WO2025235579A1

WO2025235579A1 - Apparatus and methods for positioning a radially compressed prosthetic valve relative to a host structure

Info

Publication number: WO2025235579A1
Application number: PCT/US2025/028099
Authority: WO
Inventors: Sydney Michelle MAYER; Camille Lazaro VILLADOLID; Sean Chow; Jennifer Blanche Lisauskas
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2024-05-08
Filing date: 2025-05-07
Publication date: 2025-11-13
Anticipated expiration: 2026-11-08

Abstract

Systems, apparatus, and methods for axially aligning a prosthetic valve with a native valve to achieve implantation at a desired or selected deployment position. A delivery apparatus can include a shaft and a balloon on a distal end portion of the shaft. A prosthetic valve can be radially compressed around the balloon in a valve mounting portion of the delivery apparatus. The delivery apparatus can include a radiopaque marker array attached to the shaft in the valve mounting portion of the delivery apparatus. The markers in the marker array can be sized and spaced from adjacent ones of the markers such that they define locators in the array that are indicative of a plurality of deployment positions, and each locator can be aligned relative to a portion of a host structure to result in the prosthetic valve being implanted at a respective one of the deployment positions.

Description

APPARATUS AND METHODS FOR POSITIONING A RADIALLY COMPRESSED

PROSTHETIC VALVE RELATIVE TO A HOST STRUCTURE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63/644,017, filed May 8, 2024, which is incorporated by reference herein in its entirety.

FIELD

[0002] The present disclosure relates to apparatuses, systems, and methods for delivering and aligning a prosthetic valve at a host valve or implant such that, for example, the prosthetic valve is implanted at a desired deployment position within the host valve or implant.

BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one example, a prosthetic heart valve can be mounted in a crimped (radially compressed) state on the distal end of a delivery apparatus and advanced through the patient’ s vasculature (for example, through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The radially compressed prosthetic valve can then be moved (for example, rotated and/or axially adjusted) to position and/or align the prosthetic valve relative to one or more anatomical features at the implantation site. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size. [0004] In exemplary delivery systems including mechanically expandable prosthetic valves, a degree of radial expansion of the prosthetic valve may be controllable during implantation, which can enable at least some repositioning of the prosthetic valve relative to the native anatomy while the prosthetic valve is in a partially expanded state. In other exemplary delivery systems, such as those including self-expanding or balloon-expandable prosthetic valves, the ability to reposition the prosthetic valve after it has been radially expanded may be more limited or repositioning may not be possible.

[0005] Accordingly, proper alignment of the radially compressed prosthetic valve relative to the native anatomy prior to radial expansion of the prosthetic valve is desirable.

SUMMARY

[0006] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide improved positioning of a radially compressed prosthetic heart valve to achieve a selected and/or desired deployment position relative to an anatomical target and/or a previously implanted medical device when the prosthetic valve is transitioned to a radially expanded state. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.

[0007] A prosthetic heart valve can comprise a frame and a valvular structure coupled to the frame. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[0008] A delivery apparatus for a prosthetic implant can comprise a handle and one or more shafts coupled to the handle.

[0009] An assembly can comprise a prosthetic heart valve and a delivery apparatus.

[0010] In some examples, a distal end portion of a delivery apparatus can include a valve mounting portion configured to have a prosthetic heart valve mounted thereon in a radially compressed state.

[0011] In some examples, a balloon can be mounted on the distal end of the delivery apparatus and the prosthetic heart valve can be radially compressed around the balloon. [0012] In some examples, a delivery apparatus can comprise a radiopaque marker array coupled to an inner shaft in the valve mounting portion of the delivery apparatus. [0013] In some examples, a balloon includes a distal portion, proximal portion, and a central portion disposed between the distal portion and the proximal portion, and a radiopaque marker array is coupled to a shaft in a region underlying the central portion of the balloon. [0014] In some examples, a radiopaque marker array can include a plurality of radiopaque markers.

[0015] In some examples, the plurality of radiopaque markers can be axially spaced along the shaft in a region that is between the inflow end and the outflow end of a radially compressed prosthetic heart valve.

[0016] In some examples, the plurality of radiopaque markers in a radiopaque marker array are indicative of a plurality of deployment positions for the prosthetic heart valve.

[0017] In some examples, each of the radiopaque markers of a radiopaque marker array can be alignable relative to a portion of a host structure while a prosthetic heart valve is in the compressed configuration on the valve mounting portion of a delivery apparatus such that when the compressed prosthetic heart valve is radially expanded to the expanded configuration, the radially expanded prosthetic heart valve is implanted in the host structure at a selected one of the plurality of deployment positions.

[0018] In some examples, a host structure can be a native heart valve.

[0019] In some examples, a host structure can be a previously implanted medical device.

[0020] In some examples, a host structure can be a previously implanted prosthetic heart valve.

[0021] In some examples, the radiopaque markers in a radiopaque marker array can be sized and spaced to define a plurality of locators that each correspond to one of a plurality of deployment positions.

[0022] In some examples, each of the locators can be alignable relative to a portion of the host structure for deployment of the prosthetic valve at a corresponding one of the plurality of deployment positions.

[0023] In some examples, the plurality of deployment positions comprises a higher deployment position and a lower deployment position.

[0024] In some examples, the plurality of deployment positions comprises a 100/0 deployment position, a 90/10 deployment position, an 80/20 deployment position, and/or a 70/30 deployment position. [0025] In some examples, the plurality of deployment positions comprises an aortic valve deployment position and a mitral valve deployment position.

[0026] In some examples, an assembly comprises: an implantable prosthetic heart valve that is radially compressible to a compressed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising an annular frame and a valve structure disposed with the frame; and a delivery apparatus comprising: a shaft; a balloon mounted to a distal end portion of the shaft, the balloon comprising a distal portion, proximal portion, and a central portion disposed between the distal portion and the proximal portion; and a radiopaque marker array coupled to the shaft in a valve mounting portion of the delivery apparatus within a central portion of the balloon, the radiopaque marker array comprising a plurality of radiopaque markers that are indicative of a plurality of deployment positions for the prosthetic heart valve; and wherein each of the radiopaque markers of the radiopaque marker array is alignable relative to a portion of a host structure while the prosthetic heart valve is in the compressed configuration on the valve mounting portion of the delivery apparatus such that when the compressed prosthetic heart valve is radially expanded to the expanded configuration, the radially expanded prosthetic heart valve is implanted in the host structure at a selected one of the plurality of deployment positions.

[0027] In some examples, a delivery apparatus for an expandable prosthetic heart valve comprises: a shaft; a balloon mounted to a distal end portion of the shaft; and a radiopaque marker array coupled to the shaft within the balloon in a valve mounting portion of the delivery apparatus, the valve mounting portion configured to have the prosthetic heart valve mounted thereon in the compressed configuration, the radiopaque marker array comprising a plurality of radiopaque markers that are sized and spaced to define a plurality of locators that each correspond to a specified deployment position for the prosthetic heart valve within a host structure.

[0028] In some examples, a delivery apparatus comprises: a shaft; a balloon mounted to a distal end portion of the shaft, the balloon comprising a distal portion, proximal portion, and a central portion disposed between the distal portion and the proximal portion; and a radiopaque marker array coupled to the shaft in a valve mounting portion of the delivery apparatus within the central portion of the balloon, the valve mounting portion configured to have the prosthetic heart valve mounted thereon in a radially compressed configuration, the radiopaque marker array comprising a plurality of radiopaque markers that are sized and spaced to define a plurality of locators that are indicative a plurality of deployment positions for the prosthetic heart valve; wherein each of the locators is alignable relative to a portion of a host structure while the prosthetic heart valve is in the compressed configuration on the valve mounting portion of the delivery apparatus such that radially expanding the prosthetic heart valve results in the radially expanded prosthetic heart valve being implanted in the host structure at a selected one of the plurality of deployment positions.

[0029] In some examples, a delivery apparatus comprises: a shaft; a balloon mounted to a distal end portion of the shaft, the balloon comprising a distal portion, proximal portion, and a central portion disposed between the distal portion and the proximal portion; and a valve mounting portion corresponding to a central portion of the balloon and configured to have the prosthetic heart valve mounted thereon in a radially compressed configuration; means for positioning the compressed prosthetic heart valve mounted on the valve mounting portion during delivery of the prosthetic heart valve such that radially expanding the prosthetic heart valve results in the radially expanded prosthetic heart valve being implanted in a host structure at a selected one of a plurality of deployment positions.

[0030] A method for implanting a prosthetic implant can comprise inserting a distal end portion of a delivery apparatus into vasculature of patient, the distal end portion of the delivery apparatus comprising a distal portion of a shaft, a balloon mounted to the distal end portion of the shaft, a valve mounting portion corresponding to a central portion of the balloon, and a radiopaque marker array coupled to the distal portion of the shaft, and wherein the prosthetic heart valve is mounted on the valve mounting portion in a radially compressed configuration; and delivering the radially compressed prosthetic heart valve to a host structure.

[0031] In some examples, a method for implanting a prosthetic implant can comprise visualizing the radiopaque marker array and the host structure, aligning one or more markers in the radiopaque marker array relative to a portion of the host structure, and when a selected locator on the one or more markers is aligned relative to the portion of the host structure, transitioning the prosthetic heart valve from the radially compressed configuration to a radially expanded configuration such that the prosthetic heart valve is implanted at a selected one of a plurality of deployment positions within the host structure. [0032] In some examples, the above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0033] In some examples, a delivery apparatus, an assembly, and or a method of using a delivery apparatus and/or a delivery assembly can include one or more of the components recited in Examples 1-63 below.

[0034] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] FIG. 1 is a perspective view of an exemplary prosthetic heart valve.

[0036] FIG. 2A is a side view of an exemplary delivery apparatus configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0037] FIG. 2B is a cross-sectional side view of a distal end portion of the delivery apparatus of FIG. 2A.

[0038] FIG. 3A is a schematic of an example of a three-cusp imaging view of a native valve which can be used for visualizing a delivery apparatus in a patient’s heart during an implantation procedure and rotationally aligning a prosthetic valve mounted on the delivery apparatus.

[0039] FIG. 3B is a cross-sectional view of a native valve, illustrating a location of commissures of the native valve within the imaging view of FIG. 3A.

[0040] FIG. 4A is a schematic of an example of a cusp overlap imaging view of a native valve which can be used for visualizing a delivery apparatus in a patient’s heart during an implantation procedure and rotationally aligning a prosthetic valve mounted on the delivery apparatus.

[0041] FIG. 4B is a cross-sectional view of a native valve, illustrating a location of commissures of the native valve within the imaging view of FIG. 4A. [0042] FIGS. 5 and 6 are cross-sectional views of a distal end portion of a delivery apparatus including exemplary radiopaque marker arrays.

[0043] FIGS. 7-9 are schematic illustrations of exemplary radiopaque marker arrays that can be utilized in the delivery apparatus of FIGS. 5 and 6.

[0044] FIG. 10 is a perspective view of a distal end portion of a delivery apparatus including an exemplary radiopaque marker array.

[0045] FIGS. 11A-11D are exemplary fluoroscopic views illustrating exemplary steps of implantation utilizing the delivery apparatus of FIG. 10.

[0046] FIG. 12 is a logical flow diagram illustrating an exemplary method for implanting a prosthetic heart valve utilizing the delivery apparatus disclosed herein.

DETAILED DESCRIPTION

General Considerations

[0047] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0048] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art. [0049] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0050] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’ s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0051] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”

[0052] As used herein, the terms “substantially,” “about,” and “approximately” mean within a range of a given value, such as, for example, within a range of +/- 10% of a given value, such as being within a range of +/- 5% of a given value, etc.

[0053] As used herein, the term “host valve” means a native heart valve or a previously implanted prosthetic heart valve. The previously implanted prosthetic valve can be a transcatheter heart valve or a surgical heart valve. In some examples, the host valve is a “deficient valve” that requires treatment and/or replacement.

[0054] As used herein, the term “host structure” refers to a host valve (which can be a native valve or a previously implanted prosthetic valve) or a previously implanted medical device, such as an annuloplasty ring or a docking device (such as a docking stent).

Overview of the Disclosed Technology

[0055] As introduced above, proper alignment of a radially compressed prosthetic valve relative to the native anatomy prior to radial expansion the prosthetic valve is desirable. [0056] Known delivery devices for transcatheter heart valves typically include a single radiopaque alignment marker that is aligned with a targeted anatomical landmark (for example, the plane of the native aortic valve) to axially align a radially compressed prosthetic valve with respect to the anatomical landmark prior to valve deployment. Unfortunately, an optimal or desired implantation position (for example, a desired depth of implantation within a host valve) can vary between patients based on characteristics of the patient, such as anatomy, disease condition, presence of other implants, etc., and/or characteristics of the prosthetic valve being implanted in the patient, such as its size, shape, structure, components, sub-components, etc.

[0057] As discussed in detail below, in some patients, it may be desirable to implant a prosthetic valve in a “lower” deployment position relative to a native annulus, and in other patients, it may be desirable to implant a prosthetic valve in a “higher” deployment position relative to a native annulus. Thus, a delivery apparatus including a single axial alignment radiopaque marker indicating a location of a radially compressed prosthetic valve on a distal end of the delivery apparatus may be insufficient for use across a range of different patients. [0058] Moreover, a single axial alignment marker indicating a location of a radially compressed prosthetic valve on a distal end of a delivery apparatus is typically configured for guiding implantation in a specific implantation location (for example, an aortic valve) and may not be usable in other implantation locations (for example, a mitral valve, a tricuspid valve, and/or a pulmonary valve).

[0059] Additionally, in some examples, a first prosthetic valve can have a configuration (for example, a first size and shape) for implantation in a first host valve and a second prosthetic valve can have a different configuration (for example, a second size and shape) for implantation in a second host valve. Thus, a single axial alignment marker indicating a location of a radially compressed prosthetic valve on a distal end of a delivery apparatus may be insufficient for use across a range of different implantable prosthetic devices.

[0060] Another disadvantage of a single axial alignment marker is that its relative location to a landmark may be difficult to visualize and/or approximate during an implantation procedure, thereby making the positioning of the compressed prosthetic valve imprecise. [0061] Described herein are examples of medical instruments and/or apparatus (in some examples referred to as a delivery catheter or delivery apparatus) that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, a prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the catheters are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and/or components thereof, including ultrasound transducers; positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like; performing a valvuloplasty, angioplasty, or other remodeling procedures; and delivering agents, such as drugs, into a patient’s body. [0062] The following description proceeds with reference to delivery apparatuses with inflatable balloons and methods of use thereof for implanting a balloon-expandable prosthetic heart valve at a native heart valve or within a previously implanted medical device (for example, in a valve-in- valve implantation procedure). However, it should be understood that the features of the delivery apparatuses and methods disclosed herein can be utilized with other types of delivery apparatuses (such as, for example, delivery apparatuses configured for delivery of mechanically expandable or self-expandable prosthetic valves or other implantable devices) and can be used to implant various other medical devices at various locations within a body (and/or at various locations within an anatomical model), such as any of those described above.

[0063] The delivery apparatus, assemblies, and methods disclosed herein can address one or more of the issues discussed above. In some examples, a delivery apparatus can include a balloon for radially expanding an implantable medical device (for example, a prosthetic valve) at a target implantation site (for example, within an annulus of a native heart valve or within another, previously implanted device). For example, a distal end of the delivery apparatus including a radially compressed prosthetic valve mounted over a deflated balloon can be positioned within a host structure. The distal end of the delivery apparatus can include a radiopaque marker array underlying the radially compressed prosthetic valve. During an implantation procedure, one or more markers in the array can be utilized to achieve a desired deployment position of the prosthetic valve relative to a host structure (for example, an anatomical target, a targeted portion of another, previously implanted device, etc.) depending on, for example, one or more characteristics of the patient, a size of the prosthetic valve, and/or the type of native valve or the type or structural features of the previously implanted medical device within which the prosthetic valve is being implanted. After the positioning, the balloon can be inflated to transition of the prosthetic valve from the radially compressed state to a radially expanded state.

[0064] In some examples, a radiopaque marker array includes a plurality of discrete radiopaque markers that are attached to (for example, crimped onto) an inner shaft of a delivery apparatus. The plurality of markers in the marker array can have a specified distance between each of the markers. In some examples, each of the markers can be equidistant from adjacent markers such that markers in the array are spaced at regular intervals. In some examples, a distance between one or more adjacent markers can vary relative to distances between others of the adjacent markers. In some examples, each of the markers can have an equal size (for example, an equal length and thickness). In some examples, one or more of the markers can vary in size relative to others of the markers. In some examples, each of the markers can have a same or similar shape. In some examples, one or more of the markers can vary in shape relative to others of the markers.

Examples of the Disclosed Technology

[0065] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0066] FIG. 1 shows an exemplary prosthetic valve 10, according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0067] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017/0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020/247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019/0000615, which is incorporated herein by reference.

[0068] As shown in FIG. 1, the prosthetic valve 10 can have four main components: a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19. The inner skirt 16 can be arranged on and/or coupled to an inner surface of the frame 12 while the outer skirt 18 can be arranged on and/or coupled to an outer surface of the frame 12.

[0069] The inner and/or outer skirts can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirt can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirt can comprise a fabric without interlaced yarns or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yams or fibers) include, without limitation, polyethylene (PET), ultra -high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirt can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirt can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirt can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0070] The valvular structure 14 can comprise three leaflets 40, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other examples there can be greater or fewer number of leaflets (for example, one or more leaflets 40). The leaflets 40 can be secured to one another at their adjacent sides to form commissures 22 of the valvular structure 14. The lower edge of valvular structure 14 can have an undulating, curved scalloped shape and can be secured to the inner skirt 16 by sutures (not shown). In some examples, the leaflets 40 can be formed of pericardial tissue (for example, 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 by reference herein.

[0071] The frame 12 can be radially compressible (collapsible) and expandable (for example, expanded configuration shown in FIG. 1) and comprise a plurality of interconnected struts 24. A plurality of apices 26 that are spaced circumferentially apart are formed at the inflow end portion 15 and the outflow end portion 19 of the frame 12 (only the apices 26 at the outflow end portion 19 are visible in FIG. 1). Each apex 26 is formed at a junction between two angled struts 24 at either the inflow end portion 15 or the outflow end portion 19. FIG. 1 depicts a known frame design with apices 26 that form a U-shaped bend between the two angled struts 24. In some examples, an angle 30 between the two angled struts 24, connected at the apex 26, can be in a range of 90 to 120 degrees.

[0072] The frame 12 can be formed with a plurality of circumferentially spaced slots, or commissure windows 20 that are adapted to mount the commissures 22 of the valvular structure 14 to the frame.

[0073] The frame 12 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame 12 (and thus the valve 10) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 12 (and thus the valve 10) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0074] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 12) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 12 can comprise stainless steel. In some examples, the frame 12 can comprise cobaltchromium. In some examples, the frame 12 can comprise nickel-cobalt-chromium. In some examples, the frame 12 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™/UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0075] FIG. 2A shows an exemplary delivery apparatus 100, which can be used to implant an expandable prosthetic heart valve (for example, the prosthetic valve 10 of FIG. 1), or another type of expandable prosthetic medical device (such as a stent). A distal end portion 109 of the delivery apparatus 100 is shown in cross-sectional side view in FIG. 2B. In some examples, the delivery apparatus 100 is adapted for use in introducing a prosthetic valve into a heart.

[0076] In the depicted example, the delivery apparatus 100 is a balloon catheter comprising a handle 102 and a steerable, outer shaft 104 extending distally from the handle 102. The delivery apparatus 100 can further comprise an intermediate shaft 106 (which also may be referred to as a balloon shaft) that extends both proximally and distally from the handle 102. The portion of the intermediate shaft 106 extending distally from the handle 102 also extends coaxially through the outer shaft 104. Additionally, the delivery apparatus 100 can further comprise an inner shaft 108 extending distally from the handle 102 and coaxially through the intermediate shaft 106 and the outer shaft 104. The inner shaft 108 also extends proximally from the handle 102 and coaxially through the intermediate shaft 106.

[0077] The outer shaft 104 and the intermediate shaft 106 are configured to translate longitudinally, along a central longitudinal axis 120 of the delivery apparatus 100, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0078] The intermediate shaft 106 can include a proximal end portion 110 that extends proximally from a proximal end of the handle 102, to an adaptor 112. A rotatable knob 114 can be mounted on the proximal end portion 110. The knob 114 can be configured to rotate the intermediate shaft 106 around the central longitudinal axis 120 of the delivery apparatus 100 and relative to the outer shaft 104.

[0079] The adaptor 112 can include a first port 138 configured to receive a guide wire therethrough and a second port 140 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to an inner lumen of the intermediate shaft 106.

[0080] The intermediate shaft 106 can further include a distal end portion 116 that extends distally beyond a distal end of the outer shaft 104 when the distal end of the outer shaft 104 is positioned away from an inflatable balloon 118 of the delivery apparatus. A distal end portion of the inner shaft 108 can extend distally beyond the distal end portion 116 of the intermediate shaft 106.

[0081] The balloon 118 can be coupled to the distal end portion 116 of the intermediate shaft 106. For example, a proximal end portion of the balloon 118 can be coupled to and/or around a distal end 148 of the intermediate shaft 106.

[0082] The balloon 118 can comprise a distal end portion (or section) 132, a proximal end portion (or section) 133, and an intermediate portion (or section) 135, the intermediate portion 135 disposed between the distal end portion 132 and the proximal end portion 133. [0083] In some examples, a distal end of the distal end portion 132 of the balloon 118 can be coupled to a distal end of the delivery apparatus 100, such as to a nose cone 122, or to an alternate component at the distal end of the delivery apparatus 100 (for example, a distal shoulder). In some examples, the intermediate portion 135 of the balloon 118 can overlay a valve mounting portion 124 of the distal end portion 109 of the delivery apparatus 100, the distal end portion 132 can overly a distal shoulder 126 of the delivery apparatus 100, and the proximal end portion 133 can surround a portion of the inner shaft 108 (FIG. 2B). The valve mounting portion 124 and the intermediate portion 135 of the balloon 118 can be configured to receive a prosthetic valve in a radially compressed state. In some examples, a prosthetic valve can be crimped around the valve mounting portion 124 in a radially compressed state. [0084] As described herein, rotation of the intermediate shaft 106 relative to the outer shaft 104 and/or the handle 102 can cause rotation of the balloon 118 and the prosthetic valve mounted thereon for rotational positioning of the prosthetic valve relative to the native anatomy at the target implantation site, and axial movement of the intermediate shaft 106 relative to the outer shaft 104 and/or the handle 102 can cause axial movement of the balloon 118 and the prosthetic valve mounted thereon for axial positioning of the prosthetic valve relative to the native anatomy at the target implantation site.

[0085] The delivery apparatus 100 can include a balloon shoulder assembly 170 configured to maintain the prosthetic heart valve or other medical device at a fixed position on the balloon 118 during delivery through the patient’s vasculature. The balloon shoulder assembly 170 can include a distal shoulder 126 arranged within a distal end portion of the balloon 118 and coupled to the distal end portion of the inner shaft 108. The distal shoulder 126 can be configured to resist movement of the prosthetic valve or other medical device mounted on the valve mounting portion 124 distally, in an axial direction (for example, along the central longitudinal axis 120), relative to the balloon 118.

[0086] For example, the distal shoulder 126 can include a flared portion 131 arranged adjacent to the valve mounting portion 124 (as shown in FIG. 2B). In some examples, the flared portion 131 can include a plurality of wings 130 that flare radially outward from a base portion 125 (for example, shaft) of the distal shoulder 126, toward the valve mounting portion 124. In some examples, the flared portion 131 can comprise four wings 130 spaced circumferentially apart from one another.

[0087] The outer shaft 104 can include a distal tip portion 128 mounted on its distal end. In some examples, the distal tip portion 128 can be configured as a flex adaptor including a plurality of inner and outer helical grooves. The outer shaft 104 and the intermediate shaft 106 can be translated axially relative to one another to position the distal tip portion 128 adjacent to a proximal end of the valve mounting portion 124, when a prosthetic valve is mounted in the radially compressed state on the valve mounting portion 124 and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 128 can be configured to resist movement of the prosthetic valve relative to the balloon 118 proximally, in the axial direction, relative to the balloon 1 18, when the distal tip portion 128 is arranged adjacent to a proximal side of the valve mounting portion 124. [0088] In some examples, the nose cone 122 can be disposed distal to and be coupled to the distal shoulder 126. In some examples, the nose cone 122 can be coupled to the distal end portion of the inner shaft 108.

[0089] An annular space 136 can be defined between an outer surface of the inner shaft 108 and an inner surface of the intermediate shaft 106. In some examples, the annular space 136 can be referred to as an inner lumen of the intermediate shaft 106. In some examples, the annular space 136 can be configured to receive an inflation fluid from a fluid source via the second port 140 of the adaptor 112 (for example, the annular space 136 can be in fluid communication with the second port 140 of the adaptor 112). The annular space 136 can be fluidly coupled to a fluid passageway 142 formed between the outer surface of the distal end portion of the inner shaft 108 and an inner surface of the balloon 118. As such, fluid from the fluid source can flow to the fluid passageway 142 from the annular space 136 to inflate the balloon 118 and radially expand and deploy the prosthetic valve.

[0090] In some examples, the distal end portion 132 of the balloon 118 can include a radial depression 134 that is depressed radially inwardly, toward the central longitudinal axis 120, relative to an outermost radial surface of the distal shoulder 126 and an outermost radial surface of the nose cone 122. In some examples, after crimping of the prosthetic valve onto the valve mounting portion 124, the distal tip portion 128 can be advanced over the proximal end portion 133 of the balloon 118. As a result, fluid arranged within the proximal end portion 133 of the balloon 118 can be displaced and pushed distally, within the balloon 118, to the distal end portion 132 of the balloon 118. The radially depressed, distal end portion 132 of the balloon 118 can then radially expand (for example, inflate partially) as it receives the displaced fluid to an expanded state. The radial depression 134 can be configured (for example, sized) so that the distal end portion 132 can receive the displaced fluid without radial expanding the portion of the balloon 118 within the valve mounting portion 124, thereby preventing the crimped profile of the prosthetic valve from increasing.

[0091] In some examples, the distal end portion 132 of the balloon 118 may not include the radial depression 134. In some examples, the proximal end portion 133 of the balloon may not have an outwardly formed shape (as shown in FIG. 2B), and instead may have a more cylindrical cross-section. In such examples, the distal end portion 132 may not need the radial depression 134 since there will be little to no excess fluid that gets displaced from the proximal end portion 133 as the distal tip portion 128 is advanced over the more cylindrical proximal end portion 133.

[0092] An inner lumen 144 of the inner shaft 108 can be configured to receive a guidewire therethrough, for navigating the distal end portion 109 of the delivery apparatus 100 to the target implantation site. As introduced above, the first port 138 of the adaptor 112 can be coupled to the inner lumen 144 and configured to receive the guidewire. For example, the distal end portion 109 of the delivery apparatus 100 can be advanced over the guidewire, to the target implantation site.

[0093] As shown in FIG. 2A, the handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion 109 of the delivery apparatus 100. For example, the handle 102 can include an adjustment member, such as the illustrated rotatable knob 160, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft 104 at or near the distal end of the outer shaft 104. Rotating the knob 160 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion 109 of the delivery apparatus 100. Further details on steering or flex mechanisms for the delivery apparatus are described in U.S. Patent No. 9,339,384, which is incorporated by reference herein in its entirety.

[0094] The handle 102 can further include an adjustment mechanism 161 including an adjustment member, such as the illustrated rotatable knob 162. The adjustment mechanism 161 can be configured to move (thus adjust the axial position) of the intermediate shaft 106 relative to the outer shaft 104. The handle 102 can also include a locking mechanism configured to retain (for example, lock) the position of the intermediate shaft 106 relative to the handle 102. In some examples, the locking mechanism can include another adjustment member, which can be configured as a rotatable knob 178. In some examples, rotating the knob 178 to a locked position can cause the intermediate shaft 106 to Fictionally engage with other components of the handle 102, thereby restraining movement of the intermediate shaft 106 for fine positioning of the prosthetic valve mounted on the distal end portion of the delivery apparatus 100. Rotating the knob 178 to an unlocked position allows axial and rotational movement of the intermediate shaft 106 relative to the proximal end portion of the handle 102. For example, rotation of the knob 162 can cause the intermediate shaft 106 to move axially relative to the outer shaft 104 (either in the proximal or distal direction, depending on the direction the knob 162 is rotated).

[0095] Further details on the adjustment mechanism and locking mechanism of the handle 102 can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein in its entirety. Additional examples of delivery apparatuses and related steering mechanism can be found in U.S. Patent No. 8,568,472, which is incorporated herein by reference in its entirety.

[0096] To implant a prosthetic valve (for example, prosthetic valve 10) in a native heart valve of the patient, the delivery apparatus 100 can be introduced into vasculature of the patient. The prosthetic valve can be initially retained in a radially compressed configuration on the valve mounting portion 124 (and over the balloon 118) of the delivery apparatus 100. [0097] In some examples, once inside the patient’s vasculature, the position (for example, an axial position) of the prosthetic valve relative to the balloon 118 can be adjusted such that the prosthetic valve 10 is centered on the balloon 118. In some instances, the axial position of the prosthetic valve 10 relative to the balloon 118 may not be adjusted.

[0098] When navigating the prosthetic valve through an arched region of the vasculature (for example, the aortic arch), the curvature of the distal end portion 109 of the delivery apparatus 100 can be adjusted, for example, by rotating the knob 160 to increase or decrease the tension in the pull wire which extends between the handle 102 and the distal end of the outer shaft 104. The prosthetic valve can be positioned within or adjacent an annulus of the native heart valve. Prior to inflating the balloon 118, the outer shaft 104 can be retracted proximally away from the balloon 118 for a sufficient distance so that the outer shaft does not interfere with balloon inflation. This can be accomplished, for example, by holding the adaptor 112 stationary against the operating table and rotating the knob 162 in a direction that causes the handle 102 and the outer shaft 104 to move proximally away from the balloon 118. Then, the prosthetic valve can be radially expanded and deployed by inflating the balloon 118. Inflation of the balloon 118 can radially expand the prosthetic valve 10 so that the prosthetic valve 10 contacts the native annulus. The expanded prosthetic valve 10 becomes anchored within the native aortic annulus by the radial outward force of the valve’s frame against the surrounding tissue.

[0099] As described above, the knob 114 of the handle 102 can be configured to rotate the intermediate shaft 106, thereby rotating the balloon 118 mounted on the intermediate shaft 106, a radially compressed prosthetic valve mounted on the balloon 118, around the valve mounting portion 124, and the inner shaft 108. Thus, rotating the knob 114 can rotate the prosthetic valve, around the central longitudinal axis 120, into a desired (circumferential or rotational) orientation relative to the native anatomy at the target implantation site.

[0100] In some examples, the delivery apparatus 100 can comprise one or more markers or marker bands 153 that are configured to indicate to a user a location of a specified component of the delivery apparatus. In some examples, the one or more marker bands 153 can be radiopaque. In some examples, one or more marker bands 153 can be radially compressed (for example, crimped), or otherwise mounted, onto the inner shaft 108.

[0101] As shown in FIG. 2B, in some examples, the delivery apparatus 100 can comprise three marker bands 153a, 153b, 153c. The marker band 153a can be a distal marker band mounted on the inner shaft 108 at a location at and/or adjacent to the proximal end of the flared portion 131 of the distal shoulder 126, which can be configured to indicate to a location of the distal shoulder 126 during an implantation procedure. The marker band 153c can be a proximal marker band mounted on the inner shaft 108 at a location at and/or adjacent to a distal end of the proximal end portion 133 of the balloon 118, which can be configured to indicate to a location of the proximal end portion 133 of the balloon 118 during an implantation procedure. The marker band 153b can be an intermediate marker band mounted on the inner shaft 108 a location at and/or adjacent to a center of the valve mounting portion 124, which can be configured to indicate to a location of the radially compressed prosthetic valve during an implantation procedure.

[0102] The radiopaque markers 153 are configured to be visible under medical imaging. For example, the marker(s) can comprise a radiopaque material that is configured to be visible under medical imaging, such as fluoroscopy and/or other types of X-ray imaging. In some examples, the marker(s) can comprise a radiopaque or other material that is configured to be visible under MRI, ultrasound, and/or echocardiogram. In some examples, the markers described herein can comprise tantalum. In some examples, the markers described herein can comprise another type of radiopaque material or combination of materials, such as one or more of iodine, barium, barium sulfate, tantalum, bismuth, or gold.

[0103] During an implantation procedure, a selected imaging view (for example, fluoroscopic imaging view) can be used to visualize the distal end portion of the delivery apparatus, including the markers 153 and the radially compressed prosthetic valve (for example, frame 12) relative to the surrounding native anatomy.

[0104] For example, FIG. 3A shows a schematic of a first imaging view, known as a three- cusp imaging view 250. In the three-cusp imaging view 250, the non-coronary cusp 252 of the native valve (for example, aortic valve) 260 and the left coronary cusp 254 are arranged opposite one another in the view and each are overlapped by a different portion of the right coronary cusp 256, with all three cusps aligned along a transverse axis 258. FIG. 3B shows a cross-sectional illustrating the orientation of the cusps 252, 254, 256 of the native valve 260 for the three-cusp imaging view 250 of FIG. 3A. FIG. 3B also shows the direct front 266 of the imaging view for the three-cusp imaging view 250.

[0105] In another example, FIG. 4A shows a schematic of a second imaging view that can be used by a medical professional during an implantation procedure, known as a cusp overlap view 270. In some examples, the cusp overlap view 270 can also be referred to as a two-cusp view or a right/left cusp overlap view. In some examples, in the cusp overlap view 270, the left coronary cusp 254 and the right coronary cusp 256 overlap one another and the non- coronary cusp 252 is offset from the left coronary cusp 254 and the right coronary cusp 256, with all three cusps aligned along a transverse axis 258. FIG. 4B shows a cross-sectional view illustrating the orientation of the cusps 252, 254, 256 of the native valve 260 for the cusp overlap view 270 of FIG. 4A. FIG. 4B also shows the direct front 266 of the imaging view for the cusp overlap view 270.

[0106] It will be appreciated that the above examples are directed to implantation in an aortic valve, and similar views can be made at other heart valves (for example, pulmonary, mitral, tricuspid valves).

[0107] Further details on the delivery apparatus 100 and systems and methods for prosthetic valve delivery to of a native valve are described in PCT Patent Publication No. WO 2022/046585, which is incorporated by reference herein in its entirety.

[0108] As illustrated in FIGS. 5-1 ID and described further below, the delivery apparatuses disclosed herein can include a radiopaque marker array coupled to an inner shaft of the delivery apparatus in a valve mounting region of the distal end portion thereof. In some examples, the delivery apparatuses including a radiopaque marker array disclosed herein can be configured to enable axial alignment of a radially compressed prosthetic valve relative to one or more structures at the target implantation site (for example, relative to a transverse axis along which base portion of one or more cusps of a native heart valve are aligned) to achieve a selected and/or desired deployment position (for example, a desired depth of implantation within the host valve) of the prosthetic valve in a radially expanded state. In some examples, the delivery apparatuses including a radiopaque marker array can be configured to enable utilization of the delivery apparatus for positioning and implantation of prosthetic valves at different native valves (for example, at a mitral valve and an aortic valve) or within different types or configurations of previously implanted devices (for example, within a prosthetic valve, annuloplasty ring, or docking device previously implanted within any of the native heart valves).

[0109] In some examples, the radiopaque marker arrays disclosed herein can be configured to enable axial alignment of a radially compressed prosthetic valve relative to one or more anatomical structures at the target implantation site (for example, relative to a transverse axis along which base portions of cusps of the native heart valve are aligned, such as the transverse axis 258 shown in FIGS. 3 A and 4 A and/or other portions of the native valve, such as a transverse axis extending across sinotubular junction (STJ) in an aortic valve).

[0110] In some examples, the radiopaque marker arrays disclosed herein can be configured to enable axial alignment of a radially compressed prosthetic valve relative to one or more structures of a previously implanted device at the target implantation site. For example, if the previously implanted device is a prosthetic transcatheter heart valve (which serves as a host valve), one of the markers in the array can be aligned with a transverse axis along an inflow end of the host valve, a transverse axis along an outflow end of the host valve, a portion of a frame of a host valve, such as a marker or a selected row of cells. If the previously implanted device is a prosthetic surgical heart valve (which serves as a host valve), one of the markers in the array can be aligned with a sewing ring of a host valve. If the previously implanted device is a docking device, such as a stent, one of the markers in the array can be aligned with an outflow end of the docking device, an inflow end of the docking device, a marker on the docking device, a selected row of cells of the docking device, etc.

[0111] As introduced above, based on anatomy, disease condition, and/or presence of other implantable devices it may be desirable and/or advantageous to implant a prosthetic valve in a “lower’' deployment position in a host valve (for example, where a greater portion of the prosthetic valve extends across a native annulus) or it may be desirable and/or advantageous to implant a prosthetic valve in a “higher” deployment position in a host valve (for example, where, relative to the lower deployment position, a lesser portion of the prosthetic valve extends across a native annulus).

[0112] In some examples, a lower deployment position for a prosthetic valve may be desirable if a patient has low coronary arteries and/or shallow sinuses. In some examples, a lower deployment position for a prosthetic valve may be desirable if a patient has a narrow and low STJ. In some examples, a lower deployment position for a prosthetic valve may be desirable if a patient has a low STJ with calcification. In some examples, a lower deployment position of a prosthetic valve can mitigate and/or reduce risk of sequestration (that is, reduced or no blood flow to the coronaries caused by displaced leaflets covering a blood flow path thereto). In some examples, a lower deployment position of a prosthetic valve can mitigate and/or reduce risk of balloon rupture and/or balloon slippage relative to the prosthetic valve. [0113] In some examples, a higher deployment position may be desirable when a prosthetic valve is implanted in a bicuspid valve and can improve sealing of the prosthetic valve to the native anatomy to reduce paravalvular leakage. In some examples, a higher deployment position for a prosthetic valve may be desirable where a patient has existing conduction disturbances and may reduce the likelihood of the patient requiring an implanted pacemaker. In some examples, a higher deployment position for a prosthetic valve may be desirable where a patient has a tapered-shaped ventricular outflow tract (for example, a ventricular outflow tract that narrows from native aortic annulus into the left ventricle) and/or calcification at the left ventricular outflow tract. In such examples, the higher deployment position can reduce the risk of the implanted prosthetic valve failing to fully expand to its functional diameter. In some examples, a higher deployment position for a prosthetic valve may be desirable where a patient has high coronary arteries. In some examples, a higher deployment position for a prosthetic valve may be desirable where a patient has a large sinus of Valsalva (SOV). In some examples, a higher deployment position for a prosthetic valve may be desirable where a patient has a high STJ.

[0114] In some examples, a deployment position of a prosthetic valve in an aortic can be expressed as a ratio of a portion of the prosthetic valve that is disposed within the aorta (including the native aortic annulus) relative to a portion of the prosthetic valve that is disposed within the ventricle when the prosthetic valve is in the radially expanded state. For example, a “lower” deployment position of a prosthetic valve can be a “70/30” position where approximately 70% of the radially expanded prosthetic valve extends into the aorta and approximately 30% of the radially expanded prosthetic valve extends into the ventricle. In another example, an “intermediate” deployment position of a prosthetic valve can be a “80/20” position where approximately 80% of the radially expanded prosthetic valve extends into the aorta and approximately 20% of the radially expanded prosthetic valve extends into the ventricle. In yet another example, a “higher” deployment position of a prosthetic valve can be a “90/10” position where approximately 90% of the radially expanded prosthetic valve extends into the aorta and approximately 10% of the radially expanded prosthetic valve extends into the ventricle. In yet another example, a “higher” deployment position of a prosthetic valve can be a “100/0” position where approximately 100% of the radially expanded prosthetic valve is implanted in the aorta and the prosthetic valve does not extend into the ventricle.

[0115] Turning to FIGS. 5 and 6, a distal end portion 309 of a delivery apparatus 300 can include a radiopaque marker valve positioning array 400 comprising a plurality of markers (for example, a plurality of rings formed from a radiopaque material, such as one or more of the radiopaque materials discussed above) coupled to an inner shaft 308 of the delivery apparatus in a valve mounting region 324 of the delivery apparatus. A prosthetic valve 310 can be radially compressed around and mounted on the valve mounting region 324.

[0116] In some examples, the radiopaque marker array 400 can be configured such that the markers can be used (for example, visualized via fluoroscopy) to position the prosthetic valve 310 at a plurality of differing deployment positions within a native heart valve. In some examples, the radiopaque marker array 400 can be configured such that the markers can be used (for example, visualized via fluoroscopy) to position a portion of the prosthetic valve 310 at a targeted implantation location within a native heart valve to achieve a selected deployment position for the prosthetic valve relative to the target location. For example, the radiopaque marker array 400 can enable a practitioner to selectively position the prosthetic valve 310 relative to the native anatomy such that when the prosthetic valve is radially expanded it is implanted at a higher deployment position (for example, at a selected one of a “90/10” position or a “100/0” position). In another example, the radiopaque marker array 400 can enable a practitioner to selectively position the prosthetic valve 310 relative to the native anatomy such that when the prosthetic valve is radially expanded it is implanted at a lower deployment position (for example, at a selected one of a “70/30” position or a “80/20” position). [0117] In some examples, the delivery apparatus 300 can include one or features of the delivery apparatus 100, discussed above. For example, the delivery apparatus 300 can include a nosecone 322, a balloon shoulder assembly 370, and a balloon 318 coupled to the inner shaft 308. The balloon can include a distal portion 334, a central portion 335, and a proximal portion 333. The central portion 335 of the balloon 318 can correspond to the valve mounting region 324 of the delivery apparatus 300. In some examples, the delivery apparatus 300 can include a distal marker band 353a and a proximal marker band 353c. The marker band 353a can be a distal marker band mounted on the inner shaft 308 at a location at and/or adjacent to a proximal end of a flared portion 331 of the shoulder assembly 370, which can be configured to indicate to a location of the distal shoulder 326 during an implantation procedure. The marker band 353c can be a proximal marker band mounted to the inner shaft 108 at a location at and/or adjacent to a distal end of the proximal end portion 333 of the balloon 318, which can be configured to indicate to a location of the proximal end portion 333 of the balloon 318 during an implantation procedure.

[0118] In some examples, the delivery apparatus 300 can exclude one or more of the foregoing features. In some examples, the delivery apparatus 300 can include one or more additional or alternate features.

[0119] FIG. 5 shows an exemplary configuration 400a for the radiopaque marker valve positioning array 400 (also referred to as the radiopaque marker valve positioning array 400a). As can be seen therein, the marker array 400a can include four radiopaque markers 402a, 404a, 406a, 408a, each having a similar or same size (for example, a similar or same width, wherein the width is measured along a longitudinal axis of the shaft 308). FIG. 6 shows an exemplary configuration 400b for the radiopaque marker valve positioning array 400 (also referred to as radiopaque marker valve positioning array 400b), which can include three markers 402b, 404b, 406b, where the marker 406b has a greater size than the markers 402b and 404b (for example, the marker 406b can have a greater width than each of the markers 402b and 404b). As discussed further below, in some examples, radiopaque marker valve positioning arrays can include additional or fewer markers (such as, for example three to ten markers) which can have similar or different sizes in various arrangements (see, for example, the exemplary marker arrays shown in FIGS. 7-9).

[0120] The radiopaque markers of the respective marker arrays 400a, 400b can be coupled to the inner shaft 308 within the valve mounting portion 324 of the delivery apparatus 300. The radially compressed valve 310 can mounted (for example, radially compressed via a crimping apparatus) onto the valve mounting portion 324 to have a specified orientation and/or position relative to the respective marker array 400a, 400b. For example, the radially compressed valve 310 can be mounted onto the valve mounting portion 324 such that a distal end 315 thereof (for example, an inflow end of a prosthetic valve configured for implantation in an aortic valve, or an outflow end of a prosthetic valve configured for implantation in a mitral valve) is a specified distance from a distal edge of the marker array, such as a distal edge 412a of the radiopaque marker 402a (FIG. 5) or a distal edge 412b of the radiopaque marker 402b (FIG. 6). In another example, the radially compressed valve 310 can be mounted onto the valve mounting portion 324 such that such that a proximal end 319 thereof (for example, an outflow end of a prosthetic valve configured for implantation in an aortic valve, or an inflow end of a prosthetic valve configured for implantation in a mitral valve) is a specified distance from a proximal edge of the array, such as a proximal edge 426a of the radiopaque marker 408a (FIG. 5) or a proximal edge 422b of the radiopaque marker 406b. In some examples, the radially compressed valve 310 can mounted in the valve mounting portion with a specified orientation and/or position relative to one or more other portions of the respective marker arrays 400a, 400b. In some examples, the respective marker array 400a, 400b is located axially between an inflow end and an outflow end of the frame of the compressed prosthetic heart valve 310.

[0121] As discussed above, a desired deployment position for a prosthetic heart valve may be defined (and/or selected or identified by a practitioner) based on the native anatomy, the disease condition, and/or the type of native valve in which the prosthetic valve is being implanted. In some examples, the radiopaque markers the valve positioning array 400 can have dimensions and/or can be mounted to the inner shaft 308 in an arrangement (for example, a spacing between the markers and/or an order of narrower markers relative to a wider marker) such that one or more of the markers each corresponds to a respective deployment position for the prosthetic valve in its radially expanded state. In some examples, various ones of the markers in the array can each correspond a different deployment position for the prosthetic valve. For example, the radiopaque markers in the marker array 400 can have a position, a width, and/or a spacing relative to adjacent ones of the markers that enables the marker array 400 to be used to identify one or more of a 70/30 position, an 80/20 position, a 90/10 position, and/or a 100/0 position for deployment of the prosthetic valve 310. [0122] In some examples, the radiopaque markers in the marker array 400 can have a position, a width, and/or a spacing relative to adjacent ones of the markers that enables the marker array 400 to be used to identify a deployment position for deployment of the prosthetic valve 310 in a native aortic valve and to identify a deployment position for the prosthetic valve 310 in a native mitral valve (or within an implant, such as an annuloplasty ring or a docking device, previously implanted within the native mitral valve).

[0123] In some examples, the array 400 can include at least one radiopaque marker indicating a deployment position in a first native heart valve (one of the aortic, mitral, tricuspid, or pulmonary valves) and at least one radiopaque marker indicating a deployment position in second native heart valve (one of the aortic, mitral, tricuspid, or pulmonary valves).

[0124] The marker array 400 can be visualized during an implantation procedure and one of the markers in the array 400 can be aligned with a portion or a feature of the native anatomy to achieve a desired deployment position for the prosthetic valve within the native valve. For example, while the prosthetic valve is in a radially compressed state, a marker of the marker array 400 can be aligned with or relative to a transverse axis extending along a base of the cusps of a native valve (for example, the transverse axis 258 in the three-cusp imaging view of FIG. 3 A or the transverse axis 258 the cusp overlap view of FIG. 4 A) such that when the prosthetic valve is radially expanded it is seated and/or implanted with a desired deployment position relative to the transverse axis 258.

[0125] In some examples, one or more of the distal edges 412a, 416a, 420a, 424a of the radiopaque markers 402a, 404a, 406a, 408a, one or more of the proximal edges 414a, 418a, 422a, 426a of the radiopaque markers 402a, 404a, 406a, 408a, one or more of the distal edges 412b, 416b, 420b of the radiopaque markers 402b, 404b, 406b, and/or one or more of the proximal edges 414b, 418b, 422b of the radiopaque markers 402b, 404b, 406bcan be used as locators, guides, and/or visual indicia in the respective marker array that are each indicative of specified deployment position. In some examples, one or more gaps between the radiopaque markers 402a, 404a, 406a, 408a and/or one or more gaps between the radiopaque markers 402b, 404b, 406b can be used as locators, guides, and/or visual indicia in the respective marker array that are each indicative of a specified deployment position. In some examples, one or more center portions of the radiopaque markers 402a, 404a, 406a, 408a and/or one or more center portions of the radiopaque markers 402b, 404b, 406b can be used as locators, guides, and/or visual indicia in the respective marker array that are each indicative of a specified deployment position.

[0126] In the exemplary marker array 400a shown in FIG. 5, in some examples, the distal edge 412a of the marker 402a can be aligned with a transverse axis extending along a base of the cusps of a native aortic valve for implanting the prosthetic valve 310 in a 90/10 position in the aortic valve. In some examples, a distal edge 416a of the marker 404a can be aligned with a transverse axis extending along a base of the cusps of a native aortic valve for implanting the prosthetic valve 310 in an 80/20 position in the aortic valve. In some examples, a proximal edge 418a of the marker 404a can be aligned with a transverse axis extending along a base of the cusps of a native aortic valve for implanting the prosthetic valve 310 in a 70/30 position in the aortic valve. In some examples, a proximal edge 426a of the marker 408a can be aligned with a transverse axis extending along a base of the cusps of a native mitral valve for implanting the prosthetic valve 310 in the mitral valve or a traverse axis bisecting an implant (such as an annuloplasty ring) previously in or on the native mitral valve.

[0127] In the exemplary marker array 400b shown in FIG. 6, in some examples, the distal edge 412b of the marker 402b can be aligned with a transverse axis extending along a base of the cusps of a native aortic valve for implanting the prosthetic valve 310 in a 90/10 position in the aortic valve. In some examples, a distal edge 416b of the marker 404b can be aligned with a transverse axis extending along a base of the cusps of a native aortic valve for implanting the prosthetic valve 310 in an 80/20 position in the aortic valve. In some examples, a proximal edge 418b of the marker 404b can be aligned with a transverse axis extending along a base of the cusps of a native aortic valve for implanting the prosthetic valve 310 in a 70/30 position in the aortic valve. In some examples, a proximal edge 422b of the marker 406b can be aligned with a transverse axis extending along a base of the cusps of a native mitral valve for implanting the prosthetic valve 310 in the mitral valve or a traverse axis bisecting an implant (such as an annuloplasty ring) previously in or on the native mitral valve.

[0128] It will be appreciated that the descriptions of the marker arrays 400a, 400b are merely exemplary. In some examples, the locations on the marker arrays 400a, 400b used as visual indicia can be indicative of other deployment positions (such as, for example, a 75/25 position in an aortic valve, a higher deployment position in a mitral valve, a lower deployment position in a mitral valve, etc.). In some examples, the foregoing deployment positions can be indicated by different locations and/or indicia in the marker arrays 400a, 400b (for example, the proximal edges of the markers can be aligned with a transverse axis extending along a base of the cusps of a native aortic valve for implanting the prosthetic valve at a 90/10 position and/or an 80/20 position, etc.). In some examples, the markers in the marker arrays can 400a, 400b be positioned relative to one or more other portions of the native anatomy (for example, a transverse axis extending across a sinotubular junction (STJ), a transverse axis extending across surface of the native annulus, etc.). In some examples, the markers in the marker arrays can 400a, 400b be positioned relative to one or more portions of a previously implanted medical device (for example, a transverse axis along an inflow end of a host valve, a transverse axis along an outflow end of a host valve, a portion of a frame of a host valve, such as a marker or a selected row of cells, a sewing ring of a host valve, an outflow end of a docking device, an inflow end of a docking device, a marker on a docking device, a selected row of cells of a docking device, etc.)

[0129] Turning to FIGS. 7-9, additional exemplary configurations 400c, 400d, 400e for the radiopaque marker valve positioning array 400 are shown and described (also referred to as radiopaque marker valve positioning arrays 400c, 400d, 400e). As can be seen in FIGS. 7-9, a number of markers, dimensions of the markers, and/or a distance between the markers can be varied and/or selected to in order to enable the array to be utilized for identifying and/or differentiating various deployment positions for a prosthetic valve. For example, the exemplary marker array 400c can include four markers 402c, 404c, 406c, 408c. Each of the markers 402c, 404c, 408c can have a width a, while the marker 406c can have a width b which is greater than the width a. Each of the markers 402c, 404c, 406c, 408c can be spaced apart from adjacent markers by a distance c. In some examples, the width a is in a range of 1 mm - 2 mm, the width b is in a range of 2 mm - 6 mm, and the distance c is a range of 1 mm - 2 mm. In some examples, the width a is 1.5 mm, the width b is 3 mm, and the distance c is 1 mm.

[0130] In the exemplary marker array 400d, the array can include five markers 402d, 404d, 406d, 408d, 410d. Each of the markers 402d, 404d, 406d, 408d, 410d can have a width d and can be spaced apart from adjacent markers by a distance e. In some examples, the width d is in a range of 1 mm - 2 mm and the distance e is in a range of 1 mm - 2 mm. In some examples, the width d is 1.5 mm and the distance e is 1 mm. [0131] In the exemplary marker array 400e, the array can include five markers 402e, 404e, 406e, 408e, 410e. Each of the markers 402e, 404e, 406e, 408e, 410e can have a width/and can be spaced apart from adjacent markers by a distance g. In some examples, the width/is in a range of 0.5 mm - 1.5 mm and the distance g is in a range of 1 mm - 2 mm. In some examples, the width/is 1 mm and the distance g is 1 mm.

[0132] As illustrated in the foregoing examples, a number of markers, a width of each of the markers, an order of the markers, and/or a distance between adjacent markers in a marker array can be varied, for example, to optimize and/or enable visualization of the individual markers during an implantation procedure (for example, a distance between the markers and/or a width of the markers can be selected to enable differentiation between the discrete markers under fluoroscopy). It will be appreciated that depending on the number of markers, the width(s) of the markers, the order of the markers, and/or the distance between the markers, various locations of an array (for example, proximal or distal edges of respective ones of the markers) can be indicative of various specified deployment positions. In other words, various locations on the array can be utilized as visual indicia, locators, and/or guides corresponding to a plurality of deployment positions depending on the size(s), arrangement, and spacing of the markers.

[0133] FIG. 10 shows another exemplary delivery apparatus 500 including a radiopaque marker valve positioning array 400 having a configuration 400f (also referred to the radiopaque marker valve positioning array 400f). The delivery apparatus 500 can include one or more features of the delivery apparatuses 100, 300. For example, the delivery apparatus 500 can include an outer shaft 504, a distal tip portion 528, an intermediate shaft 506, an inner shaft 508, a nose cone 522, a balloon 518 coupled to a distal end portion of the inner shaft 508. A central portion 535 of the balloon 518 (disposed between proximal portions 533, 534 thereof) corresponds to a valve mounting portion 524 of the delivery apparatus 500. The delivery apparatus 500 can include a distal marker 553a mounted on the inner shaft 508 underlying the distal portion 534 of the balloon 518 and a proximal marker 553c mounted on the inner shaft 508 underlying the proximal portion 533 of the balloon 518.

[0134] The marker array 400f can be coupled to the inner shaft 508 of the delivery apparatus in the valve mounting portion 524. In the illustrated example, the marker array 400f includes four markers 402f, 404f, 406f, 408f where the marker 404f is larger (for example, as a greater width) than the markers 402f, 406f, 408f (which can, for example, have a same or similar width). In some examples, the marker array can include one or more of the configurations or variations discussed above with respect to the marker arrays 400a-400e.

For example, the marker array 400f can include four or five markers that are each of an equal or similar size.

[0135] In some examples, a prosthetic valve is mounted onto (for example, radially compressed around) the valve mounting portion 524 such that it has an orientation and position relative to the marker array 400f. For example, a distal end (for example, an inflow end) of the compressed prosthetic valve can be a specified distance from a distal end of the marker array 400f (defined by, for example, a distal edge of the marker 402f). The marker array 400f can include and/or define a plurality of indicia, locators, and/or or guides for positioning the compressed prosthetic valve relative to a portion of a patient’s anatomy so that when the prosthetic valve is radially expanded, it is seated at a desired deployment position (such as at, for example, a higher deployment position, a lower deployment position a 100/0 deployment position, a 90/10 deployment position, an 80/20 deployment position, or a 70/30 deployment position).

[0136] FIGS. 11A- 1 ID illustrate exemplary fluoroscopic views showing a method of positioning of the delivery apparatus 500 relative to an aortic valve 600 utilizing the radiopaque marker array 400f. Prior to the implant procedure, the physician can conduct an examination of the patient (for example, using imaging technology) and determine or identify a desired deployment position for the prosthetic valve based on the various physiological conditions of the native valve and/or the size, shape, or condition of adjacent anatomical structure discussed above. In some examples, in addition to or in lieu of conducting an examination of the patient prior to the implant procedure, the physician can make a determination as to the desired deployment position while performing the implantation procedure.

[0137] As shown, a transverse axis 658 can be identified that extends along a base of the cusps of the aortic valve 600. FIG. 11A shows a compressed prosthetic valve 510 and the underlying marker array 400f as the distal portion of the delivery apparatus is inserted through the aorta toward the aortic valve 600. FIG. 1 IB illustrates a distal portion 515 (for example, an inflow end portion) opposing a proximal portion 519 (for example, an outflow end portion) of the compressed prosthetic valve 510 extending past the transverse axis 658. At this position, all of the alignment markers 402f, 404f, 406f and 408f are above the transverse axis 658. One of the markers can be selected for alignment with the axis 658 to achieve the desired deployment position for the prosthetic valve.

[0138] FIG. 11C shows the distal edge of the first (distal) marker 402f of the marker array 400f aligned with the transverse axis 658. As can be seen in FIG. 11C, in this position, approximately 30% of the compressed prosthetic valve 510 extends past the transverse axis 658 and into the ventricle, and approximately 70% of the compressed prosthetic valve 510 extends above the transverse axis. Upon radial expansion of the prosthetic valve, the prosthetic valve foreshortens, causing the inflow end 515 to move closer to the marker 402f and resulting in the prosthetic valve 510 being implanted in the native aortic valve 600 in a 90/10 deployment position.

[0139] FIG. 1 ID shows the distal edge of the second marker 404f of the marker array 400f aligned with the transverse axis 658. As can be seen in FIG. 11D, in this position, approximately 35% of the compressed prosthetic valve 510 may extend past the transverse axis 658 and into the ventricle, and approximately 65% of the compressed prosthetic valve 510 may be within the aortic valve 600. Upon radial expansion of the prosthetic valve, the prosthetic valve foreshortens, resulting in the prosthetic valve 510 being implanted in the native aortic valve 600 in an 80/20 deployment position.

[0140] As can be appreciated from FIGS. 11A-11D, when implanting a prosthetic valve that foreshortens when radially expanded, the alignment markers are positioned further away from the inlet end of the frame of the prosthetic valve than when prosthetic valve is radially compressed compared to when the prosthetic valve is radially expanded. Thus, the locations for the alignment markers along a shaft (for example, shaft 508) are determined based on the radially expanded state of the prosthetic valve. For a prosthetic valve that does not foreshorten when radially expanded, the locations of the alignment markers along a shaft (for example, shaft 508) can be determined based on the radially expanded state of the prosthetic valve or the radially compressed state of the prosthetic valve.

[0141] It will be appreciated that the foregoing positioning of the compressed prosthetic valve 510 and the radiopaque marker array 400f are merely exemplary. In some examples, other indicia in the marker array 400f can be indicative of 90/10 and/or 80/20 deployment positions. In some examples, the distal edges of the first and second markers 402f, 404f can be indicative of other deployment positions, such as 100/0 and/or 70/30 deployment positions, etc. [0142] FIG. 12 illustrates an exemplary method 700 of implanting a prosthetic heart valve at a target location within a patient and/or an anatomical model utilizing the delivery apparatus disclosed herein. As discussed above, a distal end portion of a delivery apparatus can include a prosthetic heart valve in a radially compressed state and a radiopaque marker array including a plurality of markers axially spaced on an inner shaft in a region that is between the inflow end and the outflow end of the compressed prosthetic valve. The markers can define a plurality of locators and/or indicia that are each indicative of a specified deployment position for the prosthetic valve.

[0143] As can be seen in FIG. 12, at step 702, the distal end of the delivery apparatus can be inserted into vasculature of the patient or the anatomical model. The distal end of the delivery apparatus (including the compressed prosthetic valve) can then be navigated and/or delivered to a target location (step 704). The target location can be a host structure, which can be, for example, a native heart valve, a previously implanted heart valve (which may be deficient and require replacement), and/or another implanted medical device, such as an annuloplasty ring or a docking device.

[0144] When the distal end portion of the delivery apparatus is at the target location (for example, within or proximate the host structure), the radiopaque marker array and the host structure can be visualized (for example, via fluoroscopy) (step 706). A selected one of the locators and/or indicia defined by markers in the array can be aligned to a portion of the host structure (step 708). As discussed above, in examples where the host structure is a native heart valve, a selected locator in the marker array can be aligned relative to a portion of the native anatomy. In some examples, where the host structure is a previously implanted medical device, a selected locator in the marker array can be aligned relative to portion of the previously implanted medical device. After the selected locator is aligned to the portion of the host structure, the prosthetic heart valve can be transitioned from the radially compressed state to the radially expanded state for implantation of the prosthetic valve at a desired deployment position (step 710).

[0145] In some examples, prior to insertion of the delivery apparatus and/or during insertion of the delivery apparatus, the patient or the anatomical model can be analyzed and/or evaluated to determine a desired or optimal deployment position for the prosthetic heart valve. In some examples, the determined desired or optimal deployment position can be utilized to select which indicator in the marker array will be utilized for positioning the radially compressed prosthetic valve so that the prosthetic valve will be implanted at the desired or optimal deployment position when transitioned to the radially expanded state. Delivery Techniques

[0146] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Additionally and/or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Additionally and/or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0147] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Additionally and/or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0148] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.

[0149] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0150] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0151] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat/thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. [0152] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.

Additional Examples of the Disclosed Technology

[0153] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0154] Example 1. An assembly comprising: an implantable prosthetic heart valve that is radially compressible to a compressed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising an annular frame and a valve structure disposed with the frame; and a delivery apparatus comprising: a shaft; a balloon mounted to a distal end portion of the shaft, the balloon comprising a distal portion, proximal portion, and a central portion disposed between the distal portion and the proximal portion; and a radiopaque marker array coupled to the shaft in a valve mounting portion of the delivery apparatus within a central portion of the balloon, the radiopaque marker array comprising a plurality of radiopaque markers that are indicative of a plurality of deployment positions for the prosthetic heart valve; and wherein each of the radiopaque markers of the radiopaque marker array is alignable relative to a portion of a host structure while the prosthetic heart valve is in the compressed configuration on the valve mounting portion of the delivery apparatus such that when the compressed prosthetic heart valve is radially expanded to the expanded configuration, the radially expanded prosthetic heart valve is implanted in the host structure at a selected one of the plurality of deployment positions.

[0155] Example 2. The assembly of any example disclosed herein, particularly example 1, wherein the radiopaque markers in the radiopaque marker array are sized and spaced to define a plurality of locators that each correspond to one of the plurality of deployment positions.

[0156] Example 3. The assembly of any example disclosed herein, particularly example 2, wherein each of the locators is alignable relative to the portion of the host structure for deployment of the prosthetic valve at a corresponding one of the plurality of deployment positions. [0157] Example 4. The assembly of any example disclosed herein, particularly examples 1-3, wherein the plurality of radiopaque markers in comprises three to ten markers.

[0158] Example 5. The assembly of any example disclosed herein, particularly examples 1-4, wherein the plurality of radiopaque markers comprises four markers.

[0159] Example 6. The assembly of any example disclosed herein, particularly examples 1-4, wherein the plurality of radiopaque markers comprises five markers.

[0160] Example 7. The assembly of any example disclosed herein, particularly examples 1-6, wherein the radiopaque markers in the radiopaque marker array are each equal in width. [0161] Example 8. The assembly of any example disclosed herein, particularly example 7, wherein a width of each of the radiopaque markers is in a range of 0.5 mm to 3 mm.

[0162] Example 9. The assembly of any example disclosed herein, particularly example 8, wherein the width of each of the radiopaque markers is 1.0 mm.

[0163] Example 10. The assembly of any example disclosed herein, particularly example 8, wherein the width of each of the radiopaque markers is 1.5 mm.

[0164] Example 11. The assembly of any example disclosed herein, particularly example 1- 6, wherein one of the radiopaque markers has a first width and one or more others of the radiopaque markers has a second width, wherein the first width is greater than the second width.

[0165] Example 12. The assembly of any example disclosed herein, particularly example 11 , wherein the first width is in a range of 2 mm to 3 mm and the second width is in a range of 1 mm to 1.5 mm.

[0166] Example 13. The assembly of any example disclosed herein, particularly examples 11 or 12, wherein the first width is 3 mm and the second width is 1.5 mm.

[0167] Example 14. The assembly of any example disclosed herein, particularly examples 1-13, wherein each of the radiopaque markers is equally spaced from adjacent ones of the radiopaque markers in the radiopaque marker array.

[0168] Example 15. The assembly of any example disclosed herein, particularly example 14, wherein a distance between the adjacent radiopaque markers is in a range of 1 mm to 1.5 mm.

[0169] Example 16. The assembly of any example disclosed herein, particularly examples 1-15, wherein the plurality of deployment positions comprises a higher deployment position and a lower deployment position. [0170] Example 17. The assembly of any example disclosed herein, particularly examples 1-16, wherein the plurality of deployment positions comprises a 90/10 deployment position, an 80/20 deployment position, and a 70/30 deployment position.

[0171] Example 18. The assembly of any example disclosed herein, particularly examples 1-17, wherein the plurality of deployment positions comprises an aortic valve deployment position and a mitral valve deployment position.

[0172] Example 19. The assembly of any example disclosed herein, particularly examples 1-18, wherein the radiopaque markers comprise one or more of tantalum, iodine, barium, barium sulfate, tantalum, bismuth, or gold.

[0173] Example 20. The assembly of any example disclosed herein, particularly examples 1-19, wherein prosthetic heart valve is in the compressed configuration on the central portion of the balloon and the array is located axially between an inflow end and an outflow end of the frame of the prosthetic heart valve.

[0174] Example 21. The assembly of any example disclosed herein, particularly example 20, wherein the array comprises at least two markers that located axially between and spaced axially from the inflow end and the outflow end of the frame.

[0175] Example 21. A delivery apparatus for an expandable prosthetic heart valve comprising: a shaft; a balloon mounted to a distal end portion of the shaft; and a radiopaque marker array coupled to the shaft within the balloon in a valve mounting portion of the delivery apparatus, the valve mounting portion configured to have the prosthetic heart valve mounted thereon in the compressed configuration, the radiopaque marker array comprising a plurality of radiopaque markers that are sized and spaced to define a plurality of locators that each correspond to a specified deployment position for the prosthetic heart valve within a host structure.

[0176] Example 22. The delivery apparatus of any example disclosed herein, particularly example 21, wherein the balloon comprising a distal portion, proximal portion, and a central portion disposed between the distal portion and the proximal portion, wherein the radiopaque marker array is within the central portion of the balloon.

[0177] Example 23. The delivery apparatus of any example disclosed herein, particularly examples 21 or 22, wherein each of the locators in the radiopaque marker array is alignable relative to a portion of the host structure while the prosthetic heart valve is in the compressed configuration on the valve mounting portion of the delivery apparatus such that when the compressed prosthetic heart valve is radially expanded to the expanded configuration, the radially expanded prosthetic heart valve is implanted in the host structure at the specified deployment position.

[0178] Example 24. The delivery apparatus of any example disclosed herein, particularly examples 21-23, wherein the plurality of radiopaque markers comprises three to ten markers. [0179] Example 25. The delivery apparatus of any example disclosed herein, particularly examples 21-24, wherein the plurality of radiopaque markers comprises four markers.

[0180] Example 26. The delivery apparatus of any example disclosed herein, particularly examples 21-24, wherein the plurality of radiopaque markers comprises five markers.

[0181] Example 27. The delivery apparatus of any example disclosed herein, particularly examples 21-26, wherein the radiopaque markers in the radiopaque marker array are each equal in width.

[0182] Example 28. The delivery apparatus of any example disclosed herein, particularly example 27, wherein a width of each of the radiopaque markers is in a range of 0.5 mm to 3 mm.

[0183] Example 29. The delivery apparatus of any example disclosed herein, particularly example 28, wherein the width of each of the radiopaque markers is 1.0 mm.

[0184] Example 30. The delivery apparatus of any example disclosed herein, particularly example 28, wherein the width of each of the radiopaque markers is 1.5 mm.

[0185] Example 31. The delivery apparatus of any example disclosed herein, particularly examples 21-26, wherein one of the radiopaque markers has a first width and one or more others of the radiopaque markers has a second width, wherein the first width is greater than the second width.

[0186] Example 32. The delivery apparatus of any example disclosed herein, particularly example 31, wherein the first width is in a range of 2 mm to 3 mm and the second width is in a range of 1 mm to 1.5 mm.

[0187] Example 33. The delivery apparatus of any example disclosed herein, particularly examples 31 or 32, wherein the first width is 3 mm and the second width is 1.5 mm.

[0188] Example 34. The delivery apparatus of any example disclosed herein, particularly examples 21 -33, wherein each of the radiopaque markers is equally spaced from adjacent radiopaque markers in the radiopaque marker array. [0189] Example 35. The delivery apparatus of any example disclosed herein, particularly example 34, wherein a distance between the adjacent markers is in a range of 1 mm to 1.5 mm.

[0190] Example 36. The delivery apparatus of any example disclosed herein, particularly examples 21-35, wherein the specified deployment positions defined by the plurality of landmarks comprise a higher deployment position and a lower deployment position.

[0191] Example 37. The delivery apparatus of any example disclosed herein, particularly examples 21-36, wherein the specified deployment positions defined by the plurality of landmarks comprise a 90/10 deployment position, an 80/20 deployment position, and a 70/30 deployment position.

[0192] Example 38. The delivery apparatus of any example disclosed herein, particularly examples 21-37, wherein the specified deployment positions defined by the plurality of landmarks comprise an aortic valve deployment position and a mitral valve deployment position.

[0193] Example 39. The delivery apparatus of any example disclosed herein, particularly examples 21-38, wherein the radiopaque markers comprise one or more of tantalum, iodine, barium, barium sulfate, tantalum, bismuth, or gold.

[0194] Example 40. The delivery apparatus of any example disclosed herein, particularly examples 21-39, wherein the host structure is a native heart valve, and wherein each of the landmarks defined by the radiopaque markers is alignable relative to a base portion of cusps of the native heart valve.

[0195] Example 41. The delivery apparatus of any example disclosed herein, particularly example 40, wherein each of the landmarks defined by the radiopaque markers is alignable relative to a transverse axis extending through a base portion of cusps of the native heart valve.

[0196] Example 42. A delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising: a shaft; a balloon mounted to a distal end portion of the shaft, the balloon comprising a distal portion, proximal portion, and a central portion disposed between the distal portion and the proximal portion; and a radiopaque marker array coupled to the shaft in a valve mounting portion of the delivery apparatus within the central portion of the balloon, the valve mounting portion configured to have the prosthetic heart valve mounted thereon in a radially compressed configuration, the radiopaque marker array comprising a plurality of radiopaque markers that are sized and spaced to define a plurality of locators that are indicative a plurality of deployment positions for the prosthetic heart valve; wherein each of the locators is alignable relative to a portion of a host structure while the prosthetic heart valve is in the compressed configuration on the valve mounting portion of the delivery apparatus such that radially expanding the prosthetic heart valve results in the radially expanded prosthetic heart valve being implanted in the host structure at a selected one of the plurality of deployment positions.

[0197] Example 43. The delivery apparatus of any example disclosed herein, particularly example 42, wherein the plurality of radiopaque markers comprises three to ten markers. [0198] Example 44. The delivery apparatus of any example disclosed herein, particularly examples 42 or 43, wherein the plurality of radiopaque markers comprises four markers. [0199] Example 45. The delivery apparatus of any example disclosed herein, particularly examples 42 or 43, wherein the plurality of radiopaque markers comprises five markers.

[0200] Example 46. The delivery apparatus of any example disclosed herein, particularly examples 42-45, wherein the radiopaque markers in the radiopaque marker array are each equal in width.

[0201] Example 47. The delivery apparatus of any example disclosed herein, particularly example 46, wherein a width of each of the radiopaque markers is in a range of 0.5 mm to 3 mm.

[0202] Example 48. The delivery apparatus of any example disclosed herein, particularly example 47, wherein the width of each of the radiopaque markers is 1.0 mm.

[0203] Example 49. The delivery apparatus of any example disclosed herein, particularly example 47, wherein the width of each of the radiopaque markers is 1.5 mm.

[0204] Example 50. The delivery apparatus of any example disclosed herein, particularly examples 42-49, wherein one of the radiopaque markers has a first width and one or more others of the radiopaque markers has a second width, the first width greater width than the second width.

[0205] Example 51. The delivery apparatus of any example disclosed herein, particularly example 50, wherein the first width is in a range of 2 mm to 3 mm and the second width is in a range of 1 mm to 1 .5 mm.

[0206] Example 52. The delivery apparatus of any example disclosed herein, particularly examples 50 or 51, wherein the first width is 3 mm and the second width is 1.5 mm. [0207] Example 53. The delivery apparatus of any example disclosed herein, particularly examples 42-52, wherein each of the radiopaque markers is equally spaced from adjacent ones of the radiopaque markers in the radiopaque marker array.

[0208] Example 54. The delivery apparatus of any example disclosed herein, particularly example 53, wherein a distance between the adjacent radiopaque markers is in a range of 1 mm to 1.5 mm.

[0209] Example 55. The delivery apparatus of any example disclosed herein, particularly examples 42-54, wherein the specified deployment positions defined by the plurality of locators comprise a higher deployment position and a lower deployment position.

[0210] Example 56. The delivery apparatus of any example disclosed herein, particularly examples 42-55, wherein the specified deployment positions defined by the plurality of locators comprise a 90/10 deployment position, an 80/20 deployment position, and a 70/30 deployment position.

[0211] Example 57. The delivery apparatus of any example disclosed herein, particularly examples 42-56, wherein the specified deployment positions defined by the plurality of locators comprise first deployment position for a first native heart valve and a second deployment position for a second, different native heart valve.

[0212] Example 58. A delivery apparatus for a prosthetic heart valve, the delivery apparatus comprising: a shaft; a balloon mounted to a distal end portion of the shaft, the balloon comprising a distal portion, proximal portion, and a central portion disposed between the distal portion and the proximal portion; and a valve mounting portion corresponding to a central portion of the balloon and configured to have the prosthetic heart valve mounted thereon in a radially compressed configuration; means for positioning the compressed prosthetic heart valve mounted on the valve mounting portion during delivery of the prosthetic heart valve such that radially expanding the prosthetic heart valve results in the radially expanded prosthetic heart valve being implanted in a host structure at a selected one of a plurality of deployment positions.

[0213] Example 59. The delivery apparatus of any example disclosed herein, particularly example 58, wherein the means for positioning the compressed prosthetic heart valve comprises a radiopaque marker array coupled to the shaft in a valve mounting portion of the delivery apparatus within the central portion of the balloon. [0214] Example 60. A method of implanting a prosthetic heart valve, the method comprising: inserting a distal end portion of a delivery apparatus into vasculature of patient, the distal end portion of the delivery apparatus comprising a distal portion of a shaft, a balloon mounted to the distal end portion of the shaft, a valve mounting portion corresponding to a central portion of the balloon, and a radiopaque marker array coupled to the distal portion of the shaft, and wherein the prosthetic heart valve is mounted on the valve mounting portion in a radially compressed configuration; delivering the radially compressed prosthetic heart valve to a host structure; visualizing the radiopaque marker array and the host structure; aligning one or more markers in the radiopaque marker array relative to a portion of the host structure; and when a selected locator on the one or more markers is aligned relative to the portion of the host structure, transitioning the prosthetic heart valve from the radially compressed configuration to a radially expanded configuration such that the prosthetic heart valve is implanted at a selected one of a plurality of deployment positions within the host structure.

[0215] Example 61. A method of treating a heart on a simulation comprising the steps of claim 60.

[0216] Example 62. A method comprising sterilizing the prosthetic heart valve, apparatus, and/or assembly of any example.

[0217] Example 63. An assembly or a delivery apparatus of any one of Examples 1-59, wherein the assembly or the delivery apparatus is sterilized.

[0218] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0219] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

WE CLAIM:

1. An assembly comprising: an implantable prosthetic heart valve that is radially compressible to a compressed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising an annular frame and a valve structure disposed with the frame; and a delivery apparatus comprising: a shaft; a balloon mounted to a distal end portion of the shaft, the balloon comprising a distal portion, proximal portion, and a central portion disposed between the distal portion and the proximal portion; and a radiopaque marker array coupled to the shaft in a valve mounting portion of the delivery apparatus within the central portion of the balloon, the radiopaque marker array comprising a plurality of radiopaque markers that are indicative of a plurality of deployment positions for the prosthetic heart valve; and wherein each of the radiopaque markers of the radiopaque marker array is alignable relative to a portion of a host structure while the prosthetic heart valve is in the compressed configuration on the valve mounting portion of the delivery apparatus such that when the compressed prosthetic heart valve is radially expanded to the expanded configuration, the radially expanded prosthetic heart valve is implanted in the host structure at a selected one of the plurality of deployment positions.

2. The assembly of claim 1, wherein the radiopaque markers in the radiopaque marker array are sized and spaced to define a plurality of locators that each correspond to one of the plurality of deployment positions.

3. The assembly of claim 2, wherein each of the locators is alignable relative to the portion of the host structure for deployment of the prosthetic valve at a corresponding one of the plurality of deployment positions.

4. The assembly of any of claims 1-3, wherein the plurality of radiopaque markers in the radiopaque marker array comprises three to ten markers.

5. The assembly of any of claims 1-4, wherein the radiopaque markers in the radiopaque marker array are each equal in width.

6. The assembly of claim 5, wherein a width of each of the radiopaque markers is in a range of 0.5 mm to 3 mm.

7. The assembly of any of claims 1-4, wherein one of the radiopaque markers has a first width and one or more others of the radiopaque markers has a second width, wherein the first width is greater than the second width.

8. The assembly of claim 7, wherein the first width is in a range of 2 mm to 3 mm and the second width is in a range of 1 mm to 1.5 mm.

9. The assembly of either of claim 7 or claim 8, wherein the first width is 3 mm and the second width is 1.5 mm.

10. The assembly of any of claims 1-9, wherein each of the radiopaque markers is equally spaced from adjacent ones of the radiopaque markers in the radiopaque marker array.

11. The assembly of claim 10, wherein a distance between the adjacent radiopaque markers is in a range of 1 mm to 1.5 mm.

12. The assembly of any one of claims 1-11, wherein prosthetic heart valve is in the compressed configuration on the central portion of the balloon and the array is located axially between an inflow end and an outflow end of the frame of the prosthetic heart valve.

13. A delivery apparatus for an expandable prosthetic heart valve comprising: a shaft; a balloon mounted to a distal end portion of the shaft; and a radiopaque marker array coupled to the shaft in a valve mounting portion of the delivery apparatus, the valve mounting portion configured to have the prosthetic heart valve mounted thereon in the compressed configuration, the radiopaque marker array comprising a plurality of radiopaque markers that are sized and spaced to define a plurality of locators that each correspond to a specified deployment position for the prosthetic heart valve within a host structure.

14. The delivery apparatus of claim 13, wherein the balloon comprising a distal portion, proximal portion, and a central portion disposed between the distal portion and the proximal portion, wherein the radiopaque marker array is within the central portion of the balloon.

15. The delivery apparatus of either of claim 13 or claim 14, wherein each of the locators in the radiopaque marker array is alignable relative to a portion of the host structure while the prosthetic heart valve is in the compressed configuration on the valve mounting portion of the delivery apparatus such that when the compressed prosthetic heart valve is radially expanded to the expanded configuration, the radially expanded prosthetic heart valve is implanted in the host structure at the specified deployment position.

16. The delivery apparatus of any one of claims 13-15, wherein the specified deployment positions defined by the plurality of landmarks comprise a higher deployment position and a lower deployment position.

17. The delivery apparatus of any one of claims 13-16, wherein the specified deployment positions defined by the plurality of landmarks comprise a 90/10 deployment position, an 80/20 deployment position, and a 70/30 deployment position.

18. The delivery apparatus of any one of claims 13-17, wherein the specified deployment positions defined by the plurality of landmarks comprise an aortic valve deployment position and a mitral valve deployment position.

19. The delivery apparatus of any one of claims 13-18, wherein the host structure is a native heart valve, and wherein each of the landmarks defined by the radiopaque markers is alignable relative to a base portion of cusps of the native heart valve.

20. A method of implanting a prosthetic heart valve, the method comprising: inserting a distal end portion of a delivery apparatus into vasculature of patient, the distal end portion of the delivery apparatus comprising a distal portion of a shaft, a balloon mounted to the distal end portion of the shaft, a valve mounting portion corresponding to a central portion of the balloon, and a radiopaque marker array coupled to the distal portion of the shaft, and wherein the prosthetic heart valve is mounted on the valve mounting portion in a radially compressed configuration; delivering the radially compressed prosthetic heart valve to a host structure; visualizing the radiopaque marker array and the host structure; aligning one or more markers of the radiopaque marker array relative to a portion of the host structure; and while the one or more markers is aligned relative to the portion of the host structure, transitioning the prosthetic heart valve from the radially compressed configuration to a radially expanded configuration such that the prosthetic heart valve is implanted at a selected one of a plurality of deployment positions within the host structure.