Prosthetic heart valve framework, systems, and methods

Abstract

Prosthetic valve support structures of this specification include a body portion, an atrial flange portion, and a leaflet engaging portion. As the support structure (and the valve as a whole) is pushed out of or otherwise unrestrained from a delivery device, the free end(s) of the leaflet engaging portion will begin to bend radially outward or away from the body portion and will continue bending as more is exposed until its free end(s) are angled in an inflow direction, thereby positioning themselves between the radial outside of the native valve leaflets and the outflow track beyond the native valve annulus. As the support structure fully expands, the native valve leaflets remain trapped or engaged between the leaflet engaging portion and the body portion.

Description

PROSTHETIC HEART VALVE FRAMEWORK, SYSTEMS, AND METHODSRELATED APPLICATIONS

[0001] This application claims benefit of and priority to U.S. Provisional Application Serial No. 63 / 550,910 filed February 7, 2024 entitled Docking Station For Heart Valve Replacement, U.S. Provisional Application Serial No. 63 / 554,793 filed February 16, 2024 entitled Transcatheter Delivery System for Valve Dock, U.S. Provisional Application Serial No. 63 / 554,879 filed February 16, 2024 entitled Prosthetic Heart Valve Anchor, Systems, And Methods’, and U.S. Provisional Application Serial No. 63 / 554,088 filed February 15, 2024 entitled Transcatheter Dock for Balloon Expandable Valve-, all of which are hereby incorporated herein by reference in their entireties.BACKGROUND OF THE INVENTION

[0002] Heart valve disease is a common condition affecting millions of people worldwide. The heart has four valves, which regulate blood flow by opening and closing during 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 or even death.

[0003] Traditional treatment for heart valve disease involves surgical replacement of the affected valve with a prosthetic valve. While this procedure is effective, it is invasive and requires a significant recovery period. Additionally, some patients may not be eligible for surgery due to other health conditions.

[0004] In recent years, there has been growing 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 through a catheter, typically inserted into the femoral artery. The valve is then deployed within the damaged valve, replacing it and restoring normal blood flow.

[0005] More recently, there has been a growing interest in using this technique for the replacement of the mitral and tricuspid valves, known as Transcatheter MitralValve 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 option for patients with mitral or tricuspid valve disease, who may not be eligible for traditional surgical valve replacement.

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

[0007] Overall, TMVR and TTVR offer a promising new option for patients with mitral or tricuspid valve disease, who may not be eligible 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 techniques make them an exciting area of research and development in the field of cardiology.SUMMARY OF THE INVENTION

[0008] In some aspects, the techniques described herein relate to a framework for a prosthetic heart valve having an expanded configuration, including: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; wherein the passage of the body portion has a larger diameter at the outflow end relative to the inflow end.

[0009] In some aspects, the techniques described herein relate to a framework, wherein the passage of the body portion has a tapered conical shape.

[0010] In some aspects, the techniques described herein relate to a framework, wherein walls of the body portion are straight.

[0011] In some aspects, the techniques described herein relate to a framework, wherein the walls of the body portion include a plurality of vertical body struts each having an elongated straight shape.

[0012] In some aspects, the techniques described herein relate to a framework, wherein inflow ends of the plurality of vertical body struts are closer together than outflow ends of the plurality of vertical body struts.

[0013] In some aspects, the techniques described herein relate to a framework, wherein a diameter of the passage at the outflow end may be within an inclusive range of about 5 to 40 percent larger than the diameter of the inflow end.

[0014] In some aspects, the techniques described herein relate to a framework, wherein a diameter of the passage at the inflow end is within an inclusive range of about 5 mm to about 30 mm and a diameter of the passage at the outflow end is within an inclusive range of about 15 mm to about 45 mm.

[0015] In some aspects, the techniques described herein relate to a framework, wherein walls of the body portion include a plurality of vertical body struts each having a curved region near the inflow end and a straight region extending to the outflow end.

[0016] In some aspects, the techniques described herein relate to a framework, wherein the curved region has a length within an inclusive range of about 3 mm to about 15 mm and the straight region has a length within an inclusive range of about 3 mm to about 15 mm.

[0017] In some aspects, the techniques described herein relate to a framework, wherein walls of the body portion include a plurality of vertical body struts each having a first straight region that is generally parallel to a central axis extending between the inflow end and the outflow end of the body portion, and a second straight region that is oriented at a non-parallel angle relative to the central axis, where the first straight region is located closer to the inflow end than the second straight region.

[0018] In some aspects, the techniques described herein relate to a framework, wherein the first straight region has a length within an inclusive range of about 3 mmto about 15 mm and the second straight region has a length within an inclusive range of about 3 mm to about 15 mm.

[0019] In some aspects, the techniques described herein relate to a framework for a prosthetic heart valve having an expanded configuration, including: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; wherein the passage of the body portion has a larger diameter at the inflow end relative to the outflow end.

[0020] In some aspects, the techniques described herein relate to a framework, wherein the passage of the body portion has a tapered conical shape.

[0021] In some aspects, the techniques described herein relate to a framework, wherein walls of the body portion are straight.

[0022] In some aspects, the techniques described herein relate to a framework, wherein the walls of the body portion include a plurality of vertical body struts each having an elongated straight shape.

[0023] In some aspects, the techniques described herein relate to a framework, wherein outflow ends of the plurality of vertical body struts are closer together than inflow ends of the plurality of vertical body struts.

[0024] In some aspects, the techniques described herein relate to a framework, wherein a diameter of the passage at the inflow end may be within an inclusive range of about 5 to 40 percent larger than the diameter of the outflow end.

[0025] In some aspects, the techniques described herein relate to a framework, wherein a diameter of the passage at the outflow end is within an inclusive range of about 5 mm to about 30 mm and a diameter of the passage at the outflow end is within an inclusive range of about 15 mm to about 45 mm.

[0026] In some aspects, the techniques described herein relate to a framework, wherein walls of the body portion include a plurality of vertical body struts each havinga curved region near the outflow end and a straight region extending to the inflow end from the curved region.

[0027] In some aspects, the techniques described herein relate to a framework, wherein the curved region has a length within an inclusive range of about 3 mm to about 15 mm and the straight region has a length within an inclusive range of about 3 mm to about 15 mm.

[0028] In some aspects, the techniques described herein relate to a framework, wherein walls of the body portion include a plurality of vertical body struts each having a first straight region that is generally parallel to a central axis extending between the inflow end and the outflow end of the body portion, and a second straight region that is oriented at a non-parallel angle relative to the central axis, where the first straight region is located closer to the outflow end than the first straight region.

[0029] In some aspects, the techniques described herein relate to a framework, wherein the first straight region has a length within an inclusive range of about 3 mm to about 15 mm and the second straight region has a length within an inclusive range of about 3 mm to about 15 mm.

[0030] In some aspects, the techniques described herein relate to a framework for a prosthetic heart valve having an expanded configuration, including: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; wherein the passage of the body portion is narrower in diameter between and relative to the outflow end and the inflow end.

[0031] In some aspects, the techniques described herein relate to a framework, wherein walls of the body portion are convex.

[0032] In some aspects, the techniques described herein relate to a framework, wherein a diameter of the passage at the outflow end and a diameter at the inflow end may be within an inclusive range of about 5 to 40 percent larger than the diameter of a middle region of the passage.

[0033] In some aspects, the techniques described herein relate to a framework, wherein a diameter of the passage at a middle region is within an inclusive range of about 5 mm to about 30 mm and a diameter of the passage at the outflow end and at the inflow end is within an inclusive range of about 15 mm to about 45 mm.

[0034] In some aspects, the techniques described herein relate to a framework for a prosthetic heart valve having an expanded configuration, including: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; wherein the passage of the body portion is larger in diameter at locations between and relative to the outflow end and the inflow end.

[0035] In some aspects, the techniques described herein relate to a framework, wherein walls of the body portion are concave.

[0036] In some aspects, the techniques described herein relate to a framework, wherein a diameter of a middle region of the passage may be within an inclusive range of about 5 to 40 percent larger than the diameter of the passage at the outflow end and a diameter at the inflow end.

[0037] In some aspects, the techniques described herein relate to a framework, wherein a diameter of the passage at a middle region is within an inclusive range of about 15 mm to about 45 mm and a diameter of the passage at the outflow end and at the inflow end is within an inclusive range of about 5 mm to about 30 mm.

[0038] In some aspects, the techniques described herein relate to a framework for a prosthetic heart valve, including: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; wherein the framework has a first expanded configuration and a second expanded configuration; and whereinimplanting a valve mechanism within the framework changes the framework from the first configuration to the second configuration.

[0039] In some aspects, the techniques described herein relate to a framework, wherein the plurality of engagement struts are positioned further towards the inflow end in the second configuration relative to the first configuration.

[0040] In some aspects, the techniques described herein relate to a framework, wherein the body portion includes a plurality of vertical body struts that change angles between the first configuration and the second configuration.

[0041] In some aspects, the techniques described herein relate to a framework for a prosthetic heart valve, including: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; and, a plurality of engagement structures extending from the passage.

[0042] In some aspects, the techniques described herein relate to a delivery device, including: a framework delivery portion having one or more anchor members; a framework removably located within the framework delivery portion; a valve mechanism delivery portion having an expandible structure; a valve mechanism positioned over the expandible structure; wherein the valve mechanism delivery portion is located proximal of the framework delivery portion.

[0043] In some aspects, the techniques described herein relate to a delivery device, including: a framework delivery portion; a framework removably located within the framework delivery portion; a plurality of wires connected to the framework; and, a release mechanism connected to the plurality of wires.

[0044] In some aspects, the techniques described herein relate to a method, including: implanting a framework at a native cardiac valve; implanting a temporary artificial valve within the framework; removing the temporary artificial valve from the framework; and, implanting a permanent artificial valve within the framework.BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The following figures are included to illustrate certain example aspects of the present disclosure and should not be viewed as exclusive or limiting. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to one having ordinary skill in the art and having the benefit of this disclosure. The present disclosure references the drawings as follows:

[0046] Fig. 1 is a perspective view of a prosthetic heart valve support structure.

[0047] Fig. 2 is a cross-sectional view of the prosthetic heart valve support structure of Fig. 1.

[0048] Fig. 3 is a top view of a framework of the prosthetic heart valve support structure of Fig. 1 .

[0049] Fig. 4 is a side view of the framework of the prosthetic heart valve support structure of Fig. 1.

[0050] Fig. 5 is a side view of the framework of the prosthetic heart valve support structure of Fig. 1 .

[0051] Fig. 6 is a perspective view of the framework of the prosthetic heart valve support structure of Fig. 1 .

[0052] Fig. 7 is a perspective view of the framework of the prosthetic heart valve support structure of Fig. 1 .

[0053] Fig. 8 is a strut of the framework of the prosthetic heart valve support structure of Fig. 1.

[0054] Fig. 9 is a strut of the framework of the prosthetic heart valve support structure of Fig. 1 .

[0055] Fig. 10 is a compressed view of the framework of the prosthetic heart valve support structure of Fig. 1 .

[0056] Fig. 11 is a partially compressed view of the framework of the prosthetic heart valve support structure of Fig. 1 .

[0057] Fig. 12 is a view of the framework of the prosthetic heart valve support structure of Fig. 1 after deployment.

[0058] Fig 13 is a view of the framework of the prosthetic heart valve support structure of Fig. 1 within a native valve.

[0059] Fig 14 is a view of the framework of the prosthetic heart valve support structure of Fig. 1 within a native valve.

[0060] Fig. 15 is a view of framework of the prosthetic heart valve support structure of Fig. 1 within a native valve.

[0061] Fig. 16 is a perspective view of a prosthetic heart valve.

[0062] Fig. 17 is a side view of the prosthetic heart valve of Fig. 16.

[0063] Fig. 18 is a side view of the prosthetic heart valve of Fig. 16.

[0064] Fig. 19 is enlarged cross-sectional view of the prosthetic heart valve of Fig.16.

[0065] Fig. 20 is enlarged cross-sectional view of the prosthetic heart valve of Fig. 16.

[0066] Fig. 21 is enlarged cross-sectional view of the prosthetic heart valve of Fig. 16.

[0067] Fig. 22 is enlarged cross-sectional view of the prosthetic heart valve of Fig. 16.

[0068] Fig. 23 is a perspective view of a prosthetic heart valve.

[0069] Fig. 24 is a view of the prosthetic heart valve of Fig. 23.

[0070] Fig. 25 is a side view of the prosthetic heart valve of Fig. 23.

[0071] Fig. 26 is a bottom view of the prosthetic heart valve of Fig. 3.

[0072] Fig. 27 is a top view of the prosthetic heart valve of Fig. 23.

[0073] Fig. 28 is a cross-sectional view of the prosthetic heart valve of Fig. 23.

[0074] Fig. 29 is a cross-sectional view of the prosthetic heart valve of Fig. 23.

[0075] Fig. 30 is an enlarged view of the prosthetic heart valve of Fig. 23.

[0076] Fig. 31 is an enlarged view of the prosthetic heart valve of Fig. 23.

[0077] Fig. 32 is an enlarged view of the prosthetic heart valve of Fig. 23.

[0078] Fig. 33 is an enlarged view of the prosthetic heart valve of Fig. 23.

[0079] Fig. 34 is a perspective view of a framework of the prosthetic heart valve of Fig. 23.

[0080] Fig. 35 is a side view of a framework of the prosthetic heart valve of Fig. 23.

[0081] Fig. 36 is a side view of a framework of the prosthetic heart valve of Fig. 23.

[0082] Fig. 37 is a top view of a framework of the prosthetic heart valve of Fig. 3.

[0083] Fig. 38 is a bottom view of a framework of the prosthetic heart valve of Fig.23.

[0084] Fig. 39 is an enlarged view of a framework of the prosthetic heart valve of Fig. 23.

[0085] Fig. 40 is an enlarged view of a framework of the prosthetic heart valve of Fig. 23.

[0086] Fig. 41 is an enlarged view of a framework of the prosthetic heart valve of Fig. 23.

[0087] Fig. 42 is an enlarged view of a framework of the prosthetic heart valve of Fig. 23.

[0088] Fig. 43 is an enlarged view of a framework of the prosthetic heart valve of Fig. 23.

[0089] Fig. 44 is a cross-sectional view of a framework of the prosthetic heart valve of Fig. 23.

[0090] Fig. 45 is a simplified line view of several components of the prosthetic heart valve of Fig. 23.

[0091] Fig. 46 is a view of the prosthetic heart valve of Fig. 23 with valve leaflets.

[0092] Fig. 47 is a side view of the prosthetic heart valve of Fig. 23 in a native heart valve.

[0093] Fig. 48 is a side view of the prosthetic heart valve of 3. 23 in a native heart valve.

[0094] Fig. 49 is a side view of the prosthetic heart valve of Fig. 23 in a native heart valve.

[0095] Fig. 50 illustrates a side view of a framework.

[0096] Fig. 51 illustrates a simplified cross-sectional view of one side of the framework of Fig. 50.

[0097] Fig. 52 illustrates a simplified cross-sectional view of the entire framework of Fig. 50.

[0098] Fig. 53 illustrates a simplified cross-sectional view in which the vertical body struts have a curved region near the inflow end of the body portion and a relatively straight region extending towards the outflow end of the body portion.

[0099] Fig. 54 illustrates a simplified cross-sectional view in which the vertical body struts may have a generally straight region that is generally parallel to a central axis extending between an inflow end and outflow end of the body portion, followed by a generally linear region that is oriented at a non-parallel angle relative to the central axis.

[0100] Fig. 55 illustrates a side view of a framework.

[0101] Fig. 56 illustrates a simplified cross-sectional view of one side of the framework of Fig. 55.

[0102] Fig. 57 illustrates a simplified cross-sectional view of the entire framework of Fig. 55.

[0103] Fig. 58 illustrates a simplified cross-sectional view in which the vertical body struts have a generally straight region (or gently curved region) near the inflow end of the body portion and a curved region extending towards the outflow end of the body portion.

[0104] Fig. 59 illustrates a side view of a framework.

[0105] Fig. 60 illustrates a simplified cross-sectional view of one side of the framework of Fig. 59.

[0106] Fig. 61 illustrates a simplified cross-sectional view of the entire framework of Fig. 59.

[0107] Fig. 62 illustrates a side view of a framework.

[0108] Fig. 63 illustrates a simplified cross-sectional view of one side of the framework of Fig. 62.

[0109] Fig. 64 illustrates a simplified cross-sectional view of the entire framework of Fig. 62.

[0110] Fig. 65 illustrates a simplified cross-sectional view of a framework in which the inflow end of the body portion has a larger diameter than the outflow end of the body portion.

[0111] Fig. 66. illustrates a simplified cross-sectional view of the framework of Fig. 65 in its second expanded configuration (i.e., after the valve mechanism has been implanted into the body portion of the framework).

[0112] Fig. 67 illustrates a simplified cross-sectional view of a framework on which material covering is attached to only an outflow portion.

[0113] Fig. 68 illustrates a cutaway view of a framework that may include a plurality of engagement structures.

[0114] Fig. 69 illustrates a simplified cross-sectional view of the framework of Fig. 68 that illustrates a profile of the plurality of engagement structures from a different view.

[0115] Fig. 70 illustrates a simplified side view of a delivery device that may deliver both a framework for use as a dock and a valve mechanism into the implanted framework.

[0116] Fig. 71 illustrates a simplified side view of a delivery device for a framework for allowing retrieval of the framework during a procedure if the user is not satisfied with its initial placement or deployment position.

[0117] Fig. 72 illustrates a flow chart for a method of using a temporary artificial valve during a procedure.DETAILED DESCRIPTION

[0118] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein. A variety of modifications and variations are possible in view of the teachings herein without departing their scope, spirit, or intent.

[0119] While different examples may be described in this specification, it is specifically contemplated that any of the features from the different examples can be used and brought together in any combination. In otherwords, the features of different examples can be mixed and matched with each other. Hence, while every permutation of features from different examples may not be explicitly shown or described, it is the intention of this disclosure to cover any such combinations, especially as may be appreciated by one of skill in the art.

[0120] The terminology used in this disclosure should be interpreted in a permissive manner and is not intended to be limiting. In the drawings, like numbers refer to like elements. Unless otherwise noted, all of the accompanying drawings arenot to scale. Unless otherwise noted, the term “about” is defined to mean plus-or- minus 5% of a stated value.

[0121] The terms distal or distally generally refer to a direction or area towards an end of a device within a patient (e.g., away from a physician / clinician), while the terms proximal or proximally refer to a direction or area toward an end of a device that remains outside of a patient (e.g., toward or closer to a physician / clinician or handle / hub of a device).

[0122] Numerical ranges discussed in this specification should be interpreted as both inclusive numerical ranges and as explicitly covering / disclosing a plurality of numbers within the ranges. Specifically, a range should be considered to recite numbers that increment by two decimal places (hundredths) for the purposes of support in the claims (e.g., 0.01 , 0.02, 0.03, etc.). Any of these incremented numbers from a range should be understood to have significance and importance in the context of the present specification.

[0123] The present specification is generally directed to prosthetic or artificial heart valves. These heart valves may be used to replace any of the native heart valves (e.g., aortic valve, mitral valve, pulmonary valve, or tricuspid valve), however, the artificial heart valves of this specification may be particularly useful for replacing a mitral or tricuspid valve.

[0124] Generally, the present artificial heart valves include a support structure that supports artificial valve leaflets or similar mechanisms that allow blood to generally flow in only one direction through the artificial heart valve. This specification focuses mostly on aspects of the support structure and therefore the figures may not all disclose artificial leaflets or similar structures therein. However, it should be understood that the use of leaflets and similar structures with the support structures are specifically contemplated. In other words, while much of this disclosure may focus on aspects of artificial valve support structures, the artificial valve as a whole is specifically included as part of the present invention.

[0125] The term “support structure” and “framework” and similar variations may be used throughout this specification. Such terms should be interpreted broadly toinclude support structures or frameworks from any type of artificial valve, either in part or as a whole. For example, a support structure or framework may be integrally or permanently included with valve leaflets and valve structures. In another example, a support structure or framework may be an artificial valve “dock” that is implanted first within a patient and into which a separate closure mechanism (e.g., leaflets, valve structures) is later deployed therein. Hence, a support structure or framework may specifically be a unified, integrated part of an artificial heart valve or a separate dock component that is connected to other closure / valve components within a patient.

[0126] When referring to the artificial valves and support structures in this specification, the terms “top end,” “inflow end,” and similar variants may be used interchangeably to mean an end of the device through which blood normally first enters the valve / device. For example, referring to a tricuspid valve, the end of the device in or closest to the right atrium. The terms “bottom end,” “outflow end,” and similar variants may be used interchangeably to mean an end of the device through which blood normally exits the valve / device. For example, referring to a tricuspid valve, the end of the device in or closes to the right ventricle. In addition, the artificial valves and support structures in this specification may be referred to as having proximal ends / portions and distal ends / portions in the context of a delivery device / catheter. Typically, the term proximal indicates a portion or direction along the delivery device closer to the physician and distal indicates a portion or direction along or away from the delivery device in the opposite direction of the physician. In some of the 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.

[0127] Generally, some of the artificial valve support structures of this specification include a body portion, an atrial flange portion, and a leaflet engaging portion. These features may take on different shapes, depending on whether the support structures are in a radially compressed configuration for deployment or a radially expanded configuration after deployment.

[0128] When the support structure is in its expanded configuration, the body portion may have a generally tubular or cylindrical shape with a passage extending between an inflow end and an outflow end. Alternatively, the body portion may have a generallyconcave, convex, or funnel shape, or may have a middle region with an increased or decreased diameter relative to the ends (e.g., hourglass shape or “bulging middle"). Typically, artificial leaflets or similar valve structures are fixed, mounted, deployed, or connected within the passage, such as at the middle or at either end of the passage. These artificial leaflets or similar valve structures can be tied to the body portion, connected with adhesive, fictionally engaged, or connected by similar means.

[0129] In the expanded configuration of the support structure, the atrial flange portion is a flange, lip, projection, or overhang that forms a generally annular region that extends radially outward from an inflow end of the body portion. The atrial flange portion may help seal around an inflow end of the device with the annulus of the native valve being replaced, thereby preventing blood from circumventing the passage of the body portion. In that respect, it may be desirable forthe atrial flange portion to conform to the shape of the annulus of the valve. The atrial flange may extend completely and continuously around the entire circumference of the body portion or may only extend partially around the circumference of the body portion (e.g., two or more segments or a plurality of struts).

[0130] In the expanded configuration of the support structure, the atrial flange portion may be relatively flat or may have one or more curved surfaces. Additionally or alternatively, the flange may be generally perpendicular to an axis of the body portion or may radially extend at any angle 0 and 180 degrees relative to said axis. In one example, the atrial flange has an initial angle of about 110 degrees (plus or minus 10 degrees) bending slightly towards the direction of the annulus and then further bends upward (e.g., away from the annulus) to conform to the walls of the atrium. In some instances, it may be helpful for the atrial flange to generally conform to a top or inflow surface of a valve annulus (e.g., mitral or tricuspid valve annulus), as well as sidewalls of the surrounding atrium. Hence, depending on the length of the atrial flange, it may be helpful for the end region of the atrial flange to bend or be angled such that its edges are direction generally in an inflow direction similar to the walls of the right / left atrium (e.g., a similar angle to the longitudinal axis of the body portion).

[0131] In the expanded configuration of the support structure, the leaflet engaging portion may be positioned radially around the outside of the body portion in a manner to capture the native valve leaflets of the patient between the leaflet engaging portionand the body portion of the support structure. In one example, the leaflet engaging portion may be a plurality of struts and / or may be a continuous radial member. The leaflet engaging portion may further be connected to the body portion at or near an outflow end of the body portion and extend towards the inflow end of the body when the support structure is in its fully expanded configuration. The leaflet engaging portion may include one or more curved regions, such as a curved region near the free end(s) of the leaflet engaging portion that curves radially outward so as to engage an outflow surface of a native annulus of a native heart valve. Additionally or alternatively, the leaflet engaging portion may include one or more curves that position at least a portion of the leaflet engaging structure closer to or in contact with the body portion to help pinch or engage the native valve leaflets. Alternatively, the leaflet engaging portion may be spaced with a gap (e.g., uniform or non-uniform) with the body portion.

[0132] In the compressed configuration of the support structure, the body portion may be radially or diametrically compressed. The atrial flange may also be radially compressed and may further be 1 ) folded proximally or in an inflow direction such that its free end(s) are positioned further away from the body portion, or 2) may be folded distally or in an outflow direction such that the atrial flange is pressed against the body portion. The leaflet engaging portion may be 1) folded distally or in an outflow direction such that its free end(s) are positioned further away from the body portion, or 2) may be folded proximally or in an inflow direction such that the leaflet engaging portion is pressed against the body portion.

[0133] In some examples, it can be helpful to have the leaflet engaging portion folded distally in a delivery device in its compressed configuration such that its free end(s) are positioned away from the body portion. As the support structure (and the valve as a whole) is pushed out of or otherwise unrestrained from a delivery device, the free end(s) of the leaflet engaging portion will exit and be exposed first. As the free end(s) 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 engaging portion will continue bending as more is exposed until its free end(s) are angled in an inflow direction, thereby positioning themselves between the radial outside of the native valve leaflets and the outflow track beyond the native valve annulus. As the support structure fully expands, the native valve leaflets remaintrapped or engaged between the leaflet engaging portion and the body portion. This functionality should be understood to also be a method of deployment of the support structure.

[0134] In some examples, it can be helpful to construct the support structure such that in its expanded configuration, the end(s) of the leaflet engaging portion and the atrial flange portion each contact and therefore pinch or engage each side of the native valve annulus (or nearby tissue). This may help provide a better seal to the atrial flange portion to prevent blood from bypassing the artificial valve or creating a paravalvular leak. This may also help maintain the artificial valve in its intended position within a patient’s heart.

[0135] In some examples, it can be helpful to construct the support structure such that in its expanded configuration, the end(s) of the leaflet engaging portion are positioned at a more proximal location or further in an inflow direction than at least some radially-adjacent portions (e.g., struts) of the atrial flange portion. When these portions are viewed from a side perspective, they overlap each other with regard to the axial position of their ends. This may be particularly helpful in two respects. First, this arrangement forces the leaflets and the annulus to be positioned over the leaflet engaging portion and then below the lower portion flange (e.g., lower radial strut), forcing the leaflets / annulus into an alternating or wave-like shape. Hence, the leaflet engaging portion and the atrial flange portion tend to pinch the leaflets / annulus and create a paperclip effect. Second, this arrangement may hold the material covering on the underside of the atrial flange portion taut around the top of the leaflet engaging portion so that there is good contact between the material covering and the leaflets / annulus to promote sealing, healing, and possibly tissue in-growth.

[0136] The support structure may have different approaches to its construction. In one example, the support structure comprises an underlying framework and a material covering placed onto or over part or all of the framework.

[0137] The framework may be composed of a shape memory material which has a specific shape imparted to it and which it returns to after being constrained. Example shape memory materials include Nitinol and similar alloys.

[0138] The framework may be composed of an entire single unitary framework. For example, the framework may be created from a shape memory tube (e.g., Nitinol) that is laser cut and then heat set to its desired expanded shape. Alternatively, a plurality of shape memory struts / shapes may be welded or otherwise connected together and then the desired expanded shape imparted to the connected struts / shapes.

[0139] The framework may also be composed of separate components that are connected to each other, either by welding, tying, adhesive, or via each component being separately connected to the material covering (i.e., the material covering interconnects the components). For example, the body portion, the atrial flange portion, and the leaflet engaging portion may all be separate components (e.g., welded together or connected via the material covering).

[0140] Some components of the framework may be composed of different types and structures material. For example, the body portion may be composed of a plurality of braided shape memory wires while the atrial flange portion and the leaflet engaging portion may be composed of non-braided shape memory struts / shapes (e.g., laser cut Nitinol components). In another example, the body portion and the leaflet engaging portion may be composed of non-braided shape memory struts / shapes (e.g., laser cut Nitinol components) and the atrial flange portion may be composed of a flexible polymer or similar material (e.g., silicone, PET, EPTFE etc.).

[0141] The framework may have different thicknesses in different areas (i.e., not only different lengths and widths, but thickness of the framework material itself). For example, the atrial flange portion may have a larger thickness than the body portion. In another example, the leaflet engaging portion may have a larger thickness than the body portion.

[0142] Certain components of the framework may be composed of elongated arms or struts without the material covering located on them. For example, the leaflet engaging portion may be composed of a plurality of struts positioned and connected at circumferential locations around the body portion. These locations can be either uniformly spaced or non-uniformly spaced only in certain areas. However, these arms or struts may have a coating and / or caps on their distal end. For example, the arms or struts may have a flexible coating that helps frictionally engage the leaflets and anend cap on the free ends of the arms / struts that is also composed of a flexible material to help minimize tissue damage during deployment and chronic implantation. Such a coating / cap may be composed of pericardial tissue, EPTFE, textile material, PET, polyurethane, silicone, and similar materials. The elongated arms or struts may all have the same length or may have different lengths, such as alternating between longer and shorter lengths.

[0143] The material covering may be connected to or otherwise positioned on part or all of the framework. Additionally or alternatively, the material covering may be disposed on only the inside of the framework, only the outside of the framework, or on both the inside and outside of the framework. In one example, the material covering is positioned on the body portion and the atrial flange portion, but not on the leaflet engaging portion. In another example, the material covering is positioned only on the atrial flange portion. In another example, the material covering is positioned only on the body portion. Additionally or alternatively, the material may create openings or other shapes (e.g., triangular edges) against the framework.

[0144] The material covering may be composed of a biocompatible, flexible material. The material covering may be a solid, non-porous sheet (e.g., a polymer sheet) or a woven fabric. Example materials include textile material, EPTFE sheets, PET sheets, Silicone, polyurethane, similar materials, or derivatives thereof. This material covering may also be configured, at least in certain areas, to encourage ingrowth of tissue.

[0145] The valve leaflets may be connected to the body portion, such as near the middle or near either end of the body portion. Generally, the valve leaflets are configured to open to allow blood flow from the inflow end (e.g., from the left / right atrium) and remain closed against blood pressure from the outflow end (e.g., from the 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 may all be attached to each other into a valve assembly that is then attached to the support structure. The valve leaflets may be attached to the body portion in a normally open or a normally closed position. The shape of the valve leaflets is such that the leaflets take a natural cusp like shape similar to a native aortic valve, or similar valve. This shape along with the covering material of the body structure can create a sinus likeshape similar to a valve sinus to allow for favorable flow conditions and beneficial blood flow washout to prevent stasis locations and thrombus formation. The valve leaflets may be attached to the valve body in a configuration to allow for an amount of overlap or coaptation at the free edge with a range of 0 to 20mm. There may be an intentional gap in the valve leaflet coaptation to allow for a small amount of blood to leak through the valve so as to not over pressure the heart after the new valve is in place. The valve leaflets may be composed of an artificial material or from natural biological material. The valve leaflets may be processed using anti-calcification and tissue fixation processes to prevent the human body from rejecting the implanted device and to also prevent leaflet calcification. The tissue may be processed in a condition that allows for the valve prosthesis to be stored and sterilized in glutaraldehyde or in dry storage after other means of sterilization such as ETO. The tissue can also be processed with or coated with antithrombotic chemicals or coatings.

[0146] The support structure may also include features that allow engagement with a delivery device to assist in deployment of the support structure. Additionally or alternatively, features may be included that allow the support structure to be recaptured after at least partial deployment from the delivery device. For example, the support structure may include one or more apertures or enlargements, such as on its framework, that are releasably engaged with portions of the delivery device. The apertures or enlargements 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 enlargements may be located at locations at the edge of the atrial flange portion and / or at locations near the end of the body portion. The delivery device may include a breakable thread that passes through / around the apertures / enlargements, depressions in an inner pusher that capture the apertures / enlargements, hooks, posts, loops, stent-like mesh, or similar mechanisms such that a physician may advance, retract, and / or release the support structure from the delivery device.

[0147] Any of the support structures in this specification may be delivered from one of several known heart valve delivery devices. For example, the devices in U.S. Pub. No. 2017 / 0165064, 2019 / 0008640, and 2022 / 0287836, the content of which is hereby incorporated by reference.

[0148] Figs. 1-13 illustrate various aspects of one example of a support structure 100 of an artificial valve in its expanded configuration. As seen best in Figs. 1 and 2, the support structure 100 generally includes a body portion 110, an atrial flange portion 106, and a leaflet engaging portion 108.

[0149] In the present example, the body portion 110 has a generally cylindrical shape, though other shapes are possible, such as an hourglass shape, a conical shape, a concave shape, or a convex shape.

[0150] In the present example, the atrial flange portion 106 extends radially outward from a top end or an inflow end of the body portion 1 10. The atrial flange portion 106 may form a complete circular or annular shape beyond that of the body portion 110, though it may alternatively have other shapes such as an oval shape and may only extend around a portion of the circumference of the body portion 110 (e.g., flange regions on only opposite sides of each other).

[0151] In the present example, the atrial flange 106 may have at least two regions having different angles relative to each other, as best seen in the cross-sectional view of Fig. 2. A first region initially extends radially away from the inflow end of the body portion 110. Relative to an axis extending through the inner passage of the support structure, the first region may have an angle within an inclusive range of about 70 degrees and 140 degrees (e.g., about 110 degrees). A second region radially extends from the first region and has an angle within an inclusive range of 120 degrees and 170 degrees (e.g., about 160 degrees). Generally, these two regions of the atrial flange portion 106 may help it conform to the top / inflow surface of the native valve annulus, as well walls or other areas of the atrium.

[0152] In the present example, the leaflet engagement portion 108 may comprise a plurality of engagement struts 114 that are connected at an outflow end of the body portion 110 and extend in an inflow or upward direction. As will be described in further detail later, the engagement struts 114 curve towards the body portion 110 and then away from the body portion 1 10, terminating with a cap member 120. The initial curve towards the body portion 1 10 may help pinch or engage the native leaflets with the body portion 1 10. The cap 120 may comprise a flexible or relatively softer material (e.g., pericardial tissue, EPTFE, PET, textile materials, silicone, polyurethane, orsimilar materials) to help prevent damage to the patient’s heart tissue. The cap may be adhered to or otherwise connected to the very distal end of the engagement strut 114.

[0153] In the present example, the engagement struts 114 are positioned at equal distances from each other around the circumference of the body portion 1 10. Again, non-uniform positioning of these struts 114 is also possible, such as only on opposite sides of the body portion 110 or in locations that may help avoid chordae within the ventricle.

[0154] The support structure 100 in the present example includes a rigid framework 102 and a material covering 104 that is disposed over portions of the framework 102. The material covering 104 is positioned over all or most of an outside of the body portion 110 of the framework 102, over an outside of the atrial flange portion 106 of the framework 102, and around on an inner side of the atrial flange portion 106 of the framework 102. The engagement struts 1 14 are generally left uncovered by the material covering 104. As previously described, other variations are also possible, such as locating the material covering on only the inside, only the outside, and / or on any combination of the portions 106, 108, 110.

[0155] In the present example, the material covering 104 may be attached by adhesive, stitches, combinations thereof, and similar mechanisms. The material covering 104 may be composed of textile material, EPTFE sheets, PET sheets, and similar materials discussed elsewhere in this specification. In addition to the material covering 104, additional materials may be included on an underside of the atrial flange 106 to help create a better seal with the native valve annulus, such as hydrogel.

[0156] Figs. 3-9 illustrate various aspects of the framework 102 in the present example. The body portion 110 of the framework 102 is composed of a plurality of elongated vertical body struts 116B and a plurality of horizontal body struts 116A. The vertical body struts 116B are generally parallel to an axis through the support structure’s passage (i.e., an axis from the inflow end to the outflow end), while the horizontal body struts 116A are positioned around this axis in a circular shape.

[0157] The horizontal body struts 116A may form a “V” shape or a relatively sharp angle pointing towards the outflow direction, though the opposite direction is also possible. Each end of a horizontal body strut 116A connects to a vertical body strut 116B. The “V” shape of the horizontal body strut 116A provides a bend 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. Alternatively, other shapes with angles in them may also be possible for the horizontal body structure 116A, such as a “W” shape with two or more angles. In the present example, there are two rows of horizontal body struts 1 16A, though more rows are possible.

[0158] In one example, the body portion 110 of the framework 102 has a length within an inclusive range of about 14 mm to about 18 mm, and has a diameter within an inclusive range of about 27 mm to about 30 mm.

[0159] The atrial flange portion 106 of the framework 102 includes a plurality of flange struts 1 12. The shape of these flange struts 112 can be best seen in Fig. 8. Each flange strut 112 extends from one of the vertical body struts 116B and forms a first angle 112A within an inclusive range of about 90 degrees and 130 degrees, a relative straight portion 112B with a length within an inclusive range of about 3 mm and about 10 mm, a second angle 112C within an inclusive range of about 20 degrees and about 150 degrees, and a terminal portion 112D with a length within an inclusive range of about 1 mm and 7 mm (again, angles relative to an inflow / outflow oriented axis of the support structure 100). Generally, the specific angles and sizes may vary somewhat depending on the heart and valve size of the patient.

[0160] The leaflet engaging portion 108 of the framework 102 includes a plurality of engagement struts 114, the shape of which can be best seen best in Fig. 9. The leaflet engaging struts 114 are connected to the outflow end of the vertical body struts 116B. From the vertical body strut 116B, the engagement strut forms a first curve 114E which curves around beyond 180 degrees (e.g., an inclusive range of about 150 degrees to about 230 degrees), a first straight portion 114D with a length within an inclusive range of about 3 mm and about 10 mm, a second curve 1 14C curving in an opposite direction of curve 114D within an inclusive range of about 90 degrees to about 150 degrees, a second straight portion 114B with a length within an inclusive range ofabout 2 mm to about 10 mm, and finally a third curve 114A in the same direction as the second curve 114C and within an inclusive range of about 60 degrees and about 150 degrees. While these curves all generally occur in the same plane, it is possible to include additional curves that may take some of the engagement struts 114 out of a single plane (i.e., curving in multiple dimensions).

[0161] As previously discussed, the engagement struts 114 are not covered by the material covering 104 in the present example, but may be. Additionally, the engagement struts 114 may be coated or wrapped in a relatively softer material (e.g., a textile or EPTFE layer). Further, the ends of the engagement struts may include cap members 120 composed of similar materials or other materials described in this specification.

[0162] The framework 102 of the present example may be composed of a single unitary body, such as laser cut from a shape memory tube (e.g., Nitinol tube). Alternatively, one or more of the struts of the framework may be welded or otherwise attached to each other. Alternatively, some of the components may be separate from each other, only connected by other materials, such as the material covering 104 or other attachment mechanisms. For example, the body portion 110, the leaflet engagement portion 108, and / or the atrial flange portion 106 may not be directly attached to each other in any combination. If shape memory material is used for the framework 102, the framework may be cut to a desired pattern and then heat set to impart a desired shape in its expanded configuration.

[0163] Figs. 10-12 illustrate how the support structure 100 may deploy from a delivery catheter 50. In Fig. 10, the support structure 100 is illustrated mostly within with delivery catheter 50 (note, for clarity only the framework 102 is illustrated in this figure). As the support structure 100 begins to be pushed out, the free ends of the engagement struts 114 begin to radially expand outward.

[0164] In Fig. 11 , the support structure 100 has moved further distally out of the delivery catheter 50. The distal or outflow end of the body portion 110 has radially expanded and the engagement struts 114 of the leaflet engagement portion 108 have completely escaped the delivery catheter 50 and have inverted themselves such thattheir free ends are now located towards a proximal or inflow end of the body portion 110.

[0165] In Fig. 12, the support structure is fully deployed to its expanded configuration. Fig. 13 illustrates the expanded configuration within a tricuspid valve 14. As can be seen, the engagement struts 1 14 have been positioned around the leaflets 14B so as to capture the leaflets 14B against the body portion 110. Additionally, it can be seen that the bottom of the atrial flange portion 106 contacts and engages a top portion of the valve annulus 14A, while the angled free ends of the engagement struts engage a bottom portion of the valve annulus 14A. Hence, the support structure 100 may better engage the annulus 14A and keep the valve leaflets 14B out of the way.

[0166] Fig. 14 illustrates one approach to delivering a support structure 100 within a tricuspid valve 14 of a heart 10 by advancing a delivery catheter through the inferior vena cava 16 and into the right atrium18, such that the support structure is delivered from an inflow or atrial end relative to the tricuspid valve 14.

[0167] Fig. 15 illustrates another approach to delivering a support structure 100 with a mitral valve 12 by performing a transeptal procedure to allow the 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 from an inflow or atrial end relative to the mitral valve 12.

[0168] Additional approaches to delivering the support structure 100 are also possible. For example, either valve 14, 20 may be approached from its respective ventricle (22, 24). In such cases, the support structure may be arranged in an opposite orientation as shown in Figs. 10-12.

[0169] Figs. 16-22 illustrate 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 to two adjacent flange struts 112 and forms a “V” shape downward towards an outflow end of the framework 130. While this strut 132 may be considered part of the atrial flange portion 106, it may be positioned within the annulus of the valve while portions of the flange struts 112 remain on a top or atrialsurface of the annulus of the native valve. Hence, the atrial flange portion 106 of this embodiment may be further considered to have a top sealing portion (i.e., flange struts 112) and an intra-annulus engaging / sealing portion (struts 132). In that manner, the framework 130 may better seal the framework / valve to prevent blood leakage around the framework / valve.

[0170] As best seen in Fig. 20, the strut 132 initially extends relatively horizontal from the flange strut 112 and then forms a first angle 132A that may be within an inclusive range of about 135 degrees to about 180 degrees towards an outflow end of the framework 130. The strut 132 may further have a straight region 132B with a length in an inclusive range of about 3 mm to about 10 mm. Finally, the strut 132 forms a middle angle 132C, opposite of the first angle 132A within an inclusive range of about 90 degrees and about 120 degrees. The straight region 132B and angle 132A symmetrically repeat on the opposite side of the middle angle 132C, thereby creating a generally “V” shape between two of each of the flange struts 1 12.

[0171] As seen best in Fig. 21 , the “V” shaped strut 132 may be further angled generally straight / parallel to an axis of the framework 130 or may be angled such that the tip of the “V” shape, or angle 132C, is positioned somewhat close to the body portion 1 10. In other words, the strut 132 may angle radially inwards toward the outflow end of the framework. This may help the “V” shape of the strut 132 to fit into and engage the annulus of the native valve. In one example, the strut 132 is angled radially inward within a range of about 0 degrees to about 30 degrees.

[0172] Figs. 23-33 illustrate various aspects of another example of a support structure 150 that is generally similar to the previously described support structure 100, but includes several notable differences discussed further below. As seen best in Fig. 18, the support structure 150 generally includes a body portion 110, an atrial flange portion 106, and a leaflet engaging portion 108.

[0173] In the present example, the body portion 160 has a generally cylindrical shape, though other shapes are possible, such as an hourglass shape, a conical shape, a concave shape, or a convex shape.

[0174] In the present example, the atrial flange portion 156 extends radially outward from a top end or an inflow end of the body portion 160. The atrial flange portion 156 may form a complete circular or annular shape beyond that of the body portion 160, though it may alternatively have other shapes such as an oval shape and may only extend around a portion of the circumference of the body portion 160 (e.g., flange regions on only opposite sides of each other). As seen best in Fig. 23, the atrial flange portion 156 also generally forms a plurality of petal shapes, pointed shapes, or outwardly narrowing shapes, such that the width of each of these areas decreases as the distance from the body portion 160 increases.

[0175] In the present example, the atrial flange 156 may have at least two regions having different angles relative to each other, as best seen in the cross-sectional view of Fig. 22. A first region initially extends radially away from the inflow end of the body portion 160. Relative to an axis extending through the inner passage of the support structure, the first region may have an angle within an inclusive range of about 70 degrees and 140 degrees (e.g., about 120 degrees). A second region radially extends from the first region and has an angle within an inclusive range of 150 degrees and 220 degrees (e.g., about 200 degrees). Generally, these two regions of the atrial flange portion 156 may help it conform to the top / inflow surface of the native valve annulus, as well as walls or other areas of the atrium or leaflet / annulus.

[0176] In the present example, the leaflet engagement portion 158 may comprise a plurality of engagement struts 164 that are connected at an outflow end of the body portion 160 and extend in an inflow or upward direction. As will be described in further detail later, the engagement struts 164 curve generally parallel to the body portion 160 and then away from the body portion 160, terminating with an enlargement 164A (Fig. 23). The initial curve towards the body portion 160 may help engage or capture the native leaflets with the body portion 160. The enlargement 164A may be generally rounded to prevent damage to a patient’s valve tissue and may further include one or more apertures that may be optionally used to releasably engage the support structure 150 by a delivery catheter 50.

[0177] In the present example, the engagement struts 164 are positioned at equal distances from each other around the circumference of the body portion 160. Again, non-uniform positioning of these struts 164 is also possible, such as only on oppositesides of the body portion 160 or in locations that may help avoid chordae within the ventricle.

[0178] The support structure 150 in the present example includes a rigid framework 152 and a material covering 154 that is disposed over portions of the framework 152. The material covering 154 is positioned over all or most of an inside and outside of the body portion 160 of the framework 152 (seen best in Figs. 28 and 29), and over an outside of the atrial flange portion 156 of the framework 152. The engagement struts 164 are generally left uncovered by the material covering 154. As previously described, other variations are also possible, such as locating the material covering 154 on only the inside, only the outside, and / or on any combination of the portions 156, 158, 160.

[0179] As best seen in Figs. 28 and 29, the material covering 154 at the outflow end of the body portion 160 may form petals, pointed areas, or triangular areas 154A that generally match the underlying shapes of the framework 152 of the body portion 160. Alternatively, the outflow end of the body portion 160 may have a uniform circular-shaped edge.

[0180] Similarly, the edge of the material covering 154 at the inflow end of the body portion 160 may include one or more inset pointed or triangular gaps, spaces, or recesses 154B. While the triangular areas 154A are shown immediately adjacent to each other, the recesses 154B may be less frequent between relatively uniform edge regions. However, the inflow edge or outflow edge may take on either of the disclosed patterns in any combination, as well as have a completely uniform and perpendicular edge. As also seen in Fig. 23, the material covering 154C may also conform to the shape of the triangles or pointed petal shape of the atrial flange portion 156.

[0181] In the present example, the material covering 154 may be attached by adhesive, stitches, combinations thereof, and similar mechanisms. The material covering 154 may be composed of textile material, EPTFE sheets, PET sheets, and similar materials discussed elsewhere in this specification. In addition to the material covering 154, additional materials may be included on an underside of the atrial flange portion 156 to help create a better seal with the native valve annulus, such as hydrogel.

[0182] Figs. 34-44 illustrate various aspects of the framework 152 in the present example. The body portion 160 of the framework 152 is composed of a plurality of elongated vertical body struts 166B and a plurality of horizontal body struts 166A (best seen in the cross-sectional view of Fig. 37). The vertical body struts 166B are generally parallel to an axis through the support structure’s passage (i.e., an axis from the inflow end to the outflow end), while the horizontal body struts 166A are positioned around this axis in a circular shape.

[0183] The vertical body struts 166B may alternate between different heights or axial positions, such that a first vertical body strut 166B has a first axial position and the two vertical body struts 166B adjacent to the first is positioned further in an inflow direction relative to the adjacent two. Hence, the vertical body struts 166B may form an alternating pattern.

[0184] The horizontal body struts 166A may form a “V” shape or a relatively sharp angle pointing towards the outflow direction, though the opposite direction is also possible. Each end of a horizontal body strut 166A connects to a vertical body strut 166B, as well as a vertical body strut 166B passes directly through the middle of the “V” shape. The “V” shape of the horizontal body strut 166A provides a bend point at the apex of its “V” to increase and 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. Alternatively, other shapes with angles in them may also be possible for the horizontal body structure 166A, such as a “W” shape with two or more angles. In the present example, there are two rows of horizontal body struts 166A, though more rows are possible.

[0185] In one example, the body portion 160 of the framework 152 has a length within an inclusive range of about 14 mm to about 18 mm, and has a radius within an inclusive range of about 27 mm to about 30 mm.

[0186] The atrial flange portion 156 of the framework 152 includes a plurality of flange struts 162. The shape of these flange struts 162 can be best seen in Figs. 38- 46. The atrial flange portion 156 alternates with an upper radial strut 162C and a lower radial strut 162D. Both struts 162C, 162D each extend from a vertical body strut 166B.While both struts 162C, 162D may have similar shapes / size / curvature, the upper radial struts 162C are generally higher (i.e., further in an inflow direction) than lower radial struts 162D, due to the higher and lower positions of the vertical body struts 166B (e.g., due to the “V” shape / position of the horizontal body struts 166A). In the present example, an aperture portion 166C is located adjacent to the vertical body strut 166A and the upper radial strut 162. This aperture portion 166C may be optionally included for use with a delivery catheter 50.

[0187] As seen in Fig. 33, each upper radial flange strut 1620 forms a first angle 162E within an inclusive range of about 90 degrees and 130 degrees, a relative straight portion 162F with a length within an inclusive range of about 3 mm and about 10 mm, a second angle 162G within an inclusive range of about 20 degrees and about 150 degrees, and a terminal portion 162A with a length within an inclusive range of about 1 mm and 7 mm (again, angles relative to an inflow / outflow oriented axis of the support structure 150). Generally, the specific angles and sizes may vary somewhat depending on the heart and valve size of the patient. The terminal portion 162A may optionally include an aperture that can be used by a delivery catheter 50 to help releasably retain the support structure 150 during deployment.

[0188] As seen in Fig. 40, each lower radial flange strut 162D forms a first angle 162H within an inclusive range of about 90 degrees and 150 degrees, a relative straight portion 1621 with a length within an inclusive range of about 0 mm and about 5 mm, a second angle 162J within an inclusive range of about 0 degrees and about 60 degrees, and a terminal portion 162K with a length within an inclusive range of about 1 mm and 7 mm (again, angles relative to an inflow / outflow oriented axis of the support structure 150). Generally, the specific angles and sizes may vary somewhat depending on the heart and valve size of the patient. The terminal portion 162K may optionally include an aperture that can be used by a delivery catheter 50 to help releasably retain the support structure 150 during deployment.

[0189] The radially outer ends of each upper radial strut 162C and lower radial strut 162D are connected to each other via one of a plurality of circumferential radial struts 162B. Since the upper radial strut 162C and lower radial strut 162D are located at different heights and distances from each other, the circumferential radial struts 162B tend to form relatively triangular or petal shapes that terminate with terminal portion162A. Hence, the circumferential radial struts 162B may curve in several dimensions to accommodate the upper radial strut 162C and lower radial strut 162D position difference.

[0190] The leaflet engaging portion 158 of the framework 152 includes a plurality of engagement struts 164, the shape of which can be best seen best in Fig. 39. Generally the engagement struts 164 have a straight portion 164B that is parallel to an axis through the support structure’s passage (i.e., an axis from the inflow end to the outflow end). In other words, the engagement strut 164 does not angle towards the body portion 160 like the prior support structure 100, though such a configuration is possible. The engaging struts 164 are connected to the outflow end of the vertical body struts 166B. From the vertical body strut 166B, the engagement strut 164 forms a first curve 164C which curves around to about 180 degrees (e.g., an inclusive range of about 150 degrees to about 230 degrees), a first straight portion 164B with a length within an inclusive range of about 3 mm and about 10 mm, a second curve 164D curving in an opposite direction of curve 164C within an inclusive range of about 90 degrees to about 150 degrees, and a rounded portion 164A with a length within an inclusive range of about 2 mm to about 10 mm. While these curves all generally occur in the same plane, it is possible to include additional curves that may take some of the engagement struts 114 out of a single plane (i.e., curving in multiple dimensions). The rounded portion 164A may optionally include an aperture that may be used by the delivery catheter 50 to releasably retain the support structure 150 during deployment.

[0191] As previously discussed, the engagement struts 164 are not covered by the material covering 154 in the present example, but may be. Additionally, the engagement struts 164 may be coated or wrapped in a relatively softer material (e.g., a textile or EPTFE layer). Further, the rounded portion 164A of the engagement struts 164 may include a coating composed of similar materials or other materials described in this specification.

[0192] One aspect of the support structure 150 and framework 152 of note is the positions of the atrial flange 156 relative to the engagement struts 164, as seen best in the simplified line view of Fig. 45, as well as Fig. 39. In its expanded configuration, the end portions of the engagement struts 164 (i.e., portions of the leaflet engaging portion) are positioned at a more proximal location or further in an inflow direction thanportions the radially-adjacent lower radial struts 162D of the atrial flange portion 156. In other words, lower radial struts 162D on each side of each of the engagement struts 164 curve axially in a distal / outflow direction beyond the end portion of the engagement struts 164. In one example, the axially-adjacent overlap is within an inclusive range of about .1 mm to about 10 mm.

[0193] This arrangement may be particularly helpful in several respects. First, this arrangement forces the leaflets and the annulus of the native valve to be positioned over the engagement struts 164 and then below the lower radial struts 162D, forcing the leaflets / annulus into an alternating or wave-like shape. Hence, the leaflet engaging portion 158 (i.e., engagement struts 164) and the atrial flange portion 156 (i.e., lower radial struts 162D) tend to pinch the leaflets / annulus and create a paperclip effect. This design may allow for positive remodeling (e.g., size reduction of any enlargement) of the ventricle as the body adapts to the reduced regurgitation vs the prior faulty native valve. Some other prosthetic replacement valves may be relatively large plug-like designs and may rely on radial force to anchor and seal, but the present top-down approach to sealing at the annulus may allow the ventricle to better recover over time and reduce in diameter without interference from the present replacement valve.

[0194] Second, this arrangement may hold the material covering on the underside of the atrial flange portion taut around the top of the leaflet engaging portion so that there is good contact between the material covering and the leaflets / annulus to promote sealing, healing, and possibly tissue in-growth.

[0195] Third, portions of the lower radial struts 162D (e.g., those closes to the outflow end of the framework 152, such as 162H) may be positioned within the annulus of the native valve. Since portions of the lower radial struts 162D may curve radially outward, this shape may help further seal the framework 152 with the native annulus, further limiting the passage of blood around the framework / valve.

[0196] The framework 152 of the present example may be composed of a single unitary body, such as laser cut from a shape memory tube (e.g., Nitinol tube). Alternatively, one or more of the struts of the framework may be welded or otherwise attached to each other. Alternatively, some of the components may be separate fromeach other, only connected by other materials, such as the material covering 154 or other attachment mechanisms. For example, the body portion 160, the leaflet engagement portion 158, and / or the atrial flange portion 156 may not be directly attached to each other in any combination. If shape memory material is used for the framework 152, the framework may be cut to a desired pattern and then heat set to impart a desired shape in its expanded configuration.

[0197] The support structure 150 may deploy from a delivery catheter 50 in the same manner as described for the support structure 100 in Figs. 10-12. In that respect, the engagement struts 164 may begin in a compressed configuration with their ends (rounded enlargement 164A) positioned distally away from the body portion 160 within the delivery catheter 50. As the support structure 150 is pushed out or an outer sheath is retracted from over 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 advance or be exposed, the engagement struts 164 bend backward such that the rounded enlarged end 164A is positioned in an inflow direction relative to the outflow end of the body portion 160. In other words, as deployment occurs, the engagement struts 164 bend radially backward or invert which allows them to capture the native valve leaflets 14B with the body portion 160 and press against the valve annulus, as seen in Fig. 47.

[0198] In a compressed configuration within the delivery catheter 50, it should be noted that the terminal portion 162A with an aperture may be located at a proximal end of the compressed support structure 150 while engagement struts 164 are constrained distally such that the rounded portion 164A is at a distal most location within the delivery device 50. In that respect, apertures are located at both the proximal and distal ends of the support structure 150 in its compressed configuration. Additionally, aperture portion 166C also includes an aperture midway along the length of the compressed configuration. These apertures may be engaged with features of the delivery device 50, such as posts, hooks, tethers, or similar structures that help retain portions of the support structure until 150 until fully deployed.

[0199] As previously discussed, although the support structure 100 and 150 are mostly described in this specification, it is specifically contemplated that a valvemechanism 170, such as prosthetic or biological valve leaflets, be attached within the valve support mechanism, as seen in Fig. 46.

[0200] Fig. 48 illustrates one approach to delivering a support structure 150 within a tricuspid valve 14 by advancing a delivery catheter through the inferior vena cava 16 and into the right atrium 18, such that the support structure 150 is delivered from an inflow or atrial end relative to the tricuspid valve 14.

[0201] Fig. 49 illustrates another approach to delivering a support structure 150 with a mitral valve 12 by performing a transeptal procedure to allow the delivery catheter to pass through the septum between the right atrium 18 and the left atrium 20. This allows the support structure 150 to be delivered from an inflow or atrial end relative to the mitral valve 12.

[0202] Additional approaches to delivering the support structure 150 are also possible. For example, either valve 14, 20 may be approached from its respective ventricle. In such cases, the support structure may be arranged in an opposite orientation as shown in Figs. 10-12.

[0203] Any of the support structures in this specification, including support structures 100 and 150, may be delivered from one of several known heart valve delivery devices. For example, the devices in U.S. Pub. No. 2017 / 0165064, 2019 / 0008640, and 2022 / 0287836, the content of which is hereby incorporated by reference.

[0204] The support structures and frameworks previously described in this specification illustrate their body portions as forming a generally cylindrical shape in which the sides are generally parallel to a central axis between the inflow end and the outflow end when the support structure of framework is in an expanded configuration. However, it may also be helpful if the walls of the body portions form non-parallel orientations relative to the central axis and / or non-linear shapes.

[0205] For example, Figs. 50, 51 , and 52 illustrate various aspects of a framework 200 having a body portion 160 that tapers to have a larger diameter of its passage at its outflow end as compared with its inflow end. Fig. 50 illustrates a side view of the framework 200, Fig. 51 illustrates a simplified cross-sectional view of one side of theframework 200, and Fig. 52 illustrates a simplified cross-sectional view of the entire framework 200. These figures will are discussed concurrently below.

[0206] Generally, the framework 200 is similar to the previously described framework 152, though the changes of framework 200 are also applicable to any of the frameworks described in this specification. As with all frameworks in this specification, the framework 200 may be unified or permanently connected to valve components or may act as a dock that valve components are later delivered / attached to within a patient.

[0207] In the expanded configuration of the framework 200, the vertical body struts 202 may have a generally elongated linear or straight shape such that their inflow ends (i.e., ends closer to the atrial flange portion 156) are closer together than at their outflow ends (i.e., ends closer to the attachment points of the leaflet engagement portion 158). Additionally, the horizontal body struts 166A may similarly conform to the angles / orientations of the vertical body struts 202. In this respect, the walls of the body portion 160 form a generally linear, straight, conical shape where its inflow end has a smaller diameter than the outflow end, as especially noted by the arrows in Fig. 52.

[0208] In some examples, the diameter of the passage of the outflow end of the body portion 160 may be within an inclusive range of about 5 to 40 percent larger than the diameter of the passage of the inflow end of the body portion 160. In some examples, an uppermost inflow end of the passage of the body portion 160 may have a diameter within an inclusive range of about 5 mm to about 30 mm, and a lowermost outflow end of the passage of the body portion 160 may have a diameter within an inclusive range of about 15 mm to about 45 mm.

[0209] While the walls of the body portion 160 or the vertical body struts 202 have a generally linear or straight shape, other non-linear shapes are also possible. For example, Fig. 53 illustrates a simplified cross-sectional view similar to Fig. 51 in which the vertical body struts 204 have a curved region 204A near the inflow end of the body portion 160 and a relatively straight region 204B extending towards the outflow end of the body portion 160. This may result in a body portion 160 similar to that of framework200 in which the inflow end has a smaller diameter than the outflow end of the body portion 160.

[0210] In another example, Fig. 54 illustrates a simplified cross-sectional view similar to Fig. 51 in which the vertical body struts 206 may have a first straight region 206A that is generally parallel to a central axis extending between an inflow end and outflow end of the body portion 160, followed by a second straight region 206B that is oriented at a non-parallel angle relative to the central axis. The first straight region 206A may be located closer to the inflow end than the second straight region 206B. This may result in a body portion 160 similar to that of framework 200 in which the inflow end has a smaller diameter than the outflow end of the body portion 160.

[0211] In some examples, the curved region 204A and the first straight region 206A have lengths within an inclusive range of about 3 mm to about 15 mm. In some examples, the relatively straight region 204B and the second straight region 206B have similar lengths within an inclusive range of about 3 mm to about 15 mm.

[0212] The smaller diameter of the inflow end of the body portion 160 and the larger diameter of the outflow end of the body portion 160 of the examples of Figs. 50-54 may provide certain advantages. For example, these shapes may promote flow washout similar to the native sinus of a cardiac valve, creating flow dynamics that help prevent or remove any stagnant blood within or near the outflow end of the framework 200. Stagnant blood flow may increase the likelihood of thrombosis and therefore complications such as stroke or embolisms.

[0213] In another example, the smaller diameter of the inflow end of the body portion 160 may allow for the use of the framework 200 as a dock to support the implantation of an artificial valve that is not designed or approved for replacement of a specific native valve. For example, a framework 200 may be first implanted at a native tricuspid valve so that an artificial aortic valve may then be implanted or connected to the framework 200. The approval process in different countries often requires many years to complete for completely new artificial valve designs, but existing artificial valves may sometimes enjoy quicker approval for alternative uses with other native valves. Hence, such a framework design may allow for the quicker use of artificial heart valves within a patient.

[0214] Figs. 55, 56, and 57 illustrate various aspects of a framework 210 having a body portion 160 that tapers to have a smaller diameter at its outflow end as compared with its inflow end. Fig. 55 illustrates a side view of the framework 210, Fig. 56 illustrates a simplified cross-sectional view of one side of the framework 210, and Fig. 57 illustrates a simplified cross-sectional view of the entire framework 210. These figures are discussed concurrently below.

[0215] Generally, the framework 210 is similar to the previously described framework 152, though the changes of framework 210 are also applicable to any of the frameworks described in this specification. As with all frameworks in this specification, the framework 210 may be unified or permanently connected to valve components or may act as a dock that valve components are later delivered / attached to within a patient.

[0216] In the expanded configuration of the framework 210, the vertical body struts 212 may have a generally linear or straight shape such that their inflow ends (i.e. , ends closer to the atrial flange portion 156) are further away from each other than at their outflow ends (i.e., ends closer to the attachment points of the leaflet engagement portion 158). Additionally, the horizontal body struts 166A may similarly conform to the angles / orientations of the vertical body struts 212. In this respect, the passage of the body portion 160 forms a generally conical shape where its outflow end has a smaller diameter than the inflow end, as especially noted by the arrows in Fig. 57.

[0217] In some examples, the diameter of passage of the inflow end of the body portion 160 may be within an inclusive range of about 5 to 40 percent larger than the diameter of the passage of the outflow end of the body portion 160. In some examples, an uppermost inflow end of the passage of the body portion 160 may have a diameter within an inclusive range of about 15 mm to about 45 mm, and a lowermost outflow end of the passage of the body portion 160 may have a diameter within an inclusive range of about 5 mm to about 30 mm.

[0218] While the vertical body struts 212 have a generally linear or straight shape, other non-linear shapes are also possible. For example, Fig. 58 illustrates a simplified cross-sectional view similar to Fig. 56 in which the vertical body struts 214 have a generally straight region 214A (or gently curved region) near the inflow end of the bodyportion 160 and a curved region 214B extending towards the outflow end of the body portion 160. This may result in a body portion 160 similar to that of framework 210 in which the inflow end has a larger diameter than the outflow end of the body portion 160. In some examples, the curved region 214B has a length within an inclusive range of about 3 mm to about 15 mm and the generally straight region 214A has a length within an inclusive range of about 3 mm to about 15 mm. In an alternative example, the curved region 214B may instead be a smaller non-parallel straight segment forming an inverted arrangement of the Fig. 54 example.

[0219] The larger diameter of the inflow end of the body portion 160 and the smaller diameter of the outflow end of the body portion 160 of the examples of Figs. 56-58 may provide certain advantages. For example, when the framework 210 is used as a dock that is first implanted within a native valve of a patient, the framework 210 may better support, engage, or “catch” the later-deployed valve mechanism 170. For example, the curved region 214B may act as a ledge for the valve mechanism 170 once deployed in the framework 210.

[0220] In another example, the smaller diameter of the outflow end of the body portion 160 may allow for the use of the framework 210 as a dock to support the implantation of an artificial valve that is not designed or approved for replacement of a specific native valve. For example, a framework 210 may be first implanted at a native tricuspid valve so that an artificial aortic valve may then be implanted or connected to the framework 210. The approval process in different countries often requires many years to complete for completely new artificial valve designs, but existing artificial valves may sometimes enjoy quicker approval for alternative uses with other native valves. Hence, such a framework design may allow for the quicker use of artificial heart valves within a patient.

[0221] Figs. 59, 60, and 61 illustrate various aspects of a framework 220 having a body portion 160 with convex inner walls. Fig. 59 illustrates a side view of the framework 220, Fig. 60 illustrates a simplified cross-sectional view of one side of the framework 220, and Fig. 61 illustrates a simplified cross-sectional view of the entire framework 220. These figures are discussed concurrently below.

[0222] Generally, the framework 220 is similar to the previously described framework 152, though the changes of framework 220 are also applicable to any of the frameworks described in this specification. As with all frameworks in this specification, the framework 220 may be unified or permanently connected to valve components or may function as a dock that valve components are later delivered / attached to within a patient.

[0223] In the expanded configuration of the framework 220, the vertical body struts 222 (and / or the passage as a whole) may have a convex or curved shape such that their inflow and outflow ends are further apart than a middle region in between, as shown in Fig. 61 . In other words, each of the vertical body struts 222 curved such that the walls and passage of the body portion 160 is narrower at middle regions longitudinally between the inflow and outflow ends of the body portion 160 and widest at regions located at both of those ends. The convex curve of the vertical body struts 222 may be longitudinally symmetrical such that the middle of each represents the furthest point radially inwards into the diameter of the body portion 160. The convex curve of the vertical body struts 222 may be longitudinally non-symmetrical such that the furthest point radially inwards into the diameter of the body portion 160 is above or below a longitudinal middle of the body portion 160.

[0224] In some examples, the diameter of the outflow end and inflow end of the passage of the body portion 160 may be within an inclusive range of about 5 to 40 percent larger than the diameter of a middle region of the passage of the body portion 160. In some examples, an uppermost portion and lowermost portion of the passage of the body portion 160 may have a diameter within an inclusive range of about 15 mm to about 45 mm, and a middle portion of the passage of the body portion 160 may have a diameter within an inclusive range of about 5 mm to about 30 mm.

[0225] The larger diameter of the middle region of the body portion 160 and the smaller diameters of the inflow end and outflow end of the body portion 160 of the examples of Figs. 59-61 may provide certain advantages. For example, when the framework 220 is used as a dock that is first implanted within a native valve of a patient, the framework 220 may better support, engage, or “catch” the later-deployed valve mechanism 170.

[0226] Figs. 62, 63, and 64 illustrate various aspects of a framework 230 having a body portion 160 with concave inner walls. Fig. 62 illustrates a side view of the framework 230, Fig. 63 illustrates a simplified cross-sectional view of one side of the framework 230, and Fig. 64 illustrates a simplified cross-sectional view of the entire framework 230. These figures are discussed concurrently below.

[0227] Generally, the framework 230 is similar to the previously described framework 152, though the changes of framework 230 are also applicable to any of the frameworks described in this specification. As with all frameworks in this specification, the framework 230 may be unified or permanently connected to valve components or may function as a dock that valve components are later delivered / attached to within a patient.

[0228] In the expanded configuration of the framework 230, the vertical body struts 232 (or the walls of the passage as a whole) may have a concave or curved shape such that their inflow and outflow ends are closer together than a middle region in between, as shown in Fig. 64. In other words, each of the vertical body struts 232 curved such that the body portion 160 and its passage is wider at a middle region longitudinally between the inflow and outflow ends of the body portion 160 than at regions at either of those ends. The concave curve of the vertical body struts 232 may be longitudinally symmetrical such that the middle of each represents the furthest point radially outwards of the diameter of the body portion 160. The concave curve of the vertical body struts 232 may be longitudinally non-symmetrical such that the furthest point radially outwards of the diameter of the body portion 160 is above or below a longitudinal middle of the body portion 160.

[0229] In some examples, the diameter of the outflow end and inflow end of the body portion 160 may be within an inclusive range of about 5 to 40 percent smaller than the diameter of a middle region of the body portion 160. In some examples, an uppermost portion and lowermost portion of the passage of the body portion 160 may have a diameter within an inclusive range of about 5 mm to about 30 mm, and a middle portion of the passage of the body portion 160 may have a diameter within an inclusive range of about 15 mm to about 45 mm.

[0230] The smaller diameter of the middle region of the body portion 160 and the larger diameters of the inflow end and outflow end of the body portion 160 of the examples of Figs. 62, 63, and 64 may provide certain advantages. For example, when the framework 230 is used as a dock that is first implanted within a native valve of a patient, the framework 230 may better support, engage, or “catch” the later-deployed valve mechanism 170.

[0231] In a further example, walls of a body portion 160 and the vertical body struts may form a plurality of concave and convex shapes (i.e., wave shapes) extending longitudinally between the inflow end and the outflow end of the body portion 160. These waves may be of similar sizes as the convex and concave shapes previously discussed, or may be smaller in size. In some examples, these longitudinal waves of each vertical body struts may all be horizontally and symmetrically aligned with each other such that they form rings of concave / convex shapes, or they may be horizontally non-symmetrically aligned (e.g., the peaks and troughs on adjacent vertical body struts may oppositely alternate at horizontal locations). Overall, the passage of the body portion 160 may have a larger inflow or outflow end, like previously described examples, while also including the longitudinal wave shapes.

[0232] When any of the example frameworks of this specification, and particularly of Figs. 50-64, are used as docks for a separate valve mechanism 170, they may be further configured to change shape after the valve mechanism 170 is implanted within the framework. In other words, a framework may have a compressed configuration when within a delivery device / catheter, a first expanded configuration when deployed within a native valve, and a second expanded configuration after the valve mechanism 170 is then deployed within the framework.

[0233] For example, Fig. 65 illustrates a simplified cross-sectional view of a framework 240 that is generally similar to the framework 200 in which the inflow end of the body portion 160 has a larger diameter than the outflow end of the body portion 160. In Fig. 65, the framework 240 is illustrated in its first expanded configuration (i.e., after deployment within a native valve but prior to a valve mechanism 170 being implanted within the framework 240).

[0234] Fig. 66 illustrates a simplified cross-sectional view of the framework 240 in its second expanded configuration (i.e., after the valve mechanism 170 has been implanted into the body portion 160 of the framework 240). As seen by the arrows in this figure, the framework 240 is configured such that the outflow end of the body portion 160 expands in diameter and that the engagement struts 164 attached to the vertical body struts 202 move longitudinally in an inflow direction. This shape change may be created by a combination of the “memorized” shape imparted to the shape memory material of the framework 240 and via the outward radial force created by the valve mechanism 170. Typically, the annulus of the native valve remains roughly constant and therefore as the valve mechanism 170 creates radially outward force on the framework 240, portions of the framework 240 are compressed, such as the annular space between the vertical body struts 202 and the straight portion 164B. As the vertical body struts 202 and / or engagement struts 164 are compressed, they may change shape and / or orientation as they are displaced.

[0235] In some examples, the change in shape between the first expanded configuration and the second expanded configuration moves the engagement struts 164 in the inflow direction, as seen in Fig. 66. This may help the engagement struts 164 better capture the native leaflets and / or better engage with the shape of the native annulus. In other examples, the change in shape between the first expanded configuration and the second expanded configuration moves the engagement struts 164 in the outflow direction, which may also enhance anchoring, depending on the shape of the engagement struts 164. In otherexamples, the change in shape between the first expanded configuration and the second expanded configuration moves part or all of the upper radial strut 162C in a radially outward direction, an inflow direction, and / or an outflow direction.

[0236] In some examples, the change in shape between the first expanded configuration and the second expanded configuration changes the orientation of the vertical body struts 202 from a position non-parallel to a central axis to a generally parallel position (i.e., the conical shape of the body portion 160 changes to a uniform cylindrical shape), as seen in Figs. 65 and 66. The shapes of vertical body struts 204, 206, 212, 222, and 232 may undergo similar changes to a uniform, parallel cylindrical shape, or to other shapes (e.g., conical shapes, shapes with a reduced curve, or othershapes). These changes may also change the position or shape of the engagement struts 164, upper radial strut 162C, and / or the lower radial struts 162D.

[0237] Additionally, changes in shape of the vertical body struts 204, 206, 212, 222, and 232 may be such that the further engage or lock the valve mechanism 170 into place after it is deployed. For example, an outflow portion of the body portion 160 may decrease in diameter to support or pinch the valve mechanism 170. In another example, anchoring features may be extended from the interior of the body portion 160 to engage with the valve mechanism 170 (e.g., barbs, corners / edges of struts, blunt protrusions, friction material, bumps, ridges, or similar structural features).

[0238] A framework may include any combination of the previously described vertical body struts 166B, 204, 206, 212, 222, and 232. For example, all of the vertical body struts of a framework may be the same shape or a framework may include two or more shapes in any combination of the vertical body struts 204, 206, 212, 222, and 232 (e.g., alternating between shapes).

[0239] The previously described support structure 150 of Figs. 23-33 illustrates material covering 154 on the framework 152. If the support structure 150 (or any other support structure or framework from this specification) is used as a dock into which a valve mechanism 170 is later delivered into, the framework may not need to be entirely covered by material covering 154. For example, Fig. 67 illustrates a simplified cross- sectional view of a framework 250 on which material covering 154 is attached to only an outflow portion. In some examples, only a top half (outflow half) of the framework 250 may include the material covering 154. In other examples, only a top third or quarter of the 250 may include the material covering 154. In one example, the material covering 154 may cover the atrial flange portion 156 and a top length of the body portion 160 within an inclusive range of about 1 mm to about 20 mm.

[0240] If any of the support structures of this specification are used as a dock for an implantable valve, such a support structure may include one or a plurality of engagement structures that help engage or anchor the implantable valve within the support structure. Generally, these engagement structures may include barbs, corners / edges of struts, blunt protrusions, friction material, bumps, ridges, sutures, hooks, rings of resilient material, or similar structural features.

[0241] In one example, Fig. 68 illustrates a cutaway view of a framework 260 that may include a plurality of engagement structures 264, noted in areas 262 for clarity. The framework 260 may be otherwise similar to the previously described framework 200, but any framework described in this specification may include these plurality of engagement structures 264. Fig. 69 illustrates a simplified cross-sectional view of the framework 260 that illustrates a profile of the plurality of engagement structures 264 from a different view.

[0242] In some examples, the plurality of engagement structures 264 may be portions or areas of the framework 260 bent inwardly into the interior passage of the body portion 160 to form a bump or ridge. In the present example, these plurality of engagement structures 264 are located at the interface of three different struts, but may also be formed via single struts, such as the horizontal body struts 166A or vertical body struts 202 via an imparted memory shape. Alternatively, the plurality of engagement structures 264 may be solid material, such as welded metal or a resilient material such as silicone or a polymer.

[0243] As previously discussed, the plurality of engagement structures 264 may change shape or orientation as a valve mechanism 170 is implanted within the framework 260 to provide better engagement. For example, the plurality of engagement structures 264 may include finger structures, hooks, or other elongated elements that move outward and around structural elements of the valve mechanism 170 as it is deployed and the framework 260 changes shape.

[0244] One example method of using the framework 260 includes deploying the framework 260 within the annulus of a native valve, and then deploying a valve mechanism 170 within the framework 260, wherein deploying the valve mechanism 170 causes the framework 260 to change a shape and / or orientation of a plurality of engagement structures 264 of the framework 260 to increase frictional and / or mechanical force on the valve mechanism 170.

[0245] Fig. 70 illustrates a simplified side view of a delivery device 270 that may deliver both a framework 200 for use as a dock and a valve mechanism 170 into the implanted framework 200. Generally, the delivery device 270 may include a framework delivery portion 272 and a valve mechanism delivery portion 274. Theframework delivery portion 272 may be proximal to the valve mechanism delivery portion 274, allowing the framework 200 to be delivered first, followed by the valve mechanism 170 second.

[0246] Generally, the delivery device 270 may include an elongated body 275 of which the framework delivery portion 272 and valve mechanism delivery portion 274 are located on or are part of. An enlarged distal tip 276 may be connected at or near the end of the elongated body 275. An outer sheath 277 may be located over the framework delivery portion 272, the valve mechanism delivery portion 274, and the elongated body 275 to provide protection to these components as they are advanced through a patient. The outer sheath 277 and the elongated body 275 may be moved relative to each other, allowing either the outer sheath 277 to be proximally withdrawn or the elongated body 275 to be distally advanced, thereby exposing the framework delivery portion 272 and / or valve mechanism delivery portion 274.

[0247] The framework delivery portion 272 may include one or more anchor members 278 that engage a proximal end, a distal end, or both ends of the framework 200. Additionally details and alternative arrangements / components of the framework delivery portion 272 may be found in PCT Pub. WO2024 / 118663, which is hereby incorporated by reference in its entirety.

[0248] The valve mechanism delivery portion 274 may include a balloon 273 connected to the elongated body 275 and located underneath the valve mechanism 170 in its compressed configuration. This allows the balloon 273 to inflate the valve mechanism 170 during a procedure. The elongated body 275 may include an inflation passage extending between an interior of the balloon 273 and a proximal end of the delivery device 270, thereby allowing a user to selectively inflation the balloon 273 during a procedure. Alternatively, an expandible mesh, expandible strut structure, expandable coil, or other expandible structures may be used instead of the balloon 273.

[0249] During use, the delivery device 270 may be partially advanced through a native valve so that the framework delivery portion 272 aligns with at least part of an annulus of the native valve. The outer sheath 277 may be proximally withdrawn to uncover the framework delivery portion 272 (or alternatively the 275 may be distallyadvanced), allowing the framework 200 (or any other framework of this specification) to expand within the native valve as previously described.

[0250] After the framework 200 has been fully deployed within the native valve, the delivery device 270 may be advanced distally further through the native valve such that the valve mechanism delivery portion 274 is aligned within the framework 260 of the framework 200. The outer sheath 277 may be further proximally withdrawn to expose the valve mechanism 170. The balloon 273 may then be inflated to expand or help expand the valve mechanism 170 within the framework 200.

[0251] Fig. 71 illustrates a simplified side view of a delivery device 280 for a framework 152 (or other frameworks disclosed in this specification), for allowing retrieval of the framework 152 during a procedure if the user is not satisfied with its initial placement or deployment position. The delivery device 280 may include a plurality of threads or wires 282 that are connected to the framework 152, such as at the proximal tips of the atrial flange portion 156. The wires 282 may be further connected to a location on the outer sheath 277, such as a release mechanism 284. The wires 282 may allow a user to selectively release the wires 282 when the user is satisfied with placement of the framework 152.

[0252] In one example, the release mechanism 284 may be an electrical release mechanism such as a heater or electrolytic connection that breaks a connection to the wires 282 when electrical current is supplied. In another example, the delivery device 280 may include an elongated control wire that extends from the release mechanism 284 to a proximal end of the delivery device 280, allowing a user to move the control wire and release the wires 282 (e.g., opening a closed loop or breaking a connection member between the release mechanism 284 and the wires 282).

[0253] Fig. 72 illustrates a flow chart for a method of using a temporary artificial valve during a procedure. Ideally, a permanent artificial valve is quickly and efficiently delivered into a native heart valve. In some circumstances, however, it may be helpful to implant a temporary valve for a brief time before the permanent artificial valve is delivered. A temporary valve may be quicker and easier to deploy, as well as may be less expensive than a permanent valve. In one specific example, a temporary valve may be useful for allowing use of an existing valve designed for a different anatomythat is already approved by a governmental regulatory agency and that has a long clinical history. This may allow the patient to remain stable without excessive regurgitation while the permanent valve is being delivered.

[0254] Turning to step 290, a support structure or framework (e.g., framework 200) may first be implanted within a native cardiac valve of a patient. This step may be optional if an initial “dock” is not used with the procedure.

[0255] In step 292, a temporary artificial valve is implanted within the framework (or the native valve is no dock is used). This may allow the heart to maintain normal function and remain stable while a permanent valve is being delivered, which may take several minutes. Without the temporary valve, there may be nothing preventing blood from moving backward in the heart. Hence the temporary valve may provide better performance and safety.

[0256] In step 294, the temporary artificial valve is removed from the framework or native valve. By “temporary,” the use may be for as little as a minute or as long as a week, as compared with a “permanent” artificial valve which typically are expected to last about 10-15 years within a patient. In one example, the delivery device for the temporary valve may be similar to the previously discussed delivery device 270, allowing the 282 to help retract and repack the temporary valve back into the delivery device for removal.

[0257] In step 296, a permanent artificial valve is implanted within the framework or native valve.

[0258] It should also be noted that since the temporary valve is intended for temporary use, its design may be different than a typical permanent valve since the durability requirements are much different. For example, a single-leaflet design or a bi-leaflet design may be possible to provide adequate performance for up to a week but may not be appropriate for a permanent valve.

Claims

What is claimed is:

1. A framework for a prosthetic heart valve having an expanded configuration, comprising: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; wherein the passage of the body portion has a larger diameter at the outflow end relative to the inflow end.

2. The framework of claim 1 , wherein the passage of the body portion has a tapered conical shape.

3. The framework of claim 1 , wherein walls of the body portion are straight.

4. The framework of claim 3, wherein the walls of the body portion comprise a plurality of vertical body struts each having an elongated straight shape.

5. The framework of claim 4, wherein inflow ends of the plurality of vertical body struts are closer together than outflow ends of the plurality of vertical body struts.

6. The framework of claim 1 , wherein a diameter of the passage at the outflow end may be within an inclusive range of about 5 to 40 percent larger than the diameter of the inflow end.

7. The framework of claim 1 , wherein a diameter of the passage at the inflow end is within an inclusive range of about 5 mm to about 30 mm and a diameter of the passage at the outflow end is within an inclusive range of about 15 mm to about 45 mm.

8. The framework of claim 1 , wherein walls of the body portion comprise a plurality of vertical body struts each having a curved region near the inflow end and a straight region extending to the outflow end.

9. The framework of claim 8, wherein the curved region has a length within an inclusive range of about 3 mm to about 15 mm and the straight region has a length within an inclusive range of about 3 mm to about 15 mm.

10. The framework of claim 1 , wherein walls of the body portion comprise a plurality of vertical body struts each having a first straight region that is generally parallel to a central axis extending between the inflow end and the outflow end of the body portion, and a second straight region that is oriented at a non-parallel angle relative to the central axis, where the first straight region is located closer to the inflow end than the second straight region.11 . The framework of claim 10, wherein the first straight region has a length within an inclusive range of about 3 mm to about 15 mm and the second straight region has a length within an inclusive range of about 3 mm to about 15 mm.

12. A framework for a prosthetic heart valve having an expanded configuration, comprising: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; wherein the passage of the body portion has a larger diameter at the inflow end relative to the outflow end.

13. The framework of claim 12, wherein the passage of the body portion has a tapered conical shape.

14. The framework of claim 12, wherein walls of the body portion are straight.

15. The framework of claim 14, wherein the walls of the body portion comprise a plurality of vertical body struts each having an elongated straight shape.

16. The framework of claim 15, wherein outflow ends of the plurality of vertical body struts are closer together than inflow ends of the plurality of vertical body struts.

17. The framework of claim 12, wherein a diameter of the passage at the inflow end may be within an inclusive range of about 5 to 40 percent larger than the diameter of the outflow end.

18. The framework of claim 12, wherein a diameter of the passage at the outflow end is within an inclusive range of about 5 mm to about 30 mm and a diameter of the passage at the outflow end is within an inclusive range of about 15 mm to about 45 mm.

19. The framework of claim 12, wherein walls of the body portion comprise a plurality of vertical body struts each having a curved region near the outflow end and a straight region extending to the inflow end from the curved region.

20. The framework of claim 19, wherein the curved region has a length within an inclusive range of about 3 mm to about 15 mm and the straight region has a length within an inclusive range of about 3 mm to about 15 mm.21 . The framework of claim 1 , wherein walls of the body portion comprise a plurality of vertical body struts each having a first straight region that is generally parallel to a central axis extending between the inflow end and the outflow end of the body portion, and a second straight region that is oriented at a non-parallel angle relative to the central axis, where the first straight region is located closer to the outflow end than the first straight region.

22. The framework of claim 21 , wherein the first straight region has a length within an inclusive range of about 3 mm to about 15 mm and the second straight region has a length within an inclusive range of about 3 mm to about 15 mm.

23. A framework for a prosthetic heart valve having an expanded configuration, comprising: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; wherein the passage of the body portion is narrower in diameter between and relative to the outflow end and the inflow end.

24. The framework of claim 23, wherein walls of the body portion are convex.

25. The framework of claim 23, wherein a diameter of the passage at the outflow end and a diameter at the inflow end may be within an inclusive range of about 5 to 40 percent larger than the diameter of a middle region of the passage.

26. The framework of claim 23, wherein a diameter of the passage at a middle region is within an inclusive range of about 5 mm to about 30 mm and a diameter of the passage at the outflow end and at the inflow end is within an inclusive range of about 15 mm to about 45 mm.

27. A framework for a prosthetic heart valve having an expanded configuration, comprising: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; wherein the passage of the body portion is larger in diameter at locations between and relative to the outflow end and the inflow end.

28. The framework of claim 27, wherein walls of the body portion are concave.

29. The framework of claim 27, wherein a diameter of a middle region of the passage may be within an inclusive range of about 5 to 40 percent larger than the diameter of the passage at the outflow end and a diameter at the inflow end.

30. The framework of claim 27, wherein a diameter of the passage at a middle region is within an inclusive range of about 15 mm to about 45 mm and a diameter of the passage at the outflow end and at the inflow end is within an inclusive range of about 5 mm to about 30 mm.31 . A framework for a prosthetic heart valve, comprising: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; wherein the framework has a first expanded configuration and a second expanded configuration; and wherein implanting a valve mechanism within the framework changes the framework from the first configuration to the second configuration.

32. The framework of claim 31 , wherein the plurality of engagement struts are positioned further towards the inflow end in the second configuration relative to the first configuration.

33. The framework of claim 32, wherein the body portion comprises a plurality of vertical body struts that change angles between the first configuration and the second configuration.

34. A framework for a prosthetic heart valve, comprising: a body portion having a passage extending longitudinally between an inflow end and an outflow end; a plurality of atrial flange struts extending radially outward from the inflow end of the body portion; a plurality of engagement struts connected near the outflow end of the body portion and positioned along an outer side of the body portion toward the inflow end; and, a plurality of engagement structures extending from the passage.

35. A delivery device, comprising: a framework delivery portion having one or more anchor members; a framework removably located within the framework delivery portion; a valve mechanism delivery portion having an expandible structure; a valve mechanism positioned over the expandible structure; wherein the valve mechanism delivery portion is located proximal of the framework delivery portion.

36. A delivery device, comprising: a framework delivery portion; a framework removably located within the framework delivery portion; a plurality of wires connected to the framework; and, a release mechanism connected to the plurality of wires.

37. A method, comprising: implanting a framework at a native cardiac valve; implanting a temporary artificial valve within the framework; removing the temporary artificial valve from the framework; and, implanting a permanent artificial valve within the framework.