JP2022132510A - Transcatheter anchoring assembly for mitral valve, mitral valve, and related methods - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a transcatheter anchoring assembly for a mitral valve, a mitral valve, and related methods.

SOLUTION: The invention provides a medical assembly for implanting a transcatheter heart valve in the heart at a valve deployment site, and related methods of implantation and delivery. An anchor is endovascularly introduced into the heart and implanted in a cardiac wall by means of an anchor delivery system and delivery cable. A second delivery system introduces a tether which coupled to the implanted anchor and a transcatheter heart valve. The transcatheter heart valve includes a top or bottom brim which is positioned to conform to the atrial floor at the deployment site.

SELECTED DRAWING: Figure 1

COPYRIGHT: (C)2022,JPO&INPIT

Description

The present invention relates generally to medical assemblies for minimally invasive implantation of valves in the heart, novel valves for replacing natural heart valves, and anchoring devices for positioning and constraining valves. The present invention also relates to methods of implanting components of medical assemblies and valves. More particularly, the present invention is associated with novel transcatheter valves, transcatheter valve skirts, anchor devices, anchor delivery systems, and valve delivery devices, and such assemblies to replace the function of the natural mitral valve. Therefore, it relates to a method for implanting a valve across a mitral valve in a blood vessel.

Transcatheter valves have been proven safe and effective to replace natural heart valves such as the aortic and pulmonary valves. With respect to mitral valve replacement, early clinical trials of transcatheter mitral valve replacement (TMVR) had significant problems due to the clinical and anatomical complexity of mitral valve disease, thus reducing reliability. low.

Mitral valve disease, which primarily causes mitral regurgitation (MR), results from primary valve degeneration (e.g., mucomatous degeneration, endocarditis, rheumatic disease, or other causes). Alternatively, leaflet mal-coaptation (secondary or due to "functional" mitral regurgitation). MR increases left atrial pressure and causes pulmonary congestion, which leads to the signs and symptoms of congestive heart failure: peripheral edema, sedentary breathing, paroxysmal nocturnal dyspnea, and progressive dyspnea on exertion. In addition, MR exacerbates left ventricular dysfunction and reduces survival. Because many MR patients have significant comorbidities and high surgical risks, it is important to develop minimally invasive (ie, transcatheter) methods of treating MR.

Early-developed transcatheter techniques have significant limitations as they repair the mitral valve rather than replace it. For example, transcatheter annuloplasty devices (Arto (MVRx, Inc., San Mateo, CA, USA), Cardioband (Edwards Lifesciences, Irvine, CA, USA), Carillon (Cardiac Dimensions, Kirkland, WA, USA), Millipede (Boston Scientific Marlborough, Mass., USA), Mitral Loop Cerclage (Tau-PNU Medical Co. Ltd., Busan, South Korea), and Mitraalign (Mitraalign, Inc., Tewksbury, Mass., USA) directly or indirectly measure the size of the mitral annulus. mimics surgical annuloplasty by reducing the size and allowing the mitral leaflets to more fully coapt.In any event, these techniques are subject to uncertain reproducibility , and is limited by the inability to address leaflet tethering or abnormalities.Conversely, the MitraClip repair system (Abbott Vascular, Abbott Park, Ill., USA) or the Pascal system (Edwards Lifesciences) stitch the leaflets together. The MitraClip system is FDA approved and effective in many patients, but a significant number of patients (>10 %) have relapsed MR after MitraClip, and many patients are unable to undergo MitraClip due to anatomical limitations. St. Louis Park, State), Harpoon TSD-5 and V-chordal (Edwards Lifesciences)) are currently limited to very specific anatomy (eg, single leaflet prolapse).

Transcatheter mitral valve replacement (TMVR) is not limited by anatomical limitations, and few patients relapse to MR. Current techniques still have limitations and disadvantages based on the manner in which they are anchored to the mitral valve. The Fortis valve (Edward Lifesciences) had an unacceptable thrombus formation rate when anchored to the mitral valve leaflets. Tiara valves (Neovasc, Richmond, BC, Canada) have also been successfully implanted without the same problem of thrombus formation when anchored to the native leaflets. Similarly, CardiAQ (Edwards Lifesciences), which directly engages the mitral annulus, NaviGate (Navigate Cardiac Structures, Lake Forest, Calif., USA), which uses "winglets" to perforate the annulus and leaflets, "Hourglass" The Cephea (Abbott Vascular), which engages the annulus by shape, and the Intrepid valve (Medtronic, Minneapolis, MN, USA), which engages the annulus by a "champagne-cork-like" action, have all been implanted without problems with thrombus formation. It's here.

In any event, these devices anchor directly to the mitral annulus, thus constraining the degree of freedom of mitral annulus motion to varying degrees. Constraints in this degree of freedom can contribute to left ventricular dysfunction. For example, studies comparing transcatheter mitral valve repair (using Abbott Vascular's MitraClip device) with open heart surgery have shown that mitral annular motion is significantly less with open heart surgery. , the authors propose, was a factor in the lower left ventricular ejection fraction (LVEF) after open-heart surgery compared to transcatheter repair. Similarly, studies comparing flexible mitral annuloplasty rings to rigid ones found that the rigid ring had significantly less LVEF, thereby increasing the mitral annulus motion found to be constrained. Therefore, by constraining the mitral annulus, these devices can have detrimental effects on left ventricular function.

Similarly, a TMVR device using a docking system may reduce left ventricular function by constraining mitral annulus motion. In particular, Caisson (LivaNova, PLC, London, UK), HighLife (HighLife SAS, Paris, France), MValve (Boston Scientific), and Sapien M3 (Edwards Lifesciences) valves all use docking systems for transcatheter prosthesis. Secure the organ to the mitral annulus.

In addition to constraining the mitral annulus, these devices also pose a risk of left ventricular outflow tract (LVOT) occlusion, which occurs when the valve holds the anterior mitral leaflet open, thereby Creates a fixed occlusion that drains from the LVOT. This is a specific limitation of TMVR devices in patients with small hypertrophied ventricles (more common in women) or in patients with significant mitral annulus calcification.

To alleviate these concerns and limitations, the Tendyne valve (Abbott Vascular) poses less risk of LVOT occlusion and does not constrain the mitral annulus as much as other TMVR devices. Tendyne accomplishes this by having the valve anchor attached to the epicardial tether via the chordae tendineae. Therefore, no rigid anchoring to the mitral annulus is required and the narrow intra-annular portion of this valve does not push the mitral anterior leaflet into the LVOT to the same extent as other valves. A problem with Tendyne is that it requires transapical access (left ventricular incision), 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 Therapies) is held in place by a large flexible ball cage in the left atrium It consists of a supra-annular valve that is 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. Furthermore, the continued functioning of the native mitral valve leaflets can cause blood flow impairment, thereby altering the function of the prosthetic valve leaflets.

Therefore, it can be delivered without transapical access, has minimal risk of LVOT occlusion, and does not stick to the atrial or mitral annulus, thereby allowing the atrial and mitral annulus to function normally. It remains desirable in the related art to provide a transcatheter valve placed across the mitral annulus that is fully repositionable and recoverable during the procedure.

Presented herein is a medical assembly that is minimally invasively implanted across the mitral valve to replace the function of the natural mitral valve. The methods disclosed herein involve transseptal access of the mitral valve and by implanting a valve anchor in the interventricular septum, which can be an intra-annular or supra-annular anchor. Minimize the risk of LVOT occlusion while avoiding sticking and binding. Beneficially, therefore, no part of the system requires open-chest surgery and trans-leaflet access for implantation.

In one aspect, the system comprises a transfemoral interatrial transseptal guide and a transseptal crossing needle that permits crossing of the atrial septum for delivery of a snare sheath into the left ventricle. , snare delivery into the left ventricle is performed adjacent to the interventricular septum.

The system further includes a transjugular interventricular transseptal guide and a high frequency cross wire that allows the wire to cross the interventricular septum and then snare into a snare sheath positioned within the left ventricle. Prepare. A wire is externalized through the interatrial transseptal guide and a wire loop is formed with the wire extending from the outside of the transjugular guide to the outside of the transfemoral guide. The exchange catheter is advanced over the wire loop and the high frequency wire is exchanged for a larger, stiffer wire.

In one aspect, the system includes an antegrade or retrograde anchor delivery sheath advanced over a wire loop and an antegrade or retrograde interventricular septum attached to an anchor cap configured to receive a tether. Anchor. A tether is configured to attach to one or more cords, and the tether attaches to the transcatheter valve.

According to various aspects, a ventricular septal anchor may consist of right and left ventricular discs connected by a ventricular septal element, each of which may be made of Nitinol, stainless steel, titanium, cobalt-chromium, or the like. It may be composed of any alloy, including but not limited to. Each element of the anchor is made of 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. Either may be coated.

The anchor cap is also constructed of any alloy and is bonded to the left ventricular disc of the ventricular septal anchor. With a retrograde ventricular septal anchor (delivered from the left ventricular side of the septum), the proximal end of the anchor cap has an inner "female" thread that receives the "male" distal end of the delivery cable. 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 mates with the anchor. Finally, the delivery cable may be loosened from the anchor cap and removed.

With an antegrade ventricular septal anchor (delivered from the right ventricular side of the septum), the anchor cap is the conduit for the wire loop. The right ventricular disc has a cable connector defining an inner "female" thread that receives the "male" distal end of the antegrade delivery cable. The antegrade delivery cable also serves as a conduit for the wire loop so that the wire begins outside the transfemoral sheath, passes through the anchor cap of the interventricular septal anchor, and exits the right ventricular side of the septal anchor. through a delivery cable attached to the venous sheath and exiting the transjugular sheath. A wire loop extending through the anchor cap guides the tether until the docking ring of the tether mates with the anchor. After coupling, the wire loop may be removed, the antegrade delivery cable may be loosened, the interventricular septal anchor fully deployed, and the tether 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 a tether rod that attaches to the eyelet through a hook. The tether rod is constructed of any alloy and the proximal end of the tether rod is attached to the cord. In one aspect, the docking ring of the tether is advanced over the anchor cap to depress the protruding locking arms of the anchor cap. Alternatively, the docking ring can reach the end of the anchor cap and push out the protruding locking arms, thereby locking the docking ring, and thus the tether, in place. Alternatively, even after being locked in place, the tether is free to rotate about the longitudinal axis of the anchor cap without affecting the position of the anchor cap or anchor screw. . When withdrawn, the valve delivery catheter moves back over the locking arm, thereby pushing the arm down and allowing the docking ring of the tether to retract.

In one aspect, the system comprises a tether configured to couple and/or secure the valve to the interventricular septum, the transcatheter valve comprising a body containing the leaflets integrated into the apex or inferior rim. .

In one aspect, the transcatheter valve is self-expanding, composed of Nitinol, a synthetic material such as, but not limited to, polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET), or bovine or porcine heart. Either covered by a biological membrane such as, but not limited to, surrounding tissue.

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

The frame of a transcatheter valve, in its intra-annular form, begins with a cylindrical shape, with the base of the cylinder below the level of the annulus and the top of the cylinder extending into the atrium. A top rim extends from the top of the cylinder and is composed of one or more wire extensions and is made of laser cut or shaped 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 and/or connected with a synthetic or biological membrane, like the body of the valve. The superior rim may be perpendicular to the disc or may curve toward the atrial floor as either a convex or concave curve. To facilitate sealing as the superior edge bends toward the atrial floor, the covering fabric consists of either a woven or knitted fabric that allows for "stretchability" and the ability to conform to the topography of the atrial floor. are improving.

In the supra-annular configuration of the transcatheter valve, the frame begins with the inferior border positioned on the floor of the left atrium. The lower edge is constructed 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 inferior edge is coated with and/or connected with a synthetic or biological membrane, like the body of the valve. The inferior rim may be perpendicular to the transcatheter valve body or may curve toward the atrial floor as either a convex or concave curve. To facilitate sealing as the inferior border bends toward the atrial floor, the cover fabric consists of either a woven or knitted fabric that allows for "stretch" and the ability to conform to the topography of the atrial floor. are improving. From the inferior border, a cylinder containing the leaflets extends into the left atrium.

In one aspect, it takes the shape of a cylinder whose cross-section is any portion of a circle, ellipse, parabola, or hyperbola, adjacent to the top of the cylinder of the valve, extending longitudinally along the interior or exterior of the valve body. , or a conduit or conduits that take the shape of a polyhedron with a flat base and top in the shape of a polygon with three or more sides. These conduits may be constructed of a membrane that coats the valve body, or may be made of stainless steel, nitinol, or other alloys, but are not so limited. One or more conduits are hollow and contain at least one cord attached to at least one tether, each conduit attaching to a separable lock near the atrial surface of the valve.

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

The system further comprises at least one atrial positioning rod having a proximal end attached to the delivery system and a distal end reversibly coupled to a separable lock attached to the proximal end of the transcatheter valve body. . As sutures and/or cords pass through the lumen of the positioning rod, the positioning rod either pushes or pulls on the transcatheter valve body, thereby exerting differential forces and flexions on the associated superior or inferior rims, thereby depressing the atrial floor. can be added to In another aspect, rotation of the positioning rod and/or pushing or pulling of an internal element of the positioning rod causes the separable lock to engage the cord and/or suture to transcatheter the cord and/or suture. Anchor to the valve body to maintain force and flexion of the superior or inferior rim against the atrial floor, fixing the position of the transcatheter valve.

A related method of implantation is also provided. Other apparatus, methods, systems, features, and advantages of medical devices and systems minimally invasively implanted in the heart will become apparent to one of ordinary skill in the art upon examination of the following drawings and detailed description. be. All such additional devices, methods, systems, features, and advantages are included within this specification, within the scope of the minimally invasive heart implant medical assembly, and protected by the accompanying claims. shall be
For example, the present application provides the following items.
(Item 1)
An anchor assembly for implanting an anchor in the interventricular septum of the heart to minimally invasively fixate the mitral valve to replace the native mitral valve, comprising:
a left ventricular disc, a right ventricular disc, and a medium extending between the left ventricular disc and the right ventricular disc, configured and sized for intravascular introduction and anchoring to the anchoring site of the interventricular septum; an anchor cap extending proximally from a septal connector, said septal connector being sized and configured to extend through said interventricular septum, said left ventricular disc and said right ventricular disc being connected to said ventricular septum; said anchors positioned on opposite sides of the interventricular septum;
A delivery cable having a distal end portion defined by a first surface configuration, the anchor having a second configuration for mating with the first surface configuration of the distal end portion of the delivery cable. an anchor delivery system comprising a mating portion;
a docking ring and at least one tether rod connected to the docking ring, the docking ring defining a central aperture configured to be positioned over the anchor cap; and a tether assembly.
(Item 2)
said second configuration being defined by a proximal end of said anchor cap and defining a threaded cavity, said anchor cap being positioned in mating engagement with said threaded cavity of said anchor cap; 2. The anchor assembly of item 1, wherein a distal end portion of the delivery wire is screwed.
(Item 3)
The anchor further comprises a delivery cable connector extending distally from the right ventricular disc, such that the delivery cable connector defines a threaded cavity and matingly engages the threaded cavity of the connector. 2. The anchor assembly of claim 1, wherein the first surface of the delivery cable defines a threaded distal end.
(Item 4)
said delivery cable defining a longitudinally extending lumen, said anchor cap defining a longitudinally extending lumen, said septal connector defining a longitudinally extending lumen, and The delivery cable connector defines a longitudinally extending lumen, and the anchor delivery system extends through the lumen of the anchor cap, the septal connector, the delivery cable connector, and the delivery cable. 4. The anchor assembly of item 3, further comprising a delivery wire extending through.
(Item 5)
2. The anchor assembly of claim 1, wherein said anchor cap comprises at least one locking member extending radially outwardly from said anchor cap.
(Item 6)
said at least one locking member in a first locked position in which said at least one locking member extends a first distance from an outer surface of said anchor cap; 6. The anchor assembly of item 5, moving between a second position extending a second distance from an outer surface, wherein the first distance is greater than the second distance.
(Item 7)
When the tether docking ring is positioned over the at least one locking member, urging the at least one locking member from the first locking position to the second position; The at least one locking member engages the docking ring in the first locking position when a docking ring is positioned on the anchor cap distally of the at least one locking arm. 7. An anchor assembly according to item 6, wherein the anchor assembly is
(Item 8)
2. The anchor assembly of item 1, wherein the first and second ventricular discs are formed of a material selected to allow the discs to enter and exit the sheath.
(Item 9)
a second configuration of the anchor mating portion defined by the anchor cap, the anchor assembly further comprising an anchor shaft and at least one locking member on the anchor shaft; 2. The anchor assembly of item 1, wherein the portion is an anchor connector configured to removably mate with the anchor shaft.
(Item 10)
said at least one locking member is biased outwardly from said anchor shaft, said anchor connector defines a distal cavity, and a proximal portion of said anchor shaft is selectively received within said cavity; 10. Anchor assembly according to item 9, connecting said anchor and said anchor delivery system.
(Item 11)
11. 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 receive the anchor flange.
(Item 12)
configured to receive a valve, introduced intravascularly, and implanted at a deployment site; configured and sized to replace a native heart valve; substantially at the atrial floor adjacent the deployment site of the atrial sealing skirt An atrial sealing skirt that conforms and is configured to substantially rest on the atrial floor, comprising:
an atrial skirt body that is generally cylindrical and defines a valve receptacle;
an atrial skirt lower edge extending circumferentially around a lower edge of said atrial skirt body that is compressible when constrained and expands when released from constraint;
at least one conduit having an open upper end defined by an aperture in said skirt body;
at least one extension member supporting the skirt edge and having a base end adjacent the skirt body lower edge extending substantially outwardly to an outer edge of the skirt edge;
at least one body support supporting the skirt body;
An atrial sealing skirt comprising a membrane covering said at least one extension member and said at least one body support to form said skirt rim and body.
(Item 13)
13. The atrial sealing skirt of clause 12, wherein the atrial sealing skirt body defines a valve receptacle and is configured to receive a valve.
(Item 14)
13. The atrial sealing skirt of item 12, wherein the at least one conduit is configured to receive a locking system that locks the atrial sealing skirt positioned on the atrial floor.
the port.
(Item 15)
15. The atrial sealing skirt of item 14, wherein the locking system comprises a separable lock positioned within the conduit that locks the inferior rim to the atrial floor.
(Item 16)
13. The atrial sealing skirt of item 12, wherein the atrial skirt edge is generally convex prior to conforming with the atrial floor.
(Item 17)
An anchor assembly for anchoring a mitral valve to the interventricular septum of the heart for minimally invasive implantation of the mitral valve to replace a natural mitral valve, comprising:
an anchor screw configured for implantation in the interventricular septum and extending from a proximal end of the anchor screw; a flexible connector extending from a proximal end of the anchor base; and the anchor base. an anchor comprising an anchor shaft extending proximally from
a connector rod having a distal end configured to cooperate with the anchor base to selectively connect to the anchor base; and an anchor connector defining a channel for receiving the connector rod; an anchor delivery system, wherein an anchor connector is configured to receive said anchor shaft.
(Item 18)
18. The anchor of item 17, wherein the anchor shaft comprises at least one locking member extending radially outwardly from the anchor shaft and configured to cooperate with a proximal end surface of the anchor connector. ·assembly.
(Item 19)
18. The anchor assembly of clause 17, further comprising at least one stabilizer extending radially outwardly from the anchor base adjacent the anchor screw.
(Item 20)
20. An anchor assembly according to item 19, wherein said at least one stabilizer is non-linear.
(Item 21)
20. The anchor assembly of item 19, wherein the at least one stabilizer extends radially outward at an acute angle to the horizontal axis of the anchor base.
(Item 22)
a distal end of the connector rod having a first surface configuration, the anchor shaft defining a channel having a second surface configuration, the first and surface configurations matingly engaging the connector rod; to the anchor shaft.
(Item 23)
23. An anchor assembly according to item 22, wherein the connector rod is removable from the anchor shaft.
(Item 24)
further comprising a tether assembly including a docking ring and at least one tether rod, the docking ring configured to receive the anchor connector, the at least one tether rod proximate to the docking ring; 19. An anchor assembly according to item 18, extending in the lateral direction.
(Item 25)
said at least one locking member in a first locked position in which said at least one locking member extends a first distance from an outer surface of said anchor cap; 25. The anchor assembly of item 24, moving between a second position extending a second distance from an outer surface, said first distance being greater than said second distance.
(Item 26)
When the tether docking ring is positioned over the at least one locking member, urging the at least one locking member from the first locking position to the second position; The at least one locking member engages the docking ring in the first locking position when a docking ring is positioned on the anchor cap distally of the at least one locking arm. 26. An anchor assembly according to item 25, wherein the anchor assembly is
(Item 27)
A method of implanting an anchor in the interventricular septum of a heart for minimally invasive fixation of a mitral valve to replace a native mitral valve, comprising:
An anchor assembly comprising an anchor distal end configured to be implanted in the interventricular septum at an implantation site, said anchor comprising: an anchor base extending from a proximal end of said anchor distal end; and said anchor base providing an anchor assembly comprising a flexible connector flexibly connected to a proximal end of a and an anchor shaft extending proximally from the flexible connector;
connecting an anchor delivery system including a connector rod and an anchor connector to the anchor assembly by positioning the anchor connector over the anchor base;
locking the anchor connector to the anchor base;
advancing the anchor assembly over a guidewire adjacent the interventricular septum such that the anchor distal end penetrates the interventricular septum at the implantation site and the anchor distal end emerges on the opposite side; embedding the posterior end;
advancing a tether docking system including a docking ring and at least one tether arm from the docking ring over the anchor connector;
and removing said connector rod.
(Item 28)
28. The method of item 27, wherein the anchor distal end is an anchor screw and the step of advancing the anchor assembly to penetrate the interventricular septum comprises rotating the anchor screw.
(Item 29)
The anchor assembly further comprises at least one stabilizer extending radially outwardly from the anchor base, and the step of embedding the anchor distal end uses the at least one stabilizer to stabilize the anchor distal end. 28. A method according to item 27, comprising the step of stabilizing.

1 is a cutaway perspective view of a heart showing the transcatheter valve system of the present application positioned within the heart, according to one aspect; FIG. FIG. 12 is a perspective view, depicting a retrograde anchor for securing a tether to the interventricular septum; FIG. 12 is a perspective view, depicting a retrograde anchor delivery cable for anchoring the tether to the heart wall; FIG. 10 is a perspective view showing a tether for securing a transcatheter valve to a retrograde anchor; A perspective view showing a retrograde anchor assembly consisting of a tether for connecting a transcatheter valve to an anchor, the tether coupled to an anchor for affixing the tether to the interventricular septum, and the anchor's LV disc connected to a delivery cable. It is a diagram. FIG. 10 is a perspective view showing a delivery cable of an antegrade anchor for securing a transcatheter valve to the anchor; FIG. 12 is a perspective view, depicting an antegrade anchor for securing a tether to the interventricular septum; FIG. 12 is a perspective view, depicting a tether for securing a transcatheter valve to an antegrade anchor; An antegrade, consisting of a tether for connecting the transcatheter valve to an anchor, the tether coupled to an anchor for anchoring to the interventricular septum, the anchor's RV disc connected to the delivery cable, and a guidewire threaded through the assembly. Fig. 10 is a perspective view of a sexual anchor assembly; FIG. 10 is a side view of an intra-annular valve consisting of a superior rim attached to a transcatheter valve body with integrated leaflets. FIG. 3B is a top perspective view of an intra-annular valve consisting of a superior rim attached to a transcatheter valve body with integrated leaflets. FIG. 2 is a perspective view of a valve consisting of a lower rim attached to a transcatheter valve body with integrated leaflets. FIG. 10 is a top view of a valve consisting of a lower rim attached to a transcatheter valve body with integrated leaflets. FIG. 10 is a side view of a transcatheter valve having a valve that transitions from a concave configuration to a convex configuration on one edge of the upper edge. FIG. 10 is an enlarged side view showing a transcatheter valve plug coupled to an atrial positioning rod and cord; Fig. 3 is an enlarged side view of the locking system; Fig. 3 is a perspective view of a locking system; Fig. 3 is a cutaway perspective view of the locking system; FIG. 10 is a cross-sectional view showing a locking system for a transcatheter valve body positioned in an unlocked position; FIG. 10 is a cross-sectional view showing a locking system for a transcatheter valve body positioned in a locked position; Fig. 10 is a partial cutaway view of the locking system in the locked position; Fig. 3 is a perspective view of a locking system; FIG. 10 is a perspective view showing one stage of an anchor having an anchor screw and an anchor cap configured to receive a connecting ring and a tethering system; FIG. 10 is a perspective view showing a next stage of an anchor having an anchor screw and an anchor cap configured to receive a connecting ring and tethering system; FIG. 10 is a perspective view showing a next stage of an anchor having an anchor screw and an anchor cap configured to receive a connecting ring and tethering system; FIG. 10 is a perspective view showing a next stage of an anchor having an anchor screw and an anchor cap configured to receive a connecting ring and tethering system; FIG. 10 is a perspective view showing a next stage of an anchor having an anchor screw and an anchor cap configured to receive a connecting ring and tethering system; FIG. 10 is a perspective view showing a next stage of an anchor having an anchor screw and an anchor cap configured to receive a connecting ring and tethering system; FIG. 18A is a perspective view showing a transseptal puncture being performed and the interventricular crossing guide in place. FIG. 18B is a perspective view showing the snare positioned within the left ventricle after transseptal puncture. FIG. 19A is a perspective view showing a snare that receives an interventricular septal cross wire. FIG. 19B is a perspective view showing a ventricular septal crossing catheter being advanced across the septum. FIG. 19C is an enlarged perspective view showing the ventricular septal crossing catheter being advanced across the septum. FIG. 20A is a perspective view showing a ventricular septal crossing catheter advanced into a transseptal guide. FIG. 20B is a perspective view showing the interventricular septal crossing wire being replaced with a 0.035 inch wire. FIG. 21A is a perspective view showing a retrograde anchor delivery sheath advanced over a 0.035 inch rail wire and into the interventricular septum. FIG. 21B is a perspective view showing a retrograde anchor delivery sheath positioned across the interventricular septum with its end in the right ventricle and a retrograde anchor positioned within the sheath. FIG. 22A is a perspective view showing deployment of the right ventricular disc of the retrograde anchor. FIG. 22B is a perspective view showing the left ventricular disc of the retrograde anchor deployed and the 0.035 inch rail wire retracted. FIG. 12 is a perspective view showing the retrograde anchor fully deployed to receive a transcatheter valve; FIG. 24A is a perspective view showing an antegrade anchor delivery sheath advanced through the septum and over a 0.035 inch rail wire. FIG. 24B is a perspective view showing an antegrade anchor delivery sheath positioned across the interventricular septum with its end in the left ventricle and an antegrade anchor positioned within the sheath. FIG. 25A is a perspective view showing the deployment of the left ventricular disc of the antegrade anchor. FIG. 25B is a perspective view showing the deployment of the right ventricular disc of the antegrade anchor. FIG. 26A is a perspective view showing the antegrade anchor delivery cable being loosened and removed. FIG. 26B is a perspective view showing the antegrade anchor delivery cable removed leaving the 0.035 inch rail wire in place. FIG. 26C shows the transseptal guide removed leaving the 0.035 inch rail wire in place to receive the transcatheter valve and advance it over the antegrade anchor on the dock. It is a perspective view. FIG. 27A is a perspective view showing the valve delivery system approaching the anchor. FIG. 27B is a perspective view showing the tether coupled to the anchor cap of the anchor; FIG. 28A is a perspective view showing the valve delivery guide partially retracted to expose the intra-annular portion of the valve. FIG. 28B is a perspective view showing the valve delivery guide fully retracted exposing the upper rim of the valve in the left atrium while the atrial positioning rod remains connected to the transcatheter valve body. FIG. 28C is an enlarged perspective view showing the valve fully exposed with the atrial positioning rod still connected to the transcatheter valve body. FIG. 29A is a perspective view showing the atrial lock engaged and the atrial positioning rod retracted, with only the sutures remaining connected to the body of the transcatheter valve. FIG. 29B is an enlarged perspective view showing the atrial lock engaged and the atrial positioning rod retracted, with only the sutures remaining connected to the body of the transcatheter valve. FIG. 29C is a perspective view showing the valve deployed and the valve delivery system withdrawn from the body while the sutures connected to the transcatheter body exit the body through the valve delivery sheath. FIG. 30A is a perspective view showing the suture cutter advanced through the valve delivery sheath to just above the upper edge of the transcatheter valve. FIG. 30B is a perspective view showing the fully deployed valve after the suture has been cut above the upper edge of the valve. Figure 30C is a perspective view of Figure 30A including a mitral valve according to another aspect of the invention. FIG. 30D is a perspective view of FIG. 30B including the mitral valve shown in FIG. 30C. FIG. 10 is a side view of a supra-annular valve consisting of a superior rim attached to a transcatheter valve body with integrated leaflets. FIG. 2B is a top perspective view of a supra-annular valve consisting of a superior rim attached to a transcatheter valve body with integrated leaflets. FIG. 4 is an exploded view of an anchor having an anchor screw and an anchor cap configured to receive a connecting ring and tethering system according to another aspect of the invention; 32B is a side view showing the anchoring system of FIG. 32A with the connected ring advanced over the anchor cap and locked in place; FIG. FIG. 32B is a side view of FIG. 32B with the delivery cable separated from the system; 33 is a perspective view of the anchor of FIG. 32 including stabilizers according to another aspect of the invention; FIG. 33 is an end view of the anchor screw of FIG. 32; FIG.

The present invention is more readily understood by reference to the following detailed description, examples, and claims, and their descriptions above and below. Before disclosing and describing the systems, devices and/or methods of the present invention, since this invention is, of course, susceptible to variation, no particular system, device and/or method disclosed unless otherwise specified. It should be understood that there is no limitation. Also, it is to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

The following description of the invention is provided as an enabling teaching of the invention in its best currently known mode. Those skilled in the art will recognize that numerous modifications can be made to the described embodiments and still yield beneficial results of the invention. It will also be apparent that some of the desired benefits of the present invention are obtained by selecting some features without utilizing other features of the present invention. Accordingly, those skilled in the art will recognize that many modifications and adaptations to the present invention are possible, and may even be desirable in certain circumstances, and are part of the present invention. Accordingly, the following description is offered as an illustration of the principles of the invention and not as a limitation thereof.

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

Ranges can be expressed herein as from "about" one particular value, and/or to "about" another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations using the antecedent "about," it is understood that the particular value forms another aspect. Further, each endpoint of a range is understood to be significant in relation to and independently of the other endpoint.

As used herein, the term "optional" or "optionally" means that the event or situation subsequently described may or may not occur, and that description indicates that the event or situation It is meant to include cases that do and cases that do not occur. As used herein, "fluid" refers to any free-flowing substance, including liquids, gases, and plasmas. "Fluid communication," as used herein, refers to any connection or relative positioning that allows material to flow freely between associated 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 the minimally invasive implantation of medical devices and systems into the heart and methods of implanting those devices and systems. More specifically, the present application introduces and anchors a retrograde or antegrade anchor 22 or 49 endovascularly to the interventricular septum 20 and valve 66 (see FIGS. 10A and 10B, 11A and 11B). ) into the heart tethered to retrograde or antegrade anchors 22 or 49 to replace the natural mitral valve. The tethering assembly also cooperates with anchor 22 or 49 to connect valve 66 or 156 to anchor 22 or 49 . Additionally, the valve 66 has an upper rim 67 or 157 connected to the valve body 68 such that the valve conforms to the respective atrial bed via the upper rim 67 or lower rim 157 to prevent paravalvular regurgitation of the prosthesis. Includes lower edge 157 . According to the disclosure herein, the anchor is implanted independently of the tether and transcatheter valve.

Retrograde Anchor Assembly The components of retrograde anchor assembly 44 shown in FIGS. Anchor cap 27 is attached to left ventricular disc 26 , which connects to right ventricular disc 23 via septal connector 24 . Delivery cable 32 is removably connected to anchor cap 27 . Septal connector 24 is sized and configured to span the interventricular septum as shown. Optionally, however, the septal connector 24 may be differently sized (longer or shorter depending on the thickness of the interventricular septum) and any circular, elliptical, parabolic, or hyperbolic cross-section. It may take the shape of a partial cylinder, or it may take the shape of a polyhedron with a flat base and top in the shape of a polygon with three or more sides. The septal connector may be constructed of 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, ovine, porcine, or equine pericardium, or any combination of anti-inflammatory agents to promote healing and limit inflammation. good too. The right ventricular and left ventricular discs may be constructed of 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 portion of a circle, ellipse, parabola, or hyperbola, or a polygon with three or more sides. The right and left ventricular discs are coated with a synthetic material from the group consisting of polycarbonate, polyurethane, polyester, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubber, or combinations thereof. may be, but are not limited to. The right and left ventricular discs may also be coated with adult or juvenile bovine, ovine, equine, or porcine pericardium. In a further aspect, anchor 22 has anchoring elements (not shown) positioned along its right and left ventricular discs. These anchoring elements allow anchoring to the interventricular septum, but are not necessarily the primary anchoring mechanism used.

In use, retrograde anchor 22 unsheaths right ventricular disc 23 to contact right ventricular surface 17 of interventricular septum 20, then exposes septal connector 24, and then sheaths left ventricular disc 26. It is anchored to the interventricular septum by extending it out and touching the left ventricular surface 16 of the interventricular septum 20 . By re-sheathing the left ventricular disc 26, then the septal connector 24, and finally the right ventricular disc 23, the retrograde anchor is safely removed from the heart wall and repositioned or completely removed. be done.

Anchor cap 27 includes at least one locking arm 29 extending radially outward from anchor cap 27 . Locking arm 29 is sized and configured to releasably secure a portion of tether 36 (described below) to anchor cap 27 . The at least one locking arm 29 is positioned in 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 extends from the anchor cap 27 . Move to and from a second unlocked position extending a second distance that is less than the first distance. Anchor cap 27 includes at least one biasing member (not shown), such as a spring, configured to urge each locking arm 29 into the first locked position. As shown, a plurality of locking arms 29 are provided and evenly spaced around the circumference of anchor cap 27, but it is contemplated that locking arms 29 need not be evenly spaced. be.

Referring now to FIG. 3, the delivery cable 32 comprises 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. The delivery wire is constructed of, but not limited to, stainless steel, nitinol, or other alloys, with or without a hydrophilic coating, or with a polymer coating such as polytetrafluoroethylene (PTFE). or not. Distal threaded end portion 34 is sized and configured to selectively engage complementary threads formed in a cavity defined in proximal end 31 of anchor cap 27 . . See FIGS. 2 and 5. FIG. In use, the distal threaded end portion 34 is advanced into the proximal end 31 of the anchor cap 27 and is, for example, threaded to attach the anchor cap 27 to the distal end of the flexible wire 33. Join. Distal threaded end portion 34 is loosened from the proximal end of anchor 22 to separate flexible wire 33 from anchor 22, as will be described more fully below.

According to another aspect of the present disclosure, an anchor assembly 91 is shown as shown in FIGS. 17A-17F. Anchor 91 includes anchor shaft 92 and antegrade anchor 49, but in this anchor assembly 91, retrograde anchor 22 can be replaced. As shown, antegrade anchor 49 extends distally from anchor base 94 . Anchor base 94 defines at least one, or as shown, a plurality of anchor flanges 96 and a recessed area 97 therebetween. Anchor shaft 92 includes at least one or, as shown, a plurality of locking members 98 shown in FIG. 17B. The locking member 98 is biased radially outward from the anchor shaft 92 by a spring (not shown) or the like. Anchor connector 99 and connector rod 101 cooperate with anchor shaft 92 to connect to antegrade anchor 49 . Anchor connector 101 defines at least one, or as shown a plurality of apertures 1020 , configured to receive anchor flange 96 . Accordingly, the anchor connector 99 and connector rod 101 are matingly connected to the anchor shaft 92, thereby forcing the locking member 98 inwardly. Aperture 100 and flange 96 cooperate to integrate anchor connector 101 and anchor base 94 .

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

Anterograde Anchor Assembly The components of the anterograde anchor assembly 63 shown in FIGS. 6-9 allow delivery of the anchor 49 with anchor cap 58 and delivery cable connector 51, and tether 36. and delivery cable 46 . Anchor cap 58 is coupled to left ventricular disc 57 , which connects to right ventricular disc 54 via septal connector 56 . Delivery cable 46 is removably connected to delivery cable connector 51 via threaded end 52 . Septal connector 56 is sized and configured to span the interventricular septum as shown. Optionally, however, the septal connector 56 may be differently sized (longer or shorter depending on the thickness of the interventricular septum) and any circular, elliptical, parabolic, or hyperbolic cross-section. It may take the shape of a partial cylinder, or it may take the shape of a polyhedron with a flat base and top in the shape of a polygon with three or more sides. The septal connector may be constructed of any known alloy including, but not limited to, stainless steel, nitinol, titanium, cobalt-chromium, or other alloys. In another aspect, the alloy of septal connector 56 is coated with living tissue such as bovine, ovine, porcine, or equine pericardium, or any combination of anti-inflammatory agents to promote healing and limit inflammation. good too. The right ventricular and left ventricular discs may be constructed of 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 portion of a circle, ellipse, parabola, or hyperbola, or a polygon with three or more sides. The right and left ventricular discs are coated with a synthetic material from the group consisting of polycarbonate, polyurethane, polyester, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubber, or combinations thereof. may be, but are not limited to. The right and left ventricular discs may also be coated with adult or juvenile bovine, ovine, equine, or porcine pericardium. In a further aspect, anchor 49 has anchoring elements (not shown) positioned along its right and left ventricular discs. These anchoring elements allow anchoring to the interventricular septum, but are not necessarily used as the primary fixation mechanism.

In use, the antegrade anchor 49 unsheaths the left ventricular disc 57 to contact the left ventricular surface 16 of the interventricular septum 20 , then exposes the septal connector 56 and subsequently the right ventricular disc 54 . It is secured to the interventricular septum by coming out of the sheath and contacting the right ventricular surface 17 of the interventricular septum 20 . By re-sheathing the right ventricular disc 54, then the septal connector 56, and finally the left ventricular disc 57, the antegrade anchor is safely removed from the heart wall and repositioned or completely repositioned. removed.

Anchor cap 58 includes at least one locking arm 61 extending radially outwardly from anchor cap 58 . Locking arm 61 is sized and configured to releasably secure a portion of tether 36 (described below) to anchor cap 58 . At least one locking arm 61 is positioned in a first locking position, where locking member 61 extends a first distance away from the body of anchor cap 58 and locking member 61 extends from anchor cap 58 . Move to and from a second unlocked position extending a second distance that is less than the first distance. Anchor cap 58 includes at least one biasing member (not shown), such as a spring, configured to urge each locking arm 61 into the first locked position. As shown, a plurality of locking arms 61 are provided and evenly spaced around the circumference of anchor cap 58, although it is contemplated that locking arms 61 need not be evenly spaced. be.

Referring now to FIG. 6, delivery cable 46 comprises a flexible delivery wire 47 having a distal threaded end portion 48 positioned or formed at the distal end of delivery wire 47 . include. Delivery cable 46 has a central channel (not shown) in which a wire rail can be accommodated. The delivery wire is constructed of, but not limited to, stainless steel, nitinol, or other alloys, with or without a hydrophilic coating, or with a polymer coating such as polytetrafluoroethylene (PTFE). or not. Distal threaded end portion 48 is sized and configured to selectively engage complementary threads formed in a cavity defined in proximal end 52 of delivery cable connector 51 . be. See FIGS. 7 and 9. In use, distal threaded end portion 48 is advanced into proximal end 52 of anchor cap 51 and is, for example, threaded to connect delivery cable connector 51 to the distal end of flexible wire 47 . bind to Distal threaded end portion 48 is loosened from the proximal end of delivery cable connector 51 to separate flexible wire 47 from anchor 49, as will be described more fully below.

Halo Anchor Assembly According to another aspect of the present disclosure, a halo anchor assembly 91 is shown as shown in FIGS. 17A-17F. Halo anchor assembly 91 includes an anchor base 94 connected to an anchor shaft 92 (in place of anchor cap 58 according to other aspects) and fused to the remainder of antegrade anchor 49, but with this halo. • The anchor assembly 91 can consist of an anchor base 94 connected to the anchor shaft 92 and fused to the remainder of the retrograde anchor 22, instead of the anchor cap 27 as shown in FIG. As shown, antegrade anchor 49 extends distally from anchor base 94 . Anchor base 94 defines at least one, or as shown, a plurality of anchor flanges 96 and a recessed area 97 therebetween. Anchor shaft 92 includes at least one, or as shown a plurality, of a plurality of locking members 98 shown extended in FIG. 17B. The locking member 98 is biased radially outward from the anchor shaft 92 by a spring (not shown) or the like. Anchor connector 99 and connector rod 101 travel over wire rail 64 extending through anchor shaft 92 and threaded end 52 (such as that shown in FIG. 9) to connect to connector rod 101 . The anchor connector 99 cooperates with the anchor shaft 92 . Anchor connector 99 defines at least one, or as shown a plurality of apertures 100 , configured to receive anchor flange 96 . Accordingly, the anchor connector 99 and connector rod 101 are matingly connected to the anchor shaft 92, thereby forcing the locking member 98 inwardly. Anchor connector 99 and anchor base 94 are brought together by cooperating aperture 100 and flange 96 . After tether ring 102 is secured to locking member 98 , anchor connector 99 and connector rod 101 are removed leaving wire rail 64 extending through anchor shaft 92 attached to anchor base 94 . left. With anchor assembly 91 fused to retrograde anchor 22, anchor connector 99 and connector rod 101 travel over delivery cable 32 that remains after anchor connector 99 and connector rod 101 are removed.

Figures 32 and 33
Another aspect of a halo anchor assembly is shown in FIGS. 32A-32C and 33. FIG. Anchor assembly 91 further includes a flex connector 170 that extends between anchor base 94 and anchor shaft 92 and may be formed of a suitable material such as a metal or alloy. As shown, flex connector 170 is in a coiled configuration, although other configurations are envisioned. Secured to the bottom of the anchor shaft 92 are at least one, or as shown, three locking arms 98 extending radially outward from the anchor shaft 92 . Arm 98 is formed of, for example, any metal or alloy. The locking arms 98 are forced radially inward, but are biased as shown. Thus, when locking member 98 is positioned to engage locking member 98, it cooperates with tether ring 202 and the flex connector of anchor assembly 91, particularly when anchor screw 93 is implanted. Allowing the tether to remain axially aligned (eg, parallel to the interventricular septum) with the valve in which it is implanted.

To embed the anchor screw 93, a torque driver (not shown) preloaded onto the delivery cable 232 engages the anchor base 94, allowing the screw to be driven into tissue by rotating. Once fully implanted, the torque driver is removed, leaving anchor assembly 91 connected to delivery cable 232 . Tether ring 202 , connected to the tether via tether rod 208 (attached to tether ring 202 via aperture 206 ), is advanced over delivery cable 232 and over anchor axis 92 . Tether ring 202 advances over locking arms 98, thereby pushing the arms down inwards. As the proximal end of tether ring 202 passes under locking arms 98 , locking arms 98 spring outwardly, constraining tether ring 202 in place and securing the tether to tether rod 208 . unintentional movement is prevented. Finally, the delivery cable 232 is rotated so that the “male” threads 234 pass out of the threads defined by the threaded cavities of the anchors 92 .

The anchor assembly 91 shown in these figures also stabilizes the anchor, limits or prevents movement, such as rotational movement, due to tension transmitted from the tether, and provides traction so that the screw anchor 93 can be inadvertently removed. It includes a stabilizer 172 that limits or prevents it from rotating and decoupling from the implanted tissue. 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, stabilizers 172 extend radially outwardly from the longitudinal axis of the anchor. Stabilizer 172 is configured to have a non-linear configuration. Other configurations are envisioned. The stabilizer 172 shown in FIG. 33 also extends radially outwardly from the anchor longitudinal axis and along the horizontal hokoji shim at an acute angle, eg, 45 degrees. The angles generally face the opposite direction of the screw anchor 93 . The stabilizer is generally linear, but other configurations are envisioned. For example, when inserted into the interventricular septum, the stabilizer 172 forces tissue and possibly enters the tissue in a direction opposite to anchor screw implantation to prevent unintentional withdrawal of the anchor screw 93 .

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

Tether Assembly Once flexible wire 33 is coupled to retrograde anchor 22 , the flexible wire acts as a guide rail for advancing tether 36 to retrograde anchor 22 . For antegrade anchor 49, wire rail 64 enters distal end 62 of anchor cap 58, passes through the central channel of delivery cable 46, and exits delivery cable connector 51 via threaded end 52. serves as a guide rail for tether 36 to antegrade anchor 49 . Tether 36 includes one or more tether rods 38 rotatably connected to docking ring 43 . Tether rod 38 is connected to eyelet 41 defined in docking ring arm 42, as shown in FIG. The tether 36 is advanced over the flexible wire 32 of the delivery cable 33 (for retrograde anchors) or over the wire rail 64 (for antegrade anchors) and the docking ring of the tether 36 is advanced. 43 depresses at least one locking arm 29 or 61 of anchor cap 27 or 58 to the second unlocked position. When locking arm 29 or 61 is in the second position, tether 36 is pushed until docking ring 43 abuts distal end 28 of anchor cap 27 or distal end 59 of anchor cap 58, and /or advance over locking arm 29 or 61 of anchor cap 27 or 58, respectively, until adjacent. At this point, the biasing member of anchor cap 27 or 58 urges at least one locking arm 29 or 61 to the first locked position, thereby removing docking ring 43 and thus the rest of tether 36 . is releasably coupled to retrograde anchor 22 or antegrade anchor 49 .

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

As shown in FIG. 4, in one aspect, tether 36 includes at least one docking ring arm 42 coupled to docking ring 43 and at least one tether arm 42 coupled to docking ring arm 42 . and a rod 38 . As shown, the distal end of docking ring arm 42 is rigidly coupled to or integrally formed with docking ring 43 . The at least one docking ring arm comprises a plurality of docking ring arms 42 as shown. As shown, the plurality of docking ring arms 42 are evenly spaced around the circumference of the docking ring, but it is contemplated that the docking ring arms 42 need not be evenly spaced. be done. Eyelets 41 are defined by docking ring arms 42 . Tether rod 38 includes tether rod hook 39 configured to cooperate with eyelet 41 .

A proximal end of each docking ring arm 42 is rotatably coupled to a distal end of a respective tether rod 38 . A tether rod hook 39 is defined by the tether rods 38 as shown and is coupled to or integrally formed with the distal end of each tether rod 38 . Alternatively, eyelet 41 and tether rod hook 39 are configured such that tether rod hook 39 is inserted into eyelet 41 to securely and rotatably couple tether rod 38 to docking ring 43 . Sized and configured. In use, each tether rod hook 39 rotates around the circumference of eyelet 41 . The proximal end of each tether rod is coupled to cord 37, as shown in FIG. Tether rod 38 and tether rod hook 39 may be constructed of any alloy.

Wire Rail Delivery System Referring now to FIGS. 18A and 18B, the wire rail delivery system consists of an interatrial transseptal guide 118 and an interventricular transseptal guide 111 . An interatrial transseptal guide 118 is inserted into the femoral vein through a transfemoral sheath 117, the guide 118 having a proximal hub 119 through which a transseptal needle 121 is introduced, which needle 121 extends distally of the guide. It exits the transseptal guide 121 through the posterior dilator 122 . Interventricular transseptal guide 111 is inserted into the jugular vein via transjugular sheath 109 and guided over guidewire 116 into right ventricle 18 . The interventricular transseptal guide 111 has a deflectable distal tip 114 controlled by a deflection knob 113 attached to the guide's proximal handle 112 , the tip touching the right ventricular surface 17 of the interventricular septum 20 . can be deflected towards

Anterograde and Retrograde Anchor Delivery Sheath Referring now to FIGS. 21A and 21B, the retrograde anchor delivery sheath 131 passes over the wire rails 64 and into the proximal hub 119 of the interatrial transseptal guide 118 . Advance and exit the distal end 120 of the transseptal guide. A dilator 133 passes through the distal end 132 of the retrograde anchor delivery sheath 131, advances over the wire rail 64, enters the left ventricular surface 16 of the interventricular septum 20, and exits the right ventricular surface 17 of the interventricular septum 20. Get out. Once traversed, the dilator 133 is removed to allow delivery of the retrograde anchor 22 , leaving the distal end 132 of the retrograde anchor delivery sheath within the right ventricle 18 .

24A and 24B, the antegrade anchor delivery sheath 134 is advanced over the wire rail 64 and into the proximal handle 112 of the interventricular transseptal guide 111 to Exiting distal end 114 . A dilator 137 passes through the distal end 136 of the antegrade anchor delivery sheath 134, advances over the wire rail 64, enters the right ventricular surface 17 of the interventricular septum 20, and penetrates the left ventricular surface 16 of the interventricular septum 20. get out of Once traversed, the dilator 137 is removed, leaving the distal end 136 of the antegrade anchor delivery sheath within the left ventricle 14 to allow delivery of the retrograde anchor 49 .

As shown in FIG. 18A, sheath 109 is configured to receive interventricular transseptal guide 111 and sheath 117 is configured to receive interatrial transseptal guide 118 . Sheath 109 is in fluid communication with interventricular transseptal guide 111 and sheath 117 is in fluid communication with interatrial transseptal guide 118 so that fluids such as heparinized saline can flow through sheath 109 and into the interventricular transseptal. It surrounds the septal guide 111 and also surrounds the interatrial transseptal guide 118 through the sheath 117 .

Method of Making a Wire Rail As shown at 18A, J-wire 116 is introduced through sheath 109 and endovascularly guided into right ventricle 18 by the user. Over J-wire 116, interventricular transseptal guide 111 is advanced into sheath 109 and endovascularly guided into right ventricle 18 by the user. Once in the right ventricle 18 , the J-wire 116 is removed and the guide tip 114 is pushed through the proximal handle of the interventricular transseptal guide 111 until the guide tip 114 is adjacent the right ventricular surface 17 of the interventricular septum 20 . It is deflected by deflection knob 113 at 112 .

As shown at 18A, a J-wire (not shown) is introduced through sheath 117 and endovascularly guided into right atrium 19 by the user. Beyond this J-wire, the interatrial transseptal guide 118 is endovascularly guided by the user until it enters the right atrium 19 with a dilator 122 projecting out of the distal tip 120 of the guide. The J-wire is then removed and transseptal needle 121 is advanced through proximal hub 119 of interatrial transseptal guide 118 until the needle is close to the end of dilator 122 . The proximal hub 119 of the interatrial transseptal guide 118 is then withdrawn and rotated until the dilator 122 projecting out from the distal tip 120 is pressed against the atrial septum 21 . Under fluoroscopic and echocardiographic guidance, the transseptal needle 121 is advanced across the atrial septum 21 into the left atrium 11 and then through the dilator 122 and distal tip of the interatrial transseptal guide 118 . 120 is advanced. Once distal tip 120 enters left atrium 11 , dilator 122 and transseptal needle 121 are both withdrawn from proximal hub 119 of interatrial transseptal guide 118 .

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

As shown in FIG. 19A, a radiofrequency wire 127 connected to a radiofrequency generator 126 or an electrocautery system (not shown) is placed between the ventricles until the wire 127 exits the distal end 114 of the interventricular transseptal guide 111. Advance through the proximal handle 112 of the transseptal guide 111 , cross the interventricular septum 20 and into the left ventricle 14 , then the wire 127 is captured by the snare 124 . The snare 124 pulls the wire 127 into the interatrial transseptal guide 118 until the wire exits the proximal hub 119 of the guide 118, as shown in FIG. 19B. Microcatheter 128 is then advanced across interventricular septum 120 and over wire 127 over the portion of wire 127 extending from proximal handle 112 of interventricular transseptal guide 111 . FIG. 19C shows an enlarged view of microcatheter 128 with distal dilator 129 advanced over wire 127 and across interventricular septum 20 .

Microcatheter 128 is advanced over wire 127 until it enters distal tip 120 of interatrial transseptal guide 118, as shown in FIG. 20A. Once the microcatheter 128 is more than a few centimeters inside the interatrial transseptal guide 118 , the wire 127 is removed by withdrawing the proximal hub 119 of the interatrial transseptal guide 118 . As shown in FIG. 20B, the larger, stiffer J-wire 64 exits the microcatheter 128 where the J-wire 64 is positioned inside the interatrial transseptal guide 118 and eventually out of the guide 118. It is advanced through the interventricular transseptal guide 111 via the microcatheter 128 until it exits the proximal hub 119 .

Once the retrograde anchor sheath 131 is positioned within the right ventricle 18 adjacent the right ventricle surface 17, as described in Methods of Implanting Retrograde Anchors [0018] and shown in FIGS. Retrograde anchor 22 is positioned adjacent wire 64 through retrograde anchor sheath 131 and at distal tip 132 .

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

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

Antegrade Anchor Implantation Methods As described in [0019] and shown in FIGS. 24A and 24B, an antegrade anchor sheath 134 is positioned within the left ventricle 14 adjacent the left ventricular surface 16. Then, antegrade anchor 49 is advanced over wire 64 through antegrade anchor sheath 134 and positioned at distal tip 136 .

Distal tip 136 is first retracted until it is adjacent right ventricular surface 17 and into right ventricle 18, as shown in FIG. 25A. As the distal tip 136 is retracted, the self-expanding left ventricular disc 57 of the antegrade anchor 49 deploys to abut the left ventricular surface 16 of the interventricular septum 20 and the septal connector 56 at the interventricular septum 20 . expose. As the distal tip 136 is further retracted, the self-expanding right ventricular disc 54 unfolds to abut the right ventricular surface 17 of the interventricular septum 20, as shown in FIG. 25B. Antegrade anchor sheath 134 is then removed from proximal handle 112 of interventricular septal guide 111 .

26A-26B, the delivery cable 46 is loosened so that its distal threaded end 48 separates from the delivery connector 51, removing the flexible wire 47 of the delivery cable 46. becomes possible. As shown in FIG. 26C, the interatrial transseptal guide 118 is withdrawn from the body through the transfemoral sheath 117 with the antegrade anchor 49 in place and the wire 64 therethrough. there is

Transcatheter Valve As shown in FIGS. 10A, 10B, 11A, 11B, system 10 includes an atrial sealing skirt upper edge 67 extending circumferentially along the upper end of transcatheter heart valve 66 . and a transcatheter heart valve 66 having. The transcatheter heart valve 66 includes a transcatheter valve body 68, shown as substantially cylindrical, and an atrial sealing skirt upper edge 67 configured to conform to the left atrial bed 12 as shown. include. Transcatheter heart valve 66 is coupled to retrograde anchor 22 or antegrade anchor 49 by tether 36, as described herein. Cord 37 is fused or otherwise coupled to tether rod 38 of tether 36 to connect transcatheter heart valve 66 to anchor 22 or 49 once anchor 22 or 49 is anchored in interventricular septum 20 . Connecting.

Transcatheter heart valve 66 is sized and configured to accommodate the mitral valve between left atrium 11 and left ventricle 14, as shown in FIG. Transcatheter heart valve 66 is pre-assembled with leaflets 77 (FIGS. 11A, 11B). This is an example. Accordingly, and thereby, including slight variations, these devices, systems, and methods may be used to treat any internal jugular vein, any subclavian vein, any subclavian vein, or any femoral vein. It may be positioned intravascularly by venous structures including, but not limited to.

Transcatheter heart valve 66 is self-expanding (i.e., the valve is compressible to fit through the catheter of system 1) and is constructed of Nitinol, although stainless steel, Nitinol, or other materials may be used. Elements made of, but not limited to, alloys may also be accommodated. In another aspect, the transcatheter heart valve has a smaller diameter than or approximately equal to the annulus at mitral annulus site deployment 13, thereby reducing mitral annulus constraint.

An alternative embodiment of transcatheter heart valve 66 is transcatheter heart valve 156, as shown in FIGS. 31A and 31B. In contrast to transcatheter heart valve 66 having an atrial sealing skirt upper edge 67, transcatheter heart valve 156 is connected to the bottom of transcatheter valve body 68 instead of the top like transcatheter heart valve 66. has a lower edge 157 of the atrial sealing skirt. The atrial sealing skirt inferior edge 157 conforms to the atrial bed 12 and the transcatheter valve body 68 of the transcatheter heart valve 157 extends into the left atrium 11 thereby interacting with the native mitral valve leaflets. is minimized, further reducing the risk of LVOT occlusion.

At least one conduit 74 is defined within the transcatheter heart valve 66 or 156, as shown in FIGS. 10A-10B, 11A-11B, and 31A-31B. Each conduit has a portion of cord 37 (attached at its proximal end to suture 148) extending through conduit 74, thereby connecting tether 36 to transcatheter heart valve 66 or 156 to provide valve 66 or It is sized and shaped to allow 156 to move freely until locked in place. In a further aspect, the transcatheter valve 66 or 156 has anchoring elements (not shown) positioned along its outer diameter. These anchoring elements allow anchoring to the mitral annulus and/or leaflets, but are not necessarily used as the primary fixation mechanism.

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

11A and 11B also show a transcatheter valve 66. FIG. Transcatheter valve 66 has leaflets 77 that extend radially inwardly from transcatheter valve body 68 . Leaflets 77 are composed of bovine, equine, or porcine pericardial leaflets. Similar to the function of any conventional valve, the leaflets 77 sutured inside the transcatheter valve body 68 are open during diastole (cardiac relaxation) to allow blood to flow from the left atrium 11 into the left ventricle 14. It allows entry and closes during systole (contraction of the heart) to prevent blood from flowing backward from the right or left ventricle into the right or left atrium respectively.

As shown in FIGS. 10A and 10B, 11A and 11B, and 31A and 31B, the transcatheter heart valve 66 or 156 includes a transcatheter valve body 68 and an atrial sealing skirt superior edge 67 or atrial sealing. Defined by the skirt lower edge 157 and comprising membranous material, the atrial sealing skirt upper edge 67 or lower edge 157 has a larger diameter than the annulus at the deployment site. For example, the atrial sealing skirt superior edge 67 or inferior edge 157 may have a diameter greater than the diameter of the mitral valve annulus. In another aspect, the transcatheter heart valve is synthetic from the group consisting of polycarbonate, polyurethane, polyester, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubber, or combinations thereof. It is formed of, but not limited to, materials. The transcatheter heart valve 66 or 156 may also be covered with adult or juvenile bovine, ovine, equine, or porcine pericardium. Optionally, at least a portion of the atrial sealing skirt upper edge 67 or lower edge 157 may be formed from alternative materials such as, but not limited to, polyurethane foam or other polymers.

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 to provide pressure to the left atrial bed and/or mitral annulus. Prosthesis instability (e.g., rocking) and perivalvular regurgitation.

The transcatheter heart valve 66 or 156 comprises at least a transcatheter valve body 68 and an atrial sealing skirt superior edge 67 or inferior edge 157 . As shown, the transcatheter valve body 68 is cylindrical and has a variable length and diameter. Optionally constructed of laser cut or molded nitinol, but may also contain elements of any other alloy, along the circumference or any portion of its length, biomembrane or synthetic as described above. It may be coated with any of the materials. As shown, the superior edge 67 or inferior edge 157 extends radially outwardly and downwardly from the transcatheter valve body 68 to form a substantially concave superior rim with the concave surface facing the left atrial floor 11 . form a rim. The upper rim 67 or the lower rim 157 extends circumferentially around the upper end of the transcatheter valve body 68 in the case of the transcatheter heart valve 66, and of the transcatheter valve body 68 in the case of the transcatheter heart valve 156. It extends circumferentially around the lower end.

At least one, or a plurality of flexible extension members 69 as shown, are provided, for example laser cut or molded nitinol, attached to the top of the skirt body by extension member base 71 and terminating in extension member tip 72. It may consist of, but is not limited to: Between one or more extension members 69 , elastic sealing membranes 73 extend perpendicular to adjacent extension members 69 . As shown in FIGS. 10A and 10B, the extension members 69 may extend radially outwardly and substantially linearly, but this is exemplary. As shown in FIGS. 11A, 11B, 31A, and 31B, the extension member may be non-linear and generally U-shaped. As shown, sealing membrane 73 extends circumferentially around upper edge 67 or lower edge 157 . It may extend only part of the circumference. Transcatheter valve body 68 includes a plurality of supports 78, such as extension members 69 of upper edge 67 or lower edge 157, which may be constructed of, for example, but not limited to, laser cut or molded nitinol. . As shown, supports 78 form a grid-like configuration, although other configurations are envisioned including, but not limited to, vertically extending supports.

The sealing member 73 is constructed of either biological tissue or synthetic fabric as described above. In one aspect, the synthetic fabric is either a woven or knitted fabric that allows for the necessary "stretch" to conform to the topography of the atrial bed. 10A and 10B, 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 downward, thereby extending the mitral annulus. prevent backflow of This configuration includes one or more separable locks 83 (FIGS. 14A-14A) attached to one or more conduits 74 and integrated within the atrial end of the conduits 74 as described herein. Downward force must be applied via one or more atrial positioning rods 147, which are locked in place via FIGS. 14B, 15A-15B, 16A-16B).

Figures 30A-30D show the placement of a valve to 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. FIG. A mitral valve with a lower sealing skirt 157 is positioned above the atrial floor 12 shown in these figures. Use of this valve with the tether described above prevents substantial vertical or floating movement of the valve.

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

27A and 27B, and as discussed above, tether 36 is routed through a transcatheter heart valve delivery system, shown in the form of delivery guide 141, over wire rail 64 of delivery cable 32 (not shown). or advanced over the delivery wire 33 . Tether 36 locks to anchor cap 27 or 58 by coupling docking ring 43 to anchor cap 27 or 58 . Coupled to at least one tether rod 38 is at least one cord 37 extending therefrom. At least one cord 37 is proximally connected to at least one suture 148 that extends outside the body through central lumen 151 of delivery guide 141 . Once the tether is locked into the anchor cap 27 or 58, the guide 141 leaves the anchor 22 or 49, tether 36, cord 37, and suture extending from the implantation site, as shown in FIG. 27B. be pushed back. The same guide 141 delivers both the tether 36 and the transcatheter heart valve 66 or 156, as shown in FIGS. 27A-27B, 28A-28B.

27A-27B and 28A-28B, transcatheter heart valve delivery system 139 is shown for positioning and deploying transcatheter heart valve 66 or 156 at desired deployment site 13 . Transcatheter valve delivery system 139 comprises transcatheter valve delivery guide 141 , nosecone 146 , transcatheter valve deployment knob 142 , and at least one atrial positioning rod 147 . Transcatheter valve delivery guide 141 has a distal end 144, opposing proximal valve deployment knobs 142, and an inner guide lumen 143 extending therebetween. Inner guide lumen 143 is sized and configured for selective and removable insertion of transcatheter valve 66 or 156 and other system components. Because at least a portion of transcatheter valve delivery guide 141 is flexible, tip 144 at the distal end of transcatheter valve guide 141 is positioned beyond deployment site 13 and into left ventricle 14 .

Transcatheter valve deployment knob 142 is coupled to the proximal end of transcatheter valve delivery guide 141 . Transcatheter valve deployment knob 142 defines a central channel 151 in fluid communication with inner guide lumen 143 . Accordingly, atrial positioning rod 147 , guidewire 64 , and/or at least one suture 148 may extend through central channel 151 and into inner guide lumen 143 . As shown, the transcatheter deployment knob 142 is rotatable such that rotation of the knob 142 in a first direction moves the distal tip of the transcatheter valve delivery guide 141 around the transcatheter valve 66 or 156 . 144 is configured to be retracted to allow transcatheter valve 66 or 156 to expand. Nosecone 146 may be any conventional nosecone coupled to transcatheter valve delivery guide 141 and configured to guide transcatheter valve 66 or 156 to deployment site 13 .

Locking System Referring to FIGS. 27A-27B, 28B-28C, and 29A, at least one atrial positioning rod 147 extends at a distal end 153, a proximal end 150, and therebetween. and an inner rod lumen 149, which is sized and configured such that a portion of suture 148 and/or cord 37 is inserted therethrough. Because at least a portion of atrial positioning rod 147 is flexible, distal end 153 of atrial positioning rod may be positioned at or adjacent deployment site 13 .

At least one positioning rod 147 is coupled to 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, cord 37 is securely attached to tether rod 38 of tether 36, which is coupled to anchor cap 27 or 58, through the ventricular disc or septal connector of either retrograde anchor 22 or antegrade anchor 49. Secured to the interventricular septum 20, a separable lock 83, for example, secures the cord 37 in the left atrium.

13A, 13B, 14A, 14B, 15A, 15B, 16A and 16B, locking system 82 includes separable lock 83, first gateway hypotube 84 and and an integrated internal conduit 74 attached to a second retreating hypotube 86 . Inside the separable lock 83 is a locking clip 87 . 30A, system 10 includes a suture cutter 154 sized and configured to cut at least one suture 148 through delivery sheath 117 (as shown in FIG. 30B). Further prepare.

Methods of Implanting, Positioning, and Locking an Atrial Skirt In use, system 10 utilizes a transcatheter approach by placing interventricular anchor 22 or 49 and docking tether 36 to anchor 22 or 49. to implant the transcatheter heart valve 66 or 156. As shown in FIG. 27A, transcatheter valve system 139 is inserted into a portion of heart 9 over either wire 64 or flexible wire 33 of delivery cable 32 . Because 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 . threaded, and as the transcatheter valve delivery guide 141 is advanced, the suture 148 and at least a portion of the cord 37 are proximally along and beyond the inner guide lumen 143 of the transcatheter valve delivery guide 141. extend to the side. Accordingly, a portion of the at least one cord 37 extends through and beyond the distal end 144 of the transcatheter valve delivery guide 141 and a portion of the at least one suture 148 extends through the transcatheter valve delivery guide 141. through and extend beyond. Transcatheter valve delivery guide 141 passes through deployment site 13 and into left ventricle 14 with distal end 144 of transcatheter valve delivery guide 141 having transcatheter valve 66 or 156 preloaded at distal end 144 . positioned to enter the

Transcatheter valve 66 or 156 is preloaded into distal end 144 of transcatheter valve delivery guide 141 for positioning at deployment site 13 . As shown, the sutures 148 are arranged such that each suture 148 is passed 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 transcatheter valve 66 or 156 and the distal end 144 of the transcatheter valve delivery guide 141 are advanced as a unit and approach the deployment site, the ends of the sutures 148 and a portion of the cord 37 are pushed through the transcatheter valve 66 or 156 or the distal end 144 of the transcatheter valve delivery guide 141. It passes through a conduit 74 defined within 156 . As such, the transcatheter valve 66 or 156 can move along the length of at least one cord before reaching the desired deployment site 13 . That is, the transcatheter valve is free floating on cord 37 until it is locked in place by separable lock 83 .

Once the transcatheter valve 66 or 156 is at the desired deployment site 13 , the transcatheter valve deployment knob 142 is utilized to at least partially retract the delivery guide 141 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, since the position of the transcatheter valve is adjustable, the transcatheter valve deployment knob 142 can be used to collapse 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 over each suture 148 so that a portion of each suture extends within the inner rod lumen 149 and each suture is extends beyond the proximal end 150 of the positioning rod 147 . 28B and 29A, positioning rod 147 is then advanced through transcatheter valve guide 141 such that a portion of cord 37 is received by inner rod lumen 149 of rod 147 (separable lock 83 is The distal end 153 of the positioning rod (attached) is adjacent to the transcatheter valve 66 or 156 . Locating rod 147 is depressed by the user until the sealing skirt is in the desired position relative to the mitral valve annulus.

Transcatheter valve 66 or 156 over 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 it 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 withdrawn until the suture 148 extending through each atrial positioning rod 147 is released.

28B, the transcatheter valve 66 or 156 within the left atrium 11 such that the superior edge 67 of the transcatheter valve 66 or the inferior edge 157 of the transcatheter valve 156 conforms to the topography of the left atrial bed 12. Positioning is shown. Via transcatheter valve delivery system end 144 , the practitioner can access one or more transcatheter valves 66 or 156 extending through one or more conduits 74 defined by transcatheter valve body 68 . One or more atrial positioning rods 147 are advanced in translation over multiple cords 37 . As shown in FIG. 28B, when the transcatheter superior edge 67 or inferior edge 157 contacts the atrial floor 12, the one or more extension members 69 bend differently according to the local anatomy. . Because each atrial positioning rod 147 is pushed with a different force, a precise amount of tension can be achieved so that the extension member 69 bends more or less so that the transcatheter valve superior edge 67 or inferior edge 157 is positioned against the atrial floor 12 . to facilitate confining regurgitation through the orifice of the mitral valve.

FIG. 12 shows the transformation 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 atrial floor 12 by the atrial positioning rod 147 attached to the extension member base 71 of the extension member 69, the extension member tip 72 flexes upward to conform to the convex atrial bed anatomy. conforms to the Further distal movement of transcatheter valve 66 (shown from left to right in FIG. 12) or further distal movement of transcatheter valve 156 (not shown) causes upper edge 67 or lower edge 157 to change shape. , is further modified when it conforms to the atrial floor and when the extension member base 71 is pushed downward by the atrial positioning rod 147 (FIG. 28B).

15A and 15B, pulling on the retracting hypotube 86 retracts the locking clip 87, thereby depressing the locking tab 88 and the engaged cord 37. FIG. More specifically, the second hypotube 86 is retracted and its connection to the locking clip 87 causes the locking clip 87 to also be retracted. Locking clip 87, upon retraction, contacts contact point 89 of first gateway hypotube 84 and separates clip 87 so that second hypotube 86 can be removed. As the retracting hypotube 86 is pulled, the inner arm of the gateway hypotube 84 deflects inward, allowing the gateway hypotube to be removed. The first gateway hypotube 84 is beneficial because it allows the cord 37 to be locked while the second hypotube 86 is retracted. Gateway hypotube 84 is then removed, leaving clip 87 within conduit 74 of transcatheter valve 66 or 156 . FIG. 16A shows a cutaway view of a fully engaged lock. According to one aspect, the positioning rod 147 may be integrated with or removably connected to the gateway hypotube. FIG. 16B shows a complete view of the fully engaged lock.

With the transcatheter valve tightly conforming to the atrial bed 12, the suture cutter 154 is advanced over the suture 148 to the transcatheter valve superior border 67, as shown in FIG. 30A. Suture cutter 154 cuts and releases the distal end of each suture 148 above separable lock 83 . Suture 148 and suture cutter 154 are then removed from heart 9 .

In one aspect, transcatheter valve 66 or 156 may be retrieved or repositioned prior to cutting suture 148 . For example, if it is determined that the transcatheter valve should be removed or repositioned, the atrial positioning rod 147 is positioned over each suture with a portion of the suture within the inner rod lumen 149. be. If the distal end 153 of the positioning rod is adjacent to or in contact with the separable lock 83, advancing the gateway hypotube 84 and the retracting hypotube 86 causes the separable lock to move to the distal end of the positioning rod. , thereby disengaging the lock from the cord 37. Once each cord is unlocked, the valve may be removed from deployment site 13 and/or repositioned at deployment site 13 .

In another aspect, the transcatheter valve 66 or 156 is repositioned and/or removed days to weeks after deployment of the valve. In this aspect, the suture is not cut but wrapped around a spool or other wrapping device. This device is then attached to the transcatheter valve upper edge 67 of valve 66 or to the transcatheter valve body 68 of valve 156 . A few days after deploying the valve and completing the procedure, the spool/wrapping device may be recaptured to allow unwinding and retrieval of the suture. Atrial positioning rods 147 are then positioned over each suture such that a portion of the suture is within inner rod lumen 149 . If the distal end 153 of the positioning rod is adjacent to or in contact with the separable lock 83, advancing the gateway hypotube 84 and the retracting hypotube 86 causes the separable lock to move to the distal end of the positioning rod. , thereby disengaging the lock from the cord 37. Once each cord is unlocked, the valve is removed from and/or repositioned at deployment site 13 .

While certain aspects of the invention have been disclosed in the foregoing specification, many modifications and other aspects of the invention to which the invention pertains have the benefit of the teachings presented in the foregoing specification and associated drawings. It will be appreciated by those skilled in the art that It is therefore understood that the invention is not limited to the particular aspects disclosed above, but that many modifications and other aspects are included within the scope of the appended claims. Moreover, although specific terms are employed herein and in the claims that follow, they are used in a generic and descriptive sense only and are not intended to limit the invention as described. not intended.

Claims (18)

An atrial sealing skirt configured to receive a valve, be introduced endovascularly, and be implanted at a deployment site, said atrial sealing skirt configured and sized to replace a natural heart valve. wherein the atrial sealing skirt is configured to substantially conform to and substantially rest on the atrial floor adjacent a deployment site of the atrial sealing skirt;
The atrial sealing skirt comprises:
an atrial skirt body that is generally cylindrical and defines a valve receptacle;
a lower edge of the atrial skirt extending circumferentially around the lower edge of the atrial skirt body, wherein the atrial sealing skirt is compressible when constrained and expands when released from constraint; , the lower edge of the atrial skirt and
at least one conduit having an open upper end defined by an aperture in said skirt body;
at least one extension member for supporting said skirt edge, said extension member having a base end adjacent said skirt body lower edge extending substantially outwardly to an outer edge of said skirt edge; at least one extension member, comprising:
at least one body support for supporting the skirt body;
a membrane covering said at least one extension member and said at least one body support to form said skirt edge and body;
an atrial sealing skirt. The atrial sealing skirt of claim 1, wherein the atrial sealing skirt body defines a valve receptacle, the atrial sealing skirt body configured to receive a valve. 2. The atrial sealing skirt of claim 1, wherein the at least one conduit is configured to receive a locking system for locking the atrial sealing skirt positioned on the atrial floor. 4. The atrial sealing skirt of Claim 3, wherein the locking system comprises a separable lock positioned within the conduit to lock the inferior rim against the atrial floor. 2. The atrial sealing skirt of claim 1, wherein the atrial skirt edge is generally convex prior to conforming with the atrial floor. An anchor assembly for anchoring a mitral valve to the interventricular septum of the heart to replace a natural mitral valve by minimally invasively implanting the mitral valve, comprising:
An anchor comprising an anchor screw configured for implantation in the interventricular septum, said anchor extending from a proximal end of said anchor base and an anchor base extending from said anchor screw proximal end. and an anchor shaft extending proximally from the anchor base;
a connector rod having a distal end configured to cooperate with the anchor base to selectively connect to the anchor base; and an anchor connector defining a channel for receiving the connector rod. An anchor delivery system, wherein the anchor connector is configured to receive the anchor shaft;
An anchor assembly, comprising: The anchor shaft includes at least one locking member, the at least one locking member extending radially outward from the anchor shaft and cooperating with a proximal end face of the anchor connector. 7. The anchor assembly of claim 6, wherein the assembly is configured as: 7. The anchor assembly of claim 6, wherein the anchor assembly further comprises at least one stabilizer, the at least one stabilizer extending radially outwardly from the anchor base adjacent the anchor screw. 9. The anchor assembly of claim 8, wherein said at least one stabilizer is non-linear. 9. The anchor assembly of claim 8, wherein the at least one stabilizer extends radially outward at an acute angle to the horizontal axis of the anchor base. The distal end of the connector rod has a first surface configuration and the anchor shaft defines a channel having a second surface configuration, the first surface configuration and the second surface configuration comprising: , in mating engagement to connect the connector rod to the anchor shaft. 12. The anchor assembly of claim 11, wherein said connector rod is removable from said anchor shaft. The anchor assembly further comprises a tether assembly including a docking ring and at least one tether rod, the docking ring configured to receive the anchor connector, the at least one tether - Anchor assembly according to claim 7, wherein a rod extends proximally from said docking ring. The at least one locking member moves between a first locking position and a second position, wherein the at least one locking member moves outside the anchor cap in the first locking position. extending a first distance from a surface, wherein in said second position said at least one locking member extends a second distance from said outer surface, said first distance being greater than said second distance; 14. Anchor assembly according to claim 13, longer than the distance. The tether docking ring, when positioned over the at least one locking member, urges the at least one locking member from the first locking position to the second position; A docking ring is positioned distally of the at least one locking arm on the anchor cap such that the at least one locking member locks the docking ring in the first locking position. 15. The anchor assembly of claim 14, mating. 1. A system for implanting an anchor in the interventricular septum of the heart to replace the native mitral valve by minimally invasive fixation of the mitral valve, said system comprising:
An anchor assembly comprising an anchor distal end configured for implantation into the interventricular septum at an implantation site, said anchor assembly comprising: an anchor base extending from a proximal end of said anchor distal end; an anchor assembly comprising a flexible connector flexibly connected to a proximal end of the anchor base; and an anchor shaft extending proximally from the flexible connector;
An anchor delivery system including a connector rod and an anchor connector, wherein the anchor connector is configured to be positioned over the anchor base to connect the anchor delivery system to the anchor assembly. an anchor delivery system comprising:
a tether docking system including a docking ring and at least one tether arm extending from the docking ring;
with
the anchor assembly configured to lock the anchor connector to the anchor base;
The anchor assembly is configured to be advanced over a guidewire adjacent the interventricular septum so that the anchor distal end penetrates the interventricular septum at the implantation site and exits on the contralateral side. cage,
A system, wherein the tether docking system is configured to be advanced over the anchor connector. 17. The system of claim 16, wherein the anchor distal end is an anchor screw and advancing the anchor assembly through the interventricular septum comprises rotating the anchor screw. 17. The system of claim 16, wherein the anchor assembly further comprises at least one stabilizer for stabilizing the anchor distal end, the at least one stabilizer extending radially outwardly from the anchor base. .

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