BR112021007597A2 - transcatheter anchor set for a mitral valve, a mitral valve, and related methods - Google Patents

Abstract

TRANSCATETER ANCHOR ASSEMBLY FOR A MITRAL VALVE, A MITRAL VALVE, AND RELATED METHODS. A medical kit that implants a transcatheter heart valve into the heart at a valve implementation site and related methods of implantation and delivery. An anchor is introduced endovascularly into the heart and implanted into the cardiac wall with an anchor delivery system and delivery cable. A second delivery system introduces a tether coupled to the implanted anchor and a transcatheter heart valve. The transcatheter heart valve includes an upper or lower flap that is positioned to conform to the atrial floor at the deployment site.

Description

TRANSCATETER ANCHOR ASSEMBLY FOR A MITRAL VALVE, A MITRAL VALVE, AND RELATED METHODS FIELD OF INVENTION

[001] The present invention generally relates to a medical assembly for minimally invasive implantation of a valve in the heart, a new valve to replace the native heart valve and an anchor device to position and restrict the valve. The present invention also relates to methods of implanting medical assembly and valve components. More specifically, the invention relates to a novel transcatheter valve, transcatheter valve skirt, anchor device, anchor delivery system and a valve delivery device, as well as methods related to such assembly for endovascularly implanting the valve through the valve. mitral valve to replace native mitral valve function.

BACKGROUND OF THE INVENTION

[002] Transcatheter valves have proven to be safe and effective for replacing native heart valves such as the aortic and pulmonary valves. There is less certainty for mitral valve replacement because early clinical trials of transcatheter mitral valve replacement (TMVR) faced significant challenges posed by the clinical and anatomical complexity of mitral valve disease.

[003] Mitral valve disease, which primarily causes mitral regurgitation (MR), results from primary valve degeneration (eg, myxomatous degeneration, endocarditis, rheumatic disease, congenital disease, or other causes), or from incomplete leaflet coaptation (secondary or "functional" mitral regurgitation) that can occur from a combination of mitral annular dilation and/or mitral leaflet binding secondary to left ventricular dilation and papillary muscle displacement. MR increases the left atrial pressure, causing pulmonary congestion, leading to signs and symptoms of congestive heart failure, that is, peripheral edema, orthopnea, paroxysmal nocturnal dyspnea and progressive dyspnea on exertion. Additionally, RM aggravates left ventricular dysfunction, decreasing survival. Because many patients suffering from MR have significant comorbidities and high surgical risk, the development of minimally invasive methods (ie, transcatheter) to treat MR is important.

[004] The early transcatheter techniques developed have important limitations because they repair, but do not replace, the mitral valve. For example, transcatheter annuloplasty devices [Arto (MVRx, Inc., San Mateo, CA, USA); Cardioband (Edwards Lifesciences, Irvine, CA, USA); Carillon (Cardiac Dimensions, Kirkland, WA, USA); Millipede (Boston Scientific, Marlborough, MA, USA); Mitral Loop Cerclage (Tau-PNU Medical Co, Ltd. Pusan, Korean); Mitralign (Mitralign, Inc., Tewksbury, MA, USA) mimics surgical annuloplasty by directly or indirectly reducing the dimensions of the mitral annulus, allowing the mitral leaflets to co-approve more completely. Either way, these techniques are limited by uncertain reproducibility and the inability to deal with leaflet binding or abnormalities. On the other hand, the MitraClip repair system (Abbott Vascular, Abbott Park, Illinois, USA) or the Pascal system (Edwards Lifesciences) can treat leaflet abnormalities by folding the leaflets together, replicating the Alfieri surgical stitch. Although the MitraClip system is FDA approved and effective for many patients, a significant number of patients (>10%) have recurrent MR after MitraClip and many patients cannot receive MitraClip due to anatomical restrictions. Similarly, artificial cord therapies [NeoChord DS1000 (NeoChord, Inc., St. Louis Park, Minnesota, USA); Harpoon TSD-5 and V-chordal (Edwards LifeSciences)] are currently limited to a very specific anatomy (eg, isolated leaflet prolapse).

[005] Transcatheter mitral valve replacements (TMVR) are not as limited by anatomical restrictions and few patients have recurrent MR. Also, current technologies have limitations and disadvantages based on how they anchor to the mitral valve. In anchoring to the mitral valve leaflets, the Fortis valve (Edward Lifesciences) had an unacceptable rate of thrombosis. Also anchored in native leaflets, the Tiara valve (Neovasc, Richmond, BC, Canada) was successfully implanted without the same thrombosis problems. Similarly, CardiAQ (Edwards Lifesciences), which wraps the mitral annulus directly, NaviGate (NaviGate Cardiac Structures, Lake Forest, CA, USA), which pierces the annulus and leaflets with winglets, Cephea (Abbott Vascular ), which surrounds the annulus with its “hourglass” shape and the Intrepid valve (Medtronic, Minneapolis, Minnesota, USA), which engages the annulus via a “champagne-cork-like” effect, were all implanted without thrombotic problems. .

[006] Even so, as these devices anchor directly into the mitral annulus, they restrict, to varying degrees, the freedom of mitral annulus movement. Restricting this freedom can contribute to left ventricular dysfunction. For example, a study comparing transcatheter mitral valve repair (using the Abbott Vascular MitraClip device) in open heart surgery showed that mitral annular motion was significantly less with open heart surgery, which the authors suggested to be a factor in the fraction of Inferior left ventricular ejection (LVEF) after open heart surgery compared with transcatheter repair. Similarly, a study comparing flexible and rigid mitral annuloplasty rings found a significantly lower LVEF with rigid rings, which restrict mitral annular motion more than flexible rings. Thus, by restricting the mitral annulus, these devices can have deleterious effects on left ventricular function.

[007] Similarly, TMVR devices using docking systems may, by restricting mitral annular movement, decrease left ventricular function. In particular, the Caisson (LivaNova, PLC, London, England), HighLife (HighLife SAS, Paris, France), MValve (Boston Scientific) and Sapien M3 (Edwards Lifesciences) valves use docking systems to anchor transcatheter prostheses to the mitral annulus.

[008] In addition to restricting the mitral annulus, these devices also incur the risk of left ventricular outflow tract (LVOT) obstruction, which occurs when valve accessories open the anterior mitral leaflet, thus creating a fixed obstruction to flow out of LVOT. This is a particular limitation for TMVR devices in patients with small, hypertrophied ventricles (more common in women) or in patients with significant mitral annular calcification.

[009] To mitigate these concerns and limitations, the Tendyne valve (Abbott Vascular) has a lower risk of LVOT obstruction and does not restrict the mitral annulus as much as other TMVR devices. Tendyne achieves this because the valve is anchored through cords attached to an epicardial tether. Thus, it does not require rigid attachment to the mitral annulus, and the narrow intra-annular portion of this valve does not push the anterior mitral leaflet into the LVOT to the same degree as the other valves. The problem with Tendyne is that it requires transapical access (incision in the left ventricle), which can be detrimental to left ventricular function in some patients.

[010] Avoiding transapical access and not restricting the mitral annulus or inducing LVOT obstruction, the Upper Valve (4C Medical Therapies) consists of a supra-annular valve held in position with a large flexible ball cage in the left atrium. It is unclear, however, whether this ball cage will induce atrial abnormalities, such as fibrosis, causing atrial fibrillation and/or loss of atrial systolic function. Additionally, the continued function of native mitral leaflets can cause flow disturbances that alter the function of the prosthetic leaflet.

[011] Therefore, it remains desirable in the pertinent technique to provide a transcatheter valve for placement through the mitral annulus that can be delivered without transapical access, which has minimal risk of LVOT obstruction, allows for normal atrial and mitral annular function by not anchoring in the atrium or mitral annulus, and is fully repositionable and recoverable during the procedure.

SUMMARY OF THE INVENTION

[012] It is presented in the present invention a medical set that is implanted in a minimally invasive way through the mitral valve, to replace the function of the native mitral valve. The method disclosed in the present invention implants the mitral valve through a transseptal access, and the valve, which can be intra or supra-annular, anchors in the interventricular septum, thus avoiding the mitral annular anchorage and restriction and, at the same time, minimizing the risk of LVOT obstruction. Consequently, and beneficially, no portion of the system requires surgical thoracotomy and transapical access for implantation.

[013] In one aspect, the system comprises a transfemoral venous interatrial transseptal guide and transseptal crossing needle that allows crossing the interatrial septum for the delivery of a snare sheath in the left ventricle, with snare delivery in the left ventricle adjacent to the interventricular septum.

[014] The system additionally comprises a trans-septal interventricular venous transjugular guide and a radiofrequency crossing wire that allows crossing the interventricular septum, followed by looping the wire in the loop sheath positioned in the left ventricle. With the externalization of the wire outside the body through the interatrial transseptal guide, a wire loop is formed, with the wire extending from outside the transjugular guide to the external transfemoral guide. An exchange catheter is advanced over the wire loop, and the radiofrequency wire is replaced with a larger, stiffer wire.

[015] In one aspect, the system comprises an anterograde or retrograde anchor delivery sheath that advances over the wire loop and an antegrade or retrograde interventricular septum anchor attached to an anchor cap configured to accept a tether. The tie is configured to attach to one or more cords and the tie is attached to the transcatheter valve.

[016] According to various aspects, the interventricular septum anchor can consist of a right ventricular and left ventricular disc, connected by an interventricular septum element, and each of them can be composed of any metallic alloy, such as, but not if limiting to, nitinol, stainless steel, titanium or cobalt-chromium. Each anchor element can be covered with either synthetic materials such as, but not limited to, polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET), or biological membranes such as, but not limited to, bovine pericardial tissue or pig.

[017] The anchor cap is also composed of any metallic alloy and is coupled to the left ventricular disc of the interventricular septum anchor. With a retrograde interventricular septal anchor (delivered from the left ventricular side of the septum), the proximal end of the anchor cap defines a "female" internal thread that accepts the "male" of a distal end of a delivery cord. In one aspect, the delivery cable remains attached to the anchor cap and is used to guide the lanyard until the lanyard snap ring engages with the anchor. Finally, the delivery cable can be unscrewed from the anchor cap and removed.

[018] With an antegrade interventricular septal anchor (delivered from the right ventricular side of the septum), the anchor cap is a conduit for the wire loop. The right ventricular disc has a cable connector that defines a “female” internal thread that accepts the “male” from a distal end of an anterograde delivery cable. The antegrade delivery cable also serves as a conduit for the wire loop so that the wire starts externally in the transfemoral sheath, passes through the anchor cap of the interventricular septum anchor, through the delivery cable attached to the right ventricular side of the septum anchor, and exits the transjugular sheath. The wire loop extending through the anchor cap guides the lanyard until the lanyard snap ring engages with the anchor. After coupling, the wire loop can be removed and the antegrade delivery cable can be unthreaded, fully implementing the interventricular septum anchor, with the lanyard attached to the anchor cap.

[019] In one aspect, the loop has a snap ring attached to at least one snap ring arm with an eyelet defined at the proximal end of the snap ring arm. Each eyelet attaches to a distal end of a tying rod that attaches to the eyelet via a hook. The binding rod is composed of any metallic alloy and a proximal end of the binding rod is attached to a string. In one aspect, the lanyard snap ring is advanced over the anchor cap, decompressing the locking arms protruding from the anchor cap. In another aspect, the snap ring hits the end of the anchor cap, allowing the protruding locking arms to push outward, thereby locking the snap ring, and therefore the loop, in place. In another aspect, even after being locked in place, the loop is free to rotate around the longitudinal axis of the anchor cap, without affecting the position of the anchor cap or anchor bolt. For retrieval, the valve delivery catheter is rolled back over the lock arms, depressing them and thus allowing the lanyard snap ring to be retracted.

[020] In one aspect, the system comprises the loop configured to couple and/or secure the valve to the interventricular septum and the transcatheter valve comprises a body that houses the valve leaflets integrated to an upper or lower flap.

[021] In one aspect, the transcatheter valve is self-expanding and composed of nitinol and covered with synthetic materials such as, but not limited to, polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET), or biological membranes such as, but not limited to, bovine or porcine pericardial tissue.

[022] Transcatheter heart valve leaflets are composed of, but not limited to, bovine, equine, or porcine pericardial tissue, according to one aspect. In another aspect, the transcatheter heart valve is covered with a membrane having a larger diameter than the annulus at the implantation site, such that in use the membrane substantially covers the mitral annulus.

[023] The structure of the transcatheter valve, in its intra-annular form, begins as a cylindrical shape, with the bottom of the cylinder at or below the annular valve level, and with the top of the cylinder extending into the atrium . From the top of the cylinder extends a top flap, composed of one or more lengths of wire, made of laser cut or formed nitinol. These extensions are designed in formats such as, but not limited to, lines, arcs, hooks, circles, ellipses, sinusoidal curves, or polygon curves of three or more sides. Top flap extensions, like the valve body, are covered and/or connected with synthetic or biological membranes. The upper flap is perpendicular to the valve body or can bend toward the atrial floor as either a convex or concave curve. To facilitate sealing as the upper flap folds towards the atrial floor, the covering tissue consists of a braided or woven fabric, which allows for “elasticity”, improving the ability to conform to the topography of the atrial floor.

[024] In the supra-annular shape of the transcatheter valve, the structure begins with an inferior flap positioned on the floor of the left atrium. The lower flap is comprised of one or more lengths of wire, made from laser cut or formed nitinol. These extensions are designed in formats such as, but not limited to, lines, arcs, hooks, circles, ellipses, sinusoidal curves, or polygon curves of three or more sides. The lower flap extensions, like the valve body, are covered and/or connected with synthetic or biological membranes. The lower flap is perpendicular to the transcatheter valve body or can bend toward the atrial floor as either a convex or concave curve. To facilitate sealing as the lower flap folds towards the atrial floor, the covering tissue consists of a braided or woven fabric, which allows for “elasticity”, improving the ability to conform to the topography of the atrial floor. From the lower flap, a cylinder, housing the valve leaflets, extends into the left atrium.

[025] In one aspect, adjacent to the top of the valve cylinder, running longitudinally along the interior or exterior of the valve body, are one or more conduits, which take the form of a cylinder whose cross section is any portion of a circle. , ellipse, parabola, or hyperbola, or takes the form of a polyhedron with a flat base and top that takes the form of a polygon with three or more sides. These conduits are constructed from the membrane covering the valve body or may be made of, but not limited to, stainless steel, nitinol or other metal alloys. The one or more conduits are hollow and accommodate at least one cord attached to at least one brace, and each conduit attaches to a detachable latch near the atrial surface of the valve.

[026] The detachable locks securely secure the transcatheter valve to the anchorage system, composed of the tie coupled to the interventricular septum anchor, which is securely attached to the interventricular septum. In one aspect, a lanyard is coupled to the interventricular septum anchor via the anchor cap and at least one strand extends from the lanyard through the at least one duct of the skirt body. Thus, the transcatheter valve is threaded into the cord through the conduit so that the transcatheter valve slides interact with the cord. In another aspect, the proximal end of the cord attaches to a suture, which extends outside the heart to be accessible by a user.

[027] The system further comprises at least one atrial positioning rod whose proximal end is attached to the delivery system and whose distal end is reversibly coupled to a detachable latch, which is attached to the proximal end of the conduit of the transcatheter valve body. Through the internal lumen of the positioning stick, the suture and/or cord passes, so that the positioning stick pushes or pulls the transcatheter valve body, thereby applying differential force and flexion on the associated upper or lower flap, allowing apposition to the atrial floor. In another aspect, rotation of the positioning stick and/or pushing or pulling the internal elements of the positioning stick causes the detachable latch to engage the cord and/or suture, securing the cord and/or suture to the transcatheter valve body, maintaining the strength and flexion of the upper or lower flap to the atrial floor and safety position of the transcatheter valve.

[028] Related methods of deployment are also provided. Other apparatus, methods, systems, features, and advantages of medical devices and systems that are minimally invasively implanted in the heart will or will become apparent to the skilled person upon examination of the following figures and detailed description. All such additional devices, methods, systems, features and advantages are intended to be included in this description, are within the scope of the medical suite that is minimally invasively implanted in the heart, and are protected by the accompanying claims.

BRIEF DESCRIPTION OF THE FIGURES

[029] Figure 1 is a sectional perspective view of a heart showing the transcatheter valve system of the present application positioned in the heart, according to an aspect; Figure 2 is a perspective view of a retrograde anchor for anchoring a tether to the interventricular septum; Figure 3 is a perspective view of the retrograde anchor delivery cable for anchoring a tether to a cardiac wall; Figure 4 is a perspective view of a tether for anchoring the transcatheter valve to the retrograde anchor; Figure 5 is a perspective view of the retrograde anchor assembly, comprising the tether for connecting the transcatheter valve to the anchor, coupled to the anchor, for anchoring the tether to the interventricular septum with the LV disk of the anchor connected to the delivery cable; Figure 6 is a perspective view of the anterograde anchor delivery cable for anchoring the transcatheter valve to the anchor;

Figure 7 is a perspective view of an anterograde anchor for anchoring a tether to the interventricular septum; Figure 8 is a perspective view of the tie for anchoring the transcatheter valve to the antegrade anchor; Figure 9 is a perspective view of the antegrade anchor assembly, composed of the tether, for connecting the transcatheter valve to the anchor, coupled to the anchor, for anchoring the tether to the interventricular septum with the RV disk of the anchor connected to the delivery cable and a guide wire passing through set; Figures 10A and 10B are the side elevation view and the top perspective view of the intra-annular valve, comprising the upper flap attached to the transcatheter valve body with integral valve leaflets; Figures 11A and 11B are the perspective view and the top plan view of the valve, comprising the top flap attached to the transcatheter valve body with the integrated valve leaflets; Figure 12 is a side elevational view of the valved transcatheter valve with an upper flap edge transitioning from a concave to a convex configuration; Figure 13A is an enlarged side elevation view of the transcatheter valve body coupled to atrial positioning rods and cords; Figure 13B is an enlarged side elevation view of the locking system; Figure 14A is a perspective view of the locking system; Figure 14B is a perspective sectional view of the locking system;

Figure 15A is a cross-sectional side view of the locking system for positioning the transcatheter valve body in an unlocked position; Figure 15B is a cross-sectional side view of the locking system for positioning the transcatheter valve body in a locked position; Figure 16A is a partially cut away view of the locking system in the locked position; Figure 16B is a perspective view of the locking system; Figures 17A to 17F are perspective views of an anchor having an anchor bolt and anchor cap configured to receive the connecting ring and a mooring system illustrated in sequential steps; Figure 18A is a perspective view of the transseptal puncture being performed and the interventricular septum crossing guide in position; Figure 18B is a perspective view of the loop being positioned in the left ventricle after the transseptal puncture; Figure 19A is a perspective view of the loop receiving the interventricular septum crossing wire; Figure 19B is a perspective view of the interventricular septum crossing catheter advancing through the septum; Figure 19C is an enlarged perspective view of the interventricular septum crossing catheter advancing through the septum; Figure 20A is a perspective view of the interventricular septum crossing catheter advancing into the transseptal guide; Figure 20B is a perspective view of the interventricular septum crossing wire being exchanged for a 0.889 mm (0.035 in) wire;

Figure 21A is a perspective view of the retrograde anchor delivery sheath advancing over the 0.889 mm (0.035 in) trail wire to the interventricular septum; Figure 21B is a perspective view of the retrograde anchor delivery sheath positioned through the interventricular septum with its end in the right ventricle and the retrograde anchor positioned within the sheath; Figure 22A is a perspective view of the right ventricular disk of the retrograde anchor being implemented; Figure 22B is a perspective view of the left ventricular disc of the retrograde anchor deployed and the 0.889 mm (0.035 in) trail wire being withdrawn; Figure 23 is a perspective view of the fully implemented retrograde anchor ready to receive the transcatheter valve; Figure 24A is a perspective view of the antegrade anchor delivery sheath advancing through the septum over the 0.889 mm (0.035 in) trail wire; Figure 24B is a perspective view of the anterograde anchor delivery sheath positioned through the interventricular septum with its end in the left ventricle and the anterograde anchor positioned within the sheath; Figure 25A is a perspective view of the left ventricular disc of the anterograde anchor being implemented; Figure 25B is a perspective view of the right ventricular disc of the antegrade anchor being implemented; Figure 26A is a perspective view of the antegrade anchor delivery cable being unthreaded and removed;

Figure 26B is a perspective view of the antegrade anchor delivery cable removed with the 0.889 mm (0.035 in) rail wire remaining in place; Figure 26C is a perspective view of the trans-septal guide removed, leaving the 0.889 mm (0.035 in) rail wire in place for receiving the transcatheter valve to advance into the socket for the antegrade anchor; Figure 27A is a perspective view of the valve delivery system approaching the anchor; Figure 27B is a perspective view of the loop coupled to the anchor cap of the anchor; Figure 28A is a perspective view of the valve delivery guide partially withdrawn and the intra-annular portion of the valve is exposed; Figure 28B is a perspective view of the valve delivery guide fully withdrawn, exposing the upper valve flap in the left atrium with the atrial positioning rods still connected to the transcatheter valve body; Figure 28C is an enlarged perspective view of the fully exposed valve with the atrial positioning rods still attached to the transcatheter valve body; Figure 29A is a perspective view of the atrial latches engaged and the atrial positioning rods removed, leaving the suture alone connected to the transcatheter valve body; Figure 29B is an enlarged perspective view of the atrial latches engaged and the atrial positioning rods removed, leaving the suture alone connected to the transcatheter valve body; Figure 29C is a perspective view of the implemented valve and valve delivery system withdrawn from the body, leaving the suture connected to the transcatheter valve body exiting the body through the valve delivery sheath; Figure 30A is a perspective view of the suture cutter advanced through the valve delivery sheath to just above the upper flap of the transcatheter valve; Figure 30B is a perspective view of the valve fully implemented after the suture has been cut above the upper flap of the valve; Figure 30C is a perspective view of Figure 30A with a mitral valve in accordance with another aspect of the invention; Figure 30D is a perspective view of Figure 30B with the mitral valve shown in Figure 30C; Figures 31A and 31B are the side elevation view and the top perspective view of the supra-annular valve, comprising the upper flap attached to the transcatheter valve body with integral valve leaflets; Figure 32A is an exploded view of an anchor having an anchor bolt and anchor cap configured to receive the connecting ring and mooring system in accordance with another aspect of the invention; Figure 32B is a side elevation view of the anchoring system of Figure 32A with the connected ring advanced over the anchor cap and locked in place; Figure 32C is a side elevation view of Figure 32B with the delivery cable disconnected from the system; Figure 33A is a perspective view of the anchor of Figure 32 with stabilizers in accordance with another aspect of the invention; and Figure 33B is an end plan view of the anchor bolt of Figure 32.

DETAILED DESCRIPTION OF THE INVENTION

[030] The present invention is more readily understood by reference to the following detailed description, examples and claims, and the foregoing and following description thereof. Before the present system, devices and/or methods are disclosed and described, it is to be understood that this invention is not limited to the specific systems, devices and/or methods disclosed, unless otherwise specified, as such may, of course, vary. It is also to be understood that the terminology used in the present invention is for the purpose of describing particular aspects only and is not intended to be limiting.

[031] The following description of the invention is provided as an enabling teaching of the invention in its presently known best aspect. Those skilled in the relevant subject will recognize that many changes are made in the aspects described, while still obtaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention are obtained by selecting some of the features of the present invention without using other features. Consequently, those working in the art will recognize that many modifications and adaptations to the present invention are possible and may even be desirable under certain circumstances and are part of the present invention. Thus, the following description is provided as illustrative of the principles of the present invention and not as a limitation thereof.

[032] As used in the present invention the singular forms "a, "an" and "a/o" include the plural referents, unless the context clearly dictates otherwise. Thus, for example, reference to a "tangle" includes aspects having two or more ties, unless the context clearly indicates otherwise.

[033] Ranges are expressed in the present invention as "about" a particular value and/or "about" another particular value. When such a range is expressed, another aspect includes from a particular value and/or to another particular value. Similarly, when values are expressed as approximations, using the background "about", it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint and independently of the other endpoint.

[034] As used herein, the terms "optionally" or "optionally" mean that the event or circumstance subsequently described may or may not occur, and that the description includes instances where such an event or circumstance occurs and instances where it does not occur. . As used in the present invention, "fluid" refers to any substance that is free to flow and includes liquids, gases and plasma. "Fluid communication" as used in the present invention refers to any connection or relative positioning allowing substances to flow freely between the relevant components. As used in the present invention, "distal" refers to the application direction and "proximal" refers to the user's direction of the device.

[035] The application refers to medical devices and systems to be minimally invasively implanted in the heart and methods of implanting these devices and systems. More specifically, the application relates to devices, methods and systems for introducing and endovascular anchoring a retrograde or anterograde anchor 22 or 49 to the interventricular septum 20 and implanting a valve 66 (see figure 10A and 10B, 11A and 11B) in the tethered heart to the retrograde or antegrade anchor 22 or 49 to replace the native mitral valve. In addition, a slack assembly cooperates with anchor 22 or 49 connecting valve 66 or 156 to anchor 22 or 49.

Additionally, valve 66 includes an upper flap 67 or lower flap 157 to be connected to the valve body 68 so that the valve via the upper flap 67 or lower flap 157 conforms to the respective atrial floor to prevent paravalvular regurgitation of the prosthesis. . In accordance with the disclosure in the present invention, the anchor is deployed independently of the loop and the transcatheter valve. The Retrograde Anchor Set

[036] The components of the retrograde anchor assembly 44 shown in Figures 2 to 5 include an anchor 22 having an anchor cap 27 and a delivery cable 32 enabling the delivery of a tether 36. The anchor cap 27 is coupled to the ventricular disc left 26, which connects via septal connector 24 to right ventricular disk 23. Delivery cable 32 is detachably connected to anchor cap 27. Septal connector 24, as shown, is sized and configured to span the septum interventricular. Optionally, however, the septal connector 24 can be differentially sized (longer or shorter, depending on the thickness of the interventricular septum) and take the form of a cylinder whose cross-section is any portion of a circle, ellipse, parabola, or hyperbola, or takes the form of a polyhedron with a flat base and top that takes the form of a polygon with three or more sides. The septal connector may be constructed of any known metal alloy, including but not limited to stainless steel, nitinol, titanium, cobalt chromium or other metal alloys. In another aspect, the metal alloy of the septal connector 24 can be coated with biological tissue, such as bovine, ovine, porcine or equine pericardium, or with any combination of anti-inflammatory drugs that can promote healing and limit inflammation. Right and left ventricular discs can be constructed of any known metallic alloy, including but not limited to stainless steel, nitinol, titanium, cobalt chromium or other metallic alloys. Additionally, the right and left ventricular discs can take the shape of any part of a circle, ellipse, parabola, or hyperbola, or take the shape of a polygon with three or more sides. Right and left ventricular discs may be covered with, but not limited to, synthetic materials from the classes consisting of polycarbonate, polyurethane, polyester, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubbers or a combination of them. The right and left ventricular discs may also be covered by adult or juvenile bovine, ovine, equine, or porcine pericardium. In a further aspect, anchor 22 has anchorage elements (not shown) positioned along its left and right ventricular discs. These anchorage elements allow fixation to the interventricular septum, but are not necessarily used as a primary fixation mechanism.

[037] In use, the retrograde anchor 22 is fixed to the interventricular septum by unsheathing the right ventricular disc 23 against the right ventricular surface 17 of the ventricular septum 20, then exposing the septal connector 24, followed by unsheathing the left ventricular disc 26 against the left ventricular surface 16 of the interventricular septum 20. By re-sheathing the left ventricular disc 26, then the septal connector 24, and finally the right ventricular disc 23, the retrograde anchor is securely removed from the cardiac wall to be repositioned or removed completely.

[038] The anchor cap 27 comprises at least one locking arm 29 extending radially outward from the anchor cap 27. The locking arm 29 is sized and configured to releasably secure a portion of the loop 36 (described below) to the anchor cap 27. The at least one locking arm 29 moves between a first locked position, in which the locking member 29 extends a first distance away from the anchor cap body 27 and a second position unlocked in which the locking member 29 extends a second distance away from the anchor cap 27 which is less than the first distance. Anchor cap 27 comprises at least one biasing member (not shown), such as a spring, configured to urge each locking arm 29 into the first locked position. As shown, a plurality of lock arms 29 are provided and are equally spaced around the circumference of the anchor cap 27, although it is contemplated that the lock arms 29 need not be evenly spaced.

[039] Referring now to Figure 3, the delivery cable 32 includes a flexible delivery wire 33 having a distal threaded end portion 34 positioned or formed at the distal end of the delivery wire 33. The delivery wire is constructed of, but not limited to stainless steel, nitinol or other metal alloys, with or without hydrophilic coatings, or with or without a polymer coating, such as polytetrafluoroethylene (PTFE). The distal threaded end portion 34 is sized and configured to selectively engage complementary threads formed in a cavity defined in a proximal end 31 of the anchor cap 27. See Figures 2 and 5. In use, the distal threaded end portion 34 advances, for example, screws, inwardly through the proximal end 31 of the anchor cap 27 to couple the anchor cap 27 to the distal end of the flexible wire 33. As described more fully below, the distal threaded end portion 34 is unthreaded from the end. proximal from anchor 22, detaching flexible wire 33 from anchor 22.

[040] In accordance with another aspect of the disclosure, as shown in Figures 17A to 17F, an anchor assembly 91 is illustrated. Anchor 91 includes an anchor rod 92 and an antegrade anchor 49, although a retrograde anchor 22 is interchangeable in this anchor assembly 91. As shown, an antegrade anchor 49 extends distally from an anchor base

94. Anchor base 94 defines at least one, or a plurality as shown, of anchor flanges 96 and recessed areas 97 therebetween. Anchor rod 92 includes at least one or, as shown, a plurality of locking members 98 shown in Figure 17B. The locking members 98 are biased, as by a spring (not shown), radially away from the anchor rod 92. An anchor connector 99 and connecting rod 101 cooperate with the anchor rod 92 to connect to the antegrade anchor

49. Anchor connector 101 defines at least one or, as shown, a plurality of apertures 1020 configured for receiving anchor flanges 96. Therefore, anchor connector 99 and connecting rod 101 are matingly connected to the rod of anchor 92, thus urging the locking members 98 inward. The cooperation of openings 100 and flanges 96 integrates anchor connector 101 and anchor base 94.

[041] After the antegrade anchor 49 has been deployed, a tethering ring 102 is applied over the connecting rod 101 and the anchor connector 99 and braces at the proximal end of the antegrade anchor 49. The tethering ring 102 includes a first portion distal 103 generally cylindrical and a second proximal portion 104 having a greater diameter than the first portion 103. The second portion 104 defines at least one or, as shown, a plurality of apertures 106 configured to receive tying rods 108 as shown. in figures 17E and 17F. As shown in Figure 17D, the Anchor Connector 99 and Connector Rod 101 are removed. The locking members 98 are biased radially outwardly to engage the second portion 104 of the tie ring 102 to lock the tie ring 102 to the anchor base 94. The tie rods 108 are operative as described above to cooperate with the 66 or 156 transcatheter valve. The Anterograde Anchor Set

[042] The components of the anterograde anchor assembly 63 shown in Figures 6 to 9 include an anchor 49 having an anchor cap 58 and delivery cable connector 51 and a delivery cable 46 allowing the delivery of a tether 36. anchor 58 is coupled to left ventricular disc 57, which is connected via septal connector 56 to right ventricular disc

54. Delivery cable 46 is detachably connected to delivery cable connector 51 via its threaded end 52. Septal connector 56, as shown, is sized and configured to span the interventricular septum. Optionally, however, the septal connector 56 can be differentially sized (longer or shorter, depending on the thickness of the interventricular septum) and take the form of a cylinder whose cross-section is any portion of a circle, ellipse, parabola, or hyperbola, or takes the form of a polyhedron with a flat base and top that takes the form of a polygon with three or more sides. The septal connector may be constructed of any known metal alloy, including but not limited to stainless steel, nitinol, titanium, cobalt chromium or other metal alloys. In another aspect, the metal alloy of septal connector 56 can be coated with biological tissue, such as bovine, ovine, porcine, or equine pericardium, or with any combination of anti-inflammatory drugs that can promote healing and limit inflammation. Right and left ventricular discs can be constructed of any known metallic alloy, including but not limited to stainless steel, nitinol, titanium, cobalt chromium or other metallic alloys.

Additionally, the right and left ventricular discs can take the shape of any part of a circle, ellipse, parabola, or hyperbola, or take the shape of a polygon with three or more sides. Right and left ventricular discs may be covered with, but not limited to, synthetic materials from the classes consisting of polycarbonate, polyurethane, polyester, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubbers or a combination of them. The right and left ventricular discs may also be covered by adult or juvenile bovine, ovine, equine, or porcine pericardium. In a further aspect, anchor 49 has anchorage elements (not shown) positioned along its left and right ventricular discs. These anchorage elements allow fixation to the interventricular septum, but are not necessarily used as a primary fixation mechanism.

[043] In use, the antegrade anchor 49 is fixed to the interventricular septum by unsheathing the left ventricular disc 57 against the left ventricular surface 16 of the ventricular septum 20, then exposing the septal connector 56, followed by unsheathing the right ventricular disc 54 against the right ventricular surface 17 of the interventricular septum 20. By re-sheathing the right ventricular disc 54, then the septal connector 56, and finally the left ventricular disc 57, the antegrade anchor is safely removed from the cardiac wall, both to be repositioned or to be completely removed.

[044] The anchor cap 58 comprises at least one locking arm 61 extending radially outward from the anchor cap 58. The locking arm 61 is sized and configured to releasably secure a portion of the loop 36 (described below) to the anchor cap 58. The at least one locking arm 61 moves between a first locked position, in which the locking member 61 extends a first distance away from the anchor cap body 58 and a second position unlocked in which the locking member 61 extends a second distance away from the anchor cap 58 which is less than the first distance. Anchor cap 58 comprises at least one biasing member (not shown), such as a spring, configured to urge each locking arm 61 into the first locked position. As shown, a plurality of lock arms 61 are provided and are equally spaced around the circumference of anchor cap 58, although it is contemplated that the lock arms 61 need not be evenly spaced.

[045] Referring now to Figure 6, delivery cable 46 includes a flexible delivery wire 47 having a distal threaded end portion 48 positioned or formed at the distal end of delivery wire 47. Delivery cable 46 has a central channel (not shown) which can accommodate the wire rail. The delivery wire is constructed of, but not limited to, stainless steel, nitinol or other metal alloys, with or without hydrophilic coatings, or with or without a polymer coating such as polytetrafluoroethylene (PTFE). The distal threaded end portion 48 is sized and configured to selectively engage complementary threads formed in a cavity defined in a proximal end 52 of the delivery cable connector 51. See Figures 7 and 9. In use, the distal threaded end portion 48 advances, for example, screws, inwardly through the proximal end 52 of the delivery cable connector 51 to couple the delivery cable connector 51 to the distal end of the flexible wire 47. As described more fully below, the threaded end portion The distal end 48 is unscrewed from the proximal end of the delivery cable connector 51, detaching the flexible wire 47 from the anchor.

49. The Halo Anchor Set

[046] In accordance with another aspect of the disclosure, as shown in Figures 17A to F, a halo anchor assembly 91 is illustrated. Halo anchor assembly 91 includes an anchor base 94, connected to anchor rod 92 (which takes the place of an anchor cap 58 in other respects) and is fused to the rest of an anterograde anchor 49, although this halo anchor assembly 91 may consist of anchor base 94, connected to anchor rod 92, taking the place of anchor cap 27, as shown in figure 2, merging with the rest of a retrograde anchor 22. As shown, anterograde anchor 49 extends distally from an anchor base 94. Anchor base 94 defines at least one, or a plurality as shown, of anchor flanges 96 and recessed areas 97 therebetween. Anchor rod 92 includes at least one or, as shown, a plurality of locking members 98 shown extended in Figure 17B. The locking members 98 are biased, as by a spring (not shown), radially outward from the anchor rod 92. An anchor connector 99 and connecting rod 101 travel over wire rail 64 extending through anchor rod 92 and the threaded end 52, as illustrated in Figure 9) wherein the anchor connector 99, which is connected to the connecting rod 101, cooperates with the anchor rod 92. The anchor connector 99 defines at least one or, as shown, a plurality of apertures 100 configured to receive the anchor flanges 96. Therefore, the anchor connector 99 and connector rod 101 are matingly connected to the anchor rod 92, thus urging the locking members 98 inwardly. Co-operating apertures 100 and flanges 96 integrate anchor connector 99 and anchor base 94. After tethering ring 102 is secured by locking members 98, anchor connector 99 and connecting rod 101 are removed, leaving the wire rail 64 extending through anchor rod 92 attached to anchor base 94. Relative to anchor assembly 91 fused to retrograde anchor 22, anchor connector 99 and connector rod 101 travel over delivery cable 32, which remains after the anchor connector 99 and the connecting rod 101 are removed. Figures 32 and 33

[047] Another aspect of the halo anchor assembly is shown in Figures 32A through C and 33. The anchor assembly 91 additionally includes a flexible connector 170, which may be formed of a suitable material such as metal or metal alloy if extending between anchor base 94 and anchor rod 92. As shown, flexible connector 170 is a spiral configuration, but other configurations are envisioned. Affixed to the underside of anchor rod 92 are at least one, or three, as shown, locking arms 98 extending radially outwardly from anchor rod 92. Arms 98 are formed, for example, of any metal or alloy. The lock arms 98 are pushed radially inward, but are skewed towards what is shown. Therefore, the locking members 98 cooperate with the tie ring 202 when positioned to engage with the locking members 98 and the anchor assembly flexible connector 91 allows the loops to remain axially aligned with the valve to be implanted (such as, parallel to the interventricular septum), particularly when the anchor screw 93 is implanted.

[048] To deploy the anchor bolt 93, a torque conductor (not shown) preloaded onto the delivery cable 232 matches the anchor base 94 and allows the bolt to be rotated and thus driven into the tissue. Once fully deployed, the torque conductor is removed, leaving the anchor assembly 91 connected to the delivery cable 232. On the delivery cable 232, a lanyard 202, connected to the lanyards by means of lanyard rods 208 (attached to the tethering ring 202 through openings 206) is advanced over the anchor rod 92. The tethering ring 202 advances over the locking arms 98, depressing them inwardly. Once the proximal end of the tie ring 202 has passed under the lock arms 98, the lock arms 98 spring out, thereby restraining the tie ring 202 in place, preventing it from unintended movement by the ties affixed to the tying rods 208. Finally, the delivery cable 232 is rotated so that the "male" threads 234 are disengaged from the threads defined by the threaded cavity of the anchor rod 92.

[049] The anchor assembly 91 shown in these drawings also includes stabilizers 172 to stabilize the anchor and limit or prevent movement, such as rotational movement, from tension transferred from the ties and to provide traction to limit or prevent it. the screw anchor 93 inadvertently rotates so as to decouple from the tissue in which it was implanted. At least one stabilizer 172 can be provided. As shown in Figure 32, eight stabilizers 172 are illustrated and Figure 33 illustrates three. As shown in Figure 32, the stabilizers 172 extend radially outward from the longitudinal axis of the anchor. Outriggers 172 are configured to have a non-linear configuration. Other configurations are provided. The stabilizers 172 shown in Figure 33 also extend radially outward forming the anchor's longitudinal axis and extend at an acute angle, eg, 45 degrees, along the horizontal axis. The angle is generally facing away from the bolt anchor 93. Outriggers are generally linear, but other configurations are anticipated. When inserted into the interventricular septum, for example, the stabilizers 172 will push against and perhaps into the tissue in a direction opposite to the implantation of the anchor screw to prevent unintended withdrawal of the anchor screw 93.

[050] After the halo anchor assembly, consisting of either an anterograde anchor 49 or a retrograde anchor 22, has been deployed, a tethering ring 102 is applied over the connecting rod 101 and the anchor connector 99 and braces the base of anchor 94, fused to an anterograde anchor 49 or a retrograde anchor 22. The tethering ring 102 includes a generally cylindrical first distal portion and a second proximal portion 104 having a greater diameter than the first portion 103. The second portion 104 defines by by at least one or, as shown, a plurality of apertures 106 configured for receiving tying rods 108 as shown in Figures 17E and 17F. As shown in Figure 17D, the Anchor Connector 99 and Connector Rod 101 are removed. The locking members 98 are biased radially outwardly so as to engage the second portion 104 of the tie ring 102 to lock the tie ring 102 to the anchor base 94. The tie rods 108 are operative as described above to cooperate with a 66 or 156 transcatheter heart valve. The Tie Set

[051] When the flexible wire 33 is coupled to the retrograde anchor 22, the flexible wire serves as a guide rail for advancing the loop 36 to the retrograde anchor 22. For the retrograde anchor 49, the wire rail 64 serves as a rail lanyard 36 guide to antegrade anchor 49, entering distal end 62 of anchor cap 58, exiting delivery cable connector 51 via threaded end 52 through delivery cable center channel 46. Loop 36 includes one or more tie rods 38 rotatably connected to a snap ring 43. The tie rods 38 are connected to an eyelet 41 defined by snap ring arms 42, as shown in Figure 4. The tie 36 is advanced both over the flexible wire 32 of the delivery cable 33 (in the case of retrograde anchor) or over the wire rail 64 (in the case of antegrade anchor), and the snap ring 43 of the tie 36 depresses the at least one locking arm 29 or 61 of the anchor cap 27 or 58, for the second position unlocked. With the locking arm 29 or 61 in the second position, the loop 36 is advanced over the locking arm 29 or 61 in the anchor cap 27 or 58, respectively, until the snap ring 43 scores and/or is adjacent to one end. distal 28 of the anchor cap 27 or to a distal end 59 of the anchor cap 58. At this point, the anchor cap biasing member 27 or 58 urges the at least one locking arm 29 or 61 to the first locked position, thereby releasably coupling the snap ring 43, and thus the remainder of the loop 36, to the retrograde anchor 22 or the antegrade anchor 49.

[052] In one aspect, when coupled to the retrograde anchor 22 or the antegrade anchor 49, the loop 36 rotates about a longitudinal axis of the anchor a full 360 degrees. Optionally, in another aspect, loop 36 may be restricted to minor degrees of rotation by the interaction of a portion of loop 36 with the at least one locking arm 29 or 61.

[053] As shown in Figure 4, in one aspect, the loop 36 comprises at least one snap ring arm 42 coupled to snap ring 43 and at least one loop rod 38 coupled to a snap ring arm 42. As shown, a distal end of snap ring arm 42 is securely coupled to or formed monolithically with snap ring 43. As shown, the at least one snap ring arm comprises a plurality of snap ring arms 42. As shown, the plurality of snap ring arms 42 are equally spaced around the circumference of the snap ring, although it is contemplated that the snap ring arms 42 need not be equally spaced. A grommet 41 is defined by the snap ring arm 42. The tying stick 38 includes a tying stick hook 39 configured to cooperate with the grommet 41.

[054] A proximal end of each snap ring arm 42 is rotatably coupled to a distal end of a respective tying rod 38. A tying rod hook 39 is defined by tethering rod 38 as shown and is coupled to or formed monolithically with the distal end of each tying rod 38. In another aspect, the eyelet 41 and the tying rod hook 39 are sized and configured such that the tethering rod hook 39 is inserted into the eyelet 41 for engaging with rotatably and secures the tie rod 38 to the snap ring

43. In use, each tethering pole hook 39 rotates around the circumference of the eyelet 41. As shown in Figure 4, the proximal end of each tethering pole is attached to a string 37. The tethering pole 38 and hook of tie rod 39 can be composed of any metallic alloy. The Wire Rail Delivery System

[055] Referring now to Figures 18A and 18B, the wire rail delivery system consists of an interatrial transseptal guide 118 and an interventricular transseptal guide 111. The interatrial transseptal guide 118 is inserted into a femoral vein via the transfemoral sheath 117 and the guide 118 has a proximal pole 119 through which a transseptal needle 121 is introduced and this needle 121 exits the transseptal guide 121 through the distal dilator 122 of the guide. The interventricular transseptal guide 111 is inserted into a jugular vein via the transjugular sheath 109 and is guided into the right ventricle 18 over a guidewire 116. The interventricular transseptal guide 111 has a deflectable distal tip 114 that is controlled by the stent knob. deflection 113 attached to the proximal loop 112 of the guide and the tip can be deflected towards the right ventricular surface 17 of the interventricular septum 20. The Anterograde and Retrograde Anchor Delivery Sheaths

[056] Referring now to Figures 21A and 21B, the retrograde anchor delivery sheath 131 passes over the wire path 64 into the proximal pole 119 of the transseptal interatrial guide 118 and exits the distal end 120 of the transseptal guide. Across distal end 132 of retrograde anchor delivery sheath 131 is dilator 133, which passes over wire path 64 and enters left ventricular surface 16 of interventricular septum 20 until it exits right ventricular surface 17 of interventricular septum 20. once traversed, the dilator 133 is removed, leaving the distal end 132 of the retrograde anchor delivery sheath in the right ventricle 18 to allow delivery of the retrograde anchor 22.

[057] Referring now to Figures 24A and 24B, the antegrade anchor delivery sheath 134 passes over the wire path 64 to the proximal loop 112 of the interventricular transseptal guide 111 and exits the distal end 114 of the transseptal guide. Across distal end 136 of antegrade anchor delivery sheath 134 is dilator 137, which passes over wire path 64 and enters right ventricular surface 17 of interventricular septum 20 until exiting left ventricular surface 16 of interventricular septum 20. once traversed, the dilator 137 is removed, leaving the distal end 136 of the antegrade anchor delivery sheath in the left ventricle 14 to allow for the delivery of the antegrade anchor 49.

[058] As shown, in Fig. 18A a sheath 109 is configured to receive the interventricular transseptal guide 111 and a sheath 117 is configured to receive the interatrial transseptal guide 118. The sheath 109 is in fluid communication with the interventricular transseptal guide 111, and the sheath 117 is in fluid communication with the interatrial transseptal guide 118 such that fluids such as heparinized saline and the like surround the interventricular transseptal guide 111 through the sheath 109 and surround the interatrial transseptal guide 118 through the sheath 117. The Wire Rail Creation Method

[059] As shown in 18A, a J wire 116 is introduced through the sheath 109 and guided endovascularly by the user into the right ventricle 18. Over the J wire 116, the interventricular transseptal guide 111 is advanced into the sheath 109 and guided endovascularly by the user into the right ventricle 18. Once in the right ventricle 18, the J wire 116 is removed and the guide tip 114 is deflected by the deflection knob 113 of the proximal loop 112 of the transseptal interventricular guide 111, until the guide tip 114 is adjacent to the right ventricular surface 17 of the interventricular septum

20.

[060] As shown in 18A, a J-wire (not shown) is introduced through sheath 117 and guided endovascularly by the user into the right atrium 19. Over this J-wire, the transseptal interatrial guide 118, with dilator 122 extending outward from the distal tip 120 of the guide, it is endovascularly guided by the user until it is within the right atrium 19. Then the J wire is removed and a transseptal needle 121 is advanced through the proximal pole 119 of the interatrial transseptal guide. 118, until the needle is near the end of the dilator 122. Then, the proximal pole 119 of the transseptal interatrial guide 118 is withdrawn and rotated until the dilator 122,

extending outward from the distal tip 120, is pushing against the interatrial septum 21. Using fluoroscopic and echocardiographic guidance, the transseptal needle 121 is advanced through the interatrial septum 21 into the left atrium 11, followed by advancement of the dilator 122 and tip distal 120 of the interatrial transseptal guide 118. Since the distal tip 120 is in the left atrium 11, the dilator 122 and the transseptal needle 121 are both withdrawn from the proximal pole 119 of the interatrial transseptal guide 118.

[061] As shown in Figure 18B, a loop sheath 123 is introduced into the proximal pole 119 of the transseptal interatrial guide 118 until the loop sheath 123 exits the distal end 120 of the guide 118, and advances from the left atrium 11 into the ventricle left 14. A loop 124 is advanced through the loop sheath 123 into the left ventricle 14 until the loop 124 is adjacent to the left ventricular surface 16 of the interventricular septum 20.

[062] As shown in Figure 19A, a radio frequency wire 127, connected to a radio frequency generator 126 or electrocautery system (not shown), is advanced through the proximal loop 112 of the interventricular transseptal guide 111, until the wire 127 exit the distal end 114 of the interventricular transseptal guide 111 and traverse the interventricular septum 20 into the left ventricle 14, followed by the capture of wire 127 by loop 124. As shown in Figure 19B, loop 124 pulls wire 127 into the guide. interatrial transseptal 118, until the wire exits proximal pole 119 of guide 118. Then, over the portion of wire 127 extending from proximal loop 112 of interventricular transseptal guide 111, a microcatheter 128 is advanced over wire 127 through the septum. interventricular 120. Figure 19C shows an enlarged view of microcatheter 128, with a distal dilator 129, advancing through the interventricular septum 20 over wire 127.

[063] As shown in Figure 20A, microcatheter 128 is advanced over wire 127 until it enters distal tip 120 of transseptal interatrial guide 118. Since microcatheter 128 is several or more centimeters within transseptal interatrial guide 118, the wire 127 is removed by pulling out proximal pole 119 of the interatrial transseptal guide 118. As shown in Figure 20B, a larger, stiffer J wire 64 is advanced through the interventricular transseptal guide 111 via microcatheter 128, until the J wire 64 exit microcatheter 128, positioned within transseptal interatrial guide 118, and finally exit proximal pole 119 of guide 118. The Retrograde Anchor Implantation Method

[064] As described in [018] and shown in figures 21A and 21B, once the retrograde anchor sheath 131 is positioned in the right ventricle 18 adjacent to the right ventricular surface 17, the retrograde anchor 22 is adjacent to wire 64 through the retrograde anchor sheath 131 and positioned at the distal end 132.

[065] As shown in Figure 22A, the distal tip 132 of the retrograde anchor sheath 131 is first retracted backwards until it is in the left ventricle 14 adjacent to the left ventricular surface 16. As the distal tip 132 is retracted backwards, the self-expanding right ventricular disk 23 of the retrograde anchor 22 deploys, bracing the right ventricular surface 17 of the interventricular septum 20 and the septal connector 24 is exposed in the interventricular septum 20. As shown in Figure 22B, as the distal tip 132 is additionally retracted, the self-expanding left ventricular disc 26 deploys, bracing the left ventricular surface 16 of the interventricular septum 20. The retrograde anchor sheath 131 is then removed from the proximal pole 119 of the interatrial septum guide 118 and the J wire 64 is removed by pulling it from the proximal loop 112 of the interventricular transseptal guide 111.

[066] As shown in Figure 23, the transseptal interatrial guide 118 is pulled out of the body through the transfemoral sheath 117, leaving the retrograde anchor 22 in position and still connected to flexible wire 33 of the delivery cable 32. The Method of Antegrade Anchor Deployment

[067] As described in [019] and shown in figures 24A and 24B, once the antegrade anchor sheath 134 is positioned in the left ventricle 14 adjacent to the left ventricular surface 16, the antegrade anchor 49 is advanced over wire 64 through of the anterograde anchor sheath 134 and positioned at the distal tip 136.

[068] As shown in Figure 25A, the distal tip 136 is first retracted backwards until it is in the right ventricle 18 adjacent to the right ventricular surface 17. As the distal tip 136 is retracted backwards, the left ventricular self-expanding disc 57 of the antegrade anchor 49 is implemented, bracing the left ventricular surface 16 of the interventricular septum 20 and the septal connector 56 is exposed in the interventricular septum 20. As shown in Fig. 25B, as the distal tip 136 is further retracted, the right ventricular disc auto-retracts expandable 54 is implemented, bracing the right ventricular surface 17 of the interventricular septum 20. The anterograde anchor sheath 134 is then removed from the proximal loop 112 of the interventricular septum guide 111.

[069] As shown in Figures 26A and B, the delivery cable 46 is unscrewed so that its distal threaded end 48 protrudes from the delivery connector 51, allowing the flexible wire 47 of the delivery cable 46 to be removed. As shown in Fig. 26C, the interatrial transseptal guide 118 is pulled out of the body via the transfemoral sheath 117, leaving the antegrade anchor 49 in place, with wire 64 passing through it.

The Transcatheter Valve

[070] As shown in Figure 10A, 10B, 11A, 11B, the system 10 comprises a transcatheter heart valve 66 having an upper flap of the atrial seal skirt 67 extending circumferentially along the upper end of the transcatheter heart valve 66. The valve Transcatheter heart rate 66 includes a transcatheter valve body 68, shown substantially cylindrical, and the upper flap of the atrial seal skirt 67 which is configured to conform to the floor of the left atrium 12, as shown. The transcatheter heart valve 66 is coupled to the retrograde anchor 22 or the anterograde anchor 49 by tether 36, as described in the present invention. Lanyard 37, fused or otherwise coupled to tether rod 38 of tether 36, connects transcatheter heart valve 66 to anchor 22 or 49 when anchor 22 or 49 is secured to interventricular septum 20.

[071] The Transcatheter Heart Valve 66 is sized and configured to seat in the mitral valve between the left atrium 11 and the left ventricle 14, as illustrated in Figure 1. The Transcatheter Heart Valve 66 is pre-assembled with the valve leaflets 77 (Fig. 11A, 11B). This is by way of example. Therefore, then, with minor variations, these devices, systems, and methods can be placed endovascularly through a venous structure including, but not limited to, the internal jugular vein, subclavian vein, subclavian vein, or femoral vein.

[072] Transcatheter 66 heart valve is self-expanding (ie, the valve is compressible so that it fits through a system 1) catheter and composed of nitinol, but may also contain elements made of, but not limited to, , stainless steel, nitinol or other metallic alloys. In another aspect, the transcatheter heart valve has a smaller diameter that is less than or approximately equal to the annulus at implementation site 13 of the mitral annulus, thus reducing the restriction of the mitral annulus.

[073] As shown in Figures 31A and 31B, an alternative embodiment of the transcatheter heart valve 66 is the transcatheter heart valve 156. In contrast to the transcatheter heart valve 66, which has an upper flap of the atrial seal skirt 67, the heart valve transcatheter 156 has a lower flap of the atrial seal skirt 157, which is connected to the lower portion of the transcatheter valve body 68, rather than the upper portion, as in transcatheter heart valve 66. The lower flap of the atrial seal skirt 157 conforms to the atrial floor 12 and the transcatheter valve body 68 of the transcatheter heart valve 157 extends into the left atrium 11, thereby minimizing interaction with native mitral leaflets, further reducing the risk of LVOT obstruction.

[074] At least one conduit 74 is defined in transcatheter heart valve 66 or 156, as illustrated in figures 10A and 10B, 11A and 11B and 31A and 31B. Each conduit is sized and shaped so that a portion of cord 37 (attached at the proximal end to suture 148) extends through conduit 74, thereby connecting loop 36 to transcatheter heart valve 66 or 156, allowing free movement to the valve 66 or 156 is locked in place. In a further aspect, the transcatheter valve 66 or 156 has anchoring elements (not shown) positioned along its outside diameter. These anchors allow attachment to the mitral annulus and/or leaflets, but are not necessarily used as a primary attachment mechanism.

[075] The at least one strand 37 is attached to tying stick 38 of lanyard 36 and the proximal portion of strand 37 is attached to suture 148. In one aspect, the strand can be a strong but flexible strand, as per example and without limitation, a bead of expanded polytetrafluoroethylene (ePTFE) or ultra high molecular weight polyethylene (UHMWPE, UHMW). In use, described more fully below, a central portion of cord 37 (between the distal end and the proximal end) extends through and/or is coupled to transcatheter valve 66 or 156 to maintain the skirt in the desired position relative to the mitral annulus .

[076] Figures 11A and 11B also illustrate the transcatheter valve 66. The transcatheter valve 66 has leaflets 77 extending radially inward from the body of the transcatheter valve 68. The leaflets 77 are composed of bovine, equine, or porcine pericardium leaflets . Like the functioning of any conventional valve, leaflets 77, sewn to the interior of the transcatheter valve body 68, open during diastole (relaxation of the heart), allowing blood to enter from the left atrium 11 into the left ventricle 14 and close during systole (contraction of the heart), preventing blood from regurgitating either from the right or left ventricle back into the right or left atrium, respectively.

[077] As shown in figures 10A and 10B, 11A and 11B, and 31A and 31B, the transcatheter heart valve 66 or 156, defined by the transcatheter valve body 68 and upper flap of the atrial seal skirt 67 or lower flap of the atrial seal skirt atrial seal 157 includes a membrane-like material and the upper flap of the atrial seal skirt 67 or lower flap 157 has a larger diameter than the annulus at the deployment site. For example, the upper flap of the atrial seal skirt 67 or the lower flap 157 may have a larger diameter than the diameter of the mitral annulus. In another aspect, the transcatheter heart valve is formed from, but not limited to, synthetic materials from the classes consisting of polycarbonate, polyurethane, polyester, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubbers, or a combination of them. Transcatheter heart valve 66 or 156 may also be covered with adult or juvenile bovine, ovine, equine, or porcine pericardium. Optionally, at least a portion of the upper flap of the atrial sealing skirt 67 or lower flap 157 may be formed from alternative materials such as, for example and without limitation, polyurethane foam or other polymers.

[078] In another aspect, at least a portion of the transcatheter heart valve 66 or 156 has one or more fixation members (not shown) along its length, allowing for additional anchorage to the left atrial floor and/or other portions on the side. annulus of the mitral annulus, preventing migration of the transcatheter 66 or 156 heart valve to the proximal left atrium 11, thereby preventing instability (eg, rocking) and paravalvular regurgitation of the prosthesis.

[079] The transcatheter heart valve 66 or 156 comprises at least one transcatheter valve body 68 and an upper flap of the atrial seal skirt 67 or lower flap 157. As shown, the transcatheter valve body 68 is a cylinder and is of length and variable diameter. It is selectively composed of laser cut or molded nitinol, but it can also contain elements of any other metallic alloy and can be covered along any portion of its circumference or length with biological membranes or synthetic materials mentioned above. As shown, the upper flap 67 or lower flap 157 extends radially out of the transcatheter valve body 68 and downwards, forming a substantially concave upper flap with the concavity facing the floor of the left atrium 11. The upper flap 67 or lower 157 extends circumferentially around the upper end of the transcatheter valve body 68, in the case of the transcatheter heart valve 66,

or extends circumferentially around the lower end of the transcatheter valve body 68, in the case of the transcatheter heart valve 156.

[080] At least one, or shown a plurality of flexible extension members 69 are provided which may, for example, be composed of, but not limited to, laser-cut or molded nitinol attached to the top of the skirt body by extension member base 71 and terminating at the tip of extension member 72. Between one or more extension members 69 is an elastic sealing membrane 73 extending perpendicularly to adjacent extension members 69. As shown in Figures 10A and 10B, the extension member 69 can extend radially outwardly and substantially linearly, but this is exemplary. As shown in Figures 11A, 11B, 31A and 31B, the extension members may be non-linear and generally U-shaped. As shown, the sealing membrane 73 extends circumferentially around the upper 67 or lower flange 157. It may extend only part of the circumference as well. The transcatheter valve body 68 includes a plurality of supports 78 which, like the extension members 69 of the upper 67 or lower flap 157, may, for example, be composed of, but not limited to, laser-cut or molded nitinol. As shown, brackets 78 form a net-like configuration, but other configurations are contemplated including, but not limited to, brackets extending vertically.

[081] Sealing member 73 is composed of biological tissues or synthetic tissues as mentioned above. In one aspect, the synthetic fabric is braided or knitted, allowing for the "elasticity" required to conform to the topography of the atrial floor. In Figures 10A and 10B, 31A and 31B, the extension member 69 is attached to the transcatheter valve body 68 via the base of the extension member 71 and the tip of the extension member 72 is bending down, thereby preventing the regurgitation around the mitral annulus. This conformation requires downward force applied via one or more atrial positioning rods 147, attached to one or more conduits 74 and locked in place via one or more detachable latches 83 (figure 14A and B, 15A and B, 16A and B) integrated into the atrial end of conduits 74, as described in the present invention.

[082] Figures 30A to 30D illustrate valve placement as a replacement for a native mitral valve. Figures 30A and B illustrate the valve having an upper flap of the atrial seal skirt 67 and Figures 30C and D illustrate the valve having a lower flap of the atrial seal skirt 157. The mitral valve with a lower seal skirt 157 is positioned above the atrial floor 12 shown in these figures. The use of this valve with the aforementioned ties prevents substantial vertical or floating movement of the valve. The Transcatheter and Tie-Down Valve Delivery Assemblies

[083] According to the method described above, the retrograde anchor 22 or the antegrade anchor 49 is introduced by the retrograde anchor delivery sheath 131 or the antegrade anchor delivery sheath 134 and secured to the interventricular septum 20. The anchor cap 27 or 58 and delivery cable 33 (for retrograde anchor) or wire rail 64 (for retrograde anchor) remain within the heart and are ready to receive the loop 36 described above.

[084] Referring now to Figures 27A and 27B, and as described above, the loop 36 is advanced over the wire rail 64 or delivery wire 33 of the delivery cable 32 (not shown) through the heart valve delivery system transcatheter shown in delivery guide form 141. Loop 36 locks onto anchor cap 27 or 58 by coupling snap ring 43 to anchor cap 27 or 58. Coupled to at least one tie rod 38 is at least one lanyard 37 extending from the tying rod 38. The at least one strand 37 is proximally connected to at least one suture 148, which extends outwardly from the body through the central lumen 151 of the delivery guide.

141. Once the lanyard is locked onto the anchor cap 27 or 58, the guide 141 is retracted as shown in figure 27B, leaving the deployed anchor 22 or 49, lanyard 36, strands 37 and suture extending from the location of implantation. As shown in figures 27A and B, 28A and B, the same guide 141 delivers both the tie 36 and the transcatheter heart valve 66 or 156.

[085] Referring now to Figures 27A and B and 28A and B, transcatheter heart valve delivery system 139 for positioning and deploying transcatheter heart valve 66 or 156 in desired deployment locations 13 is illustrated. The transcatheter valve delivery system 139 comprises a transcatheter valve delivery guide 141, a nose cone 146, a transcatheter valve deployment button 142 and at least one atrial positioning stick 147. The transcatheter valve delivery guide 141 it has a distal end 144, an opposite proximal valve implementation knob 142 and an internal guide lumen 143 extending therebetween. Inner guide lumen 143 is sized and configured such that transcatheter valve 66 or 156 and other system components are selectively and removably inserted therethrough. At least a portion of transcatheter valve delivery guide 141 is flexible so that a tip 144 at the distal end of transcatheter valve guide 141 is positioned beyond deployment site 13 and into left ventricle 14.

[086] The transcatheter valve implementation knob 142 is coupled to the proximal end of the transcatheter valve delivery guide 141. The transcatheter valve implementation knob 142 defines a central channel 151 that is in fluid communication with the internal guide lumen 143 Therefore, the atrial positioning rod 147, guidewire 64 and/or the at least one suture 148 may extend through the central channel 151 and into the inner guide lumen 143. As shown, the transcatheter deployment knob 142 is rotatable and configured such that rotation of knob 142 in a first direction causes distal end 144 of transcatheter valve delivery guide 141 about transcatheter valve 66 or 156 to be retracted, allowing transcatheter valve 66 or 156 that expands. Nose cone 146 may be any conventional nose cone coupled to transcatheter valve delivery guide 141 and configured to guide transcatheter valve 66 or 156 to deployment location 13. The Locking System

[087] Referring to Figures 27A and B, 28B and C and 29A, the at least one atrial positioning rod 147 has a distal end 153, a proximal end 150 and an inner rod lumen 149 extending therebetween, the lumen rod interior being sized and configured such that a portion of a suture 148 and/or a strand 37 is inserted therethrough. At least a portion of the atrial positioning stick 147 is flexible so that the distal end 153 of the atrial positioning stick can be positioned at or adjacent to the deployment site 13.

[088] The at least one positioning stick 147 is coupled to conduit 74. As illustrated in Figures 13A and 13B, each conduit 74 contains a detachable latch 83, which is configured to securely attach at least one lanyard 37. Thus, tether 37 is securely attached to tether rod 38 of tether 36, which is coupled to anchor cap 27 or 58, secured to interventricular septum 20 via ventricular discs and retrograde anchor 22 or antegrade anchor septal connectors 49 , and the removable lock 83 securely attached to the cord 37 in the left atrium, for example.

[089] With reference to figure 13A, 13B, 14A, 14B, 15A, 15B, 16A and 16B, the locking system 82 consists of a detachable lock 83, integrated into the duct 74, attached to the first passage hypotube 84 and to the second retraction hypotube 86. Within the detachable latch 83 is a latch clip 87. Referring now to Figure 30A, system 10 further comprises a suture cutter 154 sized and configured to pass through delivery sheath 117 to cut the hair. minus one suture 148 (as shown in Figure 30B). The Atrial Skirt Implantation, Positioning and Locking Method

[090] In use, the system 10 implants the transcatheter 66 or 156 heart valve using a transcatheter approach by positioning the interventricular anchor 22 or 49 and attaching a tie 36 to the anchor 22 or 49. As shown in figure 27A, the valve system transcatheter 139 is inserted over wire 64 or flexible wire 33 of delivery cable 32 and into a portion of heart 9. As per transcatheter valve delivery guide 141, with transcatheter valve 66 or 156 preloaded at the distal end 144, is inserted into the heart, at least a portion of suture 148 is also preloaded and threaded through at least one conduit 74, and as transcatheter valve delivery guide 141 advances, at least a portion of suture 148 and the strand 37 extends along and proximally beyond the inner guide lumen 143 of the transcatheter valve delivery guide 141. Thus, a portion of at least one strand 37 extends through and beyond the distal end 144 of the valve delivery guide. transcatheter valve 141 and a portion of the at least one suture 148 extends through and beyond the transcatheter valve delivery guide

141. The transcatheter valve delivery guide 141 is positioned so that the distal end 144 of the transcatheter valve delivery guide 141, with the transcatheter valve 66 or 156 preloaded at the distal end 144, is passed through the deployment site 13 and into the left ventricle 14.

[091] Transcatheter valve 66 or 156 is preloaded into distal end 144 of transcatheter valve delivery guide 141 for positioning at deployment site 13. As shown, suture 148 is pre-assembled with transcatheter valve 66 or 156 such that each suture 148 is threaded through at least one conduit 74 of transcatheter valve 66 or 156 illustrated in Figures 11A and B and Figures 31A and B. Like transcatheter valve 66 or 156 and distal end 144 of the delivery guide of transcatheter valve 141 advance as a unit and approach the deployment site, the end of suture 148 and a portion of strand 37 will be threaded through conduit 74 defined in transcatheter valve 66 or 156. As such, transcatheter valve 66 or 156 it is movable along the length of the at least one strand until the desired implementation location 13 has been reached. That is, the transcatheter valve is free-floating on the cord 37 until it is locked in place by the detachable latch 83.

[092] When the transcatheter valve 66 or 156 is at the desired implementation location 13, the transcatheter valve implementation button 142 is used to at least partially withdraw the delivery guide 141 around the transcatheter valve 66 or 156. With the guide 141 free of transcatheter 66 or 156 valve, 66 or 156 valve expands to its full and unrestricted size. Optionally, because the position of the transcatheter valve is adjustable, transcatheter valve deployment knob 142 can be used to collapse transcatheter valve 66 or 156, allowing repositioning at the desired deployment location.

[093] An atrial positioning rod 147, preloaded into the transcatheter delivery guide 141, is then advanced over each suture 148 so that a portion of each suture extends into the rod inner lumen 149 and a portion of each suture extends beyond the proximal end 150 of the positioning stick 147. Referring to Figures 28B and 29A, the positioning stick 147 is then advanced through the transcatheter valve guide 141 and a portion of the cord 37 is received by the inner lumen. rod 149 of rod 147 and the distal end 153 of the positioning rod (with the detachable latch 83 attached thereto) is adjacent to the transcatheter valve 66 or 156. The positioning rods 147 are pushed down by the user until the valve exits. seal is in a desired position relative to the mitral annulus.

[094] Transcatheter valve 66 or 156 over tie 36 until desired valve position 66 or 156 is reached. After the desired valve position is reached, the at least one atrial positioning rod 147 urges the transcatheter valve 66 or 156 into position and is locked in place by means of a detachable latch 83 nested within each conduit 74 and connected to the end. of each positioning rod 147. The transcatheter valve 66 or 156 can be repositioned or retrieved until the release of the sutures 148 that extend through each atrial positioning rod

147.

[095] As shown in Figure 28B, positioning the transcatheter valve 66 or 156 within the left atrium 11 such that the upper flap 67 of the transcatheter valve 66 or the lower flap 157 of the transcatheter valve 156 conforms to the topography of the atrial floor left 12 is shown. Through the end of the transcatheter valve delivery system 144, the physician advances one or more atrial positioning rods 147 such that the transcatheter valve 66 or 156 translates over one or more strands 37 extending through one or more conduits. 74, defined by transcatheter valve body 68. As shown in Figure 28B, as the upper flap of transcatheter 67 or lower flap 157 contacts the atrial floor 12, and one or more extension members 69 flex differentially according to the anatomy local. As each atrial positioning rod 147 is pushed with differential force, precise amounts of tension are achievable and therefore more or less flexion of the extension members 69 to facilitate the conformation of the upper flap of the transcatheter valve 67 or lower flap 157 around the entire perimeter of the atrial floor 12 to limit regurgitation through the mitral valve orifice.

[096] Figure 12 illustrates the conversion of the upper flap of the transcatheter valve 67 from concave to convex (the same conformational change can occur with the lower flap 157). As the valve is pushed down to the atrial floor 12 by the atrial positioning rod 147, which is attached to the base of the extension member 71 of the extension member 69, the tip of the extension member 72 flexes upward accordingly. with the convex anatomy of the atrial floor. Additional distal movement of the transcatheter valve 66 (shown left to right in figure 12) or transcatheter valve 156 (not shown) further modifies the shape of the upper flap 67 or lower flap 157 as it conforms to the atrial floor and conforms to base of extension member 71 is urged downward by atrial positioning rod 147 (Figs. 28B).

[097] Referring now to Figures 15A and 15B, pulling the retraction hypotube 86 causes the locking clamp 87 to retract, which pushes down the locking tabs 88 and lanyard 37. More specifically, the second hypotube 86 is retracted and, due to its connection to the locking clip

87, it also retracts locking clip 87. Locking clip 87, upon retraction, contacts contact points 89 of first hypotube 84, disconnecting clip 87 allowing second hypotube 86 to be removed. Once the retraction hypotube 86 is pulled, the inner arms of the pass-through hypotube 84 spring inward, allowing the pass-through hypotube to be removed. The first passageway hypotube 84 is beneficial as it allows the cord 37 to be locked while the second hypotube 86 is being retracted. Hypotube passage 84 is then removed, leaving clip 87 within conduit 74 of transcatheter valve 66 or 156. Figure 16A shows a cross-sectional view of a fully engaged latch. According to one aspect, the positioning rod 147 can be integrated with the passageway hypotube or detachably connected thereto. Figure 16B shows an intact view of a fully engaged latch.

[098] As illustrated in Figure 30A, with the transcatheter valve conforming to the atrial floor 12, the suture cutter 154 is advanced over the sutures 148 and to the upper flap of the transcatheter valve 67. The suture cutter 154 cuts and releases the distal end of each suture 148 above the detachable latch 83. The sutures 148 and suture cutter 154 are then removed from the heart 9.

[099] In one aspect, prior to cutting sutures 148, the transcatheter valve 66 or 156 can be retrieved or repositioned. For example, if it is determined that the transcatheter valve must be removed or repositioned, an atrial positioning rod 147 is positioned over each suture so that a portion of the suture is in the rod inner lumen 149. positioning is adjacent to or in contact with the detachable latch 83, the passageway hypotube advancement 84 and the retraction hypotube 86 attaches the detachable latch to the distal end of the positioning rod, thereby unlocking the cord latch 37. With each cord unlocking , the valve can be removed and/or repositioned at the implementation site 13.

[100] In another aspect, transcatheter valve 66 or 156 is repositioned and/or removed days to weeks after valve implementation. In this regard, the sutures are not cut but wrapped around a spool or other winding device. This device is then attached to the upper flap of the transcatheter valve 67 of the valve 66 or the transcatheter valve body 68 of the valve 156. Days after valve implementation and procedure completion, the spool/winding device can be captured again, allowing unwrap and remove sutures. An atrial positioning rod 147 is then positioned over each suture so that a portion of the suture is in the inner rod lumen 149. When the distal end 153 of the positioning rod is adjacent to or in contact with the detachable latch 83, advancement of passageway hypotube 84 and retraction hypotube 86 attach the detachable latch to the distal end of the positioning rod, thereby unlocking the cord latch 37. With each cord unlocked, the valve is removed and/or repositioned at deployment site 13.

[101] Although various aspects of the invention have been disclosed in the foregoing specification, it is understood by those skilled in the art that many modifications and other aspects of the invention will come to mind to which the invention belongs, having the teaching benefit presented in the foregoing description and drawings. associates. It is understood, therefore, that the invention is not limited to the specific aspects disclosed above, and that many modifications and other aspects are intended to be included within the scope of the appended claims. Furthermore, although specific terms are used here, as well as in the claims that follow, they are used only in a generic and descriptive sense and are not intended to limit the described invention.

Claims (29)

1. Anchor set to implant an anchor in an interventricular septum of a heart, characterized in that it is to minimally invasively fix a mitral valve to replace the native mitral valve, comprising: the anchor configured and sized for endovascular introduction to anchorage to an anchorage site in the interventricular septum comprising an anchor cap extending proximally from a left ventricular disc, a right ventricular disc and a septal connector extending between said left ventricular disc and said right ventricular disc in which the said septal connector is sized and configured to extend through the interventricular septum, wherein said left ventricular disk and said right ventricular disk are positioned on opposite sides of the interventricular septum; an anchor delivery system comprising a delivery cable having a distal end portion defined by a first surface configuration and wherein said anchor comprises a mating portion having a second configuration so as to mate with said first configuration. delivery cable distal end portion surface; and a tethering assembly comprising a snap ring and at least one tether rod connected to said snap ring, wherein said snap ring defines a central opening configured to be positioned in said anchor cap. 2. Anchor assembly according to claim 1, characterized in that said second configuration is defined by a proximal end of said anchor cap and defines a threaded cavity and said delivery wire distal end portion is threaded to conjugately engage said anchor cap threaded cavity to position said anchor cap. 3. Anchor assembly according to claim 1, characterized in that said anchor further comprises a delivery cable connector extending distally from said right ventricular disc wherein said delivery cable connector defines a the threaded cavity and said first delivery cable surface defines a threaded distal end so as to matingly engage said threaded connector cavity. 4. Anchor assembly of claim 3, wherein said delivery cable defines a longitudinally extending lumen, said anchor cap defines a longitudinally extending lumen, said septal connector defines a septal lumen. extending longitudinally and said delivery cable connector defines a longitudinally extending lumen and said anchor delivery systems further comprise a delivery wire extending through said lumens of said anchor cap, of said septal connector, of said delivery cable connector and said delivery cable. 5. Anchor assembly according to claim 1, characterized in that said anchor cap comprises at least one locking member extending radially outwardly from said anchor cap. 6. Anchor assembly according to claim 5, characterized in that said at least one locking member moves between a first locked position wherein the at least one locking member extends a first distance from from an outer surface of said anchor cap to a second position wherein said at least one locking member extends a second distance from said outer surface wherein said first distance is greater than said second distance. 7. Anchor assembly according to claim 6, characterized in that said tethering snap ring urges said at least one locking member from said first locked position to said second position when positioned over said at least one locking member and said at least one locking member, in said first locked position, engages said locking ring when said locking ring is positioned distal to said at least one locking arm in said anchor cap. 8. Anchor assembly according to claim 1, characterized in that said first and second ventricular discs are formed of a material selected to allow the sheathing and desheathing of said discs. 9. Anchor assembly according to claim 1, characterized in that said second anchor mating portion configuration is defined by said anchor cap and said anchor assembly further comprises an anchor rod and at least a locking member on said anchor rod and wherein said delivery cable distal end portion is an anchor connector configured to releasably mate with said anchor rod. 10. Anchor assembly according to claim 9, characterized in that said at least one locking member is biased outwardly from said anchor rod and wherein said anchor connector defines a distal cavity and a proximal portion of said anchor rod is selectively housed within said cavity to connect said anchor and said anchor delivery system. 11. Anchor assembly according to claim 10, characterized in that said anchor base defines at least one anchor flange and said anchor connector defines at least one opening configured for receiving said anchor flange. 12. Atrial seal skirt, characterized in that it is configured to receive a valve and for endovascular introduction and implantation at an implementation site and configured and sized to replace a native heart valve, said atrial seal skirt being configured to be substantially conforming to and substantially resting on an atrial floor adjacent to the atrial seal skirt implementation site and comprising: an atrial skirt body which is generally cylindrical and defining a valve receptacle; a lower atrial skirt flap circumferentially extending around a lower edge of said atrial skirt body, and wherein said atrial seal skirt is compressible when constrained and expands when released from the restraints; at least one duct having an open top end defined by an opening in said skirt body; at least one extension member for supporting said skirt flap, said extension member having a base end adjacent said skirt body lower edge extending outward substantially to an outer edge of said skirt flap; at least one body support for supporting said skirt body; and a membrane covering said at least one extension member and said at least one body support to form the skirt flap and the body. 13. Atrial sealing skirt according to claim 12, characterized in that said atrial sealing skirt body defines a valve receptacle and configured to receive a valve. 14. Atrial sealing skirt, according to claim 12, characterized in that said at least one conduit is configured to receive a locking system to lock said atrial sealing skirt positioned on the atrial floor. 15. Atrial sealing skirt according to claim 14, characterized in that said locking system comprises a detachable lock positioned within said conduit to lock said lower flap against the atrial floor. 16. Atrial sealing skirt according to claim 12, characterized in that said atrial skirt flap is generally convex before conforming to the atrial floor. 17. Anchor assembly for anchoring a mitral valve to an interventricular septum of a heart, characterized in that it is for minimally invasive implantation of a mitral valve to replace the native mitral valve comprising: an anchor comprising a configured anchor screw for interventricular septum implantation, said anchor comprising an anchor base extending from a proximal end of said anchor screw, a flexible connector extending from a proximal end of said anchor base, and an anchor shank. extending proximally from said anchor base; and an anchor delivery system comprising a connecting rod having a distal end configured to cooperate with said anchor base to selectively connect thereto and an anchor connector defining a channel for receiving said connecting rod and wherein said connecting rod anchor connector is configured to receive said anchor rod. 18. Anchor assembly according to claim 17, characterized in that said anchor rod comprises at least one locking member extending radially outwardly thereof and configured to cooperate with a proximal end surface of said connector of anchor. 19. Anchor assembly according to claim 17, further comprising at least one stabilizer extending radially outward from said anchor base adjacent to said anchor bolt. 20. Anchor set according to claim 19, characterized in that said at least one stabilizer is non-linear. 21. Anchor assembly according to claim 19, characterized in that said at least one stabilizer extends radially outward at an acute angle to a horizontal axis of said anchor base. 22. Anchor assembly according to claim 17, characterized in that said connector rod distal end has a first surface configuration and said anchor rod defines a channel having a second surface configuration wherein said first and surface configurations matingly engage to connect said connecting rod to said anchor rod. 23. Anchor assembly according to claim 22, characterized in that said connecting rod is removable from said anchor rod. 24. Anchor assembly according to claim 18, further comprising a tether assembly including a snap ring and at least one tether rod wherein said snap ring is configured to receive said connector of anchor and said at least one tether rod extends proximally from said snap ring. 25. Anchor assembly according to claim 24, characterized in that said at least one locking member moves between a first locked position wherein the at least one locking member extends a first distance from from an outer surface of said anchor cap to a second position wherein said at least one locking member extends a second distance from said outer surface wherein said first distance is greater than said second distance. 26. An anchor assembly according to claim 25, characterized in that said tethering snap ring urges said at least one locking member from said first locked position to said second position when positioned over said at least one locking member and said at least one locking member, in said first locked position, engages said locking ring when said locking ring is positioned distal to said at least one locking arm in said anchor cap. 27. Method of implanting an anchor in an interventricular septum of a heart, characterized in that it is to minimally invasively anchor a mitral valve to replace the native mitral valve, comprising the steps of: providing an anchor assembly including a anchor distal end configured for interventricular septum implantation at an implantation site, said anchor comprising an anchor base extending from a proximal end of said anchor distal end, a flexible connector flexibly connected to a proximal end of said anchor base, and an anchor rod extending proximally from said flexible connector; and connecting an anchor delivery system including a connecting rod and anchor connector to the anchor assembly by positioning the anchor connector over the anchor base; lock anchor connector to anchor base; advancing the anchor assembly over a guidewire adjacent to the interventricular septum where the anchor distal end penetrates the interventricular septum at the implantation site and deploying the anchor distal end where the anchor distal end exits an opposite side; advancing a tethering engagement system including a engagement ring and at least one tethering arm extending from the engagement ring over the anchor connector; and remove the connector stick. 28. The method of claim 27, wherein said anchor distal end is an anchor screw and said step of advancing the anchor assembly to penetrate the interventricular septum includes turning the anchor screw. 29. The method of claim 27, wherein said anchor assembly further includes at least one stabilizer extending radially outward from said anchor base and said anchor distal end deployment step includes the step of stabilizing the anchor distal end with the at least one stabilizer.