Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application claims the priority of U.S. Provisional Application No. 60/531,855 filed on Dec. 23, 2003 (pending) and U.S. Provisional Application No. 60/554,314 filed Mar. 18, 2004 (pending), the disclosures of which are hereby incorporated herein by reference.  
         [0002]     The present application is also a Continuation-In-Part of U.S. Ser. No. 10/689,872, filed Oct. 21, 2003 (pending) which claims the priority of U.S. Provisional Application Ser. No. 60/420,095, filed Oct. 21, 2002 (abandoned). The disclosures of these applications are hereby fully incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION  
       [0003]     The present invention relates generally to techniques for treating mitral valve insufficiencies such as mitral valve leakage due to prolapse, papillary muscle dysfunction, or annular dilation. More particularly, the present invention relates to systems and methods for treating a leaking mitral valve in a minimally invasive manner. Various aspects of the invention further pertain more generally to magnetic guidance and/or fastener delivery systems used for approximating or otherwise operating on tissue.  
       BACKGROUND OF THE INVENTION  
       [0004]     Congestive heart failure (CHF), which is often associated with an enlargement of the heart, is a leading cause of death. As a result, the market for the treatment of CHF is becoming increasingly prevalent. For instance, the treatment of CHF is a leading expenditure of Medicare and Medicaid dollars in the United States. Typically, the treatment of CHF enables many who suffer from CHF to enjoy an improved quality of life.  
         [0005]     Referring initially to Fig. A, the anatomy of a heart  10 , specifically the left side of the heart  10 , includes a left atrium (LA)  12  and a left ventricle (LV)  14 . An aorta  16  receives 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 blood from the left atrium  12  to the left ventricle  14 .  
         [0006]     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  which serve as “tension members” that prevent the leaflets  22 ,  24  of mitral valve  20  from going past their closing point and prolapsing back into the left atrium. When left ventricle  14  contracts during systole, cordae tendonae  26  limit the upward (toward the left atrium) motion of the anterior and posterior leaflets past the point at which the anterior and posterior leaflets  22 ,  24  meet and seal to prevent backflow from the left ventricle to the left atrium (“mitral regurgitation” or “mitral insufficiency”). Cordae tendonae  26  arise from a columnae carnae or, more specifically, a musculi papillares (papillary muscles)  28  of the columnae carnae. In various figures herein, some anatomical features have been deleted solely for clarity.  
         [0007]     Fig. B is a cut-away top-view representation of mitral valve  20  and aortic valve  18 . Anterior leaflet  22  and posterior leaflet  24  of the mitral valve  20  are generally thin, flexible membranes. When mitral valve  20  is closed (as shown in Fig. B), 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 .  
         [0008]     Many problems relating to mitral valve  20  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 or prolapse of mitral valve  20 . That is, leakage often occurs when the anterior and posterior leaflets to not seal against each other, resulting in a gap  32  between anterior leaflet  22  and posterior leaflet  24 .  
         [0009]     In general, a relatively significant gap  32  may exist between anterior leaflet  22  and posterior leaflet  24  (as shown in Fig. C) for a variety of different reasons. For example, a gap  32  may exist due to congenital malformations, because of ischemic disease, or because the heart  10  has been damaged by a previous heart attack. A gap  32  may also be created when congestive heart failure, e.g., cardiomyopathy, or some other type of distress which causes a heart to be enlarged. Enlargement of the heart 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, because the anterior annulus is a relataively rigid fibrous structure. When the posterior annulus enlarges, it causes the posterior leaflet to move away from the anterior leaflet, causing a gap because the two leaflets no longer form proper coaptation, and this results in leakage of blood through the valve, or regurgitation.  
         [0010]     Leakage through mitral valve  20  generally causes a heart  10  to operate less efficiently, as the heart  10  must pump blood both out to the body via the aorta, and also back (in the form of mitral regurgitation) back into the left atrium. Leakage through mitral valve  20 , or general mitral insufficiency, is thus often considered to be a precursor to CHF or a cause of progressive worsening of heart failure. There are generally different levels of symptoms associated with heart failure. Such 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 on mild physical exertion. By eliminating the flow of blood backwards into the left atrium, therapies that reduce mitral insufficiency reduce the work load of the heart and may prevent or slow the worsening of heart function and congestive heart failure symptoms that is common when a significant degree of mitral insufficiency remains uncorrected.  
         [0011]     Treatments used to correct for mitral valve leakage or, more generally, CHF, are typically highly invasive, open-heart surgical procedures as described below. In extreme cases, this may include implantation of a ventricular assist device such as an artificial heart 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.  
         [0012]     Rather than implanting a ventricular assist device, bi-ventricular pacing devices similar to pace makers 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.  
         [0013]     Open-heart surgical procedures which 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 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.  
         [0014]     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. In other words, the opening occurs between the ribs in a port access procedure, rather than opening a patient&#39;s sternum.  
         [0015]     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—an annuloplasty ring—may be implanted surgically on the left atrial side of mitral annulus (the attachment of the base of the mitral valve to the heart) to cause the size of a dilated mitral valve annulus to be reduced to a relatively normal size, and specifically to move the posterior leaflet closer to the anterior leaflet to aid anterior—posterior leaflet coaptation and thus improve the quality of mitral valve closure and significantly reduce the amount of mitral insufficiency. Fig. D is a schematic representation of an annuloplasty ring  34 . An annuloplasty ring  34  is shaped approximately like the contour of a normal mitral valve  20 . That is, annuloplasty ring  34  is shaped substantially like the letter “D.” Typically, annuloplasty ring  34  may be formed from a rod or tube of biocompatible material, e.g., plastic, that has a DACRON mesh covering.  
         [0016]     In order for annuloplasty ring  34  to be implanted, a surgeon surgically attaches annuloplasty ring  34  to the mitral valve on the atrial side of the mitral valve  20 . Conventional methods for installing ring  34  require open-heart surgery which involve opening a patient&#39;s sternum and placing the patient on a heart bypass machine. As shown in Fig. E, annuloplasty ring  34  is sewn to a posterior leaflet  24  and an anterior leaflet  22  of a top portion of mitral valve  20 . In sewing annuloplasty ring  34  onto mitral valve  20 , 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 annuloplasty ring  34 . Once a thread has loosely coupled annuloplasty ring  34  to mitral valve tissue, annuloplasty ring  34  is slid into contact with the mitral annulus  40  such that 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  34  by the thread that binds the annuloplasty ring  34  to the mitral annulus tissue. As a result, a gap, such as gap  32  of Fig. C, between anterior leaflet  22  and posterior leaflet  24  during ventricular contraction (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 ring  34 , the anterior and posterior leaflets  22 ,  24  will reform typically by pulling the posterior leaflet forward to properly meet the anterior leaflet and create a new contact line that will enable mitral valve  20  to appear and to function properly.  
         [0017]     Once implanted, tissue generally grows over annuloplasty ring  34 , and a line of contact between annuloplasty ring  34  and mitral valve  20  will essentially enable mitral valve  20  to appear and function normally. Although a patient who receives annuloplasty ring  34  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 annuloplasty ring  34 .  
         [0018]     A second surgical procedure which 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. With reference to Fig. F, such a surgical procedure, e.g., an Alfieri stitch procedure or a bow-tie repair procedure, will be described. An edge-to-edge stitch  36  is used to stitch together an area at approximately the center of the gap  32  defined between an anterior leaflet  22  and a posterior leaflet  24  of a mitral valve  20 . Once stitch  36  is in place, stitch  36  is pulled in to form a suture which holds anterior leaflet  22  against posterior leaflet  24 , as shown. By reducing the size of gap  32 , the amount of leakage through mitral valve  20  may be substantially reduced.  
         [0019]     Although the placement of edge-to-edge stitch  36  is generally successful in reducing the amount of mitral valve leakage through gap  32 , edge-to-edge stitch  36  is conventionally made through open-heart surgery. In addition, the use of edge-to-edge stitch  36  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 edge-to-edge stitch  36 . For instance, blood pressure of approximately 120/80 or higher is typically sufficient to cause the heart  10  to dilate outward to the extent that edge-to-edge stitch  36  may become undone, or tear mitral valve tissue.  
         [0020]     Another surgical procedure which reduces mitral valve leakage involves placing sutures along a mitral valve annulus around the posterior leaflet. A surgical procedure which places sutures along a mitral valve  20  will be described with respect to Fig. G. Sutures  38  are formed along the annulus  40  of a mitral valve  20  that surrounds the posterior leaflet  24  of mitral valve  20 . These sutures may be formed as a double track, e.g., in two “rows” from a single strand of suture material  42 . Sutures  38  are tied off at approximately a central point (P 2 ) of posterior leaflet  24 . Pledgets  44  are often positioned under selected sutures, e.g., at the two ends of the sutured length of annulus or at the central point P 2 , to prevent sutures  38  from tearing through annulus  40 . When sutures  38  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 gap  32  between posterior leaflet  24  and an anterior leaflet  22  may be reduced.  
         [0021]     The placement of sutures  38  along annulus  40 , in addition to the tightening of sutures  38 , is generally successful in reducing mitral valve leakage. However, the placement of sutures  38  is conventionally accomplished through open-heart surgical procedures. That is, like other conventional procedures, a suture-based annuloplasty procedure is invasive.  
         [0022]     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 who 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 who most need open heart surgery, e.g., people at a Class 4 classification, may either be too frail or too weak to undergo the surgery. Hence, many people who may benefit from a surgically repaired mitral valve may not undergo surgery.  
         [0023]     Fig. H illustrates the cardiac anatomy, highlighting the relative position of the coronary sinus (CS)  46  running behind the posterior leaflet  24  of the mitral valve  20 . FIG. I is an illustration of the same anatomy but schematically shows a cinching device  48  which is placed within the CS  46  using a catheter system  50 , with distal, mid, and proximal anchors  52   a ,  52   b ,  52   c  within the lumen of the CS  46  to allow plication of the annulus  40  via the CS  46 . In practice, these anchors  52   a - c  are cinched together, i.e., the distance between them is shortened by pulling a flexible tensile member  54  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 which forms the CS  46  is relatively delicate, the anchors  52   a - c  are prone to tear the tissue during the cinching procedure, and the effect on the mitral annulus may be reduced by the position of the coronary sinus up more towards the left atrium rather than directly over the mitral annulus itself. Other minimally invasive techniques have been proposed and/or developed but have various drawbacks related to such factors as effectiveness and/or cases and accuracy of catheter-based implementation.  
         [0024]     Therefore, there remains a need for improved minimally invasive treatments for mitral valve leakage. Specifically, what is desired is a method for decreasing the circumference of the posterior mitral annulus, moving the posterior leaflet forwards towards the anterior leaflet and thereby reducing leakage between an anterior leaflet and a posterior leaflet of a mitral valve, in a manner that does not require conventional surgical intervention.  
       SUMMARY OF THE INVENTION  
       [0025]     The invention provides a method of modifying an annulus of a heart valve in a first general aspect. The annulus lies generally below the coronary sinus at least at one location. The method comprises fastening the coronary sinus to the annulus to bring the annulus closer to the coronary sinus at least at the one location, and then reducing regurgitation by modifying the annulus. For example, the annulus may be modified by shortening the circumferential length (i.e., the arc length) of the annulus or changing the shape or other physical characteristic of the annulus. Fastening the coronary sinus can further comprise inserting a first guide element into the coronary sinus, directing a second guide element into the left ventricle so it lies under and/or adjacent to the annulus, securing the first and second guide elements together, and applying a fastener between the annulus and the coronary sinus.  
         [0026]     The guide elements may be removed after applying the fastener, and therefore act as a temporary anchor for the fastener delivery device and/or the tissue to be secured. Alternatively, the guide elements, or portions thereof, may be left in place. The guide elements may comprise mechanical fasteners or other types of fasteners such as magnets (i.e., magnetic elements), or combinations thereof. One guide element of the invention comprises first and second spaced apart magnets on the distal support portion of a catheter. Repelling poles of the magnets face each other to create a circumferential virtual pole emanating around the gap formed between the spaced apart magnets. Securing the first and second guide elements together can further comprise magnetically attracting the first and second guide elements together. The same catheter device may be used to direct the second guide element and apply the fastener. In addition, the method can include applying a second fastener to the annulus, coupling the first and second fasteners together, and reducing the distance between the first and second fasteners to reduce the circumference of the annulus. In this case applying the first and second fasteners can occur through the same catheter device. More particularly, the method can involve serially applying the first and second fasteners through one lumen in a catheter device or, as another example, applying the first and second fasteners through different lumens of the same catheter device. In another aspect of the invention, at least one flexible tensile member is used to couple the first and second fasteners together and the flexible tensile member is tensioned to reduce the distance between the first and second fasteners. Shortening the circumferential length of the annulus can further comprise fastening a flexible fabric to the annulus and shortening the circumferential length of the flexible fabric.  
         [0027]     In another general aspect, a method of modifying an annulus of a heart valve comprises applying first and second fasteners on opposite sides of the annulus through at least one catheter thereby holding heart tissue between the first and second fasteners, applying third and fourth fasteners on opposite sides of the annulus through at least one catheter thereby holding heart tissue between the third and fourth fasteners. As with the fasteners applied in the various aspects of this invention, different chateters or different catheter portions may be used to apply the different fasteners or the same catheter may be used. The first and second fasteners are coupled and the third and fourth fasteners are coupled using at least one flexible tensile member. The distance between adjacent ones of at least two of the first, second, third and fourth fasteners is reduced by applying tension to the flexible tensile member thereby modifying the annulus.  
         [0028]     The first, second, third, and fourth fasteners can include at least one magnet and/or at least one mechanical fastening element, such as a mechanical element configured to penetrate and engage with tissue. In addition, the method can include using at least one magnet delivered through a catheter to guide at least one of the fasteners into position. As one option, the guiding magnet may be removed after guiding the fastener or fasteners into position. The fastener or fasteners may be delivered through the guiding magnet.  
         [0029]     In another general aspect of the invention, a heart valve annulus is modified by delivering a first fastener through a catheter into the coronary sinus, and delivering a second fastener through a catheter to at least one of two locations, the two locations being 1) generally above the annulus in the left atrium, and 2) generally below the annulus in the left ventricle. The fasteners are secured to the annulus and the distance between the first and second fasteners is reduced to thereby modify the annulus with the respectively delivered fasteners. In another aspect, a flexible tensile member is connected between the fasteners, and the distance between the fasteners is reduced by tensioning the flexible tensile member to modify the annulus. The flexible tensile member may be locked into position with respect to the fasteners by applying a crimp member or other locking element, which may or may not be part of a fastener, to the flexible tensile member. In another embodiment, the fasteners are held in spaced apart positions while securing the fasteners to heart tissue at the two locations. The fasteners are biased toward each other to reduce the distance between adjacent fasteners and modify the annulus with the respectively delivered fasteners. Biasing the fasteners can further comprise magnetically attracting adjacent fasteners toward one another or, as another example, spring biasing adjacent fasteners toward one another. As one option, pressurized air may be used to hold the fasteners in the spaced apart positions prior to biasing the fasteners together. In another aspect, radio frequency energy or any other suitable method is used to form an aperture in the heart tissue in order to apply the fastener(s) through the tissue.  
         [0030]     The invention further provides a system for modifying an annulus of a heart valve comprising a first catheter, a first magnet coupled with the first catheter in such a manner that the first catheter is operative to deliver the first magnet adjacent to the annulus. The system further includes a second catheter and a second magnet coupled with the second catheter in such a manner that the second catheter is operative to deliver the second magnet adjacent to the annulus. A fastener delivery portion may be operatively associated with the first catheter. The fastener delivery portion may be coupled at predetermined angle relative to an axis of magnetic attraction between the first and second magnets.  
         [0031]     The fastener delivery portion can be movable relative to the first and second magnets so as to enable delivery of a fastener to a desired position. The system can further comprise a plurality of fastener delivery portions configured to deliver respective fasteners at spaced apart locations along the annulus. The plurality of fasteners may be coupled together with at least one flexible tensile member such that the flexible tensile member is capable of drawing the fasteners together and thereby modifying the annulus.  
         [0032]     In another embodiment, a catheter system for modifying an annulus of a heart valve comprises a catheter having at least one lumen and first and second fasteners coupled together by an elongate flexible member such that the first fastener is movable along the elongate flexible member to a position closer to the second fastener. An actuation device is coupled in a releasable manner to the elongate flexible member and adapted to pull the elongate flexible member to thereby reduce the distance between the first and second fasteners. A coupling secures the elongate flexible member in a locked position relative to the first and second fasteners. The first and second fasteners can further comprise magnets and/or mechanical fasteners, such as fasteners having projections configured to penetrate heart tissue. The coupling further can further comprise a crimpable or other type of locking member. The first and second fasteners may be further coupled together by a length adjustable member configured to allow the distance between the first and second fasteners to be shortened as the actuation mechanism pulls the flexible tensile member. The length adjustable member can include first and second telescoping portions coupled together or, as another example, a generally accordion-shaped section.  
         [0033]     In another embodiment, a catheter system for modifying an annulus of a heart valve comprises a catheter having at least one lumen and first and second fasteners coupled together by a flexible tensile member such that the first fastener is movable along the flexible tensile member relative to the second fastener. A first fastener delivery portion is coupled with the catheter and delivers the first fastener into a first position proximate the annulus. A second fastener delivery portion is coupled with the catheter and moves with respect to the first fastener delivery portion. The second fastener delivery portion delivers the second fastener into a second position proximate the annulus and spaced from the first position. This system can further include a third fastener coupled to the flexible tensile member, and a third fastener delivery portion coupled with the catheter and capable of delivering the third fastener into a third position-proximate the annulus and spaced from the first and second positions. The system can also include first and second fastener drive members coupled respectively with the first and second fastener delivery portions, and being selectively movable to drive the first and second fasteners into the tissue proximate the annulus.  
         [0034]     The systems of this invention can include fastener delivery portions comprising at least one spring and drive member each located, for example, at the distal end of a catheter device. Such fastener delivery portions can force the fastener(s) into tissue proximate the annulus. Catheters used in the invention can include a magnet at the distal end for coupling with another magnet located proximate the annulus thereby stabilizing the catheter during delivery of the fastener(s). A lock member may be secured to the flexible tensile member and used to selectively prevent relative movement between the delivered fasteners.  
         [0035]     In another embodiment, a catheter system for modifying an annulus of a heart valve includes a catheter having at least one lumen and first and second fasteners coupled together by a flexible tensile member and adapted to be secured to heart tissue proximate the annulus. A rod is movable between a compact state within the lumen and an expanded state outside of the lumen. The first and second fasteners are further coupled to the rod such that the first fastener is movable along the rod relative to the second fastener by applying tension to the flexible tensile member. The rod may be generally C-shaped in the expanded state so as to follow the annulus. A third fastener may be coupled for movement along the rod and adapted to be secured to heart tissue proximate the annulus. A second flexible tensile member can be secured to the third fastener. The third fastener may then be moved along the rod relative to the second fastener by applying tension to the second flexible tensile member. A magnet can be connected to the rod and adapted to magnetically couple with a magnet in the coronary sinus for stabilizing the position of the rod as the fasteners are secured to the heart tissue.  
         [0036]     Another catheter system for modifying an annulus of a heart valve generally comprises a catheter having at least one lumen and first and second fasteners adapted to be secured to heart tissue proximate the annulus. At least one flexible tensile member couples the first and second fasteners together. A locking device activated by way of a catheter to fix the fastener positions is provided. For example, a locking element delivery device is deployable through a catheter, which may be the same catheter as a fastener delivery catheter, or a different catheter. For example, the locking element can be a crimp and a compression applying mechanism deployed from the catheter can be configured to compress the crimp onto the flexible tensile member after the fasteners are pulled toward one another with the flexible tensile member to modify the annulus. Other types of locking elements may, for example, include spring elements or other biased elements which are held in an open position and then released into a closed or locked position onto one or more flexible tensile members. Any locking element which is selectively lockable onto a flexible tensile member may be used as appropriate for the application. A flexible tensile member releasing device is provided which releases the flexible tensile member from the catheter system is also provided. This may involve a mechanical disconnection mechanism, such as threads or other connectors, or a cutting mechanism associated which cuts the flexible tensile member after locking takes place, such as mentioned above. A third fastener is adapted to be secured to the heart tissue, and separate flexible tensile members may be connected with each of the fasteners and threaded through the locking element, such as a crimp. It will be appreciated that the term “flexible tensile members”, as used herein, will apply to separate portions of a single element, such as a suture strand, wire, cable or other solid or hollow elongate structure which may be looped back on itself and locked in place, and it will also apply to separate elements altogether.  
         [0037]     Another catheter system for modifying an annulus of a heart valve comprises first, second and third fasteners adapted to be secured to heart tissue proximate the annulus. First, second and third flexible tensile members are respectively connectable to the first, second and third fasteners. A generally V-shaped valve support member is provided having a pair of legs movable between a compact state suitable for carrying the valve support member within a catheter and an expanded state in which the legs are more separated. A free end of each leg includes respective first and second eyelets receiving the first and second flexible tensile members and an apex between the pair of legs including a third eyelet receiving the third flexible tensile member. First, second and third crimp members may be provided for respectively securing the first, second and third flexible tensile members with respect to the first, second and third eyelets after at least one of the flexible tensile members is pulled tight to modify the shape of the annulus.  
         [0038]     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  
       [0039]     Fig. A is a cutaway of the left side of the heart showing the internal muscular and valve structure.  
         [0040]     Fig. B is a top view showing the normal positions of a mitral valve and adjacent aortic valve.  
         [0041]     Fig. C is a top view similar to Fig. B but illustrating the mitral valve in a prolapsed condition in which the posterior leaflet is separated from the anterior leaflet.  
         [0042]     Fig. D is an elevational view illustrating a conventional annuloplasty ring.  
         [0043]     Fig. E is a top view similar to Fig. B, but illustrating the attachment of the annuloplasty ring to the mitral valve annulus.  
         [0044]     Fig. F is a top view of the mitral valve illustrating an Alfieri stitch technique for reducing the gap between the posterior and anterior leaflets.  
         [0045]     Fig. G is a top view of the mitral valve illustrating another suturing technique which has been used to close the gap between the posterior and anterior leaflets.  
         [0046]     Fig. H is a cross sectional view of the heart anatomy illustrating the coronary sinus (CS) running behind the posterior leaflet of the mitral valve.  
         [0047]      FIG. 1  is a cross sectional view of the heart anatomy similar to Fig. H, but illustrating a technique for inserting anchors into the CS using a catheter based system.  
         [0048]      FIG. 1A  is a cross sectional view of the heart anatomy similar to  FIG. 1  but illustrating an improved catheter based procedure for inserting anchors into the CS and correcting for mitral valve insufficiency according to the invention.  
         [0049]      FIG. 1B  is an enlarged view of the connector placed in accordance with the invention through the CS and the annulus tissue of the mitral valve.  
         [0050]      FIG. 2A  is a cross sectional view of the mitral valve illustrating the posterior and anterior leaflets and the relative position of the CS with respect to the valve annulus.  
         [0051]      FIG. 2B  is a view similar to  FIG. 2A  and illustrating the effect of cinching or pulling the CS toward the mitral valve opening at a location which is above the level of the valve annulus.  
         [0052]      FIG. 2C  is a view similar to  FIG. 2B , but illustrating the placement of a fastener in accordance with the invention to bring the level of the CS closer to the annulus before cinching.  
         [0053]      FIG. 3  is a cross sectional view of the heart anatomy, on the left side of the heart, illustrating a catheter based system according to the invention.  
         [0054]      FIGS. 3A-3D  illustrate a progression of steps in a catheter based method for correcting a mitral valve insufficiency in accordance with the invention.  
         [0055]      FIGS. 4 and 5  illustrate a cross section of the mitral valve in which anchors have been daisy chained together and then cinched to close the gap between the leaflets of the valve.  
         [0056]     FIGS.  6 A- 6 E- 1  illustrate a cross section of the heart anatomy through the CS and illustrating a pair of catheter devices being used to successively apply fasteners in a daisy chained fashion and both cinch and lock the fasteners in place.  
         [0057]     FIGS.  6 F and  6 F- 1  illustrate the final locked positions of the fasteners, flexible tensile member and locking member placed via catheters.  
         [0058]      FIGS. 7A-7F  are enlarged cross sectional views of the mitral valve at the valve annulus taken generally along line  7 - 7  of  FIG. 6A  and showing the placement of a fastener from the CS downwardly through the valve annulus to the underside or left ventricle side of the valve.  
         [0059]      FIGS. 8A and 8B  illustrate cross sectional views, respectively, through the CS and illustrating the use of a pair of magnets in the CS for magnetically guiding and locking up with a magnet on an anchor delivery catheter.  
         [0060]      FIG. 8C  is an enlarged view of the various magnets and their magnetic fields.  
         [0061]      FIG. 9  is a cross sectional view of the heart anatomy through the CS, and illustrating the use of electromagnets in a catheter device.  
         [0062]      FIG. 10  is a cross sectional view of the heart anatomy through the CS and illustrating the successive positioning of a catheter device relative to another catheter device in the CS through the use of magnets.  
         [0063]      FIGS. 11A and 11B  illustrate cross sectional views of the heart anatomy through the CS and respectively illustrating nonactivated and activated positions of a series of magnetic fasteners used for correcting a mitral valve insufficiency.  
         [0064]      FIGS. 11A-1  and  11 B- 1  respectively illustrate enlarged views of the magnetic fastener system in its nonactivated and activated states.  
         [0065]      FIG. 11C  is a cross sectional view through the mitral valve and CS illustrating the final activated position of the fastener system placed in accordance with  FIGS. 11A and 11B .  
         [0066]      FIGS. 12A and 12B  illustrate an alternative in which the magnetic fasteners are placed respectively in the CS and in the left atrium.  
         [0067]      FIGS. 13A and 13B  are cross sections of the heart anatomy through the CS and illustrating an additional magnetic fastener placed below the annulus in left ventricle to assist with reducing the mitral valve insufficiency.  
         [0068]      FIGS. 14A and 14B  are cross sections through the CS and mitral valve and illustrating another alternative magnetic fastening system.  
         [0069]      FIG. 14C  is similar to  FIG. 14B , but illustrates a magnetic fastener with additional mechanical fastening elements in the form of projections which engage and penetrate tissue proximate the valve annulus.  
         [0070]      FIGS. 14D and 14E  are perspective views illustrating the magnetic fastening elements with mechanical tissue engaging projections.  
         [0071]      FIGS. 15A-15C  are cross sections through the CS and mitral valve illustrating an alternative fastener delivery mechanism in which a fastener is delivered through a catheter and also through magnetic guiding elements.  
         [0072]      FIGS. 15D and 15E  are cross sections similar to  FIG. 15A , but illustrating a series of fasteners delivered through magnetic guiding elements and daisy chained together using a flexible tensile member.  
         [0073]      FIGS. 16A-16C  are cross sectional views similar to  FIGS. 15A-15C , but illustrating the use of magnetic guiding elements which have separable portions.  
         [0074]      FIGS. 16A-1  and  16 A- 2  are perspective views of the magnetic guiding elements respectively shown in nonseparated and separated positions.  
         [0075]      FIGS. 16D and 16E  are similar to  FIGS. 15D and 15E , and illustrate the daisy chained connection of the fasteners with the magnetic guiding elements removed.  
         [0076]      FIG. 17  is a perspective view showing a fastener delivery mechanism on a catheter which includes a magnetic guiding element magnetically coupled to a second magnetic guiding element of a second catheter.  
         [0077]      FIGS. 18A-18C  respectively illustrate cross sectional views of the heart anatomy through the CS and the mitral valve and the placement of an alternative catheter delivered fastening system.  
         [0078]      FIG. 19A  is a cross sectional view of the heart anatomy through the CS and the placement of another alternative catheter delivered fastening system.  
         [0079]      FIGS. 19B and 19C  illustrate the daisy chained fasteners of  FIG. 19A  respectively before and after cinching of the fasteners to shorten the valve annulus.  
         [0080]      FIGS. 20A and 20B  illustrate a cross sectional view of tissue receiving fasteners formed from shape memory alloy both before and after activation of the shape memory effect to shorten the overall length of the tissue engaged with the fasteners.  
         [0081]      FIG. 21A  is a cross sectional view of the heart anatomy through the CS and illustrating the use of a catheter to delivery a series of fasteners in the form of tissue penetrating fasteners separated by pledgets along a flexible tensile member.  
         [0082]      FIGS. 21B-21D  respectively illustrate enlarged views of the fastener delivery system shown in  FIG. 21A  as well as the final cinching thereof.  
         [0083]      FIG. 22  illustrates an alternative system to  FIGS. 21A-21D  in which a secondary cinching mechanism is provided in the form of a second flexible tensile member.  
         [0084]      FIGS. 23A-23E  illustrate respective cross sections of the heart anatomy through the CS and the use of another alternative catheter based system for serially delivering fasteners coupled with a flexible tensile member used to cinch valve tissue and correct a mitral valve insufficiency.  
         [0085]      FIGS. 24A-24C  are respective cross sections through the heart anatomy including the CS above the mitral valve and illustrating another alternative catheter based fastener system.  
         [0086]      FIGS. 25A-25D  illustrate an enlarged cross section of the catheter based system of  FIGS. 24A-24C , and showing the cinching and locking thereof.  
         [0087]      FIGS. 26A-26B  illustrate another alternative cinching and locking system for a catheter based fastener system similar to  FIGS. 25A-25D .  
         [0088]      FIGS. 27A-27C  illustrate yet another alternative cinching and locking mechanism associated with a catheter based fastener system similar to  FIGS. 26A and 26B .  
         [0089]      FIGS. 28A and 28B  are respective cross sections similar to  FIGS. 27A and 27B , but illustrating another alternative fastening system.  
         [0090]      FIGS. 29A and 29B  illustrate respective cross sections of yet another catheter based fastening system.  
         [0091]      FIG. 30  illustrates a cross section of yet another catheter based fastener system.  
         [0092]      FIG. 31A  is a cross section taken along line  31 A- 31 A of  FIG. 30 .  
         [0093]      FIG. 31B  is a cross section taken along line  31 B- 31 B of  FIG. 30 .  
         [0094]      FIGS. 32A and 32B  illustrate another alternative fastening system in its nonactivated and activated states.  
         [0095]      FIG. 32C  is a cross section taken along line  32 C- 32 C of  FIG. 32A .  
         [0096]      FIG. 33  is a cross section of another alternative fastening system.  
         [0097]      FIGS. 33A and 33B  are enlarged cross sectional views of portions of  FIG. 33  respectively shown in nonactivated and activated states.  
         [0098]      FIGS. 34A-34I  are respective cross sections of the heart anatomy successively showing the use of another alternative catheter based fastening system.  
         [0099]      FIG. 35A  is a cross section taken through the CS and illustrating a perspective view of another alternative catheter based fastener delivery device.  
         [0100]      FIGS. 35B-35E  are respective cross sections of the fastener delivery device shown in  FIG. 35A  and used to deliver multiple fasteners coupled to a flexible tensile member.  
         [0101]      FIG. 35F  is a cross sectional view of the fastening system delivered, cinched and locked to shorten the length of tissue engaged with the system.  
         [0102]      FIG. 36  is a perspective view of the distal end of another alternative catheter based fastener delivery system.  
         [0103]      FIG. 37A  is a fragmented view of the distal end of another catheter based system for delivering a fastener and valve support member of the invention.  
         [0104]      FIGS. 37B and 37C  respectively illustrate the deployed valve support and fastener system on the mitral valve.  
         [0105]      FIGS. 38A-38I  respectively illustrate cross sections of the mitral valve and CS and the progression of using another catheter based fastener delivery system.  
         [0106]      FIGS. 39A and 39B  respectively illustrate cross sections of the distal end of a crimping and cutting device which may be used with various catheter based systems of this invention.  
         [0107]      FIGS. 40A-40D  respectively illustrate cross sections through the heart anatomy including the mitral valve and CS, and illustrating another alternative catheter based fastener delivery system.  
         [0108]      FIGS. 41A-41C  illustrate another catheter based fastener delivery system.  
         [0109]      FIG. 42A  illustrates an elevational view of one exemplary fastener usable in the systems described herein.  
         [0110]      FIG. 42B  is a cross sectional view taken along line  42 B- 42 B of  FIG. 42A .  
         [0111]      FIG. 43  is a side elevational view of another alternative fastener having a curved shape.  
         [0112]      FIGS. 44A-44C  respectively illustrate the use of another alternative fastener suitable for the systems of the present invention. 
     
    
     DETAILED DESCRIPTION  
       [0113]     In this description of illustrative examples, like reference numerals refer to like element throughout the drawings. Like reference numerals with prime (′) marks or double prime (″) marks refer to like structure except for minor differences which will be apparent.  FIGS. 1A and 1B  illustrate an improved catheter delivered fastener system  50 ′ which involves placing a permanent fastener or anchor  60  from the CS  46  through the wall of the left atrium  12  proximate annulus  40  for anchoring purposes. This improvement may be applied to the prior cinching method illustrated in Fig. I discussed above. The fastener  60  may be deployed and anchored in various manners, including those discussed further below. Because the fastener  60  extends not only through the delicate CS tissue, but also through the thicker tissue of the left atrium  12 , secured anchoring takes place and, upon cinching using a flexible tensile member  54 , the annulus  40  may be reduced to correct for a prolapsed valve or other mitral valve insufficiency with less risk of tearing tissue.  FIGS. 2A and 2B  illustrate the anatomical relationship between the CS  46  and the mitral annulus  40 . In particular, the CS  46  can be noncoplanar with the mitral annulus  40 , causing CS based cinching approaches to the inefficient to effectively modify the shape of the annulus  40 . In many cases, the CS  46  extends above the mitral annulus  40  along the left atrial wall and, instead of pulling the annulus  40  toward the valve opening or gap  32 , the left atrial wall is instead pulled inwardly as shown in  FIG. 2B . This causes more of a restriction of the atrium  12  above the valve  20 , rather than a reduction of the annulus  40  itself and, therefore, prevents a complete correction of the valve insufficiency in this case. In an approach which is similar to the approach shown in  FIGS. 1A and 1B , but having additional benefits, a fastener or anchor  62  extends from the CS  46  into the left ventricle side of the annulus  40 . This plicates the tissue between the CS  46  and the left ventricle  14  thereby bringing the CS  46  closer to and/or more in line with the annulus  40 . Once this plication has taken place as shown in  FIG. 2C , a CS cinching device can more efficiently and effectively reduce the mitral annulus  40 . That is, when cinched toward the valve opening or gap  32 , the cinching device, which is more in line with the valve annulus  40 , can better pull the posterior leaflet  24  toward the anterior leaflet  22  thereby closing the gap  32  between the leaflets.  
         [0114]     As shown in  FIGS. 3, 3A  and  3 B, a pair of magnetically attractive catheters  64 ,  66  can be used in concert with each other using the CS  46  as an approximate guide to locate and position the tip of another catheter or catheter portion at the mitral annulus  40 . More specifically, as one example, one catheter  66  includes both a magnetic guiding portion  66   a  and an anchor delivery portion  66   b  positioned in a predetermined manner, such as at a predetermined acute angle relative to the magnetic portion  66   a . Another catheter  64  is placed in the CS  46  and includes a magnetic guiding portion  64   a . The two magnetic guiding portions  64   a ,  66   a  magnetically couple with one another to lock up the position of the anchor delivery catheter portion  66   b  at a predetermined angle which will properly deliver a fastener or anchor  68  into a desired portion of the tissue. As shown in  FIG. 3A , the magnetically locked catheters  64 ,  66  can deliver a first loop type anchor or fastener  68  through the valve annulus  40  on a skewed or otherwise known trajectory from the axis of magnetic attraction, such that the loop type anchor or fastener  68  is accurately placed, for example, through the annulus  40  from the left ventricle side to the left atrium side of the mitral valve  20 . As shown in  FIG. 3B , the CS catheter  64  can be translated to a different position within the CS  46  causing the magnetic tip  66   a  of the left ventricle catheter  66  to follow along the annulus  40  where subsequent loop type anchors or fasteners  68  may be placed in a similar fashion to the first applied anchor or fastener  68 .  FIG. 3C  illustrates that a loop type fastener or anchor  68  may capture a T-bar type anchor or fastener  70  passing from the CS  46  through the left atrial wall using a catheter delivery system  72  guided within the CS  46 . In this embodiment, fasteners  68  are therefore placed from the left ventricle  14  into the left atrium  12 , and additional connecting fasteners  70  are placed from the CS  46  into the left atrium  12  for engagement with the other fasteners  68 . As shown in  FIG. 3D , multiple loop and T-bar anchors or fasteners  68 ,  70  may be cinched together with a flexible tensile member  74  similar to a drawstring-type configuration, resulting in alignment of the CS  46  and the annulus  40  into a more coplanar relationship at several locations. The cinching or drawstring action therefore closes the gap  32  between the posterior leaflet  24  and the anterior leaflet  22  in a more even and effective manner.  
         [0115]      FIG. 4  illustrates magnetically attractive catheter portions  64   a ,  66   a  respectively in the CS  46  and under the mitral annulus  40  used to deliver a series of anchors or fasteners  76  with a T-bar shape from the left ventricle side of the mitral valve  20  to the left atrium side of the mitral valve  20 . As also shown in  FIG. 4 , the T-bar shaped anchor fasteners  76  are delivered in a daisy chained fashion from catheter portion  66   b  such that a second catheter  78  may be used to cinch a drawstring or flexible tensile member  80  to shorten or reduce the valve annulus  40 . As shown in  FIG. 5 , the anchors or fasteners  76  may be cinched together using the drawstring or flexible tensile member  80  within catheter  78  to pull the posterior leaflet  24  toward the anterior leaflet  22 . The flexible tensile member  80  is then locked in place or otherwise secured to retain the fasteners  76  in their new positions, such as in one of the manners described below.  
         [0116]      FIGS. 6A-6F  respectively illustrate catheters  82 ,  84  being placed into the heart  10  through the aortic valve into the left ventricle  14  and through the CS  46  generally adjacent the valve annulus  40 . This top view of the heart  10  shows how a first T-bar type anchor or fastener  86  having a tail, forming a flexible tensile member  88 , is loaded into the CS catheter  84  at the proximal end  84   a  so that it may be pushed down to the distal tip  84   b  to be in position for delivery. The position of the left ventrical catheter  82  with a magnetic tip  82   a  is also shown generally opposite to the distal tip  84   b  of the CS catheter  84 . As shown in  FIG. 6B , a second anchor or fastener  90  is delivered in a daisy chain fashion by running an eyelet  90   a  on the second anchor  90  over the tail or flexible tensile member  88  associated with the first anchor  86 .  FIG. 6C  illustrates the second anchor  90  of the daisy chain delivered through the valve annulus  40  at a spaced apart location from the first anchor  86 .  FIG. 6D  illustrates a third anchor  92  at the annulus  40  similarly delivered along flexible tensile member  88  using an eyelet portion  92   a . Anchor  92  is threaded through the CS catheter  84  and driven through the tissue generally at the valve annulus  40 . In the case of this type of anchor, respective transverse bar portions  86   b ,  90   b ,  92   b  of the anchors or fasteners extend into the left ventricle  14 .  FIG. 6E  illustrates a locking member  94 , including a crimp  96  delivered over the daisy chain tail or flexible tensile member  88  within the proximal CS  46 . Locking member  94  is shaped or otherwise configured to hold its position within the CS  46 .  FIG. 6E-1  illustrates the crimp  96  before crimping onto the flexible tensile member or tail  88 . As shown in FIGS.  6 F and  6 F- 1   a  catheter device  98 , which may be deployed through a suitable delivery catheter (not shown) may be used to pull the flexible tensile member  88  thereby cinching the assembly and pulling the posterior leaflet  24  toward to the anterior leaflet  22 . Once this cinching is accomplished, the crimp is crimped against the flexible tensile member  88  adjacent to the lock member  94  to keep the assembly at the desired position.  
         [0117]      FIG. 7A  illustrates how magnetically attractive portions  82   a ,  84   b  of the LV and CS catheters  82 ,  84  should be strongly attracted when the gap distance (d 1 ) is relatively short. If this gap distance d 1  is not relatively short, then other methods of increasing the lock up force may be necessary as further described herein below.  
         [0118]      FIGS. 7B and 7C  illustrate how a T-bar type anchor or fastener  86  would be pushed from an opening  84   c  in the CS catheter through the tissue from the CS  46  into the left ventricle  14  until it is fully deployed across the tissue.  FIG. 7D  illustrates a larger gap d 2 , through which two magnetic portions  82   a ,  84   b  of the respective LV and CS catheters may magnetically couple, depending on the magnetic attractive forces developed. In  FIGS. 7E and 7F , the magnetic catheter in the LV  14  has not been illustrated (only for purposes of clarity), such that the delivery of a T-bar type fastener or anchor  86  may be shown in its fully deployed state across the tissue. As shown in  FIG. 7F , the T-bar portion or transverse portion  86   b  of the fastener  86  self-rotates in order to fit snugly along the annulus  40  under the posterior leaflet  24 . In  FIG. 7G , the relative position of the CS  46  to the annulus  40  is improved after cinching of the anchor  86  plicates the tissue between the annulus  40  and the CS  46  as previously described.  
         [0119]      FIGS. 8A-8C  illustrate that multiple magnets  102   a ,  102   b  may be used in the CS, such as on a CS catheter  102 , to attract an opposite magnet pole at the tip  100   a  of the LV catheter  100 . This allows the LV catheter  100  to be steered in three axes to deliver a fastener through a second catheter portion  100   b  into the annulus  40 . It will be appreciated that multiple magnets may also or alternatively be used in the LV  14  and/or in the LA for steering purposes and/or additional magnetic force.  FIG. 8C  illustrates in detail how a pair of magnets  102   a ,  102   b  in the CS  46  mounted such that like poles are facing each other results in a 360° magnetic field which attracts the opposite pole of a magnetic catheter tip  100   a  within the LV  14 . This can eliminate the need to rotationally orient the CS catheter  102  so that its pole is facing an opposite pole in the LV  14 .  
         [0120]      FIG. 9  illustrates the use of electromagnets  104  in a CS catheter  106  which may be used in conjunction with or as replacements for permanent magnets as described in the above embodiments. It will also be appreciated that one element which generates magnetic forces may be used in conjunction with another element which is magnetically attracted to the magnetic force generating element, but not necessarily a magnetic force generating element itself. For example, an electromagnet or permanent magnet may be positioned on one side of the tissue to be anchored, and another element formed from ferrous metal may be positioned on the opposite side of the tissue for magnetic coupling purposes while a fastener or anchor is driven into the tissue.  
         [0121]      FIG. 10  illustrates a CS catheter  108  configured with multiple opposite pole magnetic pairs  110 ,  112  along its length and a steerable LV catheter that may be directed to each discrete pair of magnets  110 ,  112  to delivery anchors or fasteners (not shown), such as in one of the manners previously described.  
         [0122]     Now referring to FIGS.  11 A,  11 A- 1 ,  11 B and  11 B- 1 , a CS catheter  116  may be configured with multiple discrete magnets  118  along its length, wherein the poles of the magnets  118  are arranged such that they are magnetically attracted to each other, yet kept apart by a restraining force, such as pressurized air directed to a bladder-like structure  120  between the magnets  118 . In this case, the magnets  118  are being used as fasteners to fasten or trap tissue therebetween. A similar catheter  122  delivers magnets  124  on an opposite side of the tissue, such as within the LV  14 . When the restraining force is removed, such as by reducing the air pressure as shown in FIGS.  11 B and  11 B- 1 , the magnets  118  are attracted to each other and thereby modify the valve annulus  40  such that the posterior leaflet  24  is pulled toward the anterior leaflet  22 . As shown best in  FIGS. 11B and 11C , each strip of magnets  118 ,  124  has opposing poles along its length and thereby plicates the tissue by removing a restraining force between the magnets  118  in the CS  46 , thereby allowing the attracted magnets  118  to move toward each other and plicate the annulus tissue therebetween. The magnets  124  in the LV catheter  122  may be configured in the same manner as magnets  118 .  
         [0123]      FIGS. 12A and 12B  illustrate respective strips of magnets  118 ,  124 , as described in connection with  FIGS. 11A-11C  in the CS  46  and the LA  12  instead of the LV  14 . The two strips of respective magnets  118 ,  124  align with each other such that the magnets  118 ,  124  are anchored to each other across the left atrial wall. In this case, once again, the stronger atrial wall is used as the anchoring tissue, as opposed to the CS tissue only. When the magnets  118  in the CS  46  are brought together, as discussed above, an annular reduction of the mitral annulus  40  is achieved similar to the manner discussed above.  
         [0124]      FIGS. 13A and 13B  illustrate strips of magnets  118 ,  124  in the CS  46  and LA  12  as discussed previously. However, cinching via the CS  46  alone may not have sufficiently precise pull on the mitral annulus  40  since these two anatomical structures typically do not lie at the same level. Even the two strips of magnets  118 ,  124  shown in  FIG. 12B  are only coupled across the left atrial wall, and this may not be in line with the annulus  40  at all locations. Therefore, an additional magnet  126  shown in  FIGS. 13A and 13B , fixed to a metal or otherwise substantially rigid curved bar  128 , is placed under the mitral valve  20  in the LV  14 , such that magnet  126  locks up with the strip of magnets  118  in the CS  46 . This pulls the exterior annulus  40  toward the CS  46  and establishes a more coplanar relationship.  
         [0125]      FIG. 14A  illustrates a modification of the strip of magnets  124  positioned in the LA  12  such that there is an extension magnet  130  which is positioned at the midpoint of the strip of magnets  124 . This extension magnet  130  extends down to the mitral valve annulus  40  bridging the gap between the CS  46  and the valve annulus  40 . This may pull a magnet  132  and curved support bar  134  under the valve  20  tighter to the CS  46 , as shown in  FIG. 14B . It will be appreciated that magnet  132  and support bar  134  are similar to magnet  126  and support bar  128 , except that bar  134  has a fabric covering  136  as may be desired for tissue ingrowth purposes.  FIGS. 14C-14E  illustrate the use of additional mechanical fasteners such as projections  138  on one or more of the magnets  132  used in the embodiments described above. This can apply additional traction or fastening to the tissue than could otherwise be supplied by the use of magnets alone.  
         [0126]      FIGS. 15A-15E  comprise a series of illustrations showing another alternative catheter based fastener delivery system. In addition to showing the use of a fastener  140  to pull the CS  46  into a more coplanar relationship with the annulus  40  ( FIG. 15C ), this system utilizes magnets  142 ,  144  which have orifices  142   a ,  144   a  through which the fastener  140  is delivered such that more precise placement of the fastener  140  may be obtained in certain instances while also using a magnetic lock up force for more positively driving the anchor or fastener  140 . It will be appreciated that magnet  144  will be coupled to a catheter (not shown) for positioning within the CS  46 . Magnet  142  may be releasably coupled to a steerable catheter  146 . As shown in  FIGS. 15D and 15E , after a plurality of magnets  142 ,  144  and fasteners  140  have been delivered such that tissue is trapped therebetween, a flexible tensile member  148  and crimps  150  may be used to cinch and lock the fasteners  140  together thereby pulling the posterior leaflet  24  toward the anterior leaflet  22  and closing a gap  32  in the valve  20 .  
         [0127]      FIGS. 16A-16E , as well as  FIGS. 16A-1  and  16 A- 2  illustrate a system which is the same as the system shown in  FIGS. 15A-15E , except that the magnets  142 ′,  144 ′ are formed of separable portions, such as halves  142   a ,  142   b ,  144   a ,  144   b , so that the magnets  142 ′,  144 ′ may be removed after the fasteners  140 ′ have been properly delivered. Thus, the anchors or fasteners  140 ′ themselves have portions  140   a ,  140   b  which retain the fasteners  140 ′ in place across the tissue proximate the annulus  40 , and portions  140   b  accept a flexible tensile member  148  and crimps  150  for cinching and locking purposes as shown in  FIGS. 16D and 16E  generally in the manner or manners described herein. The separable magnet portions  142   a ,  142   b  and  144   a ,  144   b  may be coupled to suitable catheter devices allowing their release from fasteners  140 ′ and withdrawal from the patient.  
         [0128]      FIG. 17A  illustrates an alternative fastener delivery system  160  using magnetic guidance in which the fastener  140 ′ is not delivered through the magnets  162 ,  164 , but is delivered adjacent to the magnets  162 ,  164  in a fastener driving portion  166  of a catheter  168 . This is another manner of using magnetic guidance and temporary lock up without the necessity of leaving the magnets  162 ,  164  in place after completion of the procedure.  
         [0129]      FIGS. 18A-18C  illustrate a more conventional annuloplasty that may be accomplished using magnetic guidance and lock up in a temporary manner to facilitate fastener placement and driving. More specifically, a magnetic strip  170  is placed into the CS  46  using a catheter  172 . A second magnetic strip  174  with a fabric covering  176  is placed in the left atrium  12  also via a catheter  178 . Fasteners  180  are placed into the fabric  176  on the strip  174  in the left atrium  12  from the undersurface of the mitral valve  20  again using a catheter  82 . Likewise, fasteners  180  are driven through the CS  46  and left atrium wall into the fabric  176  in a manner similar to that described with respect to, for example,  FIGS. 3C and 3D  through a catheter with a sideward firing fastener driving portion (see also  FIGS. 7D-7F ). The magnetic strips  170 ,  174  are removed from the fabric covering  176  and from the CS  46  and the fabric  176  is then drawstringed or cinched with a suitable flexible tensile member  184  coupled therewith to produce annuloplasty or pulling of the posterior leaflet  24  toward the anterior leaflet  22  to eliminate or reduce a gap  32  in the mitral valve  20 .  
         [0130]      FIGS. 19A-19C  illustrate one alternative to a T-bar configuration of fasteners as previously described. In this embodiment, fasteners  190  in the form of anchor buttons  190   a  are placed below the mitral valve  20  along the annulus  40  using catheters  192 ,  194  with magnetic guidance and lock up as previously described. Although not shown, another catheter is used in the left atrium to deliver buttons  190   b  which couple with buttons  190   a . Buttons  190   a  are further coupled to a flexible tensile member  196  which may be secured with crimps  200  (one shown in  FIG. 19C ) as previously described. This compresses the mitral tissue between respective tissue engaging portions of the buttons  190   a ,  190   b . The buttons  190   a ,  190   b  are drawstringed or cinched from below using flexible tensile member  196  threaded through respective eyelet portions  198  of each button  190   a.    
         [0131]      FIGS. 20A and 20B  illustrate another way to plicate the annulus  40  by using memory alloy staples  202  driven into the tissue along the annulus  40 . When the memory alloy activates, the staples  202  shorten and plicate the tissue ( FIG. 208 ) to shorten the annulus  40  of the mitral valve  20  to pull the posterior leaflet toward the anterior leaflet as generally described above.  
         [0132]      FIGS. 21A-21D  illustrate the placement of fasteners  210  on the left atrial side of the mitral valve  20 , daisy chained to pledgets or fasteners  212  in the form of tissue trapping load spreading members underneath the annulus  40 . These fasteners  210 ,  212  are coupled together by a flexible tensile member  214  or drawstring, in this case.  FIGS. 21A-21C  illustrate a catheter  216  which delivers fasteners  210 ,  212  in a serial fashion along flexible tensile member  214  such that fasteners  210  are driven through the tissue and fasteners or pledgets  212  are released between each fastener  210 . The series of fasteners  210 ,  212  is then drawn together using the drawstring or flexible tensile member  214  as shown in  FIG. 21D . This shortens the distance between each of the fasteners  210 ,  212  and the entire structure with elements above and below the annulus  40 . The tissue becomes trapped between the fasteners  210 ,  212  spreading loads over larger areas and reducing tear out risks.  
         [0133]      FIG. 22  illustrates a modified version of the system illustrated in  FIGS. 21A-21D . In this embodiment, after the first drawstring  214  is pulled to tighten the various fasteners  210 ,  212 ′ and plicate the annulus  40  as generally shown in  FIG. 21D , a second drawstring  218  coupled to eyelets  220  each of the pledgets  212 ′ may be pulled for a secondary shortening operation which further reduces the annulus  40 , as necessary.  
         [0134]      FIGS. 23A-23E  illustrate an alternative embodiment which is similar to  FIGS. 21A-21D , except that the pledgets  212 ″ have a pair of holes  222 ,  224  through which the flexible tensile member  214  or drawstring is threaded, as opposed to an eyelet structure.  
         [0135]      FIGS. 24A-24C  illustrate another embodiment of a catheter based fastener system  230  which employs a series of connected magnets  232 ,  234  with one series of magnets  232  lying in the CS  46  lying adjacent to the mitral valve annulus  40  and another series  234  lying in the LV  14  adjacent to the annulus  40 . The magnets  232  residing in the CS  46  are coupled together by coil springs  236  and by a flexible tensile member  238 , while the magnets  234  in the LV  14  are, in one embodiment, positioned individually in the LV adjacent to magnets in the CS  232 , after release from the LV magnet delivery catheter  240 , as shown in  FIG. 24C . In another embodiment, the array of LV magnets  234  is shown in  FIG. 24A  adjacent to the CS magnets  232  and connected by a member consisting of a sheath  233  upon which the magnets  234  can slide. The array of magnets  234  and the sheath  233  are deposited in the LV  14  as the delivery catheter  240  is withdrawn. The connecting sheath  233  prevents the risk of an embolic accident resulting from a detachment of a single magnet  234 . In  FIG. 24B , the withdrawal of the LV delivery catheter  240  is shown in more detail. The most distal magnet  234  is shown attached to the sheath  233 , whereas the next more proximal magnet  234  is still on the shaft of the delivery catheter  240 . Each series of magnets  232 ,  234  is introduced into the positions shown in  FIGS. 24A-24C  by respective catheters  242 ,  240 . A coupling  244  is provided and is releasably coupled to a pull wire or cable  246  in the catheter  242  such that the series of magnets  232  may be cinched or drawn together to reduce the circumferential length of the valve annulus  40 . The LV magnets  234 , owing to their attraction to their CS counterparts  232 , are thus pulled together to accomplish plication of the dorsal cusp of the mitral valve  20  adjacent to the annulus  40 . Plication may be better facilitated by features on the surface of the CS magnets  232  which grip the endocardial surface, and promote ultimate tissue ingrowth about the magnets  232  to strengthen the plication. Once the reduction has taken place, the magnets  232  are locked in place, and the catheter  242  is removed.  
         [0136]     Referring more specifically to  FIGS. 25A-25D , the operation of the coupling  244 , and a release and locking mechanism  250  is shown. The initial position is shown in  FIG. 25A  in which the magnets  232  are spaced apart by the uncompressed coil springs  236  and the flexible tensile member  238  which is fixed to a coupling element  252  having at least a pair of arms  254 ,  256  which releasably grip a complimentary coupling element  258 . The complimentary coupling element  258  is fixed to a pull wire or cable  260  extending within the delivery catheter  242 . The wire or cable  260  is pulled as shown in  FIG. 25B  to compress the coil springs  236  and reduce the distance between each adjacent pair of magnets  232 , thereby reducing the circumferential length of the annulus  40  ( FIG. 24C ) as the magnets  234  within the LV  14  passively follow the magnets  232  in the CS  46 . At this point, the delivery catheter  242  may be pushed to the left as viewed in  FIGS. 25B and 25C  causing a crimping action of a tube  262  affixed to the most proximal magnet  232 . A crimped portion  262   a  is then retained within a recessed portion of the coupling element  252 . At the same time, the gripping arms  254 ,  256  release the complimentary coupling element  258  of the pull wire or cable  260  and the delivery catheter  242  and pull wire or cable  260  may then be removed leaving the locked fastener system  230  in place as shown in  FIG. 25D .  
         [0137]      FIGS. 26A and 26B  illustrate a fastener system  270  which operates the same as that disclosed in  FIGS. 24A-24C  and  25 A- 25 D, except that an accordion or bellows type section  272  replaces each coil spring  236 , and internally and externally threaded coupling elements  274 ,  276  replace the gripping arms  254 ,  256  and coupling element  258 . It will be appreciated that the operation of the system shown in  FIGS. 26A and 26B  is the same as that described in the previous embodiment, except that releasing the coupling element  276  will involve rotating the pull wire or cable  260  to decouple the threaded coupling elements  274 ,  276 . It will be appreciated that the recessed portion  252   a  of coupling element  252  can have an essentially square cross section. The crimped portion  262   a  of tube  262  will thus engage the recessed portion and plastically deform about it to prevent rotation of coupling element 252 with respect to threaded coupling element  276 . The coupling element  276  and cable can thus be effectively unthreaded and released.  
         [0138]      FIGS. 27A and 27B  illustrate another alternative catheter based fastener system  280  which is the same as those described with respect to the two previous embodiments, except that the coil springs  236  and accordion shaped bellows sections  272  have been replaced by respective telescoping portions  282 ,  284  which carry the magnets  232  fixed therein. Also, a releasable coupling  286  is formed by a quarter turn bayonet type fastener as opposed to the gripping arms  254 ,  256  and element  258 , or the threaded connection  274 ,  276  of the two previous embodiments. In the present embodiment, an elastomeric pad  252   b  is seated distal to the proximal component of the bayonet connector  286 . When the bayonet  286  is engaged in the delivery position, the pad  252   b  creates a load on the proximal component which prevents inadvertent release of the system  280 . The recessed segment  252   a  of the coupling element can have a square cross section to prevent rotation of the coupling during disengagement of the bayonet, in a manner similar to the previous embodiment. The telescoping portions  282 ,  284  are flexible and also pivot so that they can conform to the curved shape of the CS  46 . When the pull wire or cable  260  is pulled to the right as illustrated in  FIGS. 27A and 27B , the telescoping portions  282 ,  284  can move together such that detents  288  move from one recess  290  to an adjacent recess  292  of the respective telescoping portions. The assembly is then locked in place as previously described and the bayonet coupling  286  is released for purposes of withdrawing the delivery catheter  242 .  
         [0139]      FIGS. 28A and 28B  are illustrative of another embodiment which is the same as the system shown in  FIGS. 27A and 27B , except that the telescoping portions  282 ′,  284 ′ are fabricated of a flexible, elastomeric polymer material to allow the fastener system  280 ′ to conform to the curve of the CS  46  ( FIG. 24C ). This is to be contrasted with the fastener system  280  shown in  FIGS. 27A and 27B , in which the telescoping elements  284  are fabricated of a relatively more rigid material. In this previous embodiment, flexibility is gained primarily from the length of the detents  290  and  292 , which allow angled positioning of one telescoping element relative to an adjacent one. In the current embodiment, additional flexibility of the fastener is achieved with the length of the detents  290  and  292 .  
         [0140]      FIGS. 29A and 29B  illustrate another system  280 ″ which is similar to those described in the previous embodiment, except that the telescoping portions  282 ″,  284 ″ only have one recess location  290 ′ for initially retaining the relative positions of the telescoping portions  282 ″,  284 ″ as shown in  FIG. 29A . Also, each telescoping portion  282 ″,  284 ″ may have projections  296  which act as mechanical fasteners for engaging tissue within the CS  46  ( FIG. 24C ). When the telescoping portions  282 ″,  284 ″ are drawn together, as described above, the smaller diameter sections  282 ″ are retained in the telescoped position by a locking mechanism operating on the flexible tensile member  238 , such as previously described, thereby maintaining the shortened condition of the fastening system.  
         [0141]      FIGS. 30, 31A  and  31 B illustrate another catheter based system  300  for placing magnets adjacent the mitral annulus, such as within the LV  14  (Fig. A). In this system, a delivery catheter  304  receives a plurality of annular magnets  306 . Magnets  306 , for example, may have roughened outer surfaces  306   a  for tissue engagement purposes. The catheter  304  has an outer diameter which is expandable to frictionally retain the magnets  306  at spaced apart locations. An internal tube  308  may be withdrawn, to the left as illustrated in  FIG. 30 , to release the magnets  306  from their frictional engagement with the outer surface of the delivery catheter  304 . As one example, the delivery catheter  304  is shown with a manipulator wire  310  for orienting the direction of the distal tip  312 , and also a core wire  314  for facilitating insertion and removal of the delivery catheter  304 . Once the magnets  306  are magnetically coupled to additional magnets (not shown) across the annulus tissue, for example, the internal tube  308  may be withdrawn thereby releasing the delivery catheter  304  from magnets  306  and facilitating its removal by, for example, pulling on the core wire  314 . The magnets  306  may be coupled together by a thin flexible sheath  316  or other suitable structure.  
         [0142]      FIGS. 32A-32C  illustrate another catheter based system of fasteners comprising a series of magnets  320  held for sliding movement along parallel wires  322 ,  324 . Additional parallel wires  326 ,  328  are provided as guide wires to guide the assembly during insertion through a catheter (now shown) to a location adjacent the annulus. A suitable mechanism (not shown), is provided for pushing the magnets  320  together along wires  322 ,  324  to reduce annulus tissue, for example, with respect to additional movable magnets (not shown) on the opposite side of the tissue. The series of magnets  320  is locked in the position shown in  FIG. 32B , for example. In this embodiment, magnets  320  are coated with a soft polymer  320   a  which frictional engages small stop members  322   a ,  324   a  on wires  322 ,  324  to assist with retaining desired positions of the magnets  322 ,  324 .  
         [0143]      FIGS. 33, 33A  and  33 B illustrate another system of fasteners placed via a delivery catheter  242  and including a coupling mechanism  244  and locking mechanism  250  as described above in connection with  FIGS. 25A-25D . This system is similar to that described in  FIGS. 26A and 26B  in that bellows or crumple zones  330  are provided between magnets  232 , as best illustrated in  FIGS. 33A and 33B  to accommodate movement of adjacent magnets  232  together as they slide along the flexible tensile member  238  while flexible tensile member  238 , which is rigidly attached to the most distal magnet  232 , is pulled to the left as viewed in  FIG. 33 . The operation of this embodiment is otherwise the same as that described in connection with  FIGS. 26A and 26B .  
         [0144]      FIGS. 34A-34I  comprise a series of illustrations of a catheter based system for applying a series of fasteners through tissue generally at the mitral valve annulus and using guidance magnets  102   a ′,  102   b ′ and  100   a ′ (as previously described) in the CS  46  and the LV  14 . In this embodiment, a left ventrical catheter  340  has a portion  342  which uses radio frequency (RF) to effectively drill an initial hole through the tissue and then insert a second larger diameter catheter portion  344  which is steerable, for example, as shown in  FIGS. 34B-34D , to make a second hole in the annulus tissue  40 . It will be appreciated that the various catheters disclosed herein may have distal portions which are steerable in various manners for accurate positioning purposes. In this embodiment, tip  344  is movable into a desired hook-like position by a guiding cable  344   a  which may be pulled to configure tip  344  into the hooked shape as shown. The catheters utilized herein can include unidirectional or bi-directional steering. A steering mechanism may be positioned within and/or on the devices. Typically, the steering mechanism may include a pull wire  344   a  terminating at a flat spring or collar. The steering system has a more flexible distal section compared to the proximal catheter tube body. When tension is placed on the pull wire  344   a , the catheter distal end  344  is deflected into a curve, which helps direct the device within a heart chamber, for example. The pull wire  344   a  may be wound, crimped, spot welded or soldered to the flat spring or collar (not shown) placed in the catheter end  344 . This provides a stable point within the device for the pull wire  344   a  to exert tensile force and thus steer the device. The more proximal portion of the catheter may be reinforced by incorporating a helically wound or braided wire therein to provide column support from which to better deflect the distal section  344 . Alternatively, the steering mechanism may consist of a superelastic material having a desired three-dimensional geometric shape at its distal end and sufficient rigidity to impart this shape in the device. By retracting the preformed steering wire into the stiffer proximal section of the device, the distal end of the device straightens. Extending the preformed steering wire into the more flexible distal section of the device causes the distal section to assume the shape of the steering wire. Alternatively, a device with a curved section can incorporate a tube or rod that can be advanced through that section to straighten it. An additional feature that may be incorporated in the device is a preformed shape in the distal section of the device. The distal section may be preformed into a curve that biases the device to maximize tissue contact when the device is positioned into the appropriate heart chamber. This curve may consist of a single arc or a nonlinear geometry, such as an “S”. A pre-shaped rod, hypotube, wire or coil, created from a memory elastic material such as nickel titanium or spring steel may be thermally formed into the desired geometry, and inserted into the distal section (including a separate lumen) of the device during manufacturing or advanced through a dedicated lumen while the device is positioned in the heart. The shaped wire may be attached to the distal tip of the device for those non-removable pre-shaped rods and secured to the handle of the device at its proximal end to provide a reinforcing structure throughout the entire length of the device. The device body may also or alternatively be thermally formed into a desired geometry.  
         [0145]     As shown in  FIG. 34A , the various systems of this invention may also include different manners of ensuring that the catheter device(s) is/are properly position adjacent to tissue prior to use. For example, an impedance measurement device  343  may be coupled to the perforating element itself, such as RF wire  342 , or electrodes on the perforating element or on any separate element carried by the system. Such proximity determining devices may be used to confirm contact between the catheter device and the tissue surface by comparing the impedance between the electrode (such as RF wire  342 ) and a return path (indifferent patch electrode or second element electrode). When the electrode(s) only contact blood, the impedance is substantially higher than when the electrode element is in contact with the tissue surface. Each electrode is connected to a signal wire, with the signal wire connected to impedance measurement device  343 . The signal wire may be connected to the impedance measurement device  343  by way of a connector and cable system. The measurement device  343  may be a power supply, a simple electrical resistance meter, or any other suitable device and method of use.  
         [0146]     As further illustrated in  FIG. 34C , a balloon portion  346  of the left ventricle catheter  340  may be inflated to stabilize the catheter  340  against the tissue  40  as the holes are being formed. As shown in  FIGS. 34E and 34F , a fastener  348  is delivered through the lumen of the steerable catheter portion  344  and is coupled with a flexible tensile member  350  and another fastener  352 . The first and second fasteners  348 ,  352  are deployed on the same side of the tissue  40  at spaced apart locations with the flexible tensile member  350  coupled therebetween. These fasteners  348 ,  352  may be formed essentially as torsion spring members which may have a portion which captures and locks against the flexible tensile member  350  in the deployed position as shown in  FIG. 34F . Once the first fastener  348  is deployed as shown in  FIG. 34G , the flexible tensile member  350  may be pulled to plicate the tissue  40  between the first fastener  348  and the steerable catheter portion  344 . At this time, the second fastener  352  is delivered and captures and locks with the flexible tensile member  350  to lock the length of the flexible tensile member  350  between the two fasteners  348 ,  350  with the tissue plicated as shown in  FIG. 34H . This process may be repeated, as necessary, to plicate additional annulus tissue  40  for further annulus reduction.  
         [0147]      FIGS. 35A-35F  illustrate another catheter device  360  for delivering multiple fasteners  362  attached with a flexible tensile member  364 , for example, in the LV  14  at the annulus  40 . As best shown in  FIG. 35B , the catheter device  360  includes three fastener delivery portions  366 ,  368 ,  370 . One portion  368  is a central portion at the distal end of the catheter device  360  and deploys a first fastener  362 . Two additional fastener delivery portions  366 ,  370  are spaced on opposite sides of the central portion  368  and preferably may be actively moved to preferred positions relative to central portion  368  to deliver additional fasteners  362 . A flexible tensile member  364  couples each fastener  362  together as well as to a plurality of pledgets or tissue support members  372 . A fastener drive mechanism  374  is used to drive one or more of the fasteners  362  through the tissue and comprises a reciprocating rod  376  which is activated by spring force developed in a coil spring  378 . When a pair of magnets  380 ,  382  are decoupled by pulling a wire or cable  384 , for example, the spring forces the reciprocating rod  376  upwardly as viewed in  FIG. 35B  to drive the fastener  362  through the tissue  40 . It will be appreciated that similar mechanisms may be used with flexible drive rods  386 ,  388  in driving the outer fasteners  362  through the tissue, or this same mechanism  374  may be coupled with flexible drive rods  386 ,  388  to simultaneously drive each of the fasteners  362  through the tissue  40 . All three fasteners  362  are thereby deployed, in addition to the pledgets  372 , as illustrated in  FIG. 35E . Then, the drawstring or flexible tensile member  364  are pulled tight to plicate the tissue  40  as shown in  FIG. 35F  and a crimp member  390  is applied to lock the flexible tensile member  364  in the tensioned position to retain the plicated tissue  40  in the desired state.  
         [0148]      FIG. 36  illustrates an alternative embodiment of the catheter device  360  shown in  FIG. 35A-35F , in which the distal end of the catheter device  360 ′ includes a magnet  400  for locking up temporarily with one or more magnets (not shown) in the CS  46  (Fig. A) as previously described. This allows the catheter device  360 ′ to be accurately positioned and temporarily locked in place proximate the annulus  40  while the anchors or fasteners  362  are being delivered, cinched and locked in place as previously described with respect to  FIGS. 35A-35F .  
         [0149]      FIGS. 37A-37C  illustrate another alternative catheter delivery device or system  410 , and valve support/fastener system  412  for plicating annulus tissue  40  and pulling a posterior leaflet  24  toward an anterior leaflet  22 . In this embodiment, a C-shaped support member  414  is initially retained within a catheter  416  in a nonactivated, compact state as shown in  FIG. 37A . When the support member  414  is pushed from the distal end of the catheter  416 , it springs into a deployed or activated state as shown in  FIGS. 37B and 37C . The anchors or fasteners  418  are retained on the rod shaped support member  414  for sliding movement and are coupled together by one or more flexible tensile members  420 . An additional flexible tensile member  422  extends from another catheter portion  424  and provides for secondary cinching or drawstring action. A magnet  426  is rigidly coupled to a central fastener or anchor  418  at P 2 , as shown, or otherwise coupled to the support rod  414  and temporarily locks up with a magnet  428  in the CS  46  generally as previously described. Fasteners or anchors  418  are then connected to the annulus tissue  40  such as by using additional fastening elements (not shown) which are delivered via another catheter (not shown) within the LV  14 , in one of the manner previously described. Once the anchors or fasteners  418  are secured to the tissue  40 , the flexible tensile members  420  are pulled thereby pulling each of the fasteners or anchors  418  toward one another along the support member  414 . A final or secondary pulling action may be obtained by pulling the flexible tensile member ends  422  extending into the catheter portion  424  extending from the main catheter  416 . Various manners may be used to retain the flexible tensile members  420 ,  422  and anchors  418  at the new positions shown in  FIG. 37C , such as by using crimp members (not shown), or integrated ratchet-type or frictional engagement structure (not shown) which automatically locks the flexible tensile members  420 ,  422  in place as they are pulled.  
         [0150]      FIGS. 38A-38I  illustrate another catheter based system and method for delivering, for example, three fasteners or anchors coupled to respective flexible tensile members and cinched together to reduce a mitral valve annulus  40 . In this embodiment, as shown in  FIG. 38A , a CS catheter  430  and LV catheter  432  may temporarily lock up through magnetic coupling and an initial hole may be formed through the annulus tissue  40  using RF energy applied via a wire  434 . A first fastener or anchor  436  coupled with a flexible tensile member  438  may be deployed through the hole using a catheter  440  threaded over a guide tube  442 . The catheter  440  may be removed and another catheter  444  having bifurcated portions  444   a ,  444   b  may be used by threading one of the bifurcated portions  444   a  over the flexible tensile member  438 . Alternatively, once the first fastener  436  and flexible tensile member  438  are deployed as shown in  FIG. 38F , the second portion  444   b  of the catheter  440  may be activated and moved to a spaced apart location to form a hole using an RF wire  434  and then deploy a second fastener  446  and flexible tensile member  448  ( FIG. 38H ). Then, the first catheter portion  444   a  and second catheter portion  444   b  are removed and the first catheter portion  444   a  is threaded along the second flexible tensile member  448 . A third anchor  450  and attached flexible tensile member  452  are then deployed from the second catheter portion  444   b  resulting in three deployed anchors  436 ,  446 ,  450  and flexible tensile members  438 ,  448 ,  452  as shown in  FIG. 38H . A crimping and cutting device  460  is then used to pull the flexible tensile members  438 ,  448 ,  452  and fasteners or anchors  436 ,  446 ,  450  together to thereby pull the posterior leaflet  24  toward the anterior leaflet  22  and then a crimp member  462  is applied to the flexible tensile members  438 ,  448 ,  452  and cut to result in the system being fastened generally as shown in  FIG. 381 . As alternatives to RF energy, other manners and devices may be used for forming a hole through tissue prior to or while inserting an anchor or fastener. For example, these may include needles, blades, coring devices, etc. which can effectively create a starter hole in the tissue such that less force is required to drive an anchor into or through the tissue.  
         [0151]     As shown in  FIGS. 39A and 39B , the crimping and cutting device  460  includes a crimping portion  470  comprising jaws  472   a ,  472   b  with projections  472  for applying force to the crimp member  462  and a cutting portion  474  coupled with an RF energy source  476 . After the crimping portion  470  is actuated to crimp the crimp member  462  onto the flexible tensile members  438 ,  448 ,  452 , the RF energy source  476  is activated to cut the flexible tensile members  438 ,  448 ,  452  as shown in  FIG. 39B  using cutting element a  477 . To facilitate crimping, one threaded portion  478  of the device is rotated with respect to another portion  479 . This pulls jaws  472   a ,  472   b  proximally to bring them together against the crimp member  462 .  
         [0152]     FIGS.  40  illustrates the use of an additional magnet  480  in the left atrium  12  for supplying additional magnetic force at the junction of the annulus  40  and CS  46 . An arrangement of magnets  480 ,  482 ,  484  may be used for temporarily locking up the catheter system at the location that it is desired to deliver a fastener or anchor (not shown), such as in those manners previously described.  FIGS. 40B-40D  illustrate an alternative fastener delivery system and method for delivering fasteners  486  in the left atrium  12  as opposed to the left ventricle  14  as previously described. This system is otherwise similar in that magnetic guidance and lock up first temporarily occurs between the various magnets  480 ,  482 ,  484  in the system. Once this magnetic lock up has taken place, a fastener  486  and flexible tensile member  488  may be delivered through a steerable portion  490   a  of a catheter  490  in the left atrium  12  such that the fastener  486  is delivered into the left ventricle  14 . Steering mechanisms, such as those described elsewhere herein may be used to accurately direct catheter portion  490   a . A number of fasteners  486  and attached flexible tensile member or members  488  may be deployed as shown in  FIG. 40D  and then cinched or drawn together using a crimping and cutting device  460  as previously described.  
         [0153]      FIGS. 41A-41C  illustrate another embodiment of a catheter delivered fastening system. In this embodiment, it will be understood that a series of fasteners  500 ,  502 ,  504  and attached flexible tensile members  506 ,  508 ,  510  may be delivered as previously described and as shown in  FIGS. 41A and 41B . A delivery catheter  520  may include a balloon  522  for stabilizing against the tissue  40  and/or for positioning respective arms  520   a ,  520   b ,  520   c  of the catheter device  520  while delivering the anchors or fasteners  500 ,  502 ,  504  and each of their attached flexible tensile members  506 ,  508 ,  510 . A valve support member  530  may then be delivered through a catheter (not shown) as shown in  FIG. 41B . The support member  530  has eyelets  532 ,  534 ,  536  which are threaded over each of the respective flexible tensile members  506 ,  508 ,  510 . Respective crimps  538 ,  540  are applied to the outer eyelets  532 ,  536  and the flexible tensile members  506 ,  510  cut proximate to each crimp member  538 ,  540 . The central flexible tensile member  508  is pulled to thereby pull the posterior leaflet  24  at P 2  toward the anterior leaflet  22 . When suitable tension and pulling action has taken place, a third crimp member  542  is applied proximate the central eyelet  534  at the apex of the V-shaped and the flexible tensile member  508  is cut proximate to the crimp member  542 . This results in approximation of the posterior and anterior leaflets  22 ,  24  as shown in  FIG. 41C .  
         [0154]      FIGS. 42A and 42B  illustrate one possible anchor or fastener  550  usable with the various systems of the present invention. Such an anchor  550  may be rigidly coupled to a flexible tensile member  552 , or coupled such that the anchor or fastener  550  slides along the flexible tensile member  552 , as necessitated by the fastening system in which the fastener  550  is being used.  
         [0155]      FIG. 43  is a side elevational view of an alternative fastener  560  which is similar to that shown in  FIGS. 42A and 42B , except that the fastener  560  has a curved outer profile. The convex surface  562  of the curved outer profile is adapted to engage tissue and cause less trauma to the tissue than the flat profile shown in  FIGS. 42A and 42B .  
         [0156]      FIGS. 44A-44C  illustrate another alternative fastener  570  useful in the various systems and methods of this invention. This fastener  570  includes two radially expandable portions  572 ,  574  which may be delivered through a catheter  576  in their nonexpanded state shown in  FIG. 44A , and then expanded on opposite sides of the tissue  40  to be trapped therebetween, as shown in  FIGS. 44B and 44C .  
         [0157]     While the present invention has been illustrated by a description of various preferred embodiments and while these embodiments has been described in some detail, it is not the intention of the Applicant 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 of the invention may be used alone or in any combination depending on the needs and preferences of the user. This has been a description of the present invention, along with the preferred methods of practicing the present invention as currently known.

Technology Category: 1