Prosthetic heart valves, systems, and methods

Abstract

A prosthetic valve support structure of the present specification includes a body portion, an atrial flange portion, and a leaflet engaging portion. When the support structure (and the integral valve) is pushed out of the delivery device or is not limited by the delivery device, the free end of the leaflet engaging portion will begin to bend radially outward or away from the body portion and will continue to bend with exposure of more portions until its free end is inclined in the inflow direction, and the free end of the leaflet engaging portion is inclined in the outflow direction. Thereby positioning itself between a radially outward side of the native valve leaflet and the outflow path outside the native valve annulus. When the support structure is fully deployed, the native valve leaflet remains constrained or engaged between the leaflet engaging portion and the body portion.

Description

[0001] Related Applications

[0002] This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 364,248, filed on May 5, 2022, entitled “Valve and Valve Docking System,” U.S. Provisional Application No. 63 / 366,001, filed on June 7, 2022, entitled “Heart Valve and Valve Docking System,” and U.S. Provisional Application No. 63 / 383,335, filed on November 11, 2022, entitled “Valve and Valve Docking System,” all of which are hereby incorporated by reference in their entirety. Background Art

[0003] Heart valve disease is a common condition that affects millions of people worldwide. The heart has four valves that regulate blood flow by opening and closing with each heartbeat. When 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 and even death.

[0004] Traditional treatments for heart valve disease involve surgically replacing the affected valve with an artificial valve. While this approach is effective, it is invasive and requires a long recovery period. Additionally, some patients may not be good candidates for surgery due to other health conditions.

[0005] In recent years, there has been growing interest in minimally invasive techniques for heart valve replacement, such as transcatheter aortic valve replacement (TAVR). The technique involves inserting a collapsible valve into the heart via a catheter, usually inserted into the femoral artery. The valve then unfolds within the damaged valve, replacing it and restoring normal blood flow.

[0006] Recently, there has been growing interest in using this technology to replace 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 replacing them using traditional surgical techniques is challenging. TMVR and TTVR offer a less invasive option for patients with mitral or tricuspid valve disease who may not be eligible for traditional surgical valve replacement.

[0007] TMVR and TTVR require specialized devices that are designed to fit the unique shape of the mitral or tricuspid valve. These devices are typically made of biocompatible materials and designed to be deployed via a catheter, similar to a TAVR procedure.

[0008] Overall, TMVR and TTVR offer a promising new option for patients with mitral or tricuspid valve disease who may not be candidates for 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 exciting area of ​​research and development in the field of cardiology. Summary of the invention

[0009] The artificial valve support structure of the present specification includes a main body portion, an atrial flange portion and a leaflet engagement portion. When the support structure (and the valve as a whole) is pushed out of the delivery device or is not restricted by the delivery device, the free end of the leaflet engagement portion will begin to bend radially outward or away from the main body portion, and will continue to bend as more portions are exposed until its free end is tilted in the inflow direction, thereby positioning itself between the radially outer side of the natural valve leaflets and the outflow path outside the natural valve ring. When the support structure is fully deployed, the natural valve leaflets remain restricted or engaged between the leaflet engagement portion and the main body portion.

[0010] In certain aspects, the technology described herein relates to an artificial heart valve, comprising: a main body portion that is generally cylindrical; an atrial flange portion that extends radially outward from an inflow end of the main body portion and forms a plurality of petal shapes annularly around the main body portion; and a leaflet coupling portion that includes a plurality of coupling struts connected to an outflow end of the main body portion and extending along the outer side of the main body portion in an inflow direction.

[0011] In certain aspects, the technology described herein relates to a prosthetic heart valve wherein the body portion includes a plurality of elongated vertical body struts that alternate in axial position.

[0012] In certain aspects, the technology described herein relates to a prosthetic heart valve wherein a body portion includes a plurality of horizontal body struts forming a "V" shape or angle, each horizontal body strut being connected to two of a plurality of vertical body struts.

[0013] In certain aspects, the technology described herein relates to a prosthetic heart valve wherein the body portion has a length in a range of about 14 mm to about 18 mm and a radius in a range of about 27 mm to about 30 mm.

[0014] In certain aspects, the technology described herein relates to an artificial heart valve, wherein an atrial flange portion includes a plurality of upper radial flange struts and a plurality of lower radial flange struts, each of the upper radial flange struts and the lower radial flange struts extending from a main body portion; wherein the upper radial flange struts are located further toward the inflow end of the artificial heart valve than the lower radial flange struts.

[0015] In certain aspects, the technology described herein relates to an artificial heart valve, wherein the atrial flange portion includes a plurality of radial flange struts; wherein the upper portions of the radial flange struts are connected to the atrial flange portion, and the lower portions of the radial flange struts are not connected to the atrial flange portion and are inclined toward the outflow end of the artificial heart valve.

[0016] In certain aspects, the technology described herein relates to an artificial heart valve, wherein a plurality of upper radial flange struts and a plurality of lower radial flange struts each have: a first angle ranging from about 90 degrees to 130 degrees, a relatively straight portion having a length ranging from about 3 mm to about 10 mm, a second angle ranging from about 20 degrees to about 150 degrees, and an end portion having a length ranging from about 1 mm to 7 mm.

[0017] In certain aspects, the technology described herein relates to an artificial heart valve, wherein the outer ends of a plurality of upper radial flange struts and a plurality of lower radial flange struts are interconnected by one of a plurality of annular radial struts, wherein the annular radial struts form a petal shape to accommodate the positional difference between the plurality of upper radial flange struts and the plurality of lower radial flange struts.

[0018] In certain aspects, the technology described herein relates to an artificial heart valve wherein a plurality of joined struts form a first bend having a bend of approximately 180 degrees, a first straight portion having a length ranging from approximately 3 mm to approximately 10 mm, a second bend having a bend in the opposite direction of the bend ranging from approximately 90 degrees to approximately 150 degrees, and a circular portion having a length ranging from approximately 2 mm to approximately 10 mm.

[0019] In certain aspects, the technology described herein relates to a prosthetic heart valve wherein end regions of a plurality of engagement struts are axially located between a plurality of lower radial flange struts and a plurality of lower radial flange struts.

[0020] In certain aspects, the technology described herein relates to a prosthetic heart valve wherein end regions of a plurality of engagement struts are positioned to axially overlap a plurality of lower radial flange struts at radially adjacent locations in a range of about 0.1 mm to about 10 mm.

[0021] In certain aspects, the technology described herein relates to a prosthetic heart valve, further comprising a material covering disposed over the frame, wherein the material covering forms one or more triangular gaps along an inflow edge of the body portion.

[0022] In certain aspects, the technology described herein relates to an artificial heart valve, comprising: a valve frame having an expanded structure, comprising: a cylindrical main body portion, a plurality of radial struts extending radially from a first end of the cylindrical main body portion; and a plurality of engaging struts connected near the second end of the cylindrical main body portion, positioned along the outside of the cylindrical main body portion, and extending toward the first end; wherein end regions of the plurality of engaging struts extend beyond at least some of the plurality of radial struts.

[0023] In certain aspects, the technology described herein relates to an artificial heart valve, comprising: a valve frame having a cylindrical main body portion and a leaflet engagement portion connected to a distal region of the main body portion; wherein the leaflet engagement portion comprises a plurality of engagement struts, and when the frame is in a compressed configuration within a delivery device, the engagement struts extend distally from the main body portion, and wherein when the frame is in an expanded configuration, the plurality of engagement struts bend proximally and posteriorly along the outer side of the main body portion.

[0024] In certain aspects, the technology described herein relates to a prosthetic heart valve wherein the valve frame further comprises a plurality of radial struts extending radially outward from a proximal region of the body portion.

[0025] In certain aspects, the technology described herein relates to a prosthetic heart valve wherein end regions of a plurality of engagement struts are located beyond proximal ends of some of a plurality of radial struts.

[0026] In certain 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, wherein the first set of radial struts are located proximal to the second set of radial struts.

[0027] In certain aspects, the technology described herein relates to a prosthetic heart valve wherein end regions of a plurality of engagement struts are located beyond proximal ends of a first set of radial struts and distal ends of a second set of radial struts.

[0028] In certain aspects, the technology described herein relates to an artificial heart valve wherein a plurality of joined struts form a first bend having a bend of approximately 180 degrees, a first straight portion having a length ranging from approximately 3 mm to approximately 10 mm, a second bend having a bend in the opposite direction of the bend ranging from approximately 90 degrees to approximately 150 degrees, and a circular portion having a length ranging from approximately 2 mm to approximately 10 mm.

[0029] In certain aspects, the technology described herein relates to a method for delivering an artificial heart valve, comprising: advancing a delivery device to the vicinity of a natural valve, the delivery device comprising an artificial valve having a frame; exposing a distal end of the frame, the distal end comprising a distal end of a cylindrical main body portion and a plurality of leaflet engagement struts connected near the distal end of the cylindrical main body portion; bending the leaflet engagement struts toward the proximal end of the cylindrical main body portion and positioning the natural leaflets of the natural valve between the leaflet engagement struts and the cylindrical main body portion; and, completely releasing the remaining portion of the frame within the delivery device.

[0030] In some aspects, the technology described herein relates to an artificial heart valve, comprising: a generally cylindrical main body portion; an atrial flange portion extending radially and annularly outward from an inflow end of the main body portion; and a leaflet coaptation portion; wherein the atrial flange portion and the leaflet coaptation portion are configured to axially overlap each other at radially adjacent positions in a range of about 0.1 mm to about 10 mm.

[0031] In certain aspects, the technology described herein relates to an artificial heart valve, comprising: a main body portion that is generally cylindrical; an intra-annular sealing portion, the intra-annular sealing portion comprising a plurality of struts, the struts being located radially outside the main body portion and being configured to engage with the interior of a natural valve ring; and a leaflet engagement portion, comprising a plurality of engagement struts connected to an outflow end of the main body portion and extending along the outer side of the main body portion in an inflow direction.

[0032] In certain aspects, the technology described herein relates to a prosthetic heart valve further comprising an atrial flange portion extending radially outward from the inflow end of the body portion; wherein the intra-annular sealing portion extends distally from the atrial flange portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] These and other aspects, features and advantages of embodiments of the present invention will be apparent and elucidated from the following description of embodiments of the present invention with reference to the accompanying drawings, in which

[0034] Figure 1 A perspective view of a prosthetic heart valve support structure.

[0035] Figure 2 for Figure 1 A cross-sectional view of an artificial heart valve support structure is shown.

[0036] Figure 3 for Figure 1 A top view of the support structure frame of the artificial heart valve is shown.

[0037] Figure 4 for Figure 1 A side view of a prosthetic heart valve support structure frame is shown.

[0038] Figure 5 for Figure 1 A side view of a prosthetic heart valve support structure frame is shown.

[0039] Figure 6 for Figure 1 A perspective view of a prosthetic heart valve support structure frame is shown.

[0040] Figure 7 for Figure 1 A perspective view of a prosthetic heart valve support structure frame is shown.

[0041] Figure 8 for Figure 1 The struts of the prosthetic heart valve support structure frame are shown.

[0042] Fig. 9 for Figure 1 The struts of the support structure frame of a prosthetic heart valve are shown.

[0043] Fig.10 for Figure 1 A compressed view of a prosthetic heart valve support structure frame is shown.

[0044] Fig.11 for Figure 1 A partial compressed view of a prosthetic heart valve support structure frame is shown.

[0045] Fig.12 for Figure 1 A view of the artificial heart valve support structure frame after expansion is shown.

[0046] Fig.13 for Figure 1 A view of a prosthetic heart valve support structure frame within a native valve is shown.

[0047] Fig.14 for Figure 1 A view of a prosthetic heart valve support structure frame within a native valve is shown.

[0048] Fig.15 for Figure 1 A view of a prosthetic heart valve support structure frame within a native valve is shown.

[0049] Fig.16 A perspective view of an artificial heart valve.

[0050] Fig.17 for Fig.16 A side view of a prosthetic heart valve is shown.

[0051] Fig.18 for Fig.16 A side view of a prosthetic heart valve is shown.

[0052] Fig.19 for Fig.16 An enlarged cross-sectional view of a prosthetic heart valve is shown.

[0053] Fig. 20 for Fig.16 An enlarged cross-sectional view of a prosthetic heart valve is shown.

[0054] Fig.21 for Fig.16 An enlarged cross-sectional view of a prosthetic heart valve is shown.

[0055] Fig. 22 for Fig.16 An enlarged cross-sectional view of a prosthetic heart valve is shown.

[0056] Fig.23 A perspective view of an artificial heart valve.

[0057] Fig.24 for Fig.23 A view of a prosthetic heart valve is shown.

[0058] Fig.25 for Fig.23 A side view of a prosthetic heart valve is shown.

[0059] Fig.26 for Figure 3 A bottom view of the prosthetic heart valve is shown.

[0060] Fig. 27 for Fig.23 A top view of a prosthetic heart valve is shown.

[0061] Fig.28 for Fig.23 A cross-sectional view of an artificial heart valve is shown.

[0062] Fig.29 for Fig.23 A cross-sectional view of an artificial heart valve is shown.

[0063] Fig.30 for Fig.23 An enlarged view of a prosthetic heart valve is shown.

[0064] Fig.31 for Fig.23 An enlarged view of a prosthetic heart valve is shown.

[0065] Fig.32 for Fig.23 An enlarged view of a prosthetic heart valve is shown.

[0066] Fig.33 for Fig.23 An enlarged view of a prosthetic heart valve is shown.

[0067] Fig.34 for Fig.23A perspective view of a prosthetic heart valve frame is shown.

[0068] Fig.35 for Fig.23 A side view of a prosthetic heart valve frame is shown.

[0069] Fig.36 for Fig.23 A side view of a prosthetic heart valve frame is shown.

[0070] Fig.37 for Figure 3 A top view of a prosthetic heart valve frame is shown.

[0071] Fig.38 for Fig.23 A bottom view of the prosthetic heart valve frame is shown.

[0072] Fig.39 for Fig.23 An enlarged view of the prosthetic heart valve frame is shown.

[0073] Fig.40 for Fig.23 An enlarged view of the prosthetic heart valve frame is shown.

[0074] Fig.41 for Fig.23 An enlarged view of the prosthetic heart valve frame is shown.

[0075] Fig.42 for Fig.23 An enlarged view of the prosthetic heart valve frame is shown.

[0076] Fig.43 for Fig.23 An enlarged view of the prosthetic heart valve frame is shown.

[0077] Fig.44 for Fig.23 A cross-sectional view of a prosthetic heart valve frame is shown.

[0078] Fig.45 for Fig.23 A simplified line drawing of several components of a prosthetic heart valve is shown.

[0079] Fig.46 With leaflets Fig.23 A view of a prosthetic heart valve is shown.

[0080] Fig.47 for Fig.23 A side view of a prosthetic heart valve is shown within a native heart valve.

[0081] Fig.48 for Fig.23 A side view of a prosthetic heart valve is shown within a native heart valve.

[0082] Fig.49 for Fig.23 A side view of a prosthetic heart valve is shown within a native heart valve. DETAILED DESCRIPTION

[0083] Specific embodiments of the present invention will now be described with reference to the accompanying drawings. However, the present invention can be implemented in many different forms and should not be construed as limited to the embodiments described herein; on the contrary, these embodiments are provided to make this disclosure thorough and complete and to fully convey the scope of the present invention to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present invention. The same numbers in the drawings represent the same elements.

[0084] Although different embodiments are described in this specification, it is specifically contemplated that any features in the different embodiments may be combined in any combination. In other words, the features of the different embodiments may be mixed and matched with each other. Therefore, although each combination of features of the different embodiments may not be explicitly shown, it is intended that any such combination be covered by this specification.

[0085] This specification is mainly directed to artificial heart valves or artificial heart valves. These heart valves can be used to replace any natural heart valve (e.g., aortic valve, mitral valve, pulmonary valve or tricuspid valve), however, the artificial heart valve of this specification can be particularly used to replace the mitral valve or tricuspid valve.

[0086] Generally speaking, the artificial heart valve of the present invention includes a support structure for supporting artificial valve leaflets or similar mechanisms so that blood generally flows through the artificial heart valve in only one direction. This specification focuses primarily on the support structure, and therefore the accompanying drawings may not fully disclose the artificial leaflets or similar structures therein. However, it should be understood that the use of leaflets and similar structures in conjunction with the support structure is specifically contemplated. In other words, although much of the present disclosure may focus on the artificial valve support structure, the artificial valve as a whole is specifically included in the present invention.

[0087] When referring to artificial valves and support structures in this specification, the terms "top end", "inflow end" and similar variations can be used interchangeably to indicate the end of the device through which blood typically enters the valve / device first. For example, for the tricuspid valve, the end of the device is located at or near the right atrium. The terms "bottom end", "outflow end" and similar variations can be used interchangeably to indicate the end of the device through which blood typically flows out of the valve / device. For example, for the tricuspid valve, the end of the device is in or near the right ventricle. In addition, the artificial valves and support structures in this specification may be referred to as having a proximal end / portion and a distal end / portion in the context of a delivery device / catheter. Generally, the term "proximal end" refers to a portion or direction along the delivery device that is closer to the physician, while "distal end" refers to a portion or direction along or away from the delivery device, in the opposite direction from the physician. In some examples described in this specification, the top or inflow end of the support structure may also be the proximal end, and the bottom or outflow end of the support structure may also be the distal end.

[0088] Generally speaking, some artificial valve support structures of the present specification include a main body portion, an atrial flange portion, and a leaflet coaptation portion. These features can take on different shapes, depending on whether the support structure is in a radially compressed configuration during deployment or in a radially expanded configuration after deployment.

[0089] When the support structure is in the expanded state, the main body portion is generally cylindrical and the channel extends between the inflow end and the outflow end. Optionally, the main body portion can have a generally concave, convex or funnel shape, or the diameter of the middle region can be increased or decreased relative to the two ends (e.g., an hourglass shape or an "expanded middle"). Typically, artificial leaflets or similar valve structures are fixed, mounted or connected within the channel, such as in the middle or at both ends of the channel. These artificial leaflets or similar valve structures can be tied to the main body portion, connected with an adhesive, or connected by a similar method.

[0090] In the expanded configuration of the support structure, the atrial flange portion is a generally annular area extending radially outward from the inflow end of the main body portion formed by a flange, lip, protrusion or overhang. The atrial flange portion can help to form a seal between the inflow end of the device and the ring of the replaced native valve, thereby preventing blood from bypassing the passage of the main body portion. In this regard, it may be desirable for the atrial flange portion to conform to the shape of the valve annulus. The atrial flange can extend completely continuously around the entire circumference of the main body portion, or can extend only partially around the circumference of the main body portion (e.g., two or more segments or multiple struts).

[0091] In the expanded configuration of the support structure, the atrial flange portion can be relatively flat, or can have one or more curved surfaces. In addition or alternatively, the flange can be approximately perpendicular to the axis of the main body portion, or can extend radially at any angle from 0 to 180 degrees relative to the axis. In one instance, the atrial flange has an initial angle of approximately 110 degrees (plus or minus 10 degrees), slightly curved in the direction of the valve annulus, and then further curved upward (e.g., away from the valve annulus) to fit the wall of the atrium. In some cases, it may be helpful for the atrial flange to generally fit the top or inflow surface of the valve annulus (e.g., the mitral or tricuspid annulus) and the side walls of the surrounding atrium. Therefore, depending on the length of the atrial flange, it may be helpful for the end region of the atrial flange to be bent or tilted so that its edge is approximately in an inflow direction similar to the right / left atrial wall (e.g., at a similar angle to the longitudinal axis of the main body portion).

[0092] In the expanded configuration of the support structure, the leaflet engagement portion can be positioned radially around the outside of the main body portion to capture the patient's natural valve leaflets between the leaflet engagement portion and the main body portion of the support structure. In one example, the leaflet engagement portion can be a plurality of struts and / or can be a continuous radial member. The leaflet engagement portion can also be connected to or near the outflow end of the main body portion and extend toward the inflow end of the main body portion when the support structure is in its fully expanded configuration. The leaflet engagement portion can include one or more bending regions, such as a bending region that is radially curved outward near the free end of the leaflet engagement portion so as to engage the outflow surface of the natural annulus of the natural heart valve. In addition or alternatively, the leaflet engagement portion can include one or more bends that position at least a portion of the leaflet engagement structure closer to or in contact with the main body portion to help clamp or engage the natural valve leaflets. Optionally, the leaflet engagement portion can be spaced apart from the main body portion by a certain gap (e.g., uniform or uneven).

[0093] In the compressed configuration of the support structure, the main body portion can be radially or diametrically compressed. The atrial flange can also be radially compressed and can further 1) be folded proximally or in the inflow direction so that its free end is positioned further away from the main body portion, or 2) can be folded distally or in the outflow direction so that the atrial flange is closely attached to the main body portion. The leaflet coaptation portion can 1) be folded distally or in the outflow direction so that its free end is away from the main body portion, or 2) can be folded proximally or in the inflow direction so that the leaflet coaptation portion is closely attached to the main body portion.

[0094] In some instances, it may be helpful to fold the leaflet engagement portions distally with their free ends away from the main body portion in the compressed state of the delivery device. When the support structure (and the valve as a whole) is pushed out of the delivery device or otherwise released, the free ends of the leaflet engagement portions will withdraw and be exposed first. As the free ends are further exposed, they will begin to bend radially outward or away from the main body portion. If the position is outside the native leaflets of the valve, the leaflet engagement portions will continue to bend with more exposure until their free ends are tilted in the direction of inflow, thereby positioning themselves between the radially outer sides of the native leaflets and the outflow path outside the native valve annulus. When the support structure is fully deployed, the native valve leaflets remain constrained or engaged between the leaflet engagement portions and the main body portion. This function should be understood as also being a method of deploying the support structure.

[0095] In some instances, it may be helpful to construct the support structure so that in its expanded configuration, the ends of the leaflet coaptation portion and the atrial flange portion both contact and thus clamp or engage each side of the native valve annulus (or nearby tissue). This can help provide a better seal for the atrial flange portion to prevent blood from bypassing the artificial valve or creating paravalvular leakage. This also helps to maintain the artificial valve in a predetermined position within the patient's heart.

[0096] In some instances, it may be helpful to construct the support structure such that in its expanded configuration, the ends of the leaflet coaptation portion are positioned closer to or further toward the inflow direction than at least some radially adjacent portions (e.g., struts) of the atrial flange portion. When viewed from the side, the portions overlap each other in the axial position of their ends. This may be particularly helpful in two ways. First, this arrangement forces the leaflets and annulus to be located above the leaflet coaptation portion and then below the lower flange (e.g., lower radial struts), forcing the leaflets / annulus into an alternating or wavy shape. Thus, the leaflet coaptation portion and the atrial flange portion tend to clamp the leaflets / annulus, creating a paper clip effect. Second, this arrangement allows the material covering the underside of the atrial flange portion to be pulled taut around the top of the leaflet coaptation portion, thereby providing good contact between the material covering and the leaflets / annulus to promote sealing, healing, and possible tissue ingrowth.

[0097] The support structure can be constructed in different ways. In one example, the support structure includes an underlying frame and a material covering placed on part or all of the frame.

[0098] The frame may be constructed of a shape memory material that assumes a specific shape and returns to its original shape after being constrained. Examples of shape memory materials include Nitinol and similar alloys.

[0099] The frame can be composed of an entire single integral frame. For example, the frame can be made of a shape memory tube (e.g., Nitinol) that is laser cut and then heat set to its desired deployed shape. Alternatively, multiple shape memory struts / shapes can be welded or otherwise connected together, and then the desired deployed shape is imparted to the connected struts / shapes.

[0100] The frame can also be composed of separate parts that are connected to each other by welding, tying, gluing, or by each part being separately connected to a material covering (i.e., the material covering connects the parts to each other). For example, the main body portion, the atrial flange portion, and the leaflet coaptation portion can all be separate parts (e.g., welded together or connected by a material covering).

[0101] Certain components of the frame may be comprised of different types and structures of materials. For example, the main body portion may be comprised of a plurality of braided shape memory wires, while the atrial flange portion and the leaflet coaptation portion may be comprised of non-braided shape memory struts / shapes (e.g., laser cut Nitinol components). In another example, the main body portion and the leaflet coaptation portion may be comprised of non-braided shape memory struts / shapes (e.g., laser cut Nitinol components), and the atrial flange portion may be comprised of a flexible polymer or similar material (e.g., silicone, PET, EPTFE, etc.).

[0102] The frame can have different thicknesses in different areas (i.e., not only different lengths and widths, but also different thicknesses of the frame material itself). For example, the atrial flange portion can have a greater thickness than the main body portion. In another example, the leaflet coaptation portion can have a greater thickness than the main body portion.

[0103] Certain components of the frame may consist of long arms or struts that have no material covering on them. For example, the leaflet engagement portion may consist of a plurality of struts that are located and connected together at circumferential locations around the main body portion. These locations may be evenly distributed or may be unevenly distributed only in certain areas. However, these arms or struts may have coatings and / or caps at their distal ends. For example, the arms or struts may have a flexible coating that helps frictionally engage the leaflets and an end cap on the free end of the arm / strut that is also composed of a flexible material to help minimize tissue damage during deployment and long-term implantation. Such coatings / caps may be composed of pericardial tissue, expanded polytetrafluoroethylene (EPTFE), textile materials, PET, polyurethane, silicone, and similar materials. The long arms or struts may all be the same length, or may have different lengths, such as alternating between longer and shorter lengths.

[0104] The material covering may be connected to or positioned on part or all of the frame. Additionally or alternatively, the material covering may be disposed only on the inside of the frame, only on the outside of the frame, or on both the inside and outside of the frame. In one example, the material covering is located on the main body portion and the atrial flange portion, but not on the leaflet coaptation portion. In another example, the material covering is located only on the atrial flange portion. In another example, the material covering is located only on the main body portion. Additionally or alternatively, the material may be formed into an opening or other shape (e.g., a triangular edge) that rests against the frame.

[0105] The material covering can be made of a biocompatible flexible material. The material covering can be a solid non-porous sheet (e.g., a polymer sheet) or a fabric. Exemplary materials include textile materials, EPTFE sheets, PET sheets, silicone resins, polyurethanes, similar materials, or derivatives thereof. Such material coverings can also be configured to promote tissue ingrowth at least in certain areas.

[0106] The leaflets can be connected to the main body portion, for example, near the middle of the main body portion or near both ends. Typically, the valve leaflets are configured to open to allow blood to flow from the inflow end (e.g., from the left / right atrium) and remain closed to resist blood pressure from the outflow end (e.g., from the left / right ventricle). The valve assembly may include one, two or three leaflets. The valve leaflets can be connected to the support structure individually, or can all be connected to each other into a valve assembly and then connected to the support structure. The valve leaflets can be connected to the main body portion in a normally open or normally closed position. The shape of the valve leaflets is such that the leaflets take a natural cusp shape similar to a natural aortic valve or a similar valve. This shape, together with the material covering of the main structure, can produce a sinus-like shape similar to the valve sinus to achieve favorable flow conditions and beneficial blood flow flushing, thereby preventing stasis sites and thrombosis. The valve leaflets can be attached to the valve body in a structure that allows an overlap or engagement amount ranging from 0 to 20 mm at the free edge. There may be intentional gaps where the valve leaflets meet to allow a small amount of blood to leak through the valve without placing undue stress on the heart once the new valve is in place. The valve leaflets may be composed of artificial materials or natural biological materials. The valve leaflets may be treated with anti-calcification and tissue fixation methods to prevent the body from rejecting the implanted device and also to prevent the leaflets from calcifying. The tissue may be processed under dry storage conditions that allow the artificial valve to be stored and sterilized in glutaraldehyde or after other sterilization methods such as ETO. The tissue may also be treated or coated with anti-thrombotic chemicals or coatings.

[0107] The support structure may also include features that allow engagement with a delivery device to assist in the deployment of the support structure. In addition or alternatively, features that allow the support structure to be recaptured after at least partial deployment from the delivery device may be included. For example, the support structure may include one or more holes or expansion portions, such as on its frame, which releasably engage with a portion of the delivery device. When the support structure is in a compressed configuration, the hole or expansion portion may be located at or near the proximal end or inflow end of the support structure. For example, the hole or expansion portion may be located at an edge position of the atrial flange portion and / or a position near the end of the main body portion. The delivery device may include a breakable wire passing through / around the hole / expansion portion, a recess in the inner pusher that captures the hole / expansion portion, a hook, a post, a ring, a stent-like mesh, or a similar mechanism so that a physician can advance, retract, and / or release the support structure from the delivery device.

[0108] Any support structure described herein may be delivered by one of a variety of known heart valve delivery devices, such as those disclosed in U.S. Patent Application Nos. 2017 / 0165064, 2019 / 0008640, and 2022 / 0287836, the contents of which are incorporated herein by reference.

[0109] Figures 1 to 13 Various aspects of an example of a prosthetic valve support structure 100 are shown in an expanded state. Figure 1 and Figure 2 As shown, the support structure 100 generally includes a main body portion 110 , an atrial flange portion 106 , and a leaflet coaptation portion 108 .

[0110] In the present example, the main body portion 110 is generally cylindrical, but may also have other shapes, such as an hourglass shape, a cone, a concave shape, or a convex shape.

[0111] In the present example, the atrial flange portion 106 extends radially outward from the top or inflow end of the main body portion 110. The atrial flange portion 106 can form a complete circular or annular shape beyond the main body portion 110, although other shapes are possible, such as an elliptical shape, and can extend around only a portion of the circumference of the main body portion 110 (e.g., only the flange areas on opposite sides from each other).

[0112] In this example, the atrial flange 106 may have at least two regions with different angles relative to each other, such as Figure 2. The first region initially extends radially away from the inflow end of the main body portion 110. The first region can have an angle in the range of about 70 degrees to 140 degrees (e.g., about 110 degrees) relative to the axis of the internal channel extending through the support structure. The second region extends radially from the first region and has an angle in the range of 120 degrees to 170 degrees (e.g., about 160 degrees). In general, these two regions of the atrial flange portion 106 can help it fit the top / inflow surface of the native valve ring, as well as the wall or other area of ​​the atrium.

[0113] In the present example, the leaflet engagement portion 108 may include a plurality of engagement struts 114 that are connected to the outflow end of the main body portion 110 and extend in an inflow or upward direction. As will be described in further detail later, the engagement struts 114 bend toward the main body portion 110 and then away from the main body portion 110, terminating at the cap member 120. The initial bend toward the main body portion 110 can help clamp or engage the natural leaflet with the main body portion 110. The cap member 120 may include a flexible or relatively soft material (e.g., pericardial tissue, EPTFE, PET, a textile material, silicone, polyurethane, or a similar material) to help prevent damage to the patient's heart tissue. The cap member may be adhered or otherwise connected to the farthest end of the engagement struts 114.

[0114] In the present example, engagement struts 114 are positioned equidistant from one another around the circumference of body portion 110. Likewise, non-uniform positioning of struts 114 is possible, such as only on opposite sides of body portion 110 or at locations that may help avoid intraventricular chordae tendineae.

[0115] The support structure 100 in this example includes a rigid frame 102 and a material covering 104 disposed on portions of the frame 102. The material covering 104 is located around all or most of the outside of the main body portion 110 of the frame 102, the outside of the atrial flange portion 106 of the frame 102, and the inside of the atrial flange portion 106 of the frame 102. The engagement struts 114 are typically not covered by the material covering 104. As previously mentioned, other variations are possible, such as positioning the material covering only on the inside, only on the outside, and / or on any combination of the portions 106, 108, 110.

[0116] In the present example, the material covering 104 can be attached by adhesive, sutures, combinations thereof, and similar mechanisms. The material covering 104 can be composed of textile materials, EPTFE sheets, PET sheets, and similar materials discussed elsewhere in this specification. In addition to the material covering 104, the underside of the atrial flange 106 can include additional materials to help form a better seal with the native valve ring, such as a hydrogel.

[0117] Figures 3 to 9 Various aspects of the frame 102 in this example are shown. The main body portion 110 of the frame 102 is composed of a plurality of elongated vertical main body struts 116B and a plurality of horizontal main body struts 116A. The vertical main body struts 116B are generally parallel to the axis passing through the support structure channel (i.e., the axis from the inflow end to the outflow end), while the horizontal main body struts 116A are positioned around the axis in a circular shape.

[0118] The horizontal body struts 116A can form a "V" shape or a relatively sharp angle pointing in the direction of outflow, but it may also be the opposite direction. Each end of the horizontal body struts 116A is connected to the vertical body struts 116B. The "V" shape of the horizontal body struts 116A provides a bending point at the apex of its "V" to increase and decrease its angle depending on whether the support structure 100 is in its compressed configuration or expanded configuration. In other words, the "V" shape facilitates this radial compression and expansion. Optionally, other angled shapes are also possible for the horizontal body structure 116A, such as a "W" shape with two or more angles. In this example, there are two rows of horizontal body struts 116A, but there can be more rows.

[0119] In one example, the main body portion 110 of the frame 102 has a length ranging from about 14 mm to about 18 mm and a diameter ranging from about 27 mm to about 30 mm.

[0120] The atrial flange portion 106 of the frame 102 includes a plurality of flange struts 112. The shape of these flange struts 112 is Figure 8 Each flange strut 112 extends from one of the vertical body struts 116B and forms a first angle 112A in the range of about 90 degrees to 130 degrees, a relatively straight portion 112B in the range of about 3 mm to about 10 mm in length, a second angle 112C in the range of about 20 degrees to about 150 degrees, and an end portion 112D in the range of about 1 mm to 7 mm in length (again, angles relative to the inflow / outflow direction axis of the support structure 100). In general, the specific angles and dimensions may vary depending on the patient's heart and valve size.

[0121] The leaflet coaptation portion 108 of the frame 102 includes a plurality of coaptation struts 114, which may be shaped Fig. 910. The leaflet coaptation struts 114 are connected to the outflow end of the vertical body struts 116B. Starting from the vertical main body struts 116B, the coaptation struts form a first bend 114E that bends more than 180 degrees (e.g., in the range of about 150 degrees to about 230 degrees), a first straight portion 114D with a length in the range of about 3 mm to about 10 mm, a second bend 114C that bends in the opposite direction of bend 114D in the range of about 90 degrees to about 150 degrees, a second straight portion 114B with a length in the range of about 2 mm to about 10 mm, and finally a third bend 114A that bends in the same direction as the second bend 114C in the range of about 60 degrees to about 150 degrees. Although these bends generally occur in the same plane, additional bends may be included that may cause some of the coaptation struts 114 to be out of a single plane (i.e., bend in multiple dimensions).

[0122] As previously described, in this example, the engagement struts 114 are not covered by the material cover 104, but may be covered. In addition, the engagement struts 114 may be coated or wrapped in a relatively soft material (e.g., a textile or EPTFE layer). In addition, the ends of the engagement struts may include a cap member 120, which may be composed of similar materials or other materials described in this specification.

[0123] The frame 102 of the present example can be constructed from a single integral body, such as laser cut from a shape memory tube (e.g., a nitinol tube). Alternatively, one or more struts of the frame can be welded or otherwise connected to each other. Alternatively, some components can be separated from each other and connected only by other materials, such as a material covering 104 or other connecting mechanism. For example, the main body portion 110, the leaflet engagement portion 108 and / or the atrial flange portion 106 may not be directly connected to each other in any combination. If a shape memory material is used for the frame 102, the frame can be cut into a desired pattern and then heat set to give it the desired shape in the expanded configuration.

[0124] Figures 10 to 12 It is shown how the support structure 100 is deployed from the delivery catheter 50 . Fig.10 The support structure 100 is shown mostly within the delivery catheter 50 (note that only the frame 102 is shown in this figure for clarity). As the support structure 100 begins to be pushed out, the free ends of the engagement struts 114 begin to expand radially outward.

[0125] exist Fig.11 , the support structure 100 has been moved further distally out of the delivery catheter 50. The distal or outflow end of the main body portion 110 has been radially expanded, and the coaptation struts 114 of the leaflet coaptation portions 108 have been completely disengaged from the delivery catheter 50 and have flipped over on themselves so that their free ends are now located at the proximal or inflow end of the main body portion 110.

[0126] exist Fig.12 , the support structure is fully extended to its extended state. Fig.13 The expanded configuration within the tricuspid valve 14 is shown. It can be seen that the engagement struts 114 have been positioned around the leaflets 14B so as to capture the leaflets 14B at the body portion 110. In addition, it can be seen that the bottom of the atrial flange portion 106 contacts and engages the top of the valve annulus 14A, while the angled free ends of the engagement struts engage the bottom of the valve annulus 14A. As a result, the support structure 100 can better engage the valve annulus 14A and keep the leaflets 14B out of the way.

[0127] Fig.14 A method of delivering support structure 100 into tricuspid valve 14 of heart 10 is shown by advancing a delivery catheter through inferior vena cava 16 and into right atrium 18 such that the support structure is delivered from the inflow or atrial end relative to tricuspid valve 14 .

[0128] Fig.15 Another method of delivering support structure 100 to mitral valve 12 is shown by performing a transseptal procedure with a delivery catheter through the septum between right atrium 18 and left atrium 20. This allows the support structure to be delivered from the inflow or atrial end relative to mitral valve 12.

[0129] Other methods of delivering the support structure 100 are also possible. For example, the valves 14, 20 may be approached from the respective ventricles (22, 24) of either valve 14, 20. In this case, the support structure may be delivered in a manner similar to that of the embodiment of FIG. Figures 10 to 12 Arranged in opposite directions as shown.

[0130] Figures 16 to 22 An embodiment of a frame 130 is shown that is similar to the aforementioned frame 102. However, the frame 130 also includes a strut 132 that is connected to two adjacent flange struts 112 and forms a "V" shape downward toward the outflow end of the frame 130. Although the strut 132 can be considered to be part of the atrial flange portion 106, it can be located within the annulus of the valve while portions of the flange struts 112 remain on the top or atrial surface of the annulus of the native valve. Therefore, the atrial flange portion 106 of this embodiment can be further considered to have a top sealing portion (i.e., the flange struts 112) and an intra-annular engagement / sealing portion (struts 132). In this way, the frame 130 can better seal the frame / valve to prevent blood leakage around the frame / valve.

[0131] like Fig. 20As shown, the struts 132 initially extend relatively horizontally from the flange struts 112, and then form a first angle 132A, which can be in the range of about 135 degrees to about 180 degrees, toward the outflow end of the frame 130. The struts 132 can also have a straight region 132B, whose length is in the range of about 3 mm to about 10 mm. Finally, the struts 132 form an intermediate angle 132C, which is opposite to the first angle 132A in the range of about 90 degrees to about 120 degrees. The straight region 132B and the angle 132A are symmetrically repeated on opposite sides of the intermediate angle 132C, thereby forming a generally "V" shape between each flange strut 112.

[0132] like Fig.21 As shown, the "V"-shaped struts 132 can be further inclined to be generally in line / parallel with the axis of the frame 130, or inclined to a "V"-shaped tip or angle 132C, which is located slightly closer to the main body portion 110. In other words, the struts 132 can be inclined radially inward toward the outflow end of the frame. This can help the "V"-shaped struts 132 adapt to and engage the annulus of the native valve. In one example, the struts 132 are inclined radially inward in a range of about 0 degrees to about 30 degrees.

[0133] Figure 23 to Figure 33 Various aspects of another example of a support structure 150 are shown, which is generally similar to the previously described support structure 100, but includes several significant differences discussed further below. Fig.18 As shown, the support structure 150 generally includes a main body portion 110 , an atrial flange portion 106 , and a leaflet coaptation portion 108 .

[0134] In this example, the main body portion 160 is generally cylindrical, but may also have other shapes, such as an hourglass shape, a cone, a concave shape, or a convex shape.

[0135] In the present example, the atrial flange portion 156 extends radially outward from the top or inflow end of the main body portion 160. The atrial flange portion 156 can form a complete circular or annular shape beyond the main body portion 160, although it can also have other shapes, such as an elliptical shape, and can extend around only a portion of the circumference of the main body portion 160 (e.g., only the flange areas on opposite sides from each other). Fig.23 As seen most clearly, the atrial flange portion 156 is also generally formed into a plurality of petal-shaped, pointed, or outwardly narrowing shapes such that the width of each of these regions decreases with increasing distance from the main body portion 160 .

[0136] In this example, the atrial flange 156 may have at least two regions with different relative angles, such as Fig. 22. The first region initially extends radially away from the inflow end of the main body portion 160. The first region can have an angle in the range of about 70 degrees to 140 degrees (e.g., about 120 degrees) relative to the axis of the internal channel extending through the support structure. The second region extends radially from the first region and has an angle in the range of 150 degrees to 220 degrees (e.g., about 200 degrees). Typically, these two regions of the atrial flange portion 156 can help it fit to the top / inflow surface of the native valve annulus, as well as the wall or other area of ​​the atrium or leaflet / annulus.

[0137] In the present example, the leaflet coaptation portion 158 may include a plurality of coaptation struts 164 connected to the outflow end of the main body portion 160 and extending in the inflow or upward direction. As will be described in further detail later, the coaptation struts 164 bend generally parallel to the main body portion 160 and then extend away from the main body portion 160 to terminate at the flared portion 164A ( Fig.23 ). The initial bend toward the main body portion 160 can help engage or capture the native leaflets with the main body portion 160. The expansion portion 164A can be generally circular to prevent damage to the patient's valve tissue and can also include one or more holes that can be optionally used to releasably engage the support structure 150 via the delivery catheter 50.

[0138] In the present example, engagement struts 164 are positioned equidistant from one another around the circumference of body portion 160. Likewise, non-uniform positioning of struts 164 is possible, such as only on opposite sides of body portion 160 or in locations that may help avoid ventricular chordae tendineae.

[0139] The support structure 150 in this example includes a rigid frame 152 and a material covering 154 disposed on a portion of the frame 152. The material covering 154 is located on all or most of the interior and exterior of the main body portion 160 of the frame 152 (in the Fig.28 and 29 154 ) and are located on the exterior of the atrial flange portion 156 of the frame 152. The engagement struts 164 are typically not covered by the material covering 154. As previously mentioned, other variations are possible, such as positioning the material covering 154 only on the interior, only on the exterior, and / or on any combination of the portions 156, 158, 160.

[0140] like Fig.28 and 29 As shown, the material covering 154 of the outflow end of the body portion 160 may be formed into petals, pointed areas, or triangular areas 154A that match the basic shape of the frame 152 of the body portion 160. Alternatively, the outflow end of the body portion 160 may have uniformly rounded edges.

[0141] Similarly, the edge of the material covering 154 at the inflow end of the main body portion 160 may include one or more embedded pointed or triangular gaps, spaces or grooves 154B. Although the triangular areas 154A are shown as being adjacent to each other, the grooves 154B may be less visible between relatively uniform edge areas. However, the inflow edge or outflow edge may take any combination of the patterns disclosed herein, and may also have completely uniform and vertical edges. Fig.23 As shown, the material covering 154C may also conform to the triangular or cusp shape of the atrial flange portion 156 .

[0142] In the present example, the material covering 154 can be attached by adhesive, sutures, combinations thereof, and similar mechanisms. The material covering 154 can be composed of textile materials, EPTFE sheets, PET sheets, and similar materials discussed elsewhere in this specification. In addition to the material covering 154, the underside of the atrial flange portion 156 can include additional materials to help form a better seal with the native valve ring, such as a hydrogel.

[0143] Figures 34 to 44 The main body portion 160 of the frame 152 is composed of a plurality of elongated vertical main body struts 166B and a plurality of horizontal main body struts 166A (in Fig.37 ). The vertical body struts 166B are generally parallel to the axis of the passage through the support structure (i.e., the axis from the inflow end to the outflow end), while the horizontal body struts 166A are positioned in a circular shape about the axis.

[0144] The vertical body struts 166B may be arranged alternately between different heights or axial positions, such that a first vertical body strut 166B has a first axial position, and two vertical body struts 166B adjacent to the first vertical body strut are located closer in the inflow direction relative to the other two adjacent vertical body struts. Thus, the vertical body struts 166B may form an alternating pattern.

[0145] The horizontal main body struts 166A can form a "V" shape or a relatively sharp angle pointing in the outflow direction, but it may also be the opposite direction. Each end of the horizontal main body struts 166A is connected to the vertical main body struts 166B, and the vertical main body struts 166B pass directly through the middle of the "V". The "V" shape of the horizontal main body struts 166A provides a bending point at the apex of its "V" shape to increase or decrease its angle depending on whether the support structure 150 is in its compressed configuration or expanded configuration. In other words, the "V" shape facilitates this radial compression and expansion. Optionally, shapes with other angles are also possible for the horizontal main structure 166A, such as a "W" shape with two or more angles. In this example, there are two rows of horizontal main body struts 166A, but there can be more rows.

[0146] In one example, the body portion 160 of the frame 152 has a length in a range of about 14 mm to about 18 mm and a radius in a range of about 27 mm to about 30 mm.

[0147] The atrial flange portion 156 of the frame 152 includes a plurality of flange struts 162. The shape of these flange struts 162 is Figures 38 to 46 162C and lower radial struts 162D are arranged alternately. Both struts 162C and 162D extend from a vertical main body strut 166B. Although the two struts 162C and 162D can have similar shapes / sizes / curvatures, due to the higher and lower positions of the vertical main body struts 166B (for example, due to the "V" shape / position of the horizontal main body struts 166A), the upper radial struts 162C are generally higher (i.e., closer to the inflow direction) than the lower radial struts 162D. In this example, the hole portion 166C is located near the vertical main body struts 166A and the upper radial struts 162. The hole portion 166C can be optionally included for use in a delivery catheter 50.

[0148] like Fig.33 As shown, each upper radial flange strut 162C forms a first angle 162E in the range of about 90 degrees to 130 degrees, a relatively straight portion 162F having a length in the range of about 3 mm to about 10 mm, a second angle 162G in the range of about 20 degrees to about 150 degrees, and a terminal portion 162A having a length in the range of about 1 mm to 7 mm (again, an angle relative to the inflow / outflow direction axis of the support structure 150). In general, the specific angles and dimensions may vary depending on the patient's heart and valve size. The terminal portion 162A may optionally include a hole that the delivery catheter 50 may use to help releasably retain the support structure 150 during deployment.

[0149] like Fig.40As shown, each lower radial flange strut 162D forms a first angle 162H in the range of about 90 degrees to 150 degrees, a relatively straight portion 162I with a length in the range of about 0 mm to about 5 mm, a second angle 162J in the range of about 0 degrees to about 60 degrees, and a terminal portion 162K with a length in the range of about 1 mm to 7 mm (again, an angle relative to the inflow / outflow direction axis of the support structure 150). In general, the specific angles and dimensions may vary depending on the patient's heart and valve size. The terminal portion 162K may optionally include a hole that the delivery catheter 50 may use to help releasably retain the support structure 150 during deployment.

[0150] The radially outer ends of each upper radial strut 162C and lower radial strut 162D are interconnected by one of the plurality of circumferential radial struts 162B. Because the upper radial struts 162C and lower radial struts 162D are located at different heights and at different distances from each other, the circumferential radial struts 162B tend to form opposing triangular or petal shapes that terminate at the end portions 162A. Thus, the circumferential radial struts 162B can be bent in multiple dimensions to accommodate the positional differences between the upper radial struts 162C and lower radial struts 162D.

[0151] The leaflet engagement portion 158 of the frame 152 includes a plurality of engagement struts 164 shaped Fig.39 10. Typically, the joining strut 164 has a straight portion 164B that is parallel to the axis passing through the support structure channel (i.e., the axis from the inflow end to the outflow end). In other words, the joining strut 164 is not tilted toward the main body portion 160 as in the previous support structure 100, although this configuration is also possible. The joining strut 164 is connected to the outflow end of the vertical main body strut 166B. Starting from the vertical main body strut 166B, the joining strut 164 forms a first bend 164C that is bent about 180 degrees (e.g., in the range of about 150 degrees to about 230 degrees), a first straight portion 164B with a length in the range of about 3 mm to about 10 mm, a second bend 164D that is bent in the opposite direction of the bend 164C in the range of about 90 degrees to about 150 degrees, and a rounded portion 164A with a length in the range of about 2 mm to about 10 mm. Although these bends generally occur in the same plane, additional bends may also be included, which may cause some of the joining struts 114 to be out of a single plane (i.e., bend in multiple dimensions). Circular portion 164A may optionally include holes that may be used by delivery catheter 50 to help releasably retain support structure 150 during deployment.

[0152] As previously described, in this example, the engagement struts 164 are not covered by the material cover 154, but may be covered. In addition, the engagement struts 164 may be coated or wrapped in a relatively soft material (e.g., a textile or EPTFE layer). In addition, the circular portion 164A of the engagement struts 164 may include a coating composed of similar materials or other materials described in this specification.

[0153] One aspect of the support structure 150 and frame 152 that is worth noting is the position of the atrial flange 156 relative to the engagement struts 164, as shown in FIG. Fig.45 and Fig.39 1. In its expanded configuration, the ends of the coaptation struts 164 (i.e., portions of the leaflet coaptation portions) are located more proximal or closer to the inflow direction than portions of the radially adjacent lower radial struts 162D of the atrial flange portion 156. In other words, the lower radial struts 162D on each side of each coaptation strut 164 are axially bent in the distal / outflow direction beyond the ends of the coaptation struts 164. In one example, the axially adjacent overlap is in the range of about 0.1 mm to about 10 mm.

[0154] This arrangement is particularly useful in several respects. First, this arrangement forces the leaflets and annulus of the native valve to be positioned above the coaptation struts 164 and then below the lower radial struts 162D, forcing the leaflets / annulus into an alternating or wavy shape. Thus, the leaflet coaptation portions 158 (i.e., the coaptation struts 164) and the atrial flange portion 156 (i.e., the lower radial struts 162D) tend to clamp the leaflets / annulus and produce a paper clip effect. This design can allow for active remodeling of the ventricle (e.g., a reduction in any enlarged size) as the body adapts to reduced regurgitation compared to the previously defective native valve. Some other artificial replacement valves can be relatively large plug-in designs and can rely on radial forces for fixation and sealing, but the top-down method of sealing at the annulus of the present invention can allow the ventricle to recover better over time and reduce in diameter without interference from the replacement valve of the present invention.

[0155] Secondly, this arrangement allows the material covering the underside of the atrial flange portion to be kept taut around the top of the leaflet coaptation portion, thereby providing good contact between the material covering and the leaflet / annulus to promote sealing, healing, and possible tissue growth.

[0156] Third, a portion of the lower radial struts 162D (e.g., a portion near the outflow end of the frame 152, such as 162H) can be located within the annulus of the native valve. Because a portion of the lower radial struts 162D can be bent radially outward, this shape can help further seal the frame 152 to the native valve annulus, further limiting blood flow around the frame / valve.

[0157] The frame 152 of the present example can be formed from a single integral body, such as laser cut from a shape memory tube (e.g., a nitinol tube). Alternatively, one or more struts of the frame can be welded or otherwise interconnected. Alternatively, some components can be separated from each other and connected only by other materials, such as a material covering 154 or other connecting mechanism. For example, the main body portion 160, the leaflet engagement portion 158 and / or the atrial flange portion 156 may not be directly connected to each other in any combination. If a shape memory material is used for the frame 152, the frame can be cut into a desired pattern and then heat set to give it the desired shape in the expanded configuration.

[0158] The support structure 150 can be deployed from the delivery catheter 50 in the same manner as described above. Figures 10 to 12 The same as the support structure 100 shown. In this regard, the engagement struts 164 can be initially in a compressed state with their ends (circular expansions 164A) located at the distal end of the main body portion 160 within the delivery catheter 50. When the support structure 150 is pushed out or the outer sheath is retracted from the support structure 150, the engagement struts 164 extend radially outward from the delivery catheter 50, and then, as the support structure 150 continues to be advanced or exposed, the engagement struts 164 bend backward so that the circular expansions 164A are positioned in the inflow direction relative to the outflow end of the main body portion 160. In other words, as deployment proceeds, the engagement struts 164 bend or flip radially backward so that they capture the native valve leaflets 14B with the main body portion 160 and press against the valve annulus, as shown. Fig.47 shown.

[0159] It should be noted that in the compressed configuration within the delivery catheter 50, the holed end portion 162A can be located at the proximal end of the compressed support structure 150, while the engagement struts 164 are constrained at the distal end, so that the rounded portion 164A is located at the most distal position within the delivery device 50. In this regard, the holes are located at the proximal and distal ends of the support structure 150 in the compressed state. In addition, the hole portion 166C also includes holes along the middle of the length of the compressed configuration. These holes can be engaged with a feature structure of the delivery device 50, such as a column, hook, tether or similar structure, which helps to retain a portion of the support structure until fully deployed.

[0160] As previously mentioned, although the description of the support structures 100 and 150 is mainly carried out in this specification, special consideration is given to connecting the valve mechanism 170 (such as artificial or biological valve leaflets) within the valve support mechanism, such as Fig.46 shown.

[0161] Fig.48A method of delivering support structure 150 into tricuspid valve 14 is shown by advancing a delivery catheter through inferior vena cava 16 and into right atrium 18 such that support structure 150 is delivered from the inflow or atrial end relative to tricuspid valve 14 .

[0162] Fig.49 Another method of delivering a support structure 150 with a mitral valve 12 is shown by performing a transseptal procedure with a delivery catheter through the septum between the right atrium 18 and the left atrium 20. This allows the support structure 150 to be delivered from the inflow or atrial end relative to the mitral valve 12.

[0163] Other methods of delivering support structure 150 are also possible. For example, valves 14, 20 may be approached from the respective ventricles of either valve 14, 20. In this case, the support structure may be delivered in a manner similar to that of the ventricle 150. Figures 10 to 12 Arranged in the opposite direction to that shown.

[0164] Any support structure described herein, including support structures 100 and 150, may be delivered by one of a variety of known heart valve delivery devices, such as devices disclosed in U.S. Patent Application Nos. 2017 / 0165064, 2019 / 0008640, and 2022 / 0287836, the contents of which are incorporated herein by reference.

[0165] Although the present invention has been described according to specific embodiments and applications, those skilled in the art can obtain additional embodiments and modifications based on the teachings without departing from the spirit of the claimed invention or exceeding its scope. Therefore, it should be understood that the drawings and descriptions herein are provided by way of example to facilitate understanding of the present invention and should not be construed as limiting the scope of the present invention.

Claims

1. An artificial heart valve, comprising: A main body portion, the main body portion is substantially cylindrical; an atrial flange portion extending radially outward from the inflow end of the main body portion and forming a plurality of petal shapes annularly around the main body portion; and The leaflet coaptation portion includes a plurality of coaptation struts connected to the outflow end of the main body portion and extending along the outer side of the main body portion in the inflow direction.

2. An artificial heart valve according to claim 1, wherein the main body portion includes a plurality of elongated vertical main body struts arranged alternately in axial positions relative to each other.

3. An artificial heart valve according to claim 2, wherein the main body portion includes a plurality of horizontal main body struts forming a "V" shape or angle, and each of the horizontal main body struts is connected to two of the plurality of vertical main body struts.

4. An artificial heart valve according to claim 3, wherein the length of the main body portion is in the range of about 14 mm to about 18 mm, and the radius is in the range of about 27 mm to about 30 mm.

5. An artificial heart valve according to claim 1, wherein the atrial flange portion includes a plurality of upper radial flange struts and a plurality of lower radial flange struts, and the plurality of upper radial flange struts and the plurality of lower radial flange struts each extend from the main body portion; wherein the upper radial flange struts are located at a position closer to the inflow end of the artificial heart valve than the lower radial flange struts.

6. An artificial heart valve according to claim 1, wherein the atrial flange portion includes a plurality of radial flange struts; wherein the upper portion of the radial flange struts is connected to the atrial flange portion, and the lower portion of the radial flange struts is not connected to the atrial flange portion and is inclined toward the outflow end of the artificial heart valve.

7. An artificial heart valve according to claim 5, wherein the plurality of upper radial flange struts and the plurality of lower radial flange struts each have: a first angle in the range of approximately 90 degrees to 130 degrees, a relatively straight portion with a length in the range of approximately 3 mm to approximately 10 mm, a second angle in the range of approximately 20 degrees to approximately 150 degrees, and an end portion with a length in the range of approximately 1 mm to 7 mm.

8. An artificial heart valve according to claim 6, wherein the outer ends of the plurality of upper radial flange struts and the plurality of lower radial flange struts are interconnected by one of a plurality of annular radial struts, and the plurality of annular radial struts form a petal shape to accommodate the position difference between the plurality of upper radial flange struts and the plurality of lower radial flange struts.

9. An artificial heart valve according to claim 1, wherein the plurality of joining struts form a first bend of approximately 180 degrees, a first straight portion with a length ranging from approximately 3 mm to approximately 10 mm, a second bend bent in the opposite direction of the bend ranging from approximately 90 degrees to approximately 150 degrees, and a circular portion with a length ranging from approximately 2 mm to approximately 10 mm.

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

11. An artificial heart valve according to claim 10, wherein the end regions of the plurality of engagement struts are positioned to axially overlap the plurality of lower radial flange struts at radially adjacent positions in the range of about 0.1 mm to about 10 mm.

12. The prosthetic heart valve of claim 1 further comprising a material covering disposed over the frame, wherein the material covering forms one or more triangular gaps along an inflow edge of the body portion.

13. An artificial heart valve, comprising: A valve frame having an expanded structure, comprising: A cylindrical main body portion; a plurality of radial struts extending radially from a first end of the cylindrical body portion; and a plurality of engagement struts connected proximate the second end of the cylindrical body portion and extending along an outer side of the cylindrical body portion toward the first end; Wherein end regions of the plurality of engagement struts extend beyond at least some of the plurality of radial struts.

14. An artificial heart valve, comprising: a valve frame having a cylindrical main body portion and a leaflet engagement portion connected to a distal region of the main body portion; The leaflet coaptation portion includes a plurality of coaptation struts, which extend distally from the main body portion when the frame is in a compressed configuration within the delivery device, and which bend proximally and posteriorly along the outer side of the main body portion when the frame is in an expanded configuration.

15. An artificial heart valve according to claim 14, wherein the valve frame further comprises a plurality of radial struts extending radially outward from a proximal region of the main body portion.

16. The artificial heart valve of claim 15, wherein end regions of the plurality of engagement struts are located beyond proximal ends of some of the plurality of radial struts.

17. The prosthetic heart valve of claim 15, wherein the plurality of radial struts comprises a first group of radial struts and a second group of radial struts, wherein the first group of radial struts are located proximal to the second group of radial struts.

18. The prosthetic heart valve of claim 16, wherein end regions of the plurality of engagement struts are located beyond the proximal ends of the first group of radial struts and distal ends of the second group of radial struts.

19. An artificial heart valve according to claim 13, wherein the plurality of joining struts form a first bend of approximately 180 degrees, a first straight portion with a length ranging from approximately 3 mm to approximately 10 mm, a second bend bent in the opposite direction of the bend ranging from approximately 90 degrees to approximately 150 degrees, and a circular portion with a length ranging from approximately 2 mm to approximately 10 mm.

20. A method of delivering an artificial heart valve, comprising: advancing a delivery device adjacent to a native valve, the delivery device comprising a prosthetic valve having a frame; exposing a distal end of the frame, the distal end comprising a distal end of a cylindrical body portion and a plurality of leaflet coaptation struts connected proximate the distal end of the cylindrical body portion; bending the leaflet coaptation struts toward the proximal end of the cylindrical body portion and positioning the native leaflets of the native valve between the leaflet coaptation struts and the cylindrical body portion; and, Completely release the remaining portion of the delivery device inner frame.

21. An artificial heart valve, comprising: A main body portion, the main body portion is substantially cylindrical; an atrial flange portion extending radially and annularly outwardly from the inflow end of the body portion; and The coaptation of the leaflets; Wherein the atrial flange portion and the leaflet coaptation portion are configured to axially overlap each other at radially adjacent positions in a range of about 0.1 mm to about 10 mm.

22. An artificial heart valve, comprising: A main body portion, the main body portion is substantially cylindrical; an intra-annular sealing portion comprising a plurality of struts located radially outwardly of the main body portion and configured to engage an interior portion of a native valve annulus; and The leaflet coaptation portion includes a plurality of coaptation struts connected to the outflow end of the main body portion and extending along the outer side of the main body portion in the inflow direction.

23. The prosthetic heart valve of claim 22, further comprising an atrial flange portion extending radially outward from the inflow end of the main body portion; wherein the intra-annular sealing portion extends distally from the atrial flange portion.

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