Abstract:
Devices, systems and methods support tissue in a body organ for the purpose of restoring or maintaining native function of the organ. The devices, systems, and methods do not require invasive, open surgical approaches to be implemented, but, instead, lend themselves to catheter-based, intra-vascular and/or percutaneous techniques.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a continuation of co-pending U.S. patent application Ser. No. 10/808,216, filed Mar. 24, 2004, entitled “Devices, Systems, and Methods for Supporting Tissue and/or Structures Within a Hollow Body Organ,” which is a continuation-in-part of co-pending U.S. patent application Ser. No. 10/307,226, filed Nov. 29, 2002. This application is also a continuation-in-part of co-pending U.S. patent application Ser. No. 10/271,334, filed Oct. 15, 2002, which claims the benefit of U.S. Provisional Application Ser. No. 60/333,937 filed 28 Nov. 2001. 
     
    
     FIELD OF THE INVENTION  
       [0002]    The features of the invention are generally applicable to devices, systems, and methods that support tissue and/or structures within a hollow body organ. In a more particular sense, the features of the invention are applicable to improving heart function by supporting tissue and related structures in the heart, e.g., for the treatment of conditions such as congestive heart failure and/or atrial fibrillation and/or septal defects. 
       BACKGROUND OF THE INVENTION 
       [0003]    Hollow body organs are shaped in particular native ways to perform specific native functions. When a body organ looses its native shape due to disease, injury, or simply the natural aging process, the native functions can be adversely affected. The heart serves as a good example of this marriage between native shape and native function, as well as the dysfunctions that can occur should the native shape change. 
       I. The Anatomy of a Healthy Heart  
       [0004]    The heart (see  FIG. 1 ) is slightly larger than a clenched fist. It is a double (left and right side), self-adjusting muscular pump, the parts of which work in unison to propel blood to all parts of the body. The right side of the heart receives poorly oxygenated (“venous”) blood from the body from the superior vena cava and inferior vena cava and pumps it through the pulmonary artery to the lungs for oxygenation. The left side receives well-oxygenation (“arterial”) blood from the lungs through the pulmonary veins and pumps it into the aorta for distribution to the body. 
         [0005]    The heart has four chambers, two on each side—the right and left atria, and the right and left ventricles. The atria are the blood-receiving chambers, which pump blood into the ventricles. A wall composed of membranous and muscular parts, called the interatrial septum, separates the right and left atria. The ventricles are the blood-discharging chambers. A wall composed of membranous and muscular parts, called the interventricular septum, separates the right and left ventricles. 
         [0006]    The synchronous pumping actions of the left and right sides of the heart constitute the cardiac cycle. The cycle begins with a period of ventricular relaxation, called ventricular diastole. The cycle ends with a period of ventricular contraction, called ventricular systole. 
         [0007]    The heart has four valves (see  FIGS. 2 and 3 ) that ensure that blood does not flow in the wrong direction during the cardiac cycle; that is, to ensure that the blood does not back flow from the ventricles into the corresponding atria, or back flow from the arteries into the corresponding ventricles. The valve between the left atrium and the left ventricle is the mitral valve. The valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve is at the opening of the pulmonary artery. The aortic valve is at the opening of the aorta. 
         [0008]    At the beginning of ventricular diastole (i.e., ventricular filling) (see  FIG. 2 ), the aortic and pulmonary valves are closed to prevent back flow from the arteries into the ventricles. Shortly thereafter, the tricuspid and mitral valves open (as  FIG. 2  shows), to allow flow from the atria into the corresponding ventricles. Shortly after ventricular systole (i.e., ventricular emptying) begins, the tricuspid and mitral valves close (see FIG.  3 )—to prevent back flow from the ventricles into the corresponding atria—and the aortic and pulmonary valves open—to permit discharge of blood into the arteries from the corresponding ventricles. 
         [0009]    The heart valves are defined by fibrous rings of collagen, each called an annulus, which forms a part of the fibrous skeleton of the heart. The annulus provides attachments for the cusps or leaflets of the valves. In a healthy heart, muscles and their tendinous chords (chordae tendineae) support the valves, allowing the leaflets of the valves to open and close in accordance with their intended functions. 
       II. Heart Dysfunctions  
       [0010]    Infection, myocardial infarction, atrial fibrillation, other diseases, or anatomic defects can adversely affect the normal synchronous pumping actions of the left and right sides of the heart and/or the operation of heart valves during the cardiac cycle. 
         [0011]    For example, due to one or more of these causes, a heart chamber may become stretched and enlarged. This condition can lead to adverse consequences. For example, (1) due to its enlarged condition the heart must pump harder to move the blood, and/or too little blood may move from the heart to the rest of the body. Over time, other chambers of the heart may also become weaker. The stretching and enlargement of a heart chamber, e.g., in the left ventricle, can lead to a condition called congestive heart failure. If not treated, congestive heart failure can lead to pulmonary embolisms, circulatory shutdown, and death. 
         [0012]    The enlargement of a heart chamber can also lead to the enlargement or stretching a heart valve annulus. Also, the stretching or tearing of the chords surrounding a heart valve, or other forms of muscle failure in this region, can also change the shape of a heart valve annulus, even when enlargement of a heart chamber is absent. When the heart valve annulus changes its shape, the valve leaflets can fail to coapt. An undesired back flow of blood can occur between an atrium and a ventricle (called regurgitation), or back flow between an artery and a ventricle can occur. Such dysfunctions can eventually also weaken the heart and can result in heart failure. 
         [0013]    Anatomic defects, e.g., in the septum, can also lead to heart dysfunction. These defects can be congenital, or they can result from disease or injury. 
       III. Prior Treatment Modalities  
       [0014]    Medications can be successful in treating heart dysfunctions. For chronic or acute dysfunction, however, surgery is often necessary. For congestive heart failure, a heart transplant may be required. Like invasive, open heart surgical approaches have been used to repair or replace a dysfunctional heart valves or to correct septal defects. 
         [0015]    The need remains for simple, cost-effective, and less invasive devices, systems, and methods for treating heart conditions such as congestive heart failure and/or heart valve dysfunction and/or septal defects. A parallel need also remains for similarly treating other dysfunctions that arise from unintended shape changes in other body organs. 
       SUMMARY OF THE INVENTION 
       [0016]    The invention provides devices, systems and methods that support tissue in a hollow body organ for the purpose of restoring or maintaining native function of the organ. The devices, systems, and methods do not require invasive, open surgical approaches to be implemented, but, instead, lend themselves to catheter-based, intra-vascular and/or percutaneous techniques. 
         [0017]    One aspect of the invention provides systems and methods for supporting tissue within a hollow body organ. The systems and methods employ first and second implants that are coupled together. The first implant is sized and configured to penetrate a first region of tissue in the hollow body organ. The second implant is sized and configured to penetrate a second region of tissue in the hollow body organ spatially distinct from the first region. At least one tension element couples the first and second implants together, to apply tension to the first and second implants, and thereby draw tissue inward, supporting it. The supporting effect serves, e.g., to draw tissue surfaces together to reduce tissue volume within the hollow body organ, as well as resist subsequent enlargement of tissue volume. Desirably, the supporting effect does not interfere with contraction of the hollow body organ to a lesser tissue volume. However, if desired, this form of bracing can be achieved. 
         [0018]    Another aspect of the invention provides systems and methods for forming a tissue fold within a hollow body organ. The systems and methods employ first and second implants. The implants are sized and configured to penetrate spatially distinct regions of tissue in the hollow body organ. At least one tension element couples the first and second implants together to apply tension on the first and second implants. The tension creates a tissue fold between the first and second implants. The tissue fold serves, e.g., to reduce internal tissue volume within the hollow body organ, as well as resist subsequent enlargement of tissue volume. Desirably, the tensioning does not interfere with contraction of the hollow body organ to a lesser tissue volume. However, if desired, this form of bracing can be achieved with tissue folding. 
         [0019]    In one embodiment, the first and second implants are part of an array of implants that penetrates spatially distinct regions of tissue in the hollow body organ. In this embodiment, at least one tension element extends among the array of implants to apply tension between adjacent implants and thereby create a pattern of multiple tissue folds. The multiple tissue folds serve, e.g., to draw a circumferential region of tissue together, forming a closure or seal. 
         [0020]    Another aspect of the invention provides systems and methods for supporting tissue in a hollow body organ. The systems and methods employ a prosthesis sized and configured for placement either within an interior of the hollow body organ or about an exterior of the hollow body organ to regulate a maximum size and/or shape of the hollow body organ. The systems and methods also employ at least one fastener to secure the prosthesis to tissue in the hollow body organ. In one embodiment, the fastener comprises a helical fastener. 
         [0021]    Another aspect of the invention provides systems and methods for supporting tissue within a hollow body organ making use of an elongated implant. The elongated implant is sized and configured to penetrate tissue and extend along a curvilinear path within or partially within a tissue wall. The elongated implant regulates a maximum size and/or shape of the hollow body organ. In one embodiment, the elongated implant comprises a helical shape. 
         [0022]    The systems and methods that embody all or some of the various aspects of the invention, as described, are well suited for use in, e.g., a heart. The systems and methods can be used to support tissue within a heart chamber, e.g., of congestive heart failure or other conditions in which the volume of the heart becomes enlarged. The systems and methods can be used to seal or close perforations, holes, or defects in tissue. The systems and methods can be used to close or seal atrial appendages or septal defects. 
         [0023]    Other features and advantages of the invention shall be apparent based upon the accompanying description, drawings, and claims. 
     
    
     
       DESCRIPTION OF THE DRAWINGS  
         [0024]      FIG. 1  is a perspective, anterior anatomic view of the interior of a healthy heart. 
           [0025]      FIG. 2  is a superior anatomic view of the interior of a healthy heart, with the atria removed, showing the condition of the heart valves during ventricular diastole. 
           [0026]      FIG. 3  is a superior anatomic view of the interior of a healthy heart, with the atria removed, showing the condition of the heart valves during ventricular systole. 
           [0027]      FIG. 4A  is a perspective view of an implant for supporting tissue within a hollow body organ. 
           [0028]      FIG. 4B  is a side view of an applier instrument for implanting the implant shown in  FIG. 4A  in tissue. 
           [0029]      FIG. 4C  is a side view of the implant shown in  FIG. 4A  after implantation in tissue. 
           [0030]      FIGS. 5A and 5B  are tissue support systems established within a hollow body organ that comprises two or more of the implants as shown in  FIG. 4A  placed and maintained in tension by a clip element. 
           [0031]      FIGS. 6A and 6B  show the tissue supporting system shown in  FIG. 5  established in a left ventricle of a heart,  FIG. 6A  showing the enlarged volume of the ventricle prior to establishment of the system, and  FIG. 6B  showing the system reducing the volume of ventricle. 
           [0032]      FIGS. 7A to 7D  show the steps in establishing the system shown in  FIG. 6B  by use of intra-vascular tools and techniques. 
           [0033]      FIGS. 8A and 8B  show a tissue supporting system like that shown in  FIG. 5 , established in a left ventricle of a heart in or near the annulus of the aortic valve,  FIG. 8A  showing the dilated condition of the aortic valve annulus prior to establishment of the system, and  FIG. 8B  showing the system reshaping the annulus to restore leafet coaption. 
           [0034]      FIGS. 9A to 9D  show the steps in establishing the system shown in  FIG. 8B  by use of intra-vascular tools and techniques. 
           [0035]      FIGS. 10A and 10B  show a tissue folding system established in a left ventricle of a heart,  FIG. 10A  showing the enlarged volume of the ventricle prior to establishment of the system, and  FIG. 10B  showing the system reducing the volume of ventricle. 
           [0036]      FIGS. 11A to 11D  show the steps in establishing the system shown in  FIG. 10B  by use of intra-vascular tools and techniques. 
           [0037]      FIG. 12  shows another embodiment of a tissue folding system possessing the features of the system shown in  FIG. 10B . 
           [0038]      FIGS. 13A to 13C  show the steps in establishing, by use of intra-vascular tools and techniques, another embodiment of a tissue folding system possessing the features of the system shown in  FIG. 10B . 
           [0039]      FIGS. 14A and 14B  show the steps in establishing, by use of intra-vascular tools and techniques, another embodiment of a tissue folding system possessing the features of the system shown in  FIG. 10B . 
           [0040]      FIG. 15A  is a tissue folding system as shown in  FIG. 10B , with the including of an overlaying patch component that is secured by fasteners over the tissue fold established by the tissue folding system. 
           [0041]      FIG. 15B  is a catheter that deploys the patch component shown in  FIG. 15A  by intra-vascular access. 
           [0042]      FIG. 16A  shows the establishment of a system that creates a pattern of folds in a hollow body organ to isolate or seal one region of the hollow body organ from another region of the hollow body organ. 
           [0043]      FIG. 16B  is a plane view of the pattern of folds created by the system shown in  FIG. 16A , taken generally along line  16 B- 16 B in  FIG. 16A . 
           [0044]      FIGS. 17A and 17B  show the establishment of a pattern of multiple folds in the region between an atrial appendage and an atrial septum using the system shown in  FIGS. 16A and 16B ,  FIG. 17A  showing the atrium prior to establishment of the system, and  FIG. 17B  showing the atrium after establishment of the system to isolate and/or seal the atrial appendage from the atrial septum. 
           [0045]      FIG. 17C  is a plane view of the pattern of folds created by the system shown in  FIG. 17B , taken generally along line  17 C- 17 C in  FIG. 17B . 
           [0046]      FIGS. 18A and 18B  show the establishment of a pattern of multiple folds to seal a perforation in a hollow body organ using the system shown in  FIGS. 16A and 16B ,  FIG. 18A  showing the perforation prior to establishment of the system, and  FIG. 18B  showing the closing of the perforation after establishment of the system. 
           [0047]      FIGS. 19A to 19F  show various embodiments of a prothesis that can be installed in a hollow body organ to shape the organ and prevent its enlargement. 
           [0048]      FIG. 20A  shows a prosthesis of a type shown in  FIGS. 19A to 19F  installed in the interior of a hollow body organ. 
           [0049]      FIG. 20B  shows a prosthesis of a type shown in  FIGS. 19A to 19F  installed about the exterior of a hollow body organ. 
           [0050]      FIG. 21A  shows a prosthesis of a type shown in  FIGS. 19A to 19F  installed in the interior of a heart chamber. 
           [0051]      FIGS. 22A to 22D  show the steps in establishing, by use of intra-vascular tools and techniques, the prosthesis shown in  FIG. 20A . 
           [0052]      FIG. 23  shows a prosthesis of a type shown in  FIGS. 19A to 19F  installed about the exterior of a heart. 
           [0053]      FIGS. 24A and 24B  show a composite prosthesis having the features of the prosthesis shown in  FIGS. 19A to 19F , being formed by an array of two or more patch components installed in a left ventricle of a heart. 
           [0054]      FIG. 25  shows a prosthesis having the features of the prosthesis shown in  FIGS. 19A to 19F , being formed in the form of a ring for placement in or near a heart valve annulus. 
           [0055]      FIG. 26A  shows a prosthesis as shown in  FIG. 25  installed in or near an annulus of an aortic valve. 
           [0056]      FIG. 26B  shows a prosthesis as shown in  FIG. 25  installed in or near an annulus of a mitral valve. 
           [0057]      FIG. 27  is a catheter that deploys the prosthesis shown in  FIG. 25  by intra-vascular access. 
           [0058]      FIG. 28  shows a patch component having the features of the patch component shown in  FIG. 15A , being sized and configured for repairing a septal defect in a heart. 
           [0059]      FIGS. 29A and 29B  show the patch component shown in  FIG. 28  installed in a septal defect between the left and right ventricles of heart. 
           [0060]      FIGS. 30A and 30B  show various embodiments of an elongated implant that can be implanted in a hollow body organ to shape the organ and prevent its enlargement,  FIG. 30A  showing an implant having a generally linear shape, and  FIG. 30B  showing an implant having a generally curvilinear shape. 
           [0061]      FIG. 31  shows the elongated implant shown in  FIGS. 30A and 30B  implanted in a left ventricle of a heart. 
           [0062]      FIG. 32  shows a heart valve assembly having many of the features of the prosthesis shown in  FIGS. 19A to 19F , being formed for placement in or near a heart valve annulus. 
           [0063]      FIG. 33  shows an assembly as shown in  FIG. 32  installed in or near an annulus of an aortic valve. 
           [0064]      FIGS. 34A to 34C  show the steps in installing, by use of intra-vascular tools and techniques, the heart valve assembly shown in  FIG. 32  in or near an annulus of an aortic valve. 
       
    
    
     DETAILED DESCRIPTION 
       [0065]    Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention, which may be embodied in other specific structure. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims. 
         [0066]    The technology disclosed in this specification is divided for clarity of presentation into sections, as follows:
       I. Implants for Externally Supporting Tissue in a Hollow Body Organ
           A. Overview   B. Systems and Methods for Supporting Tissue in a Heart Chamber   C. Systems and Methods to Support Tissue In or Near a Heart Valve Annulus   
           II. Implants for Creating Tissue Folds
           A. Overview   B. Systems and Methods Defining Discrete Tissue Folds
               1. Tissue Folding with Overlaying Patch Component   
               C. Systems and Methods Defining Patterns of Tissue Folds
               1. Overview   2. Appendage Isolation and Sealing   3. Closing Perforations, Holes, or Defects   
               
           III. Prostheses for Externally Supporting Tissue in a Hollow Body Organ
           A. Overview   B. Systems and Methods for Supporting Tissue in a Heart Chamber   C. Systems and Methods for Supporting Tissue In or Near a Heart Valve Annulus   
           IV. Implants for Internally Supporting Tissue in a Hollow Body Organ       
 
         [0084]    It should be appreciated that the technology described in a given section can be combined with technology described in another section, and that there are features that are common to all technology described herein. 
       I. Implants for Externally Supporting Tissue in a  Hollow Body Organ  
       [0085]    A. Overview 
         [0086]      FIG. 4A  shows an implant  10  sized and configured for placement in a hollow body organ. The implant includes a body  12  that can be made from a formed plastic or metal or ceramic material suited for implantation in the body. 
         [0087]    The body  12  includes a distal region  14 . The distal region  14  is sized and configured to penetrate tissue. The body  12  and its distal region  14  are sized and configured to take purchase in tissue (see  FIG. 4C ) sufficient to significantly resist release and/or migration of the body  12  from tissue, once implanted. 
         [0088]    The body  12  also includes a proximal region  16 . The proximal region  16  is sized and configured to engage an instrument or tool  20  (see  FIG. 4B ) that applies a force to cause the implant  10  to penetrate tissue. 
         [0089]    As shown in  FIG. 4A , the body  12  also includes a tether element  18 . In the illustrated embodiment, the tether element  18  is carried on or near the proximal region  16  of the body  12 . By virtue of this, when the body  12  is implanted in a tissue wall in a vessel or hollow body organ (see  FIG. 4C ), the tether element  16  extends outside the tissue wall. 
         [0090]    The tether element  18  comprises a thread, braid, wire, or tube structure with a metallic or polymer material (e.g., polyester suture) having a break strength that is desirably at least equal to the resistance the distal region  14  of the body  12  has to release or migration from tissue. The tether element  18  is desirably flexible, to enable its deployment through an intra-vascular path. The tether element  18  is desirably not significantly elastic, but it can be, depending upon the tissue conditions encountered. 
         [0091]    The tether element  18  is securely fastened to the proximal region  16 , e.g., by soldering, gluing, riveting, or like attachment techniques. The junction between the tether element  18  and the body  12  desirably has a material strength that is greater than the material strength of the tether element  18  itself. 
         [0092]    The body  12  of the implant  10  can take various forms. In the illustrated embodiment (as  FIG. 4A  shows), the body  12  comprises an open helical coil. In the arrangement, the distal region  14  comprises a sharpened leading tip. This type of body  12  and distal region  14  can be deployed into tissue by rotational movement, which the applier instrument  20  imparts to the implant  10 . 
         [0093]    Also, in the illustrated embodiment (as  FIG. 4A  shows), the proximal region  16  comprises an L-shaped leg. The L-shape leg desirably bisects the entire interior diameter of the coil body  12 ; that is, the L-shaped leg  16  extends completely across the interior diameter of the coil body  12 . The L-shaped leg  16  serves as a stop to prevent the coil body  12 , when rotated, from penetrating too far into tissue. Furthermore, as  FIG. 4B  generally shows, a rotatable implant drive mechanism  22  on the applier instrument  20  is sized and configured to engage the L-shaped leg  16  and impart rotation to the coil body  12  to achieve implantation in tissue. 
         [0094]      FIGS. 5A and 5B  show a tissue shaping system  24  comprising at least two implants  10  shown in  FIG. 4A . The implants  10  are implanted in a tissue wall within a hollow body organ or vessel (shown generically in  FIGS. 5A and 5B ) in a spaced-apart relationship or pattern. The number of tethered implants  10  deployed can vary according to the size and geometry of the targeted tissue volume, as well as the tissue support objectives. 
         [0095]    The system  24  includes at least one clip element  26  joined to the tether elements  18  of the implants  10 .  FIG. 5A  shows a single clip element  26 .  FIG. 5B  shows multiple clip elements  26 . The clip element or elements  26  mutually couple the tether elements  18  together, and allow tension to be applied and maintained external to the tissue, as the arrows in  FIGS. 5A and 5B  show. The tension individually applied and maintained by each tether element  18  on its respective implant  10 , in combination, draws the surrounding tissue wall en masse inward toward the clip element  26 , to shape the hollow body organ or vessel. Conversely, the tension applied and maintained by the tether elements  18  on each implant  10 , in combination, resists movement of the tissue wall en masse outward away from the clip element  26 . The tension prevents distension of tissue wall beyond the volume created by the tissue support system  24 . The tissue support system  24 , however, desirably does not interfere with contraction of the tissue wall toward a lesser volume. 
         [0096]    The length of each individual tether element  18  and the magnitude of the tension it applies to its respective implant  10  collectively dictate a maximum shape for the body organ. In this way, the system  24  supports and shapes tissue in a body organ. 
         [0097]    The system  24  as just described can be established in various parts of the body and for various therapeutic purposes. Two embodiments will be described for the purpose of illustration. The first embodiment is directed to the treatment and/or repair of congestive heart failure. The second embodiment is directed to heart valve remodeling. 
         [0098]    B. Systems and Methods for Supporting Tissue in a Heart Chamber 
         [0099]      FIG. 6A  shows a heart afflicted with congestive heart failure. The condition shown in  FIG. 6A  is characterized by an enlarged internal volume of the left ventricle.  FIG. 6B  shows the treatment and/or repair of the condition by the implantation of a system  24  of tethered implants  10  within the left ventricle. The tethers  18  of the implants  10  are placed and held in tension (shown by arrows in  FIG. 6B ) by a clip  26 . Multiple clips  26  could be used, if desired. The tension applied by the system  24  shapes the left ventricle, pulling the chamber walls laterally closer together and thereby reducing the overall maximum internal volume. The tension prevents or restricts expansion of the left ventricle beyond the shape during ventricular diastole, which is better suited to efficient ventricular pumping. The support system  24 , however, does not interfere with normal contraction of the left ventricle during ventricular systole. 
         [0100]      FIGS. 7A to 7D  show the intra-vascular deployment of the system  24  shown in  FIG. 6B . Alternatively, the system can be established using conventional open heart surgical techniques or by thoracoscopic surgery techniques. 
         [0101]    In the intra-vascular approach shown in  FIGS. 7A to 7D , a guide component  28  is delivered over a guide wire (not shown) through the aortic valve into the left ventricle. The guide component  28  can be delivered through the vasculature under fluoroscopic guidance, e.g., through either a retrograde arterial route (via, e.g., the femoral artery or subclavian artery) (as shown) or an antegrade venous then trans-septal route. 
         [0102]    The guide component  28  can comprise, e.g., a guide sheath that desirably has a steerable or deflectable distal tip. The guide wire can be withdrawn after the guide component  28  is deployed and positioned, so that the applier instrument  20  can be introduced through the guide component  28 , as  FIG. 7A  shows.  FIG. 4B  also shows the deployment of the applier instrument  20  through the guide component  28 . 
         [0103]    In this arrangement (see  FIG. 4B ), the applier instrument  20  comprises a catheter  30  that carries an implant drive mechanism  22  on its distal tip. The drive mechanism  22  carries at least one tethered implant  10 . An motor  32  in a handle  34 , operated by the physician, drives the mechanism  22  to rotate the implant  10 . As a result, the implant  10  is caused to penetrate the myocardium (as  FIG. 7A  shows). 
         [0104]    The implantation force of the drive mechanism  22  is desirably resolved in some manner to provide positional stability and resist unintended movement of the drive mechanism  22  relative to the implantation site. A resolution force is desirably applied to counteract and/or oppose the implantation force of the drive mechanism  22 . It is desirable to resolve some or all or a substantial portion of the implantation force within the vessel lumen (or other hollow body organ) itself, and preferably as close to the implantation site as possible. 
         [0105]    The tubular body of the guide component  28  and/or the shaft of the applier instrument  20  can be sized and configured to possess sufficient column strength to resolve some or all or at least a portion of the implantation force within the vessel lumen or hollow body organ.  FIG. 7A  shows the guide component  28  braced against a wall of the ventricle to apply counterbalancing resolution force. In addition, or alternatively, the guide component  28  and/or the aopplier instrument  20  can include some form of stabilization means for applying a counteracting force at or near the drive mechanism  22 . Various types of stabilization means are disclosed in co-pending U.S. patent application Ser. No. 10/669,881, filed Sep. 24, 2003, and entitled “Catheter-Based Fastener Implantation Apparatus and Methods with Implantation Force Resolution.” 
         [0106]    The guide component  28  is reposition in succession to other intended myocardial delivery sites. At each site, the applier instrument  20  is actuated to place an implant  10 . In this way (see  FIG. 7B ), a desired spacing of implants  10  (such as a radial or spiral-like pattern) is distributed within the left ventricle. 
         [0107]    Once the desired number of implants  10  are deployed inside the left ventricle, the applier instrument  20  is withdrawn from the guide component  28 . The tether elements  18  of the implants  10  are left gathered and channeled through the guide component  28 , as  FIG. 7B  shows. 
         [0108]    As  FIG. 7C  shows, a clip-applier instrument  36  is tracked through the guide component  28  and over the bundle of tether elements  18  into the left ventricle. The tether elements  18  act as a composite guide wire to guide the clip-applier instrument  36  into the left ventricle. 
         [0109]    Once in the left ventricle, the clip-applier instrument  36  is held stationary, while the tether elements are pulled taut through the clip-applier instrument  36  (shown by arrow T is  FIG. 7C ). As the individual tether elements  18  grow taut, they apply tension on the individual implants  10 , as  FIG. 7C  shows. This, in turn, pulls the walls of the left ventricle inward towards the clip-applier instrument  26  (as a comparison of the left ventricle shown in  FIG. 7B  to the left ventricle shown in  FIG. 7C  demonstrates). Once a desired ventricular volume is, achieved (as determined, e.g., through fluoroscopy), the clip-applier instrument  36  applies a clip  26  to the tether elements, attaching the tether elements  18  together in tension (see  FIG. 7D ). The clip-applier  36  cuts the bundle of tether elements  18  proximal to the site where the clip  26  was applied. The clip-applier instrument  36  and loose tethers  18  are then withdrawn from the left ventricle through the guide component  28 , and the guide component is withdrawn, as  FIG. 7D  shows. 
         [0110]    The system  24  has been established to support the left ventricle to treat, in this instance, congestive heart failure. 
         [0111]    It should be appreciated that one or more implants  10  of the system  24  can be electrically coupled to a device that can be operated to control muscular and/or electrical activity in heart tissue. Absent this intended effect, however, it is desired that the implants  10  are not inherently electrically conductive, so as not to interfere with electrical conduction within the heart. 
         [0112]    C. Systems and Methods to Support Tissue at or Near a Heart Valve Annulus 
         [0113]      FIG. 8A  shows a heart afflicted with congestive heart failure. As shown in  FIG. 8A  this condition has resulted in an enlarged internal volume of the left ventricle, leading to a dilation or stretching the aortic heart valve annulus. As a result, the aortic valve leaflets do not properly coapt during ventricular systole. An undesired retrograde flow of blood from the left ventricle into the aorta can occur during ventricular systole. 
         [0114]      FIG. 8B  shows the treatment and/or repair of this condition by the implantation of a system  24  of tethered implants  10  in the left ventricle near the aortic valve annulus. The tethers  18  of the fasteners are placed and held in tension (shown by arrows in  FIG. 8B ) by a clip  26 . Multiple clips  26  can be used, if desired. The tension applied by the system  24  reshapes the aortic valve annulus, pulling the leaflets closer together, so that coaptation during ventricular systole occurs, and retrograde flow is prevented or reduced. 
         [0115]      FIGS. 9A to 9D  show the intra-vascular deployment of the system  24  shown in  FIG. 8B . Alternatively, the system  24  can be established using conventional open heart surgical techniques or by thoracoscopic surgery techniques. 
         [0116]    The intra-vascular approach shown in  FIGS. 9A to 9D  is the essentially the same as that shown in  FIGS. 7A to 7D , previously described. Under fluoroscopic guidance, the guide component  28  is delivered over a guide wire through either the aortic valve (via, e.g., the femoral artery or subclavian artery) into the left ventricle at or near the inferior region of the aortic valve annulus or an antegrade venous then trans-septal route. The guide wire is withdrawn, and the applier instrument  20  is introduced through the guide component  28 , as  FIG. 9A  shows. 
         [0117]    The guide component  28  is positioned in succession at intended implant delivery sites at or near the inferior region of the aortic valve annulus. At each site, the applier instrument  20  is actuated to place an implant  10 .  FIG. 9A  shows the guide component  28  braced against a wall of the ventricle to apply a counterbalancing resolution force to the implantation force. In this way (see  FIG. 9B ), a desired pattern of implants  10  is distributed at or near the inferior region of the aortic valve annulus. The tether elements of the implants  10  are gathered and channeled through the guide component  28  to outside the body. 
         [0118]    Once the desired number of implants  10  are deployed at or near the aortic valve annulus, the applier instrument  20  is withdrawn, and the clip-applier instrument  36  is tracked through the guide component  28  and over the bundle of tether elements  18  into the left ventricle (see  FIG. 9C ). The tether elements  18  act as guide wires to guide the clip-applier instrument  36  into the left ventricle. 
         [0119]    Once the clip-applier instrument  36  is in place, the tether elements  18  are pulled taut. Growing taut, the tether elements  18  apply tension on the individual implants  10 , as the arrows in  FIG. 9C  show. This, in turn, pulls the walls of the left ventricle in the region of the aortic valve annulus inward towards the clip-applier instrument  36 . The aortic valve leaflets are drawn closer together, into a geometry better suited for coaptation. The clip-applier instrument  36  applies a clip to the tether elements  18 , attaching the tether elements together in tension (see  FIG. 9D ). The clip-applier  36  cuts the bundle of tether elements  18  proximal to the site where the clip  26  was applied, and the clip-applier instrument  36  and loose tethers  18  are withdrawn. The guide component is then withdrawn, as  FIG. 9D  shows. 
         [0120]    The system  24  has been established to reshape the aortic valve annulus to treat, in this instance, congestive heart failure and/or retrograde flow through the aortic valve. The system  24  can also be used to treat retrograde flow through any other heart valve, e.g., the mitral valve. 
         [0121]    It should be appreciated that one or more implants  10  of the system  24  can be electrically coupled to a device that can be operated to control muscular and/or electrical activity in heart tissue. Absent this intended effect, however, it is desired that the implants  10  are not inherently electrically conductive, so as not to interfere with electrical conduction within the heart. 
       II. Implants for Creating Tissue Folds  
       [0122]    A. Overview 
         [0123]      FIG. 10B  shows a tissue folding system  38  comprising at least one tethered implant  10  shown in  FIG. 4A . The implant  10  is used in combination with another implant  40 , which can take the form of the implant shown in  FIG. 4B , but need not include a tether element  18 . The implants  10  and  40  are implanted in a tissue wall within a hollow body organ or vessel (shown to be within a left ventricle in  FIG. 10B ) in a spaced-apart relationship. The tether element  18  of the implant  10  is cinched through the implant  40  and held in tension by a clip element  42 , to form a fold or tuck  44  in the tissue region between the implants  10  and  40 . The presence of the fold  44  reduces the overall interior volume of the hollow body organ or vessel, as a comparison of the left ventricle shown in FIG.  10 A—before establishment of the tissue folding system  38 —and the left ventricle shown in FIG.  10 B—after establishment of the tissue folding system  38 —demonstrates. The number of implants  10  and  40  and resulting folds  44  formed can vary according to the size and geometry of the targeted tissue volume, as well as the volume reduction objectives. 
         [0124]    The tissue folding system  38  as just described can be established in various parts of the body and for various therapeutic purposes. 
         [0125]    B. Systems and Methods Defining Discrete Tissue Folds 
         [0126]    The embodiment shown in  FIG. 10B  contemplates the establishment of one or more discrete folds  44 , e.g., for the treatment and/or repair of congestive heart failure. The tissue folding system  38  can be implemented in various ways. 
         [0127]      FIGS. 11A to 11D  contemplate the intra-vascular deployment of the system  38  in a left ventricle, as generally shown in  FIG. 10B . Alternatively, the system  28  can be established using conventional open heart surgical techniques or by thoracoscopic surgery techniques. The system  38  can be deployed in other hollow body organs or vessels within the body, either by open surgical techniques or intra-vascular access. 
         [0128]    In the intra-vascular approach into the left ventricle, as shown in  FIGS. 11A to 11D , an applier instrument  20  can be introduced through a guide component  28  through either the aorta in the manner shown in  FIG. 7A  (via, e.g., the femoral artery or subclavian artery) or an antegrade venous then trans-septal route. The applier instrument  20  deploys at least one tethered implant  10  (as  FIG. 11A  shows). The applier instrument  20  is withdrawn to receive the implant  40 , and then redeployed to an adjacent tissue region, using the tether element  18  of the first implant  10  as a guide wire as  FIG. 11B  shows. The tether element  18  of the implant  10  is slidably trapped or otherwise threaded through the implant  40  as the implant  40  is deployed, as  FIG. 11B  also shows. The applier instrument  20  is withdrawn from the guide component  28 , with the tether element  18  of the implant  10  channeled through the guide component  28 . 
         [0129]    As  FIG. 11C  shows, a clip-applier instrument  36  is tracked through the guide component  28  and over the tether element  18  to the tissue site. The clip-applier instrument  36  is held stationary, while the tether element  18  is pulled taut through the clip-applier instrument  36  (see  FIG. 11C ). The tether element  18  applies tension between the implants  10  and  40 , drawing the implants  10  and  40  together to cinch the intermediate tissue. The intermediate tissue folds it upon itself, and the fold  44  is created, as  FIG. 11C  shows. The clip-applier instrument  36  applies a clip element  42 , to maintain tension and the resulting fold  44  (see  FIG. 11D ). The clip applier  36  cuts the tether element  18  proximal to the site where the clip  42  was applied. The clip-applier instrument  36  is then withdrawn through the guide component  28 , and the guide component is withdrawn, as  FIG. 11D  shows. 
         [0130]    Alternatively, or in combination with the clip element  42 , the implants  10  and  40  can include interlocking structural components  46  (see  FIG. 12 ) that are brought into engagement by pulling the tether element  18  taut. In an alternative embodiment (not shown), a separate bridging element can be applied to interlock elements  10  and  40  after they are brought into close proximity by pulling the tether element taut. The engagement between the components  46  that holds the relative positions of the implants  10  and  40 , to maintain the tissue tension and the resulting fold  44 . In this arrangement, the implant  40  can be partially installed and tension applied to the tether element  18  to draw the implants  10  and  40  toward one another, to create the desired fold  44 . Then installation of the implant  40  can be completed to bring the components  46  into interlocking engagement. 
         [0131]    As shown in  FIGS. 13A to 13C , the spacing between the implants  10  and  40 , after tension is applied to the tether element  18 , can be controlled by use of flexible, collapsible tube  48  between the implants  10  and  40 . In this arrangement, the length of the tube  48 , when collapsed, is predetermined to reflect the desired spacing between the implants  10  and  40  when in tension. As  FIG. 13A  shows, the tube  48  is guided in an uncollapsed condition over the tether element  18  after deployment of the implant  10 . The implant  40  is deployed by the applier instrument  20  in the manner previously described, placing the tube  48  (uncollapsed) between the implants  10  and  40 , as  FIG. 13B  shows. Subsequent use of the clip-applier instrument; as previously described, to draw the tether element  18  taut, collapses the tube  48  to until its predetermined length is assumed—resisting any further cinching—at which point the clip element  42  is applied, resulting in the system  38  shown in  FIG. 13C . Alternatively, a non-collapsible tube could be used as a spacer between the two implants  10  and  40 . 
         [0132]    In the foregoing embodiments, a single tether element  18  has been used to apply tension between the implant  10  that carries the tether element  18  and another implant  40  that does not. Alternatively, as shown in  FIGS. 14A and 14B , two implants  10 , each with its own tether element  18  can be deployed. In this embodiment, the clip-applier instrument  36  is guided over both tether elements  18 , so that tension can be applied individually to each tether element  18 . The clip-applier instrument  36  draws the tether elements  18  taut (as  FIG. 14B  shows), creating the fold  44 . The clip-applier instrument  36  then applies the clip element  42 , to hold the two individual tether elements  18  in tension, forming the system  38 . 
         [0133]    In any of the foregoing manners, the system  38  can be established to reduce the interior volume of a heart chamber to treat, in this instance, a left ventricle affected by congestive heart failure. 
         [0134]    The tether element(s)  18  may be elastic and/or possess a spring constant and/or be shaped and/or be otherwise compliant in the region between the implants  10  and  40 . This material characteristic can help minimize or dampen peak load conditions upon the system  38 , particularly when the tissue region is dynamic, as is the case with cardiac tissue. 
         [0135]    1. Tissue Folding with Overlaying Patch Component 
         [0136]    As shown in  FIG. 15A , the tissue folding system  38  can include a patch component  50  secured by implants  56  to span the tissue fold  44 . The patch component  50  distributes forces within the system  28  to maintain the fold  44 . 
         [0137]    The patch component  50 , when installed, comprises a relatively planar frame, or a sheet of prosthetic material, or combinations thereof. The patch material is selected on the basis of its biocompatibility, durability, and flexible mechanical properties. The patch material can comprise a polymeric or metallic material, e.g., polyester, or ePTFE, or a malleable plastic or metal material, or a self-expanding plastic or metal material like Nitinol® wire. The patch material desirably possesses some elasticity, e.g., by using stretchable materials and/or weaves/knits, like Spandex™ material or elastic waist bands. The patch material also desirably possesses a resistance to expansion. The material may be drug coated or embedded with drugs, such as with heparin. 
         [0138]    The patch component  50  is desirable sized and configured to permit non-invasive deployment of the prosthesis by an intra-vascular catheter. In this respect, the patch component  50  is desirably sized and configured to assume a compressed or collapsed, low profile condition, to permit its intra-vascular introduction into the hollow body organ by a catheter. The patch component  50  is likewise desirably sized and configured for expansion in situ from a collapsed condition into an expanded condition for contact with tissue overlaying the fold  44 . 
         [0139]    The patch component  50  carry radiopaque markers to help fluoroscopically position it. The markers can take the form, e.g. of marker bands, tight wound coils, or wire made from radiopaque materials such as platinum, platinum/iridium, or gold. 
         [0140]      FIG. 15B  shows a representative embodiment for delivering the patch component  50  by a catheter  58  deployed through intra-vascular access. The catheter  58  carries the patch component  50  in a collapsed condition. Once positioned over the site of the fold  44 , the patch component  50  is released from the end of catheter  58  on outwardly tapered guide elements  60 . 
         [0141]    The guide elements  60  comprise wires with eyes  62 . In the illustrated embodiment, the eyes  62  are secured to the patch component  50  by releasable suture  64 . The suture  64  can, e.g., comprise a loop that is threaded through each eye  62  and the patch component  50 . The ends of the suture loop extend out the proximal end of the catheter  58 . Pulling on one end of the suture loop will withdraw the suture  64  from the eyes  62 , thereby releasing the patch component  50 . 
         [0142]    The guide elements  60  (and/or the patch component  50  itself) are desirably biased to hold the patch component  50 , once released, in an open and taut fashion, as  FIG. 15B  shows. The patch component  50  placed over the fold  44 . The periphery of the patch component  50  is attached to tissue using the fasteners  56 . As  FIG. 15B  shows, the applier instrument  20 , previously described, may be deployed over the guide elements  60  to apply the fasteners  56  to the patch component  50 . Alternatively, the applier instrument  29  may be deployed independent of the guide elements  60 . 
         [0143]    It should be appreciated that one or more implants  10  and/or  40  of the system  38 , or the implants  56  associated with the patch component  50 , can be electrically coupled to a device that can be operated to control muscular and/or electrical activity in heart tissue. Absent this intended effect, however, it is desired that the implants  10  and/or  40 , or the patch component  50  are not inherently electrically conductive, so as not to interfere with electrical conduction within the heart. 
         [0144]    C. Systems and Methods Defining Patterns of Tissue Folds 
         [0145]    1. Overview 
         [0146]    As  FIGS. 16A and 16B  show, a tissue folding system  52  can comprise a plurality of folds  44  arranged in a pre-established pattern or array within a hollow body organ. The folds  44  are arranged in an annular pattern about the circumference of a tissue region. The folds  44  are formed by placement of at least one tethered implant  10  (as shown in  FIG. 4A ) in association with a plurality of other implants  40  (which need not be tethered). The tether element  18  cinches tissue between adjacent implants, and a clip element  54  holds tension in the tether element  18 . As  FIG. 16A  shows, the resulting pattern of adjacent folds  44  creates a tissue region that is circumferentially drawn in, in purse string fashion. As  FIG. 16B  shows, the system  52  can be used to establish within a given hollow body organ a restriction that essentially isolates or seals one region of a hollow body from another region. 
         [0147]    The system  52  as just described can be established in various parts of the body and for various therapeutic purposes. Two embodiments will be described for the purpose of illustration. The first embodiment is directed to isolation or sealing of an atrial appendage in the treatment of, e.g., atrial fibrillation. The second embodiment is directed to the repair of perforations, holes, or defects in tissue, e.g., atrial or ventricular septal defects. 
         [0148]    2. Appendage Isolation/Sealing 
         [0149]      FIG. 17A  shows for the purpose of illustration the two native anatomic parts of an atrium (here, the left atrium)—namely, the atrial appendage (also call the appendix auricilae) and the remainder of the atrium (also called the sinus).  FIG. 17B  shows a tissue folding system  52  that has been established within the atrium. The system  52  comprises a plurality of annular folds  44  (see  FIG. 17C ), which essentially isolates or seals the left atrial appendage from the atrial septum. In this arrangement, the system  52  can be used, e.g., to prevent the formation of blood stasis regions in an atrial appendage that is subject to dysfunction as a result of decreased contractility of the atrium following, e.g., treatment of atrial fibrillation. 
         [0150]    As shown in  FIGS. 17B and 17C , the system  52  comprises at least one tethered implant  10  used in association with a plurality of other implants  40  (which need not be tethered). The implants  10  and  40  are implanted at or near the relatively restricted, native junction between the atrial appendage and the atrial sinus. The implants  10  and  40  are implanted in a spaced-apart, annular relationship about the circumference of this junction. 
         [0151]    The tether element  18  of the implant  10  is cinched through an adjacent implant  40 , which, in turn, is cinched through the next adjacent implant  40 , and so on. The cinching between adjacent implants creates a fold  44 . The cinching between a sequence of adjacent annular implants creates a pattern of adjacent, folds  44  about the native junction. 
         [0152]    The tether element  18 —cinched sequentially about the implants  10  and  40 —is held in tension by a clip element  54 . The system  52  draws the junction together, thereby essentially closing the atrial appendage from blood flow communication with the remainder of the atrium. The number and pattern of implants  10  and  40  in the system  52  can vary according to the size and geometry of the targeted junction sought to be isolated and sealed. 
         [0153]    The system  52  can be deployed to seal or otherwise isolate an atrial appendage, either by open surgical techniques or intra-vascular access, using the instruments and methodologies that have been previously described. 
         [0154]    It should be appreciated that a patch component  50  like that shown in  FIG. 15A  could be deployed over a pattern of folds  44  formed by the system  52 . It should also be appreciated that one or more implants  10  and/or  40  of the system  52  can be electrically coupled to a device that can be operated to control muscular and/or electrical activity in heart tissue. Absent this intended effect, however, it is desired that the implants  10  and/or  40  are not inherently electrically conductive, so as not to interfere with electrical conduction within the heart. 
         [0155]    3. Closing Perforations, Holes, or Defects 
         [0156]      FIG. 18A  shows for the purpose of illustration a tissue region that has a perforation caused, e.g., by disease, injury, or genetic defect.  FIG. 18B  shows a tissue folding system  52  established at or near the perforation in the tissue region. The system  52  comprises a plurality of annular folds  44 , which essentially draw tissue together in a purse-string effect to close the perforation. The system  52  can be used, e.g., to seal septal defects in the atrium or ventricle, or in other regions of the body where perforations, holes, or defects occur. 
         [0157]    The system  52  shown in  FIG. 18B  is essentially the same as shown  52  in  FIGS. 17B and 17C . The system  52  comprises at least one tethered implant  10  in association with a plurality of other implants  40 . The implants  10  and  40  are implanted in a spaced-apart, circumferential relationship about the perforation. The tether element  18  of the implant  10  is cinched through an adjacent implant  40 , which, in turn, is cinched through the next adjacent implant  40 , and so on, creating a pattern of adjacent, folds  44  about the perforation. The tether element  18 —cinched sequentially about the implants  10  and  40 —is held in tension by a clip element  54 . The system  52  draws tissue surrounding the perforation together, thereby closing it, or at least reducing its native diameter. 
         [0158]    The number and pattern of implants  10  and  40  in the system  52  can vary according to the size and geometry of the targeted junction sought to be isolated and sealed. Furthermore, the system  52  can be deployed to seal a perforation, hole of defect in tissue either by open surgical techniques or intra-vascular access, using the instruments and methodologies previously described. 
         [0159]    It should be appreciated that, given the dimensions of the perforation, hole, or defect, a discrete system  38  like that shown in  FIG. 10B  could be used to draw tissue together in the region of the perforation, thereby repairing it. It should also be appreciated that a patch component  50  like that shown in  FIG. 15A  can be deployed over a tissue site repaired by the system  52  or  58 . 
         [0160]    In one embodiment (see  FIG. 28 ), the patch component  50  can be sized and configured to cover a discrete perforation, such as a septal defect in the heart, without association with a tissue folding system  52  or  58 . In this arrangement (see  FIG. 28 ), the patch component  50  includes, e.g., a body portion  66  and a stem portion  68 . The stem portion  68 , in use, occupies the perforation, hole, or defect (e.g., as shown in  FIGS. 29A and 29B ), to plug the site. The body portion  66  extends like “wings” from the stem portion  68  to contact and seat against wall tissue adjacent the site. 
         [0161]      FIGS. 29A and 29B  show the patch component  50  shown in  FIG. 28  installed to cover a septal defect between the left and right ventricles of a heart. As  FIGS. 29A  and  29 B show, fasteners  56  are desirably applied to anchor the body portion  66  to adjacent wall tissue. The patch component  50  shown in  FIGS. 29A and 29B  can be deployed to seal a perforation, hole of defect in tissue either by open surgical techniques or intra-vascular access, using the instruments and methodologies previously described. 
         [0162]    In the foregoing indications in the heart, it is desired that the implants  10  and/or  40 , and the patch component  50  and its associated fasteners  56 , are not inherently electrically conductive, so as not to interfere with electrical conduction within the heart. 
       III. Prostheses for Externally Supporting Tissue in a Hollow Body Organ 
       [0163]    A. Overview 
         [0164]      FIGS. 19A to 19F  show various illustrative embodiments of a prosthesis  70  that is sized and configured for placement within an interior of a hollow body organ or around the exterior of a hollow body organ (see, e.g.,  FIGS. 20A and 20B , respectively). The prosthesis  70  has a body  72  that is preformed in a desired size and shape based upon the anatomy and morphology of the hollow body organ. When placed in or around a hollow body organ, the size and shape of the prosthesis body  72  constrains tissue, to regulate the maximum size and shape of the hollow body organ in a way that achieves a desired therapeutic result. However, the prosthesis body  72  desirably does not interfere with contraction of the hollow body organ to a lesser size and shape. 
         [0165]    The body  72  can comprise a fully formed, three dimensional structure, as  FIGS. 19A to 19D  show. Alternatively, the body  72  can comprise component parts (A, B, C), as  FIG. 19E  shows, that are assembled in situ to form a composite body structure. The component parts A, B, and C may be assembled end-to-end in an adjacent relationship, or the component parts A, B, and C can be assembled in an overlapping relationship. In  FIG. 19E , the component parts A, B, C comprise hoops, bowls, or truncated cylinders, which are assembled axially. Alternatively, as will be described in greater detail later, the components could comprise patch components (like that shown in  FIG. 15A ) that are assembled together, either end-to-end or in an overlaying relationship. Still alternatively, the body  72  can comprise a sheet-like structure, as shown in  FIG. 19F , that is wrapped in situ to form a composite, three dimensional body structure. The body  72  could also include components that are coupled together with interconnecting hinges or springs. It should be appreciated that a multitude of structural configurations are possible. 
         [0166]    In the illustrated embodiments, the body  72  is shown to include a prosthetic material  74 . The prosthetic material  14  is selected on the basis of its biocompatibility, durability, and flexible mechanical properties. The material  74  can comprise, e.g., woven polyester or ePTFE. The prosthetic material  74  desirably possesses some elasticity, e.g., by using stretchable materials and/or weaves/knits, like Spandex™ material or elastic waist bands. The prosthetic material  74  also desirably possesses limited expansion or a resistance to expansion that can increase rapidly. The prosthetic material  74  may be drug coated or embedded with drugs on the inside surface, such as with heparin. Alternatively, the prosthetic material  74  may be relatively non-compliant, but can be compressed along with the rest of the prosthesis by crumpling, folding, etc. The prosthetic material  74  could also comprise a polymeric or metallic grid structure. 
         [0167]    In the illustrated embodiments, the prosthetic material  74  is shown to be supported by a scaffold-like structure  76 . It should be appreciated, however, that the prosthetic material  74  could be free of a scaffold-like structure  76 , or, conversely, the scaffold-like structure  76  could be free of a prosthetic material  74 . 
         [0168]    The prosthetic material  74  and/or scaffold-like structure  76  are desirable sized and configured to permit non-invasive deployment of the prosthesis by an intra-vascular catheter. With this criteria in mind, the prosthetic material  74  and/or scaffold-like structure  76  are sized and configured to assume a compressed or collapsed, low profile condition, to permit their intra-vascular introduction into the hollow body organ by a catheter. Also with this criteria in mind, the prosthetic material  74  and/or scaffold-like structure  76  are sized and configured for expansion in situ from a collapsed condition into an expanded condition in contact with tissue in the targeted region. 
         [0169]    In this respect, the scaffold-like structure  76 , if present, can comprise, e.g., a malleable plastic or metal material that expands in the presence of an applied force. In this arrangement, the deployment catheter can include, e.g., an expandable body, such as a balloon, to apply the expansion force to the scaffold-like structure  76  in situ. Alternatively, the scaffold-like structure  76 , if present, can comprise a self-expanding plastic or metal material (e.g., from Nitinol® wire) that can be compressed in the presence of a force, but self-expands upon removal of the compressive force. In this arrangement, the deployment catheter can include, e.g., a sleeve that can be manipulated to enclosed the scaffold-like structure  76  in a collapsed condition, thereby applying the compressive force, and to release the scaffold-like structure  76  when desired to allow the scaffold-like structure  76  to self-expand in situ. 
         [0170]    The scaffold-like structure  76  can take various alternative forms, some of which are shown for the purpose of illustration. The scaffold-like structure  76  can include longitudinally extending spines, which form an umbrella-like structure shown in  FIG. 19A . Alternatively, the scaffold-like structure  76  can comprise zigzag type stent rings ( FIG. 19B ), which can be independent or interconnected one with the other, or combinations thereof; or a helically wound stent support ( FIG. 19C ); or a woven or crisscrossing pattern. The scaffold-like structure  76  need not be present throughout the body  72 ; that is, the body  72  may include regions that include a scaffold-like structure  76  and regions that do not. The scaffold-like structure  76  can be, e.g., sewn onto prosthetic material  74 . Other attachment means could be utilized to secure the scaffold-like structure  76  to the prosthetic material  74 . These means include bonding; capturing the scaffold-like structure  76  between two layers of prosthetic material  74 ; and incorporating the scaffold-like structure  76  directly into the prosthetic material  74 . The scaffold-like structure  76  can be present either inside the prosthesis body  72 , or outside the prosthesis body  72 , or within the prosthesis body  72 , or combinations thereof. Desirably, the surface of the prosthesis  70  that is exposed to flow of blood or body fluids is relatively smooth to minimize turbulence. 
         [0171]    The prosthesis body  72  can carry radiopaque markers to help fluoroscopically position the prosthesis. The markers can take the form, e.g. of marker bands, tight wound coils, or wire made from radiopaque materials such as platinum, platinum/iridium, or gold. 
         [0172]      FIGS. 20A and 20B  show the prosthesis  70  installed within a targeted hollow body organ ( FIG. 20A ) or about a targeted hollow body organ ( FIG. 20B ). At least part of the outer surface(s) of prosthesis can be coated with substances, such as glue or drugs, or structures, such as barbs or hooks, to promote adhesion or connection to the hollow body organ. 
         [0173]    The structural strength of the prosthesis  70  resists distension of the tissue wall en masse beyond the maximum size and shaped imposed by the prosthesis body  72 . In this way, the prosthesis body  72  dictates a maximum size and shape for the body organ. However, the prosthesis body  72  does not interfere with the contraction of the hollow body organ to a lesser size and shape. 
         [0174]    Desirably, as  FIGS. 20A and 20B  show, the prosthesis body  72  accommodates the introduction of one or more fasteners  56  to anchor the prosthesis  70  in place. For this purpose, regions of the prosthesis body  72  can be specially sized and configured for the receipt and retention of fasteners. For example, the size and spacing of the scaffold-like structure  76  can be configured in the regions to specially accommodate the placement of fasteners  56 ; and/or woven fibers with an “X-pattern” or a “sinusoidal pattern” can be used in the region to specially accommodate placement of fasteners  56 ; and/or the prosthetic material can be folded-over to form multiple layers, to reinforce the prosthesis in the regions where fasteners  56  are placed; and/or denser weave patterns or stronger fibers can be used, selected from, e.g., Kevlar™ material or Vectran™ material or metallic wire woven alone or interwoven with typical polyester fibers in the regions were fasteners  56  are placed. It may also be desirable to fluoroscopically indicate the regions with auxiliary radiopaque markers on the prosthetic material  14 , and/or scaffold-like structure  76  to aid in positioning the fasteners  56 . 
         [0175]    The fasteners  56  can be variously constructed. They can, e.g., comprise staples or (as shown) helical fasteners, like that shown in  FIG. 4A , but without the tether element  18 . 
         [0176]    The prosthesis  70  as just described can be installed in various parts of the body and for various therapeutic purposes. Two embodiments will be described for the purpose of illustration. The first embodiment is directed to implantation within a heart chamber for treatment and/or repair of congestive heart failure. The second embodiment is directed to implantation in a heart valve annulus for heart valve remodeling. 
         [0177]    B. Systems and Methods for Supporting Tissue in a Heart Chamber 
         [0178]      FIG. 21  shows the prosthesis  70  as described installed in a left ventricle of a heart. The left ventricle has been enlarged due to the effects of congestive heart failure. As  FIG. 21  shows, the prosthesis is desirably secured to the walls of the ventricle using fasteners  56 . 
         [0179]    The presence of the prosthesis  70  shapes the left ventricle in a desired fashion, pulling the chamber walls laterally closer together and thereby reducing the overall maximum internal volume. The presence of the prosthesis  70  resists further enlargement of the left ventricle during ventricular diastole and provides a shape is better suited to efficient ventricular pumping. 
         [0180]    However, the presence of the prosthesis  70  does not interfere with contraction of the left ventricle during ventricular systole. 
         [0181]    In this embodiment, it is desired that the prosthesis  70  is not inherently electrically conductive, so as not to interfere with electrical conduction within the heart. 
         [0182]      FIGS. 22A to 22D  show the intra-vascular deployment of the prosthesis  70  shown in  FIG. 21 . Alternatively, the prosthesis  70  can be installed using conventional open heart surgical techniques or by thoracoscopic surgery techniques. 
         [0183]    In the intra-vascular approach shown in  FIGS. 22A to 22D , a first catheter  78  is navigated over a guide wire  80  through the aortic valve into the left ventricle (see  FIG. 22A ). The first catheter  78  can be delivered through the vasculature under fluoroscopic guidance, e.g., through either a retrograde arterial route (via, e.g., the femoral artery or subclavian artery) (as shown) or an antegrade venous then trans-septal route. 
         [0184]    The first catheter  78  carries the prosthesis  70  in a radially reduced or collapsed configuration. Once inside the left ventricle (see  FIG. 22B ), the first catheter  70  releases the prosthesis  70 , which eventually expands radially into, the configuration shown in  FIG. 21 . The first catheter  78  is then withdrawn over the guide wire  80 . 
         [0185]    The guide component  28  (previously described) is delivered over the guide wire  80  (which is then withdrawn) (see  FIG. 22C ) and maneuvered to each region where a fastener  56  is to be applied. The applier instrument  20  (previously described) is introduced through the guide component  28 , as  FIG. 22C  shows and can also been seen in  FIG. 4B . In this embodiment, the applier instrument  20  carries a helical fastener  56  generally of the type shown in  FIG. 4A , but without a tether element  18 . The applier instrument  20  rotates the fastener  56 , causing it to penetrate the myocardium. 
         [0186]    As  FIG. 22D  depicts, the guide component  28  is repositioned in succession to each intended attachment site for the fastener  56 . At each site, the applier instrument  20  is actuated to place a fastener  56 .  FIGS. 22C and 22D  show the guide component  28  braced against a wall of the ventricle to apply a counterbalancing resolution force to the implantation force. In this way, a desired pattern of fasteners  56  is applied, securing the prosthesis  70  to the left ventricle, as  FIG. 21  shows. The applier instrument  20  and guide component  28  are then withdrawn. 
         [0187]    The prosthesis  70  has been installed to shape the left ventricle to treat, in this instance, congestive heart failure. 
         [0188]    In an alternative embodiment, the prosthesis  70  could be sized and configured to contain a fluid, e.g., saline or blood. For example, the prosthesis  70  can carry fluid receiving tubes or pockets. The delivery of fluid causes the tubes or pockets to expand, thereby enlarging the occupying volume of the prosthesis  70 . As a result, the usable internal volume of the heart chamber is reduced. 
         [0189]      FIG. 23  shows an alternative embodiment, in which the prosthesis  70  as described is installed around the exterior of the ventricles of a heart afflicted with congestive heart failure. The prosthesis  70  can be installed using conventional open heart surgical techniques or by thoracoscopic surgery techniques. 
         [0190]    As shown in  FIG. 23 , the prosthesis  70  is desirably secured to the exterior walls of the ventricles using fasteners  56 . The fasteners  56  are applied from within the heart, using the intra-vascular approach and technique just described. The presence of the prosthesis  70  shapes the ventricles, reducing their overall maximum internal volume. The presence of the prosthesis  70  also resists further enlargement of the ventricles and provides a shape is better suited to efficient ventricular pumping. The presence of the prosthesis  70 , however, desirably does not interfere with contraction of the ventricles to a lesser volume. 
         [0191]      FIGS. 24A and 24B  show a prosthesis system  82  comprising an array of two or more patch components  50 , as previously described with reference to  FIG. 15A . In  FIGS. 24A and 24B , the hollow body organ comprises a left ventricle of a heart, but it should be appreciated that the system  82  can be established in other body organs, as well. In this embodiment, each patch component  50  is individually attached by one or more fasteners  56  to a localized tissue region in the hollow body organ. The patch components  50  are shown to be placed in an overlapping array (see  FIG. 24B ), but the array need not be overlapping.  FIG. 24A  shows the guide component  28  braced against a wall of the ventricle to apply a counterbalancing resolution force to the implantation force. Using a plurality of patch components  50 , the system  82  can form a composite prosthesis within the entire interior of the hollow body organ, or, alternatively, the system  82  can form a prosthesis that occupies only a portion of the entire interior to provide localized tissue shaping. While not shown, it should also be appreciated that the system  82  of patch components  50  can be installed on the exterior of the hollow body organ. 
         [0192]    The system  82  comprising an array of discrete patch components  50  can shape all or a portion of the ventricles, resisting further enlargement of the ventricles and provides a shape is better suited to efficient ventricular pumping. The presence of the patch components  50 , however, desirably does not interfere with contraction of the ventricles to a lesser volume. 
         [0193]    The prostheses  70  and prosthesis system  82  shown and described in foregoing  FIGS. 19 to 24  can be used alone or in combination with the tissue folding systems shown and described in  FIGS. 10 to 15 , as well as in combination with the tissue support systems described and shown in  FIGS. 5 to 10 . Furthermore, an implant  10  and/or  40 , previously described, can be implanted in association with an individual patch component  50 , with the patch component  50  in this arrangement serving to protect underlying tissue from abrasion and providing compliance between the implant  10 / 40  and tissue. Also, fasteners  56  used to secure a given prosthesis to any tissue wall (e.g., as shown in  FIG. 21  or  23 ) can be applied in association with an individual patch component  50 , with the patch component  50  in this arrangement serving to protect the prosthesis  70  from abrasion due to the fastener  56 , as well as providing compliance between the fastener  56  and the prosthesis  70 . 
         [0194]    C. Systems and Methods for Support Tissue at or Near a Heart Valve Annulus 
         [0195]      FIG. 25  shows a prosthesis  70 , in which the prosthesis body  72  is sized and configured as a ring, for placement in a heart valve annulus. The prosthesis body can be in the form of a continuous ring or a discontinuous ring. In this way, the prosthesis body  72  is preformed in a desired size and shape to emulate the shape of a healthy, native annulus. The prosthesis body thereby serves to shape an annulus that has experienced dilation, as well as resist future dilation. The prosthesis body  72  desirably shapes the annulus so that so that normal leaflet coaptation will occur, and/or so that retrograde flow through the valve is prevented or reduced. 
         [0196]    In this embodiment, the body  72  includes prosthetic material  74  that promotes tissue ingrowth, to aid in fixing the prosthesis  70  to tissue in or near the annulus. In this embodiment, it is desired that the material of the prosthesis body  72  is not inherently electrically conductive, so as not to interfere with electrical conduction within the heart. 
         [0197]    As before described, the prosthesis body  72  in this embodiment is also desirable sized and configured to permit its non-invasive deployment by an intra-vascular catheter. Alternatively, however, the prosthesis body  72  can be installed using conventional open heart surgical techniques or by thoracoscopic surgery techniques. 
         [0198]    In this arrangement, the prosthesis body  72  desirably includes eyelet regions  84  to receive fasteners  56 , so that the prosthesis  70  can be secured to tissue in or near the targeted heart valve annulus. 
         [0199]      FIG. 26A  shows for purposes of illustration the prosthesis  70  installed in or near the annulus of a mitral valve.  FIG. 26B  shows for the purpose of illustration the prosthesis  70  installed in or near the annulus of an aortic valve. The prosthesis  70  may be attached either inside the ventricle in or near the aortic valve (as  FIG. 26B  shows) or outside the ventricle within the aorta in or near the aortic valve. 
         [0200]    As  FIG. 27  shows, the prosthesis body  72  can be delivered through intra-vascular access by a catheter  58  like that shown in  FIG. 15B . The catheter  58  carries the prosthesis body  72  in a collapsed condition. Once positioned in the targeted heart annulus, the prosthesis body  72  can be released from the end of catheter  58  on guide elements  60 . The guide elements  60  comprise wires with eyes  62 , which are releasably secured to the eyelet regions  84  of the prosthesis body  72  by releasable sutures  64 , as previously described. Once the prosthesis body is deployed and positioned, the prosthesis body can be attached to the annulus using the fasteners  56 , and the sutures  64  then released to free the prosthesis body  72  from the catheter  58 . As  FIG. 15B  shows, the applier instrument  20 , previously described, may be deployed over the guide elements  60 , or the applier instrument  20  may be deployed independent of the guide elements (as  FIG. 27  shows) to apply the fasteners  56  to the eyelet regions. 
         [0201]    The prosthesis  70  shown and described in foregoing  FIGS. 25 to 27  can be used alone or in combination with the tissue support systems described and shown in  FIGS. 8 and 9 . 
         [0202]      FIG. 32  shows a heart valve assembly  100  having a generally cylindrical shape formed by a collapsible scaffold-like structure  102 . As shown, the scaffold-like structure  102  carries a prosthetic material  104 , although the structure  102  can be free of a prosthetic material  104 . As previously described with respect to the prosthesis  70 , the prosthetic material  104  and/or scaffold-like structure  102  of the heart valve assembly  100  are sized and configured to assume a compressed or collapsed, low profile condition, to permit their intra-vascular introduction into a hollow body organ by a catheter. Also as previously discussed, the prosthetic material  104  and/or scaffold-like structure  102  are sized and configured for expansion, and preferably self-expansion, in situ from a collapsed condition into an expanded condition in contact with tissue in the targeted region. For example, the scaffold-like structure  102  can comprise a self-expanding plastic or metal material (e.g., from Nitinol® wire) that can be compressed in the presence of a force, but self-expands upon removal of the compressive force. As illustrated, the scaffold-like structure  102  comprises zigzag type stent rings. 
         [0203]    The valve assembly  100  includes a flexible valve member  106 . In the illustrated embodiment, the valve member comprises three, coapting leaflets  108 , although the number of leaflets  108  can vary, e.g., between two and four. 
         [0204]    In use (see  FIG. 33 ), the valve assembly  100  is installed at or near a heart valve annulus. In  FIG. 33 , the targeted heart valve annulus is the aortic valve. Desirably, as  FIG. 33  shows, the valve assembly  100  accommodates the introduction of one or more fasteners  56  to anchor the assembly  100  in place either during or after its installation. 
         [0205]    As previously described with respect to the prosthesis  70 , regions of the scaffold-like structure  102  and/or prosthetic material  104  can be specially sized and configured for the receipt and retention of fasteners  56 . The fasteners  56  can be variously constructed. They can, e.g., comprise staples or (as shown) helical fasteners, like that shown in  FIG. 4A , but without the tether element  18 . 
         [0206]    The valve assembly  100  as just described can be installed in the region of a heart valve annulus by intra-vascular approach. However, it should be appreciated that the assembly  100  can be installed using an open surgical procedure. 
         [0207]    Using an intra-vascular approach (see  FIG. 34A ), the assembly  100  may be deployed by first folding and/or compressing the assembly  100  into a lumen of a trans-vascular catheter  110  for delivery. The catheter  110  may be advanced through the vasculature into the heart through a retrograde arterial route (via, e.g., the femoral artery or subclavian artery) (as  FIG. 34A  shows) or an antegrade venous and then trans-septal route, if left heart access is needed from a peripheral vessel access. Use of a standard available guide wire  112  and/or guide sheath can assist the operator in delivering and deploying the catheter  110  into position. 
         [0208]    The valve assembly  100  is then be pushed out of the lumen of the catheter  110  (as  FIG. 34B  shows). The assembly  100  self-expands into the desired shape and tension when released in situ (as  FIG. 34C  shows). After either partial or complete expansion of the valve assembly  100 , the catheter  110  is withdrawn, and the guide component  28  (previously described) is delivered over the guide wire  112 . The guide component  28  is maneuvered to each region where a fastener  56  is to be applied. The applier instrument  20  (previously described) is introduced through the guide component  28 , as  FIG. 34C  shows. 
         [0209]    The applier instrument  20  carries a helical fastener  56 . The applier instrument  20  rotates the fastener  56 , causing it to penetrate the myocardium.  FIG. 34C  shows the guide component  28  braced against a wall of the aorta to apply a counterbalancing resolution force to the implantation force. The guide component  28  is repositioned in succession to each intended attachment site for the fastener  56 . At each site, the applier instrument  20  is actuated to place a fastener  56 . In this way, a desired pattern of fasteners  56  is applied, securing the valve assembly  100  at or near the targeted heart valve annulus. The applier instrument  20  and guide component  28  are then withdrawn. 
         [0210]    The valve assembly  100  has been installed to repair, or replace, or supplement a native heart valve. 
         [0211]    The valve assembly  100  shown and described in foregoing  FIGS. 32 to 34  can be used alone or in combination with the tissue support systems described and shown in  FIGS. 8 and 9 . 
       IV. Implants for Internally Supporting Tissue in a Hollow Body Organ 
       [0212]      FIGS. 30A and 30B  show an implant  86  sized and configured for placement in a hollow body organ. The implant  86  includes an elongated body  88  that can be made from a formed plastic or metal or ceramic material suited for implantation in the body. 
         [0213]    The body  88  can possess a generally straight or linear configuration, as  FIG. 30A  shows. Alternatively, the body  88  can possess a curvilinear configuration, as  FIG. 30B  shows. As shown in  FIGS. 30A and 30B , the body  88  possesses a helical coil configuration. 
         [0214]    The body  88  includes a distal region  90 . The distal region  90  is sized and configured to penetrate tissue. 
         [0215]    The body  88  also includes a proximal region  92 . As shown in  FIGS. 30A and 30B , the proximal region  92  comprises an L-shaped leg. Like the L-shaped leg  16  shown in  FIG. 4A , the L-shape leg  92  shown in  FIGS. 30A and 30B  desirably bisects the entire interior diameter of the coil body  88 . As before described, the L-shaped leg  92  serves as a stop to prevent the coil body  88 , when rotated, from penetrating too far into tissue. Furthermore, the rotatable implant drive mechanism  22  on the applier instrument  20  (shown in  FIG. 4B ) is sized and configured to engage the L-shaped leg  92  and impart rotation to the coil body  88  to achieve implantation in tissue. 
         [0216]    The body  88  and its distal region  90  are sized and configured to be implanted within or partially within tissue in a hollow body organ. The linear body  88  shown in  FIG. 30A  can run either longitudinally or circumferentially within tissue, as  FIG. 31  shows. The curvilinear body  88  shown in  FIG. 30B  exits tissue and then re-enters tissue in a serpentine path, as  FIG. 31  also shows. When implanted, the implants  86  resist enlargement of the interior of a hollow body organ. However, the implants  86  desirably do not interfere with contraction of the hollow body organ to a lesser interior volume. 
         [0217]      FIG. 31  shows the implants  86  implanted, for the purpose of illustration, in a left ventricle of a heart. The presence of the implants  86  prevents enlargement of the heart chamber due to, e.g., congestive heart failure. Of course, the implants  86  can be implanted in other hollow body organs and achieve a comparable therapeutic effect. 
         [0218]    Like the implants  10  previously described, the implants  86  shown in  FIGS. 30A and 30B  can be installed by intra-vascular deployment using the instruments and techniques previously described. Alternatively, the implants  86  can be installed using conventional open heart surgical techniques or by thoracoscopic surgery techniques. 
         [0219]    In the many catheter-based implantation techniques described above, the catheter used to place a given prosthesis in contact with tissue is usually manipulated to be detached from the prosthesis prior to the placement of fasteners. If desired, the catheter and prosthesis can remain coupled together during the fastening procedure. In this way, control of the prosthesis can be maintained up to and during the fastening procedure. 
         [0220]    Other embodiments and uses of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. The specification and examples should be considered exemplary and merely descriptive of key technical; features and principles, and are not meant to be limiting. The true scope and spirit of the invention are defined by the following claims. As will be easily understood by those of ordinary skill in the art, variations and modifications of each of the disclosed embodiments can be easily made within the scope of this invention as defined by the following claims.