Devices and methods for enhancing mitral valve function

Abstract

Devices and methods for enhancing mitral valve function are provided. A cardiac valve prosthetic device includes a stent frame assembly having an atrial portion and a ventricular portion, a peripheral ring attached to the stent frame assembly that divides the stent frame assembly into the atrial portion and the ventricular portion, and a plurality of valve leaflets fixedly coupled to the stent frame assembly. When the prosthetic device is implanted in the native mitral valve, the peripheral ring fits over the annulus of the native mitral valve. The peripheral ring limits the protrusion of the stent frame assembly into the ventricular chamber and mitigates the effects on ventricular outflow or natural lobe offset caused by such protrusion.

Description

[0001] Cross-references

[0002] This application claims the benefit of Australian Provisional Application No. 2022900505 filed on March 3, 2022 and Australian Provisional Application No. 2022902706 filed on September 19, 2022, each of which is incorporated herein by reference in its entirety. Background Art

[0003] The mitral valve is the entrance valve of the main pumping chamber of the heart, the left ventricle. The mitral valve has two leaflets, the anterior leaflet and the posterior leaflet, both of which contribute to left ventricular function through a force feedback loop system. The anterior mitral leaflet is the most important and supports left ventricular function by resisting the force of intraventricular pressure and transferring that force back through the left ventricular muscle, thereby assisting the pumping function of the heart. Any changes to the anterior mitral leaflet can significantly impair left ventricular function and the heart's pumping ability.

[0004] With currently available bioprostheses, complete retention of the anterior mitral leaflet during mitral valve replacement carries the risk of left ventricular outflow tract (LVOT) obstruction due to the abnormal displacement of the native anterior mitral leaflet by the bioprosthesis below the aortic valve. LVOT obstruction is associated with a high mortality rate, so the current standard of care is to completely remove or substantially modify the anterior leaflet when performing valve replacement. However, as previously described, removal or modification of the anterior leaflet can substantially impair left ventricular function and cardiac pumping capacity. Therefore, an improved mitral valve bioprosthesis is desired. Summary of the invention

[0005] The present disclosure relates to devices and methods for enhancing natural heart valve function while accommodating full retention of natural heart valve leaflets without the risk of ventricular outflow obstruction caused by natural heart valve leaflets. Aspects disclosed herein provide a heart valve prosthesis device. An exemplary device will typically include (i) a stent frame assembly, (ii) a peripheral ring, and (iii) a plurality of leaflets. The stent frame assembly has an atrial portion including an upper end facing the atrium, a ventricular portion including a lower end facing the ventricle, a height between the upper and lower ends, and a central opening passing between the atrial portion and the ventricular portion. The peripheral ring is attached to the stent frame assembly and surrounds the central opening. The peripheral ring is disposed between the atrial portion and the ventricular portion. The peripheral ring has a lowermost surface facing the ventricle, which is configured to be assembled on the natural mitral valve annulus when the prosthetic device is implanted in the natural mitral valve. The plurality of leaflets are fixedly coupled to the stent frame assembly and are located at the central opening of the stent frame assembly. The peripheral ring positions the stent frame assembly on the heart valve annulus to limit protrusion of the stent frame assembly into the ventricular chamber (eg, the left ventricular chamber) and thereby mitigate effects on ventricular outflow or native leaflet excursion caused by such protrusion.

[0006] In some embodiments, the heart valve prosthesis device is a mitral valve prosthesis device. In some embodiments, the natural heart valve ring is a natural mitral valve ring. In some embodiments, the natural heart valve is a natural mitral valve. In some embodiments, the heart valve prosthesis device is a tricuspid valve prosthesis device. In some embodiments, the natural heart valve ring is a natural tricuspid valve ring, and the natural heart valve is a natural tricuspid valve. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 66% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 50% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 33% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 8 mm or less. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 5mm or less. In some embodiments, the ventricular length is measured at the front side of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 33% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 50% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 66% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the height between the lower and upper ends of the stent frame assembly is measured from the front side of the stent frame assembly. In some embodiments, each leaflet includes a flexible membrane, and wherein a plurality of leaflets are configured to open in response to ventricular diastole and close in response to ventricular contraction when the prosthetic device is implanted in the natural mitral valve. In some embodiments, the plurality of leaflets are configured to allow blood to flow from the atrium to the ventricle and to restrict blood flow from the ventricular chamber to the atrial chamber when the prosthetic device is implanted in the natural heart valve. In some embodiments, the plurality of leaflets are configured to close to each other in response to the flow of blood from the ventricular chamber to the atrial chamber when the prosthetic device is implanted in the natural heart valve. In some embodiments, the plurality of leaflets are at least partially made of decellularized tissue or synthetic tissue. In some embodiments, the stent frame assembly comprises a stent frame and a covering disposed on the stent frame. In some embodiments, the covering comprises fabric or pericardial tissue. In some embodiments, the stent frame assembly has a height between 12 mm and 20 mm. In some embodiments, the atrial portion has a height between 6 mm and 14 mm.In some embodiments, the ventricular portion has a height between 1.5 mm and 10 mm. In some embodiments, the shape of the peripheral ring is designed to match the shape of the natural mitral valve annulus when the prosthetic device is implanted in the natural mitral valve so as to be assembled on the natural mitral valve annulus. In some embodiments, the stent frame assembly has an anterior-posterior diameter and a transverse diameter, and the anterior-posterior diameter is smaller than the transverse diameter. In some embodiments, the stent frame assembly has a front edge, a first rear edge, and a second rear edge, and wherein the front edge is one or more of the following: flatter or longer than each of the first rear edge and the second rear edge. In some embodiments, the front edge, the first rear edge, and the second rear edge of the stent frame assembly are defined by the peripheral ring. In some embodiments, the stent frame assembly has an anterior-posterior diameter between 20 mm and 34 mm. In some embodiments, the stent frame assembly has a transverse diameter between 25 mm and 39 mm. In some embodiments, the stent frame assembly is non-circular. In some embodiments, the stent frame assembly is generally D-shaped. In some embodiments, the peripheral ring is scalloped in the atrioventricular direction. In some embodiments, the peripheral ring is non-circular. In some embodiments, the peripheral ring is roughly D-shaped. In some embodiments, the peripheral edges of the stent frame assembly and the peripheral ring have the same shape. In some embodiments, the peripheral ring includes a wire to facilitate visualization of the heart valve prosthesis device under imaging. In some embodiments, the peripheral ring includes a front edge, a first rear edge, and a second rear edge, and the size and shape of each of the front edge, the first rear edge, and the second rear edge are designed to match the complementary portion of the natural valve ring. In some embodiments, the peripheral ring further includes a first front angle, a second front angle, and a rear angle, wherein the front edge is located between the first front angle and the second front angle, wherein the first rear edge is located between the second front angle and the rear angle, and wherein the second rear edge is located between the rear angle and the first front angle. In some embodiments, the front edge is one or more of the following situations: flatter or longer than each of the first rear edge and the second rear edge. In some embodiments, a plurality of leaflets include a front leaflet, which is fixedly attached to the stent frame assembly adjacent to the front edge of the peripheral ring. In some embodiments, the plurality of leaflets include a first posterior leaflet and a second posterior leaflet, the first posterior leaflet being fixedly attached to the stent frame assembly adjacent to a first posterior edge of the peripheral annulus, and the second posterior leaflet being fixedly attached to the stent frame assembly adjacent to a second posterior edge of the peripheral annulus. In some embodiments, the stent frame assembly includes an asymmetric cylinder and a plurality of ventricular posts extending from the asymmetric cylinder. In some embodiments, the peripheral annulus further includes a first anterior angle, a second anterior angle, and a posterior angle, and wherein the plurality of ventricular posts include a first anterior post at the first anterior angle, a second anterior post at the second anterior angle, and a posterior post at the posterior angle. In some embodiments, the atrial end of the stent frame assembly is scalloped.In some embodiments, the ventricular end of the stent frame assembly is scalloped. In some embodiments, the peripheral ring is a sewing ring. In some embodiments, the peripheral ring is flexible in the plane of the natural heart valve annulus. In some embodiments, the peripheral ring is more flexible in the plane of the natural heart valve annulus than in a plane that crosses the plane of the natural heart valve annulus. In some embodiments, the plurality of leaflets include an anterior leaflet, a first posterior leaflet, and a second posterior leaflet, each of which includes a fixed edge and a free edge, and the fixed edge is coupled to the stent frame assembly. In some embodiments, the anterior leaflet is larger than each of the first posterior leaflet and the second posterior leaflet. In some embodiments, the stent frame assembly includes a plurality of ventricular posts, the plurality of ventricular posts including a first anterior post, a second anterior post, and a posterior post. In some embodiments, the fixed edge of the anterior leaflet is supported by the first anterior post and the second anterior post, and wherein the distance between the first anterior post and the second anterior post is greater than the distance between each anterior post and the posterior post. In some embodiments, the angle along the free edge of the anterior leaflet is greater than every angle along the free edge of the first posterior leaflet and every angle along the free edge of the second posterior leaflet. In some embodiments, the plurality of leaflets are arranged to define a first anterior commissure between adjacent free edges of the anterior leaflet and the first posterior leaflet, a second anterior commissure between adjacent free edges of the anterior leaflet and the second posterior leaflet, and a posterior commissure between adjacent free edges of the first posterior leaflet and the second posterior leaflet. In some embodiments, the heart valve prosthesis device is configured to augment a natural heart valve.

[0007] Aspects disclosed herein also provide methods for treating dysfunction of a heart valve. An exemplary method typically includes implanting a stent frame assembly of a heart valve prosthesis device in a natural heart valve of the heart, such that the lowest surface of a peripheral ring coupled to the stent frame assembly facing the ventricle is mounted on the annulus of the natural heart valve. The peripheral ring separates the stent frame assembly into an atrial portion and a ventricular portion. The peripheral ring limits the stent frame assembly from protruding into a ventricular chamber (e.g., a left ventricular chamber) to mitigate the effects of such protrusion on ventricular outflow or natural leaflet excursion.

[0008] In some embodiments, the heart valve is a mitral valve. In some embodiments, the heart valve prosthesis device is a mitral valve prosthesis device. In some embodiments, the natural heart valve is a natural mitral valve. In some embodiments, the heart valve prosthesis device is a tricuspid valve prosthesis device. In some embodiments, the natural heart valve ring is a natural tricuspid valve ring, and the natural heart valve is a natural tricuspid valve. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 66% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 50% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 33% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 8 mm or less. In some embodiments, the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 5mm or less. In some embodiments, the ventricular length is measured on the front side of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 33% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 50% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 66% of the height between the lower and upper ends of the stent frame assembly. In some embodiments, the height between the lower and upper ends of the stent frame assembly is measured from the front side of the stent frame assembly. In some embodiments, the heart valve prosthesis device is configured to enhance the natural heart valve. In some embodiments, the stent frame assembly is implanted in the natural heart valve annulus while retaining the natural anterior heart valve leaflet. In some embodiments, the stent frame assembly is implanted in the annulus of the natural heart valve without the natural anterior heart valve leaflet being removed or reshaped. In some embodiments, the stent frame assembly is implanted in the annulus of the natural heart valve without substantially changing the anatomical position of the natural anterior heart valve leaflet. In some embodiments, implanting the stent frame assembly in the natural heart valve includes positioning the stent frame assembly and a plurality of leaflets coupled to the stent frame assembly so as not to obstruct the natural anterior leaflet of the heart valve from at least partially occupying the annulus of the natural heart valve during ventricular contraction. In some embodiments, each leaflet includes a flexible membrane, and wherein the plurality of leaflets are configured to open in response to ventricular diastole and close in response to ventricular contraction when the prosthetic device is implanted in the natural heart valve.In some embodiments, the plurality of leaflets are configured to allow blood to flow from the atrium to the ventricle and to restrict blood flow from the ventricular chamber to the atrium chamber when the prosthetic device is implanted in the natural heart valve. In some embodiments, the plurality of leaflets are configured to close to each other in response to the flow of blood from the ventricular chamber to the atrium chamber when the prosthetic device is implanted in the natural heart valve. In some embodiments, the plurality of leaflets include an anterior leaflet, a first posterior leaflet, and a second posterior leaflet, each of which includes a fixed edge and a free edge, and the fixed edge is coupled to the stent frame assembly. In some embodiments, the anterior leaflet is larger than each of the first posterior leaflet and the second posterior leaflet. In some embodiments, the stent frame assembly includes a plurality of ventricular posts, which include a first anterior post, a second anterior post, and a posterior post. In some embodiments, the fixed edge of the anterior leaflet is supported by the first anterior post and the second anterior post, and wherein the distance between the first anterior post and the second anterior post is greater than the distance between each anterior post and the posterior post. In some embodiments, the stent frame assembly includes a stent frame and a covering disposed on the stent frame. In some embodiments, the shape of the peripheral ring is designed to match the shape of the natural heart valve annulus when the heart valve prosthesis device is implanted in the natural heart valve so as to be assembled on the natural heart valve annulus. In some embodiments, the stent frame assembly has an anterior-posterior diameter and a horizontal diameter, and the anterior-posterior diameter is smaller than the horizontal diameter. In some embodiments, the stent frame assembly has a front edge, a first rear edge, and a second rear edge, and wherein the first rear edge is one or more of the following situations: flatter or longer than each of the first rear edge and the second rear edge. In some embodiments, the front edge, the first rear edge, and the second rear edge of the stent frame assembly are defined by the peripheral ring. In some embodiments, the stent frame assembly is non-circular. In some embodiments, the stent frame assembly is approximately D-shaped. In some embodiments, the peripheral ring is non-circular. In some embodiments, the peripheral ring is approximately D-shaped. In some embodiments, the peripheral ring is scalloped in the atrioventricular direction. In some embodiments, the peripheral edges of the stent frame assembly and the peripheral ring have the same shape. In some embodiments, the stent frame assembly includes an asymmetric cylinder and a plurality of ventricular posts extending from the asymmetric cylinder. In some embodiments, the atrial end of the stent frame assembly is scalloped. In some embodiments, the ventricular end of the stent frame assembly is scalloped. In some embodiments, the peripheral ring is a sewing ring. In some embodiments, the peripheral ring is flexible in the plane of the heart valve annulus. In some embodiments, the peripheral ring is more flexible in the plane of the native heart valve annulus than in a plane that intersects the plane of the native heart valve annulus. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The novel features of the present disclosure are particularly set forth in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by referring to the following detailed description and accompanying drawings which set forth illustrative embodiments in which the principles of the present disclosure are utilized, in which:

[0010] Figure 1 is a perspective view of a ventricular end of an exemplary mitral valve prosthesis device of the present disclosure, the ventricular end being configured to protrude into the ventricular chamber;

[0011] Figure 2 yes Figure 1 The subject plan view of the mitral valve prosthesis device;

[0012] Figure 3 yes Figure 1 An elevation view of a mitral valve prosthesis device;

[0013] Figure 4 is a perspective view of an atrial end of an exemplary mitral valve prosthesis device of the present disclosure, the atrial end being configured to protrude into the atrial chamber;

[0014] Figure 5 is a perspective view of a stent frame of an exemplary mitral valve prosthesis device of the present disclosure;

[0015] Figure 6A-6B They are Figure 5 Elevation and cross-sectional views of the support frame;

[0016] Figure 7A-7C yes Figure 5 A plan view of the support frame;

[0017] Figure 8 It is along Figure 2 A cross-sectional view of an assembled mitral valve prosthesis device of the present disclosure taken along the section line shown in ;

[0018] Figure 9A-9B is an elevation view of a stent frame of an exemplary mitral valve prosthesis device of the present disclosure depicting locations where a peripheral annulus may be attached;

[0019] Fig.10 depicts partial and full saddle configurations of the peripheral ring of the present disclosure;

[0020] Fig.11 depicts atrialization of a mitral valve prosthetic device of the present disclosure achieved by placement of the prosthetic device on the native mitral valve annulus;

[0021] Figures 12A-12D are various views depicting a further embodiment of a mitral valve prosthetic device of the present disclosure, the prosthetic device comprising a peripheral ring having a scalloped edge at each ventricular post;

[0022] Figure 13A-13BAn elevation view and a cross-sectional view are respectively depicted of a stent frame of an exemplary mitral valve prosthesis device of the present disclosure. DETAILED DESCRIPTION

[0023] Unless otherwise defined, all art terms, symbols, and other technical and scientific terms or terminology used herein are intended to have the same meaning as those commonly understood by those of ordinary skill in the art to which the claimed subject matter belongs. In some embodiments, for clarity and / or for ease of reference, terms with commonly understood meanings are defined herein, and the inclusion of such definitions herein should not necessarily be interpreted as representing a substantial difference from what is generally understood in the art.

[0024] Throughout this application, various embodiments may be presented in a range format. It should be understood that the description in a range format is only for convenience and brevity, and should not be interpreted as a hard limit to the scope of the present disclosure. Therefore, the description of the range should be regarded as having specifically disclosed all possible sub-ranges and individual numerical values ​​within the range. For example, a range description such as 1 to 6 should be regarded as having specifically disclosed sub-ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, and individual numbers within the range, such as 1, 2, 3, 4, 5 and 6. Regardless of the breadth of the range, this description applies.

[0025] As used herein, the term 'about' when referring to a number means plus or minus 20% of that number. The term 'about' when referring to a range means the range minus 20% of its lower value and plus 20% of its upper value.

[0026] As used herein, the singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. For example, the term "sample" includes a plurality of samples, including mixtures thereof.

[0027] As used herein, the term "substantially D-shaped" means that the substantially straight side of the "D" shape is an arc having a radius of curvature substantially greater than the radius of curvature of the arc of the "D" (e.g., at least 1.1 times the radius of curvature of the arc of the "D"). In some embodiments, the "D" shape is symmetrical about the anterior-posterior midline axis. In some embodiments, the "D" shape is asymmetrical about the lateral midline axis.

[0028] As used herein, the term "atrialisation" or "achieving atrialisation" refers to reducing the protrusion of a mitral valve prosthesis device into the ventricular chamber of the heart, thereby reducing the effects on ventricular outflow or natural leaflet deviation caused by such protrusion (including displacement of the natural anterior mitral valve leaflet to block the left ventricular outflow tract). In some embodiments, the mitral valve prosthesis device has a stent frame assembly including a plurality of ventricular posts configured to protrude into the ventricular chamber of the heart. As used herein, the term "atrialisation" or "achieving atrialisation" also refers to reducing the protrusion of a plurality of ventricular posts into the ventricular chamber, thereby reducing the effects on ventricular outflow or natural leaflet deviation caused by such protrusion. In some embodiments, "atrialisation" of the prosthetic device also enables the natural leaflets (e.g., the natural anterior mitral valve leaflets) to fully deflect, thereby retaining the function of the natural leaflets (e.g., anterior mitral valve leaflet movement and associated valve-ventricular interaction).

[0029] With currently available bioprostheses for mitral valve replacement, complete retention of the native anterior mitral leaflet (AML) during mitral valve replacement carries the risk of left ventricular outflow tract (LVOT) obstruction due to abnormal displacement of the native AML beneath the aortic valve. Displacement of the native AML occurs when the implanted bioprosthesis protrudes too far through the native mitral valve and protrudes into the ventricular chamber and limits the complete displacement of the native AML. However, aspects of the present disclosure provide a mitral valve prosthesis device that exhibits reduced protrusion into the ventricular chamber and does not cause the native AML to obstruct the LVOT, even if the native AML is not resected when the prosthetic device is implanted in the native mitral valve. In some embodiments, the mitral valve prosthesis device of the present disclosure is configured to augment rather than replace the native mitral valve.

[0030] refer to Figure 1-Figure 4 , an exemplary mitral valve prosthesis device 100 of the present disclosure is shown in various views. Mitral valve prosthesis device 100 has two ends: an atrial end configured to protrude into the atrial chamber of the heart when prosthesis device 100 is implanted in the native mitral valve of the heart, and a ventricular end configured to protrude into the ventricular chamber of the heart. Figure 1-Figure 2 1 and 2 are perspective views and a thematic plan view, respectively, depicting a ventricular end of a mitral valve prosthesis device 100 configured to protrude into a ventricular chamber of the heart. In some embodiments, the mitral valve prosthesis device 100 includes a plurality of leaflets 110a, 110b, 110c fixedly coupled to a stent frame assembly 120, wherein the plurality of leaflets protrude inwardly from the stent frame assembly 120 to occupy a central opening 122 of the stent frame assembly 120. Each leaflet has free edges 116a, 116b, and 116c positioned adjacent to each other, wherein the free edges are not fixedly coupled to the stent frame assembly 120. A central flow axis 124 extends through the central opening 122.

[0031] In some embodiments, when the prosthetic device 100 is implanted in the native mitral valve, the plurality of leaflets enhance, support or improve the function of the native mitral valve. In some embodiments, the plurality of leaflets are configured to open in response to ventricular diastole and close in response to ventricular contraction when the prosthetic device is implanted in the native mitral valve. In some embodiments, the plurality of leaflets are configured to allow blood to flow from the atrioventricular chamber to the ventricular chamber when the prosthetic device is implanted in the native mitral valve. In some embodiments, the plurality of leaflets are configured to restrict the flow of blood from the ventricular chamber to the atrioventricular chamber when the prosthetic device is implanted in the native mitral valve. In some embodiments, the plurality of leaflets are configured to close to each other in response to the flow of blood from the ventricular chamber to the atrioventricular chamber when the prosthetic device is implanted in the native mitral valve. In some embodiments, each leaflet of the plurality of leaflets has a flexible membrane. In some embodiments, each leaflet of the plurality of leaflets is at least partially made of decellularized tissue or synthetic tissue. In some embodiments, each leaflet of the plurality of leaflets is made of a bioengineered material or fixed tissue in glutaraldehyde (e.g., bovine or porcine pericardium). In some embodiments, each leaflet of the plurality of leaflets is made of bovine or porcine pericardium. In some embodiments, each leaflet of the plurality of leaflets is made of a synthetic polymer (e.g., polyurethane, synthetic resin, thermoplastic elastomer). In some embodiments, each leaflet of the plurality of leaflets is coated with an anti-thrombotic agent. In some embodiments, each leaflet of the plurality of leaflets is coated with an anti-calcification agent. In some embodiments, each leaflet of the plurality of leaflets has anti-thrombotic properties, anti-calcification properties, or any combination thereof.

[0032] Bracket frame assembly

[0033] The mitral valve prosthesis device 100 includes a stent frame assembly 120, wherein the stent frame assembly includes a covering 126 surrounding the stent frame. In some embodiments, the covering 126 includes an inner skirt and an outer skirt, wherein the inner skirt and the outer skirt are attached or sutured to the stent frame.

[0034] The stent frame assembly 120 has two ends: an atrial end configured to protrude into the atrial chamber of the heart when the prosthetic device 100 is implanted in the native mitral valve of the heart and a ventricular end configured to protrude into the ventricular chamber of the heart. In some embodiments, the atrial end of the stent frame assembly 120 is scalloped. In some embodiments, the ventricular end of the stent frame assembly 120 is scalloped.

[0035] In some embodiments, the stent frame assembly 120 is non-circular. In some embodiments, the stent frame assembly 120 is roughly D-shaped (i.e., the substantially straight side of the "D" shape is an arc whose radius of curvature is substantially greater than the radius of curvature of the arc of the "D"). In some embodiments, the shape of the stent frame assembly 120 is symmetrical about the anterior-posterior midline axis. In some embodiments, the shape of the stent frame assembly 120 is asymmetrical about the transverse midline axis. In some embodiments, the stent frame assembly has a peripheral edge 128. In some embodiments, the shape of the peripheral edge 128 is non-circular. In some embodiments, the shape of the peripheral edge 128 is roughly D-shaped. In some embodiments, the shape of the peripheral edge 128 is symmetrical about the anterior-posterior midline axis. In some embodiments, the shape of the peripheral edge 128 is asymmetrical about the transverse midline axis.

[0036] Ventricular column

[0037] In some embodiments, the stent frame assembly 120 has a plurality of ventricular posts 140a, 140b, 140c. Each ventricular post has a lower end facing the ventricle that is configured to protrude into the ventricular chamber when the prosthetic device 100 is implanted in the native mitral valve. In some embodiments, the plurality of ventricular posts include a first front post 140a, a second front post 140b, and a rear post 140c.

[0038] In some embodiments, the anterior leaflet 110a is fixedly attached to the first anterior post 140a and the second anterior post 140b. In some embodiments, the first posterior leaflet 110b is fixedly attached to the second anterior post 140b and the posterior post 140c. In some embodiments, the second posterior leaflet 110c is fixedly attached to the posterior post 140c and the first anterior post 140a. In some embodiments, the anterior leaflet 110a, the first posterior leaflet 110b, the second posterior leaflet 110c, or any combination thereof, have a flexible membrane. In some embodiments, the anterior leaflet, the first posterior leaflet, the second posterior leaflet, or any combination thereof are at least partially made of decellularized tissue or synthetic tissue.

[0039] In some embodiments, the anterior leaflet 110a is larger than each of the first posterior leaflet 110b and the second posterior leaflet 110c. In some embodiments, the angle along the free edge 116a of the anterior leaflet is greater than each angle along the free edge 116b of the first posterior leaflet and each angle along the free edge 116c of the second posterior leaflet.

[0040] Peripheral ring

[0041] In some embodiments, the peripheral ring 150 surrounds the central opening 122 and is fixedly attached to the stent frame assembly 120. In some embodiments, the peripheral ring 150 contacts the peripheral edge 128 of the stent frame assembly 120. In some embodiments, the peripheral ring 150 is sutured or stitched to the stent frame assembly 120.

[0042] In some embodiments, the peripheral ring 150 is a sewing ring. In some embodiments, the peripheral ring or sewing ring provides a platform through which an attachment structure (e.g., sutures, staples, clips, or fasteners) can pass to secure the prosthetic device 100 to the native mitral valve annulus. The diameter of the peripheral ring or sewing ring can be made thinner or thicker to accommodate different suturing techniques and will not affect the hemodynamic performance of the prosthetic device. In some embodiments, the interior of the peripheral ring or sewing ring has a wire to aid in visualization of the prosthetic device 100 under imaging. In some embodiments, the peripheral ring or sewing ring comprises one or more layers. In some embodiments, the peripheral ring or sewing ring comprises one or more fabrics.

[0043] In some embodiments, the peripheral ring 150 is configured to fit over the native mitral valve annulus of the native mitral valve when the prosthetic device 100 is implanted in the subject's native mitral valve. In some embodiments, the shape of the peripheral ring 150 is designed to match the shape of the native mitral valve annulus when the prosthetic device 100 is implanted in the native mitral valve annulus so as to fit over the native mitral valve annulus. In some embodiments, the peripheral ring 150 is flexible in the plane of the native mitral valve annulus. In some embodiments, the peripheral ring 150 is more flexible in the plane of the native mitral valve annulus than in a plane that is transverse to the plane of the native mitral valve annulus.

[0044] In some embodiments, the peripheral ring 150 is non-circular. In some embodiments, the peripheral ring is generally D-shaped (i.e., the substantially straight side of the "D" shape is an arc whose radius of curvature is substantially greater than the radius of curvature of the arc of the "D"). In some embodiments, the shape of the peripheral ring 150 is symmetrical about the anterior-posterior midline axis. In some embodiments, the shape of the peripheral ring 150 is asymmetrical about the transverse midline axis. In some embodiments, the peripheral ring 150 has the same shape as the peripheral edge 128 of the stent frame assembly. In some embodiments, the peripheral ring 150 has a peripheral edge 151. In some embodiments, the peripheral edge 151 of the peripheral ring 150 and the peripheral edge 128 of the stent frame assembly 120 have the same shape. In some embodiments, the peripheral edge 151 of the peripheral ring 150 is generally D-shaped. In some embodiments, the shape of the peripheral edge 151 of the peripheral ring 150 is symmetrical about the anterior-posterior midline axis. In some embodiments, the shape of the peripheral edge 151 of the peripheral ring 150 is asymmetrical about the transverse midline axis.

[0045] Figure 2 Depicted Figure 1 1, showing a plan view of a mitral valve prosthesis device of FIG. 1, showing the generally “D” shape of the peripheral ring 150, the peripheral edge 151, and the peripheral edge 128 of the stent frame assembly 120.

[0046] As a non-limiting example, an exemplary peripheral ring of an exemplary device can be measured, where the exemplary device corresponds to a circular valve device of approximately 31 mm diameter. The exemplary peripheral ring 150 can have an outer anterior-posterior (AP) diameter of approximately 39.8 mm. The exemplary peripheral ring 150 can have an outer transverse diameter of approximately 47.1 mm. The exemplary peripheral ring 150 can have an inner anterior-posterior (AP) diameter of approximately 26.4 mm. The exemplary peripheral ring 150 can have an inner transverse diameter of approximately 32.6 mm. The exemplary peripheral ring can be made thinner or thicker from such dimensions to accommodate different suturing techniques. Although such an exemplary device is described as having an outer circumference corresponding to the outer circumference of a heart valve device having a circular stent frame with a diameter of 31 mm, the devices of the present disclosure can also correspond to stent frames of other sizes, such as those having circular valves with diameters between approximately 20 mm and approximately 40 mm.

[0047] In some embodiments, the peripheral edge 151 of the peripheral ring has a first front angle 253a, a second front angle 253b, and a rear angle 253c. In some embodiments, the first front post 140a is located at the first front angle 253a, the second front post 140b is located at the second front angle 253b, and the rear post 140c is located at the rear angle 253c.

[0048] In some embodiments, the peripheral edge 151 of the peripheral ring has an anterior edge 255a, wherein the anterior edge is located between the first anterior corner 253a and the second anterior corner 253b. In some embodiments, the peripheral ring 150 has a first posterior edge 255b, wherein the first posterior edge is located between the second anterior corner 253b and the posterior corner 253c. In some embodiments, the peripheral ring 150 has a second posterior edge 255c, wherein the second posterior edge is located between the posterior corner 253c and the first anterior corner 253a. In some embodiments, the size and shape of the anterior edge 255a, the first posterior edge 255b, and the second posterior edge 255c of the peripheral ring 150 are designed to match the complementary portion of the natural mitral valve annulus. In some embodiments, the anterior edge 255a is one or more of the following: flatter or longer than each of the first posterior edge 255b and the second posterior edge 255c.

[0049] In some embodiments, the front edge 255a is longer than each of the first rear edge 255b and the second rear edge 255c.

[0050] Leaflets

[0051] In some embodiments, each leaflet of the plurality of leaflets 110a, 110b, and 110c has a fixed edge coupled to the stent frame assembly 120. In some embodiments, the front leaflet 110a has a fixed edge 217a supported by the first front post 140a and the second front post 140b. In some embodiments, the first rear leaflet 110b has a fixed edge 217b supported by the second front post 140b and the rear post 140c. In some embodiments, the second rear leaflet 110c has a fixed edge 217c supported by the rear post 140c and the first front post 140a.

[0052] In some embodiments, the anterior leaflet 110a is fixedly attached to the stent frame assembly 120 adjacent to the anterior edge 253a of the peripheral annulus 150. In some embodiments, the first posterior leaflet 110b is fixedly attached to the stent frame assembly 120 adjacent to the first posterior edge 253b of the peripheral annulus 150. In some embodiments, the second posterior leaflet 110c is fixedly attached to the stent frame assembly 120 adjacent to the second posterior edge 253c of the peripheral annulus 150.

[0053] In some embodiments, the front leaflet 110a is larger than each of the first and second rear leaflets 110b, 110c. In some embodiments, the distance 244a between the first and second front pillars 140a, 140b is greater than the distances 244b and 244c between each of the front and rear pillars 140c. In some embodiments, the ratio of the distance 244a between the first and second front pillars to the sum of the distances 244a, 244b, and 244c is greater than 0.33. In some embodiments, the ratio of the distance 244a between the first and second front pillars to the sum of the distances 244a, 244b, and 244c is about 0.4. In some embodiments, the ratio of the distance 244a between the first and second front pillars to the sum of the distances 244a, 244b, and 244c is between about 0.35 and about 0.45.

[0054] Atrial and ventricular portions of a stent frame assembly

[0055] Figure 3 An elevation view of a mitral valve prosthetic device 100 is depicted. In some embodiments, the stent frame assembly 120 has an atrial portion 360 facing the atrium and a ventricular portion 370 facing the ventricle. In some embodiments, the central opening 122 passes between the atrial portion and the ventricular portion. In some embodiments, the stent frame assembly 120 is configured such that when the prosthetic device 100 is implanted in a native mitral valve or on the side of a native mitral valve annulus facing the atrium, the atrial portion 360 is located in the atrial chamber of the heart and the ventricular portion 370 is located in the ventricular chamber of the heart.

[0056] In some embodiments, the atrial portion 360 is scalloped. In some embodiments, the ventricular portion 360 is scalloped. In some embodiments, the peripheral ring 150 is scalloped in the atrioventricular direction.

[0057] In some embodiments, the atrial portion 360 includes an upper end 362 facing the atrium. In some embodiments, the ventricular portion 370 includes a lower end 372 facing the ventricle. In some embodiments, the stent frame assembly 120 has a height 329 measured between the upper end 362 and the lower end 372.

[0058] As a non-limiting example, the atrial portion of an exemplary device can be measured, where the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the height 329 measured between the upper end 362 and the lower end 372 is about 16.3 mm. In some embodiments, the height 329 is between about 12 mm and about 20 mm. In some embodiments, the height 329 is between about 12 mm and about 14 mm, about 14 mm and about 16 mm, about 16 mm and about 18 mm, or about 18 mm and about 20 mm. In some embodiments, the height 329 is about 12 mm, about 12.2 mm, about 12.4 mm, about 12.6 mm, about 12.8 mm, about 13 mm, about 13.2 mm, about 13.4 mm, about 13.6 mm, about 13.8 mm, about 14 mm, about 14.2 mm, about 14.4 mm, about 14.6 mm, about 14.8 mm, about 15 mm, about 15.2 mm, about 15.4 mm, about 15.6 mm, about 15.8 mm, about 16 mm, about 16.9 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 68 mm, .8mm, about 16mm, about 16.2mm, about 16.4mm, about 16.6mm, about 16.8mm, about 17mm, about 17.2mm, about 17.4mm, about 17.6mm, about 17.8mm, about 18mm, about 18.2mm, about 18.4mm, about 18.6mm, about 18.8mm, about 19mm, about 19.2mm, about 19.4mm, about 19.6mm, about 19.8mm or about 20mm.

[0059] In some embodiments, the ventricular portion 370 includes a plurality of ventricular posts 140a, 140b, 140c. In some embodiments, the first front post 140a has a lower post end 342a facing the ventricle. In some embodiments, the second front post 140b has a lower post end 342b facing the ventricle. In some embodiments, the rear post 140c has a lower post end 342c facing the ventricle. In some embodiments, the lower end 372 of the ventricular portion 370 is one of the lower post ends 342a, 342b, 342c. In some embodiments, the height 329 is measured between the upper end 362 and one of the lower post ends 342a, 342b, 342c.

[0060] In some embodiments, the peripheral ring 150 is disposed between the atrial portion 360 and the ventricular portion 370. In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 over the mitral valve annulus such that protrusion of the stent frame assembly into the ventricular chamber is reduced. In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 over the mitral valve annulus such that protrusion of the stent frame assembly into the ventricular chamber and the effects of such protrusion on ventricular outflow or native leaflet excursion are reduced.

[0061] In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 on the mitral valve annulus such that protrusion of the plurality of ventricular posts 140a, 140b, 140c into the ventricular chamber is reduced. In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 on the mitral valve annulus such that protrusion of the plurality of ventricular posts 140a, 140b, 140c into the ventricular chamber is reduced, and the effects on ventricular outflow or native leaflet excursion caused by such protrusion are also mitigated.

[0062] In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 on the mitral valve annulus such that protrusion of the first and second anterior pillars 140a, 140b into the ventricular chamber is reduced. In some embodiments, the peripheral ring 150 positions the ventricular portion 370 of the stent frame assembly 120 on the mitral valve annulus such that protrusion of the first and second anterior pillars 140a, 140b into the ventricular chamber is reduced, and the effects on ventricular outflow or native leaflet excursion caused by such protrusion are also mitigated.

[0063] In some embodiments, the peripheral ring 150 has an uppermost surface 356 facing the atrium and an inferiormost surface 357 facing the ventricle. In some embodiments, the inferiormost surface 357 facing the ventricle is configured to fit over the native mitral valve annulus when the prosthetic device 100 is implanted in the native mitral valve. In some embodiments, the inferiormost surface 357 contacts the side of the native mitral valve annulus facing the atrium.

[0064] Ventricular length of stent frame assembly

[0065] In some embodiments, ventricular portion 370 has a ventricular length 374 measured between the lowermost surface 357 of peripheral annulus 150 and the lower end 372 of stent frame assembly 120. In some embodiments, ventricular length 374 is less than about 66% of the height 329 of stent frame assembly 120. In some embodiments, ventricular length 374 is less than about 50% of the height 329 of stent frame assembly 120. In some embodiments, ventricular length 374 is less than about 33% of the height 329 of stent frame assembly 120. In some embodiments, ventricular length 374 and / or height 329 are measured at the anterior side of valve prosthesis 100.

[0066] In some embodiments, the ventricle length 374 is less than about 66%, about 64%, about 62%, about 60%, about 58%, about 56%, about 54%, about 52%, about 50%, about 48%, about 46%, about 44%, about 42%, about 40%, about 38%, about 36%, about 34%, about 32%, about 30%, about 28%, about 26%, about 24%, about 22%, about 20%, about 18%, or about 16% of the height 329 of the stent frame assembly 120.

[0067] As a non-limiting example, the ventricular length of an exemplary device can be measured, wherein the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the ventricular length 374 is less than about 10 mm. In some embodiments, the ventricular length 374 is about 8.8 mm or less. In some embodiments, the ventricular length 374 is about 5.2 mm or less. In some embodiments, the ventricular length 374 is less than about 10 mm, less than about 9.5 mm, less than about 9 mm, less than about 8.5 mm, less than about 8 mm, less than about 7.5 mm, less than about 7 mm, less than about 6.5 mm, less than about 6 mm, less than about 5.5 mm, less than about 5 mm, less than about 4.5 mm, less than about 4 mm, less than about 3.5 mm, less than about 3 mm, less than about 2.5 mm, less than about 2 mm, or less than about 1.5 mm.

[0068] In some embodiments, the ratio of the ventricle length 374 to the height 329 of the stent frame assembly 120 is less than 13:20, less than 12:20, less than 11:20, less than 10:20, less than 9:20, less than 8:20, less than 7:20, less than 6:20, less than 5:20, less than 4:20, or less than 3:20. In some embodiments, the ratio of the ventricle length 374 to the height 329 of the stent frame assembly 120 is less than 2:3, less than 1:2, or less than 1:3.

[0069] In some embodiments, the ventricle length 374 is between about 15% and about 65% of the height 329 of the stent frame assembly 120. In some embodiments, the ventricle length 374 is between about 15% and about 20%, between about 20% and about 25%, between about 25% and about 30%, between about 30% and about 35%, between about 35% and about 40%, between about 40% and about 45%, between about 45% and about 50%, between about 50% and about 55%, between about 55% and about 60%, or between about 60% and about 65% of the height 329 of the stent frame assembly 120.

[0070] As a non-limiting example, the ventricular length of an exemplary device can be measured, where the exemplary device corresponds to a circular valve device with a diameter of about 31 mm. In some embodiments, the ventricular length 374 is about 5.2 mm. In some embodiments, the ventricular length 374 is about 8.8 mm. In some embodiments, the ventricular length 374 is between about 1.5 mm and about 10 mm. In some embodiments, the ventricular length 374 is between about 1.5 mm and about 2 mm, between about 2 mm and about 2.5 mm, between about 2.5 mm and about 3 mm, between about 3 mm and about 3.5 mm, between about 3.5 mm and about 4 mm, between about 4 mm and about 4.5 mm, between about 4.5 mm and about 5 mm, between about 5 mm and about 5.5 mm, between about 5.5 mm and about 6 mm, between about 6 mm and about 6.5 mm, between about 6.5 mm and about 7 mm, between about 7 mm and about 7.5 mm, between about 7.5 mm and about 8 mm, between about 8 mm and about 8.5 mm, between about 8.5 mm and about 9 mm, between about 9 mm and about 9.5 mm, or between about 9.5 mm and about 10 mm.

[0071] In some embodiments, the ventricular length 374 is about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.4 mm, about 2.6 mm, about 2.8 mm, about 3 mm, about 3.2 mm, about 3.4 mm, about 3.6 mm, about 3.8 mm, about 4 mm, about 4.2 mm, about 4.4 mm, about 4.6 mm, about 4.8 mm, about 5 mm, about 5.2 mm, about 5.4 mm, about 5.6mm, about 5.8mm, about 6mm, about 6.2mm, about 6.4mm, about 6.6mm, about 6.8mm, about 7mm, about 7.2mm, about 7.4mm, about 7.6mm, about 7.8mm, about 8mm, about 8.2mm, about 8.4mm, about 8.6mm, about 8.8mm, about 9mm, about 9.2mm, about 9.4mm, about 9.6mm, about 9.8mm or about 10mm.

[0072] In some embodiments, the ratio of the ventricle length 374 to the height 329 of the stent frame assembly 120 is about 7:20. In some embodiments, the ratio of the ventricle length 374 to the height 329 of the stent frame assembly 120 is about 11:20. In some embodiments, the ratio of the ventricle length 374 to the height 329 of the stent frame assembly 120 is between 3:20 and 13:20. In some embodiments, the ratio of the ventricle length 374 to the height 329 of the stent frame assembly 120 is about 3:20, about 4:20, about 5:20, about 6:20, about 7:20, about 8:20, about 9:20, about 10:20, about 11:20, about 12:20, or about 13:20. In some embodiments, the ratio of the ventricle length 374 to the height 329 of the stent frame assembly 120 is about 1:3, about 1:2, or about 2:3.

[0073] Atrial Length of Stent Frame Assembly

[0074] In some embodiments, the atrial portion 360 has an atrial length 364 measured between the lowermost surface 357 of the peripheral annulus 150 and the upper end 362 of the stent frame assembly 120. In some embodiments, the atrial length 364 is greater than about 33% of the height 329 of the stent frame assembly 120. In some embodiments, the atrial length 364 is greater than about 50% of the height 329 of the stent frame assembly 120. In some embodiments, the atrial length 364 is greater than about 66% of the height 329 of the stent frame assembly 120. In some embodiments, the atrial length 364 and / or height 329 are measured at the anterior side of the valve prosthesis 100.

[0075] In some embodiments, the atrial length 364 is greater than about 34%, about 36%, about 38%, about 40%, about 42%, about 44%, about 46%, about 48%, about 50%, about 52%, about 54%, about 56%, about 60%, about 62%, about 64%, about 66%, about 68%, about 70%, about 72%, about 74%, about 76%, about 78%, about 80%, about 82%, or about 84% of the height 329 of the stent frame assembly 120.

[0076] As a non-limiting example, the atrial length of an exemplary device can be measured, wherein the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the atrial length 364 is greater than about 6 mm. In some embodiments, the atrial length 364 is about 7.5 mm or greater. In some embodiments, the atrial length 364 is about 11.1 mm or greater. In some embodiments, the atrial length 364 is greater than about 6 mm, greater than about 6.5 mm, greater than about 7 mm, greater than about 7.5 mm, greater than about 8 mm, greater than about 8.5 mm, greater than about 9 mm, greater than about 9.5 mm, greater than about 10 mm, greater than about 10.5 mm, greater than about 11 mm, greater than about 11.5 mm, greater than about 12 mm, greater than about 12.5 mm, greater than about 13 mm, greater than about 13.5 mm, or greater than about 14 mm.

[0077] In some embodiments, the atrium length 364 is between about 35% and about 85% of the height 329 of the stent frame assembly 120. In some embodiments, the atrium length 364 is between about 35% and about 40%, between about 40% and about 45%, between about 45% and about 50%, between about 50% and about 55%, between about 55% and about 60%, between about 60% and about 65%, between about 65% and about 70%, between about 70% and about 75%, between about 75% and about 80%, or between about 80% and about 85% of the height 329 of the stent frame assembly 120.

[0078] As a non-limiting example, the atrial length of an exemplary device can be measured, where the exemplary device corresponds to a circular valve device with a diameter of about 31 mm. In some embodiments, the atrial length 364 is about 7.5 mm. In some embodiments, the atrial length 364 is about 11.1 mm. In some embodiments, the atrial length 364 is between about 6 mm and about 14 mm. In some embodiments, the atrial length 364 is between about 6 mm and about 6.5 mm, about 6.5 mm and about 7 mm, about 7 mm and about 7.5 mm, about 7.5 mm and about 8 mm, about 8 mm and about 8.5 mm, about 8.5 mm and about 9 mm, about 9 mm and about 9.5 mm, about 9.5 mm and about 10 mm, about 10 mm and about 10.5 mm, about 10.5 mm and about 11 mm, about 11 mm and about 11.5 mm, about 11.5 mm and about 12 mm, about 12 mm and about 12.5 mm, about 12.5 mm and about 13 mm, about 13 mm and about 13.5 mm, or about 13.5 mm and about 14 mm.

[0079] In some embodiments, the atrial length 364 is about 6 mm, about 6.2 mm, about 6.4 mm, about 6.6 mm, about 6.8 mm, about 7 mm, about 7.2 mm, about 7.4 mm, about 7.6 mm, about 7.8 mm, about 8 mm, about 8.2 mm, about 8.4 mm, about 8.6 mm, about 8.8 mm, about 9 mm, about 9.2 mm, about 9.4 mm, about 9.6 mm, about 9.8 mm, about 10 mm m, about 10.2mm, about 10.4mm, about 10.6mm, about 10.8mm, about 11mm, about 11.2mm, about 11.4mm, about 11.6mm, about 11.8mm, about 12mm, about 12.2mm, about 12.4mm, about 12.6mm, about 12.8mm, about 13mm, about 13.2mm, about 13.4mm, about 13.6mm, about 13.8mm or about 14mm.

[0080] Figure 4 1 is a perspective view of the atrial end of the mitral valve prosthesis device 100 of the present disclosure, which is configured to protrude into the atrial chamber. In some embodiments, the atrial end of the stent frame assembly 120 is scalloped. In some embodiments, the atrial end of the stent frame assembly has a plurality of scalloped tips 465a, 465b, and 465c. In some embodiments, each scalloped tip is approximately flush with the peripheral ring 150.

[0081] In some embodiments, the plurality of leaves 140a, 140b, and 140c define a first anterior junction 418a between adjacent free edges of the anterior leaflet 110a and the first posterior leaflet 110b, a second anterior junction 418b between adjacent free edges of the anterior leaflet 110a and the second posterior leaflet 110c, and a posterior junction 418c between adjacent free edges of the first posterior leaflet 110b and the second posterior leaflet 110c.

[0082] Bracket frame

[0083] In some embodiments, a stent frame assembly includes a stent frame. Figure 5 is a perspective view of a stent frame 530 of an exemplary mitral valve prosthetic device 100 of the present disclosure. In some embodiments, the stent frame 530 is non-circular. In some embodiments, the stent frame 530 is generally D-shaped (i.e., the generally straight side of the "D" shape is an arc whose radius of curvature is substantially greater than the radius of curvature of the arc of the "D"). In some embodiments, the shape of the stent frame 530 is symmetrical about the anterior-posterior midline axis. In some embodiments, the shape of the stent frame 530 is asymmetrical about the lateral midline axis. In some embodiments, the stent frame 530 is configured to fit within a peripheral ring of a prosthetic device.

[0084] In some embodiments, the stent frame 530 is made of a biocompatible material (eg, metal or plastic). In some embodiments, the stent frame 530 is made of stainless steel, Elgiloy, Delrin, or a biocompatible plastic (eg, polyethylene, PEEK, and similar materials).

[0085] In some embodiments, the stent frame 530 has a plurality of suture holes 531. In some embodiments, the plurality of suture holes 531 are used to fixedly couple the plurality of leaflets to the stent frame assembly using sutures. In some embodiments, the plurality of suture holes 531 are used to attach the peripheral ring to the stent frame assembly using sutures. In some embodiments, the plurality of suture holes 531 are used to attach the covering to the stent frame 530 using sutures. In some embodiments, the suture holes are used to assemble the stent frame assembly 120 and to attach the peripheral ring 150 to the stent frame assembly. In some embodiments, a plurality of sutures may be passed through the holes in the plurality of suture holes. In some embodiments, at least two of the plurality of leaflets, peripheral rings, or coverings may be attached to the stent frame in sequence, wherein a plurality of sutures are passed through the holes in the plurality of suture holes, or the holes in the plurality of suture holes are threaded multiple times.

[0086] In some embodiments, the support frame 530 has an inner front frame edge 533a and an outer front frame edge 535a. In some embodiments, the support frame 530 has an inner first rear frame edge 533b and an outer first rear frame edge 535b. In some embodiments, the support frame 530 has an inner second rear frame edge 533c and an outer second rear frame edge 535c. In some embodiments, the inner front frame edge 533a is one or more of the following: flatter or longer than each of the inner first rear frame edge 533b and the inner second rear frame edge 533c. In some embodiments, the outer front frame edge 535a is one or more of the following: flatter or longer than each of the outer first rear frame edge 535b and the outer second rear frame edge 535c.

[0087] In some embodiments, the outer frame edges 535a, 535b, and 535c are defined by a peripheral ring or peripheral edges of a peripheral ring surrounding the stent frame 530 or stent frame assembly.

[0088] In some embodiments, the stent frame 530 has a plurality of frame columns 540a, 540b, 540c, each of which extends from the ventricular end 581 of the cylinder 580. In some embodiments, the central flow axis 124 runs through the cylinder 580. In some embodiments, the cylinder is an asymmetric cylinder. In some embodiments, the cylinder 580 has a non-circular cross-section. In some embodiments, the cylinder 580 has a substantially D-shaped cross-section. In some embodiments, the cross-section of the cylinder 580 is symmetrical about the anterior-posterior midline axis. In some embodiments, the cross-section of the cylinder 580 is asymmetric about the lateral midline axis. In some embodiments, the cross-section of the cylinder 580 and the peripheral edge 128 of the stent frame assembly 120 have the same shape.

[0089] Each of the plurality of frame posts has a lower end facing the ventricle that is configured to protrude into the ventricle chamber when the prosthetic device 100 is implanted in the native mitral valve. In some embodiments, the plurality of frame posts include a first anterior frame post 540a, a second anterior frame post 540b, and a posterior frame post 540c.

[0090] In some embodiments, the first front frame post 540a is configured to fixedly attach the front leaflet and the second rear leaflet to the stent frame 530. In some embodiments, the second front frame post 540b is configured to fixedly attach the front leaflet and the first rear leaflet. In some embodiments, the rear frame post 540c is configured to fixedly attach the first rear leaflet and the second rear leaflet to the stent frame 530.

[0091] Fig. 6A yes Figure 5 Elevation view of the support frame. Figure 6B It is along Fig. 6A A cross-sectional view taken along the cutting line shown in FIG.

[0092] In some embodiments, the cylinder 580 has two ends: an atrial end configured to protrude into the atrial chamber of the heart when the prosthetic device 100 is implanted in the native mitral valve of the heart, and a ventricular end 581 adjacent to the plurality of frame posts 540a, 540b, and 540c. In some embodiments, the cylinder 580 has an uppermost atrial end 582.

[0093] In some embodiments, the stent frame 530 has an overall height 639, which can be measured from the uppermost end 582 of the cylinder 580 to the lowermost end of one or more frame columns 540a, 540b, and 540c.

[0094] As a non-limiting example, the overall height 639 of the stent frame of an exemplary device can be measured, where the exemplary device corresponds to a circular valve device with a diameter of about 31 mm. In some embodiments, the overall height 639 is about 16.3 mm. In some embodiments, the overall height 639 is between about 12 mm and about 20 mm. In some embodiments, the overall height 639 is between about 12 mm and about 14 mm, about 14 mm and about 16 mm, about 16 mm and about 18 mm, or about 18 mm and about 20 mm. In some embodiments, the overall height 639 is about 12 mm, about 12.2 mm, about 12.4 mm, about 12.6 mm, about 12.8 mm, about 13 mm, about 13.2 mm, about 13.4 mm, about 13.6 mm, about 13.8 mm, about 14 mm, about 14.2 mm, about 14.4 mm, about 14.6 mm, about 14.8 mm, about 15 mm, about 15.2 mm, about 15.4 mm, about 15.6 mm, about 15.8 mm, about 16 mm, about 16.9 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, .8mm, about 16mm, about 16.2mm, about 16.4mm, about 16.6mm, about 16.8mm, about 17mm, about 17.2mm, about 17.4mm, about 17.6mm, about 17.8mm, about 18mm, about 18.2mm, about 18.4mm, about 18.6mm, about 18.8mm, about 19mm, about 19.2mm, about 19.4mm, about 19.6mm, about 19.8mm or about 20mm.

[0095] In some embodiments, the frame column height 674 can be measured from the ventricular end 581 of the cylinder 580 to the lowest end of one or more frame columns 540a, 540b, and 540c. In some embodiments, the frame column height 674 is the same whether measured from the lowest end of the frame column 540a, 540b, or 540c.

[0096] As a non-limiting example, the frame post height 674 of an exemplary device can be measured, where the exemplary device corresponds to a circular valve device with a diameter of about 31 mm. In some embodiments, the frame post height 674 is about 5.2 mm. In some embodiments, the frame post height 674 is about 8.8 mm. In some embodiments, the frame post height 674 is between about 1.5 mm and about 10 mm. In some embodiments, the frame column height 674 is between about 1.5 mm and about 2 mm, between about 2 mm and about 2.5 mm, between about 2.5 mm and about 3 mm, between about 3 mm and about 3.5 mm, between about 3.5 mm and about 4 mm, between about 4 mm and about 4.5 mm, between about 4.5 mm and about 5 mm, between about 5 mm and about 5.5 mm, between about 5.5 mm and about 6 mm, between about 6 mm and about 6.5 mm, between about 6.5 mm and about 7 mm, between about 7 mm and about 7.5 mm, between about 7.5 mm and about 8 mm, between about 8 mm and about 8.5 mm, between about 8.5 mm and about 9 mm, between about 9 mm and about 9.5 mm, or between about 9.5 mm and about 10 mm.

[0097] In some embodiments, the frame column height 674 is about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.4 mm, about 2.6 mm, about 2.8 mm, about 3 mm, about 3.2 mm, about 3.4 mm, about 3.6 mm, about 3.8 mm, about 4 mm, about 4.2 mm, about 4.4 mm, about 4.6 mm, about 4.8 mm, about 5 mm, about 5.2 mm, about 5.4 mm, about 5.6mm, about 5.8mm, about 6mm, about 6.2mm, about 6.4mm, about 6.6mm, about 6.8mm, about 7mm, about 7.2mm, about 7.4mm, about 7.6mm, about 7.8mm, about 8mm, about 8.2mm, about 8.4mm, about 8.6mm, about 8.8mm, about 9mm, about 9.2mm, about 9.4mm, about 9.6mm, about 9.8mm or about 10mm.

[0098] As a non-limiting example, the frame column height 674 of an exemplary device can be measured, wherein the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the frame column height 674 is less than about 10 mm. In some embodiments, the frame column height 674 is about 8.8 mm or less. In some embodiments, the frame column height 674 is about 5.2 mm or less. In some embodiments, the frame column height 674 is less than about 10 mm, less than about 9.5 mm, less than about 9 mm, less than about 8.5 mm, less than about 8 mm, less than about 7.5 mm, less than about 7 mm, less than about 6.5 mm, less than about 6 mm, less than about 5.5 mm, less than about 5 mm, less than about 4.5 mm, less than about 4 mm, less than about 3.5 mm, less than about 3 mm, less than about 2.5 mm, less than about 2 mm, or less than about 1.5 mm.

[0099] In some embodiments, the barrel 580 has a barrel height 684 as measured from the uppermost atrial end 582 to the ventricular end 581 of the barrel.

[0100] As a non-limiting example, the barrel height 684 of an exemplary device can be measured, where the exemplary device corresponds to a circular valve device with a diameter of about 31 mm. In some embodiments, the barrel height 684 is about 7.5 mm. In some embodiments, the barrel height 684 is about 11.1 mm. In some embodiments, the barrel height 684 is between about 6 mm and about 14 mm. In some embodiments, the barrel height 684 is between about 6 mm and about 6.5 mm, about 6.5 mm and about 7 mm, about 7 mm and about 7.5 mm, about 7.5 mm and about 8 mm, about 8 mm and about 8.5 mm, about 8.5 mm and about 9 mm, about 9 mm and about 9.5 mm, about 9.5 mm and about 10 mm, about 10 mm and about 10.5 mm, about 10.5 mm and about 11 mm, about 11 mm and about 11.5 mm, about 11.5 mm and about 12 mm, about 12 mm and about 12.5 mm, about 12.5 mm and about 13 mm, about 13 mm and about 13.5 mm, or about 13.5 mm and about 14 mm.

[0101] In some embodiments, the barrel height 684 is about 6 mm, about 6.2 mm, about 6.4 mm, about 6.6 mm, about 6.8 mm, about 7 mm, about 7.2 mm, about 7.4 mm, about 7.6 mm, about 7.8 mm, about 8 mm, about 8.2 mm, about 8.4 mm, about 8.6 mm, about 8.8 mm, about 9 mm, about 9.2 mm, about 9.4 mm, about 9.6 mm, about 9.8 mm, about 10 mm m, about 10.2mm, about 10.4mm, about 10.6mm, about 10.8mm, about 11mm, about 11.2mm, about 11.4mm, about 11.6mm, about 11.8mm, about 12mm, about 12.2mm, about 12.4mm, about 12.6mm, about 12.8mm, about 13mm, about 13.2mm, about 13.4mm, about 13.6mm, about 13.8mm or about 14mm.

[0102] As a non-limiting example, the barrel height 684 of an exemplary device can be measured, wherein the exemplary device corresponds to a circular valve device of about 31 mm diameter. In some embodiments, the barrel height 684 is greater than about 6 mm. In some embodiments, the barrel height 684 is about 7.5 mm or greater. In some embodiments, the barrel height 684 is about 11.1 mm or greater. In some embodiments, the barrel height 684 is greater than about 6 mm, greater than about 6.5 mm, greater than about 7 mm, greater than about 7.5 mm, greater than about 8 mm, greater than about 8.5 mm, greater than about 9 mm, greater than about 9.5 mm, greater than about 10 mm, greater than about 10.5 mm, greater than about 11 mm, greater than about 11.5 mm, greater than about 12 mm, greater than about 12.5 mm, greater than about 13 mm, greater than about 13.5 mm, or greater than about 14 mm.

[0103] In some embodiments, the atrial end of the barrel 580 is scalloped. In some embodiments, the atrial end of the barrel 580 has a scalloped tip 583. In some embodiments, the atrial end of the barrel 580 has multiple scalloped tips. In some embodiments, the scalloped portion height 689 is measured from the uppermost atrial end 582 to the scalloped tip 583.

[0104] In some embodiments, the scallop height 689 is about 4.9 mm. In some embodiments, the scallop height 689 is about 7.2 mm. In some embodiments, the scallop height 689 is between about 3 mm and about 10 mm.

[0105] In some embodiments, the width between the outer frame edge and the inner frame edge (eg, outer frame edge 535a and inner frame edge 533a) defines a wall thickness 638, such as Figure 6B In the cross-sectional diagram and Fig. 7AIn some embodiments, the wall thickness 638 is about 1.8 mm. In some embodiments, the wall thickness 638 is between about 0.5 mm and about 5 mm.

[0106] Diameter and size of the stent frame

[0107] Figure 7A-7C Depicted Figure 5 A plan view of the support frame. Fig. 7A and Figure 7B An anterior-posterior (AP) axis 705 is depicted intersecting the transverse axis 707 at an intersection 709. Due to the wall thickness 638 of the stent frame, the stent frame 530 has at least two diameters in each axial direction.

[0108] In some embodiments, the stent frame 530 has an inner anteroposterior (AP) diameter 791 along the AP axis 705, wherein the inner AP diameter 791 is measured from an inner frame edge of the stent frame 530. In some embodiments, the stent frame 530 has an outer AP diameter 793 along the AP axis 705, wherein the outer AP diameter 793 is measured from an outer frame edge of the stent frame 530.

[0109] In some embodiments, the stent frame 530 has an inner transverse diameter 794 along the transverse axis 707, wherein the inner transverse diameter 794 is measured from an inner frame edge of the stent frame 530. In some embodiments, the stent frame 530 has an outer transverse diameter 796 along the transverse axis 707, wherein the outer transverse diameter 796 is measured from an outer frame edge of the stent frame 530.

[0110] As a non-limiting example, the stent frame 530 of an exemplary device can be measured, where the exemplary device corresponds to a circular valve device of about 31 mm diameter. The inner AP diameter 791 can be about 25 mm or between about 20 mm and about 30 mm. The outer AP diameter 793 can be about 29 mm or between about 24 mm and about 34 mm. The inner transverse diameter 794 can be about 30 mm or between about 25 mm and about 35 mm. The outer transverse diameter 796 can be about 34 mm or between about 29 mm and about 39 mm.

[0111] In some embodiments, a first front angle 701 exists between a first reference line 741a and a second reference line 741b, wherein the first reference line 741a extends from the intersection 709 through the first front frame post 540a, and wherein the second reference line 741b extends from the intersection 709 through the second front frame post 540b.

[0112] In some embodiments, the first rake angle 701 is between about 140 degrees and about 164 degrees. In some embodiments, the first rake angle 701 is about 153 degrees.

[0113] In some embodiments, the first rake angle 701 is greater than 140 degrees, greater than 142 degrees, greater than 144 degrees, greater than 146 degrees, greater than 148 degrees, greater than 150 degrees, or greater than 152 degrees.

[0114] In some embodiments, there is a first P1 angle 703a between the second reference line 741b and the AP axis 705. In some embodiments, there is a first P2 angle 703b between the first reference line 741a and the AP axis 705.

[0115] In some embodiments, the first P1 angle 703a is between about 90 degrees and about 110 degrees. In some embodiments, the first P1 angle 703a is about 103 degrees.

[0116] In some embodiments, the first P2 angle 703b is between about 90 degrees and about 110 degrees. In some embodiments, the first P2 angle 703b is about 103 degrees.

[0117] In some embodiments, the sum of the first P1 angle 703a and the first P2 angle 703b is between about 196 and about 220 degrees. In some embodiments, the sum of the first P1 angle 703a and the first P2 angle 703b is less than 214 degrees, less than 212 degrees, less than 210 degrees, less than 208 degrees, less than 206 degrees, less than 204 degrees, less than 202 degrees, or less than 200 degrees.

[0118] Figure 7C A center point 708 defined by the intersection of a first line 706a, a second line 706b, and a third line 706c is depicted, wherein the first line 706a is perpendicular to a first tangent line 745a tangent to the frame column 540a, wherein the second line 706b is perpendicular to a second tangent line 745b tangent to the frame column 540b, and wherein the third line 706c is perpendicular to a third tangent line 745c tangent to the frame column 540c.

[0119] In some embodiments, there is a second rake angle 702 between the first line 706a and the second line 706b. In some embodiments, there is a second P1 angle 704a between the second line 706b and the third line 706c. In some embodiments, there is a second P2 angle 704b between the third line 706c and the first line 706a.

[0120] Bracket frame covering

[0121] Figure 8 It is along Figure 200 . 0 ...

[0122] In some embodiments, the stent frame assembly 120 includes a covering 126 disposed on the stent frame 530. In some embodiments, the covering 126 includes an inner skirt 825 and an outer skirt 827. In some embodiments, at least one of the covering, the inner skirt, or the outer skirt comprises fabric or pericardial tissue.

[0123] In some embodiments, the peripheral ring 150 includes an inner fabric 852 and an outer fabric 854. In some embodiments, the peripheral ring includes at least one of a braided polyester fabric (e.g., polyethylene terephthalate or polyester), silk, polypropylene, other fiber or fabric materials, silicone, PET, or expanded PTFE. In some embodiments, the peripheral ring includes a wire 858, wherein the wire enables visualization of the prosthetic device 100 under imaging. In some embodiments, the fabric covering encapsulates the wire.

[0124] In some embodiments, the fixed edge 217a of the leaflet 110a is attached to the stent frame 530 by passing sutures through the plurality of suture holes 531. In some embodiments, the covering 126 (e.g., the inner skirt 825 and / or the outer skirt 827) is attached to the stent frame 530 by passing sutures through the plurality of suture holes 531.

[0125] Alternative attachment locations for peripheral rings

[0126] Figure 9A-9B is an elevation view of a stent frame depicting changes in the attachment position of the peripheral ring to the stent frame. Fig. 9B Compared to either of the attachment locations 959b and 959c depicted in FIG. Fig. 9A Attachment location 959a depicted in achieves a higher degree of atrialization. In some embodiments, the lowermost surface 957a of the peripheral ring facing the ventricle is positioned further away from the uppermost atrial end 582 of the barrel 580 than from the ventricular end 581 of the barrel. In some embodiments, the uppermost surface 956a of the peripheral ring facing the atrium is generally aligned horizontally with the surface of the scalloped tip 583.

[0127] Attachment location 959c achieves minimal atrialization compared to attachment locations 959a and 959b.In some embodiments, the ventricle-facing inferiormost surface 957c of the peripheral ring is positioned closer to the superiormost atrial end 582 of the barrel 580 than to the ventricular end 581 of the barrel.

[0128] Attachment location 959b has a degree of atrialization between attachment locations 959a and 959c. Attachment location 959b represents a "horizontal" or "flat" position of the peripheral ring, wherein the lowermost surface 957b of the peripheral ring facing the ventricle is aligned with the horizontal surface of the ventricular end 581 of the cylinder.

[0129] Complete or partial saddle-shaped peripheral ring

[0130] In some embodiments, the peripheral ring has a flat (i.e., horizontal) configuration. In some embodiments, atrialization can be achieved or improved by giving the peripheral ring a partial saddle or a full saddle configuration. In some embodiments, the peripheral ring 1050 can be saddle-shaped so that the peripheral ring is closer to the scalloped portion of the atrial end of the cylinder 580 on the anterior side along the AP diameter and closer to the scalloped portion of the atrial end of the cylinder 580 along the transverse diameter (e.g., a full saddle configuration), such as Fig.10 In some embodiments, the various suture holes on the cylinder 580 can be shifted to better align with or follow the fully saddled peripheral ring 1050 on the cylinder.

[0131] In some embodiments, the peripheral ring 1050 can be saddle-shaped, such that the peripheral ring is closer to the scalloped portion of the atrial end of the cylinder 580 on the anterior side along the AP diameter, and the peripheral ring is horizontal or flat on the posterior side of the AP diameter (e.g., a first partially saddle-shaped configuration). In some embodiments, the peripheral ring 1050 can be saddle-shaped, such that the peripheral ring is closer to the scalloped portion of the atrial end of the cylinder 580 on the anterior side along the AP diameter, the peripheral ring is horizontal or flat on the posterior side of the AP diameter, and the peripheral ring is also horizontal or flat along the transverse diameter (e.g., a second partially saddle-shaped configuration), such as Fig.10 In some embodiments, the various suture holes on the cylinder 580 can be shifted to better align with or follow the partially saddled peripheral ring 1050 on the cylinder.

[0132] Complete or partial saddle-forming can achieve or improve atrialization because the ventricular end 581 of the cylinder can be reverse scalloped toward the lowest surface of the peripheral ring 1050 adjacent to the ventricular end 581, thereby aligning the shape of the ventricular end 581 of the cylinder with or following the shape of the saddle-shaped peripheral ring 1050 and thereby reducing the total area of ​​the stent frame 530 protruding into the ventricular chamber.

[0133] Atrialization of mitral valve prosthesis by implantation method

[0134] The native mitral valve separates the atrial chamber (e.g., left atrium LA) and the ventricular chamber (e.g., left ventricle LV) of the heart. The native mitral valve annulus has a side facing the atrium and a side facing the ventricle. In some embodiments, atrialization can be achieved or improved by implanting a mitral valve prosthesis device on the atrial-facing side of the native mitral valve annulus. Fig.11 An exemplary mitral valve prosthesis device 100 is depicted being placed in the native mitral valve annulus MV by a method of achieving atrialization. In some embodiments, a higher degree of atrialization of the prosthetic device 100 is achieved by suturing the peripheral ring to the atrial-facing side of the native mitral valve annulus, such as Fig.11 , thereby reducing the protrusion of the prosthetic device 100 (e.g., the multiple ventricular posts 140a, 140b, and 140c) into the ventricular chamber. Achieving a higher degree of atrialization can mitigate the effects on ventricular outflow (e.g., LOVT obstruction) or native leaflet excursion caused by such protrusion because the native anterior leaflet of the native mitral valve is not displaced by the prosthetic device 100 or is minimally displaced below the aortic valve. In addition, in the case of a higher degree of atrialization, the native anterior mitral leaflet does not need to be resected or altered, and thus the structure of the left ventricle as well as the chordae CH and papillary muscles PM can continue to be maintained, thereby maintaining their natural support for left ventricular function. Further, in the case of a higher degree of atrialization, the effects on native leaflet excursion will be mitigated (e.g., the protrusion of the stent frame assembly into the ventricular chamber causes limited or less than maximal excursion).

[0135] In some embodiments, when implanting the prosthetic device 100, a standard suture implantation technique can be applied, including suturing the peripheral ring 150 to the atrial side of the mitral valve annulus with a first suture, and then suturing the peripheral ring to the mitral valve wall with a second suture. In some embodiments, a continuous flat stitch (e.g., a whip stitch) can be used for the second suture. In some embodiments, the addition of a second suture helps to cover any cracks that occur at the junction of the sewing ring and the atrial wall or annulus, thereby further preventing the risks associated with stasis and thrombosis.

[0136] In some embodiments, first anterior post 140a and second anterior post 140b are positioned adjacent to the anterior side of the native mitral valve annulus when prosthetic device 100 is implanted. In some embodiments, posterior post 140c is positioned adjacent to the posterior side of the native mitral valve annulus.

[0137] Atrialization of mitral valve prosthesis by scalloping of the peripheral annulus

[0138] Figures 12A-12Dare various views depicting an alternative version of atrialization, wherein an exemplary mitral valve prosthesis device 1200 of the present disclosure includes a peripheral ring 1205 that is scalloped toward a ventricular-facing end 1210 of a plurality of ventricular posts. Figure 13A-13B Depicted separately Figures 12A-12D Elevation and cross-sectional views of a stent frame 1215 of an exemplary mitral valve prosthesis device 1200 are depicted in FIG. Fig.13A The overall height 1220 , column height 1225 , barrel height 1230 , and scallop height 1235 of the stent frame are shown. Fig. 13B Shown along Fig.13A A cross-sectional view of the stent frame 1215 taken along line 13B in FIG.

[0139] In some embodiments, atrialization is achieved by changing the ratio of the cylinder height to the total height compared to the previously shown embodiments. In some embodiments, the sewing ring is scalloped in the ventricular direction along each ventricular column of the stent frame assembly. Such scalloping significantly reduces the ventricular length of the stent frame assembly, thereby reducing the protrusion of the stent frame assembly into the ventricular chamber. In some embodiments, the lowermost surface of the peripheral ring can be measured from the scalloped portion of the peripheral ring.

[0140] The devices described herein may be applicable to other heart valves, such as the tricuspid valve.In some embodiments, a heart valve prosthetic device is configured to enhance, support, or improve the function of a native tricuspid valve when the prosthetic device is implanted in the native tricuspid valve.

[0141] Although preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided only as examples. The present disclosure is not intended to be limited by the specific examples provided in the specification. Although embodiments of the present disclosure have been described in accordance with the foregoing description, the description and illustration of the embodiments herein are not intended to be interpreted in a restrictive sense. Without departing from the scope of the present disclosure, those skilled in the art will now think of many variations, changes and replacements. In addition, it should be understood that all aspects of the present disclosure are not limited to the specific depictions, configurations or related proportions depending on various conditions and variables set forth herein. It should be understood that various alternatives of the embodiments of the present disclosure described herein can be adopted when practicing the embodiments of the present disclosure. It is therefore expected that the present disclosure should also cover any such alternatives, modifications, variations or equivalents. The appended claims are intended to define the scope of the present invention, and thus cover methods and structures and their equivalents within the scope of these claims.

Claims

1. A heart valve prosthesis device, comprising: a stent frame assembly having an atrial portion including an upper end facing the atrium, a ventricular portion including a lower end facing the ventricle, a height between the upper and lower ends, and a central opening passing between the atrial portion and the ventricular portion; a peripheral ring attached to the stent frame assembly and surrounding the central opening, wherein the peripheral ring is disposed between the atrial portion and the ventricular portion, wherein the peripheral ring has an inferiormost surface facing the ventricle, the inferiormost surface being configured to fit over a native heart valve annulus when the prosthetic device is implanted in the native heart valve; as well as a plurality of leaflets fixedly coupled to the stent frame assembly and located at the central opening of the stent frame assembly, wherein the peripheral ring limits protrusion of the stent frame assembly into the ventricular chamber, The effects on ventricular outflow or native leaflet excursion caused by such protrusions are mitigated.

2. The heart valve prosthetic device of claim 1, wherein the heart valve prosthetic device is a mitral valve prosthetic device.

3. A heart valve prosthesis device according to any one of the preceding claims, wherein the native heart valve annulus is a native mitral valve annulus.

4. A heart valve prosthetic device according to any one of the preceding claims, wherein the native heart valve is a native mitral valve.

5. The heart valve prosthetic device of claim 1, wherein the heart valve prosthetic device is a tricuspid valve prosthetic device.

6. A heart valve prosthesis device according to claim 1 or 5, wherein the native heart valve annulus is a native tricuspid valve annulus, and the native heart valve is a native tricuspid valve.

7. A heart valve prosthesis device according to any of the preceding claims, wherein the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 66% of the height between the lower end and the upper end of the stent frame assembly.

8. A heart valve prosthesis device according to any of the preceding claims, wherein the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 50% of the height between the lower end and the upper end of the stent frame assembly.

9. A heart valve prosthesis device according to any of the preceding claims, wherein the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is less than 33% of the height between the lower end and the upper end of the stent frame assembly.

10. A heart valve prosthetic device according to any one of the preceding claims, wherein the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 8 mm or less.

11. A heart valve prosthesis device according to any of the preceding claims, wherein the ventricular length between the lowermost surface of the peripheral ring and the lower end of the stent frame assembly is 5 mm or less.

12. The heart valve prosthesis device of any one of claims 7-11, wherein the ventricle length is measured at the front side of the stent frame assembly.

13. A heart valve prosthesis device according to any of the preceding claims, wherein the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 33% of the height between the lower end and the upper end of the stent frame assembly.

14. A heart valve prosthesis device according to any of the preceding claims, wherein the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 50% of the height between the lower end and the upper end of the stent frame assembly.

15. A heart valve prosthesis device according to any of the preceding claims, wherein the atrial length between the lowermost surface of the peripheral ring and the upper end of the stent frame assembly is greater than 66% of the height between the lower end and the upper end of the stent frame assembly.

16. The heart valve prosthesis device according to any one of claims 13-15, wherein the height between the lower end and the upper end of the stent frame assembly is measured from the front side of the stent frame assembly.

17. A heart valve prosthetic device according to any of the preceding claims, wherein each leaflet comprises a flexible membrane, and wherein the plurality of leaflets are configured to open in response to ventricular relaxation and to close in response to ventricular contraction when the prosthetic device is implanted in the native mitral valve.

18. A heart valve prosthetic device according to any of the preceding claims, wherein the plurality of leaflets are configured to allow blood flow from the atrium to the ventricle and restrict blood flow from the ventricular chamber to the atrium chamber when the prosthetic device is implanted in the native heart valve.

19. A heart valve prosthetic device according to any of the preceding claims, wherein the plurality of leaflets are configured to close together in response to blood flow from the ventricle chamber to the atrial chamber when the prosthetic device is implanted in the native heart valve.

20. The heart valve prosthetic device of any of the preceding claims, wherein the plurality of leaflets are at least partially made of decellularized or synthetic tissue.

21. The heart valve prosthesis device of any one of the preceding claims, wherein the stent frame assembly comprises a stent frame and a cover disposed on the stent frame.

22. The heart valve prosthesis device of claim 21, wherein the covering comprises fabric or pericardial tissue.

23. A heart valve prosthesis device according to any one of the preceding claims, wherein the stent frame assembly has a height of between 12 mm and 20 mm.

24. A heart valve prosthesis device according to any of the preceding claims, wherein the atrial portion has a height between 6 mm and 14 mm.

25. A heart valve prosthesis device according to any of the preceding claims, wherein the ventricular portion has a height of between 1.5 mm and 10 mm.

26. A heart valve prosthetic device according to any one of the preceding claims, wherein the shape of the peripheral ring is designed to match the shape of the natural mitral valve annulus when the prosthetic device is implanted in the natural mitral valve so as to be assembled on the natural mitral valve annulus.

27. A heart valve prosthesis device according to any of the preceding claims, wherein the stent frame assembly has an anterior-posterior diameter and a transverse diameter, the anterior-posterior diameter being smaller than the transverse diameter.

28. A heart valve prosthesis device according to any of the preceding claims, wherein the stent frame assembly has a front edge, a first rear edge, and a second rear edge, and wherein the front edge is one or more of the following: flatter or longer than each of the first rear edge and the second rear edge.

29. The heart valve prosthesis device of claim 28, wherein the leading edge, the first trailing edge, and the second trailing edge of the stent frame assembly are defined by the peripheral ring.

30. The heart valve prosthesis device of any of the preceding claims, wherein the stent frame assembly has an anterior-posterior diameter of between 20 mm and 34 mm.

31. A heart valve prosthesis device according to any of the preceding claims, wherein the stent frame assembly has a transverse diameter of between 25 mm and 39 mm.

32. The heart valve prosthesis device of any of the preceding claims, wherein the stent frame assembly is non-circular.

33. The heart valve prosthesis device of any of the preceding claims, wherein the stent frame assembly is generally D-shaped.

34. A heart valve prosthetic device according to any one of the preceding claims, wherein the peripheral ring is scalloped in the atrioventricular direction.

35. A heart valve prosthetic device according to any of the preceding claims, wherein the peripheral annulus is non-circular.

36. A heart valve prosthetic device according to any of the preceding claims, wherein the peripheral ring is generally D-shaped.

37. A heart valve prosthesis device according to any one of the preceding claims, wherein the peripheral edges of the stent frame assembly and the peripheral ring have the same shape.

38. The heart valve prosthetic device of any of the preceding claims, wherein the peripheral ring comprises a wire to facilitate visualization of the heart valve prosthetic device under imaging.

39. A heart valve prosthetic device according to any of the preceding claims, wherein the peripheral ring includes a front edge, a first rear edge and a second rear edge, and the size and shape of each of the front edge, the first rear edge and the second rear edge are designed to match the complementary portion of the natural valve annulus.

40. A heart valve prosthesis device according to claim 39, wherein the peripheral ring further includes a first front angle, a second front angle and a rear angle, wherein the front edge is located between the first front angle and the second front angle, wherein the first rear edge is located between the second front angle and the rear angle, and wherein the second rear edge is located between the rear angle and the first front angle.

41. A heart valve prosthesis device according to claim 39 or 40, wherein the leading edge is one or more of the following: flatter or longer than each of the first rear edge and the second rear edge.

42. A heart valve prosthetic device according to any one of claims 39 to 41, wherein the plurality of leaflets includes an anterior leaflet fixedly attached to the stent frame assembly adjacent the anterior edge of the peripheral annulus.

43. A heart valve prosthesis device according to any one of claims 39 to 42, wherein the plurality of leaflets include a first posterior leaflet and a second posterior leaflet, the first posterior leaflet being fixedly attached to the stent frame assembly adjacent to the first posterior edge of the peripheral ring, and the second posterior leaflet being fixedly attached to the stent frame assembly adjacent to the second posterior edge of the peripheral ring.

44. The heart valve prosthetic device of any of the preceding claims, wherein the stent frame assembly comprises an asymmetric cylinder and a plurality of ventricular posts extending from the asymmetric cylinder.

45. A heart valve prosthesis device according to claim 44, wherein the peripheral ring further includes a first anterior corner, a second anterior corner and a posterior corner, and wherein the plurality of ventricular columns include a first anterior column located at the first anterior corner, a second anterior column located at the second anterior corner, and a posterior column located at the posterior corner.

46. ​​The heart valve prosthetic device of any of the preceding claims, wherein the atrial end of the stent frame assembly is scalloped.

47. The heart valve prosthesis device of any of the preceding claims, wherein the ventricular end of the stent frame assembly is scalloped.

48. A heart valve prosthetic device according to any of the preceding claims, wherein the peripheral ring is a sewing ring.

49. A heart valve prosthetic device according to any of the preceding claims, wherein the peripheral ring is flexible in the plane of the native heart valve annulus.

50. The heart valve prosthesis device of claim 49 wherein the peripheral ring is more flexible in the plane of the native heart valve annulus than in a plane transverse to the plane of the native heart valve annulus.

51. A heart valve prosthesis device according to any of the preceding claims, wherein the plurality of leaflets include an anterior leaflet, a first posterior leaflet and a second posterior leaflet, the anterior leaflet, the first posterior leaflet and the second posterior leaflet each including a fixed edge and a free edge, the fixed edge being coupled to the stent frame assembly.

52. The heart valve prosthetic device of claim 51 , wherein the anterior leaflet is larger than each of the first posterior leaflet and the second posterior leaflet.

53. The heart valve prosthesis device of claim 51 or 52, wherein the stent frame assembly comprises a plurality of ventricular posts comprising a first anterior post, a second anterior post, and a posterior post.

54. A heart valve prosthesis device according to claim 53, wherein the fixed edge of the anterior leaflet is supported by the first anterior post and the second anterior post, and wherein the distance between the first anterior post and the second anterior post is greater than the distance between each anterior post and the posterior post.

55. A heart valve prosthesis device according to any one of claims 51-54, wherein the angle along the free edge of the anterior leaflet is greater than every angle along the free edge of the first posterior leaflet and every angle along the free edge of the second posterior leaflet.

56. A heart valve prosthesis device according to any one of claims 51-55, wherein the plurality of leaflets are arranged to define a first anterior juncture between adjacent free edges of the anterior leaflet and the first posterior leaflet, a second anterior juncture between adjacent free edges of the anterior leaflet and the second posterior leaflet, and a posterior juncture between adjacent free edges of the first posterior leaflet and the second posterior leaflet.

57. A heart valve prosthetic device according to any of the preceding claims, wherein the heart valve prosthetic device is configured to augment the native heart valve.

58. A method of treating a dysfunction of a heart valve, the method comprising: implanting a stent frame assembly of a heart valve prosthesis device in a natural heart valve of the heart so that the lowermost surface of a peripheral ring coupled to the stent frame assembly, which faces the ventricle, is mounted on the valve ring of the natural heart valve, the peripheral ring dividing the stent frame assembly into an atrial portion and a ventricular portion, and wherein the peripheral ring limits protrusion of the stent frame assembly into the ventricular chamber, To mitigate the effects on ventricular outflow or native leaflet excursion caused by such protrusions.

59. The method of claim 58, wherein the heart valve is a mitral valve.

60. The method of claim 58 or 59, wherein the heart valve prosthetic device is a mitral valve prosthetic device.

61. The method of any one of claims 58-60, wherein the native heart valve is a native mitral valve.

62. The method of claim 58, wherein the heart valve prosthetic device is a tricuspid valve prosthetic device.

63. The method of claim 58 or 62, wherein the native heart valve annulus is a native tricuspid valve annulus and the native heart valve is a native tricuspid valve.

64. The method of any one of claims 58-63, wherein the ventricular length between the inferiormost surface of the peripheral ring and the lower end of the stent frame assembly is less than 66% of the height between the lower and upper ends of the stent frame assembly.

65. The method of any one of claims 58-64, wherein a ventricular length between the inferiormost surface of the peripheral annulus and the lower end of the stent frame assembly is less than 50% of the height between the lower and upper ends of the stent frame assembly.

66. The method of any one of claims 58-65, wherein a ventricular length between the inferiormost surface of the peripheral annulus and the lower end of the stent frame assembly is less than 33% of the height between the lower and upper ends of the stent frame assembly.

67. The method of any one of claims 58-66, wherein the ventricular length between the inferiormost surface of the peripheral ring and the lower end of the stent frame assembly is 8 mm or less.

68. The method of any one of claims 58-67, wherein the ventricular length between the inferiormost surface of the peripheral ring and the inferior end of the stent frame assembly is 5 mm or less.

69. The method of any one of claims 59-68, wherein the ventricle length is measured at the anterior side of the stent frame assembly.

70. The method of any one of claims 58-69, wherein an atrial length between the inferiormost surface of the peripheral ring and the superior end of the stent frame assembly is greater than 33% of the height between the inferior and superior ends of the stent frame assembly.

71. The method of any one of claims 58-70, wherein an atrial length between the inferiormost surface of the peripheral ring and the superior end of the stent frame assembly is greater than 50% of the height between the inferior and superior ends of the stent frame assembly.

72. The method of any one of claims 58-71, wherein an atrial length between the inferiormost surface of the peripheral ring and the superior end of the stent frame assembly is greater than 66% of the height between the inferior and superior ends of the stent frame assembly.

73. The method of any one of claims 69-72, wherein the height between the lower end and the upper end of the stent frame assembly is measured from a front side of the stent frame assembly.

74. The method of any one of claims 58-73, wherein the heart valve prosthesis device is configured to augment the native heart valve.

75. The method of any one of claims 58-74, wherein the stent frame assembly is implanted in the native heart valve annulus while preserving the native anterior heart valve leaflets.

76. The method of any one of claims 58-75, wherein the stent frame assembly is implanted in the native heart valve annulus without the native anterior heart valve leaflet having been resected or reshaped.

77. The method of any one of claims 58-76, wherein the stent frame assembly is implanted in the native heart valve annulus without substantially altering the anatomical position of the native anterior heart valve leaflet.

78. The method of any one of claims 58-77, wherein implanting the stent frame assembly in the native heart valve comprises positioning the stent frame assembly and a plurality of leaflets coupled to the stent frame assembly so as not to obstruct the native anterior leaflet of the heart valve from at least partially occupying the annulus of the native heart valve during ventricular contraction.

79. The method of claim 78, wherein each leaflet comprises a flexible membrane, and wherein the plurality of leaflets are configured to open in response to ventricular relaxation and to close in response to ventricular contraction when the prosthetic device is implanted in the native heart valve.

80. The method of claim 78 or 79, wherein the plurality of leaflets are configured to allow blood flow from the atrium to the ventricle and restrict blood flow from the ventricular chamber to the atrium chamber when the prosthetic device is implanted in the native heart valve.

81. The method of any one of claims 78-80, wherein the plurality of leaflets are configured to close against one another in response to blood flow from the ventricle chamber to the atrial chamber when the prosthetic device is implanted in the native heart valve.

82. A method according to any one of claims 78-81, wherein the multiple leaflets include an anterior leaflet, a first posterior leaflet, and a second posterior leaflet, and the anterior leaflet, the first posterior leaflet, and the second posterior leaflet each include a fixed edge and a free edge, and the fixed edge is coupled to the stent frame assembly.

83. The method of claim 82, wherein the anterior leaflet is larger than each of the first posterior leaflet and the second posterior leaflet.

84. The method of any one of claims 78-83, wherein the stent frame assembly comprises a plurality of ventricular posts comprising a first anterior post, a second anterior post, and a posterior post.

85. A method according to claim 84, wherein the fixed edge of the anterior leaflet is supported by the first anterior post and the second anterior post, and wherein the distance between the first anterior post and the second anterior post is greater than the distance between each anterior post and the posterior post.

86. The method of any one of claims 58-85, wherein the stent frame assembly comprises a stent frame and a covering disposed on the stent frame.

87. A method according to any one of claims 58-86, wherein the shape of the peripheral ring is designed to match the shape of the natural heart valve annulus when the heart valve prosthesis device is implanted in the natural heart valve so as to be assembled on the natural heart valve annulus.

88. The method of any one of claims 58-87, wherein the stent frame assembly has an anterior-posterior diameter and a horizontal diameter, the anterior-posterior diameter being smaller than the horizontal diameter.

89. The method of any one of claims 58-88, wherein the stent frame assembly has a front edge, a first rear edge, and a second rear edge, and wherein the first rear edge is one or more of: flatter or longer than each of the first rear edge and the second rear edge.

90. The method of any one of claims 58-89, wherein the leading edge, the first trailing edge, and the second trailing edge of the stent frame assembly are defined by the peripheral ring.

91. The method of any one of claims 58-90, wherein the stent framework assembly is non-circular.

92. The method of any one of claims 58-91, wherein the stent frame assembly is generally D-shaped.

93. The method of any one of claims 58-92, wherein the peripheral ring is non-circular.

94. The method of any one of claims 58-93, wherein the peripheral ring is generally D-shaped.

95. The method of any one of claims 58-94, wherein the peripheral ring is scalloped in the atrioventricular direction.

96. The method of any one of claims 58-95, wherein the peripheral edges of the stent framework assembly and the peripheral ring have the same shape.

97. The method of any one of claims 58-96, wherein the stent frame assembly comprises an asymmetric cylinder and a plurality of ventricular posts extending from the asymmetric cylinder.

98. The method of any one of claims 58-97, wherein the atrial end of the stent frame assembly is scalloped.

99. The method of any one of claims 58-98, wherein the ventricular end of the stent frame assembly is scalloped.

100. The method of any one of claims 58-99, wherein the peripheral ring is a suture ring.

101. The method of any one of claims 58-101, wherein the peripheral ring is flexible in the plane of the heart valve annulus.

102. The method of claim 101, wherein the peripheral ring is more flexible in the plane of the native heart valve annulus than in a plane transverse to the plane of the native heart valve annulus.

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