Abstract:
An implant is sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant, when deployed, engages a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. The implant is deployed into the left atrium through an intravascular access path that extends from a right atrium through a septum and into a left atrium.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a divisional of co-pending U.S. patent application Ser. No. 10/695,433, filed Oct. 28, 2003, which is a continuation of International Patent Application Serial No. PCT/US02/31376, entitled “Methods and Devices for Heart Valve Treatment”, having an international filing date of Oct. 1, 2002 and a priority date of Oct. 1, 2001, based upon the benefit of U.S. Provisional Patent Application Ser. No. 60/326,590, filed Oct. 1, 2001 and entitled “Methods and Systems for Herat Chamber Endocardial and Epicardial Scaffold Therapies.” 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to methods and devices to improve the function of heart valves. More particularly, the invention relates to methods and devices to treat mitral valve regurgitation. 
       BACKGROUND OF THE INVENTION 
       [0003]    The opening and closing of heart valves occur primarily as a result of pressure differences. For example, the opening and closing of the mitral valve occurs as a result of the pressure differences between the left atrium and the left ventricle. During ventricular diastole, when ventricles are relaxed, the venous return of blood from the pulmonary veins into the left atrium causes the pressure in the atrium to exceed that in the ventricle. As a result, the mitral valve opens, allowing blood to enter the ventricle. As the ventricle contracts during ventricular systole, the intraventricular pressure rises above the pressure in the atrium and pushes the mitral valve shut. 
         [0004]    The high pressure produced by contraction of the ventricle could push the valve leaflets too much and evert them. Prolapse is a term used to describe this condition. This is normally prevented by contraction of the papillary muscles within the ventricle, which are connected to the mitral valve leaflets by the chordae tendineae (chords). Contraction of the papillary muscles is simultaneous with the contraction of the ventricle and serves to keep healthy valve leaflets tightly shut at peak contraction pressures exerted by the ventricle. 
         [0005]    Valve malfunction can result from the chords becoming stretched, and in some cases tearing. When a chord tears, the result is a flailed leaflet. Also, a normally structured valve may not function properly because of an enlargement of the valve annulus. This condition is referred to as a dilation of the annulus and generally results from heart muscle failure. In addition, the valve may be defective at birth or because of an acquired disease. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention provides a group of medical devices designed to improve heart valve function. The medical devices may be used individually, or in combination to supplement damaged valves, replace damaged valves, or improve damaged valves function. The medical devices include leaflet retainers, a neo-annulus, neo-leaflet, and a framework. In addition, the present invention includes novel methods for surgically treating heart valves. 
         [0007]    One aspect of the invention provides heart implant comprising an implant structure sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant structure includes a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. 
         [0008]    Another aspect of the invention provides a system comprising an implant structure sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant structure includes a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. The system also includes an access tool sized and configured to establish an intravascular access path that extends from a right atrium through a septum and into a left atrium. The system further includes a deployment tool sized and configured to deploy the implant structure through the intravascular path into the left atrium and position the implant structure in the left atrium with the portion engaging a wall of the left atrium above the plane of the native mitral valve annulus such that the portion interacts with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. 
         [0009]    Another aspect of the invention provides a method comprising deploying a guide wire through an vasculature path into a: right atrium, and introducing the guide wire through a septum from the right atrium into a left atrium. The method includes advancing a catheter over the guide wire and releasing from the catheter a heart implant sized and configured to be positioned in the left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant includes a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. The method positions the implant in the left atrium with the portion engaging a wall of the left atrium above the plane of the native mitral valve annulus such that the portion interacts with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. 
         [0010]    Another aspect of the invention provides a system comprising a guide wire sized and configured to be deployed through an vasculature path into a right atrium and through a septum from the right atrium into a left atrium. The system includes a catheter sized and configured to be introduced into the left atrium along the guide wire. The system further includes an implant structure carried within the catheter. The implant structure being sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant structure includes a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. 
         [0011]    Another aspect of the invention provides a method comprising deploying a catheter through an vasculature path into a right atrium, through a septum and into a left atrium. The method includes releasing from the catheter a heart implant sized and configured to be positioned in the left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant includes a portion sized and configured for engagement with a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. The method includes positioning the implant in the left atrium with the portion engaging a wall of the left atrium above the plane of the native mitral valve annulus such that the portion interacts with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. 
         [0012]    In one embodiment, the implant or implant structure is sized and configured so that, in use, the portion spans the left atrium. 
         [0013]    In one embodiment, the implant or implant structure is sized and configured so that, in use, the portion changes the shape of the native mitral heart valve annulus. 
         [0014]    In one embodiment, the implant or implant structure comprises, at least in part, nitinol, dacron, polytetrafluoroethylene, silicon, polyurethane, human pericardium, or animal pericardium. 
         [0015]    In one embodiment, the implant or implant structure comprises, at least in part, a super elastic material. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  shows a posterior oblique cutaway view of a patient&#39;s heart  100 . 
           [0017]      FIG. 2  shows a cutaway view of a patient&#39;s heart  200  with a prolapsed mitral valve that does not form a tight seal during ventricular systole, and thus allows blood to be regurgitated back into the left atrium during ventricular contraction. 
           [0018]      FIG. 3  shows a cutaway view of a patient&#39;s heart  300  with a flailing mitral valve  320  that does not form a tight seal during ventricular systole, and thus allows blood to be regurgitated back into the left atrium during ventricular contraction as indicated by arrows. 
           [0019]      FIG. 4  shows a perspective view of a spring bridge neo-leaflet used to supplement or replace a native leaflet. 
           [0020]      FIG. 5  shows a perspective view of an embodiment of the invention comprised of a bridge  540 , spanning material  530 , attachment means  550 , and a base  520 . In addition, the device is shown to have a framework  510 . 
           [0021]      FIG. 6  shows a perspective view of the embodiment of  FIG. 5  in the open valve position. 
           [0022]      FIG. 7  shows a perspective view of the embodiments shown in  FIGS. 5 and 6  positioned within the left atrium of the heart. 
           [0023]      FIGS. 8 and 9  show a perspective view of the embodiments of  FIGS. 5 and 6  positioned within the left atrium of the heart. 
           [0024]      FIG. 10  shows a perspective view of an embodiment of the invention having a framework  1010  that avoids the pulmonary veins (not shown). 
           [0025]      FIGS. 11 and 12  show a perspective view of a dual spring bridge neo-leaflet having an anterior bridge spanned by an anterior material  1110 , and a posterior bridge spanned by a posterior material  1120 . 
           [0026]      FIG. 13  shows a perspective view of a damaged native anterior leaflet  1310  that is not connected to the chordae tendineae. 
           [0027]      FIG. 14  shows a perspective view of a device  1400  having a half sewing ring  1420  with a membrane  1410  that serves as a neo-annulus or a neo-leaflet. 
           [0028]      FIG. 15  shows a perspective view of a device  1500  having a full sewing ring  1530  with a membrane  1510  that serves as a neo-annulus or a neo-leaflet. 
           [0029]      FIG. 16  shows a perspective view of a leaflet retainer  1600  that is positioned within the atrium on top of both native mitral valve leaflets. 
           [0030]      FIG. 17  shows a perspective view of a leaflet retainer  1700  that is positioned within the atrium on top of both native mitral valve leaflets. 
           [0031]      FIG. 18  shows a perspective view of a leaflet retainer  1800  that is positioned within the atrium on top of both native mitral valve leaflets. 
           [0032]      FIG. 19  shows a perspective view of a leaflet retainer  1900  that is positioned on top of both native mitral valve leaflets. 
           [0033]      FIG. 20  shows a side view of the embodiment shown in  FIG. 19 . 
           [0034]      FIG. 21  shows a perspective view of the embodiment shown in  FIG. 19 . 
           [0035]      FIG. 22 through 26  show the sequence of steps for a catheter-based percutaneous deployment of an embodiment of the invention. 
           [0036]      FIG. 27  shows a perspective view of an embodiment of the invention  2700  having a framework that partially fills the atrium. 
           [0037]      FIG. 28  shows a perspective view of an embodiment of the invention  2800  having dual neo-leaflets,  2830  and  2840 . 
           [0038]      FIG. 29  shows a perspective view of an embodiment of the invention  2900  having a leaflet retainer  2910  positioned against a native leaflet as well as a framework structure  2920  that meanders about the atrium without interfering with the pulmonary veins. 
           [0039]      FIG. 30  shows a perspective view of another embodiment of the invention  3000  consisting of a continuous wire or tube that forms a leaflet retainer and framework. 
           [0040]      FIG. 31  shows a perspective view of a tulip shaped wire form configuration  3100  of the invention. 
           [0041]      FIG. 32  shows cutaway view of a tulip shaped wire form configuration  3200  of the invention. 
           [0042]      FIG. 33  shows a cutaway view of a tulip with a twist wire form configuration  3300  of the invention. 
           [0043]      FIG. 34  shows a cutaway view of the left atrium and left ventricle. The arrows on the left side of the figure indicate by way of example three different ways in which an embodiment of the invention, such as a leaflet retainer, neo-leaflet, or neo-annulus, may interact with the mitral valve, or be positioned if replacing a leaflet. 
           [0044]      FIG. 35  shows a perspective view of mesh leaflet with buttressing  3500 . 
           [0045]      FIG. 36  shows a side view of a corona configuration  3600  of the invention. 
           [0046]      FIG. 37  shows a perspective view of a corona configuration  3700  of the invention in situ within a patient&#39;s left atrium. 
           [0047]      FIG. 38  shows a cutaway view of a heart, having both native leaflets,  3810  and  3820 , intact. 
           [0048]      FIG. 39  shows a cutaway view of a heart with one embodiment of the invention  3900 . 
           [0049]      FIG. 40  shows a cutaway view of a heart with one intact mitral valve leaflet  4010 , and one mitral valve leaflet excised, or missing. 
           [0050]      FIG. 41  shows a cutaway view of a heart with one embodiment of the invention  4100 . In addition, the shown embodiment has one neo-leaflet  4110 . 
           [0051]      FIG. 42  shows a cutaway view of a heart with both mitral valve leaflets removed. 
           [0052]      FIG. 43  shows a cutaway view of a heart with one embodiment of the invention  4300  having two neo-leaflets. 
       
    
    
     DETAILED DESCRIPTION 
       [0053]      FIG. 1  shows a posterior oblique cutaway view of a patient&#39;s heart  100 . Two of the four heart chambers are shown, the left atrium  170 , and the left ventricle  140  (not shown are the right atrium and right ventricle). The left atrium  170  fills with blood from the pulmonary veins. The blood then passes through the mitral valve (also known as the bicuspid valve, and more generally known as an atrioventricular valve) during ventricular diastole and into the left ventricle  140 . During ventricular systole, the blood is then ejected out of the left ventricle  140  through the aortic valve  150  and into the aorta  160 . At this time, the mitral valve should be shut so that blood is not regurgitated back into the left atrium. The mitral valve consists of two leaflets, an anterior leaflet  110 , and a posterior leaflet  115 , attached to chordae tendineae  120  (hereafter, chords), which in turn are connected to papillary muscles  130  within the left atrium  140 . Typically, the mitral valve has a D-shaped anterior leaflet  110  oriented toward the aortic valve, with a crescent shaped posterior leaflet  115 . The leaflets intersect with the atrium  170  at the mitral annulus  190 . 
         [0054]      FIG. 2  shows a cutaway view of a patient&#39;s heart  200  with a prolapsed mitral valve that does not form a tight seal during ventricular systole, and thus allows blood to be regurgitated back into the left atrium during ventricular contraction. The anterior  220  and posterior  225  leaflets are shown being blown into the left atrium with arrows indicating the direction of regurgitant flow. Among other causes, regurgitation can result from stretched chords  210  that are too long to prevent the leaflets from being blown into the atrium. As a result, the leaflets do not form a tight seal and blood is regurgitated into the atrium. 
         [0055]      FIG. 3  shows a cutaway view of a patient&#39;s heart  300  with a flailing mitral valve  320  that does not form a tight seal during ventricular systole, and thus allows blood to be regurgitated back into the left atrium during ventricular contraction as indicated by arrows. Among other causes, regurgitation can result from torn chords  310 . 
         [0056]      FIG. 4  shows a perspective view of a spring bridge neo-leaflet used to supplement or replace a native leaflet. The device  400  is shown to be formed of a base  420  that is positioned around the mitral annulus, and then closes in over the anterior leaflet to form a bridge  430  over the anterior leaflet. The bridge  430  may be a rigid, semi-rigid, or flexible. The bridge may act like a spring, and thus respond dynamically to pressure differentials within the heart. The bridge  430  may have a spanning material  410  that spans the bridge  430 . The spanning material  410  may be attached to the device  400  with one or more attachment means  440  (for example, it may be sewn, glued, or welded to the device  400 , or it may be attached to itself when wrapped around the device  400 ). The spanning material  410  maybe made from a synthetic material (for example, thin Nitinol, Dacron fabric, Polytetrafluoroethylene or PTFE, Silicone, or Polyurethane) or a biological material (for example, human or animal pericardium). The device  400  may be delivered percutaneously, through the chest (thoracoscopy), or using open heart surgical techniques. If delivered percutaneously, the device may be made from a super-elastic material (for example, Nitinol) enabling it to be folded and collapsed such that it can be delivered in a catheter, and will subsequently self-expand when released from the catheter. The device may be secured to the mitral annulus with sutures or other attachment means (i.e. barbs, hooks, staples, etc). 
         [0057]      FIG. 5  shows a perspective view of an embodiment of the invention comprised of a bridge  540 , spanning material  530 , attachment means  550 , and a base  520 . In addition, the device is shown to have a framework  510 . Preferably the framework  510  does not interfere with atrial contractions, instead contracting with the atrium. As such, the device  500  may have non-uniform flexibility to improve its function within the heart. The framework is shown here rising from the base  520  with two substantially parallel arched wires that connect to form a semicircular hoop above the base  520 . The framework  510  helps to accurately position the device within the atrium, and also helps to secure the device within the atrium. The neo-leaflet comprised of the bridge  540  and spanning material  530  is shown in the closed valve position. 
         [0058]      FIG. 6  shows a perspective view of the embodiment of  FIG. 5  in the open valve position. 
         [0059]      FIG. 7  shows a perspective view of the embodiments shown in  FIGS. 5 and 6  positioned within the left atrium of the heart. 
         [0060]      FIGS. 8 and 9  show a perspective view of the embodiments of  FIGS. 5 and 6  positioned within the left atrium of the heart.  FIG. 8  shows the embodiment in a closed valve position, and  FIG. 9  shows the embodiment in an open valve position. The sizing of the base  810  can vary depending upon the patient&#39;s needs. 
         [0061]      FIG. 10  shows a perspective view of an embodiment of the invention having a framework  1010  that avoids the pulmonary veins (not shown). 
         [0062]      FIGS. 11 and 12  show a perspective view of a dual spring bridge neo-leaflet have an anterior bridge spanned by an anterior material  1110 , and a posterior bridge spanned by a posterior material  1120 . The framework  1130  shown here illustrates an alternative design. This embodiment also illustrates a base having clips  1140  that protrude below an imaginary plane formed by the annulus of the valve.  FIG. 11  shows the dual neo-leaflets in a closed valve position, and  FIG. 12  shows the dual neo-leaflets in an open valve position. 
         [0063]      FIG. 13  shows a perspective view of a damaged native anterior leaflet  1310  that is not connected to the chordae tendineae. 
         [0064]      FIG. 14  shows a perspective view of a device  1400  having a half sewing ring  1420  with a membrane  1410  that serves as a neo-annulus or a neo-leaflet. When serving as a neo-annulus, the membrane  1410  is a relatively immobile structure covering one of the native valve leaflets, particularly a damaged, missing or nonfunctional leaflet. The neo-annulus serves to extend the native annulus and coapts with the remaining functional native leaflet to create a functioning mitral valve. When serving as a neo-leaflet, the membrane  1410  is a mobile structure that moves in response to blood flow, coating with one of the native leaflets to create a functioning mitral valve. The neo-leaflet replaces the function of a damaged, missing or nonfunctional native leaflet. The device  1400  is attached to the mitral valve annulus via the half sewing ring  1420 . This embodiment could be surgically attached to the valve annulus and/or combined with a framework for anchoring the device within the patient&#39;s atrium using catheter based intraluminal techniques. 
         [0065]      FIG. 15  shows a perspective view of a device  1500  having a full sewing ring  1530  with a membrane  1510  that serves as a neo-annulus or a neo-leaflet. The device  1500  has an opening  1520  though the sewing ring  1530  opposite the membrane  1510  for blood flow. Alternatively, this embodiment could have two neo-leaflets. This embodiment could be surgically attached to the valve annulus and/or combined with a framework for anchoring the device within the patient&#39;s atrium using catheter based intraluminal techniques. 
         [0066]      FIG. 16  shows a perspective view of a leaflet retainer  1600  that is positioned within the atrium on top of both native mitral valve leaflets. This embodiment is comprised of an outer ring  1610  and an inner ring  1630  connected by radial struts  1620 . The interior region of the valve orifice remains unobstructed to blood flow with this embodiment. This embodiment could be surgically attached to the valve annulus and/or combined with a framework for anchoring the device within the patient&#39;s atrium using catheter based intraluminal techniques. 
         [0067]      FIG. 17  shows a perspective view of a leaflet retainer  1700  that is positioned within the atrium on top of both native mitral valve leaflets. This embodiment could be surgically attached to the valve annulus and/or combined with a framework for anchoring the device within the patient&#39;s atrium using catheter based intraluminal techniques. 
         [0068]      FIG. 18  shows a perspective view of a leaflet retainer  1800  that is positioned within the atrium on top of both native mitral valve leaflets. This embodiment could be surgically attached to the valve annulus and/or combined with a framework for anchoring the device within the patient&#39;s atrium using catheter based intraluminal techniques. 
         [0069]      FIG. 19  shows a perspective view of a leaflet retainer  1900  that is positioned on top of both native mitral valve leaflets. Alternatively, the leaflet retainers may be designed to retain only one leaflet, or a portion of a leaflet, depending on patient needs. The outer sections of this embodiment have anchors  1910  that distribute stresses along the atrial wall, helping to prevent erosion of the atrial walls. This embodiment could be surgically attached to the valve annulus and/or combined with a framework for anchoring the device within the patient&#39;s atrium using catheter based intraluminal techniques. 
         [0070]      FIG. 20  shows a side view of the embodiment shown in  FIG. 19 . 
         [0071]      FIG. 21  shows a perspective view of the embodiment shown in  FIG. 19 . 
         [0072]      FIG. 22 through 26  show the sequence of steps for a catheter-based percutaneous deployment of an embodiment of the invention. This deployment technique applies to other embodiments as well. Initially, a guidewire is introduced into the vasculature via a peripheral venous access site, such as the femoral or jugular vein, or alternatively by means of surgical access through the right atrium.  FIG. 22  shows the introduction of a guidewire  2210  through the septum  2220  between the right and left atria. The guidewire is shown being introduced into the right atrium via the inferior vena cava  2230 .  FIG. 23  shows a catheter  2320  being advanced over the guidewire  2310 .  FIG. 24  shows an embodiment of the invention  2400  being released from the catheter after the guidewire has been removed. Alternatively, a guidewire could be used to place the device.  FIG. 25  shows an embodiment of the invention having an additional feature, a looped eyelet  2500  that is being placed within a pulmonary vein to help position the device within the atrial chamber. The looped eyelet  2500  could be advanced over a guidewire.  FIG. 26  shows an embodiment of the invention  2600  being positioned within the left atrium. The device  2600  can be positioned or repositioned within the atrium using a catheter deployed grasping instrument  2610 . 
         [0073]      FIG. 27  shows a perspective view of an embodiment of the invention  2700  having a framework that partially fills the atrium. 
         [0074]      FIG. 28  shows a perspective view of an embodiment of the invention  2800  having dual neo-leaflets,  2830  and  2840 . The device is comprised of a framework  2810  an annular base  2820 , and the neo-leaflets,  2830  and  2840 . The neo-leaflets supplement or replace native leaflets, and thus function as a one-way valve to allow blood to flow from the atrium to the ventricle, and to prevent blood from flowing from the ventricle to the atrium. This is accomplished because the neo-leaflets structure is similar to native leaflet structure. 
         [0075]      FIG. 29  shows a perspective view of an embodiment of the invention  2900  having a leaflet retainer  2910  positioned against a native leaflet as well as a framework structure  2920  that meanders about the atrium without interfering with the pulmonary veins. The leaflet retainer  2910  prevents the leaflet from prolapsing into the atrium due to the pressure differential during ventricular contractions, thus improving closure of the mitral valve and reducing regurgitation. 
         [0076]      FIG. 30  shows a perspective view of another embodiment of the invention  3000  consisting of a continuous wire or tube that forms a leaflet retainer and framework. The geometry of the framework is such that it spirals upward within the atrium. The device  3000  is secured in place because the framework expands within the atrium, and experiences mural pressures. The leaflet retainer is secured in place over a native leaflet by its coupling to the framework, and the leaflet retainer functions to prevent the native leaflet from experiencing prolapse. In addition, a coating that promotes tissue growth may aid in the fixation process of the framework within the atrium. However, the leaflet retainer section of the device  3000  may benefit from a coating that inhibits tissue growth, thus allowing the native leaflet to allow blood to flow into the ventricle. 
         [0077]      FIG. 31  shows a perspective view of a tulip shaped wire form configuration  3100  of the invention. 
         [0078]      FIG. 32  shows cutaway view of a tulip shaped wire form configuration  3200  of the invention. The illustration shows the device  3200  making contact with native leaflets,  3220  and  3210 , to prevent prolapse. The device  3200  is comprised of a leaflet retainer section that functions to prevent the native leaflets,  3210  and  3220 , from being blown into the atrium when the ventricle contracts. The leaflet retaining section is positioned directly over the native leaflets. In this embodiment, the leaflet retaining aspect of the device  3200  is shown to be integrally formed with the framework section of the device. However, in other embodiments, the leaflet retainer and framework may be separate structures which can be deployed separately for individual use or in combination. 
         [0079]      FIG. 33  shows a cutaway view of a tulip with a twist wire form configuration  3300  of the invention. The twist aspect enables the device to be shortened through twisting to decrease the longitudinal spring constant. The device  3300  is comprised of a leaflet retainer section that functions to prevent the native leaflets from being blown into the atrium when the ventricle contracts. The leaflet retaining section is positioned directly over the native leaflets. In this embodiment, the leaflet retaining aspect of the device  3300  is shown to be integrally formed with the framework section of the device. However, in other embodiments, the leaflet retainer and framework may be separate structures which can be deployed separately for individual use or in combination. 
         [0080]      FIG. 34  shows a cutaway view of the left atrium and left ventricle. The arrows on the left side of the figure indicate by way of example three different ways in which an embodiment of the invention, such as a leaflet retainer, neo-leaflet, or neo-annulus, may interact with the mitral valve, or be positioned if replacing a leaflet. In other words, an embodiment of the invention may lie in a plane formed by the annulus of the mitral valve as indicated by the middle arrow  3410 . Also, an embodiment of the invention may lie either above or below the plane of the annulus, as indicated by the top  3400  and bottom  3420  arrows, respectively. In addition,  FIG. 34  could also be used to illustrate potential movements when these components of the invention are configured as a spring bridge that spans the mitral annulus and actively moves with the valve leaflet(s). A spring bridge may be configured so that it is biased in the open valve position, and is forced shut by increasing pressure within the ventricle. Alternatively, the spring bridge may not be biased open or closed, but simply move in response to pressure differentials. Also, the spring bridge may be biased in the closed position. 
         [0081]      FIG. 35  shows a perspective view of mesh leaflet with buttressing  3500 . The embodiment is comprised of a framework  3510  and leaflet retainer  3520 . The interior region of the valve orifice  3530  of this embodiment is left open to facilitate the flow of blood between the heart&#39;s chambers. The leaflet retainer  3520  prevents native leaflets from being blown into the atrium upon ventricular contraction. The framework  3510  transmits mural pressures to the leaflet retainer, encouraging the leaflet retainer to remain positioned over the native leaflets. 
         [0082]      FIG. 36  shows a side view of a corona configuration  3600  of the invention. This embodiment may be used as a framework, to which a leaflet retainer or other valve enhancing device could be attached or coupled to. 
         [0083]      FIG. 37  shows a perspective view of a corona configuration  3700  of the invention in situ within a patient&#39;s left atrium. 
         [0084]      FIG. 38  shows a cutaway view of a heart, having both native leaflets,  3810  and  3820 , intact. 
         [0085]      FIG. 39  shows a cutaway view of a heart with one embodiment of the invention  3900 . 
         [0086]      FIG. 40  shows a cutaway view of a heart with one intact mitral valve leaflet  4010 , and one mitral valve leaflet excised, or missing. The chords  4020  of the removed leaflet are shown disconnected. 
         [0087]      FIG. 41  shows a cutaway view of a heart with one embodiment of the invention  4100 . In addition, the shown embodiment has one neo-leaflet  4110 . This neo-leaflet  4110  may be rigid, semi-rigid, or flexible. 
         [0088]      FIG. 42  shows a cutaway view of a heart with both mitral valve leaflets removed. The chords  4210  are shown disconnected. 
         [0089]      FIG. 43  shows a cutaway view of a heart with one embodiment of the invention  4300  having two neo-leaflets. 
         [0090]    These devices may be delivered to the heart via open heart surgery, through the chest, or through a remote blood vessel. Examples of delivery through a remote blood vessel include the use of guidewires and catheters. They can be advanced into the right atrium through the superior or inferior vena cava (transluminally, via a peripheral venous insertion site, such as the femoral or jugular vein), or into the left ventricle through the aorta. The left atrium can be accessed from the right atrium through the septum. Alternatively, the left atrium can be accessed from the left ventricle through the mitral valve using a transluminal procedure gaining access via a peripheral arterial insertion site, such as the femoral artery. Echo techniques are used to determine whether a patient is experiencing regurgitation, and various imaging techniques can be used to position the device. 
         [0091]    The devices shown may be anchored within the left atrium using barbs, staples, adhesives, magnets, etc. In addition, the devices may be coated with various materials to either promote (Dacron) or inhibit (heparin) tissue growth around the devices, to prevent thrombosis, or coated with other desired materials to encourage other desirable characteristics. Anchoring can also be done on the opposite (ventricular) side of the valve. 
         [0092]    While the present invention has been described herein with respect to the exemplary embodiments and the best mode for practicing the invention it will become apparent to one of ordinary skill in the art that many modifications, improvements and sub combinations of the various embodiments, adaptations and variations can be made to the invention without departing from the spirit and scope thereof.