Patent Description:
The human heart is a four chambered, muscular organ that provides blood circulation through the body during a cardiac cycle. The four main chambers include the right atrium and right ventricle which supplies the pulmonary circulation, and the left atrium and left ventricle which supplies oxygenated blood received from the lungs into systemic circulation. To ensure that blood flows in one direction through the heart, atrioventricular valves (tricuspid and mitral valves) are present between the junctions of the atrium and the ventricles, and semi-lunar valves (pulmonary valve and aortic valve) govern the exits of the ventricles leading to the lungs and the rest of the body. These valves contain leaflets or cusps that open and shut in response to blood pressure changes caused by the contraction and relaxation of the heart chambers. The valve leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream manner.

Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening.

<CIT> describes a catheter assembly with valve crimping accessories.

<CIT> relates to an assembly for collapsing a prosthetic heart valve including a compression member having a plurality of arms pivotable between a first orientation in which side edges of adjacent arms are spaced apart from one another and a second orientation in which the adjacent arms contact one another. A translating member is movable along the arms to pivot the arms from the first orientation to the second orientation to collapse the prosthetic heart valve. A separation tool includes ribs defining channels sized to receive the struts of a stent of a prosthetic heart valve to keep the struts separated from one another as the prosthetic heart valve is collapsed.

Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient's vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

The present disclosure relates to tools to facilitate loading or crimping of a heart valve prosthesis as well as other types of protheses into a catheter-based delivery system.

According to a first embodiment hereof, the present disclosure provides a loading tool to facilitate loading a self-expanding prosthesis into a delivery system. The loading tool includes a hinged body and a collar slidingly disposed over 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 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 body portion and the second body portion includes a resilient clip formed thereon that includes a radial protrusion on an outer surface thereof. Each resilient clip is configured to displaced radially inwards when a pinching 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 disposed over the first ends of the first and second body portions. 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 disposed directly adjacent to each other and the collar is disposed over the second ends of the first and second body portions. The radial protrusions are configured to lock the loading tool in the closed configuration when the resilient clips are not displaced radially inwards.

The disclosure provides that each of the first body portion and the second body portion has a flange on an outer surface thereof at the second end thereof and the collar is sandwiched between the flanges and the radial protrusions on the resilient clips when the collar locks the hinged body in the closed configuration.

The disclosure provides that each flange has a square profile.

The disclosure provides that each radial protrusion has a tapered outer surface that permits the collar to slide in a direction from the first ends of the first and second body portions towards the second ends of the first and second body portions and each radial protrusion has an end surface that does not permit the collar to slide in a direction from the second ends of the first and second body portions towards the first ends of the first and second body portions unless the resilient clips are displaced radially inwards by the pinching force.

The disclosure provides that the first end of the first body portion is attached to the first end of the second body via adhesive.

The disclosure provides that the first end of the first body portion is attached to the first end of the second body via a mechanical fastener.

The disclosure provides that the loading tool is prevented from opening when the radial protrusions lock the loading tool in the closed configuration.

The disclosure provides the resilient clips are configured to be displaced radially inwards to release the collar.

The disclosure provides that the hinged body is configured to be disposed over a distal end of the delivery system during loading of the self-expanding prosthesis into the delivery system.

The disclosure provides that the hinged body is configured to be disposed over a capsule of the delivery system when the self-expanding prosthesis is positioned into the capsule.

The disclosure provides that the second ends of the first and second body portions each include a stepped edge formed on an inner surface thereof configured to prevent the self-expanding prosthesis from contacting a first end of the capsule when the self-expanding prosthesis is positioned into the capsule and configured to retain attachment bars of the self-expanding prosthesis.

The disclosure provides that the first and second body portions collectively have a tubular configuration when the loading tool is in the closed configuration.

According to a first embodiment hereof, the present disclosure provides a method of loading a self-expanding prosthesis into a delivery system includes placing a loading tool in an open configuration. The loading tool includes a hinged body and a collar slidingly disposed over 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 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 body portion and the second body portion includes a resilient clip formed thereon that includes a radial protrusion on an outer surface thereof. Each resilient clip is configured to displaced radially inwards when a pinching 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 disposed over the first ends of the first and second body portions. The loading tool is disposed in the open configuration over a distal end of the delivery system and while the loading tool is disposed over a distal end of the delivery system, the collar is slid over the hinged body until the loading tool is in a closed configuration. In the closed configuration the second end of the first body portion and the second end of the second body portion are disposed directly adjacent to each other and the collar is disposed over the second ends of the first and second body portions, and wherein the radial protrusions lock the loading tool in the closed configuration when the resilient clips are not displaced radially inwards. The self-expanding prosthesis is loaded into the distal end of the delivery system while the radial protrusions lock the loading tool in the closed configuration.

The disclosure provides that after the self-expanding prosthesis is loaded into the distal end of the delivery system, a pinching force is applied to displace the resilient clips radially inward. The collar is slid over the hinged body while the resilient clips are displaced radially inward until the loading tool is in the open configuration and the loading tool is removed from the distal end of the delivery system.

The disclosure provides that the self-expanding prosthesis is a mitral valve prosthesis.

The disclosure provides that each flange has a square profile and the flange sets against a flat surface during the step of loading the self-expanding prosthesis.

The disclosure provides that each radial protrusion has a tapered outer surface that permits the collar to slide in a direction from the first ends of the first and second body portions towards the second ends of the first and second body portions and wherein each radial protrusion has an end surface that does not permit the collar to slide in a direction from the second ends of the first and second body portions towards the first ends of the first and second body portions unless the resilient clips are displaced radially inwards by the pinching force.

The disclosure provides that the loading tool is prevented from opening to the open configuration when the radial protrusions lock the loading tool in the closed configuration.

The disclosure provides that the distal end of the delivery system is a capsule.

The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments thereof as illustrated in the accompanying drawings.

Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers 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, a delivery device, or a catheter-based delivery system are with respect to a position or direction relative to the treating clinician. Thus, "distal" and "distally" refer to positions distant from, or in a direction away from the treating clinician, and the terms "proximal" and "proximally" refer to positions near, or in a direction toward the treating clinician.

Embodiments of the present invention relate to loading tools to facilitate loading a self-expanding prosthesis into a delivery system. A loading tool according to embodiments hereof is configured to be disposed over a distal end of a delivery system while a self-expanding prosthesis is positioned or pulled into the distal end of the delivery system. The loading tool according to embodiments hereof is configured to prevent damage to the self-expanding prosthesis during loading thereof into the delivery system, as will be explained in more detail herein. In addition, the loading tool includes integral resilient clips that are configured to automatically lock a slidable collar of the loading tool into place once it reaches a predetermined position. When the slidable collar is locked into position, the resilient clips provide a robust hard mechanical stop and the loading tool is likewise locked in a closed configuration such that the loading tool is prevented from opening. The slidable collar may be unlocked only when a user pinches or radially compresses the resilient clips to thereby release the slidable collar. When locked, the loading tool can withstand high radial loading forces, including loading forces equal to or greater than <NUM> N. In an embodiment, the loading tool can withstand radial loading forces greater than <NUM> N. As such, the loading tool may be utilized with self-expanding prostheses that have a high radial loading force such as but not limited to transcatheter valve prostheses which are configured for implantation within a native mitral valve. Further, the loading tool is easy to operate by the user and is also provided to the user as a single unit such that assembly by the user is not required.

<FIG> illustrate a transcatheter valve prosthesis <NUM> that may be utilized with embodiments of loading tools described herein. The heart valve prosthesis <NUM> is illustrated herein in order to facilitate description of the present invention. The following description of the transcatheter valve prosthesis <NUM> is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. It is understood that any number of alternate heart valve prostheses can be used with the loading tools described herein. Other non-limiting examples of transcatheter heart valve prostheses that can be used with the loading tools described herein are described in <CIT>, <CIT> and International Patent Application No. <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>. Although the transcatheter valve prosthesis <NUM> is a heart valve prosthesis configured for placement within a mitral heart valve, embodiments of loading tools described herein may be utilized when loading any self-expanding transcatheter valve prostheses into a delivery system. For example, embodiments of loading tools described herein may be utilized with a transcatheter heart valve configured for placement within a pulmonary, aortic, mitral, or tricuspid valve, or may be utilized with a transcatheter valve prosthesis configured for placement within a venous valve or within other body passageways where it is deemed useful. There is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. In addition, embodiments of loading members described herein may be utilized when loading any self-expanding prostheses into a delivery system, and it is not required that the self-expanding prosthesis include a prosthetic valve component disposed therein.

A perspective view of the transcatheter valve prosthesis <NUM> in accordance with an aspect of the disclosure is shown in <FIG>. The transcatheter valve prosthesis <NUM> is configured to be radially compressed into a reduced-diameter crimped configuration for delivery within a vasculature (not shown) and to return to an expanded, deployed configuration, as shown in <FIG>. Stated another way, the transcatheter valve prosthesis <NUM> has a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. In accordance with embodiments hereof, when in the crimped configuration, the transcatheter valve prosthesis <NUM> has a low profile suitable for delivery to and deployment within a native heart valve via a suitable delivery catheter that may be tracked to the deployment site of the native heart valve of a heart via any one of a transseptal, retrograde, or transapical approach. The transcatheter valve prosthesis <NUM> includes a stent or frame <NUM> and a prosthetic valve component <NUM> including at least one leaflet disposed within and secured to the frame <NUM>.

Any portion of the frame <NUM> described herein as an element of a heart valve prothesis <NUM> may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as Nitinol™, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill. ), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials. A suitable biocompatible material would be selected to provide the transcatheter heart valve prothesis <NUM> to be configured to be compressed into a reduced-diameter crimped configuration for transcatheter delivery to a native valve, whereby release from a delivery catheter returns the prosthesis to an expanded, deployed configuration.

In an aspect of the disclosure, the frame <NUM> of the transcatheter valve prosthesis <NUM> includes a valve support <NUM> at least partially surrounded by and coupled to an anchor element <NUM>. The valve support <NUM> is a tubular stent-like or frame structure that defines a central lumen <NUM> from an inflow end <NUM> of the valve support <NUM> to an outflow end <NUM> of the valve support <NUM>. The valve support <NUM> is configured to support the prosthetic valve component <NUM> therein, which will be described in more detail below. In an embodiment, the valve support <NUM> has a substantially cylindrical shape in which the outflow end <NUM> of the valve support <NUM> has a diameter that is substantially the same as a diameter of the inflow end <NUM> of the valve support <NUM>.

The valve support <NUM> includes a skirt <NUM> coupled to a surface thereof. More particularly, the skirt <NUM> is coupled to an inner surface of the valve support <NUM> to line a portion thereof. Alternatively, the skirt <NUM> may be coupled to an outer surface of the valve support <NUM> to enclose a portion thereof as would be known to one of ordinary skill in the art of prosthetic valve construction. The skirt <NUM> may be a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa. Alternatively, the skirt <NUM> may be a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE, which creates a one-way fluid passage when attached to the stent. In one embodiment, the skirt <NUM> may be a knit or woven polyester, such as a polyester or PTFE knit, which can be utilized when it is desired to provide a medium for tissue ingrowth and the ability for the fabric to stretch to conform to a curved surface. Polyester velour fabrics may alternatively be used, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. These and other appropriate cardiovascular fabrics are commercially available from Bard Peripheral Vascular, Inc. of Tempe, Ariz. , for example.

In an aspect of the disclosure, the anchor element <NUM> is a stent-like or frame structure that functions as an anchor for the transcatheter valve prosthesis <NUM> to secure its deployed position within a native annulus. The anchor element <NUM> is a substantially cylindrically-shaped structure that is configured to engage heart tissue at or below an annulus of a native heart valve, such as an annulus of a native mitral valve. At the inflow end <NUM> of the valve support <NUM>, the anchor element <NUM> is radially spaced a distance S from the valve support <NUM> to mechanically isolate the inflow end <NUM> of the valve support <NUM> from the anchor element <NUM>. The anchor element <NUM> includes one or more cleats or prongs <NUM> that extend outward from an exterior side thereof to engage heart tissue. In another embodiment, the anchor element <NUM> may employ barbs, spikes, or other tissue fixation mechanisms for engaging heart tissue.

The transcatheter valve prosthesis <NUM> further includes a brim or rim element <NUM> that extends outwardly from an upstream end of the anchor element <NUM>. The brim element <NUM> includes overlapping, <NUM> degree out of phase sinusoidal wire forms that are attached and hinged to the anchor element <NUM> by a suitable biocompatible low-profile fabric <NUM> used in bioprosthetic implants namely endovascular grafts, heart valves or left atrial appendage devices to promote bio-integration, such as woven polyethylene terephthalate (PET) fabric. The brim element <NUM> may act as an atrial retainer, if present, and to serve such a function the brim element <NUM> may be configured to engage tissue above a native annulus, such as a supra-annular surface or some other tissue in the left atrium, to thereby inhibit downstream migration of a prosthetic heart valve <NUM>, for e.g., during atrial systole.

Referring to <FIG>, the structure of the valve support <NUM> will now be described in more detail. The valve support <NUM> includes a plurality of crowns 119A and a plurality of struts 119B with each crown 119A being formed between a pair of opposing struts 119B. Each crown 119A is a curved segment or bend extending between opposing struts 119B. The valve support <NUM> is tubular, with the plurality of side openings <NUM> being defined by edges of the plurality of crowns 119A and the plurality of struts 119B. In an embodiment, the plurality of side openings <NUM> may be substantially diamond-shaped. The valve support <NUM> includes a plurality of nodes <NUM>. A node <NUM> is defined as a region where two crowns of the plurality of crowns 119A within the valve support <NUM> meet or connect. The skirt <NUM> is attached to an inner surface of the valve support <NUM> around a circumference thereof. The skirt <NUM> lines the inner surface of the valve support <NUM>. At the inflow end <NUM> thereof, the valve support <NUM> includes a plurality of attachment bars <NUM> extending therefrom that function to releasably couple the transcatheter valve prosthesis <NUM> to a delivery system.

The prosthetic valve component <NUM> of the transcatheter valve prosthesis <NUM> is capable of regulating flow therethrough via valve leaflets that may form a replacement valve. <FIG> illustrate an exemplary prosthetic valve component having three leaflets, although a single leaflet or bicuspid leaflet configuration may alternatively be used in embodiments hereof. When deployed in situ, the prosthetic valve component <NUM> in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen <NUM> of the valve support <NUM>. <FIG> depicts a perspective view of the valve support <NUM> with a prosthetic valve component <NUM> secured therein, the valve support <NUM> being shown in <FIG> removed from the remainder of the transcatheter valve prosthesis <NUM> shown in <FIG> for ease of illustration. <FIG> depicts an atrial or inflow end view of the transcatheter valve prosthesis <NUM> shown in <FIG>, and <FIG> depicts a ventricular or outflow end view of the transcatheter valve prosthesis <NUM> shown in <FIG>. The prosthetic valve component <NUM> includes valve leaflets <NUM>, e.g., three valve leaflets <NUM>, that are disposed to coapt within an upstream portion of the valve support <NUM> with leaflet commissures 109A, 109B, 109C of the valve leaflets <NUM> being secured within a downstream portion of the valve support <NUM>, such that the valve leaflets <NUM> open during diastole. Leaflets <NUM> are attached along their bases to the valve support <NUM>, for example, using sutures or a suitable biocompatible adhesive. Adjoining pairs of leaflets <NUM> are attached to one another at their lateral ends to form leaflet commissures 109A, 109B, 109C. The orientation of the leaflets <NUM> within the valve support <NUM> depends upon on which end of the transcatheter valve prosthesis <NUM> is the inflow end and which end of the transcatheter valve prosthesis <NUM> is the outflow end, thereby ensuring one-way flow of blood through the transcatheter valve prosthesis <NUM>.

The valve leaflets <NUM> may be attached to the skirt <NUM>. The valve leaflets <NUM> may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

For delivery, the transcatheter valve prosthesis <NUM> is radially compressed into a reduced-diameter crimped configuration onto a delivery system for delivery within a vasculature. As known in the art, the delivery system includes an inner shaft that receives the transcatheter valve prosthesis <NUM> on a distal portion thereof and an outer sheath or capsule that is configured to compressively retain the transcatheter valve prosthesis <NUM> on the distal portion of the inner shaft during delivery. Stated another way, the outer sheath or capsule surrounds and constrains the transcatheter valve prosthesis <NUM> in the radially compressed or crimped configuration. An exemplary delivery system for delivering the transcatheter valve prosthesis <NUM> is described in <CIT> and International Patent Application No. <CIT>,. However, it will be apparent to one of ordinary skill in the art that other delivery systems may be utilized and that the components of the delivery system may vary depending upon the configuration and structure of the transcatheter valve prosthesis that is being delivered.

As stated above, embodiments of the present invention relate to a loading tool to facilitate loading the transcatheter valve prosthesis <NUM> into a delivery system. The loading tool is disposed over a distal end of the delivery system while the transcatheter valve prosthesis <NUM> is retracted or pulled into the distal end of the delivery system. For sake of illustration, use of the loading tool is described herein with respect to the transcatheter valve prosthesis <NUM>, as the structure of the transcatheter valve prosthesis <NUM> has already been described in detail above. However, as previously stated, the loading tools described herein may be utilized when loading any self-expanding prosthesis into a delivery system, and it is not required that the self-expanding prosthesis include a prosthetic valve component disposed therein.

More particularly, a loading tool <NUM> is depicted in <FIG>. <FIG> depicts a perspective view of the loading tool <NUM>, while <FIG> depicts an exploded view of the loading tool <NUM> for illustrative purposes. The loading tool <NUM> includes a hinged body <NUM>, a collar <NUM> slidingly disposed over the hinged body <NUM>, and a fastener <NUM>. The hinged body <NUM> includes a first body half or portion 524A and a second body half or portion 524B. The first and second body portions 524A, 524B collectively define the hinged body <NUM>, which is configured to dynamically open and close mechanically via sliding movement of the collar <NUM> as will be described in more detail herein. The hinged body <NUM> is sized or configured to be disposed over a distal end of the delivery system during loading of the transcatheter valve prosthesis <NUM> into a delivery system, as described in more detail with respect to <FIG>.

Each of the first body portion 524A and the second body portion 524B has a first end 526A, 526B and a second end 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 via the fastener <NUM> 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 a hinged end <NUM> of the loading tool <NUM>. The attached first ends 526A, 526B may include interlocking or mating surfaces 538A, 538B as best shown on the exploded view of <FIG>.

Each of the first body portion 524A and the second body portion 524B includes a resilient clip 530A, 530B integrally formed thereon that includes a radial protrusion 532A, 532B on an outer surface 534A, 534B thereof, respectively. Each resilient clip 530A, 530B is a flap or tab formed on its respective body portion such that it is configured to be displaced radially inwards when a pinching force is applied thereto. Each resilient clip 530A, 530B includes a first end 529A, 529B that is attached to or extends from the respective body portion 524A, 524B and a second end 531A, 531B that is detached from the respective body portion 524A, 524B. The radial protrusions 532A, 532B are formed on the second ends 531A, 531B of the resilient clips 530A, 530B. Each resilient clip 530A, 530B has a thickness that tapers along a length thereof in the direction from the first end 529A, 529B thereof to the second end 531A, 531B thereof. More particularly, as best shown on <FIG>, each resilient clip 530A, 530B has a first thickness T<NUM> at the first end 529A, 529B thereof which is greater than a second thickness T<NUM> at the second end 531A, 531B thereof. The thickness of each resilient clip 530A, 530B may continuously or gradually taper between the first thickness T<NUM> to the second thickness T<NUM>. The tapering thicknesses of the resilient clips 530A, 530B provide or result in sufficient clearance for the resilient clips 530A, 530B to be displaced radially inwards when a pinching force is applied thereto and thereby allow the collar <NUM> to slidingly advance over the radial protrusions 532A, 532B, as will be described in more detail herein.

The collar <NUM> has a tubular body <NUM> with a first end <NUM> and a second or opposing end <NUM>, and the tubular body <NUM> defines a lumen or passageway <NUM> therethrough such that the tubular body <NUM> may be slidingly disposed over the hinged body <NUM>. An outer surface <NUM> of the collar <NUM> includes a plurality of ribs <NUM> so that the collar <NUM> may be easily gripped by a user for sliding motion of the collar <NUM> along the hinged body. An inner surface <NUM> of the collar <NUM> is sized or configured to be only slightly larger than the outer surface of the hinged body <NUM> so that the collar <NUM> may be easily moved back and forth along the hinged body <NUM>, and so that the collar <NUM> forces the second ends 528A, 528B of the first and second body portions 524A, 524B together when disposed thereover as will be described in more detail herein.

The fastener <NUM> includes a disk <NUM> that is flat, round, and configured to close an end of the hinged body <NUM> when assembled to the first and second body portions 524A, 524B. The fastener <NUM> also includes two opposing fingers 556A, 556B extending axially from the disk <NUM>. Each finger 556A, 556B has a rounded or arc cross-section along its length and the fingers 556A, 556B are spaced apart from each other by a transverse opening <NUM>. The transverse opening <NUM> is sized or configured to receive the first ends 526A, 526B of the first and second body portions 524A, 524B, and the fingers 556A, 556B are configured to mechanically couple to the first ends 526A, 526B of the first and second body portions 524A, 524B. The fastener <NUM> thus attaches or fastens the first and second body portions 524A, 524B together. The fastener <NUM> also contains the collar <NUM> so that the collar <NUM> cannot slide off the hinged body <NUM>. Particularly, the disk <NUM> has an outer diameter that is slightly greater than the outer diameter of the collar <NUM> so that when the collar <NUM> is disposed over the hinged body <NUM>, the collar <NUM> cannot slide over the disk <NUM> of the fastener <NUM>. Stated another way, the disk <NUM> of the fastener <NUM> functions as a stopper for the collar <NUM>. The loading tool <NUM> is thus provided to the user as a single, assembled tool that does not require any assembly by the user.

Adjacent to the second ends 528A, 528B of the first and second body portions 524A, 524B, each body portion includes a fin or flange 536A, 536B extending radially outward from the outer surface thereof. In an embodiment, each flange 536A, 536B has a square profile so that the loading tool <NUM> is configured to rest upon a flat surface, i.e., a tabletop, without rolling. Similar to the fastener <NUM> adjacent to the first ends 526A, 526B of the first and second body portions 524A, 524B, the flanges 536A, 536B also function to contain the collar <NUM> so that the collar <NUM> cannot slide off the hinged body <NUM> adjacent to the second ends 528A, 528B of the first and second body portions 524A, 524B. Particularly, collectively the flanges 536A, 536B have an outer diameter that is slightly greater than the outer diameter of the collar <NUM> so that when the collar <NUM> is disposed over the hinged body <NUM>, the collar <NUM> cannot slide over the flanges 536A, 536B. Stated another way, the flanges 536A, 536B function as a stopper for the collar <NUM>.

The loading tool <NUM> is initially formed or shape set in an open configuration in which 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 as shown in <FIG> and the side view of <FIG>. Further, when in the open configuration, the collar <NUM> is disposed over the first ends 526A, 526B of the first and second body portions 524A, 524B. The open configuration provides the loading tool <NUM> with a splayed opening <NUM> at an end thereof which allows the loading tool <NUM> to easily slide over the delivery system during the loading process, and further to easily slide off the delivery system after the loading process is complete.

<FIG> depict side and perspective views of the loading collar <NUM> in a closed configuration in which the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B are disposed directly adjacent to each other and the collar <NUM> is disposed over the second ends 528A, 528B of the first and second body portions 524A, 524B. As used herein with respect to the closed configuration of loading collars described herein, "disposed directly adjacent to each other" includes the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B contacting or abutting against each other, as well as the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B being disposed relative to each other with a small nominal, predetermined radial gap therebetween with no intervening structures therebetween. When in the closed configuration, the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B are disposed radially closer to each other relative to the open configuration thereof. When in the closed configuration, the radial protrusions 532A, 532B of the resilient clips 530A, 530B are configured to abut against the collar <NUM> to lock the loading tool <NUM> in the closed configuration. Thus, the collar <NUM> is sandwiched between the radial protrusions 532A, 532B of the resilient clips 530A, 530B and the flanges 536A, 536B when the collar <NUM> locks the hinged body <NUM> in the closed configuration. Each of the first and second body portions 524A, 524B further include a tapered outer surface 539A, 539B, respectively, (which is best shown on <FIG>) adjacent to the flanges 536A, 536B which ensure a tight interference fit when the collar <NUM> is sandwiched between the radial protrusions 532A, 532B of the resilient clips 530A, 530B and the flanges 536A, 536B. The loading tool <NUM> is prevented from opening when the radial protrusions 532A, 532B lock the collar <NUM> and the loading tool <NUM> in the closed configuration so that the loading tool <NUM> will not slip or pop open until the loading procedure is complete. Being locked in the closed configuration ensures that the transcatheter valve prosthesis <NUM> is protected from mis-load related damage during loading.

Each radial protrusion 532A, 532B has a tapered outer surface 533A, 533B that permits the collar <NUM> to slide in a direction from the first ends 526A, 526B of the first and second body portions 524A, 524B towards the second ends 528A, 528B of the first and second body portions 524A, 524B. Stated another way, when the user moves the collar <NUM> in a direction from the first ends 526A, 526B of the first and second body portions 524A, 524B towards the second ends 528A, 528B of the first and second body portions 524A, 524B, the collar <NUM> traverses the radial protrusions 532A, 532B via the tapered outer surfaces 533A, 533B without any additional user intervention. As the collar <NUM> traverses the radial protrusions 532A, 532B, the resilient clips 530A, 530B may be displaced radially inwards by the collar <NUM>. However, after the collar <NUM> traverses the radial protrusions 532A, 532B, the resilient clips 530A, 530B spring or revert back to their formed or shape set position once the collar <NUM> is no longer disposed thereover. When the resilient clips 530A, 530B spring or revert back to their formed or shape set position, a tactile click is felt by the user to provide feedback that the loading tool <NUM> is locked in the closed configuration.

Each radial protrusion 532A, 532B has an end surface 537A, 537B that does not permit the collar <NUM> to slide in a direction from the second ends 528A, 528B of the first and second body portions 524A, 524B towards the first ends 526A, 526B of the first and second body portions 524A, 524B unless the resilient clips 530A, 530B are displaced radially inwards by a user. When in the closed configuration, the end surfaces 537A, 537B of the radial protrusions 532A, 532B are configured to abut against the collar <NUM> and thereby provide a hard mechanical stop for the collar <NUM>, which also provides the user with visual feedback that the loading tool <NUM> is locked in the closed configuration.

When it is desired to unlock the loading tool <NUM> for removal thereof, i.e., after the loading procedure is complete, the user moves or radially displaces the resilient clips 530A, 530B inwards to release the collar <NUM>. Stated another way, when the user pinches the resilient clips 530A, 530B, the collar <NUM> may traverse the radial protrusions 532A, 532B since the end surfaces 537A, 537B of the radial protrusions 532A, 532B are displaced radially inwards. Thus, when the resilient clips 530A, 530B are displaced inwards by the user, the user may retract the collar <NUM> to revert the loading tool <NUM> back to its open configuration. When in the open configuration, the loading tool <NUM> may be easily removed from the delivery system.

The set-up of the loading tool <NUM> onto a delivery system will now be generally described with respect to <FIG> depicts a side view of the loading tool <NUM> prior to positioning over a distal end <NUM> of a delivery system <NUM>, with the loading tool <NUM> in the open configuration. In this embodiment, the delivery system <NUM> is configured to deliver the transcatheter valve prosthesis <NUM> via a transfemoral approach. When configured for transfemoral delivery, the outflow end <NUM> of the transcatheter valve prosthesis <NUM> is disposed distal to the inflow end <NUM> of the transcatheter valve prosthesis <NUM> within the distal end <NUM> of the delivery system <NUM>. Further, when configured for transfemoral delivery, the outflow end <NUM> of the transcatheter valve prosthesis <NUM> is released and deployed prior to the inflow end <NUM> of the transcatheter valve prosthesis <NUM>. In this embodiment, the distal end <NUM> includes a capsule <NUM> which is configured to constrain the transcatheter valve prosthesis <NUM> in a radially reduced configuration during delivery in situ.

When a user is preparing to load the transcatheter valve prosthesis <NUM> into the capsule <NUM> of the distal end <NUM> of the delivery system <NUM>, the user will first position the loading tool <NUM> over the capsule <NUM> by advancing the splayed opening <NUM> of the loading tool <NUM> over the capsule <NUM>. After the loading tool <NUM> is disposed over the capsule <NUM>, the user transitions the loading tool <NUM> into the closed configuration. <FIG> depicts a side view of the loading tool <NUM> after positioning over the capsule <NUM> of the delivery system <NUM>, with the loading tool <NUM> in the closed configuration. An inner diameter of the hinged body <NUM> of the loading tool <NUM> is substantially equal to the outer diameter of the capsule <NUM> of the delivery system <NUM>. The first and second body portions 524A, 524B that are disposed over the capsule <NUM> collectively have a tubular configuration when the loading tool <NUM> is in the closed configuration. With the loading tool <NUM> in the closed configuration and disposed over the distal end <NUM>, the loading tool <NUM> is in position for the transcatheter valve prosthesis <NUM> to be pulled into the capsule <NUM> of the delivery system <NUM>. The process of loading the transcatheter valve prosthesis <NUM> into the capsule <NUM> is described with respect to <FIG>. Further, the hinged body <NUM> of the loading tool <NUM> includes several integral features including chamfers, piston ledges, and capsule overhangs for interacting with the delivery system and avoiding damage to the transcatheter valve prosthesis <NUM> as the transcatheter valve prosthesis <NUM> is pulled into the delivery system, and these features are described with respect to <FIG>.

<FIG> depicts an exploded view of a loading tool <NUM> according to another embodiment hereof in which the first and second body portions of the loading tool are attached to each other via adhesive. The loading tool <NUM> includes a hinged body <NUM> and a collar <NUM> slidingly disposed over the hinged body <NUM>. Similar to the hinged body <NUM>, the hinged body <NUM> 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, 1124B collectively define the hinged body <NUM>, which is configured to dynamically open and close mechanically via sliding movement of the collar <NUM> similar to the hinged body <NUM>. The hinged body <NUM> is sized or configured to be disposed over a distal end of the delivery system during loading of the transcatheter valve prosthesis <NUM> into a delivery system.

Similar to the loading tool <NUM>, the loading tool <NUM> includes resilient clips for locking the collar <NUM> and the loading tool <NUM> in a closed configuration. Particularly, the first body portion 1124A and the second body portion 1124B includes a resilient clip 1130A, 1130B formed thereon that includes a radial protrusion 1132A, 1132B on an outer surface thereof, respectively. Each resilient clip 1130A, 1130B is a flap or tab formed on its respective body portion such that it is configured to be displaced radially inwards when a pinching force is applied thereto. Each resilient clip 1130A, 1130B includes a first end 1129A, 1129B that is attached to or extends from the respective body portion 1124A, 1124B and a second end 1131A, 1131B that is detached from the respective body portion 1124A, 1124B. The radial protrusions 1132A, 1132B are formed on the second ends 1131A, 1131B of the resilient clips 1130A, 1130B.

Each of the first body portion 1124A and the second body portion 1124B has a first end 1126A, 1126B and a second end 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 <NUM> and 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 a hinged end <NUM> of the loading tool <NUM>. With the first and second body portions 1124A, 1124B being attached via adhesive, the mechanical fastener of the loading tool <NUM> is omitted. Adjacent to the first ends 1126A, 1126B, each of the first body portion 1124A and the second body portion 1124B includes a semi-circular blunt end such that the semi-circular blunt ends are configured to close one end of the hinged body <NUM> when the first and second body portions 1124A, 1124B are joined together. The opposing end of the loading tool <NUM> includes a splayed opening <NUM>, which is similar to splayed opening <NUM> of the loading tool <NUM>, which allows the loading tool <NUM> to easily slide over the delivery system during the loading process, and further to easily slide off the delivery system after the loading process is complete.

Since one end of the hinged body <NUM> is closed when the first and second body portions 1124A, 1124B are joined together, the loading tool <NUM> is configured for use with a delivery system that is configured to deliver the transcatheter valve prosthesis <NUM> via a transfemoral approach similar to the loading tool <NUM> described above with respect to <FIG>.

<FIG> depicts an exploded view of a loading tool <NUM> according to another embodiment hereof in which the first and second body portions of the loading tool are attached to each other via adhesive, but the loading tool <NUM> is open at both ends thereof. The loading tool <NUM> includes a hinged body <NUM> and a collar <NUM> slidingly disposed over the hinged body <NUM>. Similar to the hinged body <NUM>, the hinged body <NUM> 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, 1224B collectively define the hinged body <NUM>, which is configured to dynamically open and close mechanically via sliding movement of the collar <NUM> similar to the hinged body <NUM>. The hinged body <NUM> is sized or configured to be disposed over a distal end of the delivery system during loading of the transcatheter valve prosthesis <NUM> into a delivery system.

Similar to the loading tool <NUM>, the loading tool <NUM> includes resilient clips for locking the collar <NUM> and the loading tool <NUM> in a closed configuration. Particularly, the first body portion 1224A and the second body portion 1224B includes a resilient clip 1230A, 1230B formed thereon that includes a radial protrusion 1232A, 1232B on an outer surface thereof, respectively. Each resilient clip 1230A, 1230B is a flap or tab formed on its respective body portion such that it is configured to be displaced radially inwards when a pinching force is applied thereto. Each resilient clip 1230A, 1230B includes a first end 1229A, 1229B that is attached to or extends from the respective body portion 1224A, 1224B and a second end 1231A, 1231B that is detached from the respective body portion 1224A, 1224B. The radial protrusions 1232A, 1232B are formed on the second ends 1231A, 1231B of the resilient clips 1230A, 1230B.

Each of the first body portion 1224A and the second body portion 1224B has a first end 1226A, 1226B and a second end 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 <NUM> 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 a hinged end <NUM> of the loading tool <NUM>. The attached first ends 1226A, 1226B may include interlocking or mating surfaces 1238A, 1238B. With the first and second body portions 1224A, 1224B being attached via adhesive, the mechanical fastener of the loading tool <NUM> is omitted. Adjacent to the first ends 1226A, 1226B, at the hinged end <NUM>, the loading tool <NUM> has a fixed opening <NUM>. The opposing end of the loading tool <NUM> includes a splayed opening <NUM>, which is similar to splayed opening <NUM> of the loading tool <NUM>, which allows the loading tool <NUM> to easily slide over the delivery system during the loading process, and further to easily slide off the delivery system after the loading process is complete.

Since both ends (i.e., splayed opening <NUM> and fixed opening <NUM>) of the loading tool <NUM> are open when the first and second body portions 1224A, 1224B are joined together, the loading tool <NUM> may be used with a delivery system configured to deliver the transcatheter valve prosthesis <NUM> in a transfemoral approach similar to the loading tools <NUM>, <NUM> as well as a delivery system configured to deliver the transcatheter valve prosthesis <NUM> in a transapical approach. The set-up of the loading tool <NUM> onto a delivery system configured to deliver the transcatheter valve prosthesis <NUM> with a transapical approach will now be generally described with respect to <FIG> depicts a side view of the loading tool <NUM> prior to positioning over a distal end <NUM> of a delivery system <NUM>, with the loading tool <NUM> in the open configuration. In this embodiment, the delivery system <NUM> is configured to deliver the transcatheter valve prosthesis <NUM> via a transapical approach. When configured for transapical delivery, the inflow end <NUM> of the transcatheter valve prosthesis <NUM> is disposed distal to the outflow end <NUM> of the transcatheter valve prosthesis <NUM> within the distal end <NUM> of the delivery system <NUM>. Further, when configured for transapical delivery, the inflow end <NUM> of the transcatheter valve prosthesis <NUM> is released and deployed prior to the outflow end <NUM> of the transcatheter valve prosthesis <NUM>.

When a user is preparing to load the transcatheter valve prosthesis <NUM> into the distal end <NUM> of the delivery system <NUM>, the user will first position the loading tool <NUM> over the distal end <NUM> by advancing the fixed opening <NUM> at the hinged end <NUM> of the loading tool <NUM> over the distal end <NUM>. After the loading tool <NUM> is disposed over the distal end <NUM>, the user transitions the loading tool <NUM> into the closed configuration. <FIG> depicts a side view of the loading tool <NUM> after positioning over the distal end <NUM> of the delivery system <NUM>, with the loading tool <NUM> in the closed configuration. An inner diameter of the hinged body <NUM> of the loading tool <NUM> is substantially equal to the outer diameter of the distal end <NUM> of the delivery system <NUM>. The first and second body portions 1224A, 1224B that are disposed over the distal end <NUM> collectively have a tubular configuration when the loading tool <NUM> is in the closed configuration. With the loading tool <NUM> in the closed configuration and disposed over the distal end <NUM>, the loading tool <NUM> is in position for the transcatheter valve prosthesis <NUM> to be pulled into the distal end <NUM> of the delivery system <NUM>.

15A and 15B depict perspective views of a loading tool <NUM> according to another embodiment hereof in which the first and second body portions of the loading tool are attached to each other via an annular or ring fastener such that the loading tool <NUM> is open at both ends thereof. The loading tool <NUM> includes a hinged body <NUM>, a collar <NUM> slidingly disposed over the hinged body <NUM>, and a fastener <NUM>. Similar to the hinged body <NUM>, the hinged body <NUM> 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, 1524B collectively define the hinged body <NUM>, which is configured to dynamically open and close mechanically via sliding movement of the collar <NUM> similar to the hinged body <NUM>. The hinged body <NUM> is sized or configured to be disposed over a distal end of the delivery system during loading of the transcatheter valve prosthesis <NUM> into a delivery system.

Similar to the loading tool <NUM>, the loading tool <NUM> includes resilient clips for locking the collar <NUM> and the loading tool <NUM> in a closed configuration. Particularly, the first body portion 1524A and the second body portion 1524B includes a resilient clip 1530A, 1530B formed thereon that includes a radial protrusion 1532A, 1532B on an outer surface thereof, respectively. Each resilient clip 1530A, 1530B is a flap or tab formed on its respective body portion such that it is configured to be displaced radially inwards when a pinching force is applied thereto. Each resilient clip 1530A, 1530B includes a first end 1529A, 1529B that is attached to or extends from the respective body portion 1524A, 1524B and a second end 1531A, 1531B that is detached from the respective body portion 1524A, 1524B. The radial protrusions 1532A, 1532B are formed on the second ends 1531A, 1531B of the resilient clips 1530A, 1530B.

Each of the first body portion 1524A and the second body portion 1524B has a first end 1526A, 1526B and a second end 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 via the fastener <NUM> and 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, 1526B form a hinged end <NUM> of the loading tool <NUM>.

The fastener <NUM> is an annular or ring component that is disposed over the first ends 1526A, 1526B of the loading tool <NUM>. The fastener <NUM> attaches or fastens the first and second body portions 524A, 524B together. The fastener <NUM> also contains the collar <NUM> so that the collar <NUM> cannot slide off the hinged body <NUM>. Particularly, the fastener <NUM> has an outer diameter that is slightly greater than the outer diameter of the collar <NUM> so that when the collar <NUM> is disposed over the hinged body <NUM>, the collar <NUM> cannot slide over the fastener <NUM>. Stated another way, the fastener <NUM> functions as a stopper for the collar <NUM>. The loading tool <NUM> is thus provided to the user as a single, assembled tool that does not require any assembly by the user.

Adjacent to the first ends 1526A, 1526B, adjacent to the hinged end <NUM>, the loading tool <NUM> has a fixed opening <NUM>. The opposing end of the loading tool <NUM> includes a splayed opening <NUM>, which is similar to splayed opening <NUM> of the loading tool <NUM>, which allows the loading tool <NUM> to easily slide over the delivery system during the loading process, and further to easily slide off the delivery system after the loading process is complete.

Since both ends (i.e., splayed opening <NUM> and fixed opening <NUM>) of the loading tool <NUM> are open when the first and second body portions 1524A, 1524B are joined together, the loading tool <NUM> may be used with a delivery system configured to deliver the transcatheter valve prosthesis <NUM> in either a transfemoral approach similar to the loading tool <NUM> described above with respect to <FIG> as well as a transapical approach similar to the loading tool <NUM> described above with respect to <FIG>.

Referring now to <FIG>, a method of loading a self-expanding prosthesis into a delivery system will be described. For sake of illustration, use of the loading tool is described herein with respect to loading the transcatheter valve prosthesis <NUM> which is configured for implantation within a native mitral valve, as the structure of the transcatheter valve prosthesis <NUM> has already been described in detail above. However, as previously stated, the loading tools described herein may be utilized when loading any self-expanding prosthesis into a delivery system, and it is not required that the self-expanding prosthesis include a prosthetic valve component disposed therein. Further, for sake of illustration, use of the loading tool is described herein with respect to loading the transcatheter valve prosthesis <NUM> onto a delivery system <NUM> having a distal end <NUM>. In this embodiment, the distal end <NUM> includes a capsule <NUM> which is configured to constrain the transcatheter valve prosthesis <NUM> in a radially reduced configuration during delivery in situ and includes a piston <NUM> for hydraulic actuation of the capsule <NUM>. The delivery system <NUM> is described in FIGS. 54A-55C of <CIT> and International Patent Application No. <CIT>.

The transcatheter valve prosthesis <NUM> is first be crimped down to a reduced diameter by advancing the transcatheter valve prosthesis <NUM> into a loading cone or funnel <NUM>. In another embodiment (not shown), the transcatheter valve prosthesis <NUM> may be crimped down to a reduced diameter via a radial crimper. The loading funnel <NUM> is a conical or tapered component that includes a first end <NUM> having a first diameter and a second end <NUM> having a second diameter that is less than the first diameter. The transcatheter valve prosthesis <NUM> in its expanded or shape set configuration is positioned into the first end <NUM> of the loading funnel <NUM> and advanced through the loading funnel <NUM> towards the second end <NUM> thereof to reduce its diameter. With the transcatheter valve prosthesis <NUM> disposed therein, the assembly of the loading funnel <NUM> and the transcatheter valve prosthesis <NUM> disposed therein is placed over an inner shaft <NUM> of a delivery system <NUM> in a saline bath. The assembly of the loading funnel <NUM> and the transcatheter valve prosthesis <NUM> is positioned proximal to a proximal end of the capsule <NUM>. The transcatheter valve prosthesis <NUM> is advanced through the loading funnel <NUM> until attachment bars <NUM> of the transcatheter valve prosthesis <NUM> extend or protrude from the second end <NUM> of the loading funnel <NUM>. The attachment bars <NUM> are releasably coupled to the piston <NUM> of the delivery system <NUM>. For example, the transcatheter valve prosthesis <NUM> may be releasably coupled to the piston <NUM> by, for example, corresponding or mating slots (not shown) formed on a tubular shaft of the piston that is slidably mounted over the inner shaft <NUM>, the slots being configured to receive the attachment bars <NUM>.

At this stage or point of the method of loading, which is illustrated in the side view of <FIG>, the loading tool <NUM> may be positioned over the capsule <NUM> of the delivery system <NUM>. The delivery system <NUM> is still located within the saline bath, and the assembly of the loading funnel <NUM> and the transcatheter valve prosthesis <NUM> is positioned proximal to a proximal end of the capsule <NUM> as described above. <FIG> depicts a side view of the loading tool <NUM> prior to positioning over the capsule <NUM> of the delivery system <NUM>, with the loading tool <NUM> in its open configuration. As described herein, when in the open configuration, 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 <NUM> is disposed over the first ends 526A, 526B of the first and second body portions 524A, 524B.

While in the open configuration, the loading tool <NUM> is positioned or placed over the capsule <NUM> of the delivery system <NUM> and while the loading tool <NUM> is disposed over the capsule <NUM> of the delivery system <NUM>, the collar <NUM> is slid over the hinged body <NUM> until the loading tool <NUM> is in a closed configuration. As described herein, when in the closed configuration, the second end 528A of the first body portion 524A and the second end 528B of the second body portion 524B are disposed directly adjacent to each other and the collar <NUM> is disposed over the second ends 528A, 528B of the first and second body portions 524A, 524B, and the radial protrusions 532A, 532B abut against the collar <NUM> to lock the loading tool <NUM> in the closed configuration. <FIG> depicts a side view of the loading tool <NUM> after transitioning the loading tool <NUM> to its closed configuration.

The loading tool <NUM> includes several features for interacting with the delivery system <NUM> and avoiding damage to the transcatheter valve prosthesis <NUM> as the transcatheter valve prosthesis <NUM> is pulled into the delivery system <NUM>. More particularly, such features are best shown in <FIG> depicts a sectional side view of a portion of the loading tool <NUM> in the closed configuration, while <FIG> depicts the same sectional side view with the capsule <NUM> and the piston <NUM> disposed within the loading tool <NUM>. Each of the first and second body portions 524A, 524B of the loading tool <NUM> includes a chamfer or transitional leading edge 1882A, 1882B on an inner surface 1881A, 1881B thereof at the second ends 528A, 528B thereof. The chamfers 1882A, 1882B provide a smooth transition between the loading funnel <NUM> and the capsule <NUM>, and thus help to avoid damage to the transcatheter valve prosthesis <NUM> as it is pulled into the capsule <NUM>.

In addition, with continued reference to <FIG>, each of the first and second body portions 524A, 524B of the loading tool <NUM> includes a piston ledge 1884A, 1884B at the second ends 528A, 528B thereof. The piston ledges 1884A, 1884B extend beyond the flanges 536A, 536B. During use, the piston ledges 1884A, 1884B initially extend over the connection between the attachment bars <NUM> and the piston <NUM> of the delivery system <NUM>, which are releasably attached together. The piston ledges 1884A, 1884B form a ring gauge around the piston <NUM> and help to retain the attachment bars <NUM> in place during loading, as undesired movement of the attachment bars <NUM> may cause mis-loading and/or damage to the transcatheter valve prosthesis <NUM> and/or the delivery system <NUM>.

In addition, with continued reference to <FIG>, each of the first and second body portions 524A, 524B of the loading tool <NUM> includes a capsule overhang 1886A, 1886B formed on the inner surfaces 1881A, 1881B thereof at the second ends 528A, 528B thereof. The capsule overhangs 1886A, 1886B are integral stepped edges that are configured to grip or cover the proximal edge of the capsule <NUM>, thereby preventing direct contact between the transcatheter valve prosthesis <NUM> and the proximal end of the capsule <NUM> when the transcatheter valve prosthesis <NUM> is pulled into the capsule <NUM>. The transcatheter valve prosthesis <NUM> may inadvertently be damaged by friction and/or direct contact with the capsule <NUM> during loading, so the capsule overhangs 1886A, 1886B help to avoid damage to the transcatheter valve prosthesis <NUM> as it is pulled into the capsule <NUM>. In addition, the capsule overhangs 1886A, 1886B are configured to retain the attachment bars <NUM> in place during loading to ensure that the attachment bars <NUM> do not dislodge or pop out after loading, as undesired movement of the attachment bars <NUM> may cause mis-loading and/or damage to the transcatheter valve prosthesis <NUM> and/or the delivery system <NUM>.

After the loading tool <NUM> is positioned over the capsule <NUM> as shown in <FIG>, the transcatheter valve prosthesis <NUM> is pulled into the capsule <NUM> via movement of the piston <NUM>. Stated another way, the piston <NUM> pulls or retracts the transcatheter valve prosthesis <NUM> into the delivery system <NUM>. While the transcatheter valve prosthesis <NUM> is being pulled into the delivery system <NUM>, the loading tool <NUM> remains locked in its closed configuration over the capsule <NUM> via the resilient clips 530A, 530B of the loading tool <NUM>. The loading tool <NUM> being locked in the closed configuration ensures that the transcatheter valve prosthesis <NUM> is protected from mis-load related damage during loading.

After the transcatheter valve prosthesis <NUM> is loaded into the distal end <NUM> of the delivery system <NUM>, the loading tool <NUM> is removed from the delivery system <NUM>. The loading tool <NUM> may be removed when a pinching force is applied to displace the resilient clips 530A, 530B radially inward as described herein. The collar <NUM> is slid over the hinged body <NUM> while the resilient clips 530A, 530B are displaced radially inward until the loading tool <NUM> reverts to its open configuration. Once in the open configuration, the loading tool <NUM> is removed from the distal end <NUM> of the delivery system <NUM>.

Claim 1:
A loading tool (<NUM>) to facilitate loading a self-expanding prosthesis (<NUM>) into a delivery system (<NUM>), the loading tool comprising:
a hinged body (<NUM>) including a first body portion (524A) and a second body portion (524B), each of the first body portion and the second body portion having a first end (526A, 526B) and a second end (528A, 528B), wherein 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, and wherein each of the first body portion and the second body portion includes a resilient clip (530A, 530B) formed thereon that includes a radial protrusion (532A, 532B) on an outer surface thereof, each resilient clip being configured to displaced radially inwards when a pinching force is applied thereto; and
a collar (<NUM>) slidingly disposed over the hinged 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 disposed over the first ends of the first and second body portions, and wherein 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 disposed directly adjacent to each other and the collar is disposed over the second ends of the first and second body portions, and
wherein the radial protrusions are configured to lock the loading tool in the closed configuration when the resilient clips are not displaced radially inwards.