Abstract:
The invention includes a novel method and system to achieve leaflet coaptation in a cardiac valve percutaneously by creation of neochordae to prolapsing valve segments. This technique is especially useful in cases of ruptured chordae, but may be utilized in any segment of prolapsing leaflet. The technique described herein has the additional advantage of being adjustable in the beating heart. This allows tailoring of leaflet coaptation height under various loading conditions using image-guidance, such as echocardiography. This offers an additional distinct advantage over conventional open-surgery placement of artificial chordae. In traditional open surgical valve repair, chord length must be estimated in the arrested heart and may or may not be correct once the patient is weaned from cardiopulmonary bypass. The technique described below also allows for placement of multiple artificial chordae, as dictated by the patient&#39;s pathophysiology.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     This application claims the benefit of priority from U.S. Provisional Patent Application Ser. No. 60/738,517 filed Nov. 21, 2005 the disclosure of which is incorporated by reference herein in its entirety. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates to a system and method for treating the luminal system of a patient. Particularly, the present invention is directed to a system and method for treating the cardiac valves of a patient and also for adjusting the geometry of a patient&#39;s heart.  
         [0004]     2. Description of Related Art  
         [0005]     Mitral regurgitation (MR), or leakage, is the backflow of blood from the left ventricle into the left atrium due to an imperfect closure of the mitral valve. MR affects 5 in 10,000 persons in the United States. Myxomatous mitral degeneration has replaced rheumatic valve disease as the most common cause of surgically treated mitral regurgitation in developed nations. The primary pathophysiology in myxomatous mitral disease is prolapse of either the anterior and/or posterior leaflets of the mitral valve, leading to malcoaptation. The disease is also marked by dilation or deformation of the mitral annulus. The only effective treatment to reduce MR-related complications is by surgically repairing or replacing the mitral valve. The outcomes of mitral repair are significantly better than those for valve replacement, and this has become the procedure of choice in patients with clinically significant MR due to myxomatous disease. The mainstays of surgical repair approaches include both mitral valve annuloplasty and a procedure to reduce the height of the prolapsing leaflet(s) to improve leaflet coaptation. The options for the latter include leaflet resection, leaflet advancement, commissuroplasty, edge-to-edge plication, chordal transfer, and creation of neochordae. Each of these approaches has advantages and disadvantages and are often used in combination. The results of open surgical mitral valve repair for myxomatous MR are excellent, with greater than 90% freedom from reoperation at 10 years.  
         [0006]     In general, a relatively significant gap may exist between the anterior leaflet and posterior leaflet of the mitral valve for a variety of different reasons. For example, a gap may exist due to congenital malformations, because of ischemic disease, or because a heart has been damaged by a previous heart attack. A gap may also be created when congestive heart failure, e.g., cardiomyopathy, or some other type of distress causes a heart to be enlarged. When a heart is enlarged, the walls of the heart, e.g., wall of a left ventricle, may stretch or dilate, causing the posterior leaflet of the mitral valve to stretch or be displaced. Accordingly, a gap can be created between the leaflets of the mitral valve when the walls of the left ventricle stretch. Hence, due to the existence of the gap, the mitral valve is unable to close properly, and may begin to leak. Leakage through the mitral valve generally causes a heart to operate less efficiently, as the heart must work harder to maintain a proper amount of blood flow therethrough.  
         [0007]     Treatments used to correct for mitral valve leakage are typically highly invasive, open-heart surgical procedures. Ventricular assist devices such as artificial hearts may be implanted in a patient whose own heart is failing. The implantation of a ventricular assist device is often expensive, and a patient with a ventricular assist device must be placed on extended anti-coagulant therapy. As will be appreciated by those skilled in the art, anti-coagulant therapy reduces the risk of blood clots being formed, as for example, within the ventricular assist device. While reducing the risks of blood clots associated with the ventricular assist device is desirable, anti-coagulant therapies may increase the risk of uncontrollable bleeding in a patient, e.g., as a result of a fall, which is not desirable.  
         [0008]     Open-heart surgical procedures which are intended to correct for mitral valve leakage, specifically, involve the implantation of replacement valves. Valves from animals, e.g., pigs, may be used to replace a mitral valve in a human. While the use of a pig valve may relatively successfully replace a mitral valve, such valves generally wear out, thereby requiring additional open surgery at a later date. Mechanical valves, which are less likely to wear out, may also be used to replace a leaking mitral valve. However, when a mechanical valve is implanted, there is an increased risk of thromboembolism, and a patient is generally required to undergo extended anti-coagulant therapies.  
         [0009]     One open-heart surgical procedure that is particularly successful in correcting for mitral valve leakage is an annuloplasty procedure. During an annuloplasty procedure, an annuloplasty ring may be implanted on the mitral valve to cause the size of a stretched mitral valve to be reduced to a relatively normal size. An annuloplasty ring is shaped approximately like the contour of a normal mitral valve. That is, an annuloplasty ring is shaped substantially like the letter “D.” Typically, annuloplasty rings may be formed from a rod or tube of biocompatible material, e.g., plastic, that as a DACRON mesh covering.  
         [0010]     In order for an annuloplasty ring to be implanted, a surgeon surgically attaches the annuloplasty ring to the mitral valve on the atrial side of the mitral valve. Conventional methods for installing such a ring require open-heart surgery which involve opening a patient&#39;s sternum and placing the patient on a heart bypass machine. The annuloplasty ring is sewn to the posterior mitral annulus and the fibrous trigones at the top portion of the mitral valve. In sewing the annuloplasty ring onto the mitral valve, a surgeon generally alternately acquires a relatively large amount of tissue from mitral tissue, e.g., a one-eighth inch bite of tissue, using a needle and thread, followed by a smaller bite from the annuloplasty ring. Once a thread has loosely coupled the annuloplasty ring to the mitral valve tissue, the annuloplasty ring is slid onto the mitral valve such that tissue that was previously stretched out, e.g., due to an enlarged heart, is effectively pulled in using tension applied by the annuloplasty ring and the thread which binds the annuloplasty ring to the mitral valve tissue. As a result, the gap between the anterior leaflet and the posterior leaflet may be substantially closed off. After the mitral valve is shaped by the annuloplasty ring, the anterior and posterior leaflets of the mitral valve will reform to create a new coaptation surface and will enable the mitral valve to appear and to function as a normal mitral valve.  
         [0011]     Once implanted, tissue generally grows over the annuloplasty ring, and a line of contact between the annuloplasty ring and the mitral valve will essentially enable the mitral valve to appear and function as a normal mitral valve. Although a patient who receives the annuloplasty ring may be subjected to anti-coagulant therapies, the therapies are not extensive, as a patient is only subjected to the therapies for a matter of weeks, e.g., until tissue grows over the annuloplasty ring.  
         [0012]     A second surgical procedure which is generally effective in reducing mitral valve leakage involves placing an edge-to-edge suture in the mitral valve. Such a surgical procedure, e.g., an Alfieri stitch procedure or a bow-tie repair procedure, will be described. An edge-to-edge stitch is used to stitch together an area at approximately the center of a gap defined between the anterior and posterior leaflets of the mitral valve. Once the stitch is in place, the stitch is pulled in to form a suture which holds anterior leaflet against the posterior leaflet, as shown. By reducing the size of the gap between the anterior leaflet and the posterior leaflet, the amount of leakage through the mitral valve may be substantially reduced.  
         [0013]     Although the placement of an edge-to-edge stitch is generally successful in reducing the amount of mitral valve leakage through the gap between the leaflets of the mitral valve, this technique is conventionally made through open-heart surgery. In addition, the use of the edge-to-edge stitch is generally not suitable for a patient with an enlarged, dilated heart, as blood pressure causes the heart to dilate outward, and may put a relatively large amount of stress on the edge-to-edge stitch.  
         [0014]     While invasive surgical procedures have proven to be effective in the treatment of mitral valve leakage, invasive surgical procedures often have significant drawbacks. Any time a patient undergoes open-heart surgery, there is a risk of infection. Opening the sternum and using a cardiopulmonary bypass machine has also been shown to result in a significant incidence of both short and long term neurological deficits.  
         [0015]     It is also possible to address mitral valve regurgitation by anchoring artificial chordae between the posterior leaflet of the mitral valve and papillary muscles in the left ventricle. In accordance with this procedure, a length of non-resorbable suture (e.g., expanded PTFE) is sutured between the two locations in an effort to make the anterior and posterior mitral valve leaflets realign, reducing regurgitation. However, this procedure suffers from certain disadvantages. First, as with other open heart surgical techniques, such procedures require that the patient&#39;s heart be stopped in order to place the sutures. Since the heart is stopped when the suture is installed, the surgeon has to estimate the length of the suture that needs to be used. After the patient is removed from bypass and the patient&#39;s heart is restarted, it is entirely possible that the length of the suture will be incorrect, resulting in no improvement to the patient&#39;s condition. This can require stopping the patient&#39;s heart again to repeat the procedure, which carries the added risk that the patient&#39;s heart might not restart.  
         [0016]     Thus, there still remains a continued need in the art for improved surgical techniques for treating mitral valve regurgitation. The present invention provides a solution for these problems, as described herein.  
       SUMMARY OF THE INVENTION  
       [0017]     The purpose and advantages of the present invention will be set forth in and apparent from the description that follows, as well as will be learned by practice of the invention. Additional advantages of the invention will be realized and attained by the methods and systems particularly pointed out in the written description hereof, as well as from the appended drawings.  
         [0018]     To achieve these and other advantages and in accordance with the purpose of the invention, as embodied herein and broadly described, in accordance with one aspect, the invention includes a method of repairing a cardiac valve. The method includes introducing a catheter through a patient&#39;s vasculature into the patient&#39;s heart and advancing a distal end of the catheter proximate a leaflet of a cardiac valve of the patient. The catheter is then used to direct a first portion of a filament through the leaflet to capture the leaflet. Tension is then applied to the filament to adjust the function of the cardiac valve.  
         [0019]     In accordance with further aspects of the invention, the method may further include adjusting a length of the filament to vary the function of the cardiac valve. The length of the filament may be adjusted while the patient&#39;s heart is beating. If desired, the patient&#39;s heart may be viewed using an imaging technique while the length of the filament is adjusted to determine a desired length for the filament.  
         [0020]     In further accordance with the invention, a second portion of the filament may be directed toward a second location within the patient&#39;s vasculature. The second portion of the filament may be directed to the second location, for example, by implanting an anchor in cardiac tissue in the second location, and directing the second portion of the filament through a portion of the anchor. If desired, the length of the filament may be adjusted by applying tension to the filament through the anchor. Moreover, tension may be applied to the filament by disposing a distal end of the catheter against the anchor and pulling on the filament using the anchor as a fulcrum.  
         [0021]     In accordance with a further aspect of the invention, the method may further include applying a lock to the filament to prevent the second portion of the filament from disengaging from the anchor. The lock may be applied to a portion of the filament that is on an opposite side of the anchor from the first portion of the filament. The filament is preferably severed on a side of the lock opposite the anchor. If desired, the lock may be applied to the filament using the same catheter used to deliver the filament to the valve leaflet. By way of further example, the filament may be severed using the same catheter used to deliver the filament to the leaflet.  
         [0022]     In accordance with still another aspect of the invention, the filament includes suture material. The suture material may include a monofilament and/or a polyfilament braided material. By way of further example, the suture material may include material selected from the group consisting of polypropylene, polyester, nylon, and silk, among others. The suture material may also include radiopaque material. The suture material may additionally or alternatively have echodense properties to facilitate visualization of the filament using fluoroscopic or echocardiographic imaging techniques. The imaging technique may be selected, for example, from the group including echocardiography and fluoroscopy.  
         [0023]     If desired, the suture material may include expanded PolyTetraFluoroEthylene (“ePTFE”). Accordingly, the ePTFE suture material may include nodes and fibrils adapted to facilitate tissue ingrowth therein.  
         [0024]     In accordance with still a further aspect of the invention, the anchor may include at least one barb, the barb being adapted and configured to resist backout of the anchor from tissue in which the anchor is implanted. The barb may be deployed from an undeployed to a deployed position after implanting the anchor in tissue of the patient.  
         [0025]     In accordance with yet further aspects of the invention, the catheter may be introduced into the patient&#39;s vasculature through a guide catheter. Moreover, the catheter may additionally or alternatively be introduced into the patient&#39;s vasculature over a guidewire.  
         [0026]     In accordance with still further aspects of the invention, the methods and systems embodied herein may be used to perform a procedure on a patient&#39;s mitral valve. If desired, a first end of a filament may be placed on a patient&#39;s mitral valve leaflet, and a second portion of the filament may be affixed to a papillary muscle portion of the patient. In accordance with a further example, the patient&#39;s tricuspid valve may be treated using the methods and systems embodied herein. The method may further include using a catheter to direct a first portion of a second filament through a valve leaflet to capture the leaflet, and applying tension to the second filament to further adjust the function of the cardiac valve being operated on.  
         [0027]     In accordance with a further aspect of a method of the invention, a second portion of the filament may be affixed to a first portion of a second filament. A second portion of the second filament may accordingly be attached to an anchoring location within the patient&#39;s heart. The second filament may be attached to the anchoring location by affixing it to an anchor embedded in cardiac tissue. In accordance with one embodiment, the anchor may be embedded in a papillary muscle. If desired, the anchor may be implanted by the same catheter used to deliver the filament. If desired, the filaments may be affixed to each other using the same catheter used to deliver the filament to the valve leaflet.  
         [0028]     The invention also provides a method of adjusting the geometry of a patient&#39;s heart. The method includes introducing a catheter through a patient&#39;s vasculature into the patient&#39;s heart and advancing a distal end of the catheter proximate a first portion of the interior of the patient&#39;s heart. The catheter is then used to attach a first portion of a filament to the first portion, and to attach a second portion of the filament to a second portion of the interior of the patient&#39;s heart. Tension is then applied to the filament to adjust the geometry of the patient&#39;s heart.  
         [0029]     In accordance with further aspects of the invention, the final length of the filament may be set. For example, the final length of the filament may be set by applying a retainer to the filament. If desired, the geometry of the patient&#39;s heart may be adjusted to decrease mitral valve regurgitation. The mitral valve regurgitation may be decreased by reducing the septal-lateral dimension of the patient&#39;s ventricle. By way of further example, the geometry of the patient&#39;s heart may be adjusted to improve operation of the patient&#39;s tricuspid valve.  
         [0030]     The invention also provides a catheter adapted and configured to deliver a filament through a patient&#39;s vasculature into the patient&#39;s heart proximate a leaflet of a cardiac valve of the patient. The catheter includes an elongate body having a proximal end and a distal end and a filament in operable association with the elongate body. The catheter further includes a deployable penetrator in operable association with the elongate body, the deployable penetrator being adapted and configured to be deployed through a portion of a patient&#39;s valve leaflet to facilitate capture of the leaflet by the filament.  
         [0031]     In further accordance with the invention, the catheter may include a leaflet grasping portion adapted and configured to hold the patient&#39;s valve leaflet in place to facilitate deploying the penetrator through the leaflet. The leaflet grasping portion is preferably adapted and configured to hold the patient&#39;s valve leaflet in place at least in part by applying suction to the valve leaflet. If desired, the leaflet grasping portion may be pivotally mounted proximate a distal region of the catheter. If further desired, the leaflet grasping portion of the catheter may be provided with two pivotally mounted arms mounted on a distal region of the catheter that are adapted and configured to grasp a valve leaflet along opposing faces of the leaflet. If further desired, the catheter may further include a second filament adapted and configured to receive the penetrator. The second filament may include a cuff adapted and configured to receive the penetrator. If desired, the second filament may further include a loop formed therein for receiving the first filament therethrough.  
         [0032]     In accordance with a further aspect of the invention, the catheter may be adapted and configured to permit the second filament to be pulled through the leaflet to permit the loop to form a knot about the leaflet to capture the leaflet. The catheter may be further adapted and configured to permit a free end of the second filament to be exteriorized from the patient. Preferably, the second filament is exteriorized through a lumen of the catheter.  
         [0033]     In accordance with yet a further aspect of the invention, the catheter may further include an anchor deployment portion for deploying an anchor into cardiac tissue of the patient. Moreover, the catheter may further include a retainer applicator for applying a retainer to the filament. The retainer applicator is preferably adapted to apply a retainer to the filament proximate an anchor embedded in the patient&#39;s vasculature. By way of further example, the retainer applicator may be adapted to apply a retainer to a plurality of filaments to secure the plurality of filaments to each other. In accordance with a further embodiment of the invention, the catheter may further include a blade disposed thereon adapted and configured to severe the filament.  
         [0034]     The invention also provides a catheter for applying an anchor into cardiac tissue of a patient. The catheter includes an elongate outer body having a proximal end, a distal end and defining a lumen therethrough. The catheter further includes a torquable elongate inner body movably disposed within the lumen of the outer body, the inner body having a fitting for receiving an anchor therein.  
         [0035]     In accordance with a further aspect of the invention, the inner body may be formed at least in part from a hypotube. If desired, the inner body and/or outer body may have a varying flexibility along their lengths. The varying flexibility may be provided at least in part by a plurality of cuts formed in the inner body, and/or by at least one stiffening wire formed into the outer body. If desired, a guide lumen may be formed on the outer body having a filament inlet port proximate the distal end of the outer body and a filament exit port proximal of the filament inlet port for receiving a filament therethrough. Preferably, the filament exit port is substantially close to the distal end of the outer body.  
         [0036]     In accordance with still further aspects of the invention, the catheter may further include an anchor disposed in the fitting, and a filament disposed about the inner body, the filament being operatively associated with the anchor. A torquable handle may be attached to the proximal end of the inner body for applying a torque to the inner body, and the anchor. If desired, the catheter may further include a steering mechanism adapted and configured to steer a distal end of the catheter. Moreover, an anchor guide may be disposed on an inside surface of the outer body, the anchor guide being adapted and configured to guide the anchor during installation of the anchor. If desired, the anchor may be a helically shaped anchor that is disposed in the fitting, wherein the anchor guide facilitates rotation of the anchor while it is being installed. Accordingly, the anchor guide preferably urges the anchor distally as it is rotated with respect to the outer body by the inner body. The anchor may include at least one barb disposed thereon to resist backout of the anchor after it has been implanted. The anchor may be formed from shape memory material, among other materials.  
         [0037]     The invention also provides a catheter for fastening together a plurality of filaments. The catheter includes an elongate body having a proximal end and a distal end, and a guide passage for receiving a plurality of filaments to be fastened together. The catheter further includes a fastener applicator disposed proximate the distal end of the elongate body for applying a fastener to the plurality of filaments received by the guide passage. The catheter may further include an actuator disposed proximate the proximal end of the elongate body operably coupled to the fastener applicator to facilitate fastening the plurality of filaments.  
         [0038]     In further accordance with the invention, the guide passage of the catheter may include a distal opening proximate the distal end of the elongate body for receiving the filaments, and a proximal exit opening spaced proximally from the distal end of the elongate body that permits passage of the filaments therethrough. The proximal exit opening may be substantially closer to the distal end of the elongate body than the proximal end of the elongate body.  
         [0039]     The invention further provides a catheter for positioning a lock on a filament. The catheter includes an inner member having a proximal end, a distal end and defining a lumen at least partially therethrough, the lumen being adapted and configured to receive a filament therethrough. The catheter further includes a filament lock biased to change from a first, relatively open state to a second, relatively closed state, the filament lock being disposed on a substantially rigid portion of the inner member, the inner member being sufficiently rigid to prevent the filament lock from changing from the first state to the second state. The catheter further includes an outer member having a proximal end, a distal end and defining a lumen at least partially therethrough. The lumen of the outer member is adapted and configured to movably receive the inner member. The lumen of the outer member is preferably sufficiently small to prevent the filament lock from entering the lumen when positioned on the inner member.  
         [0040]     In further accordance with the invention, the outer member can be used to urge the lock distally off of the inner member and onto the filament. If desired, the filament lock may include a helical body wound about the inner member biased to contract in radius from the first state to the second state. The filament lock may include a pair of jaws hingedly connected that are biased to close on the filament. By way of further example, the filament lock may include a plurality of legs that are biased to close on the filament. If desired, the filament lock may include a substantially tubular body made from shape memory material that is adapted and configured to contract about the filament when exposed to the temperature of the body of the patient. If desired, the catheter may further include a pair of jaws adapted and configured to crimp the filament lock on the filament, and an actuator for actuating the jaws. The catheter may further include a filament exit port disposed in each of the inner member and outer member to permit passage of the filament therethrough. The filament exit ports are preferably proximate the distal end of the inner and outer members.  
         [0041]     The invention further provides an anchor adapted and configured to be anchored in cardiac tissue of a patient. The anchor includes an anchoring portion having a proximal end and a distal end, the anchoring portion being adapted and configured to be anchored into cardiac tissue of a patient. The anchor further includes a filament lock disposed at the proximal end of the anchoring portion.  
         [0042]     In accordance with a further aspect of the invention, the filament lock is preferably biased to change from a first, relatively open state to a second, relatively closed state when disposed about a filament. The filament lock preferably defines a lumen therethrough for receiving an locking onto a filament. However, filament locks as disclosed herein may include a substantially planar member that is caused to deform to surround and clamp a filament. The anchor may be formed, for example, at least in part from a shape memory material. The shape memory material may include nitinol.  
         [0043]     In still further accordance with the invention, the anchor may further include a coupling member affixed to the anchoring portion, the coupling member defining a lumen therethrough for receiving a filament.  
         [0044]     The invention also provides a catheter for severing a filament inside of a patient&#39;s vasculature. The catheter includes an inner member having a proximal end, a distal end, and defining a lumen therethrough, the lumen being adapted and configured to receive a filament therethrough. The catheter also includes an outer member having a proximal end, a distal end and defining a lumen therethrough, the lumen of the outer member being adapted and configured to receive the inner member. The catheter also includes a pair of substantially arcuate cutting jaws pivotally mounted inside the lumen of the outer member in a wall of the outer member.  
         [0045]     In further accordance with the invention, the jaws are preferably biased to close about and sever the filament. The jaws may be held apart by the inner member when the inner member is positioned between the jaws, wherein the filament is severed when the inner member is moved out of alignment with the cutting jaws.  
         [0046]     In further accordance with the invention, a method of treating a cardiac valve is provided. The method includes introducing a catheter through a patient&#39;s vasculature into the patient&#39;s heart, and advancing a distal end of the catheter proximate a leaflet of a cardiac valve of the patient. The method further includes using the catheter to direct a first portion of a filament through the leaflet to capture the leaflet, and attaching a second end of the filament to cardiac tissue proximate an annulus of the cardiac valve. Tension is then applied to the filament to cause the leaflet of the cardiac valve to fold over onto itself until coaptation of the leaflet is established with an adjoining valve leaflet.  
         [0047]     In further accordance with the invention, the leaflet may be attached to the annulus of the cardiac valve using a plurality of connected filaments joined by a retainer.  
         [0048]     The invention also provides a system for treating a cardiac valve of a patient. The system includes a first catheter for directing a first portion of a filament through a leaflet of a patient&#39;s cardiac valve to capture the leaflet, and a second catheter for implanting an anchor into cardiac tissue of the patient displaced from the leaflet. These and other elements can be packaged and sold as a kit with instructions for use, if desired.  
         [0049]     In further accordance with the invention, the system may further include a third catheter for applying a filament lock to the filament after tension has been applied to the filament to change the operation of the cardiac valve. The second catheter may be adapted and configured to receive the filament from the first catheter and direct the filament through the anchor. The third catheter may further include a blade for severing the filament after the filament lock has been applied. If desired, the filament may include suture material. The suture material may include material selected from the group consisting of polypropylene, polyester, nylon, silk and expanded PolyTetraFluoroEthylene, among others.  
         [0050]     The invention also provides a method of implanting a filament in a lumenal system of a patient. The method includes introducing a catheter through a lumenal system of a patient to a location in the patient to be treated. The method further includes advancing a distal region of the catheter proximate a first location and attaching a first portion of a filament to the first location using the catheter. The method further includes advancing the distal region of the catheter proximate a second location and attaching a second portion of the filament to the second location using the catheter.  
         [0051]     In accordance with a further aspect of the invention, the location to be treated is preferably inside of the patient&#39;s heart. The filament may have a predetermined length established outside of the body of the patient. The method may further include determining a length of the filament outside of the body of the patient prior to introducing the catheter into the lumenal system of the patient. The length of the filament may be determined by using an imaging technique. The imaging technique may be selected from the group consisting of echocardiography and fluoroscopy, among others.  
         [0052]     In accordance with still a further aspect of the invention, the first region may be a valve leaflet. The second region may be a papillary muscle. The valve leaflet may be located on the patient&#39;s tricuspid valve.  
         [0053]     The invention also provides a system for implanting a filament in a lumenal system of a patient. The system includes a catheter having an elongate body, the elongate body having a proximal end and a distal end, and an elongate filament. The filament has a predetermined length. The filament further has a first means for attachment to tissue at a first portion thereof and a second means for attachment to tissue at a second portion thereof.  
         [0054]     In further accordance with the invention, the first means for attachment may be adapted and configured to connect the first portion of the filament to a valve leaflet of a patient. The second means for attachment may be adapted and configured to connect the second portion of the filament to cardiac tissue of a patient. The cardiac tissue may be a papillary muscle head of the patient. If desired, at least one of the first means for attachment and second means for attachment may include at least one barb for anchoring into tissue.  
         [0055]     The techniques described herein are especially useful in cases of ruptured chordae, but may be utilized in any segment of prolapsing leaflet. Many of the techniques described herein have the additional advantage of being adjustable in the beating heart. This allows tailoring of leaflet coaptation height under various loading conditions using image-guidance, such as echocardiography. This offers an additional distinct advantage over conventional open-surgery placement of artificial chordae. In traditional open surgical valve repair, chord length must be estimated in the arrested heart and may or may not be correct once the patient is weaned from cardiopulmonary bypass. The technique described below also allows for placement of multiple artificial chordae, as dictated by the patient&#39;s pathophysiology. The methods and systems herein are also suitable for treating other cardiovascular disorders, such as tricuspid valve regurgitation, for example, and as described herein.  
         [0056]     It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention claimed.  
         [0057]     The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the method and system of the invention. Together with the description, the drawings serve to explain the principles of the invention. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0058]      FIG. 1  is a schematic view of a first representative embodiment of a medical device made in accordance with the teachings of the present invention and an associated method.  
         [0059]      FIGS. 2-4  are views of further aspects of the device and method depicted in  FIG. 1 .  
         [0060]      FIGS. 5-10  are schematic views of another medical device made in accordance with the teachings of the present invention illustrating a representative method of valve leaflet capture.  
         [0061]      FIGS. 11-15  are schematic views of a representative embodiment of an anchor delivery catheter made in accordance with the invention and illustrations of an associated exemplary method of delivering an anchor to a location within a patient&#39;s vasculature.  
         [0062]      FIG. 16  is a further schematic depiction of a method carried out in accordance with the invention.  
         [0063]      FIG. 17  is an illustration of a representative embodiment of a catheter for attaching a plurality of sutures to one another in accordance with the present invention.  
         [0064]      FIGS. 18-19  are further schematic depictions of a method carried out in accordance with the invention.  
         [0065]      FIGS. 20-22  are schematic depictions of portions of another method carried out in accordance with the invention.  
         [0066]      FIGS. 23-24  are schematic depictions of representative anchors made in accordance with the present invention.  
         [0067]      FIGS. 25-27  are schematic depictions of another system and method for deploying an anchor and filament in accordance with the present invention  
         [0068]      FIGS. 28-29  illustrate further aspects of anchors made in accordance with the present invention and the manner in which the anchors can be retained in an associated delivery device made in accordance with the present invention.  
         [0069]      FIGS. 30-31  illustrate further embodiments of anchors made in accordance with the present invention.  
         [0070]     FIGS.  32 ( a )- 32 ( b ) illustrate a representative embodiment of a suture or filament lock and associated delivery system made in accordance with the invention.  
         [0071]      FIGS. 33-35  illustrate further representative embodiments of a suture or filament lock and portions of an associated delivery system made in accordance with the invention.  
         [0072]     FIGS.  36 ( a )- 36 ( e ) illustrate a representative embodiments of suture severing devices made in accordance with the present invention in various operating conditions.  
         [0073]      FIGS. 37-42  depict an additional representative method and system carried out in accordance with the teachings of the present invention.  
         [0074]      FIGS. 43-49  depict yet an additional representative method and system carried out in accordance with the teachings of the present invention.  
         [0075]     FIGS.  50 ( a )- 50 ( c ) depict views of various neochordae structures made in accordance with the present invention.  
         [0076]      FIGS. 51-56  depict still additional representative methods and systems carried out in accordance with the teachings of the present invention for capturing a valve leaflet.  
         [0077]      FIGS. 57-60  depict additional representative methods and systems carried out in accordance with the teachings of the present invention for anchoring an anchor and suture in cardiac tissue of a patient.  
         [0078]      FIGS. 61-63  depict still additional embodiments of methods and systems carried out in accordance with the teachings of the present invention for capturing various cardiac tissue with an anchor.  
         [0079]      FIGS. 64-68  depict further representative methods and systems for altering the geometry of a patient&#39;s heart in accordance with the present invention.  
         [0080]      FIGS. 69-73  depict illustrations of an aspect of a representative method carried out in accordance with the teachings of the present invention.  
         [0081]     FIGS.  74 ( a )- 74 ( f ) depict illustrations of still a further representative method carried out in accordance with the teachings of the present invention.  
         [0082]     FIGS.  75 ( a )- 75 ( c ) are representative schematic views of another representative of a device and associated method in accordance with the present invention. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0083]     Reference will now be made in detail to the present preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. The methods and corresponding steps of the invention will be described in conjunction with the detailed description of the system.  
         [0084]     The systems and methods provided in accordance with the teachings of the present invention allow adjustment of the geometry of various portions of a patient&#39;s heart. For example, systems and methods in accordance with the invention permit creation of an artificial mitral valve chord from a ventricular papillary muscle to the valve leaflet by a percutaneous approach and without the use of cardiopulmonary bypass or any need to stop the heart of the patient. The length of this artificial chord can be adjustable until the device used to implant the chord is uncoupled. By way of further example, neochordae of predetermined lengths can also be implanted percutaneously in accordance with the invention. Use of such artificial chordae are useful in myriad other cardiac applications as described herein. It will be appreciated by those of skill in the art that the steps of the procedures described herein need not be practiced in the identical order disclosed herein, but may instead be practiced in any suitable order.  
         [0085]     In accordance with one example, a prolapsing valve leaflet may first be captured to anchor an artificial chord thereto.  
         [0086]     For purposes of illustration, and not limitation, as embodied herein and as depicted in  FIG. 1 , a guide catheter  5  may be directed through a patient&#39;s aorta  1  into the patient&#39;s left ventricle  8 . As depicted in  FIGS. 1 and 2 , a leaflet grasping catheter  110  is advanced through guide catheter  5  toward a prolapsing leaflet  6  of a patient&#39;s mitral valve  9 . Catheter  110  is adapted and configured to pass a filament or artificial chordae, preferably made from suitable suture material, through the prolapsing leaflet  6  as depicted in  FIGS. 3 and 4 .  
         [0087]     While it may be appreciated that any suitable catheter may be used, a description of one embodiment of an exemplary leaflet catheter  110  is depicted in  FIGS. 5-10 . As embodied in  FIGS. 5-10 , leaflet catheter  110  can include a proximal portion  120  connected to a distal portion  140  by way of a rotatable hinge  112 . As depicted in  FIG. 5 , proximal portion  120  includes a proximal end  122 , a distal end  124 , and an elongate body  126  having a sidewall  128  with an inner surface  130 , and outer surface  132  and defining a lumen  134  therethrough. As depicted in  FIG. 6 , distal portion  140  includes a proximal end  142 , a distal end  144 , and an elongate body  146  having a sidewall  148  with an inner surface  150 , and outer surface  152  and defining a lumen  154  therethrough. Lumen  134  is adapted to be in fluid communication with lumen  154 . A continuous elongate slot  114  is defined through sidewalls  128 ,  148 . Catheter  110  also can include a steering mechanism  160  and/or a guidewire lumen  162  traversing the entire length of catheter  110 , or merely along distal portion  140  thereof, as with other rapid-exchange type catheters.  
         [0088]     As depicted in  FIGS. 1-10 , leaflet catheter  110  may be inserted into patient over guidewire  32  and/or through lumen  22  of guide catheter  5 . If desired, leaflet catheter  110  could be introduced through a patient&#39;s vasculature over a guidewire  32  without a guiding catheter  5 . Leaflet catheter  110  is then positioned in a similar manner in the left ventricle  8 , but aiming at the mitral valve leaflets  4 ,  6  as depicted in  FIG. 2 . Distal portion  140  of leaflet catheter  110  is advanced past the mitral valve leaflets  4 ,  6  and caused to rotate about ninety degrees such that the portion of slot  114  in distal portion  140  comes into contact with posterior leaflet  6 , as shown in  FIGS. 5-6 . Suction can then be applied through slot  114  to cause leaflet  6  to be drawn toward distal portion  140  and held in position. Additionally or alternatively, as depicted in  FIG. 8 , a pivotally mounted leaflet retainer  170  can be provided and deployed about pivot  172  using actuator  174  to compress leaflet  6  against distal portion  140 . It will be understood that all embodiments depicted herein can be used to perform surgical procedures on any cardiac valve leaflet. For example, while a number of examples described herein refer to posterior leaflet  6 , the procedures are equally applicable to anterior leaflet  4 .  
         [0089]     With leaflet  6  held stationary, a deployable needle  180  having a piercing tip  182  can be deployed through wall  128  of proximal section, for example, through slot  114  and through edge  7  of leaflet  6  into engagement with a cuff  84  on first end  82  of suture  80  as illustrated in  FIGS. 9-10 . Second end  86  of connecting suture  80  includes a loop  88  through which needle  180  is threaded when needle  180  is deployed. Needle  180  can then be retracted proximally as shown in  FIG. 9 , pulling suture  80  therewith due to the interlocking connection between cuff  84  and tip  182 . By virtue of continuous slot  114 , suture  80  can then be pulled all the way through as depicted in  FIG. 10 , forming a knotted loop about edge  7  of leaflet  6 .  
         [0090]     In addition to direct opposition of the catheter to the leaflet and/or suction applied to the tip of the catheter as described above, other techniques can be used to secure a suture  80  leaflet  6 . For example, the system and method of leaflet anchoring may additionally or alternatively include direct suturing, attachment of a clip to the leaflet edge, deployment of pledget material, or deployment of shaped metal such as nitinol through the leaflet. Some of these techniques are described in detail below.  
         [0091]     In further accordance with the invention, an artificial chordae affixed to a prolapsing valve leaflet is preferably indirectly or directly affixed to another portion of cardiac tissue.  
         [0092]     For purposes of illustration and not limitation, as embodied herein and as depicted, for example, in  FIGS. 11-19 , a first exemplary system and method for affixing artificial chord  80  to cardiac tissue of the patient&#39;s heart is presented. In the method and associated system depicted in  FIGS. 11-19 , chord  80  is affixed to a second chord  60  which, in turn, is affixed to cardiac tissue. In the method and associated systems depicted in  FIGS. 20-35 , chord  80  is affixed to cardiac tissue without the use of a second chord  60 .  
         [0093]     While it will be appreciated that many configurations of a suture delivery catheter useful for affixing a suture to cardiac tissue are within the scope of the invention, for purposes of illustration and not limitation, an exemplary embodiment of such a catheter  10  is depicted in  FIG. 11 . Delivery catheter  10  includes a proximal end  12 , a distal end  14  and an elongate body  16  having an inner surface  18 , and outer surface  20  and defining a lumen  22  therethrough.  
         [0094]     If desired, delivery catheter  10  can be adapted to include a steering mechanism  26  that is operably coupled to an actuator  28  including handle  30  at proximal end  12  of delivery catheter  10 . Steering mechanism  26  can be adapted and configured to provide uniplanar or biplanar deflection. Other types of mechanisms that can be used to facilitate steering include use of magnetic guidance, such as internal opposing-pole magnets or use of an external magnetic field for navigation (e.g., Stereotaxis, Inc). Moreover, if a steering system  26  is not provided, as partially depicted in  FIG. 16 , a guidewire  32  can be provided to traverse the patient&#39;s lumenal system prior to introduction of delivery catheter  10 . After introduction of guidewire  32 , delivery catheter  10  can be introduced by introducing proximal end  34  of guidewire  32  into distal end  14  of catheter  10  and through lumen  18 . If desired, a second lumen  24  can be provided in delivery catheter  10  for purposes of introducing over guidewire  32 . If a second lumen  24  is provided, second lumen  24  can traverse the entire length of catheter  10  or only a distal portion thereof as with other “rapid-exchange” type catheters. By way of further example, lumen  24  can traverse the entire length of catheter  10  but be provided with one or more intermediate exit ports  25  between distal port  23  and proximal port  27  of lumen  24 . Moreover, if a steering system  26  is not provided, the delivery catheter can be introduced through the lumen of a guide catheter with a steering system  26 .  
         [0095]     Delivery catheter  10  and other catheters described herein can be made from a variety of materials. For example, various polymeric materials may be used, such as nylon and the like. Moreover, it is possible to construct delivery catheter  10  from a multilayer tubular structure incorporating an inner layer of lubricious material, such as HDPE or PTFE and an outer layer of nylon or other comparatively stiff polymeric material. If additional stiffness is required, one or more stiffening wires  41  can be melted into the plastic forming catheter, and/or a layer of braided material, such as stainless steel, can be incorporated be incorporated between successive polymeric layers or melted into or extruded with a single layer of polymeric material. Moreover, a proximal portion of catheter  10  or other catheters described herein can be made at least in part from hypodermic needle tubing “hypotubing” to impart additional stiffness thereto, as desired.  
         [0096]     In use, delivery catheter  10  is introduced into the arterial system of a patient e.g., by way of the femoral artery. Delivery catheter  10  can then be advanced through the arterial system and through the aortic valve into the left ventricle  8 , for example, as depicted in  FIG. 16 . Delivery catheter  10  can be steered using uniplanar or biplanar deflection via steering mechanism  26 , if provided. Catheter  10  can also be steered by passage through an outer guide catheter or sheath  5  which may include a steering mechanism  26 . Catheter  10  can be positioned using image guidance such as echocardiography, adjacent to a papillary muscle head  2  as depicted in  FIGS. 12 and 16 .  
         [0097]     Next, an anchor  50  is provided attached to a length of suture material  60 . Anchor  50  with suture  60  attached thereto is anchored into the papillary muscle  2  as depicted in  FIGS. 12-16 . Anchor  50  includes a helically shaped coil body having a plurality of turns  52  with a distal piercing end  54 . A variety of suitable anchors  50  can be used to anchor into the papillary muscle  2 . For example, it is also possible to anchor by way of direct suturing, various anchors such as screws, helixes, clips, pins and the like, as described in further detail below. Anchor  50  can be made from a variety of materials such as stainless steel and other metals and composite and/or bioresorbable materials, such as Dacron, Teflon, polypropylene, polytetrafluoroethylene (PTFE), polyvinylchloride (PVC), polydimethylsiloxane, poly(l-lactide), poly(dl-lactide), poly(dl-lactide-co-glycolide), poly(l-lactide-co-dl-lactide), poly(glycolide-co-trimethylene carbonate). Anchor  50  can additionally or alternatively include radiopaque and/or echodense material to facilitate visualization thereof using fluoroscopic or echocardiographic imaging techniques as an aid in implantation. It will be further appreciated by those of skill in the art that anchor  50  need not be helical, but may be formed in any suitable shape for acting as a tissue anchor.  
         [0098]     It is also possible to construct anchor  50  from shape memory material, such as nitinol, wherein anchor can be adapted and configured to deploy and expand inside the tissue of papillary muscle  2  to secure suture  60  in place. Moreover, pledget material could be used to facilitate attachment, as described below. Anchor  50  can additionally be provided with one or more barbs  56  (as depicted, for example, in  FIG. 11  in a deployed position) to prevent backout of anchor  50  from the papillary muscle  2 . If anchor  50  is made from shape memory material such as nitinol, barbs  56  can be adapted and configured to deploy when they reach body temperature. If anchor  50  needs to be removed from the patient after installation, it is possible to locally cool anchor  50  with a cooling device to cause barbs  56  to retract. This can accordingly reduce tissue damage in the event of removal of anchor  50 .  
         [0099]     Sutures  60 ,  80  are preferably nonabsorbable, permanent and made from a material that is not likely to cause formation of thrombi thereon. Suitable materials for suture  60  can include, for example, expanded polytetrafluoroethylene (“ePTFE”), obtainable, for example, from W.L. Gore &amp; Associates (Newark, Del.). Preferably, the node and fibril dimensions of the ePTFE suture material will be of suitable dimensions to permit tissue ingrowth therein, such as those described in U.S. Pat. No. 6,436,135 to Goldfarb, the disclosure of which is incorporated herein by reference in its entirety. Other materials can also be used to form sutures herein, either monofilament or polyfilament braided, including polypropylene, polyester, nylon, and silk. Suture  60  can additionally or alternatively include radiopaque and/or echodense properties to facilitate visualization thereof using fluoroscopic or echocardiographic imaging techniques as an aid in implantation.  
         [0100]     Anchor  50  and suture  60  can be passed through lumen  22  of delivery catheter  10  using an inner catheter  70  disposed inside lumen  22  as depicted in detail, for example, in  FIG. 13 . Inner catheter  70  includes a proximal end  72  having a handle  73 , a distal end  74  and an elongate body  75 . Inner catheter  70  further includes an anchor engaging portion  76  (e.g., a groove or the like) to engage with anchor  50 . As depicted in  FIG. 13 , fitting  76  includes a groove that is adapted and configured to engage an engagement portion  58  of anchor  50 . By applying a torque T to handle  73 , anchor  50  is screwed into papillary muscle  2 . Additionally, the distal tip  14  of catheter  10  may incorporate one or more guides  14 ( e ) on the inner surface  14 ( d ) to facilitate appropriate helical/forward motion of anchor  50 . This may include, for example, a spiral groove to accommodate helical anchor and/or may include a series of spaced protruding members or knobs  14 ( e ) on the inner surface of catheter  10  to guide the forward movement of anchor  50 . Providing guides  14 ( e ) can be advantageous as it helps ensure that anchor  50  will not be pushed out of the end of catheter  10  without sufficiently implanting it, and also ensures that anchor  50  is advanced distally as it is rotated at an appropriate rate (e.g., the pitch of the threads of anchor  50 ) to prevent maceration of tissue and helping to ensure a successful implantation.  
         [0101]     Elongate body  75  may include a plurality of cuts therein to provide regions of varying flexibility. For example, it by be desirable for a distal region of elongate body  75  to be more flexible than a proximal region thereof. To accomplish this, a plurality of longitudinal and or radial slots  75   a  may be disposed therein. Suitable configurations of slots  75   a  are described, for example, in U.S. Pat. No. 5,477,856, which is incorporated by reference herein in its entirety. By way of further example, varying stiffness of any portion of any catheter described herein can be supplied in accordance with the teachings disclosed in U.S. Pat. Nos. 5,399,164, 5,605,543, and 5,674,208, for example. Each of these patents is hereby incorporated by reference herein in its entirety.  
         [0102]     After anchor  50  is secured in papillary muscle  2 , inner catheter  70  can be withdrawn from the patient. As depicted, after removal of inner catheter  70  and leaflet catheter  110 , sutures  60  and  80  traverse the entirety of lumen  22  to a point outside of the patient. As a variation, it is possible to coil suture about distal end  74  of inner catheter  70  such that it uncoils as catheter  70  is withdrawn proximally through lumen  22  and out of catheter  10 . If desired, delivery catheter  10  can next be withdrawn from the patient, leaving a trail of suture material  60  through the vascular system and outside of the patient as depicted in  FIG. 5 . While catheters  10 ,  110  have been depicted herein as discrete devices, it is within the scope of the invention to have all functions performed by these catheters to be performed by a single catheter to facilitate the procedure.  
         [0103]     Next, as depicted in  FIGS. 17-19 , a fastening catheter  210  may be introduced through guide catheter  5  to the operating site in order to facilitate attachment of sutures  60 ,  80  to each other to form an artificial chordae. As depicted in  FIG. 17 , fastening catheter  210  includes a proximal end  215 , a distal region  214  and an elongate body  216  that can include a lumen  218  therethrough. Distal region  214  of catheter  210  can also be provided with a device  220  disposed proximate distal tip  212  for attaching the sutures  60 ,  80  to each other to form an artificial valve chord, described in detail below. In operation, fastening catheter  210  can be introduced over or along side of sutures  60 ,  80  and positioned in the left ventricle  8 .  
         [0104]     If delivery catheter  110  or other guiding catheter is not used and sutures  60 ,  80  are exposed to the patient&#39;s bloodstream, catheter  210  can be introduced alongside sutures  60 ,  80  if, for example, catheter  210  is provided with a steering mechanism as disclosed herein or inserted over guidewire  32 . Catheter  210  can alternatively be introduced over guidewire  32  by inserting guidewire  32  through lumen  218 . Lumen  218  can traverse the entirety of the length of catheter  210  or a portion thereof. By way of further example, if lumen  218  traverses the entirety of catheter  210  it can be provided with one or more exit ports  219  located proximate distal end  214  of catheter  210 . Alternatively, catheter  210  can be introduced over one or more of sutures  60 ,  80  by threading sutures through lumen  218  and introducing catheter over sutures. In this embodiment, it can be advantageous to use an exit port proximate the distal end of the catheter to facilitate introduction.  
         [0105]     Alternatively, it may be desired to leave delivery catheter  10  (or other guiding catheter) in place so that sutures  60 ,  80  traverse the length of lumen  22 . Catheter can accordingly be introduced either independently of sutures  60 ,  80 , or over sutures  60 ,  80  as described above.  
         [0106]     Once the proximal ends  61 ,  81  of sutures  60 ,  80  have been exteriorized from the patient, they can be manipulated by the operator as depicted in  FIG. 18 . Next, the distal tip  212  of catheter  210  is positioned below the mitral valve  9  between the two previously placed anchor points of sutures  60 ,  80 . Tension is applied to each of the sutures  60 ,  80  by the operator such that they are coupled proximate the distal end  212  of catheter  210 . Sutures  60 ,  80  can be brought into proximity by virtue of threading them through lumen  218  or lumen  22 , as desired. At this point, sutures  60 ,  80  effectively form a single length of suture running from anchor point  311  on the papillary muscle head to the anchor point  12  on the mitral valve leaflet  6 , as depicted in  FIG. 19 . The length of this combined artificial chord  260  can be adjusted by altering the amount of suture material  60  from papillary muscle  2  to catheter  210  and/or the amount of material from leaflet  6  to catheter  210 . Preferably, this procedure is performed under image guidance such as echocardiography in order to be certain that the length of chord  260  is correct. The operator can determine the correct length of chord  260  by experimentation. That is to say, the length of suture  260  can be adjusted until the operator is satisfied that artificial chord  260  is at a suitable length to reduce, and preferably minimize, mitral valve regurgitation.  
         [0107]     Once the desired length of suture  260  is achieved, the two sutures  60 ,  80  are affixed to one another by fastening device  220  located at distal end  214  of catheter  210  as shown in  FIG. 19 . Fastening device  220  can accomplish this function in a variety of ways. For purposes of illustration and not limitation, as depicted in  FIGS. 17 and 19 , a clip or fastener  230  can be deployed by fastening device  220 . Fastening device  220  can be actuated by an actuator  213  mounted on a handle  211  disposed at the proximal end  215  of catheter  210 . The tails of sutures  60 ,  80  are cut by a cutting mechanism  221  disposed on fastening device  221  and removed, then catheter  210  is removed. The patient is now left with a single artificial chord created by the union of two separately placed sutures. Additional artificial chordae  260  may be placed, as dictated by the clinical situation. More generally, fasteners  230  as depicted herein may include any suitable clip or suture that can mechanically compress two or more sutures together without slipping once the clip is attached. Alternatively, the chordal sutures can be permanently joined by thermal or chemical means.  
         [0108]     By way of further example, still further embodiments of systems and methods in accordance with the present invention are provided.  
         [0109]     With continued reference to  FIGS. 1-4 ,  FIG. 1  illustrates the left-sided structures of the heart, including aorta  1 , left ventricle  8 , papillary muscle  2 , left atrium  13 , and mitral valve  9  including posterior mitral leaflet  6 , and anterior mitral leaflet  4 . A guide catheter  5  is shown in the aorta  1 , traversing the aortic valve to enter the left ventricle  8 . Preferably, guide catheter  5  will be deflectable to allow for steering and positioning, although it is within the scope of the present invention to use multiple guide catheters of fixed or variable shapes could also be used to position the described devices. The guide catheter  5  is shown positioned in the left ventricle  8  in order to achieve a repair of the mitral valve  9 .  
         [0110]     As depicted, the guide catheter  5 , once in the ventricular cavity, is directed toward the atrioventricular (mitral or tricuspid) valve leaflet edge using image guidance, as illustrated in  FIG. 2 . This image guidance may include, but is not limited to, echocardiography, fluoroscopy, computed tomography, magnetic resonance imaging, and intracardiac imaging utilizing technology such as catheter-based infrared imaging. A leaflet catheter (e.g.,  110 ) is passed through the guide catheter  5  and the prolapsing valve leaflet segment  6  is engaged by the catheter and a nonabsorbable suture  180  is anchored to the leaflet edge as shown in  FIGS. 3-4 . As embodied herein, the leaflet  6  may be engaged by one of several methods including direct opposition of the catheter to the leaflet, suction applied to the tip of the catheter, a snare positioned on the atrial side of the leaflet  6 , or a cross-bar to catch the underside of the leaflet, and the like. The system of leaflet anchoring may include but is not limited to direct suture, attachment of a clip to the leaflet edge, deployment of pledget material, or deployment of shaped metal such as nitinol through the leaflet. As described herein, suture  180  is formed from a permanent, flexible and relatively inelastic biocompatible material such as ePTFE but other suitable materials that may be used as described herein. Multiple such sutures may be placed as deemed appropriate to achieve repair of the dysfunctional valve  9 .  
         [0111]     Next, the leaflet catheter is withdrawn through the guide catheter  5  such that the suture  180  affixed to the leaflet is traverses the length of the guide catheter  5  and is exteriorized as depicted in  FIG. 4 . If multiple guide catheters are to be used, the guide catheter can be removed from the patient, leaving the proximal end of the suture exteriorized through the arterial access sheath. Subsequent catheters may then be passed either over or alongside the existing suture for the remainder of the procedure.  
         [0112]     As depicted in  FIG. 20 a  second delivery catheter (such as catheter  70  depicted herein) can be passed through guide catheter  5  and positioned toward one of the papillary muscles  2 . The correct positioning and appropriate papillary muscle  2  is directed using the image guidance as described for the leaflet capture. The delivery catheter places a papillary muscle anchor  150  into the papillary muscle head  2 . In the presently preferred embodiment, the papillary muscle anchor  150  has a permanently attached suture fastener through which the previously placed suture  180  is passed as depicted in  FIG. 21 . This can be loaded upon initially passing the second delivery catheter into the patient. If multiple sutures  180  had been placed into the valve leaflet, these may all be passed through the fastener  150  of a single papillary muscle anchor or may be passed individually through separate anchors  150 , depending on the anatomic situation.  
         [0113]     Next, as depicted in  FIG. 21 , the length of the artificial chorda(e), can be adjusted by applying tension to a the suture  180 , which was previously exteriorized through the guide catheter or arterial access sheath  5 . The fastener  150  acts as a grommet, or fulcrum, such that the artificial chorda(e)/suture  180  now forms a straight line from papillary muscle anchor  150  to the leaflet attachment site  12 . The length of the artificial chorda(e) can be adjusted under the image guidance previously described by altering the amount of applied tension to the end of the suture. Once the appropriate length of suture is reached to achieve the desired clinical effect, the fastener  150  is secured to fix the length of the suture/artificial chorda(e)  180 , the suture  180  is cut proximate to the fastener  150 , and the guiding catheter  5  is removed, leaving a fixed length artificial chord  180 , as depicted in  FIG. 22 .  
         [0114]     As depicted in  FIGS. 23-24 , a first embodiment of anchor member  150  includes a first or anchor portion  152  for anchoring into papillary muscle head  2  coupled to a suture lock  156  by way of a connecting portion  154 . As depicted, the suture  180  previously passed through leaflet  4  can be passed through the lumen lock portion  156  of anchor  150  before anchor  150  is passed into the patient through the guide catheter, thus facilitating chordal length adjustment. As will be appreciated, anchor  150  can take on a variety of forms conducive to this type of procedure. After an appropriate length has been determined for the suture  180 , the lock portion  156  can be crimped or otherwise caused to bear down on suture, locking it in place. This and other embodiments of lock  156  are described in detail more fully below.  
         [0115]     By way of further example, anchor  150  can be formed of a shape memory material such as nitinol. Anchor  150  can be fixed in a larger diameter configuration until deployed, then assume a resting state of a smaller inner diameter sufficient to lock the suture(s) in place, for example, between turns  158  of coil making up guide portion  156 , or by guide portion contracting and bearing down on suture  180 . If desired, one or more barbs  156 ( a ) can be provided to prevent the back out of anchor. If formed of shape memory material, for example, barbs  156 ( a ) may be adapted and configured to deploy after implantation as described herein.  
         [0116]     By way of further example, an additional embodiment of an anchor  250  and an associated method of implantation are illustrated in  FIGS. 25-27 . As depicted in  FIGS. 25-27 , suture  180  is not attached to the anchor  250  directly, but uses a coupling  260  operatively associated with anchor  250  whereby the suture  180  extending from the leaflet  6  which has been previously exteriorized from the body is passed through this coupling  260  that is attached to the anchor  250 . Thus, once the anchor  250  is deployed by way of catheter  10 , the coupling  260  acts as a guide or fulcrum whereby pulling on the suture  180  outside the body urges catheter  10  and/or guide catheter  5  against the papillary muscle  2  to facilitate adjusting the length of suture/artificial chord  180  from anchor  250  to leaflet  6 .  FIG. 25  depicts the anchor delivery catheter  10  (which, as will be understood by those of skill in the art, can be passed through the same deflectable guide catheter or sheath  5  used to pass the leaflet delivery catheter  110 ) containing anchor  250 , actuating rod  75  affixed to torquable handle  73  and a coupling member  260 . The coupling member  260  can be a simple ring or figure-eight ring, or other suitable shape, that is temporarily affixed to the end of catheter  10 . The coupler  260  accommodates both the tip of the anchor  250  and the suture  180  from the leaflet  6 .  
         [0117]     As seen in  FIG. 26 , as the anchor  250  is rotated and advances through the papillary muscle tissue, the coupler  260  stays fixed relative to catheter  10  and winds down the anchor  250  from its distal tip  254  to its proximal end  252 . The proximal end  252  of the anchor  250  is closed upon itself to prevent the coupler  260  from coming off the end. Thus, as depicted in  FIG. 26 , as the anchor  250  is driven into the papillary  2 , the coupler  260  stays on the outside of the papillary  2 . Moreover, by staying in a fixed position as the anchor  250  rotates, the suture  180  is prevented from becoming entangled by the rotating mechanism of the anchor  250 . The suture  180  can then be freely adjusted in length until the operator is ready to fix the suture in position by a locker as described herein, or other suitable method. Once the anchor  250  is fully deployed in to the papillary  2 , the entire assembly, including the coupler  260 , may be released from the delivery catheter as shown in  FIG. 27 .  
         [0118]      FIGS. 28-29  depict further embodiments illustrating different methods of temporarily fixing the anchor coupler  260  in the tip of the delivery catheter  10 . The distal tip portion  14  of delivery catheter  10  can be a short segment of hypotube affixed to delivery catheter  10  or simply be made from a plastic and/or composite material (e.g., carbon fiber reinforced material) having stiffer properties than the certain other portions of the catheter  10 . For example, if made of nylon, delivery catheter can include a distal tip portion made of stiffer nylon than more proximal segments of the delivery catheter  10 . FIGS.  28 ( a )- 28 ( c ) depict the coupler  260  as a simple ring, with one half inside the distal region  14  of the delivery catheter  10  and one half outside thereof.  FIG. 28 ( a ) represents a schematic side view of the distal region  14  of the delivery catheter,  FIG. 28 ( b ) represents a top view of the distal region  14  without the coupler  260  in place, and  FIG. 28 ( c ) depicts an end view of the distal region of the catheter  10  with the coupler  260  in place.  FIG. 28 ( b ) clearly indicates the distal region  14  having two cutout slots  262 , each slot  262  being defined by a rounded coupler receiving portion  262 ( a ) and a slightly narrower groove portion  262 ( b ) connecting the coupler receiving portion to the extreme distal tip  14 ( a ) of catheter  10 . In operation, coupler  260  is securely held in place by coupler receiving portions  262 ( a ) while the anchor  250  is still in the catheter  10 , but can be pushed out through groove portions  262 ( b ) by deflecting the material from which distal region  14  is formed once the anchor has been deployed.  
         [0119]     The anchor  250  is preferably preloaded in the delivery catheter  10  such that the tip of anchor  250  is passed through the a lumen  264  of the coupler  260 , ensuring that forward rotation of the anchor maintains the coupler on the anchor. FIGS.  29 ( a )- 29 ( c ) show a similar set of schematics wherein the coupler  260  is of a figure-eight shape rather than a simple ring, with one lumen  264  for the anchor  250  and one for the suture  180 . By using one of these couplers  260  in combination with a suture locking mechanism (described in detail below) that is larger in diameter than the lumen  264  of the coupler  260  can effectively secure the length of the suture/artificial chord  180 .  FIGS. 30-31  depict still further embodiments of anchor  350 . Anchor  350  is similar to the anchor  150  depicted in  FIGS. 23-24 , except that anchor  350  further includes coupler  360  and lock  356 . Lock  356  is similar to lock  156  described above, and to the locks described in detail below.  
         [0120]     In further accordance with the invention, a suture locking system is provided to lock a suture into place to maintain tension on an artificial chord(ae).  
         [0121]     For purposes of illustration and not limitation, as embodied herein and as depicted in  FIGS. 32-35 , a variety of suture lock or retainers  400  and supporting devices are depicted. As depicted in FIGS.  32 ( a )- 32 ( b ), a first representative embodiment of a suture lock or retainer  400  is depicted. The suture  180  is seen passing through the coupler  260  on the anchor  250 . Suture  180  is further directed through an inner catheter  410 , preferably having a rigid distal tip  414  as described herein. Inner catheter  410  is accordingly slidably disposed within a lumen of an outer catheter  420 . As is further depicted, a lock  400  is provided that is adapted and configured to radially contract from a first, larger diameter condition to a second, smaller diameter condition. As depicted, lock  400  is maintained in the first condition by virtue of lock  400  being wound around inner catheter  410 , which has an outside diameter that is larger than that of suture, since suture passes through a lumen defined by inner catheter  410 . As inner catheter  410  is withdrawn proximally into the distal end  424  and interior of the lumen  426  of outer catheter  420 , lock  400  is pushed off of inner catheter  410  and permitted contract into its second, smaller diameter condition about suture  180 , thereby clamping itself about suture  180 . Preferably, the lumen  426  of outer catheter  420  is substantially smaller than the outer diameter of lock  400  when lock  400  is in its second condition. As depicted, lock  400  is a coil but could include of a number of different suitable shapes and materials—preferably shape memory material such as nitinol that will assume a fixed shape when pushed off of the inner catheter  410 . Rapid exchange ports  418 ,  428  can be provided in each of inner catheter  410  and outer catheter  420 , respectively, a substantially large distance from the proximal ends  412 ,  422  of catheters, but a substantially short distance (e.g., about 5, 10, 15, 20, 25 or 30 cm.) from the distal ends  414 ,  424  of catheters  410 ,  420  to permit ready introduction of catheters  410 ,  420  over suture  180  to facilitate applying a lock  400  to suture  180 . If desired, suture  180  may include or be attached to a relatively stiff elongate member (e.g., stylet  423  via clips  423 ( a )) to facilitate passage of suture  180  through the lumen of any catheter embodied herein. Catheters  410 ,  420  can additionally include a suture severing mechanism for severing suture  180  when a procedure is complete. Exemplary embodiments of severing mechanism are described in detail below.  
         [0122]      FIGS. 33-35  depict further exemplary locking mechanisms  400 . The embodiment of  FIG. 33  uses a constraining inner catheter  410  as with the embodiment depicted in  FIG. 32 , but additionally uses a buckle and spring mechanism. The spring  402  (represented by the open circle) is forced into an open position by virtue of the leg portions  404  of lock  400  being splayed apart by surrounding the rigid inner catheter (made from a stiff material, e.g., hypotube) through which the suture  180  passes. As the inner catheter  410  is withdrawn into outer catheter  420 , the spring  402  assumes its resting position, trapping the suture  180  and locking it in place.  
         [0123]     A second filament lock  400  is depicted in  FIG. 33 , comprising a pair of jaws  411  that are biased toward each other. When deployed, jaws  411  clamp down on suture  180 .  
         [0124]     The embodiment depicted in  FIG. 34  utilizes a rigid inner catheter  410  (e.g., containing a hypotube), but uses a tube  400  of nitinol or similar shape memory material that is held open by the inner catheter  410 , but when released from the inner catheter  410  assumes its resting position, which in turn crimps the suture  410 .  
         [0125]     By way of further example, the embodiment depicted in  FIG. 35  includes an active crimping mechanism that plastically deforms lock  400  about suture  180 . For example, lock may be pushed into place by the combination of an inner catheter  410  and an outer catheter  420 . However, lock  400  does not ride on inner catheter  410 . A crimping mechanism  430  is disposed about and in operable association with the distal region  414 ( a ) of inner catheter, wherein jaws  432  of crimping mechanism  430  bear down on lock  400 , for example, when outer catheter  420  is slid over crimping mechanism  430 .  
         [0126]     FIGS.  36 ( a )- 36 ( c ) depict an exemplary embodiment of a suture cutting mechanism  500 . Cutting mechanism can be incorporated into a catheter used to deliver lock  400 . Accordingly, cutting mechanism can be incorporated into inner catheter and/or outer catheter  420 , as desired. Inner catheter  410  preferably includes a substantially stiff distal region  414   a  (including hard plastic and or a hypotube, for example) as described above. As depicted, inner catheter  410  holds apart two curved blades  510  that are mounted on pivots or hinges  512  in the lumen of outer catheter  420 . The resting position of blades  510  is preferably a closed position, as depicted in  FIG. 36 ( c ). Blades  510  are preferably forced open by inner catheter  410  when inner catheter  410  is positioned between blades  410 . As the inner catheter  410  continues to be withdrawn proximally as depicted in  FIG. 36 ( b ), blades  510  are no longer held apart by inner catheter  410  and are urged together fall on the suture  180 . The cutting action can be completed by pushing inner catheter  410  distally such that blades  510  are received by inner lumen  416  of inner catheter  410  to force the blades  510  closed.  
         [0127]     It will be appreciated that a variety of other means may be used to cut suture  180  to a desired length percutaneously. By way of example only, as depicted in  FIG. 36 ( d ) catheter  570  includes a blade  572  that can be used to sever a filament/suture  180 . By way of further example,  FIG. 36 ( e ) depicts still a further suture cutting catheter  580  including an elongate body defining a lumen  581  therethrough having a retractable hook  584  adapted and configured to capture and drag suture  180  inside of lumen  581  to a blade  582  disposed near the distal end  585  of the catheter  580  to sever the suture  180 .  
         [0128]     In further accordance with the invention, still further alternative embodiments of devices and methods in accordance with the invention are provided.  
         [0129]     For purposes of further illustration and not limitation, as embodied herein and as depicted, in  FIG. 37 , a further embodiment of a device for ensnaring a prolapsing valve leaflet  6  is provided. A delivery or guide catheter  610  contains two smaller diameter catheters. One of these catheters  622  houses a needle tip  623  at its distal end, with attached suture  624 . As in the previous embodiment, the suture is of sufficient length to traverse the length of the delivery catheter  621 , and has a loop  625  located on the end. The second catheter  626  is a snare catheter, with the snare element  627  lying perpendicular to the catheter  626  when in the open position. This catheter  626  passes through the loop  625 .  
         [0130]     The snare catheter  626  is positioned beyond the valve leaflet (e.g.,  6 ), then catheter element  622  is advanced through the leaflet and through the middle of snare element  627 , as illustrated in  FIG. 38 .  FIG. 39  illustrates the catheter  622  separated from the needle tip  623  and withdrawn back through the leaflet and into the delivery catheter  621 , leaving the suture  624  through the leaflet and snare element. The snare element  627  is tightened, as illustrated in  FIG. 40 , to capture the suture  624 .  
         [0131]     The snare catheter  626  is then withdrawn into the delivery catheter  610 , pulling the suture  624  through its own end loop  625 , as shown in  FIG. 41 . The catheter  626  is withdrawn until the suture end with attached needle tip  623  are exteriorized from the patient and the loop assembly  625  forms a point of fixation on the leaflet  6 . The delivery catheter  610  and its contents are then removed, leaving the suture  624  affixed to the leaflet  6  and the other end of suture  624  exteriorized from the patient for further manipulation as shown in  FIG. 42 .  
         [0132]     An additional embodiment of a system utilizing such a snare method may be constructed as depicted in  FIGS. 37-42  but without the use of suture loop  625 . In brief, the suture used in such an embodiment is necessarily greater than twice the length of the delivery catheter  610  and after the end  623  of the suture is captured by the snare and withdrawn, the operator is left with two ends of suture. Both these ends will be passed through the papillary muscle anchor (e.g.,  50 ) such that the resultant artificial chord  180  consists of two lengths of suture which passes through the leaflet at a single point.  
         [0133]     Specifically, and as depicted in  FIGS. 43-49  yet another embodiment of the snare system and method is shown, whereby the delivery catheter  621  houses two internal catheter elements  622  that are each constructed with a needle tip  623  at an end thereof, with each tip  623  fastened to the end of a single length of suture material  624 . The suture  624  loops around a third catheter element  626  that houses a snare  627 . These catheter elements  622  may also be formed into a single bifurcated unit as depicted in  FIG. 44 . Each tip  623  is spaced at a defined distance from the other, most preferably from about 2 mm apart to about 5 mm apart. The delivery catheter  621  is adapted and configured to orient the tips  623  parallel to the leaflet edge so that each tip passes through the leaflet  6  at about the same distance from the edge. Once both tips  623  are through the leaflet and snared ( FIGS. 46-49 ), withdrawing the snare catheter will cause the suture to pass through its own loop formed by passing around catheter  626 . This loop will then pull snug against the leaflet edge, securely fastening the suture to the leaflet  6 . The new chordae will then include two ends of suture brought through the papillary muscle anchor (e.g.,  50 ).  
         [0134]     Thus, as embodied herein, the snare catheter embodiments describe several ways of implanting artificial chordae. This is illustrated in detail in FIGS.  50 ( a )- 50 ( c ). In  FIG. 50 ( a ), a single length of suture  180  passes through its own distal loop  182  before being secured to the papillary muscle anchor  50 . In  FIG. 50 ( b ), a simple suture  180  directed through the leaflet  6  leaves two ends of suture  180  to secure to the papillary muscle anchor  50 . In  FIG. 50 ( c ), two ends of the same suture  180  are passed through the leaflet  6 , then pass through their own loop before being secured at the papillary muscle anchor  50 .  
         [0135]     As depicted in  FIGS. 51-52 , by way of still further example, designs for the leaflet delivery catheter  110  using the snare approach described herein can include a simple point assembly  113  with attached suture  180  where the suture is captured by the snare or a tip assembly that itself is grasped by the snare. In the former, an example of which is illustrated in  FIG. 51 , a catheter  110  a houses a sharp tip  113  with attached suture  180 . The lumen of catheter  110  houses a pushrod or stiff wire  115 . Once passed through the leaflet  6  and open snare  117 , the pushrod  115  ejects the tip  113  from catheter  110 , allowing suture  180  to be captured by the snare without entraining catheter  110 . The tip assembly depicted in  FIG. 52  includes a sharp tip element  113  with attached segment  113 ( a ) that can detach from catheter  110 . The segment  113 ( a ) can be, for example, a tightly wound coil or a segment of material with non-brittle properties such that it remains straight when pushed from the end, but will fold when grasped in its mid-section. For example, a metal coil would be suitable. The suture  180  can be attached either to the tip  113  or segment  113 ( a ). Thus, once passed through the leaflet and grasped by the snare  117 , the assembly  113 ( a ) can easily be folded in half (since it is made from a coil) and be pulled into the lumen of snare catheter  121  before being withdrawn through the body, thus increasing the safety of pulling the sharp tip  113  back through a guide catheter (e.g.,  5 ).  
         [0136]     An additional embodiment of a leaflet capture device include the use of a catheter  710  with hollow-bore needle  728  at its distal end that traverses the valve leaflet (e.g.,  4 ), as illustrated in  FIG. 53 . Contained within this catheter and needle assembly are the suture  729  and an anchoring element  730 , as depicted in  FIG. 54 . The anchoring element  730  may be a compressed pledget of felt, fabric, or similar material with either nonabsorbable or bioabsorbable properties. This will fit within the delivery catheter  710  and needle assembly  728 , be deployed by a pushrod element, then either unfurl or expand to prevent it from pulling back through the tract created by the needle. The needle  728  is withdrawn once the pledget is deployed, leaving the pledget anchor on the far side of the leaflet and the suture  729  exiting the near side of the leaflet. This anchor can also include a flat disc of metal or similarly rigid material that in its resting state assumes a flat shape with the suture affixed at its mid point. The disc can be rolled around the suture such that its profile will fit within the needle  728  until it is deployed as shown in  FIG. 54 .  
         [0137]     Moreover, multiple possible anchors can be deployed using this method, such as a T-bar anchor  731  that has the suture fixed at its mid-point and is fashioned of a rigid material. Such an anchor  731  preferably will lie vertical within the needle shaft, then rotate horizontal when deployed as depicted in  FIG. 55 . As depicted in  FIG. 56 , a suitable anchor  732  may also be fashioned of a material with shape memory properties, such as nitinol. Such an anchor can lie compressed within a lumen  728   a  of the needle assembly  728  until deployed from the needle tip, then assume its non-compressed state to act as an anchor  732 .  
         [0138]     As depicted in  FIGS. 57-60  in yet another embodiment, the use of a hollow-bore needle  742  affixed to a catheter  710  for placement of papillary muscle anchor is illustrated. Needle  742  is passed through the papillary muscle  2  after which an anchor (e.g.,  743 ,  744 ,  745 ) is pushed out of lumen  712  of the catheter  710  and needle  742  to deploy on the distal side  2   d  of the papillary muscle  2 . By way of example, anchors may be constructed of pledget material or a flat disc  743  as depicted in  FIG. 58 . A T-bar  744  may also be used as depicted in  FIG. 59 , or an anchor  745  of shape memory material such as nitinol may be used as depicted in  FIG. 60 .  
         [0139]     A further embodiment of papillary muscle anchoring method may be by direct suture of the papillary muscle  2  using a device similar to that in  FIG. 5  or  FIG. 37 .  
         [0140]     In accordance with another embodiment, as depicted in  FIGS. 61-63 , an anchor  850  is provided that may be used for either leaflet capture or as a papillary muscle anchor. Anchor  850  is formed of a shape memory material such as nitinol or a material with analogous physical properties. Anchor  850  can be constrained in a catheter  810 , with attached suture  860  and a solid or hollow-bore push rod  870 . Once the delivery catheter  810  is positioned firmly against the leaflet  4 ,  6  or papillary head  2 , the pushrod  870  is extended, driving the sharp points  852  of the staple anchor  850  into the target. Once free of the constraints of the outer delivery catheter, the anchor  850  assumes its resting memory position as depicted in  FIG. 62 , capturing the leaflet or papillary muscle. The delivery catheter  810  is then withdrawn as depicted in  FIG. 63 , leaving the anchor  850  and attached suture  860 .  
         [0141]     While the systems depicted herein are generally described for repair of a regurgitant and prolapsing mitral or tricuspid valve, these systems may also be used for valve repair in other circumstances.  
         [0142]     For example, restricted leaflet motion, as may occur in dilated, ischemic, or rheumatic disease, may be addressed by one of several means. A method treating this condition will now be described. First, an artificial chordae may be placed as described herein, and the native restrictive chordae may then be cut, releasing the tethered portion of the valve leaflet. This will result in a valve leaflet with an increased range of motion.  
         [0143]     With reference to  FIG. 64 , by way of further example, an anchor  950   a  can be placed to the papillary muscle  2  and a second anchor  950   b  can be applied to the mitral valve annulus  1350 , then the suture  960  joining them may be tightened to alter the geometric relationship of papillary muscle  2  to mitral valve  9 , loosening the tethered native chordae.  
         [0144]     As depicted in  FIGS. 65-68 , anchors  1050  may be implanted into one or both papillary muscles  2  and an additional anchor or anchors  1050  may be implanted in the ventricular septum  319 , then the suture(s)  1060  between these anchor points may be tensioned and fastened in a manner analogous to that described for the artificial chordal adjustment. This technique is illustrated in a long-axis left ventricular view in  FIG. 68  and in short-axis left ventricular views in  FIGS. 65-67 . This will create a catheter-delivered endoventricular restraint, reducing the septal-lateral dimension of the ventricle and reversing valvular regurgitation due to ventricular dilation.  
         [0145]     The devices and systems described herein can be used for percutaneous repair of mitral valves arising from degenerative mitral valve disease as well as other causes, such as enlarging of the heart. Systems made in accordance with the teachings herein can have significant utility among both interventional cardiologists, who have traditionally applied catheter-based techniques, and surgeons, who have traditionally treated severe mitral valve disease. Moreover, the systems devices and methods described herein update the traditional replacement of mitral valve chordae using open-heart surgery and will complement the current valve repair approaches currently in development and testing.  
         [0146]     Systems and methods in accordance with the present invention may also be used to repair the tricuspid valve by positioning in the right heart. This may be achieved by passing a catheter through the venous system to the right atrium, then directing the system toward the tricuspid valve and subvalvular apparatus. This technique is illustrated in  FIGS. 69-73 . The catheter  1110  is directed through either the superior vena cava  321  as depicted in  FIGS. 69-70  or the inferior vena cava  323  as depicted in  FIGS. 71-72  to the right atrium  325  and directed at a leaflet  329  of the tricuspid valve  327 . The suture  1160  is affixed to the leaflet edge as previously described for the mitral valve  9 , then an anchor  1150  is placed in the papillary muscle  2  by advancing the catheter  1110  into the right ventricle  331 . The length of suture from the tricuspid valve  327  to the papillary muscle  2  is adjusted by the operator under image guidance until the desired length of neochorda(e) is created to reduce or eliminate the tricuspid regurgitation. The suture  1160  is fixed at this length with a fastener  1170  and the suture tail cut, leaving the fixed length of neochorda(e) as depicted in  FIG. 73 .  
         [0147]     By way of still further example, a method and associated system are provided for facilitating coaptation between leaflets of a cardiac valve of a patient by at least partially folding over a valve leaflet, and securing the valve leaflet in place.  
         [0148]     For purposes of illustration and not limitation, as embodied herein and as depicted in FIGS.  74 ( a )- 74 ( f ), a method and associated system are depicted herein for achieving valve leaflet coaptation. As depicted in  FIG. 74 , leaflets  2 ,  4  of valve  1  are not properly coapting. Specifically, the leaflets are too large in order to close valve  1  properly. Accordingly, to “shorten” on the of the leaflets  4 , a suture  2060  is passed through leaflet  4  near an edge thereof to capture leaflet  4 , as depicted in  FIG. 74 ( a ). Next, an anchor is deployed connected to a second end of suture material  2080 , and anchored into a wall of vascular tissue  5 . The sutures  2060 ,  2080  are drawn taut, and a clip  2090  is affixed to create a neochordae  3000 . The “resized” leaflet  4  now aligns well with, and coapts with, leaflet  2 , permitting valve  1  to close properly, thereby decreasing the risk of regurgitation.  
         [0149]     As will be appreciated, the method as embodied in  FIG. 74  can be practiced on any suitable cardiac valve (e.g., mitral, tricuspid and the like) and can be performed by connecting two sutures  2060 ,  2080 , as well as by using a single suture and anchor mechanism as described herein above.  
         [0150]     By way of further example, it is possible to use a modification of the components listed in this application to implant premeasured, fixed-length chordae rather than adjustable chordae. The potential advantage of this technique is elimination of need for a fastening and cutting system. For purposes of illustration and not limitation, an exemplary embodiment of such a system and associated are depicted in FIGS.  75 ( a )- 75 ( c ).  
         [0151]     In accordance with this embodiment of the invention, measurement of appropriate chordal length can be done pre- or intra-procedure using an imaging modality such as echocardiography. The appropriate length of the chordae  2180  may then be determined accordingly, such as from the anterior leaflet  4  to the papillary  2 . However, as will be appreciated, such a method can be carried out for myriad applications within the patient&#39;s lumenal system. Accordingly, one or more catheters  2110  as appropriate having chordae/filaments/sutures  2180  with varying lengths preloaded on the catheter  2110 , or the operator could prefix a chordal length before inserting the device  2110  into a patient. If desired, guide catheter  5  may contain a plurality of delivery catheters—one catheter  2110  with a leaflet anchor  2115  and one  2120  with a papillary muscle anchor  2150 , both anchors joined by the length of chord  2180 , which could be, for example, a single length of suture material or a loop, as depicted in  FIG. 75 . The leaflet anchor  2115  may be deployed and then the papillary or ventricular anchor  2150  may be deployed, leaving the chord  2180  anchored at both locations. The operator may be provided with flexibility in the effective chordal length during implantation in choosing the exact location for papillary or ventricular anchoring. Fine-tuning of the chordal length can be performed under image-guidance (e.g. echocardiography) akin to the adjustable chord method.  
         [0152]     It will be further appreciated that the present invention embraces percutaneous placement of neochordae anywhere in the vascular system, anchoring anchors into any suitable tissue. For example, while significant illustrations were described herein affixing anchors (e.g.,  50 ) to papillary muscle tissue  2 , it will be appreciated that anchors can be affixed to any suitable tissue, including, e.g., the ventricular wall of the heart.  
         [0153]     It will also be understood that while multiple catheters have been described herein (e.g., for leaflet capture, for anchor installation, for retainer application, for lock application, for severing filamentary material), any two or more of these and other suitable functions may be combined in a single catheter.  
         [0154]     The methods and systems of the present invention, as described above and shown in the drawings, provide for a system and method of cardiac valve repair with superior advantages over prior art approaches. These advantages include, by way of example only, adjusting the size of artificial chordae while the patient&#39;s heart is beating. This is advantageous because it greatly increases the chances for successful procedures, and eliminates the need for open heart surgery, permitting cardiac valve repair on an out patient basis.  
         [0155]     It will be apparent to those skilled in the art that various modifications and variations can be made in the system and method of the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention include modifications and variations that are within the scope of the appended claims and their equivalents.