Replacement heart valve apparatus and method

Abstract

To provide a system for replacing a native heart valve comprising an expansible helical anchor formed as multiple coils adapted to support a heart valve prosthesis.SOLUTION: An expansible helical anchor 12 is formed as multiple coils 22 adapted to support a heart valve prosthesis 60. An expansible heart valve prosthesis 60 is provided and is configured to be delivered into the helical anchor 12 and expanded inside the multiple coils 22 into engagement with at least one of the coils 22. The system further includes a seal 90 on the expansible heart valve prosthesis 60 configured to engage the helical anchor 12 and prevent blood leakage past the heart valve prosthesis 60 after implantation of the heart valve prosthesis 60 in the helical anchor 12.SELECTED DRAWING: Figure 14A

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Provisional Patent Application No. 61 / 865,657, filed Aug. 14, 2013 (pending), U.S. Provisional Patent Application No. 61 / 942,300, filed Feb. 20, 2014 (pending), and U.S. Provisional Patent Application No. 61 / 943,125, filed Feb. 21, 2014 (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. It occurs most commonly in ischemic heart disease when the leaflets of the mitral valve do not contact or close properly after multiple infarctions, idiopathic cardiomyopathy, and hypertensive cardiomyopathy, which causes the left ventricle to dilate, as well as due to 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 traditional treatment has been valve replacement by open-heart procedures. This procedure is very invasive and requires a significant amount of recovery time. Fortunately, in the last decade, there has been great progress in replacing this open-heart surgical procedure with catheter procedures that can be performed quickly without surgical incisions or the need to support circulation with a heart-lung machine during cardiac arrest. 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 or 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. In the last decade, many companies have been successful in creating catheter or minimally invasive implantable aortic valves, but 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 with 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 with creating a 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 can 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, the patient can 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 were 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 catheterization, 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 for 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 fiber 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 fiber 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 numerous 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 perforating the heart and injuring 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 stable 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] International application number PCT / US2013 / 024114 [Patent Document 2] International application number PCT / US2014 / 050525 [Patent Document 3] International application number PCT / IB2013 / 000593 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 an exemplary embodiment, the present invention provides 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 is normally at a first diameter and expandable to a larger second diameter upon application of a radially outward force from within the helical anchor. A gap is defined between adjacent coils sufficient to prevent engagement of at least one of the adjacent coils with the native heart valve. An expandable heart valve prosthesis is provided and is configured to be delivered within the helical anchor and expanded within the plurality of coils to engage at least one of the coils. This secures the helical anchor and the heart valve prosthesis together while moving at least the coil from the first diameter to the second diameter. The system further comprises a seal on the expandable heart valve prosthesis configured to engage the helical anchor and prevent blood leakage through the heart valve prosthesis after implantation of the heart valve prosthesis within the helical anchor.

[0023] The system may include one or more additional aspects. For example, the helical anchor may include another coil that moves from a larger diameter to a smaller diameter by expanding the heart valve prosthesis inside the coils. The seal may take many alternative forms. For example, the seal may include a portion that extends between adjacent coils to prevent blood leakage through the helical anchor and through the heart valve prosthesis. The seal may be constructed from many different alternative materials. The seal may further include a membrane or panel that extends between at least two coils of the helical anchor after implantation of the heart valve prosthesis in the helical anchor. For example, one example is a biomaterial. The helical anchor may further include a shape memory material. The heart valve prosthesis includes a blood inflow end and a blood outflow end, at least one of which may be unflared and generally cylindrical. In one exemplary embodiment, the blood outflow end is flared radially outward and includes a cushion to prevent damage to tissue structures in the heart after implantation. The gap may be formed by a coil portion of the helical anchor extending non-parallel to adjacent coil portions of the helical anchor.

[0024] In another exemplary embodiment, a system is provided substantially as described above, except that the seal is alternatively or additionally carried on a helical anchor instead of being carried on the heart valve prosthesis. Any other features as described or incorporated herein may be included.

[0025] In another exemplary embodiment, a system for docking a heart valve prosthesis comprises a helical anchor formed as a plurality of coils configured to support the heart valve prosthesis with the coil portions positioned above and / or below the heart valve annulus. An outer flexible helical tube forms an assembly with the coils of the helical anchor. A helical delivery tool is configured to carry the assembly and be rotated into place through the native heart valve. Additional or optional features may be provided. For example, the heart valve prosthesis may be expanded inside the plurality of coils. The outer tube may be formed from a low friction material adapted to disengage from the plurality of coils of the helical anchor after being rotated into place through the native heart valve. The outer tube may be secured to the helical delivery tool by sutures or by any other method. The helical delivery tool may be formed with a plurality of coils, and the outer tube may be further secured to a distal end. The distal end may further comprise a bullet or tapered shape to aid in delivery. The distal end may further comprise a resilient element, the distal end of the outer tube and the helical delivery tube being secured to the resilient element.

[0026] In another exemplary embodiment, a system for replacing a native heart valve includes a helical anchor formed as a plurality of coils configured to support a heart valve prosthesis at the native heart valve. An expandable heart valve prosthesis is provided in the system and is capable of being delivered into the helical anchor and expanded within the plurality of coils to engage at least one of the coils, thereby securing the helical anchor and the heart valve prosthesis together. A guide structure on the expandable heart valve prosthesis is configured to guide the helical anchor into position as it is pushed out of the helical anchor delivery catheter.

[0027] The guide structure may further comprise an opening in a portion of the expandable heart valve prosthesis, such as an opening in a loop, a tube, or simply an opening in a stent structure of the expandable heart valve prosthesis. The opening may be configured to receive a helical anchor delivery catheter that carries the helical anchor during the implantation procedure. The opening may be disposed on an arm of the expandable heart valve prosthesis, and the prosthesis may further comprise a plurality of arms configured to engage underneath the native heart valve. The guide structure may further comprise a tubular arm of the expandable heart valve prosthesis.

[0028] In another exemplary embodiment, a system for docking a mitral valve prosthesis and replacing a native mitral valve is provided and includes a coil guide catheter and a helical anchor configured to be received within and delivered from the coil guide catheter. The helical anchor is formed as a plurality of coils having a coiled configuration after delivery from the coil guide catheter and configured to support the mitral valve prosthesis when fully delivered from the coil guide catheter and implanted in the native mitral valve. The system further includes a tissue bundling catheter including a loop structure configured to be deployed to surround and bundle the native chordae to allow easier delivery of the helical anchor into the left ventricle.

[0029] In another exemplary embodiment, an anchor for docking a heart valve prosthesis comprises an upper helical coil portion, a lower helical coil portion, and a fastener for securing the upper helical coil portion to the lower helical coil portion.

[0030] In another exemplary embodiment, a method for implanting a heart valve prosthesis in a patient's heart includes the steps of holding a helical anchor in the form of a plurality of coils within an outer flexible tube. The assembly of the outer flexible tube and the helical anchor is secured to a helical delivery tool. The helical delivery tool is rotated adjacent to the patient's native heart valve to position the assembly on one or both sides of the native heart valve. The assembly is removed from the helical delivery tool and the outer tube is removed from the helical anchor. The heart valve prosthesis is then implanted within the helical anchor.

[0031] The step of securing the assembly may further include positioning the coils of the assembly generally along adjacent coils of the helical delivery tool. The step of removing the outer tube may further include holding the helical anchor with a pusher element and pulling the outer tube away from the helical anchor.

[0032] In another exemplary embodiment, a method for implanting an expandable heart valve prosthesis in a patient's heart includes delivering an expandable helical anchor in the form of a plurality of coils adjacent to a native heart valve. The expandable heart valve prosthesis is positioned within the plurality of 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 expanded relative to the expandable helical anchor, thereby securing the expandable heart valve prosthesis to the expandable helical anchor while expanding the expandable heart valve prosthesis. A seal is carried on the helical anchor and / or on the heart valve prosthesis and extends between at least two adjacent coils to prevent blood leakage through the helical anchor and past the heart valve prosthesis.

[0033] In another exemplary embodiment, a method of implanting an expandable heart valve prosthesis to replace a patient's native heart valve includes the steps of delivering a helical anchor in the form of a plurality of coils adjacent to the native heart valve. The expandable heart valve prosthesis is delivered adjacent to the native heart valve. The helical anchor is guided approximately around an outer periphery of the expandable heart valve prosthesis using a guide structure carried on the expandable heart valve prosthesis. The expandable heart valve prosthesis is expanded relative to the helical anchor. As discussed above, the guide structure may take a number of different forms.

[0034] In another exemplary embodiment, a method of implanting a helical anchor for docking a mitral heart valve prosthesis in a patient includes bunching the chordae using a tissue bunching catheter, and then delivering the helical anchor in the form of a plurality of coils adjacent to the native heart valve and around the bunched chordae.

[0035] In another exemplary embodiment, a method of implanting a helical anchor for docking a heart valve prosthesis in a patient includes the steps of delivering an upper helical anchor portion comprised of an upper coil to a location above the native heart valve and delivering a lower helical anchor portion comprised of a lower coil to a location below the native heart valve, the upper and lower helical anchor portions being secured together with a fastener either before or after delivery of each helical anchor portion.

[0036] In another exemplary embodiment, a system for replacing a native heart valve is provided, comprising an expandable helical anchor formed as a plurality of coils configured to support a heart valve prosthesis. At least one of the coils is normally at a first diameter and is expandable to a larger second diameter upon application of a radially outward force from within the helical anchor. A gap is defined between adjacent coils sufficient to prevent engagement of at least one of the adjacent coils with the native heart valve. An expandable heart valve prosthesis is provided and delivered within the helical anchor and is expandable within the plurality of coils to engage with at least one of the coils. In this manner, the expandable coil secures the helical anchor and the heart valve prosthesis together while moving from the first diameter to the second diameter. The expandable heart valve prosthesis comprises an inflow end and an outflow end. The inflow end is non-flared and generally cylindrical, while the outflow end is radially outwardly flared.

[0037] 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]

[0038] [Figure 1] FIG. 13 is a perspective view showing the introduction of a helical anchor into the position of the native mitral valve. [Figure 2A] FIG. 2 is an enlarged cross-sectional view showing an earlier portion of the procedure shown in FIG. 1, but involving the use of a deflectable catheter. [Figure 2B] FIG. 2B is a cross-sectional view of the heart similar to FIG. 2A, but showing deflection of the delivery catheter and introduction of the helical anchor below the native mitral valve. [Figure 3A] FIG. 2 is an enlarged elevational view showing the distal end of the delivery catheter and its deflectability. [Figure 3B] FIG. 2 is an enlarged elevational view showing the distal end of the delivery catheter and its deflectability. [Figure 4A] FIG. 3B is a perspective top view of FIG. 3A. [Figure 4B] FIG. 3C is a perspective top view of FIG. 3B. [Figure 5A] FIG. 3C is a side elevation view similar to FIG. 3B, but showing the use of wires within the delivery catheter used for deflection or steering of the distal end. [Figure 5B] FIG. 5B is a top cross-sectional view of the delivery catheter shown in FIG. 5A. [Figure 6A] FIG. 13 is a perspective view showing a combination helical anchor and an outer tube used to assist in delivery of the helical anchor to the native mitral valve position. [Figure 6B] FIG. 6B is a perspective view of the helical anchor within the outer tube shown in FIG. 6A. [Figure 7A] FIG. 6C is an elevational view showing a spiral delivery tool used to deliver the assembly of FIG. 6B to the native mitral valve position. [Figure 7B] 7B is a perspective view showing the mounting of the assembly shown in FIG. 6B to the helical delivery tool shown in FIG. 7A. [Figure 8A] FIG. 6C is a perspective view showing a cross-section of the heart and a spiral delivery tool being used to implant the assembly of FIG. 6B. [Figure 8B] 13A-13C are perspective views showing further steps of the implantation method. [Figure 8C] 13A-13C are perspective views showing further steps of the implantation method. [Figure 8D] 13A-13C are perspective views showing further steps of the implantation method. [Figure 8E] 13A-13C are perspective views showing further steps of the implantation method. [Figure 8F] FIG. 1 is a perspective view showing an implanted helical anchor. [Figure 8G] FIG. 1 is a cross-sectional view showing a replacement heart valve, such as a stented valve, within an implanted helical anchor. [Figure 9] 13A-13C are perspective views of another exemplary embodiment of a tool and assembly for implanting a helical anchor. [Figure 10] FIG. 10 is a partial cross-sectional top view of the assembly of FIG. [Figure 11A] FIG. 13 is a cross-sectional view of the distal end of an alternative embodiment of a helical anchor and delivery catheter. [Figure 11B] FIG. 13 is a perspective view of the distal end of another embodiment of a helical anchor and delivery catheter. [Figure 12] 13 is a cross-sectional view of a replacement stent-mounted valve and helical anchor implanted in the native mitral valve position according to another exemplary embodiment. FIG. [Figure 13] 1 is an enlarged cross-sectional view of another exemplary embodiment of a stented replacement heart valve. [Figure 13A] FIG. 14 is an enlarged cross-sectional view of a non-flared embodiment of the outflow end of the replacement heart valve shown in FIG. [Figure 14A] 11A-11C are cross-sectional views illustrating another exemplary embodiment of a replacement heart valve secured within a helical anchor. [Figure 14B] FIG. 14B is an enlarged cross-sectional view of the replacement valve shown in FIG. 14A. [Figure 15A] FIG. 1 is a schematic diagram showing a cross-section of the heart and the initial introduction of a delivery catheter to the mitral valve location. [Figure 15B] FIG. 13 is an enlarged cross-sectional view of the heart showing a further step in introducing a stented replacement heart valve with a helical anchor. [Figure 15C] FIG. 15C is a diagram similar to FIG. 15B, but showing further incremental steps in the method of introducing a replacement heart valve with a helical anchor and stent attached to the native mitral valve position. [Figure 15D] FIG. 15C is a diagram similar to FIG. 15B, but showing further incremental steps in the method of introducing a replacement heart valve with a helical anchor and stent attached to the native mitral valve position. [Figure 15E] FIG. 15C is a diagram similar to FIG. 15B, but showing further incremental steps in the method of introducing a replacement heart valve with a helical anchor and stent attached to the native mitral valve position. [Figure 15F]FIG. 15C is a diagram similar to FIG. 15B, but showing further incremental steps in the method of introducing a replacement heart valve with a helical anchor and stent attached to the native mitral valve position. [Figure 16A] 1A-1C are schematic elevational views showing simultaneous deployment of a stented replacement heart valve and a helical anchor using arms with loops on the stented valve. [Figure 16B] 1A-1C are schematic elevational views showing simultaneous deployment of a stented replacement heart valve and a helical anchor using arms with loops on the stented valve. [Figure 17A] FIG. 16B shows a similar but alternative embodiment to FIG. 16A. [Figure 17B] FIG. 16C shows a similar but alternative embodiment to FIG. 16B. [Figure 18A] 16A and 16B, but progressively illustrating another embodiment of a method for deploying a replacement heart valve having a helical anchor and a stent attached thereto. [Figure 18B] 16A and 16B, but progressively illustrating another embodiment of a method for deploying a replacement heart valve having a helical anchor and a stent attached thereto. [Figure 18C] 16A and 16B, but progressively illustrating another embodiment of a method for deploying a replacement heart valve having a helical anchor and a stent attached thereto. [Figure 19A] FIG. 13 is a side elevational view of a helical anchor made in accordance with another exemplary embodiment. [Figure 19B] FIG. 19B is a cross-sectional view taken along line 19B-19B of FIG. 19A. [Figure 20] 13 is a schematic perspective view showing another alternative system for delivering a helical anchor. FIG. [Figure 21A] 13 is a schematic perspective view showing the initial delivery of an alternative helical anchor. [Figure 21B] FIG. 21B is a schematic perspective view of the fully delivered helical anchor of FIG. [Figure 22A]13A-13C are cross-sectional views of another exemplary embodiment of a helical anchor including a seal. [Figure 22B] FIG. 22B is a cross-sectional view similar to FIG. 22A, but showing a helical anchor implanted in place of the native mitral valve and a replacement valve fitted with an expandable stent retained within the helical anchor. [Figure 23A] 1 is a schematic elevational view illustrating another exemplary embodiment of a helical anchor prior to expansion by a balloon catheter. FIG. [Figure 23B] FIG. 23B is an elevational view similar to FIG. 23A, but showing the helical anchor during expansion by a balloon catheter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] It will be understood that like reference numerals generally refer to similar elements of structure and function throughout this detailed description and the drawings. Differences between the embodiments will be apparent from the drawings and / or from the description and / or use of different reference numerals in each drawing. For purposes of clarity and brevity, descriptions of similar elements will not be repeated within this description.

[0040] 1 in combination with FIGs. 2A and 2B, a deflectable catheter 10, as previously discussed in applicant's U.S. Patent Application Publication No. 2006 / 0133991, the disclosure of which is incorporated herein by reference in its entirety, makes implantation of a helical anchor 12 much easier. The deflectable tip 10a of the catheter 10 assists the helical anchor 12 in engaging the commissures 14 of the native mitral valve 16, as shown in FIG. 1. The tip 10a of the catheter 10 may be designed and configured such that it may bend downward toward the native leaflets 18, 20 of the mitral valve 16. Once the tip 10a of the catheter 10 is positioned approximately above the commissures 14, as shown in FIG. 2A, the tip or distal end 10a may be bent downward, and then it becomes relatively easy to push or push the helical anchor 12 out of the distal end 10a and downward through the mitral valve 16, as shown in FIG. 2B.

[0041] 3A, 3B, 4A, 4B, 5A, and 5B, the displaceable catheter or anchor delivery catheter 10 may be deflectable at a number of different points or positions. Deflecting the catheter tip 10a outward to expand the radius of the delivery catheter tip 10a can be very useful, as shown in FIGS. 3A, 3B, 4A, and 4B, which show the effect of "before" and "after" deflection of the distal end 10a. Deflecting the catheter 10 in this manner gives the helical anchor 12 a winding or coil 22 that starts at a larger diameter. As an example, this winding or coil 22 of the helical anchor 12 may typically be 25 mm, but by manipulating the distal end 10a of the catheter 10 in this manner, it may be expanded in diameter to 30 mm. Spreading the first winding or coil 22 of the helical anchor 12 in this manner helps the helical anchor 12 capture all of the chordae 24 and leaflets 18, 20 when the helical anchor 12 is introduced as generally discussed above in connection with FIG. 1 and FIG. 2A-B. As the helical anchor 12 advances, the distal end 10a of the delivery catheter 10 can also deflect inwardly to assist the helical anchor 12 in capturing all of the chordae 24 at the opposing commissures. Moving the distal end 10a of the delivery catheter 10 from side to side as the helical anchor 12 is substantially threaded or rotated into and through the native mitral valve 16 is substantially similar to having the winding or coil 22 follow the delivery catheter 10. However, in this case, the delivery catheter 10 is only placed if the tip 10a is moving with the coil 22. Deflectability of the distal tip 10a in any direction can be achieved by embedding a wire 26 that runs the length of the delivery catheter 10. When the wire 26 is pulled, the delivery catheter tip 10a deflects and deforms into various shapes as desired or required for the procedure.

[0042] A procedure for introducing or implanting the helical anchor 12 will now be described with reference to Figures 6A, 6B, 7A, 7B, and 8A-8C. A helical delivery tool 30 with a coil 31 is used to deliver the helical anchor 12 housed within an outer tube 32 formed from, for example, Gore-Tex® or other low friction material such as PTFE. A suture 34 is used to secure the combination or assembly of the outer tube 32 and the helical anchor 12 in place on the coil 31 of the helical delivery tool 30. A groove (not shown) may be formed in the helical tool 30 to provide a fixed seat for the suture. An additional suture 36 is used to tie off the front end of the outer tube 32 through a loop 38 at the end of the helical delivery tool 30. The helical delivery tool 30 and outer tube / helical anchor combination 32, 12 are rotated into the heart 40 and through the mitral valve 16 as shown, and the sutures 34 are severed, for example, with a scalpel 42 (FIG. 8B). A set of forceps 44 is used to rotate the tool 30 inwardly and slightly further through the native mitral valve 16, thereby breaking the sutures 36 (FIG. 8C). The helical tool 30 is then rotated in the reverse direction and removed from the heart 40, leaving the helical anchor 12 combined with the outer tube 32 within the heart 40 as shown. A push rod 50 having a cupped end 52 is inserted into the rear end of the outer tube 32 (FIG. 8D). The outer tube 32 is then pulled in the reverse direction or backwards to remove the outer tube 32 while leaving the helical anchor 12 in place. The low friction material of the outer tube 32 allows it to easily disengage from the helical anchor 12. Figures 8F and 8G respectively show the complete implantation of this embodiment of the helical anchor 12 and a replacement heart valve 60 securely attached in and to the helical anchor 12. Replacement valve 60 includes leaflets 62, 64 and a body 66 which may be of any suitable design, such as an expandable stent design.

[0043] In another embodiment shown in Figures 9 and 10, a bullet shaped head 70 is provided on the helical tool 30. The bullet shaped head 70 has a slit 72 that runs parallel to the helical wire or coil 22 adjacent to the head 70. The bullet shaped head 70 is formed, for example, from an elastic polymer, and the slit 72 opens and closes due to its elasticity. Again, the outer tube 32 is secured to the helical delivery tool 30 by a suture (not shown). The front end 32a of the outer tube 32 is inserted into the bullet shaped head 70, for example, by forceps 44. In this embodiment, the bullet shaped head 70 accommodates easier insertion due to its tapered shape.

[0044] 11A and 11B show a further exemplary embodiment of a combination delivery catheter 10 with a helical anchor 12 therein prior to deployment. The distal tip 10a of the delivery catheter 10 includes a taper that may be gradually tapered as shown in FIG. 11A or more rounded as shown in FIG. 11B. In either case, this distal tip 10a configuration allows for smoother and easier delivery to the native mitral valve location and allows for movement through tissue structures such as native tissue within the heart 40. For example, the distal end 10a of the delivery catheter 10 may need to be routed through the mitral valve 16 and partially or completely encircle the chordae 24 (FIG. 1). As shown in FIG. 11A, the helical anchor 12 may be comprised of an inner wire coil 12a and an outer covering or coating 12b, such as a fiber, and may include a soft tip 12c formed from a polymer or the like to avoid damage to the heart tissue during delivery and to allow for easier delivery.

[0045] 12 is a cross-sectional view of an exemplary stented replacement heart valve or prosthesis 60 seated at the native mitral valve 16 docked within the helical anchor 12. In this embodiment, a "cushion" structure 80 is added to the annular edge at the outflow end of the valve 60. This cushion structure 80 may be formed, for example, from a foam 82 covered by a sealing material 84, such as a fabric or another suitable material or coating. This sealing layer 84 extends upwardly over the open stent structure 86 of the valve 60 to prevent blood leakage past the valve 60 and through the coils 22 of the helical anchor 12.

[0046] FIG. 13 is an enlarged view of a replacement heart valve 60 similar to the valve shown in FIG. 12, but showing inflow and outflow ends that are radially outwardly flared.

[0047] FIG. 13A is an enlarged cross-sectional view showing a generally cylindrical outflow end portion without a radially outward flare.

[0048] 14A and 14B show another exemplary embodiment of the present invention with a helical anchor 12 that docks or attaches the replacement stent-valve 60, and with a living tissue seal 90, such as pericardial tissue or other animal tissue, used at both locations of the cushion 80 to cover the inner foam layer 82 and to seal and cover the open stent structure 86 up to the location of the existing fabric layer 92 surrounding the replacement heart valve 60. The combination of the existing fabric layer 92 on the stent-valve 60 and the seal layer 90 surrounding the lower or outflow portion of the valve 60 prevents blood flow from leaking through the stent structure 86 and past the valve 60. Instead, blood neatly passes through the leaflets 62, 64 of the replacement valve 60. As further shown in FIG. 14A, the helical anchor 12 is preferably formed from spaced coils 22 to form gaps 91, such as those configured in any of the embodiments discussed above in connection with U.S. Pat. No. 6,399,323, the disclosure of which is incorporated herein by reference in its entirety, or as otherwise desired. As further described in US Pat. No. 6,399,633, the helical anchor 12 is expandable by a stent-valve 60 .

[0049] 15A-15C, an initial portion of a procedure in another exemplary embodiment is illustrated. In this figure, a sheath 100 and delivery catheter 101 are advanced through a peripheral vein into the right atrium 102 of the heart 40, across the atrial septum 104, and into the left atrium 106. The distal end 10a of the delivery catheter 101 is positioned in the left ventricle 108 by being routed through the native mitral valve 16. The delivery catheter 101 houses a self-expanding or stented mitral prosthesis or replacement valve 60 that is to be implanted in place of the native mitral valve 16. Typically, a superelastic or shape memory type material such as Nitinol is used to form the frame structure or body 66 of the self-expanding replacement valve 60, although other materials may be used instead. The frame or body 66 includes artificial valve leaflets 18, 20 that are typically formed from tissue such as bovine or porcine pericardial tissue. Alternatively, the leaflets 18, 20 may be formed from other materials, such as synthetic or other biomaterials, such as materials derived from the small intestinal mucosa. As described further below, the delivery catheter 101 further houses the helical anchor 12 and a delivery system. The helical anchor 12 may generally take the form described herein or previously disclosed, such as in U.S. Patent Nos. 5,993,333 and 5,993,362, the disclosure of which is also incorporated herein by reference.

[0050] 15B shows the delivery catheter 101 inside the left ventricle 108 with the distal tip 10a positioned just below the native mitral valve leaflets 18, 20. The procedure begins by exposing the contents of the delivery system.

[0051] FIG. 15C shows another part of the procedure after FIG. 15B, showing a prosthetic or replacement mitral valve 60 being partially delivered through the distal end 10a of the catheter 101. The end of the replacement valve 60 positioned in the left ventricle 108 has arms 110 that wrap around the native mitral valve leaflets 18, 20 and serve to secure the replacement valve 60 firmly against the edges of the native mitral valve leaflets 18, 20. The arrows 112 show how the arms 110 wrap around the inferior edges of the native mitral valve leaflets 18, 20 after they are pushed or deployed outward from the delivery catheter 101. The structure of this replacement valve 60 is shown in the above-incorporated U.S. Pat. No. 6,399,323. These arms 110 help prevent the replacement valve 60 from dislodging upward into the left atrium 106 when the replacement valve 60 is fully positioned by hooking around the edges of the native mitral valve leaflets 18, 20. The multiple arms 110 are useful for providing an inferior mounting surface of the mitral valve prosthesis 60 against the native mitral valve 16. The arms 110 may vary in length as well as in features and configurations. It will be understood that multiple arms 110 are used with this embodiment, but only two arms 110 are shown in these figures for illustration and simplicity. One of the arms 110 includes a loop 120 for delivering or controlling the helical anchor delivery catheter 10 containing the helical anchor 12. The anchor delivery catheter 10 is preloaded into the loop 120, after which the assembly is loaded into the delivery sheath 100. The arm with the loop 120 may have a heavier construction than the other arms 110 and may not be similar to the other arms 110. The arms 110 have shape memory properties such that when pushed outward or deployed from the anchor catheter 10, they wrap around the native mitral valve leaflets 18, 20. The arm 110 having the loop 120 wraps around the native mitral valve leaflets 18, 20 and the attached helical anchor delivery catheter 10 is carried by the arm 110 such that the chordae 24 and the native mitral valve leaflets 18, 20 are positioned within the exposed ends of the helical anchor 12.

[0052] When the helical anchor 12 is advanced or pushed out as initially shown in FIG. 15C, it will encircle the chordae 24 so that all the valve and chordae are captured inside the helical anchor 12. The loop 120 redirects the helical anchor delivery catheter 10 around the native mitral valve leaflets 18, 20 and above the chordae 24 into a preferred location below the native mitral valve annulus 126. The arm 110 with the loop 120 may have a dual function of attaching the valve 60 to the native leaflet margins and guiding the helical anchor 12 during delivery. The loop 120 may be large enough to allow the helical anchor delivery catheter 10 to pivot or swivel when the system is deployed. It is important that the helical anchor 12 is pushed out in a plane close to parallel to the underside of the native mitral valve 16. The helical anchor delivery catheter 10 is also pointed or oriented in this plane by the loop 120. In fact, loop 120 may be constructed from a short tube (not shown) instead of a wire as shown. The tube biases helical anchor delivery catheter 10 into a preferred plane and orientation. Alternatively, helical anchor delivery catheter 10 can be steerable in one of the ways known through the steerable catheter art.

[0053] Other mitral valve prostheses or replacement valves may be used, having a variety of attachment arms or wings or stent structures that wrap around the native mitral valve leaflets 18, 20. Any of the arms or other similar structures on such prostheses may be fitted to the loop 120, or to a tube or other similar guiding structure, to perform a function similar to that of the loop 120 just described. This function generally relates to guiding the delivery of the helical anchor 12. Furthermore, the loop 120 need not guide the delivery of the helical anchor. For example, the cells or openings of the replacement valve stent structure 86 could perform the same function as the loop 120 shown and described in these figures. Also, hooks or tubes could be used in place of the loop 120 shown. Any structure capable of performing the function of delivering the helical anchor 12 around the native mitral valve leaflets 18, 20 may be added to the prosthetic or replacement heart valve 60. This structure may be permanently manufactured as part of the replacement valve 60, or it may be a temporary structure used only during the procedure. For example, a suture loop (not shown) may be used to guide the delivery of the helical anchor 12, including any associated helical anchor delivery catheter 10. After use of the suture, the suture may be withdrawn from the patient.

[0054] The arms 110 shown in these figures are very thin. In fact, it may be more useful to have arms made of a pair or three wires welded at the ends. The thin ends of the arms 110 help the arms 110 pass between the chordae 24 at the edges of the free edges of the native mitral valve leaflets 18, 20, allowing the arms 110 to wrap around the native leaflets 18, 20. The chordae 24 are tightly packed in some areas, and the thin arms 110 allow the arms 110 to pass between these chordae 24. As the thin parts of the arms 110 pass, the thicker parts of the arms 110 can move between the chordae 24 by moving them apart. Thus, arms 110 made of a single wire or wire weld at the thin or distal ends, and sturdier or thicker closer to the main body of the prosthetic or replacement valve 60, may be the desired configuration. Also, the wires or arms 110 may be much shorter than those shown in these exemplary figures. In the illustrated method, delivery of the helical anchor 12 may begin at any desired location, and not necessarily at the commissure 14 of the native mitral valve 16. For example, delivery may begin at the native mitral leaflet 18 or the mid-portion of the native mitral leaflet 20. This is advantageous to the surgeon in that they do not need to precisely locate the commissure 14 to begin the procedure, thus greatly simplifying the procedure.

[0055] FIG. 15D shows the helical anchor 12 being delivered beneath the native mitral valve leaflets 18, 20. Arrow 130 shows the helical anchor 12 being pushed out of the helical anchor delivery catheter 10 beneath the native mitral valve 16. Any number of coils or windings 22 of the helical anchor 12 may be pushed out depending on the particular configuration of the helical anchor 12 being used in the procedure. Preferably, the inner diameter of the helical anchor 12 is slightly less than the outer diameter of the fully expanded mitral valve prosthesis 60 to facilitate firm engagement or fixation of the replacement mitral valve 60. The helical anchor 12 may be constructed of bare wire or may have a coating or covering for various reasons such as those described in the above-incorporated PCT application. The partially delivered mitral valve prosthesis 60 serves the important function of centering the delivery of the helical anchor 12. The mitral valve prosthesis or replacement valve 60 also provides a stable platform.

[0056] FIG. 15E shows three windings 22 of the helical anchor 12 positioned beneath the native mitral valve 16. These windings or coils 22 position the native mitral valve leaflets 18, 20 between the helical anchor 12 and the prosthetic mitral valve 60, which is shown in a configuration about to be expanded. When the replacement valve 60 is expanded, this fixedly positions the replacement valve 60 and prevents leakage around the replacement valve 60 by sealing the native mitral valve leaflets 18, 20 to the prosthesis 60. The delivery sheath 101 for the replacement valve 60 has been removed, and in the case of a self-expanding valve, the valve 60 will spring open upon removal of the delivery sheath 101. Arrows 132 indicate this process before that spring opening occurs. In this view, the replacement valve 60 is still in a closed position, allowing clear visibility of the windings or coils 22 of the helical anchor 12 beneath the native mitral valve 16. In this configuration, there are three helical anchor coils 22 below the native mitral valve 16, although any number of coils 22 may be used instead. The coils 22 are positioned above the underside of the native mitral valve annulus 126 and leaflets 18, 20 to provide a firm support that secures the helical anchor 12 in place and prevents migration into the left atrium 106 as the powerful left ventricle 108 contracts. When the arms 110 wrap around the helical anchor 12, the entire structure or assembly is stabilized in place. This embodiment gives the surgeon or interventionist a great deal of options, as the anchors 12 can be delivered simultaneously with the replacement valve 60. The prosthetic heart valve 60 with multiple shape memory frames can be resheathed. This means that during the procedure, the replacement valve 60 can be partially advanced out of the catheter or sheath 101 to test the fit of the replacement valve 60 within the heart 40. If the surgeon or interventionist is not satisfied with the positioning of the replacement valve 60 prior to final release of the replacement valve 60, the valve 60 may be pulled back into the sheath or catheter 101. Thus, the prosthetic or replacement valve 60 may be initially positioned without the helical anchor 12 in place. If the subsequent fixation appears strong and stable and there are no signs of migration or leakage, the valve 60 may be released. On the other hand, if the surgeon or interventionist is not satisfied, the valve 60 may be pulled back into the sheath 101.The helical anchor 12 may be implanted first and then the valve 60 may be pushed out of the delivery sheath 101. This allows the user to make a decision regarding the clinical need for further fixation below the native mitral valve 16.

[0057] 15F shows the fully implanted expandable replacement valve 60 shown in the proper position. The arms 110 wrap around the native mitral valve leaflets 18, 20, thereby preventing the replacement valve 60 from migrating upward into the left atrium 106. The native mitral valve leaflets 18, 20 are compressed under the arms 110, forming a very rigid mechanical structure and anchor to prevent the replacement valve 60 from migrating to an undesired position. The windings or coils 22 of the helical anchor 12 also compress the body 66 of the prosthetic or replacement valve 60 to position, orient and prevent the replacement valve 60 from migrating. The helical anchor 12 thus provides a friction fit for the replacement valve 60 and serves to secure the arms 110 which wrap around the helical anchor 12. The upper portion of the native mitral valve 16 is shown with a wider area that rests inside the left atrium 106 to aid in its attachment to the wall of the left atrium 106. However, the forces that move the replacement valve 60 from the left atrium 106 towards the left ventricle 108 are low, and this portion of the replacement valve 60 may not be necessary and may be removed or reduced from the clinical prosthesis. The winding or coil 22 of the helical anchor 12 is important because it allows for the variability in the length of the native mitral valve leaflets 18, 20, the length of the chordae tendineae 24, and the attachment points of the chordae 24 in the left ventricle 108 from patient to patient. When a replacement valve 60 is used that has arms 110 that wrap around the native mitral valve leaflets 18, 20 without the helical anchor 12 encircling the underside of the native leaflets 18, 20, the fixation depth of the prosthetic mitral valve 60 may vary around the circumference of the replacement valve 60 to be implanted. For example, if the chordae 24 attached to the middle of the posterior leaflet 20 are very stretched or broken, which is common, the arms 110 may not be able to wrap around and engage the native leaflet 20 at this location. Alternatively, there may be very limited engagement along or at a higher plane. This portion of the replacement valve 60 is positioned higher, resulting in a tilt of the replacement valve 60, which positions the replacement valve 60 at an angle relative to the inflow blood plane through the replacement valve 60. As the heart 40 beats, a large load is placed on the replacement valve 60, which may begin to rock and displace.The heart 40 beats just under 100,000 times per day, and after a few days, weeks, or months, the valve 60 may become displaced, migrate, and / or become dislodged. Also, if the leaflets 18, 20 and / or chordae 24 are stretched too much, there may not be a point of contact with the arms 110. This can result in a large amount of paravalvular leakage due to lack of engagement of the replacement valve 60 with the native mitral leaflets 18, 20. The anchors 12 below the native mitral leaflets 18, 20 will compress the native leaflet tissue against the replacement valve 60, preventing this problem. The helical anchors 12 are positioned in one plane, preventing problems with variations in patient anatomy.

[0058] In clinical practice, the variability in the size of the native mitral valve leaflets 18, 20, the features of the native mitral valve leaflets 18, 20, the length of the chordae and the attachment of the chordae 24, and the diameter of the mitral valve annulus 126 is virtually limitless. The use of the helical anchor 12 or other anchoring structure beneath the native leaflets 18, 20 offsets many of these variables because the fixation point of the arms 110 can be moved to the lowest coil 22 of the helical anchor 12. This location may also be predetermined by matching the winding point of the arms 110 to the lowest position of the replacement valve 60 by selecting the number of coils 22 of the helical anchor 12 and the thickness of the coils 22 of the helical anchor 12. Thus, an important feature of the helical anchor 12 delivered beneath the native mitral valve annulus 126 is that it can form a common, predetermined surface for anchoring the arms 110 of the replacement valve 60. In the situation described above where some of the chordae 24 are stretched, the attachment of the replacement valve 60 in this region can be to the helical anchor 12, which forms a common plane with the lowest point on the replacement valve 60. To ensure that the valve 60 is secured to the common lowest plane over its entire circumference, additional coils 22 can be added to the helical anchor 12, or the diameter of the coils 22 can be made larger. Additional options, such as undulations, can be added to the coils 22 of the helical anchor 12 to extend over the entire height of the helical anchor 12. Thus, the helical anchor 12 provides a fixed point or location for the arms of the replacement valve 60 to wrap around, while at the same time enhancing the stability of the replacement valve 60 by allowing the helical anchor 12 to capture the circumference of the replacement valve 60 along its length. The combination of these features provides the replacement valve 60 with improved stability and can also seal the replacement valve 60 to the native mitral valve 16 to prevent perivalvular blood leakage. As previously mentioned, there are many variations and combinations of a patient's native mitral valve and heart anatomy, and it is not practical for a manufacturer to make fixation arms 110 of various lengths and depths, or for a user to optimally deliver these products into position in every case.Rather, it is much more practical to adjust for these variations by positioning the helical anchor 12 below the native mitral valve 16 and using it to form the lowermost surface to which the anchor 12 is secured. The delivery system for the helical anchor 12 may be any of the delivery or deployment systems described, for example, in the above-incorporated PCT applications. It will be appreciated that such deployment methods and devices may be used to deliver the helical anchor 12 such that the anchor 12 is positioned solely below the native mitral valve 16 as shown herein.

[0059] 16A and 16B show another embodiment in which a loop 120 is provided at the end of the arm 110 on the replacement valve 60 to guide the helical anchor delivery catheter 10. This loop 120 can be moved into position to swivel the delivery catheter 10. In this embodiment, the helical anchor delivery catheter 10 passes through the replacement valve 60, or in other words, within the replacement valve body 66, but the helical anchor delivery catheter 10 may be routed in a manner different from that shown, and the helical anchor delivery catheter 10 may be used for additional guidance along its path, such as by being routed through the loop 120 further than shown in FIGS. 16A and 16B for delivery of the helical anchor 12 and then being steerable.

[0060] 17A and 17B show another embodiment in which a helical anchor delivery tube 140 is incorporated into the replacement valve 60 in place of the helical anchor delivery catheter 10 previously described. In this embodiment, one arm of the replacement valve 60 is actually a tube 140 loaded with and carrying the helical anchor 12. The tubular arm 140 wraps around the native mitral valve leaflets (not shown) and the helical anchor 12 is delivered to the correct location and to the correct surface for delivery. Any structure on one of the arms 110 of the replacement valve 60 or any part of the replacement valve 60 that can guide the helical anchor 12 for delivery may be used instead. In FIG. 17B, the helical anchor 12 has been pushed out of the tubular arm 140 for approximately one complete rotation or revolution. As previously described, multiple windings or coils 22 of the helical anchor 12 may be deployed in this manner to ultimately secure the replacement valve 60 in the position of the native mitral valve 16 approximately as described above. The primary difference in this embodiment is that the helical anchor delivery catheter 10 is not required.

[0061] 18A-18C show another embodiment for deployment and implantation of a replacement valve and helical anchor. In this regard, the helical anchor delivery catheter 10 and replacement valve 60 are delivered substantially side-by-side. FIG. 18A shows the helical anchor delivery catheter 10 outside or pushed out of a delivery sheath 101 that also delivers the replacement valve 60. The helical anchor delivery catheter 10 passes through the loop 120 of one of the arms 110 of the replacement valve 60. Arrow 150 indicates that the helical anchor 12 is about to be pushed out of the end of the helical anchor delivery catheter 10. As shown in FIG. 18B, with the end of the helical anchor delivery catheter 10 still located within the loop 120, nearly one complete turn of the winding or coil 22 of the helical anchor 12 has been delivered beneath the native mitral valve (not shown). 18C illustrates a further point during the implantation process where approximately three windings or coils 22 of the helical anchor 12 have been delivered below the plane 152 of the native mitral valve 16. In this view, the helical anchor delivery catheter 10 and sheath 101 delivering the replacement valve 60 have been removed. If the replacement valve 60 is formed with a self-expanding stent, the body 66 of the valve 60 will spring open once the delivery sheath 101 is removed. For purposes of clarity and illustration, the valve 60 is still shown in a closed or unexpanded state for clarity only. Generally, however, the fully implanted system or assembly will be similar to that shown in FIG. 15F.

[0062] 19A and 19B show another embodiment of the helical anchor 12. In this embodiment, the configuration of the helical anchor 12 with respect to the spacing and size of the coils 22 may vary. The cross-sectional configuration may be, for example, 0.008±0.002 inches thick, 2.12±0.18 oz / yd. 2 (72±6g / m 2) weight, 40±5 wales / inch, 90±10 courses / inch. The foam layer 162 may be, for example, a 2 mm thick polyurethane sheet material. The foam may be attached to the fabric 160 using PTFE sutures with a light straight stitch. The fabric 160 and foam 162 are then wrapped around the central wire portion 22a of the coil 22 of the helical anchor 12 and cross-stitched to the wire portion 22a using the fabric sutures.

[0063] 20 illustrates another system that may include the delivery of the helical anchor 12 described above and / or in the above-incorporated PCT applications. However, according to this embodiment, an additional tissue bundling device 170 is included in the delivery system. This device 170 delivers a temporary ring or loop 172 that can gather or enclose the bundle of chordae tendineae 24 into a smaller area. This may facilitate easier placement of the helical anchor 12 without entanglement or obstruction by the chordae tendineae 24. Also shown in this figure are an introducer sheath 100, a delivery catheter 101, and a steerable helical anchor delivery catheter 10, all substantially similar to those previously described.

[0064] 21A and 21B show another helical anchor device or assembly 12. The assembly 12 is comprised of an upper or atrial helical anchor portion 180 and a lower or ventricular helical anchor portion 182. The helical anchor portions 180, 182 are delivered simultaneously by being pushed out of the helical anchor delivery catheter 10. The lower anchor portion 182 is delivered through the mitral valve 16 between the native leaflets 18, 20. The upper anchor portion 180 and the lower anchor portion 182 may be joined together, such as by a crimp joint 184. The upper anchor portion 180 is deployed above the native mitral valve 16 in the left atrium 106 (FIG. 20). The upper anchor portion 180 and the lower anchor portion 182 may be offset such that the lower anchor portion 182 is delivered first into the commissure 14 and through the native mitral valve 16. As shown, the upper and lower spiral anchor portions 180, 182 may be counter-wound or rotated and then crimped together as shown, or may be pre-crimped or otherwise attached prior to loading of the catheter 10.

[0065] 22A and 22B show another embodiment of a helical anchor and replacement valve system similar to that discussed in connection with the above-incorporated '661 patent. In this embodiment, however, the configuration of the helical anchor 12 is shown having a gap 200 between at least the upper coil 22a and the native mitral valve 16. As in the above-incorporated '661 patent, the helical anchor 12 includes an annulus seal 202 of any desired configuration extending longitudinally through the anchor 12 or otherwise along its length. In this embodiment, a panel or membrane seal 202 is shown extending downwardly from one of the coils 22a and covering a portion of the stented replacement valve 60 that would otherwise be opened by the stent structure 86. The seal 202 thus prevents blood leakage through the open stent structure 86 and past the replacement valve 60. All other aspects of the assembly as shown in Figures 22A and 22B are as described herein and may include any of the options or features described herein or elsewhere, such as, for example, in the above-incorporated PCT applications. Gap 200 is formed by coil portion 22b extending non-parallel to adjacent coil portions 22a, 22c.

[0066] 23A and 23B show another embodiment of a helical anchor 12, also similar to the above-incorporated '661 patent. The difference between this embodiment and the similar embodiment shown in the above-incorporated PCT application is that a gap 200 is formed between the two central coils 22a, 22c of the anchor 12. These two figures show the features of the helical anchor 12 that cause the coils 22 to move or rotate as the expandable anchor 12 is expanded, for example, by a balloon catheter 210. As previously mentioned, the gap 200 formed between adjacent coils 22a, 22c can be used to ensure that native mitral valve tissue is not captured or engaged by the adjacent coils 22a, 22c. The gap 200 is formed by the coil portion 22b extending non-parallel to the adjacent coil portions 22a, 22c.

[0067] Although the present invention has been illustrated by a description of preferred embodiments, and 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 methods of carrying out the invention as currently known. However, the present invention itself should be defined only by the appended claims.

[0068] [Section 1] A system for docking a heart valve prosthesis (60), comprising: a helical anchor (12) configured to be implanted in a native heart valve (16), the helical anchor (12) being formed with a plurality of coils (22) configured to support the heart valve prosthesis (60) with a coil portion of the helical anchor (12) adjusted to be positioned above and / or below the heart valve annulus; a flexible outer tube (32) configured to retain the plurality of coils (22) of the helical anchor (12) within the outer tube (32) to form an assembly; a delivery tool (30) for carrying the assembly, the delivery tool (30) being rotatable adjacent the native heart valve (16) to position the assembly above and / or below the heart valve annulus; comprising the outer tube (32) is configured to be removed from the plurality of coils (22) of the helical anchor (12) after the assembly has been positioned above and / or below the heart valve annulus; The system further comprises an expandable heart valve prosthesis (60) capable of being delivered to the native heart valve, the expandable heart valve prosthesis (60) capable of being expanded within a plurality of the coils (22) in the native heart valve. [Section 2] 2. The system of claim 1, wherein the outer tube (32) is formed from a low friction material adapted to slide off the plurality of coils (22) of the helical anchor (12) after the assembly is positioned above and / or below the heart valve annulus. [Section 3] 2. The system of claim 1, wherein the outer tube (32) is secured to the delivery tool (30) by sutures (34, 36). [Section 4] 2. The system of claim 1, wherein the delivery tool (30) is formed with a plurality of coils (31), the system further comprising a distal end (38, 70) of the coils (31) of the delivery tool (30), and the outer tube (32) is further secured to the distal end (38, 70). [Section 5] 5. The system of claim 4, wherein the distal end (70) further comprises a bullet or tapered shape. [Section 6] 6. The system of claim 5, wherein the distal end (70) further comprises an elastic element, and the distal ends of the outer tube (32) and the delivery tool (30) are secured to the elastic element (70). [Section 7] 2. The system of claim 1, wherein the heart valve prosthesis (60) includes a seal covering an end edge of an outflow end of the heart valve prosthesis (60). [Section 8] 2. The system of claim 1, further comprising a pusher element configured to hold the anchor (12) in place with the pusher element after the assembly is positioned above and / or below the heart valve annulus and to pull the outer tube (32) away from the anchor (12) while the outer tube (32) is removed from the plurality of coils (22) of the helical anchor (12). [Section 9] 2. The system of claim 1, wherein the delivery tool (30) is adapted to deliver the assembly penetrating the commissures of the native heart valve into a location of the assembly positioned above and / or below the heart valve annulus. [Section 10] 2. The system of claim 1, wherein the plurality of coils (22) includes at least three coils. [Section 11] 2. The system of claim 1, wherein the plurality of coils (22) and the heart valve prosthesis (60) are configured to capture leaflets of the native heart valve between the plurality of coils (22) and the heart valve prosthesis (60) when implanted in the native heart valve. [Section 12] 1. A system comprising: an anchor (12) configured to be implanted in a native heart valve (16), the anchor (12) being formed with a plurality of coils (22) configured to support the heart valve prosthesis (60) with the coil portion of the anchor (12) adjusted to be positioned above and / or below the heart valve annulus; a flexible outer tube (32) configured to retain the plurality of coils (22) of the anchor (12) within the outer tube (32) to form an assembly; a delivery tool (30) for carrying the assembly, the delivery tool (30) being capable of positioning the assembly above and / or below the heart valve annulus; A pusher element; comprising the system is configured such that after the assembly is positioned above and / or below the heart valve annulus, the outer tube (32) is removed from the plurality of coils (22) of the anchor (12) while the pusher element holds the anchor (12) in a fixed position and pulls the outer tube (32) away from the anchor (12). [Section 13] 13. The system of claim 12, further comprising an expandable heart valve prosthesis (60) that can be delivered to the native heart valve and that can be expanded inside a plurality of the coils (22) in the native heart valve. [Section 14] 14. The system of claim 13, wherein the heart valve prosthesis (60) includes a seal covering an end edge of the outflow end of the heart valve prosthesis (60). [Section 15] 14. The system of claim 13, wherein the plurality of coils (22) and the heart valve prosthesis (60) are configured to capture leaflets of the native heart valve between the plurality of coils (22) and the heart valve prosthesis (60) when implanted in the native heart valve. [Section 16] 13. The system of claim 12, wherein the delivery tool (30) includes a plurality of windings. [Section 17] 13. The system of claim 12, wherein the assembly is secured to the delivery tool by sutures. [Section 18] 13. The system of claim 12, wherein the delivery tool (30) is adapted to deliver the assembly penetrating the commissures of the native heart valve into a location of the assembly positioned above and / or below the heart valve annulus. [Section 19] 13. The system of claim 12, wherein the plurality of coils (22) includes at least three coils. [Section 20] 13. The system of claim 12, wherein the plurality of coils (22) includes at least four coils. [Section 21] 1. A system comprising: an anchor (12) configured to be implanted in a native heart valve (16), the anchor (12) being formed with at least three coils (22) configured to support the heart valve prosthesis (60) with the coil portions of the anchor (12) adjusted to be positioned above and / or below the heart valve annulus; a flexible outer tube (32) configured to hold at least three of the coils (22) of the anchor (12) within the outer tube (32) to form an assembly; a delivery tool (30) for carrying the assembly, the delivery tool (30) being capable of positioning the assembly above and / or below the heart valve annulus; comprising The system is configured such that the outer tube (32) is removed from the at least three coils (22) of the anchor (12) after the assembly is positioned above and / or below the heart valve annulus. [Section 22] 22. The system of claim 21, further comprising an expandable heart valve prosthesis (60) that can be delivered to the native heart valve and that can be expanded inside at least three of the coils (22) in the native heart valve. [Section 23] 23. The system of claim 22, wherein the heart valve prosthesis (60) includes a seal covering an end edge of the outflow end of the heart valve prosthesis (60). [Section 24] 23. The system of claim 22, wherein at least three of the coils (22) and the heart valve prosthesis (60) are configured to capture leaflets of the native heart valve between the plurality of coils (22) and the heart valve prosthesis (60) when implanted in the native heart valve. [Section 25] 22. The system of claim 21, further comprising a pusher element configured to hold the anchor (12) in place with the pusher element after the assembly is positioned at the heart valve annulus, and to pull the outer tube (32) away from the anchor (12) while the outer tube (32) is removed from the at least three coils (22) of the helical anchor (12). [Section 26] 22. The system of claim 21, wherein the delivery tool (30) includes a plurality of windings. [Section 27] 22. The system of claim 21, wherein the assembly is secured to the delivery tool by sutures. [Section 28] 22. The system according to claim 21, wherein said at least three coils (22) comprise at least four coils. [Section 29] 22. The system of claim 21, wherein the delivery tool (30) is adapted to deliver the assembly penetrating the commissures of the native heart valve into a location of the assembly positioned above and / or below the heart valve annulus. [Explanation of symbols]

[0069] 10 Deflectable Catheter, Delivery Catheter 10a Distal tip 12 Helical anchor 12a Internal Wire Coil 12b External Coating 12c Soft tip 14 commissure 16 Native mitral valve 18 Natural valve leaflets, artificial valve leaflets 20 Natural valve leaflets, artificial valve leaflets 22 Winding or coil 24 chordae, chordae tendineae 26 Wire 30 Spiral Delivery Tool 31 Coil 32 Outer tube 34 Sutures 36 Sutures 38 Loop 40 Heart 42 Female 44 Forceps 50 Push Stick 52 Cupped End 60 Replacement Heart Valves 62 Valve leaflets 64 Valve leaflets 66 Main Body 70 Bullet Shape Head 72 Slit 80 Buffer structure 82 Foam 84 Sealing layer 86 Open stent structure 90 Biological Tissue Seal 91 Gap 92 Fiber layer 100 Delivery Sheath 101 Delivery sheath, delivery catheter 102 Right atrium 104 Atrial septum 106 Left atrium 108 Left ventricle 110 Arm 120 Loops 126 Native Mitral Annulus 140 Spiral anchor delivery tube, tubular arm 152 sides 160 Textile Cover 162 Foam layer, foam 170 Tissue bundling device 172 Temporary Ring or Loop 180 Upper spiral anchor portion, atrial spiral anchor portion 182 Lower spiral anchor part, ventricular spiral anchor part 184 Crimp joint 200 gap 202 Annular Seal 210 Balloon Catheter

Claims

1. a steerable delivery catheter having a deflectable distal end configured to be steered and bent in one or more directions relative to the atrial side of the biological valve annulus when the deflectable distal end is positioned within an atrium of the heart and above the biological valve annulus; a helical anchor configured to be carried within the delivery catheter in a delivery configuration when the deflectable distal end is bent in one or more directions; 1. A system for docking a heart valve prosthesis, comprising: the helical anchor is configured to be axially movable relative to the deflectable distal end of the delivery catheter; the helical anchor has a coiled configuration with a plurality of windings configured to support a heart valve prosthesis after delivery into the heart from the deflectable distal end of the delivery catheter; 1. A system for docking a heart valve prosthesis, wherein in the coiled configuration, one or more first windings of the plurality of windings are configured to be positioned above a biological valve annulus, and in the coiled configuration, one or more second windings of the plurality of windings are configured to be positioned below the biological valve annulus.

2. 10. The system of claim 1, further comprising a flexible outer tube disposed around the helical anchor when the helical anchor is in a delivery configuration and when the helical anchor is in the coiled configuration outside the delivery catheter.

3. 10. The system of claim 1, wherein the deflectable distal end is configured to bend toward the leaflets of a biological heart valve when positioned within an atrium of the heart and on a commissure of a biological valve annulus.

4. The system of claim 1 , wherein the deflectable distal end is configured to bend in one or more directions via a pull wire embedded within the delivery catheter.

5. The system of claim 1 , wherein the deflectable distal end is configured to deform into various shapes having different radii of curvature.

6. The system of claim 1 , wherein the deflectable distal end is tapered.

7. a steerable delivery catheter having a steerable distal end and comprising a wire, the wire being configured to bend the steerable distal end from a first shape to a second shape when the steerable distal end is positioned within an atrium of the heart and above an annulus of a biological valve of the heart by pulling the wire; a helical anchor configured to be carried within the steerable catheter in a delivery configuration when the steerable distal end is bent from the first shape to the second shape; 1. A system for docking a heart valve prosthesis, comprising: the helical anchor having a coiled configuration comprises a plurality of windings configured for delivery to support a heart valve prosthesis after delivery from the delivery catheter within the heart, wherein one or more first windings are positioned above an annulus of a biological heart valve of the heart and one or more second windings are positioned below the annulus; A system for docking a heart valve prosthesis, wherein the helical anchor is axially movable relative to the steerable distal end.

8. The system of claim 7 , wherein the first shape has a first radius of curvature and the second shape has a second radius of curvature, the second radius of curvature being greater than the first radius of curvature.

9. The system of claim 7 , wherein the wire is embedded within the delivery catheter and extends along the length of the steerable delivery catheter.

10. The system of claim 7 , wherein the wire is configured to bend the steerable distal end into a plurality of different shapes having different radii of curvature.

11. 8. The system of claim 7, further comprising an outer cover disposed around the helical anchor when the helical anchor is in a delivery configuration and when the helical anchor is in the coiled configuration outside the steerable delivery catheter.

12. The system of claim 11 , wherein the outer cover comprises a fabric cover.

13. The system of claim 11 , wherein the outer cover comprises a PTFE cover.

14. A first shaft; a second shaft disposed within the first shaft and configured to extend distally of the first shaft, the second shaft having a steerable distal end; a helical anchor configured to be carried within the second shaft in a delivery configuration; 1. A system for docking a heart valve prosthesis, comprising: the helical anchor has a coiled configuration including a plurality of turns configured to support a heart valve prosthesis within an annulus of a biological heart valve of the heart after delivery from the second shaft within the heart; 1. A system for docking a heart valve prosthesis, wherein, when the distal end is positioned in an atrium of a heart and the helical anchor is positioned within the distal end, the distal end is configured to be steered and bent from a first position having a first radius of curvature to a second position having a second radius of curvature, the second radius of curvature being greater than the first radius of curvature.

15. The system of claim 14 , wherein the helical anchor is movable relative to the distal end.

16. 15. The system of claim 14, further comprising a cover disposed around the helical anchor when the helical anchor is in a delivery configuration and when the helical anchor is in a coiled configuration outside the second shaft.

17. The system of claim 16 , wherein the cover comprises a fabric material.

18. The system of claim 14 , further comprising a pull wire configured to steer and bend the distal end from the first position to the second position.

19. 15. The system of claim 14, wherein the distal end is configured to be steered and bent from the first position to the second position when the distal end is located within an atrium of the heart and above a valve annulus with the helical anchor disposed within the distal end.

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