Apparatus and methods for implanting replacement heart valve

Abstract

To provide systems and methods for appropriately docking a heart valve prosthesis.SOLUTION: Systems and methods for docking a heart valve prosthesis are provided. A system includes a helical anchor (30) formed as multiple coils (32) adapted to support a heart valve prosthesis (10) with coil portions (32) positioned above and below a heart valve annulus (12). A seal (50) is coupled with the helical anchor (30) and includes portions extending between adjacent coils (32) for preventing blood leakage through the helical anchor (30) and past the heart valve prosthesis (10). An expansible helical anchor (30) is formed as multiple coils (32) adapted to support the heart valve prosthesis (10). At least one of the coils (32) is normally being at a first diameter and is expandable to a second, larger diameter upon application of radial outward force from within the helical anchor (30).SELECTED DRAWING: Figure 7D-1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 61 / 864,840, filed August 12, 2013 (pending), U.S. Provisional Patent Application No. 61 / 867,287, filed August 19, 2013 (pending), and U.S. Provisional Patent Application No. 61 / 878,280, filed September 16, 2013 (pending), the disclosures of which are hereby incorporated by reference herein.

[0002] The present invention relates generally to medical procedures and devices relating to heart valves, such as replacement techniques and devices. More particularly, the present invention relates to the replacement of heart valves having various malformations and dysfunctions. [Background technology]

[0003] Complications of the mitral valve, which controls blood flow from the left atrium to the left ventricle of the human heart, are known to cause fatal heart failure. In developed countries, one of the most common forms of valvular heart disease is mitral valve leakage, also known as mitral regurgitation, which is characterized by abnormal leakage of blood from the left ventricle back into the left atrium through the mitral valve. This is most commonly due to ischemic heart disease when the mitral valve leaflets no longer contact or close properly after multiple infarctions, idiopathic cardiomyopathy, and hypertensive cardiomyopathy that cause the left ventricle to expand, as well as abnormalities of the leaflets and chordae, such as those caused by degenerative diseases.

[0004] In addition to mitral regurgitation, narrowing or stenosis of the mitral valve is most often the result of rheumatic disease, which has been virtually eliminated in developed countries but remains common in areas with a lower standard of living.

[0005] Similar to the complications of the mitral valve are those of the aortic valve, which controls the flow of blood from the left ventricle into the aorta. For example, many elderly patients suffer from aortic stenosis. Historically, the conventional treatment has been valve replacement by a large open heart procedure. This procedure is very invasive and requires a significant amount of recovery time. Fortunately, in the last decade, there has been a great progress in replacing this large open heart surgical procedure with a catheter procedure that can be performed quickly without the need for a surgical incision or the need to support circulation with a heart-lung machine during cardiac arrest. By using a catheter, the valve is attached to a stent or stent-like structure, which is compressed and delivered through the blood vessels to the heart. The stent is then expanded and the valve begins to function. The diseased valve is not removed, but instead is crushed and deformed by the stent that houses the new valve. The deformed tissue serves to help fix the new prosthetic valve.

[0006] Delivery of the valve can be accomplished from any artery that is easily accessible within the patient. Most commonly, this is done from the groin, where the femoral and iliac arteries can be cannulated. The shoulder area has also been utilized, where the subclavian and axillary arteries are also accessible. Recovery from this procedure is remarkably rapid.

[0007] Not all patients can undergo pure catheterization procedures. In some cases, the arteries are too small to pass a catheter to the heart, or the arteries are too diseased or tortuous. In these cases, the surgeon can make a small chest incision (thoracotomy) and then place these catheter-based devices directly into the heart. Typically, a purse-string suture is made at the apex of the left ventricle and a delivery system is placed through the apex of the heart. The valve is then delivered to its final position. These delivery systems can also be used to access the aortic valve from the aorta itself. Some surgeons introduce aortic valve delivery systems directly into the aorta during open surgery. These valves are very diverse. There is a mounting structure, often in the form of a stent. The artificial leaflets are carried inside the stent on a mounting and retention structure. Typically, these leaflets are made from biomaterials used in conventional surgical valves. The valve can be actual heart valve tissue from an animal, or more often the leaflets are made from pericardial tissue from bovine, porcine, or equine animals. The leaflets are treated to reduce their immunogenicity and improve their durability. Many tissue processing techniques have been developed for this purpose. In the future, bioengineered tissues may be used, or polymers or other non-biological materials may be used for the leaflets. All of these may be incorporated into the invention described in this disclosure.

[0008] In fact, there are more patients with mitral valve disease than those with aortic valve disease. While many companies have been successful in creating catheter or minimally invasive implantable aortic valves in the last decade, implanting the mitral valve is more difficult and to date there has been no good solution. Patients would benefit from implantation of the device through a small incision surgical procedure or by catheter implantation, such as through the groin. From the patient's perspective, the catheter procedure is very attractive. At present, there is no method available on the market to replace the mitral valve through a catheter procedure. Many patients who require mitral valve replacement are elderly, and open heart procedures are painful, risky, and require long recovery times. Some patients are not even candidates for surgery due to their advanced age and frailty. Thus, there is a particular need for a remotely deployed mitral valve replacement device.

[0009] It was previously believed that mitral valve replacement, rather than valve repair, was associated with a more negative long-term outcome for patients with mitral valve disease, but this belief is beginning to be questioned. It is now believed that the outcome for patients with mitral valve leakage or regurgitation is much the same whether the valve is repaired or replaced. Furthermore, the durability of mitral valve surgical repair is now being questioned. Many patients who undergo repair develop leaks over the course of several years. As many of these are elderly, repeated interventions in elderly patients are not welcomed by patients or physicians.

[0010] The most prominent obstacle to catheter mitral valve replacement is holding the valve in place. The mitral valve is subject to large cyclic loads. The pressure in the left ventricle approaches zero before contraction and then rises to the systolic pressure (or even higher if there is aortic stenosis), which can be very high if the patient suffers from systolic hypertension. The loads on the valve are often 150 mmHg or more. As the heart is moving by pulsating, this movement and loads can combine to displace the valve. This movement and rhythmic loads can also fatigue the material, leading to its failure. Thus, there are major problems associated with fixation of the valve.

[0011] Another problem in performing catheter-delivered mitral valve replacement is size. The implant must have strong retention and leak-avoidance characteristics and must accommodate the valve. A separate prosthesis may help to eliminate this problem by placing the anchor or dock first and then implanting the valve second. However, in this situation, the patient must remain stable between the implantation of the anchor or dock and the implantation of the valve. If the patient's native mitral valve becomes incompetent due to the anchor or dock, then the patient may rapidly become unstable, forcing the practitioner to stabilize the patient by rushing to implant a new valve or possibly removing the anchor or dock and abandoning the procedure.

[0012] Another problem with mitral valve replacement is paravalvular leakage, or paravalvular leakage. If a good seal is not established around the valve, blood can leak back into the left atrium. This puts extra strain on the heart and can damage the blood by moving as a jet through the leak site. Hemolysis, or destruction of red blood cells, is a frequent complication when this occurs. Paravalvular leakage was one of the problems commonly faced when aortic valves are initially implanted on a catheter. During surgical replacement, the surgeon has a great advantage when replacing the valve because he can see the gaps outside the valve sutures and can prevent or repair them. With catheter insertion, this is not possible. Furthermore, large leaks can reduce the patient's survival rate and cause symptoms (e.g., dyspnea, edema, fatigue, etc.) that limit mobility and make the patient uncomfortable. Therefore, devices, systems, and methods related to mitral valve replacement should further incorporate measures to prevent and repair leakage around the replacement valve.

[0013] Also, the mitral annulus of a patient can be very large. When companies develop surgical replacement valves, this problem is solved by limiting the number of sizes of the actual valve made and then increasing the valve size by adding more fabric cuffs around the edge of the valve. For example, a patient may have a 45mm annulus. In this case, the actual prosthetic valve diameter may be 30mm, and this difference is made up by adding a larger fabric cuff material band around the prosthetic valve. However, in catheter procedures, adding more material to the prosthetic valve poses problems because this material must be condensed and retained by a small delivery system. This method is often very difficult and impractical, so an alternative solution is needed.

[0014] Since many valves have been developed for the aortic position, it is desirable to avoid repeating valve development and utilize existing valves. These valves are very expensive to develop and bring to market, so expanding their use can save a significant amount of time and money. In this case, it would be useful to create a mitral valve anchor or docking station for such valves. Existing valves developed for the aortic position can be implanted into the docking station, possibly with some modification. Some previously developed valves, such as the Edwards Sapien™ valve, may fit well without any modification. Others, such as the Corevalve™, may be implantable but require some modification for optimal engagement with the anchor and fit inside the heart.

[0015] Several further complications may occur due to a poorly retained or poorly positioned mitral valve replacement prosthesis: the valve may be displaced into the atrium or ventricle, which may be fatal to the patient. Previous prosthesis anchors have reduced the risk of displacement by puncturing the tissue to retain the prosthesis. However, this is a risky approach, since the puncture must be performed by a sharp object from a distant location, which poses the risk of perforation of the heart and injury to the patient.

[0016] The orientation of the mitral valve 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 can result in poor blood flow, blockage of flow by the heart wall or valve leaflets, and poor hemodynamics. Repeated contractions against the ventricular wall can also lead to dehiscence of the posterior wall of the heart and sudden death of the patient.

[0017] During surgical mitral valve repair or replacement, the anterior leaflet of the mitral valve sometimes becomes wedged into the left ventricular outflow area, resulting in poor left ventricular drainage. This syndrome is known as left ventricular outflow tract obstruction. If the replacement valve is located close to the aortic valve, the replacement valve itself may cause left ventricular outflow tract obstruction.

[0018] Yet another obstacle faced when implanting a replacement mitral valve is the need for the patient's native mitral valve to continue functioning regularly during placement of the prosthesis so that the patient may remain in a stable condition without the need for a heart-lung machine to support their circulation.

[0019] Furthermore, it is desirable to provide devices and methods that can be used in various implantation approaches. Depending on the anatomy and clinical situation of a particular patient, a medical professional may want to make a decision regarding the most suitable implantation method, such as inserting a replacement valve directly into the heart in an open procedure (open heart surgery or minimally invasive surgery) or inserting the replacement valve via a vein and an artery in a closed procedure (such as catheter-based implantation). It is preferable to give the medical professional a choice of multiple implantation options. For example, a medical professional may want to insert a replacement valve from either the ventricular side or the atrial side of the mitral valve. [Prior art documents] [Patent documents]

[0020] [Patent Document 1] U.S. Provisional Patent Application No. 61 / 864,860 Summary of the Invention [Problem to be solved by the invention]

[0021] Thus, the present invention provides devices and methods that address these and other shortcomings in the art. [Means for solving the problem]

[0022] In one exemplary embodiment, a system for docking a heart valve prosthesis is provided, comprising a helical anchor formed as a plurality of coils configured to support the heart valve prosthesis with coil portions positioned above and below the heart valve annulus, and a seal coupled to the helical anchor, the seal comprising portions extending between adjacent coils for preventing blood leakage through the helical anchor and past the heart valve prosthesis.

[0023] The system may further comprise a heart valve prosthesis that can be delivered to the patient's native heart valve location and expanded within the plurality of coils and into engagement with the leaflets of the heart valve. The seal is engaged to both the helical anchor and the heart valve prosthesis. The coils of the helical anchor may be formed of a superelastic or shape memory material, or other suitable material. The seal may be a membrane or panel that extends over at least two coils of the helical anchor. The membrane or panel is moved between a non-deployed state and a deployed state, the non-deployed state configured for delivery to the implantation site, and the non-deployed state configured for implanting the system and securing the heart valve prosthesis. The non-deployed state may be wound up on one of the coils of the helical anchor or any other buckled state. The membrane or panel may comprise an attached support element, such as an internal spring-loaded wire. The seal may further comprise one or more sealing elements carried by the helical anchor with overlapping portions configured to seal spaces between adjacent coils of the helical anchor. Each of the one or more sealing elements may include a support element, such as an inner wire, which may be a mounted, spring-loaded coil or other configuration. Each of the one or more sealing elements may have a cross-sectional shape, for example, generally circular or oval. Each of the one or more sealing elements may have a connecting portion mounted to one of the coils and an extension portion that extends toward an adjacent coil to provide a sealing function between the coils.

[0024] In another exemplary embodiment, a system for replacing a native heart valve includes an expandable helical anchor formed as a plurality of coils configured to support a heart valve prosthesis, at least one of the coils being typically defined by a first diameter and expandable to a second, larger diameter upon application of a radially outward force from within the helical anchor. The system further includes an expandable heart valve prosthesis that is delivered within the helical anchor and expanded within the plurality of coils into engagement with the at least one coil, capable of moving the at least one coil from the first diameter to the second diameter while securing the helical anchor and the heart valve prosthesis together.

[0025] In a further aspect, the helical anchor may comprise another coil that moves from a larger diameter to a smaller diameter when 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 towards each other when the heart valve prosthesis is expanded inside the multiple coils. The helical anchor may further comprise a plurality of fasteners, and the fasteners are moved from a non-deployed state to a deployed state by the movement of at least one coil from a first diameter to a second larger diameter. A seal may be coupled to the helical anchor, and comprises a portion extending between the adjacent coils for preventing blood leakage through the helical anchor and past the heart valve prosthesis. The system may further comprise at least one compressible element on the helical anchor, the compressible element being engaged by the heart valve prosthesis when the heart valve prosthesis is expanded inside the multiple coils to assist in mounting 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 a resilient spring-like material such as a polymer or foam. The at least one compressible element may further comprise multiple compressible elements spaced along the multiple coils, or a continuous compressible element extending along the multiple coils. The heart valve prosthesis may further comprise an expandable structure comprising an opening. The opening is engaged by the at least one compressible element when the heart valve prosthesis is expanded within the multiple coils to strengthen the connection between the anchor and the prosthesis. The multiple coils of the helical anchor may comprise at least two coils that cross each other. The system may comprise any feature of a system that uses a seal, and vice versa, depending on the desired function and effect.

[0026] A method of implanting a heart valve prosthesis in a patient's heart is also provided. In an exemplary embodiment, the method includes the step of delivering a helical anchor in the form of multiple coils such that a portion of the helical anchor is located above the native heart valve and a portion is located 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 to prevent blood flow leakage during operation of the heart valve prosthesis.

[0027] The step of positioning the seal may further include 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 buckled state. The step of positioning the seal may further include positioning one or more sealing elements carried by the helical anchor such that overlapping portions seal spaces between adjacent coils of the helical anchor. Each of the one or more sealing elements may include an attached support element.

[0028] In another embodiment, a method of implanting an expandable heart valve prosthesis in a patient's heart is provided. The method includes the step of delivering an expandable helical anchor in the form of multiple coils such that a portion of the expandable helical anchor is located above the native heart valve and a portion is located below the native heart valve. The expandable heart valve prosthesis is positioned within the multiple coils of the expandable helical anchor with the expandable heart valve prosthesis and the expandable helical anchor in a non-expanded state. The expandable heart valve prosthesis is then expanded relative to the expandable helical anchor, thereby securing the expandable heart valve prosthesis to the expandable helical anchor. "Expandable" means that the diameter of at least one coil of the anchor expands.

[0029] The method may further include moving the coils from a larger diameter to a smaller diameter when the heart valve prosthesis is expanded inside the coils. At least two adjacent coils of the helical anchor may be spaced apart, and the method further includes moving the at least two adjacent coils toward each other when the heart valve prosthesis is expanded inside the coils. The helical anchor may further comprise a plurality of fasteners, and the method further includes moving the fasteners from a non-deployed state to a deployed state when the expandable heart valve prosthesis is expanded relative to the expandable helical anchor. A seal may be positioned between adjacent coils to prevent blood leakage through the helical anchor and through the heart valve prosthesis, and the fasteners engage the seal in the deployed state. The fasteners may instead engage a portion of the anchor that is not the seal. Any other aspect of the method or system disclosed herein may be used in addition or alternatively with this method depending on the desired results.

[0030] Various additional advantages, methods, devices, systems and features will become more readily apparent to those of ordinary skill in the art upon consideration of the following detailed description of the illustrative embodiments in conjunction with the accompanying drawings. [Brief description of the drawings]

[0031] [Figure 1A] FIG. 1 is a schematic cross-sectional view showing a replacement heart valve implanted in a native valve position using a helical anchor. [Figure 1B] FIG. 1B is a schematic cross-sectional view similar to FIG. 1A, but showing the use of a seal in combination with a helical anchor. [Figure 2A] 1 is a perspective view showing one method of applying a seal structure to a helical anchor. FIG. [Figure 2B] 2B is a perspective view illustrating a further step in the method shown in FIG. 2A. [Figure 2C] FIG. 13 is a cross-sectional view of the helical anchor after application of a seal. [Figure 2D] FIG. 13 is an enlarged cross-sectional view of a helical anchor having one form of seal applied thereto. [Figure 2E] FIG. 2E is a cross-sectional view similar to FIG. 2D, but showing an alternative embodiment of the seal. [Figure 2F] 2F is another enlarged cross-sectional view similar to FIG. 2E, but showing another alternative embodiment of the seal. [Figure 3A] 13 is a schematic perspective view illustrating another alternative embodiment of the helical anchor and seal; FIG. [Figure 3B] FIG. 3B is a cross-sectional view of the embodiment shown in FIG. 3A with adjacent helical coils compressed together for delivery. [Figure 3C] FIG. 13 is a cross-sectional view showing the helical anchor and seal expanded after delivery. [Figure 3D] FIG. 13 is a partial perspective view of another exemplary embodiment of a helical anchor. [Figure 3E] FIG. 3E is a schematic elevation view, partially broken away, illustrating application of a seal to the helical anchor structure of FIG. 3D. [Figure 3F] FIG. 13 is an enlarged cross-sectional view of another embodiment of a helical coil structure with a seal. [Figure 3G] FIG. 3F is a cross-sectional view similar to that of FIG. 3F, but showing the structure after delivery and spreading of the seal. [Figure 3H]FIG. 3H is a cross-sectional view similar to FIG. 3G, but showing portions of the helical anchor structure and associated seal expanded after delivery. [Figure 4A] FIG. 13 is a perspective view showing a helical anchor in combination with another alternative embodiment of a seal. [Figure 4B] FIG. 13 is a perspective view of a seal illustrating an alternative embodiment that adds support structure to the seal. [Figure 4C] FIG. 4B is a schematic cross-sectional view showing the embodiment of FIG. 4A implanted in a native heart valve position. [Figure 4D] 4D is a schematic cross-sectional view showing a replacement heart valve implanted within the helical anchor and seal structure of FIG. 4C. [Figure 5A] FIG. 13 is a perspective view of a helical anchor with a membrane or panel seal applied. [Figure 5B] FIG. 5B is a perspective view of the helical anchor with the membrane or panel seal of FIG. 5A in a deployed or unfolded state. [Figure 5C] FIG. 1 is a perspective view of a membrane or panel seal having an internal support structure. [Figure 5D] FIG. 13 is an enlarged cross-sectional view of the helical coil and undeployed membrane seal. [Figure 5E] FIG. 5E is a cross-sectional view similar to FIG. 5D, but showing the membrane seal buckled and folded rather than wrapped around a helical coil. [Figure 5F] FIG. 13 is a perspective view of a portion of the coil and membrane seal showing further details including the internal support structure and sutures. [Figure 5G] FIG. 1 is a cross-sectional view showing a helical coil and membrane seal implanted at a native heart valve site. [Figure 5H] FIG. 5C is a cross-sectional view similar to FIG. 5G, but further showing a replacement or prosthetic heart valve implanted within a helical coil and a membrane seal. [Figure 6A] FIG. 1 is a cross-sectional view showing a helical coil implanted and being expanded by a balloon at a native heart valve site. [Figure 6B]FIG. 1 is a cross-sectional view showing a stented heart valve, a replacement heart valve, or a prosthetic heart valve, implanted in a helical coil and membrane seal structure. [Figure 7A] FIG. 1 is a cross-sectional view that illustrates a schematic of a helical coil having approximately two windings or coils with a first diameter and another coil with a second, larger diameter. [Figure 7B] 7B illustrates an initial step in the implantation of the helical anchor shown in FIG. 7A at a native heart valve site, with a stented replacement heart valve ready for implantation into the helical anchor. [Figure 7C] FIG. 13 illustrates a further portion of the procedure in which the stented replacement heart valve is expanded using a balloon catheter. [Figure 7D] 13A-13C show a further portion of the procedure and a cross-sectional view of a replacement heart valve implanted within a helical anchor. [Figure 7D-1] 7D, but showing an alternative configuration of the replacement heart valve and anchor. FIG. [Figure 8A] FIG. 13 is an elevational view of another embodiment of a helical anchor being expanded by a balloon catheter. [Figure 8B] FIG. 8B is similar to FIG. 8A, but showing further expansion of the balloon catheter. [Figure 8C] FIG. 8C is similar to FIG. 8B, but showing further expansion of the balloon catheter. [Figure 8D] FIG. 8D is an enlarged cross-sectional view showing compression of the helical coil from FIG. 8C. [Figure 9A] FIG. 13 is an elevational view of another embodiment of a helical anchor being expanded by a balloon catheter. [Figure 9B] FIG. 9B is similar to FIG. 9A, but showing further expansion of the balloon catheter. [Figure 9C] FIG. 9C is similar to FIG. 9B, but showing further expansion of the balloon catheter. [Figure 9D] FIG. 9D is an enlarged cross-sectional view showing compression of the helical coil from FIG. 9C. [Figure 10A] 11 is a partial cross-sectional view illustrating another embodiment of a helical anchor inserted or implanted at a native heart valve site and the insertion of a stented replacement heart valve into the helical anchor and the native heart valve site. [Figure 10B] 10B is a cross-sectional view similar to FIG. 10A, but showing the expansion and implantation of a stented replacement heart valve within a helical anchor. [Figure 10C] FIG. 10C is a cross-sectional view, partially broken away, of the implanted replacement heart valve and helical anchor shown in FIG. 10B. [Figure 10C-1] FIG. 13 is an enlarged cross-sectional view showing the engagement between a stent and a helical anchor of a replacement heart valve. [Figure 10D] 10D is a top view showing the expansion process of a stent-mounted replacement heart valve within the helical anchor of FIG. 10C. [Figure 10E] FIG. 10E is a top view similar to FIG. 10D, but showing complete expansion and implantation of the stented replacement heart valve. [Figure 11A] 11 is a partial cross-sectional view illustrating another embodiment of a helical anchor inserted or implanted at a native heart valve site and the insertion of a stented replacement heart valve into the helical anchor and the native heart valve site. [Figure 11B] 11B is a cross-sectional view similar to FIG. 11A, but showing the expansion and implantation of a stented replacement heart valve within a helical anchor. [Figure 11C] 11C is a top view showing the expansion process of a stented replacement heart valve within the helical anchor of FIG. 11B. [Figure 11D] FIG. 11D is a top view showing full expansion of a stent-mounted replacement heart valve within the helical anchor of FIG. [Figure 12A] FIG. 13 is an elevational view of another embodiment of a helical anchor. [Figure 12B] FIG. 13 is a cross-sectional view of another embodiment of a helical anchor. [Figure 12C]FIG. 12C is an enlarged cross-sectional view of the helical anchor taken along line 12C-12C of FIG. 12B. [Figure 12D] FIG. 13 is a top view of a helical anchor, illustrating schematic expansion by a balloon catheter. [Figure 12E] FIG. 12E is a cross-sectional view of the helical anchor shown in FIG. 12D, but expanded to show portions deployed within the fabric seal. [Figure 13A] FIG. 13 is an elevational view of another embodiment of a helical anchor. [Figure 13B] FIG. 13 is a cross-sectional view of another embodiment of a helical anchor. [Figure 13C] FIG. 13C is an enlarged cross-sectional view of the helical anchor taken along line 13C-13C of FIG. 13B with barbs deployed within the outer sealing layer. [Figure 14A] FIG. 13 is a perspective view of an alternative helical anchor. [Figure 14B] FIG. 14B is a top perspective view of the helical anchor shown in FIG. 14A. [Figure 14C] FIG. 14C is a front view of the helical anchor shown in FIGS. 14A and 14B. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] It will be understood that like reference numerals are used to refer to substantially similar structures or features in each of the figures. Differences between such elements will generally be explained as necessary, but identical structures need not be repeatedly explained in each figure for clarity and brevity, as reference may be made instead to the previous explanations. FIG. 1 shows, in a schematic manner, a typical replacement heart valve or prosthesis 10 that may be implanted in place of a native heart valve, such as the mitral valve 12, using a catheter (not shown). 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 systole and diastole of the heart, a sealing condition is desired around the valve 10, i.e., between the periphery of the replacement valve 10 and the native biological tissue. The portion of the replacement heart valve 10 intended to be positioned in contact with the native tissue comprises a textile or polymeric cover 18 to prevent backflow of blood. In FIG. 1A, the textile cover 18 is shown adjacent to the replacement valve leaflets 14, 16 in the replacement valve 10 with the stent attached. These replacement valve leaflets 14, 16 are typically formed from biological materials, such as from bovine or porcine, but may be synthetic or other biological forms. Approximately half of this replacement valve 10 does not have a seal, i.e., a more or less exposed stent 24 with openings 24a. This is because the coronary arteries would be directly above the aortic valve if the replacement valve 10 were placed in its native position in the aorta. If the seal 18 extended the entire length of the stented portion 24 of the replacement valve 10, the coronary arteries would be blocked. In FIG. 1A, an unmodified aortic replacement valve 10 is shown implanted in a helical anchor 30 comprised of a coil 32. Because there is a gap between the seal 18 on the stented valve 10 and its attachment to the patient's mitral valve 12, blood flow leakage can occur, as indicated diagrammatically by arrow 36. Blood flow leakage can occur in any direction. Here, arrow 36 indicates leakage from the ventricle 40 to the atrium 42 due to intraventricular pressure being higher than intraatrial pressure. An unmodified aortic valve 10 placed in the native mitral position would be prone to developing leakage. To circumvent this problem, two main approaches can be taken.First, a seal may be added to the system, for example the helical anchor 30 may add a sealing feature. Second, the position where the stented replacement heart valve 10 is placed 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 positioned so that it will not leak. One drawback of placing the valve 10 lower inside the left ventricle 40 is that the replacement heart valve 10 may cause damage inside the left ventricle 40 or the valve 10 may inhibit 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. Instead of simply placing the replacement heart valve 10 deeper or lower inside the left ventricle 40, it may be useful to keep the position of the stented replacement valve 10 positioned more atrially (i.e. positioned higher and extending into the atrium 42), as shown in FIG. 1A.

[0033] FIG. 1B illustrates an embodiment of providing a seal structure 50 at the upper portion of the 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 are added to the helical anchor 30. Specifically, a fabric covered elliptical seal structure 52 is added to the helical anchor 30 to form a seal. The seal 52 may be made of fabric or any other material that forms a sufficient seal to prevent blood flow. The seal 52 extends to the height of the attachment between the stented replacement valve 10 and the native mitral valve leaflets 12a, 12b. In this exemplary embodiment, the seal 52 is a continuous tube and includes one or more seal elements or seal portions 52a, 52b, 52c in the form of overlapping segments of fabric or other sealing material. These segments 52a, 52b, 52c of the seal structure act as clapboard structures or shingles to seal the gaps between the coils 32 or windings of the helical anchor 30.

[0034] FIG. 2A illustrates one method of applying or otherwise integrating an overlapping seal structure 50, such as that shown in FIG. 1B, onto the helical anchor 30. In this regard, the seal structure 50 may be integrated with the helical anchor 30 for delivery. The shingles or overlapping seal portions 52a-52c (FIG. 1B) may buckle and be pushed out of the catheter 60. Alternatively, once the helical anchor 30 is delivered to the native heart valve site, the fabric or other seal structure 50 may be delivered over the coil 32 of the anchor 30 from the same delivery catheter 60. Alternatively, the overlapping seal structure 50 may be affixed to the helical anchor 30 by pushing or extending the helical anchor 30 out of the delivery catheter 60. FIG. 2A specifically illustrates the helical anchor 30 with the fabric or other seal structure 50 being delivered over the helical coil 32 from the sheath or delivery catheter 60. The sealing structure 50 may be generally circular in cross section, or any other shape, such as a shape better configured to overlap as shown diagrammatically in FIG. 1B above. FIG. 2B shows fabric 62 and an internal support coil 64 that will be added to the helical anchor 30 in a further portion or step of the procedure shown in FIG. 2A. FIG. 2C shows one embodiment of the completed assembly shown in cross section, with 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 may be used simply to deliver these sealing elements 62, 64 over the helical anchor 30.

[0035] 2D shows a cross-sectional view of sealing elements 62, 64, which in this case are circular in cross-section. These sealing elements 62, 64, such as those comprising a coil support and fiber combination, may be of virtually any shape so long as they form a seal when placed together. The sealing elements 62, 64 may not overlap in use, but instead contact one another as shown to form a seal therebetween.

[0036] Figure 2E shows a seal structure 70 shaped with an oval or elliptical cross section similar to the seal 50 shown in Figure 1B, with segments 70a, 70b overlapping each other to provide a secure and liquid-tight seal. It is possible to have an oval seal structure 70 that is compressed for delivery and then springs open or is biased open when the seal structure 70 is pushed out of the delivery catheter or sheath. The coil 74 that internally supports the fibers 72 may be made from Nitinol (super elastic) wire or spring steel wire so that it can buckle and then be biased or spring open into a predetermined shape as needed.

[0037] 2F shows another alternative sealing structure 80. In this case, a sealing fabric 82 or other material is wrapped around the helical anchor 30. The fabric is sewn with a suitable thread to form a rigid structural panel 84 extending from a connecting portion 86 attached to the coil 32 of the helical anchor 30. The panel 84 also overlaps to form a liquid-tight seal similar to a shingle effect. This configuration can be delivered similar to the fabric-covered coil design previously described above by feeding the panel structure over the helical anchor 30 as shown.

[0038] FIG. 3A shows another embodiment for providing a sealing structure. There may be two or more "frame" segments 92, 94 inside a fabric cover 96 or other material seal to give the seal structure 90 additional shape and support. This gives the seal structure 90 shape and allows for more secure overlapping of the seal segments (only one is shown in FIG. 3A). This may be achieved by using a double helix, where 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 by a curved section 98 as shown in FIG. 3A. A sleeve or coating 96 of fabric or other material may be fed over the double helix during or after delivery of the helical seal structure 90.

[0039] 3B shows a cross-sectional view of a compressed seal structure 90 with wires 92, 94 inside an outer fabric or other material 96. This may allow for easy delivery to the implantation site.

[0040] 3C shows a double helix seal 90 that is spaced apart and overlaps after delivery. Two segments 90a, 90b of the helix seal 90 can be expanded by being delivered to form overlapping seal segments 90a, 90b similar to the "shingle" configuration discussed above. Here, the two overlapping seal segments 90a, 90b are supported by two double helix frames 92, 94 that are positioned adjacent and overlapping each other to provide an effective liquid-tight seal.

[0041] FIG. 3D shows another alternative method for joining the seal frame segments 92, 94, specifically for biasing the frame segments 92, 94 apart. An interconnecting segment 100 between the two frame pieces or wires 92, 94 can press the frame segments 92, 94 into the desired final shape. This double helix design can be made from multiple pieces of wire, or from a single pure Nitinol or steel tube or wire, similar to stent manufacturing techniques. The seal frames 92, 94 can also have a sinusoidal or approximately back-and-forth zigzag configuration (not shown) to hold a shingle-type shape rather than two rails or wires inside the outer seal material or fabric 96 (FIG. 3C).

[0042] 3E shows in detail how an outer sealing material or fabric 96 may be placed over the expanded frames 92, 94. The sealing material 96 may be pre-loaded onto the double helix frames 92, 94 and the two may be delivered together. Alternatively, the sealing material 96 may be delivered onto the double helix frames 92, 94 after they are already in position at the implantation site, such as the site of the native mitral valve. In the unexpanded state, the double helices 92, 94 may be pushed through a catheter as previously described.

[0043] 3F, 3G, and 3H show schematic progressions of the delivery and implantation of the seal 90. In these figures, the seal material or fabric 96 extends beyond the frames 92, 94 to form flaps or panels 102 of seal material. These flaps or panels 102 may be stiffened and reinforced with thick sutures or the material may be dipped or coated with a stiffening agent. This may be useful to ensure a liquid-tight seal. In FIG. 3F, the inner wire frame 92, 94 is buckled and the fabric cover 96, 102 is folded within the delivery sheath 60 for delivery. In FIG. 3G, the frames 92, 94 have been delivered and the segments or flaps 102 of the seal material 96 that extend beyond the frames 92, 94 are unfolded. FIG. 3H shows the frame portions 92, 94 expanded similar to a stent. This provides a tight and secure seal. The cross members or biasing members 100 that were buckled inside the double helix frames 92, 94 are now biased outward, stretching and straightening. These cross members 100 may be made from Nitinol or other spring material to provide a spring force to expand the frames 92, 94 as they are delivered from the catheter or sheath 60. Alternatively, there may be another mechanism or method for actuating and expanding the frames 92, 94 as needed during the implantation procedure.

[0044] FIG. 4A shows another embodiment for adding sealing features to the helical anchor 30. Here, a fiber streamer type shape or panel / membrane structure 110 is attached to the upper winding or coil 32 of the helical anchor 30. This panel 110 spreads or extends within the helical anchor 30 to form a sealing membrane. The fiber or other sealing material may be sewn or permanently secured to the helical anchor 30. Alternatively, this sealing panel 110 may be delivered onto the helical anchor 30 after it has been placed at the implantation site within the native heart valve. The sealing material 110 may be attached to any portion of the helical anchor 30 at any height of the anchor 30. In FIG. 4A, the sealing panel 110 is attached to the top coil 32 of the helical anchor 30, allowing the panel 110 to extend the entire length of the helical anchor 30 and provide a liquid-tight seal along the entire length.

[0045] FIG. 4B shows an open seal panel 110 and an internal support structure 112 in the form of a wire or sinusoidal type support element within or within the layer of seal material. This support structure 112 for the seal 110 can be made of, for example, Nitinol or steel. The support 112 can be sewn into the fabric or otherwise secured to the seal material. The fabric can include, for example, a channel for the support 112, which can be forced into the channel to expand the seal material 110 as needed. If the support 112 is made of Nitinol or a superelastic material and embedded within the fabric or seal material 110, it can straighten out and fold the fabric or other seal material inside the delivery catheter or sheath. During delivery, the Nitinol or superelastic support returns to its initial zigzag or sinusoidal shape, expanding the fabric by being pushed out of the delivery sheath or catheter.

[0046] FIG. 4C is a cross-sectional view showing a helical anchor 30 and a fabric seal panel 110, such as that shown in FIG. 4A, delivered and implanted at a native valve site, such as in a patient's mitral valve 12. The seal panel 110 has an annular shape and generally follows the interior of the helical anchor 30. As shown here, the fabric panel 110 is sewn to the upper winding or coil 32 of the helical anchor 30, and the fabric is folded and sewn together as shown. Stitches 114 can provide additional structural support to help the fabric shape itself correctly. The stitches can be made from steel or nitinol wire, which can help provide shape stability to the membrane or panel structure 110. The stitches 114 can also be sutures or threads. Thicker stitching material provides more support to the fabric. Here, the stitches are in horizontal lines, but can instead be in other configurations, such as vertical, zigzag, or any other suitable configuration.

[0047] Figure 4D shows the stent-mounted heart valve 10 expanded in the helical anchor 30 and seal structure 110 of Figure 4C. The seal 110 prevents blood leakage around the valve 10 and covers any areas of the stented portion 24 of the valve 10 that are not already covered and sealed. The seal 110 allows the replacement heart valve 10 to sit higher toward the atrium 42, thereby reducing the risk of left ventricular damage or left ventricular outflow obstruction.

[0048] FIG. 5A shows the helical anchor 30 with a mounted membrane or panel seal 110 being delivered onto the coil 32 of the helical anchor 30. It should also be noted that the membrane or panel seal 110 can improve the mounting of the replacement heart valve 10. In this regard, a bare helical anchor 30, specifically made from metal to mount to a metal stent, results in metal surfaces contacting each other. As the heart beats and pressure increases with each contraction, e.g., about 100,000 times per day, there is a risk of slippage between the metal surfaces and the valve becoming dislodged. Thus, the addition of a membrane, panel 110, or other sealing structure can reduce the tendency of the valve to slip and even malfunction. The membrane or seal panel 110 can be smooth or have varying degrees of texture or roughness to help maintain fixation of the replacement heart valve 10. A textured or rough surface increases friction and therefore reduces slippage. Also, the fabric or other sealing material 110 may be forced into the openings or cells of the stent portion 24 of the replacement heart valve 10 to enhance or create a locking effect, securing the stented replacement valve 10 to the helical anchor 30 that includes the sealing 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 in the patient or may be added at any point during the implantation procedure. To reduce entanglement during delivery of the helical anchor 30, it may be advantageous to add the membrane or panel seal 110 after the helical anchor 30 is positioned at the implantation site. FIG. 5B shows the membrane 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 top winding 32 of the helical anchor 30, but may be attached anywhere along the helical anchor 30. The membrane or panel seal 110 may be continuous or discontinuous and may be constructed of overlapping panel portions similar to a shingle effect.The membrane or panel seal 110 forms a complete annulus within the helical anchor 30 as shown in FIG. 5B, but may alternatively be formed as a less than complete annulus.

[0049] FIG. 5C is similar to FIG. 4B above, and merely 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 inherently rigid and springs open without any type of internal support structure. Numerous other methods for opening or deploying the membrane or panel seal 110 may instead be utilized. For example, the panel seal 110 may contain pillars or other suitable supports (not shown) that buckle for delivery and allow the membrane or panel 110 to be biased open when the membrane or panel 110 is delivered from a suitable catheter or sheath. These pillars or other supports may be formed, for example, from a shape memory material, a superelastic material, or other suitable spring-biased material.

[0050] FIG. 5D shows the panel seal 110 being unrolled or deployed. In this exemplary embodiment, the panel seal 110 is formed from two layers, with the support 116 between these two layers. As mentioned above, the support 116 is suitably secured between these 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 a separate support structure, such as a generally circular or elliptical support structure (not shown). In this regard, other useful structures may include any of those shown and described in U.S. Provisional Patent Application No. 61 / 864,860, filed August 12, 2013, the disclosure of which is hereby incorporated by reference in its entirety herein. Finally, tightening strings (not shown) may be added to the ends of the membrane seal 110 or to any portion of the membrane seal 110, which may be used to pull the membrane seal 110 open and spread or otherwise deploy the membrane seal 110.

[0051] 5E shows a membrane or panel seal 110 that is buckled or folded instead of wrapped around the coil 32 of the helical anchor 30. A buckled membrane seal 110 such as this may be more practical. The membrane or panel seal 110 may be opened with the support structure 116 normally biased to a deployed state as shown above, or may be deployed by receiving a structural support element 116, such as a shape memory support element. Also as discussed above, a drawstring (not shown) may be added for deployment.

[0052] FIG. 5F shows a close-up cross-sectional view of the helical anchor 30, with the sealing membrane 110 or panel extending adjacent to the coil 32 of the helical anchor 30. The panel seal 110 includes a suture line 118, shown as a dotted line, that maintains the seal 110 in place within the helical anchor 30. This need not be a suture, but instead the fixation may be achieved by any suitable fastener, glue, or other element that maintains the membrane or panel seal 110 in place. Additionally, the panel seal 110 may be glued or attached to the helical anchor 30, which eliminates the need for sutures or separate fasteners. As previously mentioned, the panel seal 110 may be a fabric or any other suitable biocompatible material. For example, in this and any other embodiment, the sealing material may be Dacron or Gore-Tex®, or may be a biomaterial from an animal or human. Other examples of sealing materials include engineered biomaterials or any combination of biomaterials and / or synthetic materials. In this embodiment, the panel seal 110 is opened by a spring-loaded 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.

[0053] FIG. 5G shows the helical anchor 30 and panel seal 110 combination implanted at the site of the patient's native mitral valve 12. FIG. 5H shows the replacement heart valve 10, specifically the replacement heart valve 10 with a stent secured in the helical anchor 30 and panel seal 110 combination. These figures are described above in relation to FIG. 4C and FIG. 4D. Thus, it should be understood that the panel seal structure 110 and the helical anchor 30 provide a liquid-tight seal as previously described regardless of the deployment and delivery technique. It should be understood that additional features may be used to assist in deploying the panel seal or membrane 110 in the open state as shown in FIG. 5G and FIG. 5H. Also, a foam layer (not shown) may be positioned at any desired location, for example to assist in sealing and / or valve retention. The membrane or panel seal 110 may extend the entire length of the helical anchor 30 or only a portion of its length. In these figures, FIG. 5G shows the membrane or panel 110 extending over only a portion of the length, while FIG. 5H shows the panel or membrane 110 extending over 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 a significant portion of the replacement heart valve 10 rests within the atrium. It will be appreciated that the replacement heart valve 10 may be positioned at any position 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 protrude at either end of the helical anchor 30 or from both ends of the helical anchor 30. Also, the number of coils or windings 32 of the helical anchor 30 may be varied. The important configuration is to prevent as much leakage as possible and to keep the replacement heart valve 10 fixed in place after implantation.

[0054] 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 multiple functions. The end of the stented valve 10 is sharp and may damage structures inside the left ventricle 40. Leaving the winding 32 of the anchor 30 beyond the end of the valve 10 may prevent structures inside the heart from contacting the sharp end of the valve 10. The bottom winding 32 of the anchor 30 is smooth and may act as a "buffer" to prevent injury to structures inside the ventricle 40. A smooth metal (such as Nitinol) anchor coil 32 may be very durable and prevent wear and tear inside the left ventricle 40.

[0055] The bottom winding or coil 32 of the anchor 30 may also wrap around the native mitral valve leaflet tissue around the end of the valve 10. This may also hide the sharp end of the prosthetic valve 10 from structures inside the heart.

[0056] The bottom winding or coil 32 of the helical anchor 30 may also provide tension to the chordal structure. The function of the left ventricle 40 may be improved and the shape of the left ventricle 40 may be optimized by tensioning the chordal structure. In FIG. 5H, the bottom coil 32 pulls the chordal structures toward the center of the ventricle 40, shaping the left ventricle 40 optimal for contraction. It may be useful to have multiple coils 32 of the anchor 30 that extend beyond the anchor 30 and into the left ventricle 40. These coils 32 may pull the chordal structures inward a greater distance within the heart. For example, if a patient has a very large left ventricle 40, it may be desirable to improve the left ventricular function of this patient by having a helical extension that extends well beyond the valve 10. This will tighten the chordal structures and reshape the left ventricle 40. The coils 32 of the anchor 30 may also be of a larger / thicker diameter to aid in the reshaping of the heart. The diameter of the coils 32 may also be altered to optimize the left ventricular shape change.

[0057] The concept of reshaping the left ventricle 40 using the anchor 30 need not apply solely to mitral valve replacement. The helical anchor 30 shown in these descriptions can also be used for mitral valve repair. The extension of the helical coil 32 within the left ventricle 40 can also reshape the left ventricle 40 even if a replacement prosthetic valve 10 is not used. As previously mentioned, different numbers of coils 32, different diameters of coils 32, different thicknesses of material, etc. can be used to achieve optimal results.

[0058] It may also be useful to use the helical anchor 30 to repair the native heart valve 12 and reshape the left ventricle 40, with the possibility of adding a prosthetic replacement valve 10 at a later time if the repair becomes dysfunctional over time, which is not uncommon after surgical valve repair. The anchor 30 serving as a repair device, with or without reshaping the left ventricle with coils 32 extending into the left ventricle 40, may be useful as an anchor 30 if a prosthetic valve replacement is later required.

[0059] 6A shows the helical anchor 30 implanted in the native heart valve position. In general, it is important to place the helical anchor 30 near the lower surface of the native mitral valve 12. If the diameter of the coil 32 or windings below the mitral valve 12 is relatively small, the helical anchor 30 will be biased to slide into the left ventricle 40. The attachment of the helical anchor 30 to the native valve 12 will move away from the annulus 12c, and as the heart begins to beat, the helical anchor 30 will rest inside the left ventricle 40; if there is mitral valve tissue between the helical anchor 30 and the mitral valve annulus 12c, the helical anchor 30 will not be firmly attached to the annular region of the mitral valve 12, but rather will be attached to the leaflets 12a, 12b below in the left ventricle 40, which is undesirable. In FIG. 6A, the relatively large diameter winding or coil 32 of the helical anchor 30 is positioned directly below the mitral valve leaflets 12a, 12b. This location is immediately adjacent to the native mitral valve annulus 12c. The relatively smaller diameter coil 32 is positioned lower in the left ventricle 40. It may be useful to have a gap 120 between the relatively large coil 32 positioned below the leaflets 12a, 12b at the annulus 12c and the relatively smaller coil 32 positioned further into the left ventricle 40. This will prevent the entire helical anchor 30 from being pulled further into the left ventricle 40 after implantation. The relatively smaller diameter coil 32 of the helical anchor 30 is positioned above the mitral valve 12, i.e., above the native mitral valve leaflets 12a, 12b. For illustrative purposes, a balloon 122 is shown for expanding the smaller diameter coil 32. This causes the larger diameter coil portion 32 to move relatively radially inward, thereby clamping all of the coils 32 along a similar diameter and tightening the connection between the helical anchor 30 and the native mitral valve tissue. Most importantly, the coils or windings 32 below the native mitral valve leaflets 12a, 12b grip the underside of the mitral valve annulus 12c and tend to pull the annulus radially inward, thereby reducing the diameter of the native mitral valve annulus 12c. Thus, reducing the annulus is important for improving left ventricular function when the heart is dilated. Reducing the annular diameter of the native mitral valve 12 is also important during mitral valve repair.A smaller diameter annulus increases the improvement of left ventricular function. The concept of annulus reduction using a sliding helical anchor 30 to control the leaflets 12a, 12b and pull the native mitral valve leaflets 12a, 12b and annulus 12c radially inward is particularly useful for native mitral valve repair. Concepts, methods, and devices for improving left ventricular function in mitral valve prosthesis replacements, i.e., replacements that reduce the annulus diameter, tension the chordae, and reshape the left ventricle 40, are cited herein to demonstrate mitral valve repair devices, concepts, and methods. The smooth windings or coils 32 of the helical anchor 30 below the native mitral valve annulus 12 have less tendency to grip the mitral valve tissue and reduce the mitral valve annulus diameter. For this reason, it may be useful to increase the "grip" of the windings or coils 32 below the annulus 12c. This can be accomplished in a number of ways, including roughening the surface of the coil 32, such as by texturing the metal or by adding a high friction coating or fiber. The coating, fiber, or other high friction material may be fixed to the helical anchor 30 or may slide along the helical anchor 30. The high friction portion of the helical anchor 30 may be continuous or discontinuous.

[0060] FIG. 6B shows the final position of the prosthetic replacement heart valve 10 inside the helical anchor 30 and its relationship to the native mitral valve 12 and left ventricular structures. The left ventricular chordae 130 are tensioned so that the left ventricle 40 is appropriately reshaped. The pointed end 132 of the prosthetic replacement heart valve 10 is covered by the sealing material 134, the native valve tissue 136, and the "cushion" 138 of the bottom winding or coil 32 of the helical anchor 30. This provides multiple types of protection from injury inside the left ventricle 40 by the pointed 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 structures within the left ventricle 40. This provides further protection from injury to the left ventricle 40 by the replacement heart valve 10. The fibrous membrane seal or other type of panel seal 110 may extend for any length. In this view, it extends beyond the replacement heart valve 10. The fabric or other sealing material may also extend beyond the end of the helical anchor 30 within the left ventricle 40. The fabric or other sealing 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. If the prosthetic replacement valve 10 has a seal attached or is otherwise attached to the prosthetic replacement valve 10, a seal is not necessary. In this case, the useful features disclosed relate primarily 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.

[0061] 7A-7D show devices, methods and procedures relating to the interaction of the helical anchor 30, helical anchor design features and a stented replacement heart valve 10 delivered or mounted on a balloon 140. Various catheters may be manipulated to utilize the design of the helical anchor 30 to improve valve implantation. For example, the stented replacement valve 10 may be partially deployed and the helical anchor 30 may be manipulated with the stented replacement valve 10 in a partially deployed state before reaching a final deployment position. FIG. 6A shows a helical anchor 30 having three coils or windings 32. The top two coils 32 have a relatively smaller diameter d2 and the bottom winding or coil 32 has a relatively larger dimension or diameter d1. FIG. 7B shows a stented replacement valve 10 with a balloon 140 therein for deploying the valve 10 when the valve 10 is positioned within the helical anchor 30. The helical anchor 30 is positioned with two of the coils or windings 32 positioned above the native mitral valve 12 and one coil or winding 32 positioned below the native mitral valve leaflets 12a, 12b and adjacent the mitral valve native annulus 12c. Arrows 142 indicate the radially outward direction of balloon inflation and the resulting expansion of the stented replacement heart valve 10.

[0062] FIG. 7C shows the expansion of the balloon 140 and the stented replacement heart valve 10. The diameter of the upper two coils or windings 32 of the helical anchor 30 is smaller due to the expansion of the balloon 140, so that the stented replacement heart valve 10 initially contacts the smaller windings 32 of the helical anchor 30. The stented heart valve 10 becomes engaged with these two smaller diameter windings or coils 32. While in this position, the catheter deploying the balloon 140 can be used to manipulate or reposition the helical anchor 30. Movement of the balloon catheter 140, such as in the direction of the large arrow 146, results in the large winding 32 of the helical anchor 30 being moved upward, in this illustrative example, toward the native mitral valve annulus 12c. That is, the winding or coil portion 32 adjacent to the native mitral valve annulus 12c will move in the direction of the adjacent small arrow 148. This in turn results in the upward movement of the winding or coil portion 32 above the native mitral valve annulus 12c. In fact, under sufficient force, when the winding or coil portion 32 below the annulus 12c comes into contact with the lower leaflets 12a or 12b or annular tissue 12c of the mitral valve 12, the helical anchor 30 may actually spring open such that the segments of the helical anchor 30 that connect to the winding or coil portion 32 above and below the leaflets 12a or 12b are extended. This may cause the gap between the segments of the helical anchor 30 to expand.

[0063] FIG. 7D shows the stent-mounted replacement heart valve 10 fully expanded after deployment and expansion by the balloon catheter 140, which has been removed. The largest turn or coil 32 of the helical anchor 30 is positioned at a relatively high position just below the native mitral valve annulus 12c. After the balloon catheter 140 is fully inflated, the system cannot move due to the native mitral valve leaflets 12a, 12b being captured between the helical anchor 30 and the stent-mounted replacement heart valve 10. The balloon catheter 140 holding the replacement heart valve 10 can be moved in any direction. In this view, up and down movements are clearly possible since these are done by moving the balloon catheter 140 in and out of the patient. There are many deflectable catheters that can move the balloon catheter 140 laterally as well.

[0064] This series of figures is intended to show how the procedure may be performed using a helical anchor 30. The anchor 30 may be engaged and manipulated by the stented valve 10 prior to final positioning and full expansion of the stented valve 10.

[0065] 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 the procedure, so that both the anchor 30 and the stented valve 10 can be remotely manipulated to achieve the desired results.

[0066] 7A-7D also show how the expansion of the balloon 140 inside the smaller winding 32 of the anchor 30 can serve to "tighten" the larger winding 32. The portion of the larger winding or coil 32 below the annulus 12c is pulled up above the annulus 12c as the smaller winding or coil 32 expands, thus shortening the coil 32 below the annulus 12c. This can cause the larger coil 32 to tighten around the stented valve 10. This effect is more pronounced when the larger coil 32 is located between two smaller coils 32 of the anchor 30. The two smaller coils 32 on each side of the larger coil 32 expand, thus reducing the diameter of the larger coil 32, thereby allowing the larger coil 32 to capture the valve 10 and assist in anchoring the valve 10.

[0067] It is very important to position the anchor 30 as close as possible to the annulus 12c, which is the natural anatomical location of the valve 10. If the anchor 30 is attached to the leaflet tissue 12a, 12b at a location away from the annulus 12c, the leaflet tissue 12a, 12b will move with each beat of the heart. This can cause the anchor 30 and the valve 10 to wobble. Repeated motion can cause the valve to dislodge. Therefore, strategies to allow for placement of the large coil 32 of the anchor 30 near the annulus 12c are important. It is also useful to convert the larger coil 32 to a smaller coil 32 so that the coil 32 can actually function to capture the stented valve 10.

[0068] FIG. 7D-1 illustrates another embodiment of a combination replacement valve 10 and helical anchor 30, in which the upper end of the replacement valve 10 does not flare outward, but rather is held in a generally cylindrical shape by the upper coil 32 of the anchor 30. The lower or outflow end flares radially outward as shown. It will be appreciated that a structure such as a seal (not shown) may be provided between the stent 24 and the lower coil 32 for both sealing purposes as previously described, and / or alternatively to provide a softer, more pliable surface against the native mitral valve leaflets 12a, 12b. It will further be appreciated that the upper coil 32 creates a gap and does not engage or capture tissue adjacent to the native mitral valve in the atrium. The lower coil 32, on the other hand, engages tissue immediately below the native mitral valve annulus 12c. The embodiment of replacement valve 10 shown in FIG. 7D-1 contrasts with valve 10 configured as previously shown, such as in FIGS. 1A and 1B, in that the valve retains a cylindrical shape after implantation and application of helical anchor 30; for example, as shown in FIG. 7D, valve 10 has only a very slight outwardly directed configuration at the inferior or outflow end, resulting in no significant flaring.

[0069] 8A-8D show the use of a balloon catheter 140 to expand the helical anchor 30 in the absence of a replacement heart valve 10 with a stent attached. Specifically, FIG. 8A shows a helical anchor 30 having approximately four coils or windings 32. There are two coils 32 on each side of a coaptation segment 32a that separates the two coils 32 creating a gap. The native mitral valve leaflets (not shown) can be easily positioned between the coils 32 at the location of the gap created by the coaptation segment 32a. In this view, the balloon 140 has begun to expand as indicated by the arrows 150 pointing radially outward. FIG. 8B shows further expansion of the balloon 140 causing the helical anchor 30 to indent the balloon 140 around the helical anchor 30. The balloons 140 on either side of the helical anchor 30 expand further. This results in a force on the windings or coils 32 of the helical anchor 30, which moves the windings or coils 32 together as shown diagrammatically by the arrows 152. As the balloon 140 is further expanded as shown in FIG. 8C, the gap between the windings or coils 32, 32a may gradually decrease and eventually close completely, so that the two main portions of the helical anchor 30 are pressed against each other in the direction of blood flow or the central axis of the helical anchor 30 (i.e., along the length of the balloon 140). FIG. 8D shows a cross-sectional view illustrating the windings or coils 32, 32a of the helical anchor 30 being pressed together. As shown in these figures, the coils 32, 32a of the helical anchor 30 can be pressed against each other by expanding the balloon 140 within the helical anchor 30. There need not be a joint segment 32a or gap for this to occur. The helical coils 32 will be pressed tightly against each other with or without the gap shown in this embodiment.

[0070] This compression can act as a "motor" that can produce a variety of functions. For example, a pin or fastener (not shown) can be attached to the windings 32, 32a of the anchor 30 that can be driven and actuated by the inflation of the balloon 140. The pin or fastener can be positioned to pass through the native valve leaflets, and the fastener can traverse the native leaflets and move into the anchor 30 on the opposite side of the leaflets. A fabric coating, sponge coating, or another receptive material on the anchor 30 improves retention of the fastener.

[0071] Generally, these methods and devices allow an area of ​​the mitral valve 12 near or above the annulus 12c to be anchored to a helical anchor 30. The anchor can traverse the valve tissue and engage the coil 32 on one or both sides of the leaflets. By capturing the leaflets with balloon inflation, the mitral valve 12 and its annulus 12c can be manipulated to perform a therapeutic procedure. For example, when anchor coil 32 is secured to leaflets 12a, 12b, it can be reduced in size to create a purse-string effect on the annulus 12c, resulting in an annular reduction or annuloplasty procedure. Tightening threads (not shown) can be added to the anchor 30 to reduce the diameter.

[0072] A fastener can be used to join segments of the helical anchor 30 together. For example, the windings or coils 32 of the anchor 30 above the leaflets 12a, 12b can be joined together. A fabric or other material can be wrapped around or otherwise placed on the anchor coils 32, and a pin or fastener from one coil 32 can engage and capture the fabric of an adjacent coil 32. Adjacent coils 32 can engage with each other. This creates more mass on each side of the leaflets 12a, 12b to control the mitral valve annulus 12c. In essence, balloon inflation inside the helical anchor 30 can drive the coils 32 of the anchor 30 together. This can be used as a motor or drive mechanism to operate a mechanical system, and can move the anchor coils 32 in a tight unison.

[0073] 9A-9D show another capability of the helical anchor 30 by being expanded by the balloon 140. In this regard, the actual overall length of the helical coil 32 forming the anchor 30 remains the same. Thus, in order for the diameter of the helical anchor 30 to expand, the ends 30a, 30b of the helical anchor 30 must move to allow the expansion. This movement can also be used as a motor or drive mechanism to actuate additional functions. More specifically, FIG. 9A shows the balloon 140 being expanded inside the helical anchor 30. As the balloon 140 expands, the diameter of the helical anchor 30 expands and both ends 30a, 30b of the helical anchor move to allow this expansion. As indicated by the arrows 160, the ends 30a, 30b of the coil 32 move or rotate in opposite directions. FIG. 9B shows the continuation of the balloon expansion, and the previous figures of FIGS. 8A-8D show how the balloon 140 further compresses the coils 32 of the helical anchor 30 together. FIG. 9B highlights how the expansion of the balloon 140 causes the coils 32 of the helical anchor 30 to rotate approximately. This rotation helps retain the stented replacement heart valve by increasing tension around the stented portion of the heart valve (not shown). FIG. 9C shows the helical anchor 30 being unwound by expanding under the force of the balloon 140. The number of turns or coils 32 becomes fewer and the remaining turns or coils 32 become larger in diameter. FIG. 9D shows a cross-sectional view of the expanded helical anchor 30. The movement of the ends 30a, 30b of the helical anchor 30 can be used to perform functions. For example, the movement of the coils 32 of the helical anchor 30 can be used to drive the anchor or to perform other functions, as described further below.

[0074] 10A-10E show the effect of a cover or coating 170 on the helical anchor 30. Also, replacement valve 10, such as shown in FIGS. 10B and 10C, flares outward at both the upper and lower ends. This may not be desirable for a variety of reasons, and rather it may be desirable for at least one end of the valve 10 to have and retain a generally cylindrical cross-sectional shape (as shown 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 from a fibrous material such as Dacron, Teflon, or other materials. The coating 170 may be formed from PEFE or EPTFE in a fibrous form with a fibrous texture, or as a smooth plastic sleeve, cover, or coating. A foam material, such as is commonly used in surgical valves, may be present under the coating 170. The foam material may be comprised of rolls of fiber or folded fibers. Other possible materials include elastic materials, or more specifically materials such as medical silicone. Biological materials may also be used, including animal, human, or bioengineered materials. Some materials commonly used in cardiac repair procedures are pericardial and intestinal wall materials. FIG. 10A shows a helical anchor 30 covered by a coating 170 composed of a fabric lined with a foam material. The helical anchor 30 is positioned inside the native mitral heart valve 12, with two windings or coils 32 above the native mitral valve annulus 12c and two windings or coils 32 below the native mitral valve annulus 12c. A replacement heart valve 10 with a stent attached is placed inside the helical anchor 30, and inflation of the balloon delivery catheter 140 inside the replacement heart valve 10 is initiated, as indicated by arrow 172. In FIG. 10B, the replacement stent attached valve 10 is shown fully expanded relative to the helical anchor 30. Typically, the stent portion 24 of the valve 10 is constructed from a thin metallic material with openings or cells.These openings or cells become embedded against the coating or covering 170. Thus, the stent 24 tightly engages the helical anchor 30 resulting in a very strong mounting of the replacement valve 10 inside the helical anchor 30. FIG. 10C more specifically shows an enlarged view demonstrating how the stent portion 24 deforms the fabric and foam coating 170 of the helical anchor 30. This engagement is very strong and prevents the replacement heart valve 10 from dislodging. FIG. 10C-1 is a further enlarged view showing the cells or openings 24a of the stent 24 engaged against the foam and fabric covering 170 resulting in a very strong physical connection between these two components. FIG. 10D shows the balloon catheter 140 expanding the replacement valve 10 inside the coated helical anchor 30 from a perspective above the helical anchor 30. FIG. 10E shows the same view from above the helical anchor 30 but showing the complete 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 .

[0075] 11A-11D show an embodiment with a covering or coating 180 on the helical anchor 30 that is discontinuous, 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 in allowing these segments 180 to slide along the helical anchor 30 as the helical anchor 30 is expanded, such as with balloon inflation as previously described. The segments 180 may slide along the coils 32 of the helical anchor 30, thereby allowing the helical anchor 30 to tighten, while at the same time allowing the segments 180 to securely engage the cells or openings 24a of the replacement heart valve stent 24.

[0076] FIG. 11A shows the helical anchor 30 with a cover that is discontinuous and formed with segments 180. The cover segments 180 are shown with a taper at each end to allow the anchor 30 to be placed in place without a flat leading edge that would impair placement. The taper is not necessary, but may aid in this regard as desired. The taper may be of any suitable design and may be angled or curved in any shape that facilitates easy movement of the helical anchor 30. The balloon catheter 140 is positioned in place of the stented replacement valve 10 as previously described and begins its expansion as indicated by arrow 182. FIG. 11B shows the stented replacement heart valve 10 fully expanded. The coating segments 180 are fully engaged within the cells or openings of the heart valve stent 24. As these segments 180 engage the stent 24 and enter one or more cells or openings, the segments 180 will become secured to the stent 24 and begin to slide along the helical anchor 30. The helical anchor 30 will be able to expand and tighten against the stented portion 24 of the replacement valve 10 while still having the beneficial effect of continuous and strong attachment to the helical anchor 30 provided by the segments 180 made of a high friction and elastic and / or compressible material. Figures 11C and 11D show the process from above of the helical anchor 30, showing the initial expansion of the stented replacement heart valve 10 in Figure 11C and the full expansion and engagement between the segments 180 and the stent 24 to securely attach these two structures together during the implantation procedure in the patient.

[0077] 12A-12E illustrate the helical anchor 30 and the motor or drive function provided when the helical anchor 30 expands and the ends 30a, 30b of the coil 32 move. FIG. 12A illustrates a helical anchor 30 having approximately four turns or coils 32, and FIG. 12B illustrates a helical anchor 30 having approximately three turns or coils 32. As further shown in FIG. 12B, the helical anchor 30 is mounted on a barb fastener 190 for delivery into the replacement heart valve 10. A coating or exterior surface 192 of fabric or other material is applied around the barbs 190 and around the helical anchor 30. When the balloon 140 is inflated inside the helical anchor 30, the two ends 30a, 30b of the helical anchor 30 move in opposite directions as the helical anchor 30 expands. In this manner, the barbs 190 are oriented in a counter direction relative to the movement of the helical anchor 30 such that the barbs 190 are actuated or moved as the helical anchor 30 is expanded. Figure 12C shows a cross-sectional view of a helical anchor 30 having a fabric or other covering or coating 192 and a fastener system 190 coupled to the helical anchor 30. It was previously described how the windings or coils 32 of the helical anchor 30 can be driven together by the inflation of the balloon 140. The inflation of the balloon also drives or moves the windings 32 of the helical anchor 30 together to increase the penetration of the barbs 190. 12B-12E are oriented obliquely relative to the central axis of the helical anchor 30, the barbs 190 may instead deploy in a linear or parallel direction relative to the linear axis of the helical anchor 30 toward adjacent turns or coils 32 of the helical anchor 30, driven by the expanding balloon 140 squeezing the helical coils 32 together. Upon expansion, the ends 30a, 30b of the helical anchor 30 move significantly, but the center of the anchor 30 does not pivot or rotate significantly. Barbs 190 without an oblique orientation may be preferred in the central coil 32.The angle of the barbs 190 may be enlarged and the length of the barbs 190 may be enlarged in areas near the ends 30a, 30b of the helical anchor 30 where movement upon inflation of the balloon 140 is more pronounced. FIG. 12D shows a top view of the helical anchor 30. As the balloon catheter 140 is inflated, the helical anchor 30 expands in diameter and the ends 30a, 30b of the helical anchor 30 rotate to allow for this diametric expansion. As shown in FIG. 12E, the expansion of the helical anchor 30 primes or deploys the barbs 190, which engage a coating 192 of fiber or other material in the middle or central winding or coil 32. This locks the windings or coils 32 of the helical anchor 30 together. Although no native valve leaflet tissue is shown in FIG. 12E, it will be understood that leaflet tissue can be located between the windings or coils 32 and the barbs 190 can accompany and engage the leaflet tissue to further secure the helical anchor 30 to the native mitral valve tissue.

[0078] 13A-13C show another embodiment in which a helical anchor 30 is used having relatively larger diameter windings or coils 32 at the ends of the anchor 30 and relatively smaller windings in the middle or central portion of the helical anchor 30. The helical anchor 30 is attached to barbs 190 and covered with a suitable coating material 192, such as a 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 actuated as the central smaller helical windings 30 expand outward. This particular configuration is ideal for attachment to a patient's native mitral valve. One barbed winding or coil 32 of the helical anchor 30 may be placed above the native mitral valve leaflets and one barbed winding or coil 32 may be placed below the native mitral valve leaflets. The smaller diameter winding or coil 32 may be placed above or below the native mitral valve leaflets. When the balloon (not shown) is inflated, the larger helical windings or coils 32 above and below the native mitral valve leaflets will be driven toward each other as shown diagrammatically in Figures 8A-8D and described above. Also, the anchor ends will rotate and the barbs 190 will deploy through the mitral valve leaflet tissue positioned between the larger windings or coils 32 near the native valve annulus. Also, the two larger helical windings or coils 32 may be joined together by the barbs 190 traversing the mitral valve tissue and penetrating the covers 192 on the helical coils 32 on opposite sides of the native mitral valve. These actions will trap the mitral valve between the windings or coils 32 of the helical anchor 30, although it is not necessary that this occur. Also, it will be apparent that the larger diameter windings or coils 32 at both 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 "contribute" to the middle coil or coil 32. This results in a reduction in the diameter of the upper and lower coils 32. After the coils 32 are secured to the native mitral valve circumference or annulus, this results in a reduction in the size of the diameter of the mitral valve, i.e., an annuloplasty procedure.When the barbs 190 are securely held in the native mitral valve tissue, they do not become dislodged or fall out after impaction. FIG. 13C shows a cross-sectional view of the helical anchor 30 of FIG. 13B with the barb system 190 and a coating 192, such as a fabric or other material. As previously mentioned, the barbs 190 may be deployed directly from the helical anchor 30 at approximately a 90° angle relative to the coil 32. This may be actuated by simply squeezing the coils 32 against each other as described above in connection with FIGS. 8A-8D. Additionally, longitudinal or rotational movement of the helical coil or anchor winding 32 may allow the barbs 190 or other type of fastener to be applied in a direction that is more parallel or oblique to the winding or coil 32 of the helical anchor 30.

[0079] 14A-14C show different configurations of the helical anchor 30. This anchor 30 has approximately four coils 32. There are two upper coils 32 followed by a junction segment 32a (gap segment). The junction segment 32a is typically used to separate the coils 32 of the anchor 30 placed above the leaflets from the coils 32 of the anchor 30 placed below the leaflets (in the atrium and in the ventricle, respectively). There is a coil 32b of similar size to the two upper coils 32 at the end of the junction segment 32a. This is the bottom coil 32b on the anchor 30. The final coil 32c changes direction and, instead of continuing downward, wraps back upward and overlaps or crosses the adjacent coil 32 of the anchor 30. This coil 32c is shown as a "larger turn" in FIG. 14B. This figure shows the change in direction of the anchor 30 (such as the junction segment) that allows the final coil 32c to be directed upward. Also, the final coil 32c is larger so that it can be placed on the outside of the other coils. This larger coil 32c is the middle coil of the anchor 30, but is actually sent into the native valve first during delivery. An important feature of this anchor 30 is that as it is sent into place, the upward bend of the coaptation segment 32a urges the anchor 30 upward toward the annulus. When the anchor 30 is positioned with two coils above the leaflets and two coils below the leaflets, it is placed with the larger coil 32c of the anchor 30 resting just below the mitral valve annulus. The anchor 30 does not have a tendency to fall into the ventricle. The bottom coil does not necessarily have to cross at the same point when viewed from the side (making an X). The bottom coil could cross on both sides, for example.

[0080] The important elements in the embodiments of FIGS. 14A - 14C are for sending the anchor 30 to a fixed position in order to result in upward movement of the end of the anchor 30 that drives the anchor 30 just below the mitral valve. By this anchor being "screwed in", the lowermost coil 32b biases the anchor 30 upward relative to the mitral valve annulus. Also, the larger - diameter coil 32c in the middle of the anchor 30 assists in positioning the anchor 30 just below the valve leaflets and near the annulus. The mitral valve annulus has a certain diameter, and by matching this diameter to the diameter of the largest anchor coil 32c, the anchor 30 can be placed just below the annulus. If this coil 32c is too small, the anchor 30 can catch on the valve leaflet tissue and prevent the anchor 30 from being driven upward toward the annulus when the anchor 30 is placed. Also, it will be understood that the intersecting coils 32a, 32b of the anchor 30 can be useful for valve fixation when using the anchor 30. The intersecting coil 32a occurs at the lowermost coil of this anchor 30. However, the intersecting segment 32a can occur at any position. The intersecting segment 32a can occur at the top, middle, or bottom of the anchor 30. The amount of intersection can also vary. Here, the intersection includes the two lowermost coils 32. It is possible to have a greater number of overlapping coils. FIG. 14C shows overlapping coils 32a where the lowermost coil is located outside the previous coil. The overlapping coil 32a or the intersecting segment can occur inside the previous coil. FIG. 14C also shows a sharp change in pitch for overlapping. Also, overlapping can occur by a gradual change in pitch. In FIGS. 14A - 14C, the spacing between coils in both the vertical and lateral dimensions is exaggerated for clarity. These coils will apply a compressive force from the top and bottom toward the center.

[0081] The main advantage of the configuration shown in Figures 14A-14C is that the number of coils 32 available for mounting the valve is increased, but the length of the anchor 30 is not increased. This allows for shorter anchors. For example, it may be useful to have a shorter length of the anchor positioned in the left ventricle 40 so that the valve 10 can be placed closer to the atrium 42. The overlapping or crossing coils 32a may cross in a desired manner and allow the valve 10 to be held with a strong force and a shorter overall length inside the left ventricle 40. Also, the overlapping portion 32a of the anchor may be positioned at the height where the native valve leaflets 12a, 12b are placed. This enhances the capture of the leaflets 12a, 12b, i.e., the anchor 30 may be positioned such that the overlapping coils have the leaflets between them. If the gap between the coils 32 of the anchor 30 is small enough, the leaflets 12a, 12b may be captured between the coils 32 without the need for additional fasteners. This configuration may also position the leaflets 12a, 12b to be secured to the anchor 30 or to a fixation system attached or guided by the anchor 30. This particular anchor configuration is also useful because the bottom coil of the anchor coils 32 extends in the opposite direction to the rest of the anchor 30, i.e., it is biased upward while the other coils 32 are biased downward. When this anchor 30 is delivered into position, the bottom coil 32b will tend to move back upward. This effectively creates a reverse thread. A typical helical anchor is screwed into the leaflets 12a, 12b like a corkscrew and moves downward as it is rotated. In this configuration, when the first coil of the anchor 30 is rotated into the valve 12 and reaches the coaptation segment 32a, the anchor 30 actually begins to rotate upward instead of downward as the bottom coil 32b is rotated in. This means that this particular anchor configuration will tend to rest just below the annulus 12. This helps to optimally position the anchors 30 near the underside of the annulus 12. Anchors 30 that are attached to the leaflets 12a, 12b away from the annulus 12 tend to move and wobble with the contractions of the heart because as the heart beats, the leaflets move away from the annulus 12.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. The heart beats approximately 100,000 times each day. This repetitive motion poses the risk of dislodging the anchor and the valve. Therefore, minimizing this motion by placing the anchor 30 closer to the annulus 12 reduces the risk of the valve implant failing. In Figures 14A-14C, both intersections of the anchor coils 32 are located on the same side of the anchor 30. This creates an X. The intersections do not have to occur on the same side. For example, the intersections could be located on both sides of the anchor 30.

[0082] 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 applicant to restrict or in any way limit the scope of the appended claims to such details. Further advantages and modifications will be readily apparent to those skilled in the art. The various features and concepts of the present invention may be used alone or in any combination according to the needs and preferences of the practitioner. This is a description of the present invention in accordance with the preferred manner of carrying out the invention as currently known. However, the present invention itself should be defined only by the appended claims. [Explanation of symbols]

[0083] 10 Replacement heart valves, prostheses 12 Mitral Valve 12a Native mitral valve leaflet 12b Native mitral valve leaflet 12c Native mitral valve annulus 14 Valve leaflets 16 valve leaflets 18 Textile cover, seal 24 Stents 24a opening 30 Helical Anchor 32 Coil 36 Arrow 40 Left ventricle 42 Atrium 50 Overlapped seal structure 52 Seal 52a Seal element, seal part 52b Seal element, seal part 52c Seal element, seal part 60 Catheter 62 Textiles 64 Internal support coil 70 Seal structure 70a Segment 70b Segment 72 Textiles 74 Coil 80 Seal structure 82 Sealing Fiber 84 Structural Panel 86 Connecting part 90 Seal structure 90a Segment 90b Segment 92 Frame Segments, Wires 94 Frame Segments, Wires 96 Textile cover, outer sealing material, textile 98 Curved Section 100 Cross member, biasing member 102 Textile Cover 110 Panel / membrane structure, sealing panel, sealing material 112 Internal support structures, supports 114 Stitches 116 Support 118 Suture Line 120 Gap 132 Sharp end 134 Sealing materials 136 Natural Valve Tissue 138 Buffer 140 Balloons, balloon catheters 142 Arrow 146 Arrow 150 Arrow 152 Arrow 160 Arrow 170 Cover, Coating 172 Arrow 180 Cover, Coating 182 Arrow 190 Barb Fixtures, Barbs, Fixture Systems 192 Coatings, Covers

Claims

1. 1. A system for docking a heart valve prosthesis, comprising: a helical anchor formed as a plurality of coils configured to support a heart valve prosthesis with coil portions positioned above and below the heart valve annulus; a seal coupled to the helical anchor and including a portion extending between adjacent coils for preventing blood leakage through the helical anchor and past the heart valve prosthesis; A system comprising:

2. a heart valve prosthesis capable of being delivered to a heart valve location in a patient and expanded within the plurality of coils and into engagement with leaflets of the heart valve, the seal being engaged to both the helical anchor and the heart valve prosthesis. The system of claim 1 further comprising:

3. The system of claim 1 , wherein the helical anchor further comprises a shape memory material.

4. The system of claim 1 , wherein the seal further comprises a membrane or panel extending over at least two coils of the helical anchor.

5. 5. The system of claim 4, wherein the membrane or panel is moved between an undeployed state and a deployed state, the undeployed state configured for delivery to an implantation site and the deployed state configured for implanting the system and securing the heart valve prosthesis.

6. 6. The system of claim 5, wherein the undeployed state comprises a wound up state on one of the coils of the helical anchor.

7. The system of claim 5 , wherein the undeployed state comprises a buckled state.

8. The system of claim 4 , wherein the membrane or the panel includes an attached support element.

9. 10. The system of claim 1, wherein the seal further comprises one or more sealing elements carried by the helical anchor and comprising overlapping portions configured to seal spaces between adjacent coils of the helical anchor.

10. The system of claim 9 , wherein the one or more sealing elements each include a support element attached thereto.

11. The system of claim 9 , wherein the one or more sealing elements each have a generally circular cross-sectional shape.

12. The system of claim 9 , wherein the one or more sealing elements each have an oval cross-sectional shape.

13. 10. The system of claim 9, wherein the one or more sealing elements each have a connecting portion attached to one of the coils and an extending portion extending toward an adjacent coil.

14. 1. A system for replacing a native heart valve, comprising: an expandable helical anchor formed as a plurality of coils configured to support a heart valve prosthesis, at least one of the coils being normally of a first diameter and expandable to a larger second diameter upon application of a radially outward force from within the helical anchor; an expandable heart valve prosthesis that can be delivered within the helical anchor and expanded within the plurality of 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; A system comprising:

15. 15. The system of claim 14, wherein the helical anchor comprises another coil that moves from a larger diameter to a smaller diameter when the heart valve prosthesis is expanded inside the multiple coils.

16. 16. The system of claim 15, wherein at least two adjacent coils of the helical anchor are spaced apart, and the adjacent coils move toward each other when the heart valve prosthesis is expanded within the plurality of coils.

17. 15. The system of claim 14, wherein at least two adjacent coils of the helical anchor are spaced apart, and the adjacent coils move toward each other when the heart valve prosthesis is expanded within the plurality of coils.

18. 15. The system of claim 14, wherein the helical anchor further comprises a plurality of fasteners, the fasteners being moved from an undeployed state to a deployed state by movement of the at least one coil from the first diameter to the larger second diameter.

19. 20. The system of claim 18, further comprising a seal coupled to the helical anchor and including a portion extending between adjacent coils to prevent blood leakage through the helical anchor and past the heart valve prosthesis, the fastener engaging the seal in the deployed state.

20. 15. The system of claim 14, further comprising 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 within the plurality of coils to assist in attachment of the heart valve prosthesis to the helical anchor.

21. 21. The system of claim 20, wherein the at least one compressible element further comprises a plurality of compressible elements spaced along the plurality of coils.

22. 21. The system of claim 20, wherein the at least one compressible element further comprises a continuous compressible element extending along the plurality of coils.

23. 21. The system of claim 20, wherein the at least one compressible element further comprises an elastic element.

24. 21. The system of claim 20, wherein the heart valve prosthesis further comprises an expandable structure having an opening, the opening being engaged by the at least one compressible element when the heart valve prosthesis is expanded within the plurality of coils.

25. 15. The system of claim 14, wherein the multiple coils of the helical anchor comprise at least two coils that cross each other.

26. 15. The system of claim 14, wherein the helical anchor further comprises a shape memory material.

27. 15. The system of claim 14, further comprising a seal coupled to the helical anchor and including a portion extending between adjacent coils to prevent blood leakage through the helical anchor and past the heart valve prosthesis.

28. 30. The system of claim 27, wherein the seal further comprises a membrane or panel extending over at least two coils of the helical anchor.

29. 30. The system of claim 28, wherein the membrane or panel is moved between an undeployed state and a deployed state, the undeployed state configured for delivery to an implantation site and the deployed state configured for implanting the system and securing the heart valve prosthesis.

30. 30. The system of claim 29, wherein the undeployed state comprises a wound up state on one of the coils of the helical anchor.

31. 30. The system of claim 29, wherein the undeployed state comprises a buckled state.

32. 30. The system of claim 28, wherein the membrane or panel includes an attached support element.

33. 28. The system of claim 27, wherein the seal further comprises one or more sealing elements carried by the helical anchor and comprising overlapping portions configured to seal spaces between adjacent coils of the helical anchor.

34. 34. The system of claim 33, wherein the one or more sealing elements each include a support element attached thereto.

35. 34. The system of claim 33, wherein the one or more sealing elements each have a generally circular cross-sectional shape.

36. 34. The system of claim 33, wherein the one or more sealing elements each have an oval cross-sectional shape.

37. 34. The system of claim 33, wherein the one or more sealing elements each have a connecting portion attached to one of the coils and an extending portion extending toward an adjacent coil.

38. 1. A method of implanting a heart valve prosthesis in a patient's heart, comprising: delivering a helical anchor in the form of a plurality of coils such that a portion of said helical anchor is above the native heart valve and a portion is below the native heart valve; implanting the heart valve prosthesis within the coils of the helical anchor such that the heart valve prosthesis is supported by the helical anchor; positioning a seal between at least two adjacent coils of the helical anchor and the heart valve prosthesis to prevent blood flow leakage during operation of the heart valve prosthesis; A method comprising:

39. 40. The method of claim 38, wherein the step of positioning the seal further comprises positioning a membrane or panel extending over at least two coils of the helical anchor.

40. delivering the membrane or panel in an undeployed state to the site of a native heart valve and then deploying the membrane or panel within the helical anchor; expanding the heart valve prosthesis against the membrane or panel; 40. The method of claim 39, further comprising:

41. 41. The method of claim 40, wherein the undeployed state comprises a wound up state on one of the coils of the helical anchor.

42. The method of claim 40, wherein the undeployed state comprises a buckled state.

43. 40. The method of claim 39, wherein the membrane or panel comprises an attached support element.

44. 40. The method of claim 38, wherein the step of positioning the seal further comprises positioning one or more sealing elements carried by the helical anchor such that overlapping portions seal spaces between adjacent coils of the helical anchor.

45. The method of claim 44, wherein the one or more sealing elements each include a support element attached thereto.

46. 45. The method of claim 44, wherein the one or more sealing elements each have a generally circular cross-sectional shape.

47. 47. The method of claim 46, wherein the one or more sealing elements each have an oval cross-sectional shape.

48. 45. The method of claim 44, wherein the one or more sealing elements each have a connecting portion attached to one of the coils and an extending portion extending toward an adjacent coil.

49. 1. A method of implanting an expandable heart valve prosthesis in a patient's heart, comprising: delivering an expandable helical anchor in the form of a plurality of coils such that a portion of the expandable helical anchor is above the native heart valve and a portion is below the native heart valve; positioning the expandable heart valve prosthesis within the coils of the expandable helical anchor with the expandable heart valve prosthesis and the expandable helical anchor in an unexpanded state; expanding the expandable heart valve prosthesis against the expandable helical anchor, thereby expanding the expandable heart valve prosthesis while fixing the expandable heart valve prosthesis to the expandable helical anchor. A method comprising:

50. 50. The method of claim 49, further comprising the step of: moving the coils from a larger diameter to a smaller diameter when the heart valve prosthesis is expanded within the plurality of coils.

51. 51. The method of claim 50, wherein at least two adjacent coils of the helical anchor are spaced apart, the method further comprising the step of moving the at least two adjacent coils toward each other when the heart valve prosthesis is expanded within the plurality of coils.

52. 50. The method of claim 49, wherein at least two adjacent coils of the helical anchor are spaced apart, the method further comprising the step of moving the at least two adjacent coils toward each other when the heart valve prosthesis is expanded within the plurality of coils.

53. 50. The method of claim 49, wherein the helical anchor further comprises a plurality of fasteners, the method further comprising moving the fasteners from an undeployed state to a deployed state when the expandable heart valve prosthesis is expanded relative to the expandable helical anchor.

54. 54. The method of claim 53, further comprising positioning a seal between adjacent coils to prevent blood leakage through the helical anchor and past the heart valve prosthesis, the fastener engaging the seal in the deployed state.

55. 50. The method of claim 49, further comprising at least one compressible element on the helical anchor, the compressible element being engaged by the expandable heart valve prosthesis as the heart valve prosthesis is expanded inside the plurality of coils to assist in attachment of the heart valve prosthesis to the helical anchor.

56. 56. The method of claim 55, wherein the at least one compressible element further comprises a plurality of compressible elements spaced along the plurality of coils.

57. 56. The method of claim 55, wherein the at least one compressible element further comprises a continuous compressible element extending along the plurality of coils.

58. 56. The method of claim 55, wherein the at least one compressible element further comprises a resilient element.

59. 56. The method of claim 55, wherein the expandable heart valve prosthesis further comprises an opening, the opening being engaged by the at least one compressible element when the heart valve prosthesis is expanded within the plurality of coils.

60. 50. The method of claim 49, wherein the multiple coils of the expandable helical anchor comprise at least two coils that cross each other.

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