Restricted mitral valve leaflets

Abstract

To provide a method and apparatus for transvascular implantation of neo chordae tendinae.SOLUTION: Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium, through the mitral valve, and into the left ventricle. A ventricular anchor is deployed from the catheter and into a wall of the left ventricle, leaving a ventricular suture attached to the ventricular anchor and extending proximally through the catheter. A leaflet anchor is deployed to secure a mitral valve leaflet to a leaflet suture, with the leaflet suture extending proximally through the catheter. The leaflet suture is secured to the ventricular suture to limit a range of travel of the leaflet in the direction of the left atrium. Also disclosed is an assembled in situ mitral valve leaflet restraint, having a neo papillary muscle and a neo chordae tendinea.SELECTED DRAWING: Figure 38H

Description

[Technical Field]

[0001] This application is a continuation-in-part of U.S. Application No. 15 / 638,176, filed June 29, 2017, which claims priority to U.S. Provisional Application No. 62 / 441,031, filed December 30, 2016, each of which is incorporated herein by reference.

[0002] The present disclosure relates generally to mitral valve repair devices and techniques, and more particularly to transvascular methods and devices for chordae replacement to reduce mitral valve regurgitation. [Background technology]

[0003] The heart contains four cardiac valves. These valves allow blood to pass unidirectionally through the four chambers of the heart. The four valves are the tricuspid valve, mitral valve, pulmonary valve, and aortic valve. The four chambers are the left and right atria (upper chambers) and the left and right ventricles (lower chambers).

[0004] The mitral valve is made up of two leaflets, called the anterior and posterior leaflets. These leaflets open and close in response to pressure exerted on them by the heart's contractions. Several problems can arise with the mitral valve. One such problem is mitral regurgitation (MR). Mitral regurgitation is a condition in which the mitral valve leaflets do not close properly, which can result in leakage from the mitral valve. Severe mitral regurgitation can adversely affect cardiac function and potentially reduce a patient's quality of life and lifespan.

[0005] Techniques have been developed to treat mitral regurgitation. These techniques include heart transplantation, valve replacement or repair, chordae shortening or replacement, and mitral annulus repair, also known as valvuloplasty. The choice of technique depends on the stage and etiology of the disease. Summary of the Invention [Problem to be solved by the invention]

[0006] Certain surgical and transapical approaches have been proposed for chordae replacement or repair, but despite these proposals, there remains a need for transvascular approaches for chordae replacement or repair to reduce or eliminate MR. [Means for solving the problem]

[0007] According to one aspect of the present disclosure, a method for implanting transvascular artificial chordae is provided, the method including 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 into a wall of the left ventricle, the ventricular anchor leaving ventricular sutures attached to the anchor and extending proximally through the catheter. With the leaflet sutures extending proximally through the catheter, the leaflet anchor is deployed to secure the mitral valve leaflets to the leaflet sutures. The leaflet sutures are secured to the ventricular sutures to limit the extent of movement of the leaflets toward the left atrium.

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

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

[0010] The securing step includes applying a suture lock to the ventricular sutures and the leaflet sutures. The method further includes applying tension to the leaflet sutures prior to the securing step to improve leaflet function. The method further includes applying sufficient tension to the leaflet sutures to raise the systolic leaflet movement limit to a level comparable to the annulus. The securing step includes engaging a knot to secure the leaflet sutures and the ventricular sutures. The method further includes cutting the leaflet sutures and the ventricular sutures proximal to the suture lock or knot, leaving the leaflet sutures and the ventricular sutures to function as native chordae.

[0011] The method further includes an initial step of identifying a patient with at least three characteristics selected from the group consisting of: the patient is diagnosed with primary or degenerative mitral regurgitation; the patient is diagnosed with secondary or functional mitral regurgitation; the patient is diagnosed with myxomatous mitral regurgitation; the patient is diagnosed with a flail leaflet, a torn chordae tendineae, or leaflet prolapse; the patient has mitral regurgitation grade 1 or greater; the patient has an A2 to P2 leaflet diameter that is at least 5 mm less than the total length of the P2 leaflet plus the A2 leaflet; the patient has an A2 to P2 leaflet diameter of at least 10 mm; and the patient has an access vessel diameter of at least 2 mm.

[0012] The patient further has at least one characteristic selected from the group consisting of: the patient has been evaluated by a cardiac team including at least one cardiac surgeon and determined to be not a suitable candidate for traditional open-heart surgical repair; the patient has an STS predicted mortality rate (STS score) of 2 or greater; the patient has been offered and declined open-heart surgical repair; the patient is aged 18 to 90 years; the patient does not receive blood transfusions; the patient has previously undergone open-heart surgery; and the patient has an ejection fraction of at least 10 percent.

[0013] According to a further aspect of the present disclosure, there is provided a method for increasing mitral valve leaflet coaptation area during systole, the method comprising the steps of: anchoring at least a first ventricular tension element to a wall of a ventricle; and anchoring at least a first leaflet tension element to a mitral valve leaflet. The leaflet tension element is retracted proximally during systole to move the leaflet's movement limit toward the ventricle, thereby increasing the mitral valve leaflet coaptation area during systole. The leaflet tension element is then anchored to the ventricular tension element.

[0014] The ventricular tension element includes a neo-papillary muscle having a distal end facing the ventricular anchor and a proximal end at substantially the level of the apex of the native papillary muscle. The securing step includes securing the leaflet tension element to the ventricular tension element at the proximal end of the neo-papillary muscle. The neo-papillary muscle has an elongated, atraumatic body and includes ePTFE.

[0015] The step of anchoring the leaflet tensioning element includes advancing a needle guide having a distal end through the mitral valve and into the left ventricle, and deflecting the needle guide through an angle of at least 160° to position the distal end in contact with the valve leaflet during diastole. The method further includes advancing a leaflet anchor deployment needle from the distal end of the needle guide through the valve leaflet, and deploying the anchor from the needle. 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 against the atrial side of the valve leaflet. Deploying the anchor includes deploying a pledget.

[0016] The step of retracting the leaflet tension element proximally 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 proximally with the opening acting as a fulcrum such that the tension element draws the leaflet toward the ventricle. The fulcrum is the distal opening of the catheter, and the retracting proximally includes retracting the leaflet tension element proximally through the catheter. The method further includes securing a second leaflet tension element to the leaflet and the ventricular tension element.

[0017] According to a further aspect of the present disclosure, there is provided an assembled in situ mitral valve leaflet constraint. The constraint includes an elongated, flexible neo-papillary muscle having a proximal end and a distal end, and a spiral tissue anchor attached to the distal end of the neo-papillary muscle. Elongated, flexible neo-chordae extend proximally from 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 cross-section for advancement through the leaflet to a second, enlarged cross-section for contacting the atrial side of the leaflet. The neo-chordae are attached to sutures that extend distally through the neo-papillary muscle to the spiral tissue anchor.

[0018] The spiral anchor includes a laser-cut hypotube. The spiral anchor includes one or two or more coiled circular wires. The neochordae include sutures extending from the proximal end of the neopapillary muscle to the leaflet anchor. The sutures extend through the neopapillary muscle to the spiral tissue anchor.

[0019] The neochordae include a first element extending proximally from the neopapillary muscle and a second element extending distally from the leaflet anchor. A proximal portion of the first element and a distal portion of the second element are coupled to one another by a locking device. The locking device has a locked state and an unlocked state. The locking device is configured to advance over the first element and the second element in the unlocked state and to securely clamp the first element and the second element in the locked state.

[0020] The leaflet anchor includes a pledget. The pledget is configured to collapse by pulling sutures coupled to the pledget, such that the pledget assumes a second enlarged cross-section when collapsed. The sutures pass through at least two, at least three, or more openings in the pledget. The openings are substantially collinear. The leaflet anchor includes a T-tag bar. The T-tag bar includes a bar that is rotatably coupled to the sutures such that 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 having a plurality of flexible spokes extending radially. The spokes are configured to bend to an aligned position along the longitudinal axis and are constrained within the delivery needle. When unconstrained, the spokes are biased to expand radially outward, expanding the leaflet anchor from the first reduced cross-section to the second enlarged cross-section.

[0021] The helical anchor includes a hub configured to receive and frictionally secure a suture. The helical anchor includes a loop for securing a neo-papillary muscle to the helical anchor. The neo-papillary muscle includes a flexible ribbon.

[0022] According to a further aspect of the present disclosure, a neochordae deployment system includes an elongate, flexible tubular body having a proximal end and a distal end, a helical ventricular anchor disposed within the tubular body and having a rotation driver extending proximally therethrough, and a radially expandable leaflet anchor disposed within the tubular body and having a suture extending proximally therethrough.

[0023] According to a further aspect of the present disclosure, there is provided a neochordae deployment system including a catheter having a proximal end and a distal end, a helical anchor positioned within the catheter, and a leaflet anchor radially expandable within the catheter, the helical anchor having a driver configured to rotate the helical anchor extending proximally through the catheter, and the leaflet anchor having a suture extending proximally through the catheter.

[0024] The radially expandable leaflet anchor includes a pledget that is transformable from an elongated strip-like configuration to a radially expanded and axially contracted configuration by proximal retraction of a suture. The radially expandable leaflet anchor includes a suture inserted between two sheets of material. The radially expandable leaflet anchor has a deflectable deployment tube retained within a catheter.

[0025] The distal deflection region of the deployment tube is deflectable through an angle of at least about 160° in response to operation of the proximal deflection control. The distal deflection region is within about 1.5 cm of the distal end of the deployment tube. The distal deflection region is deflectable to form a curve having an optimum radius of about 1.5 cm or less. The deflectable deployment tube includes a slotted deflection tube.

[0026] The neochordae deployment system is configured to distally deploy a helical anchor and proximally deploy a radially expandable anchor. The expandable leaflet anchor is inserted sequentially into the catheter after the helical anchor and driver are removed from the catheter. The expandable leaflet anchor, helical anchor, and driver are pre-positioned within the catheter.

[0027] According to a further aspect of the present disclosure, there is provided a valve leaflet anchor delivery system. The valve leaflet anchor delivery system includes a delivery shaft and a tissue-piercing element. The delivery shaft has a distal portion and a proximal portion, and the delivery shaft includes a deflection region disposed on the distal portion. The tissue-piercing 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 valve leaflet with the proximal portion of the delivery shaft extending into the left atrium. The deflection region includes a flexible tube. The flexible tube, when deflected, has an optimal radius of curvature of less than about 2 cm.

[0028] According to a further aspect of the present disclosure, a pledget for fixation to a heart valve leaflet is provided. The pledget has two flat sheets including a substantial overlap 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 a 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 overlap region on either side of the suture.

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

[0030] The proximal ends of the sutures extending from the first sides of the two flat sheets pass through the one or more openings. The pledget has a folded configuration in which the two flat sheets are folded at least once to form a radially expanded cross-section that extends around the sutures as they pass through the one or more openings. [Brief explanation of the drawings]

[0031] [Figure 1] FIG. 1 shows the mitral valve annulus with sutures delivered via a catheter. [Figure 2] FIG. 2 shows a distal anchor attached to a suture connected to the mitral valve annulus and delivered via a catheter. [Figure 3] FIG. 3 shows the distal anchor, including the sutures that will later be attached to the mitral valve leaflets or annulus, rotated toward the apex of the heart. [Figure 4] FIG. 4 shows the distal anchor rotated toward the apex of the heart with the suture attached to the mitral valve leaflets or annulus. [Figure 5] FIG. 5 shows the distal anchor attached and protruding above the apex of the heart, approximately level with the tops of the papillary muscles. [Figure 6] FIG. 6 shows a distal anchor attached and protruding above the apex of the heart, approximately level with the tops of the papillary muscles, and attached to the mitral valve annulus and / or mitral valve leaflets. [Figure 7] FIG. 7 shows a distal anchor attached to a looped suture that protrudes above the apex of the heart, approximately level with the tops of the papillary muscles, and travels through the catheter. [Figure 8] FIG. 8 shows a catheter-delivered suture loop through the mitral valve leaflet, including strain relief on the ventricular side of the leaflet, and a distal anchor held by a suture lock advanced over the suture tail and positioned at the base of the left ventricle under final suture tension adjustment. [Figure 9] FIG. 9 shows a catheter-delivered suture passed through the mitral valve leaflet, including a strain relief on the ventricular side of the leaflet, and a suture lock advanced to the atrial side of the mitral valve leaflet, secured to the suture tail before cutting the suture. [Figure 10] 10 shows a catheter-delivered suture threaded through the mitral valve leaflet, including a strain relief on the ventricular side of the leaflet, and a suture lock advanced to the atrial side of the mitral valve leaflet to secure the suture tail. The other end of the suture tail extends through the catheter, out of the catheter handle, and passes through a distal anchor positioned at the base of the left ventricle to tension the suture. A second suture lock is advanced over the final suture tail as the user adjusts suture tension. [Figure 11] 11 shows a suture loop delivered from a catheter penetrating the mitral valve leaflet, looping around the strain relief located on the ventricular side of the mitral valve leaflet, and a distal anchor placed at the base of the left ventricle with final suture tension adjustment held by a suture lock advanced over the suture tail. It also shows the cryocatheter attached to the mitral valve leaflet, rigidly holding the leaflet against the penetration force of the strain relief. [Figure 12]12 shows a catheter-delivered suture loop passing through the mitral valve leaflet, looping around a strain relief delivered to the ventricular side of the mitral valve leaflet, and a distal anchor placed at the base of the left ventricle with final suture tension adjustment held by a suture lock advanced over the suture tail. It also shows a cryocatheter attached to the mitral valve leaflet, rigidly holding the leaflet against the penetration force of the strain relief. [Figure 13] FIG. 13 shows the location of the mitral annulus penetration and the location of the distal anchor relative to the native papillary muscles from the atrial side. [Figure 14] FIG. 14 shows the location of the mitral annulus penetration and the location of the distal anchor relative to the native papillary muscles from the atrial side. [Figure 15] FIG. 15 illustrates various anchors for attachment to the apex of the left ventricle, including laser-cut hypotubes and coiled circular wires with vertical risers that adjust the attachment point closer to the level of the papillary muscles to more accurately simulate the correct angle and accommodate neocord attachment. [Figure 16] FIG. 16 shows a transseptal catheter delivering an anchor to the apex of the left ventricle that includes multiple displacement cords extending outside the catheter handle. [Figure 17] FIG. 17 shows a transseptal catheter delivering a penetrating tool through the mitral valve leaflets to deliver a strain relief anchor connected to a suture loop. [Figure 18] FIG. 18 shows a transseptal catheter delivering a suture loop through the mitral valve leaflets and the suture loop penetrating the leaflets. [Figure 19] FIG. 19 shows a transseptal catheter delivering strain relief to the ventricular side of the mitral valve leaflets and the exposed strain relief delivered through or by a penetrating tool. [Figure 20] FIG. 20 shows the transseptal catheter delivering the strain relief and the penetrating tool being withdrawn from the mitral valve leaflets. [Figure 21]FIG. 21 shows a transseptal catheter delivering a strain relief with suture loops extending rearward from the catheter handle and connections to distal anchors. [Figure 22] FIG. 22 shows a transseptal catheter delivering a suture lock that advances from the proximal end of the suture via the catheter handle over the suture tails during tensioning to the distal anchor to adjust the position and tension of the final implanted suture connected to the mitral valve leaflets and distal apex anchor. [Figure 23] FIG. 23 shows the final suture loop securing the distal apex anchor to the mitral valve leaflets, where the mitral anchor is single-sided flanged or single-sided as shown in the unexploded view. [Figure 24] FIG. 24 illustrates a strain relief element and distal apex anchor on the mitral valve leaflets and a continuous loop anchor delivered to its final position. [Figure 25] Figure 25 shows an example of a distal apical anchor constructed of stainless steel tubing and a silicone anchor plug to limit suture migration before delivery of the suture lock for final positioning. Materials may be varied and changed to accommodate size and material enhancements. [Figure 26] FIG. 26 shows the catheter penetrating the septum from the right atrium and into the left atrium. [Figure 27] FIG. 27 shows the anchor rotating into the left ventricle. [Figure 28] FIG. 28 shows the distal apex anchor in place with attached sutures extending through the catheter and the extension arms exposed to capture the mitral valve leaflets with the needles fired when properly positioned at the leaflets. [Figure 29] FIG. 29 shows the extension arm in contact with the mitral valve leaflet and the needle connected to the suture loop passing through the leaflet to expose the suture loop on the atrial side of the mitral valve leaflet. [Figure 30]FIG. 30 shows the suture loop piercing the mitral valve leaflet and exposed on the atrial side of the leaflet to receive a loop snare for capture of the suture loop and retrieval through the catheter. [Figure 31] FIG. 31 shows the suture loop closing around the suture loop and the suture being pulled proximally through the catheter. [Figure 32] FIG. 32 shows a catheter delivering a suture lock to the underside of the mitral valve leaflet as the suture loops along a path that includes a distal apex anchor. [Figure 33] FIG. 33 shows a second catheter that receives the suture ends to deliver a suture lock across the valve leaflets that locks the suture after applying appropriate tension to the two ends. [Figure 34] FIG. 34 shows the suture locks in their final position above and below the mitral valve leaflets, with the suture ends cut to hold the final implantation of the distal apical anchors connected to the mitral valve leaflets. [Figure 35A] FIG. 35A shows neopapillary muscles attached in the left ventricle. [Figure 35B] FIG. 35B shows the steerable leaflet puncture catheter being advanced through the mitral valve. [Figure 35C] FIG. 35C shows the steerable leaflet puncture catheter deflected at an angle of at least about 180°. [Figure 35D] FIG. 35D shows the puncture of the leaflet and deployment of the folding pledget-type leaflet anchor. [Figure 35E] FIG. 35E shows the puncture of the leaflet and deployment of the folding pledget-type leaflet anchor. [Figure 35F] FIG. 35F shows the puncture of the leaflet and deployment of the folding pledget-type leaflet anchor. [Figure 35G] FIG. 35G shows the puncture of the leaflet and deployment of the folding pledget-type leaflet anchor. [Figure 35H]FIG. 35H shows the leaflet sutures and ventricular sutures extending proximally through the deployment catheter. [Figure 35I1] FIG. 35I1 shows the deployed state of the T-tag type leaflet anchor. [Figure 35I2] FIG. 35I2 shows the deployed state of the T-tag type leaflet anchor. [Figure 35I3] FIG. 35I3 shows the deployed state of the T-tag type leaflet anchor. [Figure 35I4] FIG. 35I4 shows the deployed state of the T-tag type leaflet anchor. [Figure 35J1] FIG. 35J1 shows the radially expandable tissue anchor in a deployed state. [Figure 35J2] FIG. 35J2 shows the radially expandable tissue anchor in a deployed state. [Figure 35J3] FIG. 35J3 shows the radially expandable tissue anchor in a deployed state. [Figure 35K] FIG. 35K shows a schematic of a fulcrum located near the proximal end of the neopapillary muscle. [Figure 35L] FIG. 35L shows verification of mitral valve function before removal of the deployment system. [Figure 35M] FIG. 35M shows the attachment of the leaflet sutures to the ventricular sutures after the desired tension has been applied. [Figure 35N] FIG. 35N shows the leaflet and ventricular sutures cut to leave the neocord in place. [Figure 35O] FIG. 35O shows a steerable distal portion of a leaflet puncture catheter having a compound deflection structure. [Figure 36A] FIG. 36A shows the papillary muscle first looped and captured. [Figure 36B] FIG. 36B shows the papillary muscle looped and pulled up into a cord in the area where the cutting step is preferably performed. [Figure 37] FIG. 37 shows one embodiment of a chordae cutting tool. [Figure 38A]FIG. 38A shows a helical anchor placed near the apex of the left ventricle via a ventricular anchor delivery subsystem. [Figure 38B] FIG. 38B shows placement of the leaflet anchor delivery subsystem on the ventricular side of the leaflet using distal flexible tubing. [Figure 38C] FIG. 38C shows penetration of the leaflets with a needle located at the distal end of the ventricular leaflet delivery subsystem. [Figure 38D] FIG. 38D shows the advanced state of the pledget leaflet anchor through the needle, with a reduced radial cross section. [Figure 38E] FIG. 38E shows a pledget leaflet anchor with an enlarged radial cross section. [Figure 38F] FIG. 38F shows the pledget leaflet anchor folded to secure the suture to the atrial side of the leaflet. [Figure 38G] FIG. 38G shows the suture lock being advanced via the suture lock delivery subsystem over the leaflet anchor sutures and the ventricular anchor sutures to connect the leaflet anchor to the ventricular anchor. [Figure 38H] FIG. 38H shows the suture lock in the locked position after the tension has been adjusted with the suture tails cut. [Figure 39A] FIG. 39A is a perspective view showing the distal end of the ventricular anchor delivery subsystem. [Figure 39B] FIG. 39B is a perspective view showing the proximal end of the ventricular anchor delivery subsystem. [Figure 39C] FIG. 39C is a partially exploded view of the distal end of the ventricular anchor delivery subsystem. [Figure 40A] FIG. 40A is a perspective view of the distal end of the leaflet anchor delivery subsystem. [Figure 40B] FIG. 40B is a perspective view of the proximal end of the leaflet anchor delivery subsystem. [Figure 40C] FIG. 40C is an exploded view of the distal end of the leaflet anchor delivery subsystem. [Figure 40D]FIG. 40D is a perspective view of the flexible tubing of the leaflet anchor delivery subsystem. [Figure 40E] FIG. 40E is a side view of the transition region of the flexible tubing of the leaflet anchor delivery subsystem. [Figure 40F] FIG. 40F is a side view of the view shown in FIG. 40E illustrating the transition region of the flexible tubing of the leaflet anchor delivery subsystem. [Figure 41A] FIG. 41A is a perspective view of the distal end of the suture lock delivery subsystem. [Figure 41B] FIG. 41B is a perspective view of the proximal end of the suture lock delivery subsystem. [Figure 41C] FIG. 41C is a partially exploded view of the distal end of the suture lock delivery subsystem. [Figure 41D] FIG. 41D is a perspective view of the distal end of the cutting assembly. [Figure 41E] FIG. 41E is a side view of the cutting assembly of the suture locking delivery subsystem without the cutting head advanced to hold the suture prior to cutting. [Figure 41F] FIG. 41F is a side view of the cutting assembly of the suture lock delivery subsystem with the cutting head advanced for severing the suture. [Figure 41G] FIG. 41G is a side view of a suture lock and the distal end of a torque driver configured to engage the suture lock. [Figure 41H] FIG. 41H shows the proximal end of the suture lock. [Figure 41I] FIG. 41I shows the distal end of the suture lock. [Figure 42] FIG. 42 shows neochordae implanted between two papillary muscles in a manner that aligns them substantially parallel to the natural chordae. [Figure 43A] FIG. 43A shows a schematic of a pledget formed by integrating the distal ends of a suture between two flat sheets of the pledget. [Figure 43B]FIG. 43B is a schematic cross-sectional view of the pledget shown in FIG. 43A. [Figure 43C] FIG. 43C is a schematic illustration of the pledget shown in FIG. 43C having an opening with suture tails extending through the opening to form a collapsible anchor. DETAILED DESCRIPTION OF THE INVENTION

[0032] An example of attaching a torn or flailed cord includes a catheter delivered through the femoral vein and traversing the inferior vena cava (IVC) and septum to the left middle atrium, where attachment to the mitral valve annulus is achieved. This attachment can be achieved with an anchor inserted into the mitral valve or a single suture loop through the mitral annular tissue that rotates, penetrates, or passes through the local tissue where the mitral valve leaflets contact the atrial tissue at or near the mitral annulus. The anchor can consist of a coiled wire anchor that rotates into the tissue and includes a suture receiver for a replacement cord or a pre-attached cord secured to the anchor.

[0033] The connection to the mitral valve annulus provides a safe and secure attachment point as a stable anchor via a piercing, hook, or corkscrew-type fixation device. To this attachment point, the cord connects over the mitral valve leaflets and is further attached or anchored to the apex of the left ventricle. It may also pierce the anterior or posterior mitral leaflet at any location. The cord may be made of round or flat PTFE, PE, or nylon, as is traditionally used in cord repair procedures.

[0034] In one embodiment, the cord functions as a neocord or artificial cord. In certain embodiments, the cord may be a standard suture. In one embodiment, one or more additional artificial elements are secured across the cord. For example, a tubular structure may be advanced (e.g., slid) across the cord through a delivery device. The structure may be configured to self-position appropriately along the length of the cord, or the structure may be secured to the cord at an appropriate location (e.g., by placing locking members proximally and / or distally of the structure). Any suitable locking member may be used to secure the structure in place. The locking member may be crimpable, have a mechanical locking mechanism, and / or frictionally engage the cord so as to require a threshold amount of force to advance across the cord. Any suitable type 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 artificial structures may be secured at the proximal or distal end, or intermittently along the length of the cord. The cord may be attached to the proximal or distal end of the artificial structure. For example, two cords may be used, with 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 cords may be connected to the structure at the proximal and / or distal ends (e.g., inserted into or wrapped around a loop in the structure) or may extend parallel along the length of the structure. The artificial structure may be configured for contact with one or more physiological tissues (e.g., interacting with the valve leaflets) and / or configured to replicate the mechanical / structural properties of physiological structures (e.g., papillary muscles).

[0035] Fixation to the mitral valve annulus provides a secure and immobile attachment point for the mitral valve leaflets, which are difficult to capture with a torn cord due to movement caused by heartbeat. As described in more detail below with respect to certain exemplary embodiments, such movement can be arrested by grasping the flail leaflets with a mechanical capturing tool, a suction tube, or a cryocatheter that freeze-grasps the leaflets. Once securely attached to the mitral valve annulus, the upper anchors wrap across the mitral valve leaflets and between the existing cords to limit their lateral position relative to the leaflets. Placing the leaflets between the existing cords provides the prosthetic cord with an upper anchor point, a fixed angular position through the existing cord, and a positive anchor at another orthogonal location in the apex of the left ventricle. The replacement cord can be a single suture strand and / or multiple cords that traverse the pathways above and below to support the load, as described above.

[0036] The lower apical anchor, which may be placed in the left ventricle, may be secured via a rotating screw or plug to securely hold the cord. The anchor may be low in height and located near the base of the apex, or it may have an extended length to better fit the natural papillary muscles approximately 20-22 mm above the apex of the left ventricle. In one embodiment, the anchor extends approximately less than 5 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, or more than 50 mm above the apex, and / or any range between these values. A single cord or multiple cords are attached to one or more anchors at the base of the left ventricle. The anchors may be constructed of stainless steel, nitinol, or other metallic materials visible under fluoroscopy, or polymeric materials such as PEEK, PTFE, or other implantable materials. These polymers may optionally include radiopaque markers for visibility.

[0037] In some embodiments, the fixation system includes an apical tissue anchor bonded or attached to the left ventricle and a riser extending from the apical tissue anchor. The system may be formed from a monolithic material or a combination of materials, including polymers and metals. The structure may be entirely rigid or may have flexible joints to allow movement or an elastic region (or multiple elastic regions) for controlled movement and flexibility. The fixation system may be configured with a circular cross-sectional shape or other exterior shapes, including longitudinally varying shapes. It is approximately 6-24 French (2-8 mm) in diameter and approximately 20-40 mm in length, and is generally delivered via a catheter that can be steered with or without a centrally oriented guidewire. The superior leaflet anchor is attached to the mitral annulus or leaflet, covering the mitral leaflet and further connected to the inferior anchor, allowing for adjustment of tension via real-time imaging / monitoring (e.g., under live echocardiography) while monitoring leaflet movement and reduction of regurgitation. The final step involves tensioning the cord, locking the cord, and disconnecting the cord from the delivery system. Tension on the cord applies tension to the attached mitral valve leaflet strain relief, and a locking device, such as LSI Solutions' Cor-Knot, is advanced along the cord, ultimately severing the suture tails.

[0038] According to one embodiment (see FIGS. 1-7), the delivery of the substitution code comprises the following steps: 1. Transvenous and transfemoral entry of delivery catheter 100 2. Advancement of catheter 100 into right atrium 10 3. Transseptal advancement 12 of catheter 100 into left atrium 14 4. Advancement of catheter 100 into mitral valve annulus 16 for positioning and delivery of strain relief anchor 18 5. Positioning the Grasping Tool on the Mitral Valve Leaflets 6. Attaching the strain relief anchor 18 to the mitral valve annulus 16 7. Advancement of a replacement cord 22 across the mitral valve 25 between existing cords 17 8. Advancement of cord 22 to apex 20 of the left ventricle and distal attachment to apex 20 9. Apply tension to the cord 22 while monitoring the movement of the mitral valve leaflets.

[0039] Alternatively, in certain embodiments (see, e.g., FIGS. 26-34), the feeding may be in a slightly reversed order: 1. Transfemoral Entry of Delivery Catheter 100 2. Advancement of catheter 100 into right atrium 10 3. Transseptal advancement 12 of catheter 100 into left atrium 14 4. Advancement of the delivery catheter 100 through the mitral valve 24 to the apex 20 of the left ventricle. 5. Delivery of a distal ventricular anchor (e.g., rotational anchor 32) to the apex 20 6. Withdrawal of delivery catheter 100 to expose inferior apical anchor 30 7. Pulling the delivery catheter 100 proximally to expose the new cord suture line 22 or lines 22 8. For each new cord 22, mitral valve leaflet strain relief can be provided through the mitral valve leaflet to the ventricular side of the leaflet. 9. Advancement of the suture lock 26 over the suture tail 28 to lock the position of the suture in the strain relief anchor position. 10. Cutting the tail of the suture in the mitral valve leaflet anchor 11. Advance the suture lock 26 from the catheter handle to the tail of the suture to the mitral valve leaflet anchor. 12. Advancement of the suture lock 26 across the suture tails from the catheter handle to the distal apical anchor, locking tension applied from the distal-most suture tail outside the catheter handle. 13. Cutting the tail of the suture at the distal apical anchor Some steps of the above methods may be optional, additional steps may be included where appropriate, and steps may be rearranged in any order possible.

[0040] The embodiment shown in Figures 1-7 will now be described in more detail. Figure 1 shows sutures 22 and a mitral valve annulus 16 delivered and attached via catheter 100. Figure 2 shows a distal anchor 32 attached to sutures 22 connected to the mitral valve annulus 16 and delivered via catheter 100. Figure 3 shows the distal anchor 32 with attached sutures 22 for attachment to the subsequent mitral valve leaflet 24 or mitral valve annulus 16, rotated toward the apex 20 of the heart. Figure 4 shows the distal anchor 32 rotated toward the apex 20 with sutures 22 attached to the mitral valve leaflet 24 or mitral valve annulus 17. Figure 5 shows the distal anchor 32 attached and protruding above the apex 20, approximately level with the tops of the papillary muscles. 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 may be the same or different material, diameter, stiffness, etc. as the rest of the anchor 32. The riser 70 may be longitudinally aligned with the rest of the anchor 32 or disposed at an angle relative to the rest of the anchor 32. The riser 70 may be rigidly fixed or integral to the rest of the anchor 32, articulated (e.g., joint / socket), or flexibly connected (e.g., interconnected loops). Tension applied to the anchor 32 during deployment of the neochordae determines or changes the orientation of the riser 70 relative to the heart and / or the rest of the anchor 32. FIG. 6 shows the distal anchor 32 attached to project above the apex 20, approximately level with the tops of the papillary muscles. The distal anchor 32 may be attached to the mitral valve annulus 16 and / or mitral valve leaflets 24 via one or more sutures. FIG. 7 shows a distal anchor 32 attached to a looped suture that protrudes above the apex 20, approximately level with the tops of the papillary muscles, and that travels through the catheter 100.

[0041] 8 shows an embodiment in which a suture 50 delivered by a looped catheter penetrates a mitral valve leaflet 24, a strain relief 52 is positioned on the ventricular side of the mitral valve leaflet 24, and a distal anchor 32 is positioned at the base of the left ventricle with final suture tension maintained by a suture lock 54 advanced over a suture tail 56. A single suture loop 50 joins the distal anchor 32 to the strain relief 52, directly to the distal anchor, and / or to another leaflet anchor. Multiple loops may also be used. In one embodiment, the suture 50 may pass through a loop structure in the strain relief 52 and / or the distal anchor 32 to effectively double back. In one embodiment, the suture 50 may pass through a channel in the strain relief 52 and / or the distal anchor 32 so that the proximal end of the suture 50 enters one opening and the distal end of the suture 50 exits the other opening. The openings can be located on the same side of the distal anchor 32 and / or the strain relief 52. The openings may be located on the same side of the distal anchor 32 and / or the strain relief 52. The openings may be located on opposite sides of the distal anchor 32 and / or the strain relief 52. The relative lengths of the suture tails 56 extending from the distal anchor 32 and the strain relief 52 determine the effective final position of the suture lock 56. For example, by minimizing the length of the suture tails 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, e.g., directly across the strain relief 52. By minimizing the length of the suture tails 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 locking mechanism, including those described herein. The strain relief 52 may have an expandable structure such that the strain relief 52 is inserted into the leaflet 24 in a collapsed state (e.g., a reduced cross-sectional configuration) and expands on the ventricular side of the leaflet 24 (e.g., to an enlarged cross-sectional configuration). The strain relief 52 may be self-expanding. In one example, the strain relief 52 may be a pledget 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 advanced through the internal lumen of the needle. The needle may constrain the strain relief 52 in a folded configuration. The strain relief 52 may be inserted through the leaflet 24 with the sutures 50 pre-loaded (e.g., looped through the strain relief) so that the proximal and distal ends of the sutures 50 extending from the strain relief remain extended through the puncture through the leaflet 24 when the strain relief 52 is attached. The suture lock 54 prevents the suture tails 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 tails 56 to be severed adjacent the suture lock 54. The tail 56 of the suture 50 may be cut immediately adjacent to or proximal to the suture lock 54, allowing the length of the suture tail 56 to extend freely from the suture lock 54. The strain relief 52 and distal anchor may be loaded into the suture loop 50 and then sequentially placed through the catheter 100 in any order.

[0042] 9 illustrates an embodiment in which a catheter-delivered suture or loop 60 is passed through 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 FIG. 8. In this embodiment, the suture lock 62 is advanced toward the atrial side of the mitral valve leaflet 24 to secure the suture tails before cutting the suture 60. The suture lock 62 is advanced along only one tail of the suture 60 so as to secure only the suture tails extending from the strain relief 52, without securing the suture tails extending from the distal anchor 32. The suture lock 62 can be configured (e.g., sized and / or shaped) to prevent the suture lock from being pulled through the puncture in the mitral valve leaflet 24. The suture tails extending from the distal anchor 32 may be secured as described with reference to FIG.

[0043] 10 illustrates an embodiment in which a catheter-delivered suture 60 passes through the mitral valve leaflet 25 with the strain relief 52 positioned on the ventricular side of the mitral valve leaflet 25 and the suture lock 62 advanced to the atrial side of the mitral valve leaflet to secure the suture tail as described with reference to FIG. 9 . The other end of the suture tail extends from the catheter handle through the catheter 100, which traverses around a distal anchor 32 located at the base of the left ventricle to apply tension to the suture. Once the user adjusts the suture tension, a second suture lock 63 is advanced over the final suture tail and locked in place at the final suture tail. The second suture lock 62 can be configured (e.g., sized and / or shaped) to prevent the suture lock 62 from pulling through the distal anchor 32 under tension.

[0044] FIG. 11 illustrates an embodiment in which a catheter-delivered suture loop 60 penetrates the mitral valve leaflet 24 with a piercing element 27 (e.g., a needle) with a strain relief 52 looped and positioned on the ventricular side of the mitral valve leaflet 24, a distal anchor 32 positioned at the bottom of the left ventricle, and final suture tension adjustment held by a suture lock advanced over the suture tail. This embodiment may be similar to the embodiments shown in FIGS. 8-10. A cryocatheter 70 attached to the mitral valve leaflet 24 can be used to hold the leaflet stable and resist the penetration force of the strain relief. The cryocatheter 70 can be delivered through the same catheter 100 or a separate catheter. The cryocatheter provides a temporary cooling effect on the mitral valve leaflet 24 and temporarily attaches the tissue of the leaflet 24 to the catheter. Other holding devices, including suction devices, tissue grasping devices, and additional piercing devices, may be used alone or in combination. The application of a retaining force to the leaflets 24 advantageously aids in the application of a counter force to the leaflets during insertion of the piercing element 27 .

[0045] Figure 12 shows a suture loop 60 delivered from the catheter penetrating the mitral valve leaflet 24, with the strain relief loop positioned on the ventricular side of the mitral valve leaflet, the distal anchor 32 positioned at the base of the left ventricle, and final suture tension adjustment held by a suture lock advanced over the suture tail. A cryocatheter 70 is shown attached to the mitral valve leaflet, stabilizing the leaflet and resisting the penetrating force of the strain relief. The embodiment shown in Figure 12 is similar to the embodiment shown in Figure 11, with the piercing element 27 retracted from the tissue.

[0046] 13 and 14 illustrate the atrial view of the location of penetration through the mitral valve annulus 16 and the location of the distal anchor 32 relative to the native papillary muscles, according to certain embodiments. In one embodiment, the anterior or posterior leaflet, or the adjacent annular tissue, may be penetrated. The location of the penetration and placement of the strain relief or leaflet anchor can be used to affect the amount of tension applied to the leaflets.

[0047] FIG. 15 shows various anchors 32a, 32b, 32c, and 32d for attachment to the apex of the left ventricle. The anchors include coiled round wire 32a, 32b, and 32c with vertical risers 70 that adjust the connection point 72 closer to the level of the papillary muscles to more accurately simulate the correct angle for matching the new cord connection, and laser-cut hypotube 32d. Anchor 32a includes a single helical coil extending around the 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 with substantially the same pitch. In one embodiment, a pointed shaft like 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, connection point 72 may be a single closed loop. The suture may be tied or attached to the loop. In one embodiment, other forms of connection or cord for the suture may be used. The anchor 32c includes a riser 70 in the form of a post and a connection point 72 that receives the suture 60. The suture 60 may be secured within the connection point 72 by a silicone plug 74. Any suitable material may be used for the plug. The connection point 72 may have a channel configured (e.g., sized and shaped) to receive the plug 74. The connector may have one or more openings extending through the sidewall of the channel that allow the suture to pass through. The plug 74 may frictionally engage the channel. One or more sutures extend through the openings in the sidewall and the channel, as shown in FIG. 15. The suture slides freely through the opening when the plug 74 is not present during installation, allowing adjustment of the length of the suture and the tension in the suture. The plug 74 may be inserted into the channel and form a tight friction fit with the channel. The plug 74 frictionally secures the suture(s) between the outer surface of the plug 74 and the inner surface of the sidewall, thereby effectively locking the suture(s) in place relative to the anchor 32c. The plug 74 may be installed after adjusting the length and tension of the suture(s).In other embodiments, the suture extends through the loop to the distal end of the channel, 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-32d disclosed herein may be applied in any suitable combination.

[0048] Figures 16-22 illustrate other methods according to certain embodiments. Figure 16 illustrates a transseptal catheter 100 including multiple displacement cords 22 extending from the handle of the catheter 100 for delivering anchors 32 to the apex 20 of the left ventricle. Figure 17 illustrates the transseptal catheter 100 of Figure 16 for delivering a penetrating tool 80 through the mitral valve leaflet 24 to deliver a strain relief anchor connected to a suture loop 60. Figure 18 illustrates the transseptal catheter 100 for delivering a penetrating tool 80 through the mitral valve leaflet 24 with a suture loop 60. Figure 19 illustrates the transseptal catheter 100 for delivering a strain relief 52 to the ventricular side of the mitral valve leaflet 24, exposing the strain relief for delivery through or with the penetrating tool 80. In one embodiment, the strain relief 52 may be self-expanding when exposed, as described herein. FIG. 20 illustrates a transseptal catheter delivering strain reliefs 52 with the piercing tool 80 withdrawn from the mitral valve leaflet 24. In the embodiment illustrated in FIG. 20, two strain reliefs are positioned on either side of the mitral valve leaflet 24. The leaflet may be sandwiched between an atrial strain relief and a ventricular strain relief. After the ventricular strain relief 52 is in place and tension is applied to the sutures so that the ventricular strain relief 52 is in flush contact with the leaflet 24, the atrial strain relief may be advanced over the sutures. The atrial strain relief may be configured to be locked or fixed to the sutures to prevent contact between the strain relief and the tissue of the leaflet 24 and to prevent slack between the strain reliefs, which would remove pressure from the strain relief. In one embodiment, the suture lock may be advanced behind the atrial strain relief, bringing the atrial strain relief into flush contact with the tissue of the valve leaflet 24. In some instances, the use of two strain reliefs reduces strain at the puncture point through the valve leaflet 24, which may reduce damage to the tissue of the valve leaflet 24.Figure 21 shows a transseptal catheter 100 delivering strain relief 52, showing the suture loop 60 extending from the catheter handle and its connection to the distal anchor 32. Figure 22 shows a transseptal catheter delivering a suture lock 62 to the distal anchor 32. The suture lock 22 is advanced over the suture tail to adjust the position and tension of the final implanted suture connected to the mitral valve leaflets 24 and distal apex anchor 32 while tension is applied from the proximal end of the suture through the catheter handle.

[0049] FIG. 23 illustrates an embodiment in which the continuous suture loop secures the distal apex anchor 32 to the strain relief element 52 on the mitral valve leaflet 24 in a final position. In one embodiment, the continuous loop may be formed by applying a suture lock to the tail of the looped suture. Any other suitable means for forming the continuous suture loop may also be used. In one embodiment, the mitral valve leaflet anchor or strain relief element 52 may be double-sided (e.g., including a double-sided flange 52b) as shown, or may have a single-sided flange 52a (not shown). The double-sided flange 52b may have an expandable element (e.g., an expandable flange) configured to be positioned on either side of the mitral valve leaflet tissue. In one embodiment, the two opposing flanges are fixedly coupled to each other via an intermediate element that traverses the puncture orifice of the 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 leaflet 24.

[0050] 24 illustrates an embodiment in which the continuous loop 90 has been delivered to its final position, with the strain relief element 52 and distal apex anchor 32 positioned against the mitral valve leaflets 24. This embodiment may be similar to the embodiment shown in FIG.

[0051] FIG. 25 shows an example of a distal apex anchor 32. The distal apex anchor 32 includes a silicone anchor plug 72 and a stainless steel tube 73 configured to limit suture migration before delivering 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 is advanced over the suture in addition to or instead of the suture lock 62. If the plug 72 is used temporarily, it may be removed before implantation is complete. The material may be modified to accommodate size and / or material reinforcement. In one implementation, the anchor 32 is the same as or similar to the anchor 32c shown in FIG. 15.

[0052] Figures 26-34 show embodiments that allow for different placement orders of the distal apex anchors 32. Figure 26 shows the catheter 100 and left atrium 14 passing through the right atrium and penetrating the septum 12.

[0053] FIG. 27 shows the anchor 32 rotated toward the apex of the left ventricle. The anchor 32 rotates clockwise or counterclockwise, depending on the anchor's configuration. As described herein, the anchor 32 can be rotated by a delivery device (e.g., a rotation driver) insertable through the catheter 100. Furthermore, while in the illustrated embodiment the anchor 32 is rotated toward the apex of the left ventricle, in alternative embodiments the anchor 32 can be secured in other locations in the left ventricle. For example, as described in more detail below, the methods and devices in the embodiments described herein can be utilized in an arrangement in which the anchor 32 is positioned in the left ventricle between the papillary muscles. Such an arrangement advantageously aligns the sutures extending through the anchor 32 and the mitral valve leaflets 24 with one or more chordae tendineae extending from the secured mitral valve leaflets 24.

[0054] FIG. 28 shows the distal apex anchor 32 in place, with the suture 22 extending through the catheter 100 to the proximal end of the delivery device outside the body. As described herein, the suture is looped through the anchor 32. The extension arm 94 of the catheter 100 is exposed on the side of the catheter, slightly proximal to the distal end of the catheter 100. The extension arm 94 may be angled to extend proximally from the side of the catheter 100. The extension arm may be configured to capture the mitral valve leaflet 24, for example, on the ventricular side of the leaflet 24. The extension arm 94 may have a pointed tip. Alternatively, the extension arm 94 may have a needle that can pass through the catheter 100 and the extension arm 94. The leaflet 24 may engage an applied needle when properly positioned relative to the leaflet 24. In one embodiment, the extension arms may be formed on separate catheters configured to be independently distally advanceable and proximally retractable through catheter 100 .

[0055] 29 illustrates the extension arm 94 in contact with the mitral valve leaflet 24 and the needle 96 connected to the suture loop 60 penetrating the leaflet 24, exposing the suture loop 60 to the atrial side of the mitral valve leaflet 24. In one embodiment, the suture loop may be formed from one tail of a suture extending through the distal anchor 32. The other end may extend proximally 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 through which the suture is looped. In one embodiment, the suture loop 60 may be a loop in a suture that engages with the needle 96, which may be configured to retain the suture loop 60 and prevent the suture loop from retracting proximally 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 two of which extend to form the suture loop 60.

[0056] 30 shows the suture loop 60 exposed on the atrial side of the mitral valve leaflet after penetrating the leaflet to receive a loop snare 99 that captures the suture loop 60 and retracts through the catheter 100. The loop snare is delivered through another opening in the catheter 100 located proximal to the extender arm 94. The extender 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 such that the loop snare 99 retains the suture loop 60 and retracts proximally into the catheter 100 through the loop snare opening (advancing the suture loop distally through the extender arm 94).

[0057] FIG. 31 shows the suture loop snare 99 closing around the suture loop 60 and the suture being withdrawn proximally through the catheter 100. FIG. 32 shows the catheter 100 delivering the suture lock 62 to the posterior side of the mitral valve leaflet as the suture loops along a path that includes the distal apical anchor 32. The suture lock 62 and the distal anchor 32 may be configured so that the suture lock 62 passes freely through the connection point of the distal anchor 32 to reach the ventricular side of the 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 be retracted before or during the above step to prevent the leaflet 24 from being captured by the extension arm 94. In one embodiment, the extension arm may be formed as part of an inner catheter that is advanced through and withdrawn through the catheter 100, as described herein.

[0058] FIG. 33 shows a second catheter 101 delivering a suture lock that receives the suture end and locks the suture across the valve leaflet after applying appropriate tension to the two ends. The catheter 100 is withdrawn, carrying the suture loop 60 outside the body, where it aligns with the other end of the suture. A second suture lock is applied to the suture end and then delivered into the body using the second catheter 101. FIG. 34 shows the suture locks 62 in their final predetermined positions above and below the mitral valve leaflets 35, and the suture ends cut, leaving the final implantation of the distal apex anchor connected to the mitral valve leaflet 24. The second suture lock 62 may be placed in alternative positions relative to the valve leaflet 24, depending on the length of the suture between the two suture locks. By placing two suture locks on either side of the valve leaflet 24, the suture locks can act as strain relief. In one embodiment, the first suture lock 62 located on the ventricular side of the leaflet 24 may be omitted.

[0059] Chordae termination and suture locking structures and devices include one or more knots, pledgets, or other termination techniques to reduce focal stress at the attachment points. Penetration of the annular tissue and valve leaflets can be achieved by insertion of a sharp needle. This penetration is controlled via a steerable catheter and core shaft to push, position, and drive the needle through the mitral valve leaflets. The procedure can be guided under fluoroscopy, echo guidance, or any other suitable visualization or monitoring procedure. Locating and identifying the leaflets can be achieved by mechanical techniques to grasp or pinch the leaflets, or by aspiration or cryocapture using a cryocatheter. These techniques include cryocatheters used for ablation to freeze focal tissue, as described, for example, with reference to FIG. 12 . Cryoablation catheters used for atrial fibrillation can accidentally attach to the mitral valve leaflets and must therefore be stopped to release the attached leaflets. The same cryoattachment can be used to locate and identify the problematic leaflets for repositioning and repair. Cryocatheters use gas substitution (nitrous oxide or argon) to reduce the temperature at the tip of the catheter, resulting in temperatures as low as -75°C.

[0060] The lower apical anchor structure may consist of a coiled distal section with a flat or rounded wire structure that rotates toward the apex of the left ventricle, or it may consist of laser-cut tubing that mimics a corkscrew similar to a wine cork, similar to those described in the examples of Figures 6 and 15. Variable screw pitch allows for a more secure attachment to the surrounding tissue. Other devices for fixation to the tissue include crimping or ovalizing the screw anchor to achieve similar fixation. Attachment to the anchorizer may be by pinning, welding, or bonding via other mechanical devices. Alternatively, the anchor may be laser-cut from the same material as the tube, which may be stainless steel, Nitinol, or other implantable material. The most proximal end may have a loop or tube for receiving a replacement cord, as shown at connection 72 in Figure 15, or multiple replacement cords may be pre-installed for delivery and extending from the catheter handle.

[0061] In another embodiment, a distal anchor can be delivered to the apex of the left ventricle with multiple replacement cords looped around the anchors and extending to the proximal-most handle portion of the catheter. This allows for delivery of multiple anchors extending perpendicularly from the apex of the left ventricle to a single origin, with free ends of the replacement cords extending from the delivery catheter for access and advancement of other tools for locking or cutting. A delivery piercing element or tube is advanced over the free ends to and through the mitral valve leaflets, delivering a pledget or restraining element through the leaflets to the posterior (ventricular) side of the leaflets. This secures the loop and restraining element to prevent the loop from pulling through the leaflets and acts as a strain relief element. A locking element is delivered over the same free end of the replacement cord to securely hold the position of the cord and pledget relative to the position of the leaflets. The free ends may be cut off after delivery. Locating and holding the leaflet may be accomplished with a cryocatheter that holds the leaflet from the atrial side, or a grasping tool that grasps the leaflet from the free edge may be used. Once the first piercing is made and the pledget is delivered, tension is applied to the other free end around the distal apex anchor, and a second locking element is delivered to hold the position relative to the end of the apex anchor. The cord or suture anchor may be secured to the distal apex anchor with an interference fit and / or to other cord lines extending to the mitral valve leaflets. While the figures show delivery and placement of the mitral valve leaflet anchor at the posterior leaflet, the anchor and replacement cord may also be delivered to the anterior leaflet or anywhere in the mitral valve leaflet, including the free edge, coaptation region, or mitral annulus.

[0062] In another method, a distal rotating anchor connected to a continuous loop of suture, like a rubber band, is placed in the left ventricle. One end is fixed to the distal anchor. The other end penetrates the mitral valve leaflet and is connected to a strain relief element, which distributes force to the ventricular side of the mitral valve leaflet. This prevents the replacement cord from being pulled through the leaflet or tearing the leaflet. The strain relief element may be a laser-cut tube that expands from a small to a large shape via a compressive axial force as it passes through the leaflet. Alternatively, the strain relief element may be constructed from a shape-memory metal, such as nitinol, and may be preset to a small delivery diameter and a large expansion shape. The delivery diameter is approximately 0.5 mm and expands to approximately 2-3 mm. The delivery length is approximately 2-5 mm and can be shortened to approximately 1-2 mm. The strain relief element may also be constructed of shape-memory metal and set in a circle, as in the Amplatz device, or it may be a simple or complex suture knot placed on the ventricular side of the valve leaflet. Another configuration is a Nitinol wrapped loop wire, like a daisy containing a Nitinol wire pedal. This device may also be used to adjust the final length of the loop cord by wrapping the loop end that has passed through the valve leaflet. For example, the number of times the suture or cord is wrapped around the device may gradually reduce the free length of the suture or cord. This retraction mechanism may also be placed on a distal coil anchor placed in the left ventricle. This adjustment may be made during delivery to adjust the length of the cord and / or for post-procedure shortening or lengthening adjustment. A rotary ratchet drive coupled to the drive shaft or wire can be rotated outside the body by coupling and uncoupling when adjustment is needed. The drive shaft may be a round wire constructed of stainless steel or Nitinol, and a hexagonal coupling interface between the drive shaft and the retraction mechanism may be used to engage or disengage the two elements. The two elements are fed into mesh with each other for operation and are later joined using a loop snare to grip the winding mechanism and drive shaft which engages with the hexagonal drive.The winding mechanism may use a simple rotating spool with a toothed stop to prevent rotation, or it may use frictional resistance to maintain a tensioned position. Alternatively, the distal coil anchor can be designed to receive an internal matching 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 rotating the internal matching pitch screw to shorten the relative distance between the two threaded elements. The simplest configuration is to place one coil within another, where both coils have right- or left-handed threads and are coupled together to impart rotational motion to translational or axial motion. Locking the two coils together after processing can provide a secure position of the cord length between the valve leaflet and the distal anchor system.

[0063] Patient selection

[0064] In one embodiment, a method of treating a patient begins with selecting a suitable patient. However, the methods, devices, 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 first group of characteristics: - Have been diagnosed with primary or degenerative mitral regurgitation. - Have been diagnosed with secondary or functional mitral regurgitation. Have been diagnosed with myxomatous mitral regurgitation. - Have been diagnosed with flail leaflet, torn chordae tendineae, or leaflet prolapse. Mitral regurgitation grade ≥1, ≥2, ≥3, or ≥4. The diameter of the A2 to P2 leaflets must be at least 5, 10, 15, 20, 30, or 50 mm less than the combined length of the P2 and A2 leaflets. A similar mathematical relationship may also be used to ensure adequate coaptation after repair to ensure a durable repair. The diameter of the A2 to P2 leaflets is 10 to 50 mm, preferably 24 to 36 mm, or most preferably 26 to 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 second group of characteristics: Have been evaluated by a cardiac team including at least one, and preferably two, cardiac surgeons and determined to be not a suitable candidate for traditional open-heart surgical repair. The surgical mortality rate predicted by the STS (Society of Thoracic Surgeons score, STS score) is 2-20 or higher. The patient was offered open surgical repair and declined. -Age between 18 and 90 years, preferably between 35 and 85 years, more preferably between 40 and 85 years. · Patients do not receive blood transfusions. Previous open heart surgery. ·Ejection fraction of at least 10-60 percent. For embodiments of the device, it is preferred that the patient does not substantially have the following requirements (third group): Moderate or severe COPD ·Hypercoagulable diseases Systemic degenerative collagen diseases (i.e., Marfan syndrome) Previous septal infarction affecting the anchor region Ventricular septal defect Known allergy to contrast media 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 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, and does not meet the requirements of at least one, two, or three of Group 3.

[0066] Echocardiography and / or CT imaging may be used to evaluate the patient. MRI imaging may also be used. A contrast-gated cardiac CT scan with at least 32, 64, or 128 slices is preferably performed preprocedurally and used for patient selection and / or case planning. Using imaging software, the diameter can be measured from the A2 hinge point to the P2 leaflet hinge point, and the free leaflet length can be determined. Comparing these measurements can ensure the presence of sufficient redundant coaptation to result in a durable repair after the procedure is completed. In one example, the annulus can be reduced using other devices or methods, such as a transcatheter valvuloplasty device, to create a sufficiently small diameter.

[0067] Imaging

[0068] The present disclosure has the potential to allow for superior real-time assessment and adjustment of suture placement and tension during the procedure. Exemplary imaging methods offer significant advantages in visualization compared to methods available during open-heart surgery.

[0069] Tension optimization

[0070] During open-chest surgical mitral valve repair, the heart stops, relaxes, and contracts, and the surgeon must educate himself about the dynamic structural motions. The surgeon's initial assessment step involves filling the ventricle with saline to force the mitral valve leaflets into a closed position and visually assessing areas of leak, prolapse, and / or improper coaptation.

[0071] The assessment is limited because it is not performed on a beating heart. However, the sutures are tied and secured based on the assessment, and then the atria are closed, the heart is resuscitated, and a final echocardiographic assessment or other monitoring is performed on the beating heart. If a problem is identified, the surgeon must stop the heart again, reopen the atria, and correct the already completed repair. Because the sutures are tied and trimmed, they cannot simply be retensioned; therefore, the sutures are typically replaced or additional artificial cords are added. In one embodiment of the present disclosure, real-time echocardiographic assessment is possible to individually adjust suture tension.

[0072] In one embodiment, a method for implanting a prosthetic cord includes first anchoring one end of a plurality of prosthetic cords to the annulus of the mitral valve leaflets or surrounding tissue and anchoring the other end to anchor points mechanically connected to the left ventricle, and second adjusting tension on the prosthetic cords while viewing echocardiographic images and other images of the mitral valve.

[0073] In one embodiment of the method, the echocardiographic images include color Doppler assessment of velocity and / or flow. In one embodiment, the echocardiographic images include real-time 3D or 4D echo. In one embodiment, the color flow Doppler images and the 3D images 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 another embodiment, the echo probe is positioned in the patient's vasculature.

[0074] In one embodiment, at least one, two, three, four, or five of the following features are confirmed under echocardiography while the artificial cord is tensioned: In another embodiment, the following features are confirmed after the artificial cord is tensioned and before the cord is permanently disconnected from the delivery system, allowing for easy re-tensioning if necessary. No systolic anterior leaflet movement causing obstruction or restriction of the left ventricular outflow tract Mitral valve gradient - Appearance of a backflow jet Regurgitation speed Counterflow jet length MR grade A minimum leaflet coaptation distance of at least 3, 5, 9, 12, or 15 mm across the coaptation line is achieved. The degree of leaflet prolapse or the height to which a portion of the mitral valve leaflet moves above the mitral valve plane Areas of "smoke" or congestion (stasis) within the atria, ventricles, or atrial appendages Atresia between the left and right ventricles, especially at the anchovies or other septal sections

[0075] Additionally, while the tension of the suture is easily adjustable, during an evaluation period after initial tensioning of the suture and before severing the suture from the delivery system or trimming excess suture, at least one, two, three, four, or five of the following are evaluated: ·blood pressure ·Cardiac output ACT Actual Clotting Time EKG electrocardiogram Cardiac enzymes ckmb and troponin Coronary artery patency Fluoroscopic assessment of potential ventricular shunts from anchors or transventricular access. Perspective of ventricular anchor -Transmission system perspective position Atrial pressure or wedge pressure The oxygen content of the patient's blood

[0076] After the evaluation step is completed based on information obtained from the measurements, the physician or medical team may decide to make the results permanent, readjust the tension, add additional repair elements, or discontinue the procedure. In one embodiment, the physician has the option to remove the entire implant. In another embodiment, the physician has the option to remove the artificial cord of the implant while leaving the ventricular anchor in place. In one embodiment, the evaluation step is further augmented by including a stress echo element, in which medications such as pressure modulating agents are administered to the patient to adjust heart rate, cardiac output, and ventricular pressure to further evaluate how the repair performs under different hemodynamic conditions.

[0077] monitoring

[0078] Patients are preferably under conscious sedation during the procedure. This makes transesophageal echocardiography difficult, but minimizes anesthetic risks and allows patients to return home sooner. General anesthesia or conscious sedation during the procedure requires standard catheterization lab monitoring, including arterial pressure, EkG, ACT, and blood gases. Additionally, wedge pressure or left atrial pressure is useful for this procedure. Careful monitoring of arterial pressure for the procedure provides early indications of damage to the mitral valve apparatus, device entanglement in the chordae tendineae, and / or damage to the septal wall. Measuring left atrial pressure may provide a simple, quantifiable criterion for improvement in mitral valve function without the challenges associated with obtaining a proper echocardiogram.

[0079] access

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

[0081] A guidewire, optionally using a guide catheter, is advanced through the valve into the right ventricle. A device of the present disclosure can be advanced over the guidewire to a position near the apex of the ventricle.

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

[0083] In one embodiment, the curve is formed using a steerable catheter. Certain embodiments of steerable catheters include pull wires that, when pulled, form the inner radius of the catheter. Some embodiments also include coils, braids, and / or axial reinforcements.

[0084] In some embodiments, the curve is formed using coaxial sheaths with different shapes. For example, an outer sheath that is substantially straight or has a large radius of curvature near its tip may be used in combination with an inner sheath that has a smaller radius of curvature at its distal tip. By advancing the inner sheath from the outer sheath, the desired curvature is formed at the tip of the catheter. By advancing a sheath with a greater curve, a greater angle of curvature can be achieved.

[0085] In one embodiment, both sheaths have different relative stiffnesses at different points along their length. In certain embodiments, the outer sheath is curved to access the apex of the ventricle and to provide stability through the vena cava. To achieve this, the sheath may be shaped to extend 7-50 cm back from its distal tip. The inner sheath is substantially more flexible than the outer sheath (e.g., less than about 30, 50, 70, or 90% of its bending stiffness as measured by ASTM three-point bending) from about 7-55 cm from its distal tip. 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 vena cava. The distal portion of the inner sheath is preferably stiffer than the aforementioned portion, providing sufficient strength despite the approximate shape of the inner sheath contacting cardiac structures as it 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 toward the septal wall, preferably pointing upward toward the mitral valve. The position of the sheath may be confirmed by imaging. In one embodiment, a four-chamber echocardiogram is used. In another embodiment, a short-axis mitral view is used. In one embodiment, fluoroscopic imaging is used. Depending on the location of the area requiring repair, the desired puncture site is selected, and the appropriate angle is chosen based on the orientation of the planned replacement cord.

[0087] In one embodiment, a puncture higher, closer to the papillary muscle attachment point, and away from the apex of the ventricle is preferred, as this location provides the benefit of less change in cord tension compared to a near-apical attachment as the heart remodels and ventricular volumes decrease to more normal physiologic levels.

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

[0089] Once access to the ventricle is achieved, a guidewire can be advanced across the septum. In one embodiment, the guidewire is further advanced across the mitral valve into the atrium, and in another embodiment, the guidewire is further advanced into the pulmonary veins. Echocardiography and / or wire manipulation can be used to ensure that the wire does not become entangled in the mitral apparatus. In one embodiment, a device such as a balloon or sheath can be advanced over the wire to ensure that the wire does not pass through a cord structure.

[0090] ventricular anchor

[0091] The present disclosure includes multiple embodiments of a ventricular anchor.

[0092] In one embodiment, the ventricular anchor is similar to the Amplatz septal occluder (ST Jude Medical), which consists of blade segments that extend on either side of the septum.

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

[0094] In another embodiment, the anchor is a flanged, covered stent with the right ventricle side open to a substantially flat structure oriented in a plane substantially perpendicular to the axis of the stent.

[0095] In another embodiment, the flange is constructed from a ring that spans the circumference of the flange, with the flange itself being a layer of fabric. The flange is folded into an oval shape and delivered through a lumen. The ring can be constructed from nitinol-titanium stainless steel or cobalt-chromium alloy. The fabric lumen can extend through the center of the flange into the transseptal puncture. In one embodiment, tension is applied via the cord after implantation, urging the flange against the septum. A portion of the delivery system can be used to press the flange against the septum during the procedure. In another embodiment, the fabric sleeve incorporates a stent or barb or similar to provide stabilization within the septum.

[0096] The ventricular anchor is deployed over the guidewire. After deployment of the anchor, the cord delivery anchor and its delivery system can be delivered over the guidewire through the ventricular anchor.

[0097] positioning

[0098] Correct localization is performed using echocardiography to place the new cord. Areas of regurgitant jets or leaflet prolapse or flutter can be identified using 2D or 3D echo and / or color flow Doppler. Preferably, a combination of these imaging modalities is used.

[0099] The device for delivering the cord can be advanced across the septal puncture. In one embodiment, the same steerable or shapeable system used to create the septal puncture is advanced across the puncture. In other embodiments, the device can be a separate device that can pass through another sheath.

[0100] The position of the distal tip of the device can be oriented relative to the mitral valve anatomy as follows: The device can be biased anteriorly by increasing the curvature of the system as it enters the left ventricle through the septum. The device can be biased more posteriorly by decreasing the curvature of the system as it enters the left ventricle through the septum. The device can be biased from commissure to commissure by rotating the curved portion that passes through the sheath. The device can be biased longitudinally by extending the distal portion of the device or towards the ventricle by retracting it.

[0101] Primary

[0102] To replace the primary chord, the chord located near the free end of the leaflet, several methods of engaging the mitral valve leaflets are possible. In one embodiment, the Harpoon Medical large knot system may be used. In another embodiment, the Neochord Inc. loop suture may be used. Both of these methods appear to work well in early clinical experience. The preferred embodiment is intended to replicate the clinically proven suture-tissue interface developed based on experience in open-heart surgery.

[0103] In another embodiment, a bifurcated catheter is used. One side of the catheter engages beneath the valve leaflet and is pushed to help identify the area of ​​the leaflet through which the suture will pass. The other side passes toward the atrium. A needle or pair of needles punctures the leaflet from one side of the catheter, and a snare captures the needle or suture from the needle from the second side of the catheter. In one embodiment, the looped end of the suture passes over the snare so that when the needle end of the suture is retracted, it forms a circumferential hitch. In another embodiment, the looped end of the suture is twisted twice, and the Prusik forms a knot known as a double circumferential hitch.

[0104] Secondary

[0105] To replace a secondary chord, one located further posterior to the free edge of the valve leaflet, the device and method described for replacing the primary chord must be adapted. The fixation method using a large knot is suitable for replacing a secondary chord without requiring revision.

[0106] The bifurcated catheter technique is suitable for replacement of the second cord with minor adaptations to allow the snare side to puncture the valve leaflet.

[0107] excision

[0108] During mitral valve repair, surgeons may remove a portion of the leaflet tissue. A similar effect can be achieved using the bifurcated catheter system described above. A similar effect can be achieved by placing sutures through the leaflets and holding the tissue together as the sutures are tightened. Note that the sutures may be near the leaflet being removed or extended to serve as a new cord.

[0109] partial annuloplasty

[0110] In some cases, it may be desirable to use a double puncture technique on the annulus near the hinge point of the valve leaflets to achieve an effect similar to that of a surgical suture annuloplasty. In one embodiment, a series of suture loops are created that encircle the entire annulus. In one embodiment, suture loops are created only in safe areas of the aortic valve, coronary arteries, and conduction pathways. In one embodiment, suture loops are created in areas where the heart is most likely to dilate (i.e., areas of previous infarction) or in areas near the mitral valve commissures.

[0111] evaluation

[0112] After placing one or more repair sutures into the mitral anatomy, the results are evaluated. Tension is selectively applied to each prosthetic cord until the desired leaflet movement is achieved. Preferably, the target coaptation height is obtained by echocardiography. In one embodiment, the sutures are over-tensioned so that remodeling can occur when there is a balance between over-tension and under-tension.

[0113] Knotting

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

[0115] In another embodiment, the artificial cord is crimped directly onto the anchor sewn or tied at the suture.

[0116] Suture adjustment

[0117] In one embodiment, the tension of the artificial cord can be adjusted in a similar manner. In one embodiment, this can be accomplished entirely from the right ventricle without recrossing the septum. In one embodiment, the 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, the crimpable knot is captured and pulled, and an additional crimpable knot is deployed.

[0118] Multiple Systems

[0119] In one embodiment, one to about ten 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 minimize load on the septal anchor.

[0120] Alternative method

[0121] For some patient anatomy, it may be necessary or desirable to anchor the cord to a different region of the left ventricle rather than the septal wall. In one embodiment, the anchoring point is a papillary muscle. Preferably, the suture is attached to the papillary muscle or ventricular wall by creating a figure-of-eight suture, as commonly performed by surgeons during open cord replacement. This type of anchor may be placed transcatheterically via the transseptal ventricular puncture described above, or via the more common atrial transseptal puncture. One embodiment of a system suitable for suturing to the papillary muscle is a simple modification to a bifurcated leaflet suture system in which the needle and snare ends are curved inward toward each other, so that when actuated, they place 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, an example being a recaptureable self-expanding stent or an Amplatz-like device.

[0124] In one embodiment, the artificial cord is retrievable over a period of hemodynamic evaluation, which is accomplished by tensioning both ends of the suture for evaluation before engaging the circumferential hitch for permanent implantation.

[0125] Accompanying repair ring Alfieri procedure

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

[0127] Device

[0128] In certain embodiments, the device includes an outer sheath curved to conform to the shape of the vena cava and right ventricle. The proximal end of the outer sheath is connected to a handle of a delivery system. A conventional dilator is placed within the outer sheath to access the vessel. Once the right ventricle is accessed, the dilator transforms into a specialized transventricular dilator with a relatively flexible proximal section and a stiff, sharply curved distal section with a short, tapered, radio-opaque tip. The handle includes a locking element for the dilator, thereby preventing axial and rotational movement. The dilator's inner diameter (ID) 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 can be advanced through the distal tip of the dilator to allow for precise placement of 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 is advanced through the puncture port over the needle, and the needle is withdrawn. In one embodiment, the needle is integral with the dilator and either retracts within the dilator or extends a limited distance beyond the tip of the dilator. In one embodiment, the length is about 2-20 mm. In another embodiment, the length is about 4-40 mm. In one embodiment, the length may be less than about 2 mm or greater than about 40 mm.

[0129] One such exemplary application is described below with reference to Figures 35A-35O. With reference to Figure 35A, a 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 is advanced into the left atrium 102 using conventional techniques. The catheter 100 is advanced through the mitral valve 104 and near 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 advanced distally through the catheter 100. In certain embodiments, the anchor driver or rotary driver extends proximally through the catheter 100. After anchoring the tissue anchor 108, the catheter 100 and / or anchor driver are retracted proximally, leaving the anchor 110 secured to the wall and attached to the anchor sutures 114. The anchor sutures 114 extend proximally throughout the length of the catheter 100. The distal portion of the anchor sutures 114 carries a neo-papillary muscle 116, which may optionally include a soft ribbon or body 118 approximating the size of the trapezius papillary muscle. The neo-papillary muscle 116 has a substantially larger diameter than the sutures 114. The sutures 114 may be configured to extend through the neo-papillary muscle 116 (e.g., through a central channel) or may be attached to the proximal end of the neo-papillary muscle as described herein. In certain embodiments, the neo-papillary muscle replacement component 118 may be formed from a soft PTFE material.

[0130] Preferably, the anchor 108 is attached at a point offset from the thin tissue of the apex 112 and is implanted in the adjacent wall of the generally thicker ventricle. Preferably, the anchor is positioned so that the longitudinal axis of the implanted neo-cord is aligned substantially parallel to or concentric with the original path of the native 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 is in the form of a helical ventricular anchor.

[0131] 35B , the steerable leaflet capture catheter 120 may be advanced distally over the catheter 100, through the mitral valve 104, and into the left ventricle 106. The steerable catheter 120 is fed through the catheter 100. Alternatively, the steerable catheter 120 is fed along the catheter 100. In certain embodiments, the steerable leaflet capture catheter 120 may be positioned within the catheter 100 along with a driver (e.g., a rotary driver) coupled to a tissue anchor (e.g., a helical ventricular anchor). In certain embodiments, the driver (e.g., a rotary driver) coupled to the tissue anchor (e.g., a helical ventricular anchor) is inserted through the catheter 100 and is removed or partially removed from the catheter 100 after deployment. The steerable leaflet capture catheter 120 is then advanced 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 a variety of deflection mechanisms. For example, the catheter 120 may include a plurality of spaced transverse slots 124 along a first side thereof. The opposing second side 126 of the catheter may have an axially incompressible back portion. Proximal retraction of one or more pull wires (not shown) causes the slots 124 to collapse axially, thereby deflecting the catheter, as shown, for example, in FIG. 35C. The slots 124 may be configured to allow a variety and range of motion suitable for insertion of a leaflet anchor.

[0133] Preferably, the deflection region 122 may be deflectable through 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, and in one embodiment, less than 1.5 cm, and in another embodiment, preferably less than about 1 cm. In one embodiment, the shortest linear distance D between the distal tip 128 and the catheter shaft to position the leaflet anchor at a desired retracted position from the leaflet coaptation edge is in the range of about 0.5 cm to about 1.5 cm, and optionally about 1 cm.

[0134] The steerable leaflet capture catheter 120 is advanced through the mitral valve 104 to place the distal tip 128 in contact with the ventricular side 130 of the flail leaflet 132 and deflected as shown in FIG. 35C.

[0135] 35D, the proximal manifold control can be manipulated to advance a needle 134 from the distal end 128 through the flail leaflet 132. The needle 134 punctures the leaflet 132 during diastole when the leaflet 132 is biased toward the left ventricle 106.

[0136] The catheter 120 and / or needle 134 are utilized to deploy various tissue anchors to secure the sutures to the valve leaflets 132. In certain embodiments, as described herein, the tissue anchors are radially expandable leaflet anchors coupled to sutures extending proximally through the catheter 100. In the illustrated embodiment, a pledget 136 carried by a leaflet anchor suture 138 is deployed from the needle 134 to the atrial side of the valve leaflet 132. The pledget is in 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 threaded through one, two, four, or more openings in the elongated ribbon. 35E-35G, proximal retraction of the leaflet anchor sutures 138 causes the ribbon to axially collapse, forming a mass with sufficient cross-sectional area such that proximal tension on the leaflet sutures is insufficient to pull the resulting pledget through the leaflets. Thus, in certain configurations, proximal retraction of the sutures 138 can transform the pledget 136 from an elongated strip configuration to a radially expanded, axially contracted configuration.

[0137] The leaflet capture catheter 120 is then retracted proximally, leaving behind the structure shown in Figure 35H.

[0138] Any of a variety of leaflet anchors may be used, sharing the characteristic of being laterally expandable from a low crossing profile to cross the leaflets to a larger crossing profile to resist retraction through the leaflets. Lateral expansion is achieved by tilting the T-anchor or active deformation by control wires or elastic deformation after release from constraint.

[0139] 35I1-35I4 illustrate the deployment of a T-Tag anchor through a flail valve leaflet 132. An anchor element, such as a single T-Tag bar 140 secured to a suture 138, can be advanced distally through a needle 134 by a push wire 142. The push wire 142 includes a distal push platform 144 with a notch 146 that accommodates the suture 138. As the bar 140 exits the needle 134, it rotates about the suture attachment point to seat against the atrial side of the leaflet 132 as the leaflet suture 138 is pulled proximally. The bar 140 can be a single element, as shown, or an "X"-shaped or multi-strut configuration, depending on the desired performance characteristics.

[0140] An alternative leaflet anchor is shown in FIGS. 35J1-35J3. The tissue anchor includes a hub 150 secured to sutures 138. The hub 150 includes a plurality of spokes 152. The spokes are expandable laterally from a low-profile linear configuration when constrained within the needle 134 to an expanded configuration shown in FIG. 35J3 for resisting proximal retraction through the leaflet 132. At least two, and preferably four or six or more, spokes or struts 152 are provided, extending radially outward from the hub 150 in the deployed state to provide a footprint against the leaflet. The struts angle radially outward in the proximal direction to provide a force damper that temporarily moves the hub 150 closer to the leaflet 132 in response to tension spikes, such as during systole when the implanted neocords cause the leaflet 132 to reach its limit of travel. The spokes 152 and hub 150 may be laser cut from NiTi tubing and adhesively bonded, crimped or otherwise attached to the leaflet sutures 138 .

[0141] Referring to FIG. 35K, fulcrum 154 can be positioned near the distal end of the neo-chord and the proximal end of the neo-papillary muscle. Fulcrum 154 provides a point at which the length and / or tension between leaflet anchor 136 and distal anchor 110 can be adjusted. Because at least leaflet suture 138 passes across the fulcrum, proximal retraction of leaflet suture 138 pulls the limit of flail leaflet movement toward the ventricle toward the atrium. Fulcrum 154 can be the edge of the distal opening of the lumen of an adjustment catheter that advances distally over the leaflet sutures and potentially the ventricular anchor sutures. Alternatively, fulcrum 154 can include an eye or loop at the distal end of a fulcrum indicator, such as a hypotube or support wire. Alternatively, fulcrum 154 can be located at the suture lock, through which both the anchor sutures and leaflet sutures pass.

[0142] Prior to engagement of the suture lock, the leaflet sutures may be slowly retracted proximally to gradually limit prolapse of the flail leaflet into the left atrium. Mitral regurgitation can be observed with fluoroscopic imaging, and the leaflet sutures can be retracted until mitral regurgitation (MR) is eliminated or sufficiently minimized.

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

[0144] Once the desired cardiac function is achieved, the suture lock is engaged using known techniques or those described herein to secure the maximum distance between the tissue anchor 108 and the leaflet anchor, as shown in Figure 35M. Alternatively, if the adjustment catheter is used as a fulcrum, the suture lock or knot is advanced distally through the catheter to a position near the proximal end of the neo-papillary muscle and the distal end of the neo-chord and secured before retraction of the adjustment catheter.

[0145] 35N, leaflet sutures 138 and anchor sutures 114 are cut proximal to the suture lock using known techniques or those described herein, and catheter 100 is withdrawn from the patient, leaving the neo-cord and neo-papillary muscle in place within the left ventricle.

[0146] Referring to Figure 35O, the distal deflection region 122 of a modified leaflet capture catheter 120 is illustrated. Similar to the deflection region shown in Figure 35C, the implementation of Figure 35O includes a plurality of axially compressible slots 124 opposite a non-collapsible back portion 126. This structure forms a first recess 150 upon proximal retraction of the pull wire. As previously mentioned, the minimum distance D of the deflection region 122 at maximum deflection is generally in the range of about 0.5 to about 1.5 cm.

[0147] Depending on the desired performance, a second recess 152 may be provided that is operable by axially folding the second plurality of slots 154. Bending of the second recess 152 may be achieved by proximal retraction of a second pull wire. Alternatively, pulling a single pull wire can bend the first recess 150 and the second recess 152 simultaneously.

[0148] In the illustrated embodiment, the second recess 152 is recessed in the opposite direction in the same plane as the first recess 150. Alternatively, the second recess 152 is recessed in the same direction as the first recess 150. In either configuration, the first recess 152 is located in a first plane and the second recess 152 is located in a second plane that is rotationally offset from the first plane depending on the desired performance. Additional details of compound curved catheter shafts are disclosed in U.S. Patent Publication No. 2014 / 0243877, which is incorporated herein by reference in its entirety.

[0149] 36A-37 , in one embodiment, rather than treating purely degenerative mitral regurgitation, methods and devices according to embodiments described herein may be used to treat a small subset of patients with functional mitral regurgitation. Here, the patients have a tethered leaflet type defect. In this anatomy, the mitral valve leaflets are of adequate length to close and seal against leakage, but the chordae tendineae are too short to allow the leaflets to move into the plane of the mitral annulus. This type of anatomy typically occurs because the annulus dilates and / or the ventricle enlarges while the chordae tendineae remain approximately the same length. These patients are treated by severing all or part of the native cord as a step during 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 implant, but may result in a severe reflux condition during the procedure. Alternatively, the natural cord may be cut at any point during implantation of the artificial cord or at another step after artificial cord implantation is complete. Cutting as the last step may have the disadvantage that accurate evaluation of results may not be possible until after the cord is implanted. The injected device may be the same as or similar to one of the embodiments described herein.

[0151] In certain embodiments, after the initial leaflet and ventricular anchors are placed, the native chordae tendineae may be severed before final tensioning. In certain embodiments, this is accomplished by first separating the native cords by passing a guidewire around each papillary muscle before implanting the cords, capturing the end of the wire, and advancing a sheath over the wire to form snug loops around the papillary muscles. These loops remain intact during normal implantation of the ventricular and leaflet anchors. Once the ventricular and leaflet anchors are in place, the native cords are severed, preferably under partial tension, using one of the devices and methods described herein. This is accomplished by manipulating the loop around the papillary muscles so that it travels past the head of the papilla to the base of the chordae tendineae and then severing the loop. In one embodiment, the guidewire is simply pulled into the guide, creating the cutting action. In another embodiment, a blade-type tool is provided that fits within the guide and has a lumen for the guidewire. By pulling on both ends of the guidewire, the chordae tendineae are pulled against the blades and severed. Many other tissue cutting devices have been described in the art, and the devices and methods described herein may be adapted for such tissue cutting devices. After the native chordae tendineae are severed, the tension in the implant is adjusted. If the results are satisfactory, the implant can be made permanent by locking the suture lock and severing the suture tails, as described herein or in a similar manner. If the results are not satisfactory, additional chordae tendineae can be added, or other mitral valve repair procedures can be performed in conjunction.

[0152] Looping the papillary muscles instead of looping the chordae directly ensures that all chordae are captured, since all normal chordae are attached to the heads of the papillary muscles. Cutting with a looped guidewire is one method for cutting the native chordae, although other methods and devices, such as various types of transvascular suture cutters, may also be used.

[0153] 36A-37, FIG. 36A illustrates a looped papillary muscle 200 in an initial captured configuration. FIG. 36B illustrates the looped papillary muscle 200 pulled up onto the cord 202 in the area where the cutting step is preferably performed. FIG. 37 illustrates one embodiment of a chordae severing tool 210. The illustrated embodiment includes two lumens 212, 214, one at each end of a looped guidewire 216, as well as a cutting tip 218 and an element 220 to protect the cutting tip 218 from contact with the sheath 210 and other parts of the patient and device that are not intended to be cut. After looping the papillary muscle, the guidewire is fed through the first lumen 212, and a snare is fed through the second lumen 214 to capture the guidewire. The snare retracts the guidewire into the second lumen 214. As previously mentioned, cutting with a looped guidewire is one method of severing the native chordae, although other devices and methods may also be used, such as various types of transvascular suture cutters.

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

[0155] FIG. 38A illustrates the placement of a helical anchor 302 near the apex 112 of the left ventricle 196. While 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 implanted in the generally thicker adjacent wall of the ventricle, such as between two papillary muscles. The anchor is preferably positioned so that the longitudinal axis of the implanted neo-cord is generally parallel to or concentric with the original path of the native cord. For example, as shown in FIG. 42, in such an arrangement, the tissue anchor 302 can be placed in the left ventricle between the papillary muscles. Furthermore, while a helical anchor is illustrated, the anchor may have different configurations for engaging cardiac tissue, as previously discussed, and other configurations may have various piercing or hooking structures for engaging tissue instead of a helical structure.

[0156] The helical anchor 302 may be delivered by a ventricular anchor delivery subsystem 300. FIGS. 39A-39C illustrate the ventricular anchor delivery subsystem 300 and its components, respectively. FIG. 39A is a perspective view of the distal end of the subsystem 300. FIG. 39B is a perspective view of the proximal end of the subsystem 300. FIG. 39C is a partially exploded view of the distal end of the subsystem 300. The subsystem 300 may be delivered through a delivery catheter 100. The delivery catheter 100 may access the left atrium 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 remain in a substantially constant position throughout the procedure. For example, the distal end of the delivery catheter 100 may be positioned 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] 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 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 disposed on the outer diameter of the anchor hub 308. The helical anchor 302 may be secured to the anchor hub 308 by an interference fit or frictional engagement. The anchor hub 308 may remain implanted along with the helical anchor 302. The anchor hub 308 may have a lumen disposed substantially along a central axis of the anchor hub 308 for receiving sutures 311 (not shown) and attaching the sutures 311 to the helical anchor 302. In one embodiment, the sutures 311 may include an attachment element (e.g., a knot or a washer) having a diameter sized to prevent the sutures 311 from being pulled proximally through the lumen of the anchor hub 308. For example, the sutures 311 are tied distally of the lumen. In one embodiment, the sutures 311 may be tied to the anchor hub 308 (e.g., passed through the lumen and tied over the outer surface). The helical anchor 302 includes a distal wing section and a proximal wing section. The proximal wing sections may be spaced closer together than the distal wing sections and may be configured to secure the helical anchor 302 to the anchor hub 308. The distal sections of the wings may be spaced further apart than the proximal sections of the wings and may be configured for insertion into ventricular tissue. Anchor hub 308 may have an enlarged cross-section at its proximal end configured to abut helical anchor 302 and / or prevent helical anchor 302 from advancing proximally over the proximal end of anchor hub 308. Other helical anchors, such as those described herein, are configured for use with ventricular anchor delivery subsystem 300 described herein.

[0158] The proximal surface of the helical anchor 308 may have a recess that receives the extension portion 306′ of the driver head 306. The recess may be non-circular (e.g., oblong or polygonal) and configured to transfer torque from the driver 309 to the anchor hub 308 upon rotation of the driver 309. The recess may be disposed around a central lumen of the anchor hub 308. In other embodiments, the anchor hub 308 includes the extension portion and the driver head 306 has the recess. The driver head 306 is generally cylindrical. The driver head 306 may be fixedly coupled to a drive shaft 307. The driver 309 has a central lumen extending therethrough and configured to receive a 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 receive the guide shaft 305, the driver head 306, the anchor hub 308, and the helical anchor 302.

[0159] The outer sheath 304 is advanced via the delivery catheter 100 to near the left ventricle and the ventricular attachment location. In one embodiment, the outer sheath 304 is advanced without a delivery catheter. In one implementation, the helical anchor 308 is concealed within the outer sheath 304 until the outer sheath 304 is positioned proximal to the ventricular attachment location and then pushed distally through the outer sheath 304 to expose the helical anchor 302. The helical anchor 302 is positioned to contact the ventricular tissue. Rotation of the drive shaft 307 rotates the driver head 306, anchor hub 308, and helical anchor 302, thereby threading 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 FIG. 39B, the drive shaft 307 can be manually rotated by a user using a drive handle 312. The proximal end of the ventricular anchor delivery subsystem 300 has first and second hemostatic valves 314, 316, as shown in FIG. 39B. The first hemostatic valve 314 is disposed distally relative to the drive handle 312 and provides access to the guide shaft 305. The second hemostatic valve 316 is disposed proximally relative to the drive handle 312 and provides access to the central lumen of the driver. The ventricular anchor suture 311 can extend through the second hemostatic valve 316.

[0160] In one embodiment, ventricular delivery subsystem 300 includes a shield or guard 303 (shown in FIG. 38A ) disposed around the distal end of outer sheath 304. Guard 303 may have an open distal end and may include a tubular wall that is attached to tubular sheath 304 or may be advanced out of sheath 304. Guard 303 may be expandable from a reduced first cross-section for transluminal navigation to an enlarged second cross-section that allows for rotation of the anchor.

[0161] Guard portion 303 may have a diameter that expands distally such that the inner diameter of guard portion 303 is larger at the distal end of guard portion 303 than the outer diameter at the distal end of outer sheath 304. The expanded diameter of guard portion 303 provides sufficient space for helical anchor 302 to rotate without contacting the inner surface of guard portion 303. During deployment of helical anchor 302, guard portion 303 may be placed against or adjacent to ventricular tissue. Advantageously, during rotational insertion of helical anchor 302, guard portion 303 prevents chordae or other tissue adjacent to helical anchor 302 from becoming entangled in the wings of 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 disengages from the remainder of the ventricular anchor delivery subsystem 300.

[0162] In one implementation, the insertion portion 306' of the driver head 306 and a recess in the anchor hub 308 have a frictional engagement that temporarily holds the two elements together. Once the helical anchor 302 is inserted, reaction forces from the ventricular tissue can overcome the frictional engagement upon proximal retraction of the driver. In one implementation, proximal tension in the suture 311 provides an engagement force between the proximal hub 308 and the driver head 306 that is released upon replacement of the driver 309. 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] Non-implanted elements of the ventricular anchor delivery subsystem 300 may be removed from the delivery catheter 100, and the subsystem may be deployed on the delivery catheter 100 to complete implantation of the neo-chordae tendineae. In variations, the ventricular anchor delivery subsystem 300 and subsystems such as the leaflet anchor delivery subsystem 330 may be deployed simultaneously within the delivery catheter 100, and in certain configurations, both the tissue and leaflet anchors may be pre-loaded onto the delivery catheter. In other embodiments, implantation of the ventricular anchors may occur in a different order (e.g., after implantation of the leaflet anchors). The ventricular anchor delivery elements may be retracted proximally over the proximal end of the suture 311 or may remain extending through the delivery catheter 100 to the ventricular anchor 302. While FIGS. 38A-38H illustrate placement of neo-chordae tendineae, they do not depict the neo-papillary muscles 116 shown, for example, in FIG. 35A. However, the procedure may be performed in conjunction with neo-papillary muscles 116. The neo-papillary muscles 116 may be advanced over the sutures 311, for example, after placement of the ventricular anchor 302. In one embodiment, the neo-papillary muscles are coupled to the anchor hub 308.

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

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

[0166] As shown in FIGS. 40A and 40C , the leaflet anchor delivery subsystem 330 includes a delivery shaft 334. A deflectable flexible tube 332 may be coupled to the distal end of the delivery shaft 334. FIG. 40D illustrates one implementation of the flexible tube 332. The deflectable flexible tube 332 forms the deflection region 122, as described herein. As described herein, the deflectable flexible tube 332 may be configured to be manipulated by an operator, such as by proximal retraction of one or more pull wires (not shown) along various sides of the flexible tube 332. As shown in FIG. 40B , the operator can control the bending of the flexible tube via a knob 352 or other actuation mechanism or lever located on a handle portion 350 at the proximal end of the leaflet anchor delivery subsystem 330.

[0167] As shown in FIG. 40D, the flexible tube has transverse slots. One side of the flexible tube 332 is free of openings or slots, creating a relatively stiff or axially incompressible back. The transverse slots are located at various positions along the length of the flexible tube 332 on a substantially opposite 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 orientation of the flexible tube 332, making it more likely to bend in localized regions 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 with different patterns of transverse slots and / or different bending characteristics. For example, the flexible tube 332 shown in FIG. 40D has different patterns of transverse slots in its distal and proximal sections. FIGS. 40E and 40F are enlarged side views of the flexible tube 332 near the transition between the distal and proximal sections. In the example shown in FIGS. 40E and 40F, the sections are rotationally offset by approximately 90° from each other relative 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 valve leaflet. The flexible tube 332 is particularly advantageous for positioning the distal end on the ventricular side of the valve leaflet as the subsystem is delivered from the right atrium to the heart. As shown in FIG. 38B, the distal end of the leaflet anchor delivery subsystem 330 may be deflected (e.g., at least about 180°) so that proximal retraction of the subsystem applies pressure to the ventricular face of the leaflet. The radius of curvature, or optimal radius of curvature, of the deflected flexible tube 332 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 tubing 332 and the delivery shaft 334. An inner flexible shaft 336, terminating at its distal end with a needle tip, may extend through the delivery shaft 334 and the flexible tubing 333. The inner flexible shaft 336 may comprise a braided tube or a catheter flexible enough to conform to the shape of the flexible tubing 332. A needle tip 338 may be coupled to the distal end of the inner flexible shaft 336. As shown in FIG. 40B, the proximal end of the inner flexible shaft 336 is connected to a needle handle portion 354. The needle handle portion 354 may include a hemostatic valve 356. The leaflet suture portion 344 is inserted through the valve 356. The valve 356 may be of the epidural type. The needle handle portion 354 may have an additional port 358 for accessing the lumen of the inner flexible shaft 336. The needle handle portion 354 may be disposed proximally relative to the handle portion 350 such that the inner flexible shaft 336 extends through the lumens of the handle portion 350 and the delivery shaft 334. The handle portion 350 may have a hemostatic valve to receive the inner flexible shaft 336 and seal the interior elements of the handle portion from the surrounding environment. The hemostatic valve has an opening to the delivery shaft 334. The needle 338 may be extendable and retractable by extending the needle handle portion 354 toward the handle portion 350 or by retracting the needle handle portion 354 from the handle portion 350.

[0171] 38C, application of pressure to the valve leaflet as the needle tip 338 extends distally beyond the flexible tubing 332 and flexible jacket 333 causes the needle tip 338 to puncture the valve leaflet so that the needle tip 338 extends through the opposite (e.g., atrial) side of the leaflet. This pressure can be applied by extending the needle tip 338 and / or by retracting the entire delivery device 330 proximally with the needle tip 338 in the expanded position.

[0172] 38D-38F illustrate the deployment of a leaflet anchor. The leaflet anchor may be a pledget 340 as described herein. The pledget 340 may be coupled or attached to the distal end of a suture 344. The pledget may be formed from a soft and / or pliable material, such as a fabric. The suture 344 extends through the inner flexible shaft 336. As shown in FIGS. 38D and 40A, the pledget 340 may be folded or compressed into a configuration including a reduced radial cross-section so that it can be placed within the inner flexible shaft 336 for delivery. As shown in FIG. 38E, the pledget 340 expands to have a larger radial cross-section when deployed from the distal end of the needle tip 338. In one embodiment, the pledget 340 is similar to that shown in FIG. 35E and is pushed through the inner flexible shaft 336 via a push wire or release wire (not shown). As shown in FIG. 38F, proximal retraction of the leaflet suture 344 when delivered through the needle tip 338 causes the leaflet anchor to collapse axially and assume a radially expanded configuration, preventing the leaflet anchor from retracting through the puncture hole in the leaflet, thereby securing the leaflet suture 344 to the leaflet.

[0173] FIG. 40C schematically illustrates a pledget 340 connected to the distal end of a leaflet suture 344. The pledget 340 may have two wings 341, 342 that are folded / wrapped (e.g., clockwise or counterclockwise) around the longitudinal axis of the pledget 340 to form a reduced cross-section configuration. In one embodiment, the leaflet suture 344 is integrally formed with the pledget 340 as described herein (FIGS. 43A-43C). To form a collapsible or collapsible structure, the proximal ends of the sutures 344 extending from the pledget 340 may pass through one or more openings (e.g., two openings, three openings, four openings, etc.) formed in the pledget 340, as shown in FIG. 38E. In one embodiment, the openings are disposed along the center of the pledget 340. The openings extend through the pledget 340 and pass through the embedded portions of the sutures 344 that are integral with the pledget 340. The embedded portions of the sutures 344 are at least partially flattened within the pledget 340. In one embodiment, the openings are located substantially near the center of the pledget (e.g., immediately to the left or right of the embedded sutures 344, or alternating between the left and right sides of the sutures 344). Upon deployment, the sutures 344 are operatively connected to the distal end of the pledget 340 (e.g., the sutures 344 return to the insertion point between the pledget sheets). The pledget 340 may be formed so that the wings 341, 342 are approximately the same size or different sizes. As shown in FIG. 38F, upon proximal retraction of the leaflet sutures 344, the pledget 340 may fold into an accordion-like configuration. The pledget 340 may be configured to include a substantially flat plane that is substantially perpendicular to the longitudinal axis of the leaflet sutures 344. This configuration facilitates securement of the sutures 344 in the valve leaflets. Upon securement of the leaflet sutures 344 to the leaflets, the leaflet anchor delivery subsystem 340 may be withdrawn from the delivery catheter 100. The leaflet anchor delivery element may be retracted proximally over the proximal end of the sutures 344, with the sutures 344 still extending along the ventricular anchor sutures 311 through the delivery catheter 100 and into the leaflet anchor 340.

[0174] The ventricular anchor sutures 311 and the leaflet anchor sutures 344 may be joined together under tension to form an implanted neochordae or to connect two sections of an implanted neochordae. This causes the neochordae to extend between the ventricular anchor 302 and the leaflet anchor 340. With tension maintained by the ventricular anchor 302, the overall length of the neochordae may be adjusted so that the appropriate tension is applied to the leaflets. The sutures 311, 344 may remain extended through the delivery catheter 100 to a predetermined location outside the body. In one embodiment, the proximal ends of the sutures 311, 344 may be fed into a handle or proximal portion of the suture lock delivery system 370 during placement of the suture lock and cutting of the sutures 311, 344. In one embodiment, the proximal ends may be left free or may be joined or secured by other means.

[0175] Figures 41A-41I show various views of the suture lock delivery 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 a partially 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 suture lock 376 and the distal end of torque driver 388 configured to engage suture lock 376. Figures 41H and 41I illustrate the proximal and distal ends, respectively, of suture lock 376.

[0176] The suture lock delivery subsystem 370 may be configured to advance (e.g., slide) the suture lock 376 over both sutures 311, 344 (or additional sutures), securing the sutures 311, 344 together. Each of the sutures 311, 344 may be retracted proximally to apply tension to the sutures 311, 344 and adjust the length of each of the sutures 311, 344 between the suture lock 376 and the respective tissue anchor 302, 340. Once the length and tension of the neochordae implantation 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 severed at a point proximal to the suture lock 376. The sutures 311, 344 may be cut by the same suture lock delivery subsystem 370 that delivered the suture lock 376. In other embodiments, a separate cutting device may be inserted into the delivery catheter 100 after the suture lock is locked in place.

[0177] FIG. 38G illustrates the advancement of the suture lock 376 over the ventricular anchor suture 311 and the leaflet suture 344. The suture lock delivery subsystem 370 may be advanced through the delivery catheter 100 and may push the suture lock 376 distally along the sutures 311, 344 to approximate the proximal portions of the sutures 311, 344 at the distal end of the suture lock 376. The suture lock 376 is advanced along the sutures by a retention catheter 373. The distal end of the retention catheter 373 may be coupled to a retention element 377 (FIG. 41C). The retention element may include a flange 371 or other mechanical feature configured to engage the suture lock 376. For example, the flange 371 may be inserted into a recess in the proximal end of the suture lock 376. In one embodiment, rotation of the retention catheter 373 and / or movement of the retention catheter 373 substantially perpendicular to the axial direction may be used to disengage the retention catheter 373 from the suture lock 376. The sutures 311, 344 extend from each tissue anchor through the suture lock 376, entering through a distal channel 395 on the distal face of the suture lock 376, shown in FIG. 41I, and exiting through a proximal channel 394 on the proximal face of the suture lock 376, shown in FIG. 41H. The sutures 311, 344 may extend through a channel in the cutter head 375 proximal to the suture lock 376, along the outside of the retention catheter 373, and through the delivery catheter 100. The cutter head 375 may be coupled to the distal end of the cutter catheter 372. The retention catheter 373 may extend through the inner lumen of the cutter catheter 372, such that the two catheters 372, 373 are extendable and retractable relative to one another.

[0178] Once the sutures 311, 344 are locked within the suture lock 376, the proximal ends of the sutures 311, 344 may be severed adjacent the proximal face of the suture lock. The sutures 311, 344 may be severed by advancing a cutter catheter 372 coupled to a cutter head 375 toward the proximal face of the suture lock 376. As shown schematically in FIGS. 41E-41F, as the cutter head 375 advances along the retention catheter 373 toward the retention element 377, the cutter head brings the sutures 311, 344 into proximity with a cutting blade 379 disposed on the retention element 377. The cutter head 375 is configured to advance over the retention element 377 such that the channel in the cutter head 375 holding the sutures 311, 344 is gradually spatially occupied by the blade 379. As the blade 379 is forced into the channel of the cutter head 375, the blade 379 shears the sutures 311, 344. Application of proximal tension to the sutures 311, 344 facilitates severing the sutures 311, 344. In other embodiments, different actuations (e.g., rotation of the cutting catheter) may be configured to sever the sutures 311, 344. In one implementation, more than two sutures may be employed and may be locked within the suture lock 376 and severed by the suture lock delivery subsystem 370 in the same manner. In one embodiment, advancement of the cutter head 375 over the retention element 377 facilitates disengagement of the retention catheter 373 from the suture lock 376. For example, the cutter head 375 may be advanced to a distal position configured to stabilize the suture lock 376, thereby allowing the retention catheter 373 to disengage axially and / or rotationally from the suture lock 376.

[0179] FIG. 41G is a side view of an example suture lock 376 (shown with the outer casing / shell removed). As described herein, a 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 a push wedge 384 proximally 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 that fits into a recess 381 (e.g., a polygonal recess or other non-circular recess, as shown in FIG. 41H) located at the proximal end of the suture lock 376 so that rotation of the torque shaft 388 rotates the screw 382. The torque shaft 388 may extend through the interior lumen of the retention catheter 373. The torque shaft 388 can be rotated at its proximal end by a knob 398 or other actuation mechanism located at the proximal end of the subsystem handle 396. The handle 396 can include a hemostatic valve 397. In one implementation, the sutures 311, 344 pass through the hemostatic valve 397.

[0180] Advancement of the push wedge 384 by the torque shaft 388 causes a ramp or inclined surface 386 to gradually compress one or more springs, such as spring pins 388. Compression of the spring(s) 388 forces the clamp 390 down against the sutures 311, 344, compressing the sutures 311, 344 between the 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 interlocking notched surfaces may enhance the retention of the sutures 311, 344 between the opposing surfaces, preventing them from being pulled proximally or distally from the suture lock 376. In one embodiment, back-tightening can be achieved by rotating the torque shaft in the opposite direction.

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

[0182] 42 schematically illustrates a helical anchor 110 implanted in a portion of the ventricle having a relatively thick tissue between two papillary muscles. As described herein, the implanted neo-cord configuration, optional neo-papillary muscles, and / or helical anchor may be positioned along a longitudinal axis that is substantially parallel to or concentric with the path of the surrounding native chordae and / or the initial path of the native cord. In certain embodiments, the implanted neo-cord configuration, optional neo-papillary muscles, and / or helical anchor are positioned along a longitudinal axis that is within 5°, 10°, or 15° of parallel to the initial path of the native cord and / or the path of the surrounding native chordae.

[0183] 43A-43C schematically illustrate examples of pledgets as described herein, particularly with reference to FIGS. 38E and 38F. FIG. 43A schematically illustrates a pledget 340 formed by attaching the distal end of a seam 344 (shown in dashed lines) between two flat sheets, such as the sheets of right wings 341 and 342. FIG. 43B illustrates a cross-section of pledget 340 along axis BB shown in FIG. 43A. In one embodiment, seam 344 may be inserted between the two sheets (e.g., substantially down the center of the sheets) and 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. Seam 344 may be flattened and / or densified to improve the seam's resistance to tearing. The sheet may be a flat polytetrafluoroethylene (PTFE) sheet (e.g., a thin, uncured expanded PTFE (ePTFE) sheet) or may be formed from other suitable materials. In one implementation, the leaflet sutures 344 may be disposed between the sheets in alternative configurations, such as a zigzag or S-shaped configuration. FIG. 43C shows the pledget 340 of FIG. 43A having multiple openings 343 through which the proximal tail ends of the sutures 344 pass. In one embodiment, one or more openings 343 may be formed through the pledget in various configurations to form a collapsible structure configured to secure the sutures 344 to the mitral valve leaflets, as described herein. FIG. 43C shows alternating openings 343 on either side of the sutures 344. In one embodiment, the openings 343 are formed on the same side as the sutures 344 (e.g., wings 341 or 342). In one embodiment, the openings 343 are formed through the sutures 344. The openings 343 may be positioned along the center of the pledget 340. The openings 343 may be positioned along the length of the suture 344 (e.g., forming a straight line). The suture 344 may be at least partially flattened between two opposing sheets, which facilitates placement of the openings 343 through the suture 344. Various combinations of openings 343 may be used, including the above-mentioned placements.

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

[0185] Also, although there may be multiple embodiments that fall within the scope of this disclosure and are not explicitly listed above or elsewhere in this specification, this disclosure includes all embodiments that fall within the scope described by this disclosure. Furthermore, this disclosure includes embodiments that combine any structure, material, step, or other feature disclosed in one part of this specification with any other structure, material, step, or other feature disclosed elsewhere in this specification.

[0186] Furthermore, certain features that are described in this disclosure in the context of separate embodiments may also be implemented in combination in a single embodiment. Alternatively, various features that are described in the context of a single embodiment may also be implemented in multiple embodiments separately or in any suitable combination. Furthermore, although features may be described as operating in a particular combination, one or more features of a claimed combination may be independently of the combination, as appropriate, and a combination may be claimed as a subcombination or a variation of the subcombination.

[0187] For purposes of this disclosure, certain aspects, advantages, and features have been described herein. Not necessarily all such aspects, advantages, and features will be realized in accordance with any particular embodiment. Those skilled in the art will recognize that the present disclosure can be practiced in a manner that achieves one advantage or group of advantages taught herein, without necessarily achieving other advantages as taught or suggested herein.

[0188] Any particular feature, aspect, method, property, quality, attribute, element, etc. disclosed herein in connection with various embodiments can be used in all other embodiments described herein, and any method described herein may be performed using any apparatus suitable for performing the recited steps.

[0189] Furthermore, while components and operations may be illustrated or described in a particular arrangement or order, such components and operations need not be arranged or performed in the particular arrangement and order illustrated or described to achieve desirable results, nor need all components and operations 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 described operations. Furthermore, operations may be reordered or rearranged in other embodiments. Also, the separation of various system components in the above embodiments should not be understood as requiring such separation in all embodiments; the described components and systems may generally be integrated into a single product or packaged into multiple products.

[0190] That is, various illustrative embodiments and examples are described herein. While the systems and methods are disclosed in connection with the above embodiments and examples, the disclosure extends to other alternative embodiments and / or other uses of the embodiments, as well as modifications and equivalents, other than the specifically disclosed embodiments. The disclosure expressly contemplates that various features and aspects of the disclosed embodiments may be combined with or substituted for one another. Accordingly, the scope of the disclosure should not be limited to the particular embodiments disclosed, but should instead be determined solely by a fair reading of the following claims, along with their full scope of equivalents.

Claims

1. A mitral valve restraint system, comprising: an artificial neopapillary muscle, an elongated flexible neopapillary muscle having a proximal end and a distal end; a tissue anchor coupled to the distal end of the neopapillary muscle; an elongated, flexible neochordae connecting with and extending from the proximal end of the neopapillary muscle, the neochordae being artificial; a leaflet anchor attached to the proximal end of the neochordae; Equipped with the leaflet anchor is radially expandable from a first reduced cross-section for advancement through the leaflet to a second enlarged cross-section for contacting the atrial side of the leaflet; the neochordae are connected to sutures that extend distally through the neopapillary muscles to the tissue anchors; the leaflet anchor includes a suture positioned between two sheets of material that are overlapping and joined with a portion of the suture contained between and joined to the two sheets of material, the leaflet anchor being radially expandable from the second expanded cross-section to a third radially expanded and axially contracted configuration by proximal retraction of the suture. Mitral valve restraint system.

2. The mitral valve restraint system of claim 1 , wherein the tissue anchor comprises a laser-cut hypotube.

3. The mitral valve restraint system of claim 1 , wherein the tissue anchor comprises a coiled circular wire.

4. The mitral valve restraint system of claim 3 , wherein the tissue anchor comprises two coiled circular wires.

5. The mitral valve restraint system of claim 1 , wherein the leaflet anchor comprises a pledget.

6. 6. The mitral valve restraint system of claim 5, wherein the pledget is operable to be folded by pulling the suture, the pledget adopting the second enlarged cross section when folded.

7. The mitral valve restraint system of claim 5 , wherein the suture passes through at least two openings in the pledget.

8. The mitral valve restraint system of claim 7 , wherein the sutures pass through at least three openings in the pledget, the openings being substantially collinear.

9. The mitral valve restraint system of claim 1 , wherein the tissue anchor includes a hub operable to receive and frictionally secure the suture.

10. A mitral valve restraint system as described in claim 1, wherein the loop is operable to secure the neopapillary muscle.

11. The mitral valve restraint system of claim 1 , wherein the neopapillary muscle comprises a body approximating the size of a mitral papillary muscle.

12. the leaflet anchor comprises a T-tag bar; 2. The mitral valve restraint system of claim 1, wherein the T-tag bar includes a bar rotatably coupled to a suture such that rotation of the bar expands the leaflet anchor from the first reduced cross-section to the second enlarged cross-section.

13. 2. The mitral valve restraint system of claim 1, wherein the leaflet anchor includes a hub including a plurality of flexible radially extending spokes operable to bend into an aligned position along a longitudinal axis when constrained within a delivery needle and biased to expand radially outward when unconstrained, causing the leaflet anchor to expand from the first reduced cross-section to the second enlarged cross-section.

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