Prosthetic heart valve comprising frame with integral indicia

Abstract

The present invention relates to prosthetic valves comprising a frame having one or more integral radiopaque indicia and methods of implantation and post-implantation. A prosthetic heart valve may include a frame including interconnected struts forming units of the frame and a valve structure disposed inside the frame. The valve structure includes a plurality of commissures, wherein adjacent leaflets engage at outflow ends of the plurality of commissures. Each of the engagement portions is attached to an engagement portion support unit of the frame. A selected one of the units, such as a commissure support unit or a unit adjacent to the commissure support unit, may include an integral indicia extending from an inner edge of the unit and into an open space of the unit. In some examples, the indicia are directional indicators. The indicia may be configured to indicate the location of the selected unit during an implant procedure or a post-implant procedure when imaging the prosthetic valve via, for example, fluoroscopy.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 584,160, filed on September 20, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to prosthetic heart valves comprising a frame having one or more integral markings for indicating positions on the frame, such as for indicating the position and / or orientation of ferrule support units of the frame. Background Technology

[0004] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to significant dysfunction of the heart and ultimately require repair of the original valve or replacement with an artificial valve. Many known repair devices (e.g., stents) and artificial valves exist, along with many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery or where access is desired without surgery. In one specific instance, a prosthetic heart valve may be mounted in a coiled state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral and aortic arteries) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, thereby actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from the sheath of the delivery device so that the prosthetic valve can self-expand to its functional size.

[0005] In some instances, it may be desirable to visualize the position of at least one commissure of the prosthetic valve during the implantation procedure, so as to implant the prosthetic heart valve with a desired rotational alignment relative to the anatomical landmarks of the original valve. In some instances, it may be desirable to visualize the position of one or more commissures of the prosthetic valve during post-implantation procedures, such as when a catheter is inserted into the coronary artery after implantation of the prosthetic valve. Summary of the Invention

[0006] This document describes prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery devices, and methods may, for example, provide an integrated frame marker that can be used to identify one or more units of the frame of the prosthetic valve, such as one or more units each supporting the commissure of the prosthetic valve, and the integrated frame marker enables the positioning of the prosthetic heart valve relative to the patient's own anatomy and / or another implantation device. Therefore, the devices and methods disclosed herein particularly overcome one or more of the shortcomings of typical prosthetic heart valves and their delivery devices.

[0007] A prosthetic heart valve may include a frame and valve structures connected to the frame. In addition to these components, a prosthetic heart valve may further include one or more of the components disclosed herein.

[0008] In some instances, the frame for a prosthetic heart valve may include multiple interconnected struts forming multiple units, said multiple units including one or more merging support units.

[0009] In some instances, the valve structure for a prosthetic heart valve may include multiple leaflets, each of which engages with an adjacent leaflet at the outflow end of the valve structure to form a commissure therebetween, the commissure being attached to a frame at a commissure support unit.

[0010] In some instances, a prosthetic heart valve may include a frame that includes an integral marker extending from the inner edge of one or more struts of the unit forming the frame and into the internal opening of the unit.

[0011] In some instances, the unit is a connecting support unit.

[0012] In some instances, the unit is adjacent to the connecting support unit.

[0013] In some instances, the monolithic marking does not extend to the outside of the internal opening.

[0014] In some instances, the monolithic mark does not extend from the outer edge of the cell.

[0015] In some instances, the monolithic mark can extend from the inner edge of the outflowing top portion of the cell.

[0016] In some instances, the integrated marking can extend from the inner edge at the junction of the two interconnecting pillars at the top of the unit.

[0017] In some instances, the integrated marking can extend from the inner edge of the joint between the two interconnecting pillars on one side of the unit.

[0018] In some instances, a monolithic mark can have an asymmetrical shape.

[0019] In some instances, monolithic markings can have asymmetric orientation within a cell.

[0020] In some instances, a one-piece marker may include a head portion and a neck portion, with the neck portion connected to the unit's support and the head portion extending into the unit's open space.

[0021] In some instances, the integral marking may include a curved member, wherein a first end and a second end of the curved member are attached to one or more supports of the unit.

[0022] In some instances, the integrated marker can be a directional indicator.

[0023] In some instances, the monolithic markup can be non-directional.

[0024] In some instances, the size of the integrated marker can be designed such that the joint support unit can extend axially when the frame is in a radially compressed state.

[0025] In some instances, the shape of the integrated marker can be designed such that the joint support unit can extend axially when the frame is in a radially compressed state.

[0026] In some instances, the orientation of the integrated marker can be configured such that the joint support unit can extend axially when the frame is in a radially compressed state.

[0027] In some instances, the position of the integrated mark within the unit can be configured such that the joint support unit can extend axially when the frame is in a radially compressed state.

[0028] In some instances, the integral mark can be configured such that when the unit is in an axially elongated state, at the location of the integral mark, the width of the integral mark is less than or equal to the width of the connecting support unit.

[0029] In some instances, a unit may include more than one monolithic mark.

[0030] In some instances, the unit may include a first integral mark and a second integral mark.

[0031] In some instances, the first integral mark is a symmetrical mark that bisects at least a portion of the unit.

[0032] In some instances, the second integral mark is a directional mark with an asymmetrical shape and / or asymmetrical orientation within the unit.

[0033] In some instances, the integrated marker can be configured to enable the identification of the commissural support unit during one or more stages of the implantation procedure or post-implantation procedure of the prosthetic heart valve.

[0034] In some instances, asymmetrical integral markings can be configured to identify one or more of the foremost joint support units relative to other joint support units.

[0035] In some instances, directional asymmetric integral markings can be configured to identify one or more foremost joint support units relative to other joint support units.

[0036] In some representative examples, a prosthetic heart valve may include: an annular frame comprising a plurality of interconnected struts forming a plurality of units; and a valve structure disposed within an internal space of the frame and having an inflow end and an outflow end, the valve structure comprising a plurality of leaflets, each of the leaflets engaging at the outflow end of the valve structure with an adjacent leaflet to form a commissure therebetween, the commissure being attached to the frame at a commissure support unit of the plurality of units; wherein the commissure support unit defines an internal opening; and wherein the frame includes an integral mark extending from an inner edge of the commissure support unit into the internal opening.

[0037] In another representative example, a prosthetic valve may include: an annular frame comprising a plurality of interconnected struts forming a plurality of units, each of said units including an internal opening; and a valve structure disposed within an internal space of said frame and having an inflow end and an outflow end, said valve structure including a plurality of leaflets; wherein a selected unit among said units includes an integral mark extending from the inner edge of the respective selected unit and into the internal opening of said respective selected unit; wherein portions of said integral mark do not extend outside said internal opening; and wherein said integral mark is configured to enable identification of said respective selected unit during one or more of the implantation procedure or post-implantation procedure.

[0038] In another representative example, a prosthetic valve may include: an annular frame comprising a plurality of interconnected struts forming a plurality of units, each of said units including an internal opening; and a valve structure disposed within an internal space of said frame and having an inflow end and an outflow end, said valve structure including a plurality of leaflets; wherein a selected unit among said units includes an integral mark extending from the inner edge of the respective selected unit and into the internal opening of said respective selected unit; wherein portions of said integral mark do not extend outside said internal opening; and wherein said integral mark is configured to enable identification of said respective selected unit during one or more of the implantation procedure or post-implantation procedure.

[0039] In another representative example, a prosthetic heart valve includes: an annular frame comprising a plurality of interconnected struts forming a plurality of units, each of said units including an internal opening; and a valve structure disposed within an internal space of said frame and having an inflow end and an outflow end, said valve structure including a plurality of leaflets; wherein a selected unit among said units includes an integral mark extending from the inner edge of the respective selected unit and into the internal opening of said respective selected unit; wherein portions of said integral mark do not extend outside said internal opening; and wherein said integral mark is configured to enable identification of said respective selected unit during one or more of the implantation procedure or post-implantation procedure.

[0040] In another representative example, a prosthetic heart valve includes: an annular frame comprising a plurality of interconnected struts forming a plurality of units, each of said units including an internal opening; and a valve structure disposed within an internal space of said frame and having an inflow end and an outflow end, said valve structure including a plurality of leaflets; wherein each selected unit of said units includes one or more integral markings extending from an inner edge of said selected unit and into said internal opening of said selected unit; wherein portions of said integral markings do not extend outside said internal opening; and wherein said one or more integral markings are configured to enable identification of said selected unit during one or more periods of implantation procedure or post-implantation procedure.

[0041] In some instances, a prosthetic heart valve includes one or more components described in Examples 1 to 32 below.

[0042] The various innovations disclosed herein can be used in combination or individually. This summary is provided to introduce, in a simplified form, a series of concepts further described in the detailed embodiments below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of this disclosure will become more apparent from the following detailed description, claims, and drawings. Attached Figure Description

[0043] Figure 1A It is a perspective view of a prosthetic heart valve based on an example.

[0044] Figure 1B yes Figure 1A A perspective view of the prosthetic valve, in which components outside the frame are shown in transparent lines for illustrative purposes.

[0045] Figure 2 This is a side view of an example of a delivery device configured to deliver and implant a radially expandable prosthetic heart valve at the implantation site.

[0046] Figure 3A and 3B It is an enlarged side view of a portion of the frame, which includes an exemplary integral mark extending from the inner edge of the outflow joint portion of the frame's unit.

[0047] Figure 4A and 4B It is an enlarged side view of a portion of the frame, which includes an exemplary integral mark extending from the inner edges of the two pillars of the unit forming the frame.

[0048] Figure 5A and 5B This is an enlarged side view of a portion of the frame, which includes an exemplary integral mark extending from the inner edge of a pillar of the outflow portion of the unit forming the frame.

[0049] Figure 6A and 6B It is an enlarged side view of a portion of the frame, which includes an exemplary integral mark extending from the inner edge of the side joint portion of the frame unit.

[0050] Figure 7A and 7B This is an enlarged side view of a portion of the frame, which includes an exemplary integral mark extending from the inner edge of a pillar of the inflow portion of the unit forming the frame.

[0051] Figures 8A-8C This is a side view of a frame including an exemplary monolithic marker, showing the frame in a radial compression configuration.

[0052] Figure 9A and 9B It is a top perspective view and a front view of the frame including the first exemplary integrated mark and the second exemplary integrated mark.

[0053] Figure 10A and 10B yes Figure 9A and 9B Enlarged side views of parts of the frame, showing the frame in radial expansion and radial compression states respectively.

[0054] Figure 11 It is in a state of radial compression. Figure 9A and 9B The front view of the top part of the frame. Detailed Implementation

[0055] General considerations

[0056] For the purposes of this specification, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments, individually and in various combinations and sub-combinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, nor are the disclosed embodiments required to have any one or more particular advantages or problems solved.

[0057] Although the operations of some instances of the disclosed examples are described in a specific sequential order for ease of presentation, it should be understood that this descriptive approach encompasses rearrangements unless the specific language described below requires a particular order. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be combined with other methods. Additionally, this specification sometimes uses terms such as "provides" or "implements" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily discernible to those skilled in the art.

[0058] As used in this application and in the claims, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” include the plural forms. Additionally, the term “include” means “comprise.” Furthermore, the term “connection” generally means physical, mechanical, chemical, magnetic, and / or electrical connection or link, and does not exclude the presence of intermediate elements between connected or related items where no particular opposite language exists.

[0059] As used herein, the term "proximal" refers to a location, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a location, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., away from the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless otherwise explicitly defined.

[0060] As used in this article, “for example” means “for instance”, and “that is” means “in other words”.

[0061] Overview of open technology

[0062] As described above, in some instances, it may be desirable to use fluoroscopy to visualize the location of at least one commissure of the prosthetic valve during implantation and / or post-implantation procedures. In some instances, the prosthetic valve may include a radiopaque marker fixed to a portion of the prosthetic heart valve to allow visualization of the commissure during implantation or post-implantation procedures using imaging techniques such as fluoroscopy.

[0063] For example, it may be desirable to visualize the position of one or more sutures of a prosthetic valve at the autologous valve during the implantation procedure in order to implant the prosthetic valve in the desired location relative to the autologous valve (e.g., desired rotational alignment and / or axial position). In some instances, it may be desirable to implant a prosthetic valve such that the suture of the prosthetic valve is aligned with the suture of an autologous valve or a previously implanted prosthetic valve. By including radiopaque markers at one or more sutures of the prosthetic valve, the position of the sutures relative to the autologous valve (or other autologous anatomy or a previously implanted valve) can be visualized during the implantation procedure using medical imaging (e.g., fluoroscopy), thereby facilitating rotational positioning of the prosthetic valve relative to the autologous valve. Therefore, the user can determine the position of the sutures relative to the autologous anatomy (autologous heart valve) and more easily implant the prosthetic valve in the desired rotational, axial, and / or lateral orientation relative to the autologous heart valve.

[0064] In another instance, it may be desirable to visualize the location of one or more commissures of the prosthetic valve at the site of the implanted autologous valve during post-implantation procedures to guide transcatheter devices and / or additional implantable devices (e.g., stents) through the implanted prosthetic valve. In some instances, it may be desirable to avoid the commissures of the implanted prosthetic valve when guiding the transcatheter devices and / or additional implantable devices to their target location (e.g., the coronary artery when the prosthetic valve has been implanted with an autologous aortic valve). By including radiopaque markers at one or more commissures of the prosthetic valve, the location of the commissures can be visualized during post-implantation procedures using medical imaging (e.g., fluoroscopy), thereby facilitating the guidance of transcatheter devices and / or additional implantable devices between the commissures of the implanted prosthetic valve and into the coronary artery. Therefore, the user can determine the location of the commissures of the implanted prosthetic valve and perform post-implantation procedures more easily.

[0065] However, attaching radiopaque markers to the frame or another part of the prosthetic valve may require additional manufacturing steps, thereby increasing the manufacturing time, complexity, and cost of the prosthetic valve. In addition, the attachment of radiopaque markers can be a source of error in the manufacturing of the prosthetic valve (e.g., attachment failure, or attachment occurring off-center from the commissure or other target locations).

[0066] The prosthetic valves and frames disclosed herein can solve one or more of the aforementioned problems. In some instances, a prosthetic valve includes a frame on which one or more integral radiopaque markings are formed. In some instances, the integral markings are formed during the manufacture of the frame (e.g., frame cutting, molding, extrusion, etc.). In some instances, the frame with one or more radiopaque markings is formed by laser cutting a metal tube. In some instances, the integral markings are formed within a unit of the frame. As used herein, a frame unit is an opening in the frame that is completely surrounded by one or more struts connected to each other to form a periphery or boundary surrounding the opening. In some instances, the integral markings extend from the inner edge of one or more struts forming the unit. In some instances, the integral markings are asymmetrical so as to serve as a directional indicator of rotation. In some instances, the integral markings are formed in a portion of the frame to indicate the location of a syndesm support unit. In some instances, the integral markings are formed within and extend into the syndesm support unit.

[0067] In some instances, the prosthetic valve disclosed herein may be radially compressible and radially expandable, transitioning between a radially compressed state and a radially expanded state. In some instances, the integral radiopaque markings of the frame may be configured to achieve radial compression of the frame when the prosthetic valve is in a radially compressed state. In other words, in such instances, the integral markings do not interfere with the radial compression of the frame when the prosthetic valve is in a radially compressed state.

[0068] Therefore, the prosthetic valve can be coiled in a radially compressed state on or held by the implant delivery device while being advanced through the patient's vascular system. Once the prosthetic valve reaches the implantation site, it can be expanded into a radially expanded state. It should be understood that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and can be implanted via a variety of delivery procedures, examples of which will be discussed in more detail later.

[0069] Figure 1A-1B An exemplary prosthetic heart valve is shown. As described above, the prosthetic heart valve can be press-fitted into a delivery device (e.g., in a radially compressed state) in a delivery state. Figure 2 On the exemplary delivery device shown, it is simultaneously propelled through the patient's vascular system on the delivery device. Figure 3A-7B Figures 9A-10A show exemplary frames for prosthetic heart valves, including one or more integral markers, with the frame shown in a radially expanded state. Figures 8A-8C 10B-11 shows an exemplary frame including one or more integral markers, illustrating a frame in a radially compressed state.

[0070] Examples of the disclosed technologies

[0071] Figure 1A and 1B An exemplary prosthetic valve 50 according to one example is shown. Any of the prosthetic valves disclosed herein is suitable for implantation in an autologous aortic valve annulus, but in other examples, it may be suitable for implantation in other autologous valve annulus of the heart (pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves may also be implanted in a blood vessel communicating with the heart, including the patient's pulmonary artery (for replacing the function of a diseased pulmonary valve), or the superior or inferior vena cava (for replacing the function of a diseased tricuspid valve), or various other veins, arteries, and vessels. The disclosed prosthetic valves may also be implanted in a valve-in-valve procedure within a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve).

[0072] In some instances, the disclosed prosthetic valve can be implanted into a docking or anchoring device implanted within an autologous heart valve or blood vessel. For example, in one instance, the disclosed prosthetic valve can be implanted into a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another instance, the disclosed prosthetic valve can be implanted into a docking device implanted within or at an autologous mitral valve, as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In yet another instance, the disclosed prosthetic valve can be implanted into a docking device implanted within the superior or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0073] The prosthetic valve 50 may have three main components: a stent or frame 52, a valve structure 54, and a sealing member 56. Figure 1A ). Figure 1B This is a perspective view of the prosthetic valve 50, in which components outside the frame 52 (including the sealing member 56) are shown in transparent lines for illustrative purposes. The prosthetic valve 50 may have an inflow end 66 and an outflow end 68.

[0074] Frame 52 (and other frames disclosed herein, such as frame 252) may be made of any of a variety of suitable plastic expandable materials or self-expanding materials (e.g., nitinol). Suitable plastic expandable materials that can be used to form frame 52 include metal alloys, polymers, or combinations thereof. Example metal alloys may include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some instances, frame 52 may include stainless steel. In some instances, frame 52 may include a cobalt-chromium alloy. In some instances, frame 52 may include a nickel-cobalt-chromium alloy. In some instances, frame 52 includes a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (a trademark of SPS Technologies), which is equivalent to UNSR30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0075] When constructed from a malleable, expandable material, the frame 52 (and therefore the prosthetic valve 50) can be rolled into a radially collapsed configuration on a delivery device (e.g., a catheter) and then expanded within the patient by an inflatable balloon or an equivalent expansion mechanism. In some instances, the prosthetic valve 50 can be rolled directly onto an inflatable balloon of the delivery device, such that during advancement of the prosthetic valve to the implantation site on the delivery device, the prosthetic valve 50 is axially aligned with the balloon and positioned radially outside the balloon, as described, for example, in PCT application No. PCT / US2021 / 047056 (published as WO2022 / 046585), which is incorporated herein by reference. In some instances, prior to balloon inflation and radial expansion of the prosthetic valve, the prosthetic valve 50 may be rolled up onto the delivery device, axially offset relative to the balloon, and then exit the balloon at the implantation site, as described, for example, in U.S. Patent Application No. 9,339,384, which is incorporated herein by reference.

[0076] When constructed of a self-expanding material, the frame 52 (and therefore the prosthetic valve 50) can be compressed into a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of the delivery device. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0077] Various crimping devices can be used to crimp the prosthetic valve 50 and other prosthetic valves around the delivery device described herein, such as the crimping device described in U.S. Patent No. 7,530,253, which is incorporated herein by reference.

[0078] Return to Figure 1A and 1B The frame 52 in the illustrated example includes multiple rows of circumferentially extending, angled interconnecting struts 72 defining multiple rows of cells 74 that define openings in the frame. As shown in the illustrated example, each cell 74 is formed by the interconnecting struts 72, which form a continuous closed boundary completely surrounding the opening. In some examples, the frame 52 may have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 66 to the outflow end 68 of the frame 52, as shown. In some examples, the diameter of the frame 52 may vary along the height of the frame, as disclosed in U.S. Patent Publication No. 2012 / 0239142, which is incorporated herein by reference.

[0079] The frame 52 may include a plurality of apexes 80 spaced apart from each other around the circumference of the frame 52 at each of the inflow end 66 and the outflow end 68.

[0080] Valve structure 54 may include three leaflets 60 that together form a leaflet structure, which may be arranged in a tricuspid valve-like collapse configuration, but in other instances, there may be more or fewer leaflets (e.g., one or more leaflets 60). In some instances, leaflets 60 may be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials, as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0081] Each leaflet 60 may be attached to the frame 52 along its inflow edge 62 (lower edge in the figure; also referred to as the "cusp edge") and at the fusion portion 64 of the valve structure 54, in which adjacent portions of the two leaflets (e.g., fusion tabs) are connected to each other. In some instances, the fusion portion 64 may include attachment members (e.g., fabric, flexible polymer, etc.) arranged across units to form a fusion portion support unit 75 of the frame 52. The attachment members may be secured to the interconnecting struts 72 of the fusion portion support unit 75, and adjacent portions of the two leaflets may be connected to the attachment members to form the fusion portion 64. The fusion tabs and / or attachment members may be secured to the struts forming the fusion portion support unit 75, for example, by using sutures to form binding sutures that pass through the fusion tabs (and / or attachment members) and extend around the struts 72.

[0082] In some instances, reinforcing elements such as fabric strips or connecting skirts can be directly attached to the tip edge of the leaflet and the support of the frame to connect the tip edge of the leaflet to the frame.

[0083] In the illustrated example, the sealing member 56 is mounted externally to the frame 52 and serves to form a seal against surrounding tissue (e.g., autologous leaflets and / or autologous annulus) to prevent or at least minimize paravalvular leakage. The sealing member 56 may include an inner layer 76 (which may contact the outer surface of the frame 52) and an outer layer 78. The sealing member 56 may be attached to the frame 52 using suitable techniques or mechanisms. For example, the sealing member 56 may be sutured to the frame 52 via a suture that may surround the strut 72 and extend through the inner layer 76. In an alternative example, the inner layer 76 may be mounted on the inner surface of the frame 52, while the outer layer 78 is located on the outer surface of the frame 52.

[0084] The outer layer 78 can be configured or shaped to extend radially outward from the inner layer 76 and the frame 52 when the prosthetic valve 50 is deployed. When the prosthetic valve is fully expanded outside the patient, the outer layer 78 can expand away from the inner layer 76 to create a space between the two layers. Thus, when implanted in the body, the outer layer 78 is allowed to expand to contact the surrounding tissues.

[0085] The sealing member 56 may be formed wholly or partially from any suitable biological material, synthetic material (e.g., any of a variety of polymers), or a combination thereof. In some instances, the skirt may include a fabric having interwoven yarns or fibers, such as a woven, braided, or knitted fabric. In some instances, the fabric may have a pile or nap. Exemplary fabrics with a pile or nap include velvet, velvet, corduroy, thick fleece, velvet fabric, etc. In some instances, the sealing member may include a fabric without interwoven yarns or fibers or without randomly interwoven yarns or fibers, such as felt or electrowoven fabric. Exemplary materials that can be used to form such fabrics (with or without interwoven yarns or fibers) include, but are not limited to, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), extended polytetrafluoroethylene (ePTFE), polyamide, etc. In some instances, the sealing member may comprise a non-woven or non-fabricated material, such as a membrane made of any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (e.g., thermoplastic polyurethane (TPU)), etc. In some instances, the sealing member may comprise a sponge material or foam, such as polyurethane foam. In some instances, the sealing member may comprise natural tissue, such as pericardium (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0086] Additional details regarding the prosthetic valve 50 and its various components are described in PCT application No. PCT / US2021 / 047056 and U.S. Patent Publication No. 2018 / 0028310, which are incorporated herein by reference.

[0087] Figure 2 A delivery device 100 according to an example is shown, which can be used to implant an expandable prosthetic heart valve 150 (e.g., Figure 1A and 1B (The prosthetic valve 50 and / or any other prosthetic heart valve described herein). In some instances, the delivery device 100 is particularly suited for introducing a prosthetic valve into the heart.

[0088] Figure 2The delivery device 100 in the illustrated example is a balloon catheter, which includes a handle 102 and a steerable outer shaft 104 extending distally from the handle 102. The delivery device 100 may further include an intermediate shaft 106 (which may also be referred to as a balloon shaft) extending proximally and distally from the handle 102, the portion extending distally from the handle 102 also coaxially extending through the outer shaft 104. Additionally, the delivery device 100 may also include an inner shaft 108 extending distally from the handle 102 coaxially through the intermediate shaft 106 and the outer shaft 104, and extending proximally from the handle 102 coaxially through the intermediate shaft 106.

[0089] The outer axis 104 and the intermediate axis 106 can be configured to translate (e.g., move) longitudinally relative to each other along the central longitudinal axis 120 of the delivery device 100 to facilitate delivery and positioning of the prosthetic valve at the implantation site within the patient's body.

[0090] The intermediate shaft 106 may include a proximal portion 110 extending proximally from the proximal end of the handle 102 to the adapter 112. A rotatable knob 114 may be mounted on the proximal portion 110 and may be configured to rotate the intermediate shaft 106 about a central longitudinal axis 120 and relative to the outer shaft 104.

[0091] The adapter 112 may include a first port 138 configured to receive a guide wire passing through it and a second port 140 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 140 may be fluidly coupled to the inner lumen of the intermediate shaft 106.

[0092] The intermediate shaft 106 may also include a distal portion that extends distally beyond the distal end of the outer shaft 104 when the distal end of the outer shaft 104 is positioned away from the inflatable balloon 118 of the delivery device 100. The distal portion of the inner shaft 108 may extend distally beyond the distal portion of the intermediate shaft 106.

[0093] The balloon 118 can be attached to the distal portion of the intermediate shaft 106.

[0094] In some instances, the distal end of balloon 118 can be coupled to the distal end of delivery device 100, for example, to nasal cone 122 (e.g. Figure 2 As shown in the diagram), or an alternative component (e.g., the distal shoulder) coupled to the distal end of the delivery device 100. The intermediate portion of the balloon 118 may cover the valve mounting portion 124 of the distal portion of the delivery device 100, and the distal portion of the balloon 118 may cover the distal shoulder 126 of the delivery device 100. The valve mounting portion 124 and the intermediate portion of the balloon 118 may be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown in the diagram. Figure 2As schematically shown, a prosthetic heart valve 150 (which may be one of the prosthetic valves described herein) may be mounted around the balloon 118 at the valve mounting portion 124 of the delivery device 100.

[0095] The balloon shoulder assembly, including the distal shoulder 126, is configured to maintain the prosthetic heart valve 150 (or other medical device) in a fixed position on the balloon 118 during delivery through the patient's vascular system.

[0096] The outer shaft 104 may include a distal tip portion 128 mounted on its distal end. When the prosthetic valve 150 is mounted on the valve mounting portion 124 in a radially compressed state (e.g., Figure 2 As shown in the diagram, and during delivery of the prosthetic valve to the target implantation site, the outer axis 104 and the intermediate axis 106 can be axially translated relative to each other to position the distal tip portion 128 adjacent to the proximal end of the valve mounting portion 124. Thus, the distal tip portion 128 can be configured to resist axial movement of the prosthetic valve 150 relative to the balloon 118 proximally when the distal tip portion 128 is positioned adjacent to the proximal end of the valve mounting portion 124.

[0097] An annular space may be defined between the outer surface of the inner shaft 108 and the inner surface of the intermediate shaft 106, and may be configured to receive fluid from a fluid source via a second port 140 of the adapter 112. The annular space may be fluidly coupled to a fluid passage formed between the outer surface of the distal portion of the inner shaft 108 and the inner surface of the balloon 118. Therefore, fluid from the fluid source can flow from the annular space to the fluid passage to inflate and radially expand the balloon 118 and deploy the prosthetic valve 150.

[0098] The inner lumen of the inner shaft can be configured to receive a guidewire passing through it for guiding the distal portion of the delivery device 100 to the target implantation site.

[0099] Handle 102 may include a steering mechanism configured to adjust the curvature of the distal portion of the delivery device 100. In the illustrated example, handle 102 includes, for instance, an adjustment member, such as the illustrated rotatable knob 160, which is operatively coupled to the proximal portion of the traction wire. The traction wire extends distally from handle 102 through the outer shaft 104 and has a distal portion secured to the outer shaft 104 at or near its distal end. Rotating knob 160 increases or decreases the tension in the traction wire, thereby adjusting the curvature of the distal portion of the delivery device 100. Further details regarding the steering or deflection mechanism for the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0100] The handle 102 may further include an adjustment mechanism 161 and an associated locking mechanism. The adjustment mechanism includes an adjustment member, such as the rotatable knob 162 shown, and the locking mechanism includes another adjustment member configured as a rotatable knob 178. The adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 100 can be found in PCT application PCT / US2021 / 047056, which is incorporated herein by reference.

[0101] As described above, the prosthetic heart valves disclosed herein may include a frame having one or more integral markings. In some instances, the integral markings are formed during the fabrication of the frame (e.g., cutting, molding, extrusion, etc.). In some instances, the integral markings are formed within a unit of the frame (i.e., the integral markings extend into an opening defined by the interconnecting struts constituting the unit) and may extend from the inner edges of one or more of the interconnecting struts constituting the unit. For example, the integral markings may be formed within and extend into a commissural support unit, such that the commissural support unit can be identified (e.g., visualized by fluoroscopy) during implantation or post-implantation procedures.

[0102] Figure 3A-11 An exemplary integrated marking of a frame for a prosthetic valve is shown. Specifically, Figure 3A-11 The diagram illustrates a unit 275 formed by interconnecting pillars 272 within the flow row units of frame 252. This unit can be a selected unit within the flow row, such as a joint support unit of the frame or a unit adjacent to a joint support unit. In some instances, in addition to adding one or more integral markers (e.g., integral markers 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300), Figure 3A-11 Frame 252 may be identical to frame 52, and unit 275 may be identical to one of unit 75 of frame 52. Therefore, in some instances, prosthetic valve 50 may include frame 252 (with any of the disclosed marking configurations) and a combination of... Figure 1A-1B Any or all of the remaining parts shown or described.

[0103] like Figure 3A-11As shown, unit 275 may include one or more integral radiopaque markers (one or more of integral radiopaque markers 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300) extending from the inner edges 202 of one or more of the pillars 272 forming the unit and into the internal space or opening of the unit. In some instances, no part or segment of the marker extends outside the unit. That is, in some instances, the marker may extend only from the inner edge of the unit (i.e., from one or more inner edges of the pillars forming the unit). In some instances, the marker may additionally include portions extending from the outer edge of the unit. In some instances, the marker or combination of markers may include asymmetrical components or configurations indicating orientation. For example, the marker may be oriented within the unit to give the unit an overall asymmetrical shape (i.e., the marker may have an asymmetrical orientation), and / or the marker itself may have an asymmetrical shape. In some instances, the marker may be symmetrical, and / or may have a symmetrical orientation within the unit. In some instances, the marker can be configured to indicate (i.e., enable identification) the location of the selected unit during one or more implantation procedures or post-implantation procedures.

[0104] In some instances, multiple units in a flow path of frame 252 may include one or more transmissive markers. For example, a flow path may have three units, each including one or more integral markers, wherein the units are circumferentially spaced relative to each other, for example, at 120 degrees relative to each other in the flow path. In some instances, a flow path may include additional or fewer units, which include one or more integral markers. In some instances, other units of the frame, such as one or more units in a flow path, may include one or more integral markers.

[0105] In some instances, the monolithic markup can extend from the inner edge at the top portion of the unit within the frame. For example, Figure 3A Unit 275, including marker 200, is shown. Marker 200 may extend from the inner edge 202 at the joint between supports 272a and 272b and may be disconnected from the other supports (272c, 272d) of the unit. In some instances, the joint between supports 272a and 272b may be the top end 280 of frame 252. Figure 3AAs shown, in this example, no part of the mark 200 extends from the outer edge 210 of the unit 275. The mark 200 may include a body comprising a linear member 204 that may extend parallel to the central axis of the frame and / or may bisect at least a portion of the unit 275. The mark 200 may additionally include a protrusion (e.g., a tab portion) 206 that projects outward from the side of the member 204 toward the unit 275 (e.g., in an orientation perpendicular to the member 204). The tab portion 206 may give the mark 200 an overall asymmetrical shape. Thus, the mark 200 may be a directional indicator (indicating the left-hand or right-hand orientation of the frame 252). In some instances, the mark 200 may not include a tab portion and may consist only of the linear member 204, thereby making the mark symmetrical (or non-directional). In some instances, the mark 200 may additionally include an aperture 208 at the free end of the linear member 204 (i.e., at the end of the member 204 opposite to the position where the mark extends from the inner edge 202).

[0106] In another example, Figure 3B A unit 275 including an integral marker 300 is shown. The marker 300 can extend from the inner edge 202 at the joint between the supports 272a and 272b and can be disconnected from the other supports (272c, 272d) of the unit. In some instances, the joint between the supports 272a and 272b can be the top end 280 of the frame 252. Figure 3B As shown, no part of the mark extends from the outer edge 210 of unit 275. Mark 300 may include a body comprising a partially or semi-circular member 304 (e.g., a two-thirds portion of a circle) having a continuously curved outer edge extending from post 272a to post 272b. In some instances, mark 300 may additionally include an aperture 308 at the central portion of the circular member 304. In this example, mark 300 has an overall symmetrical shape and is therefore non-directional relative to the left-hand or right-hand orientation of frame 252. In other instances, mark 300 may have directional components or configurations. For example, mark 300 may additionally include a protrusion (e.g., a tab or other protrusion) or may have a raised shape pointing to one side of unit 275, thereby giving mark 300 an overall asymmetrical shape.

[0107] In some instances, the monolithic mark can extend beyond the top portion of the unit from the inner edges of two or more pillars of the frame. For example, Figure 4AA unit 275 including an integral marker 400 is shown. The marker 400 can extend from the inner edge 202 of each of the supports 272a and 272d and can be disconnected from the other supports (272b, 272c) of the unit. Figure 4A As shown, in this example, no part of the marker extends from the outer edge 210 of unit 275. Marker 400 may include a body comprising a curved member 404 that extends across the open space of unit 275 from post 272a (in the outflow portion of the unit) to post 272b (in the inflow portion of the unit). The curved member 404 may bend away from post 272b and toward post 272c, thereby giving marker 400 an asymmetrical orientation within unit 275. Therefore, marker 400 may be a directional indicator (indicating the left-hand or right-hand orientation of frame 252).

[0108] In another example, Figure 4B A unit 275 including an integral marker 500 is shown. The marker 500 can extend from the inner edges 202 of the supports 272a and 272c and can be disconnected from the other supports (272b, 272d) of the unit. Figure 4B As shown, in this example, no part of the marker extends from the outer edge 210 of unit 275. Marker 500 may include a body comprising a crescent-shaped member 504 continuous with the joint portion of the supports 272a, 272c. In other words, marker 500 may be formed by supports 272a, 272c, thus having a wider joint portion, which creates an asymmetrical orientation of marker 500 within unit 275. Therefore, marker 400 may be a directional indicator (indicating the left-hand or right-hand orientation of frame 252).

[0109] In some instances, the integrated marker can extend from the inner edge of the strut in the outflow portion of the unit (i.e., the portion of the unit oriented towards the outflow end of the prosthetic valve). For example, Figure 5A A unit 275 including an integral marker 600 is shown. The marker 600 can extend from the inner edge 202 of a support 272a located in the outflow portion of unit 275 and can be disengaged from the other supports (272b, 272c, 272d) of the unit. Figure 5AAs shown, in this example, no part of the mark extends from the outer edge 210 of unit 275. Mark 600 may include a body comprising a circular member 604. Mark 600 may further include a V-shaped neck portion 606 extending between the inner edge 202 and the circular member 604, the narrowest portion of the V-shaped neck portion oriented toward the inner edge 202. Mark 600 may additionally include an aperture 608 located at the center of the circular member 604. The circular member 604 may extend near the joint between the supports 272a, 272c to one side of the open area of ​​unit 275, thereby giving mark 600 an asymmetrical orientation within unit 275. Thus, mark 600 may be a directional indicator (indicating the left-hand or right-hand orientation of frame 252).

[0110] In another example, Figure 5B A unit 275 including an integral marker 700 is shown. The marker 700 may extend from the inner edge 202 of a support 272a located in the outflow end or portion of the unit 275, and may be disconnected to other supports (272b, 272c, 272d) of the unit. Figure 5B As shown, in this example, no part of the mark 700 extends from the outer edge 210 of the unit 275. The mark 700 may include a body comprising a circular member 704. The mark 700 may further include a linear neck portion 706 narrower than the body, wherein the linear neck portion 706 extends between the inner edge 202 and the circular member 704. The mark 700 may additionally include an aperture 708 located at the center of the circular member 704. The circular member 704 may extend at an angle toward the center of the unit 275 into the open region of the unit, thereby giving the mark 700 an asymmetrical orientation within the unit 275. Thus, the mark 700 may be a directional indicator (indicating the left-hand or right-hand orientation of the frame 252).

[0111] In some instances, the integrated marking can extend from the inner edge of the side portion of the unit (i.e., the inner edge at the joint between the pillars on one side of the unit). For example, Figure 6A A unit 275 including an integral marker 800 is shown. The marker 800 can extend from the inner edge 202 of the joint portion of the supports 272a, 272b located on one side of the unit 275. Figure 6AAs shown, in this example, no part of the mark 800 extends from the outer edge 210 of unit 275. The mark 800 may include a body comprising a partially circular member 804 (e.g., a semi-circular member). The mark 800 may further include a linear neck portion 806 narrower than the body, wherein the neck portion 806 extends from the inner edge 202 to a flat area of ​​the partially circular member 804. The partially circular member 804 may extend near the joint between the supports 272a, 272c to one side of the open area of ​​unit 275, thereby giving the mark 800 an asymmetrical orientation within unit 275. Thus, the mark 800 can be a directional indicator (indicating the left-hand or right-hand orientation of frame 252).

[0112] In another example, Figure 6B A unit 275 including an integral marker 900 is shown. The marker 900 can extend from the inner edge 202 of the joint portion of the supports 272a, 272b located on one side of the unit 275. Figure 5B As shown, in this example, no part of the marker extends from the outer edge 210 of unit 275. Marker 900 may include a body comprising a C-shaped member 904. Marker 900 may further include a linear neck portion 806 narrower than the body, wherein the neck portion 906 extends from the inner edge 202 to the center of the outer curved surface of the C-shaped member 904. Marker 900 may additionally include apertures 908 located at opposite ends of the C-shaped member 904. The C-shaped member 904 may extend near the joint between the supports 272a, 272c to one side of the open area of ​​unit 275, thereby giving marker 900 an asymmetrical orientation within unit 275. Thus, marker 900 may be a directional indicator (indicating the left-hand or right-hand orientation of frame 252).

[0113] In some instances, the integrated marker can extend from the inner edge of the strut in the inflow portion of the unit (i.e., the portion of the unit oriented towards the inflow end of the prosthetic valve). For example, Figure 7A A unit 275 including an integral marker 1000 is shown. The marker 1000 can extend from the inner edge 202 of a support 272d located in the inflow portion of unit 275 and can be disengaged from the other supports (272a, 272b, 272c) of the unit. Figure 7AAs shown, in this example, no part of the marker extends from the outer edge 210 of unit 275. Marker 1000 may include a body comprising a partially oval member 1004 (e.g., a semi-oval member). Marker 1000 may further include a linear extension 1006 extending from the inner edge 202 to a flat area of ​​the partially oval member 1004. Member 1004 may extend near the joint between supports 272b, 272d to one side of the open area of ​​unit 275, thereby giving marker 1000 an asymmetrical orientation within unit 275. Thus, marker 1000 may be a directional indicator (indicating the left-hand or right-hand orientation of frame 252).

[0114] In another example, Figure 7B A unit 275 including an integral marker 1100 is shown. Specifically, the marker 1100 may extend from the inner edge 202 of a support 272 located in the inflow portion of the unit 275 and may be disconnected from the other supports (272a, 272b, 272c) of the unit. Figure 7B As shown, in this example, no part of the mark 1100 extends from the outer edge 210 of the unit 275. The mark 1100 may include a body comprising an elongated D-shaped member 1104. The D-shaped member 1104 may intersect the inner edge 202 at two locations on the support 272d. The D-shaped member 1104 may extend at an angle toward the center of the unit into the open area of ​​the unit 275, thereby giving the mark 1100 an asymmetrical orientation within the unit 275. Thus, the mark 1100 may be a directional indicator (indicating the left-hand or right-hand orientation of the frame 252).

[0115] The integrated marker disclosed herein can be configured to facilitate or enable axial elongation of unit 275 during radial compression of frame 252. For example, the marker may have a size, shape, position, and / or orientation within the joint support unit such that the unit can be compressed into an axially elongated shape when the frame (and prosthetic valve) is in a radially compressed state. Figures 8A-8CA frame 252 in a radially compressed state and a unit 275 in an axially extended state are shown. As can be seen in the figure, each of the exemplary integral markers 700, 900, and 1100 may have a size, shape, position, and / or orientation within the unit 275 such that the unit can be axially extended when the frame 252 is in a radially compressed state. For example, each of the integral markers 700, 900, and 1100 may be configured such that (i.e., having a size, shape, position, and / or orientation within the unit 275 such that) when the unit is in an axially extended state, at the location of the integral marker, the width of the integral marker is less than or equal to the width of the unit 275.

[0116] See also Figure 9A-11 In some instances, frame 252 may include three units 275 (which may be connecting support units) spaced circumferentially around the frame in a unit flow path. In some instances, the three units 275 are arranged at an angle of 120° relative to each other. In some instances, each of the three units 275 may include more than one radiopaque marker. For example, each unit 275 may include a first marker 1200 and a second marker 1300.

[0117] like Figure 10A As best shown, the first mark 1200 may extend from the inner edge 202 of unit 275 at the junction between supports 272a and 272b, and may be disconnected from the other supports (272c, 272d) of the unit. In some instances, the junction between supports 272a and 272b may be the top end 280 of frame 252. In the illustrated example, no part of mark 1200 extends from the outer edge 210 of unit 275. The first mark 1200 may include a body comprising a rhomboid member 1204 having a rounded distal end 1210. Mark 1200 may further include a linear neck portion 1206 narrower than the body, wherein the linear neck portion 1206 extends between the inner edge 202 and the rhomboid member 1204. The integral mark 1200 may extend parallel to the central axis of the frame and / or may bisect at least a portion of unit 275. Thus, in some instances, the integral mark 1200 has a symmetrical (non-directional) paddle shape. In some instances, the first mark 1200 may be asymmetrical. For example, the body may include a tab portion extending from one side of the body, or the body may have an asymmetrical shape and / or may extend from the neck portion toward one side of the unit, thereby making the mark asymmetrical (directional). In some instances, the mark 1200 may additionally include an aperture at the free end of the linear member 204 (i.e., at the end of member 204 opposite to the position where the mark extends from the inner edge 202).

[0118] The second mark 1300 may extend from the inner edge 202 of unit 275 at support 272c and may be disconnected from the other supports (272a, 272b, 272d) of the unit. For example... Figure 10A and 10B As shown, no part of the mark 1300 extends from the outer edge 210 of the unit 275. The mark 1300 may include a body comprising a partially or semi-circular member 1304 (e.g., half a circle) having a continuously curved outer edge extending from the support 272c. In some instances, the mark 1300 may additionally include an opening. In this example, the semi-circular member 1304 has a generally symmetrical shape; however, the mark 1300 has an asymmetrical orientation within the unit 275 when it extends to one side of the open area of ​​the unit 275. Thus, the mark 1300 may be a directional indicator (indicating the left-hand or right-hand orientation of the frame 252).

[0119] In some instances, the frame 252, including integrated markers 1200 and 1300 in each commissural support unit 275, can be used to identify the commissural support unit 275 of the frame 252 and to identify the foremost and / or rearmost commissural support unit 275 during the implantation procedure. For example, the symmetrical integrated marker 1200 can be used to identify the central portion of the commissural support unit 275 and can be aligned with the commissure of the autologous valve and / or a previously implanted prosthetic valve during the implantation procedure. Additionally, in some instances, such as when viewed with fluoroscopy, the asymmetrical integrated marker 1300 can be used to identify which commissural support unit is located in front of and / or behind another commissural support unit. For example, as... Figure 9A As best shown, in the foremost unit 275, mark 1300 is located on the lower left portion of the unit, while in the units 275 behind the foremost unit 275, mark 1300 is located on the lower right portion of the unit. The marking of the foreground and rear background positions of the commissure support unit 275 further enables alignment of the commissure support unit with the commissure of the autologous valve and / or a previously implanted prosthetic valve during the implantation procedure. For example, during the implantation procedure, the foremost commissure support unit 275 can be aligned with the foremost commissure of the autologous valve and / or a previously implanted prosthetic valve.

[0120] As described above, the integrated markers can be configured to facilitate or enable axial elongation of unit 275 during radial compression of frame 252. For example, markers 1200 and 1300 may have a size, shape, position, and / or orientation within the connecting support unit such that unit 275 can be compressed into an axially elongated shape when frame 252 is in a radially compressed state. Additionally, markers 1200 and 1300 may have a size, shape, position, and / or orientation that prevents markers from contacting each other when unit 275 is compressed into its axially elongated shape. Figure 10B and 11 A frame 252 in a radially compressed state and a unit 275 in an axially extended state are shown. As can be seen in the figure, each of the exemplary integral markers 1200 and 1300 may have a certain size, shape, position, and / or orientation within the unit 275, which, when the frame 252 is in a radially compressed state, allows the unit to extend axially and prevents contact between the integral markers 1200 and 1300. In some instances, each of the integral markers 1200 and 1300 may be configured such that (i.e., having a certain size, shape, position, and / or orientation within the unit 275 such that) when the unit is in an axially extended shape / state, the width of the integral marker at the location of the integral marker is less than or equal to the width of the unit 275. In some instances, each of the integral markers 1200 and 1300 can be configured such that (i.e., can have a certain size, shape, position and / or orientation within unit 275 such that) when the unit is in an axially elongated shape / state, marker 1200 is positioned above marker 1300 and a gap is provided therebetween.

[0121] In some instances, the integral marking disclosed herein may include one or more features of another integral marking. In some instances, the integral marking disclosed herein may have different orientations within a unit and / or may extend from different portions of the inner edge of the unit. As described above, in some instances, the integral marking is positioned within a connecting support unit. In some instances, the integral marking may be located in another unit to indicate the location of the connecting support unit, for example, within one or more units directly upstream of the connecting support unit, or within one or more units circumferentially adjacent to and / or located on one side of the connecting support unit. In some instances, the frame may include one or more additional unit flow lines downstream of the connecting support unit, which may include one or more integral markings (in such instances, the connecting support unit does not form the outflow end of the frame).

[0122] In some instances, the frame may include an integral mark at one or more joint support units. In some instances, the frame may include an integral mark at each of its joint support units (e.g., as shown in the image). Figure 9A and 9B (As illustrated in the example). Therefore, in a prosthetic valve having three commissures and three commissure support units (e.g., prosthetic valve 50), the frame may have three integral markers (each marker located within a corresponding commissure support unit). In some instances, each integral marker may be identical. In some instances, one or more integral markers may differ from other integral markers of the frame (e.g., having different shapes and / or orientations).

[0123] In some instances, the frame may include any combination of marks disclosed herein in the same unit or in different units of the frame. For example, the frame may include mark 1200 and any one of marks 200, 300, 400, 500, 600, 700, 800, 900, 1000, and 1100 in the same unit or in different units.

[0124] As mentioned above, in some instances, Figure 3A-11 The frame shown can have Figure 1A-2 One or more of the frame 52 features shown, and / or can be used with the features described above. Figure 1A-2 The discussion concerns one or more prosthetic valves with 50 or 150 characteristics. In some instances, Figure 3A-11 The frame may have different features than frame 52, and / or may be used in prosthetic valves having different features than prosthetic valves 50, 150.

[0125] In some instances, the prosthetic valve may include markings (e.g., any one of markings 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300) that are formed separately from the frame 252 and subsequently attached to the frame (e.g., by welding).

[0126] Delivery technology

[0127] To implant a prosthetic valve with one or more integrated markers into an autologous aortic valve via a transfemoral delivery method, the prosthetic valve is mounted radially compressed along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the autologous aortic valve (e.g., aligned with the commissure of the autologous valve via the integrated markers) and radially dilated (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or by unfolding the prosthetic valve from the sheath to allow self-dilation). Alternatively, the prosthetic valve can be implanted within the autologous aortic valve during a transapical procedure, thereby introducing the prosthetic valve (on the distal portion of the delivery device) into the left ventricle through a surgical opening in the chest and the apex of the heart, and positioning the prosthetic valve within the autologous aortic valve. Alternatively, in transaortic surgery, a prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or a right parasternal thoracotomy, and then advanced through the ascending aorta toward the autologous aortic valve.

[0128] To implant a prosthetic valve with one or more integrated markers into an autologous mitral valve via a transseptal delivery method, the prosthetic valve is mounted radially compressed along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrioventricular septum (via a perforation created in the atrioventricular septum), into the left atrium, and advanced toward the autologous mitral valve. Alternatively, the prosthetic valve can be implanted into the autologous mitral valve via a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through surgical openings in the chest and at the apex, and the prosthetic valve is positioned within the autologous mitral valve.

[0129] To implant a prosthetic valve with one or more integrated markers into an autologous tricuspid valve, the prosthetic valve is mounted along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, and into the right atrium, with the prosthetic valve positioned within the autologous tricuspid valve. A similar method can be used to implant a prosthetic valve into an autologous pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the autologous tricuspid valve into the right ventricle and towards the pulmonary valve / pulmonary artery.

[0130] Another delivery method is the transatrial approach, where a prosthetic valve with one or more integral markers (mounted on the distal portion of the delivery device) is inserted through an incision in the chest and an incision made through the atrial wall (right or left atrium) to access any autologous heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary vein. Yet another delivery method is the transventricular approach, where a prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and an incision through the right ventricular wall (usually at or near the base of the heart) for implanting a prosthetic valve into an autologous tricuspid valve, autologous pulmonary valve, or pulmonary artery.

[0131] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vascular system. Furthermore, the disclosed delivery methods are not intended to be limiting. Any prosthetic valve disclosed herein can be implanted using any of the various delivery procedures and devices known in the art.

[0132] Any of the systems, devices, equipment, etc., described herein may be sterilized (e.g., by heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure their safety for patient use, and as a step in the methods described herein, any method may include sterilization of the associated systems, devices, equipment, etc. Examples of heating / heat sterilization include steam sterilization and autoclaving. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. For example, sterilization using hydrogen peroxide may be accomplished using hydrogen peroxide plasma.

[0133] Additional examples of the disclosed technology

[0134] In view of the embodiments described above for the disclosed subject matter, this application discloses further examples listed below. It should be noted that a single feature or combination of features of a single example, more than one feature of an example, and optional combinations with one or more features of one or more other examples are also further examples falling within the scope of this application's disclosure.

[0135] Example 1. A prosthetic heart valve, comprising: an annular frame including a plurality of interconnected struts forming a plurality of units; and a valve structure disposed within an interior space of the frame and having an inlet end and an outlet end, the valve structure including a plurality of leaflets, each of the leaflets engaging at the outlet end of the valve structure to an adjacent leaflet to form a commissure therebetween, the commissure being attached to the frame at a commissure support unit of the plurality of units; wherein the commissure support unit defines an internal opening; and wherein the frame includes an integral mark extending from an inner edge of the commissure support unit into the internal opening.

[0136] Example 2. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 1, wherein the integral marking does not extend to the outside of the internal opening.

[0137] Example 3. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 1 or 2, wherein the integral marking does not extend from the outer edge of the fusion support unit.

[0138] Example 4. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 1 to 3, wherein the commissural support unit includes an outflow tip portion, and wherein the integral mark extends from the inner edge at the outflow tip portion.

[0139] Example 5. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 1 to 3, wherein the integral marking extends from the inner edge of the junction of the two interconnecting struts on one side of the fusion support unit.

[0140] Example 6. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 1 to 5, wherein the integral marking has an asymmetrical shape.

[0141] Example 7. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 6, wherein the integral marking includes a body comprising at least one of a linear member or a circular member, the body having a protrusion extending outward therefrom toward a side portion of the fusion support unit.

[0142] Example 8. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 1 to 6, wherein the integral marking has an asymmetric orientation within the fusion support unit.

[0143] Example 9. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 1 to 6 or 8, wherein the integral marking includes a neck portion and a body portion, and wherein the neck portion extends between the inner edge and the body portion and has a width narrower than the body portion.

[0144] Example 10. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 9, wherein the main body portion includes a C-shaped member.

[0145] Example 11. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 9, wherein the main body portion comprises a circular member.

[0146] Example 12. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 9, wherein the main body portion includes a semi-circular member.

[0147] Example 13. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 9, wherein the main body portion comprises a semi-oval member.

[0148] Example 14. A prosthetic heart valve according to any of the examples disclosed herein, particularly the prosthetic heart valves according to Examples 9 to 13, wherein the neck portion extends at an angle toward the central portion of the internal opening of the syndesm support unit.

[0149] Example 15. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 1 to 6 or 8, wherein the integral marking includes a curved member.

[0150] Example 16. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 15, wherein the curved member extends from a first strut in the outflow portion of the merging support unit to a second strut in the inflow portion of the merging support unit.

[0151] Example 17. A prosthetic heart valve according to any of the examples disclosed herein, particularly prosthetic heart valves according to Examples 1 to 16, wherein the size and shape of the integral marker are configured such that the fusion support unit can be axially elongated when the frame is in a radially compressed state.

[0152] Example 18. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 1 to 17, wherein the integral marking includes one or more orifices.

[0153] Example 19. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 1 to 18, wherein the integrated marking is configured to enable identification of the commissural support unit during one or more periods of the implantation procedure or post-implantation procedure.

[0154] Example 20. A prosthetic heart valve, comprising: an annular frame including a plurality of interconnected struts forming a plurality of units, each of said units including an internal opening; and a valve structure disposed within an internal space of said frame and having an inlet end and an outlet end, said valve structure including a plurality of leaflets; wherein a selected unit among said units includes an integral mark extending from an inner edge of the respective selected unit and into the internal opening of said respective selected unit; wherein portions of said integral mark do not extend outside said internal opening; and wherein said integral mark is configured to enable identification of said respective selected unit during one or more of the implantation procedure or post-implantation procedure.

[0155] Example 21. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 20, wherein the selected unit in the unit is located in the unit flow row of the frame.

[0156] Example 22. A prosthetic heart valve according to any example disclosed herein, particularly a prosthetic heart valve according to Example 20 or 21, wherein the selected unit in the unit is a commissure support unit, each of the commissure support units supporting a commissure formed between adjacent leaflets in the leaflets of the valve structure.

[0157] Example 23. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 20 to 22, wherein the integrated marking is a directional indicator.

[0158] Example 24. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 23, wherein the integral marking has an asymmetrical shape.

[0159] Example 25. The prosthetic heart valve according to any of the examples disclosed herein, particularly the prosthetic heart valve according to Example 23 or 24, wherein the integral marking has an asymmetric orientation within the respective selected unit.

[0160] Example 26. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 20 to 25, wherein the integral marking includes a neck portion and a body portion, and wherein the neck portion extends between the inner edge and the body portion and has a width narrower than the body portion.

[0161] Example 27. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 26, wherein the neck portion extends from the inner edge of one of the first strut in the outflow portion of the respective selected unit or the second strut in the inflow portion of the respective selected unit, and wherein the neck portion extends at an angle toward the central portion of the internal opening of the respective selected unit.

[0162] Example 28. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 26, wherein the neck portion extends from the inner edge at the junction of two interconnecting struts on one side of the respective selected unit and extends toward the central portion of the internal opening of the respective selected unit.

[0163] Example 29. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 20 to 25, wherein the integral marking includes a curved member having two intersection points with the inner edge of the respective selected unit.

[0164] Example 30. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 20 to 25, wherein the integral marking includes a crescent-shaped member that is continuous with the engagement portion of two interconnecting struts on one side of the respective selected unit.

[0165] Example 31. A prosthetic heart valve, comprising: an annular frame including a plurality of interconnected struts forming a plurality of units, each of said units including an internal opening; and a valve structure disposed within an internal space of said frame and having an inlet end and an outlet end, said valve structure including a plurality of leaflets; wherein each selected unit of said units includes one or more integral marks extending from an inner edge of said selected unit and into said internal opening of said selected unit; wherein portions of said integral marks do not extend outside said internal opening; and wherein said one or more integral marks are configured to enable identification of said selected unit during one or more periods of implantation procedure or post-implantation procedure.

[0166] Example 32. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 31, wherein the selected unit in the unit is located in the unit flow row of the frame.

[0167] Example 33. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Example 31 or 32, wherein the selected unit in the unit is a commissure support unit, each of the commissure support units supporting a commissure formed between adjacent leaflets in the leaflets of the valve structure.

[0168] Example 34. A prosthetic heart valve according to any of the examples disclosed herein, particularly a prosthetic heart valve according to Examples 31 to 33, wherein the first of the one or more integral markings is a directional indicator having one or more of an asymmetrical shape or asymmetrical orientation within a corresponding selected unit in the selected unit.

[0169] Example 35. The prosthetic heart valve of claim 34, wherein the second integral mark of the one or more integral marks is a symmetrical mark including a neck portion and a body portion, and wherein the neck portion extends between the inner edge and the body portion and has a width narrower than the body portion.

[0170] Example 36. The prosthetic heart valve of claim 35, wherein the neck portion extends from the inner edge at the junction of two interconnecting struts at the top of the respective selected unit and extends toward the central portion of the internal opening of the respective selected unit.

[0171] Example 37. The prosthetic heart valve of claim 35 or claim 36, wherein the first integral mark and the second integral mark are configured such that one or more of the size, shape, position, or orientation of each of the first integral mark and the second integral mark enable the joint support unit to elongate axially when the frame is in a radially compressed state.

[0172] Example 38. The prosthetic heart valve according to claims 35 to 37, wherein the first integral mark in the selected unit is configured such that, during one or more periods of the implantation procedure or post-implantation procedure, the foremost selected unit among the selected units relative to the other selected units among the selected units can be identified.

[0173] Example 39. A prosthetic heart valve, comprising: an annular frame including a plurality of interconnected struts forming a plurality of units, each of said units including an internal opening; and a valve structure disposed within an internal space of said frame and having an inlet end and an outlet end, wherein said valve structure includes a plurality of leaflets, and each of said leaflets engages at said outlet end of said valve structure with an adjacent leaflet to form a commissure therebetween, and wherein said commissure is attached to said frame at commissure support units of said plurality of units; wherein each of said commissure support units includes symmetry that bisectes at least a portion of a corresponding commissure support unit. An integral marking and a directional marking, each of the symmetrical integral marking and the directional marking extending from the inner edge of the respective joint support unit and into the internal opening of the respective joint support unit, wherein the directional marking has at least one of an asymmetrical shape or an asymmetrical orientation within the respective joint support unit; and wherein the one or more integral markings are configured such that, for each of the joint support units, during one or more of the implantation procedure or post-implantation procedure, it is possible to identify whether each of the respective joint support units is in a forward orientation or a backward orientation.

[0174] Example 40. A method comprising sterilizing a prosthetic heart valve, device and / or component according to any one of Examples 1 to 39.

[0175] Example 41. The prosthetic heart valve according to any one of Examples 1 to 39, wherein the prosthetic heart valve is sterilized.

[0176] Unless otherwise stated, the features described in this document with respect to any instance may be combined with other features described in any one or more other instances. For example, any one or more features of a frame may be combined with any one or more features of another frame. As another example, any one or more features of a monolithic tag may be combined with any one or more features of another monolithic tag.

[0177] Given the many possible ways in which the principles of this disclosure can be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be construed as limiting the scope of this disclosure or the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A prosthetic heart valve, comprising: A ring-shaped frame comprising multiple interconnecting pillars forming multiple units; as well as A valve structure disposed within the internal space of the frame and having an inflow end and an outflow end, the valve structure comprising a plurality of leaflets, each of the leaflets being joined to an adjacent leaflet at the outflow end of the valve structure to form a joint therebetween, the joint being attached to the frame at a joint support unit of the plurality of units. The connecting support unit defines an internal opening; and The frame includes an integral marker that extends from the inner edge of the connecting support unit into the internal opening.

2. The prosthetic heart valve of claim 1, wherein the integral marking does not extend outside the internal opening.

3. The prosthetic heart valve according to any one of claims 1 or 2, wherein the integral marking does not extend from the outer edge of the fusion support unit.

4. The prosthetic heart valve according to any one of claims 1 to 3, wherein the commissural support unit includes an outflow tip portion, and wherein the integral mark extends from the inner edge at the outflow tip portion.

5. The prosthetic heart valve according to any one of claims 1 to 3, wherein the integral marking extends from the inner edge of the fusion support unit on one side.

6. The prosthetic heart valve according to any one of claims 1 to 5, wherein the integral marker has an asymmetrical shape.

7. The prosthetic heart valve according to any one of claims 1 to 6, wherein the integral marking has an asymmetrical orientation within the fusion support unit.

8. The prosthetic heart valve according to any one of claims 1 to 7, wherein the integral marking includes a neck portion and a body portion, and wherein the neck portion extends between the inner edge and the body portion and has a width narrower than the body portion.

9. The prosthetic heart valve according to any one of claims 1 to 7, wherein the integral marker includes a curved member, wherein the curved member extends from a first post in the outflow portion of the merging support unit to a second post in the inflow portion of the merging support unit.

10. The prosthetic heart valve according to any one of claims 1 to 9, wherein the integral marker is configured such that one or more of the size, shape, position, or orientation of the integral marker enable the fusion support unit to elongate axially when the frame is in a radially compressed state.

11. The prosthetic heart valve according to any one of claims 1 to 10, wherein the integrated marking is configured to enable identification of the commissural support unit during one or more periods of the implantation procedure or post-implantation procedure.

12. A prosthetic heart valve, comprising: A ring-shaped frame comprising a plurality of interconnected pillars forming a plurality of units, each of said units including an internal opening; as well as A valve structure disposed within the internal space of the frame and having an inflow end and an outflow end, the valve structure comprising a plurality of leaflets; At least one selected unit of the plurality of units includes one or more integral marks extending from the inner edge of the respective selected unit into the internal opening of the respective selected unit; Neither part of the integral mark extends outside the internal opening; and The one or more integrated markers are configured to enable identification of the selected unit during one or more periods of the implantation procedure or post-implantation procedure.

13. The prosthetic heart valve of claim 12, wherein the selected unit is in the unit flow path of the frame.

14. The prosthetic heart valve according to any one of claim 12 or claim 13, wherein the selected unit is a joint support unit for supporting the joint of the leaflets of the valve structure.

15. The prosthetic heart valve according to any one of claims 12 to 14, wherein the first of the one or more integral markings is a directional indicator having one or more of an asymmetrical shape or asymmetrical orientation within the selected unit.

16. The prosthetic heart valve of claim 15, wherein the second integral mark of the one or more integral marks is a symmetrical mark including a neck portion and a body portion, and wherein the neck portion extends between the inner edge and the body portion and has a width narrower than the body portion.

17. The prosthetic heart valve of claim 16, wherein the neck portion extends from the inner edge at the junction of the two interconnecting struts at the top of the selected unit and extends toward the central portion of the internal opening of the selected unit.

18. The prosthetic heart valve of claim 16 or claim 17, wherein the first integral mark and the second integral mark are configured such that one or more of the size, shape, position, or orientation of each of the first integral mark and the second integral mark enable the joint support unit to elongate axially when the frame is in a radially compressed state.

19. The prosthetic heart valve of claims 16 to 18, wherein the at least one selected unit comprises a plurality of selected units, each selected unit comprising a corresponding first integral mark and a second integral mark, wherein the first integral mark in the selected unit is configured such that, during one or more periods of the implantation procedure or post-implantation procedure, the foremost selected unit among the selected units relative to the other selected units among the selected units can be identified.

20. A prosthetic heart valve, comprising: A ring-shaped frame comprising a plurality of interconnected pillars forming a plurality of units, each of said units including an internal opening; as well as A valve structure disposed within the internal space of the frame and having an inflow end and an outflow end, wherein the valve structure includes a plurality of leaflets, and each of the leaflets engages with an adjacent leaflet at the outflow end of the valve structure to form a fusion portion therebetween, and wherein the fusion portion is attached to the frame at a fusion portion support unit of the plurality of units. Each of the connecting support units includes a symmetrical integral mark that bisects at least a portion of the respective connecting support unit and a directional mark, each of the symmetrical integral mark and the directional mark extending from the inner edge of the respective connecting support unit and into the internal opening of the respective connecting support unit, wherein the directional mark has at least one of an asymmetrical shape or an asymmetrical orientation within the respective connecting support unit. and The one or more integrated markers are configured such that, for each of the joint support units, during one or more of the implantation procedure or post-implantation procedure, it is possible to identify whether each of the respective joint support units is in a forward orientation or a backward orientation.

Images