Alignment tool for aligning a heart valve with a delivery system

Abstract

The alignment tool includes a body and a plurality of fixed arms extending from the body, each of the plurality of fixed arms adapted to releasably secure the alignment tool to the loader. The alignment tool includes a plurality of alignment arms extending from a body, each of the alignment arms including a first end having an alignment slot and an opposite second end having a handle portion, the alignment arms being movable between a closed configuration defining a minimum distance between the first ends of each of the plurality of alignment arms and an open configuration defining a maximum distance between the first ends of each of the plurality of alignment arms, the plurality of alignment arms being biased to the closed configuration.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices, and more particularly to devices for aligning a heart valve when loaded into a delivery system, and methods of using such medical devices. [Background technology]

[0002] Various medical devices have been developed for medical use, including, for example, prosthetic heart valves for repairing or replacing diseased heart valves. The prosthetic heart valves must be precisely aligned when loaded into a delivery system. Each of the previously known medical devices and methods has certain advantages and disadvantages. There is a continuing need to provide alternative methods for manufacturing and using medical devices and alternative medical devices. Summary of the Invention

[0003] The present disclosure provides design, material, manufacturing method, and specification alternatives for medical devices. An example can be found in an alignment tool for loading a stent having a plurality of alignment loops onto a delivery catheter having a corresponding plurality of alignment pins adapted to be received in the corresponding alignment loops, the stent being positioned within a loader having a loader housing. The alignment tool includes a body and a plurality of fixation arms extending from the body, each of the plurality of fixation arms adapted to releasably secure the alignment tool relative to the loader. The plurality of alignment arms extend from the body, each of the alignment arms including a first end having an alignment slot and an opposite second end having a handle portion, and are movable between a closed configuration defining a minimum distance between the first ends of the plurality of alignment arms and an open configuration defining a maximum distance between the first ends of the plurality of alignment arms. The plurality of alignment arms are biased to the closed configuration.

[0004] Alternatively or additionally, the alignment tool may further include a biasing member that biases the plurality of alignment arms into the closed configuration. Alternatively or additionally, the biasing member may include a garter spring extending around each of the plurality of alignment arms.

[0005] Alternatively or additionally, the biasing member may include an elastomeric member extending around each of the plurality of alignment arms. Alternatively or additionally, the biasing member may include a separate biasing member secured to each of the plurality of alignment arms.

[0006] Alternatively or additionally, the loader housing may include a faceplate adapted to be engaged by the plurality of locking arms when securing the alignment tool to the loader, the faceplate adapted to allow the alignment tool to be secured to the loader within a range of relative rotational positions.

[0007] Alternatively or additionally, the plurality of fixation arms may be monolithically formed as part of the body. Alternatively or additionally, the plurality of alignment arms may be pivotally fixed to the body.

[0008] Another example may be found in an alignment tool for loading a replacement heart valve having a plurality of alignment loops onto a delivery catheter having a corresponding plurality of alignment pins adapted to be received in the corresponding alignment loops, the replacement heart valve being positioned within a loader having a loader housing. The alignment tool includes a body adapted to be releasably secured to the loader. A plurality of alignment arms extend from the body, each of the alignment arms including a first end having an alignment slot and an opposite second end having a handle portion, and are movable between a closed configuration defining a minimum distance between the first ends of the plurality of alignment arms and an open configuration defining a maximum distance between the first ends of the plurality of alignment arms. A biasing member is adapted to bias the plurality of alignment arms toward the closed configuration.

[0009] Alternatively or additionally, the body may include one or more locking arms adapted to releasably secure the alignment tool to the loader. Alternatively or additionally, the body may include an annular structure adapted to releasably secure the alignment tool to the loader.

[0010] Alternatively or additionally, the biasing member may include an annular spring. Alternatively or additionally, the biasing member may include an O-ring. Alternatively or additionally, the plurality of alignment arms may be adapted to move from the closed configuration to the open configuration in response to an inward force applied to the second end of each of the plurality of alignment arms.

[0011] Alternatively or additionally, the second end of each of the plurality of alignment arms may be adapted to accept being compressed together to move from the closed configuration to the open configuration. Alternatively or additionally, the plurality of alignment arms may be adapted to pivot between a closed configuration and an open configuration.

[0012] Alternatively or additionally, the alignment tool may further include a plurality of securing arms extending from the body, each of the plurality of securing arms adapted to releasably secure the alignment tool relative to the loader.

[0013] Alternatively or additionally, the body and the plurality of fixation arms may be co-formed. Alternatively or additionally, the plurality of fixation arms may be adapted to engage a faceplate of the loader when securing the alignment tool to the loader, the faceplate being adapted to allow the alignment tool to be fixed relative to the loader within a range of relative rotational positions.

[0014] Another example can be found in a method of loading a stent onto a stent holder using an alignment tool. The method includes inserting a stent having a plurality of end loops into a stent holder having a plurality of pins on which the plurality of end loops are to be positioned, and securing the alignment tool to the stent holder. The alignment tool includes a body, a plurality of fixation arms extending from the body, each of the plurality of fixation arms adapted to releasably secure the alignment tool to a loader, a plurality of alignment arms extending from the body, each of the plurality of alignment arms including a first end with an alignment slot and an opposite second end with a handle portion, the plurality of alignment arms movable between a closed configuration defining a minimum distance between the first ends of the plurality of alignment arms and an open configuration defining a maximum distance between the first ends of the plurality of alignment arms, and a biasing member that biases the plurality of alignment arms toward the closed configuration. The method includes advancing the stent to move one stent loop over each pin, compressing the stent onto the stent holder, and removing the alignment tool from the stent holder and stent.

[0015] The above summary of some embodiments, aspects and / or examples is not intended to describe each embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. [Brief explanation of the drawings]

[0016] The present disclosure may be more fully understood from a consideration of the following detailed description of various embodiments and the associated accompanying drawings. FIG. 1A shows a stent loop positioned adjacent to a pin on a stent holder prior to compression.

[0017] FIG. 1B shows the stent holder and stent of FIG. 1A with the stent loops precisely aligned and compressed onto the pins. FIG. 1C shows the stent holder and stent of FIG. 1A with the stent loop misplaced and compressed next to the pin.

[0018] FIG. 2 is a perspective view of a delivery system for delivering a replacement heart valve, including an exemplary alignment tool. FIG. 3 is an enlarged partial view of the delivery system in FIG.

[0019] FIG. 4 is a perspective view of an exemplary alignment tool shown in a closed configuration. FIG. 5 is a perspective view of an exemplary alignment tool shown in an open configuration. FIG. 6 is a perspective view of an exemplary alignment tool positioned relative to alignment loops on a stent, with portions of the distal loader removed for clarity.

[0020] FIG. 7 is an enlarged view of a portion of FIG. 6 showing an exemplary alignment tool for aligning alignment pins with alignment loops on a stent. FIG. 8 is a perspective view of an exemplary alignment tool.

[0021] FIG. 9 is a perspective view of an exemplary alignment tool body. FIG. 10 is a perspective view of an exemplary alignment tool body. While aspects of the present disclosure are susceptible to various modifications and alternative forms, specifics have been shown by way of example in the drawings and will be described in detail. It will be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0022] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​herein are assumed to be modified by the term "about," whether explicitly stated or not. In the context of numerical values, the term "about" generally refers to a number that one of ordinary skill in the art would consider equivalent to the stated value (e.g., having a similar function or result). In various instances, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in contexts other than numerical values) are assumed to have their ordinary and accustomed definition as understood from and consistent with the context of the specification, unless otherwise specified.

[0023] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). While various dimensions, ranges and / or values ​​for certain components, features and / or specifications are disclosed, one of ordinary skill in the art inspired by this disclosure will understand that the desired dimensions, ranges and / or values ​​may deviate from those explicitly disclosed.

[0024] As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used herein and in the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise. For ease of understanding, certain features of the present disclosure may be presented in the singular, but it should be noted that these features may be plural or repeated within the disclosed embodiments. Each instance of a feature may include and / or be encompassed by a singular disclosure unless expressly stated otherwise. For simplicity and clarity, not every element of the present disclosure is shown in every figure or described in detail below. However, it will be understood that the following description may apply equally to any and / or all of a component that is present one or more times, unless expressly stated otherwise. Additionally, for clarity, not every instance of some element or feature is shown in every figure.

[0025] Relative terms such as "proximal," "distal," "advance," "retract," and variations thereof may generally be considered with respect to the positioning, orientation, and / or movement of various elements relative to a user / operator / manipulator of a device, with "proximal" and "retract" indicating or referring to being closer to or toward the user, and "distal" and "advance" indicating or referring to being further from or away from the user. For example, the terms "proximal" and "distal" may be assigned arbitrarily to facilitate understanding of this disclosure and, as such, 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 body lumen, a lumen such as a blood vessel, or within a device.

[0026] The term "range" may be understood to mean the maximum measure of a stated or specified dimension, unless the range or dimension in question is preceded by or specified as "minimum," which may be understood to mean the minimum measure of the stated or specified dimension. For example, an "outer range" may be understood to mean the largest outer dimension, a "radial range" may be understood to mean the largest radial dimension, a "longitudinal range" may be understood to mean the largest longitudinal dimension, etc. Each of the examples of "range" may be different (e.g., axially, longitudinally, laterally, radially, circumferentially, etc.) and will be apparent to one of ordinary skill in the art from the context of a particular use. Generally, a "range" may be considered the largest possible dimension measured according to the intended use, while a "minimum range" may be considered the smallest possible dimension measured according to the intended use. For example, a "range" may generally be measured orthogonally in a plane and / or cross-section, but may also be measured differently, including, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc., as will become apparent from the particular context.

[0027] The terms "monolithic" and "unitary" shall generally refer to one or more elements made from or composed of a single structure or base unit / element. Monolithic and / or unitary elements shall exclude structures and / or features made by assembling or otherwise joining together multiple separate elements.

[0028] It should be noted that references herein to "embodiments," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to similar embodiments. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one of ordinary skill in the art to implement that particular feature, structure, or characteristic in connection with other embodiments, unless expressly stated otherwise, whether or not explicitly described. That is, various individual elements described below, even if not explicitly shown in specific combinations, are contemplated as being combinable or configurable with each other to form other or additional embodiments, or to complement and / or enhance the described embodiments, as understood by one of ordinary skill in the art.

[0029] For purposes of clarity, certain distinguishing numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the description and / or claims to name and / or distinguish various description and / or claim features. It will be understood that the numerical nomenclature is not intended to be limiting, but is merely exemplary. In some embodiments, variations and departures from previously used numerical nomenclature may be made for brevity and clarity. That is, a feature identified as a "first" element may later be referred to as a "second," "third," etc., or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and names in each of the examples will be apparent to those of ordinary skill in the art.

[0030] The following description should be read with reference to the drawings, which are not necessarily to scale, and similar elements in different drawings are numbered the same. The detailed description and drawings are intended to illustrate, but not limit, the present disclosure. Those skilled in the art will recognize that the various elements described and / or shown 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. However, for clarity and ease of understanding, not all features and / or elements may be shown in each of the drawings, but the features and / or elements can be understood to be present regardless unless otherwise specified.

[0031] Current prosthetic heart valves, such as the replacement valve and expandable anchor described in U.S. Patent No. 8,992,608, must be precisely loaded into a delivery catheter, such as those described in U.S. Patent Nos. 10,245,145 and 10,682,228, the disclosures of which are incorporated herein by reference. The prosthetic heart valve may include a stent portion with a loop that must be compressed and precisely aligned within the delivery catheter immediately prior to implantation. The loading step can be complex and difficult, and typically occurs in a catheter lab. Components, including the pins on the stent holder and the loops on the stent, are small and difficult to see to achieve precise alignment. The difficulties associated with the alignment step increase the risk of valve misloading, with adverse consequences in terms of loading time if misloading is identified, and / or clinical outcomes related to suboptimal implant positioning if misloading is not identified. Only one misloading is generally tolerated; after a second misloading, the valve and delivery system must be discarded. Loading a prosthetic heart valve and associated stent is a critical part of the implantation procedure, and improvements are desirable.

[0032] Applicants have developed an automated alignment tool that facilitates precise alignment of the stent portion of a prosthetic heart valve with a delivery system to enable smooth preparation and expedite the installation process. Automated alignment of the valve with the delivery system assists individuals in installing the valve and reduces stress and anxiety in a pressurized catheter lab environment. In some examples, the installed heart valve may be a transcatheter aortic valve replacement (TAVR), such as Boston Scientific's ACURATE™ aortic valve system.

[0033] 1A-1C illustrate the loading of a stent portion of a heart valve onto a delivery device and some of the problems that can arise. FIGS. 1A-1C schematically show a portion of a stent holder 10, which is part of the delivery device, and a stent portion 12 of a prosthetic heart valve to be delivered using the delivery device. The stent holder 10 includes multiple pins 14 that must be precisely aligned with corresponding loops 16 that will be formed as the stent portion of the prosthetic heart valve 12. FIG. 1A shows the loops 16 that must be inserted into alignment to engage with the pins 14 prior to compression of the stent portion 12. The loops and pins are small and difficult to see. For example, the loops may be 1.5 mm and the pins may be 0.5 mm (0.060 inches and 0.020 inches, respectively), roughly the size of the tip of a ballpoint pen, making precise alignment difficult. FIG. 1B illustrates the precise alignment of the loops 16 onto the pins 14 and compression of the stent. A problem that can lead to valve deployment failure is when one of the three valve loops 16 is misaligned with one of the three pins 14, as shown in FIG. 1C. When the valve is compressed, it can encapsulate the valve on the stent holder 10 without all three loops properly engaging the three pins. Once the device is encapsulated, any misalignment is difficult to see. If the device were deployed during a clinical scenario, valve positioning and coaxial alignment could be compromised. Because identifying any misalignment in the catheterization lab is the responsibility of the individual who loads the valve, alignment can be a significant source of stress and anxiety. Even if the problem is identified, the valve deployment procedure must be started over, leading to scenarios in which the physician waits for the valve to be deployed and the TAVR procedure is prolonged.

[0034] FIG. 2 is a perspective view of an exemplary valve delivery system 20 that can be used to prepare a replacement heart valve for delivery, as well as to deliver and deploy the replacement heart valve. The exemplary valve delivery system 20 includes a distal loader tool 22 that can be used to prepare a replacement heart valve for securing it to the valve delivery system 20. As shown in FIG. 2, the replacement heart valve is placed within the distal loader tool 22. The valve delivery system 20 includes a delivery catheter 24 and a handle assembly 26 that can be used to actuate the delivery catheter 24 when delivering the replacement heart valve. An exemplary alignment tool 28 is shown fixed relative to the distal loader tool 22. Prior to actuating the distal loader tool 22 to compress the replacement heart valve into an inward position relative to the delivery catheter 24, the alignment tool 28 can be used to align the pins 14 on the stent holder 10 (part of the delivery catheter 24) with the loops 16 formed within the stent portion 12 of the replacement heart valve, as shown in FIGS. 1A-1C . The alignment tool 28 may be considered to provide hands-free operation when secured to the distal loader 22 .

[0035] 3 is an enlarged view of the distal loader tool 22 and the alignment tool 28. The distal loader tool 22 includes a faceplate 30 located at the distal end of the distal loader tool 22. The faceplate 30 includes several reduced diameter portions 32 that accommodate the attachment of the alignment tool 28. As shown, each of the reduced diameter portions 32 extends partially around the periphery of the faceplate 30, thereby allowing adjustment in the rotational alignment of the alignment tool 28 with the faceplate 30.

[0036] FIG. 4 shows a perspective view of the alignment tool 28 in a closed configuration, and FIG. 5 shows a perspective view of the alignment tool 28 in an open configuration. The alignment tool 28 includes a body 34 and a number of fixed arms 36 extending outward from the body 34. In some cases, the fixed arms 36 may be integrally or monolithically formed with the body 34. The body 34 and the fixed arms 36 may be, for example, injection molded as a single structure. In some cases, the fixed arms 36 may be formed separately and then secured to the body 34. Although a total of three fixed arms 36 are shown, this is merely exemplary, and in some cases, the alignment tool 28 may have one or two fixed arms 36, or may have four or more fixed arms 36. However, in some cases, the alignment tool 28 has three fixed arms 36. Each of the fixation arms 36 has a mounting portion 36a that allows the fixation arm 36 to be removably secured to the faceplate 30 (of the distal loader tool 22). In some cases, the mounting portion 36a of each of the fixation arms 36 forms a friction fit with the faceplate 30. In some cases, the mounting portion 36a of each of the fixation arms 36 may be adapted to be snap-fit ​​onto the faceplate 30. The mounting portion 36a of each of the fixation arms 36 may be considered to provide sufficient holding force to hold the alignment tool 28 in position relative to the faceplate 30 of the distal loader tool 22, while allowing the alignment tool 28 to be withdrawn after the alignment tool 28 has completed its task.

[0037] The alignment tool 28 has a plurality of alignment arms 38 movably coupled to a body 34. In some cases, as can be seen by comparing Figures 4 and 5, each of the alignment arms 38 is adapted to pivot relative to the body 34. In some cases, for example, the body 34 may include a pin (not shown) that fits into a corresponding slot formed in the alignment arm 38, allowing each of the alignment arms 38 to pivot relative to the body 34, thereby moving from the closed configuration of Figure 4 to the open configuration of Figure 5. A biasing member 40 extends around each of the alignment arms 38 to bias each of the alignment arms 38 toward the closed configuration.

[0038] In some cases, the biasing member 40 may be a ring spring or garter spring. In some cases, the biasing member 40 may be a resilient member such as a bungee or O-ring. In some cases, the alignment tool 28 may have separate biasing members 40 coupled to each of the alignment arms 38 instead of a single biasing member 40. The biasing members 40 may be adapted to provide a particular biasing force to the alignment arms 38. By way of example, the biasing member 40 may provide a biasing force in the range of 5 to 40 Newtons (N). The biasing member 40 may provide a biasing force in the range of 10 to 30 N. For example, the biasing member 40 may provide a biasing force of approximately 22 N. Comparing FIGS. 4 and 5, it can be seen that the biasing member 40 is stretched when moving from the closed configuration to the open configuration.

[0039] Each of the alignment arms 38 includes an alignment slot 38a located at a first end of the alignment arm 38 and a handle portion 38b located at an opposite second end. The handle portion 38b can be depressed to move each of the alignment arms 38 against a biasing force from a biasing member 40, thus, for example, moving from a closed configuration to an open configuration.

[0040] Figure 6 is a perspective view of an exemplary alignment tool 28 positioned relative to alignment loops 16 on a stent with a portion of the distal loader 22 removed for clarity, and Figure 7 is an enlarged view showing how alignment slots 38a, along with pins 14, help align the loops 16. In Figure 6, a portion of a replacement heart valve 42 can be seen positioned around a portion 44 of the delivery catheter 24, with each loop 16 aligned with a corresponding pin 14, in the process of compressing the replacement heart valve 42, including the stent portion 12. Each loop 16 can be seen extending distally beyond the remainder of the stent portion 12.

[0041] FIG. 8 is a perspective view of an exemplary alignment tool 128. Similar to alignment tool 28, alignment tool 128 includes a body 134, a plurality of securing arms 136 adapted for releasably securing to faceplate 30 of distal loader 22, and a plurality of alignment arms 138 including alignment slots 138a and handle portions 138b. A unique feature of alignment tool 128 relative to alignment tool 28 is that alignment tool 128 does not have a single biasing member 40 but includes separate biasing members 140 disposed along each of alignment arms 138. For example, each of biasing members 140 can be a torsion spring. Each of biasing members 140 can be a linear element formed of a shape memory material that is biased to return to its linear configuration unless any force is applied that deforms biasing member 140.

[0042] 9 is a perspective view of an exemplary alignment tool body 228 that may be used as part of an alignment tool. The alignment tool body 228 includes locking arms 230 that may be adapted to releasably secure the alignment tool 228 to the faceplate 30 of the distal loader tool 22. The locking arms 230 may align with corresponding female boss extrusions on the loader faceplate. The alignment tool body 228 includes a plurality of slots 232 that are adapted to receive and accommodate alignment arms, such as alignment arm 38 or alignment arm 138. The slots 232 are adapted to allow the alignment arms to pivot between an open configuration and a closed configuration.

[0043] 10 is a perspective view of an exemplary alignment tool body 328. The alignment tool body 328 includes a locking ring 330 that can be adapted to releasably secure the alignment tool 228 to the faceplate 30 of the distal loader tool 22. In some cases, the locking ring 330 allows rotation of the alignment tool relative to the distal loader tool 22 to facilitate alignment. The alignment tool 328 includes a plurality of slots 332 that are adapted to receive and accommodate alignment arms, such as alignment arm 38 or alignment arm 138. The slots 332 are adapted to allow the alignment arms to pivot between an open configuration and a closed configuration.

[0044] The alignment tool 28, 128 can be used to assist a user in aligning terminal stent loops on a stent or prosthetic heart valve with pins on a stent holder. A method of using the alignment tool can include inserting a heart valve or stent having multiple terminal loops into a stent holder having multiple pins on which the terminal loops are positioned. For example, as shown in FIG. 6 , the alignment tool 28, 128 can be positioned on the stent holder. The stent can be moved to align with the stent loops that align on the pins. The stent is then compressed onto the stent holder. The alignment tool 28, 128 can then be removed from the stent holder and stent.

[0045] In some embodiments, one or more components of alignment tool 28 (and variations, systems, or components disclosed herein) may be made from a metal, a metal alloy, a ceramic, zirconia, a polymer (some examples are provided below), a metal-polymer composite, a combination thereof, or the like, or any suitable material. Some examples of suitable metals and metal alloys include stainless steels such as 444V, 444L, and 314L stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic Nitinol, cobalt chromium alloys, titanium and its alloys, alumina, metals with diamond-like coatings (DLC) or titanium nitride coatings, other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKEL® 1000, etc.), and the like. VAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as MP35-N®), nickel-molybdenum alloys (UNS: N10665, such as 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., cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS: N44003, such as ELGILOY®, PHYNOX®), platinum strengthened stainless steel, titanium, platinum, palladium, gold, combinations thereof, etc., or any other suitable material.

[0046] As suggested herein, within the family of commercially available nickel-titanium or nitinol alloys, there is a category termed “linear elastic” or “non-superelastic,” which may be chemically similar to traditional shape memory and superelastic varieties but may exhibit distinct and useful mechanical properties. Linear elastic and / or non-superelastic nitinol may be distinguished from superelastic nitinol in that it does not exhibit a substantial “superelastic plateau” or “flag region” in its stress / strain curve as does superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as recoverable strain increases, stress continues to increase substantially linearly, or, although not necessarily perfectly linearly, with a somewhat linear relationship, or at least with a more linear relationship than the superelastic plateau and / or flag region that may be seen in superelastic nitinol, until plastic deformation begins. Thus, for purposes of this disclosure, linear elastic and / or non-superelastic nitinol may be referred to as “substantially” linear elastic and / or non-superelastic nitinol.

[0047] In some cases, linear elastic and / or non-superelastic Nitinol may also be distinguished from superelastic Nitinol in that superelastic Nitinol may accommodate strains of up to about 8% before plastic deformation, while linear elastic and / or non-superelastic Nitinol may accommodate strains of up to about 2-5% while remaining substantially elastic (e.g., before plastic deformation). Both materials may be distinguished from other linear elastic materials, such as stainless steel (which may also be distinguished based on its composition), which may accommodate strains of only about 0.2-0.44% before plastic deformation.

[0048] In some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys are alloys that do not exhibit any martensite / austenite phase changes detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a wide temperature range. For example, in some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys may not exhibit any martensite / austenite phase changes detectable by DSC and DMTA analysis in the range of about -60°C to about 120°C. Thus, the mechanical bending properties of such materials may be generally inert to the effects of temperature over this wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-superelastic nickel-titanium alloys at ambient or room temperatures are substantially the same as the mechanical properties at body temperature, e.g., in that they do not exhibit a superelastic plateau and / or flag region. For example, over a wide temperature range, linear elastic and / or non-superelastic nickel-titanium alloys maintain their linear elastic and / or non-superelastic properties and / or characteristics.

[0049] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may range from about 50-60 weight percent nickel, with the remainder being substantially titanium. In some embodiments, the composition ranges from about 54-57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy, available from Furukawa Techno Material Co., Ltd., Kanagawa, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In other embodiments, a superelastic alloy, such as superelastic nitinol, may be used to achieve the desired properties.

[0050] In some embodiments, one or more components of alignment tool 28 (and variations, systems, or components disclosed herein) may be made from or include a polymer or other suitable material. Some examples of suitable materials are polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetherester (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ether-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer, or Elf® available from Bayer). CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, available, for example, under the trade name 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), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS AmericanThe sheath may include GRILAMID® available from Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, polyurethane silicone copolymer (e.g., Elast-Eon® from AorTech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymer, or other suitable material, or mixtures, combinations, copolymers thereof, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0051] It will be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, the use of any of the features of one illustrative embodiment used in other embodiments. The scope of the disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. An alignment tool for loading a stent having a plurality of alignment loops onto a delivery catheter having a corresponding plurality of alignment pins adapted to be received in the corresponding alignment loops, wherein the stent is positioned within a loader having a loader housing, the alignment tool comprising: The main body and a plurality of fixation arms extending from the body, each of the plurality of fixation arms adapted to releasably fix the alignment tool relative to the loader; a plurality of alignment arms extending from the body, each of the alignment arms including a first end having an alignment slot and an opposite second end having a handle portion, the alignment arms movable between a closed configuration defining a minimum distance between the first ends of each of the plurality of alignment arms and an open configuration defining a maximum distance between the first ends of each of the plurality of alignment arms; Equipped with The alignment tool, wherein the plurality of alignment arms are biased to the closed configuration.

2. further comprising a biasing member biasing the plurality of alignment arms toward the closed configuration. The alignment tool of claim 1 .

3. the biasing member comprises a garter spring extending around each of the plurality of alignment arms; The alignment tool of claim 2 .

4. the biasing member comprises an elastomeric member extending around each of the plurality of alignment arms; The alignment tool of claim 2 .

5. the biasing member comprises a separate biasing member secured to each of the plurality of alignment arms; The alignment tool of claim 2 .

6. the loader housing includes a faceplate adapted to be engaged by the plurality of locking arms when the alignment tool is secured to the loader, the faceplate adapted to allow the alignment tool to be secured to the loader within a range of relative rotational positions; The alignment tool according to any one of claims 1 to 5.

7. 1. An alignment tool for loading a replacement heart valve having a plurality of alignment loops onto a delivery catheter having a corresponding plurality of alignment pins adapted to be received in the corresponding alignment loops, wherein the replacement heart valve is positioned within a loader having a loader housing, the alignment tool comprising: a body adapted to be releasably secured to the loader; a plurality of alignment arms extending from the body, each of the alignment arms including a first end having an alignment slot and an opposite second end having a handle portion, the alignment arms movable between a closed configuration defining a minimum distance between the first ends of each of the plurality of alignment arms and an open configuration defining a maximum distance between the first ends of each of the plurality of alignment arms; a biasing member adapted to bias the plurality of alignment arms into the closed configuration; An alignment tool comprising:

8. the body including one or more locking arms adapted to releasably lock the alignment tool relative to the loader; The alignment tool of claim 7 .

9. the body including an annular structure adapted to releasably secure the alignment tool to the loader; The alignment tool of claim 7 .

10. the biasing member comprises an annular spring; The alignment tool according to any one of claims 7 to 9.

11. the biasing member comprises an O-ring; The alignment tool according to any one of claims 7 to 9.

12. the plurality of alignment arms are adapted to move from the closed configuration to the open configuration in response to an inward force applied to the second end of each of the plurality of alignment arms. The alignment tool according to any one of claims 7 to 11.

13. the second ends of each of the plurality of alignment arms are adapted to be compressed together to move from the closed configuration to the open configuration. The alignment tool according to any one of claims 7 to 12.

14. further comprising a plurality of locking arms extending from the body, each of the plurality of locking arms adapted to releasably secure the alignment tool to the loader. An alignment tool according to any one of claims 7 to 13.

15. 1. A method of loading a stent onto a stent holder using an alignment tool, comprising: Inserting the stent having a plurality of terminal loops into the stent holder having a plurality of pins on which the terminal loops are to be positioned; securing the alignment tool to the stent holder; Equipped with The alignment tool includes: The main body and a plurality of fixation arms extending from the body, each of the plurality of fixation arms adapted to releasably fix the alignment tool relative to a loader; a plurality of alignment arms extending from the body, each of the plurality of alignment arms including a first end having an alignment slot and an opposite second end having a handle portion, the alignment arms movable between a closed configuration defining a minimum distance between the first ends of each of the plurality of alignment arms and an open configuration defining a maximum distance between the first ends of each of the plurality of alignment arms; a biasing member biasing the plurality of alignment arms toward the closed configuration; and advancing the stent to move one stent loop over each pin; compressing the stent onto the stent holder; removing the alignment tool from the stent holder and the stent; A method comprising:

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