Alignment tool for aligning heart valve with delivery system

Abstract

An alignment tool includes a body and a plurality of securing arms extending from the body, each securing arm adapted to releasably secure the alignment tool relative to a loader. The alignment tool further includes said alignment arms extending from the body, each alignment arm including a first end with an alignment slot and an opposing second end with a handle portion, the plurality of alignment arms being movable between a closed configuration in which a distance between the first ends of each alignment arm is minimal and an open configuration in which the alignment arms are spaced apart from the first ends of the alignment arms. The distance between the first ends of each alignment arm is the largest. The plurality of alignment arms are biased to a closed configuration.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 419,400, filed Oct. 26, 2022, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to medical devices, and more particularly to devices for aligning a heart valve when loading the heart valve into a delivery system, and methods of using such medical devices. Background Art

[0004] A variety of medical devices have been developed for medical use, including, for example, artificial heart valves for repairing or replacing diseased heart valves. The artificial heart valve must be precisely aligned when loaded into a delivery system. Among the known medical devices and methods, each has certain advantages and disadvantages. There has been a continuing need to provide alternative medical devices and alternative methods of manufacturing and using medical devices. Summary of the Invention

[0005] The present disclosure provides alternatives in the design, materials, manufacturing methods, and use of medical devices. An example is an alignment tool for loading a stent having a plurality of alignment rings onto a delivery catheter having a corresponding plurality of alignment pins, the alignment pins adapted to be received within corresponding alignment rings, the stent disposed within a loader having a loader housing. The alignment tool includes a body and a plurality of fixed arms extending from the body, each fixed arm adapted to releasably secure the alignment tool relative to the loader. A plurality of alignment arms extend from the body, each alignment arm including a first end having an alignment slot and an opposite second end having a handle portion, the plurality of alignment arms movable between a closed configuration and an open configuration, in the closed configuration, the distance between the first ends of each alignment arm being minimized, and in the open configuration, the distance between the first ends of each alignment arm being maximized. The plurality of alignment arms are biased to the closed configuration.

[0006] Alternatively or additionally, the alignment tool may further include a biasing member that biases the plurality of alignment arms to the closed configuration.

[0007] Alternatively or additionally, the biasing member may include a band spring extending around each alignment arm.

[0008] Alternatively or additionally, the biasing member may include an elastic member extending around each alignment arm.

[0009] Alternatively or additionally, the biasing member may include individual biasing members fixed relative to each alignment arm.

[0010] Alternatively or additionally, the loader housing may include a panel to which a plurality of fixing arms are adapted to engage when the alignment tool is fixed to the loader, and the panel is adapted to allow the alignment tool to be fixed relative to the loader within a range of rotational positions.

[0011] Alternatively or additionally, the plurality of fixing arms may be integrally formed as part of the body.

[0012] Alternatively or additionally, the plurality of alignment arms may be pivotally fixed relative to the body.

[0013] Another example is an alignment tool for loading a replacement heart valve having a plurality of alignment rings onto a delivery catheter having a corresponding plurality of alignment pins, the alignment pins being adapted to be received within the corresponding alignment rings, and the replacement heart valve being disposed in a loader having a loader housing. The alignment tool includes a body adapted to be releasably fixed to the loader. A plurality of alignment arms extend from the body, each alignment arm including a first end having an alignment slot and an opposite second end having a handle portion, and the plurality of alignment arms are movable between a closed configuration and an open configuration, in the closed configuration, the distance between the first ends of each alignment arm is minimized, and in the open configuration, the distance between the first ends of each alignment arm is maximized. A biasing member is adapted to bias the plurality of alignment arms to the closed configuration.

[0014] Alternatively or additionally, the body may include one or more fixing arms adapted to releasably fix the alignment tool relative to the loader.

[0015] Alternatively or additionally, the body may include an annular structure adapted to releasably fix the alignment tool relative to the loader.

[0016] Alternatively or additionally, the biasing member may include an annular spring.

[0017] Alternatively or additionally, the biasing member may include an O-ring.

[0018] Alternatively or additionally, 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 alignment arm.

[0019] Alternatively or additionally, the second ends of each alignment arm are adapted to be squeezed together to move from the closed configuration to the open configuration.

[0020] Alternatively or additionally, the plurality of alignment arms are adapted to pivot between the closed configuration and the open configuration.

[0021] Alternatively or additionally, the alignment tool may further include a plurality of fixing arms extending from the body, each fixing arm being adapted to releasably fix the alignment tool relative to the loader.

[0022] Alternatively or additionally, the body and the plurality of fixing arms may be molded together.

[0023] Alternatively or additionally, the plurality of fixing arms are adapted to engage with a panel of the loader when fixing the alignment tool to the loader, and the panel is adapted to allow the alignment tool to be fixed relative to the loader within a range of relative rotational positions.

[0024] Another example is a method of loading a stent onto a stent retainer using an alignment tool. The method includes inserting a stent having a plurality of terminal rings into a stent retainer having a plurality of pins, the terminal rings being placed on the pins, and fixing the alignment tool to the stent retainer. The alignment tool includes a body; a plurality of fixing arms extending from the body, each fixing arm being adapted to releasably fix the alignment tool relative to the loader; a plurality of alignment arms extending from the body, each alignment arm including a first end having an alignment slot and an opposite second end having a handle portion, the plurality of alignment arms being movable between a closed configuration and an open configuration, in the closed configuration, the distance between the first ends of each alignment arm is minimized, in the open configuration, the distance between the first ends of each alignment arm is maximized; and a biasing member that biases the plurality of alignment arms to the closed configuration. The method includes advancing the stent and moving a stent ring onto a pin, compressing the stent onto the stent retainer, and removing the alignment tool from the stent retainer and the stent.

[0025] The foregoing overview of some embodiments, aspects, and / or examples is not intended to describe every embodiment or every implementation of the present disclosure. The following drawings and detailed description more specifically illustrate these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present disclosure may be more fully understood in connection with the following detailed description of various embodiments, taken in conjunction with the accompanying drawings, in which:

[0027] Figure 1A Showing a stent ring positioned adjacent to a pin on a stent retainer before compression;

[0028] Figure 1B Showing Figure 1A the stent retainer and the stent in, where the stent ring is correctly aligned on the pin and compressed;

[0029] Figure 1C Showing Figure 1A the stent retainer and the stent in, where the stent ring is misaligned and compressed beside the pin;

[0030] Figure 2 is a perspective view of a delivery system for delivering a replacement heart valve, including a schematic alignment tool;

[0031] Figure 3 is Figure 2An enlarged view of a part of the middle conveying system;

[0032] Figure 4 Is a perspective view of a schematic alignment tool in a closed configuration;

[0033] Figure 5 Is a perspective view of a schematic alignment tool in an open configuration;

[0034] Figure 6 Is a perspective view of a schematic alignment tool positioned relative to the alignment ring on the stent, with some parts of the distal loader removed for clarity;

[0035] Figure 7 Is Figure 6 An enlarged view of a part of, showing a schematic alignment tool for aligning the alignment pins with the alignment ring on the stent;

[0036] Figure 8 Is a perspective view of a schematic alignment tool;

[0037] Figure 9 Is a perspective view of the body of a schematic alignment tool;

[0038] Figure 10 Is a perspective view of the body of a schematic alignment tool.

[0039] While various modifications and alternative forms of aspects of the present disclosure are possible, specific examples thereof have been shown in the drawings and will be described in detail. However, it should be understood that the intention is not to limit aspects of the present 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 present disclosure. Detailed Description

[0040] For the terms defined below, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0041] All numerical values herein are assumed to be modified by the term "about" whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a range of numbers that a person of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that round to the nearest significant digit. Unless otherwise specified, other uses of the term "about" (e.g., in non-numerical contexts) may be assumed to have their ordinary and customary definition as understood in the context of the specification and consistent therewith.

[0042] A numerical range expressed in terms of endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges, and / or values related to various components, features, and / or specifications are disclosed, those skilled in the art inspired by the present disclosure should understand that the desired dimensions, ranges, and / or values may differ from those explicitly disclosed.

[0043] As used in this specification and the appended claims, unless the context clearly dictates otherwise, the singular forms "a," "an," and "the" include plural referents. As used in this specification and the appended claims, the term "or" is generally used in its inclusive sense of "and / or" unless the context clearly dictates otherwise. It should be noted that for ease of understanding, some features of the present disclosure may be described in the singular, even though those features may be plural or repeated in the disclosed embodiments. Unless clearly indicated to the contrary, each instance of a feature may include and / or incorporate the singular disclosure. For simplicity and clarity, not all elements of the present disclosure are necessarily shown in each figure or discussed in detail below. However, it should be understood that the following discussion may equally apply to any and / or all of more than one component, unless clearly indicated to the contrary. In addition, for clarity, not all instances of some elements or features are shown in each figure.

[0044] Relative terms such as "proximal," "distal," "advance," "withdraw," and their variants are generally to be considered with respect to the positioning, orientation, and / or operation of various elements relative to the user / operator / handler of the device, where "proximal" and "withdraw" denote or refer to closer to or toward the user, and "distal" and "advance" denote or refer to farther from or away from the user. In some cases, for ease of understanding the present disclosure, the terms "proximal" and "distal" may be arbitrarily designated, and those skilled in the art will readily understand such cases. Other relative terms, such as "upstream," "downstream," "inflow," and "outflow," refer to the direction of fluid flow within a lumen, such as a body cavity, blood vessel, or lumen within a device.

[0045] The term "range" shall be understood to refer to the maximum measurement of the stated or identified dimension, unless the range or dimension being discussed is preceded by "minimum" or is identified as "minimum", in which case it shall be understood to refer to the minimum measurement of the stated or identified dimension. For example, "outer range" may be understood as the maximum outer dimension, "radial range" may be understood as the maximum radial dimension, "longitudinal range" may be understood as the maximum longitudinal dimension, etc. Each instance of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.), and those skilled in the art can clearly understand from the context of specific use. Generally speaking, "range" can be regarded as the maximum possible dimension measured according to the intended use, while "minimum range" can be regarded as the minimum possible dimension measured according to the intended use. In some cases, "range" can usually be measured orthogonally in a plane and / or cross-section, but depending on the specific context, different measurement methods can also be used, such as but not limited to angular measurement, radial measurement, circumferential measurement (e.g., along an arc), etc.

[0046] The terms "integral" and "one-piece" generally refer to one or more elements made or composed of a single structure or basic unit / element. Integral and / or one-piece elements do not include structures and / or features made by assembling or otherwise connecting multiple discrete elements together.

[0047] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include specific features, structures, or characteristics, but not every embodiment necessarily includes that specific feature, structure, or characteristic. Additionally, these phrases do not necessarily refer to the same embodiment. Further, when a specific feature, structure, or characteristic is described in connection with one embodiment, it is within the knowledge of those skilled in the art to implement that specific feature, structure, or characteristic in connection with other embodiments as well, unless expressly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a specific combination, can still be combined or arranged with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, which is understandable to those of ordinary skill in the art.

[0048] For clarity, certain identificatory numerical nomenclatures (e.g., first, second, third, fourth, etc.) may be used throughout the description and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numerical nomenclature is not intended to be restrictive, but is merely exemplary. In some embodiments, for the sake of brevity and clarity, the previously used numerical nomenclature may be changed and deviated from. That is, a feature identified as a "first" element may subsequently be referred to as a "second" element, a "third" element, etc., or may be omitted entirely, and / or different features may be referred to as a "first" element. The meaning and / or designation in each instance will be obvious to those skilled in the art.

[0049] The following description should be read in conjunction with the accompanying drawings, which are not necessarily drawn to scale, and like reference numerals in different drawings designate the same elements. The detailed description and the drawings are intended to illustrate and not to limit the 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 disclosure. The detailed description and the drawings illustrate example embodiments of the disclosure. However, for clarity and ease of understanding, although not every feature and / or element is shown in every drawing, it should be understood that these features and / or elements exist nonetheless, unless otherwise specified.

[0050] Current artificial 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 the delivery catheters described in U.S. Patents Nos. 10,245,145 and 10,682,228, the disclosures of which are incorporated herein by reference. The artificial heart valve may include a stent portion with a ring that must be precisely compressed and aligned within the delivery catheter prior to implantation. The loading step can be complex and difficult and is typically performed in a catheter laboratory. These components, including the pins on the stent retainer and the rings on the stent, are small and difficult to see for precise alignment. The difficulties associated with the alignment step increase the risk of valve loading errors, which can lengthen the loading time if the loading error is recognized; and / or can result in a clinical outcome of non-optimal positioning of the implant if the loading error is not recognized. Typically, only one loading error is allowed, and after a second loading error, the valve and delivery system must be discarded. The loading of the artificial heart valve and associated stent is a critical part of the implantation process and needs improvement.

[0051] The applicant has developed an automatic alignment tool that facilitates the precise alignment of the stent portion of an artificial heart valve with a delivery system, enabling a smooth preparation and accelerating the loading process. The automatic alignment of the valve with the delivery system will assist the person loading the valve and reduce stress and anxiety in the high-pressure catheter laboratory environment. In some examples, the heart valve being loaded may be a transcatheter aortic valve replacement (TAVR) valve, such as the ACURATE TM aortic valve system of Boston Scientific Corporation.

[0052] Figures 1A - 1C Illustrates the loading of the stent portion of a heart valve into a delivery device and some of the difficulties that can occur. Figures 1A - 1C Schematically shows a portion of a stent retainer 10 that is part of a delivery device and a stent portion 12 of an artificial heart valve that will be delivered using the delivery device. The stent retainer 10 includes several pins 14 that need to be precisely aligned with corresponding rings 16 that form the stent portion 12 of the artificial heart valve.Figure 1A Shows the ring 16 that must be moved and aligned before compressing the stent portion 12 to engage with the pin 14. Both the ring and the pin are very small and difficult to see. For example, the ring may be 1.5 millimeters in size and the pin may be 0.5 millimeters in size (0.060 inches and 0.020 inches respectively), approximately the size of the tip of a ballpoint pen, which makes precise alignment difficult. Figure 1B Shows the correct alignment of the ring 16 on the pin 14 and the compression of the stent. One difficulty that may lead to valve loading failure is that, as Figure 1C shown, one of the three valve rings 16 is misaligned with one of the three pins 14 on the stent retainer 10. When the valve is subsequently compressed, there is a possibility that the valve is encapsulated on the stent retainer 10, but not all three rings are correctly engaged with the three pins. Once the device is encapsulated, any misalignment may be difficult to detect. If the device is deployed in a clinical scenario, the positioning and coaxial alignment of the valve may be affected. The person loading the valve is responsible for identifying any misalignment in the catheter laboratory, so alignment can be a significant source of stress and anxiety. Even if a problem is detected, the valve loading process must start from the beginning, causing the doctor to wait for a loaded valve, thus prolonging the TAVR procedure time.

[0053] Figure 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 loading tool 22 that can be used to prepare a replacement heart valve fixed to the valve delivery system 20. As Figure 2 shown, the replacement heart valve is placed within the distal loading 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. Shown in the figure is an exemplary alignment tool 28 fixed relative to the distal loading tool 22. The alignment tool 28 can be used (as Figures 1A - 1C shown) to align the pins 14 on the stent retainer 10 (a part of the delivery catheter 24) with the rings 16 formed within the stent portion 12 of the replacement heart valve before actuating the distal loading tool 22 to compress the replacement heart valve into position relative to the delivery catheter 24. When the alignment tool 28 is adapted to the distal loader 22, it can be considered to achieve a hands-free operation.

[0054] Figure 3An enlarged view of the distal loading tool 22 and the alignment tool 28. The distal loading tool 22 includes a panel 30 at its distal end. The panel 30 includes several reduced-diameter portions 32 for attaching the alignment tool 28. As can be seen, each reduced-diameter portion 32 extends partially around the circumference of the panel 30, thereby providing a certain degree of adjustability in the rotational alignment of the alignment tool 28 with the panel 30.

[0055] Figure 4 A perspective view of the alignment tool 28 in a closed configuration, Figure 5 A perspective view of the alignment tool 28 in an open configuration. The alignment tool 28 includes a body 34 and a plurality of fixed arms 36 extending outwardly from the body 34. In some cases, the fixed arms 36 may be integrally or monolithically formed with the body 34. For example, the body 34 and the fixed arms 36 may be injection molded as a single structure. In some cases, the fixed arms 36 may be formed separately and subsequently attached to the body 34. Although a total of three fixed arms 36 are shown in the figure, this is merely an example, and in some cases, the alignment tool 28 may have only 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 fixed arm 36 has an attachment point 36a through which the fixed arm 36 can be releasably fixed to the panel 30 (of the distal loading tool 22). In some cases, the attachment point 36a of each fixed arm 36 forms a friction fit with the panel 30. In some cases, the attachment point 36a of each fixed arm 36 may be adapted to snap onto the panel 30. The attachment point 36a of each fixed arm 36 can be considered to provide sufficient gripping force to hold the alignment tool 28 in place relative to the panel 30 of the distal loading tool 22 after the alignment tool 28 has completed its task, while allowing the alignment tool 28 to be removed.

[0056] The alignment tool 28 has a plurality of alignment arms 38 movably coupled to the body 34. In some cases, by comparison Figure 4 and Figure 5 it can be seen that each alignment arm 38 is adapted to pivot relative to the body 34. For example, in some cases, the body 34 may include a pin (not shown) that fits into a corresponding slot formed in the alignment arm 38, such that each alignment arm 38 can pivot relative to the body 34, thereby moving from Figure 4 the closed configuration shown to Figure 5 the open configuration shown. A biasing member 40 extends around each alignment arm 38 to bias each alignment arm 38 to the closed configuration.

[0057] In some cases, the biasing member 40 can be an annular spring or a band spring. In some cases, the biasing member 40 can be an elastic member, such as an elastic cord or an O-ring. In some cases, the alignment tool 28 can have separate biasing members coupled to each alignment arm 38 instead of a single biasing member 40. The biasing member 40 can be adapted to provide a specific biasing force to the alignment arms 38. For example, the biasing member 40 can provide a biasing force in the range of 5 to 40 Newtons (N). The biasing member 40 can provide a biasing force in the range of 10 to 30 N. In one example, the biasing member 40 can provide a biasing force of about 22 N. Comparing Figure 4 and Figure 5 it can be seen that the biasing member 40 is stretched when moving from the closed configuration to the open configuration.

[0058] Each alignment arm 38 includes an alignment slot 38a at its first end and a handle portion 38b at its opposite second end. For example, the handle portion 38b can be pressed to move each alignment arm 38 against the biasing force of the biasing member 40, thereby moving from the closed configuration to the open configuration.

[0059] Figure 6 Perspective view of an exemplary alignment tool 28 positioned relative to the alignment ring 16 on the stent; some parts of the distal loader 22 are removed for clarity; Figure 7 Is an enlarged view showing how the alignment slot 38a helps align the ring 16 with the pin 14. In Figure 6 it can be seen that a portion of the replacement heart valve 42 is disposed around a portion 44 of the delivery catheter 24, and during the compression of the replacement heart valve 42 (including the stent portion 12), each ring 16 is aligned with a corresponding pin 14. It can be seen that each ring 16 extends distally beyond the rest of the stent portion 12.

[0060] Figure 8 Perspective view of an exemplary alignment tool 128. Similar to the alignment tool 28, the alignment tool 128 includes a body 134, a plurality of fixing arms 136 adapted to releasably fix to the panel 30 of the distal loader 22, and a plurality of alignment arms 138 including alignment slots 138a and handle portions 138b. A unique feature of the alignment tool 128 relative to the alignment tool 28 is that it does not include a single biasing member 40, but rather includes separate biasing members 140 disposed along each alignment arm 38. For example, each biasing member 140 can be a torsion spring. Each biasing member 140 can be a straight element formed of a shape memory material that is biased to return to its straight configuration in the absence of an external force attempting to deform it.

[0061] Figure 9A perspective view of an exemplary alignment tool body 228 that can be part of an alignment tool. The alignment tool body 228 includes a fixed arm 230 that can be adapted to releasably secure the alignment tool 228 to a panel 30 of the distal loading tool 22. The fixed arm 230 can be aligned with a corresponding concave boss extrusion on the loader panel. 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.

[0062] Figure 10 A perspective view of an exemplary alignment tool body 328. The alignment tool body 328 includes a fixed ring 330 that can be adapted to releasably secure the alignment tool 228 to a panel 30 of the distal loading tool 22. In some cases, the fixed ring 330 allows the alignment tool to rotate relative to the distal loader for alignment. The alignment tool body 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.

[0063] The alignment tools 28, 128 can be used to assist a user in aligning the terminal stent rings on a stent or an artificial heart valve with the pins on a stent retainer. A method of using the alignment tool can include inserting a heart valve or stent having a plurality of terminal rings into a stent retainer having a plurality of pins, and the terminal rings will be placed on these pins. As Figure 6 shown, the alignment tools 28, 128 can be placed on the stent retainer. Move the stent so that the stent rings are aligned with the pins. Then compress the stent onto the stent retainer. Thereafter, the alignment tools 28, 128 can be removed from the stent retainer and the stent.

[0064] In some embodiments, one or more components of the alignment tool 28 (and its variants, systems, or components disclosed herein) can be made of metal, metal alloy, ceramic, zirconia, polymer (some examples are disclosed below), metal-polymer composite, combinations thereof, etc., or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels such as 444V, 444L, and 314LV stainless steels; low carbon steel; nitinol alloys such as linear elastic and / or superelastic nitinol; cobalt-chromium alloys, titanium and its alloys, alumina, metals with diamond-like carbon coating (DLC) or titanium nitride coating, other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625, UNS: N06022, such as UNS: N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel cobalt chromium molybdenum alloy (e.g., UNS: R44035, such as , etc.), nickel molybdenum alloy (e.g., UNS: N10665, such as alloy ), 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 alloy; cobalt chromium molybdenum alloy (e.g., UNS: R44003, such as , etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof, etc.; or any other suitable material.

[0065] As mentioned herein, in the commercially available series of nickel-titanium or nitinol alloys, there is a class designated as "linear elastic" or "non-superelastic", which may exhibit unique and useful mechanical properties even though their chemical compositions may be similar to those of traditional shape memory and superelastic varieties. Linear elastic and / or non-superelastic nitinol differs from superelastic nitinol in that linear elastic and / or non-superelastic nitinol does not show an obvious "superelastic plateau" or "flag region" in its stress / strain curve like superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as the recoverable strain increases, the stress continues to increase in a substantially linear relationship, or to some extent but not necessarily completely linearly, until plastic deformation begins, or at least its relationship is more linear than the superelastic plateau and / or flag region of superelastic nitinol. Thus, for the purposes of this disclosure, linear elastic and / or non-superelastic nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic nitinol.

[0066] In some cases, linear elastic and / or non-superelastic nitinol can also be distinguished from superelastic nitinol because linear elastic and / or non-superelastic nitinol can withstand strains up to about 2 - 5% while remaining substantially elastic (e.g., before plastic deformation), while superelastic nitinol can withstand strains up to about 8% before plastic deformation. Both of these materials can be distinguished from other linear elastic materials (such as stainless steel, which can also be distinguished by its composition), which may only be able to withstand strains of about 0.2 to 0.44% before plastic deformation.

[0067] In some embodiments, a linear elastic and / or non-superelastic nickel-titanium alloy is an alloy in which no martensite / austenite phase transformation can be detected by differential scanning calorimetry (DSC) and dynamic mechanical thermal analysis (DMTA) over a relatively large temperature range. For example, in some embodiments, in a linear elastic and / or non-superelastic nickel-titanium alloy, in the range of about -60 degrees Celsius (°C) to about 120 °C, no martensite / austenite phase transformation can be detected by DSC and DMTA analysis. Thus, the mechanical bending properties of such a material are generally not affected by temperature over this relatively wide temperature range. In some embodiments, the mechanical bending properties of a linear elastic and / or non-superelastic nickel-titanium alloy at ambient temperature or room temperature are substantially the same as the mechanical properties at body temperature. For example, they do not exhibit a superelastic plateau and / or a flag region. For example, over a relatively wide temperature range, a linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic characteristics and / or properties.

[0068] In some embodiments, the weight percentage of nickel in a linear elastic and / or non-superelastic nickel-titanium alloy can be in the range of about 50% to about 60%, with the remainder being substantially titanium. In some embodiments, the weight percentage of nickel in its composition is in the range of about 54% to about 57%. An example of a suitable nickel-titanium alloy is the FHP-NT alloy available from Furukawa Techno Material Co. in Kanagawa, Japan. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUM METAL TM (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic Nitinol, can be used to achieve the desired performance.

[0069] In some embodiments, one or more components of the alignment tool 28 (and its variants, systems, or components disclosed herein) can be made of or include a polymer or other suitable material. Examples of some suitable polymers can include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), fluorinated ethylene propylene copolymer (FEP), polyoxymethylene (POM, e.g., Delrin from DuPont ), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., Arnitel from DSM Engineering Plastics ), ether or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as Hytrel from DuPont ), polyamide (e.g., Durethan from Bayer or Rilsan from Elf Atochem )), elastic polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., sold under the trade name ), ethylene-vinyl acetate copolymers (EVA), silicones, polyethylene (PE), high-density polyethylene, low-density polyethylene, linear low-density polyethylene (e.g., ), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (e.g., of EMS-GRILON, Inc. in the United States), perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, poly(vinylidene chloride) (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, polyurethane-silicone copolymers (e.g., of AorTech Biomaterials or of AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. thereof. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the content of LCP in the mixture can be up to about 6%.

[0070] It should be understood that the present disclosure is merely illustrative in many respects. Changes may be made in details, particularly in the aspects of shape, size, and step arrangement, etc., without departing from the scope of the present disclosure. In appropriate cases, this may include using any feature of one exemplary embodiment in other embodiments. Of course, the scope of the present disclosure is defined by the language used in the appended claims.

Claims

1. An alignment tool for loading a stent having a plurality of alignment rings onto a delivery catheter, the delivery catheter having a corresponding plurality of alignment pins adapted to be received within the corresponding alignment rings, the stent being disposed within a loader having a loader housing, the alignment tool comprising: A body; A plurality of fixing arms extending from the body, each fixing arm being adapted to releasably fix the alignment tool relative to the loader; And A plurality of alignment arms extending from the body, each alignment arm including a first end with an alignment slot and an opposite second end with a handle portion, the plurality of alignment arms being movable between a closed configuration and an open configuration, in the closed configuration, the distance between the first ends of each alignment arm is minimized, and in the open configuration, the distance between the first ends of each alignment arm is maximized; Wherein, the plurality of alignment arms are biased to the closed configuration.

2. The alignment tool according to claim 1, further comprising a biasing member for biasing the plurality of alignment arms to the closed configuration.

3. The alignment tool according to claim 2, wherein, The biasing member includes a band spring extending around each alignment arm.

4. The alignment tool according to claim 2, wherein, The biasing member includes an elastic member extending around each alignment arm.

5. The alignment tool according to claim 2, wherein, The biasing member includes a separate biasing member fixed relative to each alignment arm.

6. The alignment tool according to any one of claims 1 to 5, wherein, The loader housing includes a panel, and when the alignment tool is fixed to the loader, the plurality of fixing arms are adapted to engage with the panel, and the panel is adapted to allow the alignment tool to be fixed relative to the loader within a certain range of relative rotational positions.

7. An alignment tool for loading a replacement heart valve having a plurality of alignment rings onto a delivery catheter, the delivery catheter having a corresponding plurality of alignment pins adapted to be received within the corresponding alignment rings, the replacement heart valve being disposed within a loader having a loader housing, the alignment tool comprising: A body, the body being adapted to be releasably fixed to the loader; A plurality of alignment arms extending from the body, each alignment arm including a first end with an alignment slot and an opposite second end with a handle portion, the plurality of alignment arms being movable between a closed configuration and an open configuration, in the closed configuration, the distance between the first ends of each alignment arm is minimized, and in the open configuration, the distance between the first ends of each alignment arm is maximized; And A biasing member adapted to bias the plurality of alignment arms to the closed configuration.

8. The alignment tool according to claim 7, wherein, The body includes one or more fixing arms adapted to releasably fix the alignment tool relative to the loader.

9. The alignment tool according to claim 7, wherein, The body includes an annular structure, and the annular structure is adapted to releasably fix the alignment tool relative to the loader.

10. The alignment tool according to any one of claims 7 to 9, wherein, The biasing member includes an annular spring.

11. The alignment tool according to any one of claims 7 to 9, wherein, The biasing member includes an O-ring.

12. The alignment tool according to any one of claims 7 to 11, wherein, 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 alignment arm.

13. The alignment tool according to any one of claims 7 to 12, wherein, The second end of each alignment arm is adapted to be squeezed together to move from the closed configuration to the open configuration.

14. The alignment tool according to any one of claims 7 to 13 further includes a plurality of fixed arms extending from the body, each fixed arm being adapted to releasably fix the alignment tool relative to the loader.

15. A method of loading a bracket onto a bracket holder using an alignment tool, the method comprising: Insert a bracket having a plurality of terminal rings into the bracket holder having a plurality of pins, and the terminal rings will be placed on these pins; Fix the alignment tool to the bracket holder, and the alignment tool has: A body; A plurality of fixing arms extending from the body, each fixing arm being adapted to releasably fix the alignment tool relative to the loader; A plurality of alignment arms extending from the body, each alignment arm including a first end with an alignment slot and an opposite second end with a handle portion, the plurality of alignment arms being movable between a closed configuration and an open configuration, in the closed configuration, the distance between the first ends of each alignment arm is minimized, and in the open configuration, the distance between the first ends of each alignment arm is maximized; And A biasing member that biases the plurality of alignment arms to the closed configuration; Push the bracket and move a bracket ring onto a pin; Compress the bracket onto the bracket holder; And Remove the alignment tool from the bracket retainer and the bracket.

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