Low-profile prosthetic mitral valve

Abstract

A low-profile prosthetic valve for treating a native valve includes a radially expandable frame having an expanded configuration and a collapsed configuration. An atrial end of the prosthetic valve forms a flared shape that engages a surface of an atrium of the native valve. The flared shape flares downward toward a ventricle of the native valve upon initial expansion, and then inverts the flared shape to form a tapered shape that tapers toward the ventricle and flares toward the atrium of the native valve upon full expansion. The prosthetic valve also has a plurality of prosthetic valve leaflets that open and close to control fluid flow through the prosthetic valve.

Description

[0001] Priority requirements

[0002] This application is non-provisional and claims the benefit of U.S. Provisional Patent Application No. 62 / 864,008 (Agency File No. 5131.019PRV), filed June 20, 2019, the entire contents of which are incorporated herein by reference. Background Technology

[0003] Mitral regurgitation, also known as mitral insufficiency, is a serious heart condition in which the mitral valve fails to close properly and prevents retrograde blood flow through the natural mitral valve. This condition can impair heart function and lead to weakness or even death.

[0004] Current treatments for mitral valve insufficiency include traditional surgical repair of the natural valve. Less invasive transcatheter treatments are under development. Attached Figure Description

[0005] In the accompanying drawings, which are not necessarily drawn to scale, similar reference numerals may describe similar parts in different views. Similar reference numerals with different letter suffixes may indicate different instances of similar parts. The drawings generally illustrate the various embodiments discussed herein by way of example rather than limitation.

[0006] Figure 1 This is a schematic diagram of the left ventricle of the heart, showing the blood flow during cardiac contraction.

[0007] Figure 2 This is a schematic diagram of the left ventricle of a heart with prolapsed leaflets in the mitral valve.

[0008] Figure 3A This is a schematic diagram of the heart in a patient with cardiomyopathy, where the heart is dilated and the lobules are not connected.

[0009] Figure 3B This shows the normal closure of the leaflet.

[0010] Figure 3C An abnormal closure is shown in an dilated heart.

[0011] Figure 4 The illustration shows mitral regurgitation in the left ventricle of a heart with damaged papillary muscles.

[0012] Figures 5A to 5B The diagram illustrates the anatomical structure of the mitral valve.

[0013] Figure 6A A top view of an example of a low-profile prosthetic valve is shown.

[0014] Figure 6B It shows Figure 6AExample of a ventricular anchor in the image.

[0015] Figure 6C It shows that it can be attached to Figure 6A The covering of the ventricular anchors in the valves.

[0016] Figure 6D It shows Figure 6A A three-dimensional diagram of the valves.

[0017] Figure 7A A top view shows another example of a low-profile prosthetic valve.

[0018] Figure 7B It shows Figure 7A Example of a ventricular anchor in the image.

[0019] Figure 7C It shows that it can be used in Figure 7B An example of a covering on a ventricular anchor.

[0020] Figure 7D It shows Figure 7A A 3D diagram of an example.

[0021] Figure 8A A top view shows another example of a low-profile prosthetic valve.

[0022] Figure 8B It shows Figure 8A The prosthetic valve is in a partially deployed configuration.

[0023] Figure 8C It shows Figure 8A The prosthetic valve is in its fully deployed configuration.

[0024] Figure 8D It shows Figure 8A The prosthetic valve is placed within the natural mitral valve.

[0025] Figures 9A to 9F A delivery catheter that is releasably attached to a prosthetic valve is shown.

[0026] Figures 10A to 10C A locking mechanism is shown for releasably connecting a prosthetic valve to a delivery catheter.

[0027] Figure 11 A side view is shown of a locking mechanism for releasably connecting a prosthetic valve to a delivery catheter.

[0028] Figures 12A to 12B A locking mechanism is shown for releasably connecting a prosthetic valve to a delivery catheter.

[0029] Figures 13A to 13DAn example of a method for deploying a prosthetic valve in a natural valve is illustrated.

[0030] Figure 14 An example of a prosthetic valve in a natural valve is shown.

[0031] Figures 15A to 15D Another example of a method for deploying a prosthetic valve in a natural valve is shown. Detailed Implementation

[0032] Traditional surgical repair of the mitral valve may be an effective treatment, but it requires open-heart surgery, long hospital stays, and recovery periods. Less invasive transcatheter treatments are under development and show promise, but implantation can be challenging, and many have not yet received regulatory approval for commercial distribution. Therefore, there is a need for improved devices to treat mitral valve dysfunction. At least some of these challenges are addressed through the examples disclosed in this article.

[0033] While the examples disclosed herein relate to implantable prosthetic mitral valves for the treatment of mitral regurgitation, those skilled in the art will understand that this is not intended to be limiting, and that the devices and methods disclosed herein can also be used to treat other heart valves such as tricuspid valves, aortic valves, pulmonary valves, and other valves in the body such as venous valves or any anatomical structure used to control the flow of fluids or other substances.

[0034] Cardiac Anatomy

[0035] Figure 1 The diagram illustrates the left ventricle (LV) of a normal heart (H) during contraction. The left ventricle (LV) is contracting, and blood flows outwards in the direction of the arrows, passing through the aortic valve (AV) and the tricuspid valve. Because the mitral valve is designed as a check valve to prevent backflow when the pressure in the left ventricle is higher than the pressure in the left atrium (LA), it prevents blood from flowing back or "regurgitating" through the mitral valve (MV). Figure 1 As illustrated in the diagram, the mitral valve (MV) comprises a pair of leaflets with free edges (FE) that are uniformly joined together to close. Opposite ends of the leaflets (LF) attach to surrounding cardiac structures along a ring-shaped region called the valve annulus (AN). The free edges (FE) of the leaflets (LF) are secured to the lower portion of the left ventricle (LV) via chordae tendineae (CT) (also referred to herein as tendons). The chordae tendineae (CT) comprise multiple branch tendons secured above the lower surface of each leaflet within the valvular leaflet (LF). The tendon (CT) is further attached to the papillary muscles (PM) extending upwards from the lower portion of the left ventricle and to the interventricular septum (IVS).

[0036] Now refer to Figures 2 to 4Many structural defects in the heart can lead to mitral valve prolapse because insufficient tension is transmitted to the leaflets via the tendon. When the other leaflet, LF1, maintains its normal contour, the two leaflets do not properly engage, and leakage will occur from the left ventricle (LV) to the left atrium (LA), as indicated by the arrow.

[0037] Regurgitation can also occur in patients with cardiomyopathy whose heart is dilated and enlarged to the point that the valve leaflets (LF) fail to properly connect. Figure 3A As shown in the diagram. The enlargement of the heart causes the mitral valve annulus to enlarge, thus preventing the free edges (FE) from meeting during systole. The free edges of the anterior and posterior lobules typically follow a line as shown in the diagram. Figure 3B The junction lines C shown are connected, but in patients with cardiomyopathy, a noticeable gap G may remain, such as... Figure 3C As shown in the image.

[0038] Mitral regurgitation can also occur in patients with ischemic heart disease whose papillary muscle PM function is impaired, such as... Figure 4 As illustrated in the diagram, when the left ventricle (LV) contracts during systole, the papillary muscles (PM) cannot contract sufficiently to achieve proper closure. As shown, lobules LF1 and LF2 then prolapse. Leakage from the LV to the left atrium (LA) occurs again, as indicated by the arrows.

[0039] Figure 5A The anatomy of the mitral valve (MV) is illustrated more clearly. The mitral valve (MV) is a bicuspid valve with an anterior (ANT) portion and a posterior (POST) portion. The valve consists of the anterior (aortic) leaflet (AL) and the posterior (mural) leaflet (PL). The chordae tendineae connect the AL and PL leaflets to the anterolateral papillary muscles (ALPM) and the posteromedial papillary muscles (PMPM). The AL and PL leaflets are connected to each other along lines called the anterolateral commissure (ALC) and the posteromedial commissure (PMC). The annulus (AN) lateralizes the leaflets, and two regions adjacent to the anterior portion of the annulus on opposite sides of the anterior leaflet are called the left fibrous triangle (LFT) and the right fibrous triangle (RFT). These regions are typically represented by solid-lined triangles. Figure 5B The left fiber triangle (LFT) and right fiber triangle (RFT) are illustrated more clearly.

[0040] Prosthetic valve

[0041] Prosthetic valves have been surgically implanted into the heart as a treatment for mitral regurgitation. Some of these valves are derived from animals, such as porcine valves, and others are prosthetic mechanical valves with or without tissue coverings. Recently, minimally invasive catheter techniques have been used to deliver prosthetic valves to the heart. These valves typically consist of an anchor for securing the prosthetic valve to the patient's heart and a valve mechanism attached to the anchor. The valve mechanism is typically a mechanical valve, a valve with animal tissue, or a combination thereof. Once implanted, a prosthetic valve takes over the malfunctioning natural valve, thereby reducing or eliminating valvular insufficiency. Some of these valves are difficult to deliver, and some are difficult to anchor accurately. Other, larger valves may obstruct the ventricles of the heart. While some of these valves appear promising, improvements are needed to address at least some of these challenges. The following specification discloses examples of prosthetic valves, delivery systems for prosthetic valves, and methods for delivering valves, which can overcome some of the challenges associated with existing prosthetic valves.

[0042] Figure 6A An example of a low-profile prosthetic mitral valve 600 is illustrated in a planar sectional view. The prosthetic mitral valve 600 is an expandable frame formed by multiple interconnected struts and can be cut from a flat sheet material such as stainless steel, nickel-titanium alloy, or other biocompatible materials. The prosthetic mitral valve 600 can be balloon-expandable or self-expandable. The expandable frame is in a flat planar configuration after being cut from the sheet material and can be heat-treated and shaped into the desired form as will be described below. The planar pattern includes multiple concentric annular rings 602, 604, formed by multiple struts extending around the periphery of the prosthesis. As the rings are closer to the center of the prosthetic valve, the diameter and circumference of the rings are smaller. Therefore, ring 602 has a larger diameter and a larger circumference than ring 604. Adjacent rings are connected to multiple radially extending struts 612 to form multiple closure units arranged circumferentially around the prosthetic valve, wherein adjacent closure units share at least one common strut. Each ring 602, 604 may include multiple circumferentially oriented struts all having the same geometry. For example, the outermost ring 602 includes a plurality of forked struts connected together to form an annular ring. The forked struts in ring 602 may all be identical and may include two relatively inclined struts connected to an arcuate strut, the arcuate strut forming a protrusion or peak in the forked strut at the inflection point between the two relatively inclined struts.

[0043] The next adjacent ring 604, arranged radially inward from ring 602, is similarly formed by a plurality of connected forked struts. The forked struts in ring 604 can all be identical and can be similarly formed by two relatively inclined struts connected to an arcuate strut, the arcuate strut forming a protrusion or peak in the forked strut at the inflection point between the two relatively inclined struts. The size and angle of the struts in ring 604 can differ from those in ring 602 because the two rings are concentric and ring 604 has a smaller diameter and circumference than the outer ring 602. A plurality of linear struts 612 extending radially outward from the center of the prosthesis connect rings 602 and 604 to form a closing unit 610. The closing unit 610 formed between rings 602 and 604 can all have the same geometry, or the closing unit 610 can vary.

[0044] The strut can be in a forked shape to transfer stress and strain away from the apex of the forked bone, thus allowing for a greater range of angular motion for a given maximum strain, or allowing for a lower maximum strain for the same given range of motion.

[0045] Y-shaped strut 616 connects to a frill-shaped second ring 604, wherein the tail of the Y extends radially inward toward the center of the prosthesis, forming a lemon-shaped closure unit having peaks and valleys on opposite sides and apexes on the other two sides. The tails of the Y can be joined together to define a central opening 618 in the prosthesis. In this example, the central opening 618 is star-shaped, wherein three pointed arms extend radially outward to form a star shape.

[0046] Multiple internal closure units 620, specifically three closure units 620, are formed by two V-shaped struts 622 on opposite sides of the closure unit 620. The V-shaped struts 622 are connected to the tails of adjacent Y-shaped struts 616 to form the closure unit 620. Each closure unit 620 includes a connecting protrusion 606 and two ventricular anchoring struts 614.

[0047] The commissural protrusion 606 may be adjacent to the center of the prosthesis and may include multiple suture holes, allowing the prosthetic leaflets to be sutured to the commissural protrusion. The commissural protrusion 606 may be a rectangular strut with a central slit for receiving the prosthetic leaflets. In this example, three prosthetic leaflets (not shown) are attached to the commissural protrusion, forming a tricuspid prosthetic valve. The prosthetic leaflets are not shown to allow observation of the expandable frame. The commissural protrusion is arranged between struts 614 forming a ventricular anchoring protrusion that anchors the prosthesis to the ventricular portion of the natural valve, such as the anterior portion (e.g., the fibrous trigone) and the posterior portion of the natural valve. The struts 614 form portions of the ventricular anchor. Two struts 614 are arranged on either side of the commissural protrusion 606. One end of each strut 614 is connected to the tail of a Y-shaped strut 616, and the opposite end of each strut 614 is a free end that can be bent radially outward. The free end may include a through-hole (not shown) for attaching a cover. The cover can be any material, such as a polymer like polyester, and the cover forms a foot for attaching a soft, non-damaging tip to the tissue. Polyester or other polymer cover materials provide a larger surface area and thus reduce the chance of the ventricular anchoring protrusion piercing the tissue. During dilation, the ventricular protrusion can then be angled away from the valve frame to allow anchoring to the fibrous triangle of the natural valve, any other anterior portion on the ventricular side, or any portion of the posterior annulus of the natural valve.

[0048] Multiple anchoring protrusions 608 may be radially inwardly facing the center of the device. These anchoring protrusions 608 are mushroom-shaped protrusions or T-shaped heads, allowing the prosthesis to be attached to a delivery conduit as described below. In this example or any other example, the T-shaped or mushroom-shaped anchoring protrusions may be omitted and simply have openings through the protrusions, allowing pins or other connector elements to be arranged in the openings for releasable engagement with the delivery conduit, as will be described in more detail below. The anchoring protrusions 608 are arranged on a portion of the strut that connects the two tails of the Y-shaped strut 616. Thus, in this example, there are three connection points that can operate with the delivery conduit.

[0049] Figure 6B The illustration shows a prosthetic valve 600, in which a covering 624 is arranged above the strut 614 and the prosthetic frame to form a foot that facilitates the formation of a ventricular anchor. This is shown by the shaded area. The foot comprises an enlarged head region and a narrower body. Again, the enlarged head provides a larger surface area and thus minimizes the pressure applied to the tissue during anchoring to eliminate or reduce tissue trauma. Figure 6B Other aspects and Figure 6A same.

[0050] Figure 6CAn example of a cover 624 is shown, which can be attached to a post 614 to form a non-damaging tip of a ventricular anchor. The cover can be polyester or other polymers or any material with the desired mechanical properties. The cover 624 has an enlarged head region and an elongated body region. The enlarged head region provides a larger surface area to reduce contact pressure with tissue during anchoring, thereby eliminating or minimizing tissue puncture and trauma.

[0051] Figure 6D yes Figures 6A to 6B The diagram shows a perspective view of the prosthetic valve 600, but in which the covering 630 is shown disposed above the expandable frame and disposed above the expandable frame after shaping. In addition to the covering disposed above the ventricular anchor 614 to form a non-damaging anchoring protrusion, the same or similar material may also be disposed above either or all of the struts and closure units to minimize perivalvular leakage and promote inward tissue growth. Figure 6D The diagram shows a fully deployed prosthetic valve 600 after shaping, wherein the prosthesis expands upwards along the atrial direction (or tapers along the ventricular direction), with the upper atrial end, which is the inflow end of the prosthesis, having the largest diameter, and the valve tapers to a smaller diameter at the ventricular end, which is the outflow end. The funnel shape of the frame can also be described as parabolic, wherein the concave portion of the parabola faces upwards toward the atrium and the convex portion faces downwards toward the ventricle. The prosthetic valve has an intermediate expansion configuration, in which the parabola is inverted such that the prosthesis expands outwards from the upper end to the lower end, thus expanding along the ventricular direction or tapering along the atrial direction. If it is parabolic in shape, then the concave portion of the parabola faces downwards toward the ventricle and the convex portion faces upwards toward the atrium. This intermediate expansion configuration is explained and described in more detail below. The prosthetic valve 600 also includes three syndesmotic posts, wherein three prosthetic valve leaflets 632 are connected to the syndesmotic posts to form the prosthetic valve mechanism.

[0052] Figure 7AAn example of a low-profile prosthetic mitral valve 700 is illustrated in a planar sectional view. The prosthetic mitral valve 700 is an expandable frame formed by multiple interconnected struts and can be cut from a flat sheet material such as stainless steel, nickel-titanium alloy, or other biocompatible materials. The prosthetic mitral valve 700 can be balloon-expandable or self-expanding. The expandable frame is in a flat planar configuration after being cut from the sheet material and can be heat-treated and shaped into the desired form as will be described below. The flat pattern includes multiple concentric annular rings 702, 704, formed by multiple struts extending around the periphery of the prosthesis. As the rings are closer to the center of the prosthetic valve, the diameter and circumference of the rings are smaller. Therefore, ring 702 has a larger diameter and a larger circumference than ring 704. Adjacent rings are connected to multiple radially extending struts 712 to form multiple closure units arranged circumferentially around the prosthetic valve, wherein adjacent closure units share at least one common strut. Each ring 702, 704 may include multiple circumferentially oriented struts all having the same geometry. For example, the outermost ring 702 includes a plurality of forked struts connected together to form an annular ring. The forked struts in ring 702 may all be identical and may include two relatively inclined struts connected to an arcuate strut, the arcuate strut forming a protrusion or peak in the forked strut at the inflection point between the two relatively inclined struts.

[0053] The next adjacent ring 704, arranged radially inward from ring 702, is similarly formed by a plurality of connected forked struts. The forked struts in ring 704 can all be identical and can be similarly formed by two relatively inclined struts connected to an arcuate strut, the arcuate strut forming a protrusion or peak in the forked strut at the inflection point between the two relatively inclined struts. The size and angle of the struts in ring 704 can differ from those in ring 702 because the two rings are concentric and ring 704 has a smaller diameter and circumference than the outer ring 702. A plurality of linear struts 712 extending radially outward from the center of the prosthesis connect rings 702 and 704 to form a closed unit 710. The closed units 710 formed between rings 702 and 704 can all have the same geometry, or the closed units 710 can vary. The configuration of connecting struts to link the rings together to form closed units creates a lattice structure that, once formed, provides, for example, a daisy-like flower shape.

[0054] The strut can be in a forked shape to transfer stress and strain away from the apex of the forked bone, thus allowing for a greater range of angular motion for a given maximum strain, or allowing for a lower maximum strain for the same given range of motion.

[0055] Y-shaped support 716 connects to the frill-shaped second ring 704, wherein the tail of the Y extends radially inward toward the center of the prosthesis, thereby forming several teardrop-shaped closed units and connecting with... Figure 6A The example in the text uses several lemon-shaped closure units that are substantially the same, while the teardrop-shaped closure units have pointed ends on opposite sides of the teardrop shape. The tail of the Y can be connected to a V-shaped strut to define the internal closure unit 720 and the central opening 718 in the prosthesis. In this example, the central opening 718 has a central circular hole with multiple pointed arms extending radially outward from the central circular hole.

[0056] The internal closure unit 720 is formed by V-shaped struts 722, which are coupled to the tails of adjacent Y-shaped struts 716 to form the closure unit 720. The closure unit 720 includes three connecting protrusions 706 and three V-shaped struts extending radially outward from the closure unit 720, forming a ventricular anchor 724 configured to engage with the inferior ventricular surface of the natural valve. Legs of the ventricular anchor may be coupled to the tails of the Y-shaped struts, and the apex of the V (or the groove of the V or the free end of the V) may include a sized hole extending through the apex to receive a suture, such that... Figure 6C Similar coverings can be attached to anchors to form undamaged tips.

[0057] The commissure 706 may be adjacent to the center of the prosthesis and may include multiple suture holes, allowing the prosthetic valve leaflets to be sutured to the commissure. The commissure 706 may be a rectangular strut with a central slit for receiving the prosthetic leaflets. In this example, three prosthetic valve leaflets (not shown) are attached to the commissure, forming a tricuspid prosthetic valve. The prosthetic valve leaflets are not shown to allow observation of the expandable frame. The commissure is arranged between adjacent ventricular anchors 724, which anchor the prosthesis to the ventricular portion of the natural valve, such as the anterior portion (e.g., the fibrous trigone) and the posterior portion of the natural valve. The free ends of the ventricular anchors may be radially outwardly bent. The free ends may include through-holes (not shown) for attaching a cover. The cover may be any material, such as a polymer like polyester, and the cover forms a foot for attaching a soft, non-damaging tip to the tissue. Polyester or other polymer covering materials provide a larger surface area and thus reduce the chance of the ventricular anchoring protrusion piercing the tissue. During dilation, the ventricular protrusion can then be angled away from the valve frame to allow anchorage on the fibrous triangle of the natural valve, or on any other anterior portion of the ventricular side, or on any portion of the posterior annulus of the natural valve.

[0058] Multiple anchoring protrusions 708, connected to the connector 706, can face radially inward toward the center of the device. These anchoring protrusions 708 are mushroom-shaped or T-shaped, allowing the prosthesis to attach to a delivery conduit as described below. In addition to the three anchoring protrusions 708 on the connector, three additional anchoring protrusions 726 are connected to the struts connecting the tails of two adjacent Y-shaped struts 716, and these anchoring protrusions 726 face radially inward toward the center of the prosthesis. The anchoring protrusions 726 can also be mushroom-shaped, T-shaped, or other shapes. Both anchoring protrusions 708 and 726 can be used to releasably connect the prosthesis to the delivery conduit. Therefore, in this example, there are six connection points that can interact with the delivery conduit. Figure 7A Other aspects of the example in the example can be compared with Figure 6A The examples in the text are basically similar.

[0059] Figure 7B The illustration shows a prosthetic valve 700, in which a covering 730 is disposed above the ventricular anchor 714 and the prosthetic frame to form a foot that facilitates the formation of the ventricular anchor. The foot includes an enlarged head region and a narrower body. Similarly, the enlarged head provides a larger surface area and thus minimizes the pressure applied to the tissue during anchoring to eliminate or reduce tissue trauma. Figure 7B Other aspects and Figure 7A same.

[0060] Figure 7C An example of a cover 730 is shown, which can be attached to a ventricular anchor 714 to form a non-damaging tip of the ventricular anchor. The cover can be polyester or other polymers or any material with the desired mechanical properties. The cover 730 has an enlarged head region and an elongated body region. The enlarged head region provides a larger surface area to reduce contact pressure with tissue during anchoring, thereby eliminating or reducing tissue puncture and trauma.

[0061] Figure 7D yes Figures 7A to 7B The diagram shows a three-dimensional view of the prosthetic valve 700, but the overlay has been removed after shaping to allow observation of the expandable frame struts. In addition to the overlay positioned above the ventricular anchors, the same or similar material may be positioned above either or both of the struts and the closure unit. Figure 7DA prosthetic valve 700 in its fully expanded configuration after shaping is shown, wherein the prosthesis opens towards the atrium (or tapers towards the ventricle), with the upper atrial end, which is the inflow end of the prosthesis, having the largest diameter, and tapers to a smaller diameter at the ventricular end, which is the outflow end. The funnel shape of the frame can also be described as parabolic, wherein the concave portion of the parabola faces upward toward the atrium and the convex portion faces downward toward the ventricle. The prosthetic valve has an intermediate expansion configuration in which the prosthesis tapers towards the atrium or opens towards the ventricle, and if it is parabolic, the parabola is inverted such that the prosthesis expands outward from the upper end to the lower end, with the concave portion of the parabola facing downward toward the ventricle and the convex portion facing upward toward the atrium. This intermediate expansion configuration is described and illustrated in more detail below.

[0062] Figure 8A Another example of a low-profile prosthetic mitral valve 800 is illustrated in a planar sectional view. The prosthetic valve 800 and... Figures 6A to 6D The prosthetic mitral valve 600 is essentially similar, with the main difference being the addition of a ventricular valve 830 or ventricular wing 830 to help anchor the prosthesis to the ventricular side of the natural valve and capture adjacent natural valve leaflets. The prosthetic mitral valve 800 is an expandable frame formed by multiple interconnected struts and can be cut from a flat sheet material such as stainless steel, nickel-titanium alloy, or other biocompatible materials. The prosthetic mitral valve 800 can be balloon-expandable or self-expandable. The expandable frame, after being cut from the sheet material, is in a flat planar configuration and can be heat-treated and shaped into the desired form as described below. The flat pattern includes multiple concentric annular rings 802, 804, formed by multiple struts extending around the periphery of the prosthesis. As the rings are closer to the center of the prosthetic valve, their diameter and circumference decrease. Therefore, ring 802 has a larger diameter and a larger circumference than ring 804. Adjacent rings are connected to a plurality of radially extending struts 812 to form a plurality of closed units arranged circumferentially around the prosthetic valve, wherein adjacent closed units share at least one common strut. Each ring 802, 804 may include a plurality of circumferentially oriented struts all having the same geometry. For example, the outermost ring 802 includes a plurality of frustum-shaped struts connected together to form an annular ring. The frustum-shaped struts in ring 802 may all be identical and may include two relatively inclined struts connected to an arcuate strut, the arcuate strut forming a protrusion or peak in the frustum-shaped strut at the inflection point between the two relatively inclined struts.

[0063] The next adjacent ring 804, arranged radially inward from ring 802, is similarly formed by a plurality of connected forked struts. The forked struts in ring 804 can all be identical and can be similarly formed by two relatively inclined struts connected to an arcuate strut, the arcuate strut forming a protrusion or peak in the forked strut at the inflection point between the two relatively inclined struts. The size and angle of the struts in ring 804 can differ from those in ring 802 because the two rings are concentric and ring 804 has a smaller diameter and circumference than the outer ring 802. A plurality of linear struts 812 extending radially outward from the center of the prosthesis connect rings 802 and 804 to form a closing unit 810. The closing unit 810 formed between rings 802 and 804 can all have the same geometry, or the closing unit 810 can vary.

[0064] The strut can be in a forked shape to transfer stress and strain away from the apex of the forked bone, thus allowing for a greater range of angular motion for a given maximum strain, or allowing for a lower maximum strain for the same given range of motion.

[0065] The Y-shaped strut 816 connects to the frill-shaped second ring 804, wherein the tail of the Y extends radially inward toward the center of the prosthesis to form a lemon-shaped closure unit having a peak and a valley on opposite sides and a tip on the other two sides. The Y-shaped strut can also connect to the frill-shaped second ring 804, wherein the tail of the Y extends radially inward toward the center of the prosthesis to form several teardrop-shaped closure units, each teardrop-shaped closure unit having a tip on opposite sides of the teardrop shape. The tails of the Y can be joined together to define a central opening 818 in the prosthesis. In this example, the central opening 818 is star-shaped, wherein three pointed arms extend radially outward to form a star shape.

[0066] Multiple internal closure units 820, specifically three closure units 820, are formed by two V-shaped struts 822 on opposite sides of the closure unit 820. The V-shaped struts 822 are connected to the tails of adjacent Y-shaped struts 816 to form the closure unit 820. Each closure unit 820 includes a connecting protrusion 806 and two ventricular anchoring struts 814.

[0067] The commissural protrusion 806 may be adjacent to the center of the prosthesis and may include multiple suture holes, allowing the prosthetic leaflets to be sutured to the commissural protrusion. The commissural protrusion 806 may be a rectangular strut with a central slit for receiving the prosthetic leaflets. In this example, three prosthetic leaflets (not shown) are attached to the commissural protrusion, forming a tricuspid prosthetic valve. The prosthetic leaflets are not shown to allow observation of the expandable frame. The commissural protrusion is arranged between struts 814 forming a ventricular anchoring protrusion that anchors the prosthesis to the ventricular portion of the natural valve, such as the anterior portion (e.g., the fibrous trigone) and the posterior portion of the natural valve. The struts 814 form portions of the ventricular anchor. Two struts 814 are arranged on either side of the commissural protrusion 806. One end of the strut 814 is connected to the tail of a Y-shaped strut 816, and the opposite end of the strut 814 is a free end that can be bent radially outward. The free end may include a through-hole for attachment, such as a suture cover (not shown). The cover can be any material, such as a polymer like polyester, and forms a foot for attaching a soft, non-damaging tip to the tissue. Polyester or other polymer cover materials provide a larger surface area and thus reduce the chance of the ventricular anchoring protrusion piercing the tissue. During expansion, the ventricular protrusion can then be angled away from the valve frame to allow anchoring to the fibrous triangle of the natural valve or any other anterior portion on the ventricular side, or any portion on the posterior annulus of the natural valve. The ventricular anchor can also help capture the natural valve leaflet between the ventricular anchor and the outer surface of the expandable frame. If the prosthetic valve has a ventricular wing or ventricular valve (described below), the natural valve leaflet can also be captured by the wing or valve, and this may help keep the natural valve leaflet outside the flow path. Any number of ventricular anchors can be present, but three ventricular anchors are present in this example.

[0068] Multiple anchoring protrusions 808 may be radially inwardly facing the center of the device. These anchoring protrusions 808 are mushroom-shaped or T-shaped heads, allowing the prosthesis to be attached to a delivery conduit as described below. The anchoring protrusions 808 are arranged on a portion of the strut that connects the two tails of the Y-shaped strut 816. Therefore, in this example, there are three connection points that can interact with the delivery conduit.

[0069] The prosthetic valve 800 also includes arcuate struts 830 having opposite ends inclined in opposite directions and a bent connector at the inflection point. Here, three arcuate struts 830 are present, and each end of the arcuate strut is coupled to an arm of a Y-shaped strut 818 to form a valve or wing. The valve or wing forms a second ventricular anchor on the ventricular side of the prosthesis, also aiding in capturing the natural valve leaflet. During delivery and initial deployment, the valve or wing may extend downward toward the ventricle away from the prosthesis, and then in a fully expanded configuration, the valve or wing extends radially outward and away from the anchor to form a flange arranged circumferentially around the expandable frame. This flange can engage with the ventricular portion directly beneath the annulus of the natural valve, such that the annulus is captured between the valve or wing and the superior annulus. The opening region of the upper atrium and the wings or valves of the lower ventricle thus provide upper and lower shoulders that can be used as clamping elements. These upper and lower shoulders can capture or clamp the natural valve annulus between the upper and lower shoulders, providing good tissue grip for anchoring the prosthesis to the natural anatomy. Furthermore, the ventricular wings or valves can also help capture the natural valve leaflets and remove them from the flow channel to ensure optimal valve function. Three struts 830 are shown here, but any number of struts 830 can be used. The ventricular anchor 814 is similar to that previously described... Figure 6A The description is essentially the same and can be combined with a flap or wing to further aid in securing the prosthetic valve to the natural valve.

[0070] Figure 8B The diagram illustrates the finalized configuration, which is in a partially deployed state. Figure 8A In a partial deployment configuration, the atrial end of the prosthetic valve 800 has expanded into a conical shape as the atrial diameter increases toward the ventricle to form a conical or dilatating region. The expansion configuration can be a paraboloid with a concave portion facing downward toward the ventricle but still positioned above the valve annulus 850. For convenience, the delivery catheter is not shown. The valve 830 or wing 830 extends axially downward from the expandable frame and passes through the valve annulus 850 and through the natural valve orifice. In this partial deployment configuration, the valve 830 or wing 830 extends generally parallel to the longitudinal axis of the prosthesis. Figure 6B Covering 624, similar to a cover (not shown), can be positioned above any or all of the strut 814 and the prosthesis frame to form a foot that facilitates the formation of the ventricular anchor. The foot may include an enlarged head region and a narrower body. Similarly, the enlarged head provides a larger surface area and thus minimizes pressure applied to the tissue during anchoring to eliminate or reduce tissue trauma. Figure 8B Other aspects and Figure 8A same.

[0071] Figure 8C It shows Figure 8BThe prosthetic valve 800 is in a fully deployed configuration, in which the atrial cone has been inverted to form a paraboloid with a concave portion facing upward toward the atrium but located above the valve annulus 850. The cone can then be fitted into the natural valve, and the open walls of the cone prevent the valve from sliding through the natural valve orifice. Additionally, the valve 830 or wing 830 is now radially outwardly expanded, so that the valve 830 or wing 830 is orthogonal or otherwise transverse to the longitudinal axis of the prosthesis to form a flange that can be anchored against the lower surface of the ventricular side of the natural valve. Furthermore, the prosthetic valve also has ventricular anchors, and the ventricular anchors shown extend radially outward to engage the lower side of the valve annulus, for example, on the fibrous triangle on the anterior side of the natural valve or on the posterior side of the natural valve. Similarly, a device such as a ventricular anchor 814 can be arranged above the ventricular anchor 814. Figure 6B Covers such as 624 are used to form the non-damaging tip of the ventricular anchor. The cover can be polyester or a similar polymer or any material with the desired mechanical properties. The cover can have an enlarged head region and an elongated body region. The enlarged head region provides a larger surface area to reduce contact pressure with tissue during anchoring, thereby eliminating or minimizing tissue puncture and trauma.

[0072] Figure 8D It shows Figure 8A The prosthetic valve 800 is fully deployed within the natural mitral valve MV. When fully deployed, the larger diameter portion of the dilatation rests in the left atrium LA and prevents the prosthesis from migrating into the left ventricle LV. The ventricular anchoring protrusion 814 may include two anterior and posterior anchoring protrusions, the anterior anchoring protrusions anchoring to the fibrous triangle on the anterior portion of the natural valve, and the posterior anchoring protrusion anchoring to the posterior portion of the natural valve, such as the posterior strut. The ventricular wing 830 or ventricular valve 830 is also positioned on the lateral portion of the ventricle to further facilitate anchoring to the lateral portion of the natural valve. Figure 8D A cover 860, such as polyester or a similar polymer, fabric, or tissue, is shown attached to an expandable frame. A prosthesis leaflet 862 is shown attached to a connecting post. Anchoring protrusions 808 on the connecting post are used to releasably connect the prosthesis to the delivery conduit. Three anchoring protrusions are present here.

[0073] Releasable connection with delivery catheter

[0074] Figures 9A to 9F The illustration shows a delivery catheter that can be used to carry any of the prosthetic valves disclosed herein. The delivery catheter is releasable to the prosthesis so that once the prosthesis has been properly positioned and deployed, the prosthetic valve is released from the delivery catheter and remains in place, while the delivery system is removed from the patient.

[0075] Figure 9AThe outer surface of the delivery catheter 900, including an outer sheath 902 and a tapered, atraumatic distal tip 904, is shown. The tapered, atraumatic distal tip 904 can be removed before insertion and dilation of the prosthetic valve.

[0076] Figure 9B The outer sheath 902 is shown as a tubular shaft with a single cavity 906 extending through it. The cavity 906 is configured to accommodate any of the prosthetic valves disclosed herein and to provide constraints that hold the prosthetic valve in a folded configuration during delivery.

[0077] Figure 9C A prosthesis 908 is schematically shown disposed in a cavity 906 of an outer sheath 902. The prosthesis 908 may be any of the prosthetic valves disclosed herein and is constrained in a folded configuration.

[0078] Figure 9D The outer sheath 902 is shown retracting proximally to remove restraints on the prosthesis 908 and allow partial self-expansion of the prosthesis, but the sheath remains positioned above the portion of the prosthesis that engages releasably with the delivery catheter, providing restraint to prevent inversion and full expansion of the prosthesis. Only the portion of the prosthesis releasably connected to the delivery catheter is illustrated here. For convenience, from... Figures 9D to 9F The remaining portion of the prosthetic valve has been omitted. As the outer sheath 906 retracts proximally, the prosthesis self-expands to form a partially deployed prosthesis, in which a parabolic shape is formed with a concave portion facing downward toward the ventricle of the patient's heart. This results in an inverted cone shape, with the smaller end of the cone facing the atrium and the larger end facing downward toward the ventricle. Only the prosthetic arm with the connector protrusion remains connected to the delivery catheter. Examples of the protrusion include the mushroom-shaped protrusion or T-shaped protrusion previously described above. During this delivery and expansion phase, the prosthesis remains above the natural valve in the atrium.

[0079] Figure 9E The outer sheath 902 is shown to retract further proximally (or the intermediate shaft 910 disposed in the cavity 906 of the outer sheath 902 advances distally) allowing the prosthetic valve to continue opening and inverting such that the parabola faces the opposite direction when the concave portion of the parabola faces the atrium. The prosthetic valve 908 remains connected to the delivery catheter 900.

[0080] Figure 9FThe diagram illustrates that once the prosthetic valve has been correctly positioned and dilated into the natural valve, the prosthetic valve 908 is released from the delivery catheter 900. Here, the inner shaft 912 is slidably arranged within the lumen of the intermediate shaft 910. As the inner shaft 912 advances distally, the disc 914 or cap 914 moves away from the hub coupled to the intermediate shaft 910. The hub includes a groove 916 that captures the mushroom-shaped or T-shaped head of the prosthesis. Thus, as the cap 914 moves away from the hub and groove 914, the mushroom-shaped or T-shaped head becomes unrestrained and can freely dilate out of the groove 914. Once out of the groove, the prosthesis 908 then dissociates from the delivery catheter 900. Further details regarding the coupling mechanism are described below.

[0081] exist Figures 9A to 9F In the example, only three connectors exist between the prosthetic valve and the delivery catheter. Additional connectors can be used, for example, via... Figure 7A The addition of protrusions to the ventricular anchors, as seen in the example, creates six connection points. Any number of connection points can be used, and any combination of connectors on the ventricular anchors or connectors on the joints can be used. Furthermore, in this example, or in any example where multiple releasable connectors exist between the prosthesis and the delivery catheter, the connectors can be released simultaneously, sequentially, one after another, independently of each other, or in desired groups or stages.

[0082] Figures 10A to 10C Another example of a coupling mechanism that can be used to releasably connect a prosthetic valve to a delivery system is shown. This example is related to... Figures 9A to 9F The example shown is similar, with the main difference being that the grooved area on the hub is reversed compared to the disc or cap. For convenience, Figures 10A to 10C The outer sheath is omitted from the text.

[0083] exist Figure 10A In this view, the delivery catheter includes an inner shaft 1006 and an intermediate shaft 1004 slidably disposed on the inner shaft 1006. A prosthetic valve 1002 is releasably coupled to the delivery catheter. Again, only the portion of the prosthetic valve coupled to the delivery catheter is shown. The prosthetic valve 1002 can be any of the prosthetic valves disclosed herein. Furthermore, in this view, the prosthesis is partially deployed and expanded to form a parabola with a concave portion facing downward toward the ventricle. The parabola can also be described as an inverted cone, wherein the small end of the cone faces the atrium and the large end of the cone faces downward toward the ventricle.

[0084] exist Figure 10BIn the middle, the outer sheath (not shown) further retracts to allow the prosthesis to continue expanding and inverting, causing the prosthesis to form a cone shape, wherein the larger diameter end faces the atrium and the smaller diameter end faces the ventricle. A hub 1008 with a groove 1010 is connected to an inner shaft 1006. The groove 1010 is sized to receive a T-shaped head or mushroom head on the prosthesis and retains the T-shaped head or mushroom head on the prosthesis when the disc 1012 or cap 1012 abuts against the hub 1008. The disc 1012 or cap 1012 is connected to an intermediate shaft 1004.

[0085] exist Figure 10C In this process, the inner shaft 1006 advances distally, moving the hub 1008 away from the cap 1012 or disc 1012, thereby exposing the groove 1010 and allowing the mushroom-shaped or T-shaped head of the prosthesis to be released from the delivery catheter. Alternatively, the intermediate shaft 1004 can be retracted proximally to separate the disc or cap from the hub, or a combination of retraction of the intermediate shaft 1004 proximally and advancement of the inner shaft 1006 distally can be used to separate the two and release the prosthetic valve from the delivery catheter.

[0086] exist Figures 10A to 10C In the example, there are only three connections between the prosthetic valve and the delivery catheter. Additional connection points can be used, such as via... Figure 7A The addition of protrusions to the ventricular anchors, as seen in the diagram, creates six connection points. Any number of connection points can be used, and any combination of connectors on the ventricular anchors or the ferrule can be employed.

[0087] Figure 11 A side view is shown of the releasable connection between the prosthetic valve and the delivery catheter, and an example of a locking mechanism is highlighted that allows the prosthetic valve to be releasably connected to the delivery catheter.

[0088] The delivery catheter 1100 includes an outer sheath 1102 slidably disposed on an intermediate shaft 1104, which is slidably disposed on an inner shaft 1106. All three shafts are movable proximally or distally relative to each other. The outer sheath 1102 includes a cavity for receiving a prosthetic valve 1116. The prosthetic valve 1116 can be any of the prosthetic valves disclosed herein. This figure shows only the portion of the prosthetic valve releasably coupled to the delivery catheter. For convenience, the remainder of the valve has been omitted. A hub 1108 with a groove 1110 is coupled to the intermediate shaft. A cap 1112 or disc 1112 is coupled to the inner shaft 1106. For example, the protrusion 1114 of the mushroom-shaped or T-shaped head can fit into the groove 1110 in the hub, and when the cap 1112 abuts against the hub, the protrusion 1114 is captured, thus connecting the prosthetic valve to the delivery catheter. Once the prosthetic valve is fully deployed and positioned, the inner shaft 1106 can move relative to the intermediate shaft 1104, causing the cap to move away from the hub, thereby allowing the protrusion 1114 to be released from the groove 1110 and disengaging the prosthetic valve from the delivery catheter.

[0089] Figures 12A to 12B Another example of a locking mechanism for releasably connecting a prosthetic valve to a delivery catheter is illustrated.

[0090] Figure 12A A delivery catheter 1200 is shown, comprising: an outer sheath (not shown) for receiving a prosthetic valve; an intermediate shaft 1202 slidably disposed within the outer sheath; and an inner shaft 1210 slidably disposed within the intermediate shaft 1202. A cap 1206 is coupled to the intermediate shaft 1202, and a hub 1208 has a pin 1212 extending proximally from the hub and parallel to the longitudinal axis of the delivery catheter 1200. Here, only an arm or portion of the prosthetic valve 1204 releasably coupled to the delivery catheter is shown. The prosthetic valve 1204 may be any of the examples disclosed herein and includes a protrusion 1214 having an opening through a tip of the protrusion. The pin 1212 may be disposed in the opening to releasably engage the prosthetic valve to the delivery catheter when the cap engages with the pin.

[0091] Figure 12B The release of the prosthetic valve 1204 from the delivery catheter 1200 is illustrated. Here, the intermediate shaft 1202 retracts proximally or the inner shaft 1210 advances distally, or a combination of both the proximal and distal movements of shaft 1202 and shaft 1210, causes the cap 1206 to move away from the pin 1212, thereby allowing the opening 1214 in the connector protrusion on the prosthetic valve 1204 to slide off the pin, thus disengaging the prosthetic valve from the delivery catheter.

[0092] In any of the examples of locking mechanisms used to engage and disengage the prosthesis from the delivery catheter, it may be desirable to recapture the prosthesis valve. This can be done at any time before the prosthesis valve is released from the delivery catheter. Therefore, if the prosthesis needs to be repositioned or, for some other reason, the physician decides not to implant the prosthesis, the operator can allow the prosthesis to return to its unbiased shape with a downstream-facing concave surface, and the prosthesis can be re-fitted and constrained in its constricted configuration. Once the prosthesis has been repositioned or the decision to deploy the prosthesis has been made, the deployment procedure can be restarted.

[0093] Conveying method

[0094] Figures 13A to 13D The illustration shows an example of a method for delivering a prosthetic valve to a patient's mitral valve.

[0095] exist Figure 13A In this procedure, using techniques known in the art, such as percutaneous insertion through a vein in the groin or via an incision and guidewire, the sheath 1302 is introduced into the patient's heart. The sheath 1302 is advanced through the septal wall from the right atrium RA to the left atrium LA. A delivery catheter 1304 carrying a prosthetic valve 1306, such as any of the prosthetic valves described herein, is advanced through the sheath 1302 into the left atrium. The distal tip of the delivery catheter is positioned or manipulated such that the distal tip is adjacent to the natural mitral valve MV. The sheath may be retracted proximally or the delivery catheter may be advanced distally through the sheath to partially expose the prosthetic valve 1306.

[0096] exist Figure 13B The middle sheath is removed from the prosthetic valve 1306, thereby removing the restraints and allowing the prosthetic valve 1306 to expand into the intermediate configuration. The intermediate configuration is a cone shape or parabola with its concave surface facing down towards the ventricle. The smaller diameter portion of the cone faces the left atrium, and the larger diameter portion faces the ventricle. The prosthetic valve remains connected to the delivery catheter and is positioned in the left atrium (LA) above the mitral valve (MV).

[0097] exist Figure 13C The prosthetic valve 1306 is further dilated and, optionally, when distal pressure is applied to the prosthesis against the mitral valve MV, the prosthesis 1306 is inverted such that the large-diameter portion of the cone faces the left atrium LA and the small-diameter portion faces the left ventricle LV. The cone may be parabolic in shape, with the concave portion facing the left atrium LA and the convex portion facing the left ventricle. The ventricular anchoring protrusions also expand radially outward to engage the ventricular portion of the natural valve. For example, the prosthetic valve may have two anterior ventricular anchors 1308 that engage with the fibrous trigone on the anterior portion of the natural mitral valve and a posterior ventricular anchor 1310 that engages with the posterior portion of the natural valve on the lateral portion of the ventricle. If the posterior portion has a posterior annular strut region, the posterior ventricular anchor may rest there.

[0098] exist Figure 13D In the procedure, the 1306 prosthetic valve was fully deployed and anchored into the natural valve, and the delivery catheter and sheath had been removed from the patient.

[0099] Figure 14 A prosthetic valve 1402 is shown positioned within a natural mitral valve (MV). When fully deployed, the larger diameter portion of the cone rests within the left atrium (LA) and prevents the prosthesis from migrating into the left ventricle. The ventricular anchoring protrusion may include a posterior anchoring protrusion 1404 and two anterior anchoring protrusions 1406. The anterior anchoring protrusions 1406 are anchored to the fibrous trigone region on the anterior portion of the natural valve, while the posterior anchoring protrusions 1404 are anchored to the posterior portion of the natural valve, such as the posterior strut. Figure 14 The diagram shows the absence of a cover and prosthetic leaflet to illustrate the struts of ventricular anchoring protrusions 1404 and 1406 and the strut of commissural protrusion 1408. In this example, all three ventricular anchoring protrusions and all three commissural protrusions include anchoring protrusions for releasable coupling with delivery catheters such as those previously described.

[0100] Figures 15A to 15D The diagram illustrates deployment, for example. Figures 8A to 8C Another example of a prosthetic valve is shown in the example.

[0101] exist Figure 15A In this process, using techniques known in the art, such as percutaneous insertion through a vein in the groin or via an incision and guidewire, the sheath 1502 is introduced into the patient's heart. The sheath 1502 passes through the diaphragmatic wall from the right atrium RA through the diaphragm to the left atrium LA. The prosthetic valve 1506 is supported, for example... Figures 8A to 8C The valve delivery catheter 1504 is advanced through the sheath 1502 into the left atrium. The distal tip of the delivery catheter is positioned or manipulated such that the distal tip is adjacent to the natural mitral valve MV. The sheath may be retracted proximally or the delivery catheter may be advanced distally through the sheath to partially expose the prosthetic valve 1506.

[0102] exist Figure 15B The middle sheath is removed from the prosthetic valve 1506, thereby removing the constraint and allowing the prosthetic valve 1506 to expand into an intermediate configuration. The intermediate configuration is a cone shape or paraboloid with its concave surface facing downwards towards the ventricle. The smaller diameter portion of the cone faces the left atrium, and the larger diameter portion faces the ventricle. The prosthetic valve remains connected to the delivery catheter and is positioned in the left atrium (LA) above the mitral valve (MV). A wing 1508 or valve 1508 extends axially downwards from the prosthetic valve 1506 and may be substantially parallel to the longitudinal axis of the prosthetic valve. The wing or valve passes through the orifice of the natural valve.

[0103] exist Figure 15CThe prosthetic valve 1506 is further dilated and, optionally, when distal pressure is applied to the prosthesis against the mitral valve MV, the prosthesis 1506 is inverted such that the large-diameter portion of the cone faces the left atrium LA and the small-diameter portion faces the left ventricle LV. The cone may be parabolic in shape, with the concave portion facing the left atrium LA and the convex portion facing the left ventricle. Ventricular anchoring protrusions, if present, also expand radially outward to engage the ventricular portion of the natural valve. For example, the prosthetic valve may have two anterior ventricular anchors engaging with the fibrous trigone on the anterior portion of the natural mitral valve and a posterior ventricular anchor engaging with the posterior portion of the natural valve on the lateral portion of the ventricle. If the posterior portion has a posterior annular strut region, the posterior ventricular anchor may rest there. The wing 1508 or leaflet 1508 expands radially outward such that the wing 1508 or leaflet 1508 is perpendicular or otherwise transverse to the longitudinal axis of the prosthesis to form a lower flange that can engage the bottom of the mitral valve on the ventricular surface to further anchor the device, while also helping to capture the natural leaflet.

[0104] exist Figure 15D In the procedure, the 1506 prosthetic valve was fully deployed and anchored into the natural valve, and the delivery catheter and sheath had been removed from the patient.

[0105] Cover

[0106] Many of the accompanying figures only illustrate the expandable prosthetic valve frame, without the prosthetic valve leaflets attached to the frame, and without the covering attached to the frame. However, as described above, coverings such as tissue, polymer, or fabric can be applied to the ventricular anchor to help form a foot that can engage with tissue in the natural valve without puncturing or traumating the tissue.

[0107] Additionally, in any of the examples disclosed herein, the covering may be applied to the entire frame or a portion of the frame. The covering may be a fabric such as polyester, or a tissue such as pericardial tissue, or any other biocompatible material. The covering may be applied to the frame to prevent perivalvular leakage around the frame and to promote inward tissue growth to help further anchor and secure the prosthesis to the natural anatomical structure. For example, the covering may be applied to the tapered flange resting against the atrial floor, or to the ventricular flange resting against the ventricular annulus, or both. The entire frame may be covered, or only partially covered.

[0108] Furthermore, as discussed, for convenience, these examples generally do not illustrate prosthetic valve leaflets attached to the prosthetic valve frame. However, prosthetic valve leaflets are known in the art, and typically two or three prosthetic leaflets can be applied to the frame to form a mitral or tricuspid prosthetic valve. Of course, any number of leaflets can be used, such as a single prosthetic leaflet, or four or more leaflets. The prosthetic valve leaflet can be tissue such as pericardial tissue, or it can be fabric, polymer, or other materials known in the art.

[0109] Notes and Examples

[0110] The following non-limiting examples illustrate some aspects of this topic to address challenges and provide the benefits discussed in this article.

[0111] In Example 1, a low-profile prosthetic valve for treating a natural valve in a patient includes: a radially expandable frame having an expanding configuration, a contracting configuration, an atrial end, and a ventricular end, wherein, in the contracting configuration, the expandable frame is sized and shaped for minimally invasive delivery to the natural valve, wherein, in the expanding configuration, the expandable frame is configured to engage with the natural valve, wherein, in the expanding configuration, the expandable frame forms an opening shape and is configured to engage with the atrial surface of the natural valve, wherein the opening shape opens downward toward the ventricle of the natural valve upon initial expansion, and then opens upon full expansion. The shape is inverted to form a tapering shape that tapers toward the ventricle toward the natural valve and opens toward the atrium toward the natural valve; and a plurality of prosthetic valve leaflets having free ends and opposite ends connected to the inner portion of the expandable frame, an open configuration and a closed configuration, wherein, in the open configuration, the free ends of the plurality of prosthetic valve leaflets are arranged away from each other to form an opening through which fluid flows in the antegrade direction, and wherein, in the closed configuration, the free ends are arranged closer together than in the open configuration, thereby substantially closing the opening and preventing fluid from flowing through the opening in the retrograde direction.

[0112] Example 2 is a prosthetic valve according to Example 1, the prosthetic valve further comprising a plurality of syndesmotic columns, each of the plurality of syndesmotic columns having a free end and an opposite end, the opposite end being coupled to the expandable frame, the free end facing the ventricle when the expandable frame is in the expanded configuration, and wherein the plurality of prosthetic valve leaflets are coupled to the plurality of syndesmotic columns.

[0113] Example 3 is a prosthetic valve according to any one of Examples 1 to 2, wherein the free end includes a plurality of openings extending through the free end, the plurality of openings being sized to receive suture wires for securing the plurality of prosthetic valve leaflets to the plurality of synaptic posts.

[0114] Example 4 is a prosthetic valve according to any one of Examples 1 to 3, wherein each of the plurality of synaptic posts has a locking protrusion coupled to the free end, the locking protrusion being configured to releasably connect the prosthetic valve to the delivery catheter.

[0115] Example 5 is a prosthetic valve according to any one of Examples 1 to 4, the prosthetic valve further comprising a plurality of ventricular anchors coupled to the ventricular end of the expandable frame, the ventricular anchors extending radially outward from the expandable frame in the expandable configuration, and the ventricular anchors configured to engage with the ventricular side of the natural valve.

[0116] Example 6 is a prosthetic valve according to any one of Examples 1 to 5, wherein at least one of the plurality of ventricular anchors and at least one of the plurality of syndesmotic posts are arranged in a common closed unit defined by the plurality of struts in the expandable frame.

[0117] Example 7 is a prosthetic valve according to any one of Examples 1 to 6, wherein each of the plurality of ventricular anchors includes a locking protrusion coupled to a lower portion of the ventricular anchor, the locking protrusion on the ventricular anchor being configured to releasably connect the prosthetic valve to a delivery catheter.

[0118] Example 8 is a prosthetic valve according to any one of Examples 1 to 7, wherein the plurality of ventricular anchors include anterior ventricular anchors and posterior ventricular anchors, the anterior ventricular anchors being configured to engage with a fibrous trigone on the anterior portion of a natural mitral valve in a natural heart, and the posterior ventricular anchors being configured to engage with a posterior portion of the annulus of the mitral valve or the posterior ventricular portion of the natural valve.

[0119] Example 9 is a prosthetic valve according to any one of Examples 1 to 8, wherein the plurality of ventricular anchors include a covering element disposed above at least two struts coupled to the expandable frame.

[0120] Example 10 is a prosthetic valve according to any one of Examples 1 to 9, wherein the plurality of ventricular anchors include V-shaped struts coupled to the expandable frame, wherein the apex of the V-shaped struts is configured to engage with tissue, and the prosthetic valve further includes a covering element disposed above the V-shaped struts.

[0121] Example 11 is a prosthetic valve according to any one of Examples 1 to 10, wherein the expandable frame includes a plurality of annular rings connected together to form a parabolic shape.

[0122] Example 12 is a prosthetic valve according to any one of Examples 1 to 11, wherein the plurality of annular rings comprise a plurality of concentric rings having a decreasing diameter joined together.

[0123] Example 13 is a prosthetic valve according to any one of Examples 1 to 12, wherein adjacent annular rings are joined together to form a plurality of closed units extending circumferentially around the expandable frame.

[0124] Example 14 is a prosthetic valve according to any one of Examples 1 to 13, the prosthetic valve further comprising a plurality of ventricular wings on the ventricular end, wherein the plurality of ventricular wings have an expanding configuration and a contracting configuration, wherein, in the contracting configuration, the plurality of ventricular wings are substantially parallel to the longitudinal axis of the prosthetic valve, and wherein, in the expanding configuration, the plurality of ventricular wings extend radially outward from the longitudinal axis to form a flange configured to engage with the ventricular surface of the natural valve.

[0125] Example 15 is a low-profile prosthetic valve system for treating a natural valve in a patient, the system comprising: a prosthetic valve as described in any one of Examples 1 to 14; and a delivery catheter releasably coupled to the prosthetic valve, the delivery catheter being configured to deliver the prosthetic valve to the natural valve.

[0126] Example 16 is a system according to Example 15, wherein the delivery catheter includes a locking element for releasably engaging the prosthetic valve.

[0127] Example 17 is a method for delivering a prosthetic valve to a natural valve in a patient's heart, the method comprising: providing a delivery catheter carrying the prosthetic valve; positioning the prosthetic valve adjacent to the natural valve; partially deploying the prosthetic valve such that the prosthetic valve forms an open shape positioned above the natural valve and opening toward the ventricle of the heart; inverting the open shape such that the initial open shape becomes a tapered shape positioned above the natural valve and tapering toward the ventricle; radially expanding a plurality of ventricular anchors or a plurality of ventricular wings at the ventricular end of the prosthetic valve to engage with the ventricular surface of the natural valve; and releasing the prosthetic valve from the delivery catheter.

[0128] Example 18 is the method according to Example 17, wherein radially expanding the plurality of ventricular anchors or the plurality of ventricular wings includes anchoring at least some of the plurality of ventricular anchors to the fibrous trigone of the natural valve or the posterior ventricular portion of the natural valve.

[0129] Example 19 is a method according to any one of Examples 17 to 18, wherein radially expanding the plurality of ventricular anchors or the plurality of ventricular wings includes radially expanding the plurality of ventricular wings from a position generally parallel to the longitudinal axis of the prosthetic valve to a position extending radially outward from the longitudinal axis, and engaging the plurality of ventricular wings with the ventricular surface of the natural valve.

[0130] Example 20 is a method according to any one of Examples 17 to 19, the method further comprising reducing or eliminating regurgitation through the prosthetic valve.

[0131] Example 21 is a method according to any one of Examples 17 to 20, wherein the natural valve is the mitral valve.

[0132] Example 22 is a method according to any one of Examples 17 to 21, wherein releasing the prosthetic valve from the delivery catheter includes disconnecting a plurality of synaptic posts on the prosthetic valve from the delivery catheter.

[0133] Example 23 is a method according to any one of Examples 17 to 22, wherein releasing the prosthetic valve from the delivery catheter includes disengaging a plurality of locking protrusions on the plurality of ventricular anchors from the delivery catheter.

[0134] In Example 24, any device or method of any or any combination of Examples 1 to 23 may optionally be configured such that all the listed elements or options are available for use or selected from.

[0135] The above detailed description includes reference to the accompanying drawings, which form part of the detailed description. The drawings illustrate specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples that provide only those elements shown or described. Furthermore, the inventors contemplate examples of any combination or substitution of those elements (or one or more aspects thereof) shown or described herein with respect to a particular example (or one or more aspects thereof) or other example (or one or more aspects thereof) shown or described herein.

[0136] In the event of any inconsistency between the use of this document and any other document incorporated by reference, the use of this document shall prevail.

[0137] In this document, the terms “a” or “an” as commonly used in patent literature are used to include one or more elements independently of any other instance or use of “at least one” or “one or more”. In this document, unless otherwise stated, the term “or” is used to indicate non-exclusivity, such that “A or B” includes “A but not B,” “B but not A,” and “A and B.” In this document, the terms “comprising” and “in…” are used as common English equivalents to the corresponding terms “including” and “wherein.” Furthermore, in the appended claims, the terms “comprising” and “including” are open-ended, meaning that any system, apparatus, article, composition, formulation, or process that includes elements other than those listed after these terms is still considered to fall within the scope of the claim. Additionally, in the appended claims, the terms “first,” “second,” and “third,” etc., are used only as designations and are not intended to specify a quantity requirement for their contents.

[0138] The above description is intended to be illustrative and not restrictive. For example, the examples described above (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used by those skilled in the art, upon review of the above description. An abstract is provided to allow the reader to quickly determine the nature of the disclosure. The abstract is to be understood not to interpret or limit the scope or meaning of the claims. Furthermore, in the detailed description above, various features may be combined to simplify the disclosure. This should not be construed as meaning that unclaimed features are essential for any claim. Rather, the subject matter of the invention may lie in fewer features than all of the particular disclosed embodiments. Thus, the appended claims are incorporated herein by reference as examples or embodiments, wherein each claim is, in itself, a separate embodiment, and it is contemplated that these embodiments may be combined with each other in various combinations or substitutions. The scope of the invention should be determined by reference to the appended claims and the full scope of the equivalents granted by those claims.

Claims

1. A low-profile prosthetic valve for treating a patient with a natural valve, the prosthetic valve comprising: A radially expandable frame having an expanding configuration and a contracting configuration, and having an atrial end and a ventricular end. In the contractile configuration of the expandable frame, the expandable frame is sized and shaped for minimally invasive delivery to the natural valve. In the expanded configuration of the expandable frame, the expandable frame is configured to engage with the natural valve. The atrial end portion forms an open shape within the expandable configuration of the expandable frame, and the atrial end portion is configured to engage with the atrial surface of the natural valve in the open shape. The opening shape initially expands downward toward the ventricle of the natural valve, and then, upon full expansion, the opening shape is inverted to form a tapered shape that tapers toward the ventricle of the natural valve and expands toward the atrium of the natural valve. Multiple prosthetic valve leaflets, each leaflet having a free end and opposite ends connected to an internal portion of the expandable frame, and having an open configuration and a closed configuration. In the open configuration of the plurality of prosthetic valve leaflets, the free ends of the plurality of prosthetic valve leaflets are arranged away from each other, thereby forming an opening through which fluid flows in the antegrade direction. In the closed configuration of the plurality of prosthetic valve leaflets, the free ends are arranged closer together than in the open configuration, thereby substantially closing the opening and preventing fluid from flowing through the opening in the retrograde direction; and The ventricular wings at the ventricular end have both expanding and contracting configurations. In several of the contraction configurations of the ventricular wings, the ventricular wings are approximately parallel to the longitudinal axis of the prosthetic valve, and In one of the multiple expanded configurations of the ventricular wings, the ventricular wings extend radially outward from the longitudinal axis to form a flange, the flange being configured to engage with the ventricular surface of the natural valve.

2. The prosthetic valve of claim 1, further comprising a plurality of connecting columns, each of the plurality of connecting columns having a free end and an opposite end, the opposite ends of the plurality of connecting columns being connected to the expandable frame, the free ends of the plurality of connecting columns facing the ventricle when the expandable frame is in the expanded configuration, and wherein, The multiple prosthetic valve leaflets are connected to the multiple commissure columns.

3. The prosthetic valve according to claim 2, wherein, The free ends of the plurality of synaptic posts include a plurality of openings extending through the free ends of the plurality of synaptic posts, the plurality of openings being sized to receive suture wires for securing the plurality of prosthetic valve leaflets to the plurality of synaptic posts.

4. The prosthetic valve according to claim 2, wherein, Each of the plurality of connecting posts has a locking protrusion connected to a free end of the plurality of connecting posts, the locking protrusion being configured to releasably connect the prosthetic valve to the delivery catheter.

5. The prosthetic valve of claim 2, further comprising a plurality of ventricular anchors connected to the ventricular end of the expandable frame, the ventricular anchors extending radially outward from the expandable frame in an expanded configuration of the expandable frame, and the ventricular anchors configured to engage with the ventricular side of the natural valve.

6. The prosthetic valve according to claim 5, wherein, At least one of the plurality of ventricular anchors and at least one of the plurality of connecting posts are arranged in a common closed unit defined by the plurality of pillars in the expandable frame.

7. The prosthetic valve according to claim 5, wherein, Each of the plurality of ventricular anchors includes a locking protrusion connected to a lower portion of the ventricular anchor, the locking protrusion on the ventricular anchor being configured to releasably connect the prosthetic valve to the delivery catheter.

8. The prosthetic valve according to claim 5, wherein, The plurality of ventricular anchors include anterior ventricular anchors and posterior ventricular anchors, the anterior ventricular anchors being configured to engage with the fibrous trigone on the anterior portion of the natural mitral valve in the natural heart, and the posterior ventricular anchors being configured to engage with the posterior portion of the annulus of the mitral valve or the posterior ventricular portion of the natural valve.

9. The prosthetic valve according to claim 5, wherein, The plurality of ventricular anchors include a cover element disposed above at least two struts connected to the expandable frame.

10. The prosthetic valve according to claim 5, wherein, The plurality of ventricular anchors include V-shaped struts coupled to the expandable frame, wherein the apex of the V-shaped struts is configured to engage with tissue, and the prosthetic valve also includes a covering element disposed above the V-shaped struts.

11. The prosthetic valve according to claim 1, wherein, The expandable frame includes multiple annular rings connected together to form a parabolic shape.

12. The prosthetic valve according to claim 11, wherein, The plurality of annular rings include multiple concentric rings with decreasing diameters that are connected together.

13. The prosthetic valve according to claim 11, wherein, Adjacent rings are joined together to form multiple closed units that extend circumferentially around the expandable frame.

14. A low-profile prosthetic valve system for treating a patient with a natural valve, the system comprising: The prosthetic valve as described in claim 1; as well as A delivery catheter releasably connected to the prosthetic valve, the delivery catheter being configured to deliver the prosthetic valve to the natural valve.

15. The system according to claim 14, wherein, The delivery catheter includes a locking element for releasably engaging the prosthetic valve.

16. A low-profile prosthetic valve for treating a patient with a natural valve, the prosthetic valve comprising: A radially expandable frame having an expanding configuration and a contracting configuration, and having an atrial end and a ventricular end. In the contractile configuration of the expandable frame, the expandable frame is sized and shaped for minimally invasive delivery to the natural valve. In the expanded configuration of the expandable frame, the expandable frame is configured to engage with the natural valve. The atrial end portion forms an open shape within the expandable configuration of the expandable frame, and the atrial end portion is configured to engage with the atrial surface of the natural valve in the open shape. The opening shape initially expands downward toward the ventricle of the natural valve, and then, upon full expansion, inverts the opening shape to form a tapering shape that gradually narrows toward the ventricle of the natural valve and expands toward the atrium of the natural valve. Multiple prosthetic valve leaflets, each leaflet having a free end and opposite ends connected to an internal portion of the expandable frame, and having an open configuration and a closed configuration, and A plurality of ventricular anchors are connected to the ventricular end of the expandable frame, the ventricular anchors extending radially outward from the expandable frame in an expanded configuration of the expandable frame, and the ventricular anchors are configured to engage with the ventricular side of the natural valve. In the open configuration of the plurality of prosthetic valve leaflets, the free ends of the plurality of prosthetic valve leaflets are arranged away from each other, thereby forming an opening through which fluid flows in the antegrade direction. In the closed configuration of the plurality of prosthetic valve leaflets, the free ends are arranged closer together than in the open configuration, thereby substantially closing the opening and preventing fluid from flowing through the opening in the reverse direction.

17. The prosthetic valve according to claim 16, wherein, Each of the plurality of ventricular anchors includes a locking protrusion connected to a lower portion of the ventricular anchor, the locking protrusion on the ventricular anchor being configured to releasably connect the prosthetic valve to the delivery catheter.

18. The prosthetic valve according to claim 16, wherein, The plurality of ventricular anchors include V-shaped struts coupled to the expandable frame, wherein the apex of the V-shaped struts is configured to engage with tissue, and the prosthetic valve also includes a covering element disposed above the V-shaped struts.

19. The prosthetic valve according to claim 16, wherein, The expandable frame includes multiple annular rings connected together to form a parabolic shape.

20. The prosthetic valve according to claim 16, further comprising: The plurality of ventricular wings at the ventricular end have expansion and contraction configurations. In the contraction configuration of the plurality of ventricular wings, the plurality of ventricular wings are approximately parallel to the longitudinal axis of the prosthetic valve, and In the expanded configuration of the plurality of ventricular wings, the plurality of ventricular wings extend radially outward from the longitudinal axis to form a flange, the flange being configured to engage with the ventricular surface of the natural valve.

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