Loading tool for artificial valve devices

Abstract

A loading tool for facilitating loading of a prosthesis into a delivery system includes a hinged body having first and second body portions and a collar slidably disposed on the hinged body. A first end of the body portions is attached and a second end of the body portions is unattached. Each body portion includes a resilient clip including a radial protrusion. Each resilient clip is configured to be displaced radially inward when a clamping force is applied thereto. The loading tool has an open configuration in which the second ends are radially spaced apart and the collar is disposed over the first ends. The loading tool has a closed configuration in which the second ends are disposed directly adjacent one another and the collar is disposed over the second ends. The radial protrusion locks the loading tool in the closed configuration when the resilient clips are not displaced radially inward.

Description

Technical Field

[0001] This technology relates to a self-expanding artificial valve device, and particularly to a tool that facilitates loading an artificial valve device into a delivery system.

Background Art

[0002] The human heart is a muscular organ divided into four chambers that provides blood circulation to the body during the cardiac cycle. The four main chambers include the right atrium and right ventricle that supply the pulmonary circulation, and the left atrium and left ventricle that supply oxygenated blood received from the lungs into the systemic circulation. To ensure that blood flow passes through the heart in one direction, atrioventricular valves (tricuspid valve and mitral valve) are present at the junctions between the atria and ventricles, and semilunar valves (pulmonary valve and aortic valve) regulate the exits of the ventricles leading to the lungs and the rest of the body. These valves include valve leaflets or cardiac valve cusps that open and close in response to blood pressure fluctuations caused by the contraction and relaxation of the heart chambers. The valve leaflets open apart from each other to allow blood to flow downstream through the valve, and also close when joined together to prevent backflow or regurgitation upstream.

[0003] Diseases associated with heart valves, such as those caused by damage or defects, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis narrows and stiffens the valve, thereby preventing an appropriate flow rate of blood from reaching the downstream heart chamber and imposing a burden on the heart as it pumps blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backward, thereby reducing the efficiency of the heart. Diseased or damaged valves, which can be congenital, age-related, drug-induced, or possibly due to infection in some cases, can lead to hypertrophy, a thickened heart, which in turn loses elasticity and efficiency. Some symptoms of heart valve disease can include fatigue, shortness of breath, dizziness, fainting, palpitations, anemia, and edema, as well as blood clots that can increase the likelihood of stroke or pulmonary embolism. The symptoms can often be debilitating and / or life-threateningly severe.

[0004] Heart valve prostheses have been developed for the repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be delivered percutaneously through a catheter-based delivery system and deployed at the site of the diseased heart valve. Since such heart valve prostheses are delivered in a radially compressed or crimped form, they can be advanced through the patient's vascular structure. Once positioned at the treatment site, the heart valve prosthesis expands and engages with the tissue in the diseased heart valve area, for example, to hold the heart valve prosthesis in place. [Overview of the Initiative] [Means for solving the problem]

[0005] This disclosure relates to a tool for facilitating the loading or crimping of cardiac valve prostheses and other types of prostheses within a catheter-based delivery system.

[0006] According to a first embodiment of this specification, the disclosure provides a loading tool for facilitating the loading of a self-expanding prosthesis into a delivery system. The loading tool includes a hinged body and a collar slidably disposed on the hinged body. The hinged body includes a first body portion and a second body portion, each of which has a first end and a second end. The first end of the first body portion is attached to the first end of the second body, and the second end of the first body portion is not attached to the second end of the second body portion. Each of the first and second body portions includes an elastic clip formed thereon, the elastic clip having a radial projection on its outer surface. Each elastic clip is configured to be displaced radially inward when a clamping force is applied thereto. The loading tool has an open configuration in which the second end of the first body portion and the second end of the second body portion are radially spaced apart from each other, and the collar is positioned on the first ends of the first and second body portions. The loading tool also has a closed configuration in which the second end of the first body portion and the second end of the second body portion are directly adjacent to each other, and the collar is positioned on the second ends of the first and second body portions. The radial projection is configured to lock the loading tool into the closed configuration when the elastic clip is not displaced radially inward.

[0007] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the disclosure provides that each of the first and second body portions has a flange on its outer surface at its second end, and that when the collar locks the hinged body into a closed position, the collar is sandwiched between the flange and a radial projection on an elastic clip.

[0008] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the present disclosure provides that each flange has a square contour.

[0009] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the disclosure provides that each radial projection has a tapered outer surface, the tapered outer surface allowing the collar to slide in a direction from the first end of the first and second body portions toward the second end of the first and second body portions, and that each radial projection has an end face, the end face not allowing the collar to slide in a direction from the second end of the first and second body portions toward the first end of the first and second body portions unless the elastic clip is displaced radially inward by the clamping force.

[0010] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the disclosure provides that the first end of the first body portion is attached to the first end of the second body via an adhesive.

[0011] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the disclosure provides that a first end of a first body portion is attached to a first end of a second body via a mechanical fastener.

[0012] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the disclosure provides that a loading tool is prevented from opening when a radial projection locks the loading tool into a closed position.

[0013] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the disclosure provides that the elastic clip is configured to be displaced radially inward to release the collar.

[0014] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the disclosure provides that a hinged body is configured to be positioned above the distal end of a delivery system during loading of a self-expanding prosthesis into the delivery system.

[0015] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the disclosure provides that a hinged body is configured to be positioned on top of the capsule of a delivery system when a self-expanding prosthesis is positioned within the capsule.

[0016] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the disclosure provides that the second ends of the first and second body portions each include stepped edges formed on their inner surfaces, configured to prevent the self-expanding prosthesis from contacting the first end of the capsule when the self-expanding prosthesis is positioned within the capsule, and to hold the attachment bar of the self-expanding prosthesis.

[0017] In one embodiment of the first embodiment and in combination with any other aspect of this specification, the disclosure provides that the first and second body portions collectively have a tubular shape when the loading tool is in a closed configuration.

[0018] According to a first embodiment of this specification, the disclosure provides a method for loading a self-expanding prosthesis into a delivery system, comprising arranging a loading tool in an open configuration. The loading tool includes a hinged body and a collar slidably disposed on the hinged body. The hinged body includes a first body portion and a second body portion, each having a first end and a second end. The first end of the first body portion is attached to the first end of the second body, and the second end of the first body portion is not attached to the second end of the second body portion. Each of the first and second body portions includes an elastic clip formed thereon, the elastic clip having a radial projection on its outer surface. Each elastic clip is configured to be displaced radially inward when a clamping force is applied thereto. The loading tool has an open configuration in which the second end of the first body portion and the second end of the second body portion are radially spaced apart from each other, and the collar is positioned on the first ends of the first and second body portions. The loading tool is positioned in the open configuration on the distal end of the delivery system, and while the loading tool is positioned on the distal end of the delivery system, the collar slides on the hinged body until the loading tool is in the closed configuration. In the closed configuration, the second end of the first body portion and the second end of the second body portion are positioned directly adjacent to each other, and the collar is positioned on the second ends of the first and second body portions, and a radial projection locks the loading tool in the closed configuration when the elastic clip is not displaced radially inward. The self-expanding prosthesis is loaded into the distal end of the delivery system while the radial projection locks the loading tool in the closed configuration.

[0019] In one embodiment of the second embodiment and in combination with any other aspect of this specification, the disclosure provides that after a self-expanding prosthesis is loaded into the distal end of a delivery system, a clamping force is applied to displace an elastic clip radially inward. The collar slides on the hinged body while the elastic clip is displaced radially inward until the loading tool is in an open position, and the loading tool is removed from the distal end of the delivery system.

[0020] In one embodiment of the second embodiment and in combination with any other aspect of this specification, the disclosure provides that the self-expanding prosthesis is a mitral valve prosthesis.

[0021] In one embodiment of the second embodiment and in combination with any other aspect of this specification, the disclosure provides that each of the first and second body portions has a flange on its outer surface at its second end, and that when the collar locks the hinged body into a closed position, the collar is sandwiched between the flange and a radial projection on an elastic clip.

[0022] In one embodiment of the second embodiment and in combination with any other aspect of this specification, the disclosure provides that each flange has a square contour and that the flange is positioned relative to a plane during the step of loading a self-expanding prosthesis.

[0023] In one embodiment of the second embodiment and in combination with any other aspect of this specification, the disclosure provides that each radial projection has a tapered outer surface, the tapered outer surface allowing the collar to slide in a direction from the first end of the first and second body portions toward the second end of the first and second body portions, and that each radial projection has an end face, the end face not allowing the collar to slide in a direction from the second end of the first and second body portions toward the first end of the first and second body portions unless the elastic clip is displaced radially inward by the clamping force.

[0024] In one embodiment of the second embodiment and in combination with any other aspect of this specification, the disclosure provides that a loading tool is prevented from being opened to the open position when a radial projection locks the loading tool in the closed position.

[0025] In one embodiment of the second embodiment and in combination with any other aspect of this specification, the disclosure provides that the distal end of the delivery system is a capsule.

[0026] In certain aspects of the second embodiment and in combination with any other aspect of this specification, the present disclosure provides that the second ends of the first and second body portions are configured to prevent the self-expanding prosthesis from contacting the first end of the capsule when the self-expanding prosthesis is positioned within the capsule and are configured to hold the attachment bar of the self-expanding prosthesis, each including a stepped edge formed on its inner surface.

[0027] In certain aspects of the second embodiment and in combination with any other aspect of this specification, the present disclosure provides that the first and second body portions have a collectively tubular form when the loading tool is in the closed configuration.

[0028] Details of one or more aspects of the present disclosure are described in the accompanying drawings and the following description. Other features, objects, and advantages of the technology described in the present disclosure will become apparent from the description, the drawings, and the claims.

[0029] The above and other features and advantages of the present invention will become apparent from the following description of its embodiments as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part hereof, further serve to explain the principles of the present invention and to enable one of ordinary skill in the art to make and use the present invention. The drawings are not to scale. The present invention provides, for example, the following: (Item 1) A loading tool for facilitating the loading of a self-expanding prosthesis into a delivery system, A hinged body comprising a first body portion and a second body portion, each of the first body portion and the second body portion having a first end and a second end, the first end of the first body portion being attached to the first end of the second body, and the second end of the first body portion not being attached to the second end of the second body portion, each of the first body portion and the second body portion including an elastic clip formed thereon, the elastic clip including a radial projection on its outer surface, and each elastic clip being configured to be displaced radially inward when a clamping force is applied thereto, A collar slidably disposed on the hinge-shaped body, wherein the loading tool has an open configuration in which the second end of the first body portion and the second end of the second body portion are radially spaced apart from each other and the collar is positioned on the first end of the first and second body portions, and the loading tool has a closed configuration in which the second end of the first body portion and the second end of the second body portion are directly adjacent to each other and the collar is positioned on the second end of the first and second body portions, and A loading tool comprising the radial projection being configured to lock the loading tool into the closed position when the elastic clip is not displaced radially inward. (Item 2) The loading tool according to item 1, wherein each of the first and second body portions has a flange on its outer surface at the second end thereof, and when the collar locks the hinged body in the closed position, the collar is sandwiched between the flange and the radial projection on the elastic clip. (Item 3) Each flange has a square contour, as described in item 2 of the loading tool. (Item 4) The loading tool according to item 1, wherein each radial projection has a tapered outer surface, the tapered outer surface allowing the collar to slide in a direction from the first end of the first and second body portions toward the second end of the first and second body portions, and each radial projection has an end face, the end face not allowing the collar to slide in a direction from the second end of the first and second body portions toward the first end of the first and second body portions unless the elastic clip is displaced radially inward by the clamping force. (Item 5) The loading tool according to item 1, wherein the first end of the first body portion is attached to the first end of the second body via adhesive. (Item 6) The loading tool according to item 1, wherein the first end of the first body portion is attached to the first end of the second body via a mechanical fastener. (Item 7) The loading tool according to item 1, wherein the radial projection prevents the loading tool from opening when it locks the loading tool into the closed position. (Item 8) The loading tool according to item 7, wherein the elastic clip is configured to be displaced radially inward to release the collar. (Item 9) The loading tool according to item 1, wherein the hinged body is configured to be positioned on the distal end of the delivery system during loading of the self-expanding prosthesis into the delivery system. (Item 10) The loading tool according to item 9, wherein the hinged body is configured to be positioned on top of the capsule of the delivery system when the self-expanding prosthesis is positioned within the capsule. (Item 11) The loading tool according to item 10, wherein the second end of the first and second body portions each includes a stepped edge formed on its inner surface, configured to prevent the self-expanding prosthesis from contacting the first end of the capsule when the self-expanding prosthesis is positioned within the capsule, and to hold the mounting bar for the self-expanding prosthesis. (Item 12) The loading tool according to item 1, wherein the first and second main body portions collectively have a tubular shape when the loading tool is in the closed configuration. (Item 13) A method for loading a self-expanding prosthesis into a delivery system, The loading tool is positioned in an open configuration, wherein the loading tool includes a hinged body and a collar slidably disposed on the hinged body, the hinged body includes a first body portion and a second body portion, each of the first body portion and the second body portion having a first end and a second end, the first end of the first body portion being attached to the first end of the second body, and the second end of the first body portion being attached to the second end of the second body portion. Furthermore, each of the first and second body portions includes an elastic clip formed thereon, the elastic clip includes a radial projection on its outer surface, and each elastic clip is configured to be displaced radially inward when a tightening force is applied thereto, and in the open configuration, the second end of the first body portion and the second end of the second body portion are radially spaced apart from each other, and the collar is positioned on the first ends of the first and second body portions, The loading tool is positioned in an open configuration on the distal end of the delivery system, The loading tool is positioned on the distal end of the delivery system, and the collar is slid on the hinged body until the loading tool is in a closed position, wherein in the closed position, the second end of the first body portion and the second end of the second body portion are positioned directly adjacent to each other, and the collar is positioned on the second ends of the first and second body portions, and the radial projection locks the loading tool in the closed position when the elastic clip is not displaced radially inward. The self-expanding prosthesis is loaded into the distal end of the delivery system while the radial projection locks the loading tool in the closed position. A method that includes this. (Item 14) After the self-expanding prosthesis is loaded into the distal end of the delivery system, a tightening force is applied to displace the elastic clip radially inward. The collar is slid on the hinge-shaped body while the elastic clip is displaced radially inward until the loading tool is in the open position, To remove the loading tool from the distal end of the delivery system. The method described in item 13, further including the method described in item 13. (Item 15) The self-expanding prosthesis is a mitral valve prosthesis, as described in item 13. (Item 14) The method according to item 13, wherein each of the first and second body portions has a flange on its outer surface at its second end, and when the collar locks the hinged body in the closed position, the collar is sandwiched between the flange and the radial projection on the elastic clip. (Item 15) The method according to item 13, wherein each flange has a square contour, and the flange is placed against a plane during the step of loading the self-expanding prosthesis. (Item 16) The method according to item 13, wherein each radial projection has a tapered outer surface, the tapered outer surface allows the collar to slide in a direction from the first end of the first and second body portions toward the second end of the first and second body portions, and each radial projection has an end face, the end face does not allow the collar to slide in a direction from the second end of the first and second body portions toward the first end of the first and second body portions unless the elastic clip is displaced radially inward by the clamping force. (Item 17) The loading tool is prevented from being opened to the open position when the radial projection locks the loading tool in the closed position, according to the method of item 13. (Item 18) The method according to item 13, wherein the distal end is a capsule. (Item 19) The method according to item 18, wherein the second end of the first and second body portions each includes a stepped edge formed on its inner surface, configured to prevent the self-expanding prosthesis from contacting the first end of the capsule when the self-expanding prosthesis is positioned within the capsule, and to hold the mounting bar of the self-expanding prosthesis. (Item 20) The method according to item 13, wherein the first and second main body portions collectively have a tubular shape when the loading tool is in the closed configuration. [Brief explanation of the drawing]

[0030] [Figure 1] An exemplary transcatheter valve prosthesis for use with a loading tool according to one aspect of the present disclosure is shown in a perspective view. [Figure 2] Figure 1 shows a perspective view of the valve support of a transcatheter valve prosthesis in which the artificial valve components are fixed inside, according to one aspect of the present disclosure. [Figure 3] Figure 1 shows an atrial end view of a transcatheter valve prosthesis according to one aspect of this disclosure. [Figure 4] Figure 1 shows a ventricular end view of a transcatheter valve prosthesis according to one aspect of this disclosure. [Figure 5] This shows a perspective view of a loading tool according to one aspect of the present disclosure, with the loading tool in an open configuration. [Figure 6] Figure 5 shows an exploded view of the loading tool. [Figure 7] Figure 5 shows a side view of the loading tool in its open position. [Figure 8A] Figure 5 shows a side view of the loading tool in its closed position. [Figure 8B] Figure 5 shows a perspective view of the loading tool in its closed position. [Figure 9] Figure 5 shows a side view of the loading tool before positioning it on the distal end of the delivery system. The delivery system is configured for transfemoral artery delivery, and the loading tool is in an open configuration. [Figure 10] Figure 5 shows a side view of the loading tool after it has been positioned above the distal end of the delivery system, with the loading tool in a closed configuration. [Figure 11]An exploded view of a loading tool according to another aspect of the present disclosure is shown, in which the first and second body portions of the loading tool are attached to each other via adhesive, and the loading tool is open at only one end. [Figure 12] An exploded view of a loading tool according to another aspect of the present disclosure is shown, in which the first and second body parts of the loading tool are attached to each other via adhesive, and the loading tool is open at both ends. [Figure 13] Figure 12 shows a side view of the loading tool before positioning it on the distal end of the delivery system. The delivery system is configured for transcardiac apical delivery, and the loading tool is in an open configuration. [Figure 14] Figure 12 shows a side view of the loading tool after it has been positioned on the distal end of the delivery system. The delivery system is configured for transcardiac delivery, and the loading tool is in a closed configuration. [Figure 15A] A perspective view of a loading tool according to another aspect of the present disclosure is shown, in which the first and second main body portions of the loading tool are mechanically fastened together via a ring-shaped fastener, and the loading tool is open at both ends. [Figure 15B] Figure 15A shows different perspective views of the loading tool. [Figure 16] Figure 5 shows a side view of the loading tool before positioning it on the distal end of the delivery system. The delivery system is configured for transfemoral artery delivery, and the loading tool is in an open configuration, with the loading funnel-shaped portion positioned on top of the delivery system. [Figure 17] Figure 5 shows a side view of the loading tool after it has been positioned above the distal end of the delivery system, with the loading tool in a closed configuration. [Figure 18] Figure 5 shows a side cross-sectional view of a portion of the loading tool, which is in a closed configuration. [Figure 19] Figure 18 shows a side cross-sectional view of the delivery system shown in Figure 17, with the capsule and piston positioned inside. [Modes for carrying out the invention]

[0031] Herein, specific embodiments of the present invention will be described with reference to the drawings, in which similar reference numerals indicate identical or functionally similar elements. Unless otherwise indicated, the terms “distal” and “proximal” when used in the following description to refer to a sheath, delivery device or catheter-based delivery system, relate to location or direction relative to the treating clinician. Thus, “distal” and “distal side” refer to a location that is farther from or away from the treating clinician, while the terms “proximal” and “proximal side” refer to a location that is closer to or towards the treating clinician.

[0032] Embodiments of the present invention relate to a loading tool for facilitating the loading of a self-expanding prosthesis into a delivery system. The loading tool according to the embodiments herein is positioned above the distal end of the delivery system, while the self-expanding prosthesis is configured to be positioned or retracted into the distal end of the delivery system. The loading tool according to the embodiments herein is configured to prevent damage to the self-expanding prosthesis during loading into the delivery system, as will be described in more detail herein. Furthermore, the loading tool includes an integrated elastic clip configured to automatically lock a slidable collar of the loading tool into place when it reaches a predetermined position. When the slidable collar is locked into place, the elastic clip provides a robust mechanical hard stop, and the loading tool is also locked into a closed configuration, preventing the loading tool from opening. The slidable collar can only be unlocked when the user tightens or radially compresses the elastic clip, thereby releasing the slidable collar. When locked, the loading tool can withstand high radial loading forces, such as 370 N or more. In some embodiments, the loading tool can withstand radial loading forces exceeding 370 N. As such, the loading tool can be used with self-expanding prostheses that have high radial loading forces, such as transcatheter valve prostheses configured to be implanted in the patient's own mitral valve, but not limited to these. Furthermore, the loading tool is easy for the user to operate and is also provided to the user as a single unit, so it does not require user assembly.

[0033] Figures 1-4 show transcatheter valve prostheses 100 that may be used with embodiments of the loading tools described herein. The cardiac valve prostheses 100 are shown herein for the purpose of facilitating the explanation of the present invention. The following description of the transcatheter valve prostheses 100 is, in practice, merely illustrative and does not limit the present invention or its applications and uses. It will be understood that any number of alternative cardiac valve prostheses may be used with the loading tools described herein. Other non-limiting examples of transcatheter heart valve prostheses that may be used with the loading tools described herein are described in U.S. Patent Application No. 16 / 853,851 to McVeigh et al., U.S. Patent No. 9,034,032 to McLean et al., and International Patent Application PCT / U.S. Patent Publication No. 2014 / 029549 to McLean et al., U.S. Patent Publication No. 2012 / 0101572 to Kovalsky et al., U.S. Patent Publication No. 2012 / 0035722 to Tuval, U.S. Patent Publication No. 2006 / 0265056 to Nguyen et al., U.S. Patent Publication No. 2007 / 05409266 to Birdsall, and U.S. Patent Publication No. 2007 / 05409269 to Dolan et al., each of which is incorporated herein by reference in its entirety. The transcatheter valve prosthesis 100 is a cardiac valve prosthesis configured to be placed within the mitral valve of the heart, but embodiments of the loading tool described herein may be used when loading any self-expanding transcatheter valve prosthesis into the delivery system. For example, embodiments of the loading tool described herein may be used with transcatheter cardiac valves configured to be placed within the pulmonary valve, aortic valve, mitral valve, or tricuspid valve, or with transcatheter valve prostheses configured to be placed within venous valves or other body passages deemed useful. The present invention is not bound by any express or implied theories presented in the preceding technical field, background, summary, or the detailed description below. Furthermore, embodiments of the loading members described herein may be used when loading any self-expanding prosthesis into the delivery system, and it is not necessary for artificial valve components to be placed inside the self-expanding prosthesis.

[0034] Figure 1 shows a perspective view of a transcatheter valve prosthesis 100 according to one aspect of the present disclosure. The transcatheter valve prosthesis 100 is configured to be radially compressed into a reduced-diameter crimped form for delivery into a vascular structure (not shown) and to return to an expanded deployed form as shown in Figure 1. In other words, the transcatheter valve prosthesis 100 has a crimped form for delivery into a vascular structure and an expanded form for deployment within the patient's own heart valve. According to embodiments of this specification, when in the crimped form, the transcatheter valve prosthesis 100 has a thin profile suitable for delivery to and deployment within the patient's own heart valve via a suitable delivery catheter that can be tracked to the deployment site of the patient's own heart valve by one of the transseptal, retrograde, or transapical approaches. The transcatheter valve prosthesis 100 includes a stent or frame 102 and an artificial valve component 108 comprising at least one valve leaflet positioned within and fixed to the frame 102.

[0035] Any part of the frame 102 described herein as an element of the heart valve prosthesis 100 may be made from any number of suitable biocompatible materials, such as stainless steel, nickel-titanium alloy, such as Nitinol®, cobalt-chromium alloy, such as MP35N, other alloys, such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combinations of materials. Suitable biocompatible materials would be selected to provide a transcatheter heart valve prosthesis 100 configured to be compressed into a reduced-diameter crimped form for transcatheter delivery to the own valve, thereby returning the prosthesis to an expanded, deployed form upon release from the delivery catheter.

[0036] In one embodiment of the present disclosure, the frame 102 of the transcatheter valve prosthesis 100 includes a valve support 104 that is at least partially surrounded and coupled thereto by a fixing element 106. The valve support 104 is a tubular, stent-like or frame structure that defines a central lumen 110 from the inlet end 101 of the valve support 104 to the outlet end 103 of the valve support 104. The valve support 104 is configured to support therea an artificial valve component 108, which will be described in detail below. In one embodiment, the valve support 104 has a substantially cylindrical shape, where the diameter of the outlet end 103 of the valve support 104 is substantially the same as the diameter of the inlet end 101 of the valve support 104.

[0037] The valve support 104 includes a skirt 112 bonded to its surface. More specifically, the skirt 112 is bonded to the inner surface of the valve support 104 and lining a portion of it. Alternatively, as is known to those skilled in the art of artificial valve structures, the skirt 112 may be bonded to the outer surface of the valve support 104 and enclose a portion of it. The skirt 112 may be a natural or biological material, such as the pericardium or another membranous tissue, such as intestinal submucosa. Alternatively, the skirt 112 may be a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE, which, when attached to a stent, creates a unidirectional channel. In one embodiment, the skirt 112 may be a knitted or woven polyester, such as polyester or PTFE knit, which may be used when it is desired to provide a medium for inward tissue growth and the ability of the fabric to stretch to conform to a curved surface. Alternatively, polyester velour fabric may be used when it is desired to provide a medium for inward tissue growth on one side and a smooth surface on the other side. These and other suitable cardiovascular fabrics are commercially available, for example, from Bard Peripheral Vascular, Inc. (Tempe, Arizona).

[0038] In one embodiment of this disclosure, the fixation element 106 is a stent-like or frame structure that functions as an anchor for a transcatheter valve prosthesis 100 to fix it in its deployed position within the patient's own valve annulus. The fixation element 106 is a substantially cylindrical structure configured to engage with the patient's own cardiac annulus, such as the patient's own mitral valve annulus, or below it, cardiac tissue. At the inlet end 101 of the valve support 104, the fixation element 106 is radially spaced from the valve support 104 by a distance S, mechanically isolating the inlet end 101 of the valve support 104 from the fixation element 106. The fixation element 106 includes one or more cleats or prongs 114 that extend outward from its outer surface and engage with cardiac tissue. In another embodiment, the fixation element 106 may use barbs, spikes, or other tissue fixation mechanisms to engage with cardiac tissue.

[0039] The transcatheter valve prosthesis 100 further includes a rim or edge element 116 extending outward from the upstream end of the fixation element 106. The rim element 116 includes overlapping, 180-degree phase-shifted sinusoidal wire shapes, which are attached to the fixation element 106 by a suitable biocompatible thin fabric 117, such as woven polyethylene terephthalate (PET) fabric, used in bioprosthesis implants, i.e., endovascular grafts, heart valves, or left atrial appendage devices, to facilitate biointegration, and are hinged together. The rim element 116, if present, may function as an atrial retainer, and to perform such a function, the rim element 116 may be configured to engage with tissue or any other tissue in the left atrium above the annulus, for example on the supramolecular surface, thereby preventing, for example, the downstream movement of the artificial heart valve 100 during atrial contraction.

[0040] Referring to Figure 2, the structure of the valve support 104 is described in detail here. The valve support 104 includes a plurality of crown portions 119A and a plurality of struts 119B, each crown portion 119A formed between pairs of opposing struts 119B. Each crown portion 119A is a curved segment or bend extending between the opposing struts 119B. The valve support 104 is tubular, and a plurality of side openings 118 are defined by the edges of the plurality of crown portions 119A and the plurality of struts 119B. In some embodiments, the plurality of side openings 118 may be substantially diamond-shaped. The valve support 104 includes a plurality of nodule portions 117. A nodule portion 117 is defined as a region where two crown portions of the plurality of crown portions 119A within the valve support 104 touch or connect. A skirt 112 is attached to the inner surface of the valve support 104 around its circumference. The skirt 112 lines the inner surface of the valve support 104. At its inlet end 101, the valve support 104 includes a number of attachment bars 105 extending therefrom, which function to releasably connect the transcatheter valve prosthesis 100 to the delivery system.

[0041] The prosthetic valve component 108 of the transcatheter valve prosthesis 100 can regulate the flow through it by valve leaflets that can form a replacement valve. Figures 1-4 show exemplary prosthetic valve components having three leaflets, although single-leaflet or double-leaflet configurations may be used instead in embodiments herein. When deployed in situ, the closed prosthetic valve component 108 is configured to obstruct unidirectional blood flow and regulate blood flow through the central lumen 110 of the valve support 104. Figure 2 shows a perspective view of the valve support 104 in which the prosthetic valve component 108 is fixed internally, and the valve support 104 shown in Figure 2 has been removed from the rest of the transcatheter valve prosthesis 100 shown in Figure 1 for simplicity of explanation. Figure 3 shows an atrial or inflow end view of the transcatheter valve prosthesis 100 shown in Figure 1, and Figure 4 shows a ventricular or outflow end view of the transcatheter valve prosthesis 100 shown in Figure 1. The artificial valve component 108 comprises valve leaflets 109, for example, three valve leaflets 109, which are positioned within the upstream portion of the valve support 104 so as to connect with valve leaflet junctions 109A, 109B, and 109C of the valve leaflets 109 fixed within the downstream portion of the valve support 104, allowing the valve leaflets 109 to open during diastole. The valve leaflets 109 are attached to the valve support 104 along their bases, for example, using sutures or a suitable biocompatible adhesive. Adjacent pairs of valve leaflets 109 are attached to each other at their outer ends to form valve leaflet junctions 109A, 109B, and 109C. The orientation of the valve leaflets 109 within the valve support 104 depends on which end of the transcatheter valve prosthesis 100 is the inflow end and which end of the transcatheter valve prosthesis 100 is the outflow end, thereby ensuring a unidirectional flow of blood through the transcatheter valve prosthesis 100.

[0042] The valve leaflet 109 can be attached to the skirt 112. The valve leaflet 109 can be formed from a variety of flexible materials, for example, but not limited to, natural pericardial materials, such as tissues derived from cattle, horses, or pigs, or synthetic materials, such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. In some artificial valve leaflet materials, it may be desirable to coat one or both sides of the replacement leaflet with a material that prevents or minimizes abnormal growth. It is even more desirable that the artificial valve leaflet material be durable and not stretch, deform, or fatigue.

[0043] For delivery, the transcatheter valve prosthesis 100 is radially compressed into a reduced-diameter crimped form within a delivery system for delivery within a vascular structure. As is known in the art, the delivery system includes an inner shaft that receives the transcatheter valve prosthesis 100 at its distal portion, and an outer sheath or capsule configured to compressively hold the transcatheter valve prosthesis 100 at the distal portion of the inner shaft during delivery. In other words, the outer sheath or capsule surrounds and restrains the transcatheter valve prosthesis 100 in a radially compressed or crimped form. Exemplary delivery systems for delivering the transcatheter valve prosthesis 100 are described in U.S. Patent No. 9,034,032 to McLean et al. and International Patent Application PCT / U.S. Patent Publication No. 2014 / 029549 to McLean et al., which are previously incorporated herein by reference. However, it will be apparent to those skilled in the art that other delivery systems may be used, and the components of the delivery system may vary depending on the form and structure of the transcatheter valve prosthesis during delivery.

[0044] As described above, embodiments of the present invention relate to a loading tool for facilitating the loading of a transcatheter valve prosthesis 100 into a delivery system. The loading tool is positioned above the distal end of the delivery system, while the transcatheter valve prosthesis 100 is retracted or drawn into the distal end of the delivery system. For illustrative purposes, the structure of the transcatheter valve prosthesis 100 has already been described in detail above, so the method of using the loading tool for the transcatheter valve prosthesis 100 will be described herein. However, as described above, the loading tool described herein can be used when loading any self-expanding prosthesis into a delivery system, and it is not necessary for the artificial valve components to be positioned inside the self-expanding prosthesis.

[0045] More specifically, the loading tool 520 is shown in Figures 5-8B. Figure 5 shows a perspective view of the loading tool 520, while Figure 6 shows an exploded view of the loading tool 520 for illustrative purposes. The loading tool 520 includes a hinged body 522, a collar 540 slidably mounted on the hinged body 522, and a fastener 554. The hinged body 522 includes a first body half or portion 524A and a second body half or portion 524B. The first and second body portions 524A and 524B collectively define the hinged body 522, which is configured to be mechanically and dynamically opened and closed by the sliding motion of the collar 540, as will be described in more detail herein. As will be explained in more detail with respect to Figures 9 and 10, the hinged body 522 is sized or configured to be positioned above the distal end of the delivery system during the loading of the transcatheter valve prosthesis 100 into the delivery system.

[0046] Each of the first body portion 524A and the second body portion 524B has first ends 526A, 526B and second ends 528A, 528B, respectively. The first end 526A of the first body portion 524A is attached to the first end 526B of the second body 524B by a fastener 554, and the second end 528A of the first body portion 524A is not attached to the second end 528B of the second body portion 524B. The attached first ends 526A, 526B form the hinged end 535 of the loading tool 520. The attached first ends 526A, 526B may include interlocking or mating surfaces 538A, 538B, as best shown in the exploded view of Figure 6.

[0047] Each of the first body portion 524A and the second body portion 524B includes elastic clips 530A, 530B integrally formed thereon, which include radial projections 532A, 532B on their outer surfaces 534A, 534B, respectively. Each elastic clip 530A, 530B is a flap or tab formed on its respective body portion, which is configured to be displaced radially inward when a clamping force is applied thereto. Each elastic clip 530A, 530B includes a first end 529A, 529B attached to or extending from the respective body portion 524A, 524B and a second end 531A, 531B detached from the respective body portion 524A, 524B. The radial projections 532A, 532B are formed on the second end 531A, 531B of the elastic clips 530A, 530B. The thickness of each elastic clip 530A, 530B is tapered along its length from its first end 529A, 529B to its second end 531A, 531B. More specifically, as best shown in Figure 8B, each elastic clip 530A, 530B has a first thickness T1 at its first end 529A, 529B, which is greater than the second thickness T2 at its second end 531A, 531B. The thickness of each elastic clip 530A, 530B may be continuously or gradually tapered between the first thickness T1 and the second thickness T2. The tapered thickness of the elastic clips 530A and 530B provides or creates sufficient clearance for the elastic clips 530A and 530B to be displaced radially inward when a clamping force is applied thereto, thereby allowing the collar 540 to slide forward on the radial projections 532A and 532B, as will be described in more detail herein.

[0048] The collar 540 has a tubular body 542 having a first end 546 and a second or opposing end 548, and the tubular body 542 defines a lumen or passage 544 through which it can be slidably positioned on the hinged body 522. The outer surface 550 of the collar 540 includes a number of ribs 551 so that the collar 540 can be easily grasped by a user for sliding movement of the collar 540 along the hinged body. The inner surface 552 of the collar 540 is sized or configured to be only slightly larger than the outer surface of the hinged body 522 so that the collar 540 can be easily moved back and forth along the hinged body 522, and when positioned on top of the collar 540, as will be described in more detail herein, it forces the second ends 528A, 528B of the first and second body portions 524A, 524B together.

[0049] The fastener 554 includes a flat, round disc 560, which, when assembled with the first and second body portions 524A, 524B, is configured to close the ends of the hinged body 522. The fastener 554 also includes two opposing finger portions 556A, 556B extending axially from the disc 560. Each finger portion 556A, 556B has a rounded or arc-shaped cross section along its length, and the finger portions 556A, 556B are separated from each other by a transverse opening 558. The transverse opening 558 is sized or configured to receive the first ends 526A, 526B of the first and second body portions 524A, 524B, and the finger portions 556A, 556B are configured to be mechanically coupled to the first ends 526A, 526B of the first and second body portions 524A, 524B. Therefore, the fastener 554 attaches or fastens the first and second body parts 524A and 524B together. Since the fastener 544 also includes the collar 540, the collar 540 cannot slip off the hinged body 522. In particular, since the outer diameter of the disc 560 is slightly larger than the outer diameter of the collar 540, when the collar 540 is placed on the hinged body 522, the collar 540 cannot slide on the disc 560 of the fastener 554. In other words, the disc 560 of the fastener 554 acts as a stopper for the collar 540. Therefore, the loading tool 520 can be provided to the user as a single, pre-assembled tool that requires no assembly by the user at all.

[0050] Adjacent to the second ends 528A, 528B of the first and second body portions 524A, 524B, each body portion includes fins or flanges 536A, 536B extending radially outward from its outer surface. In one embodiment, each flange 536A, 536B has a square contour so that the loading tool 520 is configured to rest on a flat surface, i.e., a table, without rolling. Similar to the fasteners 544 adjacent to the first ends 526A, 526B of the first and second body portions 524A, 524B, the flanges 536A, 536B also function to accommodate a collar 540 so that the collar 540 cannot slip off the hinged body 522 adjacent to the second ends 528A, 528B of the first and second body portions 524A, 524B. In particular, since flanges 536A and 536B collectively have an outer diameter slightly larger than that of collar 540, when collar 540 is positioned on the hinged body 522, collar 540 cannot slide on flanges 536A and 536B. In other words, flanges 536A and 536B act as stoppers for collar 540.

[0051] The loading tool 520 is initially formed or shaped in an open configuration, with the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B being radially spaced apart from each other, as shown in the side views of Figures 5 and 7. Furthermore, in the open configuration, the collar 540 is positioned on the first ends 526A and 526B of the first and second body portions 524A and 524B. The open configuration provides a flared opening 562 at the end of the loading tool 520, thereby allowing the loading tool 520 to easily slide over the delivery system during the loading process and to easily slide off the delivery system after the loading process is complete.

[0052] Figures 8A and 8B show a side view and perspective view of the loading collar 520 in a closed configuration, where the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B are positioned directly adjacent to each other, and the collar 540 is positioned on the second ends 528A and 528B of the first and second body portions 524A and 524B. The term "positioned directly adjacent to each other" as used herein with respect to the closed configuration of the loading collar described herein includes the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B being in contact with or touching each other, and the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B being positioned relative to each other with a small predetermined nominal radial gap without any intervening structure between them. When in the closed position, the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B are positioned radially closer to each other than when in the open position. When in the closed position, the radial projections 532A and 532B of the elastic clips 530A and 530B are configured to contact the collar 540 and lock the loading tool 520 into the closed position. As a result, when the collar 540 locks the hinged body 522 into the closed position, the collar 540 is sandwiched between the radial projections 532A and 532B of the elastic clips 530A and 530B and the flanges 536A and 536B. Each of the first and second body portions 524A and 524B further includes tapered outer surfaces 539A and 539B adjacent to the flanges 536A and 536B, respectively (best shown in Figure 7), which ensure a tight interlock when the collar 540 is sandwiched between the radial projections 532A and 532B of the elastic clips 530A and 530B and the flanges 536A and 536B. The loading tool 520 is prevented from opening when the radial projections 532A and 532B lock the collar 540 and the loading tool 520 into a closed position, so the loading tool 540 does not slip or open abruptly until the loading procedure is complete. By being locked in a closed position, the transcatheter valve prosthesis 100 is reliably protected from damage associated with misloading during loading.

[0053] Each radial projection 532A, 532B has tapered outer surfaces 533A, 533B that allow the collar 540 to slide in the direction from the first ends 526A, 526B of the first and second body portions 524A, 524B toward the second ends 528A, 528B of the first and second body portions 524A, 524B. In other words, when the user moves the collar 540 in the direction from the first ends 526A, 526B of the first and second body portions 524A, 524B toward the second ends 528A, 528B of the first and second body portions 524A, 524B, the collar 540 traverses the radial projections 532A, 532B via the tapered outer surfaces 533A, 533B without any additional user intervention. As the collar 540 traverses the radial projections 532A and 532B, the elastic clips 530A and 530B may be displaced radially inward by the collar 540. However, after the collar 540 has traversed the radial projections 532A and 532B, the elastic clips 530A and 530B spring back or return to their formed or shaped positions when the collar 540 is no longer positioned on them. When the elastic clips 530A and 530B spring back or return to their formed or shaped positions, the user feels a tactile click, providing feedback that the loading tool 520 is locked in the closed position.

[0054] Each radial projection 532A, 532B has end faces 537A, 537B that do not allow the collar 540 to slide in the direction from the second ends 528A, 528B of the first and second body portions 524A, 524B toward the first ends 526A, 526B of the first and second body portions 524A, 524B unless the elastic clips 530A, 530B are displaced radially inward by the user. When in the closed configuration, the end faces 537A, 537B of the radial projections 532A, 532B are configured to abut against the collar 540, thereby providing a mechanical hard stop for the collar 540, which also provides the user with visual feedback that the loading tool 520 is locked in the closed configuration.

[0055] When the user wants to unlock the loading tool 520 for removal, i.e., after the loading procedure is complete, the user releases the collar 540 by moving the elastic clips 530A, 530B inward or displacing them radially. In other words, when the user tightens the elastic clips 530A, 530B, the end faces 537A, 537B of the radial projections 532A, 532B are displaced radially inward, so that the collar 540 can traverse the radial projections 532A, 532B. Therefore, when the elastic clips 530A, 530B are displaced inward by the user, the user can retract the collar 540 and return the loading tool 520 to its open state. When in the open state, the loading tool 520 can be easily removed from the delivery system.

[0056] The setup of the loading tool 520 on the delivery system will now be described in general terms with reference to Figures 9 and 10. Figure 9 shows a side view of the loading tool 520 in its open configuration before being positioned on the distal end 972 of the delivery system 970. In this embodiment, the delivery system 970 is configured to deliver the transcatheter valve prosthesis 100 by a transfemoral artery approach. When configured for transfemoral artery delivery, the outflow end 103 of the transcatheter valve prosthesis 100 is positioned distal to the inflow end 101 of the transcatheter valve prosthesis 100 within the distal end 972 of the delivery system 970. Furthermore, when configured for transfemoral artery delivery, the outflow end 103 of the transcatheter valve prosthesis 100 is released and deployed in front of the inflow end 101 of the transcatheter valve prosthesis 100. In this embodiment, the distal end 972 includes a capsule 974 configured to restrain the transcatheter valve prosthesis 100 in a radially reduced form during in situ delivery.

[0057] When a user is preparing to load the transcatheter valve prosthesis 100 into the capsule 974 at the distal end 972 of the delivery system 970, the user first positions the loading tool 520 on the capsule 974 by advancing the flared opening 562 of the loading tool 520 over the capsule 974. After the loading tool 520 is positioned on the capsule 974, the user transitions the loading tool 520 into a closed configuration. Figure 10 shows a side view of the loading tool 520 in its closed configuration after being positioned on the capsule 974 of the delivery system 970. The inner diameter of the hinged body 522 of the loading tool 520 is substantially equal to the outer diameter of the capsule 974 of the delivery system 970. The first and second body portions 524A and 524B positioned on the capsule 974 have a tubular configuration collectively when the loading tool 520 is in a closed configuration. With the loading tool 520 in a closed configuration and positioned above the distal end 972, the loading tool 520 is positioned for the transcatheter valve prosthesis 100 to be drawn into the capsule 974 of the delivery system 970. The process of loading the transcatheter valve prosthesis 100 into the capsule 974 is described with reference to Figures 16 and 17. Furthermore, the hinged body 522 of the loading tool 520 includes several integrated features, including chamfers, piston ledges, and capsule overhangs, to interact with the delivery system when the transcatheter valve prosthesis 100 is drawn into the delivery system and to avoid damage to the transcatheter valve prosthesis 100, these features are described with reference to Figures 18 and 19.

[0058] Figure 11 shows an exploded view of a loading tool 1120 according to another embodiment of this specification, in which the first and second body portions of the loading tool are attached to each other via adhesive. The loading tool 1120 includes a hinged body 1122 and a collar 1140 slidably positioned on the hinged body 1122. Similar to the hinged body 522, the hinged body 1122 includes a first body half or portion 1124A and a second body half or portion 1124B. The first and second body halves or portions 1124A and 1124B collectively define the hinged body 1122, which, similar to the hinged body 522, is configured to be mechanically and dynamically opened and closed by the sliding motion of the collar 1140. During the loading of the transcatheter valve prosthesis 100 into the delivery system, the hinged body 1122 is sized or configured to be positioned above the distal end of the delivery system.

[0059] Similar to the loading tool 520, the loading tool 1120 includes elastic clips that lock the collar 1140 and the loading tool 1120 into a closed configuration. In particular, the first body portion 1124A and the second body portion 1124B include elastic clips 1130A, 1130B formed therein, which include radial projections 1132A, 1132B on their outer surfaces, respectively. Each elastic clip 1130A, 1130B is a flap or tab formed on its respective body portion and is configured to be displaced radially inward when a tightening force is applied thereto. Each elastic clip 1130A, 1130B includes a first end 1129A, 1129B attached to or extending from the respective body portions 1124A, 1124B and a second end 1131A, 1131B detached from the respective body portions 1124A, 1124B. The radial projections 1132A and 1132B are formed on the second ends 1131A and 1131B of the elastic clips 1130A and 1130B.

[0060] Each of the first body portion 1124A and the second body portion 1124B has first ends 1126A, 1126B and second ends 1128A, 1128B, respectively. The first end 1126A of the first body portion 1124A is attached to the first end 1126B of the second body 1124B via adhesive at a joint 1190, while the second end 1128A of the first body portion 1124A is not attached to the second end 1128B of the second body portion 1124B. The attached first ends 1126A, 1126B form the hinged end 1135 of the loading tool 1120. With the first and second body portions 1124A, 1124B attached via adhesive, the mechanical fasteners of the loading tool 520 are omitted. Adjacent to the first ends 1126A, 1126B, each of the first body portion 1124A and the second body portion 1124B includes a semicircular blunt end, which is configured to close one end of the hinged body 1122 when the first and second body portions 1124A, 1124B are joined. The opposing end of the loading tool 1120 includes a flared opening 1162, which is similar to the flared opening 562 of the loading tool 520, which allows the loading tool 1120 to slide easily over the delivery system during the loading process and to slide easily off the delivery system after the loading process is complete.

[0061] When the first and second body portions 1124A and 1124B are joined, one end of the hinged body 1122 is closed, so the loading tool 1122 is configured to be used with a delivery system configured to deliver the transcatheter valve prosthesis 100 by a transfemoral artery approach, similar to the loading tool 520 described above with respect to Figures 9 and 10.

[0062] Figure 12 shows an exploded view of a loading tool 1220 according to another embodiment of this specification, in which the first and second body portions of the loading tool are attached to each other via adhesive, but the loading tool 1220 is open at both ends. The loading tool 1220 includes a hinged body 1222 and a collar 1240 slidably positioned on the hinged body 1222. Similar to the hinged body 522, the hinged body 1222 includes a first body half or portion 1224A and a second body half or portion 1224B. The first and second body halves or portions 1224A and 1224B collectively define the hinged body 1222, which, similar to the hinged body 522, is configured to be mechanically and dynamically opened and closed by the sliding motion of the collar 1240. The hinged body 1222 is sized or configured to be positioned above the distal end of the delivery system during the loading of the transcatheter valve prosthesis 100 into the delivery system.

[0063] Similar to the loading tool 1220, the loading tool 1220 includes elastic clips for locking the collar 1240 and the loading tool 1220 into a closed configuration. In particular, the first body portion 1224A and the second body portion 1224B include elastic clips 1230A, 1230B formed thereon, which include radial projections 1232A, 1232B on their outer surfaces, respectively. Each elastic clip 1230A, 1230B is a flap or tab formed on its respective body portion and is configured to be displaced radially inward when a tightening force is applied thereto. Each elastic clip 1230A, 1230B includes a first end 1229A, 1229B attached to or extending from the respective body portions 1224A, 1224B and a second end 1231A, 1231B detached from the respective body portions 1224A, 1224B. The radial projections 1232A and 1232B are formed on the second ends 1231A and 1231B of the elastic clips 1230A and 1230B.

[0064] Each of the first body portion 1224A and the second body portion 1224B has first ends 1226A, 1226B and second ends 1228A, 1228B, respectively. The first end 1226A of the first body portion 1224A is attached to the first end 1226B of the second body 1224B via adhesive at a joint 1290, and the second end 1228A of the first body portion 1224A is not attached to the second end 1228B of the second body portion 1224B. The attached first ends 1226A, 1226B form the hinged end 1235 of the loading tool 1220. The attached first ends 1226A, 1226B may include interlocking or mating surfaces 1238A, 1238B. With the first and second body portions 1224A and 1224B attached via adhesive, the mechanical fasteners of the loading tool 520 are omitted. Adjacent to the first ends 1226A and 1226B, at the hinged end 1235, the loading tool 1220 has a fixed opening 1292. The opposing end of the loading tool 1220 includes a flared opening 1262, which, like the flared opening 562 of the loading tool 520, allows the loading tool 1220 to slide easily over the delivery system during the loading process and to slide easily off the delivery system after the loading process is complete.

[0065] When the first and second main body portions 1224A and 1224B are joined, both ends of the loading tool 1220 (i.e., the flared opening 1262 and the fixed opening 1292) are open, so the loading tool 1222 can be used with a delivery system configured to deliver the transcatheter valve prosthesis 100 via a transfemoral approach and a delivery system configured to deliver the transcatheter valve prosthesis 100 via a transapical approach, similar to the loading tools 520 and 1220. The setup of the loading tool 1220 in a delivery system configured to deliver the transcatheter valve prosthesis 100 using a transapical approach will now be described in general with reference to Figures 13 and 14. Figure 13 shows a side view of the loading tool 1220 in its open configuration before being positioned on the distal end 1372 of the delivery system 1370. In this embodiment, the delivery system 1370 is configured to deliver the transcatheter valve prosthesis 100 by a transapical approach. When configured for transapical delivery, the inlet end 101 of the transcatheter valve prosthesis 100 is located distal to the outlet end 103 of the transcatheter valve prosthesis 100 within the distal end 1372 of the delivery system 1270. Furthermore, when configured for transapical delivery, the inlet end 101 of the transcatheter valve prosthesis 100 is released and deployed in front of the outlet end 103 of the transcatheter valve prosthesis 100.

[0066] When a user is preparing to load a transcatheter valve prosthesis 100 into the distal end 1372 of the delivery system 1370, the user first positions the loading tool 1220 over the distal end 1372 by advancing the fixed opening 1292 on the distal end 1372 at the hinged end 1235 of the loading tool 1220. After the loading tool 1220 is positioned over the distal end 1372, the user moves the loading tool 1220 into the closed position. Figure 14 shows a side view of the loading tool 1220 in the closed position after it has been positioned over the distal end 1372 of the delivery system 1370. The inner diameter of the hinged body 1222 of the loading tool 1220 is substantially equal to the outer diameter of the distal end 1372 of the delivery system 1370. The first and second body portions 1224A and 1224B, positioned above the distal end 1372, collectively have a tubular shape when the loading tool 1220 is in a closed configuration. With the loading tool 1220 in a closed configuration and positioned above the distal end 1372, the loading tool 1220 is positioned for the transcatheter valve prosthesis 100 to be drawn into the distal end 1372 of the delivery system 1370.

[0067] Figures 15A and 15B show perspective views of a loading tool 1520 according to another embodiment of this specification, in which the first and second body portions of the loading tool are attached to each other via annular, i.e., ring-shaped fasteners, so that the loading tool 1520 opens at both ends. The loading tool 1520 includes a hinged body 1522, a collar 1540 slidably mounted on the hinged body 1522, and a fastener 1554. Similar to the hinged body 522, the hinged body 1522 includes a first body half or portion 1524A and a second body half or portion 1524B. The first and second body halves or portions 1524A and 1524B collectively define the hinged body 1522, which, similar to the hinged body 522, is configured to open and close mechanically and dynamically by the sliding motion of the collar 1540. The hinged body 1522 is sized or configured to be positioned above the distal end of the delivery system during the loading of the transcatheter valve prosthesis 100 into the delivery system.

[0068] Similar to the loading tool 1520, the loading tool 1520 includes a collar 1540 and elastic clips for locking the loading tool 1520 into a closed configuration. In particular, the first body portion 1524A and the second body portion 1524B include elastic clips 1530A, 1530B formed thereon, which include radial projections 1532A, 1532B on their outer surfaces, respectively. Each elastic clip 1530A, 1530B is a flap or tab formed on its respective body portion and is configured to be displaced radially inward when a tightening force is applied thereto. Each elastic clip 1530A, 1530B includes a first end 1529A, 1529B attached to or extending from the respective body portions 1524A, 1524B and a second end 1531A, 1531B detached from the respective body portions 1524A, 1524B. The radial projections 1532A and 1532B are formed on the second ends 1531A and 1531B of the elastic clips 1530A and 1530B.

[0069] The first body portion 1524A and the second body portion 1524B each have first ends 1526A, 1526B and second ends 1528A, 1528B, respectively. The first end 1526A of the first body portion 1524A is attached to the first end 1526B of the second body 1524B by a fastener 1554, while the second end 1528A of the first body portion 1524A is not attached to the second end 1528B of the second body portion 1524B. The attached first ends 1526A and 1526B form the hinged end 1535 of the loading tool 1520.

[0070] The fastener 1554 is an annular, or ring-shaped, component positioned on the first ends 1526A, 1526B of the loading tool 1520. The fastener 1554 attaches or fastens the first and second body portions 524A, 524B together. The fastener 1544 also includes the collar 1540, so that the collar 1540 cannot slip off the hinged body 1522. In particular, the outer diameter of the fastener 1554 is slightly larger than the outer diameter of the collar 1540, so that when the collar 1540 is positioned on the hinged body 1522, the collar 1540 cannot slide on the fastener 1554. In other words, the fastener 1554 acts as a stopper for the collar 1540. Thus, the loading tool 1520 is provided to the user as a single, pre-assembled tool, requiring no assembly by the user whatsoever.

[0071] Adjacent to the first ends 1526A and 1526B, and adjacent to the hinged end 1535, the loading tool 1520 has a fixed opening 1592. The opposing end of the loading tool 1520 includes a flared opening 1562, which, like the flared opening 562 of the loading tool 1520, allows the loading tool 1520 to slide easily over the delivery system during the loading process and further slide easily off the delivery system after the loading process is complete.

[0072] When the first and second main body portions 1524A and 1524B are joined, both ends of the loading tool 1520 (i.e., the flared opening 1562 and the fixed opening 1592) are open, so the loading tool 1522 can be used with a delivery system configured to deliver the transcatheter valve prosthesis 100 via either a transfemoral approach similar to the loading tool 1520 described above with respect to Figures 9 and 10, or a transapical approach similar to the loading tool 1220 described above with respect to Figures 13 and 14.

[0073] Here, with reference to Figures 16-19, a method for loading a self-expanding prosthesis into the delivery system is described. For illustrative purposes, regarding the use of the loading tool, the structure of the transcatheter valve prosthesis 100 has already been detailed above, and therefore, this specification will describe the loading of the transcatheter valve prosthesis 100 configured for implantation into the autologous mitral valve. However, as stated above, the loading tool described herein can be used when loading any self-expanding prosthesis into the delivery system, and it is not necessary for the artificial valve components to be placed inside the self-expanding prosthesis. Furthermore, for illustrative purposes, regarding the use of the loading tool, this specification will describe the loading of the transcatheter valve prosthesis 100 into a delivery system 1670 having a distal end 1672. In this embodiment, the distal end 1672 includes a capsule 1674 configured to restrain the transcatheter valve prosthesis 100 in a radially smaller form during delivery in situ, and includes a piston 1680 for fluid pressure operation of the capsule 1672. The delivery system 1670 is described in Figures 54A–55C of U.S. Patent No. 9,034,032 to McLean et al., which is previously incorporated herein by reference, and in International Patent Application PCT / U.S. Patent Publication No. 2014 / 029549 to McLean et al.

[0074] The transcatheter valve prosthesis 100 is initially crimped to a reduced diameter by advancing the transcatheter valve prosthesis 100 into a loading cone or funnel-shaped portion 1676. In another embodiment (not shown), the transcatheter valve prosthesis 100 may be crimped to a reduced diameter by a radial crimper. The loading funnel-shaped portion 1676 is a conical or tapered component and includes a first end 1675 with a first diameter and a second end 1677 with a second diameter smaller than the first diameter. The transcatheter valve prosthesis 100, in its expanded or shaped form, is positioned within the first end 1675 of the loading funnel-shaped portion 1676 and advanced through the loading funnel-shaped portion 1676 toward its second end 1677 to reduce its diameter. With the transcatheter valve prosthesis 100 positioned inside, the assembly of the loading funnel-shaped section 1676 and the transcatheter valve prosthesis 100 positioned inside it is placed on the inner shaft 1678 of the delivery system 1670 in a saline bath. The assembly of the loading funnel-shaped section 1676 and the transcatheter valve prosthesis 100 is positioned proximal to the proximal end of the capsule 1674. The transcatheter valve prosthesis 100 is advanced through the loading funnel-shaped section 1676 until the mounting bar 105 of the transcatheter valve prosthesis 100 extends from or protrudes from the second end 1677 of the loading funnel-shaped section 1676. The mounting bar 105 is releasably coupled to the piston 1680 of the delivery system 1670. For example, the transcatheter valve prosthesis 100 may be releasably coupled to a piston 1680 by corresponding or paired slots (not shown) formed on the tubular shaft of the piston, which is slidably mounted on an inner shaft 1678, and these slots are configured to receive a mounting bar 105.

[0075] At this stage or point in the loading method shown in the side view of Figure 16, the loading tool 520 can be positioned over the capsule 1674 of the delivery system 1670. The delivery system 1670 is still located in the saline bath, and the assembly of the loading funnel portion 1676 and the transcatheter valve prosthesis 100 is positioned proximal to the proximal end of the capsule 1674, as described above. Figure 16 shows a side view of the loading tool 520 in its open configuration before being positioned over the capsule 1674 of the delivery system 1670. When in the open configuration, as described herein, the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B are radially spaced apart from each other, and the collar 540 is positioned over the first ends 526A and 526B of the first and second body portions 524A and 524B.

[0076] While in the open position, the loading tool 520 is positioned or placed on the capsule 1674 of the delivery system 1670, and while the loading tool 520 is placed on the capsule 1674 of the delivery system 1670, the collar 540 slides on the hinged body 522 until the loading tool 520 is in the closed position. As described herein, when in the closed position, the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B are positioned directly adjacent to each other, the collar 540 is positioned on the second ends 528A, 528B of the first and second body portions 524A, 524B, and the radial projections 532A, 532B abut against the collar 540 to lock the loading tool 520 in the closed position. Figure 17 shows a side view of the loading tool 520 after it has been moved into its closed position.

[0077] The loading tool 520 includes several features to interact with the delivery system 1670 when the transcatheter valve prosthesis 100 is drawn into the delivery system 1670 and to avoid damage to the transcatheter valve prosthesis 100. In more detail, such features are best illustrated in Figures 18 and 19. Figure 18 shows a side cross-sectional view of a portion of the loading tool 520 in a closed configuration, while Figure 19 shows a cross-sectional view of the same side with the capsule 1674 and piston 1680 positioned within the loading tool 520. Each of the first and second body portions 524A, 524B of the loading tool 520 includes chamfered portions or transitional tips 1882A, 1882B on its inner surface 1881A, 1881B at its second end portions 528A, 528B. The chamfered portions 1882A and 1882B provide a smooth transition between the loading funnel-shaped portion 1676 and the capsule 1674, thus helping to avoid damage to the transcatheter valve prosthesis 100 when it is drawn into the capsule 1674.

[0078] Furthermore, referring to Figures 18 and 19, each of the first and second body portions 524A, 524B of the loading tool 520 includes piston ledges 1884A, 1884B at its second ends 528A, 528B. The piston ledges 1884A, 1884B extend beyond flanges 536A, 536B. During use, the piston ledges 1884A, 1884B initially extend over the connection between the releasably mounted mounting bar 105 and the piston 1680 of the delivery system 1670. The piston ledges 1884A, 1884B form a ring gauge around the piston 1680 and help hold the mounting bar 105 in place during loading, as undesirable movement of the mounting bar 105 could cause misloading and / or damage to the transcatheter valve prosthesis 100 and / or the delivery system 1670.

[0079] Furthermore, referring to Figures 18 and 19, each of the first and second body portions 524A and 524B of the loading tool 520 includes capsule overhangs 1886A and 1886B formed on their inner surfaces 1881A and 1881B at their second ends 528A and 528B. The capsule overhangs 1886A and 1886B are integral stepped edges configured to grasp or cover the proximal edge of the capsule 1674, thereby preventing direct contact between the transcatheter valve prosthesis 100 and the proximal end of the capsule 1674 when the transcatheter valve prosthesis 100 is drawn into the capsule 1674. Since the transcatheter valve prosthesis 100 can be inadvertently damaged by friction and / or direct contact with the capsule 1674 during loading, the capsule overhangs 1886A and 1886B help to avoid damage to the transcatheter valve prosthesis 100 when it is drawn into the capsule 1674. Furthermore, since undesirable movement of the mounting bar 105 can cause misloading and / or damage to the transcatheter valve prosthesis 100 and / or the delivery system 1670, the capsule overhangs 1886A and 1886B are configured to hold the mounting bar 105 in place during loading and ensure that the mounting bar 105 does not become detached or suddenly come off after loading.

[0080] As shown in Figure 17, once the loading tool 520 is positioned over the capsule 1674, the transcatheter valve prosthesis 100 is retracted into the capsule 1674 by the movement of the piston 1680. In other words, the piston 1680 retracts or retracts the transcatheter valve prosthesis 100 into the delivery system 1670. While the transcatheter valve prosthesis 100 is being retracted into the delivery system 1670, the loading tool 520 remains locked in its closed position over the capsule 1674 by the elastic clips 530A and 530B of the loading tool 520. The loading tool 520, locked in the closed position, ensures that the transcatheter valve prosthesis 100 is protected from misloading-related damage during loading.

[0081] After the transcatheter valve prosthesis 100 is loaded into the distal end 1672 of the delivery system 1670, the loading tool 520 is removed from the delivery system 1672. As described herein, the loading tool 520 is removed when a clamping force is applied, displacing the elastic clips 530A, 530B radially inward. The collar 540 slides on the hinged body 522 while the elastic clips 530A, 530B are displaced radially inward until the loading tool 520 returns to its open position. Once in the open position, the loading tool 520 is removed from the distal end 1672 of the delivery system 1670.

[0082] It should be understood that the various embodiments disclosed herein may be combined in combinations different from those specifically presented in this description and accompanying drawings. It should also be understood that, as an example, some actions or events of any of the processes or methods described herein may be performed in a different order, added, combined, or omitted (for example, not all described actions or events may be necessary to carry out the art). Furthermore, while some embodiments of this disclosure are described, for clarity, as being carried out by a single module or unit, it should be understood that the art of this disclosure may be carried out by a combination of units or modules associated with, for example, a medical device.

Claims

1. A loading tool for facilitating the loading of a self-expanding prosthesis into a delivery system, A hinged body comprising a first body portion and a second body portion, each of the first body portion and the second body portion having a first end and a second end, the first end of the first body portion being attached to the first end of the second body portion, and the second end of the first body portion not being attached to the second end of the second body portion, each of the first body portion and the second body portion including an elastic clip formed thereon, the elastic clip including a radial projection on its outer surface, and each elastic clip being configured to be displaced radially inward when a clamping force is applied thereto, A collar slidably disposed on the hinge-shaped body, wherein the loading tool has an open configuration in which the second end of the first body portion and the second end of the second body portion are radially spaced apart from each other and the collar is positioned on the first end of the first and second body portions, and the loading tool has a closed configuration in which the second end of the first body portion and the second end of the second body portion are directly adjacent to each other and the collar is positioned on the second end of the first and second body portions, and A loading tool comprising the radial projection being configured to lock the loading tool into the closed position when the elastic clip is not displaced radially inward.

2. The loading tool according to claim 1, wherein each of the first body portion and the second body portion has a flange on its outer surface at the second end thereof, and when the collar locks the hinge-shaped body in the closed position, the collar is sandwiched between the flange and the radial projection on the elastic clip.

3. The loading tool according to claim 2, wherein the flange of the first body portion and the flange of the second body portion have a square contour when combined.

4. The loading tool according to claim 1, wherein each radial projection has a tapered outer surface, the tapered outer surface allows the collar to slide in a direction from the first end of the first and second body portions toward the second end of the first and second body portions, and each radial projection has an end face, the end face does not allow the collar to slide in a direction from the second end of the first and second body portions toward the first end of the first and second body portions unless the elastic clip is displaced radially inward by the clamping force.

5. The loading tool according to claim 1, wherein the first end of the first main body portion is attached to the first end of the second main body portion via an adhesive.

6. The loading tool according to claim 1, wherein the first end of the first body portion is attached to the first end of the second body portion via a mechanical fastener.

7. The loading tool according to claim 1, wherein the radial projection prevents the loading tool from opening when it locks the loading tool into the closed position.

8. The loading tool according to claim 7, wherein the elastic clip is configured to be displaced radially inward to release the collar.

9. The loading tool according to claim 1, wherein the hinged body is configured to be positioned on the distal end of the delivery system during loading of the self-expanding prosthesis into the delivery system.

10. The loading tool according to claim 9, wherein the hinged body is configured to be positioned on the capsule of the delivery system when the self-expanding prosthesis is positioned within the capsule.

11. The loading tool according to claim 10, wherein the second end of the first and second body portions each includes a stepped edge formed on its inner surface, configured to prevent the self-expanding prosthesis from contacting the first end of the capsule when the self-expanding prosthesis is positioned within the capsule, and to hold the mounting bar for the self-expanding prosthesis.

12. The loading tool according to claim 1, wherein the first and second main body portions collectively have a tubular shape when the loading tool is in the closed configuration.

13. A method for loading a self-expanding prosthesis into a delivery system, The loading tool is positioned in an open configuration, wherein the loading tool includes a hinged body and a collar slidably disposed on the hinged body, the hinged body includes a first body portion and a second body portion, each of the first and second body portions having a first end and a second end, the first end of the first body portion being attached to the first end of the second body portion, and the second end of the first body portion being attached to the second end of the second body portion. The first body portion and the second body portion each include an elastic clip formed thereon, the elastic clip includes a radial projection on its outer surface, and each elastic clip is configured to be displaced radially inward when a tightening force is applied thereto, and in the open configuration, the second end of the first body portion and the second end of the second body portion are radially spaced apart from each other, and the collar is positioned on the first ends of the first and second body portions, The loading tool is positioned in an open configuration on the distal end of the delivery system, The loading tool is positioned on the distal end of the delivery system, and the collar is slid on the hinged body until the loading tool is in a closed position, wherein in the closed position, the second end of the first body portion and the second end of the second body portion are positioned directly adjacent to each other, and the collar is positioned on the second ends of the first and second body portions, and the radial projection locks the loading tool in the closed position when the elastic clip is not displaced radially inward. The self-expanding prosthesis is loaded into the distal end of the delivery system while the radial projection locks the loading tool in the closed position. A method that includes this.

14. After the self-expanding prosthesis is loaded into the distal end of the delivery system, a tightening force is applied to displace the elastic clip radially inward. The collar is slid on the hinge-shaped body while the elastic clip is displaced radially inward until the loading tool is in the open position, To remove the loading tool from the distal end of the delivery system. The method according to claim 13, further comprising:

15. The method according to claim 13, wherein the self-expanding prosthesis is a mitral valve prosthesis.

16. The method according to claim 13, wherein each of the first body portion and the second body portion has a flange on its outer surface at the second end thereof, and when the collar locks the hinge-shaped body in the closed position, the collar is sandwiched between the flange and the radial projection on the elastic clip.

17. The method according to claim 13, wherein the flange of the first body portion and the flange of the second body portion have a square contour when combined, and the flanges are positioned relative to a plane while the self-expanding prosthesis is being loaded.

18. The method according to claim 13, wherein each radial projection has a tapered outer surface, the tapered outer surface allows the collar to slide in a direction from the first end of the first and second body portions toward the second end of the first and second body portions, and each radial projection has an end face, the end face does not allow the collar to slide in a direction from the second end of the first and second body portions toward the first end of the first and second body portions unless the elastic clip is displaced radially inward by the clamping force.

19. The method according to claim 13, wherein the loading tool is prevented from being opened to the open position when the radial projection locks the loading tool in the closed position.

20. The method according to claim 13, wherein the distal end is a capsule.

21. The method according to claim 20, wherein the second end of the first and second body portions each includes a stepped edge formed on its inner surface, configured to prevent the self-expanding prosthesis from contacting the first end of the capsule when the self-expanding prosthesis is positioned within the capsule, and to hold the mounting bar of the self-expanding prosthesis.

22. The method according to claim 13, wherein the first and second main body portions collectively have a tubular shape when the loading tool is in the closed configuration.

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