Patent Publication Number: US-2021186691-A1

Title: Apparatus and methods for implanting a replacement heart valve

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/992,535, filed May 30, 2018, issuing as U.S. Pat. No. 10,945,837, which is a divisional of U.S. patent application Ser. No. 14/911,539, filed Feb. 11, 2016, now U.S. Pat. No. 10,034,749, which is a U.S. national phase application of PCT patent application PCT/US2014/050525, filed Aug. 11, 2014, which claims the benefit of U.S. Provisional Application Ser. No. 61/878,280, filed Sep. 16, 2013, U.S. Provisional Application Ser. No. 61/867,287, filed Aug. 19, 2013, and U.S. Provisional Application Ser. No. 61/864,860, filed Aug. 12, 2013, the disclosures of which are hereby incorporated by reference herein. 
    
    
     TECHNICAL FIELD 
     The present invention generally relates to medical procedures and devices pertaining to heart valves such as replacement techniques and apparatus. More specifically, the invention relates to the replacement of heart valves having various malformations and dysfunctions. 
     BACKGROUND 
     Complications of the mitral valve, which controls the flow of blood from the left atrium into the left ventricle of the human heart, have been known to cause fatal heart failure. In the developed world, one of the most common forms of valvular heart disease is mitral valve leak, also known as mitral regurgitation, which is characterized by the abnormal leaking of blood from the left ventricle through the mitral valve and back into the left atrium. This occurs most commonly due to ischemic heart disease when the leaflets of the mitral valve no longer meet or close properly after multiple infarctions, idiopathic and hypertensive cardiomyopathies where the left ventricle enlarges, and with leaflet and chordal abnormalities, such as those caused by a degenerative disease. 
     In addition to mitral regurgitation, mitral narrowing or stenosis is most frequently the result of rheumatic disease. While this has been virtually eliminated in developed countries, it is still common where living standards are not as high. 
     Similar to complications of the mitral valve are complications of the aortic valve, which controls the flow of blood from the left ventricle into the aorta. For example, many older patients develop aortic valve stenosis. Historically, the traditional treatment had been valve replacement by a large open heart procedure. The procedure takes a considerable amount of time for recovery since it is so highly invasive. Fortunately, in the last decade great advances have been made in replacing this open heart surgery procedure with a catheter procedure that can be performed quickly without surgical incisions or the need for a heart-lung machine to support the circulation while the heart is stopped. Using catheters, valves are mounted on stents or stent-like structures, which are compressed and delivered through blood vessels to the heart. The stents are then expanded and the valves begin to function. The diseased valve is not removed, but instead it is crushed or deformed by the stent which contains the new valve. The deformed tissue serves to help anchor the new prosthetic valve. 
     Delivery of the valves can be accomplished from arteries which can be easily accessed in a patient. Most commonly this is done from the groin where the femoral and iliac arteries can be cannulated. The shoulder region is also used, where the subclavian and axillary arteries can also be accessed. Recovery from this procedure is remarkably quick. 
     Not all patients can be served with a pure catheter procedure. In some cases the arteries are too small to allow passage of catheters to the heart, or the arteries are too diseased or tortuous. In these cases, surgeons can make a small chest incision (thoractomy) and then place these catheter-based devices directly into the heart. Typically, a purse string suture is made in the apex of the left ventricle and the delivery system is place through the apex of the heart. The valve is then delivered into its final position. These delivery systems can also be used to access the aortic valve from the aorta itself. Some surgeons introduce the aortic valve delivery system directly in the aorta at the time of open surgery. The valves vary considerably. There is a mounting structure that is often a form of stent. Prosthetic leaflets are carried inside the stent on mounting and retention structure. Typically, these leaflets are made from biologic material that is used in traditional surgical valves. The valve can be actual heart valve tissue from an animal or more often the leaflets are made from pericardial tissue from cows, pigs or horses. These leaflets are treated to reduce their immunogenicity and improve their durability. Many tissue processing techniques have been developed for this purpose. In the future biologically engineered tissue may be used or polymers or other non-biologic materials may be used for valve leaflets. All of these can be incorporated into the inventions described in this disclosure. 
     There are in fact more patients with mitral valve disease than aortic valve disease. In the course of the last decade many companies have been successful in creating catheter or minimally invasive implantable aortic valves, but implantation of a mitral valve is more difficult and to date there has been no good solution. Patients would be benefited by implanting a device by a surgical procedure employing a small incision or by a catheter implantation such as from the groin. From the patient&#39;s point of view, the catheter procedure is very attractive. At this time there is no commercially available way to replace the mitral valve with a catheter procedure. Many patients who require mitral valve replacement are elderly and an open heart procedure is painful, risky and takes time for recovery. Some patients are not even candidates for surgery due to advanced age and frailty. Therefore, there exists a particular need for a remotely placed mitral valve replacement device. 
     While previously it was thought that mitral valve replacement rather than valve repair was associated with a more negative long term prognosis for patients with mitral valve disease, this belief has come into question. It is now believed that the outcome for patients with mitral valve leak or regurgitation is almost equal whether the valve is repaired or replaced. Furthermore, the durability of a mitral valve surgical repair is now under question. Many patients, who have undergone repair, redevelop a leak over several years. As many of these are elderly, a repeat intervention in an older patient is not welcomed by the patient or the physicians. 
     The most prominent obstacle for catheter mitral valve replacement is retaining the valve in position. The mitral valve is subject to a large cyclic load. The pressure in the left ventricle is close to zero before contraction and then rises to the systolic pressure (or higher if there is aortic stenosis) and this can be very high if the patient has systolic hypertension. Often the load on the valve is 150 mmHg or more. Since the heart is moving as it beats, the movement and the load can combine to dislodge a valve. Also the movement and rhythmic load can fatigue materials leading to fractures of the materials. Thus, there is a major problem associated with anchoring a valve. Another problem with creating a catheter delivered mitral valve replacement is size. The implant must have strong retention and leak avoidance features and it must contain a valve. Separate prostheses may contribute to solving this problem, by placing an anchor or dock first and then implanting the valve second. However, in this situation the patient must remain stable between implantation of the anchor or dock and implantation of the valve. If the patient&#39;s native mitral valve is rendered non-functional by the anchor or dock, then the patient may quickly become unstable and the operator may be forced to hastily implant the new valve or possibly stabilize the patient by removing the anchor or dock and abandoning the procedure. 
     Another problem with mitral replacement is leak around the valve, or paravalvular leak. If a good seal is not established around the valve, blood can leak back into the left atrium. This places extra load on the heart and can damage the blood as it travels in jets through sites of leaks. Hemolysis or breakdown of red blood cells is a frequent complication if this occurs. Paravalvular leak was one of the common problems encountered when the aortic valve was first implanted on a catheter. During surgical replacement, a surgeon has a major advantage when replacing the valve as he or she can see a gap outside the valve suture line and prevent or repair it. With catheter insertion, this is not possible. Furthermore, large leaks may reduce a patient&#39;s survival and may cause symptoms that restrict mobility and make the patient uncomfortable (e.g. short of breathe, edematous, fatigued). Therefore, devices, systems, and methods which relate to mitral valve replacement should also incorporate means to prevent and repair leaks around the replacement valve. 
     A patient&#39;s mitral valve annulus can also be quite large. When companies develop surgical replacement valves, this problem is solved by restricting the number of sizes of the actual valve produced and then adding more fabric cuff around the margin of the valve to increase the valve size. For example, a patient may have a 45 mm valve annulus. In this case, the actual prosthetic valve diameter may be 30 mm and the difference is made up by adding a larger band of fabric cuff material around the prosthetic valve. However, in catheter procedures, adding more material to a prosthetic valve is problematic since the material must be condensed and retained by small delivery systems. Often this method is very difficult and impractical, so alternative solutions are necessary. 
     Since numerous valves have been developed for the aortic position, it is desirable to avoid repeating valve development and to take advantage of existing valves. These valves have been very expensive to develop and bring to market, so extending their application can save considerable amounts of time and money. It would be useful then to create a mitral anchor or docking station for such a valve. An existing valve developed for the aortic position, perhaps with some modification, could then be implanted in the docking station. Some previously developed valves may fit well with no modification, such as the Edwards Sapien™ valve. Others, such as the Corevalve™ may be implantable but require some modification for an optimal engagement with the anchor and fit inside the heart. 
     A number of further complications may arise from a poorly retained or poorly positioned mitral valve replacement prosthesis. Namely, a valve can be dislodged into the atrium or ventricle, which could be fatal for a patient. Prior prosthetic anchors have reduced the risk of dislodgement by puncturing tissue to retain the prosthesis. However, this is a risky maneuver since the penetration must be accomplished by a sharp object at a long distance, leading to a risk of perforation of the heart and patient injury. 
     Orientation of the mitral prosthesis is also important. The valve must allow blood to flow easily from the atrium to the ventricle. A prosthesis that enters at an angle may lead to poor flow, obstruction of the flow by the wall of the heart or a leaflet and a poor hemodynamic result. Repeated contraction against the ventricular wall can also lead to rupture of the back wall of the heart and sudden death of the patient. 
     With surgical mitral valve repair or replacement, sometimes the anterior leaflet of the mitral valve leaflet is pushed into the area of the left ventricular outflow and this leads to poor left ventricular emptying. This syndrome is known as left ventricular tract outflow obstruction. The replacement valve itself can cause left ventricular outflow tract obstruction if it is situated close to the aortic valve. 
     Yet another obstacle faced when implanting a replacement mitral valve is the need for the patient&#39;s native mitral valve to continue to function regularly during placement of the prosthesis so that the patient can remain stable without the need for a heart-lung machine to support circulation. 
     In addition, it is desirable to provide devices and methods that can be utilized in a variety of implantation approaches. Depending on a particular patient&#39;s anatomy and clinical situation, a medical professional may wish to make a determination regarding the optimal method of implantation, such as inserting a replacement valve directly into the heart in an open procedure (open heart surgery or a minimally invasive surgery) or inserting a replacement valve from veins and via arteries in a closed procedure (such as a catheter-based implantation). It is preferable to allow a medical professional a plurality of implantation options to choose from. For example, a medical professional may wish to insert a replacement valve either from the ventricle or from the atrial side of the mitral valve. 
     Therefore, the present invention provides devices and methods that address these and other challenges in the art. 
     SUMMARY 
     In one illustrative embodiment, a system for docking a heart valve prosthesis is provided and includes a helical anchor formed as multiple coils adapted to support a heart valve prosthesis with coil portions positioned above and below the heart valve annulus and a seal coupled with the helical anchor. The seal includes portions extending between adjacent coils for preventing blood leakage through the helical anchor and past the heart valve prosthesis. 
     The system can further include a heart valve prosthesis capable of being delivered to a native heart valve position of a patient and expanded inside the multiple coils and into engagement with leaflets of the heart valve. The seal is engaged with both the helical anchor and the heart valve prosthesis. The coils of the helical anchor may be formed of a superelastic or a shape memory material, or other suitable material. The seal may be a membrane or panel extending over at least two coils of the helical anchor. The membrane or panel is moved between an undeployed state and a deployed state, the undeployed state being adapted for delivery to a site of implantation and the deployed state being adapted for implanting the system and anchoring the heart valve prosthesis. The undeployed state may be a rolled up state on one of the coils of the helical anchor or any other collapsed state. The membrane or panel may include a support element affixed therewith, such as an internal, spring-biased wire. The seal may further include one or more seal elements carried by the helical anchor with overlapping portions configured to seal a space between adjacent coils of the helical anchor. The one or more seal elements may each include a support element such as an internal wire, which may be a spring-biased coil or other configuration, affixed therewith. The one or more seal elements may be cross sectional shape, with examples being generally circular or oblong. The one or more seal elements may each have a connecting portion affixed to one of the coils and an extension portion extending toward an adjacent coil for providing the seal function between coils. 
     In another illustrative embodiment a system for replacing a native heart valve includes an expansible helical anchor formed as multiple coils adapted to support a heart valve prosthesis. At least one of the coils is normally defined by a first diameter, and is expandable to a second, larger diameter upon application of radial outward force from within the helical anchor. The system further includes an expansible heart valve prosthesis capable of being delivered into the helical anchor and expanded inside the multiple coils into engagement with the at least one coil to move the at least one coil from the first diameter to the second diameter while securing the helical anchor and the heart valve prosthesis together. 
     As a further aspect the helical anchor may include another coil that moves from a larger diameter to a smaller diameter as the heart valve prosthesis is expanded inside the multiple coils. At least two adjacent coils of the helical anchor may be spaced apart, and the adjacent coils move toward each other as the heart valve prosthesis is expanded inside the multiple coils. The helical anchor may further includes a plurality of fasteners, and the fasteners are moved from an undeployed state to a deployed state as the at least one coil moves from the first diameter to the second, larger diameter. A seal may be coupled with the helical anchor and include portions extending between adjacent coils for preventing blood leakage through the helical anchor and past the heart valve prosthesis. The system can further include at least one compressible element on the helical anchor, the compressible element being engaged by the heart valve prosthesis as the heart valve prosthesis is expanded inside the multiple coils to assist with affixing the heart valve prosthesis to the helical anchor. The compressible element may take any of several forms, such as fabric or other soft material, or resilient, springy material such as polymer or foam. The at least one compressible element further may include multiple compressible elements spaced along the multiple coils or a continuous compressible element extending along the multiple coils. The heart valve prosthesis may further include an expansible structure including openings. The openings are engaged by the at least one compressible element as the heart valve prosthesis is expanded inside the multiple coils for purposes of strengthening the connection between the anchor and the prosthesis. The multiple coils of the helical anchor may include at least two coils that cross over each other. This system may include any feature or features of the system that uses the seal, and vice versa, depending on the functions and effects desired. 
     Methods of implanting a heart valve prosthesis in the heart of a patient are also provided. In one illustrative embodiment, the method includes delivering a helical anchor in the form of multiple coils such that a portion of the helical anchor is above the native heart valve and a portion is below the native heart valve. The heart valve prosthesis is implanted within the multiple coils of the helical anchor such that the heart valve prosthesis is supported by the helical anchor. A seal is positioned between at least two adjacent coils of the helical anchor and the heart valve prosthesis for preventing leakage of blood flow during operation of the heart valve prosthesis. 
     Positioning the seal can further comprise positioning a membrane or panel extending over at least two coils of the helical anchor. The method further includes delivering the membrane or panel in an undeployed state to the site of the native heart valve and then deploying the membrane or panel within the helical anchor, and expanding the heart valve prosthesis against the membrane or panel. The undeployed state includes a rolled up state or other collapsed state. Positioning the seal may further include positioning one or more seal elements carried by the helical anchor such that overlapping portions seal a space between adjacent coils of the helical anchor. The one or more seal elements may each include a support element affixed therewith. 
     In another embodiment, a method of implanting an expansible heart valve prosthesis in the heart of a patient is provided. This method includes delivering an expansible helical anchor in the form of multiple coils such that a portion of the expansible helical anchor is above the native heart valve and a portion is below the native heart valve. The expansible heart valve prosthesis is positioned within the multiple coils of the expansible helical anchor with the expansible heart valve prosthesis and the expansible helical anchor in unexpanded states. The expansible heart valve prosthesis in then expanded against the expansible helical anchor thereby securing the expansible heart valve prosthesis to the expansible helical anchor. By “expansible” it is meant that at least one coil of the anchor enlarges in diameter. 
     The method may further include moving a coil from a larger diameter to a smaller diameter as the heart valve prosthesis is expanded inside the multiple coils. At least two adjacent coils of the helical anchor may be spaced apart, and the method further comprises moving the at least two adjacent coils toward each other as the heart valve prosthesis is expanded inside the multiple coils. The helical anchor further may comprise a plurality of fasteners, and the method further comprises moving the fasteners from an undeployed state to a deployed state as the expansible heart valve prosthesis is expanded against the expansible helical anchor. A seal may be positioned between adjacent coils for preventing blood leakage through the helical anchor and past the heart valve prosthesis and the fasteners engage the seal in the deployed state. The fasteners may instead engage a portion of the anchor which is not a seal. Any other aspects of the methods or systems disclosed herein may also or alternatively be used in this method depending on the desired outcome. 
     Various additional advantages, methods, devices, systems and features will become more readily apparent to those of ordinary skill in the art upon review of the following detailed description of the illustrative embodiments taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a schematic cross-sectional view illustrating a replacement heart valve implanted in a native valve position using a helical anchor. 
         FIG. 1B  is a schematic cross-sectional view similar to the  FIG. 1A , but illustrating the use of seals in conjunction with the helical anchor. 
         FIG. 2A  is a perspective view illustrating one method of applying the seal structure to the helical anchor. 
         FIG. 2B  is a perspective view illustrating a further step in the method illustrated in  FIG. 2A . 
         FIG. 2C  is a cross-sectional view showing the helical anchor after application of the seal. 
         FIG. 2D  is an enlarged cross-sectional view of the helical anchor having one form of seal applied. 
         FIG. 2E  is a cross-sectional view similar to  FIG. 2D , but illustrating an alternative embodiment of the seal. 
         FIG. 2F  is another enlarged cross-sectional view similar to  FIG. 2E  but illustrating another alternative embodiment for the seal. 
         FIG. 3A  is a schematic perspective view illustrating another alternative embodiment of the helical anchor and seal. 
         FIG. 3B  is a cross-sectional view of the embodiment shown in  FIG. 3A , with the helical adjacent coils compressed together for delivery. 
         FIG. 3C  is a cross-sectional view showing the helical anchor and seal expanded after delivery. 
         FIG. 3D  is a partial perspective view illustrating another illustrative embodiment of the helical anchor. 
         FIG. 3E  is a schematic elevational view, partially fragmented, to show the application of a seal to the helical anchor structure of  FIG. 3D . 
         FIG. 3F  is an enlarged cross-sectional view illustrating another embodiment of a helical coil structure with a seal. 
         FIG. 3G  is a cross-sectional view similar to  FIG. 3F , but illustrating the structure after delivery and unfolding of the seal. 
         FIG. 3H  is a cross-sectional view similar to  FIG. 3G  but illustrating multiple parts of the helical anchor structure and associated seal expanded after delivery. 
         FIG. 4A  is a perspective view illustrating a helical anchor in combination with another alternative embodiment of a seal. 
         FIG. 4B  is a perspective view of the seal illustrating an alternative embodiment which adds support structure to the seal. 
         FIG. 4C  is a schematic cross-sectional view illustrating the embodiment of  FIG. 4A  implanted in a native heart valve position. 
         FIG. 4D  is a schematic cross-sectional view illustrating a replacement heart valve implanted within the helical anchor and seal structure of  FIG. 4C . 
         FIG. 5A  is a perspective view of a helical anchor with a membrane or panel seal being applied. 
         FIG. 5B  is a perspective view of the helical anchor with the membrane or panel seal of  FIG. 5A  deployed or unfolded. 
         FIG. 5C  illustrates a perspective view of the membrane or panel seal with an internal support structure. 
         FIG. 5D  is an enlarged cross-sectional view of the helical coil and undeployed membrane seal. 
         FIG. 5E  is a cross-sectional view similar to  FIG. 5D  but illustrating a membrane seal which has been collapsed or folded rather than wound around a coil of the helix. 
         FIG. 5F  is a perspective view of a portion of the coil and membrane seal illustrating further details including the internal support structure and a suture line. 
         FIG. 5G  is a cross-sectional view illustrating the helical coil and membrane seal implanted at a native heart valve site. 
         FIG. 5H  is a cross-sectional view similar to  FIG. 5G , but further illustrating a replacement or prosthetic heart valve implanted within the helical coil and membrane seal. 
         FIG. 6A  is a cross-sectional view illustrating a helical coil implanted and at a native heart valve site being expanded by a balloon. 
         FIG. 6B  is a cross-sectional view illustrating a stented, replacement or prosthetic heart valve implanted within a helical coil and membrane seal structure. 
         FIG. 7A  is a cross-sectional view schematically illustrating a helical anchor having approximately two turns or coils having a first diameter and another coil having a second, larger diameter. 
         FIG. 7B  illustrates an initial step during implantation of the helical anchor shown in  FIG. 7A  at a native heart valve site with a stent mounted replacement heart valve ready for implantation within the helical anchor. 
         FIG. 7C  illustrates a further portion of the procedure in which the stented replacement heart valve is expanded using a balloon catheter. 
         FIG. 7D  is a further portion of the procedure and illustrates a cross-sectional view of the implanted replacement heart valve within the helical anchor. 
         FIG. 7D-1  is a cross-sectional view of an implanted replacement heart valve within a helical anchor, similar to  FIG. 7D  but illustrating alternative configurations for the replacement heart valve and the anchor. 
         FIG. 8A  is an elevational view of another embodiment of a helical anchor being expanded by a balloon catheter. 
         FIG. 8B  is a view similar to  FIG. 8A , but illustrating further expansion of the balloon catheter. 
         FIG. 8C  is a view similar to  FIG. 8B  but illustrating even further expansion of the balloon catheter. 
         FIG. 8D  is an enlarged cross-sectional view showing compression of the helical coils from  FIG. 8C . 
         FIG. 9A  is an elevational view of another embodiment of a helical anchor being expanded by a balloon catheter. 
         FIG. 9B  is a view similar to  FIG. 9A , but illustrating further expansion of the balloon catheter. 
         FIG. 9C  is a view similar to  FIG. 9B  but illustrating even further expansion of the balloon catheter. 
         FIG. 9D  is an enlarged cross-sectional view showing compression of the helical coils from  FIG. 9C . 
         FIG. 10A  is a partial cross-sectional view illustrating another embodiment of a helical anchor inserted or implanted at a native heart valve site and insertion of a stent mounted replacement heart valve within the helical anchor and native heart valve site. 
         FIG. 10B  is a cross-sectional view similar to  FIG. 10A , but illustrating expansion and implantation of the stent mounted replacement heart valve within the helical anchor. 
         FIG. 10C  is a cross-sectional view, partially fragmented, of the implanted replacement heart valve and helical anchor shown in  FIG. 10B . 
         FIG. 10C-1  is an enlarged cross-sectional view showing engagement between the stent of the replacement heart valve and the helical anchor. 
         FIG. 10D  is a top view illustrating the process of expanding the stent mounted replacement heart valve within the helical anchor of  FIG. 10C . 
         FIG. 10E  is a top view similar to  FIG. 10D , but illustrating full expansion and implantation of the stent mounted replacement heart valve. 
         FIG. 11A  is a partial cross-sectional view illustrating another embodiment of a helical anchor inserted or implanted at a native heart valve site and insertion of a stent mounted replacement heart valve within the helical anchor and native heart valve site. 
         FIG. 11B  is a cross-sectional view similar to  FIG. 11A , but illustrating expansion and implantation of the stent mounted replacement heart valve within the helical anchor. 
         FIG. 11C  is a top view illustrating the process of expanding the stent mounted replacement heart valve within the helical anchor of  FIG. 11B . 
         FIG. 11D  is a top view illustrating full expansion of the stent mounted replacement heart valve within the helical anchor of  FIG. 11C . 
         FIG. 12A  is an elevational view of another embodiment of a helical anchor. 
         FIG. 12B  is a cross-sectional view of another embodiment of a helical anchor. 
         FIG. 12C  is an enlarged cross-sectional view of the helical anchor taken along line  12 C- 12 C of  FIG. 12B . 
         FIG. 12D  is a top view of a helical anchor schematically illustrating expansion by a balloon catheter. 
         FIG. 12E  is a cross-sectional view of the helical anchor shown in  FIG. 12D , but expanded to show deployment of the parts into the fabric seal. 
         FIG. 13A  is an elevational view of another embodiment of a helical anchor. 
         FIG. 13B  is a cross-sectional view of another embodiment of a helical anchor. 
         FIG. 13C  is an enlarged cross-sectional view of the helical anchor taken along line  13 C- 13 C of  FIG. 13B  with deployment of the barbs into the outer seal layer. 
         FIG. 14A  is a perspective view of an alternative helical anchor. 
         FIG. 14B  is a top perspective view of the helical anchor shown in  FIG. 14A . 
         FIG. 14C  is a front view of the helical anchor shown in  FIGS. 14A and 14B . 
     
    
    
     DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS 
     It will be appreciated that like reference numerals are used to refer to generally like structure or features in each of the drawings. Differences between such elements will generally be described, as needed, but the same structure need not be described repeatedly for each figure as prior description may be referred to instead for purposes of clarity and conciseness.  FIG. 1  schematically illustrates a typical replacement heart valve or prosthesis  10  that may be implanted in the position of a native heart valve, such as the mitral valve  12 , using a catheter (not shown). A sealed condition is desired around the valve  10 , i.e., between the periphery of the replacement valve  10  and the native biologic tissue, in order to prevent leakage of blood around the periphery of the replacement valve  10  as the leaflets  14 ,  16  of the replacement valve  10  open and close during systolic and biastolyic phases of the heart. The portion of the replacement heart valve  10  intended to be positioned in contact with native tissue includes a fabric or polymeric covering  18  to prevent regurgitation of blood flow. In  FIG. 1A , the fabric cover  18  is shown adjacent to the replacement valve leaflets  14 ,  16  within the stent mounted replacement valve  10 . These replacement valve leaflets  14 ,  16  are typically formed from biologic material, such as from a cow or a pig, but may synthetic or other bioforms. Approximately half of this replacement valve  10  has no seal, i.e., it is more or less exposed stent  24  with openings  24   a . This is because when the replacement valve  10  is placed in the aortic native position, the coronary arteries arise just above the aortic valve. If the seal  18  extended the entire length of the stent portion  24  of the replacement valve  10 , the coronary artery could be blocked. In  FIG. 1A , an unmodified aortic replacement valve  10  is shown implanted in a helical anchor  30  comprised of coils  32 . Leakage of blood flow may occur as depicted schematically by the arrows  36 , because there is a gap between the seal  18  on the stented valve  10  and the attachment to the patient&#39;s mitral valve  12 . The leakage of blood flow may occur in any direction. Here, the arrows  36  depict the leak occurring from the ventricle  40  to the atrium  42  since the ventricular pressure is higher than the atrial pressure. An unmodified aortic valve  10  placed in the native mitral valve position will be prone to develop a leak. To avoid this problem, two major approaches may be taken. First, a seal may be added to the system, for example, the helical anchor  30  may have sealing features added. Second, the location where the stent mounted replacement heart valve  10  sits may be changed. In this regard, if the replacement heart valve  10  is positioned lower inside the ventricle  40 , the seal  18  on the replacement heart valve  10  will be situated such that there is no leak. One drawback to seating the valve  10  lower inside the left ventricle  40  is that the replacement heart  10  valve may cause damage inside the left ventricle  40  or the valve  10  may obstruct ventricular contraction. The replacement heart valve  10  may damage the ventricular wall or block the outflow of blood from the ventricle  40  into the aorta. Rather than simply seating the replacement heart valve  10  more deeply or lower into the left ventricle  40 , it may be useful to keep the position of the stent mounted replacement valve  10  more atrially positioned as it is depicted in  FIG. 1A  (i.e., positioned higher and extending into the atrium  42 ). 
       FIG. 1B  illustrates one embodiment of providing seal structure  50  at the upper portion of a replacement heart valve  10  to prevent blood flow leakage as discussed above and shown in  FIG. 1A . In this regard, one or more seals  52  have been added to the helical anchor  30 . Specifically, a fabric covered oval seal structure  52  is added to the helical anchor  30  to provide a seal. The seal  52  may be formed from fabric, or any other material that provides a sufficient seal and does not allow blood to flow through. The seal  52  extends down to the level of the attachment between the stent mounted replacement valve  10  and the native mitral leaflets  12   a ,  12   b . The seal  52 , in this illustrative embodiment is a continuous tube and comprises one or more seal elements or portions  52   a ,  52   b ,  52   c  in the form of overlapping segments of fabric or other sealing material. These segments  52   a ,  52   b ,  52   c  of sealing structure act as siding structure or shingles to seal the space between the coils  32  or turns of the helical anchor  30 . 
       FIG. 2A  illustrates one manner of applying the overlapping seal structure  50  such as shown in  FIG. 1B  or otherwise integrating the seal structure  50  on the helical anchor  30 . In this regard, the seal structure  50  may be integrated with the helical anchor  30  for delivery purposes. The shingles or overlapping seal portions  52   a - c  ( FIG. 1B ) may be collapsed and extruded from a catheter  60 . Alternatively, once the helical anchor  30  has been delivered to the native heart valve site, the fabric or other seal structure  50  may be delivered over the coils  32  of the anchor  30  from the same delivery catheter  60 . Alternatively, the overlapping seal structure  50  may be added to the helical anchor  30  as the helical anchor  30  is being extruded or extended from the delivery catheter  60 .  FIG. 2A  specifically illustrates a helical anchor  30  with a fabric or other seal structure  50  being fed over the helical coils  32  from a sheath or delivery catheter  60 . The seal structure  50  may be generally circular in cross section or any other shape, such as a shape that is better configured for overlapping as generally shown in  FIG. 1B  above.  FIG. 2B  illustrates fabric  62  and an internal support coil  64  being added to the helical anchor  30  in a further portion or step of the procedure illustrated in  FIG. 2A .  FIG. 2C  illustrates one embodiment of a completed assembly, shown in cross section, comprising the helical anchor  30  covered by the coil  64  and fabric  62  and delivered by a sheath or delivery catheter  60 . The delivery sheath or catheter  60  may remain over the coil and fabric combination or it may be used to merely deliver these sealing elements  62 ,  64  over the helical anchor  30 . 
       FIG. 2D  illustrates a cross sectional view of the sealing elements  62 ,  64  which, in this case, are circular in cross section. These sealing elements  62 ,  64 , including, for example, a coil support and fabric combination, may be virtually any shape as long as they provide a seal when placed together. Sealing elements  62 ,  64  may not overlap in use but instead contact each other as shown to create a seal therebetween. 
       FIG. 2E  shows an oblong or oval cross sectionally shaped seal structure  70  similar to the seal  50  shown in  FIG. 1B  in which segments  70   a ,  70   b  overlap each other to produce a secure and fluidtight seal. It is possible to have the oblong seal structure  70  compressed for delivery and then spring or bias open once the seal structure  70  is extruded from a delivery catheter or sheath. A coil  74  internally supporting fabric  72  may be made of Nitinol (superelastic) wire or spring steel wire so that it may be collapsed and then bias or spring into a predetermined shape as needed. 
       FIG. 2F  shows another alternative seal structure  80 . In this case, a sealing fabric  82  or other material is wrapped around the helical anchor  30 . The fabric is stitched together with suitable thread to form stiff, structural panels  84  extending from the connecting portion  86  that is affixed to a coil  32  of the helical anchor  30 . The panels  84  again overlap, similar to a shingle effect, to provide a fluidtight seal. This configuration may be delivered in a similar manner to the previously described fabric covered coil designs above by passing the panel structure over the helical anchor  30  as shown. 
       FIG. 3A  illustrates another embodiment for providing a sealing structure. In order to provide further shape and support to a seal structure  90 , there may be two or more “framing” segments  92 ,  94  inside a fabric covering  96  or other material seal. This will give a shape to the seal structure  90  and provide for more reliable overlap of the seal segments (only one shown in  FIG. 3A ). This may be achieved by using a double helix in which two wires  92 ,  94  run parallel to each other to form a helical shape. The two wires  92 ,  94  may be connected at their ends with a curved section  98  as shown in  FIG. 3A . The fabric or other material sleeve or coating  96  may be passed over the double helix during or after delivery of this helical seal structure  90 . 
       FIG. 3B  illustrates a cross sectional view of the seal structure  90  compressed with wires  92 ,  94  inside the outer fabric or other material  96 . This can provide for easier delivery to the site of implantation. 
       FIG. 3C  illustrates the double helix seal  90  spread apart and overlapping after delivery. Two segments  90   a ,  90   b  of the helical seal  90  can expand as they are being delivered to form overlapping seal segments  90   a ,  90   b  similar to the “shingle” configuration discussed above. Here, two overlapping seal segments  90   a ,  90   b  are supported by two double helix frames  92 ,  94  positioned adjacent and overlapping to each other to produce an effective, fluidtight seal. 
       FIG. 3D  illustrates another alternative method for coupling frame segments  92 ,  94  of a seal and, specifically, biasing the frame segments  92 ,  94  apart. Interconnecting segments  100  between the two frame parts or wires  92 ,  94  can push the frame segments  92 ,  94  into a desired final shape. This double helix design may be made from multiple wire pieces or may be made from a single solid Nitinol or steel tube or wire, similar to stent manufacture techniques. The seal frame  92 ,  94  may also have a sinusoidal or generally back and forth configuration (not shown) to hold a shingle-type shape rather than two rails or wires inside of the outer seal material or fabric  96  ( FIG. 3C ). 
       FIG. 3E  details how the outer seal material or fabric  96  may be placed over the expanded frame  92 ,  94 . The seal material  96  may be preattached to the double helix frame  92 ,  94  and the two may be delivered together. Alternatively, the seal material  96  may be delivered onto the double helix frame  92 ,  94  after the double helix frame  92 ,  94  is already in place at the implantation site, such as the site of a native mitral valve. In the unexpanded state, the double helix  92 ,  94  may be extruded through a catheter as previously described. 
       FIGS. 3F, 3G and 3H  generally show the progression of delivery and implantation of the seal  90 . In these figures, the seal material or fabric  96  extends beyond the frame  92 ,  94  to form flaps or panels  102  of seal material. These flaps or panels  102  may be stiffened and reinforced with heavy suture, or the material may be soaked or coated in a stiffening agent. This may be useful to ensure a fluidtight seal. In  FIG. 3F , the internal wire frame  92 ,  94  is collapsed and the fabric cover  96 ,  102  is folded within a delivery sheath  60  for delivery. In  FIG. 3G  the frame  92 ,  94  has been delivered and the segments or flaps  102  of seal material  96  that extend beyond the frame  92 ,  94  have unfolded.  FIG. 3H  illustrates the frame parts  92 ,  94  expanded, in a manner similar to a stent. This provides a solid and secure seal. The cross members or biasing members  100  that were collapsed inside the double helix frame  92 ,  94  are now biased outward and lengthened or straightened. These cross members  100  may be made of Nitinol or other spring material and expand the frame  92 ,  94  with a spring force as the frame  92 ,  94  is delivered from a catheter or sheath  60 . Alternatively, there may be another mechanism or manner for activating and expanding the frame  92 ,  94  as needed during the implantation procedure. 
       FIG. 4A  illustrates another embodiment for adding sealing features to a helical anchor  30 . Here, a fabric windsock-type shape or panel/membrane structure  110  has been mounted to an upper turn or coil  32  of the helical anchor  30 . This panel  110  unfolds or extends within the helical anchor  30  to provide a sealing membrane. The fabric or other seal material may be sewed or permanently fastened to the helical anchor  30 . Alternatively, this seal panel  110  may be delivered onto the helical anchor  30  after the helical anchor  30  is placed at the site of implantation within a native heart valve. The seal material  110  may be attached on any portion of the helical anchor  30  at any level of the anchor  30 . In  FIG. 4A , the seal panel  110  is attached to the uppermost coil  32  of the helical anchor  30  such that the panel  110  can then expand to the full length of the helical anchor  30  and provide a full length, fluidtight seal. 
       FIG. 4B  illustrates the seal panel  110  opened and an internal support structure  112 , in the form of a wire or sinusoidal-type support element inside or within layers of the seal material. This support structure  112  for the seal  110  may be made of, for example, Nitinol or steel. The support  112  may be sewn into the fabric or otherwise secured to the seal material. The fabric may, for example, contain a channel for the support  112  and the support  112  could be pushed into the channel, expanding the seal material  110  as needed. If the support  112  is made from Nitinol or superelastic material, and imbedded inside the fabric or seal material  110 , it may straighten and fold up the fabric or other seal material inside a delivery catheter or sheath. While being delivered, the Nitinol or superelastic support would return to its initial zigzag or sinusoidal shape, expanding the fabric as it is released and extruded from the delivery sheath or catheter. 
       FIG. 4C  is a cross sectional view illustrating a helical anchor  30  and fabric seal panel  110 , such as shown in  FIG. 4A  delivered and implanted at a native valve site, such as within the mitral valve  12  of a patient. The seal panel  110  is annular in shape and generally follows the interior of the helical anchor  30 . As shown here, the fabric panel  110  is stitched to the upper turn or coil  32  of the helical anchor  30  and the fabric is folded on itself and stitched together as shown. Stitching  114  can also provide structural support to help the fabric shape itself correctly. The stitching may be made of steel wire or Nitinol wire that may assist in providing shape stability to the membrane or panel structure  110 . The stitching  114  may also be suture or thread. The heavier the stitching material, the more support it will provide for the fabric. Here, the stitching is in horizontal lines, however, it may instead be other configurations such as vertical, zigzag, or any other suitable configuration. 
       FIG. 4D  illustrates a stent mounted heart valve  10  expanded within the helical anchor  30  and seal structure  110  of  FIG. 4C . The seal  110  prevents any leakage of blood around the valve  10  and covers any areas of the stent portion  24  of the valve  10  that are not already covered and sealed. The seal  110  allows the replacement heart valve  10  to be seated higher toward the atrium  42 , thereby reducing the risk of left ventricle injury or left ventricle blood outflow obstruction. 
       FIG. 5A  illustrates a helical anchor  30  with an attached membrane or panel seal  110  being delivered onto the coils  32  of the helical anchor  30 . It should also be noted that the membrane or panel seal  110  can also improve the attachment of the replacement heart valve  10 . In this regard, a bare helical anchor  30 , particularly one made of metal that attaches to a metal stent will result in metal surfaces contacting each other. As the heart beats and pressure rises with each contraction, e.g., about 100,000 times per day, there is a risk of slippage between the metal surfaces and potential valve dislodgement. Therefore, the addition of a membrane, panel  110  or other seal structure can reduce the tendency for the valves to slip and even fail. The membrane or seal panel  110  may be smooth or have various degrees of texture or roughness to help maintain fixation of the replacement heart valve  10 . Textured or roughened surfaces will increase friction and therefore reduce slippage. Also, the fabric or other seal material  110  may be forced inside the openings or cells of the stent portion  24  of the replacement heart valve  10  thereby improving or creating a locking effect and anchoring the stent mounted replacement valve  10  to the helical anchor  30 , including the seal material  110 . In  FIG. 5A , the membrane or panel seal  110  is attached to the helical anchor  30  and as previously described, the membrane or panel seal  110  may be attached prior to implantation within the patient or added at any point during the implantation procedure. It may be advantageous to add the membrane or panel seal  110  after the helical anchor  30  is placed at the implantation site in order to reduce complication during delivery of the helical anchor  30 .  FIG. 5B  illustrates the membrane seal or panel seal  110  unfolded or expanded within the helical anchor  30 . As previously described, the membrane or panel seal  110  is attached to the uppermost turn  32  of the helical anchor  30 , however, it may be attached anywhere along the helical anchor  30 . The membrane or panel seal  110  may be continuous or intermittent, and may be comprised of overlapping panel portions similar to a shingle effect. Although the membrane or panel seal  110  makes a complete annulus as shown in  FIG. 5B  within the helical anchor  30 , it may instead be formed as less than a complete annulus. 
       FIG. 5C  is similar to  FIG. 4B  described above and simply illustrates that in this embodiment, the delivered and deployed membrane seal  110  may also include a similar internal support  116 . It is also possible that the membrane or panel seal  110  is intrinsically stiff and springs open without internal support structure of any sort. Many other ways to open or deploy the membrane or panel seal  110  may used instead. For example, the panel seal  110  may contain pillars or other supports (not shown) that are collapsed for delivery but that allow the membrane or panel  110  to be biased open once the membrane or panel  110  is delivered from a suitable catheter or sheath. These pillars or other supports may, for example, be formed from shape memory or superelastic material, or other suitable spring biased material. 
       FIG. 5D  illustrates the panel seal  110  unwinding or being deployed. The panel seal  110 , in this illustrative embodiment, is formed of two layers with a support  116  between these two layers. The support  116 , as described above, is suitably secured between the layers of the panel seal  110 . Although shown as a sinusoidal configuration, the support  116  may be of any desired and suitable configuration, or may be comprised of separate support structures such as generally circular or oval support structures (not shown). Other useful structures in this regard may include any of those shown and described in U.S. Provisional Patent Application Ser. No. 61/864,860, filed on Aug. 12, 2013, the disclosure of which is hereby fully incorporated by reference herein. Finally, drawstrings (not shown) may be added to the end of the membrane seal  110  or to any part or parts of the membrane seal  110  that may be used to pull the membrane seal  110  open and unfold it or otherwise deploy it. 
       FIG. 5E  illustrates a membrane or panel seal  100  which has been collapsed or folded onto itself rather than wound around the coil  32  of the helical anchor  30 . A collapsed membrane seal  110  such as this may be more practical. The membrane or panel seal  110  can be opened with the support structure  116  normally biased to a deployed state as shown previously, or it may be deployed by containing structural support elements  116 , such as shape memory support elements. As also previously discussed, drawstrings (not shown) might be added for deployment purposes. 
       FIG. 5F  illustrates a cross sectional, enlarged view of the helical anchor  30  with the seal membrane  110  or panel extending adjacent to coils  32  of the helical anchor  30 . The panel seal  110  includes a suture line  118  that keeps the seal  110  in place within the helical anchor  30 , shown as a dotted line. This need not be a suture, instead, the securement may be provided by any suitable fasteners, glue, or other elements that maintain the membrane or panel seal  110  in position. In addition, the panel seal  110  may be glued or attached to the helical anchor  30  and this would eliminate the need for sutures or separate fasteners. As described previously, the panel seal  110  may be fabric or any other suitable biocompatible material. For example, the seal material in this and any other embodiment may be Dacron or Goretex, or may be biologic material from an animal or human. Other examples of seal material include engineered biomaterials or any combination of biologic and/or synthetic materials. The panel seal  110 , in this embodiment, is opened with a spring biased support wire  116  as generally described above, but may be opened in any suitable manner during or after deployment and implantation of the helical anchor  30 . 
       FIG. 5G  illustrates the helical anchor  30  and panel seal  110  combination implanted at the site of a native mitral valve  12  of a patient.  FIG. 5H  illustrates a replacement heart valve  10 , and specifically a stent mounted replacement heart valve  10  secured within the helical anchor  30  and panel seal  110  combination. These figures are described above with regard to  FIGS. 4C and 4D . Thus, it will be appreciated that the panel seal structure  110  and helical anchor  30 , regardless of deployment and delivery techniques, provide fluidtight sealing as previously described. It will be appreciated that additional features may be used to help deploy the panel seal or membrane  110  open as shown in  FIGS. 5G and 5H . A foam layer (not shown) may also be positioned at any desired location, for example, to aid in sealing and/or valve retention. The membrane or panel seal  110  may extend the full length of the helical anchor  30  or only a portion of the length. In these figures,  FIG. 5G  illustrates the membrane or panel  110  extending only part of the length while  FIG. 5H  illustrates the panel or membrane  110  extending almost the entire length of the valve  10 . As shown in  FIG. 5H , the replacement heart valve  10  is positioned within the native mitral valve  12  such that much of the replacement heart valve  10  sits within the atrium. It will be appreciated that the replacement heart valve  10  may be positioned anywhere along the helical anchor  30 . The helical anchor  30  may contain the entire prosthetic or replacement heart valve  10  or the replacement heart valve  10  may project at either end of the helical anchor  30  or from both ends of the helical anchor  30 . The number of coils or turns  32  of the helical anchor  30  may also be varied. The key arrangement is to prevent as much leakage as possible, and maintain the replacement heart valve  10  securely in position after implantation. 
     In  FIG. 5H  one coil  32  of the anchor  30  extends beyond the stented prosthetic valve  10  inside the left ventricle  40 . This may serve a number of functions. The end of the stent valve  10  is sharp and may damage structures inside the left ventricle  40 . By leaving a turn  32  of the anchor  30  beyond the end of the valve  10 , it may be possible to protect the structures inside the heart from contacting the sharp end of the valve  10 . The lowest turn  32  of the anchor  30  may act as a “bumper” that is smooth and prevents injury to structures inside the ventricle  40 . A smooth metallic (such as Nitinol) anchor coil  32  may be very well tolerated and prevent wear and abrasion inside the left ventricle  40 . 
     The lowest turn or coil  32  of the anchor  30  may also wrap native mitral valve leaflet tissue around the end of the valve  10 . This may also shield the sharp end of the prosthetic valve  10  from structures inside the heart. 
     The lowest turn or coil  32  of the helical anchor  30  may also provide tension on chordal structures. The function of the left ventricle  40  is improved and the shape of the left ventricle  40  can be optimized by placing tension on chordal structures. In  FIG. 5H , the lowest coil  32  pulls the chordae toward the center of the ventricle  40  and shapes the left ventricle  40  optimally for contraction. It may be useful to have multiple coils  32  of the anchor  30  extending inside the left ventricle  40  beyond the anchor  30 . These coils  32  could pull the chordae inward over a longer distance inside the heart. For example, if a patient had a very large left ventricle  40 , it may be desirable to improve his left ventricular function by having a helical extension well beyond the valve  10 . This would tighten the chordae and reshape the left ventricle  40 . The coils  32  of the anchor  30  could also be heavier/thicker diameter to assist in reshaping the heart. The diameter of the coils  32  could also be varied to optimize the left ventricle shape change. 
     The concept of reshaping the left ventricle  40  with the anchor  30  does not need to apply to just mitral valve replacement. The helical anchors  30  shown in these descriptions can also be used for mitral valve repair. Extensions of the helix coils  32  inside the left ventricle  40  can also re-shape the left ventricle  40  even when a replacement prosthetic valve  10  is not used. As described previously, various numbers of coils  32 , diameter of coils  32 , thickness of materials, etc. could be used to achieve an optimal result. 
     It is also useful to use the helical anchor  30  to repair a native heart valve  12  and reshape the left ventricle  40  and leave open the possibility to add a prosthetic replacement valve  10  later if the repair fails over time. After surgical valve repair, this is not uncommon. An anchor  30  that serves as a repair device with or without left ventricular reshaping with coils  32  that extend into the left ventricle  40  may be useful as an anchor  30  if a prosthetic valve replacement is needed later. 
       FIG. 6A  illustrates a helical anchor  30  implanted at the native mitral valve position. In general, it will be important to seat the helical anchor  30  close to the under surface of the native mitral valve  12 . If the diameter of the coils  32  or turns under the mitral valve  12  is relatively small, the helical anchor  30  is forced to slip down into the left ventricle  40 . The helical anchor  30  attachment to the native valve  12  will be away from the annulus  12   c  and once the heart starts beating, the helical anchor  30  will be sitting inside the left ventricle  40  and, when there is mitral valve tissue between the helical anchor  30  and the mitral valve annulus  12   c , the helical anchor  30  is not firmly attached in the annular region of the mitral valve  12 , but rather to the leaflets  12   a ,  12   b  lower in the left ventricle  40 , and this is not desirable. In  FIG. 6A , a relatively large diameter turn or coil  32  of the helical anchor  30  is positioned just under the mitral valve leaflets  12   a ,  12   b . This position is directly adjacent to the native mitral valve annulus  12   c . Relatively smaller diameter coils  32  are positioned lower in the left ventricle  40 . It may be useful to have a gap  120  between the relative larger coil  32  that is positioned under the valve leaflets  12   a ,  12   b  at the valve annulus  12   c  and the relatively smaller coil  32  positioned farther into the left ventricle  40 . This will prevent the entire helical anchor  30  from being pulled down farther into the left ventricle  40  after implantation. Relatively smaller diameter coils  32  of the helical anchor  30  are positioned above the mitral valve  12 , i.e., above the mitral valve native leaflets  12   a ,  12   b . For illustrative purposes, a balloon  122  is shown for purposes of expanding the smaller diameter coils  32 . This causes the larger diameter coil portions  32  to move relatively inward in a radial direction thereby tightening all of the coils  32  along a more similar diameter and tightening the connection between the helical anchor  30  and the native mitral valve tissue. Most importantly, the coil or turn  32  under the native mitral valve leaflets  12   a    12   b  tends to grip against the underside of the mitral annulus  12   c  and pull the annulus radially inward, reducing the diameter of the native mitral annulus  12   c . Annular reduction in this manner is important to improve left ventricular function when the heart is enlarged. Annular diameter reduction of a native mitral valve  12  is also important during mitral valve repair. The smaller diameter annulus adds to the improvement in left ventricular function. The concept of annular reduction using a sliding helical anchor  30  to control the leaflets  12   a ,  12   b  and pull the native mitral leaflets  12   a ,  12   b  and annulus  12   c  radially inward is specifically useful in mitral valve repair. The concepts, methods and devices for improving left ventricular function in mitral valve prosthetic replacement, i.e., replacements that reduce the annulus diameter and tension chordae and reshape the left ventricle  40 , will be invoked herein demonstrating mitral repair devices, concepts and methods. A smooth turn or coil  32  of the helical anchor  30  under the native mitral annulus  12  will have less tendency to grip against the mitral valve tissue and reduce the mitral valve annulus diameter. It may be useful to increase the “grip” of the turn or coil  32  under the annulus  12   c  for this reason. This may be accomplished in many ways including roughening the surface of the coil  32  such as by texturing the metal or by adding a high friction coating or fabric. The coating, fabric or other high friction material may be fixed to the helical anchor  30  or it may slide along the helical anchor  30 . The high friction portion of the helical anchor  30  may be continuous or discontinuous. 
       FIG. 6B  illustrates the final position of the prosthetic replacement heart valve  10  inside the helical anchor  30  and its relation to the native mitral valve  12  and left ventricle structures. The left ventricle chordate  130  have been tensioned and, therefore, the left ventricle  40  has been appropriately reshaped. The sharp end  132  of the prosthetic replacement heart valve  10  has been covered by seal material  134 , native valve tissue  136  and a “bumper”  138  of a lowest turn or coil  32  of the helical anchor  30 . This provides multiple types of protection from injury inside the left ventricle  40  due to the sharp end of the stented prosthetic valve  10 . Also note that the stented prosthetic heart valve  10  is positioned higher toward the atrium  42 , and away from the structure in the left ventricle  40 . This provides further protection from injury to the left ventricle  40  by the replacement heart valve  10 . The fabric membrane seal, or other type of panel seal  110 , may extend for any length. In this illustration it extends beyond the replacement heart valve  10 . The fabric or other seal material may also extend beyond the end of the helical anchor  30  within the left ventricle  40 . The fabric or other seal material  110  should cover the end of the replacement heart valve  10  until there is a seal at the level of the mitral valve  12 . There is no need for a seal if the prosthetic replacement valve  10  has an attached seal or a seal is otherwise attached to the prosthetic replacement valve  10 . In this case, useful features disclosed relate mainly to the attachment of the replacement valve  10  to the helical anchor  30  and the ability of the helical anchor  30  to reshape the left ventricle  40 . 
       FIGS. 7A-7D  illustrates devices, methods and procedures relating to the interaction of the helical anchor  30 , helical anchor design features and the stent mounted replacement heart valve  10  delivered or mounted on a balloon  140 . Various catheters may be manipulated to take advantage of a design of the helical anchor  30  to improve valve implantation. For example, the stent mounted replacement valve  10  may be partially deployed and the helical anchor  30  manipulated with the stent mounted replacement valve  10  in a partially deployed state before the final deployment position is reached.  FIG. 6A  illustrates the helical anchor  30  with three coils or turns  32 . The top two coils  32  have a relatively smaller dimension d 2  while the lowest turn or coil  32  has a relatively larger dimension or diameter d 1 .  FIG. 7B  illustrates a stent mounted replacement valve  10  with a balloon  140  inside to deploy the valve  10  once the valve  10  has been positioned inside the helical anchor  30 . The helical anchor  30  is placed with two of the coils or turns  32  positioned above the native mitral valve  12  and one coil or turn  32  positioned below the native mitral valve leaflets  12   a ,  12   b  and adjacent to the mitral valve native annulus  12   c . The arrows  142  indicate the radially outward direction of balloon inflation and the resulting expansion of the stent mounted replacement heart valve  10 . 
       FIG. 7C  illustrates expansion of the balloon  140  and stent mounted replacement heart valve  10 . Since the diameter of the upper two coils or turns  32  of the helical anchor  30  are smaller, as the balloon  140  is expanded, the stent mounted replacement heart valve  10  first contacts the smaller turns  32  of the helical anchor  30 . The stent mounted heart valve  10  becomes engaged against these two smaller diameter turns or coils  32 . While in this position, the catheter deploying the balloon  140  may be used to manipulate or reposition the helical anchor  30 . The movement of the balloon catheter  140 , such as in the direction of the large arrow  146 , will result in the large turn  32  of the helical anchor  30  being moved upwardly toward the native mitral annulus  12   c  in this illustrative example. That is, the turn or coil portion  32  adjacent to the native mitral annulus  12   c  will move in the direction of the small arrows  148  adjacent thereto. This also results in an upper movement of the turns or coil portions  32  above the native mitral valve annulus  12   c . In fact, with enough force, once the turn or coil portion  32  below the annulus  12   c  comes in contact with the leaflet  12   a  or  12   b  or annulus tissue  12   c  below the mitral valve  12 , the helical anchor  30  can actually be sprung open such that a segment of the helical anchor  30  that connects the turn or coil portion  32  above the leaflet  12   a  or  12   b  and below the leaflet  12   a  or  12   b , becomes extended. This can increase the gap between segments of the helical anchor  30 . 
       FIG. 7D  illustrates a stent mounted replacement heart valve  10  fully expanded after deployment and expansion by a balloon catheter  140 , which has been removed. The largest turn or coil  32  of the helical anchor  30  is positioned relatively high just under the native mitral annulus  12   c . After full inflation of the balloon catheter  140 , the system cannot move because the native mitral valve of leaflets  12   a ,  12   b  are now trapped between the helical anchor  30  and the stent mounted replacement heart valve  10 . The balloon catheter  140  that holds the replacement heart valve  10  may be moved in any direction. In this figure, up and down motions are clearly possible as these would be made by moving the balloon catheter  140  in and out of the patient. There are many deflectable catheters which would allow the balloon catheter  140  to move laterally also. 
     This series of figures is intended to show how procedures can be conducted with a helical anchor  30 . The anchor  30  can be engaged and manipulated by the stent mounted valve  10  prior to the final positioning and full expansion of the stent valve  10 . 
     It is also possible to manipulate the anchor  30  prior to its release. The anchor  30  can have a catheter or other element attached to it during this procedure. So both the anchor  30  and the stent mounted valve  10  could be remotely manipulated to achieve a desired result. 
       FIGS. 7A-7D  also show how inflating the balloon  140  inside smaller turns  32  of the anchor  30  can serve to “tighten” a larger turn  32 . Part of the larger turn or coil  32  under the annulus  12   c  is drawn up above the annulus  12   c  when the smaller turn or coil  32  is expanded, thus shortening the coil  32  under the annulus  12   c . This allows the large coil  32  to tighten around the stent valve  10 . This effect is more pronounced when a larger coil  32  is located between two smaller coils  32  of the anchor  30 . The two small coils  32  on each side of the larger coil  32  expand and thus decrease the diameter of the larger coil  32  so the larger coil  32  can trap and assist in anchoring the valve  10 . 
     It is very important to position the anchor  30  as close to the annulus  12   c  as possible. This is the natural anatomic location for the valve  10 . If the anchor  30  is attached to leaflet tissue  12   a ,  12   b  remote from the annulus  12   c , the leaflet tissue  12   a ,  12   b  moves with each beat of the heart. This can cause rocking of the anchor  30  and the valve  10 . Repeated motion can lead to valve dislodgement. So strategies to allow placement of large coils  32  of the anchor  30  near the annulus  12   c  are important. It is also useful to convert a larger coil  32  to a smaller coil  32  so that the coil  32  can actually function to trap the stent valve  10 . 
       FIG. 7D-1  illustrates another embodiment of a replacement valve  10  and helical anchor  30  combination in which the upper end of the replacement valve  10  does not flare outward but rather is retained in a generally cylindrical shape, for example, by upper coils  32  of the anchor  30 . The lower end or outflow end is flared radially outward as shown. It will be appreciated that structure, such as a seal (not shown) may be included between the stent  24  and the lower coils  32  for both sealing purposes as previously described as well as or alternatively to provide a softer, more compliant surface against the native mitral leaflets  12   a ,  12   b . In addition, it will be appreciated that the upper coils  32  create a gap and do not engage or trap the tissue adjacent the native mitral valve in the atrium. On the other hand, the lower coils  32  engage tissue just underneath the native mitral annulus  12   c . The embodiment of replacement valve  10  shown in  FIG. 7D-1  stands in contrast to valves  10  configured as previously shown, such as in  FIGS. 1A and 1B , in which the valve retains a cylindrical shape after implantation and application of a helical anchor  30 , and, for example, that shown in  FIG. 7D  in which the valve  10  includes a very slight outwardly directed configuration at the lower or outflow end but does not result in any significant flare. 
       FIGS. 8A-8D  illustrate the use of a balloon catheter  140  to expand a helical anchor  30  without the presence of a stent mounted replacement heart valve  10 . Specifically,  FIG. 8A  illustrates a helical anchor  30  with approximately four coils or turns  32 . There are two coils  32  on each side of a joining segment  32   a  which separates them to create a gap. Mitral valve native leaflets (not shown) could easily be positioned between the coils  32  at the position of the gap created by the joining segment  32   a . In this figure, the balloon  140  is beginning to be expanded as shown by the radially outward directed arrows  150 .  FIG. 8B  illustrates further expansion of the balloon  140  thereby causing the helical anchor  30  to create an indentation in the balloon  140  around the helical anchor  30 . The balloon  140  on both sides of the helical anchor  30  expands further. This results in a force on the turns or coils  32  of the helical anchor  30  that moves them together generally shown by the arrows  152 . As the balloon  140  is expanded further, as shown in  FIG. 8C , the gap between the turns or coils  32 ,  32   a  diminishes and eventually may be completely closed such that the two main portions of the helical anchor  30  are compressed against each other in the direction of the blood flow or central axis of the helical anchor  30  (i.e., along the length of the balloon  140 ).  FIG. 8D  illustrates a cross sectional view showing the turns or coils  32 ,  32   a  of the helical anchor  30  compressed together. As shown in these figures, the coils  32 ,  32   a  of the helical anchor  30  may be compressed against each other by inflating a balloon  140  inside the helical anchor  30 . There does not need to be a joining segment  32   a  or gap for this to occur. The helical coils  32  would be compressed tightly against each other with or without the gap illustrated in this embodiment. 
     This compression can serve as a “motor” to allow various functions to occur. For example, it can be possible to mount pins or fasteners (not shown) to the turns  32 ,  32   a  of the anchor  30  that can be driven and activated by the inflation of the balloon  140 . The pins or fasteners could be positioned so they pass through the native valve leaflet. The fasteners could also traverse the native leaflets and move into the anchor  30  on the opposite side of the leaflet. A fabric coating, spongy coating or another receptive material on the anchor  30  would improve the retention of fasteners. 
     Generally, these methods and devices would allow for areas of the mitral valve  12  near the annulus  12   c  or on the annulus  12   c  to be fastened to a helical anchor  30 . The fasteners could traverse the valve tissue and engage coils  32  on the one or on both sides of the leaflets. Leaflet trapping by balloon inflation can allow the mitral valve  12  and its annulus  12   c  to be manipulated and to perform therapeutic procedures. For example, the anchor coils  32  once fastened to a valve leaflet  12   a ,  12   b  could be reduced in size to create a purse string effect on the valve annulus  12   c —resulting in an annular reduction or annuloplasty procedure. A drawstring (not shown) could be added to the anchor  30  to reduce the diameter. 
     The fasteners could be used to join segments of the helical anchor  30  together. For example, turns or coils  32  of the anchor  30  above the leaflet  12   a ,  12   b  could be joined together. Fabric or other material could be wrapped around or otherwise placed on the anchor coils  32  and pins or fasteners from one coil  32  could engage and trap themselves in the fabric of an adjacent coil  32 . Adjacent coils  32  could engage each other. This can create a greater mass on each side of the leaflet  12   a ,  12   b  to control the mitral annulus  12   c . In summary, balloon inflation inside a helical anchor  30  can drive coils  32  of the anchor  30  together. This maneuver can be used as a motor or drive mechanism to activate mechanical systems. It can also move anchor coils  32  tightly together. 
       FIGS. 9A-9D  illustrate another ability of the helical anchor  30  as the helical anchor  30  is expanded by a balloon  140 . In this regard, the actual total length of the helical coils  32  forming the anchor  30  remains the same. Therefore, to increase the diameter of the helical anchor  30 , the ends  30   a ,  30   b  of the helical anchor  30  must move to accommodate the expansion. This movement may also be used as a motor or drive mechanism to activate additional functions. More specifically,  FIG. 9A  illustrates a balloon  140  being expanded inside the helical anchor  30 . As the balloon  140  expands, the diameter of the helical anchor  30  increases and the opposite ends  30   a ,  30   b  of the helical anchor move to accommodate the expansion. As shown by the arrows  160 , the ends  30   a ,  30   b  of the coils  32  move or rotate in opposite directions.  FIG. 9B  illustrates continuation of the balloon expansion and the previous figures of  FIGS. 8A-8D  show how the balloon  140  also compresses the coils  32  of the helical anchor  30  together.  FIG. 9B  highlights how the coils  32  of the helical anchor  30  rotate generally as the balloon  140  expands. This rotation is helpful in retaining a stent mounted replacement heart valve as the tension around the stent portion of the heart valve (not shown) increases.  FIG. 9C  illustrates that the helical anchor  30  has unwound as it expands under the force of the balloon  140 . There are fewer turns or coils  32  and the remaining turns or coils  32  are now larger in diameter.  FIG. 9D  shows a cross sectional view of the expanded helical anchor  30 . The motion of the ends  30   a ,  30   b  of the helical anchor  30  can be used to perform functions. As further described below, for example, the movement of the coils  32  of the helical anchor  30  may be used to drive anchors, or perform other functions. 
       FIGS. 10A-10E  illustrate the effect of a cover or coating  170  on the helical anchor  30 . Also, the replacement valve  10  as shown, for example, in  FIGS. 10B and 10C , takes on an outward flare at both the upper and lower ends. This may not be desirable for various reasons, but rather, at least one end of the valve  10  may be desired to have and retain a generally cylindrical cross sectional shape (as viewed from above or below). The coating or covering  170  may be in the form of any type of sheath or material applied to the helical anchor  30  and may be comprised of any biocompatible material. For example the coating  170  may be made of fabric material, such as Dacron, Teflon or other material. It may be formed from PTFE or EPTFE in fabric form that has a fabric texture or as a plastic sleeve, or cover or coating that is smooth. There may be a foam material under the coating  170  as is commonly used in, for example, surgical valves. The foam material may consist of rolls of fabric or folds of fabric. Other possible materials include resilient materials or, more specifically, material such as medical grade silicone. Biological materials may also be used, and may include animal, human, or bioengineered materials. Some materials commonly used in cardiac repair procedures are pericardium and intestinal wall materials.  FIG. 10A  illustrates a helical anchor  30  which is covered by a coating  170  comprised of a fabric backed by a foam material. The helical anchor  30  is positioned inside the native mitral heart valve  12  with two turns or coils  32  above and two turns or coils  32  below the native mitral valve annulus  12   c . A stent mounted replacement heart valve  10  is placed inside of the helical anchor  30  and inflation of the balloon delivery catheter  140  inside the replacement heart valve  10  has begun as indicated by the arrows  172 . In  FIG. 10B , the replacement stent mounted valve  10  is shown fully expanded against the helical anchor  30 . Typically, the stent portion  24  of the valve  10  is comprised of thin metal material that includes openings or cells. These openings or cells become embedded against the coating or covering  170 . The stent  24  therefore firmly engages with the helical anchor  30  creating a very strong attachment for the replacement valve  10  inside the helical anchor  30 .  FIG. 10C  more specifically illustrates an enlarged view demonstrating how the stent portion  24  has deformed the fabric and foam coating  170  of the helical anchor  30 . This engagement is very strong and prevents the replacement heart valve  10  from becoming dislodged.  FIG. 10C-1  is an even further enlarged view showing a cell or opening  24   a  of the stent  24  that is engaged against the foam and fabric covering  170 , creating a very strong physical connection between these two components.  FIG. 10D  illustrates a balloon catheter  140  expanding a replacement valve  10  inside of the coated helical anchor  30  from a view above the helical anchor  30 .  FIG. 10E  illustrates the same view from above the helical anchor  30 , but illustrating full expansion of the valve  10  after inflation of the balloon catheter  140  ( FIG. 10A ). The stent portion  24  of the replacement heart valve  10  is then fully engaged into the resilient, frictional coating  170  on the helical anchor  30 . 
       FIGS. 11A-11D  illustrate an embodiment that includes a covering or coating  180  on the helical anchor  30  which is intermittent, as opposed to the continuous coating  170  shown in the previous figures. In this regard, there are segments of coating  180  along the helical anchor  30  and these segments  180  may be rigidly fixed to the helical anchor  30 . However, there may also be an advantage to allowing these segments  180  to slide along the helical anchor  30  as the helical anchor  30  is expanded using, for example, balloon inflation as previously described. The segments  180  may slide along the coils  32  of the helical anchor  30  to allow the helical anchor  30  to tighten and at the same time the segments  180  can firmly engage with the cells or openings  24   a  of the replacement heart valve stent  24 . 
       FIG. 11A  illustrates a helical anchor  30  with a covering that is intermittent and formed with segments  180 . The covering segments  180  are shown with a taper at each end to allow the anchor  30  to be turned into position without a flat leading edge to impair placement. The taper is not necessary, but assists if desired in this regard. This taper may be of any suitable design and may be angular, or curved in any shape that promotes easy motion of the helical anchor  30 . A balloon catheter  140  is positioned inside of a stent mounted replacement valve  10  as previously described and is initiating its inflation as indicated by the arrows  182 .  FIG. 11B  illustrates the stent mounted replacement heart valve  10  fully expanded. The coating segments  180  have become fully engaged within the cells or openings of the heart valve stent  24 . Once these segments  180  engage with the stent  24  and enter one or more cells or openings, they become fixed to the stent  24  and they will begin to slide along the helical anchor  30 . The helical anchor  30  can expand and tighten against the stent portion  24  of the replacement valve  10  and at the same time there will still be the beneficial effect of intermittent and strong attachment to the helical anchor  30  afforded by the segments  180  of high friction and resilient and/or compressible material.  FIGS. 11C and 11D  illustrate the process from above the helical anchor  30  showing initial expansion of the stent mounted replacement heart valve  10  in  FIG. 11C  and full expansion and engagement between the segments  180  and the stent  24  in  FIG. 11D  firmly attaching these two structures together during the implantation procedure within a patient. 
       FIGS. 12A-12E  illustrate a helical anchor  30  and the motor or drive function provided when the helical anchor  30  expands and the ends  30   a ,  30   b  of the coils  32  move.  FIG. 12A  illustrates a helical anchor  30  with about four turns or coils  32 , while  FIG. 12B  illustrates a helical anchor  30  with about three turns or coils  32 . As further shown in  FIG. 12B  the helical anchor  30  is attached to barbed fasteners  190  for delivery into a replacement heart valve  10 . A fabric or other material coating or exterior  192  is applied around the barbs  190  and around the helical anchor  30 . When a balloon  140  is inflated inside of the helical anchor  30 , the two ends  30   a ,  30   b  of the helical anchor  30  move in opposite directions as the helical anchor  30  is expanded. In this manner, the barbs  190  are oriented in opposite directions to the movement of the helical anchor  30  so that these barbs  190  will be activated or move when the helical anchor  30  is expanded.  FIG. 12C  illustrates a cross section of the helical anchor  30  with the fabric or other covering or coating  192  and a fastener system  190  coupled with the helical coil  30 . It was previously described as to how the turns or coils  32  of the helical anchor  30  may be driven together by inflation of a balloon  140 . Balloon inflation also drives or moves the turns  32  of the helical anchor  30  together, increasing the penetration of the barbs  190 . The barbs  190  in  FIGS. 12B-12E  are oriented obliquely relative to the central axis of the helical anchor  30 , however, the barbs  190  may instead deploy in a straight or parallel direction relative to the axis of the helical anchor  30 , straight toward an adjacent turn or coil  32  of the helical anchor  30 , driven by the compression of the helical coils  32  together by the inflating balloon  140 . With expansion, the ends  30   a ,  30   b  of the helical anchor  30  move considerably, but the central part of the anchor  30  does not turn or rotate considerably. Barbs  190  without an oblique orientation may be preferred at the center coils  32 . The angle of the barbs  190  may increase and their length can be increased in areas toward the ends  30   a ,  30   b  of the helical anchor  30  where the movement during inflation of a balloon  140  is more pronounced.  FIG. 12D  illustrates a top view of the helical anchor  30 . As the balloon catheter  140  is inflated, the helical anchor  30  increases in diameter and the ends  30   a ,  30   b  of the helical anchor  30  rotate to allow this diameter expansion. As shown in  FIG. 12E , the expansion of the helical anchor  30  has mobilized or deployed the barbs  190  and the barbs  190  engage into the fabric or other material coating  192  within the middle or central turn or coil  32 . This locks the turns or coils  32  of the helical anchor  30  together. No native valve leaflet tissue is shown in  FIG. 12E , however, it will be appreciated that leaflet tissue could be located between the turns or coils  32  and the barbs  190  could entail and engage the leaflet tissue for further securing the helical anchor  30  to the native mitral valve tissue. 
       FIGS. 13A-13C  illustrate another embodiment in which a helical anchor  30  is used having relatively larger diameter turns or coils  32  at the ends of the anchor  30  and a relatively smaller turn or turns in a middle or central portion of the helical anchor  30 . The helical anchor  30  is attached to barbs  190  and covered by a suitable coating material  192 , such as fabric or other material. When the balloon  140  is inflated the ends of the helical anchor  30  begin to move and the barbs  190  are activated as the central, smaller helical turn  30  is expanded outwardly. This particular arrangement is ideal to attach to the native mitral valve of a patient. One barbed turn or coil  32  of the helical anchor  30  may be placed above the native mitral valve leaflets and one barbed turn or coil  32  may be placed below the native mitral valve leaflets. The smaller diameter turn or coil  32  may sit above or below the native mitral valve leaflets. When the balloon (not shown) is inflated, the large helical turns or coils  32  above and below the native mitral valve leaflets will be driven towards each other as generally shown and described above in  FIGS. 8A-8D . Also, the anchor ends will rotate and barbs  190  will deploy through the mitral valve leaflet tissue positioned between the larger turns or coils  32  close to the native annulus. The two large helical turns or coils  32  can also be bound together as the barbs  190  cross the mitral tissue and penetrate the covering  192  on the helical coil  32  at the opposite side of the native mitral valve. These actions will trap the mitral valve between the turns or coils  32  of the helical anchor  30 , although it is not necessary for this to occur. It is also apparent that the large diameter turns or coils  32  at the opposite ends of the helical anchor  30  will become smaller in diameter as the balloon is expanded. In this regard, the upper and lower turns or coils  32  “donate” to the middle coil or turn  32 . This will result in a diameter reduction for the upper and lower coils  32 . After the coils  32  have been fastened to the native mitral valve perimeter or annulus, this will result in a downsizing of the diameter of the mitral valve, i.e., an annuloplasty procedure will result. When the barbs  190  are retained in the native mitral valve tissue firmly, they should not dislodge or withdraw after penetration.  FIG. 13C  illustrates a cross sectional view of a helical anchor  30  from  FIG. 13B , as well as a barb system  190  and coating  192 , such as fabric or other material. As described previously, barbs  190  can deploy directly from the helical anchor  30  at a roughly 90° angle relative to the coil  32 . This may be driven simply by compressing coils  32  relative to one another as described above in connection with  FIGS. 8A-8D . The movement of the helical coil or anchor turns  32  longitudinally or rotationally also allows barbs  190  or other types of fasteners to be applied in a direction which is more parallel or oblique relative to the turns or coils  32  of the helical anchor  30 . 
       FIGS. 14A-14C  illustrate a different configuration for a helical anchor  30 . This anchor  30  has generally four coils  32 . There are two upper coils  32  followed by a joining segment  32   a  (gap segment). The joining segment  32   a  is typically used to separate the coils  32  of the anchor  30  that sit above the valve leaflets from those that are below (in the atrium and in the ventricle, respectively). There is a coil  32   b  of similar size as the two upper coils  32  at the end of the joining segment  32   a . This is the lowest coil  32   b  on the anchor  30 . The final coil  32   c  changes direction—instead of continuing on downward, it coils back up and overlaps or crosses over an adjacent coil  32  of the anchor  30 . This coil  32   c  is shown as the “larger convolution” in  FIG. 14B . The figure shows a directional change (like the joining segment) in the anchor  30  that allows the final coil  32   c  to be directed upward. The final coil  32   c  is also larger to allow it to sit on the outside of the other coils. This larger coil  32   c  is the middle coil of the anchor  30  but is actually turned into the native valve first when being delivered. The important feature of this anchor  30  is that as it is turned into position, the upward bend in the joining segment  32   a  forces the anchor  30  up toward the annulus. This anchor  30 , when positioned with two coils above and two coils below the leaflets, sits with the larger coil  32   c  of the anchor  30  sitting right under the mitral valve annulus. The anchor  30  does not tend to fall into the ventricle. The lowest coils do not necessarily have to cross on the same point when viewed from the side (producing an X). They could cross for example on opposite sides. 
     The key element in the embodiment of  FIGS. 14A-14C  is for the turning of the anchor  30  into position to result in an upward motion of the end of the anchor  30  which drives the anchor  30  into position right under the mitral valve. As this anchor is “screwed in” the lowest coil  32   b  forces the anchor  30  upward against the mitral annulus. The larger diameter coil  32   c  in the middle of the anchor  30  also helps the anchor  30  positioning right under the leaflets and close to the annulus. The mitral annulus has a certain diameter and by matching this diameter with the diameter of the largest anchor coil  32   c , the anchor  30  is able to sit right under the annulus. If this coil  32   c  is too small, the anchor  30  can drag against the leaflet tissue and inhibit the anchor  30  from riding upward toward the annulus as it is placed. It will be appreciated that crossing coils  32   a ,  32   b  in an anchor  30  may also be useful for valve anchoring when using an anchor  30 . The crossing coil  32   a  occurs in the lowest coil of this anchor  30 . But a crossing segment  32   a  could occur in any location. It could occur at the top, in the middle or at the bottom of the anchor  30 . The amount of crossover could also vary. Here the cross over includes the lowest two coils  32 . There could be more coils that overlap.  FIG. 14C  shows the overlapping coil  32   a  with the lowest coil being outside the prior coils. The overlapping coil  32   a  or crossing segment could occur inside the prior coils.  FIG. 14C  also shows an abrupt change in pitch to cause an overlap. The overlap can also occur with a gentle change of pitch. In  FIGS. 14A through 14C , the spacing between coils in both the top to bottom and side to side dimensions are exaggerated for clarity. The coils will apply compression from the top and bottom toward the center. 
     A major advantage of the configuration shown in  FIGS. 14A-14C  is that the number of coils  32  available to attach the valve is increased, but the length of the anchor  30  does not increase. This allows a shorter anchor. For example, it may be useful to have less anchor length positioned in the left ventricle  40  so the valve  10  can sit more towards the atrium  42 . The overlapping or crossing coils  32   a  may crossover in a desired manner and allow the valve  10  to be retained with strong force and a shorter overall length inside the left ventricle  40 . The overlap  32   a  in the anchor could also be positioned at the level where the native leaflets  12   a ,  12   b  are sitting. This would increase the trapping of the leaflets  12   a ,  12   b —the anchor  30  could be positioned such that overlapping coils had leaflet between them. If the gap between the coils  32  of the anchor  30  were sufficiently small, the leaflets  12   a ,  12   b  could be trapped between the coils  32  without the need for additional fasteners. This arrangement may also position the leaflets  12   a ,  12   b  to be fastened to the anchor  30  or an anchoring system attached or guided by the anchor  30 . This particular anchor arrangement is also useful because the lowest coil of the anchor coils  32  extends in the opposite direction to the remainder of the anchor  30 —while the other coils  32  are biased downward, this is biased upward. As this anchor  30  is turned into position, the lowest coil  32   b  will tend to move back upward. This is actually creating a virtual reverse thread. A typical helical anchor is screwed into the valve leaflets  12   a ,  12   b  like a corkscrew and as it is turned, it moves downward. With this configuration, once the first coil of the anchor  30  is turned into the valve  12  and the joining segment  32   a  is reached, the anchor  30  actually begins to turn upward instead of downward as the lowest coil  32   b  is being turned in. This means this particular anchor arrangement will tend to sit right under the annulus  12 . This is useful in optimally positioning the anchor  30  close to the underside of the annulus  12 . An anchor  30  attached to the leaflets  12   a ,  12   b  away from the annulus  12  will tend to move and rock as the heart contracts. This is because of leaflet motion away from the annulus  12  as the heart beats. In contrast the annulus  12  itself moves very little as the heart beats. By placing the anchor  30  closer to the annulus  12  (away from the leaflets), the amount of movement of the anchor  30  is reduced. Each day the heart beats about 100,000 times. This repetitive motion will produce a risk of anchor and valve dislodgement. Thus minimizing the motion by placing the anchor  30  close to the annulus  12  will reduce the risk of valve implant failure. In  FIGS. 14A-14C , the crossing points for the anchor coils  32  are both on the same side of the anchor  30 . This creates an X. It is not necessary for the crossing points to occur at the same side. For example, they could be on opposite sides of the anchor  30 . 
     While the present invention has been illustrated by a description of preferred embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features and concepts of the invention may be used alone or in any combination depending on the needs and preferences of the operator. This has been a description of the present invention, along with the preferred methods of practicing the present invention as currently known. However, the invention itself should only be defined by the appended claims.