Prosthetic heart valves, systems and methods

Abstract

The prosthetic valve support structure herein includes a body portion, an atrial flange portion, and a leaflet attachment portion. As the support structure (and the valve as a whole) is pushed out of the delivery device or otherwise unconstrained, the free ends of the leaflet attachment portions begin to bend radially outward or away from the body portion, and continue to bend so as to become more exposed until the free ends are angled in the inflow direction, thereby positioning them between the radially outward side of the native valve leaflets and the outflow path beyond the native valve annulus. When the support structure is fully expanded, the native valve leaflets remain trapped or attached between the leaflet attachment portions and the body portion.

Description

[Background technology]

[0001] Related Applications This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 364,248, entitled, VALVES AND VALVE DOCKING SYSTEMS, filed on May 5, 2022, U.S. Provisional Application No. 63 / 366,001, entitled, HEART VALVES AND VALVE DOCKING SYSTEMS, filed on June 7, 2022, and U.S. Provisional Application No. 63 / 383,335, entitled, VALVES AND VALVE DOCKING SYSTEMS, filed on November 11, 2022, all of which are incorporated by reference in their entireties herein.

[0002] Heart valve disease is a common condition that affects millions of people worldwide. The heart has four valves that control blood flow by opening and closing during each heartbeat. If these valves become damaged or diseased, they may not function properly, leading to a variety of symptoms such as shortness of breath, fatigue, and chest pain. In severe cases, heart valve disease can lead to heart failure or sudden death.

[0003] Traditional treatment for heart valve disease involves surgically replacing the affected valve with an artificial valve. Although this procedure is effective, it is invasive and requires a significant recovery period. In addition, some patients may not be suitable candidates for surgery due to other health conditions.

[0004] In recent years, there has been interest in minimally invasive techniques for heart valve replacement, such as Transcatheter Aortic Valve Replacement (TAVR). This technique involves inserting a collapsible valve into the heart, typically through a catheter inserted into the femoral artery. The valve is then deployed into the damaged valve, replacing it and restoring normal blood flow.

[0005] More recently, there has been interest in using this technique for replacement of the mitral and tricuspid valves, known as Transcatheter Mitral Valve Replacement (TMVR) and Transcatheter Tricuspid Valve Replacement (TTVR), respectively. These valves are more complex than the aortic valve, and their replacement using traditional surgical techniques can be challenging. TMVR and TTVR offer a less invasive alternative for patients with mitral or tricuspid valve disease who may not be able to tolerate traditional surgical valve replacement.

[0006] TMVR and TTVR require specialized instruments that are designed to fit within the unique geometry of the mitral or tricuspid valve. These devices are typically made from biocompatible materials and are designed to be placed through a catheter, similar to a TAVR procedure.

[0007] Overall, TMVR and TTVR offer promising new options for patients with mitral or tricuspid valve disease who may not be able to tolerate traditional surgical valve replacement. As with any new medical technology, there are still many challenges to be addressed including device design, patient selection, and long-term outcomes. However, the potential benefits of these technologies make them an active area of ​​research and development in the cardiology field. SUMMARY OF THE INVENT

[0008] The prosthetic valve support structure herein includes a body portion, an atrial flange portion, and a leaflet attachment portion. As the support structure (and the valve as a whole) is pushed out of the delivery device or otherwise unconstrained, the free ends of the leaflet attachment portion begin to bend radially outward or away from the body portion, and continue to bend so as to become more exposed until their free ends are angled in the inflow direction, thereby positioning them between the radially outward side of the native valve leaflets and the outflow path beyond the native valve. When the support structure is fully expanded, the native valve leaflets remain trapped or attached between the leaflet attachment portion and the body portion.

[0009] In some aspects, the technology described herein relates to a prosthetic heart valve comprising: a body portion having a generally cylindrical shape; an atrial flange portion extending radially outward from an inflow end of the body portion and forming a plurality of petal shapes annularly surrounding the body portion; and a leaflet attachment portion including a plurality of attachment struts connected to an outflow end of the body portion and extending in an inflow direction along an exterior of the body portion. Includes.

[0010] In some aspects, the technology described herein relates to a prosthetic heart valve, the body portion including a plurality of extending vertical body struts axially alternating relative to each other.

[0011] In some aspects, the technology described herein relates to a prosthetic heart valve, the body portion comprising a plurality of horizontal body struts that form a "V" shape or angle and each connect two of a plurality of vertical body struts.

[0012] In some aspects, the technology described herein relates to a prosthetic heart valve, the body portion having an inclusion length of about 14 mm and about 18 mm and an inclusion diameter of about 27 mm and about 30 mm.

[0013] In some aspects, the technology described herein relates to a prosthetic heart valve, the atrial flange portion including a plurality of upper radial flange struts and a plurality of lower radial flange struts each extending from the body portion, the upper radial flange struts positioned further toward an in-flow end of the prosthetic heart valve than the lower radial flange struts.

[0014] In some aspects, the technology described herein relates to a prosthetic heart valve, wherein the atrial flange portion includes a plurality of radial flange struts, the upper portions of the radial flange struts being connected to the atrial flange portion and the lower portions of the radial flange struts being unconnected to the atrial flange portion and angled toward an outflow end of the prosthetic heart valve.

[0015] In some aspects, the technology described herein relates to a prosthetic heart valve, wherein the plurality of upper radial flange struts and the plurality of lower radial flange struts each have: a first angle within an inclusion region of about 90° and 130°, a relatively straight portion with a length within the inclusion region of about 3 mm and about 10 mm, a second angle within an inclusion region of about 20° and about 150°, and a terminal portion with a length within the inclusion region of about 1 mm and about 7 mm.

[0016] In some aspects, the technology described herein relates to a prosthetic heart valve in which outer ends of the plurality of upper radial flange struts and the plurality of lower radial flange struts are connected to one another via one of a plurality of circumferential radial struts that form a petal shape to accommodate differences in position between the plurality of upper radial flange struts and the plurality of lower radial flange struts.

[0017] In some aspects, the technology described herein relates to a prosthetic heart valve, the plurality of connecting struts forming a first curve that bends through about 180°, a first straight portion having a length within an inclusive range of about 3 mm and about 10 mm, a second curve that bends in the opposite direction within an inclusive range of about 90° and about 150°, and a rounded portion having a length within an inclusive range of about 2 mm and about 10 mm.

[0018] In some aspects, the technology described herein relates to a prosthetic heart valve, wherein end regions of the plurality of joining struts are axially positioned between the plurality of lower radial flange struts and the plurality of lower radial flange struts.

[0019] In some aspects, the technology described herein relates to a prosthetic heart valve wherein the end regions of the plurality of joining struts are positioned to axially overlap a plurality of lower radial flange struts at radially adjacent positions within an inclusive area of ​​about .1 mm and about 10 mm.

[0020] In some aspects, the technology described herein relates to a prosthetic heart valve, further comprising a material covering disposed over the framework, the material covering forming one or more triangular shaped gaps along an in-flow end of the body portion.

[0021] In some aspects, the technology described herein relates to a prosthetic heart valve: comprising a valve framework having an expanded configuration: a cylindrical body portion; a plurality of radial struts extending radially from a first end of the cylindrical body portion; and a plurality of joining struts connected near a second end of the cylindrical body portion and positioned along an outer side of the cylindrical body portion extending toward the first end, wherein end regions of the plurality of joining struts extend beyond at least some of the plurality of radial struts.

[0022] In some aspects, the technology described herein relates to a prosthetic heart valve: comprising a valve framework having a cylindrically shaped body portion and a leaflet attachment portion coupled to a distal region of the body portion; the leaflet attachment portion including a plurality of attachment struts extending distally from the body portion when the framework is in a compressed configuration within a delivery device, the plurality of attachment struts bending proximally rearwardly along the outside of the body portion when the framework is in an expanded configuration.

[0023] In some aspects, the technology described herein relates to a prosthetic heart valve, wherein the valve framework further includes a plurality of radial struts extending radially outward from a proximal region of the body portion.

[0024] In some aspects, the technology described herein relates to a prosthetic heart valve wherein end regions of the plurality of joining struts are positioned proximally beyond some of the plurality of radial struts.

[0025] In some aspects, the technology described herein relates to a prosthetic heart valve, wherein the plurality of radial struts includes a first set of radial struts and a second set of radial struts, the first set of radial struts positioned proximal to the second set of radial struts.

[0026] In some aspects, the technology described herein relates to a prosthetic heart valve wherein the end regions of the plurality of joining struts are positioned proximally beyond the first set of radial struts and distal to the second set of radial struts.

[0027] In some aspects, the technology described herein relates to a prosthetic heart valve, the plurality of connecting struts forming a first curve that bends through about 180°, a first straight portion having a length within an inclusive range of about 3 mm and about 10 mm, a second curve that bends in the opposite direction within an inclusive range of about 90° and about 150°, and a rounded portion having a length within an inclusive range of about 2 mm and about 10 mm.

[0028] In some aspects, the technology described herein relates to a method of delivering a prosthetic heart valve, comprising: advancing a delivery device including a prosthetic valve having a framework proximal to a native valve; exposing a distal end of the framework including a distal end of a cylindrical body portion and a plurality of leaflet attachment struts coupled near the distal end of the cylindrical body portion; allowing the leaflet attachment struts to bend toward the proximal end of the cylindrical body portion and position native leaflets of the native valve between the leaflet attachment struts and the cylindrical body portion; and completely releasing the remainder of the framework within the delivery device.

[0029] In some aspects, the technology described herein relates to a prosthetic heart valve having: a generally cylindrically shaped body portion; an atrial flange portion extending radially and annularly outward from an in-flow end of the body portion; and a leaflet attachment portion; the atrial valve flange portion and the leaflet attachment portion are configured to axially overlap one another at radially adjacent locations within a containment area of ​​about .1 mm and about 10 mm.

[0030] In some aspects, the technology described herein relates to a prosthetic heart valve including: a generally cylindrical body portion; an inner annulus sealing portion positioned radially outward of the body portion and including a plurality of struts configured to couple to the inside of a native valve annulus; and a leaflet attachment portion including a plurality of attachment struts connected at an outflow end of the body portion and extending in an inflow direction along the outside of the body portion.

[0031] In some aspects, the technology described herein relates to a prosthetic heart valve, further including an atrial flange portion extending radially outward from the in-flow end of the body portion; and the intra-annular seal portion extending distally from the atrial flange portion. [Brief description of the drawings]

[0032] These and other enabling aspects, features, and advantages of the embodiments of the present invention will become apparent and elucidated from the following detailed description of the embodiments of the present invention taken in conjunction with the accompanying drawings.

[0033] FIG. 1 is a perspective view of a prosthetic heart valve support structure.

[0034] FIG. 2 is a cross-sectional view of the prosthetic heart valve support structure of FIG.

[0035] FIG. 3 is a top view of the framework of the heart valve support structure of FIG.

[0036] 4 is a side view of the framework of the heart valve support structure of FIG. 1. FIG.

[0037] 5 is a side view of the framework of the heart valve support structure of FIG. 1. FIG.

[0038] 6 is a perspective view of the framework of the heart valve support structure of FIG. 1. FIG.

[0039] 7 is a perspective view of the framework of the heart valve support structure of FIG. 1. FIG.

[0040] FIG. 8 is a strut of the framework of the heart valve support structure of FIG.

[0041] FIG. 9 is a strut of the framework of the heart valve support structure of FIG.

[0042] FIG. 10 is a condensed view of the framework of the heart valve support structure of FIG.

[0043] FIG. 11 is a partially compressed view of the framework of the heart valve support structure of FIG.

[0044] FIG. 12 is a view of the prosthetic heart valve support structure framework of FIG. 1 after deployment.

[0045] FIG. 13 is a view of the framework of the prosthetic heart valve support structure of FIG. 1 within the native valve.

[0046] FIG. 14 is a view of the framework of the prosthetic heart valve support structure of FIG. 1 within the native valve.

[0047] FIG. 15 is a view of the framework of the prosthetic heart valve support structure of FIG. 1 within the native valve.

[0048] FIG. 16 is a perspective view of an artificial atrial valve.

[0049] FIG. 17 is a side view of the prosthetic atrial valve of FIG.

[0050] FIG. 18 is a side view of the prosthetic atrial valve of FIG.

[0051] FIG. 19 is an enlarged cross-sectional view of the prosthetic atrial valve of FIG.

[0052] FIG. 20 is an enlarged cross-sectional view of the prosthetic atrial valve of FIG.

[0053] FIG. 21 is an enlarged cross-sectional view of the prosthetic atrial valve of FIG.

[0054] FIG. 22 is an enlarged cross-sectional view of the prosthetic atrial valve of FIG.

[0055] FIG. 23 is a perspective view of a prosthetic heart valve.

[0056] FIG. 24 is a diagram of the prosthetic heart valve of FIG.

[0057] FIG. 25 is a side view of the prosthetic heart valve of FIG.

[0058] FIG. 26 is a bottom view of the prosthetic heart valve of FIG. 3.

[0059] 27 is a top view of the prosthetic heart valve of FIG. 23. FIG.

[0060] FIG. 28 is a cross-sectional view of the prosthetic heart valve of FIG.

[0061] FIG. 29 is a cross-sectional view of the prosthetic heart valve of FIG.

[0062] FIG. 30 is an enlarged view of the prosthetic heart valve of FIG.

[0063] FIG. 31 is an enlarged view of the prosthetic heart valve of FIG.

[0064] FIG. 32 is an enlarged view of the prosthetic heart valve of FIG.

[0065] FIG. 33 is an enlarged view of the prosthetic heart valve of FIG.

[0066] 34 is a perspective view of the framework of the prosthetic heart valve of FIG. 23. FIG.

[0067] 35 is a side view of the framework of the prosthetic heart valve of FIG. 23. FIG.

[0068] 36 is a side view of the framework of the prosthetic heart valve of FIG. 23. FIG.

[0069] 37 is a top view of the framework of the prosthetic heart valve of FIG. 3. FIG.

[0070] 38 is a bottom view of the framework of the prosthetic heart valve of FIG. 23. FIG.

[0071] FIG. 39 is an enlarged view of the framework of the prosthetic heart valve of FIG.

[0072] FIG. 40 is an enlarged view of the framework of the prosthetic heart valve of FIG.

[0073] FIG. 41 is an enlarged view of the framework of the prosthetic heart valve of FIG.

[0074] FIG. 42 is an enlarged view of the framework of the prosthetic heart valve of FIG.

[0075] FIG. 43 is an enlarged view of the framework of the prosthetic heart valve of FIG.

[0076] 44 is a cross-sectional view of the framework of the prosthetic heart valve of FIG.

[0077] FIG. 45 is a simplified diagrammatic view of some components of the prosthetic heart valve of FIG.

[0078] FIG. 46 is a diagram of the prosthetic heart valve of FIG. 23 with valve leaflets.

[0079] FIG. 47 is a side view of the prosthetic heart valve of FIG. 23 within a native heart valve.

[0080] FIG. 48 is a side view of the prosthetic heart valve 3.23 within the native heart valve.

[0081] Figure 49 is a side view of the prosthetic heart valve of Figure 23 within a native heart valve.

[0082] Specific embodiments of the present invention will now be described with reference to the accompanying drawings. The present invention may, however, be embodied in many other forms and should not be construed as being limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. The terminology used in the detailed description of the embodiments shown in the accompanying drawings is not intended to be limiting of the present invention. In the drawings, like numerals refer to like elements.

[0083] Although different embodiments may be described herein, it is specifically contemplated that any features of the different embodiments may be combined with each other in any combination. In other words, features of the different embodiments may be mixed and matched with each other. Thus, although all permutations of features from different embodiments are not explicitly set forth, the intent of this specification is to cover any such combinations.

[0084] This specification is generally directed to prosthetic or artificial heart valves, which can be used to replace any of the native heart valves (e.g., aortic, mitral, pulmonary, or tricuspid valves), however, the prosthetic heart valves herein are particularly useful for replacing the mitral or tricuspid valves.

[0085] Generally, the prosthetic heart valve of the present invention includes a support structure that supports prosthetic valve leaflets or similar features that generally allow blood to flow through the prosthetic heart valve in only one direction. This specification focuses in large part on the support structure aspects, and therefore not all of the drawings may disclose all of the prosthetic leaflets or similar structures therein. However, it should be understood that the use of leaflets and similar structures with support structures is specifically contemplated. In other words, while much of this disclosure may focus on the support structure aspects of the prosthetic valve, the prosthetic valve as a whole is specifically included as part of the present invention.

[0086] In referring to the prosthetic valves and support structures herein, the terms "apex end," "inflow end," and similar variations can be used interchangeably to mean the end of the device where blood normally first enters the valve / device. For example, in reference to the tricuspid valve, the end of the device is in or near the right atrium. The terms "bottom end," "outflow end," and similar variations can be used interchangeably to mean the end of the device where blood normally exits the valve / device. For example, in reference to the tricuspid valve, the end of the device is in or near the right ventricle. Additionally, the prosthetic valves and support structures herein, in the context of a delivery device / catheter, can be referred to as having a proximal end / portion and a distal end / portion. Typically, the term proximal refers to the portion or direction along the delivery device closer to the physician, and distal refers to the portion or direction along or away from the delivery device in a direction away from the physician. In some embodiments described herein, the top or inflow end of the support structure can also be the proximal end, and the bottom or outflow end of the support structure can also be the distal end.

[0087] Generally, some of the support structures of the prosthetic valves herein include a body portion, an atrial flange portion, and a leaflet attachment portion. These features can take on different shapes depending on whether the support structure is in a radially compressed configuration for deployment or a radially expanded configuration after deployment.

[0088] When the support structure is in its expanded configuration, the body portion can have a generally cylindrical shape with a passageway extending between an inflow end and an outflow end. Alternatively, the body portion can have a generally concave or convex or funnel shape, or can have an intermediate region with an increased or decreased diameter relative to the ends (e.g., an hourglass shape or a median bulge). Typically, artificial leaflets or similar valve structures are secured, mounted or connected within the passageway, such as in the middle or at either end of the passageway. These artificial leaflets or similar structures are sutured, adhesively bonded, or connected by similar means to the body portion.

[0089] In the expanded configuration of the support structure, the atrial flange portion is a flange, lip, protrusion, or overhang that forms a generally annular region that extends radially outward from the inflow end of the body portion. The atrial flange portion can assist in sealing around the inflow end of the device with the native valve annulus being replaced, thereby preventing blood from bypassing the passageway of the body portion. In that regard, it may be preferable for the atrial flange portion to conform to the shape of the valve annulus. The atrial flange can extend completely and continuously around the entire circumference of the body portion, or it can extend partially around the circumference of the body portion (e.g., two or more segments or multiple struts).

[0090] In the expanded configuration of the support structure, the atrial flange portion can be relatively flat or can have one or more curved surfaces. Additionally or alternatively, the flange can be generally perpendicular to the axis of the body portion, or can extend radially at angles between 0 and 180° relative to said axis. In one embodiment, the atrial flange has an initial angle of about 110° (±10°) slightly bent toward the annulus, and then bends upward (e.g., away from the annulus) to conform to the atrial wall. In some instances, it may be useful for the atrial flange to conform to the inflow surface of the apex or generally of the valve annulus (e.g., mitral or tricuspid annulus) as well as the surrounding atrial lateral wall. For this reason, depending on the length of the atrial flange, it may be useful for the end regions of the atrial flange to be curved or angled so that their ends face generally in the inflow direction similar to the right / left atrial walls (e.g., at a similar angle relative to the longitudinal axis of the body portion).

[0091] In the expanded configuration of the support structure, the leaflet attachment portion can be disposed radially around the outside of the body portion in a manner to capture the patient's native valve leaflets between the leaflet attachment portion of the support structure and the body portion. In one embodiment, the leaflet attachment portion can be a plurality of struts and / or a continuous radial member. The leaflet attachment portion can further be attached to the body portion at or near the outflow end of the body portion, and the support structure can extend to the inflow end of the body in its fully expanded configuration. The leaflet attachment portion can include one or more curved regions, such as a curved region near a free end of the leaflet attachment portion that curves radially outward to attach to the outflow surface of the native annulus of the native heart valve. Additionally or alternatively, the leaflet attachment portion can include one or more curves that position at least a portion of the leaflet attachment structure in proximity to or contact with the body portion to assist in pinching or attaching the native valve leaflets. Alternatively, the leaflet attachment portion can be separated from the body portion by a gap (e.g., uniform or non-uniform).

[0092] In the compressed configuration of the support structure, the body portion can be radially or diametrically compressed. The atrial flange can also be radially compressed and folded 1) in a proximal or inflow direction so that its free ends are positioned further away from the body portion, or 2) in a distal or outflow direction so that the atrial flange is pressed against the body portion. The leaflet attachment portion can be folded 1) in a distal or outflow direction so that its free ends are positioned further away from the body portion, or 2) in a proximal or inflow direction so that the leaflet attachment portion is pressed against the body portion.

[0093] In some embodiments, it may be useful to fold the leaflet attachment portion into its compressed shape distal to the delivery device such that its free ends are positioned away from the body portion. When the support structure (and the valve as a whole) is pushed out of the delivery device or otherwise unconstrained, the free ends of the leaflet attachment portion will escape and be exposed initially. As the free ends are further exposed, they will begin to bend radially outward or away from the body portion. If positioned beyond the native leaflets of the valve, the leaflet attachment portions that continue to bend further will be exposed until their free ends are angled in the inflow direction, thereby positioning them between the native valve leaflets and the outflow path beyond the native valve annulus. When the support structure is fully expanded, the native valve leaflets are left trapped or attached between the leaflet attachment portion and the body portion. This function can also be understood as a method of positioning the support structure.

[0094] In some embodiments, it may be helpful to configure the support structure such that in its expanded configuration, the ends of the leaflet attachment portion and the atrial flange portion each contact the native valve annulus (or nearby tissue) and thus pinch or attach to the respective sides. This helps provide a better seal to the atrial flange portion to prevent blood from bypassing the prosthetic valve or creating a perivalvular leak. This can also help retain the prosthetic valve in its desired position within the patient's heart.

[0095] In some embodiments, it may be useful to configure the support structure such that in its expanded configuration the end(s) of the leaflet attachment portion are located more proximally or further in the inflow direction than at least some radially adjacent locations of the atrial flange portion (e.g., struts). When viewed obliquely from the side, these locations overlap each other relative to the axial location of their ends. This may be particularly useful in two ways. First, this arrangement forces the leaflets and annulus to be located above the leaflet attachment portion and then below the flange (lower radial struts), forcing the leaflets / annulus into an alternating or wavy shape. Thus, the leaflet attachment portion and the atrial flange portion help pinch the leaflets / annulus, creating a paper clip effect. Second, this arrangement allows for keeping the material covering on the underside of the atrial flange portion stretched around the top of the leaflet attachment portion, providing good contact between the material covering and the leaflets / annulus to guide the tissue in sealing, healing, and growing.

[0096] The support structure can have different approaches to its construction. In one embodiment, the support structure comprises an underlying framework and a material covering disposed over or covering some or all of the framework.

[0097] The framework can be constructed of a shape memory material that can be given a particular shape and then returned to its original shape after being restrained. Examples of shape memory materials include Nitinol and similar alloys.

[0098] The framework can be comprised entirely of a single, unitary framework. For example, the framework can be made from a shape memory tube (e.g., Nitinol) that is laser cut and then heat set into its desired expanded shape. Alternatively, multiple shape memory struts / shapes can be welded or otherwise connected together and then the connected struts / shapes can be given the desired expanded shape.

[0099] The framework may also be comprised of separate components that are connected together by welding, suturing, gluing, or by each component being separately bonded to a material covering (i.e., a material covering interconnects the components). For example, the body portion, atrial flange portion, and leaflet attachment portion may all be separate components (e.g., welded together or connected via a material covering).

[0100] Several components of the framework can be constructed of different types and configurations of materials. For example, the body portion can be constructed of a plurality of woven shape memory wires, and the atrial flange portion and leaflet attachment portion can be constructed of non-woven shape memory struts / shapes (e.g., laser cut Nitinol components). In another embodiment, the body portion and leaflet attachment portion can be constructed of non-woven shape memory struts / shapes (e.g., laser cut Nitinol components), and the atrial flange portion can be constructed of a flexible polymer or similar material (e.g., silicone, PET, EPTFE, etc.).

[0101] The framework can have different thicknesses in different regions (i.e., different lengths, widths, as well as the thickness of the framework material itself). For example, the atrial flange portion can have a greater thickness than the body portion. In another embodiment, the leaflet attachment portion can have a greater thickness than the body portion.

[0102] Certain components of the framework can be comprised of extended arms or struts with no material covering disposed thereon. For example, the leaflet attachment portion can be comprised of multiple struts disposed and connected at circumferential positions around the body portion. These positions can be either uniformly spaced or non-uniformly spaced in certain areas only. However, these arms or struts can have coatings and / or caps at their distal ends. For example, the arms or struts can have end caps on the free ends of the arms / struts that are comprised of flexible coatings and flexible materials that frictionally bond with the leaflets to help minimize tissue damage during placement and long-term implantation. Such coatings / caps can be comprised of tissue surrounding the heart, EPTFE, fibrous materials, PET, polyurethane, silicone and similar materials. The extended arms or struts can all have the same length or can have different lengths, alternating between longer and shorter lengths.

[0103] The material covering is coupled to or otherwise disposed on some or all of the framework. Additionally or alternatively, the material covering can be disposed only on the inside of the framework, only on the outside of the framework, or both on the inside and outside of the framework. In one embodiment, the material covering is positioned over the body portion and the atrial flange portion but not over the leaflet attachment portion. In another embodiment, the material covering is positioned only over the atrial flange portion. In another embodiment, the material covering is positioned only over the body portion. Additionally or alternatively, the material can form openings or other shapes (e.g., triangular ends) for the framework.

[0104] The material covering can be constructed of a biocompatible, flexible material. The material covering can be a solid, non-porous sheet (e.g., a polymer sheet) or a woven fabric. Exemplary materials include fibrous materials, EPTFE sheets, PET sheets, silicone, polyurethane, similar materials or derivatives thereof. The material covering can also be configured to promote tissue growth in at least some areas.

[0105] The valve leaflets are coupled to the body portion, such as near the center or near either end of the body portion. Generally, the valve leaflets are configured to open to allow blood flow from an inflow end (e.g., left / right atrium) and remain closed against blood pressure from an outflow end (e.g., left / right ventricle). The valve component may include one, two or three leaflets. The valve leaflets may be individually attached to the support structure or all attached together in a valve assembly that is subsequently attached to the support structure. The valve leaflets may be attached to the body portion in a normally open or normally closed position. The shape of the valve leaflets is such that the leaflets assume a natural tip-like shape similar to the native aortic valve or similar valve. The material covering of the body structure along with this shape may create a curve-like shape similar to the curvature of the valve that allows favorable flow conditions and beneficial blood flow to flush out stagnant sites and prevent clot formation. The valve leaflets may be attached to the valve body in a configuration that allows for an amount of overlap or coaptation at the free ends with an area of ​​0-20 mm. In the coaptation of the valve leaflets, there may be an intentional gap to allow a small amount of blood to leak through the valve to not overpressure the heart after it is replaced by a new valve. The valve leaflets may be composed of artificial or natural biological materials. The valve leaflets can be treated using anti-calcification and tissue fixation treatments to prevent the body from expelling the implanted device and also to prevent calcification of the leaflets. The tissue can be treated under conditions that allow the valve prosthesis to be stored and sterilized in glutaraldehyde or other sterilization means such as ETO followed by desiccation. The tissue can also be treated or coated with anti-thrombogenic chemicals or coatings.

[0106] The support structure may also include features that allow coupling to a delivery device to aid in placement of the support structure. Additionally or alternatively, features include allowing the support structure to be recaptured after being at least partially deployed from the delivery device. For example, the support structure may include one or more apertures or extensions, such as on its framework, that are releasably coupled to portions of the delivery device. The apertures or extensions may be included at or near the proximal or inflow end of the support structure when in its compressed configuration. For example, the apertures or extensions may be located at an end location of the atrial flange portion and / or at a location near the end of the body portion. The delivery device may include a breakable thread passing through / around the aperture / extension, a recess in the inner pusher that captures the aperture / extension, a hook, post, loop, stent-like mesh, or similar mechanism to allow the physician to advance, withdraw, and / or release the support structure from the delivery device.

[0107] Any of the support structures herein can be delivered from one of several known heart valve delivery devices, such as those in U.S. Patent Publication Nos. 2017 / 0165064, 2019 / 0008640, and 2022 / 0287836, the contents of which are incorporated herein by reference.

[0108] 1-13 illustrate various aspects of one embodiment of a prosthetic valve support structure 100 in its expanded configuration. As best seen in FIGs. 1 and 2, the support structure 100 generally includes a body portion 110, an atrial flange portion 106, and a leaflet attachment portion 108.

[0109] In this embodiment, body portion 110 has a generally cylindrical shape, although other shapes are possible, such as an hourglass shape, a cone shape, a concave shape, or a convex shape.

[0110] In this embodiment, the atrial flange portion 106 extends radially outward from the top or inflow end of the body portion 110. The atrial flange portion 106 can form a complete circular or annular shape beyond that of the body portion 110, although it can alternatively have other shapes, such as an elliptical shape, and can extend only around a portion of the circumference of the body portion 110 (e.g., flange regions only on opposite sides of each other).

[0111] In this embodiment, the atrial flange 106 can have at least two regions with different angles relative to each other, best seen in the cross-sectional view of FIG. 2. The first region initially extends radially away from the in-flow end of the body portion 110. Relative to an axis extending through the inner passage of the support structure, the first region has an angle within the inclusion range of about 70° and 140° (e.g., about 110°). The second region extends radially from the first region and has an angle within the inclusion range of about 120° and 170° (e.g., about 160°). Generally, these two regions of the atrial flange portion 106 can help it to fit into other regions of the atrium and into the apex / in-flow surface of the native valve annulus.

[0112] In this embodiment, the leaflet attachment portion 108 may include a plurality of attachment struts 114 connected at an outflow end of the body portion 110 and extending in an inflow or upward direction. As will be described in more detail below, the attachment struts 114 bend toward the body portion 110 and then away from the body portion 110, terminating at a cap member 120. The initial curve toward the body portion 110 aids in pinching or attaching the native leaflet to the body portion 110. The cap 120 may include a compliant or relatively softer material (e.g., pericardial tissue, EPTFE, PET, fibrous material, silicone, polyurethane, or similar material) to help prevent damage to the patient's heart tissue. The cap may be glued or otherwise attached to the very distal ends of the attachment struts 114.

[0113] In this embodiment, joining struts 114 are positioned at equal distances from one another around the circumference of body portion 110. Again, non-uniform placement of these struts 114 is also possible, such as only on opposite sides of body portion 110, or in a placement that may help avoid tendons within the ventricle.

[0114] The support structure 100 in this embodiment includes a rigid framework 102 and a material covering 104 disposed over portions of the framework 102. The material covering 104 is positioned surrounding all or the outermost of the body portion 110 of the framework 102, the outer side of the atrial flange portion 106 of the framework 102, and the inner side of the atrial flange portion 106 of the framework 102. The connecting struts 114 are left generally uncovered by the material covering 104. As previously mentioned, other variations are also possible, such as having material covering only on the inner side, only on the outer side, and / or on any combination of the portions 106, 108, 110.

[0115] In this embodiment, the material covering 104 may be attached by adhesives, sutures, combinations thereof, and similar mechanisms. The material covering 104 may be comprised of fabric materials, EPTFE sheets, PET sheets, and similar materials as discussed elsewhere herein. In addition to the material covering 104, an additional material, such as a hydrogel, may be included on the underside of the atrial flange 106 to help create a better seal with the native valve annulus.

[0116] 3-9 illustrate various aspects of the framework 102 in this embodiment. The body portion 110 of the framework 102 is comprised of a number of extending vertical body struts 116B and a number of horizontal body struts 116A. The vertical body struts 116B are generally parallel to an axis through the passageway of the support structure (i.e., from the inflow end to the outflow end), while the horizontal body struts 116A are arranged around this axis in an annular configuration.

[0117] The vertical body struts 116A can form a "V" shape or a relatively sharp angle pointing in the outflow direction, although the opposite direction is also possible. Each end of the horizontal body struts 116A connects to a vertical body strut 116B. The "V" shape of the horizontal body struts 116A provides a bending point at the apex of the "V" to increase or decrease the angle depending on whether the support structure 100 is in its compressed or expanded configuration. In other words, the "V" shape facilitates this radial compression and expansion. Alternatively, other shapes with angles in them, such as a "W" shape with two or more angles, are also possible for the horizontal body structure 116A. In this embodiment, there are two rows of horizontal body struts 116A, although more rows are possible.

[0118] In one embodiment, the body portion 110 of the framework 102 has a length within its containment region of about 14 mm to about 18 mm, and a diameter within its containment region of about 27 mm to about 30 mm.

[0119] The atrial flange portion 106 of the framework 102 includes a plurality of flange struts 112. The shape of these flange struts 112 can best be seen in FIG. 8. Each flange strut 112 extends from one of the vertical body struts 116B and forms a first angle 112A within a range of inclusion between about 90° and 130°, a relatively straight portion 112B with a length within a range of inclusion between about 3 mm and about 10 mm, a second angle 112C within a range of inclusion between about 20° and about 150°, and a terminal portion 112D with a length within a range of inclusion between about 1 mm and 7 mm (again, the angles are with respect to an axis disposed inflow / outflow of the support structure 100). Generally the specific angles and sizes may vary somewhat depending on the patient's heart and valve size.

[0120] The leaflet connecting portion 108 of the framework 102 includes a plurality of connecting struts 114, the shape of which can be best seen in FIG. 9. The leaflet connecting struts 114 are connected to the outflow ends of the vertical body struts 116B. From the vertical body struts 116B, the connecting struts form a first curve 114E that bends around and bends over 180° (e.g., an inclusion area of ​​about 150° and about 230°), a first straight portion 114D with a length within the inclusion area of ​​about 3 mm and about 10 mm, a second curve 114C that bends in the opposite direction to the curve 114D with a length within the inclusion area of ​​about 90° and about 150°, a second straight portion 114B with a length within the inclusion area of ​​about 2 mm and about 10 mm, and a final third curve 114A in the same direction as the second curve 114C with a length within the inclusion area of ​​about 60° and about 150°. These curves all generally occur in the same plane, although additional curves that take some of the joining struts 114 outside of a single plane are possible (ie, bending in multiple dimensions).

[0121] As previously discussed, the joining struts 114 in this embodiment are not covered by a material covering 104, but need not be. Additionally, the joining struts 114 may be covered or wrapped with a relatively flexible material (e.g., a fabric or EPTFE sheet layer). Additionally, the ends of the joining struts may include cap members 120 constructed of materials similar to those described herein or other materials.

[0122] The framework 102 of this embodiment may be comprised of a single, integral body laser cut from a shape memory tube (e.g., Nitinol tubing). Alternatively, one or more struts of the framework may be welded or otherwise attached to one another. Alternatively, some of the components may be separate from one another and only connected by other materials, such as material coverings 104 or other attachment mechanisms. For example, the body portion 110, leaflet attachment portion 108, and / or atrial flange portion 106 are not directly attachable to one another in any combination. If a shape memory material is used for the framework 102, the framework may be cut into the desired pattern and then heat set to impart the desired shape in its expanded configuration.

[0123] 10-12 illustrate how the support structure 100 can be deployed from the delivery catheter 50. In FIG. 10, the support structure 100 is shown mostly within the delivery catheter 50 (note that for clarity only, only the framework 102 is shown in this drawing). As the support structure 100 attempts to be pushed out, the free ends of the joining struts 114 begin to expand radially outward.

[0124] 11 , the support structure 100 is moved further distally outwardly of the delivery catheter 50. The distal or outflow end of the body portion 110 expands radially and the attachment struts 114 of the leaflet attachment portions 108 exit the delivery catheter 50 completely and evert themselves so that their free ends are now positioned toward the proximal or inflow end of the body portion 110.

[0125] In Fig. 12, the support structure is fully deployed into its expanded shape. Fig. 13 illustrates the expanded shape within the tricuspid valve 14. As can be seen, the connecting struts 114 are disposed around the leaflets 14B to capture the leaflets 14B against the body portion 110. Additionally, the bottom of the atrial flange portion 106 can be seen to contact and connect to the top portion of the valve annulus 14A, while the angled free ends of the connecting struts connect to the bottom portion of the valve annulus 14A. Thus, the support structure 100 better connects to the annulus 14A and holds the valve leaflets 14B out of the way.

[0126] FIG. 14 illustrates one approach for delivering a support structure 100 into the tricuspid valve 14 of the heart 10 by advancing a delivery catheter through the inferior vena cava 16 and into the right atrium 18, where the support structure is delivered from the inflow or atrial end to the tricuspid valve 14.

[0127] 15 illustrates another approach for delivering a support structure 100 to the mitral valve 12 by performing a transseptal procedure to allow a delivery catheter to pass through the septum between the right atrium 18 and the left atrium 20. This allows the support structure to be delivered to the mitral valve 12 from the relative inflow or atrial end.

[0128] Additional approaches to delivering the support structure 100 are also possible. For example, either of the valves 14, 20 may be approached from its respective ventricle (22, 24). In such a case, the support structure would be positioned in the opposite orientation as shown in Figures 10-12.

[0129] 16-22 show an embodiment of a framework 130 that is otherwise similar to the previously described framework 102. However, the framework 130 further includes a strut 132 that connects two adjacent flange struts 112 to form a downwardly directed "V" shape at the outflow end of the framework 130. This strut 132 can be considered part of the atrial flange portion 106, and it can be placed within the valve annulus while a portion of the flange strut 112 remains on the cranial or atrial face of the native valve annulus. Thus, the atrial flange portion 106 of this embodiment can be further considered to have an apex sealing portion (i.e., flange strut 112) and an inner annulus bonding / sealing portion (strut 132). In that way, the framework 130 can better seal the framework / valve to prevent blood leakage around the framework / valve.

[0130] As can be best seen in FIG. 20, the struts 132 initially extend relatively horizontally from the flange struts 112 and then form a first angle 132A toward the outflow end of the framework 130, which may be within the inclusive range of about 135° and about 180°. The struts 132 may further have a straight region 132B having a length within the inclusive range of about 3 mm and about 10 mm. Finally, the struts 132 form an intermediate angle 132C opposite the first angle 132A, within the inclusive range of about 90° and about 120°. The straight region 132B and the angle 132A repeat symmetrically on the opposite side of the intermediate angle 132C, thereby creating a generally "V" shape between each two flange struts 112.

[0131] 21, the "V" shaped struts 132 can be further angled generally straight / parallel to the axis of the framework 130, or angled such that the tip or angle 132C of the "V" shape is positioned somewhat closer to the body portion 110. In other words, the struts 132 are angled radially inward toward the outflow end of the framework. This can help the "V" shape of the struts 132 fit and interface within the native valve annulus. In one embodiment, the struts 132 are angled radially inward within a range between about 0° and about 30°.

[0132] 23-33 illustrate various aspects of another embodiment of a support structure 150 that is generally similar to the previously described support structure 100, but includes several notable differences that are discussed further below. As can be best seen in FIG. 18, the support structure 150 generally includes a body portion 110, an atrial flange portion 106, and a leaflet attachment portion 108.

[0133] In this embodiment, body portion 160 has a generally cylindrical shape, although other shapes are possible, such as an hourglass shape, a cone shape, a convex shape, or a concave shape.

[0134] In this embodiment, the atrial flange portion 156 extends radially outward from the apex or inflow end of the body portion 160. The atrial flange portion 156 can form a complete circular or ring shape beyond that of the body portion 160, although it can alternatively have other shapes, such as an oval, and can only extend to encircle a portion of the circumference of the body portion 160 (e.g., the flange region on only opposite sides). As can be best seen in FIG. 23, the atrial flange portion 156 can also form a generally multiple petal, pointed, or outwardly tapering pointed shape in which the width of each of these regions decreases with increasing distance from the body portion 160.

[0135] In this embodiment, the atrial flange 156 can have at least two regions with different angles from each other, which can be best seen in the cross-sectional view of FIG. 22. The first region initially extends radially away from the in-flow end of the body portion 160. Relative to an axis extending through the inner passage of the support structure, the first region has an angle within the inclusive range of about 70° and 140° (e.g., 120°). The second region extends radially from the first region and has an angle within the inclusive range of 150° and 220° (e.g., about 200°). In general, these two regions of the atrial flange portion 156 help it conform to the apex / in-flow surface of the native valve annulus in addition to other regions of the atrium or leaflets / annulus.

[0136] In this embodiment, leaflet attachment portion 158 can include a plurality of attachment struts 164 connected at the outflow end of body portion 160 and extending in an inflow or upward direction. As will be described in more detail below, attachment struts 164 are generally parallel to body portion 160 and then curve away from body portion 160, terminating at extension 164A (FIG. 23). The initial curve toward body portion 160 can aid in attaching or capturing the native leaflet at body portion 160. Extension 164A can be generally rounded to prevent damage to the patient's valve tissue, and can further include one or more apertures that can optionally be used to releasably attach to support structure 150 via delivery catheter 50.

[0137] In this embodiment, joining struts 164 are positioned equidistant from one another around the circumference of body portion 160. Again, non-uniform positioning of these struts 164 is also possible, such as only on opposite sides of body portion 160 or in positions that avoid tendons within the ventricle.

[0138] The support structure 150 in this embodiment includes a rigid framework 152 and a material covering 154 disposed over portions of the framework 152. The material covering 154 is positioned to cover all or most of the inner and outer sides of the body portion 160 of the framework 152 (as best seen in FIGS. 28 and 29 ), and to cover the outer side of the atrial flange portion 156 of the framework 152. The connecting struts 164 are generally left uncovered by the material covering 154. As previously discussed, other variations of the material covering 154 are possible, such as only on the inner side, only on the outer side, and / or on any combination of portions 156, 158, 160.

[0139] 28 and 29, the material covering 154 on the outflow end of the body portion 160 can form petals, pointed regions, or triangular regions 154A that generally conform to the shape of the underside of the framework 152 of the body portion 160. Alternatively, the outflow end of the body portion 160 can have a uniform circular edge.

[0140] Similarly, the end of the material covering 154 at the inflow end of the body portion 160 may include one or more inward penetrations or triangular gaps, spaces, or grooves 154B. Although the triangular regions 154A are shown immediately adjacent to one another, the grooves 154B may be less frequent between the relatively uniform end regions. However, the inflow or outflow ends may take on any of the disclosed patterns in any combination other than having completely uniform and perpendicular ends. Also, as shown in FIG. 23, the material covering 154C may also conform to the triangular or pointed petal shape of the atrial flange portion 156.

[0141] In this embodiment, the material covering 154 may be attached by adhesives, sutures, combinations thereof, and similar mechanisms. The material covering 154 may be comprised of fabric materials, EPTFE sheets, PET sheets, and similar materials discussed elsewhere herein. In addition to the material covering 154, an additional material, such as a hydrogel, may be included under the atrial flange portion 156 to help create a better seal with the native valve annulus.

[0142] Figures 34-44 illustrate various aspects of the framework 152 in this embodiment. The body portion 160 of the framework 152 is comprised of a plurality of extending vertical body struts 166B and a plurality of horizontal body struts 166A (best seen in cross section in Figure 37). The vertical body struts 166B are generally parallel to an axis passing through the passageway of the support structure (i.e., the axis from the inflow end to the outflow end), while the horizontal body struts 166A are arranged about this axis in a circular configuration.

[0143] The vertical body struts 166B may alternate between different heights or axial positions such that a first vertical body strut 166B is positioned in the inflow direction relative to a first axial position, two vertical body struts 166B adjacent to the first one, and two further adjacent ones. Thus, the vertical body struts 166B may form an alternating pattern.

[0144] The horizontal body struts 166A can have a "V" shape or a shape that points in the outflow direction at a relatively sharp angle, although the opposite direction is also possible. Each end of the horizontal body struts 166A connects to a vertical body strut 166B with the vertical body strut 166B passing directly through the center of the "V". The "V" shape of the horizontal body struts 166A provides a bending point at the apex of the "V" shape to increase or decrease its angle depending on whether the support structure 150 is in its compressed or expanded shape. In other words, the "V" shape allows for its radial compression and expansion. Alternatively, other shapes are also possible for the horizontal body structures 166A, such as a "W" shape with two or more angles in their angles. In this embodiment, there are two rows of horizontal body struts 166A, but more rows are possible.

[0145] In one embodiment, the body portion 160 of the framework 152 has a length within the containment region of about 14 mm to about 18 mm, and a diameter within the containment region of about 27 mm to about 30 mm.

[0146] The atrial flange portion 156 of the framework 152 includes a plurality of flange struts 162. These flange struts 162 are best seen in FIGS. 38-46. The atrial flange portion 156 alternates with upper radial struts 162C and lower radial struts 162D. Both struts 162C, 162D each extend from a vertical body strut 166B. Both struts 162C, 162D may have a similar shape / size / curvature, but due to the higher and lower position of the vertical body strut 166B (due to the "V" shape / position of the horizontal body strut 166A), the upper radial strut 162C is generally higher (i.e., further in the inflow direction) than the lower radial strut 162D. In this embodiment, the aperture portion 166C is disposed adjacent to the vertical body strut 166A and the upper radial strut 162. This aperture portion 166C is optionally included for use with delivery catheter 50.

[0147] As shown in FIG. 33, each upper radial flange strut 162C forms a relatively straight portion 162F having a first angle 162E within the range of inclusion between about 90° and about 130°, a length within the range of inclusion between about 3 mm and about 10 mm, a second angle 162G within the range of inclusion between about 20° and about 150°, and a terminal portion 162A having a length within the range of inclusion between about 1 mm and about 7 mm (again, the angles are relative to an axis oriented toward the inflow / outflow of the support structure 150). In general, the specific angles and sizes may vary somewhat depending on the size of the patient's heart and valve. The terminal portion 162A may optionally include an aperture that is used by the delivery catheter 50 to help releasably hold the support structure 150 during deployment.

[0148] As shown in FIG. 40, each lower radial flange strut 162D forms a relatively straight portion 1621 having a first angle 162H within the inclusion range of about 90° and 150°, a length within the inclusion range of about 0 mm and about 5 mm, a second angle 162J within the inclusion range of about 0° and about 60°, and a terminal portion 162K having a length within the inclusion range of about 1 mm and about 7 mm (again, the angles are relative to an axis oriented toward the inflow / outflow of the support structure 150). In general, the specific angles and sizes may vary somewhat depending on the size of the patient's heart and valve. The terminal portion 162K may optionally include an aperture used by the delivery catheter 50 to help releasably hold the support structure 150 during deployment.

[0149] The radially outer ends of each of the upper and lower radial struts 162C, 162D are connected to one another via one of a number of circumferential radial struts 162B. Because the upper and lower radial struts 162C, 162D are positioned at different heights and distances from one another, the circumferential radial struts 162B tend to form a relative triangular or petal shape that terminates at the end portions 162A. This allows the circumferential radial struts 162B to bend in several dimensions to accommodate the difference in position of the upper and lower radial struts 162C, 162D.

[0150] The leaflet connecting portion 158 of the framework 152 includes a plurality of connecting struts 164, the shape of which can be best seen in FIG. Typically, the joining strut 164 has a straight portion 164B that is parallel to an axis through the passage of the support structure (i.e., from the inflow end to the outflow end). In other words, the joining strut 164 is not angled toward the body portion 160 as in the previous support structure 100, although such a shape is possible. The joining strut 164 is connected to the outflow end of the vertical body strut 166B. From the vertical body strut 166B, the joining strut 164 forms a first curve 164C that encompasses about 180° (e.g., an inclusive range of about 150° and about 230°), a first straight portion 164B that has a length within an inclusive range of about 3 mm and about 10 mm, a second curve 164D that curves in the opposite direction to the curve 164C within an inclusive range of about 90° and about 150°, and a rounded portion 164A that has a length within an inclusive range of about 2 mm and about 10 mm. These curves all generally occur in the same plane, but can include additional curves that may take some of the joining struts 114 outside of a single plane (i.e., curves in multiple dimensions). Rounded portion 164A can optionally include an aperture used by delivery catheter 50 to releasably hold support structure 150 during deployment.

[0151] As previously discussed, the joining struts 164 are not covered by the material covering 154 in this embodiment, but may be. Additionally, the joining struts 164 may be covered or wrapped with a relatively more flexible material (e.g., a fabric or EPTFE layer). Further, the rounded portions 164A of the joining struts 164 may include a coating composed of materials similar to those described herein or other materials.

[0152] One aspect of the support structure 150 and framework 152 that is of particular note is the position of the atrial flange 156 relative to the joining struts 164, as best seen in the simplified line drawing of FIG. 45 as well as FIG. 39. In this expanded configuration, the end portions of the joining struts 164 (i.e., portions of the leaflet joining portion) are positioned in a more proximal or further inflow position than the radially adjacent portions of the lower radial struts 162D of the atrial flange portion 156. In other words, the lower radial struts 162D on each side of each joining strut 164 bend axially in the distal / outflow direction beyond the end portions of the joining struts 164. In one embodiment, the axially adjacent overlap is within a containment area of ​​about .1 mm and about 10 mm.

[0153] This arrangement may be particularly useful in several ways. First, it places the leaflets / annulus in an alternating or wave-like shape in an attempt to position the leaflets and native valve annulus above the connecting struts 164 and then below the lower radial struts 162D. Thus, the leaflet connecting portion 158 (i.e., connecting struts 164) and the atrial flange portion 156 (i.e., lower radial struts 162D) tend to pinch the leaflets / annulus, creating a perforated clip effect. This design allows for reduced regurgitation and positive redesign of the ventricle (e.g., reduction in size of any dilation) as the body conforms to the previously incompetent native valve. While some other prosthetic replacement valves may be relatively large plug-like designs and rely on radial forces to anchor and seal, the top-down approach of the present invention to seal the annulus may allow for better repair of the ventricle over the long term and allow for diameter reduction without interference from the original replacement valve.

[0154] Second, this arrangement can keep the material covering on the underside of the atrial flange portion taut around the top of the leaflet attachment portion, allowing for good contact between the material covering and the leaflets / annulus, guiding the tissue to seal, heal, and grow.

[0155] Third, portions of the lower radial struts 162D (i.e., portions near the outflow end of the framework 152, such as 162H) can be positioned within the annulus of the native valve. Because portions of the lower radial struts 162D can bend radially outward, this shape further helps seal the framework 152 with the native annulus and further restricts the passage of blood around the framework / valve.

[0156] The framework 152 of the present invention can be comprised of a single, integral body, such as laser cut from a shape memory tube. Alternatively, one or more struts of the framework can be welded or otherwise attached to one another. Alternatively, some of the components can be separate from one another and connected only by other materials, such as material coatings 154 or other attachment mechanisms. For example, the body portion 160, leaflet attachment portion 158 and / or atrial flange portion 156 may not be directly attached to one another in any combination. If a trend memory material is used for the framework 152, the framework can be cut into the desired pattern and then heat set to impart the desired shape in its expanded configuration.

[0157] The support structure 150 can be deployed from the delivery catheter 50 in the same manner as described for the support structure 100 in FIGS. 10-12. At that point, the joining struts 164 begin in a compressed configuration with their ends (rounded extensions 164A) positioned distally away from the body portion 160 within the delivery catheter 50. As the support structure 150 is pushed out or the outer sheath is withdrawn from the support structure 150, the joining struts 164 expand radially outward from the delivery catheter 50, and then as the support structure 150 continues to advance or become exposed, the joining struts 164 bend backwards so that the rounded, extended ends 164A are positioned in the inflow direction relative to the outflow end of the body portion 160. In other words, as deployment occurs, the joining struts 164 bend radially backwards or opposite, which allows them to capture the native valve leaflets 14B with the body portion 160 and press against the valve annulus, as shown in FIG.

[0158] It should be noted that in the compressed configuration within the delivery catheter 50, the apertured end portion 162A can be located at the proximal end of the compressed support structure 150, while the connecting struts 164 are distally constrained such that the rounded portion 164A is at the most distal location within the delivery device 50. In this regard, apertures are located at both the proximal and distal ends of the support structure 150 in its compressed configuration. Additionally, the aperture portion 166C also includes a central aperture along the length of the compressed configuration. These apertures are connected to features such as posts, hooks, tethers, or similar structures that help hold the portions of the support structure 150 in place until the delivery device 50 150 is fully deployed.

[0159] As previously discussed, support structures 100 and 150 have been primarily described herein, however, it is specifically envisioned that a valve mechanism 170, such as an artificial or biological valve leaflet, as shown in FIG. 46, is mounted within the valve support mechanism.

[0160] FIG. 48 illustrates one approach to delivering the support structure 150 within the tricuspid valve 14 by advancing a delivery catheter through the inferior vena cava 16 into the right atrium 18, where the support structure 150 is delivered to the inflow or atrial end relative to the tricuspid valve 14.

[0161] FIG. 49 illustrates another approach for delivering a support structure 150 to the mitral valve 12 by performing a transseptal procedure that allows a delivery catheter to be passed through the septum between the right atrium 18 and the left atrium 20. This allows the support structure 150 to be delivered relative to the mitral valve 12 from the inflow or atrial end.

[0162] Additional approaches for delivering the support structure 150 are also possible. For example, either of the valves 14, 20 can be approached from its respective ventricle. In such a case, the support structures are positioned in opposite orientations as shown in Figures 10-12.

[0163] Any of the support structures herein, including support structures 100 and 150, can be delivered from one of several known heart valve delivery devices, such as those in U.S. Patent Publication Nos. 2017 / 0165064, 2019 / 0008640, and 2022 / 0287836, the contents of which are incorporated herein by reference.

[0164] Although the present invention has been described in terms of specific embodiments and applications, those skilled in the art can, in light of the present teachings, generate additional embodiments and modifications without departing from the spirit or scope of the invention as set forth in the claims. Therefore, the drawings and descriptions in this specification should be understood as being provided by way of example to facilitate the completeness of the present invention, and should not be construed as limiting its scope.

Claims

1. 1. A prosthetic heart valve comprising: a body portion having a generally cylindrical shape; an atrial flange portion extending radially outward from the inflow end of the body portion and forming a plurality of petal shapes annularly surrounding the body portion; a leaflet attachment portion including a plurality of attachment struts connected to an outflow end of the body portion and extending in an inflow direction along an exterior of the body portion; 2. An artificial heart valve comprising:

2. 10. The prosthetic heart valve of claim 1, wherein said body portion includes a plurality of extending vertical body struts axially alternating relative to each other.

3. 3. The prosthetic heart valve of claim 2, wherein the body portion comprises a plurality of horizontal body struts that form a "V" shape or angle and each connect two of the plurality of vertical body struts.

4. 4. The prosthetic heart valve of claim 3, wherein the body portion has a length within the containment region between about 14 mm and about 18 mm and a diameter within the containment region between about 27 mm and about 30 mm.

5. 2. The prosthetic heart valve of claim 1, wherein the atrial flange portion includes a plurality of upper radial flange struts and a plurality of lower radial flange struts each extending from the body portion, the upper radial flange struts positioned further toward an in-flow end of the prosthetic heart valve than the lower radial flange struts.

6. 2. The prosthetic heart valve of claim 1, wherein the atrial flange portion includes a plurality of radial flange struts, the upper portions of the radial flange struts being connected to the atrial flange portion and the lower portions of the radial flange struts being free from connection to the atrial flange portion and angled toward an outflow end of the prosthetic heart valve.

7. 6. The prosthetic heart valve of claim 5, wherein the plurality of upper radial flange struts and the plurality of lower radial flange struts each have: a first angle within an inclusion range of about 90° and 130°, a relatively straight portion with a length within an inclusion range of about 3 mm and about 10 mm, a second angle within an inclusion range of about 20° and about 150°, and a terminal portion with a length within an inclusion range of about 1 mm and about 7 mm.

8. 7. The prosthetic heart valve of claim 6, wherein outer ends of the upper and lower radial flange struts are connected to one another via one of a plurality of circumferential radial struts that form a petal shape to accommodate differences in position between the upper and lower radial flange struts.

9. 2. The prosthetic heart valve of claim 1, wherein the plurality of joining struts form a first curve that bends through about 180 degrees, a first straight portion having a length within an inclusive range of about 3 mm and about 10 mm, a second curve that bends in the opposite direction within an inclusive range of about 90 degrees and about 150 degrees, and a rounded portion having a length within an inclusive range of about 2 mm and about 10 mm.

10. The prosthetic heart valve of claim 5 , wherein end regions of the plurality of joining struts are axially positioned between the plurality of lower radial flange struts and the plurality of lower radial flange struts.

11. 11. The prosthetic heart valve of claim 10, wherein the end regions of the plurality of joining struts are positioned to axially overlap a plurality of lower radial flange struts at radially adjacent locations within an inclusive area of ​​about .1 mm and about 10 mm.

12. 10. The prosthetic heart valve of claim 1, further comprising a material covering disposed over the framework, said material covering forming one or more triangular shaped gaps along an in-flow end of said body portion.

13. 1. A prosthetic heart valve comprising:

1. A valve framework having an expanded shape, comprising: A cylindrical body and a plurality of radial struts extending radially from a first end of the cylindrical body portion; a plurality of connecting struts connected to the cylindrical body portion near the second end and positioned along an outer side of the cylindrical body portion extending toward the first end; The prosthetic heart valve, wherein end regions of the plurality of joining struts extend beyond at least some of the plurality of radial struts.

14. 1. A prosthetic heart valve comprising: a valve framework having a cylindrically shaped body portion and a leaflet attachment portion connected to a distal region of the body portion; The prosthetic heart valve, wherein the leaflet attachment portions include a plurality of attachment struts that extend distally from the body portion when the framework is in a compressed configuration within a delivery device, and the plurality of attachment struts bend proximally backward along the outside of the body portion when the framework is in an expanded configuration.

15. 15. The prosthetic heart valve of claim 14, wherein the valve framework further comprises a plurality of radial struts extending radially outward from a proximal region of the body portion.

16. The prosthetic heart valve of claim 15 , wherein end regions of the plurality of joining struts are positioned proximally beyond some of the plurality of radial struts.

17. 16. The prosthetic heart valve of claim 15, wherein the plurality of radial struts includes a first set of radial struts and a second set of radial struts, the first set of radial struts positioned proximal to the second set of radial struts.

18. 17. The prosthetic heart valve of claim 16, wherein the end regions of the plurality of joining struts are positioned proximally beyond the first set of radial struts and distal to the second set of radial struts.

19. 14. The prosthetic heart valve of claim 13, wherein the plurality of joining struts form a first curve that bends through about 180 degrees, a first straight portion having a length within an inclusive range of about 3 mm and about 10 mm, a second curve that bends in the opposite direction within an inclusive range of about 90 degrees and about 150 degrees, and a rounded portion having a length within an inclusive range of about 2 mm and about 10 mm.

20. 1. A method of delivering a prosthetic heart valve, comprising: advancing a delivery device including a prosthetic valve having a framework proximal to the native valve; exposing a distal end of the framework including a distal end of a cylindrical body portion and a plurality of leaflet connecting struts coupled near the distal end of the cylindrical body portion; the leaflet attachment struts bend toward the proximal end of the cylindrical body portion and allow positioning of the native leaflets of the native valve between the leaflet attachment struts and the cylindrical body portion; and Completely releasing the remaining portion of the framework within the delivery device. A method for delivering a prosthetic heart valve comprising:

21. 1. A prosthetic heart valve comprising: a generally cylindrical body portion; an atrial flange portion extending radially and annularly outwardly from the inflow end of the body portion; a leaflet binding portion; the atrial valve flange portion and the leaflet attachment portion are configured to axially overlap one another at diametrically adjacent locations within a containment area of ​​about 0.1 mm and about 10 mm.

22. 1. A prosthetic heart valve comprising: a generally cylindrical body portion; an inner annular seal portion positioned radially outward of the body portion and including a plurality of struts configured to couple to an inner side of a native valve annulus; a leaflet connecting portion including a plurality of connecting struts connected at an outflow end of the body portion and extending in an inflow direction along an exterior of the body portion; 13. An artificial heart valve comprising:

23. 23. The prosthetic heart valve of claim 22, further comprising an atrial flange portion extending radially outward from the in-flow end of said body portion; and said intra-annular seal portion extending distally from said atrial flange portion.

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