Harmonizing markers for delivery systems

Abstract

An implant delivery system for delivering a replacement heart valve implant to a natural heart valve may include an elongated shaft assembly containing an implant holder configured to restrain the replacement heart valve implant in a radially folded configuration. The elongated shaft assembly may include a plurality of longitudinal marker elements configured to be visible under fluorescence fluoroscopy using an imaging device. The plurality of longitudinal marker elements are configured to rotate the commissure posts of the replacement heart valve implant with the natural valve commissures of the natural heart valve under fluorescence fluoroscopy using an imaging device, once the replacement heart valve implant has transitioned to a radially expanded configuration within the natural heart valve.

Description

Technical Field

[0001] The present disclosure generally relates to medical devices, and more specifically to medical devices adapted for implanting stents and medical devices including stent components.

Background Art

[0002] [[ID=十二]]A variety of implantable medical devices for medical use have been developed, including artificial heart valves for the repair or replacement of diseased heart valves. The artificial heart valve needs to be accurately aligned with the native valve annulus during implantation. Known medical devices and methods each have specific advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and using medical devices.

Summary of the Invention

[0003] In one example, an implant delivery system for delivering a replacement heart valve implant to a native heart valve includes a elongate shaft assembly including an implant holder, which may include a proximal sheath and a distal sheath. The implant holder may be configured to radially constrain the replacement heart valve implant in a folded configuration. The elongate shaft assembly may include a plurality of longitudinal marker elements configured to be visible under fluoroscopy using an imaging device. The plurality of longitudinal marker elements may be configured to align a plurality of commissural posts of the replacement heart valve implant with a plurality of native valve commissures of the native heart valve in a rotational direction under fluoroscopy using an imaging device when the replacement heart valve implant transitions to a radially expanded configuration within the native heart valve.

[0004] In addition to, or alternatively to, any example disclosed herein, the plurality of longitudinal marker elements are oriented parallel to the central longitudinal axis of the elongate shaft assembly. In addition to or as an alternative to any examples disclosed herein, a plurality of longitudinal marker elements are arranged radially outward from the inner shaft of a slender shaft assembly.

[0005] In addition to or as an alternative to any examples disclosed herein, a plurality of longitudinal marker elements are arranged circumferentially and equally spaced from one another around the central longitudinal axis of a long shaft assembly.

[0006] In addition to, or as an alternative to, any example disclosed herein, an elongated shaft assembly includes a stent holder configured to engage with an expandable framework of a replacement heart valve implant in a radially folded configuration.

[0007] In addition to or as an alternative to any examples disclosed herein, the plurality of longitudinal marker elements include a plurality of fingers extending distally from the body of the stent holder. In addition to or as an alternative to any examples disclosed herein, the plurality of fingers may include exactly three fingers.

[0008] In addition to or as an alternative to any examples disclosed herein, a longitudinal shaft assembly includes at least one fluorescently transparent component positioned radially outward of a plurality of longitudinal marker elements and radially inward of the distal sheath.

[0009] In addition to, or as an alternative to, any of the examples disclosed herein, multiple longitudinal marker elements are visible only under fluorescence projection. In addition to, or as an alternative to, any examples disclosed herein, a plurality of longitudinal marker elements are arranged longitudinally spaced from a replacement heart valve implant in a radially folded configuration.

[0010] In addition to or as an alternative to any examples disclosed herein, multiple longitudinal marker elements are positioned distal to the replacement heart valve implant when the replacement heart valve implant is constrained in a radially folded form within the implant retainer.

[0011] In addition to, or as an alternative to, any example disclosed herein, an implant delivery system for delivering a replacement heart valve implant to a natural heart valve may include an elongated shaft assembly comprising an outer tubular member, an inner shaft, and an implant retainer. The implant retainer may be configured to restrain the replacement heart valve implant in a radially folded form. The elongated shaft assembly may include a stent holder configured to engage with the distal portion of an expandable framework of the replacement heart valve implant when the replacement heart valve implant is restrained within the implant retainer of the implant delivery system, and a plurality of longitudinal marker elements extending distally from the distal end of the stent holder, configured to be visible under fluorescence imaging using an imaging device. The plurality of longitudinal marker elements may include a first longitudinal marker element, a second longitudinal marker element, and a third longitudinal marker element arranged circumferentially and equally spaced from one another around the central longitudinal axis of the elongated shaft assembly. Multiple longitudinal marker elements may be configured to rotate the commissure posts of the replacement heart valve implant with the natural valve commissures of the natural heart valve under fluorescence imaging, when the replacement heart valve implant transitions to a radially expanded form within the natural heart valve.

[0012] In addition to or as an alternative to any examples disclosed herein, the implant retainer includes a proximal sheath positioned around the inner shaft of an elongated shaft assembly and a distal sheath positioned around the inner shaft of an elongated shaft assembly. The proximal sheath is fixedly attached to an outer tubular member, and the distal sheath is fixedly attached to the inner shaft.

[0013] In addition to or as an alternative to any examples disclosed herein, the stent holder is fixedly mounted to an intermediate tubular member positioned radially inward of the outer tubular member and radially outward of the inner shaft. The inner shaft and the outer tubular member are each independently movable axially relative to the intermediate tubular member.

[0014] In addition to or as an alternative to any examples disclosed herein, a method for delivering a replacement heart valve implant to a natural heart valve may include: configuring an imaging device to generate a view of the three leaflets of the natural heart valve at a first position and a view of the leaflet overlap of the natural heart valve at a second position; advancing an implant delivery system to a position adjacent to the natural heart valve such that the replacement heart valve implant is constrained within the implant retaining portion of the implant delivery system; imaging the implant delivery system adjacent to the natural heart valve using the imaging device to determine the initial orientation of the replacement heart valve implant relative to the natural heart valve by the relative positioning of a plurality of longitudinal marker elements of the implant delivery system within the natural heart valve; rotating the implant delivery system in place to position the replacement heart valve implant in a desired final orientation by aligning the plurality of longitudinal marker elements with a plurality of natural commissures of the natural heart valve; and positioning the replacement heart valve implant within the natural heart valve with the plurality of commissure posts of the replacement heart valve rotated relative to the plurality of natural commissures of the natural heart valve.

[0015] In addition to or as an alternative to any examples disclosed herein, imaging the implant delivery system adjacent to the natural heart valve in order to determine the initial orientation of a replacement heart valve implant relative to the natural heart valve includes imaging the implant delivery system and the natural heart valve in three leaflet views, and switching to a leaflet overlap view to determine the rotational direction of the implant delivery system required to position the replacement heart valve implant in the desired final orientation with as few rotations as possible.

[0016] In addition to or as an alternative to any examples disclosed herein, the method may further include switching back to a three-leaflet view before placing the replacement heart valve implant.

[0017] In addition to or in lieu of any examples disclosed herein, an implant delivery system includes an elongated shaft assembly comprising an implant retainer and a stent holder, the stent holder configured to engage with an expandable framework of a replacement heart valve implant when the replacement heart valve implant is confined within the implant retainer of the implant delivery system. The stent holder comprises a plurality of longitudinal marker elements.

[0018] In addition to or as an alternative to any examples disclosed herein, rotating the implant delivery system in place includes rotating the implant delivery system by 60 degrees or less around the central longitudinal axis of the elongated shaft assembly of the implant delivery system.

[0019] In addition to, or as an alternative to, any example disclosed herein, in a desired final orientation, one of the multiple longitudinal marker elements is positioned further away from the non-coronary leaflets of the natural heart valve than the other marker elements of the multiple longitudinal marker elements in the leaflet overlap view.

[0020] The above summary of some embodiments, aspects, and / or examples is not intended to describe each embodiment or all implementations disclosed in this disclosure. The following drawings and “Modes for Carrying Out the Invention” illustrate these embodiments more specifically. [Brief explanation of the drawing]

[0021] This disclosure can be better understood by considering the following "Modes for Carrying Out the Invention" in relation to the attached drawings. [Figure 1]FIG. 1 is a partial cutaway view showing a selected aspect of a replacement heart valve implant positioned within a native heart valve of the heart. [Figure 2] FIG. 2 is a partial cross-sectional view along line 2-2 of FIG. 1 showing a selected aspect of the heart. [Figure 3] FIG. 3 shows a selected aspect of a delivery system for delivering a replacement heart valve implant. [Figure 4] FIG. 4 is a partial cross-sectional view showing a selected aspect of a portion of the delivery system according to the present disclosure. [Figure 5] FIG. 5 shows a selected aspect of a stent holder of the delivery system according to the present disclosure. [Figure 6] FIG. 6 shows a selected aspect of the delivery system according to the present disclosure. [Figure 7] FIG. 7 is a fluoroscopic image showing a selected aspect of the delivery system according to the present disclosure. [Figure 8A] FIG. 8A is a three-cusp view of the native heart valve schematically showing the relative positioning of the delivery system and selected aspects of the native heart valve during delivery of a replacement heart valve implant to the native heart valve. [Figure 8B] FIG. 8B is a cusp overlap view of the native heart valve schematically showing the relative positioning of the delivery system and selected aspects of the native heart valve during delivery of a replacement heart valve implant to the native heart valve. [Figure 8C] FIG. 8C is a schematic view corresponding to the views of FIGS. 8A and 8B during delivery of a replacement heart valve implant to the native heart valve. [Figure 9A] FIG. 9A is a three-cusp view of the native heart valve schematically showing the relative positioning of the delivery system and selected aspects of the native heart valve during delivery of a replacement heart valve implant to the native heart valve. [Figure 9B] FIG. 9B is a cusp overlap view of the native heart valve schematically showing the relative positioning of the delivery system and selected aspects of the native heart valve during delivery of a replacement heart valve implant to the native heart valve. [Figure 9C]Figure 9C is a schematic diagram corresponding to the views in Figures 9A and 9B during the delivery of a replacement heart valve implant to a natural heart valve. [Modes for carrying out the invention]

[0022] The embodiments of this disclosure may be subject to various modifications and alternative forms, the details of which are shown in the drawings as examples and described in detail. However, it should be understood that this is not intended to limit the embodiments to any particular set of embodiments illustrating the embodiments of this disclosure. On the contrary, it is intended to cover all modifications, equivalents, and alternative forms that fall within the spirit and scope of this disclosure.

[0023] The following description should be read with reference to the drawings, which are not necessarily to scale, but similar reference numerals indicate similar elements in several figures. The detailed description and drawings are intended to be illustrative and not limit the disclosure. Those skilled in the art will recognize that various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of this disclosure. The modes and drawings for carrying out the invention illustrate exemplary embodiments of this disclosure.

[0024] The following definitions of terms shall apply unless otherwise given in a claim or herein. All numerical values, whether explicitly stated or not, are assumed to be modified by the term “approximately.” In the context of numerical values, “approximately” generally refers to a range of numerical values ​​that a person skilled in the art would consider to be equal to the stated value (e.g., having the same function or result). In many examples, “approximately” includes multiple numerical values ​​rounded to the nearest significant figure. Any other use of the term “approximately” (e.g., in a non-numerical context) is assumed, unless explicitly stated, to have a general and customary definition that can be understood and is consistent with the context of this Specified Publication.

[0025] When specifying a numerical range with an endpoint, all numbers within that range, including the endpoint, are included (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0026] While several preferred dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, a person skilled in the art inspired by this disclosure will understand that desired dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0027] When used herein and in the appended claims, the singular forms “a,” “an,” and “the” include multiple references unless the context clearly indicates otherwise. When used herein and in the appended claims, the term “or” is generally used to include “and / or” unless the context clearly indicates otherwise. For ease of understanding, note that some features of this disclosure may be described in the singular form even if they may be multiple or repeated within the embodiments in which they are disclosed. Each example of a feature includes and / or may be encompassed by a singular disclosure unless the opposite is explicitly stated. For example, a reference to a feature may also apply to all other instances and quantities of that feature unless the opposite is explicitly stated. Therefore, it should be understood that the following descriptions may also apply to any and / or all components that are multiple within a device, etc., unless the opposite is explicitly stated.

[0028] Relative terms such as “proximal,” “distal,” “forward,” “backward,” and their variations may generally be considered in relation to the position, orientation, and / or movement of various elements of the apparatus with respect to the user / operator / manipulator. “Proximal” and “backward” indicate or refer to being closer to or toward the user, while “distal” and “forward” indicate or refer to being further away from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of this disclosure, and in such cases, will be readily apparent to those skilled in the art. Other relative terms such as “upstream,” “downstream,” “inflow,” and “outflow” refer to the direction of fluid flow within a lumen, such as a body lumen, a blood vessel, or within an apparatus. Yet other relative terms and / or their variations, such as “axial,” “circumferential,” “longitudinal,” “lateral,” and “radial,” generally refer to the direction and / or orientation with respect to the central longitudinal axis of the disclosed structure or apparatus.

[0029] The term “range” may be understood to mean the maximum measurement of a stated or specified dimension unless it is preceded by “minimum” or specifically identified as “minimum,” where “minimum” may be understood to mean the minimum measurement of the stated or identified dimension. For example, the term “outer range” may be understood to mean the outer dimension, the term “radial range” may be understood to mean the radial dimension, and the term “longitudinal range” may be understood to mean the longitudinal range. The examples of “range” are all different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and can be understood from the context in which they are used by a person skilled in the art. In general, “range” may be considered to be the maximum possible dimension measured according to the intended use, while the term “minimum range” may be considered to be the minimum possible dimension measured according to the intended use. In some examples, “range” is measured orthogonally within a plane and / or cross-section, but may also be measured obliquely, radially, circumferentially (e.g., along an arc), etc., as is evident from the specific context.

[0030] The terms “monolithic” and “integrated” generally refer to one or more elements made from or consisting of a single structure or basic unit / element. Monolithic elements and / or integrated elements shall exclude structures and / or features made by assembling or otherwise joining together multiple separate structures or elements.

[0031] The descriptions in the specification such as "embodiments," "several embodiments," and "another embodiment" mean that the described embodiments possess a particular element, structure, or characteristic, but not all embodiments necessarily possess that particular element, structure, or characteristic. Furthermore, such phrasing does not necessarily refer to the same embodiment. Moreover, if a particular element, structure, or characteristic is described in relation to a certain embodiment, it is within the knowledge of a person skilled in the art to relate that particular element, structure, or characteristic to another embodiment, regardless of whether it is explicitly stated or not, unless it is clearly denied. In other words, even if the various elements described below are not explicitly stated in a particular combination, a person skilled in the art will understand that they can be combined or configured to form another additional embodiment or to complement or improve the described embodiments.

[0032] For clarity, specific identification numbering schemes (e.g., 1st, 2nd, 3rd, 4th, etc.) may be used throughout this specification and / or claims to name or distinguish features described in the specification or features described in the claims. Numerical naming should be understood as illustrative only and not restrictive. In some embodiments, changes or deviations from previously used numerical naming may be made for the purpose of brevity and clarity. That is, a feature previously identified as the "1st" element may later be called the "2nd" element, the "3rd" element, or be completely omitted, and / or a different feature may be called the "1st" element. The meaning and naming in each example will be understandable to those skilled in the art.

[0033] In addition, it should be noted that in any given figure, some features may be omitted or schematically represented for clarity and / or simplification. Additional details regarding some components and / or method steps may be illustrated in more detail in other figures. The devices and / or methods disclosed herein may offer several desirable features and advantages, as will be described in more detail below.

[0034] Figure 1 shows a schematic partial section of a patient's heart 10, including an aortic valve 12 having native valve leaflets 14 located within and / or extending from the natural annulus, a left ventricle 16, and a specific connecting vascular system, the specific connecting vascular system being the aorta 20 connected to the aortic valve 12 of the patient's heart 10 via the aortic arch 22, the left coronary artery 24, the right coronary artery 25, and other aortas 26 (e.g., subclavian artery, carotid artery, brachiocephalic artery) extending from the aortic arch 22 to important internal organs. For the purposes of this disclosure, the description herein is intended for use in treating natural heart valves such as the aortic valve 12, and is described so for brevity. However, this is not intended to limit it, and those skilled in the art will recognize that the following description is also applicable to other heart valves, blood vessels, and / or treatment sites in a patient without any or minimal modification to the structure and / or scope of the disclosure.

[0035] Figure 1 further illustrates a selected embodiment of a replacement heart valve implant 100 placed within a natural heart valve (e.g., aortic valve 12). It should be understood that the replacement heart valve implant 100 can be any type of replacement heart valve (e.g., mitral valve, aortic valve, etc.). When in use, the replacement heart valve implant 100 can be implanted into the heart of a mammal (e.g., surgically or by percutaneous delivery using a catheter). The replacement heart valve implant 100 may be configured to allow unidirectional flow through the replacement heart valve implant 100 from the inlet end to the outlet end.

[0036] The replacement heart valve implant 100 may include an expandable framework 110 that forms a central lumen. In some embodiments, the expandable framework 110 may have a substantially circular cross-section. In some embodiments, the expandable framework 110 may have a non-circular (e.g., D-shaped, elliptical, etc.) cross-section. Some suitable but non-limiting examples of materials that may be used to form the expandable framework 110 (including, but not limited to, metals and metal alloys, composites, ceramics, polymers, etc.) are described below. The replacement heart valve implant 100 and / or the expandable framework 110 may be configured to transition between a radially collapsed form and a radially expanded form. In some embodiments, the expandable framework 110 may be self-expanding. In some embodiments, the expandable framework 110 may be self-biased toward a radially expanded form. In some embodiments, the expandable framework 110 may be mechanically expandable. In some embodiments, the expandable framework 110 may be an expandable balloon. Other configurations, including combinations thereof, are also contemplated.

[0037] In some embodiments, the expandable framework 110 may define a lower crown 112 adjacent to and / or at the inlet end, an upper crown 114 adjacent to and / or at the outlet end, and a plurality of stabilization arches 116 extending downstream from the outlet end. In some embodiments, the plurality of stabilization arches 116 may extend downstream of the upper crown 114 and / or away from the upper crown 114 in the opposite direction to the lower crown 112. In some embodiments, the upper crown 114 may be positioned longitudinally and / or axially between the lower crown 112 and the plurality of stabilization arches 116. The expandable framework 110 may define a central lumen extending through the expandable framework 110.

[0038] In some embodiments, the replacement heart valve implant 100 may include a proximal and a distal portion. In some embodiments, the orientation of the replacement heart valve implant 100 may relate to the direction of implantation relative to the implant delivery system 30 and / or the target site (e.g., the natural heart valve). In some embodiments, the proximal portion may include an outflow end and / or a plurality of stabilizing arches 116. In some embodiments, the proximal portion may include an upper crown 114. In some embodiments, the distal portion may include an inflow end and / or a lower crown 112. Other configurations are also conceivable.

[0039] In some embodiments, the replacement heart valve implant 100 may include a plurality of valve leaflets 120 positioned within the central lumen. The plurality of valve leaflets 120 may be connected to, fixed to, and / or fixedly mounted to an expandable framework 110 at a plurality of posts 122 so as to form and / or define a plurality of commissures. The plurality of valve leaflets 120 may be configured to move between an open position and a closed position. The plurality of valve leaflets 120 may be configured to substantially restrict the flow of fluid through the replacement heart valve implant 100 in the closed position. The plurality of valve leaflets 120 may move away from each other and / or radially outward within the central lumen in the open position to allow fluid to flow through the replacement heart valve implant 100 and / or the central lumen.

[0040] In some embodiments, the multiple valve leaflets 120 may be composed of a polymer (e.g., a thermoplastic polymer). In some embodiments, the multiple valve leaflets 120 may contain at least 50% by weight of polymer. In some embodiments, the multiple valve leaflets 120 may be formed from bovine pericardium or other biological tissue. Other configurations and / or materials are also intended.

[0041] In some embodiments, the replacement heart valve implant 100 may include an inner skirt positioned on and / or extending along the inner surface of an expandable framework 110. In at least some embodiments, the inner skirt may be fixedly attached to the expandable framework 110. The inner skirt can direct fluids, such as blood, flowing through the replacement heart valve implant 100 toward the valve leaflets 120. In at least some embodiments, the inner skirt may be fixedly attached to and / or integrally formed with the valve leaflets 120. The inner skirt can ensure that fluids flow through the central lumen of the replacement heart valve implant 100 and that fluids do not flow around the valve leaflets 120 when the valve leaflets 120 are in the closed position.

[0042] In some embodiments, the replacement heart valve implant 100 may be positioned on the outer surface of an expandable framework 110 and / or include an outer skirt extending along its outer surface. In some embodiments, the outer skirt may be positioned on the lower crown and / or adjacent to the lower crown. The outer skirt can ensure that fluid flows through the replacement heart valve implant 100 and not around it (e.g., between the expandable framework 110 and the vascular wall).

[0043] In some embodiments, the inner and / or outer skirts may contain a polymer and / or at least 50 weight percent of a polymer. In some embodiments, the inner and / or outer skirts may be substantially impermeable to fluids. In some embodiments, the inner and / or outer skirts may be formed from a thin tissue (e.g., bovine pericardium), a coated woven material, or a non-porous and / or impermeable woven material. Other configurations are also considered. Some suitable but non-limiting examples of materials that may be used to form the inner and / or outer skirts (including, but not limited to, polymers, composite materials, etc.) are described below.

[0044] In some embodiments, the inner skirt and / or outer skirt may seal one, some, some, or each of the interstices formed in the expandable framework 110. In at least some embodiments, sealing the interstices may be considered as preventing fluid from flowing through the interstices in the expandable framework 110. In some embodiments, the inner skirt and / or outer skirt may be attached to the expandable framework 110 by one or more methods, including but not limited to ligation with sutures or filaments, adhesive bonding, fusion bonding, embedding or overmolding, welding, etc.

[0045] In some embodiments, the expandable framework 110 and / or replacement heart valve implant 100 may have an outer diameter of approximately 23 mm, 25 mm, 27 mm, or 30 mm in an unconstrained configuration (e.g., radially expanded configuration). In some embodiments, the expandable framework 110 and / or replacement heart valve implant 100 may have an outer diameter of approximately 10 mm, 9 mm, 8 mm, 7 mm, or 6 mm in a radially folded configuration. Other configurations are also contemplated.

[0046] Figure 2 is a partial cross-sectional view showing a selected embodiment of a native heart valve (e.g., aortic valve 12) obtained along line 2-2 in Figure 1. As shown in Figure 2, the aorta 20 may include and / or form three cusps in the vicinity of and / or immediately downstream of a plurality of native valve leaflets 14. The three leaflets are the left coronary artery leaflet L, the right coronary artery leaflet R, and the non-coronary artery leaflet N. The left coronary artery leaflet L, the right coronary artery leaflet R, and the non-coronary artery leaflet N may form and / or have a similar shape to three lobes that meet at a plurality of native valve commissures 18. The plurality of native valve leaflets 14 meet at a plurality of native valve commissures 18. The left coronary artery 24 opens into and / or extends from the left coronary artery leaflet L. The right coronary artery 25 opens into or extends from the right coronary valve leaflet R. No coronary arteries are present in the non-coronary valve leaflet N. For reference, the post (reference numeral 122) visible in the front view in Figure 1 may be located between the left coronary valve leaflet L and the right coronary valve leaflet R in Figure 2, and / or adjacent to a number of natural valve commissures (reference numeral 18) formed by the left coronary valve leaflet L and the right coronary valve leaflet R (other locations are also included).

[0047] Figures 3 and 4 show selected embodiments of a heart valve replacement system, including a heart valve replacement implant 100 and an implant delivery system 30 for delivering the heart valve replacement implant to a natural heart valve (e.g., the aortic valve 12). The implant delivery system 30 may be compatible with and / or usable with the heart valve replacement implant 100. Note that Figure 3 includes at least one scale change (e.g., not all parts of the figure are drawn at the same scale) to improve visibility and to show additional details of the selected embodiment of the implant delivery system 30. In addition, the expandable framework 110 is shown in Figure 3 in a radially folded form, although some elements of the heart valve replacement implant 100 are not shown for clarity. In Figure 4, the heart valve replacement implant 100 is omitted.

[0048] The implant delivery system 30 may include a handle 40 and an elongated shaft assembly 50 extending distally from the handle 40. The handle 40 may include a first end 42 and a second end 44 opposite to the first end 42. The elongated shaft assembly 50 may extend distally from the second end 44 of the handle 40. The handle 40 may include one or more rotatable knobs. In some embodiments, one or more rotatable knobs may include a first rotatable knob and a second rotatable knob. In at least some embodiments, the first rotatable knob and / or the second rotatable knob may be configured to rotate about the central longitudinal axis of the implant delivery system 30 and / or the handle 40.

[0049] In some embodiments, the distal portion of the implant delivery system 30 and / or elongated shaft assembly 50 may include an implant retainer 60 configured to engage with a replacement heart valve implant 100 and / or expandable framework 110 in a radially folded configuration and / or to restrain the replacement heart valve implant 100 and / or expandable framework 110 in a radially folded configuration. The elongated shaft assembly 50 may include an outer tubular member 52 extending distally from the handle 40 and an inner shaft 54 ​​(e.g., Figure 4) extending distally from the handle 40 within the outer tubular member 52 and reaching a distal tip 58 located distal to the implant retainer 60. In some embodiments, the implant retainer 60 may comprise a proximal sheath 62 and a distal sheath 64. In some embodiments, the proximal sheath 62 and / or distal sheath 64 may be formed from a polymer material. In some embodiments, the proximal sheath 62 and / or distal sheath 64 may include reinforcing structures disposed inside and / or on them. In some embodiments, the reinforcing structure may be a coil, a mesh, one or more filaments, a band, or a strip, or other suitable structure. Other configurations are also contemplated.

[0050] In some embodiments, the inner shaft 54 ​​may be slidably positioned within the lumen of the outer tubular member 52. In some embodiments, the elongated shaft assembly 50 may include an intermediate tubular member 56 positioned inside and / or radially inward of the outer tubular member 52 and around and / or radially outward of the inner shaft 54. In at least some embodiments, the inner shaft 54 ​​and the outer tubular member 52 are each independently axially translatable relative to the intermediate tubular member 56. For example, the inner shaft 54 ​​may be translated relative to the intermediate tubular member 56 without translating the outer tubular member 52 relative to the intermediate tubular member 56, and vice versa.

[0051] In some embodiments, the proximal sheath 62 may be fixedly attached to the outer tubular member 52. In some embodiments, the proximal sheath 62 may be fixedly attached to the distal end of the outer tubular member 52 and / or may extend distally from the distal end of the outer tubular member 52. In some embodiments, the distal sheath 64 and / or distal tip 58 may be fixedly attached to the inner shaft 54. In some embodiments, the distal sheath 64 may be fixedly attached to the distal tip 58. In some embodiments, the distal sheath 64 may extend proximal from the distal tip 58. In some embodiments, the inner shaft 54 ​​may include and / or at least partially define a guidewire lumen extending through the inner shaft 54. In some embodiments, the guidewire lumen may extend through the handle 40.

[0052] In some embodiments, the handle 40 may be configured to operate and / or move the proximal sheath 62 and / or distal sheath 64 relative to each other using a first rotatable knob and / or a second rotatable knob. In some embodiments, the handle 40 may be configured to operate and / or move the inner shaft 54 ​​and / or distal sheath 64 relative to the elongated shaft assembly 50, the outer tubular member 52, the intermediate tubular member 56, and / or proximal sheath 62. In some embodiments, the handle 40 may be configured to operate and / or move the outer tubular member 52 and / or proximal sheath 62 relative to the elongated shaft assembly 50, the inner shaft 54, the intermediate tubular member 56, and / or distal sheath 64.

[0053] When delivering the replacement heart valve implant 100 to a treatment site (e.g., a natural heart valve, aortic valve, etc.), the replacement heart valve implant 100 may be at least partially positioned within the proximal sheath 62 and / or distal sheath 64 in a radially folded state when the implant retainer 60 is closed. In some embodiments, the proximal sheath 62 and / or distal sheath 64 may jointly form the implant retainer 60 of the implant delivery system 30. In some embodiments, the implant retainer 60 may be configured to restrain the replacement heart valve implant 100 in a radially folded state when the implant retainer 60 is closed. In some embodiments, the replacement heart valve implant 100 may be releasably connected to an intermediate tubular member 56 and / or a stent holder 70 when the replacement heart valve implant 100 is restrained in a radially folded state within the implant retainer 60 of the implant delivery system 30.

[0054] In some embodiments, the proximal sheath 62 may be configured to cover the proximal portion of the replacement heart valve implant 100 in a radially folded configuration when the implant holder 60 is in a closed configuration, and the distal sheath 64 may be configured to cover the distal portion of the replacement heart valve implant 100 in a radially folded configuration when the implant holder 60 is in a closed configuration. In some embodiments, the replacement heart valve implant 100 and / or expandable framework 110 may be constrained to a radially folded configuration by the proximal sheath 62 and distal sheath 64 in the closed configuration of the implant holder 60. In some embodiments, the proximal sheath 62 may be positioned adjacent to the distal sheath 64 in the closed configuration. In some embodiments, the proximal sheath 62 may abut the distal sheath 64 in the closed configuration. In some embodiments, the proximal sheath 62 may be positioned axially spaced from the distal sheath 64 in the closed configuration. In some embodiments, the proximal sheath 62 may be axially spaced from the distal sheath 64 by less than 20% of the total length of the replacement valve implant 100 and / or expandable framework 110 in the closed configuration. In some embodiments, the proximal sheath 62 may be axially spaced from the distal sheath 64 by less than 15% of the total length of the replacement valve implant 100 and / or expandable framework 110 in the closed configuration. In some embodiments, the proximal sheath 62 may be axially spaced from the distal sheath 64 by less than 10% of the total length of the replacement valve implant 100 and / or expandable framework 110 in the closed configuration. In some embodiments, the proximal sheath 62 may be axially spaced from the distal sheath 64 by less than 5% of the total length of the replacement valve implant 100 and / or expandable framework 110 in the closed configuration. Other configurations are also conceivable.

[0055] In some embodiments, the implant retainer 60 and / or the elongated shaft assembly 50 may include a stent holder 70, as shown in detail in Figure 5. In at least some embodiments, the stent holder 70 may be fixedly attached to the elongated shaft assembly 50. In some embodiments, the stent holder 70 may be fixedly attached to an intermediate tubular member 56 of the elongated shaft assembly 50. In some embodiments, the stent holder 70 may be integrally formed with the elongated shaft assembly 50 and / or the intermediate tubular member 56. In some embodiments, the stent holder 70 may be configured to engage with an expandable framework 110 in a radially folded configuration and / or when the replacement heart valve implant 100 is confined within the implant retainer 60 of the implant delivery system 30. In some embodiments, the stent holder 70 may include at least one projection 73 configured to engage with the expandable framework 110 in a radially folded configuration.

[0056] The implant delivery system 30 and / or elongated shaft assembly 50 may include a primary visual indicator 68 configured and / or adapted to be visible under fluoroscopy using an imaging device. Other imaging means suitable for use in transcatheter surgical procedures are also intended. The implant delivery system 30 and / or primary visual indicator 68 may be configured in cooperation with an imaging device to position the replacement heart valve implant 100 to a desired insertion depth within a natural heart valve (e.g., aortic valve 12).

[0057] During use, the implant delivery system 30 can be advanced percutaneously through vascular structures to a position adjacent to the treatment site (e.g., the natural valve annulus). In one example, the implant delivery system 30 can be advanced through the vascular system, across the aortic arch 22, to a position adjacent to the natural heart valve (e.g., the aortic valve 12). Alternative approaches for treating defective aortic valves and / or other heart valves (one or more) are also intended with the implant delivery system 30.

[0058] The desired insertion depth may be selected to maximize the radially outward force of the expandable framework 110 within the natural heart valve (e.g., aortic valve 12). By positioning the replacement heart valve implant 100 at the desired insertion depth and / or within the maximum allowable range from the desired insertion depth, the replacement heart valve implant 100 and / or the expandable framework 110 can exhibit optimal arch formation within the natural heart valve (e.g., aortic valve 12), thereby preventing the replacement heart valve implant 100 and / or the expandable framework 110 from moving downstream (or upstream).

[0059] Positioning the replacement heart valve implant 100 and / or expandable framework 110 within the natural heart valve (e.g., aortic valve 12) can be achieved by locating the primary visual indicator 68 relative to the natural heart valve (e.g., aortic valve 12). During visualization, the natural heart valve (e.g., aortic valve 12) can be identified and / or visualized under fluoroscopy using known means and / or methods such as contrast agent injection.

[0060] Figure 4 is a partial cross-sectional view showing a selected embodiment of the implant delivery system 30 of Figure 3 according to this disclosure. For clarity, some parts of the replacement heart valve implant 100 and the implant delivery system 30 are not shown. For example, the distal sheath 64 is shown in Figure 4, but the proximal sheath 62 is not.

[0061] As shown in Figure 4, the elongated shaft assembly 50 may include a primary visual indicator 68. In some embodiments, the primary visual indicator 68 may be fixedly attached to the elongated shaft assembly 50 and / or the intermediate tubular member 56. In some embodiments, the primary visual indicator 68 may be a marker band embedded within the elongated shaft assembly 50. In some embodiments, the primary visual indicator 68 may be fixedly attached to the elongated shaft assembly 50 and / or the intermediate tubular member 56 by heat shrink tubing or adhesive elements. Other configurations are also conceivable. As described herein, the primary visual indicator 68 may be configured and / or adapted to be visible under fluorescence imaging using an imaging apparatus.

[0062] In some embodiments, the implant delivery system 30 and / or the elongated shaft assembly 50 may include a stent holder 70 configured to engage with the expandable framework 110 of the replacement heart valve implant 100 when the replacement heart valve implant 100 is confined within the implant retaining portion 60 of the implant delivery system 30 in a radially folded configuration. The stent holder 70 is shown in detail in Figure 5. As shown in Figure 5, the stent holder 70 may include a body 74, a first end 72 extending proximal to the body 74, and a second end 76 positioned opposite the first end. In some embodiments, the first end may have a substantially bulbous shape. In some embodiments, the stent holder 70 may be configured and / or adapted to be visible under fluorescence. In some embodiments, the stent holder 70 may be formed from stainless steel. Some suitable but not limited materials for the stent holder 70 and / or its components or elements are described below.

[0063] In some embodiments, the outermost radial range of the first end 72 of the stent holder 70 may be positioned close to the distal end of the first end 72 of the stent holder 70. In some embodiments, the first end 72 of the stent holder 70 may be tapered radially inward toward the proximal direction from the outermost radial range of the stent holder 70. In some embodiments, the stent holder 70 may include a lumen extending longitudinally and / or axially through the stent holder 70. In at least some embodiments, at least a portion of the elongated shaft assembly 50 may extend longitudinally and / or axially through the lumen of the stent holder 70.

[0064] The first end 72 may be configured to engage with and / or fit to the expandable framework 110 of the replacement heart valve implant 100 when it is radially folded and / or confined within the implant retaining portion 60 of the implant delivery system 30. In some embodiments, the first end 72 may include at least one projection 73 configured to engage with and / or fit to the expandable framework 110 of the replacement heart valve implant 100 when it is radially folded and / or confined within the implant retaining portion 60 of the implant delivery system 30.

[0065] In some embodiments, at least one projection 73 may be configured to engage with and / or fit with the distal portion and / or lower crown 112 of the expandable framework 110 of the replacement heart valve implant 100 when the replacement heart valve implant 100 is confined within the implant retaining portion 60 of the implant delivery system 30, in a radially folded configuration. In some embodiments, at least one projection 73 may extend radially outward from the first end 72 of the stent holder 70. In some embodiments, at least one projection 73 may be configured to extend radially outward through the expandable framework 110 of the replacement heart valve implant 100 when the replacement heart valve implant 100 is confined within the implant retaining portion 60 of the implant delivery system 30, in a radially folded configuration, and / or fit with.

[0066] The elongated shaft assembly 50 includes a plurality of longitudinal marker elements 80 configured to be visible under fluorescence fluoroscopy using an imaging device. In some embodiments, the plurality of longitudinal marker elements 80 may include two longitudinal marker elements, three longitudinal marker elements, and so on. In some embodiments, the plurality of longitudinal marker elements 80 may extend distally from the body 74 of the stent holder 70. In some embodiments, the plurality of longitudinal marker elements 80 may extend distally from the distal end of the body 74. In some embodiments, the second end 76 may include the plurality of longitudinal marker elements 80.

[0067] In some embodiments, the longitudinal marker elements 80 may be oriented parallel to the central longitudinal axis of the elongated shaft assembly 50. In some embodiments, the longitudinal marker elements 80 may be spaced radially outward from the inner shaft 54 ​​of the elongated shaft assembly 50. In some embodiments, the longitudinal marker elements 80 may be spaced equally apart circumferentially around the central longitudinal axis of the elongated shaft assembly 50.

[0068] In certain exemplary configurations, the multiple longitudinal marker elements 80 may include a first longitudinal marker element 81, a second longitudinal marker element 82, and a third longitudinal marker element 83. In some embodiments, the first, second, and third longitudinal marker elements 81, 82, and 83 may be oriented parallel to the central longitudinal axis of the elongated shaft assembly 50. In some embodiments, the first, second, and third longitudinal marker elements 81, 82, and 83 may be spaced radially outward from the inner shaft 54 ​​of the elongated shaft assembly 50. In some embodiments, the first, second, and third longitudinal marker elements 81, 82, and 83 may be spaced equally apart circumferentially around the central longitudinal axis of the elongated shaft assembly 50. For example, the first longitudinal marker element 81, the second longitudinal marker element 82, and the third longitudinal marker element 83 may be positioned 120 degrees apart from each other around the central longitudinal axis, and / or the first longitudinal marker element 81, the second longitudinal marker element 82, and the third longitudinal marker element 83 may be positioned and / or arranged on a virtual circle around the central longitudinal axis, spaced circumferentially with an arc length equal to one-third of the circumference of the virtual circle.

[0069] In some embodiments, the multiple longitudinal marker elements 80 may include multiple fingers extending distally from the body 74 of the stent holder 70. In some embodiments, the multiple fingers may include two fingers, three fingers, four fingers, and so on. In one example, the multiple fingers may include exactly three fingers.

[0070] In some alternative configurations, the multiple longitudinal marker elements 80 may be embedded within and / or fixedly mounted to the elongated shaft assembly 50. In some further alternative configurations, the multiple longitudinal marker elements 80 may extend from the first end 72 of the stent holder 70. Other configurations are also conceivable.

[0071] In some embodiments, the multiple longitudinal marker elements 80 and / or the multiple fingers may extend away from the body 74 of the stent holder 70. In some embodiments, the multiple longitudinal marker elements 80 and / or the multiple fingers may be aligned longitudinally and / or axially with at least one projection 73. In some embodiments, the multiple longitudinal marker elements 80 and / or the multiple fingers may be configured and / or fitted to align with the multiple posts 122 and / or the multiple commissures of the replacement heart valve implant 100. In some embodiments, the multiple longitudinal marker elements 80 and / or the multiple fingers may be configured and / or fitted to be visible under fluoroscopy. In some embodiments, a plurality of longitudinal marker elements 80 and / or a plurality of fingers may be configured and / or fitted to align a plurality of posts 122 and a plurality of commissures of the implant delivery system 30, stent holder 70, and / or replacement heart valve implant 100 with a plurality of natural valve commissures 18 of a natural heart valve (e.g., aortic valve 12) under fluoroscopy. In some embodiments, a plurality of longitudinal marker elements 80 and / or a plurality of fingers may be configured and / or fitted to align a plurality of posts 122 and a plurality of commissures of the implant delivery system 30, stent holder 70, and / or replacement heart valve implant 100 with a plurality of natural valve commissures 18 of a natural heart valve (e.g., aortic valve 12) under fluoroscopy.

[0072] Returning to Figure 4, in some embodiments, the implant delivery system 30 and / or elongated shaft assembly 50 may include a distal tip 58 and a distal sheath 64. The distal sheath 64 may extend proximal from the distal tip 58. The implant delivery system 30 and / or elongated shaft assembly 50 may include a distal cap 77 positioned distal to at least a portion of the stent holder 70. In some embodiments, the distal cap 77 may be fixedly attached to the distal end of the intermediate tubular member 56, adjacent to the distal end of the intermediate tubular member 56, and / or to the distal end of the intermediate tubular member 56. In some embodiments, the distal cap 77 may be positioned distal to the body 74 of the stent holder 70. In some embodiments, the distal cap 77 may be positioned between the body 74 of the stent holder 70 and the distal tip 58. In some embodiments, at least a portion of the distal cap 77 may be positioned radially inward of the plurality of longitudinal marker elements 80 and / or axially overlapping with the plurality of longitudinal marker elements 80. In some embodiments, the proximal end of the distal cap 77 may extend proximal to the distal end of the plurality of longitudinal marker elements 80.

[0073] The implant delivery system 30 and / or elongated shaft assembly 50 may include a cage 78 positioned radially outward of the elongated shaft assembly 50, distal cap 77, and / or stent holder 70, and / or extending radially outward from the elongated shaft assembly 50, distal cap 77, and / or stent holder 70. In some embodiments, the cage 78 may be configured to cover the elongated shaft assembly 50 and / or to substantially center the distal sheath 64 around the elongated shaft assembly 50 as the distal sheath 64 moves from an open to a closed position. Other configurations are also contemplated.

[0074] The cage 78 is located radially outward of the plurality of longitudinal marker elements 80 and may overlap the plurality of longitudinal marker elements 80 axially. In some embodiments, the cage 78 is located radially outward of the body 74 of the stent holder 70 and may overlap the body 74 of the stent holder 70 axially. In some embodiments, the cage 78 is located radially outward of a portion of the distal cap 77 and may overlap the portion of the distal cap 77 axially. In some embodiments, the distal cap 77 may include a flanged portion extending radially outward from the central longitudinal axis of the elongated shaft assembly 50. The flanged portion of the distal cap 77 and the first end 72 of the stent holder 70 may cooperate to cover the second end 76 of the stent holder 70 and / or the plurality of longitudinal marker elements 80 to hold the cage 78 in place axially.

[0075] In at least some embodiments, the distal cap 77 and cage 78 may be formed from a fluoroscopically transparent (or fluoroscopically translucent) material so that the plurality of longitudinal marker elements 80 are clearly visible under fluorescence. In some embodiments, the distal cap 77 and cage 78 may be formed from a polymer material. In some embodiments, the elongated shaft assembly 50 may include at least one fluoroscopically transparent (or fluoroscopically translucent) component positioned radially outward of the plurality of longitudinal marker elements 80 and radially inward of the distal sheath 64 of the implant retainer 60. In some embodiments, the plurality of longitudinal marker elements 80 are not visible to the naked eye even when the replacement heart valve implant 100 is absent and the implant retainer 60 is in an open configuration (e.g., the distal sheath 64 is moved distally relative to the intermediate tubular member 56 and / or stent holder 70). In some embodiments, the plurality of longitudinal marker elements 80 are visible only under fluorescence.

[0076] In some embodiments, the implant delivery system 30 and / or implant retainer may include an atraumatic transition shield 79. The atraumatic transition shield 79 may be positioned adjacent to the stent holder 70. In some embodiments, the atraumatic transition shield 79 may be positioned between the stent holder 70 and the handle 40. In some embodiments, the atraumatic transition shield 79 may be positioned proximal to the stent holder 70. In some embodiments, the atraumatic transition shield 79 may be positioned at and / or adjacent to the first end 72 of the stent holder 70. In some embodiments, the atraumatic transition shield 79 may axially overlap the first end 72 of the stent holder 70. In some embodiments, the atraumatic transition shield 79 may be positioned radially outward from at least a portion of the first end 72 of the stent holder 70. In some embodiments, the non-traumatic transition shield 79 may be tapered proximally and / or radially inward toward the handle 40. The non-traumatic transition shield 79 may be configured to prevent the replacement heart valve implant 100, the expandable framework 110, the multiple valve leaflets 120, etc. from getting caught on the stent holder 70 when the implant delivery system 30 withdraws the replacement heart valve implant 100 after the replacement heart valve implant 100 has been placed.

[0077] During use, after the implant delivery system 30 and / or implant retainer 60 have been advanced and / or navigated to the treatment site (e.g., on a guidewire), the proximal sheath 62 and / or distal sheath 64 may be axially translated relative to each other, thereby transitioning the implant retainer 60 to an open configuration. When not constrained by the implant retainer 60, the replacement heart valve implant 100 and / or expandable framework 110 may be configured to transition from a radially folded configuration to a radially expanded configuration. By axially translating the proximal sheath 62 and / or distal sheath 64 away from each other and / or the stent holder 70, and then transitioning the replacement heart valve implant 100 and / or expandable framework 110 to a radially expanded configuration, it may be possible to separate and / or detach the replacement heart valve implant 100 and / or expandable framework 110 from the implant delivery system 30. An implant delivery system 30, a handle 40, an elongated shaft assembly 50, a proximal sheath 62, a distal sheath 64, a primary visual indicator 68, a non-traumatic transition shield 79, and / or several suitable but not limited materials for their components or elements, such as metallic materials and / or polymer materials, are described below.

[0078] In at least some interventions, the replacement heart valve implant 100 can be placed within the natural heart valve (for example, the natural heart valve is left intact and not removed). Alternatively, the natural heart valve may be removed (for example, by valve repair surgery), and the replacement heart valve implant 100 may be placed in its place as a replacement.

[0079] Figure 6 shows a selected embodiment of the replacement heart valve system according to this disclosure, including a selected embodiment of the implant delivery system 30 and the replacement heart valve implant 100. For clarity, some elements of the implant delivery system 30 and the replacement heart valve implant 100 are not shown but should be understood to be present. Figure 7 is a fluorescence fluoroscopic image of the replacement heart valve system showing a selected embodiment of the replacement heart valve system shown in Figure 6.

[0080] As shown in Figure 6, the distal portion of the replacement heart valve implant 100 and / or expandable framework 110 can engage with a plurality of projections 73 formed on the stent holder 70. In Figure 6, the cage 78 and distal cap 77 are not shown in order to clearly indicate the plurality of longitudinal marker elements 80 for the replacement heart valve implant 100 and / or expandable framework 110.

[0081] The majority of the replacement heart valve implant 100 and / or expandable framework 110 may be positioned proximal to the stent holder 70 when constrained in a radially folded form within the implant retainer 60. Multiple longitudinal marker elements 80 may be positioned longitudinally apart from the replacement heart valve implant 100 and / or expandable framework 110 when the replacement heart valve implant 100 is constrained in a radially folded form within the implant retainer 60 of the implant delivery system 30, as shown in Figure 6. In at least some embodiments, multiple longitudinal marker elements 80 may be positioned distal to the replacement heart valve implant 100 and / or expandable framework 110 when the replacement heart valve implant 100 is constrained in a radially folded form within the implant retainer 60 of the implant delivery system 30.

[0082] As shown in the fluoroscopic image of Figure 7, the multiple longitudinal marker elements 80 may be clearly visible inside the cage 78 and distal sheath 64 under fluoroscopy. Therefore, the multiple longitudinal marker elements 80 may be used to orient the replacement heart valve implant 100 relative to the natural heart valve (e.g., aortic valve 12) under fluoroscopy so that the multiple posts 122 and / or multiple commissures of the replacement heart valve implant 100 are rotationally aligned with the multiple natural valve commissures 18 of the natural heart valve (e.g., aortic valve 12). Alignment of the multiple posts 122 and / or multiple commissures of the replacement heart valve implant 100 with the multiple natural valve commissures 18 of the natural heart valve (e.g., aortic valve 12) is important to avoid occlusion of the left coronary artery 24 and the right coronary artery 25 by the multiple posts 122 and / or multiple commissures, as the distance between the coronary arteries and the natural valve annulus may vary from patient to patient. Furthermore, the alignment of multiple posts 122 and / or multiple commissures of a replacement heart valve implant 100 with multiple natural commissures 18 of a natural heart valve (e.g., aortic valve 12) may be useful in maintaining proper valve function and / or limiting, reducing, and / or eliminating paravalvular leakage.

[0083] When delivering a replacement heart valve implant 100 to a natural heart valve (e.g., aortic valve 12), fluoroscopy is used to visualize the procedure and is well known in the art. In some procedures, the imaging device may be configured to use two different views, namely a three-cusp view and a cusp overlap view, which will be understood by those skilled in the art. In some embodiments, the three-cusp view is used first, and once satisfactory positioning is confirmed in the three-cusp view, the imaging device is switched to the cusp overlap view to verify the orientation and / or positioning of the replacement heart valve implant 100, multiple posts 122, and multiple commissures relative to the natural heart valve (e.g., aortic valve 12) and multiple natural commissures 18. In some embodiments, the imaging device may be switched between the three-cusp view and the cusp overlap view multiple times during the procedure.

[0084] Figures 8A to 9C schematically illustrate selected embodiments of using an imaging device to visualize the orientation of a replacement heart valve implant 100, multiple posts 122, and multiple commissures for a natural heart valve (e.g., aortic valve 12) and multiple natural valve commissures 18.

[0085] The three leaflet views are schematically shown in Figures 8A and 9A, and the general viewpoints for the three leaflet views are indicated by arrow 8A in Figure 8C and arrow 9A in Figure 9C. The leaflet overlap view is schematically shown in Figures 8B and 9B, and the general viewpoints for the leaflet overlap view are indicated by arrow 8B in Figure 8C and arrow 9B in Figure 9C.

[0086] Figures 8C and 9C schematically show selected embodiments of a replacement heart valve implant 100 and implant delivery system 30 in a partial cross-sectional view of a natural heart valve (e.g., aortic valve 12) shown in Figure 2. For clarity, some features of the implant delivery system 30 and replacement heart valve implant 100 are not shown. In addition, it should be noted that some illustrated features, such as multiple longitudinal marker elements 80, may not be actually visible in the illustrated view but are shown schematically for reference. Similar to Figure 2, the left coronary valve leaflet L, the right coronary valve leaflet R, and the non-coronary valve leaflet N are illustrated in Figures 8C and 9C. Figures 8C and 9C illustrate two exemplary orientations of the replacement heart valve implant 100, multiple posts 122, and multiple commissures relative to a natural heart valve (e.g., aortic valve 12) and multiple natural valve commissures 18, demonstrating the advantages of using both three leaflet views and leaflet overlap views. In some alternative embodiments, the replacement heart valve implant 100 may be delivered to the natural heart valve using only one of these views, for example, the leaflet overlap view.

[0087] As can be seen by comparing Figures 8A and 9A with Figures 8C and 9C, in the three leaflet views, the multiple longitudinal marker elements 80 appear to be roughly aligned with the multiple natural valve commissures 18. However, as shown in Figures 8C and 9C, the replacement heart valve implant 100 may be positioned in one of two different orientations relative to the natural heart valve and / or the multiple natural valve commissures 18. This may be due to the inherent limitations of the two-dimensional nature of the three leaflet views when viewing the three-dimensional arrangement of the multiple longitudinal marker elements 80. In Figure 8C, the multiple longitudinal marker elements 80 and multiple posts 122 (and multiple commissures) of the replacement heart valve implant 100 are rotationally aligned with the natural valve commissure 18, whereas in Figure 9C, the multiple longitudinal marker elements 80 and multiple posts 122 (and multiple commissures) of the replacement heart valve implant 100 are not rotationally aligned with the natural valve commissure 18, even though the three leaflet views corresponding to the arrangements in Figures 8C and 9C (e.g., Figures 8A and 9A) appear the same (e.g., the multiple longitudinal marker elements 80 appear to be positioned substantially equally spaced). If the multiple posts 122 (and multiple commissures) of the replacement heart valve implant 100 are not rotationally aligned with the multiple natural valve commissures 18, the multiple posts 122 (and multiple commissures) of the replacement heart valve implant 100 may overlap, at least partially, with the left coronary artery 24 and the right coronary artery 25, as seen in Figure 9C.

[0088] Therefore, once it is confirmed that the multiple longitudinal marker elements 80 are roughly aligned with the natural valve commissure 18 in the three leaflet views, as shown in Figures 8A and 9A, the imaging device can be switched to the leaflet overlap view shown in Figures 8B and 9B. From this viewpoint, the left coronary artery leaflet L and the right coronary artery leaflet R appear to be substantially overlapping in the right portion of the view, while the non-coronary artery leaflet N is displayed alone in the left portion of the view. This arrangement can be used to make the positioning of the multiple longitudinal marker elements 80 relative to the left coronary artery leaflet L, the right coronary artery leaflet R, and the non-coronary artery leaflet N visible.

[0089] When the replacement heart valve implant 100 is correctly positioned and its multiple longitudinal marker elements 80 and multiple posts 122 (and multiple commissures) are rotationally aligned with the multiple natural valve commissures 18, as shown in Figure 8C (e.g., in the desired final orientation), then, as shown in Figure 8B, in the leaflet overlap view, it can be seen that one of the multiple longitudinal marker elements 80 is positioned further away from the non-coronary leaflets N of the natural heart valve (e.g., aortic valve 12) than the other marker elements of the multiple longitudinal marker elements 80. For example, in the leaflet overlap view of Figure 8B, when the replacement heart valve implant 100 is correctly positioned, one of the multiple longitudinal marker elements 80 is positioned to the right of two longitudinal marker elements 80 that are overlapping and / or very close to each other.

[0090] If the replacement heart valve implant 100 is mispositioned, and the multiple longitudinal marker elements 80 and multiple posts 122 (and multiple commissures) of the replacement heart valve implant 100 are not rotationally aligned with the multiple natural valve commissures 18, as shown in Figure 9C, then in the leaflet overlap view, as shown in Figure 9B, it can be observed that one of the multiple longitudinal marker elements 80 is positioned closer to the non-coronary leaflets N of the natural heart valve (e.g., aortic valve 12) than the other marker elements of the multiple longitudinal marker elements 80. For example, in the leaflet overlap view of Figure 9B, if the replacement heart valve implant 100 is mispositioned, one of the multiple longitudinal marker elements 80 is positioned to the left of two longitudinal marker elements 80 that are overlapping and / or very close to each other.

[0091] Therefore, in the leaflet overlap view (e.g., Figures 8B and 9B), the relative positioning of a single longitudinal marker element among the multiple longitudinal marker elements 80 relative to other marker elements among the multiple longitudinal marker elements 80 may be useful in determining whether the multiple posts 122 and multiple commissures of the replacement heart valve implant 100 overlap with the left coronary artery 24 and the right coronary artery 25. When delivering the replacement heart valve implant 100 to ensure proper placement and / or orientation within the natural heart valve (e.g., the aortic valve 12), the operator may use both the three leaflet view and the leaflet overlap view.

[0092] During delivery of the replacement heart valve implant 100 to the natural heart valve, the placement of the replacement heart valve implant 100 may include transitioning the replacement heart valve implant 100 from a radially folded state to a radially expanded state. In some embodiments, the proximal portion of the replacement heart valve implant 100 may be released and / or radially expanded first, and / or before the distal portion of the replacement heart valve implant 100.

[0093] As described herein, the multiple longitudinal marker elements 80 can be aligned with the multiple posts 122 and multiple commissures of the replacement heart valve implant 100 when the replacement heart valve implant 100 is confined within the implant retaining portion 60 of the implant delivery system 30. The multiple longitudinal marker elements 80 can be configured to rotate-align the multiple commissures of the replacement heart valve implant 100 with the multiple natural valve commissures 18 of the natural heart valve (e.g., aortic valve 12) under fluoroscopy using an imaging device as the replacement heart valve implant 100 transitions from a radially folded state to a radially expanded state within the natural heart valve (e.g., aortic valve 12). Therefore, when the replacement heart valve implant 100 transitions from a radially folded state to a radially expanded state within the natural heart valve (e.g., aortic valve 12), if the multiple longitudinal marker elements 80 are rotationally aligned with the multiple natural valve commissures 18 of the natural heart valve (e.g., aortic valve 12), then the multiple posts 122 and multiple commissures of the replacement heart valve implant 100 are aligned with the multiple natural valve commissures 18 of the natural heart valve (e.g., aortic valve 12).

[0094] In some embodiments, a method for delivering a replacement heart valve implant 100 to a natural heart valve (e.g., an aortic valve 12) may include configuring an imaging device to produce a three-leaflet view of the natural heart valve (e.g., an aortic valve 12) at a first position and a leaflet overlap view of the natural heart valve (e.g., an aortic valve 12) at a second position. In some alternative embodiments, two separate imaging devices may be used, the first imaging device configured to produce a three-leaflet view and the second imaging device configured to produce a leaflet overlap view. Other configurations are also conceivable.

[0095] A method for delivering a replacement heart valve implant 100 to a natural heart valve (e.g., an aortic valve 12) may include advancing an implant delivery system 30 to a position adjacent to the natural heart valve (e.g., an aortic valve 12), in which case the replacement heart valve implant 100 is constrained within the implant retaining portion 60 of the implant delivery system 30.

[0096] A method for delivering a replacement heart valve implant 100 to a natural heart valve (e.g., aortic valve 12) may include imaging the implant delivery system 30 adjacent to the natural heart valve (e.g., aortic valve 12) under fluoroscopy using an imaging device to determine the initial orientation of the replacement heart valve implant 100 relative to the natural heart valve (e.g., aortic valve 12) by determining the relative positioning of a plurality of longitudinal marker elements 80 of the implant delivery system 30 within the natural heart valve (e.g., aortic valve 12). In at least some embodiments, it may be desirable to rotate the multiple posts 122 and multiple commissures of the replacement heart valve implant 100 to the multiple natural valve commissures 18 of the natural valve (e.g., aortic valve 12), as generally shown in Figures 8A and 9A.

[0097] In some embodiments, a method for delivering a replacement heart valve implant 100 to a natural heart valve (e.g., an aortic valve 12) may include evaluating the initial orientation under fluoroscopy in three leaflet views to determine whether rotation of the implant delivery system 30 and the replacement heart valve implant 100 is necessary to rotationally align the multiple posts 122 and multiple commissures of the replacement heart valve implant 100 with the multiple natural valve commissures 18 of the natural heart valve (e.g., an aortic valve 12). In some embodiments, the desired final orientation of the replacement heart valve implant 100 may include multiple longitudinal marker elements 80 arranged at equal intervals under fluoroscopy in three leaflet views. If the multiple longitudinal marker elements 80 appear to show a single longitudinal marker element of the multiple longitudinal marker elements 80 isolated to the right of the other marker elements of the multiple longitudinal marker elements 80 in three leaflet views, or a single longitudinal marker element of the multiple longitudinal marker elements 80 isolated to the left of the other marker elements of the multiple longitudinal marker elements 80 in three leaflet views, then the multiple longitudinal marker elements 80 (and by extension, the multiple posts 122 and multiple commissures of the replacement heart valve implant 100) are not aligned with the multiple natural valve commissures 18.

[0098] In some embodiments, imaging an implant delivery system 30 adjacent to a natural heart valve (e.g., aortic valve 12) under fluoroscopy using an imaging device may include imaging the implant delivery system 30 and the natural heart valve (e.g., aortic valve 12) in three leaflet views, and switching to a leaflet overlap view to determine the rotational direction of the implant delivery system 30 and the replacement heart valve implant 100 necessary to position the replacement heart valve implant 100 in the desired final orientation with as few rotations as possible. In situ rotation of the implant delivery system 30 and the replacement heart valve implant 100 should be minimized where necessary to limit unnecessary risk and / or discomfort to the patient, as this could damage the patient's vascular system and / or natural heart valve. In some embodiments, evaluating the initial orientation under fluoroscopy in three leaflet views may include determining that the direction of rotation is counterclockwise if the multiple longitudinal marker elements 80 appear to indicate a single longitudinal marker element among the multiple longitudinal marker elements 80 that is isolated to the left of the other marker elements among the multiple longitudinal marker elements 80 in the three leaflet views. In some embodiments, evaluating the initial orientation under fluoroscopy in three leaflet views may include determining that the direction of rotation is clockwise if the multiple longitudinal marker elements 80 appear to indicate a single longitudinal marker element among the multiple longitudinal marker elements 80 that is isolated to the right of the other marker elements among the multiple longitudinal marker elements 80 in the three leaflet views.

[0099] In some embodiments, a method for delivering a replacement heart valve implant 100 to a natural heart valve (e.g., an aortic valve 12) may include rotating the implant delivery system 30 and the replacement heart valve implant 100 in place to position the replacement heart valve implant 100 in a desired final orientation by aligning a plurality of longitudinal marker elements 80 with a plurality of natural valve commissures 18 of the natural heart valve (e.g., an aortic valve 12). In some embodiments, rotating the implant delivery system 30 and the replacement heart valve implant 100 in place may include rotating the implant delivery system 30 and the replacement heart valve implant 100 by 60 degrees or less around the central longitudinal axis of the elongated shaft assembly 50 of the implant delivery system 30. In some embodiments, rotating the implant delivery system 30 and the replacement heart valve implant 100 in place may include rotating the implant delivery system 30 and the replacement heart valve implant 100 until, as shown in Figures 8A and 9A, a plurality of longitudinal marker elements 80 appear to be equally spaced in three leaflet views under fluoroscopy.

[0100] In some embodiments, in a desired final orientation, one of the multiple longitudinal marker elements 80 may be positioned further away from the non-coronary leaflets N of the natural heart valve (e.g., aortic valve 12) in the leaflet overlap view than the other marker elements of the multiple longitudinal marker elements 80, as shown in Figure 8B. In some embodiments, the method may include switching from the leaflet overlap view back to the three leaflet view before rotating the implant delivery system 30 and the replacement heart valve implant 100 in place. In some embodiments, the method may include switching from the leaflet overlap view back to the three leaflet view before placing the replacement heart valve implant 100 within the natural heart valve (e.g., aortic valve 12).

[0101] In some embodiments, a method for delivering a replacement heart valve implant 100 to a natural heart valve (e.g., an aortic valve 12) may include positioning the replacement heart valve implant 100 within the natural heart valve (e.g., an aortic valve 12) with the multiple posts 122 and multiple commissures of the replacement heart valve implant 100 rotated in alignment with the multiple natural valve commissures 18 of the natural heart valve (e.g., an aortic valve 12). Positioning the replacement heart valve implant 100 within the natural heart valve (e.g., an aortic valve 12) may include radially expanding the replacement heart valve implant 100 and / or expandable framework 110 within the natural heart valve (e.g., an aortic valve 12) in a radially expanded form when the multiple posts 122 and multiple commissures of the replacement heart valve implant 100 rotated in alignment with the multiple natural valve commissures 18 of the natural heart valve (e.g., an aortic valve 12).

[0102] The various components of the replacement heart valve systems disclosed herein and the materials that can be used for those various components may include materials generally associated with medical devices. For simplicity of explanation, the following description refers to the system. However, this is not intended to limit the devices, components, and methods described herein, and the description may apply to other elements, members, components, or devices disclosed herein, including but not limited to replacement heart valve implants, expandable frameworks, multiple valve leaflets, implant delivery systems, handles, elongated shaft assemblies, and / or their elements or components, etc.

[0103] In some embodiments, the system and / or its components may be made from metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, or other suitable materials.

[0104] Other examples of some suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluoroethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block esters, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL®), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers (HYTREL®, etc.)), polyamides (e.g., DURETHAN® or CRISTAMID®), elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly-p-phenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (GRILAMID®, etc.), perfluoro(propyl hydroxypropyl nitrile) This may include nyl ethers (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonates, polycarbonates, polyurethane silicone copolymers (e.g., Elast-Eon® or ChronoSil®), ions, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc.In some embodiments, the system and / or its components may be blended with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0105] Some examples of suitable metals and metal alloys include stainless steel such as 304 and / or 316 stainless steel and its variations; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic Nitinol; and nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, HASTELLOY® C276®, etc.). UNS:N10276, other HASTELLOY® alloys, etc., nickel-copper alloys (e.g., UNS:N04400, etc., such as MONEL® 400, NICKELVAC® 400, NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY Other nickel alloys such as UNS:N10665 (e.g., B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, e.g., ELGILOY®, PHYNOX®); platinum-enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0106] In at least some embodiments, some or all of the system and / or components may also be doped with, fabricated from, or include radiopaque materials. Radiopaque materials are understood to be materials that can produce relatively bright images on a fluoroscopy screen or by other imaging techniques (e.g., ultrasound, etc.) during medical procedures. These relatively bright images assist the system user in determining their location. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials loaded with radiopaque fillers. Furthermore, other radiopaque marker bands and / or coils may be incorporated into the system design to achieve the same result.

[0107] In some embodiments, a certain degree of magnetic resonance imaging (MRI) compatibility is imparted to the systems and / or other elements disclosed herein. For example, the systems and / or their components or parts may be made of materials that do not substantially distort the image and do not produce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they can produce artifacts in MRI images. The systems or parts thereof may also be made from materials that can be imaged by MRI equipment. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nitinol, and others.

[0108] In some embodiments, the systems and / or other elements disclosed herein may include textile materials arranged structurally or within a structure. The textile materials may consist of biocompatible materials such as polymeric materials or biomaterials adapted to promote tissue internal growth. In some embodiments, the textile materials may include bioabsorbable materials. Some examples of suitable textile materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyethylene, polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0109] In some embodiments, the systems and / or other elements disclosed herein may include and / or be formed from textile materials. Some examples of suitable textile materials include synthetic yarns that may be flat, moldable, twisted, textured, pre-shrunk, or unshrunk. Suitable synthetic biocompatible yarns for use in this disclosure include, but are not limited to, polyesters including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyvinyl, polymethylacetates, polyamides, naphthalenedicarboxylic acid derivatives, natural silk, and polytetrafluoroethylene. Furthermore, at least one of the synthetic yarns may be a metallic yarn, a glass or ceramic yarn, or a fiber. Useful metallic yarns include yarns made from stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr alloys, or yarns containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr alloys. The yarns may further include carbon fibers, glass fibers, or ceramic fibers. Preferably, the thread is made from a thermoplastic material including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, and polytetrafluoroethylene. The thread may be multifilament, monofilament, or spun. The type and denier of the thread selected may be chosen to form a biocompatible and implantable prosthesis, more specifically, a vascular structure with desirable properties.

[0110] In some embodiments, the systems and / or other elements disclosed herein may include and / or be treated with a suitable therapeutic agent. Some examples of appropriate therapeutic agents include: antithrombotic agents (heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone), etc.); proliferation inhibitors (enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid, etc.); anti-inflammatory agents (dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine, etc.); antitumor / antiproliferative / antimitotic agents (paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epotilon, endostatin, angiostatin, and thymidine kinase inhibitors, etc.); anesthetics (lidocaine, bupivacaine, and ropivacaine, etc.); anticoagulants (D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin) Examples of drugs include antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and mite antiplatelet peptides; vasodilators (growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation accelerators); vasodilators (growth factor inhibitors, growth factor receptor antagonists, transcription inhibitors, translation inhibitors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins); immunosuppressants ("Olimus" family drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picrolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol-lowering agents; vasodilators; and drugs that interfere with intrinsic vasoactive mechanisms.

[0111] It should be understood that this disclosure is illustrative in many respects. Modifications can be made in detail, particularly with respect to shape, size, and process configuration, without exceeding the scope of this disclosure. This may include, to a reasonable extent, using any feature of one exemplary embodiment in other embodiments. The scope of this disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. An implant delivery system for delivering a replacement heart valve implant to a natural heart valve, It comprises an elongated shaft assembly including an implant retainer, the implant retainer including a proximal sheath and a distal sheath, The implant holder is configured to restrain the replacement heart valve implant in a radially folded state. The aforementioned elongated shaft assembly includes a plurality of longitudinal marker elements configured to be visible under fluorescence fluoroscopy using an imaging device, An implant delivery system wherein the plurality of longitudinal marker elements are configured to rotately align the plurality of commissure posts of the replacement heart valve implant with the plurality of natural valve commissures of the natural heart valve under fluorescence fluoroscopy using the imaging device when the replacement heart valve implant transitions to a radially expanded form within the natural heart valve.

2. The implant delivery system according to claim 1, wherein the plurality of longitudinal marker elements are oriented parallel to the central longitudinal axis of the elongated shaft assembly.

3. The implant delivery system according to claim 1 or 2, wherein the plurality of longitudinal marker elements are arranged at intervals radially outward from the inner shaft of the elongated shaft assembly.

4. The implant delivery system according to any one of claims 1 to 3, wherein the plurality of longitudinal marker elements are arranged circumferentially at equal intervals from one another around the central longitudinal axis of the elongated shaft assembly.

5. The implant delivery system according to any one of claims 1 to 4, wherein the elongated shaft assembly includes a stent holder configured to engage with the expandable framework of the replacement heart valve implant in the radially folded configuration.

6. The implant delivery system according to claim 5, wherein the plurality of longitudinal marker elements include a plurality of fingers extending distally from the body of the stent holder.

7. The implant delivery system according to claim 6, wherein the plurality of fingers include exactly three fingers.

8. The implant delivery system according to any one of claims 1 to 7, wherein the elongated shaft assembly includes at least one fluorescently transparent component located radially outward of the plurality of longitudinal marker elements and radially inward of the distal sheath.

9. The implant delivery system according to any one of claims 1 to 8, wherein the plurality of longitudinal marker elements are visible only under fluorescence fluoroscopy.

10. The implant delivery system according to any one of claims 1 to 9, wherein the plurality of longitudinal marker elements are arranged longitudinally apart from the replacement heart valve implant, which is in a radially folded configuration.

11. The implant delivery system according to claim 10, wherein the plurality of longitudinal marker elements are positioned distal to the replacement heart valve implant when the replacement heart valve implant is constrained in the radially folded form within the implant holder.

12. An implant delivery system for delivering a replacement heart valve implant to a natural heart valve, The device comprises an elongated shaft assembly including an outer tubular member, an inner shaft, and an implant holding portion. The implant holder is configured to restrain the replacement heart valve implant in a radially folded state. The aforementioned elongated shaft assembly is When the replacement heart valve implant is confined within the implant retaining portion of the implant delivery system, a stent holder configured to engage with the distal portion of the expandable framework of the replacement heart valve implant, The stent holder comprises a plurality of longitudinal marker elements extending distally from its distal end, wherein the longitudinal marker elements are configured to be visible under fluorescence fluoroscopy using an imaging device, The plurality of longitudinal marker elements include a first longitudinal marker element, a second longitudinal marker element, and a third longitudinal marker element, which are arranged circumferentially at equal intervals from each other around the central longitudinal axis of the elongated shaft assembly. An implant delivery system wherein the plurality of longitudinal marker elements are configured to rotately align the plurality of commissure posts of the replacement heart valve implant with the plurality of natural valve commissures of the natural heart valve under fluorescence fluoroscopy using the imaging device when the replacement heart valve implant transitions to a radially expanded form within the natural heart valve.

13. The implant retaining portion includes a proximal sheath positioned around the inner shaft of the elongated shaft assembly and a distal sheath positioned around the inner shaft of the elongated shaft assembly. The implant delivery system according to claim 12, wherein the proximal sheath is fixedly attached to the outer tubular member, and the distal sheath is fixedly attached to the inner shaft.

14. The stent holder is fixedly attached to an intermediate tubular member that is positioned radially inward of the outer tubular member and radially outward of the inner shaft. The implant delivery system according to any one of claims 12 to 13, wherein the inner shaft and the outer tubular member are each independently movable in the axial direction relative to the intermediate tubular member.

15. A method for delivering a replacement heart valve implant to a natural heart valve, Setting up the imaging device to generate a view of the three leaflets of the natural heart valve at a first position and a view of the overlapping leaflets of the natural heart valve at a second position. The implant delivery system is advanced to a position adjacent to the natural heart valve, such that the replacement heart valve implant is confined within the implant holding portion of the implant delivery system. In order to determine the initial orientation of the replacement heart valve implant relative to the natural heart valve by the relative positioning of a plurality of longitudinal marker elements of the implant delivery system within the natural heart valve, the imaging device is used to image the implant delivery system adjacent to the natural heart valve. By aligning the plurality of longitudinal marker elements with the plurality of natural valve commissures of the natural heart valve, the implant delivery system is rotated in place to position the replacement heart valve implant in the desired final orientation. A method comprising positioning the replacement heart valve implant within the natural heart valve such that the multiple commissure posts of the replacement heart valve implant are rotationally aligned with the multiple natural valve commissures of the natural heart valve.

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