JP2022508943A - Transcatheter fixation assembly for mitral valve, mitral valve, and related methods - Google Patents

Abstract

A medical assembly that implants a transcatheter heart valve into the heart at the valve deployment site, and related methods of implantation and delivery. Anchor delivery system and delivery cable are used to introduce the anchor into the heart within the blood vessel and implant it in the heart wall. The second delivery system introduces an implanted anchor and a tether coupled to a transcatheter heart valve. Transcatheter heart valves include either the upper or lower edge, which is positioned to conform to the atrium bed at the deployment site.

Description

The present invention, as a whole, relates to a medical assembly for minimally invasively implanting a valve in the heart, a novel valve for replacing a natural heart valve, and an anchor device for positioning and constraining the valve. The present invention also relates to methods of implanting medical assemblies and valve components. More specifically, the present invention replaces the functions of novel transcatheter valves, transcatheter valve skirts, anchor devices, anchor delivery systems, and valve delivery devices, as well as the natural mitral valve associated with such assemblies. Therefore, it relates to a method for implanting a valve in a blood vessel across the mitral valve.

Transcatheter valves have proven safe and effective in replacing natural heart valves such as the aortic and pulmonary valves. Regarding mitral valve replacement, reliability was uncertain due to the significant clinical and anatomical complexity of mitral valve disease in early clinical trials of transcatheter mitral valve replacement (TMVR). Low.

Mitral valve disease is primarily responsible for mitral regurgitation (MR), but is caused by primary valve degeneration (eg, mucosal degeneration, endocarditis, rheumatic disease, or other causes). Or, it may be caused by a combination of mitral valve annulus dilation and / or mitral valve leaflet tethering that occurs secondary to left ventricular dilatation and papillary muscle displacement, leaflet junction failure (secondary or Due to "functional" mitral valve insufficiency). MR increases left atrial pressure and causes pulmonary congestion, which leads to signs and symptoms of congestive heart failure: peripheral edema, sedentary breathing, paroxysmal nocturnal dyspnea, and progressive exertional dyspnea. In addition, MR exacerbates left ventricular dysfunction and reduces survival. Since many MR patients have a significant simultaneous morbidity and a high surgical risk, it is important to develop a minimally invasive (ie, transcatheter) method of treating MR.

Early-developed transcatheter techniques have significant limitations because they repair the mitral valve rather than replace it. For example, transcatheter annuloplasty devices (Arto (MVRx, Inc., San Mateo, CA, USA), Cardioband (Edwards Lifescientes, Irvine, California, USA), Carillon (Cardiac Dimension, Kirkland, Washington, USA), Millipeed. , Marlborough, Massachusetts, USA), Mitral Loop Cervical (Tau-PNU Medical Co. Ltd., Busan, Korea), Mitrallign (Mitralign, Inc., Tuxbury, Mass., USA) directly or indirectly mitral valve annulus dimensions. It mimics surgical annuloplasty by reducing and allowing the mitral valve leaflets to join more completely. In any case, these techniques are due to uncertain reproducibility. Also limited by the inability to cope with valve leaflet tethering or abnormalities. Conversely, the MitralClip repair system (Abbott Vascalar, Abbott Park, Illinois, USA) or the Pascal system (Edwards Lifesciences) sews the valve leaflets to each other. Then, by reproducing the surgical Alfieri suture, valve leaflet abnormalities can be treated. The MitralClip system is FDA approved and effective for many patients, but in a significant number of patients (> 10). %) Have relapsed MR after MitralClip and many patients are unable to receive MitralClip due to anatomical structural limitations. Similarly, NeoCord DS1000 (NeoCord, Inc., Minnesota, USA) St. Louis Park, Mass.), Harpon TSD-5 and V-cordal (Edwards Lifescientes) are currently limited to very specific anatomical structures (eg, single leaflet deviations).

Transcatheter mitral valve replacement (TMVR) is not limited by anatomical limitations and few patients have a recurrence of MR. Still, current techniques have limitations and disadvantages based on how they stick to the mitral valve. When anchored to the mitral valve leaflet, the Fortis valve (Edward Lifesciences) had an unacceptable rate of thrombus formation. Also, when sticking to the natural leaflet, the Tiara valve (Neovasc, Richmond, British Columbia, Canada) was successfully implanted without the same thrombus formation problem. Similarly, CardiAQ (Edwards Lifescientes), which directly engages the mitral valve annulus, NaviGate (Navigate Cardiac Structures, Lake Forest, Calif., USA), which pierces the annulus and leaflet using a "winglet", "hourglass". The Cephae (Abbott Laboratories), which engages the annulus by shape, and the Intrepid valve (Medtronic, Minneapolis, Minnesota, USA), which engages the annulus by the action of a "Champen-cork-like", are all implanted without problems with thrombosis. I came.

In any case, these devices attach directly to the mitral valve annulus, thus constraining the degree of freedom of mitral valve annulus movement to varying degrees. This constraint on the degree of freedom may contribute to left ventricular dysfunction. For example, studies comparing transcatheter mitral valve repair (using Abbott Vascalar's MitraClip device) with cardiotomy have shown that mitral valve annulus movement is significantly less with cardiotomy. The authors suggest that it was the cause of the low left ventricular ejection rate (LVEF) after cardiotomy compared to transcatheter repair. Similarly, studies comparing flexible mitral valve annulus forming rings with rigid ones show that rigid rings have significantly less LVEF, which results in greater mitral valve annulus motion than flexible rings. It has been found to be detained. Therefore, by restraining the mitral valve annulus, these devices may have a detrimental effect on left ventricular function.

Similarly, TMVR devices that use a docking system may reduce left ventricular function by constraining mitral valve annulus movement. In particular, Caisson (LiveNova, PLC, London, UK), HighLife (HighLife SAS, Paris, France), MValve (Boston Scientific), and Sapien M3 (Edwards Lifescientes) valves all use a docking system with a catheter system. The organ is attached to the mitral valve annulus.

In addition to restraining the mitral annulus, these devices also pose a risk of left ventricular outflow tract (LVOT) obstruction that occurs when the valve leaves the anterior leaflet of the mitral valve open. Creates a fixed blockage that flows out of the LVOT. This is a specific limitation to TMVR devices in patients with small hypertrophied ventricles (mostly in females) or in patients with marked mitral annulus calcification.

To alleviate these concerns and limitations, the Tendyne valve (Abbott Laboratories) has a lower risk of LVOT obstruction and does not constrain the mitral valve annulus as much as other TMVR devices. Tendyne achieves this by attaching a valve anchor to the extracardiac tether via the chordae tendineae. Therefore, firm fixation to the mitral valve annulus is not required, and the narrow inner portion of the valve annulus does not push the mitral valve anterior leaflet into the LVOT to the same extent as other valves. The problem with Tendyne is that it requires transapical access (incision of the left ventricle), which can be detrimental to left ventricular function in some patients.

Avoiding transapical access, not constraining the mitral annulus, or inducing LVOT occlusion, the Alta valve (4C Medical Therapy) is held in place by a large flexible ball cage in the left atrium. It consists of an annulus superior valve. However, it is unclear whether this ball cage induces atrial abnormalities such as fibrosis, thereby causing atrial fibrillation and / or loss of atrial systolic function. In addition, the continued functioning of the natural mitral valve leaflet can cause impaired blood flow, which can alter artificial valve leaflet function.

Therefore, it can be delivered without transapical access, the risk of LVOT occlusion is minimal, and by not sticking to the atrium or mitral annulus, it allows the atrium and mitral annulus to function normally. It is still desirable in the art to provide a transcatheter valve placed across the mitral annulus that is fully repositionable and recoverable during the procedure.

Presented herein are medical assemblies that are minimally invasively implanted across the mitral valve, replacing the function of the natural mitral valve. The methods disclosed herein are of the mitral valve annulus by implanting the mitral valve by transseptal access and the valve anchor, which can be an intra-annular or supraglar anchor, into the interventricular septum. Minimize the risk of LVOT blockage while avoiding sticking and restraint. Therefore, beneficially, no part of the system requires thoracotomy and transvalvular access for implantation.

In one aspect, the system comprises a transfemoral interatrial septal guide and a transseptal crossing needle that allows the septal crossing to deliver the snare sheath into the left ventricle. The delivery of the snare to the left ventricle is adjacent to the interventricular septum.

The system also includes a transjugular interventricular septal guide and a high frequency crossing wire that allows the wire to cross the ventricular septum and then snare into a snare sheath positioned in the left ventricle. To prepare for. The wire is externalized outside the body via the interatrial transseptal guide to form a wire loop, which extends from the outside of the transjugular guide to the outside of the transfemoral guide. The exchange catheter is advanced beyond the wire loop and the high frequency wire is replaced with a larger, stiffer wire.

In one aspect, the system has an anterograde or retrograde anchor delivery sheath that advances beyond the wire loop and an anterograde or retrograde interventricular septum attached to an anchor cap configured to accept the tether. Equipped with an anchor. The tether is configured to attach to one or more cords, and the tether attaches to the transcatheter valve.

According to various aspects, the interventricular septal anchor may consist of right and left ventricular discs connected by ventricular septal elements, such as nitinol, stainless steel, titanium, or cobalt chrome, respectively. It may be composed of any alloy, but not limited to them. Each element of the anchor is a synthetic material such as, but not limited to, polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET), or a biological membrane such as, but not limited to, bovine or porcine pericardial tissue. It may be coated with either.

The anchor cap is also made of any alloy and is attached to the left ventricular disc of the interventricular septal anchor. With a retrograde interventricular septal anchor (delivered from the left ventricular side of the septum), the proximal end of the anchor cap has an inner "female" screw that receives the "male" at the distal end of the delivery cable. Specify (define). In one aspect, the delivery cable remains attached to the anchor cap and is used to guide the tether until the tether's docking ring binds to the anchor. Finally, the delivery cable may be loosened and removed from the anchor cap.

With an anterograde 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 an inner "female" screw that receives the "male" at the distal end of the anterograde delivery cable. The anterograde delivery cable also acts as a conduit for the wire loop, so the wire begins outside the transfemoral sheath, via the anchor cap of the interventricular septal anchor, and on the right ventricular side of the septal anchor. It passes through the delivery cable attached to and exits the transjugular sheath. A wire loop extending through the anchor cap guides the tether until the tether's docking ring joins the anchor. After coupling, the wire loop may be removed, the anterograde delivery cable may be loosened, the interventricular septal anchor is fully deployed, and the tether is coupled to the anchor cap.

In one aspect, the tether has a docking ring attached to at least one docking ring arm with an eyelet defined at the proximal end of the docking ring arm. Each eyelet connects to the distal end of the tether rod, which attaches to the eyelet via a hook. The tether rod is made of any alloy and the proximal end of the tether rod is attached to the cord. In one aspect, the tether docking ring is advanced over the anchor cap to push down on the protruding locking arm of the anchor cap. In another aspect, the docking ring reaches the end of the anchor cap and pushes out a protruding locking arm, thereby allowing the docking ring and thus the tether to be locked in place. In another aspect, the tether can rotate freely around the longitudinal axis of the anchor cap without affecting the position of the anchor cap or anchor screw, even after being locked in place. .. Upon recovery, the valve delivery catheter returns beyond the locking arm, thereby pushing down on the arm and allowing the tether's docking ring to retract.

In one aspect, the system comprises a tether configured to connect and / or secure the valve to the interventricular septum, and the transcatheter valve comprises a body containing the leaflet integrated at the apex or inferior edge. ..

In one aspect, the transcatheter valve is self-expandable, composed of nitinol, a synthetic material such as, but not limited to, polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET), or bovine or porcine heart. It is covered with either a biological membrane, such as, but not limited to, surrounding tissues.

The leaflets of transcatheter heart valves are, in one aspect, composed of, but not limited to, bovine, horse, or porcine pericardiac tissue. In another aspect, the transcatheter heart valve is coated with a membrane having a diameter larger than the annulus at the deployment site, so that the membrane substantially covers the mitral annulus during use.

The frame of the transcatheter valve, in its intravalvular form, begins in a cylindrical shape with the bottom of the cylinder below the height of the annulus and the top of the cylinder extending into the atrium. The upper edge extends from the top of the cylinder and consists of one or more wire extensions, made of laser-cut or molded nitinol. These extensions are adapted to shapes such as, but not limited to, lines, arcs, hooks, circles, ellipses, sinusoids, or polygons with three or more sides. The extension of the upper edge is covered with a synthetic or biological membrane and / or connected to it, like the body of a valve. The upper edge may be perpendicular to the valve body or may bend towards the atrioventricular bed as either a convex or concave curve. To facilitate sealing as the upper edge bends towards the atrioventricular bed, the covering fabric consists of either a woven or knitted fabric that allows for "stretchability" and is capable of adapting to the topography of the atrioventricular bed. Is improving.

In the annulus morphology of the transcatheter valve, the frame begins at the lower edge positioned on the floor of the left atrium. The lower edge consists of one or more wire extensions and is made of laser-cut or molded nitinol. These extensions are adapted to shapes such as, but not limited to, lines, arcs, hooks, circles, ellipses, sinusoids, or polygons with three or more sides. The extension of the lower edge is covered with a synthetic or biological membrane and / or connected to it, like the body of a valve. The lower edge may be perpendicular to the transcatheter valve body or may bend towards the atrioventricular bed as either a convex or concave curve. To facilitate sealing as the lower edge bends towards the atrioventricular bed, the covering fabric consists of either a woven or knitted fabric that allows for "stretchability" and is capable of adapting to the topography of the atrioventricular bed. Is improving. From the lower edge, a cylinder containing the leaflet extends into the left atrium.

In one aspect, whether it takes the form of a cylinder whose cross section is any part of a circle, ellipse, parabola, or hyperbola, adjacent to the top of the cylinder of the valve, extending longitudinally along the inside or outside of the valve body. Alternatively, there may be one or more conduits in the form of a polyhedron with a flat base and apex in the shape of a polygon with three or more sides. These conduits may be constructed from the membrane covering the valve body, or may be made of stainless steel, nitinol, or other alloys, but are not limited to them. One or more ducts are hollow and contain at least one cord attached to at least one tether, each conduit attached to a separable lock near the atrial surface of the valve.

The separable lock secures the transcatheter valve to a fixation system consisting of tethers attached to the interventricular septal anchor, which is securely attached to the interventricular septum. In one aspect, the tether is attached to the interventricular septal anchor via an anchor cap and at least one cord extends from the tether through at least one duct in the skirt body. Thus, the transcatheter valve is screwed onto the cord via the conduit so that the transcatheter valve interacts slidably with the cord. In another aspect, the proximal end of the cord attaches to a suture that extends outside the user-accessible heart.

The system further comprises at least one atrial positioning rod with the proximal end attached to the delivery system and the distal end reversibly coupled to a separable lock attached to the proximal end of the transcatheter valve body. .. As the suture and / or cord passes through the lumen of the positioning rod, the positioning rod pushes or pulls on the transcatheter valve body, thereby applying different forces and flexions to the associated upper or lower edge, resulting in the atrioventricular bed. It becomes possible to add to. In another embodiment, by rotation of the positioning rod and / or pushing or pulling of an internal element of the positioning rod, a separable lock engages the cord and / or suture to transcatheter the cord and / or suture. It is fixed to the valve body, maintains the force and flexion of the upper or lower edge with respect to the atria bed, and fixes the position of the transcatheter valve.

Implantation related methods are also provided. Other devices, methods, systems, features, and advantages of minimally invasively implanted medical devices and systems in the heart will be apparent to those of skill in the art by examining the drawings and detailed description below. There will be. All such additional devices, methods, systems, features, and advantages are contained herein, within the scope of the medical assembly that is minimally invasively implanted in the heart, and protected by the appended claims. It shall be.

FIG. 3 is a notched perspective view of the heart showing the transcatheter valve system of the present application positioned within the heart, according to one aspect. FIG. 3 is a perspective view showing a retrograde anchor for anchoring a tether to the interventricular septum. FIG. 3 is a perspective view showing a delivery cable of a retrograde anchor for anchoring a tether to the heart wall. It is a perspective view which shows the tether for fixing a transcatheter valve to a retrograde anchor. A perspective showing a retrograde anchor assembly consisting of a tether for connecting the transcatheter valve to the anchor, coupled to the anchor for anchoring the tether to the interventricular septum, and the anchor's LV disk connected to the delivery cable. It is a figure. FIG. 3 is a perspective view showing a delivery cable of an antegrade anchor for anchoring a transcatheter valve to an anchor. FIG. 3 is a perspective view showing an antegrade anchor for anchoring a tether to the interventricular septum. It is a perspective view which shows the tether for fixing a transcatheter valve to an antegrade anchor. Consists of a tether to connect the transcatheter valve to the anchor, is attached to the anchor to secure the tether to the interventricular septum, the RV disk of the anchor is connected to the delivery cable, and the guide wire goes through the assembly. FIG. 3 is a perspective view showing a sex anchor assembly. It is a side view of an annulus inner valve composed of an upper edge attached to a transcatheter valve body in which a valve leaflet is integrated. It is a top perspective view of the valve annulus inner valve composed of the upper edge attached to the transcatheter valve body in which the valve leaflet is integrated. FIG. 3 is a perspective view of a valve composed of a lower edge attached to a transcatheter valve body with an integrated valve leaflet. Top view of a valve consisting of a lower edge attached to a transcatheter valve body with integrated valve leaflets. FIG. 6 is a side view showing a transcatheter valve having a valve in which one edge of the upper edge transitions from a concave configuration to a convex configuration. FIG. 3 is an enlarged side view showing a transcatheter valve body coupled to an atrial positioning rod and cord. It is an enlarged side view of the locking system. It is a perspective view of the locking system. It is a notch perspective view of a locking system. FIG. 6 is a cross-sectional view showing a locking system for a transcatheter valve body positioned in a non-locking position. FIG. 6 is a cross-sectional view showing a locking system for a transcatheter valve body positioned at a locking position. It is a partial cutaway drawing of the locking system in the locking position. It is a perspective view of the locking system. FIG. 6 is a perspective view showing one stage of an anchor having an anchor screw and an anchor cap configured to accept a connecting ring and a tethering system. FIG. 3 is a perspective view showing the next stage of an anchor having an anchor screw and an anchor cap configured to accommodate a connecting ring and tethering system. FIG. 3 is a perspective view showing the next stage of an anchor having an anchor screw and an anchor cap configured to accommodate a connecting ring and tethering system. FIG. 3 is a perspective view showing the next stage of an anchor having an anchor screw and an anchor cap configured to accommodate a connecting ring and tethering system. FIG. 3 is a perspective view showing the next stage of an anchor having an anchor screw and an anchor cap configured to accommodate a connecting ring and tethering system. FIG. 3 is a perspective view showing the next stage of an anchor having an anchor screw and an anchor cap configured to accommodate a connecting ring and tethering system. FIG. 18A is a perspective view showing a state in which transseptal puncture is performed and the interventricular septal crossing guide is in place. FIG. 18B is a perspective view showing a snare positioned in the left ventricle after transseptal puncture. FIG. 19A is a perspective view showing a snare receiving a ventricular septal crossing wire. FIG. 19B is a perspective view showing an interventricular septal crossing catheter advancing across the septum. FIG. 19C is an enlarged perspective view showing an interventricular septal crossing catheter advancing across the septum. FIG. 20A is a perspective view showing an interventricular septal crossing catheter advancing into the transseptal guide. FIG. 20B is a perspective view showing a state in which the interventricular septal crossing wire is replaced with a 0.889 mm (0.035 inch) wire. FIG. 21A is a perspective view showing a retrograde anchor delivery sheath that advances beyond the 0.889 mm (0.035 inch) rail wire into the interventricular septum. FIG. 21B is a perspective view showing a retrograde anchor delivery sheath whose end is positioned across the interventricular septum in the right ventricle and a retrograde anchor positioned within the sheath. FIG. 22A is a perspective view showing a state in which the right ventricular disc of the retrograde anchor is unfolded. FIG. 22B is a perspective view showing a state in which the left ventricular disc of the retrograde anchor is unfolded and the 0.889 mm (0.035 inch) rail wire is withdrawn. FIG. 3 is a perspective view showing a retrograde anchor fully deployed to accept a transcatheter valve. FIG. 24A is a perspective view showing an antegrade anchor delivery sheath advancing across a 0.889 mm (0.035 inch) rail wire through a septum. FIG. 24B is a perspective view showing an antegrade anchor delivery sheath whose end is positioned across the interventricular septum in the left ventricle and an antegrade anchor positioned within the sheath. FIG. 25A is a perspective view showing a state in which the left ventricular disc of the antegrade anchor is unfolded. FIG. 25B is a perspective view showing a state in which the right ventricular disc of the antegrade anchor is unfolded. FIG. 26A is a perspective view showing an antegrade anchor delivery cable that is loosened and removed. FIG. 26B is a perspective view showing an antegrade anchor delivery cable that is removed leaving a 0.889 mm (0.035 inch) rail wire in place. FIG. 26C shows a transseptal guide removed leaving a 0.889 mm (0.035 inch) rail wire in place to accept the transcatheter valve and advance it onto the anterograde anchor on the dock. It is a perspective view. FIG. 27A is a perspective view showing a valve delivery system approaching the anchor. FIG. 27B is a perspective view showing a tether coupled to an anchor cap of an anchor. FIG. 28A is a perspective view showing a state in which the valve delivery guide is partially withdrawn and the inner portion of the annulus of the valve is exposed. FIG. 28B is a perspective view showing a condition in which the valve delivery guide is completely withdrawn, the upper edge of the valve in the left atrium is exposed, and the atrial positioning rod remains connected to the transcatheter valve body. FIG. 28C is an enlarged perspective view showing a state in which the atrial positioning rod is still connected to the transcatheter valve body and the valve is completely exposed. FIG. 29A is a perspective view showing a state in which the atrial lock is engaged and the atrial positioning rod is withdrawn while only the suture is connected to the main body of the transcatheter valve. FIG. 29B is an enlarged perspective view showing a state in which the atrial lock is engaged and the atrial positioning rod is withdrawn while only the suture is connected to the main body of the transcatheter valve. FIG. 29C is a perspective view showing a state in which the valve is deployed and the valve delivery system is withdrawn from the body while the suture connected to the transcatheter body is exiting the body through the valve delivery sheath. It is a perspective view which shows the suture cutter advanced to just above the upper edge of a transcatheter valve through a valve delivery sheath. FIG. 3 is a perspective view showing a fully unfolded valve after the suture has been cut above the upper edge of the valve. FIG. 30A is a perspective view of FIG. 30A including a mitral valve according to another aspect of the present invention. FIG. 30B is a perspective view of FIG. 30B including the mitral valve shown in FIG. 30C. It is a side view of an annulus superior valve composed of an upper edge attached to a transcatheter valve body in which a valve leaflet is integrated. It is a top perspective view of an annulus superior valve composed of an upper edge attached to a transcatheter valve body in which a valve leaflet is integrated. It is an exploded view of an anchor having an anchor screw and an anchor cap configured to accept a connecting ring and a tethering system according to another aspect of the invention. FIG. 32A is a side view showing the anchoring system of FIG. 32A, in which the connected ring advances beyond the anchor cap and is locked in place. FIG. 32B is a side view of FIG. 32B where the delivery cable is separated from the system. FIG. 3 is a perspective view showing an anchor of FIG. 32 including a stabilizer according to another aspect of the present invention. It is an end view which shows the anchor screw of FIG. 32.

The invention is more easily understood by reference to the following detailed description, examples, and claims, as well as those above and below. Prior to disclosing and describing the systems, devices, and / or methods of the invention, the invention is, of course, variable and therefore, unless otherwise specified, the specific systems, devices, and / or methods disclosed. It should be understood that it is not limited. It should also be understood that the terminology used herein is merely to describe a particular embodiment and is not intended to be limiting.

The following description of the invention is provided as enabling the teachings of the invention in the best currently known embodiments. One of ordinary skill in the art will recognize that numerous changes have been made to the embodiments described and that the beneficial results of the present invention are still obtained. It will also be apparent that some of the desired benefits of the invention can be obtained by selecting some features without utilizing the other features of the invention. Accordingly, one of ordinary skill in the art will recognize that many modifications and adaptations to the invention are possible and may even be desirable in certain circumstances and are part of the invention. Therefore, the following description is provided as an illustration of the principles of the present invention and is not intended to limit it.

As used herein, the singular forms "a", "an", and "the" include the plural unless otherwise specified by context. Thus, for example, the reference to "tether" includes an embodiment having two or more tethers, unless otherwise specified by the context.

The range is represented herein as from "approximately" one particular value and / or "approximately" another particular value. When such a range is expressed, another embodiment includes from one particular value and / or to the other particular value. Similarly, when a value is expressed as an approximation using the antecedent "about", it is understood that a particular value forms another aspect. Furthermore, the endpoints of each of the ranges are understood to be significant in relation to the other endpoint and independently of the other endpoint.

As used herein, the term "arbitrary" or "arbitrarily" means that the event or situation subsequently described may or may not occur, and that the description is such that the event or situation is described. It means to include examples that occur and examples that do not occur. As used herein, "fluid" refers to any freely flowing substance, including liquids, gases, and plasmas. "Fluid communication" as used herein refers to any connection or relative positioning in which a substance can flow freely between related components. As used herein, "distal" refers to the direction of application and "proximal" refers to the direction of the user of the device.

The present application relates to minimally invasive implants of medical devices and systems in the heart and methods of implanting those devices and systems. More specifically, the present application introduces and anchors a retrograde or prograde anchor 22 or 49 intravascularly into the interventricular septum 20 and valves 66 (see FIGS. 10A and 10B, 11A and 11B). ) Into a device, method, and system for implanting a retrograde or prograde anchor 22 or 49 into a tethered heart to replace a natural mitral valve. The tethering assembly also works with the anchor 22 or 49 to connect the valve 66 or 156 to the anchor 22 or 49. Further, the valve 66 is connected to the upper edge 67 or the valve body 68 so that the valve conforms to the respective atria bed via the upper edge 67 or the lower edge 157 and prevents perivalvular regurgitation of the prosthesis. Includes lower edge 157. According to the disclosure herein, the anchor is implanted independently of the tether and transcatheter valves.

Retrograde Anchor Assembly The components of the retrograde anchor assembly 44 shown in FIGS. 2-5 include an anchor 22 with an anchor cap 27 and a delivery cable 32 that allows delivery of the tether 36. The anchor cap 27 is coupled to the left ventricular disc 26, which is connected to the right ventricular disc 23 via the septal connector 24. The delivery cable 32 is removably connected to the anchor cap 27. The septal connector 24 is sized and configured to straddle the interventricular septum, as shown. However, optionally, the septal connector 24 may be of a different size (longer or shorter, depending on the thickness of the interventricular septum) and may have a circular, elliptical, parabolic, or bicurved cross section. It may take the shape of a cylinder that is a portion, or it may take the shape of a polyhedron having a flat base and top in the shape of a polygon with three or more sides. The septal connector may be constructed from any known alloy including, but not limited to, stainless steel, nitinol, titanium, cobalt-chromium, or other alloys. In another aspect, the alloy of the septal connector 24 is coated with living tissue such as bovine, sheep, porcine, or horse pericardium, or with any combination of anti-inflammatory agents that promote healing and limit inflammation. May be good. Right ventricular and left ventricular discs may be constructed from any known alloy including, but not limited to, stainless steel, nitinol, titanium, cobalt-chromium, or other alloys. In addition, the right and left ventricular discs may take the shape of any part of a circle, ellipse, parabola, or hyperbola, or the shape of a polygon with three or more sides. Right and left ventricular discs are coated with a synthetic material from the group consisting of polycarbonate, polyurethane, polyester, stretched polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubber, or a combination thereof. It may be, but it is not limited to them. The right and left ventricular discs may also be covered with adult or juvenile bovine, sheep, horse, or porcine pericardium. In a further aspect, the anchor 22 has a anchoring element (not shown) positioned along its right and left ventricular discs. These fixation elements allow fixation to the interventricular septum, but are not always the primary fixation mechanism used.

In use, the retrograde anchor 22 removes the right ventricular disc 23 from the sheath and brings it into contact with the right ventricular surface 17 of the interventricular septum 20, then exposes the septal connector 24, followed by the sheath of the left ventricular disc 26. It is fixed to the interventricular septum by coming out of and in contact with the left ventricular surface 16 of the interventricular septum 20. By inserting the left ventricular disc 26 again, then the septal connector 24, and finally the right ventricular disc 23 into the sheath, the retrograde anchor is safely removed from the heart wall and repositioned or completely removed. Will be done.

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 tether 36 (described below) to the anchor cap 27. The at least one locking arm 29 has a first locking position in which the locking member 29 extends a first distance away from the body of the anchor cap 27, and the locking member 29 is from the anchor cap 27. It travels to and from a second unlocked position that extends a second distance shorter than the first distance. The anchor cap 27 includes at least one urging member (not shown), such as a spring, configured to press each locking arm 29 to a first locking position. As shown, it was conceived that a plurality of locking arms 29 are provided and evenly spaced around the circumference of the anchor cap 27, but the locking arms 29 do not need to be evenly separated. To.

Next, referring to FIG. 3, the delivery cable 32 has a flexible delivery wire 33 having a distal threaded end portion 34 positioned or formed at the distal end of the delivery wire 33. include. Delivery wires are constructed from stainless steel, nitinol, or other alloys, but not limited to them, with or without a hydrophilic coating, or with a polymer coating such as polytetrafluoroethylene (PTFE). Or not. The distal threaded end portion 34 is sized and configured to selectively engage complementary threads formed in the cavity defined in the proximal end 31 of the anchor cap 27. .. See FIGS. 2 and 5. In use, the distal threaded end portion 34 advances into the proximal end 31 of the anchor cap 27 and is, for example, screwed into the anchor cap 27 to the distal end of the flexible wire 33. Join. As will be fully described later, the distal threaded end portion 34 is loosened from the proximal end of the anchor 22 to separate the flexible wire 33 from the anchor 22.

According to another aspect of the present disclosure, the anchor assembly 91 is shown, as shown in FIGS. 17A-17F. The anchor 91 includes an anchor shaft 92 and an anterograde anchor 49, in which the retrograde anchor 22 is replaceable in the anchor assembly 91. As shown, the antegrade anchor 49 extends distally from the anchor base 94. The anchor base 94 defines at least one or more anchor flanges 96 as shown and a recessed area 97 between them. The anchor shaft 92 includes at least one or, as shown, the plurality of locking members 98 shown in FIG. 17B. The locking member 98 is urged radially outward from the anchor shaft 92 by a spring (not shown) or the like. The anchor connector 99 and the connector rod 101 cooperate with the anchor shaft 92 to connect to the antegrade anchor 49. The anchor connector 101 defines at least one aperture 1020 configured to accommodate the anchor flange 96, or as shown. Therefore, the anchor connector 99 and the connector rod 101 are meshed and connected to the anchor shaft 92, thereby pushing the locking member 98 inward. By the cooperation of the aperture 100 and the flange 96, the anchor connector 101 and the anchor base 94 are integrated.

After the anterograde anchor 49 is embedded, the tether ring 102 is applied over the connector rod 101 and the anchor connector 99 to abut on the proximal end of the anterograde anchor 49. The tether ring 102 includes a nearly cylindrical first distal portion 103 and a second proximal portion 104 having a diameter larger than the first portion 103. The second portion 104 defines at least one or, as shown, a plurality of apertures 106 configured to receive the tether rod 108, as shown in FIGS. 17E and 17F. As shown in FIG. 17D, the anchor connector 99 and the connector rod 101 are removed. The locking member 98 is pushed outward radially, thereby engaging the second portion 104 of the tether ring 102 and locking the tether ring 102 on the anchor base 94. The tether rod 108 operates in cooperation with the transcatheter valve 66 or 156 as described above.

Anthropomorphic Anchor Assembly The components of the anterior anchor assembly 63 shown in FIGS. 6-9 enable delivery of an anchor 49 having an anchor cap 58 and a delivery cable connector 51 and a tether 36. Includes delivery cable 46. The anchor cap 58 is coupled to the left ventricular disc 57, which is connected to the right ventricular disc 54 via the septal connector 56. The delivery cable 46 is removably connected to the delivery cable connector 51 via a threaded end 52. The septal connector 56 is sized and configured to straddle the interventricular septum, as shown. However, optionally, the septal connector 56 may be of a different size (longer or shorter, depending on the thickness of the interventricular septum) and may have a circular, elliptical, parabolic, or bicurved cross section. It may take the shape of a cylinder that is a portion, or it may take the shape of a polyhedron having a flat base and top in the shape of a polygon with three or more sides. The septal connector may be constructed from any known alloy including, but not limited to, stainless steel, nitinol, titanium, cobalt-chromium, or other alloys. In another embodiment, the alloy of the septal connector 56 is coated with living tissue such as bovine, sheep, porcine, or horse pericardium, or with any combination of anti-inflammatory agents that promote healing and limit inflammation. May be good. Right ventricular and left ventricular discs may be constructed from any known alloy including, but not limited to, stainless steel, nitinol, titanium, cobalt-chromium, or other alloys. In addition, the right and left ventricular discs may take the shape of any part of a circle, ellipse, parabola, or hyperbola, or the shape of a polygon with three or more sides. Right and left ventricular discs are coated with a synthetic material from the group consisting of polycarbonate, polyurethane, polyester, stretched polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubber, or a combination thereof. It may be, but it is not limited to them. The right and left ventricular discs may also be covered with adult or juvenile bovine, sheep, horse, or porcine pericardium. In a further aspect, the anchor 49 has a anchoring element (not shown) positioned along its right and left ventricular discs. These anchoring elements allow fixation to the interventricular septum, but may not necessarily be used as the primary fixation mechanism.

In use, the anterograde anchor 49 removes the left ventricular disc 57 from the sheath into contact with the left ventricular surface 16 of the interventricular septum 20, then exposes the septal connector 56, followed by the right ventricular disc 54. It is fixed to the interventricular septum by being taken out of the sheath and brought into contact with the right ventricular surface 17 of the interventricular septum 20. By inserting the right ventricular disc 54 again, then the septal connector 56, and finally the left ventricular disc 57 into the sheath, the anterograde anchor is safely removed from the heart wall and repositioned or completely repositioned. Will be removed.

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 tether 36 (described below) to the anchor cap 58. The at least one locking arm 61 has a first locking position in which the locking member 61 extends a first distance away from the body of the anchor cap 58, and the locking member 61 is from the anchor cap 58. It moves to and from a second unlocked position that extends a second distance shorter than the first distance. The anchor cap 58 includes at least one urging member (not shown), such as a spring, configured to press each locking arm 61 to a first locking position. As shown, it is conceived that a plurality of locking arms 61 are provided and evenly spaced around the circumference of the anchor cap 58, but the locking arms 61 do not need to be evenly separated. To.

Next, referring to FIG. 6, the delivery cable 46 has a flexible delivery wire 47 having a distal threaded end portion 48 positioned or formed at the distal end of the delivery wire 47. include. The delivery cable 46 has a central channel (not shown) capable of accommodating wire rails. Delivery wires are constructed from stainless steel, nitinol, or other alloys, but not limited to them, with or without a hydrophilic coating, or with a polymer coating such as polytetrafluoroethylene (PTFE). Or not. The distal threaded end portion 48 is sized and configured to selectively engage complementary threads formed in the cavity defined in the proximal end 52 of the delivery cable connector 51. To. See FIGS. 7 and 9. In use, the distal threaded end portion 48 advances into the proximal end 52 of the anchor cap 51 and is, for example, screwed into the delivery cable connector 51 to the distal end of the flexible wire 47. Combine to. As will be fully described later, the distal threaded end portion 48 is loosened from the proximal end of the delivery cable connector 51 to separate the flexible wire 47 from the anchor 49.

Hello Anchor Assembly According to another aspect of the present disclosure, a halo anchor assembly 91 is shown, as shown in FIGS. 17A-17F. The halo anchor assembly 91 includes an anchor base 94 connected to an anchor shaft 92 (instead of the anchor cap 58 according to another aspect) and fused to the rest of the antegrade anchor 49, the halo. The anchor assembly 91 can consist of an anchor base 94 that is connected to the anchor shaft 92 and fused to the rest of the retrograde anchor 22 instead of the anchor cap 27 as shown in FIG. As shown, the antegrade anchor 49 extends distally from the anchor base 94. The anchor base 94 defines at least one or more anchor flanges 96 as shown and a recessed area 97 between them. The anchor shaft 92 includes at least one, or a plurality of locking members 98 as shown, extended in FIG. 17B. The locking member 98 is urged radially outward from the anchor shaft 92 by a spring (not shown) or the like. The anchor connector 99 and the connector rod 101 travel beyond the wire rail 64 extending through the anchor shaft 92 and the threaded end 52 (such as those shown in FIG. 9) and connect to the connector rod 101. The anchor connector 99 is cooperated with the anchor shaft 92. The anchor connector 99 defines at least one aperture 100 configured to accommodate the anchor flange 96, or a plurality of apertures 100 as shown. Therefore, the anchor connector 99 and the connector rod 101 are meshed and connected to the anchor shaft 92, thereby pushing the locking member 98 inward. The collaborative aperture 100 and flange 96 integrate the anchor connector 99 and the anchor base 94. After the tether ring 102 is secured to the locking member 98, the anchor connector 99 and the connector rod 101 are removed so that the wire rail 64 extends through the anchor shaft 92 attached to the anchor base 94. Be left behind. For the anchor assembly 91 fused to the retrograde anchor 22, the anchor connector 99 and the connector rod 101 move over the delivery cable 32 that remains after the anchor connector 99 and the connector rod 101 are removed.

32 and 33
Another aspect of the halo anchor assembly is shown in FIGS. 32A-32C and 33. The anchor assembly 91 further includes a bending connector 170, which may be made of a suitable material such as metal or alloy, extending between the anchor base 94 and the anchor shaft 92. As shown, the bend connector 170 has a coiled configuration, but other configurations are conceivable. At least one or, as shown, three locking arms 98 extending radially outward from the anchor shaft 92 are secured to the bottom of the anchor shaft 92. The arm 98 is made of, for example, any metal or alloy. The locking arm 98 is pushed inward in the radial direction, but is urged as shown. Thus, when the locking member 98 is positioned to engage the locking member 98, it cooperates with the tether ring 202 and the bend connector of the anchor assembly 91 is particularly when the anchor screw 93 is embedded. Allows the tether to remain axially aligned (eg, parallel to the interventricular septum) with the valve to be implanted.

To embed the anchor screw 93, a torque driver (not shown) preloaded onto the delivery cable 232 can engage the anchor base 94 and rotate the screw to drive it into the tissue. When fully embedded, the torque driver is removed, leaving the anchor assembly 91 connected to the delivery cable 232. Beyond the delivery cable 232, the tether ring 202 connected to the tether via the tether rod 208 (attached to the tether ring 202 via the aperture 206) is advanced beyond the anchor shaft 92. The tether ring 202 advances beyond the locking arm 98, thereby pushing the arm inward. As the proximal end of the tether ring 202 passes below the locking arm 98, the locking arm 98 bounces outwards, constraining the tether ring 202 in place and anchoring it to the tether rod 208. Unintended movement is prevented. Finally, the delivery cable 232 is rotated so that the "male" thread 234 is displaced from the thread defined by the threaded cavity of the anchor 92.

The anchor assembly 91 shown in these figures also stabilizes the anchor, limits or prevents movement such as rotational movement due to the tension transmitted from the tether, provides traction, and the screw anchor 93 carelessly. Includes a stabilizer 172 that limits or prevents decoupling from the tissue implanted by rotating into. At least one stabilizer 172 may be provided. As shown in FIG. 32, eight stabilizers 172 are shown, and FIG. 33 shows three. As shown in FIG. 32, the stabilizer 172 extends radially outward from the longitudinal axis of the anchor. The stabilizer 172 is configured to have a non-linear configuration. Other configurations are conceived. The stabilizer 172 shown in FIG. 33 also extends radially outward from the anchor longitudinal axis and extends at an acute angle, eg, 45 degrees, along the horizontal Hokoji struggle. The angle faces approximately in the opposite direction of the screw anchor 93. The stabilizer is almost linear, but other configurations are conceivable. For example, when inserted into the interventricular septum, the stabilizer 172 pushes the tissue and possibly enters the tissue in the direction opposite to the implantation of the anchor screw, preventing the anchor screw 93 from being unintentionally withdrawn.

After the halo anchor assembly consisting of either the antegrade anchor 49 or the retrograde anchor 22 is embedded, the tether ring 102 is applied over the connector rod 101 and the anchor connector 99 and antegrade. It abuts on the anchor base 94 fused to the sex anchor 49 or the retrograde anchor 22. The tether ring 102 includes a nearly cylindrical first distal portion and a second proximal portion 104 having a diameter larger than the first portion 103. The second portion 104 defines at least one or, as shown, a plurality of apertures 106 configured to receive the tether rod 108, as shown in FIGS. 17E and 17F. As shown in FIG. 17D, the anchor connector 99 and the connector rod 101 are removed. The locking member 98 is pushed outward radially, thereby engaging the second portion 104 of the tether ring 102 and locking the tether ring 102 on the anchor base 94. The tether rod 108 operates in cooperation with the transcatheter heart valve 66 or 156, as described above.

Tether Assembly When the flexible wire 33 is coupled to the retrograde anchor 22, the flexible wire acts as a guide rail for advancing the tether 36 to the retrograde anchor 22. For anterograde anchor 49, the wire rail 64 enters the distal end 62 of the anchor cap 58, passes through the central channel of the delivery cable 46, and exits the delivery cable connector 51 via the threaded end 52. Acts as a guide rail for the tether 36 up to the anterograde anchor 49. The tether 36 includes one or more tether rods 38 rotatably connected to the docking ring 43. The tether rod 38 is connected to the eyelet 41 defined on the docking ring arm 42, as shown in FIG. The tether 36 is advanced beyond the flexible wire 32 of the delivery cable 33 (in the case of a retrograde anchor) or beyond the wire rail 64 (in the case of a forward anchor) and the docking ring of the tether 36. 43 pushes at least one locking arm 29 or 61 of the anchor cap 27 or 58 down to a second non-locking position. When the locking arm 29 or 61 is in the second position, the tether 36 is used until the docking ring 43 abuts on the distal end 28 of the anchor cap 27 or the distal end 59 of the anchor cap 58. / Or advance beyond the locking arm 29 or 61 of the anchor cap 27 or 58, respectively, until adjacent. At this point, the urging member of the anchor cap 27 or 58 pushes at least one locking arm 29 or 61 to the first locking position, thereby pushing the docking ring 43 and thus the rest of the tether 36. Is releasably coupled to the retrograde anchor 22 or the antegrade anchor 49.

In one aspect, when coupled to the retrograde anchor 22 or the forward anchor 49, the tether 36 rotates entirely 360 degrees around the longitudinal axis of the anchor. Optionally, in another aspect, the tether 36 may be constrained to a smaller angle of rotation by the interaction of a portion of the tether 36 with at least one locking arm 29 or 61.

As shown in FIG. 4, in one aspect, the tether 36 has at least one docking ring arm 42 coupled to the docking ring 43 and at least one tether coupled to the docking ring arm 42. A rod 38 is provided. As shown, the distal end of the docking ring arm 42 is either tightly coupled to or integrally formed with the docking ring 43. As shown, at least one docking ring arm comprises a plurality of docking ring arms 42. As shown, the plurality of docking ring arms 42 are evenly spaced around the circumference of the docking ring, but the idea is that the docking ring arms 42 do not need to be evenly spaced. Will be done. The eyelet 41 is defined by the docking ring arm 42. The tether rod 38 includes a tether rod hook 39 configured to work with the eyelet 41.

The proximal end of each docking ring arm 42 is rotatably coupled to the distal end of each tether rod 38. The tether rod hook 39 is defined by the tether rod 38 as shown and is coupled to or integrally formed with the distal end of each tether rod 38. In another aspect, the eyelet 41 and the tether rod hook 39 are such that the tether rod hook 39 is inserted into the eyelet 41 and the tether rod 38 is securely rotatably coupled to the docking ring 43. It is sized and composed. In use, each tether rod hook 39 rotates around the circumference of the eyelet 41. As shown in FIG. 4, the proximal end of each tether rod is coupled to the cord 37. The tether rod 38 and the tether rod hook 39 may be made of any alloy.

Wire-Rail Delivery System With reference to FIGS. 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 the femoral vein via the transfemoral sheath 117, through which the guide 118 has a proximal hub 119 through which the transseptal needle 121 is introduced, the needle 121 being the guide's distance. It exits the transseptal guide 121 through the position dilator 122. The interventricular transseptal guide 111 is inserted into the jugular vein via the transjugular vein sheath 109 and guided over the guide wire 116 into the right ventricle 18. The interventricular septal guide 111 has a deflectable distal tip 114 controlled by a deflection knob 113 attached to the proximal handle 112 of the guide, the tip of which is the right ventricular surface 17 of the ventricular septum 20. Can be deflected towards.

Forward and Retrograde Anchor Delivery Sheath With reference to FIGS. 21A and 21B, the retrograde anchor delivery sheath 131 extends beyond the wire rail 64 into the proximal hub 119 of the interatrial septal guide 118. Proceed and exit from the distal end 120 of the transseptal guide. The dilator 133 passes through the distal end 132 of the retrograde anchor delivery sheath 131, travels beyond the wire rail 64, enters the left ventricular surface 16 of the interventricular septum 20, and from the right ventricular surface 17 of the interventricular septum 20. Get out. 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.

Next, with reference to FIGS. 24A and 24B, the anterograde anchor delivery sheath 134 travels beyond the wire rail 64 into the proximal handle 112 of the interventricular transseptal guide 111 and of the transseptal guide. Exit from the distal end 114. The dilator 137 passes through the distal end 136 of the anterograde anchor delivery sheath 134, travels beyond the wire rail 64, enters the right ventricular surface 17 of the interventricular septum 20, and enters the left ventricular surface 16 of the interventricular septum 20. Get out of. Crossing the heart leaves the distal end 136 of the anterograde anchor delivery sheath in the left ventricle 14, and the dilator 137 is removed, allowing delivery of the retrograde anchor 49.

As illustrated, in FIG. 18A, the sheath 109 is configured to receive the interventricular transseptal guide 111 and the sheath 117 is configured to receive the interatrial transseptal guide 118. Since the sheath 109 communicates fluidly with the interventricular septal guide 111 and the sheath 117 communicates fluidly with the interatrial transseptal guide 118, fluids such as heparinized physiological saline are in interventricular transluminal through the sheath 109. It surrounds the septal guide 111 and also surrounds the interatrial transseptal guide 118 through the sheath 117.

As shown in Method 18A of Creating Wire Rails, the J-shaped wire 116 is introduced via the sheath 109 and guided intravascularly into the right ventricle 18 by the user. Beyond the J-shaped wire 116, the interventricular transseptal guide 111 is advanced into the sheath 109 and guided intravascularly into the right ventricle 18 by the user. Upon entering the right ventricle 18, the J-shaped wire 116 is removed and the guide tip 114 is a proximal handle of the interventricular septal guide 111 until the guide tip 114 is adjacent to the right ventricular surface 17 of the interventricular septum 20. It is deflected by the deflection knob 113 of 112.

As shown in 18A, a J-shaped wire (not shown) is introduced via the sheath 117 and guided intravascularly into the right atrium 19 by the user. Beyond this J-shaped wire, the interatrial transseptal guide 118 is guided intravascularly by the user until it enters the right atrium 19 using a dilator 122 that projects outward from the distal tip 120 of the guide. The J-shaped wire is then removed and the transseptal needle 121 is advanced through the proximal hub 119 of the interatrial transseptal guide 118 until the needle approaches the end of the dilator 122. The proximal hub 119 of the interatrial septal guide 118 is then withdrawn and rotated until the dilator 122 projecting outward from the distal tip 120 is pressed against the atrial septum 21. Under fluoroscopy and echocardiography, the transseptal needle 121 is advanced across the atrial septum 21 into the left atrium 11, and then the dilator 122 and distal tip of the interatrial septal guide 118. 120 is advanced. When the distal tip 120 enters the left atrium 11, both the dilator 122 and the transseptal needle 121 are withdrawn from the proximal hub 119 of the interatrial transseptal guide 118.

As shown in FIG. 18B, the snare sheath 123 is introduced into the proximal hub 119 of the interatrial transseptal guide 118 and from the left atrium 11 until the snare sheath 123 exits the distal tip 120 of the guide 118. Advance into the left ventricle 14. The snare 124 is advanced into the left ventricle 14 via the snare sheath 123 until the snare 124 is adjacent to the left ventricular surface 16 of the interventricular septum 20.

As shown in FIG. 19A, the high frequency wire 127 connected to the high frequency generator 126 or an electrocautery system (not shown) is interventricular until the wire 127 exits the distal end 114 of the interventricular septal guide 111. It is advanced through the proximal handle 112 of the transseptal guide 111, crosses the interventricular septum 20 and enters the left ventricle 14, and then the wire 127 is captured by the snare 124. As shown in FIG. 19B, the snare 124 pulls the wire into the 127 interatrial transseptal guide 118 until the wire exits the proximal hub 119 of the guide 118. The microcatheter 128 is then advanced across the ventricular septum 120 and beyond the wire 127 beyond the portion of the wire 127 extending from the proximal handle 112 of the interventricular septal guide 111. FIG. 19C shows an enlarged view of the microcatheter 128 in which the distal dilator 129 is advancing across the wire 127 and across the interventricular septum 20.

As shown in FIG. 20A, the microcatheter 128 is advanced beyond the wire 127 until it enters the distal tip 120 of the interatrial transseptal guide 118. Once the microcatheter 128 has entered the interatrial transseptal guide 118 for more than a few centimeters, the wire 127 is removed by pulling out the proximal hub 119 of the interatrial transseptal guide 118. As shown in FIG. 20B, the larger and more rigid J-shaped wire 64 exits the microcatheter 128, where the J-shaped wire 64 is positioned inside the interatrial transseptal guide 118, and finally the guide 118. It is advanced through the interventricular transseptal guide 111 via the microcatheter 128 until exiting the proximal hub 119.

When the retrograde anchor sheath 131 is positioned in the right ventricle 18 adjacent to the right ventricle surface 17 as described in the retrograde anchor implantation method [0018] and shown in FIGS. 21A and 21B. The retrograde anchor 22 is adjacent to the wire 64 through the retrograde anchor sheath 131 and is positioned at the distal tip 132.

As shown in FIG. 22A, the distal tip 132 of the retrograde anchor sheath 131 is first retracted until it enters the left ventricle 14 adjacent to the left ventricle surface 16. As the distal tip 132 retracts, the self-expanding right ventricular disc 23 of the retrograde anchor 22 unfolds and abuts on the right ventricular surface 17 of the interventricular septum 20, exposing the septal connector 24 at the interventricular septum 20. do. As shown in FIG. 22B, as the distal tip 132 is further retracted, the self-expanding left ventricular disc 26 unfolds and abuts on the left ventricular surface 16 of the interventricular septum 20. The retrograde anchor sheath 131 is then removed from the proximal hub 119 of the interatrial septal guide 118, and the J-shaped wire 64 is removed by pulling from the proximal handle 112 of the interventricular septal guide 111. To.

As shown in FIG. 23, the interatrial transseptal guide 118 is via the transfemoral sheath 117 with the retrograde anchor 22 in place and still connected to the flexible wire 33 of the delivery cable 32. It is pulled out of the body.

Prograde Anchor Implantation Method As described in FIG. 24A and FIG. 24B, the antegrade anchor sheath 134 is positioned in the left ventricle 14 adjacent to the left ventricle surface 16. The antegrade anchor 49 is advanced past the wire 64 through the antegrade anchor sheath 134 and is positioned at the distal tip 136.

As shown in FIG. 25A, the distal tip 136 is first retracted until it enters the right ventricle 18 adjacent to the right ventricle surface 17. As the distal tip 136 retracts, the self-expanding left ventricular disc 57 of the anterograde anchor 49 unfolds and abuts on the left ventricular surface 16 of the interventricular septum 20, with the septal connector 56 at the interventricular septum 20. Be exposed. As shown in FIG. 25B, as the distal tip 136 is further retracted, the self-expandable right ventricular disc 54 unfolds and abuts on the right ventricular surface 17 of the interventricular septum 20. The antegrade anchor sheath 134 is then removed from the proximal handle 112 of the interventricular septal guide 111.

As shown in FIGS. 26A-26B, the loosening of the delivery cable 46 separates its distal threaded end 48 from the delivery connector 51 and removes the flexible wire 47 of the delivery cable 46. Will be possible. As shown in FIG. 26C, the interatrial transseptal guide 118 is pulled out of the body through the transfemoral sheath 117 with the anterograde anchor 49 in place and the wire 64 passing through. There is.

Transcatheter valve As shown in FIGS. 10A, 10B, 11A, 11B, the system 10 has an atrial sealing skirt upper edge 67 extending circumferentially along the upper end of the transcatheter heart valve 66. It comprises a transcatheter heart valve 66. The transcatheter heart valve 66 comprises a transcatheter valve body 68, which is shown to be substantially cylindrical, and, as shown, an atrial encapsulation skirt upper edge 67 configured to conform in shape to the left atrial bed 12. include. The transcatheter heart valve 66 is coupled to the retrograde anchor 22 or the anterograde anchor 49 by the tether 36 as described herein. The cord 37 is fused or otherwise coupled to the tether rod 38 of the tether 36, and when the anchor 22 or 49 is anchored to the interventricular septum 20, the transcatheter heart valve 66 is attached to the anchor 22 or 49. Connecting.

The transcatheter heart valve 66 is sized and configured to fit the mitral valve between the left atrium 11 and the left ventricle 14, as shown in FIG. The transcatheter heart valve 66 is preassembled with the leaflet 77 (FIGS. 11A, 11B). This is an example. Thus, thereby, these devices, systems, and methods, including slight variations, include any internal jugular vein, any subclavian vein, any subclavian vein, or any femoral vein. It may be placed within the blood vessel by a venous structure including, but not limited to, venous structures.

The transcatheter heart valve 66 is self-expandable (ie, the valve is compressible to fit through the catheter of System 1) and is composed of nitinol, but stainless steel, nitinol, or other. Elements made of alloys but not limited to them may also be accommodated. In another aspect, the transcatheter heart valve has a smaller diameter than or approximately equal to the annulus at the site deployment 13 of the mitral annulus, thereby reducing the restraint of the mitral annulus.

As shown in FIGS. 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 atrial sealing skirt upper edge 67, the transcatheter heart valve 156 is connected to the bottom of the transcatheter valve body 68 instead of the apex like the transcatheter heart valve 66. Has a heart valve sealing skirt lower edge 157. The inferior edge 157 of the atrioventricular sealing skirt conforms to the atrium bed 12, and the transcatheter valve body 68 of the transcatheter heart valve 157 extends into the left atrium 11 thereby interacting with the natural mitral valve leaflet. Is minimized and the risk of LVOT obstruction is further reduced.

As shown in FIGS. 10A and 10B, FIGS. 11A and 11B, and FIGS. 31A and 31B, at least one conduit 74 is defined within the transcatheter heart valve 66 or 156. For each conduit, a portion of the cord 37 (attached to the suture 148 at the proximal end) extends through the conduit 74, thereby connecting the tether 36 to the transcatheter heart valve 66 or 156 and the valve 66 or The size and shape are determined so that the 156 can move freely until it is locked in place. In a further aspect, the transcatheter valve 66 or 156 has a anchoring element (not shown) positioned along its outer diameter. These anchoring elements allow fixation to the mitral annulus and / or leaflet, but may not necessarily be used as the primary fixation mechanism.

At least one cord 37 is attached to the tether rod 38 of the tether 36 and the proximal portion of the cord 37 is attached to the suture 148. In one aspect, the cord may be a strong but flexible cord, such as, but not limited to, stretched polytetrafluoroethylene (ePTFE) or ultra high molecular weight polyethylene (UHMWPE, UHMW) cords. Upon use, the central portion of the cord 37 (between the distal and proximal ends) extends through and / or is coupled to the transcatheter valve 66 or 156, as will be further fully described below. And hold the skirt in the desired position with respect to the mitral valve annulus.

11A and 11B also show the transcatheter valve 66. The transcatheter valve 66 has a valve apex 77 extending radially medially from the transcatheter valve body 68. The valve leaflet 77 is composed of a bovine, horse, or porcine pericardial leaflet. Similar to the function of any conventional valve, the leaflet 77 sutured inside the transcatheter valve body 68 opens during the diastolic phase (relaxation of the heart) and blood flows from the left atrium 11 into the left ventricle 14. It allows entry and closes during the contractile phase (contraction of the heart) to prevent blood from flowing back from the right or left ventricle into the right or left ventricle, respectively.

As shown in FIGS. 10A and 10B, FIGS. 11A and 11B, and FIGS. 31A and 31B, the transcatheter heart valve 66 or 156 is a transcatheter valve body 68 and an atrial sealing skirt upper edge 67 or atrial sealing. Defined by the lower edge of the skirt 157 and comprising a membranous material, the upper or lower edge 67 of the atrioventricular sealing skirt has a larger diameter than the annulus at the unfolded site. For example, the upper edge 67 or lower edge 157 of the atrioventricular sealing skirt may have a diameter larger than the diameter of the mitral valve annulus. In another aspect, the transcatheter heart valve is synthesized from the group consisting of polycarbonate, polyurethane, polyester, stretched polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubber, or a combination thereof. Formed by, but not limited to, materials. Transcatheter heart valves 66 or 156 may also be coated with adult or juvenile bovine, sheep, horse, or porcine pericardium. Optionally, at least a portion of the upper edge 67 or lower edge 157 of the atrioventricular sealing skirt may be formed from an alternative material, such as, but not limited to, polyurethane foam or other polymer.

In another aspect, at least a portion of the transcatheter heart valve 66 or 156 has one or more anchoring members (not shown) along its length of the left atrial bed and / or the mitral annulus. Instability of the prosthesis (eg, by preventing transcatheter heart valve 66 or 156 from moving into the proximal left atrium 11 by allowing further fixation to other parts of the atrial side. Sway) and prevent backflow around the valve.

The transcatheter heart valve 66 or 156 comprises at least a transcatheter valve body 68 and an atrial sealing skirt upper edge 67 or lower edge 157. As shown, the transcatheter valve body 68 is cylindrical and has a variable length and diameter. Although selectively composed of laser-cut or molded nitinol, elements of any other alloy may also be accommodated, along the circumferential direction or along any portion of length, the biological membrane or the synthesis described above. It may be coated with any of the materials. As shown, the upper edge 67 or lower edge 157 extends radially outward and downward from the transcatheter valve body 68, with a substantially concave upper surface facing the left atrial bed 11. Form an edge. The upper edge 67 or the lower edge 157 extends circumferentially around the upper end of the transcatheter valve body 68 in the case of the transcatheter heart valve 66, and extends in the circumferential direction in the case of the transcatheter heart valve 156, and in the case of the transcatheter heart valve 156, the transcatheter valve body 68. It extends in the circumferential direction around the lower end.

At least one or more flexible extension members 69 as illustrated are provided, for example, a laser cut or molded nitinol attached to the top of the skirt body by the extension member base 71 and terminated at the extension member tip 72. It may consist of, but is not limited to. Between one or more extension members 69, an elastic sealing film 73 extends perpendicular to the adjacent extension member 69. As shown in FIGS. 10A and 10B, the extension member 69 may extend radially outward and substantially linearly, which is exemplary. As shown in FIGS. 11A, 11B, 31A, and 31B, the extension member may be non-linear and approximately U-shaped. As shown, the sealing film 73 extends circumferentially around the upper edge 67 or the lower edge 157. It may extend to only a part of the circumference. The transcatheter valve body 68 includes a plurality of supports 78, such as, but not limited to, the extension member 69 of the upper edge 67 or the lower edge 157, which may be composed of, for example, laser cut or molded nitinol. .. As shown, the support 78 forms a grid configuration, but other configurations are conceivable that include, but are not limited to, vertically extending supports.

The sealing member 73 is composed of either a biological tissue or a synthetic fabric as described above. In one aspect, the synthetic fabric is either a woven or knitted fabric that allows for the "stretchability" needed to fit the topography of the atrioventricular bed. In FIGS. 10A and 10B, FIGS. 31A and 31B, the extension member 69 is attached to the transcatheter valve body 68 via the extension member base 71, and the extension member tip 72 bends downwards thereby around the mitral valve annulus. Prevent backflow. This configuration is attached to one or more conduits 74 and integrated into one or more separable locks 83 inside the atrioventricular end of the conduit 74 as described herein (FIGS. 14A-. 14B, 15A-15B, 16A-16B) requires a downward force to be applied via one or more atrial positioning rods 147 locked in place.

30A-30D show the arrangement of valves that replace the natural mitral valve. 30A and 30B show a valve with an atrial sealing skirt upper edge 67, and FIGS. 30C and 30D show a valve with an atrial sealing skirt lower edge 157. The mitral valve with the lower sealing skirt 157 is positioned above the atrioventricular bed 12 shown in these figures. When used with the tether described above, this valve prevents substantial vertical or floating movement of the valve.

Tether and Transcatheter Valve Delivery Assembly According to the method described above, the retrograde anchor 22 or anterograde anchor 49 is introduced by the retrograde anchor delivery sheath 131 or the anterograde anchor delivery sheath 134 and fixed to the interventricular septum 20. Will be done. Anchor cap 27 or 58, and either delivery cable 33 (for retrograde anchors) or wire rail 64 (for forward anchors) remain in the heart and are ready to accept the tether 36 described above. be.

Next, with reference to FIGS. 27A and 27B, and as described above, the tether 36 passes through the transcatheter heart valve delivery system illustrated in the form of the delivery guide 141 to the wire rail 64 of the delivery cable 32 (not shown). Alternatively, it is advanced beyond the delivery wire 33. The tether 36 engages the anchor cap 27 or 58 by coupling the docking ring 43 to the anchor cap 27 or 58. At least one tether rod 38 is coupled with at least one cord 37 extending from the tether rod 38. The at least one cord 37 is proximally connected to at least one suture 148 extending extracorporeally through the central lumen 151 of the delivery guide 141. When the tether is locked to the anchor cap 27 or 58, the guide 141 is as shown in FIG. 27B, leaving the anchor 22 or 49, the tether 36, the cord 37, and the suture extending from the implantation site. Be retreated. As shown in FIGS. 27A-27B and 28A-28B, the same guide 141 delivers both the tether 36 and the transcatheter heart valve 66 or 156.

Next, with reference to FIGS. 27A-27B and 28A-28B, a transcatheter heart valve delivery system 139 is shown that positions and deploys the transcatheter heart valve 66 or 156 at the desired deployment site 13. The transcatheter valve delivery system 139 includes a transcatheter valve delivery guide 141, a nose cone 146, a transcatheter valve deployment knob 142, and at least one atrial positioning rod 147. The transcatheter valve delivery guide 141 has a distal end 144, an opposing proximal valve deployment knob 142, and an inner guide lumen 143 extending between them. The medial guide lumen 143 is sized and configured for the transcatheter valve 66 or 156 and other system components to be selectively and removablely inserted. Since at least a portion of the transcatheter valve delivery guide 141 is flexible, the distal end 144 of the transcatheter valve guide 141 is positioned beyond the deployment site 13 into the left ventricle 14.

The transcatheter valve deployment knob 142 is coupled to the proximal end of the transcatheter valve delivery guide 141. The transcatheter valve deployment knob 142 defines a central channel 151 that communicates fluidly with the medial guide lumen 143. Therefore, the atrial positioning rod 147, the guide wire 64, and / or at least one suture 148 may extend through the central channel 151 into the medial guide lumen 143. As shown, the transcatheter deployment knob 142 is rotatable and by rotating the knob 142 in the first direction, the distal tip of the transcatheter valve delivery guide 141 around the transcatheter valve 66 or 156. The 144 is configured to retract so that the transcatheter valve 66 or 156 can be expanded. The nose cone 146 may be any conventional nose cone coupled to the transcatheter valve delivery guide 141 and configured to guide the transcatheter valve 66 or 156 to the deployment site 13.

Locking System With reference to FIGS. 27A-27B, 28B-28C, and 29A, at least one atrial positioning rod 147 extends between the distal end 153 and the proximal end 150. It has an inner rod lumen 149 and is configured to be sized so that a portion of suture 148 and / or cord 37 is inserted through it. Since at least a portion of the atrial positioning rod 147 is flexible, the distal end 153 of the atrial positioning rod may be positioned at or adjacent to the deployment site 13.

At least one positioning rod 147 is coupled to the conduit 74. As shown in FIGS. 13A and 13B, each conduit 74 houses a separable lock 83 configured to securely attach at least one cord 37. Thus, the cord 37 is securely attached to the tether rod 38 of the tether 36, coupled to the anchor cap 27 or 58, via the ventricular disc or septal connector of either the retrograde anchor 22 or the anterograde anchor 49. The lock 83, which is fixed to the interventricular septum 20 and is separable, firmly attaches, for example, the cord 37 in the left atrium.

With reference to FIGS. 13A, 13B, 14A, 14B, 15A, 15B, 16A, and 16B, the locking system 82 includes a separable lock 83 and a first gateway hypotube 84 and It consists of an integrated internal conduit 74 attached to a second retracting hypotube 86. Inside the separable lock 83 is a locking clip 87. With reference to FIG. 30A, the system 10 is sized and configured to cut at least one suture 148 through the delivery sheath 117 (as shown in FIG. 30B). Further prepare.

Methods of Embedding, Positioning and Locking the Atrioventricular Skirt When used, the system 10 utilizes a transcatheter approach by placing an interventricular anchor 22 or 49 and docking the tether 36 to the anchor 22 or 49. The transcatheter heart valve 66 or 156 is implanted. As shown in FIG. 27A, the transcatheter valve system 139 is inserted beyond either the wire 64 or the flexible wire 33 of the delivery cable 32 into a portion of the heart 9. Since the transcatheter valve delivery guide 141 is inserted into the heart with the transcatheter valve 66 or 156 preloaded at the distal end 144, at least a portion of the suture 148 is also preloaded into at least one conduit 74. As the transcatheter valve delivery guide 141 advances, at least a portion of the suture 148 and cord 37 is proximal to and beyond the medial guide lumen 143 of the transcatheter valve delivery guide 141. It extends to the side. Thus, a portion of at least one cord 37 extends past the distal end 144 of the transcatheter valve delivery guide 141 and a portion of at least one suture 148 extends through the transcatheter valve delivery guide 141. It goes through and extends beyond it. The transcatheter valve delivery guide 141 passes through the deployment site 13 with the distal end 144 of the transcatheter valve delivery guide 141 preloaded with the transcatheter valve 66 or 156 into the distal end 144 and the left ventricle 14 Positioned to enter.

The transcatheter valve 66 or 156 is preloaded at the distal end 144 of the transcatheter valve delivery guide 141 for positioning at the deployment site 13. As shown, the sutures 148 are such that each suture 148 is threaded through at least one conduit 74 of the transcatheter valve 66 or 156, as shown in FIGS. 11A-11B and 31A-31B. And pre-assembled with the transcatheter valve 66 or 156. As the distal end 144 of the transcatheter valve 66 or 156 and the transcatheter valve delivery guide 141 advances as a unit and approaches the deployment site, the end of suture 148 and a portion of the cord 37 become the transcatheter valve 66 or It is passed through a conduit 74 defined in 156. Therefore, the transcatheter valve 66 or 156 can be moved along the length of at least one cord before reaching the desired deployment site 13. That is, the transcatheter valve is free to float on the cord 37 until it is locked in place by the separable lock 83.

When the transcatheter valve 66 or 156 arrives at the desired deployment site 13, the transcatheter valve deployment knob 142 is utilized to withdraw the delivery guide 141 at least partially around the transcatheter valve 66 or 156. Since the guide 141 does not have a transcatheter valve 66 or 156, the valve 66 or 156 expands to its full unconstrained size. Optionally, the position of the transcatheter valve is adjustable so that the transcatheter valve deployment knob 142 can be used to fold the transcatheter valve 66 or 156 to allow repositioning to the desired deployment site.

The atrial positioning rod 147 preloaded in the transcatheter delivery guide 141 is then advanced beyond each suture 148 so that a portion of each suture extends within the medial rod lumen 149 and each suture. A portion of the locating rod 147 extends beyond the proximal end 150 of the positioning rod 147. Referring to FIGS. 28B and 29A, the positioning rod 147 is then advanced through the transcatheter valve guide 141 and a portion of the cord 37 is received by the inner rod lumen 149 of the rod 147 (separable lock 83 is provided). The distal end 153 of the positioning rod (attached) is adjacent to the transcatheter valve 66 or 156. The positioning rod 147 is pushed down by the user until the sealing skirt is in the desired position with respect to the mitral valve annulus.

Transcatheter valve 66 or 156 on tether 36 until the desired valve 66 or 156 position is achieved. After the desired valve position is achieved, at least one atrial positioning rod 147 pushes the transcatheter valve 66 or 156 into place and locks in place via a separable lock 83 housed in each conduit 74. And connected to the end of each positioning rod 147. The transcatheter valve 66 or 156 may be repositioned or recovered until the suture 148 extending through each atria positioning rod 147 is released.

As shown in FIG. 28B, the transcatheter valve 66 or 156 in the left atrium 11 such that the upper edge 67 of the transcatheter valve 66 or the lower edge 157 of the transcatheter valve 156 fits the topography of the left atrium bed 12. Positioning is shown. Through the transcatheter valve delivery system end 144, the practitioner has one or more transcatheter valves 66 or 156 extending through one or more conduits 74 defined by the transcatheter valve body 68. One or more atrial positioning rods 147 are advanced so as to translate beyond the plurality of cords 37. As shown in FIG. 28B, when the transcatheter upper edge 67 or lower edge 157 comes into contact with the atrioventricular bed 12, one or more extension members 69 flex differently according to the local anatomy. .. Since each atrial positioning rod 147 is pushed with a different force, an accurate amount of tension can be achieved, and therefore the more or less flexion of the extension member 69 causes the transcatheter valve upper edge 67 or lower edge 157 to become the atrioventricular bed 12 Shape-fitting around the entire circumference of the mitral valve makes it easier to limit regurgitation through the orifice of the mitral valve.

FIG. 12 shows the conversion of the transcatheter valve upper edge 67 from concave to convex (the same shape change can occur at the lower edge 157). When the valve is pushed down to the atrioventricular bed 12 by the atrial positioning rod 147 attached to the extension member base 71 of the extension member 69, the extension member tip 72 bends upward and the anatomy of the convex atrioventricular bed. Fits the shape. Further distal movement of the transcatheter valve 66 (shown from left to right in FIG. 12) or further distal movement of the transcatheter valve 156 (not shown) results in the shape of the upper edge 67 or lower edge 157. It is further modified when it conforms to the shape of the atrioventricular bed and when the extension member base 71 is pushed downward by the atrial positioning rod 147 (FIG. 28B).

Next, referring to FIGS. 15A and 15B, pulling the retracting hypotube 86 retracts the locking clip 87, thereby pushing down the locking tab 88 and the engaging cord 37. More specifically, the second hypotube 86 is retracted, and by connecting it to the locking clip 87, the locking clip 87 is also retracted. When retracting, the locking clip 87 contacts the contact point 89 of the first gateway hypotube 84 to separate the clip 87, so that the second hypotube 86 can be removed. When the retracting hypotube 86 is pulled, the inner arm of the gateway hypotube 84 bends inward, allowing the gateway hypotube to be removed. The first gateway hypotube 84 is useful because it allows the cord 37 to be locked while retracting the second hypotube 86. The gateway hypotube 84 is then removed, leaving the clip 87 in the conduit 74 of the transcatheter valve 66 or 156. FIG. 16A shows a cutaway drawing of a fully engaged lock. According to one aspect, the positioning rod 147 may be integrated with or detachably connected to the gateway hypotube. FIG. 16B shows a complete view of a fully engaged lock.

As shown in FIG. 30A, the transcatheter valve is tightly conformed to the atrium bed 12 and the suture cutter 154 is advanced beyond the suture 148 to the transcatheter valve upper edge 67. The suture cutter 154 cuts and releases the distal end of each suture 148 above the separable lock 83. The suture 148 and the suture cutter 154 are then removed from the heart 9.

In one aspect, the transcatheter valve 66 or 156 may be recovered or repositioned prior to cutting the suture 148. For example, if it is determined that the transcatheter valve should be removed or repositioned, the atrial positioning rod 147 is positioned on each suture so that a portion of the suture is within the medial rod lumen 149. Ru. When the distal end 153 of the positioning rod is adjacent to or in contact with the separable lock 83, the separable lock is placed at the distal end of the positioning rod by advancing the gateway hypotube 84 and the retracting hypotube 86. Attached to, thereby unlocking the cord 37. Once the cords are unlocked, the valve may be removed from the deployment site 13 and / or repositioned at the deployment site 13.

In another embodiment, the transcatheter valve 66 or 156 is repositioned and / or removed within days to weeks after valve deployment. In this aspect, the suture is not cut and is wound around a spool or other winding device. The device is then attached to the transcatheter valve upper edge 67 of the valve 66 or to the transcatheter valve body 68 of the valve 156. Within days of deploying the valve and completing the procedure, the spool / winding device may be recaptured to allow suture unwinding and recovery. The atrial positioning rod 147 is then positioned beyond each suture so that a portion of the suture is within the medial rod lumen 149. When the distal end 153 of the positioning rod is adjacent to or in contact with the separable lock 83, the separable lock is placed at the distal end of the positioning rod by advancing the gateway hypotube 84 and the retracting hypotube 86. Attached to, thereby unlocking the cord 37. When each cord is unlocked, the valve is removed from the deployment site 13 and / or repositioned at the deployment site 13.

Although some aspects of the invention have been disclosed herein above, many modifications and other aspects of the invention to which the invention relates will benefit from the teachings presented in the above specification and related drawings. Is understood by those skilled in the art. Therefore, it is understood that the present invention is not limited to the specific aspects disclosed above, and many modifications and other aspects are included in the appended claims. Furthermore, although certain terms are used herein and in the claims below, they are used merely in a general and descriptive sense, limiting the invention described. Not intended.

Claims (29)

An anchor assembly that implants an anchor into the interventricular septum of the heart to minimally invasively fix the mitral valve and replace the natural mitral valve.
Introduced intravascularly, configured and sized to adhere to the fixation site of the interventricular septum, and extending between the left ventricular disc, the right ventricular disc, and the left ventricular disc and the right ventricular disc. Anchor caps extending proximally from the interventricular septum are provided, the septal connector is sized and configured to extend through the interventricular septum, and the left ventricular disc and the right ventricular disc are said. With the anchor positioned on the opposite side of the interventricular septum,
It comprises a delivery cable having a distal end portion defined by a first surface configuration, having a second configuration such that the anchor meshes with a first surface configuration of the distal end portion of the delivery cable. Anchor delivery system with meshing part,
It comprises a docking ring and at least one tether rod connected to the docking ring, defining a central aperture configured such that the docking ring is positioned on the anchor cap. Anchor assembly with a tether assembly. The second configuration is defined by the proximal end of the anchor cap, defining a threaded cavity and engaging and engaging the threaded cavity of the anchor cap to position the anchor cap. The anchor assembly according to claim 1, wherein the distal end portion of the delivery wire is screwed. The anchor further comprises a delivery cable connector extending distally from the right ventricular disc so that the delivery cable connector defines a threaded cavity and meshes and engages the threaded cavity of the connector. The anchor assembly according to claim 1, wherein the first surface of the delivery cable defines a threaded distal end. The delivery cable defines a longitudinally extending lumen, the anchor cap defines a longitudinally extending lumen, and the septal connector defines a longitudinally extending lumen. The delivery cable connector defines a longitudinally extending lumen, through which the anchor delivery system passes through the anchor cap, the septal connector, the delivery cable connector, and the lumen of the delivery cable. The anchor assembly according to claim 3, further comprising an extension of the delivery wire. The anchor assembly according to claim 1, wherein the anchor cap comprises at least one locking member extending radially outward from the anchor cap. The at least one locking member has a first locking position where the at least one locking member extends a first distance from the outer surface of the anchor cap, and the at least one locking member is said. The anchor assembly according to claim 5, wherein the anchor assembly moves from the outer surface to a second position extending a second distance and the first distance is longer than the second distance. When the tether docking ring is positioned on the at least one locking member, the at least one locking member is pushed from the first locking position to the second locking position, said. When the docking ring is positioned distal to the at least one locking arm on the anchor cap, the at least one locking member engages the docking ring at the first locking position. The anchor assembly according to claim 6. The anchor assembly of claim 1, wherein the first and second ventricular discs are made of a material selected so that the discs can be placed in and out of the sheath. A second configuration of the anchor engagement portion is defined by the anchor cap, the anchor assembly further comprising an anchor shaft and at least one locking member on the anchor shaft, and the distal end of the delivery cable. The anchor assembly according to claim 1, wherein the portion is an anchor connector configured to engage the anchor shaft in a removable manner. The at least one locking member is urged outward from the anchor shaft, the anchor connector defines a distal cavity, and a proximal portion of the anchor shaft is selectively housed within the cavity. The anchor assembly according to claim 9, which connects the anchor and the anchor delivery system. 10. The anchor assembly of claim 10, wherein the anchor base defines at least one anchor flange, and the anchor connector defines at least one aperture configured to accept the anchor flange. Configured to accept the valve, introduce it intravascularly, implant it in the deployment site, and be configured and sized to replace the natural heart valve, substantially in the atrial bed adjacent to the deployment site of the atrioventricular skirt. An atrio-sealing skirt that is shape-fitting and configured to substantially rest on the atrioventricular bed.
The atrium skirt body, which is almost cylindrical and defines the valve receptacle,
With the lower edge of the atrial skirt, which is compressible when restrained and expands when released from the restraint, extends circumferentially around the lower edge of the atrial skirt body.
With at least one conduit having an open top end defined by the aperture of the skirt body,
An at least one extension member that supports the skirt edge and has a base end adjacent to the lower edge of the skirt body that extends substantially outward to the outer edge of the skirt edge.
At least one body support that supports the skirt body,
An atrial encapsulating skirt comprising the at least one extension member and a membrane covering the at least one body support to form the skirt edge and body. 12. The atrial-sealing skirt according to claim 12, wherein the atrio-sealing skirt body is configured to define a valve receptacle and receive a valve. 12. The atrial encapsulation skirt according to claim 12, wherein the at least one duct is configured to receive a locking system that engages the atrial encapsulation skirt positioned on the atrioventricular bed. 14. The atrial encapsulation skirt of claim 14, wherein the locking system comprises a separable lock positioned within the conduit that locks the inferior edge to the atrioventricular bed. The atrial sealing skirt according to claim 12, wherein the atrial skirt edge is substantially convex before conforming to the shape of the atrial bed. An anchor assembly that anchors the mitral valve to the interventricular septum of the heart in order to implant the mitral valve in a minimally invasive manner to replace the natural mitral valve.
Anchor base extending from the proximal end of the anchor screw, a flexible connector extending from the proximal end of the anchor base, and the anchor base extending from the proximal end of the anchor screw comprising an anchor screw configured to be embedded in the interventricular septum. Anchor, with an anchor axis extending proximally from
A connector rod having a distal end configured to work with the anchor base and selectively connect to the anchor base, and an anchor connector defining a channel to receive the connector rod. An anchor assembly comprising an anchor delivery system in which the anchor connector is configured to accept the anchor axis. 17. Anchor assembly. 17. The anchor assembly of claim 17, further comprising at least one stabilizer extending radially outward from the anchor base adjacent to the anchor screw. 19. The anchor assembly of claim 19, wherein the at least one stabilizer is non-linear. 19. The anchor assembly of claim 19, wherein the at least one stabilizer extends radially outward at an acute angle with respect to the horizontal axis of the anchor base. The distal end of the connector rod defines a channel having a first surface configuration and the anchor shaft having a second surface construction, and the first and surface configurations engage and engage with the connector rod. 17. The anchor assembly according to claim 17, wherein the anchor assembly is connected to the anchor shaft. 22. The anchor assembly of claim 22, wherein the connector rod is removable from the anchor shaft. Further comprising a tether assembly including a docking ring and at least one tether rod, the docking ring is configured to accept the anchor connector, and the at least one tether rod is close to the docking ring. The anchor assembly according to claim 18, which extends in the direction of the position. The at least one locking member has a first locking position where the at least one locking member extends a first distance from the outer surface of the anchor cap, and the at least one locking member is said. 24. The anchor assembly of claim 24, wherein the anchor assembly travels from an outer surface to and from a second position extending a second distance, wherein the first distance is longer than the second distance. When the tether docking ring is positioned on the at least one locking member, the at least one locking member is pushed from the first locking position to the second locking position, said. When the docking ring is positioned distal to the at least one locking arm on the anchor cap, the at least one locking member engages the docking ring at the first locking position. 25. The anchor assembly according to claim 25. A method of implanting an anchor in the interventricular septum of the heart to replace the natural mitral valve with a minimally invasive fixation of the mitral valve.
An anchor assembly comprising an anchor distal end configured to be implanted in the interventricular septum at the implantation site, wherein the anchor extends from the proximal end of the anchor distal end and the anchor base. A step of providing an anchor assembly comprising a flexible connector flexibly connected to its proximal end and an anchor shaft extending proximally from the flexible connector.
A step of connecting an anchor delivery system, including a connector rod and an anchor connector, to the anchor assembly by positioning the anchor connector onto the anchor base.
The step of locking the anchor connector to the anchor base,
A step of advancing the anchor assembly over a guide wire adjacent to the interventricular septum, wherein the distal end of the anchor penetrates the interventricular septum at the implantation site and exits from the opposite side. Embedding the ends, steps and
A step of advancing a tethered docking system, including a docking ring and at least one tethered arm, from the docking ring over the anchor connector.
A method comprising removing the connector rod. 27. The method of claim 27, wherein the distal end of the anchor is an anchor screw, wherein the step of advancing the anchor assembly and penetrating the interventricular septum comprises rotating the anchor screw. The anchor assembly further comprises at least one stabilizer extending radially outward from the anchor base, and the step of implanting the anchor distal end uses the at least one stabilizer to provide the anchor distal end. 27. The method of claim 27, comprising the step of stabilizing.

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