Replacement mitral valve

Abstract

A prosthetic mitral valve includes an anchor assembly, a strut frame, and a replacement leaflet secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular and atrial anchors are configured to radially open relative to the central portion. The annular strut frame is mounted radially within and attached to the anchor assembly. The central portion is configured to align with a native valve hole, and the ventricular anchor and the atrial anchor are configured to compress native heart tissue therebetween.

Description

[0001] This application is a divisional application of the invention patent application with application number "201980054042.4" (international application number PCT / US2019 / 037729), application date "June 18, 2019", and invention name "Replacement Mitral Valve".

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application is a continuation of U.S. application No. 16 / 012,666, filed on June 19, 2018, which is a continuation-in-part of International Patent Application PCT / US2018 / 14902, entitled “Replacement Mitral Valve,” filed on January 23, 2018, which claims priority to U.S. Provisional Application No. 62 / 513,877, filed on June 1, 2017, and U.S. Provisional Patent Application No. 62 / 449,498, entitled “Replacement Mitral Valve,” filed on January 23, 2017, the entire contents of the above applications are incorporated herein by reference.

[0004] This application may also be related to International Patent Application PCT / US2016 / 032550, entitled “Replacement Mitral Valve,” filed on May 13, 2016, U.S. Patent Application No. 14 / 170,388, entitled “Systems and Methods for Heart Valve Repair and Replacement,” filed on January 31, 2014, now U.S. Patent No. 8,870,948, and U.S. Patent Application No. 14 / 677,320, entitled “Replacement Heart Valve, Methods of Use, and Methods of Manufacturing,” filed on April 2, 2015, the entire contents of which are incorporated herein by reference.

[0005] Reference Compilation

[0006] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Background Art

[0007] The mitral valve is located between the left atrium and the left ventricle of the heart. Various diseases can affect the function of the mitral valve (including degenerative mitral valve disease and mitral valve prolapse). These diseases can cause mitral stenosis (where the valve does not open fully, thereby obstructing blood flow) and / or mitral regurgitation (where the mitral valve does not function properly and blood passively flows in the wrong direction).

[0008] Many patients with heart disease, including those with mitral valve problems, cannot tolerate the trauma of open-heart surgery. Age or advanced disease may have impacted a patient's ability to recover from the trauma of open-heart surgery. Additionally, the high costs associated with open-heart surgery and extracorporeal perfusion can make this procedure unaffordable.

[0009] Minimally invasive surgical techniques are available for patients who require heart valve repair or heart valve replacement. In many minimally invasive procedures, small devices are manipulated within the patient's body after visualization using a real-time imaging source such as ultrasound, fluoroscopy, or endoscopy. Minimally invasive cardiac surgery is inherently less invasive than open surgery and can be performed without extracorporeal perfusion, which carries a significant risk of surgical complications.

[0010] Minimally invasive aortic valve replacement devices (such as the Medtronic Corevalve or Edwards Sapien) deliver aortic valve prostheses through small tubes that can be positioned inside the heart through the aorta (via the femoral artery) or through the apex of the heart. However, the mitral valve is different from the aortic valve in that the shape and anatomy around the valve vary greatly from one side of the valve to the other. Moreover, current heart valve prostheses are not designed to work effectively within the mitral valve. In addition, heart valve prostheses currently delivered via minimally invasive devices are often difficult to place correctly within the native valve, are difficult to match in size to the native valve, and are difficult to retrieve and replace if they are initially placed incorrectly.

[0011] This article describes these and other shortcomings in existing approaches. Summary of the invention

[0012] Generally speaking, in one embodiment, a prosthetic mitral valve comprises an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly comprises a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to be radially outwardly flared relative to the central portion. The annular strut frame is radially within the anchor assembly and is attached to the anchor assembly at a plurality of attachment locations, the attachment locations being between the central portion of the anchor assembly and the extreme edge of the atrium. The central portion is configured to align with the native valve orifice, and the ventricular anchor and the atrial anchor are configured to compress native heart tissue therebetween.

[0013] This embodiment and other embodiments may include one or more of the following features. The atrial end of the strut frame may be attached to the anchor assembly. The atrial tip of the strut frame may be attached to the anchor assembly. The atrial end of the strut frame may flare radially outward. The flaring of the strut frame may be configured to substantially conform to the flaring of the atrial anchor. The ventricular end of the strut frame may be spaced apart from the anchor assembly. The radial distance between the ventricular end of the strut frame and the anchor assembly may be 1-15 mm. The anchor assembly and the strut frame may be configured to self-expand from a constrained configuration to an expanded configuration. The strut frame may be attached to the anchor assembly with a plurality of rivets. Each of the plurality of attachment locations may be radially aligned with the tip of the atrial anchor. The plurality of attachment locations may each be a portion of the anchor assembly that extends radially inward further than the remainder of the anchor assembly. The anchor assembly may include a plurality of rhombus-shaped units. The plurality of attachment locations may be positioned at the midpoint of the outermost atrial rhombus-shaped unit. The strut frame may include a plurality of linear struts and v-shaped connectors therebetween. The anchor assembly may form a generally hourglass shape.

[0014] In general, in one embodiment, a prosthetic mitral valve comprises an anchor assembly, an annular strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly comprises a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outward relative to the central portion. In addition, the anchor assembly comprises a plurality of rhombus-shaped units. The annular strut frame is radially disposed within the anchor assembly and is attached to the anchor assembly at a plurality of attachment locations, the attachment locations being located at the midpoints of the outermost atrial rhombus-shaped units between the central portion of the anchor assembly and the outermost edge of the atrium.

[0015] This embodiment and other embodiments may include one or more of the following features. The atrial end of the strut frame may be attached to the anchor assembly. The atrial tip of the strut frame may be attached to the anchor assembly. The atrial end of the strut frame may flare radially outward. The flaring of the strut frame may be configured to substantially conform to the flaring of the atrial anchor. The ventricular end of the strut frame may be spaced apart from the anchor assembly. The radial distance between the ventricular end of the strut frame and the anchor assembly may be 1-15 mm. The anchor assembly and the strut frame may be configured to self-expand from a constrained configuration to an expanded configuration. The strut frame may be attached to the anchor assembly with a plurality of rivets. Each of the plurality of attachment locations may be radially aligned with the tip of the atrial anchor. The plurality of attachment locations may each be a portion of the anchor assembly that extends radially inward further than the remainder of the anchor assembly. The strut frame may include a plurality of linear struts and v-shaped connectors therebetween. The anchor assembly may form a generally hourglass shape.

[0016] Generally speaking, in one embodiment, a prosthetic mitral valve comprises an anchor assembly, an annular strut frame, and a plurality of replacement leaflets fixed to the annular strut frame. The anchor assembly further comprises a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to be radially outwardly spread relative to the central portion. In addition, the atrial anchor comprises a plurality of atrial units, and the ventricular anchor comprises a plurality of ventricular units. The annular strut frame is radially disposed within the anchor assembly. A first plurality of atrial units are positioned radially inwardly relative to a second plurality of atrial units, such that the first plurality of units attach the strut frame to the anchor assembly.

[0017] This embodiment and other embodiments may include one or more of the following features. The central portion may be configured to align with the native valve orifice, and the ventricular anchor and the atrial anchor may be configured to compress native heart tissue therebetween. The atrial end of the strut frame may be attached to the anchor assembly. The atrial tip of the strut frame may be attached to the anchor assembly. The atrial end of the strut frame may be radially flared outward. The flare of the strut frame may be configured to substantially conform to the flare of the atrial anchor. The ventricular end of the strut frame may be spaced from the anchor assembly. The radial distance between the ventricular end of the strut frame and the anchor assembly may be 1-15 mm. The anchor assembly and the strut frame may be configured to self-expand from a constrained configuration to an expanded configuration. The strut frame may be attached to the anchor assembly with a plurality of rivets. The first plurality of atrial units may terminate at a disconnected vertex. The disconnected vertex may be radially aligned with the outermost tip of the second plurality of atrial units. The first plurality of atrial units may be inclined about 70-80 degrees relative to an axis extending through the central portion. The second plurality of atrial units may be inclined about 20-30 degrees relative to an axis extending through the central portion. The annular strut framework may flare radially outwardly at 70-80 degrees relative to an axis extending through the central portion.

[0018] Generally speaking, in one embodiment, an artificial mitral valve includes an anchor assembly, an annular strut frame, and a plurality of replacement leaflets fixed to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outward relative to the central portion. In addition, the atrial anchor includes a plurality of atrial units. The annular strut frame is radially located within the anchor assembly. A first plurality of atrial units are inner disconnected vertices, and a second plurality of atrial units are outermost atrial units. The first plurality of atrial units are positioned radially inward relative to the second plurality of atrial units, such that the first plurality of units attach the strut frame to the anchor assembly.

[0019] This embodiment and other embodiments may include one or more of the following features. The central portion may be configured to align with the native valve orifice. The ventricular anchor and the atrial anchor may be configured to compress native heart tissue therebetween. The atrial end of the strut frame may be attached to the anchor assembly. The atrial tip of the strut frame may be attached to the anchor assembly. The atrial end of the strut frame may be radially flared outward. The flaring of the strut frame may be configured to substantially conform to the flaring of the atrial anchor. The ventricular end of the strut frame may be spaced from the anchor assembly. The radial distance between the ventricular end of the strut frame and the anchor assembly may be 1-15 mm. The anchor assembly and the strut frame may be configured to self-expand from a constrained configuration to an expanded configuration. The strut frame may be attached to the anchor assembly with a plurality of rivets. The disconnected apex may be radially aligned with the outermost tip of the second plurality of atrial units. The first plurality of atrial units may be inclined about 70-80 degrees relative to an axis extending through the central portion. The second plurality of atrial units may be inclined about 20-30 degrees relative to an axis extending through the central portion. The annular strut framework may flare radially outwardly at 70-80 degrees relative to an axis extending through the central portion.

[0020] Generally speaking, in one embodiment, an artificial mitral valve includes a valve support assembly including a ventricular anchor and an atrial anchor. The valve support assembly has a plurality of grooves extending therethrough. The artificial mitral valve also includes a plurality of replacement leaflets. Each leaflet has a leaflet arm extending through one of the plurality of grooves. The artificial mitral valve also includes a plurality of commissures. Each commissure is circumferentially and axially aligned with one of the plurality of grooves to form a commissure attachment mechanism. Each commissure also includes a plurality of channels on its side. At least one suture is positioned at each commissure attachment mechanism and surrounds a portion of the valve support assembly, passes through a plurality of recesses and is wrapped around the commissure.

[0021] This embodiment and other embodiments may include one or more of the following features. The valve support assembly may include: an anchor assembly including a ventricular anchor and an atrial anchor, and an annular strut frame including a plurality of grooves. The annular strut frame may be radially positioned within the anchor assembly. The plurality of grooves may be in a portion of the strut frame that extends through the anchor assembly in the ventricular direction. The anchor assembly may also include a central portion, and the ventricular anchor and the atrial anchor may be radially open relative to the central portion. A plurality of channels may extend from the side of each commissure toward the center of the commissure. The plurality of channels may be substantially straight. There may be 6 to 12 channels in each commissure. Each groove may be in an axially extending strut. The arm of the leaflet may extend through the plurality of grooves. The arm may also be wrapped around the periphery of the inner strut frame of the valve support assembly. The plurality of grooves may be positioned equidistantly around the circumference of the valve support assembly. Each of the plurality of grooves may be positioned toward the ventricular end of the valve support assembly. The valve support assembly may be configured to self-expand from a constrained configuration to an expanded configuration. The atrial edge of the leaflet may be sutured around the inner periphery of the valve support assembly. Each leaflet also includes a leaflet protector thereon. The leaflet protector may be made of a lubricating fabric and may be configured to protect the respective leaflet from the inner periphery of the valve support assembly.

[0022] Generally speaking, in one embodiment, an artificial mitral valve includes a valve support assembly. The valve support assembly includes: an anchor assembly including a ventricular anchor and an atrial anchor, and an annular strut frame radially positioned within the anchor assembly. The annular strut frame includes a plurality of slots extending therethrough. The artificial mitral valve also includes a plurality of replacement leaflets. Each leaflet has a leaflet arm extending through one of the plurality of slots. The artificial mitral valve also includes a plurality of commissures. Each commissure is circumferentially and axially aligned with one of the plurality of slots to form a commissure attachment mechanism. Each commissure also includes a plurality of channels on its side.

[0023] This embodiment and other embodiments may include one or more of the following features. The artificial mitral valve may include at least one suture at each commissure attachment mechanism. The at least one suture may be positioned around the strut frame, through multiple recesses and around the commissure. Multiple grooves may be in a portion of the strut frame that extends through the anchor assembly in the ventricular direction. The anchor assembly may also include a central portion, and the ventricular anchor and the atrial anchor may be radially open relative to the central portion. Multiple channels may extend from the side of each commissure to the center of the commissure. Multiple channels may be substantially straight. There may be 6 to 12 channels on each commissure. Each groove may be in an axially extending strut. The arm of the leaflet may extend through multiple grooves. The arm may also be wrapped around the periphery of the strut frame. Multiple grooves may be positioned equidistantly around the circumference of the strut frame. Each of the multiple grooves may be positioned toward the ventricular end of the strut frame. The valve support assembly may be configured to self-expand from a constrained configuration to an expanded configuration. The atrial edge of the leaflet may be sutured around the inner periphery of the valve support assembly. Each leaflet may also include a leaflet protector thereon. The leaflet protector may be made of a lubricating fabric and may be configured to protect the leaflets from the inner circumference of the valve support assembly.

[0024] Generally speaking, in one embodiment, an artificial mitral valve includes a valve support assembly, a plurality of leaflets fixed to the valve support assembly, and a plurality of retaining hooks. The valve support assembly includes a ventricular anchor, a central portion, and an atrial anchor. The valve support assembly is configured to self-expand from a folded configuration to an expanded configuration. A plurality of retaining hooks are attached to the ventricular anchor. When the valve support assembly is in the expanded configuration, each retaining hook is bent radially outward to point in the direction of the atrium. The ratio of the radius of curvature to the thickness of each retaining hook is greater than 4:1.

[0025] This embodiment and other embodiments may include one or more of the following features. Each of the multiple retaining hooks may be configured to point at an angle of 50°-80° relative to the central longitudinal axis of the artificial mitral valve. The angle may be approximately 65°. The radius of curvature of each of the multiple retaining hooks may be between 3-5 mm. The thickness of each retaining hook may be between 0.8 mm and 1.6 mm. Multiple retaining hooks may be integrated with the valve support assembly. The valve support assembly may include an anchor assembly, which also includes a ventricular anchor, an atrial anchor and a central portion, and an annular strut frame radially positioned within the anchor assembly. Multiple retaining hooks may be attached to the anchor assembly. The central portion may be configured to align with the native valve hole, and the ventricular anchor and the atrial anchor may be configured to compress native heart tissue therebetween. The valve support assembly may include multiple rhombus units. Each retaining hook may extend from the vertex of the inner rhombus unit. In addition to the position closest to the leaflet attachment point, the retaining hook may extend from each vertex on the circumference around the artificial mitral valve.

[0026] Generally speaking, in one embodiment, the artificial mitral valve comprises a valve support assembly, a plurality of leaflets fixed to the valve support assembly, and a plurality of retaining hooks. The valve support assembly comprises a ventricular anchor, a central portion, and an atrial anchor. Each retaining hook is attached to the ventricular anchor and is bent radially outward, pointing in the direction of the atrium. The ratio of the radius of curvature to the thickness of each retaining hook is greater than 4:1, and the angle it points to is 10°-40° relative to the central longitudinal axis of the artificial mitral valve.

[0027] This embodiment and other embodiments may include one or more of the following features. The angle may be approximately 65°. The radius of curvature of each of the plurality of retaining hooks may be between 3-5 mm. The thickness of each retaining hook may be between 0.8 mm and 1.6 mm. The plurality of retaining hooks may be integral with the valve support assembly. The valve support assembly may include an anchor assembly, which also includes a ventricular anchor and an atrial anchor and a central portion and an annular strut frame radially positioned within the anchor assembly. The plurality of retaining hooks may be attached to the anchor assembly. The central portion may be configured to align with the native valve orifice, and the ventricular anchor and the atrial anchor may be configured to compress the native heart tissue therebetween. The valve support assembly may include a plurality of rhombus-shaped units. Each retaining hook may extend from the vertex of an inner rhombus-shaped unit. On a circumference around the artificial mitral valve, the retaining hook may extend from each vertex except at a position closest to the leaflet attachment point.

[0028] In general, in one embodiment, a replacement mitral valve comprises a self-expandable valve support assembly comprising a ventricular anchor, a central portion, and an atrial anchor. The valve support assembly has a self-expanding configuration in which the ventricular anchor and the atrial anchor are radially expanded relative to the central portion. When the valve assembly is in the self-expanding configuration, the atrial anchor has a larger diameter than the ventricular anchor. The replacement mitral valve also comprises a plurality of replacement leaflets secured to the valve assembly.

[0029] This embodiment and other embodiments may include one or more of the following features. The outer diameter of the ventricular anchor may be less than 55 mm. The diameter of the atrial anchor may be 3-10% larger than the diameter of the ventricular anchor. The valve support assembly may include an anchor assembly including a central portion and a ventricular anchor and an atrial anchor. The valve support assembly may further include an annular strut frame, which is radially positioned within the anchor assembly. The anchor assembly may be composed of a plurality of rhombus-shaped units. The valve support assembly may be configured to self-expand from a constrained configuration to an expanded configuration. The anchor assembly may be configured to shorten when transitioning from a constrained configuration to an expanded configuration. The anchor assembly may be configured to be hourglass-shaped. The tip of the atrial anchor may point in the direction of the ventricle. The atrial anchor and the ventricular anchor may be configured to compress native heart tissue therebetween. The atrial anchor may include multiple atrial tips, and the ventricular anchor may include multiple ventricular tips. There may be more ventricular tips than atrial tips.

[0030] In general, in one embodiment, a replacement mitral valve comprises a valve support assembly comprising a ventricular anchor, a central portion, and an atrial anchor. The valve support assembly has a self-expanding configuration in which the ventricular anchor and the atrial anchor are radially open relative to the central portion. The diameter of the atrial anchor is 3-10% larger than the diameter of the ventricular anchor. The replacement mitral valve also comprises a plurality of replacement leaflets secured to the valve assembly.

[0031] This embodiment and other embodiments may include one or more of the following features. The outer diameter of the ventricular anchor may be less than 55 mm. The valve support assembly may include an anchor assembly including a central portion and a ventricular anchor and an atrial anchor. The valve support assembly may also include an annular strut frame, which is radially positioned within the anchor assembly. The anchor assembly may be composed of a plurality of rhombus-shaped units. The valve support assembly may be configured to self-expand from a constrained configuration to an expanded configuration. The anchor assembly may be configured to shorten when transitioning from a constrained configuration to an expanded configuration. The anchor assembly may be configured to be hourglass-shaped. The tip of the atrial anchor may point in the direction of the ventricle. The atrial anchor and the ventricular anchor may be configured to compress native heart tissue therebetween. The atrial anchor may include multiple atrial cusps, and the ventricular anchor may include multiple ventricular cusps. There may be more ventricular cusps than atrial cusps.

[0032] Generally speaking, in one embodiment, an artificial mitral valve includes an anchor assembly, which includes a ventricular anchor, an atrial anchor and a central portion therebetween. The anchor assembly is configured to compress native heart tissue between the ventricular anchor and the atrial anchor. An annular strut frame is radially mounted within the anchor assembly and connected thereto. The artificial mitral valve also includes a plurality of replacement leaflets fixed to the annular strut frame. The anchor assembly and the annular strut frame are configured to self-expand from a folded configuration to an expanded configuration. The anchor assembly is configured to shorten along the central axis of the artificial mitral valve when self-expanding from the folded configuration to the expanded configuration. The annular strut frame is configured to substantially not shorten along the central axis when expanding from the folded configuration to the expanded configuration.

[0033] This embodiment and other embodiments may include one or more of the following features. The anchor assembly may include a plurality of diamond-shaped units. The ventricular anchor may include a plurality of struts and v-shaped connectors. When in the expanded configuration, the ventricular anchor and the atrial anchor may be radially expanded relative to the central portion. The anchor assembly may be configured to shorten by 20-30% when self-expanding from a collapsed configuration to an expanded configuration.

[0034] Generally, in one embodiment, a prosthetic mitral valve comprises an anchor assembly comprising a ventricular anchor, an atrial anchor, and a central portion therebetween. The anchor assembly is configured to compress native heart tissue between the ventricular anchor and the atrial anchor. An annular strut frame is radially mounted within the anchor assembly such that the annular strut frame is radially spaced from the central portion of the anchor assembly. The prosthetic mitral valve also comprises a plurality of replacement leaflets secured to the annular strut frame.

[0035] This embodiment and other embodiments may include one or more of the following features. The annular strut frame may be spaced 2-3 mm radially from the central portion. The annular strut frame may be flared at the atrial end. The atrial tip of the annular strut frame may be attached to the anchor assembly. A portion of the anchor assembly may be pulled radially inward relative to the remainder of the anchor assembly to attach to the annular strut frame.

[0036] In general, in one embodiment, a prosthetic mitral valve comprises a valve assembly comprising a ventricular anchor, a central portion, and an atrial anchor. The anchor assembly is configured to expand from a folded configuration to an expanded configuration. The atrial anchor comprises a plurality of atrial units forming peaks and valleys around its circumference, and the ventricular anchor comprises a plurality of ventricular units forming peaks and valleys around its circumference. A plurality of replacement leaflets are secured to the valve assembly. A plurality of retaining hooks are attached only to the ventricular anchor. When the valve assembly is in the expanded configuration, each of the plurality of retaining hooks is positioned in a valley between the ventricular units.

[0037] This embodiment and other embodiments may include one or more of the following features. When the anchor assembly is in the expanded configuration, the plurality of retaining hooks may be bent to point in the direction of the atria. The valve assembly may be configured to self-expand. The plurality of retaining hooks may be pointed at an angle of 50°-80° relative to the horizontal axis of the artificial mitral valve. The plurality of retaining hooks may be positioned in each valley except the valley closest to the leaflet attachment point.

[0038] Generally speaking, in one embodiment, an artificial mitral valve includes an anchor assembly, which includes a ventricular anchor, a central portion, and an atrial anchor. The anchor assembly is configured to expand from a folded configuration to an expanded configuration. The atrial anchor includes a plurality of atrial units at the atrial edge of the atrial anchor, and the ventricular anchor includes a plurality of ventricular units at the ventricular edge of the ventricular anchor. The number of ventricular units is divisible by 2, and the number of atrial units is divisible by 3. An annular strut frame is positioned within the anchor assembly and includes a plurality of struts connected by connecting members. Three of the struts include commissure attachment points. The three commissure attachment points are equidistantly arranged on the circumference of the annular strut frame. Three replacement leaflets are fixed to the annular strut frame at the commissure attachment points.

[0039] This embodiment and other embodiments may include one or more of the following features. There may be 30 ventricular units, 15 atrial units, and 15 struts. There may be 24 ventricular units, 12 atrial units, and 12 struts. The number of ventricular units may be greater than the number of atrial units. The number of ventricular units may also be divisible by 3.

[0040] Generally speaking, in one embodiment, an artificial mitral valve includes a valve support assembly, a plurality of leaflets, and a plurality of retaining hooks. The valve support assembly includes a ventricular anchor, a central portion, and an atrial anchor. The valve support assembly is configured to self-expand from a folded configuration to an expanded configuration. A plurality of leaflets are fixed to the valve support assembly, and a plurality of retaining hooks are attached to the ventricular anchor. When the valve support assembly is in the expanded configuration, each retaining hook is bent radially outward to point in the direction of the atrium, and the ratio of the radius of curvature to the thickness of each retaining hook is 4:1 or greater.

[0041] This embodiment and other embodiments may include one or more of the following features. The ratio may be between 4:1 and 8:1. Each of the plurality of retaining hooks may be configured to point at an angle of 10-40 degrees relative to the central longitudinal axis of the artificial mitral valve. The angle may be approximately 28°. The radius of curvature of each of the plurality of retaining hooks may be less than 4 mm. The radius of curvature of each of the plurality of retaining hooks may be between 2 mm and 4 mm. The thickness of each of the plurality of retaining hooks may be less than 1.6 mm. The thickness of each retaining hook may be between 0.25 mm and 1 mm. The ratio of the width to the thickness of each retaining hook may be between 0.3:1 and 1:1. Each hook may be configured to engage approximately 3-10 mm of mitral valve tissue when the valve support assembly is in an expanded configuration. The plurality of retaining hooks may be integrated with the valve support assembly. The valve support assembly may include an anchor assembly including a ventricular anchor, an atrial anchor and a central portion, and an annular strut frame radially positioned within the anchor assembly. The plurality of retaining hooks may be attached to the anchor assembly. The central portion can be configured to align with the native valve orifice, and the ventricular anchor and the atrial anchor can be configured to compress native heart tissue therebetween. The valve support assembly can include a plurality of rhombus-shaped units, and each retaining hook can extend from an apex of an inner rhombus-shaped unit. The retaining hook can extend from each apex on a circumference around the artificial mitral valve, except for a position proximal to the leaflet attachment point.

[0042] Generally speaking, in one embodiment, an artificial mitral valve comprises a valve support assembly, a plurality of leaflets, and a plurality of retaining hooks. The valve support comprises a ventricular anchor, a central portion, and an atrial anchor. The plurality of leaflets are fixed to the valve support assembly, and the plurality of retaining hooks are attached to the ventricular anchor. Each retaining hook is curved radially outwardly toward the atrium, and the ratio of the radius of curvature to the thickness of each retaining hook is greater than 4:1, and is directed at an angle of 10°-40° relative to the central longitudinal axis of the artificial mitral valve.

[0043] This embodiment and other embodiments may include one or more of the following features. The ratio of the width to the thickness of each retaining hook may be between 0.3:1 and 1:1. Each hook may be configured to engage approximately 3-10 mm of mitral valve tissue when the valve support assembly is in the expanded configuration. Each radius of curvature of the plurality of retaining hooks may be less than 4 mm. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] The novel features of the invention are particularly pointed out in the following claims.The features and advantages of the invention may be better understood by referring to the following detailed description, which sets forth illustrative embodiments in which the principles of the invention are utilized and the accompanying drawings therein.

[0045] Figure 1A-Figure 1C An exemplary mitral valve prosthesis is shown. Figure 1A-1B An expanded configuration of the mitral valve prosthesis is shown. Figure 1C A portion of an expanded anchor assembly is shown in 2D.

[0046] Figure 2A-2E Another exemplary mitral valve prosthesis is shown. Figure 2A-2B An expanded configuration of the mitral valve prosthesis is shown. Figure 2C A portion of an expanded anchor assembly is shown in 2D. Figure 2D An expanded annular strut framework is shown. Figure 2E A 2D pattern of the strut framework (pre-expansion) is shown.

[0047] Figure 3A-3C Another exemplary mitral valve prosthesis is shown. Figure 3A-3B An expanded configuration of the mitral valve prosthesis is shown. Figure 3C An expanded annular strut framework is shown.

[0048] Figure 4A-4C Another exemplary mitral valve prosthesis is shown in an expanded configuration.

[0049] Figure 5A-5C An exemplary unshortened anchor assembly expanded configuration is shown.

[0050] Figure 6A-6C Another exemplary unshortened anchor assembly expanded configuration is shown.

[0051] Figure 7A-7B An exemplary anchor assembly is shown prior to heat setting into an hourglass shape.

[0052] Figure 8A-8G Another exemplary mitral valve prosthesis is shown. Figure 8A-8C An expanded configuration of the mitral valve prosthesis is shown. Figure 8D-Figure 8E An expanded anchor assembly is shown. Fig.8F A portion of an expanded anchor assembly is shown in 2D. Figure 8G The 2D pattern of the anchor assembly (pre-expansion) is shown.

[0053] Figure 9A-9D Another exemplary unshortened anchor assembly is shown. Figure 9A-9C An expanded configuration of the anchor assembly is shown. Fig.9DThe 2D pattern of the anchor assembly (pre-expansion) is shown.

[0054] Fig.10 An exemplary valve assembly including an anchor assembly, a strut frame, a skirt, and leaflets is shown.

[0055] Figures 11A-11E An exemplary mechanism for attaching the leaflets to the strut frame is shown. Fig.11A Exemplary commissure plates are shown. Fig. 11B A cross-sectional view of the leaflet extending between two commissures is shown. Fig. 11C A valve assembly is shown having posts with a series of holes therein for attaching leaflets to the valve assembly. Fig.11D A cross-sectional view of the leaflets and commissures attached to the struts is shown. Fig.11E A close-up of a portion of a strut with a hole therein is shown.

[0056] Fig.12 Another exemplary mechanism for attaching the leaflets to the strut frame is shown.

[0057] Figure 13A-13B Deployment of the ventricular anchor of an exemplary mitral valve prosthesis is shown removed from the sheath.

[0058] Fig.14 is a cross-section showing another exemplary mechanism for attaching the leaflets.

[0059] Figure 15A-Figure 15C Another exemplary mechanism for attaching the leaflets is shown. Fig.15A An auxiliary component comprising a slot is shown. Fig. 15B is a cross-sectional view showing the leaflets passing through the slots of the auxiliary member and surrounding the struts of the strut frame. Fig. 15C The alignment of the auxiliary members and the struts is shown.

[0060] Figures 16A-16D A holder comprising an exemplary mitral valve prosthesis with a skirt or cover is shown.

[0061] Figures 17A-17J Exemplary methods of deploying a valve prosthesis are shown.

[0062] Figure 18A-18E Another exemplary mechanism for attaching the leaflets to the strut frame is shown. Fig.18A A plate is shown attached to the valve assembly to attach the leaflets thereto. Fig.18B is a cross-sectional view showing the leaflets attached between the plate and struts. Fig. 18C It is a top view of a schematic mechanism. Fig.18D A plate is shown positioned over the two leaflets and the struts of the valve assembly. Fig.18E The plates are shown attached to the strut frame.

[0063] Fig.19 A method of sewing the leaflets around the periphery of the strut frame is shown.

[0064] Figure 20A-Figure 20Q Another exemplary mitral valve prosthesis is shown. Fig. 20A An exemplary mitral valve prosthesis is shown in an expanded configuration. Figure 20B-Figure 20C The expanded prosthesis is shown without leaflets or skirt for clarity. Figure 20D-20G An expanded anchor assembly is shown. Fig. 20H The atrial end of the expanded valve prosthesis is shown. Fig.20I The ventricular end of the expanded valve prosthesis is shown. Fig. 20J is a 2D view of the (unexpanded) Anchor component. Figure 20K An expanded pillar framework is shown. Figure 20L is a 2D view of the (unexpanded) strut framework. Figure 20M is a side view of the strut frame. Fig.20N It is a top view (atrial) of the strut frame. Fig.20O is another view of the expanded anchor component. Figure 20P-Figure 20Q Additional views of the prosthesis without leaflets or skirt expansion for clarity.

[0065] Fig.21 Exemplary leaflets for use with the mitral valve prostheses described herein are shown.

[0066] Fig. 22 The inflow edge of the leaflet is shown sewn to the strut frame.

[0067] Figure 23A-23C An exemplary mitral valve prosthesis is shown with a skirt overlying it.

[0068] Figure 24A-Figure 24C An exemplary mitral valve prosthesis is shown having a first set of sizes.

[0069] Figure 25A-Figure 25C An exemplary mitral valve prosthesis having a second set of sizes is shown.

[0070] Fig.26 An exemplary mandrel for forming the skirt is shown.

[0071] Figure 27A-Figure 27Q Another exemplary method of attaching leaflets to a mitral valve prosthesis is shown. Fig.27A A strut framework is shown with slots in the struts around which the first suture is positioned. Fig.27B A second suture is shown positioned thereabout. Fig.27C A third suture is shown positioned therearound. Fig.27D The arrangement of the leaflet protectors is shown. Fig.27EPositioning of the leaflets so that they are flush with each other is shown. Figure 27F-27H The placement of the leaflet arms through the slots in the strut frame is shown. Fig.27I The separation of the two leaflets is shown for attachment at an additional commissure point. Fig.27J An inflow view of the leaflets is shown after the leaflets have been attached at the commissural attachment points. Figure 27K An outflow view of the leaflets is shown after they have been attached at the commissure attachment points. Figure 27L The arms of the leaflets are shown wrapped around the strut frame. Fig.27M The leaflet protector is shown wrapped within the strut frame. Fig.27N The alignment of the leaflet arms with the strut frame is shown. Fig.27O The placement of the panels on the strut frame is shown. Figure 27P Two sutures are shown wrapped around the plate. Figure 27Q The final sutures wrapped around the plate are shown to attach the leaflets to the strut frame.

[0072] Fig.28 An exemplary valve prosthesis is shown placed in the native mitral valve orifice.

[0073] Figure 29A-29E A mitral valve prosthesis is shown with a delivery system attachment mechanism. Fig.29A An expanded valve assembly is shown with pins therein. Fig.29B A close-up of the pin is shown. Fig.29C The slots on the skirt are shown to allow access to the pins. Fig.29D A 2D (unexpanded) view of the anchor assembly with the pin is shown. Fig.29E A close-up of the pins with some spatial extent is shown.

[0074] Fig.30 Another exemplary mitral valve prosthesis is shown having a skirt thereon.

[0075] Figure 31A-Figure 31C An exemplary hook for a mitral valve prosthesis is shown.

[0076] Fig.32 The engagement radius R of the hook on the mitral valve prosthesis is shown.

[0077] Fig.33 An exemplary plate for leaflet attachment is shown.

[0078] Fig.34 Another exemplary plate for leaflet attachment is shown.

[0079] Fig.35 An exemplary tubular preformed skirt is shown.

[0080] Figure 36A-36BAn exemplary anchor assembly and strut frame having a skirt extending thereon are shown.

[0081] Figure 37A-Figure 37B Another exemplary mitral valve prosthesis is shown without the leaflets and skirt. DETAILED DESCRIPTION

[0082] The present disclosure includes replacement heart valves (also referred to herein as artificial heart valves), methods of making replacement heart valves (including subassemblies thereof), and methods of using replacement heart valves. The present disclosure describes prostheses in the context of replacement mitral valves, but it is envisioned that the prostheses herein can be used or modified for use as other replacement heart valves. In some embodiments, the replacement heart valve is a self-orienting replacement mitral valve that is configured to be delivered using minimally invasive techniques.

[0083] The replaceable heart valve described herein includes an anchor assembly including an atrial anchor (e.g., configured to be placed on the atrial side of the mitral annulus), a ventricular anchor (e.g., configured to be placed on the ventricular side of the mitral annulus), and a central portion axially positioned between the atrial anchor and the ventricular anchor. The anchor assembly is adapted to be folded to a delivery or folded configuration and expanded to an expanded configuration. The replaceable heart valve also includes a strut frame secured to at least one of the central portion, the ventricular anchor, or the atrial anchor for attaching a plurality of replacement leaflets thereto. The strut frame can be configured to deform and fold as the remainder of the anchor assembly is folded. The struts of the strut frame extend toward and / or through the ventricular anchor.

[0084] The replacement heart valves described herein are configured to secure the replacement heart valve in a native valve by clamping the heart hole between a ventricular anchor and an atrial anchor (the diameters of the ventricular anchor and the atrial anchor are larger than the valve hole), by applying an axial compressive force from the anchors, a radial force against the heart hole applied outward from the central portion, and / or by using hooks or barbs extending into the valve tissue.

[0085] In addition, the replacement heart valves described herein (e.g., mitral valves) can be delivered to the heart valve orifice by using minimally invasive techniques to access the heart valve. In some embodiments, the mitral valve prosthesis can be delivered via a transatrial approach, i.e., a small incision is made in the patient's body and the prosthesis is delivered to, for example, the mitral valve through the apex of the heart. In other embodiments, the mitral valve prosthesis can be delivered via a transventricular approach, i.e., through the venous system and a transseptal puncture into the left atrium. In both transatrial and transventricular delivery methods, the most distal anchor can be delivered to the ventricle, while the most proximal anchor can be delivered to the atrium.

[0086] Figure 1A-Figure 1CAn expanded configuration of an exemplary mitral valve prosthesis 100 is shown. The portion of the replacement valve prosthesis 100 in Figure 1 may be referred to as a prosthetic subassembly, which includes the anchor assembly 101 and the strut frame 105, but does not include the leaflets and any skirt that may be incorporated into the final replacement valve. The anchor assembly 101 includes an atrial anchor 102, a ventricular anchor 104, and a center portion 103 therebetween. In this embodiment, the atrial anchor 102 is configured and adapted to be located on the atrial side of the mitral valve orifice, and the ventricular anchor 104 is configured and adapted to be located on the ventricular side of the mitral valve orifice. In addition, the center portion 103 can be configured to be located in the mitral valve orifice. In some embodiments, the diameter of the center portion 103 is substantially the same as the size of the native mitral valve annulus (i.e., it is designed to be no larger than the annulus).

[0087] In some embodiments, the anchor assembly 101 and / or the strut frame 105 can be made of a metal wire, such as a shape memory metal wire (e.g., Nitinol). In other embodiments, the anchor assembly and / or the strut frame can be laser cut from one or more tubes, such as shape memory metal tubes (e.g., Nitinol). For example, the anchor assembly 101 can be laser cut from a first subcutaneous tube, while the strut frame 105 can be laser cut from a second subcutaneous tube of smaller diameter. The anchor assembly 101 can be cut from a tube having a diameter of 9-12 mm, such as 10 mm, and the strut frame 105 can be cut from a tube having a diameter of 7-9 mm, such as 8 mm.

[0088] Valve prosthesis 100 can be configured to expand (e.g., self-expand) from a collapsed or constrained (delivery) configuration to an expanded (treatment) configuration. Figure 1A-1B In the expanded configuration shown, the atrial anchor 102 and the ventricular anchor 104 extend radially outward from the central portion 103 and are considered to be flared outward relative to the central portion 103. The atrial anchor 102 and the ventricular anchor 104 can also be considered to be flanges relative to the central portion 103. The flared configuration of the atrial anchor 102 and the ventricular anchor 104 relative to the central portion 103 is depicted in a side view of the anchor assembly, Figure 1B 104 and the center portion 103. In some embodiments, the two anchors 102, 104 and the center portion 103 in the splayed configuration define a generally hourglass shape in a side view of the anchor assembly 101. That is, the anchors 102, 104 can splay outwardly relative to the center portion 103 and then bend or flex to at least partially point back in the axial direction. However, it should be understood that the hourglass configuration is not limited to a symmetrical configuration.

[0089] Anchor assembly 101 can be configured to expand circumferentially and shorten axially when valve prosthesis 100 expands from a collapsed delivery configuration to an expanded treatment configuration. Figure 1A-Figure 1CAs shown in , the anchor assembly 101 can be made of a plurality of units 111, each of which is configured to expand circumferentially and shorten axially when the anchor assembly 101 is expanded. Figure 1C As shown in , the units 111 can each be diamond-shaped. In addition, the units 111 can be interconnected and configured so that each diamond vertex 117 is connected to another diamond vertex 117, except at the atrial apex 112 or the ventricular apex 114 of the assembly 101. The anchor assembly 101 can include, for example, three circumferential rows of diamond-shaped units 111. For example, the atrial anchor 102 can include a row of circumferentially extending diamond-shaped units 111, the central portion 103 can include a row of circumferentially extending diamond-shaped units 111, and the ventricular anchor 104 can include a row of circumferentially extending diamond-shaped units 111.

[0090] Strut frame 105 can be configured to expand circumferentially as valve prosthesis 100 expands from a collapsed delivery configuration to an expanded treatment configuration, but maintains the same axial dimension (i.e., does not shorten). By virtue of not shortening, strut frame 105 can advantageously ensure that less pressure is applied to the leaflets during delivery and / or packing. Thus, while anchor assembly 101 is designed to shorten, strut frame 105 is designed to not shorten substantially. As in Figure 1B As best seen in FIG. 1 , the strut frame 105 may include a plurality of longitudinally extending struts 151 and interconnected V-shaped members 153. Additionally, in some embodiments, and also as Figure 1A-1B As shown, strut frame 105 can have fewer (e.g., half as many) V-shaped members 151 extending circumferentially around its diameter than cells 111 of anchor assembly 101. In addition, strut frame 105 can flare radially outward at the atrial end, e.g., to conform to the flaring of atrial anchor 102.

[0091] The support frame 105 and the anchor assembly 101 can be connected together by connecting members (such as rivets). Figure 1A-1B As shown in FIG. 1 , the atrial apex 129 of the strut frame 105 can be connected to the atrial apex 112 of the anchor assembly 101. When there are fewer v-shaped members 151 in the strut frame 105 than cells 111 in the anchor assembly 101 (e.g. Figure 1B As shown), the strut frame 105 can be attached to the atrial apex 112 on every other anchor assembly 101.

[0092] The radially inner surface of the strut frame 105 can substantially define the perimeter of the central opening 106. For clarity, Figure 1A-1B Replacement valve leaflets, not shown, may be secured to strut frame 105 and may be at least partially located within central opening 106. The valve leaflets are configured to control blood flow therein.

[0093] In some embodiments, valve 100 may include hooks 188 or barbs to help anchor the assembly in the mitral valve orifice. Figure 1A-Figure 1C As shown in FIG. 1 , in one embodiment, the hook 188 can be on the ventricular-most tip 114 of the ventricular anchor 104 .

[0094] Figure 2A-2E Another exemplary valve prosthesis 200 is shown. Valve prosthesis 200 is similar to valve prosthesis 100 and may include many of the same features as valve prosthesis 100, such as anchor assembly 201 (having atrial anchor 202, ventricular anchor 204, and central portion 203) and strut frame 205. In contrast to prosthesis 100, cells 211 of anchor 201 are not connected together at each interior vertex 217. Instead, the middle row of cells 211 may be disconnected at every other atrial vertex 219 on the atrial side. As a result, there may be fewer atrial cusps 212 than ventricular cusps 214, and the cells closest to the atrium may be truncated or V-shaped (i.e., spanning each disconnected vertex 219 and corresponding diamond-shaped cells). For example, there may be 15 atrial cusps 212 (and 15 v-shaped cells 211 at the atrial cusps) and 30 ventricular cusps 214 (and 30 diamond-shaped cells at the ventricular cusps). Advantageously, the atrial apex 212 can provide greater flexibility in conforming the atrial anchor 202 to tissue because the atrial apex 212 is larger / wider than the ventricular apex 214. The atrial apex 219 can be radially aligned with the atrial apex 212 and can be located about midway along the diamond-shaped cells at the atrial apex 212 along the central longitudinal axis (as discussed above, the outermost cells can also be considered v-shaped, especially in 2D format, because the inner cells and apex 219 are located within the outer larger diamond, making it v-shaped).

[0095] In some embodiments, each of the atrial apex 219 may have a rivet hole for connection to the atrial tip 229 of the strut frame 205. In addition, in some embodiments (and as Figure 2A and 2B205 ), the atrial apex 219 can be slightly bent radially inward toward the strut frame 205 (e.g., bent radially inward further than the rest of the anchor assembly 201 to contact the strut frame 205). The atrial apex 219 can be radially aligned with the atrial tip 212 of the atrial anchor 202. In addition, when the apex 219 is bent radially inward, it can effectively act as an integral suspension, holding the central portion 203 and the ventricular anchor 204 radially outward relative to the strut frame 205 and spatially separated from the strut frame 205. For example, the radial distance between the ventricular anchor 204 and the strut frame 205 can be 1-15 mm, such as 2-11 mm, such as about 3 mm. In addition, the central portion 203 can be separated from the strut frame 205 by a radial distance of, for example, 2-3 mm. Such separation of the ventricular anchor 204 and / or the central portion 203 can advantageously isolate the leaflets from the anchor assembly 201 on the ventricular side, wherein the greatest degree of deformation is placed on the anchor assembly 201.

[0096] Additionally, in this embodiment, the strut frame 205 and anchor assembly 201 can be attached at the center point of the atrial anchor 202 (i.e., at the apex 219) rather than at the outermost or atrial tip 212 of the atrial anchor 202. By attaching the inner strut frame 205 to the anchor assembly 201 at the midpoint of the atrial anchor 202 rather than at the atrial tip 212, less torque or twisting force is applied to the strut frame 205 as the atrial anchor 202 conforms to the tissue, thereby helping to ensure that the leaflets maintain their desired position.

[0097] As in Figure 2D and 2E As best shown in , the strut frame 205 can include a plurality of struts 221 and v-shaped members 223 (so as not to be substantially shortened as described with respect to the strut frame 105). In this embodiment, there are four axially extending v-shaped members 223 between each pair of struts 221. The two v-shaped members 223 closest to the ventricle and the v-shaped member 223 closest to the atrium are both pointed in the direction of the atria. The remaining v-shaped members 223 are pointed in the direction of the ventricles. Having the v-shaped members 223 pointed in the direction of the ventricles can increase the rigidity of the strut frame 205. In addition, having the last v-shaped member 223 pointed in the atrium can reduce the length of the strut and reduce the number of vertices pointing in the ventricles (to reduce trauma to the ventricles). The atrial tips 229 of the strut frame 205 can be formed by the vertices of the "V". Each atrial tip 229 can include a rivet hole therein for connection to the anchor assembly 201. Additionally, the strut frame 205 may include flares at its atrial end to enable the strut frame to meet the apex 219 and / or conform to the flared atrial anchor 202. Additionally, in some embodiments (and as Figure 2D), the flare at the atrial end of the strut frame 205 may include a relatively flexible member 209 or zigzag feature therein. The flexible member 209 may be configured to allow the atrial flare to be easily folded during packing / delivery.

[0098] In some embodiments, the number of ventricular cells or ventricular cusps 214 in the valve 200 (or any valve described herein) can be evenly divisible by 2 and 3. For example, there can be 18, 24, or 30 ventricular cells or cusps 214. Since the number of ventricular cusps 214 is evenly divisible by 2, the number of atrial cusps 212 can be half that. In addition, since the number of cells is evenly divisible by 3, the three connection points of the three leaflets (e.g., struts 221a, b, c) of the strut frame 205 can be evenly distributed around the circumference of the central opening 206. In any given design, the increased number of ventricular cusps / cells (e.g., from 18 cells to 30 cells) means that the total amount of circumferential expansion required for each cell is reduced, thereby shortening the longitudinal length of the cell and reducing the total length of the packed assembly (i.e., during delivery). In some embodiments, the cell, when folded (e.g., before expansion), is between 4-6 mm in length and between 0.2-0.4 mm in width. At these dimensions, the packed assembly can be, for example, 30-40 mm, such as 32-35 mm. Additionally, in some embodiments, the cell size is selected such that the width to length ratio produces no more than 8-10% sheath strain when the anchor assembly is retracted into the catheter for delivery.

[0099] Figures 3A-3C Another exemplary valve prosthesis 300 is shown. Valve prosthesis 300 is similar to valve prosthesis 200 (its anchor assembly 302 is similar to assembly 201). However, strut frame 305 includes reduced thickness members 310 at the atrial flare instead of flexible members 209. Reduced thickness members 310 can have a smaller diameter than the rest of strut frame 305. Reduced thickness members 310, like flexible members 209, can make strut frame 305 more easily bendable at the flare, thereby making packing easier.

[0100] Figure 4A-4C Another exemplary valve prosthesis 400 is shown. Valve 400 is similar to valves 100-300, except that the point of attachment between the strut frame 405 and the anchor assembly 401 is at the ventricular end of the strut frame 405. To connect the anchor assembly 401 to the ventricular end of the strut frame 405, a connecting member 494 extends from the anchor assembly 401 (e.g., from the central portion 403 or the ventricular anchor 404) to the ventricular tip of the strut frame 405. The connecting member 494 can be integral, for example, integral with the anchor assembly 401 and then riveted to the strut frame 405. In some embodiments, such as in Figure 4A-4C, the connecting member 414 can be a single longitudinal member. In other embodiments, the connecting member 494 can be cells or tips 414 of the ventricular anchor 404 that are pulled radially inward (e.g., every other tip 414 of the ventricular anchor 404 can be pulled inward). Furthermore, in some embodiments, additional layers of cells can be coupled or riveted to the ventricular anchor 404 to adjust its rigidity. As shown in Figure 4A-4C As shown in , the tips of the strut framework 405 may still be opened to a certain angle, for example, to generally conform to the opening of the atrial anchor 402 of the anchor assembly 401.

[0101] Figure 8A-8G Another exemplary valve prosthesis 800 is shown including a valve assembly 801 and a strut frame 805. Valve prosthesis 800 is similar to valve prosthesis 200, except that the flare of the ventricular anchor 804 of valve prosthesis 800 has a greater curvature, which helps to improve the retention force in some embodiments. For example, the ventricular anchor 804 can be opened at an initial angle of 5°-15°, such as 10°, relative to a horizontal plane passing through the central portion 803 (and / or 75°-95°, such as 80°, relative to a central axis passing through the prosthesis 800). In addition, the anchor assembly 801 includes a plurality of barbs or hooks 888 extending from the ventricular anchor 804. Positioning the hooks on the ventricular anchor 804 advantageously helps to hold the prosthesis in place because the ventricular side of the mitral valve is subjected to the highest pressure. The hooks 888 are located in the valley between the ventricular cusps 814. In addition, when the anchor assembly 801 is in the expanded configuration, each hook 888 is curved backward and is at least partially pointed in the direction of the atrium.

[0102] Figure 20A-Figure 20QAnother exemplary valve prosthesis 2000 is shown, which includes a valve component 2001 and a strut frame 2005. Prosthesis 2000 is similar to valve prosthesis 800, except that the tip 2014 of the ventricular anchor 2004 can bend away from the horizontal axis 2020, such as at an angle of 60-70°, such as 67°, relative to the horizontal plane 2020, after radially flaring at an angle of 5-15° relative to the horizontal plane 2020, to generally point in the axial (ventricular) direction. The curvature of the two portions can be between 2 mm and 8 mm, respectively. Similarly, the atrial anchor 2002 can extend at an initial angle of 20°-30°, such as about 26°, relative to the horizontal plane 2020 passing through the central portion 2003. The tip 2012 of the atrial unit can bend away from the axis 2020, such as at an angle of 60-70°, such as 67°, relative to the horizontal plane 2020, to point more in the axial (atrium) direction. The curvature of the two portions may be between 2 mm and 8 mm, respectively. In addition, the atrial apex 2019 with the rivet holes therein may extend at an angle of about 50-70°, e.g., 60°, relative to the axis 2020 to meet and be secured to the strut frame 2050. Similarly, the atrial tip 2029 of the strut frame 2005 may be flared about 70°-80° relative to the horizontal axis 2020 to substantially conform to the flaring of the atrial apex 2019. There may be 30 atrial units and only 15 ventricular units along a single circumference.

[0103] In addition, it is best to Figure 20K-Figure 20N As shown in , the difference between the strut frame 2005 and the strut frame 805 is that the strut frame 2205 does not include a flexible member (e.g., a zigzag feature) at the flared end of the strut frame 2005. Instead, the connecting member on the anchor structure can make it more compliant. Like the strut frame 205, the strut frame 2005 includes a plurality of struts 2021 and v-shaped members 2023 so as not to shorten. However, in the strut frame 2005, there are 5 v-shaped members 2023 (instead of 4) extending between each pair of struts 2021. The additional v-shaped member 2023 is located at the position of the v-shaped member 2023 closest to the atrium and extends from the strut 2023 in the atrium direction. The additional v-shaped member can advantageously increase the circumferential strength of the strut frame 2005. The strut frame 2005 can also include one or more grooves 2733 in the strut 2021 to allow attachment of the leaflets, as described below.

[0104] Anchor assembly 2001 also includes a barb or hook 2088, which is similar to hook 888 and is located in the valley between the ventricular apexes 2014 and is bent back toward the atrial end. Figure 20O-Figure 20QAs shown in , hooks 2088 can be positioned between each ventricular unit 2011 (e.g., in the valleys), except for those valleys closest to the commissure attachment points. At these points, one or more (e.g., one, two, or three) of the hooks 2088 can be removed to prevent interference with the commissures and / or leaflets when the prosthesis is in the folded configuration.

[0105] In some embodiments, such as for anchor assembly 2000, atrial anchor 2002 can have a larger diameter than ventricular anchor 2004. Having an atrial anchor 2002 that is larger than a ventricular anchor 2004 allows anchors 2002, 2004 to grasp tissue while preventing atrial anchor 2004 from obstructing blood flow to the aortic valve. Fig.28 As shown in , if the ventricular anchor is too large, the left ventricular outflow tract (LVOT) 2828 may be blocked and restrict flow through the adjacent aortic valve 2829. In some embodiments, for example, the diameter of the atrial anchor 2002 can be 3-10% larger than the diameter of the ventricular anchor 2004. Thus, the ventricular anchor 2004 can be less than 55 mm, such as less than or equal to 54 mm, such as less than or equal to 52 mm.

[0106] As mentioned above, the number of ventricular units or ventricular cusps in any of the valves described herein can be evenly divisible by 2 and 3. For example, Fig.37A As shown in , there may be 30 ventricular apexes and 15 atrial apexes. As another example, Fig.37B As shown, there may be 24 ventricular cusps and 12 atrial cusps.

[0107] In some embodiments, the prostheses described herein can be made in a variety of different sizes to fit within the range of the native valve orifice. Figure 24A-Figure 24C In some embodiments, the valve prosthesis 2400 can have an atrial anchor 2402 with an outer diameter of 54 mm, a ventricular anchor 2404 with an outer diameter of 52 mm, and a central portion 2403 with an outer diameter of 36 mm. In addition, the inner diameter of the strut frame 2405 can be 27 mm-30 mm (e.g., about 29 mm). The overall height of the prosthesis 2400 can be, for example, 22-28 mm, such as 26 mm. In contrast, Figure 25A-Figure 25CThe valve prosthesis 2500 can have a larger diameter to fit within a larger native valve orifice. For example, the outer diameter of the atrial anchor 2502 is 59 mm, the outer diameter of the ventricular anchor is 54 mm, and the outer diameter of the center portion 2503 is 40 mm. The strut frame 2505, similar to the strut frame 2405, can have an inner diameter of 27 mm-30 mm (e.g., 29 mm). To compensate for the increased diameter of the valve assembly 2501 relative to the strut frame 2505, the disconnected atrial apex 2519 can be pulled further radially inward (e.g., the disconnected atrial apex 2519 can be pulled downward in an S-shape to move further inward). The total length of the expanded valve 2500 can be 28-29 mm. In addition, to maintain low packing strain, the sheathing or packing length of the valve 2500 can be longer than the packing length of the valve 2400. For example, the valve 2400 may have a packed length of 32 mm to 35 mm, while the valve 2500 may have a packed length of 34 mm to 37 mm.

[0108] The anchor assemblies 101-401, 801, 2001, 2401 and 2501 will shorten when expanded (due to their cell design). For example, the anchor assembly may shorten by 20%-30%. In contrast, the corresponding strut frames 105-405, 805, 2005, 2405 and 2505 maintain substantially the same axial length.

[0109] In some embodiments, the prosthesis can be designed so that the entire prosthesis does not shorten during expansion. The prosthesis does not shorten, advantageously allowing the packing length to be significantly shortened, such as less than 35 mm, such as less than 30 mm, or less than 25 mm.

[0110] For example, Figure 5A-5C An anchor assembly 501 is shown, which includes a plurality of struts 505 and a circumferential v-shaped connector 507 that does not substantially shorten when expanded. The anchor assembly 501 forms a substantially hourglass shape in the expanded configuration. In addition, the atrial end includes a flexible member 519 (e.g., a zigzag member) to help conform to the native hole.

[0111] Figure 6A-6C Another exemplary unshortened anchor assembly 601 is shown having a plurality of struts 605 and a circumferential v-shaped connector 607. In this embodiment, the ventricular anchor 604 is curled inward at the tip to minimize interaction with native ventricular anatomy.

[0112] Figure 9A-9DAnother exemplary unshortened anchor assembly 901 having a plurality of struts 905 and circumferential v-shaped connectors 907 is shown. In this embodiment, five v-shaped connectors 907 extend between each set of struts 905. Like the ventricular anchor 604, the ventricular end of the ventricular anchor 904 is curled at its tip to minimize interaction with native anatomy. In addition, each strut 905 includes a flexible portion 929 (e.g., a zigzag or serpentine portion) extending from the atrial tip to the central portion 903. The flexible portion 929 helps to conform the atrial anchor 902 to the native orifice. In this embodiment, the strut frame (which can be any strut frame described herein) can be configured to be attached (e.g., rivet locations 939) along the middle of the atrial anchor 902. Advantageously, by attaching the strut frame at the atrial anchor (i.e., rather than the ventricular anchor), deformation of the strut frame that may occur when the ventricular anchor is expanded during delivery can be reduced.

[0113] A variety of hook or barb mechanisms may be used with any of the valves described herein. For example, the hook or barb may be riveted to the anchor assembly, may be laser cut from the assembly, and / or may form part of a v-shaped feature of the anchor assembly. The hook or barb mechanism may be designed to point radially outward (i.e., not into tissue) during deployment and not contact tissue until fully released, thereby preventing interference with deployment. This may be accomplished by using a hook having an appropriate radius of curvature to thickness ratio.

[0114] In some embodiments, such as in Figure 1A-Figure 1C As shown in FIG. 1 , the hook can be placed at the apex of the ventricle of the ventricular anchor. In other embodiments, the hook can be in the valley (i.e., between the valves or apex, such as Figure 8A-8G and Figure 20A-Figure 20N ). For example, the hook can be placed in a valley on the ventricular anchor (e.g., starting from the vertex of the inner rhombus unit). When placed between the valleys on the ventricular anchor, the hook can be bent around and pointed in the atrial direction at an angle of 40°-90°, such as 50°-80°, such as 57-67°, such as about 62° relative to the central longitudinal axis of the device (or up to 50°, such as 10°-40°, such as 23°-33°, such as about 28° relative to the central longitudinal axis of the device). This angle can advantageously allow the hook to be pointed in the atrial direction to dig into tissue.

[0115] refer to Figure 31A-Figure 31C, each hook 3188 on the implant 3100 (which can be any implant described herein) can be curved along an angle α between 99°-119°, for example 104°-114°, for example approximately 109°. In addition, the ratio of the radius of curvature RC to the thickness T of each hook 3188 can be 4:1 or greater. Having a ratio of the radius of curvature RC to the thickness T of 4:1 or greater ensures that the hook 3188 can be bent from its curved configuration to a flat state during folding (e.g., for delivery). In some embodiments, the ratio of the width W to the thickness T of each hook 3188 can be between 0.3:1 and 1:1, for example between 0.4:1 and 0.6:1. Ratios within this range advantageously ensure that the hook 3188 does not twist or bend laterally when folded or flattened (e.g., for delivery of an implant).

[0116] In some embodiments, the ratio of the radius of curvature RC to the thickness T is between 4:1 and 10:1, such as between 5:1 and 9:1. The radius of curvature RC, for example, can be less than 4 mm, such as between 2 mm and 4 mm, such as between 2.5 mm and 3.5 mm, such as about 3 mm. The thickness T of the hook can be less than 1.6 mm, such as between 0.25 mm and 1 mm, such as between 0.3 mm and 0.5 mm, such as between 0.39 mm and 0.45 mm, such as about 0.42 mm. The width W of the hook can be between 0.1 mm and 0.4 mm, such as between 0.2 mm and 0.3 mm, such as about 0.22 mm.

[0117] In one exemplary embodiment, the radius of curvature of the hook is 3 mm, the thickness of the hook is 0.42 mm, and the width of the hook is 0.22 mm. Therefore, the ratio of the radius of curvature to the thickness is about 7.1:1, and the ratio of the width to the thickness is about 0.5:1.

[0118] refer to Fig.32 In some embodiments, the hooks 3288 on the implant 3200 (which can be any implant described herein) can be configured to engage tissue (e.g., extend within tissue of the native mitral valve annulus) with a radius R of 2-20 mm, such as 3-10 mm, such as approximately 3.4 mm. Having an engagement radius within this range advantageously ensures that the hooks 3288 can engage tissue even when the native valve is not circular, while ensuring that the hooks 3288 do not interfere with the adjacent aortic valve. For example, the diameter D1 of the implant 3200 at the connection of each hook 3288 (e.g., the radially innermost point of the hook) can be 30-50 mm, such as 40-48 mm, such as approximately 45 mm. The diameter D2 of the implant 3200 at the tip of each hook 3288 (e.g., the radially outermost point of the hook) can be 40-60 mm, such as 45-55 mm, such as 52 mm.

[0119] In some embodiments, the hook can be riveted to the anchor assembly. In other embodiments (such as in Figure 7A-7B ), the hook may be a flap that extends out from the anchor assembly.

[0120] In some embodiments, such as in Figure 9A-9D , a portion of the anchor assembly 901 can include a portion pointing radially outward to act as a hook or barb in the tissue. For example, a set of v-shaped circumferential members 907 can be curved to point outward. For example, the curved v-shaped members can be positioned on the inner diameter of the ventricular anchor 904 pointing toward the atrium.

[0121] Any of the valve prostheses described herein may include a fabric cover and / or skirt on one or more portions of the device. Figures 16A-16D (For clarity, the valve is shown on the holder), a covering or skirt 1616 can be sewn down along the inner diameter of the atrial anchor 1616 and the flare of the strut frame 1605, and along the entire inner diameter of the strut frame 1605. The skirt 1616 can thus provide a smooth entry for blood to enter the valve leaflets 1622. In addition, the skirt 1616 can extend along the entire outer diameter of the anchor assembly and then around the tip of the ventricular anchor 1604. In some embodiments, the skirt 1616 can be a single piece, while in other embodiments, the skirt 1616 can be made of multiple pieces.

[0122] In some embodiments, such as in Fig. 20A As shown in FIG. 2 , skirt 2016 may leave the ventricular apex of ventricular anchor 2004 uncovered. Fig.30 As shown in FIG. 3 , skirt 3006 can be wrapped completely around the ventricular apex of ventricular anchor 3004 .

[0123] In some embodiments, the skirt or a portion of the skirt can be knitted into a three-dimensional shape, such as an hourglass shape, to help maintain the seal of the skirt against the prosthesis and to help pack the prosthesis covered by the skirt during delivery. Figure 23A-23C As shown in , skirt 2316 can be cut into an hourglass shape and configured to cover all exposed portions of the valve on the atrial side (leaving only the ventricular side of the ventricular anchor and the outer diameter of the strut frame uncovered).

[0124] Furthermore, in some embodiments, as in Figure 23A-23C As shown in Figure 23, the skirt 2316 can be cut in a sawtooth pattern on the ventricular side to mimic the pattern of cells extending to the outer diameter of the ventricular anchor. Cutting the skirt in this manner can help pack the ventricular anchor into the delivery device by reducing the packing diameter of the ventricular anchor.

[0125] refer to Fig.35, the skirt 3516 can be preformed into a tubular three-dimensional structure. The skirt 3516 can have a wide portion 3535 configured to be formed around the outside or outer surface of the anchor assembly, and a narrow portion 3553 configured to be formed against the inside or inner surface of the strut frame. The central portion 3552 between the wide portion 3535 and the narrow portion 3552 can have a tapered diameter. The skirt 3515 can be wrapped around the anchor assembly and the strut frame with the first end 3554 positioned at the tip of the ventricular anchor, the wide portion 3535 conforming to the outside of the anchor assembly, the tapered central portion 3552 extending between the ventricular anchor and the atrial end of the strut frame, and the narrow portion 3553 folded or everted into the strut frame to conform to the inner surface of the strut frame (where the second end 3555 is positioned at the ventricular end of the strut frame). As shown, the first end 3554 can have a sawtooth pattern to simulate the points of the cells that form the ventricular anchor, and / or the second end 3555 can have a sawtooth pattern to simulate the apex at the ventricular end of the strut frame. In some embodiments, the skirt 3516 can have a pre-formed cutout (e.g., a laser cutout) to provide access for hooks, commissure attachment mechanisms, delivery system attachment mechanisms, or other elements of the underlying frame.

[0126] FIG. 36 shows a skirt 3616 formed and wrapped around a valve similar to that described for skirt 3516. However, in this embodiment, first end 3654 and second end 3655 are not serrated. Instead, end 3654 is straight and ends at the tip of the ventricular anchor 3604, while end 3655 is straight and wraps around the tip of the ventricular end of strut frame 3605. It should be understood that one or both of ends 3655, 3654 can be serrated, one or both can be wrapped, and / or one or both can end at the tip. In addition, skirt 3655 can be sutured to the frame at its edges (e.g., using polyethylene sutures).

[0127] refer to Fig.26 , if the skirt is woven or otherwise formed into a three-dimensional shape, an inner mandrel 2626 can be used (e.g., the skirt can be woven or formed on the mandrel). After the skirt is formed around the mandrel 2626, the mandrel 2626 can be dissolved or otherwise decomposed, leaving the formed skirt. In some embodiments, a fabric such as polyester can be used to form the skirt on the mandrel 2626. In other embodiments, a polyurethane layer can be painted or otherwise applied to the mandrel 2626. Polyurethane can advantageously produce fewer wrinkles than woven cloth. If a polyurethane layer is used, a layer of material can be added to the skirt when the valve is packaged and / or unpacked to provide the skirt with a certain degree of elasticity. In addition, in some embodiments, one or more layers of polyurethane can be added after the skirt is sewn to the frame (e.g., to fill the material into any holes caused by sewing the skirt to the frame).

[0128] The skirt described herein may be made of polyethylene terephthalate (PET), polyester or PET of a polyurethane dispersion.

[0129] The skirt can advantageously help prevent blood from flowing from one side of the valve to the other. The skirt can also help prevent anatomical structures from interacting unfavorably with the frame itself.

[0130] In some embodiments, a connector can be used to connect the strut frame to the anchor assembly. A rivet is an example of a connector coupler herein. The location where the components are fixed to each other may be referred to herein as a connection. A connection also refers to two components fixed together. The rivet used herein is an example of a method that causes a connector to plastically deform to fix two or more components together at a connection. Connectors and rivets are further described in U.S. Patent Application No. 14 / 677,334, entitled "Replaceable Heart Valve, Method of Use, and Method of Manufacturing," filed on April 2, 2015, the entire contents of which are incorporated herein by reference.

[0131] In some embodiments, the valve prosthesis is shown without leaflets for clarity. It should be understood that each of the embodiments described herein may include replacement leaflets 1022a, b, c attached thereto, such as in Fig.10 In Fig.21 An exemplary leaflet 2122 is shown in FIG. The leaflet may include: an outflow (or free) edge 2191 configured to float within a support frame, an inflow edge 2193 configured to be sutured to the support frame, and two arms 2195a, b. A plurality of suture holes 2197 may be used to suture the leaflet 2122 to the support frame. Thus, as shown in FIG. Fig.19 As shown in , the periphery of the leaflet at the inflow edge can be sutured to the strut frame and / or to the skirt covering the skirt frame. That is, although the commissures or edges of the leaflet can be attached as described above, the inflow edge of the leaflet can also be sutured all around the strut frame.

[0132] Furthermore, the leaflets can be attached to any valve prosthesis design in a variety of different ways.

[0133] For example, refer to Figures 11A-11E, two commissure plates 1010a,b can be used to sandwich the arms 1022a,b of the leaflets therebetween. The leaflets 1022a,b can then be sutured together (and to the plates 1010a,b) using one or more sutures 1011 through holes 1013a,b,c. After being sutured together, the combined leaflets and commissure plates can then be attached to the strut frame 1105 using sutures 1017 (which can be the same or different than sutures 1011) through a series of holes 1113a,b,c on, for example, one of the struts 1121. The commissure plates 1010a,b can be made of, for example, stainless steel or plastic. Advantageously, the commissure plates 1010a,b can apply pressure to the leaflets 1022a,b and distribute strain along the length of the commissure plates, thereby reducing the propagation of tears or strain in the tissue.

[0134] Fig.12 Another exemplary leaflet attachment mechanism is shown in . Here, instead of using two commissure plates, a U-shaped plate 1110 is used with a set of holes on each side. Compared to commissure plates 1010a, b, plate 1110 can provide a fixed amount of compression to the leaflets sandwiched therein.

[0135] Fig.14 and Figure 15A-Figure 15C Other exemplary mechanisms for leaflet attachment are shown in FIG. Fig.14 In a version of the invention, the arms of the two leaflets 1022a, b are pulled through the slot 1333, which is part of the strut 1321 of the strut frame. An auxiliary member 1313 having a width greater than the width of the slot 1313 is placed against the two arm leaflets, and then the arms of the leaflets 1022a, b are wrapped around the auxiliary member 11313 and the arms are attached together using sutures 1311 or staples. The auxiliary member 1313 can be connected to the strut frame using, for example, rivets. In a similar embodiment, as in Figure 15A-Figure 15C As shown in FIG. 1 , the leaflets 1022a, b can be passed through the slots in the auxiliary member 1515 and then wrapped around the struts 1521 of the strut frame. Advantageously, Fig.14 and Figure 15A-Figure 15C The mechanism evenly distributes the high stress areas of the leaflet along the length of the strut 1312 or rivet slot 1321. The load distribution along a given length of these components reduces stress compared to attachment methods (i.e., suturing) that produce many stress concentrations.

[0136] Figure 18A-18EAnother exemplary leaflet attachment mechanism is shown in . In this embodiment, a plate 1818 including a plurality of holes 1819 can be positioned on the outside of the strut frame 1805. In addition, the strut frame 1805 can include a slot 1833 extending therethrough. The arms of the leaflets 1822a, b can extend through the slot 1833 and lie flat against the outer surface of the strut frame 1805. The plate 1818 can be placed against the arms of the leaflets 1822a, b and then sutured to the arms of the leaflets, for example, through the holes 1819. Thus, the arms of the leaflets 1822a, b can be sandwiched between the plate 1818 and the strut frame 1805. In some embodiments, the sutures are attached to a skirt or fabric layer on the strut frame 1805 rather than being directly connected to the strut frame.

[0137] Figure 27A-Figure 27Q Another exemplary leaflet attachment mechanism is shown in . In this embodiment, a plate 2727 having a plurality of channels 2733 (or slots or notches) on its side can be positioned on the exterior of the strut frame 2705. The channels 2773 can extend diagonally toward the center of the plate 2727. There can be two or more channels 2773, such as 6-12 channels 2773, such as ten channels 2773. In addition, the frame 2705 can include three slots 2733 extending therethrough (one for each attachment point) that are positioned equidistant from one another around the circumference of the strut frame 2705. The slots 2733 can be positioned within the struts 2721 at the ventricular end. In order to attach the leaflets 2722a, b to the frame 2705, a first suture 2772a can first be passed between the frame 2705 and the skirt 2716 fabric and around the slots 2733. The first suture 2772a can then be slid distally toward the ventricular apex 2777 ( Fig.27A ).exist Fig.27B , the second suture 2772b is inserted similarly to the first suture 2772a. Fig.27C , the third suture 2772c penetrates the fabric from the outside and the back, just at the distal end of the groove 2733, and wraps the third suture 2772c around the frame 2705. Fig.27D , the two leaflets 2722a, b can be aligned, and a leaflet protector 2773 (e.g., made of a smooth fabric such as a polyester braid) can be placed along the outward-facing side of each arm 2795a, b of the leaflets 1022a, b. Fig.27E , the arms 2795a, b of the leaflets 1022a, b and the leaflet protectors 2773a, b can remain flush. Figure 27G-Figure 27I As shown in FIG. 2 , the leaflet arms 2795a, b can slide through the slots 2733. Fig.27F As shown in FIG. 27, arms 2795a, b can be positioned at approximately 90 degrees relative to slot 2733. Figure 27GAs shown in FIG. 1 , each arm 2795a, b can slide through the slot 2733 until the starting point of the protrusion 2778 on the arm 2795a, b is flush with the inner side of the slot 2733 (to do this, the inflow edge 2793 can be folded inwardly toward each other toward the central axis. Fig.27H , arms 2795a,b can be approximately 90 degrees relative to slot 2733 after being pulled through slot 2733. Fig.27I , the two leaflets 2722a, b can be separated, and, in Fig.27J and 27K , this process can be repeated for other slots and attachment points (e.g., two additional slots / leaflet attachment points). Figure 27L and Fig.27M As shown in , the leaflet arms 2795a, b can be folded over each other, and the leaflet protectors 2773a, b can be folded over each other. Fig.27N As shown in FIG. 2 , the edge of each arm 2795a, b can be placed horizontally with the outflow plane, and the side edge / vertical edge can be parallel to the support member 2721. Fig.27O , the plate 2727 can be placed on the leaflet arm and aligned with the slot 2733. The vertical edge 2761 of the retaining plate 2727 can be aligned parallel to the vertical strut member 2721. The top 2762 of the retaining plate 2727 can be aligned with the outflow tip 2777 of the strut frame 2705. The center of the retaining plate 2727 can be aligned with the center of the slot 2733. Figure 27P , the first suture 2772a can be wrapped around the top notch set 2773a,b in the plate 2727, and the third suture 2772c can be wrapped around the bottom notch set 2773i,j. Figure 27Q , the second suture 2772b can be woven around the plate 2727 in a staggered pattern into the remaining notches 2773c-h (the dashed lines represent the sutures on the back of the plate 2727). This process can be repeated at each commissure attachment point. The sutures can advantageously help prevent translation of the plate 2727 relative to the slots 2733 and the frame 2705. In addition, the plate 2727 and slots 2733 can advantageously securely attach the leaflets 2722 to the frame 2705 without damaging the frame 2705, the leaflets 2722a, b, and / or the skirt 2716.

[0138] Figure 33-Figure 34 Other plate embodiments similar to plate 2727 are shown. Fig.33, plate 3327 is similar to plate 2727, except that notches 3373 are longer and at a different angle than notches 2773 of plate 2727. Thus, the tops of notches 3373a,b in plate 3427 are angled at approximately 90 degrees relative to the longitudinal axis 3333 of the device. Notches 3373c,d are angled upwardly at 30-60 degrees, such as approximately 45 degrees, relative to the longitudinal axis 3333. Notches 3373e,f are angled downwardly at 30-60 degrees, such as approximately 45 degrees, relative to the longitudinal axis 3333. Notches 3373g,h are again angled upwardly at 30-60 degrees, such as approximately 45 degrees, relative to the longitudinal axis 3333, and notch 3373i is angled at approximately 90 degrees relative to the longitudinal axis 3333. In addition, each of notches 3373c-h extends 15-30%, such as 20-25%, of the width of plate 3327.

[0139] refer to Fig.34 , plate 3427 is similar to plate 2727, except that notches 3473 are angled substantially 90 degrees relative to longitudinal axis 3433. In addition, the inner edge of each notch 3473c-h has a generally circular shape. Each of notches 3473c-h extends approximately 10%-25%, such as 15%-20%, of the width of plate 3427.

[0140] In some embodiments, reference Fig. 22 Once the arms of the leaflets 2222 are attached to the strut frame 2205 , the inflow edge can be sewn to the strut frame 2205 . Fig. 22 An exemplary suture 2525 is shown in FIG. 2 (rivet 2527 near the atrial end of strut frame 2205).

[0141] In some embodiments, the valve prostheses described herein may include a delivery system connection mechanism. Figure 2A-2B As shown in FIG. 2 , each atrial apex 212 can have a pin 215 extending therefrom (eg, in the ventricular direction) around which a tether from a delivery system can be wrapped.

[0142] Figure 29A-29E Another delivery system connection mechanism is shown in FIG. Each atrial apex 2912 has a pin 2915 extending therefrom (e.g., in the ventricular direction). Each pin can be, for example, 0.030 inches long and about 0.012 inches thick. In addition, as shown in FIG. Fig.29E , skirt 2916 can have a slot 2985 therein that aligns with pin 2915. Slot 2985 can allow a tether to pass therethrough (ie, provide access to pin 2195).

[0143] Figures 17A-17J An exemplary method of delivering a valve prosthesis 1700 (which may be any of the valve prostheses described herein) after attachment to a tether of a delivery system is shown in FIG. Fig.17Aand 17B , the valve is packed within the sheath with the tip of the ventricular anchor 1704 pointing toward the ventricular end (i.e., away from the central portion 1703) and the tip of the atrial anchor 1702 pointing toward the atrial end (i.e., away from the central portion 1703). The valve 1700 can be delivered (e.g., transseptally) to the native annulus in this packed orientation. Figure 17C-17E , the ventricular anchor 1704 is partially deployed, i.e., the ventricular anchor 1704 is allowed to begin to expand outward. In this embodiment, during the initial deployment step, the barbs on the device point radially outward rather than toward the atrium. Fig.17F and Figure 17G , the valve is pulled out 1-3 cm toward the atrium so that the ventricular anchor 1704 is placed on the ventricular side of the ring. Fig.17H , the ventricular anchor 1704 is fully deployed, allowing the barbs to extend into the tissue. At this point, the strut frame 1705 (holding the leaflets) is also fully exposed. Fig.17I , the atrial anchor 1702 is partially released to allow the anchor 1702 to fall against the wall of the atrium. Fig.17J , the atrial anchor 1702 is fully released and the valve 1700 is in place.

[0144] The valve prostheses described herein can advantageously be packed to a very low packing length, e.g., less than 4 cm, less than 3.8 cm, less than 3.6 cm, less than 3.2 cm, or less than 3.0 cm, for delivery with a 32 French catheter. Such a low axial packing length advantageously allows the prosthesis to be delivered transseptally, e.g., to be easily maneuvered through the septum and around elbows.

[0145] In addition, the cells and / or v-shaped patterns of the valve prostheses described herein can be specifically designed to ensure that the ventricular side does not unfold during delivery. For example, by making the atrial anchor flexible (e.g., using a flexible member), the ventricular anchor is less likely to get hooked during delivery. As another example, the radius of the valve (anchor or strut frame) can be adjusted and / or the valve can be made more flexible in specific areas (of the anchor or strut frame) to ensure that the valve is less likely to get hooked / unfolded during delivery. That is, reference Fig.13A and 13B In one embodiment, the change in radius of curvature in region 1401 will produce a deployment angle of the ventricular anchor in region 1402. Reducing the curvature of region 1401 will make the frame less likely to wrap around the catheter tip when the ventricular anchor emerges from the catheter. In another embodiment, by making region 1401 flexible and making the rest of the ventricular and atrial anchors relatively rigid, the deployment angle of region 1402 is reduced when the ventricular anchor emerges from the catheter tip. Does not easily get tangled around the catheter tip.

[0146] The valve prosthesis described herein can advantageously avoid interfering with the flow of blood through the valve. For example, the skirt and shape of the nitinol on the inflow (or atrial) portion of the valve can be contoured to provide a smooth path to the valve orifice. This helps to reduce the risk of any turbulence or blood stagnation. As another example, the attachment points between the inner struts and the outer frame can be adjusted longitudinally to change the relative obstruction of the inner struts to the blood flow and the ventricular subvalve device. As another example, the skirt can be selectively applied to areas where there is only a risk of blood escaping between the prosthesis and the anatomical structure. By allowing some cells to be open, especially on the ventricular anchor member, obstruction to flow is reduced.

[0147] Any valve features or structural details of any device embodiment described herein may be combined or combined with any other embodiment described herein. For example, the central member described herein is not limited to use with the anchor assembly and strut frame of a specific embodiment, but can be replaced with any features described in any other embodiment.

[0148] In use, the device described herein can be used as a mitral valve replacement. In some embodiments, when a replacement heart valve has been delivered close to the mitral valve, the ventricular anchor can be first deployed in a heart chamber (e.g., a ventricle) and then retracted to a placement position against the valve orifice (e.g., a mitral valve orifice). The central portion and the ventricular anchor portion can then be deployed in another heart chamber (e.g., an atrium), wherein the expansion and reconfiguration of the ventricular anchor and the central portion securely sandwiches the valve orifice between the anchors that have been deployed on either side of the annulus. Other exemplary aspects of the delivery method are described in U.S. Patent No. 8,870,948, issued on October 28, 2014, International Patent Application PCT / US2016 / 032546, entitled “Heart Valve Delivery Apparatus and System,” filed on May 13, 2016, and U.S. Provisional Patent Applications Nos. 62 / 424,021 and 62 / 424,051, both filed on November 18, 2016, entitled “Heart Valve Delivery Apparatus and System,” the contents of which are incorporated herein by reference in their entirety.

[0149] When a feature or element is referred to as "on" another feature or element here, it can be directly on another feature or element, or it can also be on the middle feature and / or element. On the contrary, when a feature or element is referred to as "directly on" another feature or element, there is no middle feature or element. It should be understood that when a feature or element is referred to as "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to another feature or element, or it can also be a feature or element with a middle. On the contrary, when a feature or element is referred to as "directly connected", "directly attached" or "directly coupled" to another feature or element, there is no middle feature or element. Although an embodiment is described or shown, such description or shown features and elements can be applicable to other embodiments. Those skilled in the art will also understand that the reference to the structure or feature of another feature located in "adjacent" may have a part overlapping or located under the adjacent feature.

[0150] The terms used herein are only for describing specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an", and "the" also include the plural forms, unless the context clearly indicates otherwise. It should also be understood that the terms "comprises" and / or "comprising", when used in this specification, specifically refer to the presence of the features, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components and / or other groups. As used herein, the term "and / or" includes any or all combinations of one or more associated items and may be abbreviated as " / ".

[0151] For ease of description, spatially relative terms such as "under", "below", "below", "above", "above", etc. may be used here to describe the relationship between one element or feature and another element or feature, as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the figure is inverted, the elements described as "under" or "below" other elements or features will be oriented to be "above" other elements or features. Therefore, the exemplary "under it" may include two directions, above and below it. The device can be oriented in other ways (rotated 90 degrees or in other directions), and the spatially relative descriptors used here are interpreted accordingly. Similarly, unless otherwise specifically stated, the terms "upward", "downward", "vertical", "horizontal", etc. used herein are only for explanation purposes.

[0152] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element without departing from the teachings of the present invention.

[0153] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise," and variations such as "comprises" and "comprising," mean that various components can be used together in methods and articles (e.g., compositions and devices including apparatus and methods). For example, the term "comprising" will be understood to mean the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0154] As used herein in the specification and claims, including in the examples, unless otherwise expressly stated, all numbers may be understood as if prefaced by the word "about" or "approximately", even if the term does not explicitly appear. When describing amplitude and / or position, the phrase "about" or "approximately" may be used to indicate that the value and / or position is within a reasonable expected range of values ​​and / or positions. For example, the value of a numerical value may be + / -0.1% of the value (or numerical range), + / -1% of the value (or numerical range), + / -2% of the value (or numerical range), + / -5% of the value (or numerical range), + / -10% of the value (or numerical range), etc. Any numerical range recited herein is intended to include all subranges contained therein.

[0155] Although various illustrative embodiments are described above, any number of changes may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may often be changed, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention set forth in the claims.

[0156] The embodiments and figures contained herein show, by way of illustration and not limitation, specific embodiments in which the subject matter may be implemented. As described above, other embodiments may be utilized and derived therefrom, so that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. For convenience only, the term "invention" may be used herein to refer to these embodiments of the subject matter, either individually or collectively, without any intention to voluntarily limit the scope of the present application to any single invention or inventive concept, if in fact more than one invention or concept is disclosed. Therefore, although specific embodiments have been illustrated and described herein, the specific embodiments shown may be replaced by any arrangement calculated to achieve the same purpose. The present disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the above description.

Claims

1. An artificial mitral valve, comprising: a valve support assembly comprising a ventricular anchor, a central portion, and an atrial anchor, wherein the valve support assembly comprises a plurality of diamond-shaped cells, the valve support assembly being configured to self-expand from a collapsed configuration to an expanded configuration; a plurality of leaflets secured to the valve support assembly; as well as A plurality of retaining hooks are attached to the ventricular anchor, each of the retaining hooks extending from a vertex of an inner rhombus-shaped unit, wherein when the valve support assembly is in the expanded configuration, each of the retaining hooks is radially bent outward to point toward the atrium, and the ratio of the radius of curvature to the thickness of each retaining hook is 4:1 or greater.

2. The artificial mitral valve according to claim 1, wherein: The ratio is between 4:1 and 8:

1.

3. The artificial mitral valve according to claim 1, wherein: Each of the plurality of retaining hooks is configured to be directed at an angle of 10-40 degrees relative to a central longitudinal axis of the prosthetic mitral valve.

4. The artificial mitral valve according to claim 3, wherein: The angle is approximately 28°.

5. The artificial mitral valve according to claim 1, wherein: The radius of curvature of each of the plurality of retaining hooks is less than 4 mm.

6. The artificial mitral valve according to claim 1, wherein: The curvature radius of each of the plurality of retaining hooks is between 2 mm and 4 mm.

7. The artificial mitral valve according to claim 1, wherein: The thickness of each of the plurality of retaining hooks is less than 1.6 mm.

8. The artificial mitral valve according to claim 1, wherein: The thickness of each retaining hook is between 0.25 mm and 1 mm.

9. The artificial mitral valve according to claim 1, wherein: The ratio of the width to the thickness of each retaining hook is between 0.3:1 and 1:

1.

10. The artificial mitral valve according to claim 1, wherein: Each hook is configured to engage approximately 3-10 mm of mitral valve tissue when the valve support assembly is in the expanded configuration.

11. The artificial mitral valve according to claim 1, wherein: The plurality of retaining hooks are integral with the valve support assembly.

12. The artificial mitral valve according to claim 1, wherein: The valve support assembly includes an anchor assembly and an annular strut frame positioned radially within the anchor assembly, the anchor assembly including the ventricular anchor, the atrial anchor, and the central portion.

13. The artificial mitral valve according to claim 12, wherein: The plurality of retaining hooks are attached to the anchor assembly.

14. The artificial mitral valve according to claim 1, wherein: The central portion is configured to align with a native valve orifice, and wherein the ventricular anchor and the atrial anchor are configured to compress native heart tissue therebetween.

15. The artificial mitral valve according to claim 1, wherein: A retaining hook extends from each apex around the circumference of the prosthetic mitral valve, except for the location closest to the leaflet attachment point.

16. An artificial mitral valve, comprising: a valve support assembly comprising a ventricular anchor, a central portion, and an atrial anchor, the valve support assembly being configured to self-expand from a collapsed configuration to an expanded configuration; a plurality of leaflets secured to the valve support assembly; as well as A plurality of retaining hooks attached to the ventricular anchor, wherein each of the retaining hooks is bent radially outward to point toward the atrium when the valve support assembly is in the expanded configuration, each retaining hook has a radius of curvature to thickness ratio greater than 4:1, and points at an angle of approximately 28° relative to a central longitudinal axis of the artificial mitral valve.

17. The artificial mitral valve according to claim 16, wherein: The ratio of the width to the thickness of each retaining hook is between 0.3:1 and 1:

1.

18. The artificial mitral valve according to claim 16, wherein: Each hook is configured to engage approximately 3-10 mm of mitral valve tissue when the valve support assembly is in the expanded configuration.

19. The artificial mitral valve according to claim 16, wherein: The radius of curvature of each of the plurality of retaining hooks is less than 4 mm.

20. An artificial mitral valve, comprising: a valve support assembly configured to self-expand from a collapsed configuration to an expanded configuration and comprising an anchor assembly having a ventricular anchor, a central portion, and an atrial anchor, the anchor assembly comprising a plurality of diamond-shaped cells; a plurality of leaflets attached to the valve support assembly; as well as A plurality of retaining hooks are attached to the anchor assembly, each retaining hook being bent radially outward and extending from a vertex of a corresponding one of the plurality of rhombus-shaped units when the valve support assembly is in the expanded configuration.

21. The artificial mitral valve according to claim 20, wherein: The valve support assembly includes a strut frame positioned radially within the anchor assembly and attached to the anchor assembly.

22. The artificial mitral valve according to claim 21, wherein: The plurality of leaflets are attached to the strut frame.

23. The prosthetic mitral valve of claim 21, wherein the ventricular anchor is located at a distal end of the valve support assembly and the atrial anchor is located at a proximal end of the valve support assembly.

24. The prosthetic mitral valve of claim 23, wherein the atrial anchor extends further proximally than the strut frame.

25. The prosthetic mitral valve of claim 20, wherein the atrial anchor flares radially outward in the expanded configuration.

26. The prosthetic mitral valve according to claim 20, wherein: In the expanded configuration, the atrial anchor has a diameter greater than a diameter of the central portion.

27. The prosthetic mitral valve of claim 20, wherein at least some of the retaining hooks are directed toward the atrium.

28. The prosthetic mitral valve according to claim 20, wherein: The thickness of each of the plurality of retaining hooks is less than 1.6 mm.

29. The prosthetic mitral valve according to claim 20, wherein: The plurality of retaining hooks are integral with the valve support assembly.

30. An artificial mitral valve, comprising: A valve support assembly configured to self-expand from a collapsed configuration to an expanded configuration and comprising: an anchor assembly having a ventricular anchor, a central portion, and an atrial anchor, the anchor assembly comprising a plurality of units; a strut frame positioned radially within the anchor assembly and attached to the anchor assembly; a plurality of leaflets attached to the strut frame; and A plurality of retaining hooks are attached to the anchor assembly, each retaining hook being bent radially outward and extending from an apex of a corresponding one of the plurality of cells when the valve support assembly is in the expanded configuration.

31. An artificial mitral valve according to claim 30, wherein the plurality of leaflets are attached to the strut frame.

32. The prosthetic mitral valve of claim 31 , wherein the ventricular anchor is located at a distal end of the valve support assembly and the atrial anchor is located at a proximal end of the valve support assembly.

33. The prosthetic mitral valve of claim 32, wherein the atrial anchor extends further proximally than the strut frame.

34. The prosthetic mitral valve of claim 30, wherein the atrial anchor flares radially outward in the expanded configuration.

35. The prosthetic mitral valve of claim 30, wherein in the expanded configuration, a diameter of the atrial anchor is greater than a diameter of the central portion.

36. The prosthetic mitral valve of claim 30, wherein at least some of the retaining hooks are directed toward the atrium.

37. The prosthetic mitral valve of claim 30, wherein a thickness of each of the plurality of retaining hooks is less than 1.6 mm.

38. An artificial mitral valve according to claim 30, wherein the plurality of retaining hooks are integrated with the valve support assembly.

39. The prosthetic mitral valve of claim 30, wherein each of the plurality of cells is diamond-shaped.

40. An artificial mitral valve, comprising: a valve support assembly configured to self-expand from a collapsed configuration to an expanded configuration and comprising an anchor assembly; a plurality of leaflets attached to the valve support assembly; a plurality of retaining hooks attached to the anchor assembly, wherein the plurality of retaining hooks extend outwardly from the anchor assembly; as well as A skirt is configured to be formed around an outer surface of the anchor assembly, wherein the skirt includes a plurality of pre-formed cutouts configured to provide access for the plurality of retaining hooks.

41. An artificial mitral valve according to claim 40, wherein the skirt is a prefabricated three-dimensional structure.

42. The prosthetic mitral valve of claim 40, wherein the skirt is further configured to be formed against an inner surface of the valve support assembly.

43. The prosthetic mitral valve according to claim 40, wherein: The valve support assembly includes a strut frame positioned radially within and attached to the anchor assembly.

44. The prosthetic mitral valve of claim 43, wherein the anchor assembly comprises an atrial anchor and a central portion.

45. The prosthetic mitral valve of claim 44, wherein the skirt is formed against an outer surface of the atrial anchor, an outer surface of the central portion, and an inner surface of the strut frame.

46. ​​The prosthetic mitral valve according to claim 45, wherein: The skirt is folded from the outer surface of the atrial anchor into the inner surface of the strut frame such that the skirt extends continuously from the outer surface of the central portion to the inner surface of the strut frame.

47. The prosthetic mitral valve of claim 44, wherein the anchor assembly further comprises a ventricular anchor.

48. The prosthetic mitral valve according to claim 47, wherein: The skirt extends continuously from a ventricular end of the ventricular anchor to a strut frame end of the strut frame, each of the ventricular end and the strut frame end being located on a first end of the prosthetic mitral valve.

49. The prosthetic mitral valve of claim 40, wherein the plurality of preformed incisions are further configured to provide access for one or more commissure attachment mechanisms or one or more delivery system attachment mechanisms.

50. The prosthetic mitral valve of claim 40, wherein the anchor assembly comprises a plurality of diamond-shaped units.

51. The prosthetic mitral valve of claim 50, wherein the first end of the skirt comprises a sawtooth pattern corresponding to one or more vertices of the plurality of rhombus-shaped units, the first end of the skirt being positioned over the first end of the anchor assembly.

52. The prosthetic mitral valve of claim 50, wherein each of the plurality of retaining hooks extends from a vertex of a corresponding one of the plurality of rhombus-shaped units.

53. An artificial mitral valve according to claim 40, wherein a first end of the skirt is wrapped around an end of the valve support assembly, and a second end of the skirt is wrapped around an end of the anchor assembly, so that each of the ends of the valve support assembly and the ends of the anchor assembly are covered by the skirt.

54. The prosthetic mitral valve of claim 40, wherein the skirt is coupled to at least one of the valve support assembly or the anchor assembly.

55. A prosthetic mitral valve according to claim 54, wherein the skirt is coupled to at least one of the valve support assembly or the anchor assembly by one or more sutures.

56. An artificial mitral valve, comprising: a valve support assembly configured to self-expand from a collapsed configuration to an expanded configuration and comprising an anchor assembly having a ventricular anchor, a central portion, and an atrial anchor, the anchor assembly comprising a plurality of diamond-shaped cells; a plurality of leaflets attached to the valve support assembly; a plurality of retaining hooks attached to the anchor assembly; as well as A skirt is configured to be formed around an outer surface of the anchor assembly, wherein the skirt includes a plurality of pre-formed cutouts configured to provide access for the plurality of retaining hooks.

57. The prosthetic mitral valve of claim 56, wherein: The valve support assembly includes a strut frame positioned radially within and attached to the anchor assembly; and The skirt is also configured to be formed around an inner surface of the strut frame.

58. The prosthetic mitral valve of claim 57, wherein: the skirt is formed around the anchor assembly and the strut frame such that a first end of the skirt is positioned at a first end of the ventricular anchor, and The skirt is folded from the outer surface of the anchor assembly into the inner surface of the strut frame such that the skirt extends continuously from the first end of the ventricular anchor to the first end of the strut frame, and Each of the first end of the ventricular anchor and the first end of the strut frame is positioned on a first end of the prosthetic mitral valve.

59. The prosthetic mitral valve according to claim 56, wherein: The skirt is a prefabricated three-dimensional structure.

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