STENT DELIVERY DEVICE WITH SECONDARY VISUAL INDICATOR TO ASSURE PROPER PLACEMENT FOR VISUALIZATION OF PRIMARY VISUAL INDICATOR - Patent application

Abstract

The implant delivery system is for delivering a replacement heart valve implant relative to a biological valve annulus and may include an elongate shaft assembly including an implant retainer configured to restrain the replacement heart valve implant in a radially collapsed configuration. The elongate shaft assembly includes a primary visual indicator that is visible under fluoroscopy by an imaging device. The elongate shaft assembly also includes a secondary visual indicator configured to be visible by the imaging device under fluoroscopy when the imaging device is aligned with a reference plane associated with the biological valve annulus. When the imaging device is out of alignment with the reference plane associated with the biological valve annulus, the secondary visual indicator is not visible by the imaging device under fluoroscopy.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices, and more particularly to medical devices adapted for implanting stents and medical devices including stent members. [Background technology]

[0002] A wide variety of internal medical devices are being developed for medical applications, including prosthetic heart valves for repairing or replacing diseased heart valves. When implanted, prosthetic heart valves must be precisely aligned with the natural valve annulus. Known medical devices and methods each have their own advantages and disadvantages. There is a continuing need to provide alternative medical devices and methods for their manufacture and use. Summary of the Invention

[0003] In one embodiment, an implant delivery system for delivering a replacement heart valve implant to a biological annulus can include an elongate shaft assembly with an implant holder including a proximal sheath and a distal sheath. The implant holder is configured to restrain the replacement heart valve implant in a radially collapsed configuration. The elongate shaft assembly includes a primary visual indicator configured to be visible under fluoroscopy by an imaging device. The elongate shaft assembly also includes a secondary visual indicator configured to be visible under fluoroscopy by the imaging device when the imaging device is aligned with a reference plane associated with the biological annulus. The secondary visual indicator is configured to be invisible under fluoroscopy by the imaging device when the imaging device is misaligned with a reference plane associated with the biological annulus.

[0004] Additionally or alternatively, in any embodiment disclosed herein, the desired insertion depth of the replacement heart valve implant is approximately 7 millimeters from a reference plane associated with the biological annulus to the inflow end of the replacement heart valve implant.

[0005] Additionally or alternatively, in any embodiment disclosed herein, the primary visual indicator is configured to define the actual insertion depth of the replacement heart valve implant relative to a reference plane associated with the biological annulus.

[0006] Additionally or alternatively, in any embodiment disclosed herein, when the secondary visual indicator is visible under fluoroscopy and the primary visual indicator is aligned with the reference plane under fluoroscopy, the actual insertion depth is within 10% of the desired insertion depth.

[0007] Additionally or alternatively, in any embodiment disclosed herein, when the secondary visual indicator is not visible under fluoroscopy and the primary visual indicator is aligned with the reference plane under fluoroscopy, the actual insertion depth deviates from the desired insertion depth by at least 10%.

[0008] Additionally or alternatively, in any embodiment disclosed herein, the elongate shaft assembly includes a stent holder configured to engage with an expandable framework of the replacement heart valve implant in a radially collapsed configuration.

[0009] Additionally or alternatively, in any embodiment disclosed herein, the secondary visual indicator includes an annular recess formed in the stent holder. Additionally or alternatively, in any embodiment disclosed herein, when the imaging device is aligned with a reference plane associated with the biological valve annulus and the primary visual indicator is aligned with that reference plane under fluoroscopy, the annular recess is visible to the imaging device as a void oriented generally parallel to the reference plane.

[0010] Additionally or alternatively, in any embodiment disclosed herein, when the imaging device is misaligned with a reference plane associated with the biological valve annulus and the primary visual indicator is aligned with that reference plane under fluoroscopy, the annular recess is at least partially hidden from view by the imaging device.

[0011] Additionally or alternatively, in any embodiment disclosed herein, the annular recess has a width of 0.3 millimeters to 0.4 millimeters. Additionally or alternatively, in any embodiment disclosed herein, the annular recess has a radial depth that defines a remaining radial material thickness of 0.07±0.01 millimeters.

[0012] Additionally or alternatively, in any embodiment disclosed herein, the elongate shaft assembly includes a secondary visual indicator axially spaced from the primary visual indicator.

[0013] Additionally or alternatively, in any embodiment disclosed herein, the replacement heart valve system may include a replacement heart valve implant. The replacement heart valve implant includes an expandable framework and a plurality of valve leaflets secured to the expandable framework. The expandable framework is configured to transition between a radially collapsed configuration and a radially expanded configuration. The replacement heart valve system may further include an implant delivery system for delivering the replacement heart valve implant to the biological valve annulus. The implant delivery system may include an elongate shaft assembly with an implant holder including a proximal sheath and a distal sheath. The implant holder is configured to restrain the replacement heart valve implant in the radially collapsed configuration. The elongate shaft assembly includes a primary visual indicator visible under fluoroscopy by an imaging device. The elongate shaft assembly also includes a secondary visual indicator configured to be visible under fluoroscopy by the imaging device when the imaging device is aligned with a reference plane associated with the biological valve annulus. The secondary visual indicator is configured to be invisible under fluoroscopy by the imaging device when the imaging device is misaligned with a reference plane associated with the biological valve annulus.

[0014] Additionally or alternatively, in any embodiment disclosed herein, the implant delivery system is configured to cooperate with an imaging device to position the replacement heart valve implant within the biological annulus.

[0015] Additionally or alternatively, in any embodiment disclosed herein, the implant delivery system is configured to position the replacement heart valve implant within the biological annulus such that when the primary visual indicator and the secondary visual indicator are both visible to the imaging device under fluoroscopy, the actual insertion depth is within 10% of the desired insertion depth relative to a reference plane associated with the biological annulus.

[0016] Additionally or alternatively, in any embodiment disclosed herein, if the primary visual indicator is aligned with a reference plane, the secondary visual indicator is visible under fluoroscopy by the imaging device only when the imaging device is aligned with a reference plane associated with the biological valve annulus.

[0017] Additionally or alternatively, in any embodiment disclosed herein, a method of delivering a replacement heart valve implant into a biological annulus may include advancing an implant delivery system constrained within an implant holder of the implant delivery system to a position adjacent the biological annulus, positioning an imaging device in alignment with a reference plane associated with the biological annulus, fluoroscopically aligning a primary visual indicator of the implant delivery system with the reference plane using the imaging device, fluoroscopically viewing a secondary visual indicator of the implant delivery system when the primary visual indicator is aligned with the reference plane to verify alignment of the imaging device with the reference plane, and deploying the replacement heart valve implant from the implant delivery system into the biological annulus.

[0018] Additionally or alternatively, in any embodiment disclosed herein, the secondary visual indicator is configured to be visible under fluoroscopy with the imaging device when the imaging device is aligned with a reference plane associated with the biological annulus and the primary visual indicator is aligned with the reference plane, and to be invisible under fluoroscopy with the imaging device when the imaging device is misaligned with a reference plane associated with the biological annulus and the primary visual indicator is aligned with the reference plane.

[0019] Additionally or alternatively, in any embodiment disclosed herein, when the primary visual indicator is aligned with a reference plane, the secondary visual indicator is visible under fluoroscopy with the imaging device only when the imaging device is not oriented at an oblique angle that intersects with the reference plane associated with the biological valve annulus.

[0020] Additionally or alternatively, in any embodiment disclosed herein, the secondary visual indicator is an annular recess formed in a stent holder of the implant delivery system, the stent holder configured to engage the expandable framework of the replacement heart valve implant when the replacement heart valve implant is restrained within the implant holder.

[0021] The above summary of some embodiments, aspects and / or examples of the present invention is not intended to describe every disclosed embodiment or every embodiment of the present disclosure. The figures and detailed description that follow more particularly exemplify these embodiments.

[0022] The present disclosure may be more fully understood from the following detailed description considered in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0023] [Figure 1] 1A-1C are partial cutaway views illustrating selected aspects of a replacement heart valve implant positioned within a natural annulus of the heart. [Figure 2] 1A-1D illustrate selected aspects of a delivery system for delivering a replacement heart valve implant. [Figure 3] 1A-1C are partial cutaway views illustrating selected aspects related to the use of an imaging device in delivering a replacement heart valve implant to the heart. [Figure 4] 4 is a partial cutaway view illustrating an example of incorrect alignment of the imaging device of FIG. 3. [Figure 5] FIG. 1 is a diagram illustrating the parallax effect. [Figure 5A] FIG. 1 is a diagram illustrating the parallax effect. [Figure 5B] FIG. 1 is a diagram illustrating the parallax effect. [Figure 6] 1 is a partial cross-sectional view illustrating selected aspects of a delivery system according to the present disclosure. [Figure 7A] 1A-1D illustrate selected aspects of a stent holder of a delivery system according to the present disclosure. [Figure 7B] 1A-1D illustrate selected aspects of a stent holder of a delivery system according to the present disclosure. [Figure 8A] FIG. 10 shows a perspective image of an assembly with a secondary visual indicator visible to an imaging device. [Figure 8B] FIG. 8B shows a perspective view of the assembly of FIG. 8A with the secondary visual indicator hidden from the imaging device. [Figure 9] 1 is a fluoroscopic image showing the primary and secondary visual indicators of the present disclosure relative to the native valve annulus when the imaging device is properly aligned with the native valve annulus. DETAILED DESCRIPTION OF THE INVENTION

[0024] While aspects of the present disclosure are susceptible to various modifications and alternative forms, specific examples thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the present disclosure to the particular embodiments. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0025] The following description should be read with reference to the drawings, which are not necessarily to scale, and in which like reference numerals refer to like elements throughout the several views. The detailed description and drawings are intended to illustrate, not limit, the present disclosure. Those skilled in the art will appreciate that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings illustrate exemplary embodiments of the present disclosure.

[0026] For the following defined terms, these definitions shall be applied, unless a different definition is given elsewhere in the specification or in the claims. All numerical values ​​herein are deemed to be modified by the word "about," whether explicitly stated or not. In the context of numerical values, the word "about" generally refers to a range of numbers that one of ordinary skill in the art would consider substantially equivalent to the numerical value in question (e.g., a range having the same function or result). In many cases, the word "about" may include numerical values ​​that have been rounded to the nearest significant figure. When the word "about" is used in a context other than numerical values, its ordinary or customary meaning as understood in the context of this specification is deemed to apply, unless otherwise defined.

[0027] Where numerical ranges are stated by endpoints, it is intended that all numbers within that range, including the endpoints, are included (e.g., the range 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0028] Although certain suitable dimensions, ranges and / or values ​​are disclosed for various components, features and / or specifications, those skilled in the art, inspired by this disclosure, will understand that desired dimensions, ranges and / or values ​​may deviate from those explicitly disclosed.

[0029] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It should be noted that as used in this specification and the appended claims, the word "or" is generally used to include "and / or" unless the context clearly dictates otherwise. For ease of understanding, certain features of the present disclosure may be described in the singular; however, these features may be present in multiple or repeated instances in the disclosed embodiments. Individual instances of each feature are considered to be encompassed by or included in the singular disclosure unless expressly stated to the contrary. For example, reference to a feature is understood to equally apply to all instances and quantities of more than one of that feature unless specifically stated to the contrary. Accordingly, it is understood that the following description may equally apply to multiple instances of any and / or all components present in a device, unless specifically stated to the contrary.

[0030] Relative terms such as "proximal," "distal," "advancing," "retracting," and variations thereof, and similar terms, are generally understood with respect to the position, orientation, and / or movement of each element relative to a user / operator / operator of a device, with "proximal" and "retracting" referring to a direction closer to or toward the user, and "distal" and "advancing" referring to a direction further from or away from the user. In some instances, the terms "proximal" and "distal" may be used for convenience to facilitate understanding of the present disclosure, and such terms would be readily understood by those skilled in the art. Additionally, other relative terms, such as "upstream," "downstream," "inflow," and "outflow," refer to the direction of fluid flow within a lumen, such as within a body cavity, blood vessel, or device. "Axial," "circumferential," "longitudinal," "lateral," "radial," and the like, and variations thereof, generally refer to directions and / or orientations relative to a central longitudinal axis of the disclosed structure or device.

[0031] The term "dimension (or range)" may be understood to mean the maximum measurement in a specified or stated direction. However, if the dimension or range is preceded by the word "minimum" or is specified as "minimum," it may be understood to mean the smallest measurement in that dimension or range. For example, an "outer extent" may mean the dimension in the outward direction, a "radial extent" may mean the dimension in the radial direction, and a "longitudinal extent" may mean the dimension in the longitudinal direction. Instances of each dimension or range (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) may differ from one another and are clear to those skilled in the art from the context of their usage. In general, a "dimension" or "range" may be understood as the largest possible dimension measured according to the intended use, while a "minimum dimension" or "minimum range" may be understood as the smallest possible dimension measured according to the intended use. In some examples, a "dimension" or "extent" may generally be measured in orthogonal directions in a plane or cross section, but may also be measured in different ways, such as angular, radial, circumferential (e.g., along an arc), etc., as is clear from the particular context.

[0032] The terms "monolithic" and "unitary" generally refer to an element or elements made from or composed of a single structure or a single basic unit / element. Monolithic and / or unitary element shall exclude structures and / or mechanisms formed by assembling or otherwise joining multiple individual structures or elements.

[0033] References herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but note that not all embodiments necessarily include that feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with one embodiment, it will be understood that it is within the knowledge of one skilled in the art to contemplate that particular feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary. That is, it will be understood by one skilled in the art that various individual elements described below, even if not explicitly shown in a specific combination, can be combined or arranged with other elements to form other or additional embodiments, or to complement and / or expand the described embodiments.

[0034] It should be noted that, for clarity, distinct numerical designations (e.g., first, second, third, fourth, etc.) may be used throughout this specification and / or claims to identify or distinguish various described and / or claimed features. These numerical designations are not intended to be limiting and should be understood as merely exemplary. In some embodiments, previously used numerical designations may be modified or omitted for the sake of brevity and clarity. That is, a feature identified as a "first element" may later be referred to as a "second element," a "third element," etc., or may be omitted altogether. Also, a different feature may be referred to as a "first element." The meaning and / or referent in each instance will be apparent to one of ordinary skill in the art.

[0035] Additionally, it should be noted that in any figure, some features may not be shown or may be shown only diagrammatically for clarity and / or brevity. Additional details regarding some components and / or method steps may be shown in more detail in other figures. The apparatus and / or methods disclosed herein may provide numerous desirable features and advantages, as described in more detail below.

[0036] As shown in FIG. 1 , a portion of a patient's heart 10 includes an aortic valve 12 having biological valve cusps 14 disposed within and / or extending from a biological annulus, a left ventricle 16, and a portion of connected vascular structures. These vascular structures include an aorta 20 connected to the aortic valve 12 of the patient's heart 10 by an aortic arch 22, coronary arteries 24, ostia (or openings) 23 of the coronary arteries 24, and other aortas 26 (e.g., subclavian, carotid, and brachiocephalic arteries) extending from the aortic arch 22 to important internal organs. FIG. 1 illustrates a plane A aligned with the biological annulus of the aortic valve 12. For purposes of this disclosure, the following description will be described with respect to use in repairing an aortic valve 12 and is so described for simplicity's sake. However, this is not intended to be limiting, and those skilled in the art will understand that the following description may be applied to other heart valves, blood vessels, and / or other treatment sites within a patient's body with little or no change to the structure and / or scope of the present disclosure.

[0037] FIG. 1 further illustrates selected aspects of a replacement heart valve implant 100 positioned within an aortic valve 12 and / or a biological annulus of the aortic valve 12, where the biological annulus is identified and / or illustrated schematically by a reference plane A associated with the biological annulus. It should be understood that the replacement heart valve implant 100 may be any type of replacement heart valve (e.g., mitral valve, aortic valve, etc.). In use, the replacement heart valve implant 100 may be implanted (e.g., surgically or via transcatheter delivery) within a mammalian heart. The replacement heart valve implant 100 may be configured to allow unidirectional flow from the inflow end to the outflow end. In some embodiments, the desired insertion depth 102 of the replacement heart valve implant 100 is approximately 7 millimeters relative to the reference plane A associated with the biological annulus and represents the distance from the reference plane A to the inflow end of the replacement heart valve implant 100. This value is by way of example only, and other configurations and / or desired insertion depths are contemplated. In some embodiments, different sized replacement heart valve implants 100 may have different desired insertion depths.

[0038] The replacement heart valve implant 100 may include an expandable framework 110 defining 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 cross-section (e.g., D-shaped, oval, etc.). Suitable, but non-limiting, examples of materials that may be used to form the expandable framework 110 include metals and metal alloys, composites, ceramics, polymers, etc., which are described below. The replacement heart valve implant 100 and / or the expandable framework 110 may be configured to transition between a radially collapsed configuration and a radially expanded configuration. In some embodiments, the expandable framework 110 may be self-expanding. In some embodiments, the expandable framework 110 may be self-biased toward the radially expanded configuration. In some embodiments, the expandable framework 110 may be mechanically expandable. In some embodiments, the expandable framework 110 may be balloon-expandable. Other configurations are also contemplated.

[0039] In some embodiments, the expandable framework 110 can define a lower crown located proximal to the inflow end and / or at the inflow end, an upper crown located proximal to the outflow end and / or at the outflow end, and a plurality of stabilizing arches extending downstream from the outflow end. In some embodiments, the plurality of stabilizing arches can extend in a direction opposite to the lower crown, downstream from and / or away from the upper crown. In some embodiments, the upper crown can be longitudinally and / or axially disposed between the lower crown and the plurality of stabilizing arches. The expandable framework 110 can define a central lumen extending therethrough.

[0040] In some embodiments, the replacement heart valve implant 100 may include a proximal portion and a distal portion. In some embodiments, the orientation of the replacement heart valve implant 100 may be related to the implantation direction relative to the implant delivery system 30 (e.g., FIG. 2) and / or the target site. In some embodiments, the proximal portion may include an outflow end and / or multiple stabilizing arches. In some embodiments, the proximal portion may include an upper crown. In some embodiments, the distal portion may include an inflow end and / or a lower crown. Other configurations are also contemplated.

[0041] In some embodiments, the replacement heart valve implant 100 may include multiple leaflets 120 disposed within the central lumen. The multiple leaflets 120 may be coupled, secured, and / or anchored to the expandable framework 110 at multiple commissures. The multiple leaflets 120 may be configured to transition between an open position and a closed position. The multiple leaflets 120 may be configured to substantially restrict fluid flow through the replacement heart valve implant 100 in the closed position. The multiple leaflets 120 may be configured to move away from each other in the open position to allow fluid flow through the replacement heart valve implant 100.

[0042] In some embodiments, the leaflets 120 can be constructed from a polymer, such as a thermoplastic polymer. In some embodiments, the leaflets 120 can include at least 50 percent or more polymer by weight. In some embodiments, the leaflets 120 can be formed from bovine pericardium or other biological tissue. Other configurations and / or materials are also contemplated.

[0043] In some embodiments, the replacement heart valve implant 100 can include an inner skirt disposed on and / or extending along the inner surface of the expandable framework 110. In at least some embodiments, the inner skirt can be fixedly attached to the expandable framework 110. The inner skirt can direct fluids, such as blood, passing through the replacement heart valve implant 100 toward the plurality of valve leaflets 120. In at least some embodiments, the inner skirt can be fixedly attached to and / or integrally formed with the plurality of valve leaflets 120. The inner skirt can ensure that fluid passes through the central lumen of the replacement heart valve implant 100 and does not flow around the leaflets 120 when the leaflets 120 are in the closed position.

[0044] In some embodiments, the replacement heart valve implant 100 may include an outer skirt disposed on and / or extending along the outer surface of the expandable framework 110. In some embodiments, the outer skirt may be disposed on and / or near the lower crown. The outer skirt may ensure that fluid flows through the replacement heart valve implant 100 and not around the replacement heart valve implant 100 (e.g., between the expandable framework 110 and the vessel wall).

[0045] In some embodiments, the inner skirt and / or outer skirt may comprise a polymer and / or may comprise at least 50 percent or more polymer by weight. In some embodiments, the inner skirt and / or outer skirt may be substantially impermeable to fluids. In some embodiments, the inner skirt and / or outer skirt may be formed from thin tissue (e.g., bovine pericardium), a coated fabric-like material, or a non-porous and / or impermeable fabric-like material. Other configurations are also contemplated. Suitable, but non-limiting, examples of materials that may be used to form the inner skirt and / or outer skirt include polymers, composites, and the like, as described below.

[0046] In some embodiments, the inner skirt and / or outer skirt may seal one, some, multiple, or all of the gaps formed in the expandable framework 110. In at least some embodiments, sealing the gaps is believed to prevent fluid flow through the gaps in the expandable framework 110. In some embodiments, the inner skirt and / or outer skirt may be attached to the expandable framework 110 using one or more methods, including, but not limited to, ligation with sutures or filaments, adhesive bonding, fusion bonding, embedding or overmolding, welding, etc.

[0047] In some embodiments, the expandable framework 110 and / or replacement heart valve implant 100 can have an outer dimension in an unconstrained configuration (e.g., a radially expanded configuration) of about 23 millimeters (mm), about 25 mm, about 27 mm, about 30 mm, etc. In some embodiments, the expandable framework 110 and / or replacement heart valve implant 100 can have an outer dimension in a radially collapsed configuration of approximately 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, etc. Other configurations are also contemplated.

[0048] Figure 2 illustrates selected aspects of a replacement heart valve system including a replacement heart valve implant 100 and an implant delivery system 30 that is compatible with and / or usable with the replacement heart valve implant 100. Note that Figure 2 includes at least one scale change (e.g., not all parts of the figure are drawn to scale) to improve visibility and to show additional details of selected aspects of the implant delivery system 30. Additionally, the expandable framework 110 is shown in a radially collapsed configuration, while some elements of the replacement heart valve implant 100 are not shown for clarity.

[0049] The implant delivery system 30 can include a handle 40 and an elongate shaft assembly 50 extending distally from the handle 40. The handle 40 can include a first end 42 and an opposing second end 44. The elongate shaft assembly 50 can extend distally from the second end 44 of the handle 40. The handle 40 can include one or more rotatable knobs. In some embodiments, the one or more rotatable knobs can 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 can be configured to rotate about a central longitudinal axis of the implant delivery system 30 and / or the handle 40.

[0050] In some embodiments, the distal portion of the implant delivery system 30 and / or the elongate shaft assembly 50 can include an implant retaining portion configured to engage and / or restrain the replacement heart valve implant 100 and / or the expandable framework 110 in a radially collapsed configuration. The elongate shaft assembly 50 can include an outer tubular member extending distally from the handle 40 and an inner shaft extending distally from the handle 40 within the outer tubular member to a distal tip 58 disposed distally of the implant retaining portion. In some embodiments, the implant retaining portion can include a proximal sheath 52 and a distal sheath 54. In some embodiments, the inner shaft can be slidably disposed within the lumen of the outer tubular member. In some embodiments, the inner shaft can be fixedly attached to the distal sheath 54 and / or the distal tip 58. In some embodiments, the distal sheath 54 can be fixedly attached to the distal tip 58. In some embodiments, the distal sheath 54 can extend proximally from the distal tip 58. In some embodiments, the inner shaft includes and / or at least partially defines a guidewire lumen, which may extend through the inner shaft. In some embodiments, the guidewire lumen may extend through the handle 40.

[0051] In some embodiments, the handle 40 can be configured to manipulate and / or move the proximal sheath 52 and / or the distal sheath 54 relative to one another. In some embodiments, the handle 40 can be configured to manipulate and / or move the inner shaft relative to the elongate shaft assembly 50, the outer tubular member, and / or the proximal sheath 52.

[0052] When delivering the replacement heart valve implant 100 to a treatment site, the replacement heart valve implant 100 may be disposed at least partially within the proximal sheath 52 and / or the distal sheath 54 in a radially collapsed configuration with the implant holder in a closed configuration. In some embodiments, the proximal sheath 52 and / or the distal sheath 54 may collectively define an implant holder of the implant delivery system 30. In some embodiments, the implant holder may be configured to restrain the replacement heart valve implant 100 in the radially collapsed configuration in the closed configuration. In some embodiments, the replacement heart valve implant 100 may be removably coupled to the inner shaft and / or the stent holder 70.

[0053] In some embodiments, the proximal sheath 52 can be configured to cover a proximal portion of the replacement heart valve implant 100 in a radially collapsed configuration when the implant holder is in the closed configuration. The distal sheath 54 can also be configured to cover a distal portion of the replacement heart valve implant 100 in a radially collapsed configuration when the implant holder is in the closed configuration. In some embodiments, the replacement heart valve implant 100 and / or the expandable framework 110 can be constrained in a radially collapsed configuration by the proximal sheath 52 and the distal sheath 54 in the closed configuration of the implant holder. In some embodiments, the proximal sheath 52 can be positioned adjacent to the distal sheath 54 in the closed configuration. In some embodiments, the proximal sheath 52 can abut the distal sheath 54 in the closed configuration. In some embodiments, the proximal sheath 52 can be axially spaced from the distal sheath 54 in the closed configuration. In some embodiments, the proximal sheath 52, in the closed configuration, can be axially spaced from the distal sheath 54 by less than 20% of the total length of the replacement heart valve implant 100 and / or the expandable framework 110. In some embodiments, the proximal sheath 52, in the closed configuration, can be axially spaced from the distal sheath 54 by less than 15% of the total length of the replacement heart valve implant 100 and / or the expandable framework 110. In some embodiments, the proximal sheath 52, in the closed configuration, can be axially spaced from the distal sheath 54 by less than 10% of the total length of the replacement heart valve implant 100 and / or the expandable framework 110. In some embodiments, the proximal sheath 52, in the closed configuration, can be axially spaced from the distal sheath 54 by less than 5% of the total length of the replacement heart valve implant 100 and / or the expandable framework 110. Other configurations are also envisioned.

[0054] In some embodiments, the implant holder and / or elongate shaft assembly 50 can include a stent holder 70. The stent holder 70 is shown in more detail in FIGS. 6-7B. In at least some embodiments, the stent holder 70 can be fixedly attached to the elongate shaft assembly 50. In some embodiments, the stent holder 70 can be integrally formed with the elongate shaft assembly 50. In some embodiments, the stent holder 70 can be configured to engage the expandable framework 110 in the radially collapsed configuration. In some embodiments, the stent holder 70 can include at least one protrusion 73 (e.g., FIG. 7A ) configured to engage the expandable framework 110.

[0055] Returning to FIG. 2 , the implant delivery system 30 and / or the elongate shaft assembly 50 may include a primary visual indicator 68 configured and / or adapted to be visible under fluoroscopy by the imaging device 300 (e.g., FIGS. 3-4 ). Other imaging modalities suitable for use in transcatheter surgical procedures are also contemplated. In some embodiments, the implant delivery system 30 and / or the elongate shaft assembly 50 may include a secondary visual indicator 78 (e.g., FIGS. 6-7B ) configured and / or adapted to be visible under fluoroscopy by the imaging device 300 (e.g., FIGS. 3-4 ). This is shown in the fluoroscopic images of FIGS. 8-9 . In some embodiments, the stent holder 70 may include the secondary visual indicator 78. In at least some embodiments, the primary visual indicator 68 may be axially spaced from the secondary visual indicator 78. The implant delivery system 30 may be configured to cooperate with the imaging device 300 to position the replacement heart valve implant 100 within the biological annulus.

[0056] 3 illustrates selected components associated with delivering a replacement heart valve implant 100 to a biological valve annulus. In use, the implant delivery system 30 may be advanced percutaneously intravascularly to a location adjacent to the treatment site (e.g., the biological valve annulus). For example, the implant delivery system 30 may be advanced intravascularly across the aortic arch 22 to a location adjacent to the aortic valve 12. Alternative approaches to treating defective aortic and / or other heart valves using the implant delivery system 30 are also contemplated.

[0057] The desired insertion depth 102 (e.g., FIG. 1) is selected to maximize the outward radial force of the expandable framework 110 within the biological annulus. By placing the replacement heart valve implant 100 at the desired insertion depth 102 and / or within a maximum tolerance from the desired insertion depth 102, the replacement heart valve implant 100 and / or the expandable framework 110 may exhibit an optimal arch shape within the biological annulus, thereby preventing downstream (or upstream) migration of the replacement heart valve implant 100 and / or the expandable framework 110.

[0058] Positioning of the replacement heart valve implant 100 and / or expandable framework 110 within the biological annulus may be accomplished by positioning the primary visual indicator 68 in a location aligned with a reference plane A within and / or associated with the biological annulus, as shown in Figure 3. During visualization, the aortic valve 12 may be identified and / or viewed under fluoroscopy using known means and / or methods, such as contrast injection. After the aortic valve 12 is identified, the reference plane A associated with the biological annulus may also be identified.

[0059] In some embodiments, the primary visual indicator 68 can be configured to define the actual insertion depth of the replacement heart valve implant 100 relative to a reference plane A associated with the biological annulus. The primary visual indicator 68 can be highly effective in properly positioning the replacement heart valve implant 100 relative to the reference plane A when the field of view from the imaging device 300 is aligned with the reference plane A associated with the biological annulus.

[0060] Unfortunately, as shown in Figure 4, it is possible for the imaging device 300 to become misaligned with and / or with respect to the reference plane A associated with the biological annulus, which can compromise the accuracy of placement of the replacement heart valve implant 100. If the imaging device 300 becomes misaligned with and / or with respect to the reference plane A associated with the biological annulus, the actual insertion depth may be off or incorrect by up to 5 millimeters.

[0061] If the imaging device 300 is not aligned with and / or misaligned with respect to the reference plane A associated with the biological annulus, a parallax effect may occur during fluoroscopy. The parallax effect is illustrated diagrammatically with respect to FIG. 5. For reference, when the imaging device 300 is aligned with the reference plane A associated with the biological annulus, the target 230 (e.g., primary visual indicator 68) appears to be aligned with the correct position 250 (e.g., the biological annulus and / or the reference plane A associated with the biological annulus). If the imaging device 300 is positioned at an oblique angle with respect to and / or the reference plane A associated with the biological annulus, a parallax effect may be observed. The greater the misalignment of the imaging device 300 with respect to the reference plane A associated with the biological annulus, the greater the actual insertion depth may deviate from the desired insertion depth 102.

[0062] As an example of the parallax effect, if the imaging device 300 is positioned proximal to the reference plane A associated with the biological annulus, the imaging device 300 may provide a proximal viewpoint 210, which may cause the apparent location of the target 230 (e.g., the primary visual indicator 68) to appear shifted to a distal position 260 relative to the correct position 250 (e.g., the biological annulus and / or reference plane A associated with the biological annulus) (see FIG. 5A ). As a result of this viewpoint, the user may perceive the primary visual indicator 68 as being located too deep within the left ventricle and may pull back the implant delivery system 30 before deploying the replacement heart valve implant 100 until the primary visual indicator 68 appears aligned with the reference plane A associated with the biological annulus. Even though the primary visual indicator 68 is actually correctly aligned with the reference plane A associated with the biological annulus, the parallax effect may cause the primary visual indicator 68 to appear misaligned with the reference plane A. Thus, the parallax effect associated with the proximal viewpoint 210 will actually result in the replacement heart valve implant 100 being positioned too far downstream relative to the biological annulus.

[0063] As another example of the parallax effect, if the imaging device 300 is positioned distal to the reference plane A associated with the biological annulus, the imaging device 300 provides a distal viewpoint 220, which may cause the apparent location of the target 230 (e.g., the primary visual indicator 68) to appear displaced to a proximal position 240 relative to the correct position 250 (e.g., the biological annulus and / or reference plane A associated with the biological annulus), as shown in FIG. 5B . As a result of this viewpoint, the user may perceive the primary visual indicator 68 as not being positioned deep enough within the left ventricle and advance the implant delivery system 30 until the primary visual indicator 68 appears aligned with the reference plane A associated with the biological annulus before deploying the replacement heart valve implant 100. Due to the parallax effect, the primary visual indicator 68 appears misaligned with the reference plane A, even though in reality the primary visual indicator 68 is properly aligned with the reference plane A associated with the biological annulus. Thus, the parallax effect associated with the distal viewpoint 220 will actually result in the replacement heart valve implant 100 being positioned too far upstream relative to the biological annulus.

[0064] When the imaging device 300 is properly aligned with the reference plane A associated with the biological annulus, the imaging device 300 provides a viewpoint located between the proximal viewpoint 210 and the distal viewpoint 220, thereby aligning the target 230 (e.g., the primary visual indicator 68) with the correct location 250 (e.g., the biological annulus and / or the reference plane A associated with the biological annulus). When the imaging device 300 is accurately aligned with the reference plane A associated with the biological annulus, the actual insertion depth matches the desired insertion depth 102 and the replacement heart valve implant 100 is properly positioned within the biological annulus.

[0065] Given the difficulties that can arise from the parallax effect, the effectiveness of the procedure and / or patient safety may be compromised without additional, costly and / or time-consuming visual verification steps. The present disclosure relates to devices and methods developed to reduce the need for these additional, costly and / or time-consuming visual verification steps by reducing and / or eliminating the possibility of the parallax effect occurring during delivery of a replacement heart valve implant 100 to a biological valve annulus.

[0066] Figure 6 is a partial cross-sectional view illustrating selected aspects of the implant delivery system 30 of Figure 2 according to the present disclosure. For clarity, portions of the replacement heart valve implant 100 and the implant delivery system 30 are not shown. For example, in Figure 6, the distal sheath 54 is shown, while the proximal sheath 52 is not.

[0067] 6, the elongate shaft assembly 50 may include a primary visual indicator 68. In some embodiments, the primary visual indicator 68 may be fixedly attached to the elongate shaft assembly 50. In some embodiments, the primary visual indicator 68 may be a marker band embedded within the elongate shaft assembly 50. Other configurations are also envisioned. As described herein, the primary visual indicator 68 may be configured and / or adapted to be visible under fluoroscopy using the imaging device 300.

[0068] In some embodiments, the implant delivery system 30 and / or the elongate shaft assembly 50 may include a secondary visual indicator 78. In some embodiments, the secondary visual indicator 78 may be fixedly attached to the elongate shaft assembly 50. In some embodiments, the primary visual indicator 68 may be axially spaced from the secondary visual indicator 78. The secondary visual indicator 78 may be configured and / or adapted to be visible under fluoroscopy with the imaging device 300 when the imaging device 300 is aligned with a reference plane A associated with the biological annulus. The secondary visual indicator 78 may be configured and / or adapted to be invisible under fluoroscopy with the imaging device 300 when the imaging device 300 is misaligned with a reference plane A associated with the biological annulus.

[0069] In some embodiments, the implant delivery system 30 and / or the elongate shaft assembly 50 may include a stent holder 70 configured to engage the expandable framework 110 of the replacement heart valve implant 100 in a radially collapsed configuration and / or when the replacement heart valve implant 100 is restrained within the implant holder of the implant delivery system 30. The stent holder 70 is shown in more detail in FIGS. 7A and 7B . The stent holder 70 may include a first end 72, a central cylindrical portion 74, and a second end 76 disposed opposite the first end 72. In some embodiments, the first end 72 may have a generally spherical shape. In some embodiments, the stent holder 70 may be configured and / or adapted to be visible under fluoroscopy. In some embodiments, the stent holder 70 may be formed from stainless steel. Non-limiting examples of suitable materials applicable to the stent holder 70 and / or its components or members include metallic and / or polymeric materials, as described below.

[0070] In some embodiments, the outermost radial dimension of the first end 72 of the stent holder 70 can be disposed near 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 can be tapered radially inward from the outermost radial dimension of the stent holder 70 in a proximal direction. In some embodiments, the stent holder 70 can include a lumen extending longitudinally and / or axially therethrough. In at least some embodiments, at least a portion of the elongate shaft assembly 50 can extend longitudinally and / or axially within the lumen of the stent holder 70.

[0071] The first end 72 may be configured and / or adapted to engage the expandable framework 110 of the replacement heart valve implant 100 when the expandable framework 110 is in a radially collapsed configuration and / or when the replacement heart valve implant 100 is constrained within an implant holder of the implant delivery system 30. In some embodiments, the first end 72 may include at least one protrusion 73. The at least one protrusion 73 may be configured and / or adapted to engage the expandable framework 110 of the replacement heart valve implant 100 when the expandable framework 110 is in a radially collapsed configuration and / or when the replacement heart valve implant 100 is constrained within an implant holder of the implant delivery system 30. In some embodiments, the at least one protrusion 73 may extend radially outward from the first end 72 of the stent holder 70. In some embodiments, at least one protrusion 73 may extend radially outward through the expandable framework 110 of the replacement heart valve implant 100 when the framework 110 is in a radially collapsed configuration and / or when the replacement heart valve implant 100 is constrained within the implant holder of the implant delivery system 30.

[0072] The second end 76 can include a plurality of fingers 77. The plurality of fingers 77 extend longitudinally along and / or parallel to the central longitudinal axis of the elongate shaft assembly 50. In some embodiments, the plurality of fingers 77 can extend away from the first end 72 and / or the central cylindrical portion 74. In some embodiments, the plurality of fingers 77 can be longitudinally and / or axially aligned with at least one protrusion 73. In some embodiments, the plurality of fingers 77 can be configured and / or adapted to align with a plurality of commissures of the replacement heart valve implant 100. In some embodiments, the plurality of fingers 77 can be configured and / or adapted to be visible under fluoroscopy. In some embodiments, the plurality of fingers 77 can be configured and / or adapted to align the implant delivery system 30, the stent holder 70, and / or the replacement heart valve implant 100 with a biological valve commissure of the aortic valve 12 under fluoroscopy. In some embodiments, the plurality of fingers 77 may be configured and / or adapted to rotationally align the implant delivery system 30, stent holder 70 and / or replacement heart valve implant 100 with the biological valve commissures of the aortic valve 12 under X-ray fluoroscopy.

[0073] In some embodiments, the secondary visual indicator 78 may comprise an annular recess formed in the stent holder 70, as shown in FIGS. 7A and 7B. In some embodiments, the secondary visual indicator 78 and / or the annular recess may be formed in the central cylindrical portion 74 of the stent holder 70. In some embodiments, the secondary visual indicator 78 and / or the annular recess may be configured and / or adapted to be visible by the imaging device 300 as a void under fluoroscopy. In some embodiments, the secondary visual indicator 78 and / or the annular recess may have a width W of about 0.3 millimeters to about 0.4 millimeters. In some embodiments, the secondary visual indicator 78 and / or the annular recess may have a radial depth D that defines a remaining radial material thickness T of 0.07±0.01 millimeters. Thus, after forming the secondary visual indicator 78 and / or the annular recess, the remaining radial material thickness T between the lumen of the stent holder 70 and the radially outward surface of the annular recess is 0.07±0.01 millimeters. Other configurations and / or dimensions are also contemplated. In some embodiments, the remaining radial material thickness T may be sized, configured, and / or adapted to perform mechanical function and to be thin enough that the secondary visual indicator 78 appears as a void under fluoroscopy when the imaging device 300 is properly aligned with the reference plane A associated with the biological annulus.

[0074] Returning to FIG. 6 , in some embodiments, the implant delivery system 30 and / or the elongate shaft assembly 50 can include a distal tip 58 and a distal sheath 54. The distal sheath 54 can extend proximally from the distal tip 58. The implant delivery system can include a distal cap 60 disposed distally of the stent holder 70 and / or between the stent holder 70 and the distal tip 58. The implant delivery system and / or the implant retainer can include a cage 62 extending radially outward from the elongate shaft assembly 50, the distal cap 60, and / or the stent holder 70. In some embodiments, the distal cap 60 can be configured to axially retain the cage 62 on the second end 76 of the stent holder 70. In some embodiments, the cage 62 can be configured to maintain the distal sheath 54 in a substantially centered position over and / or around the elongate shaft assembly 50 as the distal sheath 54 moves from the open configuration to the closed configuration. Other configurations are also contemplated.

[0075] In some embodiments, the implant delivery system 30 and / or the implant holder can include an atraumatic transition shield 80. The atraumatic transition shield 80 can be positioned adjacent to the stent holder 70. In some embodiments, the atraumatic transition shield 80 can be positioned between the stent holder 70 and the handle 40. In some embodiments, the atraumatic transition shield 80 can be positioned proximally of the stent holder 70. In some embodiments, the atraumatic transition shield 80 can be positioned on or near the first end 72 of the stent holder 70. In some embodiments, the atraumatic transition shield 80 can axially overlap the first end 72 of the stent holder 70. In some embodiments, the atraumatic transition shield 80 can be positioned radially outward of at least a portion of the first end 72 of the stent holder 70. In some embodiments, the atraumatic transition shield 80 can be tapered proximally and / or radially inward toward the handle 40. The atraumatic transition shield 80 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 is withdrawn after the replacement heart valve implant 100 has been deployed.

[0076] In use, after navigating the implant delivery system 30 and / or implant holder to a treatment site (e.g., via a guidewire 90 (see FIG. 9 )), the proximal sheath 52 and / or distal sheath 54 may be moved axially relative to one another to transition the implant holder to an open configuration. When not constrained by the implant holder, the replacement heart valve implant 100 and / or the expandable framework 110 may be configured to transition from a radially collapsed configuration to a radially expanded configuration. Transitioning the replacement heart valve implant 100 and / or the expandable framework 110 to a radially expanded configuration after moving the proximal sheath 52 and / or distal sheath 54 axially away from one another and / or the stent holder 70 may allow the replacement heart valve implant 100 and / or the expandable framework 110 to be separated and / or detached from the implant delivery system 30. Suitable, but non-limiting, materials, such as metallic and / or polymeric materials, that may be applied to the implant delivery system 30, the handle 40, the elongate shaft assembly 50, the proximal sheath 52, the distal sheath 54, the primary visual indicator 68, the atraumatic transition shield 80, and / or their components or parts are described below.

[0077] In at least some procedures, the replacement heart valve implant 100 may be deployed within a natural heart valve (e.g., the natural heart valve is left in place and not removed), or the natural heart valve may be removed (e.g., by valvuloplasty) and replaced with the replacement heart valve implant 100.

[0078] FIGS. 8A, 8B, and 9 are fluoroscopic images showing selected aspects of the implant delivery system 30. For reference, FIG. 8A corresponds to the image seen by the imaging device 300 when the imaging device 300 is aligned with a reference plane A associated with the biological annulus (e.g., as shown in FIG. 3), while FIG. 8B corresponds to the image seen by the imaging device 300 when the imaging device 300 is misaligned with the reference plane A associated with the biological annulus (e.g., as shown in FIG. 4). Note that the images shown in FIGS. 8A and 8B were taken using a reference structure for clarity; therefore, the actual patient anatomy is not visible in these images. Similarly, the replacement heart valve implant 100 is not shown in FIGS. 8A and 8B. The distal sheath 54, distal tip 58, and stent holder 70 are shown in FIGS. 8A and 8B for reference points. FIG. 9 includes additional elements of the patient anatomy and replacement heart valve system to further illustrate selected aspects of the disclosure.

[0079] 8A and 9, the secondary visual indicator 78 may be configured and / or adapted to be visible under fluoroscopy by the imaging device 300 when the imaging device 300 is aligned with the reference plane A associated with the biological annulus. In some embodiments, when the imaging device 300 is aligned with the reference plane A associated with the biological annulus and the primary visual indicator 68 is aligned under fluoroscopy with the reference plane A associated with the biological annulus, the secondary visual indicator 78 and / or the annular recess may be visible to the imaging device 300 as a void oriented generally parallel to the reference plane A associated with the biological annulus.

[0080] In some embodiments, when the secondary visual indicator 78 is visible under fluoroscopy and the primary visual indicator 68 is aligned with reference plane A associated with the biological annulus under fluoroscopy, the actual insertion depth can be within 10% of the desired insertion depth 102 (see, e.g., FIG. 1 ). In some embodiments, when the secondary visual indicator 78 is visible under fluoroscopy and the primary visual indicator 68 is aligned with reference plane A associated with the biological annulus under fluoroscopy, the actual insertion depth can be within 7.5% of the desired insertion depth 102. In some embodiments, when the secondary visual indicator 78 is visible under fluoroscopy and the primary visual indicator 68 is aligned with reference plane A associated with the biological annulus under fluoroscopy, the actual insertion depth can be within 5% of the desired insertion depth 102. In some embodiments, when the secondary visual indicator 78 is visible under fluoroscopy and the primary visual indicator 68 is aligned with reference plane A associated with the biological annulus under fluoroscopy, the actual insertion depth can be within 2.5% of the desired insertion depth 102. In some embodiments, when the secondary visual indicator 78 is visible under fluoroscopy and the primary visual indicator 68 is aligned with reference plane A associated with the biological annulus under fluoroscopy, the actual insertion depth can be within 1% of the desired insertion depth 102. Other configurations are also contemplated.

[0081] 8B, when the imaging device 300 is out of alignment with the reference plane A associated with the biological annulus, the secondary visual indicator 78 is not visible under fluoroscopy with the imaging device 300. In some embodiments, when the imaging device 300 is out of alignment with the reference plane A associated with the biological annulus and the primary visual indicator 68 is fluoroscopically aligned with the reference plane A associated with the biological annulus, the secondary visual indicator 78 and / or the annular recess may be at least partially occluded from the view of the imaging device 300.

[0082] In some embodiments, when the secondary visual indicator 78 is not visible under fluoroscopy and the primary visual indicator 68 is aligned with reference plane A associated with the biological annulus under fluoroscopy, the actual insertion depth may deviate from the desired insertion depth 102 (see, e.g., FIG. 1 ) by at least 1%. In some embodiments, when the secondary visual indicator 78 is not visible under fluoroscopy and the primary visual indicator 68 is aligned with reference plane A associated with the biological annulus under fluoroscopy, the actual insertion depth may deviate from the desired insertion depth 102 (see, e.g., FIG. 1 ) by at least 2.5%. In some embodiments, when the secondary visual indicator 78 is not visible under fluoroscopy and the primary visual indicator 68 is aligned with reference plane A associated with the biological annulus under fluoroscopy, the actual insertion depth may deviate from the desired insertion depth 102 (see, e.g., FIG. 1 ) by at least 5%. In some embodiments, when the secondary visual indicator 78 is not visible under fluoroscopy and the primary visual indicator 68 is aligned with a reference plane A associated with the biological annulus under fluoroscopy, the actual insertion depth may deviate from the desired insertion depth 102 (see, e.g., FIG. 1) by at least 7.5%. In some embodiments, when the secondary visual indicator 78 is not visible under fluoroscopy and the primary visual indicator 68 is aligned with a reference plane A associated with the biological annulus under fluoroscopy, the actual insertion depth may deviate from the desired insertion depth 102 (see, e.g., FIG. 1) by at least 10%.

[0083] In some embodiments, when the primary visual indicator 68 is aligned with the reference plane A associated with the biological annulus, the secondary visual indicator 78 may be configured to be visible under fluoroscopy with the imaging device 300 only when the imaging device 300 is aligned with the reference plane A associated with the biological annulus. In some embodiments, when the primary visual indicator 68 is aligned with the reference plane A associated with the biological annulus, the secondary visual indicator 78 may be configured to be visible under fluoroscopy with the imaging device 300 only when the imaging device 300 is not oriented in an oblique direction that intersects with the reference plane A associated with the biological annulus. In some embodiments, the secondary visual indicator 78 may disappear from the fluoroscopic field of view when the imaging device 300 has a change or deviation of only 5 degrees from the reference plane A associated with the biological annulus. At this time, the secondary visual indicator 78 is blocked by the stent holder 70 (e.g., the first end 72 and / or the central cylindrical portion 74).

[0084] When the primary visual indicator 68 is aligned with the reference plane A associated with the biological annulus and the secondary visual indicator 78 is viewed by the imaging device 300, the primary visual indicator 68 can be used to accurately and / or reliably position the replacement heart valve implant 100 such that the actual insertion depth is within a tolerance range of the desired insertion depth 102. In some embodiments, the tolerance range can be about 10%, about 7.5%, about 5%, about 2.5%, about 1%, or other suitable value determined by testing and / or experimentation.

[0085] In some embodiments, the implant delivery system 30 can be configured to position the replacement heart valve implant 100 within the biological annulus to within 10% of the desired insertion depth relative to a reference plane A associated with the biological annulus when both the primary visual indicator 68 and the secondary visual indicator 78 are viewed under fluoroscopy by the imaging device 300. In some embodiments, the implant delivery system 30 can be configured to position the replacement heart valve implant 100 within the biological annulus to within 7.5% of the desired insertion depth relative to a reference plane A associated with the biological annulus when both the primary visual indicator 68 and the secondary visual indicator 78 are viewed under fluoroscopy by the imaging device 300. In some embodiments, the implant delivery system 30 can be configured to position the replacement heart valve implant 100 within the biological annulus to within 5% of the desired insertion depth relative to a reference plane A associated with the biological annulus when both the primary visual indicator 68 and the secondary visual indicator 78 are viewed under fluoroscopy by the imaging device 300. In some embodiments, the implant delivery system 30 can be configured to position the replacement heart valve implant 100 within the biological annulus to within 2.5% of the desired insertion depth relative to a reference plane A associated with the biological annulus when both the primary visual indicator 68 and the secondary visual indicator 78 are viewed under fluoroscopy by the imaging device 300. In some embodiments, the implant delivery system 30 can be configured to position the replacement heart valve implant 100 within the biological annulus to within 1% of the desired insertion depth relative to a reference plane A associated with the biological annulus when both the primary visual indicator 68 and the secondary visual indicator 78 are viewed under fluoroscopy by the imaging device 300.

[0086] In some embodiments, a method of delivering a replacement heart valve implant 100 to a biological annulus may include advancing an implant delivery system 30 to a position adjacent the biological annulus. In some embodiments, a method of delivering a replacement heart valve implant 100 to a biological annulus may include positioning an imaging device 300 in alignment with a reference plane A associated with the biological annulus. In some embodiments, a method of delivering a replacement heart valve implant 100 to a biological annulus may include aligning a primary visual indicator 68 of the implant delivery system 30 with a reference plane A associated with the biological annulus under fluoroscopy using the imaging device 300. In some embodiments, a method of delivering a replacement heart valve implant 100 to a biological annulus may include viewing a secondary visual indicator 78 of the implant delivery system 30 under fluoroscopy using the imaging device 300 to verify alignment of the imaging device 30 with the reference plane A associated with the biological annulus when the primary visual indicator 68 is aligned with the reference plane A associated with the biological annulus. In some embodiments, a method of delivering a replacement heart valve implant 100 to a biological annulus may include verifying that the imaging device 300 is aligned with a reference plane A associated with the biological annulus and aligning the primary visual indicator 68 with the reference plane A associated with the biological annulus, followed by deploying the replacement heart valve implant 100 from the implant delivery system 30 into the biological annulus.

[0087] The components of the replacement heart valve system disclosed herein, and the materials that may be used for those components, may include materials commonly used in medical devices. For brevity, the following description refers to the system, but is not intended to limit the devices, components, and methods described in this disclosure. This description may apply to other elements, members, components, or devices disclosed herein, such as replacement heart valve implants, expandable frameworks, multiple valve leaflets, implant delivery systems, handles, elongate shaft assemblies, etc., and / or elements or components thereof.

[0088] In some embodiments, the system and / or its components may be formed from metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, other suitable materials, and the like.

[0089] Examples of suitable polymeric materials include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM; e.g., DELRIN®), polyether block esters, polyurethanes, 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 such as HYTREL®), polyamides (e.g., DURETHAN® or CRISTAMID®), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA; e.g., PEBAX®), ethylene-vinyl acetate copolymers (EVA), silicones, 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), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., GRILAMID®), par Examples include fluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonates, polyurethane-silicone copolymers (e.g., Elast-Eon® or ChronoSil®), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like.In some embodiments, the system and / or its components can be blended with a liquid crystal polymer (LCP), for example, the blend can include up to about 6% LCP.

[0090] Examples of suitable metals and metal alloys include stainless steel (e.g., 304 stainless steel and / or 316 stainless steel and variations thereof), mild steel, nickel-titanium alloys (e.g., linear elastic and / or superelastic nitinol), other nickel alloys (e.g., nickel-chromium-molybdenum alloys (UNS: N06625 (e.g., INCONEL® 625), UNS: N06022 (e.g., HASTELLOY® C-22®), UNS: N10276 (e.g., HASTELLOY® C-22®), and the like). HASTELLOY® C276®), other HASTELLOY alloys, etc.), nickel-copper alloys (e.g., UNS: N04400 (e.g., MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.)), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 (e.g., MP35-N®, etc.)), nickel-molybdenum alloys (e.g., UNS: N10665 (e.g., HASTELLOY® ALLOY 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, etc. Also included are cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 (e.g., ELGILOY®, PHYNOX®, etc.)), platinum-strengthened stainless steel, titanium, platinum, palladium, gold, combinations thereof, or other suitable materials.

[0091] In at least some embodiments, some or all of the system and / or its components may be doped with, constructed from, or otherwise include a radiopaque material. By radiopaque material, we mean a material that can produce a relatively bright image on a fluoroscopy screen or other imaging technique (e.g., ultrasound) during a medical procedure. This relatively bright image assists the user in locating the system. Examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may be incorporated into the system design to achieve a similar effect.

[0092] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility may be imparted to the system and / or other elements disclosed herein. For example, the system and / or its components, or portions thereof, may be constructed from materials that do not substantially distort images or cause significant artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable for MRI imaging because they may cause artifacts in MRI images. The system or portions thereof may be constructed from materials that can be imaged by MRI machines. Examples of materials that exhibit these properties include, but are not limited to, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 (e.g., ELGILOY®, PHYNOX®, etc.)), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 (e.g., MP35-N®, etc.)), nitinol, etc.

[0093] In some embodiments, the system and / or other elements disclosed herein may include a fabric-like material disposed on or within the structure. The fabric-like material may be composed of a biocompatible material, such as a polymeric or biomaterial adapted to promote tissue growth. In some embodiments, the fabric-like material may comprise a bioabsorbable material. Examples of suitable fabric-like materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin-based materials such as polyethylene, polypropylene, polyester, polyurethane, and mixtures or combinations thereof.

[0094] In some embodiments, the system and / or other elements disclosed herein may include or be formed from a woven material. Examples of suitable woven materials include synthetic yarns that may be smooth, shaped, twisted, textured, pre-shrunk, or unshrunk. Synthetic biocompatible yarns suitable for use in the present disclosure include, but are not limited to, polyester (including polyethylene terephthalate (PET) polyester), polypropylene, polyethylene, polyurethane, polyolefin, polyvinyl, polymethyl acetate, polyamide, naphthalene dicarboxylene derivatives, natural silk, polytetrafluoroethylene, and the like. Additionally, at least one synthetic yarn may be a metal yarn, or a glass or ceramic yarn or fiber. Useful metal yarns include yarns made of or containing stainless steel, platinum, gold, titanium, tantalum, or nickel-cobalt-chromium alloys. The yarn may further include carbon, glass, or ceramic fibers. Preferably, the yarn is formed from a thermoplastic material, such as polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, or the like. The yarn may be a multifilament, monofilament, or spun yarn type. The type and denier of the yarn selected may be selected to form a biocompatible and implantable prosthesis, particularly a vascular structure, with desirable properties.

[0095] In some embodiments, the system and / or other components disclosed herein may include and / or be treated with a suitable therapeutic agent. Examples of suitable therapeutic agents include, but are not limited to:

[0096] Antithrombotic agents (heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine-proline-arginine-chloromethylketone) etc.), antiproliferative agents (enoxaparin, angiopeptin, monoclonal antibodies capable of inhibiting 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, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors, etc.), anesthetics (lidocaine, bupivacaine, and ropivacaine, etc.), anticoagulants (D-phe-pro-arginine-chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and mite-derived antiplatelet peptides, etc.), vascular cell proliferation promoters (growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters, etc.), vascular cell proliferation inhibitors (growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules of growth factor and cytotoxin, bifunctional molecules of antibody and cytotoxin, etc.), immunosuppressants (so-called "-limus" drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picrolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus, etc.), cholesterol-lowering agents, vasodilators, and agents that interfere with endogenous vasoactive mechanisms, etc.

[0097] It should be understood that this disclosure is, in many respects, merely illustrative. Details such as shape, size, and arrangement of steps may be changed without departing from the scope of the disclosure. This may include, to the extent appropriate, applying any feature of one embodiment to other embodiments. The scope of the disclosure is, of course, defined by the language of the appended claims.

Claims

1. 1. An implant delivery system for delivering a replacement heart valve implant to a biological valve annulus, comprising: an elongated shaft assembly including an implant holder having a proximal sheath and a distal sheath; the implant retainer is configured to restrain a replacement heart valve implant in a radially collapsed configuration; the elongate shaft assembly includes a primary visual indicator configured to be visible under fluoroscopy using an imaging device; the elongate shaft assembly includes a secondary visual indicator configured to be visible under fluoroscopy using an imaging device in alignment with a reference plane associated with a biological valve annulus; If the imaging device is displaced from a reference plane associated with the biological annulus, the secondary visual indicator is not visible under fluoroscopy with the imaging device. Implant delivery system.

2. 2. The implant delivery system of claim 1, wherein the desired insertion depth of the replacement heart valve implant relative to the reference plane associated with the biological valve annulus is approximately 7 millimeters from the reference plane associated with the biological valve annulus to the inflow end of the replacement heart valve implant.

3. 3. The implant delivery system of claim 2, wherein the primary visual indicator is configured to define an actual insertion depth of the replacement heart valve implant relative to the reference plane associated with the biological annulus.

4. 4. The implant delivery system of claim 3, wherein the actual insertion depth is within 10% of the desired insertion depth when the secondary visual indicator is visible under fluoroscopy and the primary visual indicator is aligned with the reference plane under fluoroscopy.

5. 5. The implant delivery system of claim 3, wherein the actual insertion depth deviates from the desired insertion depth by at least 10% when the secondary visual indicator is not visible under fluoroscopy and the primary visual indicator is aligned with the reference plane under fluoroscopy.

6. 6. The implant delivery system of claim 1, wherein the elongate shaft assembly includes a stent holder configured to engage an expandable framework of the replacement heart valve implant in a radially collapsed configuration.

7. The implant delivery system of claim 6 , wherein the secondary visual indicator comprises an annular recess formed in the stent holder.

8. 8. The implant delivery system of claim 7, wherein when the imaging device is aligned with the reference plane associated with the biological valve annulus and the primary visual indicator is aligned with the reference plane under fluoroscopy, the annular recess is visible to the imaging device as a void, the void being oriented generally parallel to the reference plane.

9. 9. The implant delivery system of claim 7, wherein the annular recess is at least partially hidden from view by the imaging device when the imaging device is out of alignment with the reference plane associated with the biological valve annulus and the primary visual indicator is aligned with the reference plane under fluoroscopy.

10. An implant delivery system according to any one of claims 7 to 9, wherein the annular recess has a width of 0.3 to 0.4 millimeters.

11. 11. The implant delivery system of claim 10, wherein the annular recess has a radial depth that defines a remaining radial material thickness of 0.07±0.01 millimeters.

12. The implant delivery system of any preceding claim, wherein the primary visual indicator is axially spaced from the secondary visual indicator.

13. 1. A replacement heart valve system comprising: a replacement heart valve implant comprising an expandable framework and a plurality of leaflets secured to the expandable framework, the expandable framework configured to transition between a radially collapsed configuration and a radially expanded configuration; Equipped with an implant delivery system according to any one of claims 1 to 12 Replacement heart valve systems.

14. 14. The replacement heart valve system of claim 13, wherein the implant delivery system is configured to cooperate with the imaging device to position the replacement heart valve implant within the biological annulus.

15. 15. The replacement heart valve system of claim 13 or 14, wherein when the primary visual indicator is aligned with the reference plane, the secondary visual indicator is visible to the imaging device under fluoroscopy only when the imaging device is aligned with the reference plane associated with the biological valve annulus.

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