Docking station with helical struts

Abstract

An implant may include an expandable frame configured to expand from a compressed state to an expanded state when deployed, where the expandable frame may include a longitudinal direction along a central axis through a central lumen formed by the expandable frame. The implant may also include a plurality of struts at a first end of the expandable frame, where the struts extend away from the expandable frame in a series of generally tangential directions away from a circular shape, where the circular shape is disposed within the central lumen, and where the circular shape is perpendicular to the longitudinal direction, where the struts extend away from the expandable frame in a series of generally tangential directions away from the circular shape. And wherein the circular shape is centered substantially about the central axis.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 514,326, filed July 18, 2023. Application 63 / 514,326 is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to an implantable adapter system for engaging and retaining a prosthetic implant, such as a prosthetic heart valve, in a cavity of the body, such as a blood vessel or valve of the heart. Background Technology

[0004] Prosthetic heart valves can be used to treat valvular heart disease. Natural heart valves (aortic, pulmonary, tricuspid, and mitral valves) prevent regurgitation or backflow while allowing forward flow. These valves can become less effective due to congenital conditions, inflammation, infection, or other factors. Such conditions can ultimately lead to serious cardiovascular damage or death. For many years, doctors have attempted to treat these conditions by surgically repairing or replacing the valves during open-heart surgery.

[0005] Transcatheter techniques for introducing and implanting prosthetic heart valves using catheters can reduce complications associated with open-heart surgery, resulting in less trauma than open-heart surgery. In this technique, the prosthetic valve can be mounted in a coiled state on the distal portion of a catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the catheter tip can then be inflated to its functional size at the site of a defective natural valve, such as by inflating a balloon on which the valve is mounted, or, for example, by having a resilient self-expanding stent or frame that allows the valve to inflate to its functional size as a delivery sheath is advanced from the distal end of the catheter. Optionally, the valve can have a balloon-inflatable frame, a self-expanding frame, a mechanically inflatable frame, and / or a combination of inflatable frames in various ways or combinations thereof.

[0006] Transcatheter heart valves (THVs) can be appropriately sized to fit within numerous natural heart valves or orifices. However, for larger natural valves, vessels (e.g., an enlarged aorta), grafts, etc., aortic TCVs may be too small to be secured to larger implantation or deployment sites. In such cases, the TCV may not be large enough to expand within a natural valve or other implantation or deployment site, or the implantation / deployment site may not provide a suitable seat for securing the THV. As an example, aortic insufficiency may be associated with difficulties in securely implanting the THV into the aorta and / or aortic valve. Therefore, there is a need for improved systems and methods for securing THVs in relatively large-diameter vessels or rings. Summary of the Invention

[0007] Certain embodiments of the present disclosure relate to docking stations, frame adapters, pre-stents, and the like for engaging and retaining a prosthetic implant, such as a prosthetic heart valve, in a lumen of a body, such as a blood vessel or valve of a heart. In representative embodiments, an implant can include an expandable frame configured to expand from a compressed state to an expanded state when deployed, where the expandable frame can include a longitudinal direction along a central axis through a central lumen formed by the expandable frame. The implant can also include a plurality of struts at a first end of the expandable frame, where the struts extend away from the expandable frame in a series of generally tangential directions away from a circular shape seated within the central lumen, where the circular shape is perpendicular to the longitudinal direction, and where the circular shape is generally centered about the central axis.

[0008] The foregoing and other objects, features and advantages of the described technology will become more apparent from the following DETAILED DESCRIPTION, which proceeds with reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0009] Figure 1A is a cross-sectional view of a human heart in diastole.

[0010] Figure 1B is a cross-sectional view of a human heart in systole.

[0011] Figure 2A is a cross-sectional view of a human heart with an example embodiment of an example docking station positioned in the inferior vena cava (IVC) of the blood vessel.

[0012] Figure 2B is an end view of an example docking station and valve, showing the valve in an open configuration so that blood can flow through the valve, for example, when the heart is in diastole.

[0013] Figure 2C is an end view of the docking station and valve of Figure 2B , showing the valve in a closed configuration, for example, when the heart is in systole.

[0014] Figure 3A is a cross-sectional view of an example embodiment of a docking station with an example transcatheter valve seated inside the docking station.

[0015] Figure 3B is a top view of the docking station and valve shown in Figure 3A .

[0016] Figure 3C is a perspective view of an example embodiment of a docking station showing that the docking station can be Figures 3A-3BExamples of frame portions used in docking stations of the type shown in

[0017] Figure 3D is Figure 3A a cross-sectional view of a docking station shown in

[0018] Figure 4A and 4B Deployment of a docking station is shown schematically.

[0019] Figure 4C and 4D Deployment of a valve in a docking station is shown schematically.

[0020] Figure 5 Components of another example implant configured to dock and / or support one or more prosthetic valves and / or valve components are shown.

[0021] Figure 6 Components of another example implant configured to dock and / or support one or more prosthetic valves and / or valve components are shown.

[0022] Figure 7A A side view of components of another example implant configured to dock and / or support one or more prosthetic valves and / or valve components is shown.

[0023] Figures 7B-7F An example deployment of an implant shown in Figure 7A

[0024] Figure 8 A top view of components of another example implant configured to dock and / or support one or more prosthetic valves and / or valve components is shown.

[0025] Figure 9A A portion of an implant of Figure 8

[0026] Figure 9B An implant of Figure 8 is shown, where various measurements and shapes are shown.

[0027] Figure 10 An example of an implant of Figure 8 is shown when cut or etched from a cylindrical tube.

[0028] Figure 11 Another example of an implant configured to dock and / or support one or more prosthetic valves and / or valve components is shown.

[0029] Figures 12A-12C An example of a strut of an implant is shown. ​​DETAILED DESCRIPTION

[0030] Terminology

[0031] For purposes of this description, certain aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any manner. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination of aspects and features, nor do the disclosed embodiments require the presence of any one or more of the recited advantages or solutions to problems.

[0032] It should be understood that the disclosed embodiments can be adapted for delivery and implantation in any of the natural rings and vessels of the heart (e.g., the pulmonary, mitral, and tricuspid annuli, the inferior and superior vena cava, etc.) and can be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0033] Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenience only, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures can not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The

[0034] All features described herein are independent of each other and can be used in combination with any other feature described herein, unless structurally impossible.

[0035] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Furthermore, the term “coupled” and “associated” generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between coupled or associated items absent specific contrary language. As used herein, the term “and / or” used between the last two items in a list of elements means any one or more of the listed elements. For example, the phrase “A, B, and / or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C,” or “A, B, and C.”

[0036] In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow,” respectively. Thus, for example, the lower end of a valve or docking station as depicted in the figures is generally its inflow end, and the upper end of the valve or docking station is its outflow end, unless otherwise expressly described.

[0037] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to a user (e.g., a clinician) and further from an implant site and / or body lumen orifice. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further from a user and closer to an implant site and / or body lumen orifice. Thus, for example, proximal movement of a device is movement of the device toward the user, while distal movement of the device is movement of the device away from the user.

[0038] Unless otherwise expressly defined, the terms “longitudinal” and “axial” refer to an axis extending in an upstream and downstream direction or in a proximal and distal direction.

[0039] While there are alternatives to the various components, features, parameters, operating conditions, etc. set forth herein, this does not mean that the alternatives are necessarily equivalent and / or perform equally well. Nor does it mean that the alternatives are listed in a preferred order, unless otherwise stated.

[0040] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) can be used herein to facilitate discussion of the drawings and principles of the present disclosure, but are not intended to be limiting. For example, certain terms, such as "inner," "outer," "top," "bottom," "interior," "exterior," etc., can be used. Such terms are used to provide some clear description, particularly with respect to the illustrated embodiments, where applicable. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, an "upper" portion of an object can simply become a "lower" portion by turning the object over. Nonetheless, the object is still the same portion and the object remains unchanged. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0041] As used herein, the terms "integrally formed" and "unitary construction" refer to a construction that does not require any sutures, fasteners, or other fixation devices to attach two portions of the construction together.

[0042] Examples of the disclosed technology

[0043] The present disclosure relates to valve adapters / docking stations / landing zones / pre-implanted strut technology for implanting a prosthetic heart valve, such as a transcatheter heart valve, in a chamber or valve of the heart where the diameter of the chamber or valve is significantly larger than the functional diameter of the prosthetic valve. In certain instances, the docking station can include a radially expandable and collapsible frame formed of a plurality of struts, and including a valve seat within the frame configured to receive an expandable prosthetic valve. In certain embodiments, the valve seat can include a plurality of struts coupled to the frame and angled inwardly toward a longitudinal axis of the frame. The valve seat can be configured to engage and hold various types and sizes of prosthetic valves. The outer aspect of the docking station frame can engage the surrounding tissue of the native chamber and form a seal, and the valve seat can engage and hold a prosthetic heart valve within the docking station. In certain embodiments, the frame can include a sealing member configured to form a seal between the frame and the surrounding anatomy without substantially interfering with blood flow into an upstream portion of the frame, such as adjacent the ostium of the hepatic vein when implanted in the inferior vena cava.

[0044] In certain embodiments, the struts of the valve seat can form valve seat frame cells of the frame. In certain embodiments, the struts and / or cells of the valve seat can include free end portions / apices that can be seated within a lumen of the docking station frame and define a reduced diameter portion configured to engage and retain the prosthetic heart valve. In certain embodiments, the struts of the valve seat can be coupled to the docking station frame at a frame joint, and the free end portions / apices of the valve seat can be offset from the frame joint in a downstream direction toward the outflow end of the frame. This reduces or minimizes the length of the prosthetic valve that protrudes or extends distally or in a downstream direction from the docking station. In certain embodiments, the struts of the valve seat can be seated entirely within the docking station frame, or the free end portions / apices of the valve seat can define the most downstream end of the docking station frame.

[0045] In certain embodiments, the docking station frame can include a plurality of circumferentially arranged longitudinal struts. The longitudinal struts can reduce or prevent foreshortening of the frame between the collapsed and expanded configurations. This can facilitate more accurate and / or predictable deployment of the docking station from the collapsed delivery configuration. The longitudinal struts can also facilitate recovery of the docking station frame from a partially deployed state by limiting the angle formed by the portion of the frame that is deployed and the longitudinal axis of the delivery apparatus. The longitudinal struts can also strengthen the frame and reduce or eliminate folding or invagination of the frame during recovery.

[0046] In certain embodiments, the docking station frame can include a plurality of free end portions or apices circumferentially arranged about the frame. In certain embodiments, the free apices can be located between pairs of adjacent longitudinal struts. In certain embodiments, the free apices can be proximal and / or distal apices that define frame cells between pairs of longitudinal frame struts. In certain embodiments, the frame cells can be axially spaced apart from one another. The free apices can be configured to engage surrounding tissue of a body lumen in which the docking station frame is implanted to prevent movement / migration / rotation of the frame relative to the body lumen.

[0047] In some embodiments, docking stations / devices for prosthetic valves or THVs are shown for use within the superior vena cava (SVC), the inferior vena cava (IVC), or both the SVC and the IVC, although the docking stations / devices (e.g., docking station / device 10, other docking stations / devices described herein, modified versions of the docking stations, etc.) can be used in other areas of the anatomy, heart, or vasculature (e.g., the tricuspid valve, the pulmonary valve, the pulmonary artery, the aortic valve, the aorta, the mitral valve, or other locations). The docking stations / devices described herein can be configured to compensate for a deployed transcatheter valve or THV that is smaller than and / or has a different geometry than the space (e.g., the anatomy / heart / vasculature, etc.) in which it is placed. For example, a native anatomy (e.g., the IVC) can be oval, ovoid, or another shape, while a prosthetic valve or THV can be cylindrical.

[0048] Various embodiments of docking stations / devices and examples of prosthetic valves or transcatheter valves are disclosed herein, and any combination of these options can be made unless specifically excluded. For example, any of the docking stations / devices disclosed can be used with any type of valve and / or any delivery system, even if a particular combination is not explicitly described. Likewise, different configurations and features of docking stations / devices and valves can be mixed and matched, such as by combining any docking station type / feature, valve type / feature, covering / sealing element, etc., even if not explicitly disclosed. Simply put, the various components of the systems disclosed can be combined unless mutually exclusive or physically impossible.

[0049] For uniformity, in the present disclosure, docking stations are generally depicted with the right atrial end (e.g., outflow end) up and the ventricular or IVC end (e.g., inflow end) down, unless otherwise noted.

[0050] First representative embodiment

[0051] Figure 1A and 1B are cross-sectional views of a human heart (H) during diastole and systole, respectively. The right ventricle (RV) and left ventricle (LV) are separated from the right atrium (RA) and left atrium (LA), respectively, by the tricuspid valve (TV) and mitral valve (MV); i.e., atrioventricular valves. In addition, the aortic valve (AV) separates the left ventricle (LV) from the ascending aorta (not shown), and the pulmonary valve (PV) separates the right ventricle from the pulmonary artery (PA). Each of these valves has flexible leaflets that extend inward across a respective orifice that come together or “coapt” in a flow stream to form a unidirectional fluid obstruction surface. For illustration, the docking stations and valves of the present application are described primarily with respect to the inferior vena cava (IVC), superior vena cava (SVC), and aorta / aortic valve. For example, a defective aortic valve can be a stenotic aortic valve and / or suffer from insufficiency and / or regurgitation. The vessels (e.g., aorta, IVC, SVC, pulmonary artery) can be healthy, or can be dilated, twisted, enlarged, have an aneurysm, or otherwise be compromised. The anatomy of the right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV will be explained in greater detail. The devices described herein can be used in various regions, whether explicitly described herein or not, such as in the IVC and / or SVC, in the aorta (e.g., an enlarged aorta) for treating a defective aortic valve, in other regions of the heart or vasculature, in a graft, etc.

[0052] The right atrium RA receives deoxygenated blood from the venous system through the superior vena cava SVC and inferior vena cava IVC, the former entering the right atrium from above and the latter entering the right atrium from below. The hepatic veins 17 carry blood from the liver to the inferior vena cava IVC. The coronary sinus (CS) is a collection of veins that join together to form a large vessel that collects deoxygenated blood from the heart muscle (myocardium) and delivers it to the right atrium RA. During diastole or diastolic phase, seen in Figure 1A , as the right ventricle RV expands, deoxygenated blood that has collected in the right atrium RA from the IVC, SVC, and CS moves through the tricuspid valve TV and into the RV. During systole or systolic phase, seen in Figure 1B , the right ventricle RV contracts to force deoxygenated blood collected in the RV through the pulmonary valve PV and pulmonary artery into the lungs.

[0053] The devices described herein can be used to supplement the function of a defective tricuspid valve and / or to prevent excessive pressure buildup in the RA. During systole, the leaflets of a normally functioning tricuspid valve TV close to prevent venous blood from regurgitating or flowing back into the right atrium RA. During systole, when the tricuspid valve does not function properly, blood can flow or regurgitate back into the right atrium RA, inferior vena cava IVC, superior vena cava SVC, and / or other blood vessels. Blood that regurgitates back into the right atrium increases the volume of blood in the atrium and blood vessels that direct blood to the heart. This can cause the right atrium to enlarge and cause blood pressure in the right atrium and blood vessels to rise, which can cause damage and / or swelling of the liver, kidneys, legs, other organs, etc. A transcatheter valve (THV) implanted in the inferior vena cava IVC and / or superior vena cava SVC can prevent or inhibit blood from flowing back into the inferior vena cava IVC and / or superior vena cava SVC during systole.

[0054] The length L, diameter D, and curvature or profile of the superior vena cava SVC and inferior vena cava IVC can vary greatly between different patients. The relative orientation and position of the IVC and / or SVC can also vary between patients. Furthermore, the size or diameter D can vary significantly along the length L of an individual IVC and / or SVC. Additionally, the anatomy of the IVC and / or SVC is soft, flexible, and dynamic compared to other heart vessels, such as the aorta. This more soft, flexible, and / or dynamic (moving and / or shape changing) nature of the IVC and SVC makes it more difficult to support a transcatheter valve frame or docking station that anchors a transcatheter valve in the IVC and / or SVC than in the aorta. Furthermore, other regions of the body and other regions or other vasculature within a patient that can use a docking station can also vary significantly in shape and size.

[0055] The left atrium LA receives oxygenated blood from the left and right pulmonary veins, which then travels through the mitral valve to the left ventricle. During diastole or diastolic phase, seen in Figure 1AAs observed, as the left ventricle (LV) expands, oxygen-rich blood collected in the left atrium (LA) moves through the mitral valve (MV) and into the left ventricle (LV). During systole or contraction, in... Figure 1B As observed, the left ventricle (LV) contracts to force oxygen-rich blood through the aortic valve (AV) and the aorta into the body via the circulatory system. In some embodiments, the device described herein can be used to supplement or replace the function of a defective aortic valve. For example, the device described herein may be particularly effective for treating aortic insufficiency. During diastole, the leaflets of a normally functioning aortic valve (AV) close to prevent oxygen-rich blood from flowing back into the left ventricle (LV). When the aortic valve malfunctions, blood flows back or regurgitates into the left ventricle (LV). The THV implanted in the aortic valve helps prevent or inhibit blood flow back into the left ventricle (LV) during diastole. The length L, diameter D, and curvature or profile of the aortic root can vary considerably between patients, especially if the aorta is dilated, tortuous, or enlarged. Furthermore, the size or diameter D can vary significantly along the length L of the individual aorta.

[0056] refer to Figure 2A , 3A In some embodiments, such as 3B and 3C, the expandable docking station / device / valve adapter / landing zone / pre-implanted strut 10 includes one or more sealing portions 12, a valve seat 18, and one or more retaining portions 14. The sealing portion 12 provides a seal between the docking station 10 of the circulatory system and the inner surface 16 (see [link to documentation]). Figure 2A The valve seat 18 provides a support surface for implanting or deploying the valve 29 in the docking station 10 after it has been implanted in the circulatory system. Optionally, the docking station 10 and the valve 29 may be integrally formed; for example, in one embodiment, the valve seat 18 may be omitted. When integrally formed, the docking station 10 and the valve 29 can be deployed as a single device, rather than deploying the docking station 10 first and then deploying the valve 29 into the docking station. Any of the docking stations and / or valve seats 18 described herein may be provided with an integrated valve 29 or form an integrated valve.

[0057] The retaining portion 14 helps to hold the docking station 10 and the valve 29 at their implantation or deployment site in the circulatory system. The retaining portion 14 can take many different forms. In some embodiments, the retaining portion 14 includes friction-enhancing features that reduce or eliminate migration of the docking station 10. Friction-enhancing features can take many different forms. For example, friction-enhancing features may include barbs, spikes, textures, adhesives, and / or a cloth or polymer cover with high frictional properties on the retaining portion 14. Such friction-enhancing features can also be used on any of the various docking stations or retaining portions described herein.

[0058] The expandable docking station 10 and valve 29 described in the various embodiments herein also represent various docking stations and / or valves described herein, or may be known or developed, for example, various different types of valves may replace and / or be used as valve 29 in various docking stations.

[0059] Figure 2A , 2B Figures 1 and 2C illustrate representative examples of the operation of the docking station 10 and valve 29 disclosed herein. Figure 2A , 2B In the 2C example, docking station 10 and valve 29 are deployed in the inferior vena cava (IVC). However, docking station 10 and valve 29 can be deployed in any internal surface within a cavity of the heart or body. For example, the various docking stations and valves described herein can be deployed in the superior vena cava (SVC), tricuspid valve (TV), pulmonary valve (PV), pulmonary artery, mitral valve (MV), aortic valve (AV), aorta, or other vascular systems / cavities within the body.

[0060] Figure 2A and 2B The diagram shows valve 29, docking station 10, and heart H when implanted in the IVC and heart H is in diastole. During diastole, valve 29 is open. Blood flows from the inferior vena cava (IVC) and superior vena cava (SVC) into the right atrium (RA). Blood flowing from the inferior vena cava (IVC) passes through docking station 10 and valve 29, as indicated by arrow 20. Additionally, during diastole, blood in the right atrium flows through the tricuspid valve (TV) and into the right ventricle (RV) and valves, as indicated by arrow 22. Figure 2B Space 24 is shown, which indicates that valve 29 is open when the heart is in diastole. Various types of valves that can open and close in multiple ways can be used (e.g., including valves with leaflets that open and then clasp together to close), so the figures are intended to illustrate various valves that can operate in different ways. Figure 2B The interface between docking station 10 and the inferior vena cava is not shown to simplify the figures. Figure 2B The crossed lines in the diagram represent blood flow through valve 29. In some embodiments, blood flow between the inferior vena cava (IVC) and docking station 10 is prevented or inhibited by the sealing portion 12, and blood flow between docking station 10 and valve is prevented or inhibited by implanting or placing the valve in the seat 18 of docking station 10. In this example, when the valve is open (e.g., in some embodiments, only during diastole), blood flows essentially or is only able to flow through valve 29.

[0061] Figure 2CThe valve 29 and docking station 10 are shown when the valve 29 is closed (e.g., when implanted in the IVC and the heart H is in systole). When implanted in the IVC and the heart is in systole, the valve 29 is closed. Blood is prevented from flowing from the right atrium RA into the inferior vena cava IVC by the closed valve 29. Thus, the closed valve 29 prevents any blood that is regurgitated through the tricuspid valve TV during systole from being forced into the inferior vena cava IVC. Figure 2C The solid region 26 in the center represents the closed valve 29 (e.g., when the heart is in systole in some embodiments). Figure 2C It is intended to represent various valves, even though the valves can close in different ways.

[0062] In some embodiments, the docking station 10 acts as an isolator that prevents or substantially prevents the transmission of radial outward forces of the valve 29 to the inner surface 16 of the circulatory system. In one embodiment, the docking station 10 includes a valve seat 18 that resists expansion, e.g., does not expand or substantially does not expand radially outward (e.g., the diameter of the valve seat does not increase by more than 4 mm) by the radial outward forces of the transcatheter valve or valve 29. The valve seat can be configured so that when the docking station is implanted, the expansion of the THV / valve 29 only increases the diameter of the valve seat to a diameter that is less than the outer diameter of the docking station 10. The retention portion 14 and the sealing portion 12 can be configured to exert only a relatively small radial outward force on the inner surface 16 of the circulatory system (compared to the radial outward force exerted by the valve 29 on the valve seat 18). As in various docking stations described herein, having a valve seat 18 that is stiffer or expands less radially than the outer portions of the docking station (e.g., the retention portion 14 and the sealing portion 12) provides a number of benefits, including allowing the THV / valve 29 to be implanted in vasculature or tissue that has different strengths, sizes, and / or shapes. The outer portions of the docking station can better conform to the anatomy (e.g., vasculature, tissue, heart, etc.) without exerting too much pressure on the anatomy, while the THV / valve 29 can be securely and safely implanted in the valve seat 18 with forces that will prevent or mitigate the risk of migration or slippage.

[0063] The docking station 10 may include any combination of one or more different types of valve seat 18, retaining portion 14, and / or sealing portion 12. For example, the valve seat 18 may be a separate component attached to the frame 28 of the docking station 10, while the sealing portion is integrally formed with the frame 28 of the docking station. Alternatively, the valve seat 18 may be a separate component attached to the frame 28 of the docking station 10, while the sealing portion 12 is also a separate component attached to the frame 28 of the docking station. Optionally, the valve seat 18 may be integrally formed with the frame 28 of the docking station 10, while the sealing portion is integrally formed with the frame 28 of the docking station. Furthermore, the valve seat 18 may be integrally formed with the frame 28 of the docking station 10, while the sealing portion is a separate component attached to the frame 28 of the docking station 10.

[0064] The sealing portion 12, valve seat 18, and one or more retaining portions 14 of the various docking stations described herein can take on various forms and characteristics. Figures 3A-3C In this structure, the expandable frame 28 provides the shapes of the sealing portion 12, the valve seat 18, and the retaining portion 14. The expandable frame 28 can take many different forms. Figures 3A-3C The expandable frame 28 shown has an end portion 30 having an inner diameter 32 and an outer diameter 34. An annular or cylindrical outer portion or wall 36 extends downward from the outer diameter 34 of the end portion 30. An annular or cylindrical valve seat 18 or wall extends downward from the inner diameter 32 of the end portion 30. In the illustrated example, the expandable frame 28 is an expandable grid. Expandable grids can be manufactured in various ways, such as by joining together to form a grid, by individual threads of a braid, by cutting from a sheet and then rolling it up, or otherwise forming it into the shape of an expandable frame, by molding, by cutting from a cylindrical tube (e.g., from a nitinol tube), or by other methods or combinations thereof.

[0065] Frame 28 can be made of highly flexible metals, metal alloys, or polymers. Examples of metals and metal alloys that can be used include, but are not limited to, nitinol and other shape memory alloys, elgiloy, and stainless steel, but other metals and highly elastic or flexible non-metallic materials can be used to manufacture frame 28. These materials allow the frame to be compressed to a small size and then, when the compressive force is released, the frame will self-expand back to its pre-compression diameter, and / or the frame can be expanded by the inflation of a device positioned inside the frame. Frame 28 can also be made of other materials and is inflatable and collapsible in different ways, such as mechanically inflatable, balloon-inflatable, self-inflatable, or a combination thereof.

[0066] The sealing components can take many different forms. Figures 3A-3CIn this example, the cover / material 21 is attached to a portion of the frame 28 to form the sealing portion 12. However, the sealing portion 12 can be formed in a variety of other ways. The cover / material 21 can be a fabric material, a polymer material, or other materials. The sealing portion 12 can take any form that prevents or inhibits the flow of blood around the outer surface of the valve 29 and through the docking station. Figure 3A , 3B In the example of 3C, the sealing portion 12 includes a cover / material 21 extending to the valve seat 18 (e.g., a fabric or other covering material that may be the same as or similar to other covers / materials described herein). The cover / material 21 can be shaped and positioned in various ways; for example, the cover / material can be configured to partially cover, completely cover, or not cover the valve seat 18 when the frame 28 expands. The cover / material 21 forming the sealing portion 12 (e.g., fabric or other covering material) can also extend radially outward, covering the end 30 of the frame 28, and can optionally extend (e.g., longitudinally, downward, etc.) to cover at least a portion of the annular outer portion or wall 36. The sealing portion 12 provides a seal between the docking station 10 of the circulatory system and the inner surface 16 (see FIG. 2). That is, the sealing portion 12 and the closed valve 29 prevent or inhibit blood flow in the direction indicated by arrow 38. Figure 3A and 3B In this example, blood is not inhibited from flowing into the region 42 between the valve seat 18 and the annular outer portion or wall 36 in the direction indicated by arrow 40.

[0067] Valve seats can take many different forms. Valve seat 18 is... Figures 3A-3C The valve seat 18 is part of the frame 28 in the example. However, the valve seat 18 may be formed separately from the frame 28. The valve seat 18 may take any form to provide a supporting surface for implanting or deploying the valve 29 in the docking station 10 after the docking station 10 is implanted in the circulatory system. The valve seat may optionally be reinforced with a reinforcing material (e.g., sutures, threads, bands, collars, etc.) that may surround the valve seat or a portion thereof. The valve 29 is in Figure 3A The diagram illustrates that valve 29 can take various forms. Figure 3D A more specific example is shown, where valve 29 is a leaflet type THV, such as SAPIEN, available from Edwards Lifesciences Corporation. ®The valve 29 comprises a plurality of leaflets 58. In some embodiments, the valve 29 is integrated with or replaces the valve seat 18, such that the docking station 10 is configured as a transcatheter valve delivered as a single unit in the same step (as opposed to implanting the docking station first and then implanting a separate valve / THV in the docking station). Optionally, any of the docking stations described herein may be formed as a valve or THV, for example, wherein valve tissue or other valve material is integrated into the docking station.

[0068] The retaining portion 14 can take many different forms. For example, the retaining portion 14 can be any structure that positions the docking station 10 within the circulation system. For example, the retaining portion 14 can press against or be pressed into the inner surface 16 or travel / extend along the contours of the anatomical structure of the circulation system to position and maintain the docking station 10. The retaining portion 14 can be part of or define part of the body and / or sealing portion of the docking station 10, or the retaining portion 14 can be a separate component attached to the body of the docking station. The docking station 10 may include a single retaining portion 14 or two or more retaining portions. The retaining portion 14 may include friction-enhancing features as discussed above.

[0069] exist Figures 3A-3C In one example, the retaining portion 14 includes an annular outer portion or wall 36 of the frame 28. The shape setting of the annular outer portion or wall 36 (e.g., a programmed shape of shape memory material) can be radially outwardly biased and contact / abut against the inner surface 16 of the circulatory system to hold the docking station 10 and valve 29 in the implantation position. In the illustrated embodiment, the retaining portion 14 is elongated to allow relatively small forces to be applied to a large area of ​​the inner surface 16, while the valve 29 can apply relatively large forces to the valve seat 18. For example, the length of the retaining portion 14 can be two, three, four, five, or more than five times the outer diameter of the transcatheter valve. Applying small radially outward forces over a large area may be sufficient to securely hold the docking station in place, and this design / construction allows the docking station to conform to the unique shape / size of the anatomical structure and avoids / reduces the possibility of damage to relatively weak natural tissue. Thus, the valve 29 can be securely held in various positions and anatomical structures (e.g., Figure 3A -D docking stations can be used for IVC, SVC, aorta, etc.

[0070] In some instances, the retaining portion 14 may include an annular outer portion or wall 36 of the frame 28. The shape setting of the annular outer portion or wall 36 (e.g., a programmed shape of shape memory material) may be radially outwardly biased and contact / abut against the inner surface 16 of the aorta to retain the docking station 10 and valve 29 in the implantation position. In some instances, the shape set may also be selected to substantially match the shape of a portion of the aorta. The retaining portion 14 may be elongated to allow relatively small forces to be applied to a large area of ​​the inner surface 16, while the valve 29 can apply relatively large forces to the valve seat 18, as discussed above.

[0071] Figures 4A-4D An exemplary deployment of docking station 10 and valve 29 in a circulatory system is illustrated schematically. (Reference) Figure 4A The docking station 10 is in a compressed form / construction and is introduced into a deployment site within the circulatory system. For example, the docking station 10 can be positioned at a deployment site in the SVC, IVC, aorta, or other locations. (See reference) Figure 4B The docking station 10 expands within the circulation system, causing the sealing portion 12 and the retaining portion 14 to engage with the inner surface 16 of a portion of the circulation system. The docking station may be self-expanding and can be advanced from the delivery capsule into an expanded state, or it may be plastically expandable, allowing it to expand using a balloon or other expansion device. Reference Figure 4C After the docking station 10 is deployed, the valve 29 is compressed and introduced into the valve seat 18 of the docking station 10. (Reference) Figure 4D Valve 29 expands within the docking station, such that valve 29 engages valve seat 18, and seat 18 of the docking station supports the valve. The docking station 10 allows valve 29 to operate within its designed expansion diameter range. In the example described herein, docking station 10 is longer than the valve. However, in some embodiments, the length of docking station 10 may be equal to or shorter than the length of valve 29. Similarly, the length of valve seat 18 may be longer than, shorter than, or equal to the length of valve 29. Any docking station embodiment described herein may be deployed in the manner described above.

[0072] Second representative embodiment

[0073] Figure 5Components of another example implant 500, configured to dock and / or support one or more prosthetic valves and / or valve components, are shown according to one or more embodiments. Implant 500 may include a frame 502 and / or a sealing element 504, the sealing element including a skirt, a cover, and / or similar devices. Frame 502 may be configured to form an inner frame 506 and / or an outer frame 508. The inner frame 506 may form a first diameter smaller than a second diameter of the outer frame 508. The inner frame 506 and the outer frame 508 may be extensions of a common device and / or may extend into each other.

[0074] Frame 502 may comprise a wire frame formed by a network of supports 512 (e.g., wires, ropes, and / or rods) forming one or more units 514. Frame 502 may primarily comprise the spaces between supports 512 and / or units 514. For example, supports 512 may be generally thin and / or may be spaced apart to create relatively large gaps between supports 512, such as... Figure 5 As shown in the diagram. In some instances, the outer frame 508 may include a series of longitudinally extending struts 512 circumferentially connected and / or parallel aligned around the implant 500. Each of the struts 512 may engage with one or more adjacent struts 512 at the proximal end 516 of the implant 500, and / or may engage with one or more adjacent struts 512 and / or the inner frame 506 at the distal end 518 of the implant 500.

[0075] The inner frame 506 may similarly comprise a network of generally thin, elongated, and / or spaced-apart struts 512. In some instances, one or more struts 512 of the inner frame 506 may extend generally in series and / or parallel longitudinally along the length of the implant 500. One or more struts 512 of the inner frame 506 may be positioned between the struts 512 of the outer frame 508.

[0076] In some instances, the outer frame 508 may have a generally cylindrical shape and / or may at least partially surround a portion of the inner frame 506 and / or sealing element 504. The outer frame 508 may include a network of struts 512, which may include lines, arms, rods, cords, walls, and / or similar components forming one or more units 514 and / or openings through the outer frame 508. One or more units 514 may be configured to allow blood flow through the outer frame 508. Units 514 may have any suitable shape and / or size. The outer frame 508 may form generally elongated units 514 that generally extend the entire length of the outer frame 508 and / or extend from the proximal end 516 to the distal end 518 of the implant 500. One or more units 514 may have a triangular shape at the endpoints of one or more units 514. However, one or more struts 512 may form units 514 with different shapes. For example, struts 512 may be configured to form generally rectangular and / or rhomboid units 514. Although the strut 512 is shown as having a generally thick structure, one or more struts 512 may have a linear and / or generally thin form. In some instances, the inner frame 506 and / or the outer frame 508 may be configured to maintain a uniform structure and / or strut 512 pattern along the length of the frame 502.

[0077] The implant 500 can be configured for delivery and / or placement at the SVC and / or IVC of the heart. For example, the implant 500 can be configured to be placed at or near the inflow junction of the SVC and / or IVC of the heart to the right atrium.

[0078] At the distal end 518 of the implant 500, the outer frame 508 and the inner frame 506 may be joined together, and / or the inner frame 506 may extend away from the outer frame 508 and / or along the lumen formed by the outer frame 508. In some instances, both the outer frame 508 and the inner frame 506 may have a generally open and / or conical shape at or near the distal end 518 of the implant 500. The opening angle of the inner frame 506 may be greater than that of the outer frame 508, such that the diameter of the inner frame 506 may be smaller than the diameter of the outer frame 508. The inner frame 506 may be configured to extend along at least a portion of the length of the outer frame 508.

[0079] The flared ends (e.g., distal 518) of the outer frame 508 and / or inner frame 506 may be configured to engage the atria and / or other chambers upon implantation. The sealing element 504 may be configured to extend along the inner frame 506 and / or to wrap around the outer frame 508 and / or extend between the outer frame 508 and natural tissue. The outer frame 508 may be configured to extend into the IVC and / or other blood vessels, and / or the sealing element 504 may be configured to extend from the outer frame 508 to the inner surface of the inner frame 506. The sealing element 504 may be configured to engage with a prosthetic valve and / or other implants. For example, the sealing element 504 may be configured to provide a mounting surface for the prosthetic valve and / or may be configured to securely retain the prosthetic valve. The sealing element 504 may be configured to extend only a portion of the implant 500, such that the sealing element 504 may not extend across one or more branch vessels of the blood vessel.

[0080] In some instances, the implant 500 may include one or more outwardly projecting spheres configured to extend outwardly from the diameter of the outer frame 508 to facilitate anchoring of the implant 500 within a blood vessel.

[0081] Frame 502 may include one or more downwardly extending arms 517 (e.g., extending toward a proximal end 516) configured to form an inner frame 506. For example, arms 517 may extend downwardly from an outer frame 508 at or near a distal end 518 of frame 502. One or more arms 517 may be configured to extend at an acute angle away from the outer frame into a cavity of frame 502, and / or may extend substantially parallel to the outer frame 508 at or near the distal end of one or more arms 517.

[0082] Figure 6 Components of another example implant 600, configured to dock and / or support one or more prosthetic valves and / or valve components, are shown according to one or more embodiments. Implant 600 may include a frame 602 and / or a sealing element 604, the sealing element including a skirt, a cover, and / or similar devices. Frame 602 may be configured to form an inner frame 606 and / or an outer frame 608. The inner frame 606 may form a first diameter smaller than a second diameter of the outer frame 608. The inner frame 606 and the outer frame 608 may be extensions of a common device and / or may extend into each other.

[0083] Frame 602 may comprise a wire frame formed by a network of supports 612 (e.g., wires, ropes, and / or rods) forming one or more units 614. Such supports 612 may be referred to as vertical supports. Frame 602 may primarily comprise the spaces between supports 612 and / or units 614. For example, supports 612 may be generally thin and / or may be spaced apart to create relatively large gaps between supports 612, such as... Figure 6 As shown in the diagram. In some instances, the outer frame 608 may include a series of longitudinally extending struts 612 circumferentially connected and / or parallel aligned around the implant 600. Each of the struts 612 may engage with one or more adjacent struts 612 at the proximal end 616 of the implant 600, and / or may engage with one or more adjacent struts 612 and / or the inner frame 606 at the distal end 618 of the implant 600.

[0084] The inner frame 606 may similarly comprise a network of generally thin, elongated, and / or spaced-apart struts 612. In some instances, one or more struts 612 of the inner frame 606 may extend generally in series and / or parallel longitudinally along the length of the implant 600. One or more struts 612 of the inner frame 606 may be positioned between the struts 612 of the outer frame 608.

[0085] In some instances, the outer frame 608 may have a generally cylindrical shape and / or may at least partially surround a portion of the inner frame 606 and / or sealing element 604. The outer frame 608 may include a network of struts 612, which may include lines, arms, rods, cords, walls, and / or similar components forming one or more units 614 and / or openings through the outer frame 608. One or more units 614 may be configured to allow blood flow through the outer frame 608. Units 614 may have any suitable shape and / or size. The outer frame 608 may form generally elongated units 614 that generally extend the entire length of the outer frame 608 and / or extend from the proximal end 616 to the distal end 618 of the implant 600. One or more units 614 may have a triangular shape at the endpoints of one or more units 614. However, one or more struts 612 may form units 614 with different shapes. For example, struts 612 may be configured to form generally rectangular and / or rhomboid units 614. Although the strut 612 is shown as having a generally thick structure, one or more struts 612 may have a linear and / or generally thin form. In some instances, the inner frame 606 and / or the outer frame 608 may be configured to maintain a uniform structure and / or strut 612 pattern along the length of the frame 602.

[0086] The implant 600 can be configured for delivery and / or placement at the SVC and / or IVC of the heart. For example, the implant 600 can be configured to be placed at or near the inflow junction of the SVC and / or IVC of the heart to the right atrium.

[0087] At the distal end 618 of the implant 600, the outer frame 608 and the inner frame 606 may be joined together, and / or the inner frame 606 may extend away from the outer frame 608 and / or along the lumen formed by the outer frame 608. In some embodiments, both the outer frame 608 and the inner frame 606 may have a generally open and / or conical shape at or near the distal end 618 of the implant 600. The opening angle of the inner frame 606 may be greater than that of the outer frame 608, such that the diameter of the inner frame 606 may be smaller than the diameter of the outer frame 608. The inner frame 606 may be configured to extend along at least a portion of the length of the outer frame 608.

[0088] The flared ends (e.g., distal 618) of the outer frame 608 and / or inner frame 606 may be configured to engage the atria and / or other chambers upon implantation. The sealing element 604 may be configured to extend along the inner frame 606 and / or to wrap around the outer frame 608 and / or extend between the outer frame 608 and natural tissue. The outer frame 608 may be configured to extend into the IVC and / or other blood vessels, and / or the sealing element 604 may be configured to extend from the outer frame 608 to the inner surface of the inner frame 606. The sealing element 604 may be configured to engage with a prosthetic valve and / or other implants. For example, the sealing element 604 may be configured to provide a mounting surface for the prosthetic valve and / or may be configured to securely retain the prosthetic valve. The sealing element 604 may be configured to extend only a portion of the implant 600, such that the sealing element 604 may not extend across one or more branch vessels of the blood vessel.

[0089] In some instances, the implant 600 may include one or more outwardly projecting spheres configured to extend outwardly from the diameter of the outer frame 608 to facilitate anchoring of the implant 600 within a blood vessel.

[0090] Frame 602 may include one or more upwardly extending arms 619 configured to form an inner frame 606 (e.g., extending toward a distal end 618). For example, arms 619 may extend downward from the outer frame 608 at or near the distal end 618 of frame 602. One or more arms 619 may be configured to extend at an acute angle away from the outer frame into a cavity of frame 602, and / or may extend substantially parallel to the outer frame 608 at or near the distal end of one or more arms 619.

[0091] Arms 619 of implant 600 may extend upward from proximal end 616 to distal end 618. For example, one or more arms 619 may extend at or near distal end 618 of implant 600 at an angle of approximately 45 degrees to outer frame 608, and / or may extend upward along the middle of implant 600 generally parallel to outer frame 608.

[0092] Third representative embodiment

[0093] Figure 7A A side view of components of another example implant 700 configured to dock and / or support one or more prosthetic valves and / or valve components according to one or more embodiments of the present disclosure is shown. The implant 700 may include a frame 702 and / or a sealing element 704, the sealing element including a skirt, a cover, and / or similar devices. The frame 702 may be configured to form a valve seat 715. The valve seat 715 may be positioned within a central lumen created by the frame 702. At the distal end 718 of the implant 700, the implant may include a flange 720 to facilitate a seal of the sealing element 704 against the patient's anatomy. For convenience, the central axis 750 of the implant 700 is also... Figure 7A As shown in the image.

[0094] Flange 720 can provide a protrusion extending beyond the remainder of frame 702. For example, as shown in FIG7, flange 720 can create a lip 722, which is shaped or configured to adjoin the patient's anatomy. For example, not entirely housed within the IVC (such as...). Figure 2A In the embodiment shown, the distal end 718 of the implant 700 can extend into the right atrium, wherein the flange 720 rests against the lateral wall of the right atrium, close to the location where the IVC enters the right atrium (RA). By providing a lip 722, in embodiments that radially press against the IVC, such as... Figure 2A Compared to the embodiments shown, a better seal can be produced by the sealing element 704.

[0095] In some embodiments, the shape or profile of the frame 702 or other components forming the distal end 718 of the implant 700, such as the flange 720 or the flared end, may include those consistent with... Figure 5 And / or a contour similar to or equivalent to the one shown in 6. For example, frame 702 may include one or more units, wherein the arm extends beyond the remainder of frame 702 at the distal end 718 of implant 700.

[0096] In some embodiments, the flange 720 may be substantially perpendicular to the central axis 750. Alternatively or additionally, the flange 720 may be substantially centered around the line depicting the central axis 750.

[0097] Figures 7B-7F It showsFigure 7A The example deployment of implant 700 is shown. Implant 700 can traverse the patient's circulatory system 716 to reach the target deployment location.

[0098] like Figure 7B As shown, a catheter (not shown) carrying the implant 700 can traverse the circulatory system 716 toward the deployment location. For example, as Figure 7B As shown, it may be necessary to deploy the implant 700 between the IVC and RA. The implant 700 may traverse the circulatory system 716 in the distal direction indicated by arrow 751. In some embodiments, the implant 700 may be included in a delivery capsule, or may be deployable via a balloon or other deployment mechanism.

[0099] like Figure 7C As shown, implant 700 can begin to move through the IVC and into the RA as the implant continues in the distal direction of travel indicated by arrow 752.

[0100] like Figure 7D As shown, implant 700 can be partially or fully deployed upon reaching the deployment or target location. For example, the sheath or outer cover of the delivery capsule associated with the catheter can be moved proximally relative to implant 700, thereby exposing flange 720 and / or other portions of implant 700. The radial expansion of implant 700 during deployment is indicated by arrows 753a and 753b. Although shown partially within the RA and partially within the IVC, it should be understood that implant 700 can be completely within the RA when partially or fully deployed.

[0101] like Figure 7E As shown, the implant 700 can be deployed until the flange 720 is substantially or fully deployed. Further deployment is indicated by arrows 754a and 754b. In some embodiments, the implant 700 can be deployed until the radial edge of the flange 720 extends beyond the circumference of the IVC. Such deployment may include full or partial deployment of the flange 720 and / or full or partial deployment of the implant 700.

[0102] In some embodiments, Figure 7E The unfolded state shown can include implants 700 that are at least 30% unfolded, at least 40% unfolded, at least 50% unfolded, at least 60% unfolded, at least 70% unfolded, at least 80% unfolded, at least 90% unfolded, or 100% unfolded (or fully unfolded). Alternatively or alternatively, Figure 7EThe unfolded state shown may include the flange 720 portion of the implant 700 unfolded at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or 100% (or fully unfolded).

[0103] like Figure 7F As shown, upon reaching Figure 7E Following the deployment phase shown, the conduit can be pulled back in the proximal direction, as indicated by arrow 755. This facilitates the placement of flange 720 against the wall of RA to create a seal.

[0104] In some embodiments, after the flange 720 is placed against the wall of the RA, the implant 700 can be fully deployed. Additionally, the implant 700 can be disengaged from the catheter and the catheter can be removed from the patient's body. For example, the connecting foot of the frame 702 can be separated from the attachment feature of the delivery capsule. Alternatively or additionally, after the implant 700 is fully deployed, the valve can be traversed across the patient's circulatory system 716 and attached to the implant 700 (e.g., via a catheter attached to the valve delivery capsule, traversing the patient's circulatory system 716 until the valve can be deployed from the valve delivery capsule and attached to the implant 700, and the catheter and valve delivery capsule are removed).

[0105] Figure 8 A top view of components of another example implant 800 configured to dock and / or support one or more prosthetic valves 29 and / or valve components according to one or more embodiments of the present disclosure is shown. Implant 800 may include a frame 802 and / or a sealing element 804, the sealing element including a skirt, a cover, and / or similar devices. Frame 802 may be configured to form a valve seat 18 and a flange 820 similar to or equivalent to the flange 720 shown in FIG. 7.

[0106] In some respects, implant 800 can be combined with Figure 5 500 and / or implants Figure 6 One or more of the 600 are similar to or equivalent to those of implants 500 and 600. However, the strut 803 of implant 800 at flange 820 may differ from the struts of implants 500 and 600. Figure 8 As shown, the frame 802 may include a plurality of struts 803 (such as struts 803a-803j) that project outward and away from the frame 802 to facilitate the formation of the flange 820. In doing so, the struts 803 may project in a spiral manner away from the point of contact with the rest of the frame 802. Or in other words, a series of struts 803 may create a spiral visual effect by extending the struts 803 away from the rest of the frame 802.

[0107] By providing a support column 803 in a spiral shape, the support column 803 can produce a structure with... Figure 5 and Figure 6 The flange 820 shown has similar or equivalent dimensions, but the flange 820 formed by the helical strut 803 can provide additional rigidity within the flange 820 itself. For example, the strut 803 can sweep in the radially outward and circumferential directions around the generally circular shape 819 formed by the edge of the frame 802 at the outer edge of the valve seat 18, rather than protruding directly from the frame away from the frame to the edge of the flange in the direct radially outward direction (e.g., as shown). Figure 5 and Figure 6 (As shown in the diagram). Because the strut 803 extends away from the frame 802 in the helical manner shown, the flange 820 can provide more consistent stiffness throughout the flange 820, and therefore can provide greater stiffness to the patient's anatomy than... Figure 5 and Figure 6 The implant shown provides a better seal. Alternatively, the flange 820 can be better adapted to variations in anatomical structures because the flange can be pressed in a more consistent manner around the outer edge of the flange 820 to produce a seal for various anatomical contours.

[0108] In some embodiments, the strut 803 may protrude away from the generally circular shape 819. For example, the strut 803 may protrude away from the circular shape 819 in a generally tangential direction. In some embodiments, the tangential direction may include a lateral curvature (the lateral curvature may be referenced to...). Figure 9A and 9B (A more detailed description and explanation) or may include a generally straight outline (the generally straight outline may refer to...) Figure 11 (A more detailed description and explanation).

[0109] In some embodiments, the strut 803 may include a node 805 at its distal end. For example, the node 805 may include a circular shape or protrusion of material at the end of the strut 803. In some embodiments, the node 805 may include a hole 806 through which a sealing element 804 may be sutured or otherwise securely attached to the strut 803. In some embodiments, the node 805 may reduce, control, or mitigate the amount of tissue penetration caused by the distal end of the strut 803. For example, during implant deployment 800, the distal end of the strut 803 may bite into or otherwise penetrate the patient's tissue. By providing the node 805, tissue penetration can be controlled.

[0110] In some embodiments, node 805 may include a widening of the material used to make frame 802. For example, strut 803 may be a continuation of frame 802, and node 805 may be integrally formed with strut 803. In some embodiments, frame 802 (including strut 803 and node 805) may be made of nitinol or other shape memory alloys and cut from a single tube.

[0111] In some embodiments, node 805 may include a coating, material, pad, foam, or other feature added to the distal end of strut 803 to facilitate control over the amount of tissue penetration caused by strut 803. Although shown on each of struts 803, it should be understood that a limited number of struts 803 may include node 805. For example, every other strut 803 or every third strut 803 may include a node, rather than every strut 803 including a node.

[0112] In some embodiments, implant 800 may include one or more radiopaque markers to facilitate guidance, orientation, and otherwise facilitate procedures for guiding implant 800 through a patient's body to a target location, deploying implant 800, and / or otherwise positioning implant 800 in a desired location. For example, when performing procedures involving implant 800, radiopaque markers may help clinicians view axial or radial orientation, deployment status, or other information. In some embodiments, radiopaque markers may be located on node 805. For example, node 805 may include radiopaque material cast into node 805, such as tantalum, bismuth, iodine, barium, or gold. In some embodiments, aperture 806 may be partially or completely filled with radiopaque markers.

[0113] In some embodiments, each of nodes 805 may include a radiopaque marker. Alternatively or additionally, not all nodes 805 may include a radiopaque marker. For example, every other node 805, every third node 805, every fourth node 805, etc., may include a radiopaque marker. As another example, every third node 805, every fourth node 805, etc., may not include a radiopaque marker, and the remainder of nodes 805 may include a radiopaque marker.

[0114] Figure 9A One or more embodiments according to this disclosure are shown. Figure 8 Part of the implant 800. Figure 9A Example tangents 807 (such as tangents 807c and 807d) extending from the circular shape 819 are shown. For example, tangent 807 may represent the tangent of the circular shape 819 at the contact point where the associated support 803 extends from the frame 802.

[0115] like Figure 9AAs shown, strut 803c extends from frame 802 with a generally tangential direction that generally follows the tangent 807c at the contact point where strut 803c contacts the rest of frame 802, and strut 803d extends from frame 802 with a generally tangential direction that generally follows the tangent 807d. However, strut 803 may include a lateral curvature that deviates from the tangent 807.

[0116] Figure 9B It shows Figure 8 Implant 800, showing various measurements and shapes. (Example) Figure 9B As shown, a circle 861 defined by the radius of curvature of the pillar 803c is shown relative to the circular shape 819. Additionally, a radius 865 of the circular shape 819 is shown relative to the radius 866 of the circle 861. In these and other embodiments, Figure 9B The radius of curvature of the pillar 803, which defines the lateral curvature of the pillar 803, can be greater than the radius of curvature of the circular shape 819. In these and other embodiments, the helical shape of the pillar 803 can be formed by the pillar 803, which protrudes from the frame 802 in a direction generally following the tangent 807 (e.g., Figure 9A (as shown), but with the following characteristics Figure 9B The radius of curvature shown.

[0117] Although Figure 8 , 9A While a given radius of curvature and profile are shown in Figure 9B, it should be understood that strut 803 may include profiles with larger or smaller radii of curvature. Additionally or alternatively, although strut 803 of a given length is shown, it should be understood that strut 803 may extend to any length. With strut 803 having a shorter length and a larger radius of curvature, flange 820 may be less stiff, while strut 803 with a smaller radius of curvature and a longer length may produce a stiffer flange 820. Furthermore, although all struts 803 are shown as having a uniform length, it should be understood that struts 803 of different lengths are contemplated (e.g., four struts of a first length, four struts of a second length longer than the first length, and four struts of a third length longer than the second length).

[0118] Figure 10 An illustration is provided according to one or more embodiments. Figure 8 Examples of implants 800. For example, implant 800 may be depicted as an embodiment when cut or etched from a cylindrical tube. Figure 10 The view shown depicts a tube sliced ​​and unfolded in the longitudinal direction, such that the outer surface of the implant 800, having a tubular shape, is visible in a single plane for ease of visualization. It should be understood that, in embodiments, the tube may be cut or etched while maintaining its tubular shape.

[0119] likeFigure 10 As shown, implant 800 can be cut or etched in a compressed state to facilitate its transverse traverse of the patient's body to the delivery site (e.g., IVC, right atrium, etc.). Figure 10 As can be seen, in the compressed state before deployment, the struts 803 can be placed on the distal end of the implant and can be approximately parallel to each other when in the compressed / delivered state.

[0120] In some embodiments, the frame 802 of the implant 800 may include one or more feet 835 at the proximal end of the implant 800. The feet 835 may be used to detachably engage the implant 800 with a delivery device, such as a catheter or delivery capsule. The feet 835 may engage with the delivery device prior to delivery and may disengage from the delivery device after or during deployment.

[0121] Figure 11 Another example of an implant 1100 configured to dock with and / or support one or more prosthetic valves and / or valve components is shown. Implant 1100 can be used with... Figure 8 The implant 800 is equivalent to or similar to the implant 1100. For example, the implant 1100 may include implants that can be similar to... Figure 8 The implant 800 has a frame 802, a strut 803 and a sealing element 804 similar or equivalent to a frame 1102, a strut 1103 and a sealing element 1104 and other elements.

[0122] like Figure 11 As shown, strut 1103 may extend away from frame 1102 from circular shape 1119 at tangent 1107, said circular shape being comparable to or similar to circular shape 819 of implant 800. Strut 1103 may extend away from frame 1102 in a generally linear rather than curved manner. For example, strut 1103 may follow or run parallel to tangent 1107 (such as strut 1103a following tangent 1107a and strut 1103b following tangent 1107b).

[0123] Figures 12A-12C Examples of support pillars 1203 are shown, namely support pillars 1203a, 1203b and 1203c. Figures 12A-12B A side view of the support column 1203 projecting away from the frame 1202 is shown. The support column 1203 may be consistent with and / or applicable to any other embodiment of this disclosure. For example, Figure 8 , 9A 9B, 10 pillars 803 and / or Figure 11 The pillar 1103 may include those from, for example Figures 12A-12C The outline of the side view disclosed in the paper.

[0124] like Figure 12AAs shown, the support column 1203a may include a curved profile when viewed from the side. The support column 1203a may initially rise and move away from the rest of the frame 1202 until the support column reaches a apex 1210a. After reaching the apex 1210a, the support column 1203a may extend downward to a low point 1215a at the distal tip of the support column 1203a.

[0125] In some embodiments, the curved profile of the strut 1203a can provide a more rigid structure within the associated flange. Additionally or alternatively, the curved profile of the strut 1203a can facilitate a spring effect due to the curve of the strut 1203a being able to be pulled by a clinician (e.g., Figure 7E (as shown in the diagram) to form a seal that is designed to fit the patient's anatomical structure.

[0126] like Figure 12B As shown, the support column 1203b may include a curved profile when viewed from the side. The support column 1203b may initially rise and move away from the rest of the frame 1202 until it reaches a apex 1210b. After reaching apex 1210b, the support column 1203b may extend downwards to a low point 1215b. After reaching low point 1215b, the support column 1203b may rise again until it reaches its distal tip 1211b. In some embodiments, the distal tip 1211b may be above or below apex 1210b.

[0127] By providing a curved profile for the strut 1203b, the associated flange can enjoy similar benefits of stiffness and spring force as hinged to the strut 1203a. Additionally or alternatively, the inverse curve toward the distal tip 1211b of the strut 1203b can reduce or minimize the amount of tissue penetration caused by the distal tip 1211b of the strut 1203.

[0128] like Figure 12C As shown, in some embodiments, the profile of the strut 1203c may include a relatively flat profile when viewed from the side.

[0129] Further examples of the disclosed technology

[0130] In view of the above-described embodiments of the disclosed subject matter, this application discloses further examples listed below. It should be noted that a single feature or combination of features in an individual example, as well as more than one feature in an example optionally combined with one or more features of one or more other examples, are also further examples falling within the scope of this application's disclosure.

[0131] Example 1. An implant comprising: an expandable frame configured to expand from a compressed state to an expanded state upon deployment, the expandable frame including a longitudinal direction along a central axis through a central cavity formed by the expandable frame; and a plurality of struts at a first end of the expandable frame extending away from the expandable frame in a series of generally tangential directions away from a circular shape, the circular shape within the central cavity being perpendicular to the longitudinal direction and generally centered around the central axis.

[0132] Example 2. According to any of the foregoing examples, such as Example 1, it further includes a material skirt that covers the plurality of pillars and extends into the central cavity of the inflatable frame.

[0133] Example 3. According to any of the foregoing examples, such as any of Examples 1 to 2, it further includes a valve deployed within the central cavity.

[0134] Example 4. According to any of the preceding examples, such as Example 3, the circular shape corresponds to the valve seat in which the valve is deployed.

[0135] Example 5. According to any of the foregoing examples, such as any of Examples 1 to 4, the generally tangential direction includes curvature in the same direction as the circular shape and has a radius of curvature larger than the radius of curvature of the circular shape.

[0136] Example 6. According to any of the foregoing examples, such as any of Examples 1 to 5, the generally tangential direction includes lateral curvature in the same direction as the circular shape and has a radius of curvature larger than the radius of curvature of the circular shape.

[0137] Example 7. According to any of the foregoing examples, such as any of Examples 1 to 6, wherein the plurality of struts form a flange at the first end of the expandable frame, the flange extending radially outward from the central axis beyond the remainder of the expandable frame.

[0138] Example 8. According to any of the preceding examples, such as any of Examples 1 to 7, a given pillar of the plurality of pillars includes curvature from a contact point at the inflatable frame to a vertex and from the vertex to the distal end of the given pillar, wherein the curvature increases in the longitudinal direction as the given pillar extends away from the inflatable frame to the vertex, and decreases in the longitudinal direction as the given pillar extends from the vertex to the distal end of the given pillar.

[0139] Example 9. According to any of the foregoing examples, such as any of Examples 1 to 8, a given pillar of the plurality of pillars includes curvatures from a contact point at the inflatable frame to a apex, from the apex to a low point, and from the low point to a distal end of the given pillar, wherein the curvature increases in the longitudinal direction as the given pillar extends away from the inflatable frame to the apex, decreases in the longitudinal direction as the given pillar extends from the apex to the low point, and increases as the given pillar extends from the low point to the distal end of the given pillar.

[0140] Example 10. According to any of the preceding examples, such as any of Examples 1 to 9, a given pillar of the plurality of pillars includes a node at the distal end of the given pillar.

[0141] Example 11. According to any of the preceding examples, such as Example 10, the node includes an opening through which a material skirt is connected to the given support using stitching.

[0142] Example 12. According to any of the preceding examples, such as any of Examples 10 to 11, the width of the node is greater than the width of the arm of the given support.

[0143] Example 13. According to any of the foregoing examples, such as any of Examples 10 to 12, it further includes a material skirt that covers the plurality of pillars and extends into the central cavity of the inflatable frame, the material skirt being positioned on the exterior of the node such that, when deployed, the material skirt is located between the node and the patient's anatomy.

[0144] Example 14. According to any of the preceding examples, such as any of Examples 10 to 13, the node has a pad on the node.

[0145] Example 15. According to any of the preceding examples, such as Example 14, the pad is made of the same material as the material skirt covering the plurality of pillars.

[0146] Example 16. According to any of the foregoing examples, such as any of Examples 1 to 15, wherein the plurality of pillars are integrally formed with the expandable frame.

[0147] Example 17. According to any of the preceding examples, such as any of Examples 1 to 16, the expandable frame includes a plurality of vertical struts spanning between the proximal and distal ends of the expandable frame.

[0148] Example 18. According to any of the preceding examples, such as Example 17, wherein the plurality of pillars are interfaced with the frame at the distal end of the expandable frame.

[0149] Example 19. According to any of the preceding examples, such as any of Examples 17 to 18, wherein the plurality of pillars extend from where the vertical pillar meets the distal end of the frame.

[0150] Example 20. According to any of the foregoing examples, such as any of Examples 17 to 19, the inflatable frame includes a foot extending from the proximal end of the inflatable frame.

[0151] Example 21. According to any of the preceding examples, such as any of Examples 1 to 20, wherein the plurality of pillars each have the same length.

[0152] Example 22. A method comprising: extending a delivery capsule through a patient in a first direction to a target location; deploying an implant at least partially at the target location, the implant including an expandable frame and a plurality of helical struts extending in a helical shape away from the expandable frame; and disengaging the implant from the delivery capsule.

[0153] Example 23. According to any of the foregoing examples, such as Example 22, it further includes pulling the implant back in a second direction opposite to the first direction to place the plurality of spiral struts against the patient's anatomy to create a seal between the implant and the anatomy.

[0154] Example 24. According to any of the foregoing examples, such as Example 23, it further includes completing any remaining deployment of the implant after placing the plurality of spiral struts against the anatomical structure.

[0155] Example 25. According to any of the preceding examples, such as Example 24, any remaining deployment of the implant includes releasing the foot of the inflatable frame from the delivery capsule and retracting the delivery capsule through the patient.

[0156] Example 26. According to any of the preceding examples, such as any of Examples 23 to 25, the seal is formed by attaching a material skirt around the spiral strut to the implant and extending at least into the valve seat within the expandable frame.

[0157] Example 27. According to any of the foregoing examples, such as any of Examples 23 to 26, it further includes mounting a valve at a valve seat within the expandable frame.

[0158] Example 28. According to any of the foregoing examples, such as Example 27, wherein installing the valve comprises: extending a valve delivery capsule on which the valve is mounted through the patient; deploying the valve within the implant; and securing the valve to the implant in the valve seat.

[0159] Example 29. According to any of the preceding examples, such as any of Examples 10 to 15, the node includes a non-transmissive marker.

[0160] Example 30. According to any of the preceding examples, such as any of Examples 1 to 20, each of the plurality of pillars includes a node at the far end of the respective pillar.

[0161] Example 31. According to any of the preceding examples, such as Example 30, each of the nodes includes a non-transparent marker.

[0162] Example 32. According to any of the preceding examples, such as Example 30, not every node in the above examples includes a radiopaque marker.

[0163] Example 33. According to any of the preceding examples, such as Example 30, every other node therein includes a non-transmissive marker.

[0164] Given that the principles of the disclosed technology can be applied to many possible embodiments, it should be recognized that the embodiments shown are merely examples and should not be considered as limiting the scope of this disclosure. Rather, the scope of this disclosure is at least as broad as the following claims. Therefore, protection is claimed for all contents falling within the scope and spirit of these claims.

Claims

1. An implant comprising: An expandable frame configured to expand from a compressed state to an expanded state upon deployment, the expandable frame including a longitudinal direction along a central axis through a central cavity formed by the expandable frame; and Multiple pillars at the first end of the expandable frame extend away from the expandable frame in a series of generally tangential directions away from the circular shape, the circular shape within the central cavity being perpendicular to the longitudinal direction and generally centered around the central axis.

2. The implant of claim 1, further comprising a material skirt that covers the plurality of struts and extends into the central cavity of the inflatable frame.

3. The implant of claim 2, further comprising a valve deployed within the central cavity.

4. The implant of claim 3, wherein the circular shape corresponds to the valve seat in which the valve is deployed.

5. The implant of claim 1, wherein the generally tangential direction includes curvature in the same direction as the circular shape and has a radius of curvature larger than that of the circular shape.

6. The implant of claim 1, wherein the generally tangential direction includes a lateral curvature in the same direction as the circular shape and has a radius of curvature larger than that of the circular shape.

7. The implant of claim 1, wherein the plurality of struts form a flange at the first end of the expandable frame, the flange extending radially outward from the central axis beyond the remainder of the expandable frame.

8. The implant of claim 1, wherein a given pillar of the plurality of pillars includes curvature from a contact point at the expandable frame to a vertex and from the vertex to a distal end of the given pillar, the curvature increasing in the longitudinal direction as the given pillar extends away from the expandable frame to the vertex, and the curvature decreasing in the longitudinal direction as the given pillar extends from the vertex to the distal end of the given pillar.

9. The implant of claim 1, wherein a given pillar of the plurality of pillars includes curvatures from a contact point at the expandable frame to a apex, from the apex to a low point, and from the low point to a distal end of the given pillar, wherein the curvature increases in the longitudinal direction as the given pillar extends away from the expandable frame to the apex, the curvature decreases in the longitudinal direction as the given pillar extends from the apex to the low point, and the curvature increases as the given pillar extends from the low point to the distal end of the given pillar.

10. The implant of claim 1, wherein a given pillar of the plurality of pillars includes a node at the distal end of the given pillar.

11. The implant of claim 10, wherein the node includes an opening through which a material skirt is connected to the given post using sutures.

12. The implant of claim 10, wherein the width of the node is greater than the width of the arm of the given strut.

13. The implant of claim 10, further comprising a material skirt covering the plurality of struts and extending into the central cavity of the inflatable frame, the material skirt being positioned on the exterior of the node such that, when deployed, the material skirt is positioned between the node and the patient's anatomy.

14. The implant of claim 10, wherein the node has a pad on the node.

15. The implant of claim 14, wherein the pad is made of the same material as the skirt of material covering the plurality of struts.

16. The implant of claim 10, wherein the node includes a radiopaque marker.

17. The implant of claim 1, wherein each of the plurality of struts includes a node at the distal end of the respective strut.

18. The implant of claim 17, wherein each of the nodes includes a radiopaque marker.

19. The implant of claim 17, wherein not every node in the described nodes includes a radiopaque marker.

20. The implant of claim 17, wherein every other node comprises a radiopaque marker.

21. The implant of claim 1, wherein the plurality of struts are integrally formed with the expandable frame.

22. The implant of claim 1, wherein the expandable frame includes a plurality of vertical struts spanning between the proximal and distal ends of the expandable frame.

23. The implant of claim 22, wherein the plurality of struts interface with the frame at the distal end of the expandable frame.

24. The implant of claim 23, wherein the plurality of struts extend from the point where the vertical struts meet the distal end of the frame.

25. The implant of claim 22, wherein the expandable frame includes a foot extending from the proximal end of the expandable frame.

26. The implant of claim 1, wherein each of the plurality of struts has the same length.

27. A method comprising: The delivery capsule extends through the patient in the first direction to reach the target location; The implant is at least partially deployed at the target location, the implant comprising an expandable frame and a plurality of helical struts extending in a helical shape away from the expandable frame; and Disengage the implant from the delivery capsule.

28. The method of claim 27, further comprising pulling the implant back in a second direction opposite to the first direction to position the plurality of helical struts against the patient's anatomy to create a seal between the implant and the anatomy.

29. The method of claim 28, further comprising, after placing the plurality of spiral struts against the anatomical structure, completing any remaining deployment of the implant.

30. The method of claim 29, wherein completing any remaining deployment of the implant comprises releasing the foot of the inflatable frame from the delivery capsule and retracting the delivery capsule through the patient.

31. The method of claim 28, wherein the seal is formed by attaching a material skirt around the helical strut to the implant and extending at least into the valve seat within the expandable frame.

32. The method of claim 27, further comprising mounting a valve at a valve seat within the expandable frame.

33. The method of claim 32, wherein installing the valve comprises: The valve delivery capsule, on which the valve is mounted, extends through the patient; The valve unfolds within the implant; and The implant that secures the valve to the valve seat.

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