Patent Publication Number: US-11660190-B2

Title: Tissue anchors, systems and methods, and devices

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application is a divisional of U.S. patent application Ser. No. 15/144,182, filed May 2, 2016, which is a divisional of U.S. patent application Ser. No. 14/010,950, filed Aug. 27, 2013, now U.S. Pat. No. 9,358,111, issued Jun. 7, 2016, which is a continuation of U.S. patent application Ser. No. 11/685,240, filed Mar. 13, 2007, each of which is incorporated by reference as if expressly set forth in their respective entirety herein. 
    
    
     TECHNICAL FIELD 
     The present invention relates generally to tissue fastening and, more particularly, tissue fastening performed in a minimally invasive and percutaneous manner. 
     BACKGROUND 
     Referring initially to  FIGS.  1 - 4    solely for purposes of understanding the anatomy of a heart  10 , and specifically the left side of the heart  10 , the left atrium (LA)  12  and left ventricle (LV)  14  are shown. An aorta  16  receives oxygenated blood from left ventricle  14  through an aortic valve  18 , which serves to prevent regurgitation of blood back into left ventricle  14 . A mitral valve  20  is positioned between left atrium  12  and left ventricle  14 , and allows one-way flow of the oxygenated blood from the left atrium  12  to the left ventricle  14 . 
     Mitral valve  20 , which will be described below in more detail, includes an anterior leaflet  22  and a posterior leaflet  24  that are coupled to cordae tendonae  26 ,  28  ( FIG.  4   ). Cordea tendonea  26 ,  28  serve as “tension members” that prevent the leaflets  22 ,  24  of mitral valve  20  from moving past their closing point and prolapsing back into the left atrium  12 . When left ventricle  14  contracts during systole, cordae tendonae  26 ,  28  limit the upward motion (toward the left atrium) of the anterior and posterior leaflets  22 ,  24  past the point at which the anterior and posterior leaflets  22 ,  24  meet and seal to prevent backflow from the left ventricle  14  to the left atrium  12  (“mitral regurgitation” or “mitral insufficiency”). Cordae tendonae  26 ,  28  arise from a columnae carnae or, more specifically, a musculi papillares (papillary muscles) of the columna carnae. In various figures herein, some anatomical features have been deleted solely for clarity. 
     Anterior leaflet  22  and posterior leaflet  24  of the mitral valve  20  are generally thin, flexible membranes. When mitral valve  20  is closed, anterior leaflet  22  and posterior leaflet  24  are generally aligned and contact one another along a “line of coaptation” several millimeters back from their free edges, to create a seal that prevents mitral regurgitation. Alternatively, when mitral valve  20  is opened, blood flows downwardly through an opening created between anterior leaflet  22  and posterior leaflet  24  into left ventricle  14 . 
     Many problems relating to the mitral valve may occur and may cause many types of ailments. Such problems include, but are not limited to, mitral regurgitation. Mitral regurgitation, or leakage, is the backflow of blood from left ventricle  14  into the left atrium  12  due to an imperfect closure of mitral valve  20 . That is, leakage often occurs when the anterior and posterior leaflets  22 ,  24  do not seal against each other, resulting in a gap between anterior leaflet  22  and posterior leaflet  24  when the leaflets are supposed to be fully coapted during systole. 
     In general, a relatively significant systolic gap may exist between anterior leaflet  22  and posterior leaflet  24  for a variety of different reasons. For example, a gap may exist due to congenital malformations, because of ischemic disease, or because the heart  10  has been damaged by a previous heart attack. Such a gap may also be created when congestive heart failure, e.g., cardiomyopathy, or some other type of distress which causes a heart  10  to be enlarged. Enlargement of the heart  10  can result in dilation (stretching) of the mitral annulus. This enlargement is usually limited to the posterior valve annulus and is associated with the posterior leaflet  24 , because the anterior annulus is a relatively rigid fibrous structure. When the posterior annulus enlarges, it causes the posterior leaflet  24  to move away from the anterior leaflet  22 , causing a gap during systole because the two leaflets no longer form proper coaptation. This results in leakage of blood through the valve  20 , or regurgitation. 
     Blood leakage through mitral valve  20  generally causes a heart  10  to operate less efficiently, as the heart  10  pumps blood both out to the body via the aorta  16 , and also back (in the form of mitral regurgitation) into the left atrium  12 . Leakage through mitral valve  20 , or general mitral insufficiency, is thus often considered to be a precursor to congestive heart failure (CHF) or a cause of progressive worsening of heart failure. There are generally different levels of symptoms associated with heart failure. These levels are classified by the New York Heart Association (NYHA) functional classification system. The levels range from a Class 1 level which is associated with an asymptomatic patient who has substantially no physical limitations to a Class 4 level which is associated with a patient who is unable to carry out any physical activity without discomfort and has symptoms of cardiac insufficiency even at rest. In general, correcting or reducing the degree of mitral valve leakage may be successful in allowing the NYHA classification grade of a patient to be reduced. For instance, a patient with a Class 4 classification may have his classification reduced to Class 3 or Class 2 and, hence, be relatively comfortable at rest or even during mild physical exertion. By eliminating the flow of blood backwards into the left atrium  12 , therapies that reduce mitral insufficiency reduce the workload of the heart  10  and may prevent or slow the degradation of heart function and congestive heart failure symptoms that is common when a significant degree of mitral insufficiency remains uncorrected. 
     Treatments used to correct for mitral valve leakage or, more generally, CHF, are typically highly invasive, open-heart surgical procedures. In extreme cases, this may include implantation of a ventricular assist device such as an artificial heart in a patient with a failing heart. 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. Anti-coagulant therapy reduces the risk of blood clot formation for example, within the ventricular assist device. Reducing the risks of blood clots associated with the ventricular assist device is desirable, but anti-coagulant therapies may increase the risk of uncontrollable bleeding in a patient, e.g., as a result of a fall. 
     Rather than implanting a ventricular assist device, bi-ventricular pacing devices similar to pacemakers may be implanted in some cases, e.g., cases in which a heart beats inefficiently in a particular asynchronous manner. While the implantation of a bi-ventricular pacing device may be effective, not all heart patients are suitable for receiving a bi-ventricular pacing device. Further, the implantation of a bi-ventricular pacing device is expensive, and is generally not effective in significantly reducing or eliminating the degree of mitral regurgitation. 
     Open-heart surgical procedures that are intended to correct for mitral valve leakage, specifically, can involve the implantation of a replacement valve. Valves from animals, e.g., pigs, may be used to replace a mitral valve  20  in a human. While a pig valve may relatively successfully replace a mitral valve, such replacement 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. 
     A less invasive surgical procedure involves heart bypass surgery associated with a port access procedure. For a port access procedure, the heart may be accessed by cutting between ribs or sometimes removing parts of one or more ribs, as opposed to dividing the sternum to open the entire chest of a patient. 
     One open-heart surgical procedure that is particularly successful in correcting for mitral valve leakage and, in addition, mitral regurgitation, is an annuloplasty procedure. During an annuloplasty procedure, a medical device such as an annuloplasty ring may be implanted surgically on the left atrial side of mitral annulus (i.e., generally the attachment location of the base of the mitral valve to the heart). The device reduces a dilated mitral valve annulus to a relatively normal size and, specifically, moves the posterior leaflet closer to the anterior leaflet to aid anterior-posterior leaflet coaptation and thus improve the quality of mitral valve closure during systole. Annuloplasty rings are often shaped substantially like the letter “D” to correspond to the natural shape of the mitral annulus as viewed from above. Typically, the rings are formed from a rod or tube of biocompatible material, e.g., plastic, that has a DACRON mesh covering. 
     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 a ring require open-heart surgery which involves opening a patient&#39;s sternum and placing the patient on a heart bypass machine. The annuloplasty ring is sewn on a top portion of the mitral valve. In sewing the annuloplasty ring onto the mitral valve, a surgeon generally sews the straight side of the “D” to the fibrous tissue located at the junction between the posterior wall of the aorta and the base of the anterior mitral valve leaflet. As the curved part of the ring is sewn to the posterior aspect of the annulus, the surgeon alternately acquires a relatively larger amount of tissue from the mitral annulus, e.g., a one-eighth inch bite of tissue, using a needle and thread, compared to a relatively smaller bite taken of the fabric covering of the annuloplasty ring. Once the thread has loosely coupled the annuloplasty ring to the mitral valve annulus tissue, the annuloplasty ring is slid into contact with the mitral annulus. The tissue of the posterior mitral annulus that was previously stretched out, e.g., due to an enlarged heart, is effectively reduced in circumference and pulled forwards towards the anterior mitral leaflet by the tension applied by annuloplasty ring with the suture or thread. As a result, a gap between anterior leaflet  22  and posterior leaflet  24  during ventricular contraction or systole may be reduced and even substantially closed off in many cases thereby significantly reducing or even eliminating mitral insufficiency. After the mitral valve  20  is shaped by the ring, the anterior and posterior leaflets  22 ,  24  will reform typically by pulling the posterior leaflet  24  forward to properly meet the anterior leaflet  22  and create a new contact line that will enable mitral valve  20  to appear and to function properly. 
     Although a patient that receives an 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. 
     Another type of procedure that is generally effective in reducing mitral valve leakage associated with prolapse of the valve leaflets involves placing a single edge-to-edge suture in the mitral valve  20  that apposes the mid-portions of anterior and posterior leaflets  22 ,  24 . For example, in an Alfieri stitch or a bow-tie repair procedure, an edge-to-edge stitch is made at approximately the center of the gap between an anterior leaflet  22  and a posterior leaflet  24  of a mitral valve  20 . Once the stitch is in place between the anterior and posterior leaflets  22 ,  24 , it is pulled in to form a suture which holds anterior leaflet  22  against posterior leaflet  24 . 
     Another surgical procedure that reduces mitral valve leakage involves placing sutures along a mitral valve annulus around the posterior leaflet  24 . These sutures may be formed as a double track, e.g., in two “rows” from a single strand of suture material. The sutures are tied off at approximately a central point (P 2 ) of posterior leaflet  24 . Pledgets are often positioned under selected sutures to prevent the sutures from tearing through annulus  40 . When the sutures are tightened and tied off, the circumference of the annulus  40  may effectively be reduced to a desired size such that the size of a systolic gap between posterior leaflet  24  and an anterior leaflet  22  may be reduced. 
     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. Further, given the complexity of open-heart surgery, and the significant associated recovery time, people that are not greatly inconvenienced by CHF symptoms, e.g., people at a Class 1 classification, may choose not to have corrective surgery. In addition, people that need open heart surgery the most, e.g., people at a Class 4 classification, may either be too frail or too weak to undergo the surgery. Hence, many people that may benefit from a surgically repaired mitral valve may not undergo surgery. 
     In another method, a cinching device is placed within the coronary sinus (CS) using a catheter system, with distal, mid, and proximal anchors within the lumen of the CS to allow plication of the annulus  40  via the CS. In practice, these anchors are cinched together and the distance between them is shortened by pulling a flexible tensile member such as a cable or suture with the intent being to shorten the valve annulus  40  and pull the posterior leaflet  24  closer to the anterior leaflet  22  in a manner similar to an annuloplasty procedure. Unfortunately, since the tissue that forms the CS is relatively delicate, the anchors are prone to tear the tissue during the cinching procedure. In addition, the effect on the mitral annulus may be reduced when the CS of a particular patient is not directly aligned with the mitral annulus. Other minimally invasive techniques have been proposed but have various drawbacks related to such factors as effectiveness and/or accuracy of catheter-based implementation. 
     SUMMARY 
     In one embodiment, a system is provided for accurately introducing an element into tissue proximate (i.e., either at or close to) the mitral valve annulus of the heart of a patient. The element may be any desired structure suitable for the intended purpose. In one more specific embodiment, for example, the element may advantageously comprise a guide wire. The system includes a first catheter device having a first distal end portion capable of being introduced through the vascular system of the patient and into the coronary sinus proximate the mitral valve annulus. The first catheter device includes first, second and third spaced apart radiopaque markers at the first distal end portion. The system further includes a second catheter device having a second distal end portion capable of being introduced through the vascular system of the patient and into the left ventricle of the heart proximate the mitral valve annulus. The second catheter device includes a fourth radiopaque marker at the second distal end portion and a lumen for delivering an element from the second distal end portion. The fourth radiopaque marker may be aligned with reference to at least one of the first, second or third radiopaque markers to deliver the element into the mitral valve tissue. In one exemplary embodiment, for example, the fourth radiopaque marker is aligned with the first radiopaque marker of the first catheter device generally at location P 2  of the posterior mitral annulus. The first, second and third radiopaque markers may be spaced apart to correspond to locations P 1 , P 2  and P 3  of the posterior mitral valve annulus. 
     A method is also provided for accurately introducing an element into tissue proximate the mitral valve annulus using a first catheter device having a first distal end portion with a first radiopaque marker and a second catheter device having a second distal end portion with a lumen. The method comprises introducing the first distal end portion of the first catheter device through the vascular system of the patient and into the coronary sinus proximate the mitral valve annulus. The first radiopaque marker is positioned at a desired location in the coronary sinus proximate the mitral valve annulus. The second distal end portion of the second catheter device is introduced through the vascular system of the patient and into the heart proximate the mitral valve annulus. The second distal end portion is positioned in a desired orientation relative to the first radiopaque marker. The element is then delivered through the lumen into tissue proximate the mitral valve annulus with the second distal end portion in the desired orientation. 
     The method of accurately introducing the element into tissue proximate the mitral valve annulus may further comprise delivering a first guide wire through the mitral valve annulus and into the left atrium of the heart from the left ventricle of the heart. The method may further comprise guiding a second element over the first guide wire to a position proximate the mitral valve annulus and the second element may further comprise a third catheter device. A second guide wire may be delivered from the third catheter device through the mitral valve annulus and into the left atrium of the heart from the left ventricle of the heart. The method may further comprise using the first and second guide wires to deliver first and second anchors, respectively, into the mitral valve annulus, shortening the distance between the first and second anchors, and locking the first and second anchors with respect to each other. This may, for example, form plicated annulus tissue helpful for reducing regurgitation through the mitral valve. A third guide wire may be delivered from the third catheter device through the mitral valve annulus and into the left atrium of the heart from the left ventricle of the heart. This third guide wire may be used to deliver a third anchor into the mitral valve annulus and the distance between at least two of the first, second or third anchors may be shortened and then at least these two anchors may be locked with respect to each other. In an illustrative embodiment, all three anchors are locked with respect to each other with the tissue plicated between each of the adjacent anchors. The first distal end portion may further comprise two additional radiopaque markers spaced apart on opposite sides of the first radiopaque marker. In this case, the method may further comprise positioning the first radiopaque marker at a location in the coronary sinus proximate location P 2  of the mitral valve annulus, and positioning the two additional radiopaque markers in the coronary sinus respectively more proximate to locations P 1  and P 3  of the mitral valve annulus. As further options, the second distal end portion may further include a second radiopaque marker and positioning the second distal end may further comprise positioning the second radiopaque marker in a desired orientation relative to the first radiopaque marker. The first radiopaque marker may have a predetermined cross sectional shape (e.g., circular) when viewed directly along the longitudinal axis of the first catheter device. In association with this feature, the method may further comprise viewing the first radiopaque marker directly along the longitudinal axis of the first catheter device while positioning the second distal end portion in the desired orientation. 
     In another illustrative embodiment, a catheter device is provided and capable of being directed through the vascular system of a patient and delivering first and second elements into tissue. Again, these elements may be any structure suited for the intended purpose. The catheter device comprises first, second and third catheter members respectively including first, second and third lumens. A first connecting member is coupled between the first and second catheter members and a second connecting member coupled between the first and third catheter members. The second and third catheter members are laterally movable in generally opposite directions relative to the first catheter member between collapsed positions suitable for delivery of the first, second and third catheter members through the vascular system and expanded positions in which the second and third catheter members are at laterally spaced apart positions relative to the first catheter member for delivering the first and second elements into the tissue through the second and third lumens. 
     The catheter device may further comprise a third connecting member coupled between the first and second catheter members and a fourth connecting member coupled between the first and third catheter members. The first, second, third and fourth connecting members may further comprise bars pivotally coupled between the first, second and third catheter members. The device may further comprise an outer catheter member or sheath having a fourth lumen with the fourth lumen receiving the first, second and third catheter members. In this embodiment, the first, second and third catheter members may therefore be a triple lumen catheter received within and extendable from the distal end of an outer sheath. The second and third catheter members may be movable in a lengthwise direction relative to the first catheter member as the second and third catheter members move laterally to the expanded positions. 
     The catheter device including the triple lumen catheter, or first, second and third catheter members, may further comprise first, second and third guide wires respectively received in the first, second and third lumens. For example, the first guide wire may be used as an initial guide for delivery of the catheter device to a surgical site, such as within the left ventricle of the heart, and the second and third guide wires may be extendable from the device into tissue, such as mitral valve annulus tissue. The first, second and third guide wires may further comprise radiofrequency (RF) energy delivery wires capable of applying radiofrequency energy to assist with penetrating the tissue. 
     In another embodiment, a method is provided for delivering respective elements into spaced apart locations along an annulus of a mitral valve using a catheter device including first, second and third catheter members that respectively include first, second and third lumens. The method comprises directing a first guide wire through the vascular system and into the heart of a patient. The first, second and third catheter members are introduced through the vascular system and into the heart of the patient with the first guide wire received in the first lumen and with the first, second and third catheter members are in a collapsed state relative to one another. Distal end portions of the first, second and third catheter members are positioned proximate the annulus. The distal end portions of the second and third catheter members are expanded laterally away from the first catheter member. The respective elements are then delivered respectively into tissue proximate the annulus through the second and third lumens. 
     The method of delivering respective elements into spaced apart locations along the annulus may further comprise delivering second and third guide wires respectively through the second and third lumens. The method may further comprise applying radiofrequency energy with distal tip portions of the second and third guide wires to assist with penetrating through the tissue. The distal end portions of the first, second and third guide wires may be extended into the left atrium of the heart. The method may then further comprise delivering first, second and third anchors into the tissue using the first, second and third guide wires as guides to the spaced apart locations. The first, second and third anchors may be connected to the tissue. Distances between two or more of the anchors may be shortened and locked in position as generally described above. Respective first, second and third flexible tensile member portions may be coupled to the first, second and third anchors and locking the first, second and third anchors may further comprise locking at least two of the first, second or third flexible tensile member portions together. The flexible tensile member portions may be comprised of any suitable material having requisite strength, flexibility and biocompatibility. For this purpose, for example, any suitable suture material, which may be portions of the same suture material, or discrete and separate suture threads having respective free ends, may be used. The first, second and third anchors may be respectively secured to the first, second and third flexible tensile members to form first, second and third anchor assemblies. These anchor assemblies may be delivered to the spaced apart locations via at least one anchor delivery catheter. In an illustrative embodiment, these anchor assemblies are individually delivered to the left ventricle via individual, separate anchor delivery catheters. 
     In another embodiment, a tissue anchor is provided generally comprising a flexible tensile member and a plurality of discrete, flat flexible anchor elements coupled for movement along the flexible tensile member to form one illustrative embodiment of an anchor assembly. The flexible tensile member and at least one of the plurality of discrete, flat flexible anchor elements are capable of being inserted through tissue and of moving between an elongate configuration and a shortened configuration suitable for anchoring the assembly against at least one side of the tissue. This anchor assembly includes a proximal end portion, a distal end portion, and a compressible intermediate portion between the proximal and distal end portions. The compressible intermediate portion is compressible in that it may be shortened during an anchoring process. For example, it may comprise multiple anchor elements itself, or more simply a space between proximal and distal anchor elements connected by the flexible tensile member. The anchor elements can slide relative to the flexible tensile member and the flexible tensile member is capable of being pulled to cause the anchor elements to move relative to the flexible tensile member from the elongate configuration to the shortened configuration. 
     In this anchor assembly embodiment, the anchor elements may be formed from any suitable biocompatible material. For example, the material may be selected from at least one of natural fibers, synthetic fibers, polymers, metals or any combinations thereof (i.e., combinations with one another and/or with other materials). In one embodiment, the anchor elements are formed of material that promotes tissue ingrowth such that after implantation, the anchor assembly will be essentially covered by natural tissue of the patient. The flexible tensile member may comprise a suture having a suitable lock member, such as a simple slip knot for allowing the proximal end of the flexible tensile member to be pulled causing movement of the slip knot distally and resulting in compression or relative movement of two or more anchor elements toward each other. The flexible tensile member may extend through each of the anchor elements at multiple locations and one or more of the anchor elements and/or the flexible tensile member, or both, may have at least one radiopaque marker to allow visualization under a suitable viewing device such as a fluoroscope during and/or after the anchor installation procedure. In this embodiment the plurality of discrete, flat flexible anchor elements may have any suitable shape. The anchor elements are sufficiently flexible to allow contraction or folding into an anchor delivery catheter and subsequent expansion or unfolding after deployment from the anchor delivery catheter to provide a wider retaining surface against the tissue. A deploying device may be operatively associated with the anchor delivery catheter and operable to extend or deploy the anchor assembly from the anchor delivery catheter. For example, this deploying device may further comprise a deploying member, such as a flexible rod or inner deployment catheter, capable of pushing the anchor assembly at least partially out of the lumen of the anchor delivery catheter. 
     In another embodiment, a method is provided for anchoring tissue with a first anchor assembly comprised of a first plurality of discrete, flat flexible anchor elements. The first anchor assembly includes a proximal end portion, a distal end portion and a compressible intermediate portion located between the proximal and distal end portions and movable between an elongated configuration and a shortened configuration. The method comprises inserting at least one of the anchor elements through the tissue and pulling a first flexible tensile member coupled for sliding movement relative to the first plurality of discrete, flat flexible anchor elements. This draws the proximal and distal end portions of the first anchor assembly toward each other and compresses the intermediate portion into the shortened configuration with the assembly engaged against the tissue. The tissue may comprise the mitral valve annulus and the first anchor assembly may be engaged on opposite sides of the tissue, such as on opposite sides of the mitral valve annulus. The method may further comprise inserting second and even third anchor assemblies through the tissue at spaced apart locations from the first anchor assembly and drawing the two or three anchor assemblies toward each other to plicate the tissue whereupon the anchor assemblies are locked relative to each other to lock the plicated condition of the tissue. This procedure may, for example, be repeated any number of times to plicate the posterior portion of the mitral valve annulus for purposes of achieving annuloplasty. 
     In another embodiment, a suture cutter is provided for percutaneously cutting a suture located within a patient. The suture cutter may comprise an actuator for manipulation by a medical professional and an intermediate catheter portion operatively coupled to the actuator for insertion into the vascular system of the patient. A cutting assembly is operatively coupled to the intermediate catheter portion and the actuator. The cutting assembly includes a blade housing and a blade with a cutting edge mounted for movement in the blade housing. An adjustably sized cutting window is defined between the cutting edge and the blade housing and the cutting edge cuts a suture received inside of the cutting window as the cutting edge moves in the blade housing to reduce the size of the cutting window. In one embodiment, an anvil may be positioned on an opposite side of the cutting window from the cutting edge and the suture may be cut against the anvil. In another embodiment, a blade receiving slot may be located on an opposite side of the cutting window from the cutting edge and the suture may be cut as the blade moves into the blade receiving slot. The blade housing may further comprise a first aperture on one side of the blade and a second aperture on an opposite side of the blade such that the suture is adapted to pass from the first aperture to the second aperture through the cutting window. 
     In another embodiment, a method of cutting a suture located within a patient is provided and involves positioning a suture cutter within the patient, with the suture cutter including a blade movable through an adjustably sized cutting window. A suture is directed through the cutting window, such as at a time before the suture cutter is directed into the patient through the vascular system. The size of the cutting window is reduced by moving the blade towards the suture and the suture is then cut with the blade, either against an anvil or by directing the blade into a blade receiving space past the suture (e.g., into a slot). The suture cutter may be directed through a catheter leading into the vascular system of the patient. The suture cutter may be used, for example, to cut the tails from the sutures used during one or more of the annuloplasty procedures described herein. 
     In another embodiment, a plication assistance device is provided and may be used, for example, to tension and lock the flexible tensile members described herein. The device comprises a support structure and a first carriage fixed to the support structure and configured to hold an outer plication catheter. A second carriage is fixed to the support structure at a location proximal to the first carriage. At least one of the first or second carriages is slidable along the support structure and capable of being locked in position relative to the support structure. The second or proximal carriage is configured to hold an inner plication catheter. A first suture tensioning mechanism is mounted to the support structure at a location proximal to the second carriage and a second suture tensioning mechanism is mounted to the support structure also at a location proximal to the second carriage. The plication assistance device may further comprise a third suture tensioning mechanism mounted to the support structure at a location proximal to the second carriage. The first and second suture tensioning mechanisms may further comprise first and second rotatable spools. The first and second carriages may respectively include first and second locking devices for securing the outer plication catheter and inner plication catheter thereto. The plication assistance device may include a suture tension gauge operatively connected with the support structure and configured to measure tension of a suture being tensioned by at least one of the first or second suture tensioning mechanisms. 
     Various additional features, advantages, and aspects of the invention will become more readily apparent to those of ordinary skill in the art upon review of the following detailed description of the illustrative embodiments taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a schematic illustration of a patient with the anatomy of the heart in cross section and a guide catheter introduced through the vascular system into the aorta and heart of the patient. 
         FIG.  2    is a cross sectional view of the heart from above showing the introduction of various catheters. 
         FIG.  3    is a cross sectional view of the heart similar to  FIG.  2    and illustrating the further introduction of a guide wire. 
         FIG.  4    is a partial longitudinal cross sectional view of the heart showing the positioning of the catheters in the left ventricle and coronary sinus. 
         FIG.  5    is a cross sectional view of the heart similar to  FIG.  4   , but illustrating the further introduction of a guide wire through the mitral valve annulus. 
         FIG.  6    is an enlarged view of the mitral valve in cross section and showing the introduction of an expandable triple lumen catheter into the left ventricle. 
         FIG.  7    is a cross sectional view of the mitral valve similar to  FIG.  6    and showing the further introduction of the expandable triple lumen catheter. 
         FIG.  8    is a cross sectional view of the heart similar to  FIG.  7   , but illustrating the initial expansion of the triple lumen catheter. 
         FIG.  9    is an elevational view of the expanding triple lumen catheter relative to the mitral valve annulus. 
         FIG.  10    is a view similar to  FIG.  9   , but showing the full expansion of the triple lumen catheter. 
         FIG.  11    is an elevational view showing the introduction of an anchor delivery catheter over one of the guide wires. 
         FIG.  12    is a view similar to  FIG.  11   , but showing the initial deployment of the anchor from the anchor delivery catheter. 
         FIG.  12 A  is a view similar to  FIG.  12   , but showing a portion of the anchor compressed or shortened on a distal side of the tissue. 
         FIG.  13    is a view similar to  FIG.  12   , but illustrating the full deployment of the anchor from the anchor delivery catheter and the anchor delivery catheter being retracted. 
         FIG.  14    is a view similar to  FIG.  13   , but illustrating deployment of a second anchor from an anchor delivery catheter. 
         FIG.  15    is a view similar to  FIG.  14   , but showing the deployment of a third anchor from an anchor delivery catheter and retraction of the anchor delivery catheter. 
         FIG.  16    is an elevational view showing the deployment of a suture locker over the three sutures associated with the respective anchors. 
         FIGS.  16 A,  16 B and  16 C  are enlarged views showing the progressive deployment and locking of the suture locker onto the three sutures. 
         FIG.  16 D  is a longitudinal cross sectional view of the suture locker showing the locked condition. 
         FIG.  17    is an elevational view showing retraction of the plication catheter and the mitral valve annulus in a plicated condition. 
         FIG.  18    is a perspective view of a plication assistance device useful for tensioning the sutures and deploying the suture locker. 
         FIGS.  18 A and  18 B  are respective partially cross sectioned views of a tension gauge associated with the plication assistance device of  FIG.  18    with the sections taken lengthwise along the gauge. 
         FIG.  19    is an elevational view showing the introduction of a suture cutter catheter for cutting the suture material extending from the suture locker. 
         FIGS.  20 A,  20 B and  20 C  are cross sectional views of the distal end portion of the suture cutter showing the suture cutting operation. 
         FIG.  21    is a cross sectional view of the locked anchor assembly on the plicated annulus. 
         FIG.  22    is a cross sectioned view of the mitral valve showing the locked anchor assembly. 
         FIG.  23    is a perspective view of a first alternative anchor. 
         FIG.  24    is a perspective view of a second alternative anchor. 
         FIG.  25    is an elevational view of a third alternative anchor. 
     
    
    
     DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS 
     Reference will be made to the various figures in describing the methods, devices and systems in various forms useful to the purpose of plicating tissue, for example, and particularly useful for plicating annulus tissue associated with the mitral valve of a patient. It will be appreciated that although specific details of the methods, devices and systems will be given herein, many different changes, substitutions and additions may be made to such details by those of ordinary skill while still falling within the inventive aspects more generally set forth herein and understood by those of ordinary skill upon review of the present disclosure in its entirety. It should be noted that the terms “proximal” and “distal” are used, as conventional in the art, to denote spatial relationship relative to the person using the particular device or component. That is, “proximal” refers to a position closer to the user and “distal” refers to a position farther from the user. 
     Referring first to  FIGS.  1 - 4   , a guide catheter  50  is illustrated as being directed into the vascular system of a patient, such as through an artery in the groin region of the patient, as shown in  FIG.  1   . The guide catheter  50  may be a 12 mm catheter directed through the vascular system in any suitable manner. As shown, guide catheter  50  is directed into the aorta  16 , through the aortic valve  18  and into the left ventricle  14  between the pair of cordae tendonae  26 ,  28  as best shown in  FIG.  4   . This guide catheter  50  is then used as a guide sheath or tube for guiding all of the subsequent catheter devices into the left ventricle  14  for use in a method of plicating the annulus  40  of the mitral valve  20 . It will be appreciated that other methods of guidance may be used as alternatives or in a supplemental fashion to the various methods disclosed herein. After initial insertion of the guide catheter  50 , a P 2  catheter  52  is inserted to the guide catheter  50 . As known in the art, “P 2 ” refers to the central location of the base of the posterior leaflet  24  along the annulus  40 . The P 2  catheter  52  may have a deflectable tip to allow more accurate and easier manipulation and location of the catheter tip relative to the annulus  40 . The catheter tip can include a radiopaque marker  52   a  visible under a fluoroscope. A coronary sinus or CS catheter  56  is directed into the coronary sinus  36  via the vascular system of the patient, such as through an entry point in the jugular vein of the patient and subsequently through the right atrium  38  as shown best in  FIGS.  2  and  3   . The CS catheter  56  is directed into the coronary sinus  36  as shown in  FIG.  3    such that three radiopaque markers  56   a ,  56   b ,  56   c  on or in the catheter  56  are located generally at positions approximating P 1 , P 2  and P 3  along the mitral valve annulus  40 . In this regard, the coronary sinus  36  runs generally along the mitral valve annulus  40  in most patients and therefore provides a good location for placement of markers  56   a ,  56   b ,  56   c . The distal tip  52   a  of the P 2  catheter  52  is aligned at the annulus  40  as shown in  FIG.  4    such that it is directed upward at the interior of the left atrium  12 . Radiopaque marker  56   b  in the coronary sinus  36  is used to determine and ensure proper placement of the distal tip  52   a  at the P 2  location along the annulus  40 . Contrast media injections into the LV and/or LA may also be made to confirm positioning under a fluoroscope, for example. 
     Referring to  FIG.  5   , when accurate positioning of the P 2  catheter  52  has been confirmed using a fluoroscope, for example, a first RF guide wire may be introduced through the P 2  catheter. The P 2  guide wire may have a radio frequency (RF) energy delivery tip  60   a  for assisting with penetration through mitral tissue generally at the annulus  40 . For this purpose, a suitable RF energy device (not shown) may be coupled to guide wire  60 , as well as the other RF guide wires disclosed hereinbelow. The distal portion of the P 2  guide wire  60  then extends into the left atrium and curls back on itself to help prevent tissue damage within the left atrium  12  as shown best in  FIG.  6   . 
     The method then involves the further introduction of respective P 1  and P 3  guide wires  62 ,  64  through the use of a triple lumen catheter  70  contained within a sheath  72 . Triple lumen catheter  70  and sheath  72  are introduced into the guide catheter  50  after withdrawal of the P 2  catheter  52  therefrom. Triple lumen catheter  70  more specifically comprises a central or first catheter member  74  having a lumen  74   a  threaded over the P 2  guide wire  60 . In addition to this first or P 2  catheter member  74 , triple lumen catheter  70  further comprises second and third catheter members  76 ,  78  respectively corresponding generally to the P 1  and P 3  locations generally along the posterior mitral annulus  40 . The second and third catheter members  76 ,  78  also include respective lumens  76   a ,  78   a  containing respective guide wires  62  and  64 . It will be appreciated that other locations along the annulus  40  may be chosen in addition to or instead of those discussed illustratively herein. 
     As further shown in  FIG.  7   , the combined triple lumen catheter  70  and sheath  72  are pushed through the guide catheter  50  and an expandable distal portion comprised of catheter members  74 ,  76 ,  78  is then extended from the sheath  72  in the left ventricle  14  of the patient. The initial positioning of the P 2  guide wire  60  ensures that the middle or P 2  catheter member  74  will be an accurate reference point at P 2 . When the sheath  72  reaches the distal location shown in  FIGS.  7 - 9   , the triple lumen catheter  70  is pushed outward from the distal end of the sheath  72  and expansion takes place as shown in  FIGS.  8  and  9   . As best shown in  FIG.  9   , the two outer catheter members  76 ,  78  (that is, the P 1  and P 3  catheter members) automatically expand outward due to their coupling with the central or P 2  catheter member  74  by way of connecting bars  80 ,  82 ,  84 ,  86 . These connecting bars may, for example, be formed from thin metallic plate material such as superelastic material, stainless steel, other metals or combinations of materials. It has been found that a thin plate of Nitinol™ (nickel-titanium) stacked adjacent to a thin plate of stainless steel works well for each connecting bar  80 ,  82 ,  84 ,  86 . The Nitinol exhibits spring characteristics effective for the expansion of the two outer catheter members  76 ,  78  away from the inner or central catheter member  74 , while the stainless steel plate of each connecting bar provides additional stiffness for support purposes. 
     Respective connectors  88 ,  90 ,  92 ,  94 ,  96 ,  98  couple each connecting bar  80 ,  82 ,  84 ,  86  to the respective catheter members  76 ,  74 ,  78  as shown in  FIG.  9    with a living hinge adjacent each connector  88 ,  90 ,  92 ,  94 ,  96 ,  98 . This illustrative structure therefore essentially forms two four-bar type linkage structures with one being formed by catheter members  74 ,  76  and bars  80 ,  84  and the other being formed by catheter members  74 ,  78  and bars  82 ,  86 . This expandable structure therefore causes the two outer catheter members  76 ,  78  to translate distally and also expand laterally outward to known positions dictated by the respective lengths of the bars  80 ,  82 ,  84 ,  86 . In this example, the distal end of catheter  76  is ultimately positioned approximately at position P 1  along the mitral annulus  40 , while the distal end of catheter member  78  is positioned approximately at position P 3  along the mitral annulus  40 . It will be appreciated that these positions are representative and illustrative only and that the method may be performed at any other positions along the mitral annulus  40  depending on the desires of the surgeon and needs of the patient, for example. 
     Catheter members  76 ,  78  include lumens  76   a ,  78   a  from which the respective P 1  and P 3  guide wires  62 ,  64  may be directed as shown in  FIG.  10   . Like the P 2  guide wire  60 , the P 1  and P 3  guide wires  62 ,  64  may include RF or radiofrequency energy delivery tips  62   a ,  64   a  for assisting with penetration through the annulus tissue  40 . It will be appreciated that when the “annulus tissue” is referred to herein, this refers to tissue generally along the annulus  40  and may, in fact, be tissue on the base of the posterior leaflet  24  itself. As shown in  FIG.  10   , these guide wires  62   a ,  64   a  may generally align with the radiopaque markers  56   a ,  56   c  of the CS catheter  56  located in the coronary sinus  36  ( FIG.  3   ). The RF guide wires  62 ,  64  are inserted through the annulus tissue  40  such that distal portions thereof extend into the left atrium  12  in manners similar to RF guide wire  60  as generally shown in  FIG.  6   . The triple lumen catheter  70 , including the sheath  72 , is then removed from the guide catheter  50 . 
       FIGS.  11 - 15    illustrate the procedure for attaching anchors to the annulus tissue  40 . In particular,  FIG.  11    shows the initial introduction of a P 2  anchor delivery catheter  100  over P 2  guide wire  60 . As further shown in  FIG.  12   , the distal end low of P 2  anchor delivery catheter  100  is pushed along RF guide wire  60  until it penetrates through the annulus tissue  40 . As further shown in  FIG.  12   , after the distal end  100   a  is penetrated through the annulus tissue and into the left atrium  12 , an anchor assembly  102  is partially deployed as shown. In this embodiment, the anchor assembly  102  comprises a plurality of discrete, flat flexible anchor elements  104  coupled to a flexible tensile member, for example, in the form of a suture  106 . It will be appreciated that in other forms or embodiments of the invention, other anchors (sometimes referred to as fasteners, plicating elements, etc.) may be used instead. As needed, the guide wire  60  may be removed before or after the anchor deployment process. As further shown in  FIGS.  12 A and  13   , the P 2  anchor delivery catheter  100  is pulled back into the left ventricle  14  and the remaining proximal portion of the anchor assembly  102  is then deployed from the distal end  100   a  such that a portion of the anchor elements  104  are located in the left atrium and another portion of the anchor elements are located in the left ventricle. The anchor elements  104  are coupled to the suture  106 , in this example, by threading the suture  106  upwardly through the elements  104  and then back downwardly through the anchor elements  104  as shown. A slip knot  108  is then formed, or another type of lock member is used, so that when a proximal end portion of the suture  106  is pulled, all of the anchor elements  104  will be drawn together against opposite sides of the annulus tissue  40  as shown in  FIG.  14   . This leaves a long “tail” of the suture  106  outside the patient&#39;s body for subsequent tensioning and plication as will be described below. One or more of the anchor elements  104  may have a radiopaque marker  104   a  for better visualization under a suitable viewing device during the procedure. For example, one such marker may be located on a proximal portion of the anchor  102  and one may be located on a distal portion of the anchor  102 . Alternatively or in addition, the suture material or other flexible tension members discussed herein may have one or more radiopaque areas for better visualization. 
     As shown in  FIG.  14   , a P 1  anchor delivery catheter  110  is threaded over the P 1  guide wire  62  through guide catheter  50  after the P 2  anchor delivery catheter  100  has been removed. An anchor assembly  112  again comprised of discrete, flat flexible anchor elements  114  is deployed through a distal end  110   a  of the P 1  anchor delivery catheter  110  in the same manner as described above with respect to anchor assembly  102 . Like anchor assembly  102 , anchor assembly  112  includes a flexible tensile member, such as a suture  116 , having a slip knot or other lock member for drawing the anchor elements  114  together against opposite sides of the annulus tissue  40 . 
     Likewise,  FIG.  15    illustrates a third or P 3  anchor delivery catheter  120  used in the same manner as anchor delivery catheters  100 ,  110  for deploying a third or P 3  anchor assembly  122  comprised of discrete, flat flexible anchor elements  124  coupled by a flexible tensile member, such as a suture  126 , and capable of being drawn together against opposite sides of annulus tissue  40  through the use of a slip knot or other lock member  128 . Anchor delivery catheters  100 ,  110 ,  120  may be separate catheters or may be the same catheter used to separately deliver the anchors or other fasteners or plicating elements. For ease of use, however, separate catheters that have been preloaded with separate anchors may be easiest to use in practice. Suitable pusher rods or elements  125  ( FIG.  12   ) may be used to push the anchor assemblies  102 ,  112 ,  122  from their respective catheters  100 ,  110 ,  120 . Other deployment methods may be used instead. Anchor elements  104 ,  114 ,  124  may be formed from a material such as a surgical grade fabric material (e.g., a polyester material such as Dacron™) designed to promote tissue ingrowth so that the anchors  102 ,  112 ,  122  become essentially encased in tissue over time. As mentioned herein, in various aspects of implementing systems and methods herein, any suitable anchor may be used. For example, other suitable anchors are disclosed in U.S. patent application Ser. No. 11/174,951, filed Jul. 5, 2005, assigned to the assignee of the present invention and the disclosure of which is hereby incorporated by reference herein. 
       FIGS.  16  and  16 A -D generally illustrate a cinching and locking procedure for plicating the mitral annulus tissue  40 . Specifically, this can involve the use of an outer plication catheter  130  carrying a suture locker  132  at its distal end. An inner plication catheter  134  is received for sliding movement within the lumen of the outer plication catheter  130 . The distal end  134   a  of the inner plication catheter  134  abuts a proximal portion of the suture locker  132 . The suture locker  132  includes a slidable pin  136  having ends that are received in respective slot portions  130   a ,  130   b  of outer plication catheter  130  at its distal end. More specifically, the pin  136  is initially retained in an angled slot  130   b , and in an identical slot (not shown) on the diametrically opposite side of the outer plication catheter  134 , while the catheter assembly  130 ,  134  is directed through the guide catheter  50  into the left ventricle  14  as shown in  FIG.  16   . Thus, the inner catheter  134  provides an upward force against the suture locker  132  to bias the pin upwardly to the end of the angled slot  130   b  as shown in  FIG.  16 A . 
     After the respective sutures  106 ,  116 ,  126  have been tensioned, the cinching or plicating process and locking process may begin. In this regard, and as shown in  FIG.  16 B , the outer plication catheter  130  is initially moved in a distal direction as shown by the arrow in  FIG.  16 B , relative to the inner plication catheter  134 , to force the pin  136  to ride downward in the angled slot  130   b  such that it is aligned with the vertical slot  130   a  and is pushed upwardly in the slots  138 ,  140  ( FIG.  16 D ). This tightens the pin against the respective sutures  106 ,  116 ,  126  as the suture locker travels toward the annulus tissue  40 . Once the desired amount of plicated tissue or folds  144  have been formed, the plication catheters  130 ,  134  may be withdrawn proximally through the guide catheter  50 . As shown in  FIG.  160   , the suture locker  132  may include a spring-like member  142  for preventing proximal movement of the pin  136  after the desired amount of plication or tightening has been achieved. For further detail on the suture locker, as well as other illustrative forms of useful suture lockers, reference is made to U.S. Patent Application Ser. No. 60/803,183, filed on May 25, 2006 and assigned to the assignee of the present invention, and the disclosure of which is hereby fully incorporated by reference herein. It will be understood that many types of lockers may be used for locking the anchor assemblies  102 ,  112 ,  122 , or other fasteners or plicating elements in position after the desired amount of plication has been achieved. As shown, anchor elements  114 ,  124  may also have one or more radiopaque markers  114   a ,  124   a  as discussed above relative to anchor elements  104 . Furthermore, the slip knot  108  or other lock member and/or other portions of the suture material described herein may have one or more radiopaque markers. 
     As shown in  FIG.  18   , the outer plication catheter  130  includes a proximal hub  146  and the inner plication catheter  134  includes a hub  148 .  FIG.  18    illustrates a plication assistance device  150  that may be used for tensioning the respective sutures  106 ,  116 ,  126  and moving the suture locker  132  as previously described in connection with  FIGS.  16 ,  16 A -D, and  17 . The plication assistance device  150  includes a support structure  152  which may take the form of a base plate  152 . Base plate  152  includes a longitudinally extending slot  152   a . A fixed carriage  154  is rigidly affixed to a distal end of the base plate  152  and a sliding carriage  156  is secured to a more proximal location of base plate  152 . More specifically, sliding carriage  156  is affixed by a pin or other structure (not shown) so that it may slide along slot  152   a . For this purpose as well, sliding carriage  156  includes a longitudinally extending slot  156   a  that is parallel to slot  152   a . Slot  156   a  receives a slide lock  158  that may be rotated to respectively lock and unlock the sliding carriage  156  relative to the base plate  152 . For this purpose, for example, the slide lock  158  may have a threaded member (not shown) that engages base plate  152 . When the slide lock  158  is loosened, the sliding carriage  156  may slide along slot  152   a  as the slide lock  158  slides along slot  156   a . The slide lock  158  may then be tightened at the desired position to fix the sliding carriage  156  at a desired location along the base plate  152 . 
     The carriages  154 ,  156  also include respective catheter locks  160 ,  162  that may be rotated to tighten and loosen the connections between respective catheter hubs  146 ,  148  and carriages  154 ,  156 . A proximal end portion of the base plate  152  includes suture tensioning mechanisms  164 ,  166 ,  168  for the respective sutures  106 ,  116 ,  126 . More specifically, these mechanisms include spools  170 ,  172 ,  174  for receiving proximal end portions of the respective sutures  106 ,  116 ,  126  which may be wrapped and firmly engaged with the spools  170 ,  172 ,  174 . The suture tensioning mechanisms  164 ,  166 ,  168  further comprise rotatable knobs  176 ,  178 ,  180  connected with respective right angle gear boxes  182 ,  184 ,  186  for converting rotation of the knobs  176 ,  178 ,  180  to rotation of the spools  170 ,  172 ,  174 . That is, an output of each gear box  182 ,  184 ,  186  is coupled to a respective one of the spools  170 ,  172 ,  174 . In this manner, each suture  106 ,  116 ,  126  may be separately pulled or tensioned by rotating the corresponding knob  176 ,  178 ,  180 . 
     In use, the inner and outer plication catheters  130  and  134  are respectively secured and locked into the carriages  154  and  156 , as shown in  FIG.  18   , after the suture locker  132  has been moved approximately to the position as shown in  FIG.  16   . In this position, the suture locker  132  is firmly held by the two catheters  130 ,  134  as previously described and after the sliding carriage  156  is locked down onto the base plate  152  by tightening slide lock  158 . At this point, the sutures  106 ,  116 ,  126  are wrapped around their corresponding spools  170 ,  172 ,  174  and tensioned at a suitable minimum force. In the illustrative method, the tension at P 1  and P 3  (i.e., sutures  116  and  126 ) may be in the range of 2-4 lbs, while the tension at P 2  (i.e., suture  106 ) may be in the range of 4-6 lbs. The tension at P 1  and P 3  is maintained high enough to sustain tissue plication, while the tension of P 2  is slightly higher so as to lock or activate the locker  132  after plication occurs. More specifically, the higher tension on P 2  suture  106  drives the pin  136  in the locker distally in the slot  138  relative to the body of the locker  132 . Stated another way, the body of the locker  132  moves slightly proximally as the pin  136  remains stationary and grips the sutures  106 ,  116 ,  126 . 
     As best shown in  FIGS.  18 A and  18 B , the plication assistance device  150  includes a tension gauge mechanism  188  for allowing the user to measure the tension of at least one of the sutures  106 ,  116 ,  126 . As illustrated, the tension gauge mechanism  188  is being used to measure the tension of P 2  suture  106 . More specifically, this illustrative tension gauge mechanism  188  comprises a housing or other support  190  having a lever arm  192  pivotally mounted therein by way of a pivot  194 . One end of the lever arm  192  includes an element such as a roller  196  for engaging the suture  106 , while the opposite end includes a pin or other indicator  198  for indicating the level of tension being applied to the suture  106 . A graduated scale  200  is provided in connection with the indicator  198  to indicate the tension being applied to the suture  106 . Alternatively, for example, an electronic indicator and digital readout may be used. The indicator or pin  198  moves within a slot  202  in the housing  190  to allow it to be observed by the user. A spring support member  203  is also secured rigidly to the housing  190 , for example, by a pin or fastener  204 , or is simply a part of the housing or support  190 , and does not allow pivotal movement of the spring support member  203 . An opposite end of the spring support member  203  includes a connection point, which may be a hole  205 , while an intermediate location on the lever arm  192  likewise includes a connection point, which may also be a hole  206 . A coil spring  207  is connected between these two connection points  205 ,  206  and applies a force resistive to rotation of the lever arm  192  and upward movement of the indicator  198 . Thus, this system, including the spring  207 , is designed such that an applied tension in the direction of the arrow  208  will force the lever arm  192  to rotate clockwise around the pivot  194  (arrow  209 ) against the force of the spring  207  thereby indicating a measured amount of tension through upward movement of the indicator or pin  198  along the graduated scale  200 . The scale  200 , for example, may be graduated in any suitable manner depending on the needs of the procedure. In the present case, for purposes of measuring the tension on P 2  suture  106 , the scale  200  may be graduated to indicate forces between about 4 lbs and about 6 lbs with the middle of the range being suitable for tensioning the P 2  suture  106 . 
     This suture tension provides potential energy that moves the catheters  130 ,  134  relative to each other and locks the suture locker  132  as previously described, after the sliding carriage  156  is unlocked by loosening slide lock  158 . The plication catheters  130 ,  132  are then removed from the guide catheter  50  leaving the long proximal tails of the suture  106 ,  116 ,  126  extending out of the patient through the guide catheter  50 . 
     A suture cutter  210  is threaded along the sutures  106 ,  116 ,  126  through the guide catheter  50  to the position generally shown in  FIG.  19   . In this regard, the suture cutter comprises an intermediate catheter portion  212  and a distal end portion comprising a cutting assembly  214 . The cutting assembly  214  generally comprises a blade housing  215  and a reciprocating guillotine-style blade  216  slidable mounted therein. The blade  216  includes a cutting edge  216   a  as shown best in  FIGS.  20 A,  20 B and  20 C . The blade  216  is mounted for sliding, reciprocating movement within a slot  218  of blade housing  215 . The blade  216  includes an opening  220  through which the sutures  106 ,  116 ,  126  extend to cross the path of the blade  216  within the housing  215 . The blade further includes a connecting end  222  coupled to an actuating element  224  which may, for example, comprise a wire or other member in a lumen  212   a  of catheter portion  212 . The actuating element  224  may be pulled in the direction of the arrow in  FIG.  20 A  to move the blade  216  in a proximal direction. The user may accomplish this with a suitable handle or trigger assembly (not shown) coupled to actuator element  224  and located outside the patient. The blade housing  215  includes a first aperture  226  at its distal end and a second aperture  228  along a lateral side thereof opposite to the distal aperture  226 . In this manner, the sutures  106 ,  116 ,  126  may extend into the blade housing  215  through aperture  226 , opening  220  of blade  216  and then through aperture  228  as shown in  FIG.  20 A . As further shown in  FIGS.  20 B and  20 C , actuating element  224  may be pulled to move the blade  216  in a proximal direction such that the cutting edge  216   a  crosses edge  218   a  with or without a shearing action to cut the sutures  106 ,  116 ,  126  at points just proximal to suture locker  132  as generally shown in  FIG.  21   . The cutting edge  216   a  may have a double bevel configuration instead of the single bevel design shown. 
     The completed annuloplasty or plication procedure is shown in  FIG.  22    with the posterior leaflet  24  having been moved in an anterior direction to provide better coaptation with the anterior leaflet  22  and generally moving the posterior wall  42  of the left ventricle  14  in the same anterior direction. 
       FIGS.  23 - 25    illustrate three additional embodiments of anchor assemblies which are only representative of the many variations and substitutions that may be made with respect to the anchor assemblies described herein. For example,  FIG.  23    illustrates an anchor assembly  230  having a plurality of discrete, flat flexible anchor elements  232  coupled along a flexible tensile member such as suture  234 . Unlike anchor assemblies  102 ,  112 ,  122 , these anchor elements  232  are coupled to the suture  234  such that the suture extends through points separated widthwise along the rectangular anchor elements  232  as opposed to lengthwise. As previously discussed, one or more radiopaque markers  232   a  may be used.  FIG.  24    illustrates an alternative anchor assembly  236  having similar discrete, flat flexible anchor elements  238  coupled along a flexible tensile member  240  with some anchor elements  238  coupled in a lengthwise fashion and some coupled in a widthwise fashion to the suture  240 , as shown.  FIG.  25    illustrates another alternative anchor assembly  242  comprised of discrete, flat flexible anchor elements  244  coupled for sliding movement along a flexible tensile member such as a suture  246 . In this embodiment, the option of having differently sized anchor elements is shown as well as the option of having different spacing between coupling points on each anchor element  244  to create different effects, such as fabric bunching, etc. It will be appreciated that many other forms of anchor assemblies utilizing various shapes, sizes and forms of discrete elements coupled for sliding movement along a flexible tensile member may be used with various advantages. 
     While the present invention has been illustrated by a description of various preferred embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features discussed herein may be used alone or in any combination depending on the needs and preferences of the user. This has been a description of illustrative aspects and embodiments the present invention, along with the preferred methods of practicing the present invention as currently known. However, the invention itself should only be defined by the appended claims.