fair reading of the entire scope of the following claims and equivalents.

Claims

1. A mitral valve restraint system, A neopapillary muscle that is artificial, having a proximal and distal end, and is slender and flexible, A tissue anchor connected to the distal end of the newly formed papillary muscle, A slender, flexible, artificial neochordae tendineae that is connected to the proximal end of the neopapillary muscle and extends from the said proximal end, A valve leaflet anchor attached to the proximal end of the newly formed chordae tendineae, Equipped with, The valve leaflet anchor is radially expandable from a first reduced cross-section for advancing through the valve leaflet to a second enlarged cross-section for contacting the atrial side of the valve leaflet. The newly formed chordae tendineae are connected to a suture that extends distally through the newly formed papillary muscle to the tissue anchor, The valve leaflet anchor includes a suture located between two sheet-like materials, the two sheet-like materials overlapping and joined with a portion of the suture housed and joined between them, and the valve leaflet anchor is radially expandable from the second enlarged cross-section to a third configuration that is radially enlarged and axially reduced by the proximal retraction of the suture. Mitral valve restraint system.

2. The mitral valve restraint system according to claim 1, wherein the tissue anchor includes a laser-cut hypotube.

3. The mitral valve restraint system according to claim 1, wherein the tissue anchor includes a coiled circular wire.

4. The mitral valve restraint system according to claim 3, wherein the tissue anchor includes two coiled circular wires.

5. The mitral valve restraint system according to claim 1, wherein the valve leaflet anchor includes cotton thread.

6. The mitral valve restraint system according to claim 5, wherein the cotton thread is operable to be folded by pulling the suture portion, and the cotton thread becomes the second enlarged cross-section when folded.

7. The mitral valve restraint system according to claim 5, wherein the suture portion passes through at least two openings in the cotton thread.

8. The mitral valve restraint system according to claim 7, wherein the suture passes through at least three openings in the cotton thread, and the openings are substantially located on the same straight line.

9. The mitral valve restraint system according to claim 1, wherein the tissue anchor includes a hub that can be operated to receive and secure the suture by friction.

10. The mitral valve restraint system according to claim 1, wherein the loop is operable for fixing the newly formed papillary muscle.

11. The mitral valve restraint system according to claim 1, wherein the newly formed papillary muscle includes a body that approximates the size of the trapezius papillary muscle.

12. The aforementioned valve leaflet anchor includes a T-tag bar, The mitral valve restraint system according to claim 1, wherein the T-tag bar includes a bar, the bar being rotatably connected to the suture such that the rotation of the bar expands the valve leaflet anchor from the first reduced cross-section to the second enlarged cross-section.

13. The mitral valve restraint system according to claim 1, wherein the valve leaflet anchor includes a hub, the hub includes a plurality of radially extending flexible spokes, the plurality of spokes are operable to bend to an aligned position along the longitudinal axis, thereby restraining the valve leaflet anchor within the feed needle and biasing it to expand radially outward when unrestrained, thereby expanding the valve leaflet anchor from the first reduced cross-section to the second enlarged cross-section.

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