Valve anchor and method of installation

Abstract

This application relates to valve anchors and methods of installation. Anchoring devices and methods for securing a prosthetic valve to a native valve annulus are described. The anchoring device can be a separate expandable element from the prosthetic valve, the anchoring device is first advanced to the annulus and deployed, then the expandable prosthetic valve is advanced into the annulus and deployed. The combination of the two elements can apply a clamping force to the valve leaflets that holds the prosthetic valve in place. The anchoring device can have a lower or ventricular portion and an upper or atrial portion. The anchoring device can include one or more leaflet clamping portions. One, two or more upright vertical posts between the clamping portions can extend upwardly from the valve commissures and support an upper portion, which can include one or more structures for preventing leakage.

Description

[0001] This application is a divisional application of the original application with the filing date of May 17, 2018, application number 201880033559.0, and the title of "Valve Anchors and Methods of Installation".

[0002] Cross Reference to Related Applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 509,278, filed May 22, 2017. This application is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0004] The present invention relates to repairing or replacing native valves, including devices for anchoring or docking a prosthetic valve on a native valve and corresponding methods of installation. BACKGROUND

[0005] The heart is a hollow muscular organ having four pumping chambers separated by four heart valves: the aortic valve, the mitral or bicuspid valve, the tricuspid valve, and the pulmonary valve. Heart valves are composed of a dense fibrous ring, called the annulus, and flexible tissue leaflets or cusps attached to the annulus.

[0006] Congenital, inflammatory, or infectious conditions can render a heart valve less effective. Such conditions can eventually lead to serious cardiovascular compromise or death. For many years, the definitive treatment for such disorders has been surgical repair or replacement of the valve during open-heart surgery, i.e., sewing a prosthetic valve into place while the patient is on cardiopulmonary bypass. Such surgery is time-consuming, risky, and prone to complications.

[0007] Less invasive transvascular and transapical techniques can be used to introduce and implant a prosthetic heart valve while the heart is beating and off-pump. For example, a prosthetic valve can be mounted in a crimped state on the end of a flexible catheter and advanced through the patient's blood vessels until the valve reaches the implant site. The valve at the catheter tip can then be expanded to its functional size at the site of the defective native valve, such as by inflating a balloon on which the valve is mounted. Alternatively, the valve can have a resilient, self-expanding stent or frame that expands the valve to its functional size as it is advanced from a delivery sheath at the distal end of the catheter. These are sutureless techniques that can greatly reduce procedure time.

[0008] One issue with a sutureless valve is the potential for valve migration. For example, when aortic prosthetic valves are deployed, a pressure of 100-200 mmHg is immediately loaded on the aortic valve. The pressure multiplied by the valve surface area creates a substantial load force on the prosthetic valve and can cause migration of the valve toward the aortic arch.

[0009] Treatment of the mitral valve can present other challenges, and approaches and devices suitable for aortic valves can not work well with the mitral valve. For example, the mitral valve includes a cluster of chordae tendinae extending from the valve leaflets to the ventricular wall, which can interfere with placement of a prosthesis. The shape of the mitral valve - not as circular and uniform as the aortic valve - can be elliptical or reniform, which can be less suitable for a conventional stent supporting a cylindrical configuration. Further, whereas the aortic annulus is typically completely surrounded by muscle tissue, the mitral annulus can be tethered only by muscle tissue on the outer (posterior) wall. The anterior side of the mitral annulus is tethered by the thin tube wall of the left ventricular outflow tract ("LVOT"), which must remain open to allow blood to pass into the aorta. As a result, stent-type fixation can not be suitable for the mitral valve because the anterior side of the native valve has insufficient radial strength and can distort, risking occlusion of the left ventricular outflow tract. Moreover, mitral valve disease is often accompanied by (or attributed to) gradual enlargement of the native annulus and / or left ventricle. Thus, as the size and shape of the annulus changes, treatment approaches that rely on radial engagement with or outward compression against the native annulus can fail.

[0010] Despite certain advances, there remains a need for improved methods, systems, and devices for implanting a prosthetic heart valve into a mitral annulus. SUMMARY

[0011] This summary is intended to provide examples, and is not intended to limit the scope of the application in any way. For example, any feature of the examples included in this summary is not required by the claims. Also, features described herein and elsewhere in the application can be combined in a variety of ways.

[0012] The present application discloses embodiments of anchoring devices and methods for securing a prosthetic heart valve to a native heart valve annulus. The anchoring device can be a separate expandable element from the heart valve prosthesis, which can be first advanced to the native annulus and deployed, after which the expandable heart valve prosthesis can be advanced to and deployed within the native annulus and / or the anchoring device. The combination of the anchoring device and the heart valve prosthesis can exert a clamping force on the heart valve leaflets that holds the prosthetic heart valve in place.

[0013] An anchoring device can have a lower portion (e.g., a ventricular portion disposable / positionable in a left ventricle) and an upper portion (e.g., an atrial portion disposable / positionable in a left atrium). The lower portion can include one or more leaflet clamping portions, e.g., two leaflet clamping portions opposite each other, radially positioned outside of native valve leaflets. One, two, or more upstanding vertical posts between the clamping portions can extend upward at the valve commissure and support the upper portion, which can include one or more structures for preventing leakage.

[0014] An anchoring device herein can be used to secure a prosthetic valve at a native valve (e.g., between an atrium and a ventricle, such as a mitral or tricuspid valve). The anchoring device can include a lower or ventricular portion and an upper or atrial portion. The lower or ventricular portion can be inferior to the upper or atrial portion. The lower or ventricular portion can have an expandable tubular body about a vertical axis and can include struts (e.g., undulating struts). The tubular body can define one, two, three, or more leaflet clamping portions (e.g., two leaflet clamping portions opposite each other). Each can be defined by at least one upwardly extending peak. There can also be a downward valley on opposite sides of the lower or ventricular portion or peak (e.g., between the two leaflet clamping portions). The anchoring device can be configured to receive and / or optionally include an expandable prosthetic valve within the anchoring device that expands.

[0015] The anchoring device can further include one or more upstanding vertical posts, e.g., one upstanding vertical post beginning at each valley of the undulating struts and extending upward beyond the maximum height of the peaks of the two leaflet clamping portions and terminating in the upper or atrial portion. The vertical posts can be located less than 180° from each other about the circumference of the anchoring device (e.g., if only two posts are used, they can but need not be spaced 180° apart). The upper or atrial portion can include an annular ring of porous material attached to the top ends of the vertical posts. The annular ring of porous material can be selected from polyester fabric, porous polymeric material, ePTFE, foam, other materials, or some or all of the foregoing. The upper or atrial portion can include a pair of Y-shaped struts at the end of each vertical post, which pair of Y-shaped struts can optionally include a covering. The atrial portion can include a wirering at the end of each vertical post, which wirering can optionally include a covering.

[0016] The clamping portions can each include at least two peaks and one valley therebetween. The clamping portions can be covered (e.g., with fabric, coating, polymeric material, and / or other materials).

[0017] Each pillar can have various identical or different shapes. As an example, each pillar can include an undulating S-shape, terminating asymptotically at each end at the peaks and valleys. Pillars can also define a sinusoidal pattern.

[0018] The lower or ventricular portion may include one or more integrally formed downwardly extending legs that terminate in latches below the valley to facilitate manipulation and deployment of the anchoring device. Each leg may extend downwardly from one of the peaks of the clamping portion. In one embodiment, there are three legs and three latches. The latches may be formed into square, rectangular, or other shapes with holes passing through them.

[0019] Additional parts and / or components described elsewhere in this document may also be used.

[0020] The methods described herein (e.g., the beating heart method) can be used to anchor a prosthetic valve to a natural valve (e.g., a natural valve between the atria and ventricles). The natural valve has natural leaflets (and optionally, chordaes attached in the ventricle) and commissures between the leaflets at the natural annulus of the natural valve. The method may include advancing an anchoring device to the natural valve, the device having a lower (e.g., ventricular) portion and an upper (e.g., atrium) portion. The lower or ventricular portion may have an expandable tubular body around a vertical axis, the expandable tubular body including undulating struts.

[0021] In one embodiment, the tubular body has two lobule clamping portions opposite each other. Each of the two lobule clamping portions is defined by at least one peak and two valleys between the two lobule clamping portions. The anchoring device further includes two upright vertical posts, each vertical post starting at a separate valley of an undulating strut and extending upward beyond the maximum height of the peaks of the two lobule clamping portions and terminating in the upper or atrial portion. The anchoring device struts may be nitinol, and each clamping portion may have at least two peaks and one valley therebetween. The clamping portions may be covered with fabric.

[0022] The atrial portion can be formed in a variety of ways. For example, the atrial portion may include a tubular foam component. The atrial portion may also include a pair of Y-shaped struts at the end of each vertical column. A fabric cover may be included across each pair of Y-shaped struts. Optionally, the atrial portion includes a coil at the end of each vertical column. A cover may be included across the coil.

[0023] The method may also include expanding the lower or ventricular portion of the device below the valve annulus (e.g., in the ventricle) and radially positioning the two leaflet clamps outside their respective leaflets of the natural leaflets. The method may also include positioning uprights such that they project upward at the valvular suture (e.g., two uprights at the valvular suture) and support the upper or atrial portion above the natural valve annulus (e.g., in the atrium).

[0024] The method may also include advancing the expandable prosthetic valve into the natural leaflet and expanding the expandable prosthetic valve to compress the natural leaflet outward against the leaflet clamp of the device. Optionally, one access or delivery system or two separate access or delivery systems may be used to deploy the anchoring device and the prosthetic valve.

[0025] Additional steps described elsewhere in this document may also be used, and the steps of the method may be reordered.

[0026] A system for securing a prosthetic valve to a natural valve may include an expandable / collapsible anchoring device having a first portion or lower portion below a second portion or upper portion, the first portion or lower portion having an expandable tubular body around a vertical axis and including a strut (e.g., an undulating strut, etc.), the tubular body defining a leaflet clamping portion defined by at least one upwardly extending peak, wherein a downward valley exists on the first portion or lower portion adjacent to at least one leaflet clamping portion, the device further including an upright vertical column that begins at the downward valley and extends upward beyond the maximum height of at least one peak of the leaflet clamping portion and terminates in the second portion or upper portion.

[0027] The system may also include one or more additional leaflet holding portions (e.g., second leaflet holding portions). The leaflet holding portions may be defined by at least one or more upwardly extending peaks. In one embodiment, each holding portion includes at least two peaks and a valley therebetween. The leaflet holding portions (one or more) may be covered with fabric.

[0028] The supports can take various shapes and configurations. In one embodiment, the device includes undulating supports, each of which has an S-shape and terminates abruptly at its ends at peaks and valleys.

[0029] The system may include one or more additional vertical posts (e.g., a second upright vertical post). In one embodiment, the vertical posts begin at a second downward valley and extend upward beyond the maximum height of at least one peak of the leaflet clamping portion, terminating in the second or upper portion. The vertical posts may be positioned less than 180° apart from each other around the circumference of the anchoring device. This may be advantageous when the natural commissures are not positioned 180° apart from each other (e.g., when installed in the mitral valve).

[0030] The lower portion may include one or more integrally formed downwardly extending legs that terminate in a snap-fit ​​below the valley to facilitate manipulation and deployment of the anchoring device. In one embodiment, at least one of the legs extends downwardly from at least one peak of the leaflet clamping portion. In one embodiment, three downwardly extending legs and snap-fits are present. The snap-fits may be formed into a square, rectangle, or other shape with holes passing through them.

[0031] The second part or upper portion may include an annular ring of porous material attached to the top of the vertical column. The annular ring of porous material may be selected from polyester fabric, porous polymer materials, ePTFE, and foam or other materials. The second or upper portion may include a pair of Y-shaped supports at the end of each vertical column. A fabric cover may be included across each pair of Y-shaped supports. The second part or upper portion may include a coil at the end of each vertical column. A fabric cover may be included across the coil.

[0032] The system may also include an expandable prosthetic heart valve that can expand within the anchoring device.

[0033] Additional parts and / or components described elsewhere in this document may also be used.

[0034] The methods described herein (e.g., methods for securing a prosthetic valve to a natural valve) may include advancing an anchoring device into the natural valve. The anchoring device may be the same as or similar to other anchoring devices described elsewhere herein. For example, the anchoring device may have a first or lower portion and a second or upper portion. The first or lower portion may have an expandable tubular body around a vertical axis, the tubular body including struts (e.g., undulating struts). The tubular body may have one or more leaflet clamping portions. The leaflet clamping portions may be defined by at least one peak and a valley adjacent to said at least one peak. The anchoring device may further include one or more upright vertical columns. The upright vertical columns may begin at a valley of the undulating struts and extend upward beyond the maximum height of at least one peak of the leaflet clamping portion and terminate in the second or upper portion. The anchoring device struts may be nitinol, and each clamping portion may have one or more peaks and valleys therebetween (e.g., at least two peaks and one valley). The clamping portions may be covered with fabric.

[0035] The second part or upper part may include tubular foam components. The second or upper part may include a pair of Y-shaped supports at the end of each vertical column. A fabric cover may be used across each pair of Y-shaped supports. The second part or upper part may include coils at the end of each vertical column and may include a cover spanning the coils.

[0036] The method may further include expanding a first portion or lower portion of the device below the natural valve or natural annulus, and may include radially positioning a leaflet clamping portion outside at least one leaflet of the natural leaflet of the natural valve. The method may also include positioning an upright vertical column such that it protrudes upward at the natural valve commissure and supports a second portion or upper portion above the natural annulus or natural valve.

[0037] The method may also include advancing an expandable prosthetic valve into a natural leaflet and expanding the prosthetic valve to compress at least one leaflet outward against the leaflet clamp.

[0038] Methods may include using the same access or delivery system to deploy the anchoring device and the prosthetic valve, or using two separate access systems.

[0039] Additional steps described elsewhere in this document may also be used, and the steps of the method may be reordered.

[0040] Other features and advantages of the invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings, which illustrate the principles of the invention by way of example. Attached Figure Description

[0041] Figure 1A It is a schematic three-dimensional view of the mitral valve from the atrial side and a cross-sectional view of the subvalvular anatomical part of the left ventricle;

[0042] Figure 1B It is an atrial plan view of the mitral valve leaflets, which is indicated by the first letters of the commonly used names that indicate routine anatomical features;

[0043] Figure 1C It is a laid-flat diagram of the mitral valve leaflets and the subvalvular structures with anatomical descriptors.

[0044] Figure 2A and 2B These are side perspective and top perspective views of an exemplary anchoring device of this application, featuring an undulating ventricular portion and a tubular leak-proof atrial portion. Figure 2C It is its exploded diagram;

[0045] Figure 3A It is similar to Figure 1A A schematic perspective view of the mitral lobe at the location of the anchoring device when deployed is shown.

[0046] Figure 3B It is a tiled view of the mitral valve and part of the deployed anchoring device;

[0047] Figure 3C It is similar to Figure 3A A schematic three-dimensional view of the delivery of a prosthetic heart valve within the anchoring device;

[0048] Figures 4A to 4D This is an exemplary leak-proof atrial portion that can be used with the anchoring device described herein;

[0049] Figure 5 It is an atrial plan view of the mitral valve leaflet indicating the exemplary dashed outline of the anchoring device used in this article;

[0050] Figure 6 It is configured to be with Figure 5 A plan view of only the lower or ventricular portion of the anchoring device that matches the dashed outline;

[0051] Figure 7 It is a front view of the lower or ventricular portion of the exemplary anchoring device, with undulating dashed lines superimposed on the exemplary anchoring device;

[0052] Figure 8 It is shaped like Figure 7 The undulating dashed lines in the image represent the lower part or ventricular section of an alternative anchoring device;

[0053] Figure 9 This is a front view of the lower or ventricular portion of a further exemplary anchoring device with an undulating shape and fabric covering. Detailed Implementation

[0054] The following description and accompanying drawings (which describe and show certain embodiments) illustrate, in a non-limiting manner, several possible configurations of systems, platforms, apparatuses, methods, etc., that can be used in various aspects and features of this disclosure.

[0055] An anchoring device is described for assisting in the implantation of a prosthetic heart valve at a natural valve (e.g., mitral, tricuspid, etc.). The anchoring device can be separate from the prosthetic heart valve and implanted individually before the prosthetic valve. Once the anchoring device has been placed at the natural valve (e.g., mitral, etc.), the prosthetic heart valve is delivered and coupled thereto. This process can be accomplished using a combined or two separate catheters, delivery systems / devices, or access systems / devices. While examples are given regarding the mitral valve, the use of the devices, systems, methods, etc., described herein is not limited to use with the mitral valve but can be applied to other valves (e.g., aortic, pulmonary, tricuspid) or other locations.

[0056] Anchoring devices can be used in conjunction with various types of expandable valves, such as balloon-expandable prosthetic heart valves (e.g., the Edwards SAPIEN 3 transcatheter heart valve (THV) manufactured by Edwards Lifesciences, Irvine, California, or as described in U.S. Patent No. 6,730,118, which is expressly incorporated herein by reference). However, these exemplary THVs should not be construed as limiting, and embodiments of the disclosed anchoring devices (one or more) can be used to anchor a wide variety of THVs delivered by various mechanisms (e.g., self-expanding heart valves, other balloon-expandable heart valves, mechanically expandable heart valves, etc.). The term "expandable heart valve" is intended to encompass all such types.

[0057] For anchoring devices (one or more) and prosthetic heart valves, exemplary delivery routes through the body and into the heart include transvascular (e.g., via the femoral artery), transapical, and transaortic routes. In the transvascular approach, the catheter can be inserted into the vascular system at a site relatively distal to the heart. The anchoring device or prosthetic valve can be mounted in a folded state on the tip of a flexible catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the catheter tip is then expanded to its functional size at the site of the defective natural valve, such as by inflating a balloon (on which the valve is mounted).

[0058] Various delivery or access systems with catheters or sheaths can be used. Anchoring devices and prosthetic heart valves can be deployed using a single access or delivery system for near-simultaneous delivery, or using two separate systems for sequential delivery. U.S. Patent No. 8,439,970 discloses a delivery system suitable for introducing a prosthetic valve into the heart in a transapical procedure, which is incorporated herein by reference. In a transapical procedure, the prosthetic valve is introduced into the left ventricle through a surgical opening in the apex of the heart. Similarly, the delivery system of the '970 patent can be used to introduce a prosthetic valve into the heart in a transaortic procedure. In a transaortic procedure, the prosthetic valve is introduced into the aorta through a surgical incision in the ascending aorta (e.g., via a partial J-sternotomy or a right parasternal microthoracotomy) and then advanced toward the heart through the ascending aorta. Percutaneous or transcatheter delivery systems are also possible.

[0059] Figure 1AThis is a schematic three-dimensional view of the mitral valve 200 from the atrial side and a cross-sectional view of the subvalvular anatomy of the left ventricle 202. The mitral valve 200 mainly comprises a pair of conjoined leaflets—anterior leaflet 204 and posterior leaflet 206—which are fixed to the fibrous mitral annulus 208 around their outer edges. The inner edges of the anterior leaflet 204 and posterior leaflet 206 are connected to string-like chordae tendineae 210 (extending downward into the left ventricle 202) and are tethered to papillary muscles 212 extending upward from the muscular myocardium 214 that defines the left ventricular cavity. As the main pumping chamber of the heart, the myocardium 214 contracts during systole, reducing tension in the chordae tendineae 210 and allowing the leaflets 204, 206 to converge or conjoin. The contraction of the volume within the left ventricle 202 pumps blood out through the aortic valve (not shown) and into the body. During diastole, the myocardium 214 expands outward, and under tension, it pulls down on the chordae tendineae 210 to help open the leaflets 204 and 206, and pulls blood through the mitral valve 200 to fill the cavity of the left ventricle 202.

[0060] Figure 1B This is an atrial plan view of the leaflets 204 and 206 of the mitral valve 200. The surrounding mitral annulus 208 is typically described as D-shaped, having a somewhat straight side adjacent to the anterior leaflet 204 and a more rounded or convex side adjacent to the posterior leaflet 206. The leaflets are shaped such that the junctional line resembles a smile, approximately parallel to the posterior aspect of the mitral annulus 208. The anterior leaflet 204 has a smaller span in the peripheral aspect surrounding the mitral annulus 208 than the posterior leaflet 206, but the anterior leaflet 204 has a single cusp with a convex free edge that extends further into the orifice defined by the mitral annulus 208. Typically, the anterior leaflet 204 has three marked regions or cusps A1, A2, and A3 around its periphery. On the other hand, the posterior lobule 206 is typically divided by creases into three pointed projections P1, P2, and P3 around its periphery, and has a generally concave free edge. The two commissures (anterior commissure 220 and posterior commissure 222) generally define the intersection (crossing, intersecting) of the junctional line between the two lobes 204, 206 and the mitral annulus 208. As will be seen, the areas at the anterior commissure 220 and posterior commissure 222 may not be so clearly defined, and sometimes the projections or lobes are defined at those points.

[0061] Figure 1CThis is a tiled view of the mitral valve leaflets 204 and 206 and the subvalvular structures with anatomical descriptors. Specifically, the free edges of the anterior leaflet 204 and posterior leaflet 206 (and the commissural leaflet 224, if present) are connected to the chordae tendineae 210, and then to the subvalvular papillary muscles. Two papillary muscles are present—anterolateral and posteromedial papillary muscles 226 and 228. From each of the papillary muscles, an upwardly extending chordae tendineae connect to portions of the leaflets 204 and 206. The coronary sinus 230 and circumflex artery 232 are also shown in the cardiac wall outside the left ventricle 202.

[0062] Figure 2A and 2B These are side perspective views and top perspective views of an exemplary anchoring device 20 of this application. The anchoring device 20 has an undulating lower portion 22 (generally referred to as the "ventricular portion," but can be used in other locations) and a tubular, leak-proof upper portion 24 (generally referred to as the "atrial portion," but can be used in other locations). Figure 2C This is its exploded diagram.

[0063] The ventricular portion 22 of the example anchoring device 20 includes a plurality of peaks 30 that alternate uniformly with an equal number of valleys 32 in an undulating manner around the circumference of the ventricular portion. In one exemplary embodiment, there are six peaks 30 spaced 60° apart, each spaced 30° apart from an adjacent valley 32. The peaks 30 and valleys 32 are preferably located in a tubular space such that the peaks 30 are positioned above the valleys 32 along a Z-axis that is generally parallel to the blood flow through the mitral valve when the device is implanted.

[0064] Descending and ascending circular struts 34, 36 connect every two adjacent peaks 30 and valleys 32. More specifically, when viewed downwards along the Z-axis, the first circular strut 34 extends downwards in a clockwise (CW) direction from each of the peaks 30 to each of the valleys 32, and the second circular strut 36 extends upwards from the valley CW to the next peak. The circular struts 34, 36 can typically be S-shaped, with two distinct curvatures separated by inflection points. More specifically, each of the struts 34, 36 can terminate asymptotically at its corresponding peak and valley, such that it is almost aligned with the vertical Z-axis. Figures 2A to 2C One of the circumferential struts 34 extending between peak 30 and valley 32 initially extends downward in a nearly vertical direction and has a concave upward curvature until it reaches an inflection point at the midpoint of the strut. From there, the second segment is concave downward until it is nearly vertical at valley 32. The second circumferential strut 36 may have a similar or different shape. As will be explained, struts 34, 36 may be deployed such that they are in direct contact with the natural heart valve leaflets, and this S-shaped configuration enhances their ability to clamp or hold the leaflets over a wide area against the dilatable heart valve (located within the leaflets).

[0065] exist Figures 2A to 2C In the example implementation, peak 30 and valley 32 are configured to be of the same shape and have generally flat ends. Optionally, peak 30 and valley 32 can be rounded or sharper, and the peak can be a different shape than the valley. For example, peak 30 may have a larger radius than valley 32, and vice versa. Additionally, although struts 34, 36 may be asymmetrical, such that peak 30 appears longer than valley 32 (and vice versa), struts 34, 36 are generally identical and have an inflection point midway along the Z-axis. Apart from the two locations that will be seen, the undulating shape of the ventricular portion 22 allows the anchoring device 20 to be partially fitted to the exterior of the mitral valve leaflet.

[0066] The ventricular portion 22 can be connected to the atrial portion 24 via one or more upright connecting posts 40 (e.g., one, two, three, or more upright connecting posts). In an exemplary embodiment, as will be described below, there are two posts 40, which are diametrically opposed to each other and extend upward from two of the valleys 32, which are generally arranged opposite each other and between the clamping portions of the ventricular portion 22. The posts 40 extend upward beyond the upper extent of the peaks 30 and can be embedded and secured within the tubular atrial portion 24. The atrial portion 24 may comprise an annular loop of a porous material (such as polyester fabric, porous polymer material, ePTFE, or foam). The means of connecting the connecting posts 40 to the atrial portion 24 may be by adhesive, suture, latches, friction, etc. Optionally, the posts 40 may have some barbs or roughness to achieve simple friction retention. Furthermore, the posts 40 may be covered with fabric or have one or more eyelets and be sewn to the atrial portion 24.

[0067] The ventricular portion 22 may further include one or more downwardly extending legs 42 terminating at a snap fastener 44 to facilitate the manipulation and deployment of the anchoring device 20. In an exemplary embodiment, the snap fastener is formed as a square or rectangle with a hole passing through it. The snap fastener 44 may be integrally formed with the ventricular portion 22 and preferably extends downward from one or more peaks 30. In this respect, the term "integrally formed" means that the snap fastener 44 is homogeneously formed as a single piece with the rest of the ventricular portion 22, or that the snap fastener is secured to the ventricular portion 22 in a manner that allows manipulation of the snap fastener to manipulate the internal body. For example, after the snap fastener 44 and the ventricular portion 22 are manufactured, the snap fastener 44 may be welded to the ventricular portion 22.

[0068] Now for reference Figure 3AThe diagram shows an anchoring device 20 deployed at the mitral valve, with its central ventricular portion 22 below the mitral annulus 208 and its atrial portion 24 positioned above the annulus. An upright commissure post 40 connects the two portions and extends across the mitral annulus 208 at the anterior commissure 220 and posterior commissure 222.

[0069] Figure 3B This is a tiled view of the mitral valve and the deployed anchoring device 20 (with the atrial portion 24 removed for clarity). As mentioned, except at the two syndesmotic posts 40, the undulating shape of the ventricular portion 22 allows the anchoring device 20 to be partially fitted to the exterior of the mitral valve leaflets 204, 206. That is, all three peaks 30 of the ventricular portion 22 are on the exterior of the leaflets, while the valleys 32 are on the interior of the leaflets, with the syndesmotic posts 40 extending upward from the valleys 32. Thus, the syndesmotic posts 40 can extend upward at the two valve syndesmotic points 220, 222 to support the atrial portion 24 above the valve annulus. Meanwhile, the majority of the ventricular portion 22 is located on the exterior of the leaflets to provide an anchor against which the subsequently deployed prosthetic valve can be secured. The portion of the ventricular portion 22 on the exterior of the leaflets defines the clamping portion of the anchoring device 20 and can have different configurations as described below. Furthermore, the various anchoring devices described herein may include two clamping portions as shown or an additional number (e.g., one, three, or more) of clamping portions. The ventricular portion 22 "undulates" only in the sense that the clamping portions rise from the valley 32, and the commissure post 40 protrudes from the valley 32. Again, the valley 32 is positioned between the clamping portions, and the commissure post 40 protrudes from the valley 32.

[0070] An exemplary off-beat method for securing a prosthetic heart valve at the mitral valve 200 between the left atrium 234 and the left ventricle 202 includes advancing the anchoring device 20 to the mitral valve and expanding the ventricular portion 22 of the device within the left ventricle. Using forceps or other manipulatory tools, two leaflet clamps are radially positioned outside the respective leaflets of the two leaflets 204, 206. The surgeon then positions the uprights 40 such that they protrude upward at the junctions 220, 222 of the two natural valves and support the atrial portion 24 above the mitral valve annulus in the left atrium. Subsequently, the expandable prosthetic heart valve is advanced within the mitral valve leaflets 204, 206 and expanded to compress the leaflets outward against the two leaflet clamps of the anchoring device 20.

[0071] Figure 3C It is similar to Figure 3AA schematic perspective view of the prosthetic heart valve 50 after delivery within the anchoring device 20. As mentioned, the prosthetic heart valve 50 can expand outward and sandwich the mitral valve leaflets 204, 206 (abutting against the inner surface of the clamping portion of the ventricular portion 22). As mentioned above, the prosthetic heart valve 50 can be constructed in various ways and can include an expandable structural support or frame 52 supporting the flexible leaflets 54 (such as bovine pericardial leaflets). The top edge of the frame 52 can be deployed such that it terminates within the anchoring device 20 and, as shown, within the atrial portion 24. The ventricular portion 22 of the anchoring device 20 has sufficient circumferential strength to provide a strong inward reaction force against the expandable frame 52, which in turn provides sufficient compression of the mitral valve leaflets 204, 206 to secure the valve 50 in place. Then the flexible leaflet 54 of the prosthetic heart valve 50 functions normally and replaces the natural leaflet.

[0072] Figures 4A to 4D This is an exemplary leak-proof atrial section that can be used with the anchoring device described herein. For example, the tubular atrial section 24 shown above can be replaced by a smaller structure that can provide various plugs at the natural valve commissures 220, 222 and / or exert clamping forces on the two mitral valve leaflets 204, 206 at the commissures, in both cases helping to reduce upward blood regurgitation around the prosthetic heart valve 50 (referred to as "paravalvular leakage").

[0073] For example, Figure 4A A pair of Y-shaped struts 60 formed on the upper end of the vertical column 40 are shown. The struts 60 extend on the atrial side of the valvular commissures 220, 222 and curl around to contact the outer extents of the mitral leaflets 204, 206 and urge towards each other on the outer extents of the mitral leaflets 204, 206, thus closing off any opening that may form outside the prosthetic heart valve 50 at the natural commissure. Figure 4B It is a similar structure in which small fabric coverings 62 are added across the Y-shaped pillar 60, which further helps to seal off any blood leaks.

[0074] Figure 4C An alternative implementation is shown in which a coil 70 is provided at the top of each post 40. The coil 70 may be nitinol and is shaped to apply compressive force to the mitral leaflets 204, 206 at the natural valvular syndesmosis 220, 222, which helps to close any gaps that may allow leakage. Figure 4DThe same coil 70 (with a mesh or fabric cover 72 attached thereto) is shown on each post 40. The cover 72 can be a woven metal screen or a polymer fabric, and further helps to reduce periocular leakage.

[0075] Figure 5 This is an atrial plan view of the mitral leaflets 204, 206, indicating the exemplary circular dashed outline 80 for the anchoring device described herein. The center point 82 of the outline 80, and a horizontal axis 84 oriented approximately along the main axis of the mitral annulus through the center, can be drawn. That is, the mitral annulus is typically D-shaped, bean-shaped, or at least elliptical, with the longer dimension perpendicular to the shorter dimension. The shorter dimension, or minor axis, approximately bisects the two mitral leaflets 204, 206. Due to the mismatch in expansion of the circular anchoring device within the irregularly shaped mitral annulus, the horizontal axis 84 along the diameter of the anchoring device is unlikely to intersect with the natural valvular commissures 220, 222. Two dashed lines 86 are drawn from the center point 82 through the commissures 220, 222. Since the upright vertical columns connecting the ventricle and atrium of the anchoring device must pass through and be aligned with joints 220 and 222, they can be offset from the horizontal axis 84 around the anchoring device, and specifically positioned along the dashed line 86.

[0076] Figure 6 It is configured to be compatible with Figure 5 A top view of the ventricular portion only, matching the dashed outline of the anchoring device 90. The anchoring device 90 can be constructed as described above, such that a series of pillars 92 define the peak 94 in the middle of the valley 96. As previously mentioned, two upright pillars 98 project upwards at two points in the valley 96, but as... Figure 5 The and shown Figure 6 The two uprights 98, represented by the dashed line 86, are positioned slightly offset from the horizontal axis 84. The dashed line 86 is also shown and passes through the uprights 98. That is, the two uprights 98 are positioned less than 180° apart from each other around the circumference of the anchoring device 20. The angular offset of each upright 98, defined by the angle formed by the dashed line 86 and the horizontal axis 84, is expected to be between approximately 5° and 15°. In other words, the two uprights 98 are positioned between 150° and 170° apart from each other around the circumference of the anchoring device 20. This ensures that the uprights 98 are more closely aligned with the natural valve commissures 220, 222, thereby limiting deformation of the mitral valve annulus when the anchoring device 90 is implanted.

[0077] Figure 7 This is a front view of the ventricular portion of an exemplary anchoring device 20, with undulating dashed lines 100 superimposed on the anchoring device 20. The dashed lines 100 have a sinusoidal shape to illustrate the basic undulations of the support of the anchoring device 20.

[0078] Figure 8 This is a front view of the ventricular portion of the alternative anchoring device 102, which has a shape similar to... Figure 7 The undulating dashed line 100 represents the pillar 104. In this configuration, all peaks and valleys have rounded ends to help reduce any sharp edges and potential abrasion of the mitral leaflets.

[0079] Figure 9 This is a front view of the ventricular portion of a further alternative anchoring device 110 with undulating struts 112 and fabric covering 114. The number of peaks and valleys is reduced to a minimum of one peak between the valleys from which the upright strut 116 originates. This shows one extreme of the shape of the clamping portion of the anchoring device 110 and illustrates the meaning of undulation. That is, the anchoring device undulates between the clamping portion and the valleys, with the upright strut 116 protruding from the valleys. This allows the upright strut 116 to be positioned within the mitral leaflet, thus extending upwards to its atrial side. Simultaneously, the clamping portion rises and can be positioned outside the mitral leaflet for clamping engagement with a prosthetic valve. The clamping portion may consist of only one peak or curve upwards, or as... Figure 7 and 8 Multiple peaks in the structure. The fabric covering 114 can extend across multiple peaks and help avoid entanglement with the tendineae. Alternating peaks and valleys allow the anchoring device to be contracted into a smaller diameter profile for delivery through an inlet tube or sheath, but other compressible structures can be conceived.

[0080] Although the invention has been described with reference to the accompanying drawings of specific variations and examples, the invention is not limited to the described variations or drawings. Components described with respect to one embodiment or variation may be used in other embodiments or variations. Individually described methods may be combined. Furthermore, where the methods and steps described above indicate that certain events occur in a certain order, the order of certain steps may be modified, and such modifications are made according to variations of the invention. Additionally, some steps may be performed simultaneously in parallel processes where possible, and sequentially as described above. Many modifications may be made to adapt a particular situation or apparatus to the teachings of the invention without departing from the spirit and scope of the invention. Therefore, it is intended that the invention is not limited to the specific embodiments disclosed herein, and that variations of the invention exist within the spirit of this disclosure or equivalent to the invention found in the claims, and that this patent will also cover these variations.

Claims

1. A system for fixing a prosthetic valve to a natural valve, comprising: An expandable / collapseable anchoring device having a lower portion below an upper portion, the lower portion having an expandable tubular body around a vertical axis and including undulating struts, the tubular body defining at least two leaflet clamping portions each defined by at least one upwardly extending peak, wherein at least two downward valleys exist on the lower portion, one on each side of and adjacent to the at least two leaflet clamping portions, the anchoring device further including two and only two upright vertical columns, each of the upright vertical columns starting at one of the at least two downward valleys and extending upward beyond the maximum height of the at least one peak of the leaflet clamping portion and terminating in the upper portion, wherein the lower portion further includes two or more integrally formed downwardly extending legs, the legs extending downward below the peaks and terminating in snaps below the peaks to facilitate manipulation and deployment of the anchoring device.

2. The system of claim 1, wherein each of the clamping portions comprises at least two peaks and a valley therebetween.

3. The system of claim 1, wherein each clamping part is covered with fabric.

4. The system of claim 1, wherein each undulating pillar has an S-shape and terminates asymptotically at each end of the peak and valley.

5. The system of claim 1, wherein the upright vertical columns are configured such that the circumferences of the anchoring device are less than 180° from each other.

6. The system of claim 1, wherein at least one of the legs extends downward from at least one peak of the leaflet clamping portion.

7. The system of claim 1, wherein three of the downwardly extending legs and latches are present.

8. The system of claim 1, wherein the snap fastener is formed in the shape of a square or rectangle having a hole through which it passes.

9. The system of claim 1, wherein the upper portion comprises an annular ring of porous material attached to the top of the vertical column.

10. The system of claim 9, wherein the annular ring of the porous material is selected from polyester fabric, porous polymer material, ePTFE, and foam.

11. The system of claim 1, wherein the upper portion comprises a pair of Y-shaped struts at the end of each vertical column.

12. The system of claim 11, further comprising a fabric covering spanning each pair of Y-shaped supports.

13. The system of claim 1, wherein the upper portion includes a coil at the end of each vertical column.

14. The system of claim 13, further comprising a fabric covering spanning the coil.

15. The system of claim 1, further comprising an expandable prosthetic heart valve that expands within the anchoring device.

16. The system of claim 6, wherein the snap fastener is formed in the shape of a square or rectangle having a hole through which it passes.

17. The system of claim 7, wherein the snap fastener is formed in the shape of a square or rectangle having a hole through which it passes.

18. The system of claim 1, wherein the clamping portion is covered by fabric.

19. A system for securing a prosthetic valve to a natural valve, comprising: An expandable / collapseable anchoring device having a lower portion below an upper portion, the lower portion having an expandable tubular body around a vertical axis and including undulating struts and two vertical columns, the tubular body defining at least two leaflet clamping portions each defined by at least one upwardly extending peak, wherein the undulating struts define a downward valley on both sides of the at least two leaflet clamping portions and adjacent to each of the at least two leaflet clamping portions, and the expandable tubular body having an axial dimension extending between the peaks and the valleys, the anchoring device further including two and only two vertical columns, each of the vertical columns starting at the downward valley and extending upward beyond the maximum height of the at least two leaflet clamping portions and terminating in the upper portion.

20. The system of claim 19, wherein each of the clamping portions comprises at least two peaks and a valley therebetween.

21. The system of claim 19, wherein each of the clamping portions is covered by a fabric.

22. The system of claim 19, wherein each undulating pillar has an S-shape and terminates asymptotically at each end of the peak and valley.

23. The system of claim 19, wherein the two vertical posts are configured to be less than 180° apart from each other around the circumference of the anchoring device.

24. The system of claim 19, wherein the lower portion further comprises at least two integrally formed downwardly extending legs that extend downward below the peak and terminate in a snap below the peak to facilitate the manipulation and deployment of the anchoring device.

25. The system of claim 24, wherein at least one of the legs extends downward from at least one peak of one of the leaflet clamping portions.

26. The system of claim 24, wherein the snap fastener is formed in the shape of a square or rectangle having a hole through which it passes.

27. The system of claim 19, wherein the upper portion comprises an annular ring of porous material attached to the top of the vertical column.

28. The system of claim 27, wherein the annular ring of the porous material is selected from polyester fabric, porous polymer material, ePTFE, and foam.

29. The system of claim 19, wherein the upper portion comprises a pair of Y-shaped struts at the end of each vertical column.

30. The system of claim 29, further comprising a fabric covering spanning each pair of Y-shaped supports.

31. The system of claim 19, wherein the upper portion includes a coil at the end of each vertical column.

32. The system of claim 31, further comprising a fabric covering spanning the coil.

33. The system of claim 19, further comprising an expandable prosthetic heart valve that expands within the anchoring device.

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