Patent Publication Number: US-2023141002-A1

Title: Device for applying fluid to leaflets of a heart valve prosthesis during crimping

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 63/277,788, filed Nov. 10, 2021, the entire content of which is incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to a crimping accessory for use with a crimper to manage the folding of leaflets of a transcatheter heart valve prosthesis during the crimping process. 
     BACKGROUND 
     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. 
     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 improvements in radially compressing or crimping a heart valve prosthesis to ensure that the leaflets of the heart valve prosthesis are not pinched or damaged during the crimping process. 
     BRIEF SUMMARY OF THE INVENTION 
     In accordance with an aspect hereof, an assembly comprising a transcatheter heart valve prosthesis and a crimping accessory is disclosed. The crimping accessory includes a body and at least one nozzle, the crimping accessory being configured to apply or remove pressurized fluid via the at least one nozzle to or from the at least one leaflet of the transcatheter heart valve prosthesis to hold the at least one leaflet in a substantially closed state when the crimper is radially compressing the transcatheter heart valve prosthesis into the crimped configuration. 
     In one aspect, the present disclosure provides an assembly comprising a transcatheter heart valve prosthesis including a frame and a valve component including at least one leaflet disposed within and secured to the frame, the transcatheter heart valve prosthesis having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve, and a crimping accessory configured for use with a crimper when radially compressing the transcatheter heart valve prosthesis into the crimped configuration, wherein the crimping accessory includes a body having an aperture formed on an outer surface thereof, at least one nozzle coupled to the body, and at least one fluid chamber formed between the aperture and the nozzle such that the aperture and the at least one nozzle are in fluid communication, the crimping accessory being configured to apply or remove pressurized fluid via the at least one nozzle to or from the at least one leaflet of the transcatheter heart valve prosthesis to hold the at least one leaflet in a substantially closed state when the crimper is radially compressing the transcatheter heart valve prosthesis into the crimped configuration. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the crimping accessory includes a first end and a second end opposing the first end, the first end and the second end of the crimping accessory being substantially circular in shape. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the first end of the crimping accessory has a first circumference which is larger than a second circumference of the second end of the crimping accessory. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the aperture disposed on the outer surface of the body is configured to receive tubing configured to connect the crimping accessory to a fluid source or a suction source. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the body of the crimping accessory further includes a channel extending from a first end to a second end thereof, the channel being configured to receive a balloon catheter of a delivery system for the transcatheter heart valve prosthesis. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the body of the crimping accessory further includes at least one hinge such that the crimping accessory has a clam-shell configuration that allows the crimping accessory to snap onto the balloon catheter of the delivery system. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the fluid chamber is annular and is disposed radially outward form the channel configured to receive the balloon catheter. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the transcatheter heart valve prosthesis includes exactly three leaflets and the crimping accessory includes exactly three nozzles, each nozzle being configured to remove or apply fluid to or from a leaflet of the exactly three leaflets. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the body of the crimping accessory includes a slot extending from a first end to a second end thereof, the slot being configured to receive a balloon catheter of a delivery system for the transcatheter heart valve prosthesis, and wherein the crimping accessory slides onto the balloon catheter of the delivery system via the slot. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the slot configured to house the balloon catheter extends an entire longitudinal length of the crimping accessory and has a substantially U-shaped cross-section, and wherein the fluid chamber is C-shaped and disposed radially outward from the slot configured to house the balloon catheter. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the crimping accessory is configured to be disposed within and attached to an interior surface of the crimper. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the crimping accessory contains a singular, annular nozzle. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the singular, annular nozzle applies pressurized fluid to the at least one leaflet of the transcatheter heart valve prosthesis. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the singular, annular nozzle removes pressurized fluid from the at least one leaflet of the transcatheter heart valve prosthesis. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the crimping accessory includes a seal around an outer perimeter of the first end configured to seal around the crimper. 
     In one aspect hereof, and in combination with any other aspects, the present disclosure provides a method of crimping a transcatheter heart valve prosthesis onto a delivery system comprising positioning a transcatheter heart valve prosthesis into a crimper chamber of a crimper, the transcatheter heart valve prosthesis including a frame and a valve component including at least one leaflet disposed within and secured to the frame, wherein the transcatheter heart valve prosthesis is in the expanded configuration, operating the crimper to radially compress the transcatheter heart valve prosthesis into a crimped configuration for delivery within a vasculature, wherein a crimping accessory applies or removes pressurized fluid to or from the at least one leaflet of the transcatheter heart valve prosthesis to hold the at least one leaflet in a substantially closed state during the step of operating the crimper. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the transcatheter heart valve prosthesis may be partially compressed or fully compressed during the operating step. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the crimping accessory includes a body, at least one nozzle and at least one fluid chamber fluidly connecting the at least one nozzle to an aperture disposed on an outer surface of the body, the at least one nozzle being configured to apply or remove pressurized fluid to or from the at least one leaflet of the transcatheter heart valve prosthesis to hold the at least one leaflet in a substantially closed state when the crimper is radially compressing the transcatheter heart valve prosthesis into the crimped configuration. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the crimping accessory is positioned outside the crimper. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the crimping accessory is positioned within the crimper. 
     In one aspect hereof, and in combination with any other aspects, the present disclosure provides a method of crimping a transcatheter heart valve prosthesis onto a delivery system comprising positioning a transcatheter heart valve prosthesis into a crimper chamber of a crimper, the transcatheter heart valve prosthesis including a frame and a valve component including at least one leaflet disposed within and secured to the frame, wherein the transcatheter heart valve prosthesis is in an expanded configuration and is mounted over a balloon of a balloon catheter, operating the crimper to radially compress the transcatheter heart valve prosthesis on the balloon of the balloon catheter into a partially crimped configuration, removing the partially crimped transcatheter heart valve prosthesis on the balloon catheter from the crimper and placing it within a crimping accessory, while disposed within the crimping accessory, applying pressurized fluid to the at least one leaflet of the transcatheter heart valve prosthesis to hold the at least one leaflet in a substantially closed state, removing the partially crimped transcatheter heart valve prosthesis on the balloon catheter from the crimping accessory and placing it back in the crimper chamber of the crimper, operating the crimper to further radially compress the transcatheter heart valve prosthesis into a fully crimped configuration on the balloon catheter configured for delivery within a vasculature, and removing the transcatheter heart valve prosthesis in the crimped configuration on the balloon catheter of the delivery system from the crimper. 
     In another aspect hereof, and in combination with any other aspects, the disclosure provides the crimping accessory includes a body, at least one nozzle and at least one fluid chamber fluidly connecting the at least one nozzle to an aperture disposed on an outer surface of the body, the at least one nozzle being configured to radially apply pressurized fluid to the at least one leaflet of the transcatheter heart valve prosthesis to hold the at least one leaflet in a substantially closed state when the crimper is radially compressing the transcatheter heart valve prosthesis into the crimped configuration. 
     The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the present disclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure. The drawings may not be to scale. 
         FIG.  1 A  shows a side view of a transcatheter heart valve prosthesis according to embodiments thereof. 
         FIG.  1 B  shows a top view of the transcatheter heart valve prosthesis of  FIG.  1 A . 
         FIG.  2 A  shows a schematic side view of an assembly according to embodiments thereof, the assembly including a crimper, a crimping accessory, and a balloon catheter, wherein the crimping accessory is configured to snap onto the delivery system. 
         FIG.  2 B  shows a perspective view of the crimping accessory of  FIG.  2 A . 
         FIG.  2 C  shows a cross-sectional perspective view of the crimping accessory of  FIG.  2 A . 
         FIG.  3 A  shows a front view of a crimping accessory according to another embodiment hereof, wherein the crimping accessory is configured to slide onto the delivery system. 
         FIG.  3 B  shows a cross-sectional perspective view of the crimping accessory of  FIG.  3 A . 
         FIG.  4 A  shows a perspective view of a crimping accessory according to another embodiment hereof, wherein the crimping accessory has an annular nozzle configuration. 
         FIG.  4 B  shows a cross-sectional perspective view of the crimping accessory of  FIG.  4 A . 
         FIG.  5 A  shows a schematic side view of an assembly according to embodiments thereof, the assembly including a crimper, a plurality of crimping accessories, and a balloon catheter disposed through a crimper chamber of the crimper, wherein the crimping accessories are disposed within an interior of the crimper. 
         FIG.  5 B  shows a schematic front view of the interior of the crimper of  FIG.  5 A . 
         FIG.  5 C  shows a perspective side view of a crimping accessory of  FIG.  5 A , wherein the crimping accessory is removed from the crimper for sake of illustration. 
         FIG.  6 A  shows a schematic side view of an assembly according to embodiments thereof, the assembly including a crimper, a crimping accessory, and a balloon catheter, wherein the crimping accessory is configured to be coupled to an outer surface of the crimper. 
         FIG.  6 B  shows a perspective view of the crimping accessory of  FIG.  6 A . 
         FIG.  6 C  shows a cross-sectional perspective view of the crimping accessory of  FIG.  6 A . 
         FIG.  7 A  shows a sectional perspective view of a crimping accessory according to another embodiment thereof. 
         FIG.  7 B  shows a cross-sectional perspective view of the crimping accessory of  FIG.  7 A . 
         FIG.  7 C  shows a perspective top view of the crimping accessory of  FIG.  7 A . 
         FIG.  8    is a block diagram that shows a method of using the crimping accessory of  FIGS.  7 A- 7 C  according to an embodiment hereof. 
     
    
    
     DETAILED DESCRIPTION 
     It should be understood that various embodiments disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single device or component for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of devices or components associated with, for example, a medical device. The following detailed description is merely exemplary in nature and is not intended to limit the invention of the application and uses of the invention. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding field of the invention, background, summary or the following detailed description. 
     As used in this specification, the singular forms “a”, “an” and “the” specifically also encompass the plural forms of the terms to which they refer, unless the content clearly dictates otherwise. The term “about” is used herein to mean approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 20%. It should be understood that use of the term “about” also includes the specifically recited number of value. 
     Embodiments hereof relate to a leaflet folding accessory or tool configured for use with a transcatheter valve prosthesis when radially compressing the transcatheter valve prosthesis into a crimped configuration for delivery within a vasculature. More particularly, the crimping accessory is configured to apply or remove fluid to or from the leaflets of a transcatheter heart valve prosthesis during the crimping process to prevent protrusion of the leaflets into the frame of the transcatheter heart valve prosthesis that may cause leaflet pinching and damage. The crimping accessory is spaced a distance from the transcatheter valve prosthesis during the crimping process such that it may apply or remove pressurized fluid to or from the leaflets of the transcatheter heart valve prosthesis without directly contacting the leaflets, thereby eliminating the chance of damage to the leaflets from the crimping accessory. 
       FIGS.  1 A and  1 B  illustrate a transcatheter heart valve prosthesis  125  that may be utilized with the embodiments of the crimping accessory described herein. The transcatheter heart valve prosthesis  125  is illustrated herein in order to facilitate description of the present invention. The following description of the transcatheter heart valve prosthesis  125  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 leaflet accessory tools and methods described herein. Other non-limiting examples of transcatheter heart valve prostheses that can be used with the leaflet accessory tools described herein are described in U.S. Pat. App. No. 17/186,485, filed Feb. 26, 2021, which is incorporated by reference herein in its entirety. Although the transcatheter heart valve prosthesis  125  is a balloon-expandable heart valve prosthesis configured for placement within an aortic heart valve, embodiments of the crimping accessory described herein may be utilized with any transcatheter valve prosthesis that is crimped onto a delivery system. For example, embodiments of the leaflet folding accessory 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. 
       FIGS.  1 A and  1 B  illustrate side and top views, respectively, of the transcatheter heart valve prosthesis  125 . The transcatheter heart valve prosthesis  125  includes a radially-expandable frame  126  and a valve component  127 . The frame  126  of the transcatheter heart valve prosthesis  125  is a unitary stent or scaffold that supports the valve component  127  within the interior of the frame  126 . In an embodiment, the frame  126  is balloon-expandable. The valve component  127  includes at least one leaflet  128  disposed within and secured to the frame  126 . In an embodiment, the valve component  127  of the transcatheter heart valve prosthesis  125  includes exactly three leaflets  128 , as shown in  FIG.  1 B . The valve component  127  of the transcatheter heart valve prosthesis  125  is capable of blocking flow in one direction to regulate flow there-through via the valve leaflets  128 . The transcatheter heart valve prosthesis  125  has a crimped configuration for delivery within a vasculature and an expanded configuration (as shown in  FIGS.  1 A and  1 B ) for deployment within a native heart valve. 
     As shown in  FIG.  1 A , the transcatheter heart valve prosthesis  125  includes an inflow portion  131  and an outflow portion  132 . The frame  126  of the transcatheter heart valve prosthesis  125  includes a plurality of struts  134  that are arranged to form a plurality of side openings or cells  135  arranged circumferentially around a longitudinal axis of the transcatheter heart valve prosthesis  125  and longitudinally to form a tubular structure defining a central lumen  136  of the transcatheter heart valve prosthesis  125 . The struts  134  are defined as the straight segments of the frame  126 . Two struts  134  come together to form a crown  133  and four struts  134  come together to form a node  137 , as can be seen in  FIG.  1 A . Each cell  135  of the plurality of cells  135  are disposed within exactly four struts  134  and exactly four nodes  137 , or exactly three nodes  137  and exactly one crown  133 . The frame  126  is configured to secure the valve component  127  within the central lumen  136  of the frame  126  and to secure the transcatheter heart valve prosthesis  125  in place in the vasculature of the patient. 
     The inflow portion  131  of the transcatheter heart valve prosthesis  125  includes a plurality of crowns  133  with each crown  133  being formed between a pair of adjacent struts  134 . Similarly, the outflow portion  132  of the transcatheter heart valve prosthesis  125  includes a plurality of crowns  133  with each crown  133  being formed between a pair of adjacent struts  134 . The frame  126  of the heart valve prosthesis  125  includes a plurality of cells  135  defined as the spaces between the plurality of crowns  133 , the plurality of nodes  137  and the plurality of struts  134 . In an embodiment, the plurality of cells  135  may be diamond-shaped, as shown in  FIG.  1 A . In the embodiment described herein, the plurality of cells  135 A located at the outflow portion  132  are heart-shaped and are relatively larger than the plurality of cells  135 B located at the inflow portion  132  of the frame  126  to improve access to the coronary arteries. More particularly, the cells  135 A located at the outflow portion  132  are configured to be of sufficient size to be easily crossed with a coronary guide catheter into either the right coronary artery or the left main coronary artery once the transcatheter heart valve prosthesis  125  is deployed in situ. 
     The valve component  127  of the transcatheter heart valve prosthesis  125  is capable of regulating flow therethrough via valve leaflets  128  that may form a replacement valve.  FIGS.  1 A and  1 B  illustrate an exemplary valve component  127  having three leaflets  128 , although a single leaflet or bicuspid leaflet configuration may alternatively be used in embodiments hereof. When deployed in situ, the valve component  127  in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen  136  of the frame  126  of the transcatheter heart valve prosthesis  125 .  FIG.  1 A  depicts a side view of the transcatheter heart valve prosthesis  125 , wherein the valve component  127  is shown disposed within and secured to the frame  126  of the heart valve prosthesis  125 .  FIG.  1 B  depicts an atrial or inflow end view of the transcatheter heart valve prosthesis  125  shown in  FIG.  1 A . The valve component  127  includes valve leaflets  128 , e.g., three valve leaflets  128 , such that the valve leaflets  128  open during diastole. 
     Leaflets  128  may be attached to a graft material or skirt  129  which encloses or lines a portion of the frame  126  as would be known to one of ordinary skill in the art of prosthetic tissue valve construction, for example, using sutures or a suitable biocompatible adhesive. Leaflets  128  are sutured or otherwise securely and sealingly attached along their bases to the interior surface of the graft material, or otherwise attached to the frame  126 . Adjoining pairs of leaflets are attached to one another at their lateral ends to form commissures, with free edges of the leaflets  128  forming coaptation edges that meet in a closed configuration. The orientation of the leaflets  128  within the valve component  127  depends upon on which end of the transcatheter heart valve prosthesis  125  is the inflow end  131  and which end of the transcatheter heart valve prosthesis  125  is the outflow end  132 , thereby ensuring one-way flow of blood through the transcatheter heart valve prosthesis  125 . 
     The valve leaflets  128  and graft material 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. 
     As shown in  FIGS.  1 A and  1 B , the valve component  127  includes at least one leaflet  128  disposed within and secured to the frame  126  of the transcatheter heart valve prosthesis  125 . A crimper may be used to radially compress the transcatheter heart valve prosthesis  125  from an expanded configuration to a crimped configuration for delivery within a vasculature. During the crimping process, radial compression exerted by the crimper causes the area of the cells  135  of the frame  126  to decrease. In some instances, the at least one leaflet  128  of the valve component  127  may protrude through the cells  135 A at the outflow portion  132  of the frame  126  during the process, which may cause the leaflets  128  to get pinched between struts  134  of the frame  126  and sustain damage. Leaflet protrusion becomes increasingly likely as the area of the cells  135  increase and/or in view of higher crimping forces that are needed to crimp balloon expandable implants. 
       FIG.  2 A  is a schematic illustration of an assembly including a crimper  250 , a crimping accessory  200 , and a delivery system  260  including a shaft  263  during the crimping procedure according to embodiments hereof. The crimping accessory  200  is configured for use with a transcatheter valve prosthesis, such as but not limited to the transcatheter heart valve prosthesis  125  described herein, when radially compressing the transcatheter valve prosthesis into a crimped configuration for delivery within a vasculature. For illustrative purposes only, the crimping accessory  200  will be described for use with the transcatheter heart valve prosthesis  125  since the structure thereof has been described herein. One skilled in the art would understand that when using the crimper  250  to compress the transcatheter valve prosthesis  125 , the transcatheter heart valve prosthesis  125  is first loaded onto a balloon (not shown) of the delivery system  260  in an expanded configuration. The assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  is then positioned into a crimper chamber  255  of the crimper  250 , as can be seen in  FIG.  2 A . Prior to the crimping procedure, the crimping accessory  200  is secured onto the shaft  263  of the delivery system  260  and is spaced a distance from a first end  251  of the crimper  250  such that it may apply pressurized fluid to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  during the crimping process without directly contacting the transcatheter heart valve prosthesis  125 . Stated another way, the crimping accessory  200  is configured to interact with the leaflets  128  of the transcatheter heart valve prosthesis  125  in a contactless manner. An aperture  221  of the crimping accessory  200  receives a tubing  280  that connects to a fluid source  285  such that the fluid source  285  may provide pressurized fluid to the crimping accessory  200 . The term “fluid” as used herein includes gases (i.e., air) as well as liquids such as water, saline, etc. In an embodiment, the fluid is pressurized with a pressure between 1 PSI and 10 PSI. The crimping accessories described herein are shown and described with a crimper that is oriented in a horizonal orientation for ease of use, and the crimping accessory provides fluid to the transcatheter heart valve prosthesis disposed within the crimper chamber of the crimper in an axial direction. Thus, the crimping accessory is configured to provide the fluid under pressure, i.e., a pressurized fluid, to the at least one leaflet of the transcatheter heart valve prosthesis during the crimping process due to the horizonal orientation of the crimper. However, this is not meant to be limiting and it should be understood that the fluid being applied by the crimping accessory to the at least one leaflet of the transcatheter heart valve prosthesis is not required to be pressurized if the crimper and crimping accessory are oriented in a vertical orientation (i.e., the crimper being disposed below the crimping accessory in a vertical manner) rather than the horizontal orientation shown and described herein. 
       FIG.  2 B  shows a crimping accessory  200  according to embodiments herein. The crimping accessory  200  includes a body  205 , a first end  201 , and a second end  202  that opposes the first end  201 . The first end  201  of the crimping accessory  200  has an area larger than an area of the second end  202 . The crimping accessory  200  includes a channel  230  configured to receive the shaft  263  of the delivery system  260  as shown in  FIG.  2 B . The channel  230  extends an entire longitudinal length of the crimping accessory  200 , extending from the first end  201  to the second end  202  of the body  205 . In an embodiment, the channel  230  has a substantially circular cross-section that is sized slightly greater than an outer diameter of the shaft  263  of the delivery system  260 . In embodiments, the body  205  of the crimping accessory  200  may include at least one hinge  240  such that the crimping accessory  200  has a clam-shell configuration. The clam-shell configuration allows the crimping accessory  200  to snap onto the shaft  263  of the delivery system  260  via the channel  230 . More particularly, via the hinge  240 , the crimping accessory  200  has an open configuration in which the channel  230  is enlarged and the crimping accessory  260  can be disposed over the shaft  263  of the delivery system  260  and a closed configuration in which the channel  230  resumes its substantially circular cross-section and the body  205  of the crimping accessory  200  encloses or surrounds the shaft  263  of the delivery system  260 . 
     The crimping accessory  200  further includes at least one nozzle  210 , at least one fluid chamber  220 , and an aperture  221 , as shown in  FIG.  2 C . The fluid chamber  220  fluidly connects the at least one nozzle  210  to the aperture  221  disposed on an outer surface of the body  205 . In the embodiment shown, the fluid chamber  220  is annular and disposed radially outward from the channel  230  configured to house the shaft  263  of the delivery system  260 . The aperture  221  is configured to receive the tubing  280  (shown in  FIG.  2 A ). The tubing  280  is configured to provide fluid from the fluid source  285  to the at least one nozzle  210 , as can be seen in  FIG.  2 A . In the embodiment shown, the body  205  contains exactly three nozzles  210  configured to apply pressurized fluid to the three leaflets  128  of the transcatheter heart valve prosthesis  125 . The arrows in  FIG.  2 C  represent a fluid path  270   within the crimping accessory  200  such that the fluid exits through the exactly three nozzles  210  and is directed to and aimed at the three leaflets  128  of the transcatheter heart valve prosthesis  125 . Each nozzle  210  is configured to apply fluid to a leaflet  128 . Each nozzle  210  is aligned with a center of each leaflet  128  such that when the pressurized fluid is applied, each leaflet  128  is held in a substantially closed state when the crimper  250  is radially compressing the transcatheter heart valve prosthesis  125  into the crimped configuration. In this embodiment, the three nozzles  210  are equally and circumferentially spaced apart from each other, as can be seen in  FIG.  2 B . The term “substantially closed state” is used herein to describe the leaflets  128  of the valve component  127  being positioned such that the free edges thereof abut against or contact the shaft  263  of the delivery system  260 . The closed state of the leaflets  128  against the shaft  263  of the delivery system  260  is similar to the closed state of the leaflets  128  within the vasculature of the patient, in which the leaflets  128  are configured to block blood flow in one direction to regulate the blood flow through the central lumen  136  of the heart valve prosthesis  125 , except that the shaft  263  of the delivery system  260  extends through the central lumen  136  of the heart valve prosthesis  125  during the crimping procedure. In another embodiment, when the pressurized fluid is applied, each leaflet  128  is displaced radially inward to prevent leaflet protrusion but does not abut against or contact the shaft  263  of the delivery system when the crimper  250  is radially compressing the transcatheter heart valve prosthesis  125  into the crimped configuration. 
     A method of using the crimping accessory  200  during the crimping process of the transcatheter heart valve prosthesis  125  will now be described. Referring to  FIG.  2 A , the transcatheter heart valve prosthesis  125  is first loaded onto the balloon of the balloon catheter of the delivery system  260  in an expanded configuration. The assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  is then positioned within the crimper chamber  255  of the crimper  250 . The crimping accessory  200  is then placed on the shaft  263  of the delivery system  260  and is spaced a distance from the first end  251  of the crimper  250 . When the crimper  250  operates to radially compress the transcatheter heart valve prosthesis  125  into a crimped configuration, the crimping accessory  200  applies pressurized fluid to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  to urge the at least one leaflet  128  into a substantially closed state during the crimping process.  FIG.  2 A  shows the fluid path  270  in phantom for illustrative purposes only from the at least one nozzle  210  to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  when the prosthesis  125  is being radially compressed within the crimper  250 . The fluid from the at least one nozzle  210  is applied axially to an exterior surface of the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  such that the fluid pushes the at least one leaflet  128  radially inwards. Displacing the at least one leaflet  128  radially inwards during the crimping process minimizes the risk of leaflet protrusion and damage. When fluid is applied to the leaflets  128 , pooling of the fluid may occur on or around the leaflets  128  of the valve component  127 . Such pooling can be beneficial to displacing the leaflets  128  radially inwards. When the transcatheter heart valve prosthesis  125  is fully crimped onto the delivery system  260 , the crimping accessory  200  may be removed from the shaft  263  of the delivery system  260  and the assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  may be removed from the crimper chamber  255  of the crimper  250 . 
       FIGS.  3 A- 3 B  show a crimping accessory  300  according to embodiments herein. As compared to the crimping accessory  200  described above, the crimping accessory  300  described herein includes a slot that receives the shaft  263  of the delivery system  260  and allows the crimping accessory  300  to slide onto the delivery system  260 . The slot, having a substantially U-shaped cross-section, results in the crimping accessory  300  having a fluid chamber that is substantially C-shaped and disposed radially outward from the slot, as will be described in more detail below. 
     The crimping accessory  300  described herein includes a body  305 , a first end  301 , and a second end  302 . The first end  301  and the second end  302  of the crimping accessory  300  are substantially circular in shape. The first end  301  has a first circumference larger than the second circumference of the second end  302 . The crimping accessory  300  includes a slot  330  configured to receive the shaft  263  of the balloon catheter of the delivery system  260 , as shown in  FIG.  3 A . The slot  330  extends an entire longitudinal length of the crimping accessory  300 , extending from the first end  301  to the second end  302  of the body  305 , as shown in  FIG.  3 B . The slot  330  has a substantially U-shaped cross-section that allows the crimping accessory  300  to slide onto the shaft  263  of the balloon catheter of the delivery system  260 . Once the transcatheter heart valve prosthesis  125  is loaded onto the balloon of the delivery system  260  and is placed within the crimper chamber  255  of the crimper  250 , the crimping accessory  300  slides onto the shaft  263  of the balloon catheter and is spaced a distance away from the first end  251  of the crimper  250  such that it may apply pressurized fluid to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  during the crimping process without directly contacting the transcatheter heart valve prosthesis  125 , similar to the assembly shown in  FIG.  2 A . 
     The crimping accessory  300  includes at least one nozzle  310 , a fluid chamber  320 , and an aperture  321 , as shown in  FIG.  3 B . The fluid chamber  320  fluidly connects the at least one nozzle  310  to the aperture  321  disposed on an outer surface of the body  305 . In the embodiment shown, the fluid chamber  320  is C-shaped and is disposed radially outward from the slot  330  configured to house the shaft  263  balloon catheter of the delivery system  260 . The aperture  321  is configured to receive the tubing  280 . The tubing  280  is configured to provide fluid from the fluid source  285  to the at least one nozzle  310 , similar to the assembly shown in  FIG.  2 A . In the embodiment shown, the body  305  contains three nozzles  310  configured to apply pressurized fluid to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125 . The arrows in  FIG.  3 B  represent a fluid path 370 within the crimping accessory  300  such that the fluid exits through the exactly three nozzles  310  and is directed to and aimed at the at least one leaflet  128  of the transcatheter heart valve prosthesis  125 . In some embodiments, the transcatheter heart valve prosthesis  125  includes exactly three leaflets  128  and the crimping accessory  300  includes exactly three nozzles  310 . In such embodiments, each nozzle  310  is configured to apply fluid to a leaflet  128  of the exactly three leaflets  128 . Each nozzle  310  is aligned with a center of each leaflet  128  such that when the pressurized fluid is applied axially, each leaflet  128  is held in a substantially closed state when the crimper  250  is radially compressing the transcatheter heart valve prosthesis  125  into the crimped configuration. In another embodiment, when the pressurized fluid is applied, each leaflet  128  is displaced radially inward to prevent leaflet protrusion but does not abut against or contact the shaft  263  of the delivery system. In the embodiment of  FIG.  3 A , the three nozzles  310  are equally and circumferentially spaced apart from each other. 
       FIGS.  4 A- 4 B  show a crimping accessory  400  according to embodiments herein. As compared to the embodiments described above, the crimping accessory  400  described herein contains a singular, annular nozzle configured to apply pressurized fluid to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  during the crimping process. The crimping accessory  400  described herein includes a body  405 , a first end  401 , and a second end  402 . The first end  401  and the second end  402  of the crimping accessory  400  are substantially circular in shape. The first end  401  has a first circumference larger than a second circumference of the second end  402 . The crimping accessory  400  includes a channel  430  configured to receive the shaft  263  of the balloon catheter of the delivery system  260 . The channel  430  extends an entire longitudinal length of the crimping accessory  400 , extending from the first end  401  to the second end  402  of the body  405 . The channel  430  has a substantially circular cross-section. 
     The crimping accessory  400  includes at least one nozzle  410 , a fluid chamber  420 , and an aperture  421 , as shown in  FIG.  4 B . The fluid chamber  420  fluidly connects the at least one nozzle  410  to the aperture  421  disposed on an outer surface of the body  405 . In the embodiment shown, the fluid chamber  420  is annular and disposed radially outward from the channel  430  configured to house the shaft  263  of the balloon catheter  260  of the delivery system. The aperture  421  is configured to receive the tubing  280 . The tubing  280  is configured to provide fluid from the fluid source  285  to the at least one nozzle  410 . In the embodiment shown, the body  405  contains a singular, annular nozzle  410  configured to apply pressurized fluid in a substantially annular fluid stream to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125 . The arrows in  FIG.  4 B  represent a fluid path  470  within the crimping accessory  400  such that the fluid exits through the annular nozzle  410  and is directed to and aimed at the at least one leaflet  128  of the transcatheter heart valve prosthesis  125 . In instances where more fluid may be required to displace the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  radially inward, the crimping accessory  400  having the single annular nozzle  410  is able to apply more fluid and a higher pressure compared to embodiments containing multiple, spaced apart nozzles. 
     In embodiments, the body  405  of the crimping accessory  400  may include at least one hinge similar to hinge  240  described above such that the crimping accessory  400  has a clam-shell configuration. The clam-shell configuration would allow the crimping accessory  400  to snap onto the shaft  263  of the balloon catheter of the delivery system  260 . In other embodiments, the crimping accessory  400  may slide onto the shaft  263  of the balloon catheter of the delivery system  260  via the channel  430 . 
     Similar to the configuration shown in  FIG.  2 A , once the transcatheter heart valve prosthesis  125  is loaded onto the balloon  261  of the balloon catheter in an expanded configuration and is placed within the crimper chamber  255  of the crimper  250 , the crimping accessory  400  slides or snaps onto the shaft  263  of the delivery system  260  and is spaced a distance away from the first end  251  of the crimper  250  such that the crimping accessory  400  may apply pressurized fluid to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  during the crimping process without directly contacting the transcatheter heart valve prosthesis  125 . When the transcatheter heart valve prosthesis  125  is fully crimped onto the delivery system  260 , the crimping accessory  400  may be removed from the shaft  263  of the delivery system  260  and the assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  may be removed from the crimper chamber  255  of the crimper  250 . 
       FIGS.  5 A- 5 C  show a plurality of crimping accessories  500  according to another embodiment hereof. As compared to previously described embodiments, each crimping accessory  500  described herein is configured to be disposed within the crimper  250  and applies pressurized fluid towards the leaflets  128  of the transcatheter heart valve prosthesis  125  during the crimping process.  FIG.  5 A  shows a schematic side view of the crimper  250 , the plurality of crimping accessories  500  disposed within the crimper  250 , and a balloon catheter of the delivery system  260  disposed through the crimper chamber of the crimper  250 . Similar to previous embodiments described herein, an aperture  521  of each crimping accessory  500  receives a tubing  280  that connects to a fluid source  285  such that the fluid source  285  may provide pressurized fluid to the crimping accessories  500 . Each crimping accessory  500  is attached or fixedly secured to an inner surface of the crimper  250 , and is oriented and configured to apply pressurized fluid at an angle through the crimper chamber  255  of the crimper  250 , towards at least one leaflet  128  of the transcatheter heart valve prosthesis  125  during the crimping process without directly contacting the transcatheter heart valve prosthesis  125 . 
     More particularly, each crimping accessory  500  is attached to an inner surface of the crimper  250  at the first end  250  of the crimper  250  and is positioned such that a nozzle  510  extends into the crimper chamber  255 . The nozzle  510  is oriented at an angle to apply or push fluid from the opening at the first end  251  of the crimper  250  towards the leaflets  128  of the transcatheter heart valve prosthesis  125  during the crimping process. In an embodiment, the fluid is applied at an angle such that it travels axially towards the second end  252  of the crimper  250  through the crimper chamber  255  and radially inwards to be directed towards the leaflets  128  of the transcatheter heart valve prosthesis  125  during the crimping process. In an embodiment, the orientation and/or position of the crimping accessory  500  may be adjustable such that the accessory moves radially inward during crimping and the fluid continues to contact the leaflets  128  as the transcatheter heart valve prosthesis  125  is crimped to a smaller diameter. In an embodiment, the crimper  250  is an iris-style crimper that includes a plurality of crimper elements which define at least a portion of the crimper chamber  255 , with each of the crimper elements including a surface that forms a portion of the crimper chamber  255 . Fluid is directed from the nozzle  510  towards the leaflets  128  of the transcatheter heart valve prosthesis  125  without hitting or interfering with the operation of the crimper elements that form at least a portion of the crimper chamber  255 . 
       FIG.  5 B  shows a schematic front view of an interior of the crimper  250  to illustrate the relative circumferential positioning of the plurality of crimping accessories  500  disposed within the crimper  250 . In this embodiment, more than one crimping accessory  500  is used to apply fluid radially to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  during the crimping process. In the embodiment shown in  FIG.  5 B , the valve component  127  of the transcatheter heart valve prosthesis  125  includes exactly three leaflets  128  and exactly three crimping accessories  500  are used to apply fluid to the three leaflets  128  of the transcatheter heart valve prosthesis  125 , with each crimping accessory  500  being positioned and oriented so as to apply fluid to a single leaflet of the exactly three leaflets  128 . The number of crimping accessories  500  being used may vary from that shown in  FIGS.  5 A- 5 C . While the number of crimping accessories  500  preferably correspond with the number of leaflets  128  included in the transcatheter heart valve prosthesis  125 , it is not required that the number of crimping accessories  500  match the number of leaflets  128 . The assembly may include a greater or lesser number of crimping accessories  500  than the number of leaflets  128 . 
       FIG.  5 C  shows a perspective view of a single crimping accessory  500  removed from the crimper for sake of illustration only. The crimping accessory  500  includes a body  505 , a first end  501 , and a second end 502 that opposes the first end  501 . The crimping accessory  500  further includes at least one nozzle  510 , at least one fluid chamber (not shown), and an aperture  521 . The fluid chamber fluidly connects the at least one nozzle  510  to the aperture  521  disposed on an outer surface of the body  505 . The aperture  521  is configured to receive the tubing  280  (shown in  FIG.  5 A ), and the tubing  280  is configured to provide fluid from the fluid source  285  to the at least one nozzle  510 . 
     In the embodiment shown, the body  505  contains exactly one nozzle  510  configured to apply pressurized fluid to exactly one leaflet  128  of the transcatheter heart valve prosthesis  125 . As described above with respect to  FIG.  5 B , the valve component  127  of the transcatheter heart valve prosthesis  125  includes exactly three leaflets  128  and each crimping accessory  500  is used to apply fluid radially to a single leaflet of the three leaflets  128  of the transcatheter heart valve prosthesis  125 . Each nozzle  510  of each crimping accessory  500  is oriented towards the crimper chamber of the crimper  250  and towards the leaflets  128  of the transcatheter heart valve prosthesis  125  during the crimping process. In addition, each nozzle  510  may be oriented such that fluid applied therefrom is aligned with a center of each leaflet  128 . In this embodiment, the three crimping accessories  500  are equally and circumferentially spaced apart from each other as best shown in  FIG.  5 B  so as to optimize alignment with the three leaflets  128 . 
     A method of using the crimping accessory  500  during the crimping process of the transcatheter heart valve prosthesis  125  will now be described. Referring to  FIG.  5 A , the transcatheter heart valve prosthesis  125  is first loaded onto the balloon of the balloon catheter of the delivery system  260  in an expanded configuration. The assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  is then positioned within the crimper chamber  255  of the crimper  250 . When the crimper  250  operates to radially compress the transcatheter heart valve prosthesis  125  into a crimped configuration, the crimping accessories  500  apply pressurized fluid radially to the leaflets  128  of the transcatheter heart valve prosthesis  125  to urge the leaflets  128  into a substantially closed state during the crimping process.  FIG.  5 B  shows the fluid path  270  in phantom for illustrative purposes only from each crimping accessory  500  to a corresponding leaflet  128  of the transcatheter heart valve prosthesis  125 . The fluid from each nozzle  510  is applied to an exterior surface of each leaflet  128  of the transcatheter heart valve prosthesis  125  such that the fluid pushes the leaflets  128  radially inwards. Displacing the leaflets  128  radially inwards during the crimping process minimizes risk of leaflet protrusion (through the frame  126  of the prosthesis  125 ) and damage. When the transcatheter heart valve prosthesis  125  is fully crimped onto the delivery system  260 , the assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  may be removed from the crimper chamber  255  of the crimper  250 . 
       FIGS.  6 A- 6 C  show a crimping accessory  600  according to another embodiment hereof. As compared to previously described embodiments, the crimping accessory  600  described herein is configured to suction, or remove, air from the crimper chamber  255  of the crimper  250  such that the vacuum-sealed environment holds the leaflets  128  of the transcatheter heart valve prosthesis  125  in a substantially closed state during the crimping process. 
       FIG.  6 A  is a schematic illustration of the crimper  250 , the shaft  263  of the delivery system  260 , and a crimping accessory  600  during the crimping procedure according to another embodiment hereof. The crimping accessory  600  is configured for use with a transcatheter heart valve prosthesis (such as but not limited to the transcatheter heart valve prosthesis  125  described herein) when radially compressing the transcatheter valve prosthesis into a crimped configuration for delivery within a vasculature. For illustrative purposes only, the crimping accessory  600  will be described for use with the transcatheter heart valve prosthesis  125  since the structure thereof has been described herein. One skilled in the art would understand that when using the crimper  250  to compress a transcatheter valve prosthesis  125 , the transcatheter heart valve prosthesis  125  is first loaded onto the balloon of the delivery system  260  in an expanded configuration. The assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  is then positioned into the crimper chamber  255  of the crimper  250 , as can be seen in  FIG.  6 A . Prior to the crimping procedure, the crimping accessory  600  is positioned over a distal end  262  of the shaft  263  of the delivery system  260  and is securely sealed to an outer surface of the second end  252  of the crimper  250  such that it may remove, or suction, air from the crimper chamber  255  of the crimper  250  during the crimping process without directly contacting the transcatheter heart valve prosthesis  125 . Stated another way, the crimping accessory  600  is configured to interact with the leaflets  128  of the transcatheter heart valve prosthesis  125  in a contactless manner. The crimping accessory  600  is connected to a tubing  680  that extends to a suction source  685  such that the suction source  685  may remove air from the crimper chamber  255  through the crimping accessory  600 , as will be described in more detail herein. 
     As shown in  FIGS.  6 B- 6 C , the crimping accessory  600  includes a body  605 , a first end  601 , and a second end  602 . The first end  601  and the second end  602  of the crimping accessory  600  are substantially circular in shape. The first end  601  has a first circumference larger than the second circumference of the second end  602 . The crimping accessory  600  includes a channel  630  configured to receive the shaft  263  of the balloon catheter of the delivery system  260 , as shown in  FIGS.  6 B and  6 C . The channel  630  extends an entire longitudinal length of the crimping accessory  600 , extending from the first end  601  to the second end  602  of the body  605 . The channel  630  has a substantially circular cross-section and allows the crimping accessory  600  to slide onto the distal end  262  of the shaft  263  of the balloon catheter of the delivery system  260 . 
     The crimping accessory  600  includes at least one nozzle  610 , a fluid chamber  620 , and an aperture  621 , as shown in  FIG.  6 C . The fluid chamber  620  fluidly connects the at least one nozzle  610  to the aperture  621  disposed on an outer surface of the body  605 . In the embodiment shown, the fluid chamber  620  is annular and disposed radially outward from the channel  630  configured to house the shaft  263  of the balloon catheter of the delivery system  260 . The aperture  621  is configured to receive the tubing  680 , the tubing  680  being configured to connect the crimping accessory  600  to a suction source  685 , as can be seen in  FIG.  6 A . In the embodiment shown, the body  605  contains a singular, annular nozzle  610  configured to remove, or suction, air from the crimper chamber  255  of the crimper  250 . The crimping accessory  600  also includes an O-ring or seal  640  on the first end  601  of the body  605 . When a suction force is applied via the suction source  685 , the applied suction force pulls the crimping accessory  600  into sealing engagement with an outer surface of the crimper  250 . The seal  640  is configured to seal the crimping accessory  600  to the outer surface of the second end  252  of the crimper  250  such that the crimping accessory  600  is held airtight to the crimper  250  during the entire crimping process. When the crimping accessory  600  removes the air in the crimper chamber  255  from the second end  252  of the crimper  250 , each leaflet  128  is held in a substantially closed state when the crimper  250  is radially compressing the transcatheter heart valve prosthesis  125  into the crimped configuration. 
     A method of crimping the transcatheter heart valve prosthesis  125  using the crimping accessory  600  is disclosed herein. Referring to  FIG.  6 A , the transcatheter heart valve prosthesis  125  is first loaded onto the balloon of the delivery system  260  in an expanded configuration. The assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  is then loaded into the crimper chamber  255  of the crimper  250 . The crimping accessory  600  is then disposed over the distal end  262  of the shaft  263  of the delivery system  260 . When a suction force is applied via the suction source  685 , the applied suction force pulls the crimping accessory  600  onto the outer surface of the crimper  250  such that the crimping accessory  600  is sealed airtight to the outer surface of the second end  252  of the crimper  250 . When the crimper  250  operates to radially compress the transcatheter heart valve prosthesis  125  into a crimped configuration, the crimping accessory  600  removes, or suctions, air from the crimper chamber  255  of the crimper  250  during the crimping process without directly contacting the leaflets  128  of the transcatheter heart valve prosthesis  125 . The annular nozzle  610  of the crimping accessory  600  allows the removed air to be substantially annular. The arrows in  FIG.  6 C  represent a fluid path 670 within the crimping accessory  600  such that the air is removed from the crimper chamber  255  of the crimper  250  and enters the crimping accessory  600  through the annular nozzle  610 . The suction, or removal, of air from the second end  252  of the crimper  250  results in atmospheric pressure pushing against the exterior surfaces of the leaflets  128  and thereby causes the leaflets  128  into a substantially closed state against the shaft  263  of the delivery system  260 . 
     The removal of air from the second end  252  of the crimper chamber  255  of the crimper  250  during the crimping process holds the at least one leaflet  128  in the substantially closed position against the shaft  263  of the delivery system  260  while the crimper  250  radially compresses the transcatheter heart valve prosthesis  125 , minimizing the risk of the leaflets  128  protruding through the frame  126  and causing pinching or damage to the leaflets  128 . When the transcatheter heart valve prosthesis  125  is fully crimped onto the delivery system  260 , the crimping accessory  600  may be removed from the shaft  263  of the delivery system  260  and the second end  252  of the crimper  250 , and the assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  may be removed from the crimper chamber  255  of the crimper  250 . 
     It should be understood that the crimping accessory  600  described herein could be used in conjunction with any embodiments described above such that the crimping accessory  600  vacuums, or removes, the pressurized fluid being applied by the previously mentioned crimping accessories. In such a configuration, a crimping accessory described previously applies pressurized fluid to the leaflets  128  of the transcatheter heart valve prosthesis  125  from the first end  251  of crimper  250 , while the crimping accessory  600  described herein removes, or suctions out, the pressurized fluid from the second end  252  of the crimper  250  such that the leaflets  128  are radially displaced into the substantially closed state against the delivery system  260 , further minimizing the risk of leaflet protrusion and damage. 
       FIGS.  7 A- 7 C  show a crimping accessory  700  according to embodiments herein. As compared to the crimping accessories described above, the crimping accessory  700  described herein is configured to be used in between the steps of partially crimping the transcatheter heart valve prosthesis  125  and fully crimping the transcatheter heart valve prosthesis  125 . The transcatheter heart valve prosthesis  125  is partially crimped with the crimper  250 , then the assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  is inserted into the crimping accessory  700  such that pressurized fluid is applied radially to the at least one leaflets  128  of the transcatheter heart valve prosthesis  125 , and then the assembly is reinserted into the crimper chamber  255  of the crimper  250  such that the transcatheter heart valve prosthesis  125  may be fully crimped onto the delivery system  260 , as described in more detail below. 
     As shown in  FIGS.  7 A- 7 C , the crimping accessory  700  includes a body  705 , a first end  701 , and a second end  702 . The first end  701  and the second end  702  of the crimping accessory  700  are substantially circular in shape. The first end  701  has a first circumference larger than a second circumference of the second end  702 . The crimping accessory  700  includes a channel  730  configured to receive the transcatheter heart valve prosthesis  125  mounted on the balloon of the delivery system  260 . The channel  730  extends an entire longitudinal length of the crimping accessory  700 , extending from the first end  701  to the second end  702  of the body  705 . The channel  730  has a substantially circular cross-section. 
     The crimping accessory  700  includes at least one nozzle  710 , a fluid chamber  720 , and an aperture  721 , as shown in  FIG.  7 A . The fluid chamber  720  fluidly connects the at least one nozzle  710  to the aperture  721  disposed on an outer surface of the body  705 . In the embodiment shown, the fluid chamber  720  is annular and disposed radially outward from the channel  730  configured to house the transcatheter heart valve prosthesis  125  on the delivery system  260 . The aperture  721  is configured to receive a tubing  280 , the tubing  280  being configured to provide fluid from the fluid source  285  to the at least one nozzle  710 . In the embodiment shown, the body  705  contains three nozzles  710  configured to apply pressurized fluid radially to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125 . In some embodiments, the transcatheter heart valve prosthesis  125  includes exactly three leaflets  128  and the crimping accessory  700  includes exactly three nozzles  710 . In such embodiments, each nozzle  710  is configured to apply fluid to a leaflet  128  of the exactly three leaflets  128 . Each nozzle  710  is aligned with a center of each leaflet  128  such that when the pressurized fluid is applied, each leaflet  128  is displaced radially inward and may be held in a substantially closed state against the delivery system  260 . In this embodiment, the three nozzles  710  are equally and circumferentially spaced apart from each other, as best shown in  FIG.  7 B . 
     A method of crimping a transcatheter valve prosthesis onto a delivery system utilizing the crimping accessory  700  is disclosed herein.  FIG.  8    is a block diagram outlining the steps of a method  890  of utilizing the crimping accessory  700  described herein. In this embodiment, as shown in step  891  and step  892 , the transcatheter heart valve prosthesis  125  is loaded onto a balloon of the delivery system  260  in an expanded configuration and positioned within the crimper chamber  255  of the crimper  250 . The crimper  250  is operated to radially compress the transcatheter heart valve prosthesis  125  on the balloon of the delivery system  260  into a partially crimped configuration as shown in step  893 . The assembly of the partially crimped transcatheter heart valve prosthesis  125  and the delivery system  260  is then removed from the crimper  250  and placed within the channel  730  of the crimping accessory  700  as shown in step 894. When the transcatheter heart valve prosthesis  125  is placed within the channel  730  of the crimping accessory  700 , the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  is preferably aligned with the at least one nozzle  710  of the crimping accessory  700 . The crimping accessory  700  then applies pressurized fluid radially to the at least one leaflet  128  of the transcatheter heart valve prosthesis  125  such that the at least one leaflet  128  is displaced radially inward and may be held in a substantially closed state against the balloon catheter of the delivery system  260  as shown in step 895. The assembly of the transcatheter heart valve prosthesis  125  and the delivery system  260  is then removed from the crimping accessory  700  and placed back into the crimper chamber  255  of the crimper  250  as shown in step 896. The crimper  250  is then operated to further radially compress the transcatheter heart valve prosthesis  125  into a fully crimped configuration on the delivery system  260  as shown in step  897 . The fully crimped transcatheter heart valve prosthesis  125  on the balloon catheter of the delivery system  260  may then be removed from the crimper  250  and is prepared for delivery within a vasculature. 
     It should be understood that the crimper  250  described herein 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 crimpers can be used with the leaflet accessory tools and methods described herein. Other non-limiting examples of crimpers that can be used with the leaflet accessory tools described herein are described in U.S. App. No. 17/394,025, filed Aug. 4, 2021, which is incorporated by reference herein in its entirety. In an embodiment, the crimper  250  is an iris-style crimper that includes a plurality of crimper elements which define the crimper chamber  255 , with each of the crimper elements including a surface that forms a portion of the crimper chamber  255 . A volume of the crimper chamber  255  is decreased in order to radially compress the transcatheter heart valve prosthesis  125  into a crimped configuration on the delivery system  260 . 
     It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.