Abstract:
Apparatuses and methods are provided to reconstruct an enlarged left ventricle of a human heart, using a shaper, having a size and shape substantially equal to the size and shape of an appropriate left ventricle, wherein the shaper is adapted to be temporarily placed into the enlarged left ventricle during a surgical procedure. Another aspect of one embodiment comprises a ventricular patch adapted for placement into the left ventricle of a heart made from a sheet of biocompatible material, and having a plurality of markings coupled to the sheet, wherein the markings are configured in distinct patterns for post operatively evaluating movement of the patch. In another aspect of one embodiment, a device is presented, comprising of a handle and a sizing template adapted to be coupled to the handle. Such components are also presented as a kit for use during ventricular restoration surgery.

Description:
PRIORITY CLAIM 
     This application is a continuation of U.S. patent application Ser. No. 09/864,794 entitled “Kit and Method for Use During Ventricular Restoration” filed on May 24, 2001, now U.S. Pat. No. 6,681,773, which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/272,073 filed on Feb. 28, 2001. 
    
    
     BACKGROUND 
     1. Field of the Invention 
     This invention relates generally to surgical methods and apparatus for addressing cardiomyopathy, and more specifically to methods and apparatus for restoring the architecture and normal function of a mammalian heart. 
     2. Description of the Related Art 
     The function of a heart in an animal is primarily to deliver life-supporting oxygenated blood to tissue throughout the body. This function is accomplished in four stages, each relating to a particular chamber of the heart. Initially deoxygenated blood is received in the right auricle of the heart. This deoxygenated blood is pumped by the right ventricle of the heart to the lungs where the blood is oxygenated. The oxygenated blood is initially received in the left auricle of the heart and ultimately pumped by the left ventricle of the heart throughout the body. It can be seen that the left ventricular chamber of the heart is of particular importance in this process as it is relied upon to pump the oxygenated blood initially through an aortic valve into and ultimately throughout the entire vascular system. 
     The amount of blood pumped from the left ventricle divided by the amount of blood available to be pumped is referred to as the ejection fraction of the heart. Generally, a healthier heart has a higher ejection fraction. A normal heart, for example may have a total volume of one hundred milliliters and an ejection fraction of 60 percent. Under these circumstances, 60 milliliters of blood are pumped with each beat of the heart. It is this volume in the normal heart of this example that is pumped with each beat to provide nutrients including oxygen to the muscles and other tissues of the body. 
     The heart is part of the body tissue, and the heart muscle also requires oxygenated blood. Its normal function is greatly upset by clotting or closure of the coronary arteries. When the coronary arteries are blocked, an associate portion of the heart muscle becomes oxygen-starved and begins to die. This is clinically referred to as a heart attack. Ischemic cardiomyopathy typically occurs as the rest of the heart dilates in an attempt to maintain the heart&#39;s output to the body. 
     As the ischemia progresses through its various stages, the affected myocardium dies losing its ability to contribute to the pumping action of the heart. The ischemic muscle is no longer capable of contracting so it cannot contribute to either squeezing or twisting motion required to pump blood. This non-contracting tissue is said to be “akinetic.” In severe cases the akinetic tissue, which is not capable of contracting, is elastic so that blood pressure tends to develop a bulge or expansion of the chamber. In this situation, this muscle tissue is not only akinetic, in that it does not contribute to the pumping function, but it is in fact “dyskinetic,” in that it detracts from the pumping function. This situation is particularly detrimental as the heart loses even more of its energy due to pumping the blood to the bulge instead of through the aorta. 
     After a heart attack, the body seems to realize that with a reduced pumping capacity, the ejection fraction of the heart is automatically reduced. For example, the ejection fraction may drop from a normal 60 percent to 20 percent. Realizing that the body still requires the same volume of blood for oxygen and nutrition, the body causes its heart to dilate or enlarge in size so that the smaller ejection fraction pumps about the same amount of blood. As noted, a normal heart with a blood capacity of seventy milliliters and an ejection fraction of 60 percent would pump approximately 42 milliliters per beat. The body seems to appreciate that this same volume per beat can be maintained by an ejection fraction of only 30 percent if the ventricle enlarges to a capacity of 140 milliliters. This increase in volume, commonly referred to as “remodeling”, not only changes the volume of the left ventricle, but also its shape. The heart becomes greatly enlarged. An enlarged heart will tend to change its architecture from the normal conical or apical shape, to a generally spherical shape. 
     On the level of the muscle fibers, it has been noted that enlargement or dilation of the heart causes the fibers to reorient themselves so that they are directed away from the inner heart chamber containing the blood. As a consequence, the fibers are poorly oriented to accomplish even the squeezing action, as the lines of force become less perpendicular to the heart wall. This change in fiber orientation occurs as the heart dilates and moves from its normal elliptical shape to its dilated spherical shape. The spherical shape further reduces pumping efficiency since the fibers which normally encircle the apex to facilitate writhing are changed to a more flattened formation as a result of these spherical configurations. The resulting orientation of these fibers produces lines of force, which are also directed laterally of the ventricle chamber. Thus, the dilation and resulting spherical configuration greatly reduces contraction efficiency. 
     Perhaps the most notable symptom of ischemic cardiomyopathy is the reduction in the ejection fraction which may diminish, for example, from a normal 60 percent to only 20 percent. This results clinically in fatigue and in an inability to do stressful activities that require an increase in output of blood from the heart. The output of blood by the enlarged heart at rest is kept normal, but the capacity to increase output of blood during stress (i.e., exercise, walking) is significantly reduced. Of course, the change in architecture has a dramatic effect on wall thickness, radius, and stress on the heart wall. In particular, it will be noted that absent the normal conical shape, the twisting motion of the heart, which can account for as much as one half of the pumping action, is lost. As a consequence, the more spherical architecture must rely almost totally on the lateral squeezing action to pump blood. This lateral squeezing action is inefficient and very different from the more efficient twisting action of the heart. The change in architecture of the heart will also typically change the structure and ability of the mitral valve to perform its function in the pumping process. Valvular insufficiency can also occur due to dilatation. 
     Although the dilated heart may be capable of sustaining life, it is significantly stressed and rapidly approaches a stage where it can no longer pump blood effectively. In this stage, commonly referred to as congestive heart failure, the heart becomes distended and is generally incapable of pumping blood returning from the lungs. This further results in lung congestion and fatigue. Congestive heart failure is a major cause of death and disability in the United States with approximately 400,000 new cases annually. 
     Following coronary occlusion, successful acute reprefusion by thrombolysis, (clot dissolution) percutaneous angioplasty, or urgent surgery can decrease early mortality by reducing arrhythmias and cardiogenic shock. It is also known that addressing ischemic cardiomyopathy in the acute phase, for example with reperfusion, may salvage the epicardial surface. Although the myocardium may be rendered akinetic, at least it is not dyskinetic. Post-infarction surgical re-vascularation can be directed at remote viable muscle to reduce ischemia. However, it does not address the anatomical consequences of the akinetic region of the heart that is scarred. Despite these techniques for monitoring ischemia, cardiac dilation and subsequent heart failure continue to occur in approximately 50 percent of post-infraction patients discharged from the hospital. 
     Various surgical approaches have been tried to treat the dilation of the ventricle by primarily reducing the ventricular volume. Some of these procedures involve removing or excluding dyskinetic and akinetic regions of the heart, then surgically joining the viable portions of the myocardial walls, typically with the use of a patch surgically placed in the walls using a Fontan stitch. 
     Typically, the exact placement of the patch has been visually determined using only a visual indication where the typically white scar tissue meets the typically red normal tissue. Location of the patch has been facilitated in a further procedure where a continuous suture has been placed around the ventricular wall to define a neck for receiving the patch. The neck has been formed in the white scar tissue rather than the soft viable muscle. This procedure has relied on cardioplegia methods to stop the beating of the heart and to aid in suture placement. 
     These surgical procedures have been met with some success as the ejection fraction has been increased, for example, from 24 percent to 42 percent. However, despite this level of success, it is often difficult for the surgeon to reconstruct the shape and size of the left ventricle. If the reconstructed ventricle is too small, the patient will not be able to pump enough oxygenated blood. If the reconstructed ventricle is too large, the ejection fraction may diminish. In addition to the size, the shape of the reconstructed ventricle is also important. If the left ventricle is reconstructed in a spherical shape, a twisting motion of the heart about its apex, which can account for as much as one half of the pumping action, is lost. As a consequence, the spherical shaped reconstructed ventricle must rely almost totally on the lateral squeezing action to pump blood. This lateral squeezing action is inefficient and very different from the more efficient twisting action of the heart. What is needed, therefore is a reliable method and apparatus to allow a surgeon to reconstruct the left ventricle to the appropriate shape, size and contour. 
     SUMMARY 
     In response to these and other problems, an improved apparatus and method is provided for restoring the geometry of the left ventricle to counteract the effects of cardiac remodeling. One embodiment of the present invention provides an apparatus and method to reconstruct an enlarged left ventricle of a human heart, using a shaper, having a size and shape substantially equal to the size and shape of an appropriate left ventricle, wherein the shaper is adapted to be temporarily placed into the enlarged left ventricle during a surgical procedure. Another aspect of one embodiment comprises a ventricular patch adapted for placement into the left ventricle of a heart made from a sheet of biocompatible material, and having a plurality of markings coupled to the sheet, wherein the markings are configured in distinct patterns for post operatively evaluating movement of the patch. In another aspect of one embodiment, a device is presented, comprising of a handle and a sizing template adapted to be coupled to the handle. Such components are also presented as a kit for use during ventricular restoration surgery. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       Advantages of the present invention may become apparent to those skilled in the art with the benefit of the following detailed description and upon reference to the accompanying drawings in which: 
         FIG. 1  illustrates one embodiment of a process utilizing several aspects of the present invention. 
         FIG. 2   a  is a side view of one embodiment of a shaping device. 
         FIG. 2   b  is a side view of a balloon embodiment of a shaping device. 
         FIG. 2   c  is a section view of another balloon embodiment of a shaping device. 
         FIG. 2   d  is a section view of another balloon embodiment of a shaping device. 
         FIG. 2   e  is a section view of another balloon embodiment of a shaping device. 
         FIG. 2   f  is a section view of another balloon embodiment of a shaping device. 
         FIG. 2   g  is a side view of a wire frame embodiment of a shaping device in an expanded condition. 
         FIG. 2   h  is a side view of a wire frame embodiment of a shaping device in a collapsed condition. 
         FIG. 2   j  is a section view cut transversely through the embodiment of  FIG. 2   h.    
         FIG. 3   a  is a top view of one embodiment of a patch. 
         FIG. 3   b  is a top view of one embodiment of markings which may be coupled to the patch of  FIG. 3   a.    
         FIG. 3   c  is a top view of one embodiment of markings which may be coupled to the patch of  FIG. 3   a.    
         FIG. 3   d  is a top view of one embodiment of markings which may be coupled to the patch of  FIG. 3   a.    
         FIG. 3   e  is a top view of one embodiment of markings which may be coupled to the patch of  FIG. 3   a.    
         FIG. 4   a  is a top view of one embodiment of a set of sizers. 
         FIG. 4   b  is a top view of one embodiment of a handle to be used with the set of sizers illustrated in  FIG. 4   a.    
         FIG. 4   c  is a detailed section view illustrating a connection between the handle and a sizer. 
         FIG. 4   d  is a section view of one embodiment of a sizer. 
         FIG. 4   e  is a section view of one embodiment of a sizer. 
         FIG. 4   f  is a section view of one embodiment of a sizer. 
         FIG. 4   g  is a top view of one embodiment of a sizer made of malleable wire. 
         FIG. 4   h  is a side view of the sizer illustrated in  FIG. 4   g.    
         FIG. 5   a  is a top view of one embodiment of a patch holder. 
         FIG. 5   b  is a top view of one embodiment of a suture hook. 
         FIG. 6  is a top view of one embodiment of a kit for surgically reshaping a ventricle. 
         FIG. 7   a  illustrates one embodiment of a process utilizing several aspects of the present invention. 
         FIG. 7   b  is a continuation of the process illustrated in  FIG. 7   a.   
     
    
    
     While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and may herein be described in detail. The drawings may not be to scale. It should be understood, however, that the drawings and detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the present invention as defined by the appended claims. 
     DETAILED DESCRIPTION 
     An overview method of one embodiment is presented which introduces the primary components of one embodiment. A detailed discussion of these components then follows. Finally, a method of using the components is discussed in detail. 
     Overview: 
     Turning to  FIG. 1 , there is presented an overview method  100  for performing and using one embodiment of the present invention. A more complete discussion of this method will be presented below. The method  100  may use the following components: a shaping device  200  ( FIG. 2   a ), a patch  300  ( FIG. 3   a ), a sizer  402   a  ( FIG. 4   a ), and a suture hook  520  (FIG.  5 ). Referring back to  FIG. 1 , at step  102 , a surgeon determines the appropriate size for the patient&#39;s left ventricle based on the patient&#39;s height, weight, body surface area and other patient specific conditions. Once the patient&#39;s appropriate ventricle size has been determined, at step  104 , the surgeon can then select the appropriate volume for the shaping device  200 . At step  106 , the surgeon opens up the chest cavity in a conventional manner. An incision is cut into the myocardial wall of an enlarged heart in step  108 . At step  110 , the surgeon identifies non-viable tissue. At step  112 , the surgeon may remove all or some of the non-viable tissue (i.e., the dyskinetic and akinetic areas) of the myocardium. A continuous round stitch, known in the art as a Fontan stitch, may then be woven into the ventricle, at step  114 . The stitch produces an annular protrusion, which forms an opening. At step  116 , the shaping device  200  may be inserted into the ventricle through this opening. At step  118 , the musculature of the myocardium may be pulled over the shaping device to form a left ventricle having a predetermined volume, shape and contour. The shaping device  200  may then be compressed and removed at step  120 . At step  122 , with the aid of the sizer  402   a , the surgeon may determine the preferred location of and size of the patch  300  which may be placed in the left ventricle. The patch  300  is then cut to size in step  124  and secured to the inside of the myocardium in step  126 . At step  128 , with the patch  300  suitably placed, the ventricle is closed by joining the myocardial walls over the patch. 
     Description of Components: 
     The Shaping Device: 
       FIG. 2   a  illustrates one embodiment of a shaping device  200 . In an inflated condition, the shaping device  200  is pre-shaped to generally model the appropriate volume and shape of the left ventricle. 
     The shape of the normal heart is of particular interest as it dramatically affects the way that the blood is pumped. The left ventricle which is the primary pumping chamber, is somewhat conical or apical in shape in that it is longer (long axis longest portion from aortic valve to apex) than it is wide (short axis widest portion from ventricle wall to septum) and descends from a base with a decreasing cross-sectional circumference to a point or apex. The left ventricle is further defined by a lateral and posterior ventricle wall and a septum, which extends between the auricles and the ventricles. The pumping of the blood from the left ventricle is accomplished by two types of motion. One of these motions is a simple squeezing motion, which occurs between the lateral wall and the septum. The squeezing motion occurs as a result of a thickening of the muscle fibers in the myocardium. This compresses the blood in the ventricle chamber and ejects it into the body. The thickness changes as the ventricle contracts. This is seen easily by echocardiogram and can be routinely measured. 
     The other type of motion is a twisting or writhing motion, which begins at the apex and rises toward the base. The rising writhing motion occurs because the heart muscle fibers run in a circular or spiral direction around the heart. When these fibers constrict, they cause the heart to twist initially at the small area of the apex, but progressively and ultimately to the wide area of the base. These squeezing and twisting motions are equally important, as they are each responsible for moving approximately one-half of the blood pumped. Turning now to  FIG. 2   a , there is shown a shaping device  200  that allows the left ventricle to be reconstructed back to a pre-enlarged operating condition. When the surgeon uses shaping device  200  as a guide in reconstructing the left ventricle, the reconstructed heart can be formed closer to the size and shape of the pre-enlarged heart. Consequently, the heart performs better post operatively than with conventional methods. As illustrated, the shaping device  200  is generally conical or “tear drop” in shape. The length “L” of the shaping device  200  may vary with each patient and will typically be a function of the volume selected for the shaping device. Depending on the patient, the length “L” may be in the three to four inch range to generally match the length of the pre-enlarged left ventricle. A surgeon may select the appropriate volume for the shaping device by estimating the volume of the pre-enlarged left ventricle. The appropriate volume of the pre-enlarged left ventricle for a patient may be estimated to be 50 to 70 cc per square meter of body surface area. The body surface area may be estimated according to the following formula, as known in the art:
 
 BSA =0.001*71.84 w   0428   *h   0.725 
 
Where: BSA=body surface area,
         w=body weight in kilograms, and   h=body height in centimeters.       

     The shaping device may be of an “appropriate shape” for a patient. In other words, the shaping device may be of a shape similar to the shape of the left ventricle. In one embodiment, the shaping device  200  may be a generally conical shaped object composed of portions of spherical elements having different radii. Referring back to  FIG. 2   a , the illustrative embodiment of the shaping device may be divided lengthwise into six sections where each section is a length “L2” apart. L2, therefore, may be determined from the formula: L2=0.1665*L. At line “A—A”, a width W1 of the shaping device  200  is approximately 0.543*L. The back surface  202  of the shaping device  200  is generally shaped as a portion of a sphere, having a radius of 0.802*L. At a line “C—C”, a width W2 of the shaping device  200  is approximately 0.628*L. The side surfaces  204   a  and  204   b  are combinations of portions of spheres with different radii. Between the line A—A and the line C—C, the side surfaces  204   a  and  204   b  have a radius of 0.515L. 
     At a line “E—E”, a width W3 of the shaping device  200  is 0.435*L. Between the line C—C and the line E—E, the side surfaces  204   a  and  204   b  have a radius of 0.945L. The shaping device  200  narrows from the line designated “E—E” through a line designated as “F—F” to a vertex  206  at point “G”. It is important to note that the above discussion is illustrative of only one embodiment of the present invention and is not meant to limit the invention to the above ratios or shapes. 
     In some embodiments, such as illustrated in  FIG. 2   b , the shaping device may be an inflatable balloon  201 , having a thickness of in the range of 0.02 to 0.08 inches, preferably 0.03 inches. A distal end of a filler tube  208  may be coupled to a point  207  along the exterior surface of balloon  201 . For instance, the point  207  could be located approximately ⅓ along balloon&#39;s  201  length, as illustrated in  FIG. 2   b . In other embodiments, the filler tube  208  may be coupled vertex  206 . Such tubes are well known in the art, and illustratively may be made of materials such as PVC. A proximal end of the filler tube  208  may be connected to a fluid reservoir, such as a syringe  210  which may inject a pre-specified amount of fluid into the balloon  201  through the filler tube  208 . Also coupled to the distal end of the filler tube  208  may be a fluid control device such a stopcock  212 . The injection of fluid through the filler tube  208  inflates the balloon  201  to an inflated condition, as illustrated in  FIG. 2   b . Once inflated, the fluid inside the shaping device may be prevented from escaping by locking the stopcock  212 . This allows the balloon  201  to stay inflated with the proper volume, shape and contour during the reconstruction procedure. 
     The fluid pressure inside the balloon  201  may also be monitored by a pressure transducer, such as a piezoelectric transducer (not shown) coupled to the filler tube  208  with a y-connection (not shown). In other words, one lead of the y-connection would be coupled to a pressure monitor and the other lead would be coupled to the fluid source. Alternatively, the pressure monitor could be coupled to a three way stopcock (not shown), which would monitor the pressure on the filler tube side of the three way stopcock. 
     The fluid used to fill the balloon  201  may be any one of a number of fluids, such as saline solution or distilled water. Alternatively, another embodiment could use a sealed balloon containing a silicone gel, such as a liquid methyl silicone resin capable of being vulcanized blended with a dimethyl silicone fluid. Such gels are available from Applied Silicon Inc. (Ventura, Calif.). An embodiment using a sealed balloon would not need an external fluid reservoir, such as syringe  210 . 
     The balloon  201  may be conventionally formed on a mandrel (not shown) having dimensions corresponding to the shape, contour and size of the shaping device. As is known in the art, the mandrel can be made of metal, glass or a hardened gelatin. To form the balloon  201 , the mandrel is dipped into a polymer solution, which leaves a thin polymer coating on the mandrel surface. After the polymer has cured, the balloon  201  is removed by peeling the thin coating off the mandrel or by flushing mandrel material out of the shaping device. 
     Shaping Device—Other Embodiments: 
     The shaping device of the present invention may be made out of a variety of materials in a number of configurations creating a number of embodiments. For instance if the shaping device is molded from a thermoplastic polymer such as PVC or polyethylene or a similar material, the balloon may be “non-expandable” when inflated. In other words, once the balloon is inflated, the balloon  201  will not significantly expand beyond the original shape. To illustrate, several shaping devices might have volumes ranging from 100 cc to 150 cc at 10 cc increments. If a surgeon predetermines that a patient&#39;s pre-enlarged left ventricle was 128 cc., then the surgeon might select a non-expandable balloon having a volume of 130 cc. A surgeon could also request a custom non-expandable balloon with a volume specifically sized for an individual patient. 
     In contrast, if the balloon  201  is made from an elastomeric material, the balloon  201  may significantly expand. Such elastomeric materials may include latex, polyurethane, silicone, and other elastomers sold under the trade names KRATON (Shell Chemical, New York, N.Y.), C-FLEX (Concept Polymer, Largo, Fla.) and SANTOPRENE (Monsanto, St. Louis, Mo.) Once the balloon is substantially inflated, the influx of additional fluid causes additional expansion of the balloon. Using this embodiment, the surgeon would simply inflate the balloon to a specific volume. The original shape of the balloon may be maintained during this expansion by selectively thickening the walls of the balloon.  FIG. 2   c  is a section view of an embodiment showing thickened walls of an “expandable balloon”  220 . An insertion or distal end  222  of the balloon  220  has walls at a maximum thickness. From the line A—A, the wall thickness progressively decreases to a vertex  224  at point G. In some embodiments, the vertex  224  connects to the filler tube  208 . The wall thickness will depend on the expansion range of the balloon. For example, for an expansion of 100 to 150 cc, the thickness of the balloon would vary from 0.01″ at a thin end to 0.05″ at the thick end. Thus, this size or volume of this embodiment may be controlled by controlling the amount and pressure of the fluid injected into the balloon  220 . 
     In another embodiment, the shaping device could have walls that are relatively thick and are coupled to foam spacers or thermoplastic polymer pads surrounding the exterior of the balloon. Turning now to  FIG. 2   d , there is shown a section view of an embodiment having polymer pads  232   a  through  232   l  coupled to the exterior of a balloon  230 . In a substantially inflated condition, polymer pads  232   a - 232   l  provide a plurality of contact points: “A” through “L”. Contact points “A” though “L”, if connected, would define a space of approximately the same volume occupied by the balloon  201  ( FIG. 2   a ). Consequently, the balloon  230  would need less fluid for inflation and the polymer pads  232   a  through  232   l  would also provide puncture resistance. 
     In yet another embodiment, the shaping device could be a balloon within a balloon.  FIG. 2   e  illustrates such an embodiment. A balloon  250  is generally shown in  FIG. 2   e . The balloon  250  comprises an outer balloon  252  and an inner balloon  254 . In one embodiment, the inner balloon  254  is inflatable with a fluid, such as saline solution fluid. As in other embodiments, the inner balloon  254  may be inflated through the filler tube  208 . A space  256  between the inner balloon  254  and the outer balloon  252  may be pre-filled with a gel  258 , such as a silicone gel or saline solution. 
       FIG. 2   f  is a section view illustrating another embodiment of a balloon  260  formed to be puncture resistant. In this embodiment, the wall  262  proximal to the vertex  206  is progressively thickened to protect the proximal side of the balloon  260  from punctures during the reconstruction procedure. In an alternative embodiment, the wall  262  could be coupled to protective pads located around the vertex  206  to protect the balloon  260  from punctures. In yet another embodiment, the balloon could be made from a thick, self sealing latex rubber. Such latex compounds are well known in the industry. 
     The shaping device is not limited to polymeric balloon embodiments.  FIG. 2   g  illustrates a shaping device  280  made from a wire skeleton or frame. The wire frame could be made from surgical grade stainless steel, titanium, tantalum, or nitinol, which is a commercially available nickel-titanium alloy material that has shape memory and is superelastic. Nitinol medical products are available from AMF of Reuilly, France, and Flexmedics Corp., of White Bear Lake, Minn. 
     The shaping device  280  illustrated in  FIG. 2   g  is in an expanded condition. Running through the center of shaping device  280  is a main shaft  282 . The main shaft  282  has a distal end  284  and a proximal end  286 . At the distal end  284  is a joint  288 . Coupled to the joint  288  is a series of back ribs  290   a  though  290   h  (only back ribs  290   a  through  290   e  are visible in  FIG. 2   g ). Back ribs  290   a  through  290   h  are connected to front ribs  292   a - 292   h  by hinges  294   a  though  294   h  (only front ribs  292   a - 292   e  and hinges  294   a - 294   e  are visible in  FIG. 2   g ). The proximal end of front ribs  292   a  through  292   e  are connected to a collar  296  through a series of hinges (not shown) radially spaced around collar  296 . The use of hinges around collar  296  encourages front ribs  292   a - 292   h  to form a convex angle with respect to shaft  282  at collar  296 . 
       FIG. 2   h  shows the shaping device  280  in a collapsed position. In a collapsed position, back ribs  290   a - 290   h  and front ribs  292   a - 292   h  surround shaft  282  as illustrated in  FIG. 2   j .  FIG. 2   j  is a section view cut transversely through shaft  282  and the front ribs  292   a - 292   h . In operation, once the shaping device  280  is inserted into the left ventricle, a surgeon may slide collar  296  along shaft  282  towards distal end  284 . The force exerted on collar  296  will cause the ribs to buckle radially outward as illustrated in  FIG. 2   g . Eventually, the front ribs  292   a - 292   h  will bend under the applied force. Because the front ribs  292   a - 292   h  are under stress, they will tend to push the collar  296  towards proximal end  286 . A lock  294  prevents any desired movement towards proximal end  286 . Thus, the collar  296  is held firmly in place along shaft  282  by the front ribs  292   a - 292   h  exerting a force through collar  296  to lock  294 . The lock  294  is spring (not shown) activated and is designed such that the collar  296  may easily slide over the lock when moving from the proximal end  286  to the distal end  284 . When the surgeon is ready to remove the shaping device  280 , the surgeon may collapse the shaping device  280  by pressing down on lock  294  which will allow the collar  296  to slide past the lock  294  towards the proximal end  286 . 
     Patch: 
     As will be explained in greater detail below, a patch is often used in the ventricle reconstruction procedure. A patch is made from sheet material and may be a variety of shapes, including circular, elliptical, or triangular, preferably sized and configured with a shape similar to a Fontan neck, as discussed below. As illustrated in  FIG. 3   a , an elliptical patch  300  may have a length between 30 and 50 millimeters along a major axis  302  and a width along a minor axis  304  of between 20 and 30 millimeters. The preferable thickness of the patch is in the range of 0.3 to 0.7 mm. The water permeability is preferably less than 5 ml per cm sq. per minute at 120 mm Hg. The burst strength of the patch is preferably 30 to 35 kg/cm 2 . Finally, the 45° angle suture retention strength of the patch should be greater than 3 kg. 
     The sheet material for the patch  300  may be formed from a biocompatible synthetic material, for example, from polyester, Dacron (Hemoshield) manufactured by the DuPont Corporation, or polytetrafluoroethylene (Gortex). The sheet material may also be autologous pericardium, or some other fixed mammalium tissue such as bovine pericardium or porcine tissue. The biocompatible synthetic material patch may be collagen impregnated to assist in hemostasis, or it may be sprayed with a hemostatic sealant to achieve better and instantaneous hemostasis. 
     The patch may have markings that enable the movement and position of the patch to be post-operatively observed and analyzed under imaging systems, such as Magnetic Resonance Imaging (“MRI”), x-ray machines, fluoroscopy or other external visualization methods, for post-operative clinical evaluation. Such markings will allow identification of the patch and allow for analysis of the heart&#39;s contractility in future post-operative evaluations. 
     The markings may be radiopaque. Radiopaque markings are made from material that are impenetrable to radiation such as x-rays. Radiopaque markings may be applied to the patch material in a wide variety of methods. For instance, if the patch material is from a woven fabric, then radiopaque threads could be woven into the fabric at regular intervals. Such radiopaque threads could be metal and made from alloys of gold, nitinol, platinum, or stainless steel. Radiopaque threads could also be made of a biocompatible polymeric material mixed with a metal powder, such as barium sulfate. Radiopaque markings could also be imprinted onto the fabric with radiopaque ink. Such ink is available from Creative Imprints Inc., (Norton, Mass.). 
     Other techniques for marking the patch  300  might include chemical vapor deposition, physical vapor deposition, electroplating and ion-beam assisted deposition. In ion-beam assisted deposition, an electron beam evaporator is used to create a vapor of atoms that coats the surface of the material. 
     Radiopaque threads might interfere with MRI scans because MRI is extremely sensitive to metal and metal can substantially mask MRI signals. However, if metal markings are made sufficiently small, they will show as bands in an MRI scan. Using metal fibers 0.1 mm to 0.05 mm to create the grid or pattern by weaving into the patch can make a patch MRI sensitive. Also, the metal can be applied to the patch by ion deposition which could deposit a layer of metal 0.01 mm thick onto the patch material. Small tubular strands filled with fatty acids could also be used as be used as MRI sensitive markings. Such strands could be woven into the patch material. 
     The markings may be Positron Emission Tomography (“PET”) sensitive by making the markings slightly radioactive. However, such markings would probably only be useful for a relatively short time frame after the procedure because of radioactive decay. 
     The markings may also be attached to the material by a variety of mechanical means such as sewing or weaving the markings into patch material or using microclips. Similarly, the markings such as metal threads may also be attached to the material by adhesive means, such as a bio-compatible glue. Such bio-compatible glues are available from Bioglue, Cryolife Inc. (Kennesaw, Ga.) or Cyanoacrylate, by Loc Tite Corp. 
     In order to be useful, the markings must be arranged in a pattern that allows post operative evaluation. One such pattern is a series of equally spaced substantially parallel lines as illustrated in  FIG. 3   b . Another pattern is a grid of substantially parallel lines as illustrated in  FIG. 3   c . The distance between these parallel lines may be in standard units, such as 1 centimeter. Another pattern could be in the form of concentric circles, as illustrated in  FIG. 3   d . Yet, another pattern could be a series of lines radiating from a single point at, for instance, a set angle apart. Such a pattern is illustrated in  FIG. 3   e.    
     Sizers: 
     Turning now to  FIG. 4   a , there is illustrated a set of sizers  402   a - 402   d . The sizers  402   a - 402   d  are shaped to be the approximate size of the patch  300  ( FIG. 3   a ). Similar to the patch, the sizers  402   a - 402   d  will be of various geometries, length and width combinations. For illustrative purposes, the sizers  402   a - 402   d  discussed herein will be elliptical in shape. For posterior repairs to the ventricle, however, the sizers may have a general triangular shape. Referring back to  FIG. 4   a , the length of the sizers along a major axis  403  may be in the range of 2 to 7 cm in length. The length along a minor axis  405  may be 1 to 5 cm in length. The sizers may have a connection  406  for attachment to a handle  404  ( FIG. 4   b ). The sizers  402   a - 402   d  can be made out of plastic or stainless steel or any rigid material. Four sizers  402   a - 402   d  are illustrated in  FIG. 4   a , however, any number of sizers in a variety of could be provided. 
     Turning now to  FIG. 4   b , the handle  404  may also be made from stainless steel, plastic or any other suitable material. The handle  404  includes a shaft  408  having a proximal end  410  and a distal end  412 . The distal end  412  couples to the connection  406  of the sizers  402   a - 402   d . The proximal end  410  is coupled to a hand grip  414 . The hand grip  414  is sized to fit a human hand. Such hand grips are well known in the art. A surgeon may connect any of the sizers  402   a - 402   d  to the handle  404 . The use of handle  404  with a sizer allows the surgeon to easily estimate the size of the opening to be patched by holding the sizer up to and into the opening. If the sizer is too small, another one may be selected. This process may be repeated until the surgeon feels he has a sizer of the correct shape and size. As will be explained in greater detail below, once the proper size has been determined the sizer may be placed on material and be used as a template to cut the patch  300  to the appropriate size. 
       FIG. 4   c  is a section view illustrating the connection  406  between the distal end  412  of shaft  408  and the sizer  402   a . In this embodiment, the connection  406  comprises a circular opening  422 . Embedded in the walls of the opening  422  and running through the opening  422  is a rod  420 . The rod  420  may be made of surgical stainless steel or another appropriate rigid material. In the illustrative embodiment, the distal end  412  includes a slot  425  with angular walls forming two flanges  423   a  and  423   b . At the base of the slot  425  is a circular groove. The circular grove runs generally parallel to the slot  425  and has an interior diameter slightly larger than the exterior diameter of rod  420 . The base of the slot  425  is slightly smaller than the diameter of rod  420 . When distal end  412  is inserted into circular groove, flanges  423   a  and  423   b  slide over rod  420  until rod  420  is in the circular groove. Thus, flanges  423   a  and  423   b  are “snapped” over rod  420 , and thus, will keep rod  420  in the cylindrical groove. The sizer  402   a  may rotate with respect to shaft  408 . The sizer  402   a  may be removed from handle  404  by pulling on the sizer  402   a  which causes a sufficient amount of force on rod  420  to lift flanges  423   a  and  423   b  over rod  420 . In other embodiments, connection  406  may be a screw connection. 
     In another embodiment, the sizers may have a cutting edge which can be used to cut the patch  300  to the appropriate shape. Turning now to  FIG. 4   d , a sizer  430  is shown connected to the handle  408 . In this embodiment, the sizer  430  may have a ridge  432  concentric to the shape of the sizer  430 . The ridge  432  allows a surgeon to accurately estimate the size of the opening by placing the ridge  432  into the opening. The sizer  430  may also have a circumferential flange or lip  434  around the perimeter of the sizer to assist in defining the patch size. The patch will typically be slightly larger than the size of the opening. The width of the lip  434  will preferably have a constant width around its circumference, typically in the range between 5 and 8 centimeters. A cutting edge  436  may also be coupled to the perimeter of the lip. In operation, the surgeon may use the sizer as illustrated in  FIG. 4   d  to estimate the size of the opening, remove the sizer  430  from the handle  408 , turn the handle over with respect to the handle  408 , and reattach the sizer  430  to the handle  408 . The cutting edge  436  may then be used to cut the patch material to the correct size and shape by pressing the cutting edge into the patch material. 
     A set of cutting dies could also be provided which corresponds to the set of sizers. In other words, for each sizer provided in a set of sizers, there would be a corresponding cutting die, sized to be slightly larger than the sizer. Once a surgeon has determined the correct sizer, he could then select the corresponding cutting die and use the cutting die to cut the patch material to the appropriate size. Alternatively, a set of pre-cut patches could be provided, each pre-cut patch corresponding to a particular sizer in the set of sizers. The use of pre-cut patches would eliminate the need to cut the patch material to the required shape. The pre-cut patches may also have pre-printed suture lines which may be used as a guide for the surgeon when attaching the patch to the heart. 
       FIG. 4   e  illustrates an embodiment of a sizer  440  having a protrusion  442  concentric to the shape of the sizer  440 . The protrusion  442  may also be used to define a suture line on the patch material by pressing the protrusion  442  against the patch material causing an indentation in the patch material which the surgeon can use as a guide to suture the patch. Turning now to  FIG. 4   f , which illustrates embodiment of a sizer  450  having a slot or groove  452  concentric to the shape of the sizer. The groove  452  may be used by the surgeon to define a suture line by allowing the surgeon to use a marking instrument, such as a pen, to trace the suture line on the patch material. 
       FIG. 4   g  illustrates yet another embodiment of a sizer. The sizer  460  may be a malleable wire  462  coupled to movable legs  464   a - 464   d  ( 464   a  and  464   b  are visible in  FIG. 4   g ). The moveable legs  464   a - 464   d  are coupled to a handle  466 . The handle  466  includes a shaft  468  having a proximal end  470  and a distal end  472 . The distal end  472  couples to the movable legs  464   a - 464   d . The proximal end  470  is coupled to a hand grip  474 . The hand grip  474  is similar to the handgrip  414  of  FIG. 4   b .  FIG. 4   h  is a section view of the sizer  460  cut through the movable legs  464   a - 464   d . The malleable wire  462  may be manipulated by the surgeon into any appropriate shape. Additionally, because one end  476  of the malleable wire  462  is free to slide past the moveable legs  464   a  and  464   d , the perimeter of the shape formed by the wire may be lengthened or shortened as desired. 
     Patch Holder: 
     Turning now to  FIG. 5   a , there is illustrated a patch holder  500 . The patch holder  500  comprises a patch plate  502  coupled to legs  504   a - 504   d  ( 504   a  and  504   b  are visible in  FIG. 5   a ). The legs  504   a - 504   d  are coupled to a handle  506 , which is similar to handle  466  discussed above. The patch plate  502  has an adhesive means on side  508 , such as an adhesive backing or nylon hooks, which temporarily adheres to the patch. In operation, after a surgeon has constructed the appropriate patch, the surgeon may use patch holder  500  to place the patch into the opening, after suturing has begun, the patch holder may be removed, leaving the patch in place. 
     Suture Hook: 
     Turning now to  FIG. 5   b , there is illustrated a suture hook  520 . The suture hook  520  is “L” shaped and made of stainless steel, plastic or another rigid material. The suture hook  520  has a long leg  522  which may be approximately 6 inches long. Coupled to long leg  522 , is short leg  524  which may be in the range of one-eighth to one-quarter inch long. The suture hook  520  is adapted to be used to pull up on the sutures in the patch  300  to secure the patch  300  to the heart. 
     Kit: 
     In yet another embodiment of the present invention, a kit  600  for surgically reshaping the left ventricle of the heart is illustrated in FIG.  6 . The kit  600  may include any of the components discussed above, including: the balloon  201  coupled to the syringe  210 , a set of the sizers  402  in various shapes and sizes, a handle  404  to attach to the sizers  402 , material  602  for creating the patch  300  (not shown), the suture hook  520  and, the patch holder  500  (not shown). The components of the kit  600  may be packaged in a sterile manner as known in the relevant art. 
     Operation: 
     With the primary purpose of restoring the ventricle&#39;s size, shape and contour, the intent of the procedure initially is to remove that portion of the wall, which is not capable of contracting. Such portions include the scarred dyskinetic segments, which are easy to see visually, and may also include akinetic segments, which do not contract. 
     Referring now to  FIGS. 7   a  and  7   b , which illustrate generally a method  700  for performing and using at least one embodiment of the present invention. At step  702 , a surgeon determines the appropriate size for the patient&#39;s left ventricle based on the patient&#39;s height, weight, body surface area and other patient specific conditions (as discussed previously in reference to  FIG. 2   a ). Once the patient&#39;s appropriate ventricle size has been determined, at step  704 , the surgeon can then select the appropriate volume for the shaping device. 
     In step  706 , the patient&#39;s chest cavity is opened up in a conventional manner. In step  708 , an incision is cut into the myocardial wall of the dilated heart. If the surrounding tissue is dyskinetic, it will typically be formed entirely of thin, elastic scar tissue. It is the elasticity of this scar tissue, which causes the detrimental ballooning, or bulging effects previously discussed. 
     In step  710 , a determination as to where the akinetic portions of the tissue begin and end must be made. The determination between viable and non viable tissue can be made by multiple methods, including: visual inspection, electrical methods, marking with dyes, echocardiography, radionuclear imaging, and palpation of a beating heart. 
     The electrical methods might include the use of an electromyogram which detects electrical impulses from active tissue to distinguish between the akinetic and viable tissue. Positron Emission Tomography (PET) scanning, Single Proton Emissions Computer Tomography and Electrical Mapping Electrophysiology are all other examples of a method to determine viable tissue from akinetic tissue with by electrical means. With Electrical Mapping Electrophysiology, a catheter is inserted into the heart to find areas void of electrical activity. 
     Marking with dyes can be accomplished by staining the myocardium tissue with a dye that adheres to viable tissue and does not adhere to scar tissue. Triphenyltetrazolium chloride, Tropinin I or T, and Creatine Kinase are all examples of dyes that perform this marking function. 
     Once the extent of the non-viable areas are determined, in step  712 , the portion of the tissue in the ventricle and septal walls may be excised from the epicardium from the incision to the borderline separating akinetic tissue from viable tissue. This border between akinetic and viable tissue becomes the preferred location of the patch and forms an imaginary circumferential line between the non viable areas and viable areas of the myocardium. 
     In step  714 , the preferred location of the patch  300  is been determined relative to the circumferential line. In step  716 , a continuous Fontan stitch may be placed in proximity to the line, along the long axis of the heart. The Fontan stitch produces an annular protrusion, which forms a neck relative to the circumferential line. The annular protrusion may be further defined by placing a rim support around its perimeter. This neck initially may have a round circular configuration. A second Fontan stitch may be placed 90 degrees from the initial stitch along the short axis of the heart. Other stitches may be placed as needed to form the heart to the shaping device. The stitch will serve to shape the heart along the short axis of the heart if needed. 
     In step  718 , the shaping device  200  may then be inserted into the ventricle. The shaping device  200  is then inflated or expanded, the volume of which is equivalent to the appropriate volume of the ventricle for the patient. The shaping device  200  provides the model upon which the ventricle can be shaped and contoured through the use of the Fontan suture in step  720 . The Fontan suture may then tightened with the aid of the suture hook  520 , in step  722 . As the suture or sutures are tightened, the musculature of the myocardium will form the physiologically correct volume, shape and contour over the shaping device. The appropriately oval-shaped opening in the neck defines the area where the patch will be placed. Once the suture is tightened down, the shaping device  200  may be collapsed and removed in step  724 . 
     The size of the opening in the neck formed by the Fontan stitch will vary from patient to patient. If the patch  300  is used to close the ventricle, the surgeon should determine the size of the patch to be used (step  726 ). To determine the appropriate size of the patch, the surgeon may connect any of the sizers  402   a - 402   d  to the handle  404  to measure the size of the opening, and thus, the size patch  300  that is needed to fit into the neck formed by the Fontan stitch or stitches. In step  728 , the surgeon may then construct a patch. In embodiments with different sizers, once the proper sizer has been selected, the sizer can be placed on the patch and be used as a template to cut the patch  300  to the appropriate size. Alternatively, a surgeon may select a precut patch. 
     In a preferred method for placing the patch, continuous or interrupted sutures can be threaded through the rim covered annular protrusion. The rim covering acts as a large continuous pledget along the perimeter. After the patch has been moved into position on the neck, the sutures can be tied, in step  730 . 
     Alternatively, in cases of extensive nonfibrotic trabecular tissue on the lateral ventricle, another suture method can be placement of mattressed braided sutures over a pericardial strip from outside the ventricle to its interior through the inner oval of the patch. This procedure can be done in conjunction with other procedures such as: Mitral valve repair, ablation of ventricular arrhythmias for treatment of refractory ischemic ventricular tachycardia. 
     With the patch, suitably placed, in step  732 , the suture line can be sprayed with a hemostatic agent or an agent can be applied to achieve better and instantaneous hemostasis. In step  734 , the operative site can be closed by joining or folding over the myocardial walls. Care should be taken not to distort the right ventricle by folding the septum wall over the ventricular wall. Alternatively, the lateral wall can be disposed interiorly of the septum wall so a majority of the force on the patch is diverted to the lateral wall. These walls can be overlapped in close proximity to the patch in order to avoid creating any cavity between the patch and the walls. 
     When air evacuation is confirmed by transesophageal echo, the patient can be weaned off bypass usually with minimal, if any inotropic support. Decannulasation may be accomplished with conventional methods (step  736 ). 
     As is well known, the human heart contains an electrical conduction system which sends electrical impulses to spark the heart muscle into regular cycles of contraction. This conduction system includes a Sinoatrial node (SA node), Atrioventricular Node (AV node), and Purkinie Fibers which act as conduits for the electrical pulses. The SA node is located in the right atrium. The electrical impulse leaves the SA node and travels to the right and left Atria, causing them to contract together. This takes 0.04 seconds. There is now a natural delay to allow the Atria to contract and the Ventricles to fill up with blood. The electrical impulse has now traveled to the Atrioventricular Node (AV node). The electrical impulse now goes to the Bundle of His, then it divides into the Right and Left Bundle Branches where it rapidly spreads using Purkinje Fibers to the muscles of the Right and Left Ventricle, causing them to contract at the same time. 
     Because ventricular restoration may compromise the conduction system due to the fact that a ventricle portion has been severed or excluded, the pacing or rhythm of the impulses between the right and left ventricles of the heart may get out of synchronization after ventricular restoration. This asynchronous pacing contributes to a reduced output by the left ventricle. Thus, restoring or assuring synchronization would assist the reconstructed left ventricle to maximize the output of the left ventricle. Synchronization may be restored or controlled by implanting a pacemaker or a Biventricular pacing device (“BVP”) before closing the chest cavity. 
     A pacemaker comprises: (1) an implantable controller that sets the heart rate to the desired interval, and (2) two leads that deliver electrical impulses to specific regions of the heart (i.e., one lead is placed in the right atrium and the second lead in right ventricle) to artificially cause contractions of the ventricle at the appropriate time and synchronization. In contrast, BVPs have a third lead designed to conduct signals directly into the left ventricle. When using a BVP, one lead is placed in the right atrium, the second lead in right ventricle, and third lead is placed to pace the left ventricle (i.e., in a tributary of the coronary sinus in the left ventricle). Thus, with a BVP, simultaneous electrical impulses are given to both left and right ventricles so the time delay in traveling of electrical impulse is significantly reduced which aids in restoring the normal physiology of the heart and improves the pumping action of the heart. 
     Pacemakers and biventricular pacing devices are available from Medtronic, Inc. (Minneapolis, Minn.), Guidant Corporation (Menlo Park, Calif.), and St. Jude Medical Inc. (St. Paul, Minn.). 
     The mortality associated with ventricular restoration is primarily from sudden death caused from extremely fast arrthymias. The higher risk of arrthymias may be caused from the removal of a portion of the left ventricle. This risk may be prevented by implanting a defibrillator at the time of the ventricle restoration. The automatic implantable cardioverter/defibrillator is commonly referred to as an AICD. The AICD is a device that is similar to a pacemaker, but continuously monitors the heart rhythm. If the AICD detects an abnormally fast or slow heart rhythm, it either electrically paces the heart very fast or delivers a small electrical shock to the heart to convert the heart rhythm back to normal. 
     Some BVP devices have defibrillators built into the circuitry that controls the pacing. Implanting a bi-ventricular pacing device with defibrillator after surgical ventricular restoration will not only optimize the output of the ventricle but also prevent many sudden deaths. 
     After a BVP has been installed in step  738 , closure of the chest cavity may be accomplished in step  740  by conventional methods. 
     It is further understood that other modifications, changes and substitutions are intended in the foregoing disclosure and in some instances some features of the disclosure will be employed without corresponding use of other features. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the scope of the disclosure.