Kit for improved replacement heart valve delivery - Patents.com

Abstract

The improved guidewire may include an elongate shaft including a distal section and a proximal section extending proximally from the distal section. The elongate shaft includes a coiled portion disposed within the distal section. The coiled portion is curved in a first direction within a first plane. The elongate shaft includes a reverse curve portion curved in a second direction opposite the first direction. The reverse curve portion is disposed proximal to the coiled portion. A kit for forming the improved guidewire may include a guidewire having a coiled portion and a forming tool configured to form a reverse curve portion in the guidewire proximal to the coiled portion.

Description

[Technical field]

[0001] The present disclosure relates to medical devices and methods for making and / or using medical devices. More particularly, the present disclosure relates to a method and apparatus for delivering a replacement heart valve implant. kit Regarding. [Background technology]

[0002] A wide variety of internal medical devices have been developed for medical applications, for example, for intravascular applications. Some of these devices include guidewires, catheters, medical device delivery systems, and the like (e.g., stents, grafts, replacement valves, and the like). These devices may be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and using medical devices. Summary of the Invention

[0003] In a first example, an improved guidewire for delivering a replacement heart valve implant may include an elongate shaft including a distal section and a proximal section extending proximally from the distal section. The elongate shaft may include a coiled portion disposed within the distal section. The coiled portion may be curved in a first direction within a first plane. The elongate shaft may include a reverse curved portion curved in a second direction opposite the first direction. The reverse curved portion may be disposed proximal to the coiled portion.

[0004] Additionally or alternatively to any example disclosed herein, the reverse curved portion is curved in a second direction within the first plane. In addition or in the alternative to any of the examples disclosed herein, the proximal section of the elongate shaft has a higher lateral stiffness than the distal section of the elongate shaft.

[0005] In addition, or in the alternative, to any of the examples disclosed herein, the distal section of the elongate shaft is distally tapered. In addition or in the alternative to any of the examples disclosed herein, the elongate shaft can include a polymeric coating disposed on the coiled portion.

[0006] In addition or in the alternative to any of the examples disclosed herein, the proximal section of the elongate shaft does not include a polymeric coating. In addition or in the alternative to any of the examples disclosed herein, the reverse curve portion is disposed at least partially within the proximal section of the elongate shaft.

[0007] In addition or in the alternative to any of the examples disclosed herein, the reverse curved portion extends from the distal portion of the proximal section into the distal section. In addition to or in place of any of the examples disclosed herein, a kit for use in delivering a replacement heart valve implant may include a guidewire having an elongate shaft including a distal section and a proximal portion extending proximally from the distal section, the elongate shaft including a coiled portion disposed within the distal section, the coiled portion curved in a first direction within a first plane, and a forming tool configured to form a reverse curved portion in the elongate shaft proximal to the coiled portion to produce an improved guidewire, the reverse curved portion curved in a second direction opposite the first direction.

[0008] In addition or in lieu of any examples disclosed herein, the forming tool includes a base plate, a platform secured to the base plate, a clamp configured to secure a coiled portion of the elongate shaft to the platform, at least one curve-forming element configured to be secured to a post laterally offset from the platform, and a lever arm configured to rotate about the post, The at least one curve-forming element includes a first curve-forming element having an outer surface defining a first radius.

[0009] In addition or in the alternative to any example disclosed herein, the at least one curve-forming element includes a second curve-forming element having an outer surface defining a second radius, the second radius being different from the first radius.

[0010] In addition or in the alternative to any of the examples disclosed herein, the platform includes a recess configured to receive the coiled portion of the elongate shaft. In addition or in the alternative to any of the examples disclosed herein, the clamp is configured to secure the coiled portion of the elongate shaft within the recess of the platform.

[0011] In addition or in the alternative to any of the examples disclosed herein, the reverse curve portion of the improved guidewire is curved in a second direction within the first plane. In addition to or in place of any of the examples disclosed herein, after forming the reverse curved portion of the improved guidewire, the coiled portion extends laterally on either side of a second plane that includes the central longitudinal axis of the proximal section of the improved guidewire, the second plane being substantially perpendicular to the first plane.

[0012] In addition or in lieu of any of the examples disclosed herein, a method of treating a native heart valve of a patient's heart may include the steps of advancing a catheter through the native heart valve and into a ventricle of the patient's heart; advancing an improved guidewire from a distal end of the catheter into the ventricle of the patient's heart, the improved guidewire including an elongated shaft including a distal section and a proximal section extending proximally from the distal section, the elongated shaft including a coiled portion disposed at the distal section, the coiled portion being curved in a first direction within a first plane, the elongated shaft including a reverse curved portion curved in a second direction opposite the first direction, the reverse curved portion disposed proximal to the coiled portion; The method includes positioning the coiled portion of the elongated shaft within a ventricle of the patient's heart such that when the coiled portion of the elongated shaft is positioned within the ventricle of the patient's heart, a distal portion of the proximal section is spaced radially inward from the orifice of the native heart valve; removing the catheter while maintaining the coiled portion of the elongated shaft within the ventricle of the patient's heart; advancing a deployment device over the improved guidewire to the native heart valve; deploying a replacement heart valve implant within the native heart valve, the deployment device including an expandable framework and a plurality of valve leaflets disposed within the expandable framework; and withdrawing the deployment device without contacting the expandable framework of the replacement heart valve implant.

[0013] In addition or in the alternative to any of the examples disclosed herein, the reverse curved portion biases the distal portion of the proximal section of the elongate shaft toward the center of the native heart valve. In addition or in the alternative to any of the examples disclosed herein, the reverse curve portion is disposed at least partially upstream of the native heart valve.

[0014] Additionally or alternatively to any example disclosed herein, the reverse curved portion is curved in a second direction within the first plane. In addition or in the alternative to any of the examples disclosed herein, the proximal section of the elongate shaft has a higher lateral stiffness than the distal section of the elongate shaft.

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

[0016] The present disclosure may be more fully understood from the consideration of the following detailed description in conjunction with the accompanying drawings, in which: [Figure 1] 1 illustrates a schematic of a prior art replacement heart valve delivery system. [Diagram 2] 1 illustrates selected aspects of an exemplary guidewire according to the present disclosure. [Diagram 3] 1 illustrates selected aspects of an exemplary forming tool. [Figure 4] 1 illustrates selected embodiments of a kit including a guidewire and a formation tool. [Diagram 5] 5 illustrates selected aspects of the forming tool of FIGS. 3-4. [Figure 6] 13 illustrates selected aspects of a guidewire of the kit being positioned within a forming tool of the kit. [Figure 7] 1 illustrates selected aspects of forming a guidewire using a forming tool. [Figure 8] 1 illustrates an embodiment of a method for delivering a replacement heart valve implant using an exemplary guidewire of the present disclosure. [Figure 9] 1 illustrates an embodiment of a method for delivering a replacement heart valve implant using an exemplary guidewire of the present disclosure. [Figure 10] 1 illustrates an embodiment of a method for delivering a replacement heart valve implant using an exemplary guidewire of the present disclosure. [Figure 11] 1 illustrates an embodiment of a method for delivering a replacement heart valve implant using an exemplary guidewire of the present disclosure. [Figure 12] 1 illustrates an embodiment of a method for delivering a replacement heart valve implant using an exemplary guidewire of the present disclosure. [Figure 13]1 illustrates an embodiment of a method for delivering a replacement heart valve implant using an exemplary guidewire of the present disclosure.

[0017] While aspects of the disclosure are susceptible to various modifications and alternative forms, details of which 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 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 PREFERRED EMBODIMENTS

[0018] 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, but not to 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 show exemplary embodiments of the present disclosure. However, for clarity and ease of understanding, not all features and / or elements may be shown in each drawing, but the feature(s) and / or element(s) can be understood to be present regardless unless otherwise indicated.

[0019] The following defined terms shall have these definitions applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values, whether explicitly stated or not, are assumed to be modified herein by the term "about". In the context of numerical values, the term "about" generally indicates a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in non-numerical contexts) may be assumed to have their usual customary definition(s) as understood from and consistent with the context of this specification, unless otherwise indicated.

[0020] The recitation of numerical ranges by 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 preferred dimensions, ranges and / or values ​​for various components, features and / or specifications may be disclosed, those skilled in the art inspired by this disclosure will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed.

[0021] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used to mean including "and / or," unless the content clearly dictates otherwise. For ease of understanding, it should be noted that certain features of the present disclosure may be described in the singular even though those features may be multiple or repeated within the disclosed embodiment(s). Each instance of a feature may include and / or be encompassed by the singular disclosure(s) unless expressly stated to the contrary. For purposes of brevity and clarity, not all elements of the present disclosure are necessarily shown in every drawing or discussed in detail below. However, it will be understood that the following discussion may apply equally to any and / or all of two or more components unless expressly stated to the contrary. Moreover, for purposes of clarity, not all instances of some elements or features are shown in every drawing.

[0022] 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 farther from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned to facilitate understanding of the present disclosure, and such cases will be readily apparent to those of ordinary skill in the art. Other relative terms such as "upstream," "downstream," "inflow," and "outflow" refer to the direction of fluid flow within a lumen of a body lumen, blood vessel, etc., or within a device. Still other relative terms such as "axial," "circumferential," "longitudinal," "lateral," "radial," and / or variations thereof generally refer to directions and / or orientations relative to a central longitudinal axis of the disclosed structure or device.

[0023] The term "range" may be understood to mean the maximum measurement of a stated or specified dimension, unless the range or dimension in question is preceded by "minimum" or specified as "minimum", which may be understood to mean the minimum measurement of the stated or specified dimension. For example, an "outer range" may be understood to mean an outer dimension, a "radial range" may be understood to mean a radial dimension, a "longitudinal range" may be understood to mean a longitudinal dimension, and so on. Each instance of "range" may be different (e.g., axially, longitudinally, laterally, radially, circumferentially, etc.) and will be clear to one of skill in the art from the context of the particular usage. In general, a "range" may be considered the largest possible dimension measured according to the intended application, and a "minimum range" may be considered the smallest possible dimension measured according to the intended application. In some cases, a "range" may generally be measured orthogonally in a plane and / or cross section, but may also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc., as is clear from the particular context.

[0024] The terms "monolithic" and "unitary" are intended to generally refer to one or more elements that are made up of or consist of a single structure or basic unit / element. Monolithic and / or unitary are intended to exclude structures and / or features that are made by assembling or otherwise joining together multiple separate structures or elements.

[0025] The terms "transaortic valve implantation" and "transcatheter aortic valve implantation" may be used interchangeably and each may be referred to using the acronym "TAVI." The terms "transaortic valve replacement" and "transcatheter aortic valve replacement" may be used interchangeably and each may be referred to using the acronym "TAVR." The terms TAVI and TAVR may be used to refer to the same or similar procedures, and in at least some embodiments, the terms TAVI and TAVR may be used interchangeably.

[0026] It should be noted that references herein to "an embodiment," "some embodiments," "other embodiments," and the like, indicate that the described embodiment(s) may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, when a particular feature, structure, or characteristic is described in connection with an embodiment, it will be within the knowledge of one of ordinary skill in the art to effect the particular feature, structure, or characteristic in connection with other embodiments, unless expressly stated to the contrary, whether or not explicitly described. That is, it is believed that the various individual elements described below, even if not explicitly shown in a particular combination, can be combined or arranged with one another to form other additional embodiments or to complement and / or enhance the described embodiment(s), as will be understood by one of ordinary skill in the art.

[0027] For 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 the various described and / or claimed features. It should be understood that the numerical nomenclature is not intended to be limiting, but is merely exemplary. In some embodiments, modifications 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" element, a "third" element, etc., or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and / or name in each instance will be apparent to one of ordinary skill in the art.

[0028] Diseases and / or medical conditions affecting the cardiovascular system are prevalent throughout the world. Traditionally, treatment of the cardiovascular system has often been performed by directly accessing the affected portion of the system. For example, treatment of blockages in one or more coronary arteries has traditionally been treated using coronary artery bypass surgery. As can be readily appreciated, such treatments are fairly invasive to the patient and require significant recovery time and / or treatment. More recently, less invasive treatments have been developed, for example, where blocked coronary arteries can be accessed and treated (e.g., angioplasty) via a percutaneous catheter. Such treatments have gained widespread acceptance among patients and clinicians.

[0029] The heart of some mammals (such as humans) includes four heart valves: the tricuspid valve, the pulmonary valve, the aortic valve, and the mitral valve. Several relatively common medical conditions may include or be the result of inefficiency, ineffectiveness, or complete malfunction of one or more of the valves in the heart. Treating defective heart valves poses other challenges in that the treatment often requires repair or complete replacement of the defective valve. Such treatments may be highly invasive to the patient. Disclosed herein are medical devices and / or procedures that may be used within a portion of the cardiovascular system to diagnose, treat, and / or repair the cardiovascular system, for example, during and / or in conjunction with a TAVI or TAVR procedure, or in place of a TAVI or TAVR procedure in patients not suitable for a TAVI or TAVR procedure. At least some of the medical devices and / or procedures disclosed herein may be delivered and / or performed percutaneously and thus may be much less invasive to the patient, although other surgical methods and approaches may also be used. The devices disclosed herein may also provide many additional desirable features and benefits, as described in more detail below. For purposes of this disclosure, the following discussion is directed to the treatment of native aortic valves and is so described for brevity. However, this is not intended to be limiting, and one of ordinary skill in the art will recognize that the following description may also be applied to the mitral valve or another heart valve with no or minimal changes to the structure and / or scope of the present disclosure. Similarly, the medical devices and / or procedures disclosed herein may have application and use in other parts of a patient's anatomy, such as, but not limited to, arteries, veins, and / or other body lumens.

[0030] The figures show selected components and / or arrangements of anatomical structures, guidewires, forming tools, and / or methods of using the guidewires and / or forming tools. It should be noted that in any given figure, some features of the anatomical structures, guidewires, and / or forming tools may not be shown or may be shown diagrammatically for simplicity. Further details regarding some of the components of the anatomical structures, guidewires, and / or forming tools may be shown in more detail in other figures. Furthermore, for clarity, not every instance of some elements or features is shown in every drawing.

[0031] 1 shows a schematic partial cross-sectional view of a portion of a patient's heart 10, including an aortic valve 12 with valve cusps 14, a left ventricle 16, and certain connected vascular systems, such as an aorta 20 connected to the aortic valve 12 of the patient's heart 10 by an aortic arch 22, coronary arteries 24, orifices 23 of the coronary arteries 24, and other aortas 26 (e.g., subclavian, carotid, brachiocephalic) that extend from the aortic arch 22 to vital internal organs. As noted above, for purposes of this disclosure, the discussion herein is directed to use in treating the aortic valve 12 and is so described for brevity. However, this is not intended to be limiting, and one of ordinary skill in the art will recognize that the following discussion may be applied to other heart valves, blood vessels, and / or treatment sites within a patient with no or minimal changes to the structure and / or scope of the present disclosure.

[0032] FIG. 1 further illustrates a prior art example of treating a patient's heart 10 with a schematic example of a replacement heart valve implant 30 disposed within the aortic valve 12 of the patient's heart 10. A prior art guidewire 40 may be positioned with a distal portion 42 disposed within the left ventricle 16, and a delivery device 50 may be advanced over the prior art guidewire 40 to the aortic valve 12. The delivery device 50 is shown in partial cross-section. A typical prior art guidewire 40 may be configured as shown in FIG. 1, and proximal to the distal portion 42, the proximal portion 44 of the prior art guidewire 40 may be substantially straight. That is, the prior art guidewire 40 may be sufficiently flexible to guide the patient's anatomy to the aortic valve 12, but in the absence of any constraints (e.g., vessel walls, catheter walls, tortuous anatomy, etc.), the proximal portion 44 of the prior art guidewire 40 may be substantially straight in an unstressed state. The delivery device 50 generally follows the path of the proximal portion 44 of the prior art guidewire 40. Following deployment of the replacement heart valve implant 30 within the aortic valve 12, the distal portion 52 of the delivery device 50 may be offset toward the orifice of the aortic valve 12 and / or the wall of the aortic arch 22 and / or the aorta 20, as seen in FIG. 1. The natural tendency of the delivery device 50 and / or the prior art guidewire 40 to straighten may also contribute to the discussed positioning. Unfortunately, this may lead to physical contact between the distal portion 52 of the delivery device 50 and the inflow end of the replacement heart valve implant 30 as the delivery device 50 is withdrawn from the patient's heart 10. This physical contact may be undesirable as it may damage the replacement heart valve implant 30, change the positioning and / or orientation of the replacement heart valve implant 30 within the aortic valve 12, and / or dislodge the replacement heart valve implant 30 from the aortic valve 12. Any of these outcomes may be detrimental to the patient.

[0033] FIG. 2 illustrates selected aspects of an improved guidewire 100 for delivering a replacement heart valve implant to a native heart valve (such as, for example, the aortic valve 12). In some embodiments, the improved guidewire 100 may include an elongate shaft 110 including a distal section 112 and a proximal section 114 extending proximally from the distal section 112. In some embodiments, the proximal section 114 may define a central longitudinal axis 116 that may be projected distally of the proximal section 114 for reference. The elongate shaft 110 may include a coiled portion 120 disposed within the distal section 112 in an unbiased and / or unconstrained state, the coiled portion 120 of the elongate shaft 110 being curved in a first direction in a first plane when viewed from proximal to distal. In some embodiments, the coiled portion 120 may be curved in a first direction in a first plane distally along the elongate shaft 110. In some embodiments, the coiled portion 120 may extend in a first direction in a first plane from proximal to distal along the length of the elongate shaft 110. In some embodiments, the central longitudinal axis 116 may be disposed in the first plane. Other configurations are also envisioned. In some embodiments, the first direction may be counterclockwise. In some embodiments, the first direction may be clockwise.

[0034] In some embodiments, the elongate shaft 110 can include a reverse curved portion 130 that is curved in a second direction opposite to the first direction when viewed from proximal to distal in an unbiased and / or unconstrained state. In some embodiments, the reverse curved portion 130 can be disposed in a first plane and / or curved in a second direction in the first plane. In some embodiments, the reverse curved portion 130 can be curved in a second direction in the first plane distally along the elongate shaft 110. In some embodiments, the reverse curved portion 130 can extend in a second direction in the first plane from proximal to distal along the length of the elongate shaft 110. In some embodiments where the first direction is counterclockwise, the second direction can be clockwise. In some embodiments where the first direction is clockwise, the second direction can be counterclockwise. In at least some embodiments, the reverse curved portion 130 can be disposed proximal to the coiled portion 120 of the elongate shaft 110.

[0035] In some embodiments, the reverse curve portion 130 may be at least partially disposed in the proximal section 114 of the elongate shaft 110. In some embodiments, the reverse curve portion 130 may extend from a distal portion of the proximal section 114 of the elongate shaft 110 into the distal section 112 of the elongate shaft 110. In some embodiments, the reverse curve portion 130 may span a junction and / or transition region between the proximal section 114 of the elongate shaft 110 and the distal section 112 of the elongate shaft 110. In some embodiments, the reverse curve portion 130 may be entirely disposed within the proximal section 114 of the elongate shaft 110.

[0036] In some embodiments, the coiled portion 120 of the elongate shaft 110 may extend laterally on either side of a second plane that includes the central longitudinal axis 116 of the proximal section 114 of the elongate shaft 110 in an unbiased and / or unconstrained state. In some embodiments, a first portion of the coiled portion 120 of the elongate shaft 110 may be disposed on a first side of the second plane that includes the central longitudinal axis 116 of the proximal section 114 of the elongate shaft 110, and a second portion of the coiled portion 120 of the elongate shaft 110 may be disposed on a second side of the second plane that includes the central longitudinal axis 116 of the proximal section 114 of the elongate shaft 110, the second side of the second plane being opposite the first side of the second plane with respect to the second plane. In some embodiments, the second plane may be oriented at an oblique angle with respect to the first plane. In at least some embodiments, the second plane may be substantially orthogonal to the first plane.

[0037] In some embodiments, the elongate shaft 110 has a selected level of axial stiffness and / or pushability characteristics, while also having a selected level of lateral stiffness and / or flexibility that allows for navigation through a patient's vasculature. In some embodiments, the proximal section 114 of the elongate shaft 110 has a higher lateral stiffness than the distal section 112 of the elongate shaft 110. In some embodiments, the distal section 112 may be more flexible than the proximal section 114 of the elongate shaft 110. Other configurations are envisioned.

[0038] In some embodiments, the distal section 112 of the elongate shaft 110 may taper radially inward in the distal direction. For example, a proximal portion of the distal section 112 of the elongate shaft may have an outer diameter that is greater than an outer diameter of the distal portion of the distal section 112. In some embodiments, the distal section 112 of the elongate shaft 110 may taper radially inward from the proximal section 114 of the elongate shaft 110 to the distal-most tip of the elongate shaft 110. In some embodiments, the distal section 112 of the elongate shaft 110 may taper continuously in the distal direction. In some embodiments, the distal section 112 of the elongate shaft 110 may taper stepwise in the distal direction. In some embodiments, at least a portion of the coiled portion 120 may taper radially inward in the distal direction. In some embodiments, the entire coiled portion 120 may taper radially inward in the distal direction.

[0039] In some embodiments, the elongate shaft 110 may include and / or be formed from a metallic material. In some embodiments, the elongate shaft 110 is formed from stainless steel. Other configurations are also contemplated. Some suitable, but non-limiting examples of materials for the elongate shaft 110 are described below. In some embodiments, the elongate shaft 110 may include a polymer coating 140 disposed on the coiled portion 120 of the elongate shaft 110 and / or the distal section 112 of the elongate shaft 110. In at least some embodiments, the proximal section 114 of the elongate shaft 110 may not include the polymer coating 140. Some suitable, but non-limiting examples of materials for the polymer coating are described below.

[0040] 3 illustrates selected aspects of a forming tool 200 configured to modify a guidewire 90 (e.g., FIG. 4) into an improved guidewire 100. As seen in FIG. 4, the guidewire 90 may include an elongate shaft including a distal section and a proximal section extending proximally from the distal section, the distal section including a coiled portion 92 formed in a first direction within a first plane in an unbiased and / or unconstrained state. The forming tool 200 may be configured to form a reverse curve portion in the elongate shaft of the guidewire 90 proximal to the coiled portion 92 to form and / or produce the improved guidewire 100.

[0041] In some embodiments, the forming tool 200 may include a base plate 210. The forming tool 200 may include a platform 220 secured to the base plate 210. In some embodiments, the platform 220 may be removably attached to the base plate 210. In some embodiments, the platform 220 may be fixedly attached to the base plate 210. In some embodiments, the platform 220 may be attached to the base plate 210 using mechanical fasteners, adhesive bonds, welding, or the like. These are merely examples, and other configurations are contemplated. Alternatively, in some embodiments, the platform 220 may be integrally formed with and / or monolithic with the base plate 210.

[0042] In some embodiments, the platform 220 may include a first level 222 and a second level 224. In some embodiments, the platform 220 may be stepped. In some embodiments, the platform 220 may be monolithic. In some embodiments, the first level 222 may have and / or define a first cross-sectional area when viewed from and / or in a top view of the forming tool 200 and / or platform 220. In some embodiments, the second level 224 may have and / or define a second cross-sectional area when viewed from and / or in a top view of the forming tool 200 and / or platform 220. In at least some embodiments, the second cross-sectional area may be smaller than the first cross-sectional area. In some embodiments, the second cross-sectional area may be substantially equal to the first cross-sectional area. In some embodiments, when viewed from above the forming tool 200 and / or platform 220, a portion of the first level 222 that extends beyond and / or outside the second level 224 in a top view may define a step 226. In some embodiments, the platform 220 and / or the second level 224 of the platform 220 may include a recess 228 formed therein. In some embodiments, the recess 228 may be formed by removing material from the top surface of the platform 220 and / or the second level 224 of the platform 220. In some embodiments, the recess 228 may be formed integrally and / or simultaneously with the top surface of the platform 220 and / or the second level 224 of the platform 220, such as by casting or injection molding, among other possible methods.

[0043] In some embodiments, the forming tool 200 may include a clamp 230 configured to secure the coiled portion of the elongate shaft of the guidewire 90 to the platform 220, to the top surface of the platform 220 and / or the second level 224 of the platform 220, and / or within the recess 228 of the platform 220 and / or the recess 228 of the second level 224 of the platform 220. In some embodiments, the clamp 230 may include a mounting bracket 232, a clamping foot 234, and a clamping mechanism 236 extending from the mounting bracket 232 to the clamping foot 234. The mounting bracket 232 may be attached to the platform 220 and / or the top surface of the platform 220 and / or the second level 224 of the platform 220. In some embodiments, the mounting bracket 232 may be fixedly attached to the platform 220 and / or the top surface of the platform 220 and / or the second level 224 of the platform 220. In some embodiments, the mounting bracket 232 may be removably attached to the platform 220 and / or to the top surface and / or second level 224 of the platform 220. In some embodiments, the position of the mounting bracket 232 on the platform 220 and / or on the top surface and / or second level 224 of the platform 220 may be adjustable. In some embodiments, the position of the mounting bracket 232 on the platform 220 and / or on the top surface and / or second level 224 of the platform 220 may be fixed.

[0044] The clamping mechanism 236 may be one or more of a variety of suitable mechanical mechanisms for securing the clamping foot 234 and / or the coiled portion of the elongate shaft of the guidewire 90 relative to the platform 220, to the top surface of the platform 220 and / or to the second level 224 of the platform 220, and / or within the recess 228 of the platform 220 and / or the recess 228 of the second level 224 of the platform 220. In some embodiments, the clamping mechanism 236 may include a cam mechanism, an over-center mechanism, a ratchet mechanism, or other suitable means. These are merely examples.

[0045] The forming tool 200 can include at least one curvature forming element 250 configured to be secured to a post 260 laterally offset from the platform 220. The post 260 can be fixedly fastened to the base plate 210. In at least some embodiments, the post 260 can be substantially cylindrical. In some embodiments, the post 260 can define a longitudinal axis that is substantially perpendicular to the base plate 210. In some embodiments, the at least one curvature forming element 250 can be disposed about the post 260. In some embodiments, the at least one curvature forming element 250 can be removably secured to the post 260. The at least one curvature forming element 250 can be configured to slidably engage the post 260. In some embodiments, the at least one curvature forming element 250 can be rotatable relative to the post 260. In some embodiments, the at least one curvature forming element 250 can be non-rotatable relative to the post 260. For example, the at least one curvature forming element 250 and / or the post 260 may include keying features, such as tabs and slots, non-circular shapes, or other structures configured to prevent relative rotation between the at least one curvature forming element 250 and the post 260. In some embodiments, the at least one curvature forming element 250 may be secured to the post 260 using screws, bolts, nuts, pins, or other suitable fasteners or securing means capable of preventing the at least one curvature forming element 250 from becoming dislodged from the post 260.

[0046] In some embodiments, the at least one curve forming element 250 may include one or more of a first curve forming element 252, a second curve forming element 254, a third curve forming element 256, a fourth curve forming element 258, etc. In some embodiments, the at least one curve forming element 250 may include a first curve forming element 252 having an outer surface defining a first radius. In some embodiments, the at least one curve forming element 250 may include a second curve forming element 254 having an outer surface defining a second radius. The second radius may be different from the first radius. In some embodiments, the at least one curve forming element 250 may include a third curve forming element 256 having an outer surface defining a third radius. The third radius may be different from the first radius and the second radius. In some embodiments, the at least one curve forming element 250 may include a fourth curve forming element 258 having an outer surface defining a fourth radius. The fourth radius may be different than the first radius, the second radius, and the third radius. In some embodiments, the at least one curved forming element 250 may have a radius in a range of about 8 millimeters (mm) to about 30 mm. In some embodiments, the first radius may be about 12 mm, the second radius may be about 10.5 mm, the third radius may be about 15 mm, and the fourth radius may be about 8 mm. These are merely examples. Other configurations and / or dimensions are also contemplated.

[0047] In some embodiments, the forming tool 200 may include an inventory area 212 on and / or secured to the base plate 210 for storing one or more of the at least one curved forming element 250 and / or the at least one curved forming element 250 that is not in use and / or has been removed from the post 260. In some embodiments, the inventory area 212 may include a plurality of posts configured to receive the at least one curved forming element 250 thereon. In some embodiments, the inventory area 212 may include a container or compartment having side walls configured to receive and / or hold the at least one curved forming element 250 therein. In some embodiments, the container or compartment may include a removable cover. In some embodiments, the removable cover may be hingedly attached to the container or compartment. Other configurations are also envisioned.

[0048] In some embodiments, the forming tool 200 can include a lever arm 270 having a first end 272 and a second end 274 opposite the first end 272. The lever arm 270 can be configured to rotate about the post 260 at and / or adjacent the first end 272. The lever arm 270 can define an elongated shape having a longitudinal dimension that is greater than a lateral dimension. The lever arm 270 can include a knob 276 fixed and / or disposed at the second end 274. In some embodiments, the knob 276 can be rotatable relative to the lever arm 270. In some embodiments, the knob 276 can be non-rotatable relative to the lever arm 270.

[0049] In some embodiments, the forming tool 200 can include a lever arm 270 and a mounting bar 280 secured to the post 260. In some embodiments, the mounting bar 280 can be rotatably and / or pivotally secured to the post 260. In some embodiments, the lever arm 270 can be movably secured to and / or movably attached to the lever arm 270. In some embodiments, the lever arm 270 can be pivotally attached to the mounting bar 280. In one example, the lever arm 270 can be pivotally attached to the mounting bar 280 by a pin 282 or another mechanical fastener. The pin 282 can be secured to the lever arm 270 and / or the mounting bar 280 by a press fit, a friction fit, an adhesive bond, welding, or the like. Other examples of mechanical fasteners include, but are not limited to, rivets, bolts, screws, and the like. The mounting bar 280 can define a longitudinal dimension that is greater than a lateral dimension. The mounting rod 280 may define a longitudinal mounting rod axis extending through the post 260 and the pin 282. The lever arm 270 may define a longitudinal lever arm axis extending between the axis of the pin 282 and the knob 276.

[0050] When the lever arm 270 is moved in a counterclockwise direction about the post 260, the longitudinal lever arm axis may be aligned with and / or parallel to the longitudinal mounting bar axis. In some embodiments, the lever arm 270 may include one or more protrusions extending from a bottom surface of the lever arm 270 that are configured to engage the mounting bar 280 when the longitudinal lever arm axis is aligned with and / or parallel to the longitudinal mounting bar axis, thus preventing any further relative rotational movement between the lever arm 270 and the mounting bar 280. Other means of preventing relative rotational movement between the lever arm 270 and the mounting bar 280 in the counterclockwise direction are also envisioned. For example, a pin, bolt, fastener, step, stop, or other feature may cause interference between the lever arm 270 and the mounting bar 280, thus preventing relative rotational movement between the lever arm 270 and the mounting bar 280 in the counterclockwise direction. In some embodiments, a bolt or screw may extend through the lever arm 270 to engage the mounting knob 284, which may be tightened to secure the mounting bar 280 to the lever arm 270 and / or tighten the mounting bar 280 against the lever arm 270 and / or increase the frictional resistance to relative movement therebetween. In some embodiments, as described herein with respect to operation of the forming tool 200, the bolt or screw may engage a slot in the lever arm 270 to prevent relative rotational movement between the lever arm 270 and the mounting bar 280 in a counterclockwise direction when the longitudinal lever arm axis is aligned and / or parallel with the longitudinal mounting bar axis, while allowing some relative rotational movement between the lever arm 270 and the mounting bar 280 in a clockwise direction.

[0051] In some embodiments, the lever arm 270 may include at least one detent or recess facing the mounting bar 280, and the mounting bar 280 may include at least one spring-loaded feature configured to engage the at least one detent or recess when the longitudinal lever arm axis is aligned and / or parallel with the longitudinal mounting bar axis. This engagement may be configured to prevent free relative rotational movement in a clockwise direction between the lever arm 270 and the mounting bar 280 when the lever arm 270 is rotated in a clockwise direction, except as described herein with respect to operation of the forming tool 200 and / or until described herein. In some embodiments, free relative rotational movement in a clockwise direction between the lever arm 270 and the mounting bar 280 may be prevented by friction when the lever arm 270 is rotated in a clockwise direction. Other configurations are envisioned.

[0052] In some embodiments, the forming tool 200 can include a guide arm 290 removably and / or movably secured to the platform 220 and / or to the second level 224 of the platform 220. The guide arm 290 can be configured to extend over and / or spaced apart from the first level 222 and / or step 226 of the platform 220. In some embodiments, the guide arm 290 can define a longitudinal dimension that is greater than a lateral dimension. In some embodiments, the guide arm 290 can be configured to move longitudinally toward and / or away from the post 260 and / or at least one curve forming element 250 disposed and / or secured to the post 260. Other configurations and / or movements of the guide arm 290 are also contemplated. In some embodiments, the guide arm 290 can include a distal roller 292 disposed proximate a distal end of the guide arm 290. The distal roller 292 can be configured to engage the at least one curve forming element 250 disposed and / or secured to the post 260. At least a portion of the distal roller 292 may extend distally of the distal end of the guide arm 290. In some embodiments, the distal roller 292 may be configured to translate longitudinally relative to the guide arm 290. In at least some embodiments, the distal roller 292 may be biased distally by a spring. In some embodiments, the spring may be disposed within the guide arm 290. In some embodiments, the spring may be attached to the guide arm 290. Other configurations are also envisioned.

[0053] 4 shows an embodiment of a kit for use in delivering a replacement heart valve implant. The kit may include a forming tool 200 as described herein and a guidewire 90. The guidewire 90 may comprise an elongate shaft including a distal section and a proximal section extending proximally from the distal section, the elongate shaft including a coiled portion disposed within the distal section, the coiled portion being curved in a first direction within a first plane. The forming tool 200 may be configured to form a reverse curved portion in the elongate shaft proximal to the coiled portion to produce an improved guidewire 100 (e.g., FIG. 2) as described herein.

[0054] In Fig. 4, the forming tool 200 is shown in the open position. To place the forming tool 200 in the open position, the lever arm 270 and the mounting bar 280, which may be axially aligned with one another, may be rotated and / or pivoted together in a clockwise direction about the post 260 by moving the knob 276 in a clockwise direction about the post 260 until the mounting bar 280 contacts the first level 222 of the platform 220. This contact stops the rotation of the mounting bar 280. Further and / or continued rotation and / or movement of the knob 276 and / or the second end 274 of the lever arm 270 in a clockwise direction causes the lever arm 270 to pivot about the pin 282, shifting the lever arm 270 out of alignment with the mounting bar 280 such that the longitudinal lever arm axis is tilted relative to the longitudinal mounting bar axis in the open position. The lever arm 270 may be moved over a portion of the first level 222 of the platform 220 and / or over the step 226 of the platform 220 until the lever arm 270 contacts the second level 224 of the platform 220 .

[0055] Pivoting the lever arm 270 about the pin 282 also opens a gap between the first end 272 of the lever arm 270 and at least one curve forming element 250 (such as the first curve forming element 252) disposed on the post 260. In addition, the guide arm 290 may extend over at least a portion of the mounting bar 280 and / or a portion of the lever arm 270. In some embodiments, the first end 272 of the lever arm 270 may include an upper arm portion and a lower arm portion. The upper arm portion may include a beveled corner near and laterally offset from the pin 282, and a portion of the upper arm portion is detached from the lever arm 270. When the forming tool 200 is in the open position, a side of the guide arm 290 may align and / or engage with the beveled corner of the upper arm portion of the lever arm 270. FIG. 5 illustrates selected aspects of the forming tool 200 in greater detail.

[0056] Additionally, as seen in FIG. 5 , the first end 272 of the lever arm 270 may include a roller 278 disposed between the upper and lower arm portions. The roller 278 may have an axis of rotation substantially parallel to the axis of the post 260 and / or the pin 282. The roller 278 may include a groove 279 extending circumferentially around the roller 278. The groove 279 may be formed in an outer surface of the roller 278. The groove 279 may be sized and configured to receive the elongate shaft of the guidewire 90. The groove 279 may be substantially perpendicular to the axis of rotation of the roller 278. In some embodiments, the roller 278 may extend beyond the first end 272 of the lever arm 270. In some embodiments, the roller 278 may be substantially flush with the first end 272 of the lever arm 270. In some embodiments, the roller 278 may be recessed and / or fitted within the first end 272 of the lever arm 270.

[0057] 6 illustrates an embodiment of a method of forming the improved guidewire 100. With the forming tool 200 in an open position, the guidewire 90 can be placed within the forming tool 200. The coiled portion can be placed within the recess 228 of the second level 224 of the platform 220. The elongate shaft of the guidewire 90 can be placed between at least one curve forming element 250 (e.g., the first curve forming element 252) and the first end 272 of the lever arm 270. The elongate shaft of the guidewire 90 can be placed between at least one curve forming element 250 (e.g., the first curve forming element 252) and the distal roller 292 of the guide arm 290.

[0058] The clamp 230 may then be closed onto the coiled portion of the guidewire 90 such that the clamping foot 234 is configured to hold, engage, and / or clamp the coiled portion within and / or against the recess 228 of the second level 224 of the platform 220, as shown in FIG. 7. The distal roller 292 of the guide arm 290 may be configured to bias, engage, and / or press the guidewire 90 against at least one curve forming element 250 (e.g., first curve forming element 252, etc.) disposed on the post 260. In some embodiments, the guide arm 290 may be translated longitudinally towards the post 260 to engage the distal roller 292 against the guidewire 90 and / or at least one curve forming element 250 (e.g., first curve forming element 252, etc.) disposed on the post 260. In some embodiments, when the guide wire 90 is positioned in a position between the distal roller 292 and at least one curve forming element 250 (e.g., the first curve forming element 252, etc.) disposed on the post 260, the spring of the guide arm 290 may be configured to allow the distal roller 292 to translate longitudinally away from the post 260 without moving the guide arm 290 itself, and releasing the spring and / or the distal roller 292 allows the distal roller 292 to translate longitudinally toward the post 260 to engage the guide wire 90 and / or the at least one curve forming element 250 (e.g., the first curve forming element 252, etc.) disposed on the post 260.

[0059] 7, lever arm 270 and / or knob 276 may then be rotated in a counterclockwise direction about post 260 to bend and / or shape guidewire 90 around at least one curve-forming element 250 (e.g., first curve-forming element 252, etc.) disposed on post 260 to form reverse curve portion 130 of improved guidewire 100 (e.g., converting guidewire 90 to improved guidewire 100). When lever arm 270 and / or knob 276 are rotated in a counterclockwise direction about post 260 to form reverse curve portion 130 of improved guidewire 100, roller 278 of lever arm 270 and / or distal roller 292 of guide arm 290 may bias, engage, and / or push guidewire 90 against at least one curve-forming element 250 (e.g., first curve-forming element 252, etc.) disposed on post 260. Furthermore, the guidewire 90 can be positioned within the groove 279 of the roller 278 to prevent the guidewire 90 from moving up and down along the at least one curve-forming element 250 (e.g., first curve-forming element 252, etc.) disposed on the post 260 when the lever arm 270 and / or knob 276 are rotated counterclockwise around the post 260 to form the reverse curve portion 130 of the improved guidewire 100 around the at least one curve-forming element 250 (e.g., first curve-forming element 252, etc.) disposed on the post 260. To manufacture and / or form the improved guidewire 100, after forming the guidewire 90 around the at least one curve-forming element 250 (e.g., first curve-forming element 252, etc.) disposed on the post 260, the reverse curve portion 130 can have a bend radius that matches and / or approximates the radius of the at least one curve-forming element 250 (e.g., first curve-forming element 252, etc.) disposed on the post 260.Thus, by changing at least one curve-forming element 250 (e.g., first curve-forming element 252, etc.) disposed on post 260 to use a different curve-forming element (e.g., second curve-forming element 254, third curve-forming element 256, etc.), it becomes possible to apply different bend radii to guidewire 90 when forming improved guidewire 100 and / or reverse curve portion 130 according to particular needs or patient characteristics.

[0060] 7, the roller 278 and / or the first end 272 of the lever arm 270 may be configured to engage at least one curve-forming element 250 (e.g., first curve-forming element 252, etc.) disposed on the post 260 when the lever arm 270 and the mounting bar 280 are rotated counterclockwise about the post 260. The guidewire 90 may be disposed within a groove 279 of the roller 278 to prevent vertical movement of the guidewire 90 along at least one curve-forming element 252 (e.g., first curve-forming element 250, etc.) disposed on the post 260 when the lever arm 270 and the mounting bar 280 are rotated counterclockwise about the post 260. This may also help ensure that the reverse curve portion 130 is formed in the first plane with the coiled portion 120. Other configurations are envisioned.

[0061] 8-13 illustrate aspects of a method for treating a native heart valve (e.g., aortic valve 12) of a patient's heart 10. As seen in FIG. 8, the method may include advancing a distal end 310 of a catheter 300 through the patient's vascular system (e.g., aorta 20, etc.) to and / or through the native heart valve (e.g., aortic valve 12) into a ventricle 16 of the patient's heart 10. The distal end 310 of the catheter 300 may be positioned within the ventricle 16 of the patient's heart 10. The catheter 300 may include one or more lumens extending through the catheter 300 to the distal end 310. At least one of the one or more lumens may be a guidewire lumen and / or a working lumen. In some embodiments, the patient's heart 10 may be accessed more directly and navigation through the patient's vascular system (e.g., aorta 20) may not be required.

[0062] The method may include advancing an improved guidewire 100 from a distal end 310 of a catheter 300 toward a ventricle 16 of a patient's heart 10, as shown in FIG. 9. The improved guidewire 100 may be configured as described herein. In some embodiments, the improved guidewire 100 may be housed and / or constrained in a straightened configuration within one or more lumens of the catheter 300 as the catheter 300 advances toward a native heart valve (e.g., aortic valve 12) of the patient's heart 10. In some embodiments, the improved guidewire 100 may be advanced simultaneously with and / or within the catheter 300 through the patient's vasculature to a native heart valve (e.g., aortic valve 12) of the patient's heart 10. In some embodiments, the improved guidewire 100 may be advanced through the catheter 300 after the distal end 310 of the catheter 300 is positioned within the ventricle 16 of the patient's heart 10.

[0063] The method may include placing the coiled portion 120 of the elongated shaft 110 of the improved guidewire 100 within the ventricle 16 of the patient's heart 10 such that when the coiled portion 120 of the elongated shaft 110 of the improved guidewire 100 is placed within the ventricle 16 of the patient's heart 10, a distal portion of the proximal section 114 is spaced radially inward from an orifice of a native heart valve (e.g., aortic valve 12). The method may include removing the catheter 300 while maintaining the coiled portion 120 of the improved guidewire 100 within the ventricle 16 of the patient's heart 10, as shown in FIG. 10. FIG. 10 also illustrates the elongated shaft 110 spaced radially inward from an orifice of a native heart valve (e.g., aortic valve 12) when the coiled portion 120 of the elongated shaft 110 of the improved guidewire 100 is placed within the ventricle 16 of the patient's heart 10. The reverse curve portion 130 biases the distal portion of the proximal section 114 of the elongate shaft 110 toward the center of the native heart valve (eg, aortic valve 12) in comparison to the prior art guidewire of FIG.

[0064] The method may include advancing a deployment device 400 over a modified guidewire 100 to a native heart valve (e.g., aortic valve 12) of a patient's heart 10, as seen in FIG. 11. The deployment device 400 is shown in partial cross-section. In some embodiments, the deployment device 400 may include an outer sheath and an inner shaft that is axially translatable relative to the outer sheath. In some embodiments, the inner shaft of the deployment device 400 may include a central guidewire lumen extending therethrough to a distal end of the deployment device 400.

[0065] The deployment device 400 and / or the outer sheath may include a distal containment section having the replacement heart valve implant 430 disposed therein in a restrained and / or collapsed configuration. The distal containment section may include a proximal portion 450 and a distal portion 452. In some embodiments, the proximal portion 450 and the distal portion 452 of the distal containment section may be configured to translate axially relative to one another to open the distal containment section and release the replacement heart valve implant 430. In some embodiments, the proximal portion 450 of the distal containment section may be fixedly attached to the outer sheath and / or may be integrally formed with the outer sheath. In some embodiments, the distal portion 452 of the distal containment section may be fixedly attached to the inner shaft and / or may be integrally formed with the inner shaft. Thus, relative axial translation between the outer sheath and the inner shaft can cause corresponding relative axial translation of the proximal portion 450 of the distal storage segment and the distal portion 452 of the distal storage segment to open the distal storage segment and release the replacement heart valve implant 430. The distal storage segment of the deployment device 400 can be disposed adjacent to and / or within a native heart valve (e.g., aortic valve 12) prior to opening the distal storage segment of the deployment device 400. In at least some embodiments, the distal portion 452 of the distal storage segment can be disposed at least partially upstream of the native heart valve (e.g., aortic valve 12) and / or at least partially within the ventricle 16 of the patient's heart 10 prior to opening the distal storage segment of the deployment device 400.

[0066] The method may include deploying a replacement heart valve implant 430 into a native heart valve (e.g., aortic valve 12) by releasing a distal containment segment of the deployment device 400 while the distal containment segment is disposed within the native heart valve (e.g., aortic valve 12), as seen in FIG. 12. The replacement heart valve implant 430 may include an expandable framework and a plurality of leaflets disposed within the expandable framework. In some embodiments, the expandable framework may be self-expanding. In some embodiments, the expandable framework may be mechanically expandable and / or balloon expandable. Other configurations are also envisioned.

[0067] After opening the distal storage segment, the distal portion 452 of the distal storage segment may be positioned upstream of the native heart valve (e.g., aortic valve 12) and / or within the ventricle 16 of the patient's heart 10, and the proximal portion 450 of the distal storage segment may be positioned downstream of the native heart valve (e.g., aortic valve 12) and / or within the aortic arch 22 and / or aorta 20 of the patient. The reverse curve portion 130 of the elongate shaft 110 of the improved guidewire 100 may be positioned at least partially distal and / or upstream of the native heart valve (e.g., aortic valve 12) and / or within the ventricle 16 of the patient's heart 10. Upon opening the distal storage segment, the replacement heart valve implant 430 may shift towards and / or to the expanded deployed configuration. In some embodiments, the replacement heart valve implant 430 may be released from the distal storage segment and / or the deployment device 400 before shifting to the expanded deployed configuration. In some embodiments, the replacement heart valve implant 430 may be released from the distal containment section and / or deployment device 400 after shifting to the expanded, deployed configuration.

[0068] 12, the reverse curve portion 130 of the elongate shaft 110 of the improved guidewire 100 biases a distal portion of the proximal section 114 (not shown) of the elongate shaft 110 of the improved guidewire 100 toward the center of the native heart valve (e.g., aortic valve 12) and / or away from the orifice of the native heart valve (e.g., aortic valve 12). This arrangement may prevent the distal portion 452 of the distal storage section of the deployment device 400 from contacting the replacement heart valve implant 430 when the deployment device 400 is removed from the patient's heart 10, as seen in FIG.

[0069] In some embodiments, the distal storage section may be closed prior to removal of the deployment device 400 from the patient's heart 10 and / or vasculature. In some embodiments, the deployment device 400 may be positioned and / or retracted within a delivery catheter (not shown) prior to removal from the patient's heart 10 and / or vasculature. Other configurations are also contemplated.

[0070] In some embodiments, the catheter 300, deployment device 400, distal containment segment, and / or elements thereof may include at least one radiopaque marker for visualization during delivery and / or navigation through the patient's vasculature. The at least one radiopaque marker may enable precise placement under fluoroscopic guidance of the distal end 310 of the catheter 300 and / or the distal containment segment of the deployment device 400 relative to the native heart valves (e.g., aortic valve 12), the ventricle 16, and / or the patient's heart 10.

[0071] The various components of the guidewires, catheters, replacement heart valve implants, deployment devices, and / or formation tools (and / or other elements disclosed herein) and materials that may be used for the various components disclosed herein may include those commonly associated with medical devices. For simplicity, the following discussion will refer to medical device(s). However, this is not intended to limit the devices and methods described herein, and the discussion may apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, elongate shafts, outer sheaths, inner shafts, etc. and / or elements or components thereof.

[0072] In some embodiments, the medical device(s) and / or other elements disclosed herein may be made from metals, alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials. Some examples of suitable metals and alloys include stainless steels, such as 444V, 444L, and 314LV stainless steels, mild steels, nickel-titanium alloys, such as linear elastic and / or superelastic Nitinol, other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625, such as INCONEL® 625, UNS:N06022, such as HASTELLOY® C-22®, HASTELLOY® C276®, and the like). nickel-copper alloys (e.g., UNS:N04400, such as MONEL® 400, NICKELVAC® 400, and NICORROS® 400); nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035, such as MP35-N®); nickel-molybdenum alloys (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, and other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as ELGILOY®, and PHYNOX®), platinum strengthened stainless steels, titanium, and combinations thereof, or any other suitable material.

[0073] As mentioned herein, within the family of commercially available nickel-titanium or nitinol alloys, there is a category referred to as "linear elastic" or "non-superelastic" that 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 linear elastic and / or non-superelastic nitinol 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 in a relationship that is substantially linear or some linear but not necessarily entirely linear until plastic deformation begins, or at least more linear than the superelastic plateau and / or flag region that may be found in superelastic nitinol. Thus, for 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.

[0074] In some cases, linear elastic and / or non-superelastic Nitinol may also be distinguished from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol can accommodate a maximum of about 2 to 5% strain while remaining substantially elastic (e.g., before plastic deformation), whereas superelastic Nitinol can accommodate a maximum of about 8% strain before plastic deformation. Both of these materials may be distinguished from other linear elastic materials, such as stainless steel (which may also be distinguished based on its composition), which can accommodate only about 0.2 to 0.44 percent strain before plastic deformation.

[0075] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not exhibit a martensite / austenite phase change detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a wide temperature range. For example, in some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may not have a martensite / austenite phase change detectable by DSC and DMTA analysis in the range of about -60 degrees Celsius (°C) to about 120°C. Thus, the mechanical flexural properties of such materials may generally be inert to the effects of temperature over this very wide temperature range. In some embodiments, the mechanical flexural properties of the linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not exhibit a superelastic plateau and / or flag region. In other words, over a wide temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic characteristics and / or properties.

[0076] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may include nickel in the range of about 50 to about 60 weight percent, with the remainder being substantially titanium. In some embodiments, the composition includes nickel in the range of about 54 to about 57 weight percent. One example of a suitable nickel-titanium alloy is FHP-NT alloy, available from Furukawa Techno Materials, Inc., Kanagawa, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic Nitinol, may be used to achieve desired properties.

[0077] In at least some embodiments, some or all of the medical device(s) and / or other elements disclosed herein may also be doped with, made of, or otherwise include radiopaque materials. A radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image assists the user in determining the location of the medical device(s) and / or other elements disclosed herein. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials filled with radiopaque fillers, and the like. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device(s) and / or other elements disclosed herein to achieve the same results.

[0078] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the medical device(s) and / or other elements disclosed herein. For example, the medical device(s) and / or components or portions thereof may be made of materials that do not substantially distort images and do not create substantial artifacts (e.g., gaps in images). For example, certain ferromagnetic materials may not be suitable because they may create artifacts in MRI images. The medical device(s) or portions thereof may also be made of materials that MRI machines can image. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as ELGILOY®, PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as MP35-N®), nitinol, and the like, and others.

[0079] In some embodiments, the medical device(s) and / or other elements disclosed herein may be made from or include a polymer or other suitable material. Some examples of suitable polymers are polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. Atochem's CRISTAMID®), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, available, for example, under the trade name 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., EMS AmericanThe sheath may include GRILAMID® available from Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, and polymer / metal composites thereof. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0080] In some embodiments, the medical device(s) and / or other elements disclosed herein may include a fabric material disposed on or within the structure. The fabric material may be comprised of a biocompatible material, such as a polymeric material or a biomaterial adapted to promote tissue ingrowth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials such as polyethylene, polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0081] In some embodiments, the medical device(s) and / or other elements disclosed herein may include and / or be formed from fibrous materials. Some examples of suitable fibrous materials may include synthetic threads, which may be flat, shaped, twisted, textured, pre-shrunk or unshrunk. Synthetic biocompatible threads suitable for use in the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylene, polyethylene, polyurethane, polyolefins, polyvinyls, polymethyl acetate, polyamides, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylene. Additionally, at least one of the synthetic threads may be a metal thread or a glass or ceramic thread or fiber. Useful metal threads include threads made of or containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr based alloys. The threads may further include carbon, glass, or ceramic fibers. Desirably, the threads are made of a thermoplastic material, including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, and the like. The yarns may be of the multifilament, monofilament, or spun type. The yarn type and denier selected may be selected to form a biocompatible and implantable prosthesis, and more particularly, a vascular structure, having desirable properties.

[0082] In some embodiments, the medical device(s) and / or other elements disclosed herein may include and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents include antithrombotic agents (such as, for example, heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone)), antiproliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid), anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine), antineoplastic / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors), anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine), anticoagulants, and the like. These may include solidifying agents (such as D-Phe-Pro-Arg chloromethylketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides), vascular cell growth promoters (e.g., growth factor inhibitors, growth factor receptor antagonists, transcription activators and translation promoters), vascular cell growth inhibitors (e.g., growth factor inhibitors, cell growth receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins, etc.), cholesterol lowering agents, vasodilators, and agents that inhibit endogenous vasoactive mechanisms.

[0083] It is to be understood that the present disclosure is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without departing from the scope of the present disclosure. This may include, to the extent appropriate, the use of any of the features of one illustrative embodiment used in another embodiment. The scope of the present disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. A kit for use in delivery of a replacement heart valve implant, comprising: a guidewire comprising an elongate shaft including a distal section and a proximal section extending proximally from the distal section, the elongate shaft including a coiled portion disposed within the distal section, the coiled portion being curved in a first direction within a first plane; a forming tool configured to form a reverse curved portion in the elongate shaft proximal to the coiled portion to produce an improved guidewire, the reverse curved portion being curved in a second direction opposite to the first direction; The forming tool comprises: A base plate; a platform for fixing the base plate; a clamp configured to secure the coiled portion of the elongate shaft to the platform; at least one curvature forming element configured to be secured to a post laterally offset from the platform; a lever arm configured to rotate about the post; The kit, wherein the at least one curve forming element includes a first curve forming element having an outer surface defining a first radius.

2. The kit of claim 1 , wherein the at least one curve forming element includes a second curve forming element having an outer surface defining a second radius, the second radius being different from the first radius.

3. The kit of claim 1 , wherein the platform includes a recess configured to receive the coiled portion of the elongate shaft.

4. The kit of claim 3 , wherein the clamp is configured to secure the coiled portion of the elongate shaft within the recess of the platform.

5. The kit of claim 1 , wherein the reverse curve portion of the improved guidewire is curved in the second direction within the first plane.

6. 6. The kit of claim 1, wherein after forming the reverse curved portion of the improved guidewire, the coiled portion extends laterally on either side of a second plane that includes a central longitudinal axis of the proximal section of the improved guidewire, the second plane being substantially perpendicular to the first plane.

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