Integrated basilica system

Abstract

A basilica system for use in a replacement heart valve implant procedure may comprise: a first catheter (420) having a lateral port (426) positioned proximal to the distal end; a conductive guidewire (430) slidably positioned within the first catheter and configured to advance and exit through the lateral port near the leaflets of a replacement heart valve implant positioned within the patient's natural heart valve; a second catheter (440) containing a lumen, the lumen extending to the distal end of the second catheter; and a snare shaft (450) slidably positioned within the second catheter, the snare shaft comprising a wire loop (452) configured to grasp the conductive guidewire. The basilica system may also comprise a delivery catheter (410). The first and second catheters may be positioned within the delivery catheter. The conductive guidewire may be configured to be electrically coupled to an RF energy source. The conductive guidewire may be configured to puncture the valve leaflets.

Description

【Technical Field】 【0001】 The present disclosure generally relates to medical devices, and more specifically to medical devices related to replacement heart valve implants and procedures related thereto. 【Background Art】 【0002】 A wide variety of medical devices for use within the body have been developed for medical applications, including artificial heart valves for the repair or replacement of diseased heart valves. Diseases and / or medical conditions that affect the cardiovascular system are prevalent worldwide. Relatively common medical conditions can include or be the result of one or more valves within the heart being inefficient, ineffective, and completely defective. Treating defective heart valves presents other challenges in that repair or complete replacement of the defective valve is often required. As improvements are made to devices and procedures, replacement heart valve implants are being transplanted into younger, lower-risk (i.e., having a longer average lifespan) patients. In some cases, such patients may live longer than the useful life of their first replacement heart valve implant. 【0003】 In such situations, a second replacement heart valve implantation procedure may be necessary or desirable. The second replacement heart valve implant may be directly implanted within the original / first replacement heart valve implant. However, such placement may present additional risks regarding access to the coronary arteries. As patients age, the need to replace stents in the coronary arteries becomes more common. When a second replacement heart valve implant is implanted, there is a possibility that access for coronary artery treatment and / or intra-coronary treatment will be limited and / or more difficult because the coronary ostium will be partially or completely occluded by the leaflets of the original / first replacement heart valve implant. In some cases, this can be a life-threatening complication, particularly in patients with a low coronary ostium and / or insufficient aortic sinus width. In some cases, due to the shape and / or tissue structure of the aortic sinus (e.g., aortic sinus width), blood may continue to flow into the coronary arteries even if the original / first replacement heart valve implant is held open to the coronary sinus by the second replacement heart valve implant. In the aortic sinus, the leaflets of the original / first replacement heart valve implant may be positioned higher than the natural leaflets, thus exacerbating this risk in valve-in-valve procedures and increasing the likelihood of partial or complete occlusion of the coronary artery ostium. 【0004】 When treating coronary arteries, the coronary ostium is accessed from within one or more replacement heart valve implants. If the leaflets of the original / first replacement heart valve implant partially or completely block access to the coronary artery from inside the implant, positioning and / or accessing the coronary ostium may become more difficult and / or require additional time, thereby increasing the risk to the patient. 【0005】 A valve leaflet splitting procedure known as "basilica" has been developed, which involves modifying the leaflets of the original / first replacement valve implant before implanting a second replacement valve implant to improve access to the coronary artery ostium. However, currently there is no user-friendly, dedicated device designed for the basilica procedure, and performing it accurately using "standard" equipment can be extremely difficult. There is a continuing need to provide alternative medical devices and / or systems, as well as alternative manufacturing methods and methods of use for such medical devices and / or systems. [Overview of the Initiative] 【0006】 In one example, a basilica system for use in a replacement heart valve implant procedure may comprise a pigtail catheter, a conductive guidewire, a snare catheter, and a snare shaft, wherein the pigtail catheter has a lateral port located proximal to the distal end of the pigtail catheter, the conductive guidewire is slidably positioned within the first lumen of the pigtail catheter and configured to advance and exit through the lateral port near the leaflets of a replacement heart valve implant positioned within the patient's natural heart valve, the snare catheter includes a lumen extending to the distal end of the snare catheter, and the snare shaft is slidably positioned within the lumen of the snare catheter and comprises a wire loop extending from the distal end of the snare shaft and configured to grasp the distal end of the conductive guidewire. 【0007】 In addition to or instead of any example disclosed herein, the pigtail catheter may further comprise a second lumen extending proximal to the distal tip of the pigtail catheter. 【0008】 In addition to or instead of any example disclosed herein, the first lumen extends proximal to the lateral port. In addition to or instead of any example disclosed herein, the pigtail catheter comprises a pre-formed recurved portion proximal to the distal tip of the pigtail catheter in an unrestrained configuration. 【0009】 In addition to or instead of any example disclosed herein, the side ports are located near the base of the pre-formed recurved portion. In addition to or instead of any examples disclosed herein, typically the centerline of the pre-formed recurved portion is located in a plane, and the side ports open substantially perpendicular to that plane. 【0010】 In addition to or instead of any example disclosed herein, the distal portion of the snare catheter is provided with a pre-formed bend in an unrestrained configuration. In addition to or instead of any example disclosed herein, the pre-formed bend may be configured to orient the distal end of the snare catheter toward the lateral port of the pigtail catheter. 【0011】 In addition to or instead of any example disclosed herein, the pre-formed bend causes the distal end of the snare catheter to be oriented at an inclination with respect to the longitudinal axis of the snare catheter. 【0012】 In addition to or instead of any example disclosed herein, the basilica system may further comprise a delivery catheter. In addition to or instead of any example disclosed herein, the pigtail catheter and the snare catheter are slidably arranged within the delivery catheter. 【0013】 In addition to or instead of any example disclosed herein, the basilica system may further comprise an RF energy source electrically coupled to the conductive guidewire. In addition to or instead of any examples disclosed herein, a basilica system for use in a replacement heart valve implant procedure may comprise a delivery catheter, a first catheter slidably disposed within the delivery catheter, a second catheter slidably disposed within the delivery catheter, a conductive guidewire slidably disposed within the first catheter and configured to be electrically coupled to an RF energy source, with a distal end configured to puncture the leaflets of a replacement heart valve implant, and a snare shaft slidably disposed within the lumen of the second catheter, with a wire loop extending from the distal end of the snare shaft and configured to grasp the distal end of the conductive guidewire. 【0014】 In addition to or instead of any example disclosed herein, in a deployed configuration, the first catheter comprises a pre-formed recurved portion located proximal to the distal tip and an elongated portion extending proximal to the pre-formed recurved portion. 【0015】 In addition to or instead of any example disclosed herein, when the first catheter is in its deployed state, the first catheter comprises a side port located on a pre-formed recurved portion of the first catheter. 【0016】 In addition to or instead of any example disclosed herein, the pre-formed recurved portion is shaped and configured to align with the tip of the valve leaflet of the replacement heart valve implant. 【0017】 In addition to or instead of any example disclosed herein, in a deployed configuration, the second catheter includes a distal portion having a pre-formed bend configured to orient the distal tip of the second catheter toward the lateral port. 【0018】 In addition to or instead of any examples disclosed herein, when the first catheter is in an unfolded state and the second catheter is in an unfolded state, distal advance of the delivery catheter relative to the first catheter and the second catheter biases the distal end of the second catheter closer to the lateral port formed in the first catheter than the distal tip of the first catheter. 【0019】 In addition to or instead of any example disclosed herein, if the second distal end is very close to the side port, the side port is configured to direct the conductive wire toward the wire loop as the conductive wire is advanced distally relative to the first catheter. 【0020】 In addition to or instead of any examples disclosed herein, a method for splitting the leaflets of a replacement heart valve implant placed in a patient's natural heart valve may include advancing a delivery catheter to a position adjacent to the delivery heart valve implant; advancing a first catheter distally from the delivery catheter to a position adjacent to the outer surface of the leaflet; advancing a second catheter distally from the delivery catheter to a position adjacent to the inner surface of the leaflet; advancing the delivery catheter distally relative to the first and second catheters so that the distal end of the second catheter is directed toward a lateral port formed in the first catheter that is more proximal to the distal tip of the first catheter; advancing a conductive guidewire out of the first catheter through the leaflet at the puncture site; grasping the conductive guidewire having a wire loop extending from the second catheter; and pulling the conductive guidewire through the leaflet to tear the leaflet from the puncture site to the free end of the leaflet. 【0021】 In addition to or instead of any of the examples disclosed herein, the method may further include adding RF energy to the conductive guide wire while pulling the conductive guide wire through the valve tip to tear the valve tip. 【0022】 In addition to or instead of any of the examples disclosed herein, advancing the conductive guide wire out of the first catheter through the valve tip includes advancing the distal end of the conductive guide wire to the wire loop. 【0023】 In addition to or instead of any of the examples disclosed herein, the first catheter includes a pre-formed re-curved portion disposed proximal to the distal tip in the deployed configuration, and advancing the first catheter distally out of the delivery catheter to a position adjacent to the outer surface of the valve tip further includes disposing the pre-formed re-curved portion at the tip of the valve tip such that the side port faces the valve tip. 【0024】 In addition to or instead of any of the examples disclosed herein, the method may further include pulling the wire loop back to the second catheter to pull the distal end of the conductive guide wire to the second catheter before pulling the conductive guide wire through the valve tip to tear the valve tip. 【0025】 The above summary regarding some embodiments, aspects, and / or examples is not intended to describe every disclosed embodiment or every implementation of the present disclosure. The drawings and the following detailed description illustrate these embodiments more specifically. 【Brief Description of the Drawings】 【0026】 The present disclosure may be more fully understood by considering the following detailed description in combination with the accompanying drawings. [Figure 1] FIG. 1 is a partial cross-sectional view showing a selected aspect of a replacement heart valve implant disposed within a native valve annulus of the heart. [Figure 2] Figure 2 is a partial cross-sectional view showing a selected aspect of an implantable heart valve replacement disposed within the native annulus of the heart. [Figure 3] Figure 3 is a schematic view showing a selected aspect regarding implanting a second implantable heart valve replacement within a first implantable heart valve replacement as seen from the aortic sinus. [Figure 4] Figure 4 shows a selected aspect of the basilica procedure. [Figure 5] Figure 5 shows a selected aspect of the basilica procedure. [Figure 6] Figure 6 schematically shows a second implantable heart valve replacement implanted within a first implantable heart valve replacement after the basilica procedure. [Figure 7] Figure 7 is a schematic view illustrating a selected aspect regarding implanting a second implantable heart valve replacement within a first implantable heart valve replacement after the basilica procedure as seen from the aortic sinus. [Figure 8] Figure 8 illustrates a selected aspect of an integrated basilica system according to the present disclosure. [Figure 9] Figure 9 illustrates a selected aspect of an integrated basilica system according to the present disclosure. [Figure 10] Figure 10 illustrates a selected aspect of the basilica procedure using the integrated basilica system of the present disclosure. [Figure 11] Figure 11 illustrates a selected aspect of the basilica procedure using the integrated basilica system of the present disclosure. [Figure 12] Figure 12 illustrates a selected aspect of the basilica procedure using the integrated basilica system of the present disclosure. [Figure 13] Figure 13 illustrates a selected aspect of the basilica procedure using the integrated basilica system of the present disclosure. 【0027】 The embodiments of this disclosure can be modified in various ways and alternative forms, specific examples of which are illustrated and described in detail in the drawings. However, it should be understood that the intent is not to limit the embodiments of this disclosure to the specific embodiments described. On the contrary, the intent is to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. [Modes for carrying out the invention] 【0028】 The following description should be read with reference to the drawings (not necessarily to scale), and similar reference numbers indicate similar elements across several drawings. The detailed description and drawings are intended to illustrate, not limit, the present disclosure. Those skilled in the art will recognize that the various elements described and / or illustrated may be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings illustrate exemplary embodiments of the present disclosure. 【0029】 Unless otherwise defined in the claims or elsewhere in this specification, the terms defined below should apply. In this specification, all numerical values, whether expressly indicated or not, are assumed to be modified by the term “about.” In the context of numerical values, “about” refers to a range of numerical values ​​that a person skilled in the art would ordinarily consider equivalent to (e.g., having the same function or result as) the value stated. In many cases, “about” may include numerical values ​​rounded to the nearest significant figure. Other uses of the term “about” (e.g., in non-numerical contexts) are assumed to have one or more general and conventional definitions so as to be understood from and consistent with the context of this specification, unless otherwise specified. 【0030】 Numerical ranges with multiple endpoints include all numbers within the range that include those endpoints (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). While several suitable dimensions, ranges, and / or numerical values ​​relating to various components, shapes, and / or features are disclosed, a person skilled in the art, motivated by this disclosure, will understand that desired dimensions, ranges, and / or numerical values ​​may deviate from those explicitly disclosed. 【0031】 When used herein and in the appended claims, the singular forms “a,” “an,” and “the” include multiple subjects unless explicitly indicated otherwise. When used herein and in the appended claims, the term “or” is generally adopted to include “and / or” unless explicitly indicated otherwise. For ease of understanding, even if certain forms of this disclosure may be multiple or may occur repeatedly in one or more disclosed embodiments, these forms may be described singularly. Each example of this form may include and / or be encompassed by a singular disclosure unless explicitly stated otherwise. For example, a reference to one form is equally referenced to all examples and equivalents of the form mentioned, more than one, unless explicitly stated otherwise. It will be understood that the following discussion applies equally to any and / or all components that exist in multiples within a device, etc., unless explicitly stated otherwise. 【0032】 Relative terms such as “proximal,” “distal,” “forward,” “backward,” and their variations can typically be thought of in relation to the arrangement, orientation, and / or operation of various elements of the device with respect to the user / operator / manipulator, where “proximal” and “backward” indicate or refer to being closer to or toward the user, and “distal” and “forward” indicate or refer to being further away from or away from the user. In some examples, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of this disclosure, and such examples will already be apparent to those skilled in the art. Other relative terms, e.g., “upstream,” “downstream,” “inflow,” and “outflow,” refer to the direction of fluid flow within a lumen (e.g., a body lumen, blood vessel, or within a device). Further relative terms, e.g., “axial,” “circumferential,” “longitudinal,” “lateral,” “radial,” and / or their variations, typically refer to the direction and / or orientation with respect to the central longitudinal axis of the disclosed structure or device. 【0033】 The term “extent” may be understood to mean the maximum measurement of a described or specified dimension unless the range or dimension in question is preceded or specified in the same way by “minimum” and is not understood to mean the minimum measurement of the described or specified dimension. For example, “outer range” may be understood to mean the outer dimension, “radial range” may be understood to mean the radial dimension, and “longitudinal range” may be understood to mean the longitudinal dimension. Each example of “range” can be varied (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be evident to those skilled in the art from the context of the individual use. Generally, “range” may be understood to be the maximum dimension that could have been measured according to the intended use, while “minimum range” may be understood to be the minimum dimension that could have been measured according to the intended use. In some cases, the “range” can usually be measured orthogonally within a plane and / or a cross-section, but as will be apparent to those skilled in the art, it can also be measured in various ways (for example, but not limited to, in the direction of an angle, radially, circumferentially (for example, along an arc), etc.). 【0034】 The terms “integrated” and “unit” usually refer to a single element or a single structure or multiple elements formed from or consisting of a single basic unit / element. Integrated elements and / or unit elements do not include structures and / or forms formed by assembling or combining a number of separate structures or elements. 【0035】 References in the specification such as “one embodiment,” “several embodiments,” and “other embodiments” indicate that the described (one or more) embodiments may include special features, structures, or properties, but it should be understood that not all embodiments necessarily exhibit such special features, structures, or properties. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a special feature, structure, or property is described in combination with a particular embodiment, implementing that special feature, structure, or property in combination with other embodiments is within the knowledge of those skilled in the art, whether explicitly described or not, unless explicitly stated otherwise. In other words, the various individual elements described below, even if explicitly shown in a particular combination, are still considered to be combinatorial or modifiable to form other additional embodiments or to complement and / or reinforce the described (one or more) embodiments, as can be understood by those skilled in the art. 【0036】 For clarity, specific identifying numerical nomenclature (e.g., First, Second, Third, Fourth, etc.) may be used throughout this specification and / or claims to name and / or distinguish between various described and / or claimed features. It should be understood that such numerical nomenclature is not intended to be restrictive and is illustrative only. In some embodiments, changes and deviations from previously used numerical nomenclature may be made for the sake of brevity and clarity. That is, a form identified as the “First” element may subsequently be referred to as the “Second” element, the “Third” element, etc., or may be omitted entirely, and / or a different form may be referred to as the “First” element. The meaning and / or indication in each example will be obvious to those skilled in the art. 【0037】 Furthermore, it should be noted that in any accompanying drawings, some features are not shown or are shown schematically for clarity and / or brevity. Further details regarding some components and / or method steps may be illustrated in more detail in other drawings. The apparatus and / or method disclosed herein may offer a number of desired features and advantages, as will be described in more detail below. 【0038】 Figure 1 shows a schematic partial cutaway of a portion of a patient's heart 10, including the aortic valve 12 having a natural leaflet 14 located within and / or extending from the natural annulus, the left ventricle 16, and certain connected vascular structures (e.g., the aorta 20 connected to the aortic valve 12 of the patient's heart 10 by the aortic arch 22 and ascending aorta, the coronary ostium 23 of the coronary arteries 24 extending from the aortic sinus and / or ascending aorta, and other large arteries 26 extending from the aortic arch 22 to vital viscera (e.g., the subclavian artery and / or carotid artery, etc.)). For the purposes of this disclosure, the discussion herein shall be focused on the treatment of the aortic valve 12 and may be described as such for the sake of brevity. However, this is not intended to be limiting, as those skilled in the art will recognize that the following discussion may also apply to other heart valves, blood vessels and / or treatment sites within a patient. 【0039】 Figure 1 further illustrates selected embodiments of a replacement heart valve implant 100 positioned within and / or within the original annulus of the aortic valve 12. It should be understood that the replacement heart valve implant 100 can be any type of replacement heart valve (e.g., mitral valve, aortic valve, etc.). When in use, the replacement heart valve implant 100 may be implemented in the aortic valve 12 of the heart 10 (e.g., by transcatheter delivery). The replacement heart valve implant 100 may be configured to allow unidirectional flow through the replacement heart valve implant 100 from the inlet end to the outlet end. 【0040】 The replacement heart valve implant 100 may comprise an expandable framework 110 defining the central lumen. Some suitable, but not limited, examples of materials that may be used to form the expandable framework 110 are described below, and include, but are not limited to, metals and alloys, composites, ceramics, polymers, etc. The replacement heart valve implant 100 and / or the expandable framework 110 may be configured to transition between a radially compressed state and a radially expanded state. In some embodiments, the expandable framework 110 may be self-expanding. In some embodiments, the expandable framework 110 may be self-deflecting toward a radially expanded state. In some embodiments, the expandable framework 110 may be mechanically expandable. In some embodiments, the expandable framework 110 may be balloon expandable. 【0041】 In some embodiments, the replacement heart valve implant 100 may include a plurality of leaflets 120 positioned within the central lumen. The plurality of leaflets 120 may be coupled to and fixed and / or securely attached to an expandable framework 110 at a plurality of joints 112. The plurality of leaflets 120 may be configured to transition between an open position and an closed position. The plurality of leaflets 120 may be configured to substantially restrict the flow of fluid through the replacement heart valve implant 100 in the closed position. The plurality of leaflets 120 may move away from each other in the open position to allow fluid to flow through the replacement heart valve implant 100. 【0042】 In some embodiments, the multiple valve leaflets 120 may be composed of a polymer (e.g., a thermoplastic polymer). In some embodiments, the multiple valve leaflets 120 may contain at least 50% by weight of polymer. In some embodiments, the multiple valve leaflets 120 may be formed from bovine pericardium or other biological tissue. Other configurations and / or other materials are also considered. 【0043】 Figure 2 illustrates a selected embodiment of a replacement heart valve implant 200 (e.g., a surgically replaced heart valve implant) positioned within the aortic valve 12 and / or the original annulus of the aortic valve 12. It should be understood that the replacement heart valve implant 200 can be any type of replacement heart valve (e.g., mitral valve, aortic valve, etc.). When in use, the replacement heart valve implant 200 may be implemented in the aortic valve 12 of the heart 10 (e.g., by surgical delivery). In at least some surgical delivery procedures, the original valve leaflets may be resected, as shown in Figure 2. The replacement heart valve implant 200 may be configured to allow unidirectional flow through the replacement heart valve implant 200 from the inlet end to the outlet end. 【0044】 The replacement heart valve implant 200 may comprise an expandable framework 210 defining the central lumen. Several suitable, but not limited, examples of materials that may be used to form the expandable framework 210 are described below, including, but not limited to, metals and alloys, composites, ceramics, polymers, etc. The replacement heart valve implant 200 and / or the expandable framework 210 may be configured to transition between a radially compressed state and a radially expanded state. In some embodiments, the expandable framework 210 may be self-expanding. In some embodiments, the expandable framework 210 may be self-deflecting toward a radially expanded state. In some embodiments, the expandable framework 210 may be mechanically expandable. In some embodiments, the expandable framework 210 may be balloon-expandable. 【0045】 In some embodiments, the replacement heart valve implant 200 may include a plurality of leaflets 220 coupled to and fixed and / or securely attached to an expandable framework 210 at a plurality of joints 212. The plurality of leaflets 220 may be configured to transition between an open position and an closed position. The plurality of leaflets 220 may be configured to substantially restrict the flow of fluid through the replacement heart valve implant 200 in the closed position. The plurality of leaflets 220 may move away from each other in the open position to allow fluid to flow through the replacement heart valve implant 200. 【0046】 In some embodiments, the multiple valve leaflets 220 may be composed of a polymer (e.g., a thermoplastic polymer). In some embodiments, the multiple valve leaflets 220 may contain at least 50% by weight of polymer. In some embodiments, the multiple valve leaflets 220 may be formed from bovine pericardium or other biological tissue. Other configurations and / or other materials are also considered. 【0047】 To advance the discussion, the form and / or procedure relating to the placement of a second replacement heart valve implant (e.g., replacement heart valve implant 100, similar device, etc.) delivered via a transcatheter procedure (although this is not strictly required) and implanted within a first replacement heart valve implant (e.g., replacement heart valve implant 200, similar device, etc.) is described. When used herein, the terms “first replacement heart valve implant” (which may be used herein interchangeably with “first replacement heart valve implant” or “original replacement heart valve implant”) and “second replacement heart valve implant” are not intended to indicate the order of implantation or placement. As illustrated, the drawing shows a transcatheter replacement heart valve implant (e.g., “TAV” device) as the second replacement heart valve implant, positioned and / or implanted within a surgical replacement heart valve implant (e.g., “SAV” device) as the first replacement heart valve implant. This is not intended to be limiting, and the device may be reversed and / or interchangeable with any combination within the scope of this disclosure (e.g., a SAV device in a TAV device, a TAV device in a TAV device, etc.). 【0048】 Figure 3 is a top-down view of the region of the aortic valve 12 as viewed from the ascending aorta toward the left ventricle 16. In Figure 3, a first replacement heart valve implant (e.g., replacement heart valve implant 200) is positioned within the aortic valve 12, and the multiple leaflets 220 of the first replacement heart valve implant (e.g., replacement heart valve implant 200) are biased radially outward by a second replacement heart valve implant (e.g., replacement heart valve implant 100) positioned within the first replacement heart valve implant (e.g., replacement heart valve implant 200). The multiple seams 212 of the first replacement heart valve implant (e.g., replacement heart valve implant 200) are schematically shown as rectangular shapes. The expandable framework 110 of the second replacement heart valve implant (e.g., replacement heart valve implant 100) may be seen above and / or inward of the multiple leaflets 220 of the first replacement heart valve implant (e.g., replacement heart valve implant 200). Multiple leaflets 120 of a second replacement heart valve implant (e.g., replacement heart valve implant 100) are visible inside the first replacement heart valve implant (e.g., replacement heart valve implant 200), which is attached to the expandable framework 110 of the second replacement heart valve implant (e.g., replacement heart valve implant 100) at multiple joints 112. For improved clarity, the multiple leaflets 220 are shown with dot shading having a first density, and the multiple leaflets 120 are shown with dot shading having a second density greater than the first density. The multiple leaflets 120 are shown in an open position so that the replacement heart valve is "open" and / or allows flow through the replacement heart valve. 【0049】 As can be seen in the upper left of Figure 3, one of the coronary artery ostia 23 is at least partially obscured from view. Patient tissue structures can vary from patient to patient. In some cases, one or both of the coronary artery ostia 23 may be partially or completely obscured from view, thereby making it more difficult and / or impossible to locate and / or access the coronary artery ostia 23. 【0050】 When properly placed, as shown in Figure 3, the joints of the replacement heart valve implant are typically positioned circumferentially offset from the coronary artery ostium 23 (for example, the coronary artery ostium 23 is positioned between adjacent joints). In some cases, due to the shape and / or morphology of the aortic sinus, blood can still reach and / or flow into the coronary artery ostium 23 even if the coronary artery ostium 23 is partially or completely occluded by the multiple leaflets 220 of the first replacement heart valve implant (e.g., replacement heart valve implant 200). 【0051】 To analyze the risks associated with replacement heart valve implants in replacement heart valve implant procedures, bench tests were conducted using several commercially available replacement heart valve implants. To account for the effects of differences in tissue structure, two different commercially available replacement heart valve implants (e.g., first implant A and first implant B) were evaluated as first replacement heart valve implants at several different ascending sinus-aortic junction (STJ) heights (e.g., 15 mm and 20 mm), with the same commercially available replacement heart valve implant (e.g., second implant C) used as the second replacement heart valve implant. To represent variations in surgical placement, the second replacement heart valve implant was placed at two different relative heights (e.g., low and high) within each first replacement heart valve implant. Note that each implant used in the study was different, and there were no combinations in which the same type of valve was placed inside itself (e.g., first implant A was not placed inside first implant A). 【0052】 Bench tests showed that access to the coronary artery ostium 23 is possible in approximately 25% of valve combinations that do not undergo any leaflet modification. The combinations and feasibility were tested as follows (Table 1). 【0053】 [Table 1] 【0054】 After performing basilica treatment to modify the leaflets of the first replacement heart valve implant before transplanting the second replacement heart valve implant, bench testing was performed again under the same conditions. The feasibility of the combination and access to the coronary artery ostium 23 was evaluated as follows (Table 2). 【0055】 [Table 2] 【0056】 As shown in Table 2, after basilica treatment, the feasibility of accessing the coronary ostium 23 after transplanting the second replacement heart valve implant into the first replacement heart valve implant increased to 82%. Particularly noteworthy is the increase in the feasibility of access using the first implant A from 50% to 100%, and the increase in the feasibility of access using the first implant B from 0% to 62%. In terms of testing, basilica treatment can be considered to substantially improve access to the coronary ostium 23. 【0057】 Figures 4-6 schematically illustrate the basilica procedure. Figure 4 shows a first replacement heart valve implant (e.g., replacement heart valve implant 200) positioned within the aortic valve 12. The basilica procedure involves advancing the first catheter 300 through the patient's vascular structure until its distal end 302 is positioned adjacent to the first replacement heart valve implant (e.g., replacement heart valve implant 200) and outside of the multiple valve leaflets 220. The second catheter 310 is advanced through the patient's vascular structure until its distal end 312 is advanced to and / or through the first replacement heart valve implant (e.g., replacement heart valve implant 200) inside the multiple valve leaflets 220. The conductive guidewire 320 is advanced out of the first catheter 300 and pushed through the first of the multiple valve leaflets 220 at the puncture site 226, such that the distal end 322 of the conductive guidewire 320 is positioned inside the multiple valve leaflets 220 and / or upstream of the first replacement heart valve implant (e.g., replacement heart valve implant 200). As shown in Figure 4, the snare 330 is advanced out of the second catheter 310 to a position adjacent to the distal end 322 of the conductive guidewire 320. 【0058】 Next, the snare 330 is tightened around the distal end 322 of the conductive guidewire 320, and RF energy is applied to the snare 330 and / or the conductive guidewire 320. The snare 330 is maintained inside the multiple valve leaflets 220, and the conductive guidewire 320 penetrates the first valve leaflet of the multiple valve leaflets 220. As RF energy is applied to the snare 330 and / or the conductive guidewire 320 (and / or the first catheter 300) and / or the snare 330 (and / or the second catheter 310) are pulled proximal, the first valve leaflet of the multiple valve leaflets 220 is cut from the puncture site 222 to the free end 228 of the first valve leaflet of the multiple valve leaflets 220, forming a first end 222 and a second end 224 opposite the first end 222 along the cut, as shown in Figure 5. If necessary, the procedure may be repeated on the second of the multiple valve leaflets 220. 【0059】 Figure 6 shows a second replacement heart valve implant (e.g., replacement heart valve implant 100) deployed within a first replacement heart valve implant (e.g., replacement heart valve implant 200). In Figure 6, the expandable framework 110 of the second replacement heart valve implant (e.g., replacement heart valve implant 100) is not fully expanded. As seen in Figure 6, as the second replacement heart valve implant (e.g., replacement heart valve implant 100) expands, the first end 222 and the second end 224 begin to move away from each other, forming an opening through the first leaflets of the multiple leaflets 220 from the puncture site 226 to the free end 228 of the first leaflet of the multiple leaflets 220. Assuming that this slit is correctly formed and / or positioned, when the expandable framework 110 of the second replacement heart valve implant (e.g., replacement heart valve implant 100) is expanded within the first replacement heart valve implant (e.g., replacement heart valve implant 200), the opening between the first end 222 and the second end 224 will provide access to the coronary artery 24 ostium 23 located adjacent to the opening by overlapping and / or coinciding with the ostium 23 of the coronary artery 24 located adjacent to the opening, as shown in Figure 7. 【0060】 However, basilica procedures are not without their difficulties. For example, the use of a “standard” catheter can make it difficult to precisely position the distal end 302 of the first catheter 300 and / or the conductive guidewire 320 relative to the first leaflet among the multiple leaflets 220 of the first replacement heart valve implant (e.g., replacement heart valve implant 200). In some cases, the conductive guidewire 320 may be pushed over the first leaflet among the multiple leaflets 220 (e.g., where the puncture site 226 is located) at an off-center position, thereby guiding and / or causing the tear to transition circumferentially from the desired position and / or from the ostium 23 of the coronary artery 24 located adjacent to the desired position. This can leave the ostium 23 of the coronary artery 24 located adjacent to the first leaflet among the multiple leaflets 220 partially or completely occluded even after the basilica procedure has been performed. Therefore, it is desirable to develop and / or use an easy-to-use, integrated basilica system in accordance with this disclosure in order to improve the reliability and / or accuracy of arranging the system and / or its components, and / or to improve the effectiveness of said arrangement, while requiring less time to perform training, skills and / or procedures. 【0061】 Figure 8 shows a selected embodiment of a basilica system 400 for use in a replacement heart valve implant procedure according to the present disclosure. In some embodiments, the basilica system 400 may comprise a delivery catheter 410. In at least one embodiment, the delivery catheter 410 may comprise a lumen extending proximal to the distal end of the delivery catheter 410. In some embodiments, the delivery catheter 410 may comprise a plurality of lumens extending proximal to the distal end of the delivery catheter 410. In some embodiments, the lumen or plurality of lumens may extend proximal to the proximal end of the delivery catheter 410 from the distal end of the delivery catheter 410. Other configurations may also be considered. 【0062】 In some embodiments, the basilica system 400 may include a first catheter 420. In some embodiments, the first catheter 420 may include and / or be a pigtail catheter. In some embodiments, the first catheter 420 and / or pigtail catheter may include a first lumen 422 extending longitudinally within the first catheter 420 and / or pigtail catheter. In some embodiments, the first catheter 420 and / or pigtail catheter may be slidably positioned within a delivery catheter 410. 【0063】 In some embodiments, the first catheter 420 and / or pigtail catheter may include a second lumen 424 extending longitudinally within the first catheter 420 and / or pigtail catheter. In some embodiments, the first catheter 420 and / or pigtail catheter may include an inner wall 425 that at least partially defines the first lumen 422 and / or the second lumen 424. In some embodiments, the inner wall 425 may separate the first lumen 422 from the second lumen 424. In some alternative configurations, the first lumen 422 may be a separate and / or independent tubular member located within the second lumen 424 and / or delivery catheter 410. 【0064】 The first catheter 420 and / or pigtail catheter may include a distal tip 423 located at the distal end of the first catheter 420 and / or pigtail catheter. In some embodiments, a second lumen 424 may extend proximal to the distal tip 423. The first catheter 420 and / or pigtail catheter may include a lateral port 426 located proximal to the distal tip 423. In at least some embodiments, the first lumen 422 may extend proximal to the lateral port 426. 【0065】 In some embodiments, the first catheter 420 and / or pigtail catheter may include a pre-formed recurved portion 428 located proximal to the distal tip 423 of the first catheter 420 and / or pigtail catheter in the unrestrained and / or deployed configuration. In some embodiments, when the first catheter 420 and / or pigtail catheter is unrestrained, it may be considered in the deployed configuration. The first catheter 420 and / or pigtail catheter may have an elongated portion extending proximal to the pre-formed recurved portion 428. In some embodiments, when the first catheter 420 and / or pigtail catheter is in the unrestrained and / or deployed configuration, a side port 426 may be located on the pre-formed recurved portion 428 of the first catheter 420 and / or pigtail catheter. In some embodiments, the side port 426 may be located near the base 429 of the pre-formed recurved portion 428. In the unrestricted and / or deployed configuration, the base 429 of the pre-formed recurved portion 428 may and may form the most distal range of the first catheter 420 and / or pigtail catheter. Therefore, in the unrestricted and / or deployed configuration, the base 429 of the pre-formed recurved portion 428 may be positioned distal to the distal tip 423 of the first catheter 420 and / or pigtail catheter. 【0066】 In some embodiments, the pre-formed recurved portion 428 may be shaped and / or configured to align with the tips of the valve leaflets of a replacement heart valve implant (e.g., a first replacement heart valve implant and / or replacement heart valve implant 200). In some embodiments, the base 429 of the pre-formed recurved portion 428 may be shaped and / or configured to align with and / or engage with the tips of the valve leaflets of a replacement heart valve implant (e.g., a first replacement heart valve implant and / or replacement heart valve implant 200). 【0067】 In some embodiments, the pre-formed recurved portion 428 may be considered substantially flat in the unconstrained and / or unfolded configuration. For example, the centerline of the pre-formed recurved portion 428 may typically be located within the plane 421, as shown in Figure 9. The side ports 426 may open substantially perpendicular to the plane 421. In some alternative configurations, the side ports 426 may open at an angle to the plane 421. 【0068】 Returning to Figure 8, the basilica system 400 may include a conductive guidewire 430 slidably positioned within the first lumen 422 of the first catheter 420 and / or pigtail catheter. The conductive guidewire 430 may be configured to advance and exit to a lateral port 426 of the first catheter 420 and / or pigtail catheter near the leaflets of a replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200) positioned within the patient's natural heart valve. In some embodiments, the conductive guidewire 430 may extend to the proximal end of the delivery catheter 410. In some embodiments, the conductive guidewire 430 may extend proximal within the first lumen 422 of the first catheter 420 and / or pigtail catheter to a proximal guidewire port or to an electrical connection point. In at least some embodiments, the conductive guidewire 430 may be configured to be electrically coupled to an RF energy source 460. In at least some embodiments, the conductive guidewire 430 may include a distal end 432 configured to puncture the leaflets of a replacement heart valve implant (e.g., a first replacement heart valve implant and / or replacement heart valve implant 200). Thus, the conductive guidewire 430 may lack a non-invasive distal tip or other analogous form. 【0069】 The basilica system 400 may include a second catheter 440. In some embodiments, the second catheter 440 may include a snare catheter and / or be a snare catheter. In some embodiments, the second catheter 440 and / or snare catheter may include a lumen 442 extending longitudinally to the second catheter 440 and / or snare catheter to the distal end 444 of the second catheter 440 and / or snare catheter. In some embodiments, the second catheter 440 and / or snare catheter may be slidably positioned within the delivery catheter 410. In some embodiments, the second catheter 440 and / or snare catheter may be slidably positioned within the delivery catheter 410 which is outside and / or external to the first catheter 420 and / or pigtail catheter (for example, the second catheter 440 and / or snare catheter is not positioned inside and / or internal to the first catheter 420 and / or pigtail catheter). In at least some embodiments, the second catheter 440 and / or snare catheter may be slidable relative to the delivery catheter 410 independently of the first catheter 420 and / or pigtail catheter, and vice versa. 【0070】 In at least some embodiments, the second catheter 440 and / or snare catheter may include a distal portion having a pre-formed bend 446 in an unrestrained and / or deployed state. In some embodiments, when the second catheter 440 and / or snare catheter is unrestrained, it may be considered as the second catheter 440 and / or snare catheter deployed state. The second catheter 440 and / or snare catheter may include an elongated portion extending proximal to the pre-formed bend 446. In some embodiments, the pre-formed bend 446 may be located proximal to the distal end 444 of the second catheter 440 and / or snare catheter. 【0071】 In some embodiments, the pre-formed bend 446 may be configured to orient the distal end 444 of the second catheter 440 and / or snare catheter toward the side port 426 of the first catheter 420 and / or pigtail catheter. For example, the distal end 444 of the second catheter 440 and / or snare catheter may open toward the side port 426 of the first catheter 420 and / or pigtail catheter in the unrestrained and / or deployed configuration. In some embodiments, the pre-formed bend 446 may orient the distal end 444 of the second catheter 440 and / or snare catheter at an inclination with respect to the longitudinal axis of the second catheter 440 and / or snare catheter in the unrestrained and / or deployed configuration. 【0072】 The basilica system 400 may include a snare shaft 450 slidably disposed within the lumen 442 of the second catheter 440 and / or snare catheter. In some embodiments, within the second catheter 440 and / or snare catheter, the snare shaft 450 may extend proximal to the proximal end of the second catheter 440 and / or snare catheter. In some embodiments, the snare shaft 450 may extend to a proximal port or to an electrical connection point. In some embodiments, the snare shaft 450 may be configured to be electrically coupled to an RF energy source 460. 【0073】 In some embodiments, the snare shaft 450 may include and / or be formed from a non-conductive material. In some embodiments, the snare shaft 450 may have a non-conductive coating disposed on the outer surface of the snare shaft. Other configurations are also considered. In some embodiments, the snare shaft 450 may have a wire loop 452 extending from the distal end of the snare shaft 450. In at least some embodiments, the wire loop 452 may be formed from an electrically conductive material. In some embodiments, the wire loop 452 may extend proximal to the proximal end of the snare shaft 450 and / or to an electrical connection point. In some embodiments, the wire loop 452 may be configured to be electrically coupled to an RF energy source 460. 【0074】 The wire loop 452 may be configured to grasp the distal end 432 of the conductive guidewire 430. In some embodiments, grasping the distal end 432 of the conductive guidewire 430 by the wire loop 452 may close and / or complete an electrical path electrically coupled to the RF energy source 460. As discussed herein, during use, the RF energy source may be activated to apply RF energy to the conductive guidewire 430. To grasp the distal end 432 of the conductive guidewire 430, the wire loop 452 is axially movable relative to the snare shaft 450 so as to facilitate closing the wire loop 452 around the distal end 432 of the conductive guidewire 430. Once the distal end 432 of the conductive guidewire 430 is grasped by the wire loop 452, the conductive guidewire 430 may be moved, translated, or transitioned relative to the second catheter 440 and / or the snare catheter by operation of the snare shaft 450. In some embodiments, once the distal end 432 of the conductive guidewire 430 is grasped by the wire loop 452, the snare shaft 450 may be configured to pull the distal end 432 of the conductive guidewire 430 into the second catheter 440 and / or the distal end 444 of the snare catheter and / or into the lumen 442. 【0075】 Figures 10-13 illustrate selected embodiments of the use of a basilica system according to this disclosure. A method for splitting the leaflets (e.g., the first leaflet of a plurality of leaflets 220) of a replacement heart valve implant (e.g., a first replacement heart valve implant and / or replacement heart valve implant 200) placed within a patient's natural heart valve (e.g., aortic valve 12) may include advancing a delivery catheter 410 to a position adjacent to the replacement heart valve implant (the first replacement heart valve implant and / or replacement heart valve implant 200). In at least some embodiments, as shown in Figure 10, this method may include advancing the delivery catheter 410 percutaneously and / or transvascularly to a position adjacent to the replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200). 【0076】 A method for splitting the valve leaflets may include extending the first catheter 420 and / or pigtail catheter distally from the delivery catheter 410 and advancing it to a position adjacent to the outer surface of a valve leaflet (e.g., the first valve leaflet of a plurality of valves 220) of a replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200), as shown in Figure 10. In at least some embodiments, when and / or while the first catheter 420 and / or pigtail catheter is extended distally from the delivery catheter 410 and advanced to a position adjacent to the outer surface of a valve leaflet (e.g., the first valve leaflet of a plurality of valve leaflets 220) of a replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200), the first catheter 420 and / or pigtail catheter may be considered to be in an deployed and / or unrestricted state and / or may be transitioned to such states. 【0077】 As discussed herein, the first catheter 420 and / or pigtail catheter may include a pre-formed recurved portion 428 located proximal to the distal tip 423 in the deployed and / or unrestrained configuration. In at least some embodiments, advancing the first catheter 420 and / or pigtail catheter distally from the delivery catheter 410 to a position adjacent to the outer surface of a valve leaflet (e.g., the first valve leaflet of a plurality of valve leaflets 220) of a replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200) further includes positioning the pre-formed recurved portion 428 of the first catheter 420 and / or pigtail catheter at the tip of a valve leaflet (e.g., the first valve leaflet of a plurality of valve leaflets) of the replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart implant 200) with the side port 426 facing the outer surface of a valve leaflet (e.g., the first valve leaflet of a plurality of valve leaflets). 【0078】 A method for splitting the valve leaflets may include extending a second catheter 440 and / or snare catheter distally from the delivery catheter 410 and advancing it to a position adjacent to the inner surface of a valve leaflet (e.g., the first valve leaflet of a plurality of valves 220) of a replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200), as shown in Figure 10. In some embodiments, this method may include extending the distal end 444 of the second catheter 440 and / or snare catheter distally from the delivery catheter 410 and advancing it to a position adjacent to the inner surface of a valve leaflet (e.g., the first valve leaflet of a plurality of valve leaflets 220) of a replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200). In some embodiments, this method may involve extending the second catheter 440 and / or snare catheter distally from the delivery catheter 410 and advancing it into the central lumen and / or inner surface of a replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200). In at least some embodiments, when the second catheter 440 and / or snare catheter is extended distally from the delivery catheter 410 and advanced to a position adjacent to the inner surface of a valve leaflet (e.g., the first leaflet of a plurality of valve leaflets 220) of the replacement heart valve implant (e.g., the first valve leaflet of a plurality of valve leaflets 200), and / or while it is advancing, the second catheter 440 and / or snare catheter may be considered in an deployed and / or unrestricted state, and / or may be transitioned until it becomes deployed and / or unrestricted. 【0079】 As discussed herein, the distal portion of the second catheter 440 and / or snare catheter may include a pre-formed bend 446 configured to orient the distal end 444 of the second catheter 440 and / or snare catheter toward the lateral port 426 of the first catheter 420 and / or pigtail catheter. 【0080】 In some embodiments, in the deployed and / or unrestrained configuration, the distal range of the pre-formed bend 446 of the second catheter 440 and / or snare catheter (measured axially from the distal end of the delivery catheter 410) may be within approximately 10% of the distal range of the base 429 with the pre-formed recurved portion 428 of the first catheter 420 and / or pigtail catheter (measured axially from the distal end of the delivery catheter 410). In some embodiments, in the deployed and / or unrestrained configuration, the distal range of the pre-formed bend 446 of the second catheter 440 and / or snare catheter (measured axially from the distal end of the delivery catheter 410) may be within approximately 7.5% of the distal range of the base 429 with the pre-formed recurved portion 428 of the first catheter 420 and / or pigtail catheter (measured axially from the distal end of the delivery catheter 410). In some embodiments, in the deployed and / or unrestrained configuration, the distal range of the pre-formed bend 446 of the second catheter 440 and / or snare catheter (measured axially from the distal end of the delivery catheter 410) may be within approximately 5% of the distal range of the base 429 with the pre-formed recurved portion 428 of the first catheter 420 and / or pigtail catheter (measured axially from the distal end of the delivery catheter 410). In some embodiments, in the deployed and / or unrestrained configuration, the distal range of the pre-formed bend 446 of the second catheter 440 and / or snare catheter (measured axially from the distal end of the delivery catheter 410) may be within approximately 2.5% of the distal range of the base 429 with the pre-formed recurved portion 428 of the first catheter 420 and / or pigtail catheter (measured axially from the distal end of the delivery catheter 410). Other configurations may also be considered. 【0081】 In some embodiments, the first catheter 420 and / or pigtail catheter and the second catheter 440 and / or snare catheter may include markings configured to identify the relative positions of the first catheter 420 and / or pigtail catheter and the second catheter 440 and / or snare catheter with respect to the delivery catheter 410. 【0082】 In some embodiments, the first catheter 420 and / or pigtail catheter and the second catheter 440 and / or snare catheter may include one or more features positioned near the proximal end of a delivery catheter 410 configured to fix the first catheter 420 and / or pigtail catheter to the second catheter 440 and / or snare catheter. For example, the first catheter 420 and / or pigtail catheter and the second catheter 440 and / or snare catheter may include one or more latches, fixing members, etc., configured to prevent relative axial movement between the first catheter 420 and / or pigtail catheter and the second catheter 440 and / or snare catheter once engaged. 【0083】 A method for splitting the valve leaflet may include, as shown in Figure 11, advancing the first catheter 420 and / or pigtail catheter to a position adjacent to the outer surface of the valve leaflet, and advancing the second catheter 440 and / or snare catheter to a position adjacent to the inner surface of the valve leaflet, then advancing the delivery catheter 410 distal to the first catheter 420 and / or pigtail catheter and the second catheter 440 and / or snare catheter, and biasing the distal end 444 of the second catheter 440 and / or snare catheter toward a lateral port 426 formed in a pre-formed recurved portion 428 of the first catheter 420 and / or pigtail catheter, which is located proximal to the distal tip 423 of the first catheter 420 and / or pigtail catheter. In some embodiments, when the first catheter 420 and / or pigtail catheter is in an unfolded state and the second catheter 440 and / or snare catheter is in an unfolded state, the delivery catheter 410 can be advanced distally relative to the first catheter 420 and / or pigtail catheter and the second catheter 440 and / or snare catheter, thereby biasing, moving, translating, etc., the distal end 444 of the second catheter 440 and / or snare catheter to be closer to the side port 426 formed in the pre-formed recurved portion 428 of the first catheter 420 and / or pigtail catheter than the distal tip 423 of the first catheter 420 and / or pigtail catheter. 【0084】 A method for splitting the valve leaflets may include advancing the conductive guidewire 430 distally within the first catheter 420 and / or the pigtail catheter, and / or distally relative to the first catheter 420 and / or the pigtail catheter. This method may include advancing the conductive guidewire 430 distally from the first catheter 420 and / or the pigtail catheter. In at least some embodiments, advancing the conductive guidewire 430 out of the first catheter 420 and / or the pigtail catheter may include advancing the conductive guidewire 430 out of and / or through the side port 426 of the first catheter 420 and / or the pigtail catheter. A method for splitting the valve leaflets may include advancing the conductive guidewire 430 through the valve leaflets (e.g., the first valve leaflet of a plurality of valve leaflets 220) of a replacement heart valve implant (e.g., the first replacement heart valve implant and / or the replacement heart valve implant 200) at the puncture site 226. In some embodiments, in a single movement or action, the method may include extending the conductive guidewire 430 distally from the first catheter 420 and / or pigtail catheter and advancing it through the valve leaflets (e.g., the first leaflet of a plurality of valve leaflets 220) of a replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200) at the puncture site 226. In some alternative embodiments, in multiple movements and / or multiple steps, the method may include extending the conductive guidewire 430 distally from the first catheter 420 and / or pigtail catheter and advancing it through the valve leaflets (e.g., the first leaflet of a plurality of valve leaflets 220) of a replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200) at the puncture site 226. 【0085】 The method of splitting the valve leaflets may include grasping the conductive guidewire 430 with the wire loop 452 extending from the second catheter 440 and / or snare catheter. In some embodiments, before grasping the conductive guidewire 430 with the wire loop 452, the method of splitting the valve leaflets may include advancing the snare shaft 450 and / or wire loop 452 distally outside the second catheter 440 and / or snare catheter, within the central lumen and / or inside the replacement heart valve implant (e.g., the first replacement heart valve implant and / or replacement heart valve implant 200). In some embodiments, the wire loop 452 has a diameter of up to 20 mm in its open configuration. In some embodiments, as shown in Figure 12, advancing the conductive guidewire 430 distally out of the first catheter 420 and / or pigtail catheter via the valve leaflets (e.g., the first valve leaflet among a plurality of valve leaflets 220) includes advancing the distal end 432 of the conductive guidewire 430 into and / or via the wire loop 452. 【0086】 In some embodiments, when the distal end 444 of the second catheter 440 and / or snare catheter is very close to a lateral port 426 formed in a pre-formed recurved portion 428 of the first catheter 420 and / or pigtail catheter, the lateral port 426 is configured to direct the distal end 432 of the conductive guidewire 430 toward the wire loop 452 when the conductive guidewire 430 is advanced distally toward and / or out of the first catheter 420 and / or pigtail catheter (for example, via the lateral port 426). 【0087】 In some embodiments, "close proximity" may be defined as approximately 0 mm to approximately 30 mm. In some embodiments, "close proximity" may be defined as approximately 0 mm to approximately 25 mm. In some embodiments, "close proximity" may be defined as approximately 0 mm to approximately 20 mm. In some embodiments, "close proximity" may be defined as approximately 0 mm to approximately 15 mm. In some embodiments, "close proximity" may be defined as approximately 0 mm to approximately 10 mm. In some embodiments, "close proximity" may be defined as approximately 1 mm to approximately 10 mm. In some embodiments, "close proximity" may be defined as approximately 1 mm to approximately 8 mm. In some embodiments, "close proximity" may be defined as approximately 1 mm to approximately 6 mm. In some embodiments, "close proximity" may be defined as approximately 2 mm to approximately 6 mm. Other configurations may also be considered. 【0088】 In some embodiments, the method of splitting the valve leaflets may include fixing the first catheter 420 and / or pigtail catheter to the second catheter 440 and / or snare catheter to each other. In some embodiments, the method of splitting the valve leaflets may include fixing the first catheter 420 and / or pigtail catheter to the second catheter 440 and / or snare catheter to the delivery catheter 410. In some embodiments, the method of splitting the valve leaflets may include fixing the conductive guidewire 430 to the first catheter 420 and / or pigtail catheter. In some embodiments, the method of splitting the valve leaflets may include fixing the snare shaft 450 and / or wire loop 452 to the second catheter 440 and / or snare catheter. 【0089】 A method for splitting a valve leaflet may include pulling a conductive guidewire 430 proximal and / or downstream through the valve leaflet to cut the valve leaflet (e.g., the first valve leaflet among a plurality of valve leaflets 220) from the puncture site 226 to the free end edge 228 of the valve leaflet (e.g., the first valve leaflet among a plurality of valve leaflets 220), as shown in Figure 13. 【0090】 In some embodiments, the method for splitting a valve leaflet may include applying RF energy to a conductive guidewire 430 while pulling the conductive guidewire 430 through the valve leaflet (e.g., the first valve leaflet among a plurality of valve leaflets 220) to split the valve leaflet (e.g., the first valve leaflet among a plurality of valve leaflets 220). In some embodiments, the method for splitting a valve leaflet may include applying RF energy to a conductive guidewire 430 before pulling the conductive guidewire 430 through the valve leaflet (e.g., the first valve leaflet among a plurality of valve leaflets 220) to split the valve leaflet (e.g., the first valve leaflet among a plurality of valve leaflets 220). In some embodiments, the method for splitting a valve leaflet may include applying RF energy to a conductive guidewire 430 before pulling the conductive guidewire 430 through the valve leaflet (e.g., the first valve leaflet among a plurality of valve leaflets 220) to split the valve leaflet (e.g., the first valve leaflet among a plurality of valve leaflets 220), and then continuing to apply RF energy to the conductive guidewire 430 while pulling the conductive guidewire 430 through the valve leaflet (e.g., the first valve leaflet among a plurality of valve leaflets 220) to split the valve leaflet (e.g., the first valve leaflet among a plurality of valve leaflets 220). 【0091】 In some embodiments, the method of splitting the valve leaflet may include retracting the snare shaft 450 and / or wire loop 452 to the second catheter 440 and / or snare catheter in order to pull the distal end 432 of the conductive guidewire 430 into the lumen and / or to the distal end 444 of the second catheter 440 and / or snare catheter. In some situations, this may reduce the number of structures adjacent to and / or in contact with the valve leaflets (e.g., the first valve leaflet among a plurality of valve leaflets 220) and / or allow for the formation of smoother and / or cleaner cuts. 【0092】 The various components of the system and the materials that may be used for the various elements of the system disclosed herein may include those generally associated with medical devices. For brevity, the following discussion refers to the system. However, this is not intended to limit the devices, components and methods described herein, for this discussion may also apply to other elements, members, components or devices disclosed herein (for example, but not limited to, delivery catheters, first catheters and / or pigtail catheters, second catheters and / or snare catheters, snare shafts, wire loops, conductive guidewires, etc. and / or their components or parts). 【0093】 In some embodiments, the system and / or its components may be formed from metals, alloys, polymers, metal-polymer composites, ceramics, combinations thereof, or other suitable materials. 【0094】 Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block esters, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL®), ether-based or ester-based copolymers (e.g., butylene / poly(alkylene)). Ethers, phthalates and / or other polyester elastomers (e.g., HYTREL®), polyamides (e.g., DURETHAN® or CRISTAMID®), elastic polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), This may include trimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-β-isobutylene-β-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyurethane silicone copolymer (e.g., Elast-Eon® or ChronoSil®), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer / metal composites, etc.In some embodiments, the system and / or its components may be hybridized with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP. 【0095】 Some examples of suitable metals and alloys include stainless steel (e.g., 304 and 316 stainless steel and their derivatives), mild steel, nickel-titanium alloys (e.g., linear elastic and / or superelastic Nitinol), other nickel alloys (e.g., nickel-chromium-molybdenum alloys (e.g., UNS N06625 such as INCONEL® 625, UNS N06022 such as HASTELLOY® C-22, UNS N10276 such as HASTELLOY® C276, and other HASTELLOY® alloys, etc.)), nickel-copper alloys (e.g., UNS N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), and nickel-cobalt-chromium-molybdenum alloys (e.g., UNS N04400 such as MP35-N, etc.) This includes nickel-molybdenum alloys (e.g., UNS N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys or tungsten alloys, etc., cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS R30003 such as ELGILOY®, PHYNOX®), platinum-reinforced stainless steel, titanium, platinum, gold, combinations thereof, or any other suitable material. 【0096】 In at least some embodiments, the system and / or parts or all of its components may be doped with radiopaque material, formed from radiopaque material, or contain radiopaque material. Radiopaque material is understood to be a material that can produce a relatively bright image in fluoroscopic screening or other imaging techniques (e.g., ultrasound) during medical procedures. This relatively bright image helps the user of the system to determine its position. Examples of radiopaque material include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials filled with radiopaque fillers. Furthermore, other radiopaque marker bands and / or coils may also be incorporated into the system design to achieve similar results. 【0097】 In some embodiments, the systems and / or other elements disclosed herein may include and / or be treated with suitable therapeutic agents. Some examples of suitable therapeutic agents are antithrombotic agents (heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone), etc.), antiproliferative agents (enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid, etc.), and anti-inflammatory agents (dexamethasone, prednisolone, corticosterone, budesonide, estrogen, etc.). (e.g., fasalazine and mesalamine), antitumor / antiproliferative / antimitotic agents (e.g., paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epotilon, endostatin, angiostatin, and thymidine kinase inhibitors), anesthetics (e.g., lidocaine, bupivacaine, and ropivacaine), anticoagulants (e.g., D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds) This may include, for example, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and mite antiplatelet peptides), vasodilators (growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation accelerators), vasodilators (growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxics, bifunctional molecules consisting of antibodies and cytotoxics, etc.), immunosuppressants (e.g., Olimus-type drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picrolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus, etc.), cholesterol lowering agents, vasodilators, and agents that interfere with intrinsic vasoactive mechanisms. 【0098】 Please understand that this disclosure is illustrative in many respects. Details, particularly those concerning shape, size, and step arrangement, can be modified without exceeding the scope of this disclosure. This may include, to an appropriate degree, the use of any of the exemplary embodiments used in other embodiments. The scope of this disclosure is, of course, defined by the language in which the appended claims are expressed.

Claims

[Claim 1] A basilica system for use in the procedure of replacing heart valve implants, The basilica system comprises a pigtail catheter, a conductive guidewire, a snare catheter, and a snare shaft. The pigtail catheter is provided with a lateral port located proximal to the distal tip of the pigtail catheter. The conductive guidewire is slidably positioned within the first lumen of the pigtail catheter and is configured to advance and exit through the lateral port near the leaflet of a replacement heart valve implant placed within the patient's natural heart valve. The snare catheter includes a lumen that extends to the distal end of the snare catheter. A basilica system comprising a snare shaft slidably positioned within the lumen of the snare catheter and comprising a wire loop extending from the distal end of the snare shaft and configured to grasp the distal end of the conductive guidewire. [Claim 2] The basilica system according to claim 1, wherein the pigtail catheter further comprises a second lumen extending proximal to the distal tip of the pigtail catheter, and the first lumen extending proximal to the lateral port. [Claim 3] The basilica system according to claim 1 or 2, wherein the pigtail catheter includes a pre-formed recurved portion proximal to the distal tip of the pigtail catheter in an unrestrained configuration. [Claim 4] The basilica system according to claim 3, wherein the side port is located near the base of the pre-formed recurved portion. [Claim 5] The basilica system according to claim 3, wherein the center line of the pre-formed recurved portion is substantially located in a plane, and the side ports open substantially perpendicular to the plane. [Claim 6] The basilica system according to any one of claims 1 to 5, wherein the distal portion of the snare catheter includes a pre-formed bend in an unrestrained configuration, and the pre-formed bend is configured to orient the distal end of the snare catheter toward the lateral port of the pigtail catheter. [Claim 7] The basilica system according to claim 6, wherein the pre-formed bend causes the distal end of the snare catheter to be oriented at an inclination with respect to the longitudinal axis of the snare catheter. [Claim 8] The basilica system according to any one of claims 1 to 7, further comprising a delivery catheter, wherein the pigtail catheter and the snare catheter are slidably disposed within the delivery catheter. [Claim 9] The basilica system according to any one of claims 1 to 8, further comprising an RF energy source electrically coupled to the conductive guide wire. [Claim 10] A basilica system for use in the procedure of replacing heart valve implants, The basilica system is A delivery catheter and A first catheter is slidably disposed within the delivery catheter, A second catheter is slidably disposed within the aforementioned delivery catheter, A conductive guidewire slidably positioned within the first catheter and configured to be electrically coupled to an RF energy source, the conductive guidewire having a distal end configured to puncture the leaflets of a replacement heart valve implant, A basilica system comprising: a snare shaft slidably disposed within the lumen of the second catheter, the snare shaft having a wire loop extending from the distal end of the snare shaft and configured to grasp the distal end of the conductive guidewire. [Claim 11] The basilica system according to claim 10, wherein in the deployed state, the first catheter includes a pre-formed recurved portion located proximal to the distal tip, the elongated portion extends proximal to the pre-formed recurved portion, and when the first catheter is in the deployed state, the first catheter has a side port located in the pre-formed recurved portion of the first catheter. [Claim 12] The basilica system according to claim 11, wherein the pre-formed recurved portion is formed and configured to align with the tip of the valve leaflet of the replacement heart valve implant. [Claim 13] The basilica system according to claim 11 or 12, wherein in the deployed form, the second catheter has a distal portion having a pre-formed bend configured to orient the distal end of the second catheter toward the side port. [Claim 14] The basilica system according to claim 13, wherein when the first catheter is in an unfolded state and the second catheter is in an unfolded state, the distal advance of the delivery catheter relative to the first catheter and the second catheter biases the distal end of the second catheter closer to the lateral port formed in the first catheter than the distal tip of the first catheter. [Claim 15] The basilica system according to claim 14, wherein when the distal end of the second catheter is in very close proximity to the side port and the conductive wire is advanced distally relative to the first catheter, the side port is configured to direct the conductive wire toward the wire loop.

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