Mitral valve tethering

Abstract

To provide, in general, cardiac treatment devices and techniques, and in particular, methods and devices for mitral valve repair.SOLUTION: This disclosure includes apparatuses and techniques to access the right ventricle via trans-femoral vein, threading a catheter or catheters to the apex or bottom of the right ventricle. By piercing the interventricular septum through the venous or right side of the heart to access the left ventricle, a catheter can turn upward pointing to the mitral valve. From this access point in the left ventricle, the flail mitral leaflet is sutured and tethered pulling it back into position and reattached to a grounding anchor in the right ventricle or embedding the anchor in the septal wall. The interventricular septal wall crossing technique includes passing a coaxial catheter through a first access catheter, where the first access catheter can guide an internal or second coaxial catheter toward the flail mitral leaflet.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] [Incorporation by reference of priority application] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 383,338, filed September 2, 2016, and U.S. Provisional Patent Application No. 62 / 273,300, filed December 30, 2015, the entire disclosures of which are incorporated by reference herein for all purposes and are deemed to be a part of this specification.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to cardiac treatment devices and techniques, and more particularly to methods and devices for mitral valve reconstruction. [Background technology]

[0003] The heart contains four heart valves that allow blood to pass unidirectionally through the four chambers of the heart: the tricuspid valve, the mitral valve, the pulmonary valve, and the 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 composed of two leaflets, known as the anterior and posterior leaflets. These leaflets open and close in response to pressure exerted on them by the pumping action of the heart. There are several problems that can develop or occur with the mitral valve. These problems include mitral regurgitation (MR), which occurs when the mitral valve leaflets do not close properly, potentially resulting in mitral valve leakage. Severe mitral regurgitation can adversely affect cardiac function and impair a patient's quality of life and longevity. Several techniques exist to correct mitral regurgitation, including valve replacement, shortening or replacement of the chordae tendineae, and mitral valve annulus reconstruction, also known as annuloplasty. Summary of the Invention [Problem to be solved by the invention]

[0005] Current techniques for correcting mitral regurgitation involve mitral valve reconstruction by stopping the patient's heart and performing open-heart surgery with the patient on cardiopulmonary bypass. Such techniques are highly invasive methods with attendant risks. It would be desirable to provide a less invasive procedure for reconstructing the mitral valve. [Means for solving the problem]

[0006] One embodiment disclosed herein is a method of reconstructing a mitral valve in a patient's heart that includes accessing the patient's right ventricle, extending a catheter through a vein or right side of the heart to access the left ventricle, and fixating the mitral valve leaflets with the catheter.

[0007] Another embodiment disclosed herein is a chordae tendineae replacement system that can include a catheter and a chordae tendineae replacement implant. The catheter can have an elongated, flexible tubular body with a proximal end and a distal end. The catheter can be configured for intravascular access into the right ventricle and through the interventricular septum into the left ventricle. The chordae tendineae replacement implant can be deployably delivered by the catheter. The chordae tendineae replacement implant can include an elongated body with a proximal end having a proximal tissue anchor and a distal end having a mitral valve leaflet attachment anchor.

[0008] Another embodiment disclosed herein is a method of reconstructing a mitral valve, the method including intravascularly accessing the right ventricle with a catheter and extending the catheter through the interventricular septum into the left ventricle, and placing a chordae replacement implant with the catheter. [Brief explanation of the drawings]

[0009] [Figure 1AA] Normal mitral valve leaflet attachment in the left ventricle is shown, including the chordae tendineae attachments from the free edge of the mitral valve leaflet to the papillary muscles. [Figure 1A] Shows damaged chordae attachment. [Figure 1]A technique for accessing the right ventricle by passing a catheter via the femoral vein to the apex or base of the right ventricle is shown. [Figure 2] 1 shows a catheter passing through a vein or right side of the heart and puncturing the interventricular septum wall to access the left ventricle. [Figure 3] 1 shows first and second catheters that can be guided to position their distal tips to capture the edges of the mitral valve leaflets. [Figure 4] 1 shows a magnet that can be used to position the tips of two catheters relative to one another. [Figure 4A] The suture loop is shown passing through the mitral valve leaflets and back down the catheter, where it is tied off and attached to an anchor at the apex or ventricular septum wall. [Figure 5] A grounding plug is shown. [Figure 5A] An internal anchor is shown within the tissue wall separating the left and right ventricles, i.e., the ventricular septum tissue. [Figure 5AA] Septal anchor is shown. [Figure 5B] 10 illustrates an embodiment of an internal anchor and an apical anchor. [Figure 6] 1 shows a foundation anchor placed within the heart. [Figure 7] 1 shows a coiled anchor. [Figure 8] It is shown that jugular access similarly provides access to the vena cava and right ventricle and / or access to the left atrium via transseptal puncture. DETAILED DESCRIPTION OF THE INVENTION

[0010] The normal mitral valve leaflet 10 attachment in the left ventricle includes chordae tendineae attachments 12 from the free edge of the mitral valve leaflet 10 to the papillary muscles 14. This is shown in Figure 1AA.

[0011] Reconstruction and reconnection of flail leaflets (damaged chordae tendineae 7 shown in Figure 1A) can be performed surgically with sutures by reattaching the leaflets to the papillary muscles. Another technique is trans-apical reconnection of flail leaflets, similar to technology developed by NeoChord.

[0012] Another technique is to access the right ventricle 16 via the femoral vein 18 and thread a catheter 20 or catheters 20 to the apex or base of the right ventricle 16, as shown in Figure 1. Entry begins in the femoral vein in the groin, passes through the inferior vena cava, into the right atrium 24, and through the tricuspid valve 22 to the base of the right ventricle 16. To access the left ventricle 26, a vein or right side puncture can be made at the interventricular septum wall 19 of the heart, and the catheter 20 can be threaded in an upward curve toward the mitral valve 28, as shown in Figure 2. From this access point in the left ventricle 26, the flail mitral valve leaflets can be sutured and tethered to pull the leaflets back into place and reattached using foundation anchors in the right ventricle 16, or anchors can be implanted into the septum. The ventricular septal crossing procedure involves passing a coaxial catheter 30 through a first access catheter, which can act as a guide to direct the internal or second coaxial catheter 30 toward the flail mitral valve leaflet. Both the first and second catheters 20, 30 can be manipulated to orient their distal tips to capture the edges of the mitral valve leaflet, as shown in FIG. 3 . A puncture needle can be passed through the mitral valve leaflet, into or across the septum, and through an anchor in the right ventricle to thread a suture for leaflet reattachment. Once a tether is threaded through the mitral valve leaflet and back into the second internal catheter 30 and attached to the base anchor, the leaflet can be pulled into position to replicate the incompetent or damaged chordae tendineae attachment. The novel suture attachment to the foundation anchor can be achieved by knots, sliding one-way stops, or other means of joining the anchor and suture together. Single or multiple line attachments distribute the load or allow pulling with different force vectors to move the foundation point of the mitral valve leaflet in various directions. As shown in Figure 3, secondary atrial access can be achieved through the venous system above the mitral valve via a transseptal puncture to pass an additional catheter 32 into the left atrium for positioning above the flail leaflet. Obtaining secondary fixation of the leaflet from above as well as below allows for positive positioning and suture attachment within the leaflet margin under echo and fluoroscopy.The tip of each catheter may be a magnet 36, 34 to position the tips of each catheter 30, 32 relative to one another as shown in Figure 4. The magnets 36, 34 may have a through-hole or central lumen for passing a wire, suture, or other material longitudinally from one tip to the other. As shown in Figure 4A, a suture loop 41 is passed through the mitral valve leaflet 27 and back through the lower catheter 30, where it is tied off and attached to an anchor in the leaflet or ventricular septum wall.

[0013] The foundation plug or anchor 40 can be similar to the Amplatz device used to close ASDs, or another device for distributing forces over a larger area in the right ventricle or within the ventricular septal wall to distribute loads over a larger surface, as shown in FIG. 5. Another means for securing sutures within the right ventricle is to attach the sutures to a pledget 73 or other pad to spread the load within the right ventricle. An alternative technique is to implant an internal anchor 42 within the tissue wall separating the left and right ventricles, i.e., the ventricular septal wall tissue, as shown in FIG. 5A. The internal anchor 50 of FIGS. 5B and 5AA is delivered from above or from the left atrium, through the septum and through the mitral valve leaflets, connecting the mitral valve leaflets to the sutures 43, passing them into the septum between the left and right ventricles, and securing them to an internal structure, such as an anchor, to resist movement when the sutures are pulled. As shown in FIG. 5A, the internal anchor can include barbs 80 and a suture retainer 82. It is also advantageous to extend one segment of the anchor away from the septum and into the left atrium, positioning the contact point just below the attachment point of the mitral valve leaflet. This provides a direct line of sight up and down to the attachment point without torque or moment around the septal entry point and without interfering with other chordal structures or papillary muscles. A strain relief at the anchor exit also prevents fretting of the suture line, as cyclic loading of the suture line is a stress concentration area. Similarly, as shown in FIG. 7, a coiled anchor 52 (FIG. 5B) can be delivered transseptally from above through the mitral valve into the apex or myocardial tissue. A coil 55 allows the contact point to be connected to the suture line, which is then further connected to the mitral valve leaflet. Multiple connection points can be added for additional support or to tie down additional damaged chordae. Secondary adjustments can also be made after the implant procedure by wrapping, retie, or tensioning the suture line to retie the connection line.

[0014] Access to the femoral vein can be achieved using a guidewire 70 approximately 0.035 inches (0.0889 cm) in diameter and approximately 180 centimeters in length. As shown in FIG. 8, an introducer sheath can follow to provide a conduit for accessing additional catheters at the femoral access site. The catheter 72 can be approximately 10-24 French in diameter, and the introducer can be advanced into the femoral vein using a dilator to guide the tip atraumatically. The length of the catheter 72 can be approximately 100 centimeters in length. Advancing a device delivery catheter through an introducer sheath over the guidewire 72 provides a radiopaque means for tracking the guidewire, introducer sheath, and delivery catheter by in vivo x-ray or fluoroscopy. As the catheter enters the inferior vena cava and passes through the tricuspid valve toward the right atrium, it can follow the guidewire or be actively conformed or bent through a bendable catheter in the handle via a pullwire or conforming system. Contrast injected into the heart can provide a roadmap to the structures within the heart. Aiming or directing the catheter and guidewire to the apex of the right ventricle and passing a needle or puncture tool from the right ventricle to the left ventricle provides access to the left ventricle from the femoral vein to access the mitral valve.

[0015] Access to the left ventricle through a transseptal puncture can also be achieved by advancing a guidewire and catheter system through the femoral artery in the groin, as described above. This allows for superior and inferior approximation of the mitral valve leaflets for securing and suturing them back into position. An upper catheter from the left atrium and an inferior catheter from the left ventricle via the right ventricle can position and hold the flail leaflet for suturing and restraining it back into position for coaptation with the adjacent leaflet, thereby eliminating mitral regurgitation. A puncture needle and strain-relief pledget 75 can be used to distribute local forces at the leaflet attachment site through the suture 75, as shown in Figure 6. Single or multiple passes through the leaflets replicate the normal chordae tendineae, which provide normal leaflet movement. The suture material can be #4 or #5 pTFE, silk, or other common materials used in normal valve reconstruction. The position of the suture allows normal left ventricular and mitral valve movement and freedom, as the suture passes between the papillary muscles and connects to the flail valve leaflets on one end and into the right ventricle on the other end, where it is held by the right ventricular strain relief. Jugular vein access similarly provides access to the vena cava and right ventricle, and / or access into the left atrium via a transseptal puncture, as shown in Figure 8. This jugular vein access eliminates the initial 180-degree turn from the femoral vein to the right ventricle, but is not conventional access for many interventional cardiologists.

[0016] The catheter is constructed of common polymers, including nylon, Teflon, urethane, and other commonly used materials, and has proximal and distal ends with guidewire ports. The required catheter curve can be preset, fixed, or actively bent through differential forces transmitted through a pull wire or tube, biased in one direction or another to impart column compression to one side of the catheter relative to the other. Columnar and tubular strength can be provided by embedded coiled wire, ribbon or round wire braids, laser-cut tubing, or skeleton structures to form the desired configuration and / or curve required to gain access. Variable stiffness and construction techniques are known in the art to achieve the specific pushability, stiffness, and curve required for delivery. Coatings and surface treatments, both internal and external, aid in relative movement between the vessel wall and between the wire and other catheters. Pulling means can be provided by a pull wire extending from the distal end of the catheter to a handle in the proximal section. The pull wire can be activated by a rotating screw that translates into longitudinal force, pulling on the connection at the distal end of the catheter. The femoral catheter access is approximately 100 cm long and has a through lumen to accept a guidewire for positioning within the body's vascular system. The jugular catheter is approximately 60 cm long. Both catheters are approximately 6-20 French in diameter and have at least one lumen extending from the proximal to distal end of the delivery system.

[0017] Access through the femoral vein allows for catheterization through the tricuspid valve into the right ventricle. At the apex of the right ventricle, access is gained by advancing a needle or catheter into the septum to gain access to the left ventricle. Using a needle, ultrasound, or coring tool to pass a guidewire from the right ventricle to the left ventricle is the pathway or access route for mitral valve reconstruction. Once the needle and / or guidewire are advanced, additional tools, such as catheters, can be utilized to reconstruct the mitral valve. Because the septum can be over one centimeter thick, maintaining an access port is possible with balloon dilatation, a guide catheter, or an access conduit for passing tools and catheters during reconstruction procedures. A navigable sheath, catheter, or conduit can easily direct access to specific areas of the mitral valve for reconstruction. Rotational and angular adjustments can secure or lock the position once optimal positioning is achieved. This can be achieved by a predetermined curve configuration, where the catheter curves downward to pass through the tricuspid valve, cross the interventricular septum, and then upward to the mitral valve. This shape can be fixed or variable based on the patient's needs and anatomy. A guidewire approximately 0.035 inches (0.0889 cm) in diameter and approximately 180 to 300 centimeters in length allows the catheter to be advanced over it and interchangeable with additional tools to be exchanged. Expandable dilators can be used to dilate areas where tight access is required or where a larger caliber catheter is required. Catheter sizes range from approximately 6 French to approximately 24 French in diameter and lengths include 90 centimeters to 160 centimeters. These catheter configurations can be made of conventional polymers, including nylon, polyurethane, polyethylene, or other similar polymers. Braided, coiled, or laser-cut tubing can be used in the catheter configuration to better support the required inner diameter, shape, or curve. These materials may include stainless steel, nitinol, platinum or MP35N metals suitable for catheter construction.

[0018] The interconnection of multiple catheters provides additional flexibility, movement, and translational freedom. In one embodiment, a larger catheter (24 French internal diameter) can be used to access the apex of the right ventricle to provide a stable base from which an inner catheter (18 French internal diameter) can be advanced through the interventricular septum and a third catheter (approximately 14 French internal diameter) can be advanced through this catheter into the left ventricle toward the mitral valve. These catheters can allow for multiple adjustments and angles to accommodate various anatomies. The ability to translate, rotate, and lock the position of each of these catheters together or individually provides a stable platform for delivering reconstruction tools to the valve. Locking mechanisms for each of these interconnected catheters can be achieved by hydraulically expanding the catheters to change diameter, by mechanically expanding the catheters with a rotational mechanism that creates an eccentric lock, or by longitudinal tensioning to create a diameter difference between the catheters. This push-pull translation can cause the catheter to accordion-like collapse, creating greater friction within a single catheter.

[0019] Additionally, push-pull wires can force the catheter into preset shapes and curves in a single plane or multiple planes. By laser-cutting a unique pattern into the catheter inner frame, a predetermined shape can be achieved by using a pull wire to reduce the length of one side of the catheter while collapsing the round cylindrical shape of the catheter to create a shape inside the catheter determined by the laser-cut elements. For example, slots can be cut into one side of a tube and a pull wire can be attached to the distal end of the tube. When a pulling force is applied to the wire, the collapse of the slotted side of the tube causes a curve or bias in the tubular element. These slots can also be complex shapes to lock the rotation angle into a preset shape. This complex shape can be a chevron, angled cut, a rounded shape, or other detailed pattern that stops the collapse of the tube at a preset radius. This pattern can be rotated around the tube to create three-dimensional shapes and curves from a single plane.

[0020] This patterning is laser cut into the inner tubing of the catheter, composed of a metal or polymer, and embedded in the wall of the catheter wall.

[0021] The first angle curve is approximately 180 degrees, redirecting the catheter from femoral access through the tricuspid valve toward the apex of the right ventricle. The second curve of this catheter is approximately a 90-degree bend, creating a "Shepard's Crook" shape toward the ventricular septum. This 90-degree orientation can also be achieved by passing a second, inner catheter through the first, larger diameter catheter for access through the ventricular septum. This requires a 90-degree curve to redirect the apex toward the septum. Once the septum is entered, another 90-degree curve is required to direct the catheter toward the mitral valve. Approximately 1-2 centimeters of space is required between these two 90-degree curves to traverse the septal tissue. This linear segment can be pre-defined into a curved configuration and can be actuated with a single puller wire or multiple puller wires. A preferred embodiment utilizes a first catheter to achieve a 90-degree curve toward the ventricular septum.

[0022] The next inner catheter, directed toward the mitral valve, can be advanced toward the left ventricular valve leaflet. Once aimed and positioned underneath the leaflet, the catheter tip can locate the free edge of the mitral valve leaflet and secure a tether for reconstruction of damaged chordae or flail leaflets. Single or multiple chordae can be dispersed from a single access point or from separate locations along the leaflet. With transseptal access from above, a second catheter can be placed on the superior surface of the leaflet along the same free edge. Coaxial alignment of these two catheters is achieved by magnetic tips, either incorporated into the catheter or advanced through each central lumen of the catheter.

[0023] These two catheters are placed above and below the valve leaflets to pinch the leaflets together, allowing access to the leaflets for chordae tendineae reconstruction or banding and anchoring to the inferior access point originating from the right ventricle. The chordae tendineae reconstruction can be PIFE suture or other material suitable for permanent implantation. By extending the inferior access point into the right ventricle, the anchor can be placed entirely within the right ventricle or the interventricular septum, exposing only the replacement suture material in the left ventricle. The anchor design can be a barbed anchor with single or multiple barbs to engage tissue, a plug for retention from the right ventricular side of the septum, or similar screw means for engaging tissue in the right or left ventricle. The attachment of the tissue anchor to the chordae tendineae leaflet attachment can be adjusted during or after implantation of the chordae and anchor system using in vivo monitoring of chordae tension or echocardiograms. An aspect (1) of the present disclosure may be a chordae tendineae replacement system comprising: a catheter having an elongated, flexible tubular body with a proximal end and a distal end, the catheter configured for intravascular access into the right ventricle and through the ventricular septum into the left ventricle; and a chordae tendineae replacement implant deployably carried by the catheter, the chordae tendineae replacement implant comprising an elongated body having a proximal end with a proximal tissue anchor and a distal end with a mitral valve leaflet attachment anchor. In embodiment (1), the proximal tissue anchor may comprise a helical tissue anchor for engaging tissue at the apex of the heart. In embodiment (1), the proximal tissue anchor may comprise an anchor for engaging the right ventricular surface of the transseptal crossbody. In embodiment (3), the proximal tissue anchor may comprise a pledget. In embodiment (1), the chordae replacement implant may be carried within the tubular body. Another aspect (6) of the present disclosure may be a method for reconstructing a mitral valve in a patient's heart, the method comprising accessing a right ventricle of the patient's heart with a catheter extending through a vein or right side of the heart to access the left ventricle, and fixating the mitral valve leaflets with the catheter. Yet another aspect (7) of the present disclosure may be a method of reconstructing a mitral valve, the method comprising intravascularly accessing the right ventricle with a catheter and extending the catheter through the interventricular septum into the left ventricle, and placing a chordae replacement implant with the catheter. In embodiment (7), the chordae replacement implant may comprise a proximal end having a proximal tissue anchor and a distal end having a mitral valve leaflet attachment anchor. In embodiment (7), deploying the chordae replacement implant may include engaging tissue at the apex of the heart with a helical tissue anchor. In embodiment (7), deploying the chordae replacement implant may include engaging a right ventricular surface of the transseptal traverse with an anchor. Embodiment (7) may include delivering the chordae replacement implant with a catheter. An aspect (101) of the present disclosure may be a chordae tendineae replacement system comprising: a steerable catheter having an elongated, flexible tubular body having a proximal end and a distal end, the catheter configured to provide access into the left ventricle, the steerable catheter having wires extending from a handle at a proximal section of the steerable catheter to the distal end of the steerable catheter, the wires configured to actively bend the steerable catheter to position the distal tip of the steerable catheter adjacent to a mitral valve leaflet; a chordae tendineae replacement implant deployably carried by the catheter, the chordae tendineae replacement implant comprising an elongated body carrying sutures and having ventricular tissue anchors and mitral valve leaflet attachment anchors; and a puncture needle configured to pass the sutures through the mitral valve leaflets to their attachment points. In embodiment (101), the proximal tissue anchor may comprise a helical tissue anchor for engaging tissue at the apex of the heart. In embodiment (101), the proximal tissue anchor may comprise an anchor for engaging the right ventricular surface of the transseptal traverse. In embodiment (103), the proximal tissue anchor may comprise a pledget. In embodiment (101), a chordae replacement implant may be carried within the tubular body. In embodiment (101), the steerable catheter may comprise a plurality of slots configured to collapse when tension is applied to the wires, causing the steerable catheter to bend according to a preset curve. In embodiment (101), the steerable catheter may be a first catheter, and the catheter-based system may further comprise a coaxial second catheter configured to guide the first catheter through the septum and toward the mitral valve leaflets. In embodiment (107), the first catheter and the second catheter may both be steerable catheters. In embodiment (101), a slot may be laser cut into one side of the steerable catheter. In aspect (101), the slots may be formed in one or more of a chevron shape, a beveled shape, or a rounded shape. In embodiment (101), the ventricular anchor may include a strain relief at the anchor outlet, the strain relief configured to reduce fretting of the suture. In embodiment (101), the ventricular anchor may comprise a body and a barb extending at an acute angle from an outer surface of the body. In embodiment (101), the ventricular anchor may be a coiled anchor. In embodiment (101), the ventricular anchor may be configured to be coupled to tissue just below the attachment point of the mitral valve leaflet. In embodiment (101), the mitral leaflet attachment anchor may be a strain relief pledget configured to distribute local forces at the leaflet attachment site. Another aspect (116) of the present disclosure is a catheter-based system for mitral valve chordae reconstruction, comprising: a steerable catheter configured to extend through the septum to access the mitral valve, the steerable catheter having a wire extending from a handle at a proximal section of the steerable catheter to a distal end of the steerable catheter, the wire configured to positively bend the steerable catheter to position a distal tip of the steerable catheter adjacent a mitral valve leaflet; and a ventricular anchor coupled to a first suture, the ventricular anchor configured to attach to tissue within the left ventricle. a puncture device configured to pass a second suture through the mitral valve leaflet at the mitral valve leaflet attachment site from a first side of the mitral valve leaflet to a second side of the mitral valve leaflet; a strain relief pledget attached to the second suture, the pledget configured to distribute local forces at the leaflet attachment site, the pledget configured to be positioned on the second side of the mitral valve leaflet opposite the first side of the mitral valve leaflet; and a fixation member that adjustably couples the first and second sutures to constrain the mitral valve leaflet to tissue of the left ventricle. In embodiment (116), the fixation member may be configured to adjustably fix the proper position of the mitral valve leaflets. In embodiment (117), the securing member may be a slide one-way stop. Yet another aspect (119) of the present disclosure may be a multi-catheter system for reconstructing mitral valve chordae, the multi-catheter system comprising: a first catheter configured to cross the septum and access the mitral valve; a second catheter with means for manipulating the second catheter to pass a puncture device through the mitral valve leaflets, the second catheter securing a suture to the mitral valve leaflets via a pledget, the suture extending through the mitral valve leaflets from a first side to a second side; a ventricular anchor configured to be delivered through the septum and through the mitral valve for attachment to tissue within the left ventricle; and means for adjustably coupling the suture to the ventricular anchor to constrain the mitral valve leaflets to the ventricular anchor. In embodiment (119), the ventricular anchor includes a strain relief at the anchor outlet, which may be configured to reduce fretting of sutures attached to the ventricular anchor.

Claims

1. 1. A chordae replacement system comprising: a steerable catheter having an elongated flexible tubular body with a proximal end and a distal end; a ventricular tissue anchor deployably carried by the catheter, the ventricular tissue anchor coupled to sutures and coupled via the sutures to a strain relief pledget operable to tension the mitral valve leaflets, the mitral valve leaflets including the anterior and posterior mitral leaflets, the strain relief pledget configured to distribute localized forces from the sutures at the leaflet attachment site of the anterior or posterior mitral leaflet to which the strain relief pledget is attached, the strain relief pledget configured to be positioned on a second side of the mitral valve leaflet opposite the first side of the mitral valve leaflet; a puncture needle configured to pass the suture through the mitral valve leaflet from a first side of the mitral valve leaflet at the leaflet attachment site to a second side of the mitral valve leaflet, the puncture needle configured to be removed from the body after passing.

2. The chordae replacement system of claim 1 , wherein the ventricular tissue anchor comprises a helical tissue anchor for engaging tissue at the apex of the heart.

3. The chordae replacement system of claim 1 , wherein the ventricular tissue anchor comprises an anchor for engaging a right ventricular surface of a transseptal traverse.

4. The chordae replacement system of claim 1 , wherein the ventricular tissue anchor is carried within the tubular body.

5. 10. The chordae replacement system of claim 1, wherein the steerable catheter comprises a plurality of slots configured to collapse when tension is applied to wires, causing the steerable catheter to curve according to a preset curve.

6. The chordae replacement system of claim 5 , wherein the slot is laser cut into one side of the steerable catheter.

7. The chordae replacement system of claim 5 , wherein the slots are formed in one or more of a chevron shape, a beveled shape, or a rounded shape.

8. 6. The chordae replacement system of claim 5, wherein the preset curve positions the distal tip of the steerable catheter upward to point toward the ventricular side of the mitral valve.

9. The chordae replacement system of claim 1 , wherein the ventricular tissue anchor comprises a body and a barb extending at an acute angle from an outer surface of the body.

10. The chordae replacement system of claim 1 , wherein the ventricular tissue anchor is a coiled anchor.

11. 10. The chordae tendineae replacement system of claim 1, wherein the ventricular tissue anchor is configured to be coupled to the ventricular septum immediately below the attachment point of the anterior or posterior mitral valve leaflet to which the strain relief pledget is attached.

12. 10. The chordae replacement system of claim 1, wherein the suture comprises a fixation member adjustably coupling the ventricular tissue anchor and the strain relief pledget to distribute the load exerted by the suture on the mitral valve leaflets.

13. The chordae replacement system of claim 12 , wherein the fixation member is a sliding one-way stop.

14. 2. The chordae replacement system of claim 1, wherein the steerable catheter has wires extending from a handle at a proximal section of the steerable catheter to a distal end of the steerable catheter, the wires being configured to positively bend the steerable catheter to position a distal cusp of the steerable catheter adjacent the mitral valve leaflets.

15. 1. A catheter-based system for reconstructing mitral valve chordae, comprising: a steerable catheter; a ventricular tissue anchor coupled to the first suture, the ventricular tissue anchor configured to attach to tissue within the left ventricle; a puncture tool configured to pass a second suture through the mitral valve leaflet from a first side of the mitral valve leaflet to a second side of the mitral valve leaflet at the leaflet attachment site, the puncture tool configured to be removed from the body after passing; a strain relief pledget attached to the second suture, the strain relief pledget configured to distribute localized forces from the second suture at the leaflet attachment site of the anterior or posterior mitral valve leaflet to which the strain relief pledget is attached, the strain relief pledget configured to be positioned on a second side of the mitral valve leaflet opposite the first side of the mitral valve leaflet; a fixation member that adjustably couples the first suture and the second suture to distribute a load acting on the mitral valve leaflet by the first suture and the second suture to constrain the mitral valve leaflet to tissue of the left ventricle; and A catheter-based system comprising:

16. 16. The catheter-based system of claim 15, wherein the fixation member is configured to adjustably fix the proper position of the mitral valve leaflets.

17. 17. The catheter-based system of claim 16, wherein the securing member is a sliding one-way stop.

18. 16. The catheter-based system of claim 15, wherein the steerable catheter has wires extending from a handle at a proximal section of the steerable catheter to a distal end of the steerable catheter, the wires being configured to positively bend the steerable catheter to position a distal tip of the steerable catheter adjacent the mitral valve leaflets.

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