Loading system for an implantable medical device

Abstract

A loading system for loading a heart valve prosthesis into a delivery system includes a loading cone, a loading ring, and a valve seat. The loading cone includes a passageway extending therethrough, wherein the passageway includes a tapered portion. The loading ring is configured to be coupled to the loading cone. The valve seat is configured to be coupled to the loading ring. The valve seat is rotatable relative to the loading ring when the valve seat and the loading ring are coupled together. The valve seat is configured to receive a heart valve prosthesis.

Description

Technical Field

[0001] The present technology generally relates to loading systems and methods for loading medical devices into delivery devices. Background Art

[0002] Transcatheter implantable medical devices (such as heart valve prostheses, stents, scaffolds, and other interventional devices) are loaded into a delivery device (such as a catheter) for delivery to a treatment site within the patient's vascular system. Some implantable medical devices that contain organic tissue (e.g., organic tissue from cattle and pigs) need to be installed on-site on the delivery device. Therefore, it is desirable to make the loading of implantable medical devices onto the delivery device as easy as possible. Further, in some cases, some current commercial systems may be subject to undesirable events during loading, such as valve inversion, valve infolding, and / or crown overlap. Therefore, it is desirable to minimize the occurrence of such undesirable events. Summary of the invention

[0003] In examples herein, a loading system for loading a heart valve prosthesis into a delivery system includes: a loading cone; a loading ring configured to be coupled to the loading cone; and a valve seat configured to be coupled to the loading ring. The loading cone includes a passage extending therethrough, the passage including a tapered portion. When the valve seat and the loading ring are coupled together, the valve seat can rotate relative to the loading ring. The valve seat is configured to receive the heart valve prosthesis.

[0004] In another example herein, the loading system of any of the previous or subsequent examples further includes a balloon guide tube, wherein a distal end of the balloon guide tube is configured to be disposed adjacent to a proximal end of the loading cone.

[0005] In another example herein, the loading system of any of the previous or subsequent examples further includes a tip guide tube configured to extend through the loading ring, the valve seat, and the loading cone.

[0006] In another example herein, in the loading system of any of the previous or subsequent examples, the tapered portion of the passageway tapers in a proximal direction such that a distal end of the tapered portion has a larger diameter than a proximal end of the tapered portion.

[0007] In another example herein, in the loading system of any of the previous or subsequent examples, the tapered portion of the passage tapers at a taper angle of about 15 degrees to about 30 degrees, or about 15 degrees to about 250 degrees, about 18 degrees to about 22 degrees, or about 20 degrees.

[0008] In another example herein, in the loading system of any of the previous or subsequent examples, the loading cone includes a plurality of ribs extending inwardly from an inner surface of the loading cone.

[0009] In another example herein, in the loading system of any of the previous or subsequent examples, the loading ring includes a base and a central passage extending through the base.

[0010] In another example herein, in the loading system of any of the previous or subsequent examples, the loading ring further includes a slot configured to receive a corresponding locking arm of the loading cone to rotationally couple the loading ring and the loading cone.

[0011] In another example herein, in the loading system of any of the previous or subsequent examples, the slot is defined by an inner wall, an outer wall, and a radially extending side wall connecting the inner wall to the outer wall.

[0012] In another example herein, in the loading system of any of the previous or subsequent examples, the slot includes a plurality of slots, and wherein the loading cone includes a plurality of locking arms corresponding to the plurality of slots, wherein each slot extends circumferentially around a portion of a circumference of a base of the loading ring, and wherein the plurality of locking arms rotate relative to the plurality of slots to enable the loading cone to rotate relative to the loading ring.

[0013] In another example herein, in the loading system of any of the previous or subsequent examples, the valve seat includes: a seat base having a central orifice extending therethrough; a wall extending from the periphery of the seat base in a first direction; and an orifice wall extending from the periphery of the central orifice in a second direction opposite to the first direction, wherein the orifice wall is configured to be disposed in a central passage of a loading ring so that the valve seat can rotate relative to the loading ring.

[0014] In another example herein, in the loading system of any of the previous or subsequent examples, a seat base and a wall of the valve seat are configured to receive a heart valve prosthesis.

[0015] In another example herein, in the loading system of any of the previous or subsequent examples, a wall of the valve seat includes a plurality of ribs configured to assist the valve seat in engaging the heart valve prosthesis such that rotation of the valve seat causes a corresponding rotation of the heart valve prosthesis.

[0016] In another example herein, in the loading system of any of the previous or subsequent examples, the seat base includes a plurality of recesses configured to receive a crown at a first end of a frame of a heart valve prosthesis such that rotation of the valve seat causes a corresponding rotation of the heart valve prosthesis.

[0017] In another example herein, in the loading system of any of the previous or subsequent examples, the wall of the valve seat includes two wall segments separated by two wall grooves, wherein radially inward compression of the orifice wall causes the two wall segments to radially open outward to receive the heart valve prosthesis therein.

[0018] In another example herein, in the loading system of any of the previous or subsequent examples, the seat base of the valve seat further includes a living hinge configured to enable the seat base to bend to enable the two wall segments to open.

[0019] In another example herein, in the loading system of any of the previous or subsequent examples, the loading cone, the loading ring, and the valve seat are configured to receive a heart valve prosthesis therein, and when the loading cone, the loading ring, and the valve seat are coupled together and the heart valve prosthesis is loaded therein, the loading cone, the valve seat, and the heart valve prosthesis are configured to rotate relative to the loading ring.

[0020] In another example herein, in the loading system of any of the previous or subsequent examples, the orifice wall of the valve seat includes a circumferential lip such that the circumferential lip inhibits longitudinal movement between the valve seat and the loading ring when the valve seat is coupled to the loading ring.

[0021] In another example herein, in the loading system of any of the previous or subsequent examples, the loading cone is non-rotatably coupled to the loading ring.

[0022] In another example herein, in the loading system of any of the previous or subsequent examples, the loading cone, loading ring, and valve seat are configured to receive a heart valve prosthesis therein, and when the loading cone, loading ring, and valve seat are coupled together and the heart valve prosthesis is loaded therein, the valve seat and the heart valve prosthesis are configured to rotate relative to the loading ring and loading cone.

[0023] In another example herein, the loading system of any of the previous or subsequent examples further includes a tip guide tube configured to engage an inner surface of an orifice wall of the valve seat, wherein rotation of the tip guide tube rotates the valve seat relative to the loading ring.

[0024] In another example herein, in the loading system of any of the previous or subsequent examples, the tip guide tube includes a plurality of ridges configured to engage a corresponding plurality of grooves in the orifice wall of the valve seat to rotatably engage the tip guide tube with the valve seat.

[0025] In another example herein, a method for loading a heart valve prosthesis into a delivery system includes: sliding a balloon guide tube onto the delivery system so that the distal end of the balloon guide tube is adjacent to the open distal end of the balloon of the delivery system; coupling a loading ring and a valve seat together so that the valve seat can rotate relative to the loading ring; loading the heart valve prosthesis into the valve seat; with the valve seat fixed to the loading ring and the heart valve prosthesis disposed in the valve seat, fixing a loading cone to the loading ring, thereby forming a loading system; loading the loading system into the delivery system system; rotating the valve seat and the heart valve prosthesis to align the heart valve prosthesis relative to the delivery system; connecting the heart valve prosthesis to the delivery system; translating the balloon distally to cover a portion of the heart valve prosthesis; and further translating the balloon distally so that the balloon and the balloon guide tube push the loading cone, the loading ring and the valve seat distally, and because the heart valve prosthesis is prevented from translating distally by being connected to the delivery system, the loading cone radially compresses the heart valve prosthesis, and the heart valve prosthesis leaves the proximal end of the loading cone and enters the open distal end of the balloon.

[0026] In another example herein, the method of any of the preceding or subsequent examples further includes securing the balloon guide tube to the balloon via friction.

[0027] In another example herein, the method of any of the previous or subsequent examples further includes inserting a tip guide tube through the loading ring, the valve seat, the transcatheter heart valve prosthesis, and the loading cone such that a proximal end of the tip guide tube extends proximal to a proximal end of the loading cone.

[0028] In another example herein, in a method of any of the previous or subsequent examples, the loading system further includes a tip guide tube inserted through the loading ring, the valve seat, the heart valve prosthesis, and the loading cone, wherein loading the loading system onto the delivery system includes inserting the distal tip of the delivery system into the proximal end of the tip guide tube and advancing the loading system proximally toward the sac.

[0029] In another example herein, in the method of any of the preceding or subsequent examples, rotating the valve seat and the heart valve prosthesis includes rotating the tip guide tube to rotate the valve seat, thereby rotating the heart valve prosthesis loaded into the valve seat.

[0030] In another example herein, in the method of any of the preceding or subsequent examples, the loading cone is non-rotatably coupled to the loading ring such that rotating the valve seat and the heart valve prosthesis does not rotate the loading cone.

[0031] In another example herein, in the method of any of the preceding or subsequent examples, the loading cone is rotatably coupled to the loading ring, wherein rotating the valve seat and the heart valve prosthesis includes rotating the loading cone to rotate the heart valve prosthesis and the valve seat.

[0032] In another example herein, the method of any of the preceding or subsequent examples further comprises withdrawing the tip guide tube from the loading cone, the heart valve prosthesis, the valve seat, and the loading ring before translating the balloon distally to cover a portion of the heart valve prosthesis.

[0033] In another example herein, in a method of any of the previous or subsequent examples, a valve seat comprises: a seat base having a central orifice extending therethrough; a wall extending from a periphery of the seat base in a first direction; and an orifice wall extending from a periphery of the central orifice in a second direction opposite to the first direction, wherein coupling the valve seat to the loading ring comprises: inserting the orifice wall into a central passage of the loading ring so that the valve seat can rotate relative to the loading ring.

[0034] In another example herein, in the method of any preceding or subsequent examples, loading the heart valve prosthesis into the valve seat includes inserting a portion of the heart valve prosthesis into a wall of the valve seat.

[0035] In another example herein, in the method of any of the previous or subsequent examples, the seat base includes a plurality of recesses, wherein loading the heart valve prosthesis into the valve seat includes inserting a crown at a first end of a frame of the heart valve prosthesis into the plurality of recesses.

[0036] In another example herein, in a method of any of the previous or subsequent examples, the wall of the valve seat includes two wall segments separated by two wall grooves, wherein loading the heart valve prosthesis into the valve seat includes: radially pressing the orifice wall radially inward to cause the two wall segments to expand radially outward; inserting the heart valve prosthesis into the two wall segments in the expanded state; and releasing the orifice wall to restore the two wall segments to a non-expanded state.

[0037] In another example herein, in a method of any of the previous or subsequent examples, the seat base of the valve seat further includes a living hinge, wherein squeezing the orifice wall causes the seat base to bend at the living hinge, and wherein, when the orifice wall is released, the living hinge causes the seat base to return to an unbent state.

[0038] In another example herein, in the method of any preceding or subsequent examples, coupling the heart valve prosthesis to the delivery system includes inserting tabs of a frame of the heart valve prosthesis into tab pockets of a main shaft of the delivery system. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The foregoing and other features and advantages of the present disclosure will become apparent from the following description of the embodiments herein as shown 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 those skilled in the relevant art to make and use the embodiments of the present disclosure. The drawings are not drawn to scale.

[0040] Figure 1A Depicted is an exploded perspective view of a loading system for use with a medical device according to embodiments herein.

[0041] Figure 1B Describes the embodiment according to the present invention Figure 1A Cross-sectional illustration of the loading system.

[0042] Figure 2 Depicts the connected Figure 1A and Figure 1B Outflow cone and loading ring of the loading system.

[0043] Figure 3A and Figure 3B Describes the embodiment according to the present invention Figure 1A and Figure 1B Illustration of the loading ring of the loading system.

[0044] FIG. 4A to FIG. 4C Describes the embodiment according to the present invention Figure 1A and Figure 1B Illustration of the valve seat of the loading system.

[0045] Figure 5 Depicted is an illustration of an example transcatheter heart valve prosthesis that can be radially compressed and loaded into a delivery system using the loading systems described herein.

[0046] Fig. 6A and Figure 6B Depicted is a diagram of an example delivery system into which a heart valve prosthesis may be loaded using the loading systems disclosed herein.

[0047] Figure 7 Describes the Fig. 6A and Figure 6B 2 is an illustration of an example loading tray of an example delivery system for loading a transcatheter heart valve prosthesis using the loading system described herein.

[0048] FIG. 8A to FIG. 8Y Several illustrations are depicted of methods of loading a transcatheter heart valve prosthesis into a delivery system using the loading systems disclosed herein.

[0049] Fig. 9 Depicted is a longitudinal cross-sectional illustration of a loading system including an internal loading cone support.

[0050] Fig.10 Depicted include Fig. 9 Side cross-sectional illustration of a loading system with an inner loading cone support.

[0051] Figures 11 to 13 Depicted in FIG. 8A to FIG. 8Y Figure 1. Various stages of the method. Compliant outlet of the loading cone of the loading system.

[0052] Fig.14 Depicted is an exploded perspective view of a loading system for use with a medical device according to embodiments herein.

[0053] Fig.15 Describes the embodiment according to the present invention Fig.14 Cross-sectional illustration of the loading system.

[0054] FIG. 16A to FIG. 16D Describes the embodiment according to the present invention Fig.14 Illustration of the balloon guide catheter of the loading system.

[0055] FIG. 17A to FIG. 17B Describes the embodiment according to the present invention Fig.14 Illustration of the loading cone of a loading system.

[0056] FIG. 18A to FIG. 18B Describes the embodiment according to the present invention Fig.14 Illustration of the loading ring of the loading system.

[0057] FIG. 19A to FIG. 19B Describes the embodiment according to the present invention Fig.14 Illustration of the valve seat of the loading system.

[0058] Fig. 20 Describes the embodiment according to the present invention Fig.14 Exploded view of the loading ring, valve seat and loading cone of the loading system.

[0059] Fig.21 Depicted Fig.14 Cross-sectional illustration of the assembled loading cone, loading ring and valve seat of the loading system.

[0060] Fig. 22 Describes the embodiment according to the present invention Fig.14 A three-dimensional illustration of the tip guide tube of the loading system.

[0061] Fig.23 Describes the embodiment according to the present invention Fig.14The valve seat interaction of the loading system Fig. 22 A three-dimensional illustration of the tip guide tube.

[0062] Fig.24 Depicted is a perspective view of a valve seat according to embodiments herein.

[0063] Fig.25 Describes the embodiment according to the present invention Fig.24 Cross-sectional view of the valve seat.

[0064] Fig.26 Describes the embodiment according to the present invention Fig.25 A cross-sectional view of a valve seat of FIG. 1 , wherein a wall section of the valve seat is in an expanded state.

[0065] Fig. 27 Depicted is a top perspective view of a valve seat according to embodiments herein.

[0066] Fig.28 Depicted Fig. 27 A bottom perspective view of the valve seat.

[0067] Fig.29 Depicted Fig. 27 Top view of the valve seat

[0068] Fig.30 Depicted Fig. 27 Side view of the valve seat.

[0069] Fig.31 Depicted is a top perspective view of a valve seat according to embodiments herein.

[0070] Fig.32A Depicted is a perspective view of a valve seat according to embodiments herein.

[0071] Fig.32B Depicted Fig.32A Cross-sectional view of the valve seat.

[0072] Fig.33A Depicted is a perspective view of a portion of a valve seat including a protrusion extending from an inner surface of a wall segment thereof.

[0073] Fig.33A Depicted is a perspective view of a portion of a valve seat including a protrusion extending from an inner surface of a wall segment thereof.

[0074] Fig.34A Depicted is a side view of a tip guide tube according to embodiments herein.

[0075] Fig.34B Depicted Fig.34A Perspective of the tip of the guide tube.

[0076] Fig.35A Depicted is a perspective view of a tip guide tube according to embodiments herein.

[0077] Fig.35B Depicted Fig.35A Side view of the tip of the guide tube.

[0078] Fig.36A Depicted is a perspective view of a tip guide tube according to embodiments herein.

[0079] Fig.36B Describes the use of Fig.36A A cross-sectional view of a portion of a valve seat used in conjunction with a tip guide tube.

[0080] Fig.36C Shown with Fig.36B The valve seat interacts Fig.36A A cross-sectional view of a portion of the tip guide tube.

[0081] Fig.37 Depicted is a side view of a portion of a tip guide tube according to embodiments herein.

[0082] Fig.38A Depicted is a perspective view of a tip guide tube according to embodiments herein.

[0083] Fig.38B Depicts the interaction with the valve seat Fig.38A Stereoscopic view of the tip guide tube.

[0084] Fig.38C Depicts the interaction with the valve seat Fig.38A Close-up side view of the tip of the guide tube.

[0085] Fig.39A Depicted is a side view of a tip guide tube according to embodiments herein.

[0086] Fig.39B Depicted Fig.39A Perspective of the tip of the guide tube.

[0087] Fig.40A Depicted is a perspective view of a tip guide tube according to embodiments herein.

[0088] Fig.40B Describes the Fig.40A A stereoscopic view of the tip guide tube loading system.

[0089] Fig.41A Depicted is a perspective view of a pusher for a loading system, according to embodiments herein.

[0090] Fig.41B Describes the Fig.41A Exploded view of the loading system of the pusher.

[0091] Fig.42A and Fig.42B Shown is a side view of a tip guide tube and loading ring according to embodiments herein.

[0092] Fig.43A and Fig.43B A longitudinal cross-sectional view of a tip guide tube including an internal spring according to embodiments herein is shown.

[0093] Fig.44A Shown is a perspective view of a tip guide tube including an external spring according to embodiments herein.

[0094] Fig.44B The embodiment of the present invention is shown as being arranged to pass through the loading system Fig.44A Cross-sectional view of the tip guide tube.

[0095] Fig.45A and Fig.45B Shown are perspective and longitudinal cross-sectional views of a tip guide tube having a flared end according to embodiments herein.

[0096] Fig.46 Shown is a perspective view of a tip guide tube according to embodiments herein.

[0097] Fig.47 A side view of a tip guide tube including a resection port according to embodiments herein is shown.

[0098] Fig.48A A schematic diagram of a tip guide tube according to embodiments herein is shown.

[0099] Fig.48B FIG. 1 shows a loading ring interacting with a loading system according to an embodiment of the present invention. Fig.48A Schematic diagram of the tip guide tube.

[0100] FIG. 49A to FIG. 49E A balloon guide catheter according to embodiments herein is shown.

[0101] Fig.50A A perspective view of a balloon guide catheter according to embodiments herein is shown.

[0102] Fig.50B The embodiment according to this invention is shown Fig.50A The bladder is a portion of the tube that guides the barrel (tub).

[0103] FIG. 51A to FIG. 5 1C shows a cross-sectional view of a balloon guide catheter according to an embodiment of the present invention.

[0104] FIG. 52A to FIG. 52C A balloon guide catheter according to embodiments herein is shown.

[0105] FIG. 53A to FIG. 53C A perspective view of a balloon guide catheter according to embodiments herein is shown.

[0106] FIG. 54A to FIG. 54B A view showing a locking member of a balloon guide tube according to embodiments herein.

[0107] Fig.55 A perspective view of a locking member of a balloon guide tube according to embodiments herein is shown.

[0108] Fig.56 A perspective view of a locking member of a balloon guide tube according to embodiments herein is shown.

[0109] Fig.57 A perspective view of a loading cone of a loading system according to embodiments herein is shown.

[0110] Fig.58 A perspective view of a loading cone of a loading system according to embodiments herein is shown. DETAILED DESCRIPTION

[0111] Specific embodiments of the present disclosure are now described with reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements.

[0112] The following detailed description describes examples of embodiments and is not intended to limit the technology or the application and use of the technology. Although the description of the embodiments herein is in the context of a loading device for a transcatheter heart valve prosthesis, the technology can also be used in other devices. In addition, it is not intended to be bound by any express or implied theory presented in the preceding technical field, background technology, summary of the invention, or the following detailed description.

[0113] Figure 1A and Figure 1B An example of a loading system 100 according to an embodiment of the present invention is shown. Those skilled in the art will recognize that Figure 1A and Figure 1B shows an example of a loading system, and Figure 1A and Figure 1B Existing components shown in FIG. 1 may be removed and / or additional components may be added to the loading system 100. Figure 1A As shown in FIG. 1 , the loading system 100 includes a balloon guide tube 110, a loading cone 130, a loading ring 150, a valve seat 170, and a tip guide tube 180. Further, it should be noted that Figure 1A and Figure 1B In other words, the balloon guide tube 110 is drawn in the opposite direction. Figure 1Ais shown to the right of the loading cone 130, but in Figure 1B 1 is shown to the left of the loading cone 130. This is only a change in perspective, and the relative orientation of the parts with respect to each other does not change.

[0114] The balloon guide tube 110 is configured to be disposed on a balloon of a delivery system, as explained in more detail below. The balloon guide tube 110 includes a tube 111 having a first end 112, a second end 113, and a passage or lumen 114 extending from the first end 112 to the second end 113, as shown in FIG. Figure 1B . The balloon guide tube 110 further includes a grip 115 coupled to the exterior of the tube 111, and a locking member 116 configured to lock the balloon guide tube 110 to the balloon of the delivery system, as explained in more detail below. The locking member 116 is disposed around the tube 111 and includes a lock grip 117, and a lock tube 118 extending from the lock grip 117 toward the first end 112 of the balloon guide tube 110. The locking member 116 can slide over the tube 111 and exert a radially inward force on the tube 111 to lock the balloon guide tube 110 to the balloon of the delivery device, as explained in more detail below. Figure 1A A variation of the balloon guide tube 110 is shown, in which the grip 115 is combined with the lock grip 117. Further, Figure 1A The locking tube 118 of the embodiment extends from the grip / lock grip 115 / 117 in two directions toward the first end 112 and the second end 113 of the tube 111 . Figure 1A The locking tube 118 of the embodiment further includes a slit 120 between its portions. As explained above and in more detail below, Figure 1A and Figure 1B Both balloon guide tubes 110 lock onto the balloon of the delivery device.

[0115] like Figure 1BAs shown in , the first end 112 of the balloon guide tube 110 may include a shoulder 119 that is configured to interact with the second end of the loading cone 130 to prevent the tube 111 from extending into the loading cone 130 beyond a certain distance. The lumen 114 of the tube 111 of the balloon guide tube 110 between the shoulder 119 and its first end 112 is tapered in a direction away from the first end 112, so that the opening at the first end 112 is larger than the lumen 114 at the shoulder 119. This taper makes the first (distal) end 112 of the lumen of the balloon guide tube 110 larger, thereby allowing the distal end of the balloon of the delivery system to expand during the loading of the transcatheter heart valve prosthesis into the balloon. This reduces tissue compression during loading. Further, the expansion (flaring) of the distal end of the balloon can reduce the possibility that the crown of the transcatheter heart valve prosthesis is stuck to the distal end of the balloon during loading. Further, due to the lip 122 extending radially inwardly into the lumen 114, the lumen 114 at the shoulder 119 is smaller than the lumen 114 toward the second end 113 of the balloon guide tube 110, as shown in FIG. Figure 1B . Lip 122 acts as a ring gauge to prevent incorrect loading of a transcatheter heart valve prosthesis. In other words, the inner diameter of tube 111 of balloon guide tube 110 is nominally the same as the inner diameter of the balloon of the delivery system described below. Therefore, there is insufficient space for the tabs of the heart valve prosthesis to sit over the tab recesses of the main shaft of the delivery system. Thus, lip 122 minimizes the possibility of incorrect loading into the delivery system.

[0116] The loading cone 130 includes a body 145 including a first end 131, a second end 132, and a central passage 133 extending from the first end 131 to the second end 132. Figure 1A and Figure 1B . The loading cone 130 described herein is sometimes referred to as an outflow cone because it is used with the transcatheter heart valve prosthesis 200 described herein to replace a native aortic heart valve and is delivered via transcatheter (via the aorta), and the outflow portion of the transcatheter heart valve prosthesis 200 is initially loaded into the loading cone 130, as described in more detail below. However, this is not intended to be limiting, and for other devices, other native valves, and / or other delivery pathways, the inflow portion of the medical device may be initially loaded into the loading cone 130. The loading cone 130 may also be referred to as a funnel and / or a loading funnel.

[0117] The body 145 of the loading cone 130 includes a first cylindrical portion 134 adjacent to the first end 131, a second cylindrical portion 136 adjacent to the second end 132, and a tapered portion 135 disposed between the first cylindrical portion 134 and the second cylindrical portion 136. Although described as cylindrical portions, the first cylindrical portion 134 and the second cylindrical portion 136 need not be cylindrical and may be other similar shapes. In the illustrated embodiment, both the outer surface and the central passage 133 in the tapered portion 135 are tapered. However, this is not intended to be limiting, and only the central passage 133 of the tapered portion 135 needs to be tapered. The tapered portion 135 tapers in a direction toward the second end 132 of the loading cone 130, such that the central passage 133 of the tapered portion 135 adjacent to the first cylindrical portion 134 is larger than the central passage 133 of the tapered portion 135 adjacent to the second cylindrical portion 136. The conical portion 135 of the central passageway tapers at a taper angle α of approximately 20 degrees. However, this is not intended to be limiting, and the taper angle α may be in the range of 15 to 30 degrees, or 15 to 25 degrees, or 18 to 22 degrees. This taper angle α is smaller than other loading cones on the market, thereby limiting potential damage to valve tissue during loading of the transcatheter heart valve prosthesis into the delivery system.

[0118] The loading cone 130 may also include vent holes 142 that are openings extending from an outer surface of the body 145 to a central passage 133 of the body 145 of the loading cone 130. In the illustrated embodiment, the body 145 includes a total of six vent holes 142 in its first cylindrical portion 134. However, this is not intended to be limiting, and more or fewer vent holes 142 may be utilized in appropriate locations of the body 145. In other embodiments, the body 145 does not include vent holes.

[0119] In the illustrated embodiment, the loading cone 130 further includes two locking arms 137 extending radially outward from and longitudinally toward the first end 131 of the body 145. In the illustrated embodiment, the two locking arms 137 are disposed 180 degrees apart from one another around the circumference of the body 145. Each of the locking arms 137 includes a support 138 extending radially outward from an outer surface of the body 145, and an arm 139 extending longitudinally from the support 138 toward the first end 131 of the body 145. Each arm 139 includes a distal portion (distal relative to the support 138) that tapers from a first thickness adjacent to the lip 141 to a second thickness at a distal end of the arm 139 that is less than the first thickness. In other words, the distal portion of each arm 139 includes a slope between the lip 141 and the distal end of the arm 139. The locking arms 137 are configured to couple the loading cone 130 with the loading ring 150, as described in more detail below.

[0120] As described above, loading system 100 further includes loading ring 150. Loading ring 150 is configured to be coupled to loading cone 130 and to seat transcatheter heart valve prosthesis 200 therein, such as Figure 1A , Figure 1B and Figure 2 As shown in FIG. 3A to FIG. 3B As shown in , the loading ring 150 includes a base 151, an outer wall 152 extending generally perpendicularly from the base 151, and an inner wall 153 extending generally perpendicularly from the base 151 in the same direction as the outer wall 152 but spaced radially inwardly therefrom. In the illustrated embodiment, the base 151 is substantially circular, and the outer wall 152 and the inner wall 153 are substantially cylindrical. The loading ring 150 further includes a platform 154 extending radially inwardly from the inner wall 153, opposite the base 151. The loading ring 150 further includes a central lumen or passage 155 extending from the platform 154 to the base 151. The cylindrical wall 156 defines the central passage 155.

[0121] Still reference Figure 3A and Figure 3B , the loading ring 150 further includes grooves 157, wherein each groove 157 is configured to receive a corresponding locking arm 137 of the loading cone 130 to rotationally couple the loading ring 150 and the loading cone 130. In the illustrated embodiment, there are two grooves 157 in the loading ring 150, corresponding to the two locking arms of the loading cone 130. Each groove 157 is defined by an inner wall 158, an outer wall 159, and a radially extending side wall 160 connecting the inner wall 158 to the outer wall 159. The inner wall 158 of each groove 157 includes a portion of the outer wall 152 of the loading ring 150 and continues to extend from the outer wall 152. In particular, the inner wall 158 of each groove 157 includes a portion of the outer wall 152 and extends upwardly (i.e., away from the base 151) therefrom. The outer wall 159 of each groove 157 is radially spaced outward from the inner wall 158 of each groove 157 relative to the central passage 155. Further, the inner wall 158 and the outer wall 159 of each slot 157 extend only partially around the circumference defined by the corresponding wall (if the wall extends circumferentially to define a complete circle). In particular, each inner wall 158 and each outer wall 159 can extend 40 degrees to 60 degrees around the circumference of such a circle. In other embodiments (not shown), the loading ring 150 can include a single continuous slot extending around the entire loading ring 150 instead of two slots 157. In other embodiments, the loading ring 150 can include more than two slots 157, such as three slots, four slots, or more than four slots. In some embodiments, the number of locking arms 137 of the loading cone 130 can match the number of slots 157 in the loading ring 150. In other embodiments, the number of locking arms need not match the number of slots 157.

[0122] In an embodiment, the load ring 150 has a first diameter D1 of about 40 mm to 45 mm defined by the outer wall 152. The load ring 150 has a second diameter D2 of about 42 mm to 46 mm defined by the outer wall 159 of the groove 157. Further, the outer wall 152 of the load ring 150 may have a height H1 of about 20 mm, the inner wall 158 and the outer wall 159 of the groove 157 may have a height H2 of about 50 mm, and the inner wall 153 of the load ring 150 may have a height of about 3.5 mm.

[0123] Figure 4A and Figure 4B An embodiment of a valve seat 170 of the loading system 100 is shown. The valve seat 170 includes a base 171 having a central orifice 173 and a wall 172 extending from a periphery of the base 171 in a first direction generally perpendicular to the base 171. The valve seat 170 further includes an orifice wall 174 extending from a periphery of the orifice 173 in a second direction opposite to the first direction and generally perpendicular to the base 171. A central passage 175 is defined by the orifice wall 174 and extends from the central orifice 173 of the base 171 in the second direction. The orifice wall 174 may include a lip 176 or similar feature to couple the valve seat 170 to the loading ring 150, as described in more detail below. In particular, the orifice wall 174 of the valve seat 170 extends through the central passage 155, the loading ring 150, until the lip 176 of the orifice wall 174 extends through the wall 156 defining the central passage 155, so that the lip 176 can prevent the valve seat 170 from moving longitudinally relative to the loading ring 150. However, the valve seat 170 can rotate relative to the loading ring 150 because the orifice wall 174 can rotate within the wall 156 of the loading ring 150. If the valve seat 170 and the loading ring 150 need to be separated from each other, the orifice wall 174 of the valve seat 170 can be squeezed radially inward (this can be facilitated by the groove 177 in the orifice wall 174) to enable the lip 176 to leave the end of the wall 156. The following description Fig. 8E The loading ring 150 and the valve seat 170 are shown coupled to each other.

[0124] Figure 4C Another embodiment of a valve seat 170' is shown. The valve seat 170' includes the same basic features of the valve seat 170, such as, but not limited to, a base 171' having a central orifice 173', a wall 172', and an orifice wall 174' defining a central passage 175'. Figure 4A and Figure 4BIn an embodiment of the present invention, the orifice wall 174' may include a lip (not shown) or similar features to couple the valve seat 170' to the loading ring 150. The valve seat 170' is shown herein to illustrate that the same loading cone 130, loading ring 150, tip guide tube 180, and sac guide tube 110 can be used with transcatheter heart valve prostheses of various sizes by changing the valve seat. However, only two examples of valve seats are provided, and other embodiments may also be used. By changing the features of the valve seat 170, such as but not limited to the height of the wall 172 and the diameter of the base 171, a variety of transcatheter heart valve prostheses can be loaded into the delivery system using the same sac guide tube 110, loading cone 130, loading ring 150, and tip guide tube 180.

[0125] Figure 2 The loading ring 150 is shown coupled to the loading cone 130 with the valve seat 170 coupled thereto (partially seen through the vent 142). To couple the loading cone 130 and the loading ring 150 together, the arms 137 of the loading cone 130 are disposed through the slots 157 of the loading ring 150. The loading cone 130 and the loading ring 150 are brought together such that the first end 131 of the body 145 of the loading cone 130 is disposed between the inner wall 153 and the outer wall 152 of the loading ring 150. The loading cone 130 and the loading ring 150 are brought together until the lip 141 of each locking arm 137 extends past the outer wall 159 of the corresponding slot 157, as shown. Figure 2 . This prevents longitudinal movement of the loading cone 130 relative to the loading ring 150, but allows rotational movement therebetween. Further, to disengage the loading cone 130 from the loading ring 150, the arms 139 can be pushed radially inwardly so that the lips 141 are radially inwardly of the outer wall 159 of the groove 157, thereby no longer preventing the loading cone 130 and the loading ring 150 from longitudinal movement away from each other.

[0126] As described above, the loading system 100 further includes a tip guide tube 180, such as Figure 1A and Figure 1B As shown in FIG. 1 , the tip guide tube 180 includes a tube 182 and a grip 184. Figure 1A and Figure 1B In the embodiment of the present invention, the tube 182 and the grip portion 184 are one-piece, however, this is not intended to be limiting. The tip guide tube 180 includes a first end 186 at the end of the grip portion of the tip guide tube 180, and a second end 188 opposite the first end 186. The tube 182 further includes a lumen 181 disposed at least partially therethrough (see Figure 8L). The lumen is configured to receive a distal tip of a delivery system during a loading process, as described below. The tube 182 is laterally sized (diameter) so that it fits through the central passage 175 of the valve seat 170. The tip guide tube 180 has a longitudinal length such that, with the loading cone 130 and the loading ring 150 coupled to each other and the grip 184 abutting the base 151 of the loading ring 150, the tube 182 extends through the loading ring 150 and the loading cone 130 so that its second end 188 protrudes from the second end 132 of the body 145 of the loading cone 130, as can be seen in FIG. Figure 8K Seen in.

[0127] Having described loading system 100, a brief description of an example transcatheter heart valve prosthesis 200 and delivery system 300 will be provided. Heart valve prosthesis 200 is merely an example heart valve prosthesis on which loading system 100 may be used to load heart valve prosthesis 200 into delivery system 300, which is also merely an example. Other heart valve prostheses and delivery systems may be used in conjunction with the loading system to radially compress and load such heart valve prostheses into such delivery systems.

[0128] like Figure 5 As shown in FIG. 1 , a transcatheter heart valve prosthesis 200 generally includes a radially expandable stent or frame 202, and a prosthetic valve 204. The frame 202 of the transcatheter heart valve prosthesis 200 supports the prosthetic valve 204 within the interior of the frame 202. Figure 5 In the example transcatheter heart valve prosthesis 200 shown in FIG, the frame 202 is self-expandable. However, this is not intended to be limiting, and the frame 202 may be balloon expandable or mechanically expandable. The transcatheter heart valve prosthesis 200 includes an inflow end 208 and an outflow end 210. Those skilled in the art will recognize that Figure 5 An example of a transcatheter heart valve prosthesis is shown, and Figure 5 Existing components shown in FIG. 20 may be removed and / or additional components may be added to transcatheter heart valve prosthesis 200 .

[0129] The prosthetic valve 204 includes at least one leaflet 206 disposed within and secured to the frame 202. Figure 5 In the exemplary embodiment shown in , the prosthetic valve 204 includes exactly three leaflets 206. However, this is not intended to be limiting, as the prosthetic valve 204 may include more or fewer leaflets 206. The valve leaflets 206 open and close to regulate flow through the transcatheter heart valve prosthesis 200. Adjacent prosthetic leaflets 206 are joined together at commissures 216, which are attached to the frame 202 to couple the prosthetic valve 204 to the frame 202.

[0130] like Figure 5 As shown in , the transcatheter heart valve prosthesis 200 includes an inflow end 208 and an outflow end 210. The prosthetic leaflets 206 are attached to the frame 202 so that when the pressure at the inflow end 208 exceeds the pressure at the outflow end 210, the prosthetic leaflets 206 open to allow blood to flow from the inflow end 208 through the heart valve prosthesis 200 to the outflow end 210. When the pressure at the outflow end 210 exceeds the pressure at the inflow end 208, the prosthetic leaflets 206 close to prevent blood from flowing from the outflow end 210 to the inflow end 208. The transcatheter heart valve prosthesis 200 may also include a skirt 218 coupled to the prosthetic leaflets 206 and the frame 202. In an embodiment, as shown in FIG. Figure 5 As shown in , skirt 218 is disposed adjacent inflow end 208 of transcatheter heart valve prosthesis 200 .

[0131] The frame 202 of the transcatheter heart valve prosthesis 200 further includes a plurality of struts 212 arranged to form a plurality of side openings or cells 214, which are arranged circumferentially around the longitudinal axis LA of the transcatheter heart valve prosthesis 200 and longitudinally to form a tubular structure defining the central lumen of the transcatheter heart valve prosthesis 200. The struts 212 are defined herein as elongated wire segments of the frame 202. The struts 212 gather together to form a crown or node 207. At the outflow end 210 of the frame 202, the frame 202 includes two extending tabs 220 from the crown. In the illustrated embodiment, there are two tabs 220 spaced 180 degrees apart from each other around the circumference of the frame 202. However, this is not intended to be limiting, and there may be more or fewer tabs 220 distributed around the frame 202 as desired. As will be explained in more detail below, tabs 220 are used to couple frame 202 to delivery system 300. Tabs 220 may also be radiopaque to assist in visualization of frame 202 during delivery and deployment of transcatheter heart valve prosthesis 200.

[0132] Fig. 6A and Figure 6B An example delivery system 300 for a self-expanding transcatheter heart valve prosthesis, such as transcatheter heart valve prosthesis 200, is shown. As described above, the delivery system is merely an example delivery system that can be used with the loading system 100 described above. Further, those skilled in the art will recognize that Fig. 6A and Figure 6B An example of a delivery system is shown, and Fig. 6A and Figure 6B Existing components shown in FIG. 300 may be removed and / or additional components may be added to the delivery system 300 .

[0133] The delivery system 300 includes a handle 302. The handle 302 enables the clinician to manipulate the distal portion of the delivery system 300, and includes actuators for moving multiple parts of the delivery system relative to other parts, such as an actuator 303 for moving the outer shaft 304 relative to the inner shaft 312. The distal portion of the outer shaft 304 (referred to as a sac 306) is configured to surround a transcatheter heart valve prosthesis during delivery to a treatment site (e.g., a native heart valve) and to be retracted from the transcatheter heart valve prosthesis to expose the transcatheter heart valve prosthesis so that it self-expands. The inner shaft 312 is coupled to the handle 302, and movement of the handle is converted into movement of the inner shaft 312 and the distal tip 308 coupled to the distal end of the inner shaft 312. The inner shaft 312 and the distal tip 308 can also translate relative to the outer shaft 304 and the handle 302 via a tip retractor. In the illustrated embodiment, intermediate member 314 is disposed between inner shaft 312 and outer shaft 304 and includes a retainer or main shaft 310 attached to a distal portion thereof for receiving tabs 220 of transcatheter heart valve prosthesis 200 .

[0134] In the illustrated embodiment, flush port 316 is disposed on handle 302. In the illustrated delivery system 300, when transcatheter heart valve prosthesis 200 is properly loaded into delivery system 300, certain relationships exist between features or features of transcatheter heart valve prosthesis 200 and delivery system 300 that may assist in predicting the proper rotational orientation of transcatheter heart valve prosthesis 200. In particular, when transcatheter heart valve prosthesis 200 is loaded into delivery system 300, as described in more detail below, tabs 220 are placed into tab recesses 318 of main shaft 310 that are spaced 180° apart from one another, as described below. Figure 8R One of the tabs 220 may include a C-shaped marking (sometimes referred to as a "C-shaped tab" or "C-shaped paddle") and may be aligned with one of the commissures 216 of the prosthetic valve 204. Further, when the transcatheter heart valve prosthesis 200 is loaded into the delivery system, the C-shaped tab 220 is located in a tab recess 318 that is aligned with the flushing port 316 on the handle 302 of the delivery system 300.

[0135] As noted above, this is a brief description of an example delivery system 300 . Fig. 6A and Figure 6B Other parts shown in are not described in detail herein and will be apparent to those skilled in the art.

[0136] Having described loading system 100, example transcatheter heart valve prosthesis 200, and example delivery system 300, reference will now be made to the exemplary embodiment of the present invention. Figure 7 as well as FIG. 8A to FIG. 8YA method of loading a transcatheter heart valve prosthesis 200 into a delivery system 300 using a loading system 100 is described. Figure 7 as well as FIG. 8A to FIG. 8Y Various operations that can be performed in the method are shown, but those skilled in the art will recognize that existing operations can be removed and additional operations can be added. Likewise, those skilled in the art will recognize that in some cases, the order of operations can be changed.

[0137] Figure 7 A storage and loading tray 350 is shown that can be used to transport and store the delivery system 300 and to load the transcatheter heart valve prosthesis 200 into the delivery system 300. Example storage and loading trays are described in U.S. Patent Nos. 8,584,849 and 9,486,604, which are incorporated herein by reference in their entirety. For the purposes of the methods described herein, the storage and loading tray 350 includes a reservoir 352 filled with a liquid 354 (such as chilled saline) for loading the transcatheter heart valve prosthesis 200 into the delivery system 300.

[0138] If you can Figure 7 3, the delivery system 300 is disposed in a loading tray 350, wherein the handle 302 of the delivery system 300 is disposed in a first portion of the loading tray 350, and the distal portion of the delivery system 300 (including the capsule 306 and the tip 308) is disposed in a reservoir 352 of the loading tray 350. Figure 7 As can be seen in FIG. 3 , the actuator 303 of the delivery system 300 is retracted, causing the capsule 306 of the delivery system 300 to be retracted from the tip 308, thereby exposing the main shaft 310. Figure 7 As seen in FIG. 1 , the portions of loading system 100 (including balloon guide tube 110, loading cone 130, loading ring 150, valve seat 170, and tip guide tube 180) are separated from one another in preparation for use. Further, transcatheter heart valve prosthesis 200 is seated in a cold saline bath in reservoir 352 so that its frame 202 becomes more pliable to be radially compressed by loading system 100. It should be noted that FIG. 8A to FIG. 8X The orientation of the loading system 100 shown in FIG. Figure 1A Consistent, but with Figure 1B The orientation shown in is opposite.

[0139] In the steps of the method, the balloon guide tube 110 is slid over the distal tip 308 of the delivery system 300 and moved proximally (see Fig. 8A ), until the second (distal) end 112 of the balloon guide tube 110 is adjacent to the distal end of the balloon 306, as shown in FIG. Fig. 8A and Figure 8BWith the balloon guide tube 110 in place, the locking member 116 of the balloon guide tube 110 moves distally (see Figure 8B ) to apply an inward force to tube 111 of balloon guide tube 110, which in turn applies a radially inward force to balloon 306 of delivery system 300, thereby securing balloon guide tube 110 to balloon 306 via friction, as shown in FIG. Figure 8C as shown in .

[0140] In another step of the method, the loading ring 150 and the valve seat 170 are coupled to each other by inserting the orifice wall 174 of the valve seat 170 into the central passage 155 of the loading ring 150, such as by Fig.8D As described above, the orifice wall 174 of the valve seat 170 is inserted until the lip 176 of the orifice wall 174 extends through the wall 156 defining the central passage 155 to secure the valve seat 170 to the loading ring 150. As described above, with the valve seat 170 and the loading ring 150 secured to each other, the valve seat 170 and the loading ring 150 can be rotated relative to each other. Fig. 8E The valve seat 170 and the loading ring 150 are shown secured to each other. One skilled in the art will appreciate that the valve seat 170 and the loading ring 150 may be secured to each other before or after the balloon guide tube 110 is secured to the balloon 306.

[0141] In another step of the method, the transcatheter heart valve prosthesis 200 is loaded into the valve seat 170 rotatably fixed to the loading ring 150, such as Figure 8F and Figure 8G As explained above, the order of operations of the described method is not intended to be limiting. Thus, for example, the transcatheter heart valve prosthesis 200 can be loaded into the valve seat 170 before the valve seat 170 is coupled to the loading ring 150. In the illustrated embodiment, the transcatheter heart valve prosthesis 200 is loaded into the valve seat 170 with the inflow end 208 of the transcatheter heart valve prosthesis 200 in contact with the base 171 of the valve seat 170. Further, the transcatheter heart valve prosthesis 200 can be slightly radially compressed by hand such that the inflow portion of the heart valve prosthesis is disposed radially inwardly of the wall 172 of the valve seat 170. The transcatheter heart valve prosthesis 200 and valve seat 170 combination can be rotatable relative to the loading ring 150, as determined by Figure 8F If you use Figure 24 to Figure 26 , the wall segments 672A, 672B are expanded prior to inserting the transcatheter heart valve prosthesis 200 into the valve seat 670, thereby eliminating the hand compression described above.

[0142] In another step of the method, with valve seat 170 secured to loading ring 150 and transcatheter heart valve prosthesis 200 disposed in valve seat 170, loading cone 130 and the loading ring are secured to each other, such as Figure 8H and Figure 8I . In particular, first end 131 (i.e., the larger diameter end) of loading cone 130 slides over transcatheter heart valve prosthesis 200 and toward loading ring 150 until arms 137 of loading cone 130 extend through respective slots 157, such that lips 141 of each of arms 137 extend through outer wall 159 of respective slots 157 and expand radially outward to couple loading cone 130 to loading ring 150. Those skilled in the art will recognize that the above description of sliding loading cone 130 toward loading ring 150 is not intended to be limiting, and that all that is required is relative movement between the two such that loading ring 150 can move toward loading cone 130, and / or both loading ring 150 and loading cone 130 can move toward each other. As loading cone 130 and loading ring 150 are secured to each other, the outflow portion of transcatheter heart valve prosthesis 200 is radially compressed by tapered portion 135 of loading cone 130. When loading cone 130 and loading ring 150 are fixed to each other, outflow end 210 of the transcatheter heart valve prosthesis protrudes from second end 132 (smaller diameter end) of loading cone 130. With loading cone 130 and loading ring 150 fixed to each other and transcatheter heart valve prosthesis 200 disposed within loading cone 130 and loading ring 150, the rotational orientation of heart valve prosthesis 200 can be adjusted by rotating loading cone 130 relative to loading ring 150 (which in turn rotates heart valve prosthesis 200 and valve seat 170 relative to loading ring 150).

[0143] In another step of the method, the tip guide tube 180 is inserted through the loading ring 150, the valve seat 170, the transcatheter heart valve prosthesis 200 and the loading cone 130, as shown in FIG. Figures 8J to 8L In particular, in this embodiment, with the loading cone 130 and the loading ring 150 fixed to each other, the second end 188 of the tip guide tube 180 is inserted into the central passage 175 of the valve seat 170, which is disposed within the central passage 155 of the loading ring 150, as shown in FIG. Figure 8I The second end 188 of the tip guide tube 180 continues to be advanced through the central passage 175 of the valve seat 170, through the central lumen of the transcatheter heart valve prosthesis 200 disposed within the loading cone 130, until the second end 188 of the tip guide tube 180 protrudes past the second end 132 of the loading cone 130, as shown in FIG. Figure 8K and Figure 8L As shown in Figure 8L, second end 188 of tip guide tube 180 prevents outflow end 210 of transcatheter heart valve prosthesis 200 from collapsing radially inward. In other words, second end 188 of tip guide tube 180 maintains outflow end 210 of transcatheter heart valve prosthesis 200 at an inner diameter that is substantially equal to the outer diameter of tube 182 of tip guide tube 180 at second end 188. This facilitates coupling tab 220 to tab pocket 318 of delivery system 300.

[0144] In the next step of the method, with the tip guide tube 180 disposed through the loading cone 130 coupled to the loading ring 150, the loading cone and the transcatheter heart valve prosthesis 200 disposed therein on the valve seat 170 are loaded onto the delivery system 300. In particular, the distal tip 308 of the delivery system 300 is inserted into the lumen 181 at the second end 188 of the tip guide tube 180, as shown in FIG. Figure 8M The loading system 100 is advanced toward the balloon 306 of the delivery system 300 until the second end 188 of the tip guide tube 180 is adjacent to the main shaft 310, as shown in FIG. Figure 8N as shown in .

[0145] In the next step of the method, tab 220 is placed in tab pocket 318 of main shaft 310. In particular, loading cone 130 is rotated as needed to rotate transcatheter heart valve prosthesis 200 as needed to align tab 220 with tab pocket 318. Further, tip guide tube 180 is slightly withdrawn as loading cone 130 / loading ring 150 is slightly advanced, and tab 220 is placed in tab pocket 318, as shown in FIG. Fig.8O and Figure 8P as shown in .

[0146] In the next step of the method, the tip guide tube 180 is completely removed from the loading cone 130 / loading ring 150, such as Figure 8Q Inspect transcatheter heart valve prosthesis 200 to ensure that tabs 220 are located in tab pockets 318 and that the crown at outflow end 210 is properly located at main axis 310, as shown in FIG. Figure 8R as shown in . Figure 8S The transcatheter heart valve prosthesis 200 is shown with the tab 220 positioned in the tab pocket 318 of the main shaft 310, with the sac 306 being proximal to the main shaft 310 and the loading cone 130, loading ring 150, and the remainder of the inflow end 208 of the transcatheter heart valve prosthesis 200 being distal to the main shaft 310.

[0147] In the next step of the method, the actuator 303 is rotated to advance the balloon distally (ie, toward the distal tip 308 of the delivery system). Figure 8Tand Figure 8U , the actuator 303 of the delivery system 300 rotates as indicated by the rotation arrow, which causes the balloon 306 of the delivery system 300 to translate distally, as indicated by Figure 8T and Figure 8U 318. As the balloon 306 is advanced distally, the balloon 306 first covers the tab 220 of the transcatheter heart valve prosthesis 200 located in the tab recess 318. As the balloon 306 continues to be advanced, the balloon 306 and the balloon guide tube 110 push the loading cone 130, the loading ring 150, and the valve seat 170 distally. Because the transcatheter heart valve prosthesis 200 is prevented from translating distally by the tab 220 disposed in the tab recess 318 of the main shaft 310, the loading cone 130 moves relative to the transcatheter heart valve prosthesis 200, so that the loading cone 130 radially compresses the transcatheter heart valve prosthesis 200. Further, as the loading cone 130 moves relative to the transcatheter heart valve prosthesis 200, the transcatheter heart valve prosthesis 200 leaves the second end 132 (i.e., the smaller diameter end) and enters the open distal end of the balloon 306. This actuation of actuator 303, distal advancement of balloon 306, distal translation of loading cone 130, radial compression of transcatheter heart valve prosthesis 200, and capture of transcatheter heart valve prosthesis 200 within balloon 306 continues until transcatheter heart valve prosthesis 200 is completely captured within balloon 306, as shown in FIG. Figure 8V The combination of the loading cone 130, the loading ring 150, and the valve seat 170 can then be removed from the distal tip 308 of the delivery system 300, as shown in FIG. Figure 8W as shown in .

[0148] In another step of the method, the balloon guide tube 110 may be unlocked and removed from the balloon 306 and removed distally over the distal tip 308 of the delivery system 300, as shown. Figure 8X In another step of the method, the actuator 303 is rotated, thereby causing the balloon 306 to translate distally until the distal end of the balloon 306 abuts the proximal portion of the distal tip 308, as shown in FIG. Figure 8Y Delivery system 300 (with transcatheter heart valve prosthesis 200 loaded into balloon 306 ) is ready for transluminal delivery of transcatheter heart valve prosthesis 200 to the site of a native heart valve and deployment of transcatheter heart valve prosthesis 200 from delivery system 300 .

[0149] Fig. 9 and Fig.10 A loading system 100 is shown with an inner loading cone support 190. Those skilled in the art will recognize that Fig. 9 and Fig.10 An example of an internal loading cone support is shown, and Fig. 9 and Fig.10 Components shown in the figure may be removed and / or additional components may be added to the inner loading cone support 190. The inner loading cone support 190 includes a first end 191 and a second end 192 opposite the first end 191. The first end 192 has a first lateral dimension (e.g., a first diameter) that is smaller than a second lateral dimension (e.g., a second diameter) at the second end 192 of the inner loading cone support 190. The inner loading cone support 190 includes a first portion 193 disposed adjacent to the first end 191 and a second portion 194 disposed adjacent to the second end 192. The first portion 193 includes a tapered outer surface 198 that tapers toward the first end 191 of the inner loading cone support 190.

[0150] The inner loading cone support 190 further includes a lumen 196 extending from the first end 191 to the second end 192. The lumen 196 is sized to receive the tube 182 of the tip guide tube 180 therein.

[0151] In use, the inner loading cone support 190 is disposed within the loading cone 130 such that the first end 191 of the inner loading cone support 190 is disposed adjacent to the second end 132 of the loading cone 130 and the second end 192 of the inner loading cone support 190 is disposed adjacent to the first end 131 of the loading cone 130. An annular lumen 199 is defined between an outer surface of the inner loading cone support 190 and an inner surface of the loading cone 130, such as Fig.10 The annular lumen 199 is configured to receive a heart valve prosthesis 200 ( Fig. 9 and Fig.10 not shown).

[0152] Inner loading cone support 190 provides an inner contoured surface (i.e., an outer surface of inner cone support 190) to produce a more linear compression of prosthetic valve 204 of transcatheter heart valve prosthesis 200 than would be achieved using a loading system 100 having a loading cone 130 without inner loading cone support 190 disposed within loading cone 130. In other words, the inclusion of inner loading cone support 190 avoids a more abrupt compression near second end 132 (the smaller diameter end) of loading cone 130. Fig. 9 shows the threshold diameter D C, where the cross-sectional area of ​​transcatheter heart valve prosthesis 200 (e.g., frame 202 and prosthetic valve 204) exceeds the cross-sectional area of ​​annular lumen 199. In the case of an empty loading cone 130 (i.e., without inner loading cone support 190), the location of the threshold diameter is closer to second (narrow) end 132 of loading cone 130. As explained above, this can produce rapid compression of transcatheter heart valve prosthesis 200 and potentially increase stress on prosthetic valve 204.

[0153] Using inner loading cone support 190, compression of prosthetic valve 104 may be initiated immediately once transcatheter heart valve prosthesis 200 is loaded into loading cone 130, even when transcatheter heart valve prosthesis 200 is at rest (i.e., before it is pulled through loading cone 130). As transcatheter heart valve prosthesis 200 is pulled through loading cone 130 with inner loading cone support 190, annular lumen 199 may be defined and used to control the rate of valve tissue compression, thereby avoiding abrupt changes or stresses on the tissue of prosthetic valve 204.

[0154] In an embodiment, the loading system 100 may include a compliance outlet 400 such as Figures 11 to 13 As shown in FIG. 4 , the compliant outlet 400 assists in loading the transcatheter heart valve prosthesis 200 into the delivery system 300. In particular, the compliant outlet 400 assists in loading the tab 220 of the transcatheter heart valve prosthesis 200 into the tab recess 318 of the main shaft 310 of the delivery system 300. Those skilled in the art will recognize that Figures 11 to 13 An example of a compliant outlet 400 is shown, and Figures 11 to 13 The components shown in FIG. 4 may be removed and / or additional components may be added to the compliant outlet 400 .

[0155] The compliant outlet 400 includes an annular base 402 at a first end 404 of the compliant outlet 400, with fingers 406 extending from the base 402 toward a second end 408 of the compliant outlet 400. The fingers 406 are separated by gaps 410 around the circumference of the compliant outlet 400. The compliant outlet 400 is configured to be coupled to the second (narrow) end 132 of the loading cone 130, such as Figures 11 to 134. Compliance outlet 400 follows the taper of loading cone 130, with fingers 406 of compliance outlet 400 extending past second end 132 of loading cone 130. Fingers 406 of compliance outlet 400 are more flexible than loading cone 130 and can therefore flex radially outward as outflow end 210 of transcatheter heart valve prosthesis 200 exits second end 132 of loading cone 130. This enables tabs 220 of transcatheter heart valve prosthesis 200 to be more easily loaded into tab pockets 318 of main shaft 310 of delivery system 300 than if second end 132 of loading cone 130 were located at the same position as second end 408 of compliance outlet 400. The less flexible second end 132 of loading cone 130 may force outflow end 210 of transcatheter heart valve prosthesis 200 radially inwardly, such that tabs 220 need to be manipulated to be placed in tab pockets 318. The use of compliant outlet 400 enables tabs 220 to be more radially outwardly, thereby assisting in placing tabs 220 in tab pockets 318.

[0156] Fig.11 Compliant outlet 400 and outflow end 210 of transcatheter heart valve prosthesis 200 are shown before tip guide tube 180 is positioned through loading cone 130 . Fig.12 Compliant outlet 400 is shown with tip guide tube 180 disposed through loading cone 130 and transcatheter heart valve prosthesis 200 . Fig.13 Compliant outlet 400 is shown after tip guide tube 180 has been withdrawn and with tabs 220 of transcatheter heart valve prosthesis 200 inserted into tab pockets 318 of main shaft 310 .

[0157] Those skilled in the art will recognize that while compliant outlet 400 is shown as described as a separate item coupled to loading cone 130, it may instead be a part of loading cone 130. For example, second end 132 of loading cone 130 may include fingers, such as finger 406, or may otherwise be made more flexible or compliant to assist in loading tab 220 into tab pocket 318.

[0158] Figures 14 to 23 Another embodiment of a loading system 500 according to embodiments herein is shown. Figure 4C As in the embodiment of the present invention, the loading system 500 includes a balloon guide tube 510, a loading cone 530 and a loading ring 550, as well as a valve seat 570 and a tip guide tube 580. Those skilled in the art will recognize that Figures 14 to 23 shows an example of a loading system, and Figures 14 to 23Existing components shown in FIG. 1 and FIG. 2 may be removed and / or additional components may be added to the loading system 500. Further, the various parts and features of the loading system 500 are similar to those described above with respect to FIGS. 1 to 2. Figure 4C Similar parts and features of the described loading system 100 are interchangeable. For example, and not by way of limitation, the tip guide tube 580 and valve seat 570 described with respect to the loading system 500 can be used with the rest of the loading system 100. Moreover, because the parts of the loading system 500 are similar to the like numbered parts of the loading system 100, the description of the loading system 500 will focus on the differences between the loading system 500 and the loading system 100.

[0159] As explained above, balloon guide tube 510 is configured to be disposed on a balloon of a delivery system. Fig.14 , Fig.15 and FIG. 16A to FIG. 16C As shown in , the balloon guide tube 510 includes a tube 511 having a first (distal) end 512, a second (proximal) end 513, and a passage or lumen 514 extending from the first end 512 to the second end 513. The balloon guide tube 510 further includes a grip 515 coupled to the exterior of the tube 511, and a locking member 516 configured to lock the balloon guide tube 510 to the balloon of the delivery system, as explained above. The locking member 516 is disposed around the tube 511 and includes a lock grip 517 and a lock tube 518.

[0160] FIG. 16A to FIG. 16C Some additional features of balloon guide tube 510 are shown that are not described above with respect to balloon guide tube 110. These features may also be added to balloon guide tube 110 as appropriate. In one example, internal ribs 611 protrude from the inner surface of tube 511, such as Fig.15 and Fig. 16B The internal ribs 611 are longitudinally spaced apart from each other and extend circumferentially individually (e.g. Fig.15 and Fig. 16B ) or extending at an angle (e.g., spirally) (as shown in Fig. 16C ). The internal ribs 611 distribute the forces during loading.

[0161] In another example, the balloon guide tube 510 includes a proximal bump 612 and a distal bump 613, such as Fig.16A and Fig. 16C. The proximal and distal tabs 612, 613 are used in conjunction with the locking member 516 to lock the locking member 516 in place at the distal end of the tube 511 in use, as described above. The illustrated embodiment includes four proximal tabs 612 equally distributed around the circumference of the tube 511 and four distal tabs 613 equally distributed around the circumference of the tube 511, but this is not intended to be limiting and other arrangements may be utilized.

[0162] The balloon guide tube 510 further includes an opening 614 adjacent to the second (proximal) end 513 of the tube 511, such as Fig.15 and Fig.16A The opening 614 is used for a corresponding protrusion 623 ( Fig.15 ) to couple the grip 515 to the tube 511. The second (proximal) end 513 of the tube 511 further includes a longitudinally extending groove 615. The groove 615 is configured to receive a longitudinal extension 622 extending from an inner surface of the grip 515. The groove 615 ensures that when the grip 515 is coupled to the tube 511, the tab 623 of the grip 515 is aligned with the opening 614 of the tube 511.

[0163] like Fig. 16B As shown in FIG. 1 , the tube 511 of the balloon guide tube 510 can be formed of two halves divided longitudinally. The two parts of the tube 511 can be coupled together via matching protrusions 616 and recesses 617. Thus, the protrusions 616 of one half of the tube 511 are aligned with and received by the corresponding recesses 617 in the other half of the tube 511, as shown in FIG. Fig. 16B Each of the halves of the tube 511 may further include a longitudinal recess 618 that aligns with a corresponding longitudinal recess 618 in the other half of the tube 511 to form a window 619 when the halves are coupled, as shown in FIG. Fig.16A Window 619 enables tube 511 to flex in the area of ​​window 619 .

[0164] Fig.16D An embodiment of a locking member 516 is shown. The locking member 516 includes a locking tube 518 extending from a proximal end 620 to a distal end 621 thereof. A lock grip 517 (such as a thumb grip / slide) is formed on the outer surface of the locking tube 518, between the proximal end 620 and the distal end 621. In an embodiment, the inner diameter of the locking tube 518 tapers from the proximal end 620 to the distal end 621. In a non-limiting example, the inner diameter at the proximal end 620 is about 10.10 mm, and the inner diameter at the distal end 621 is about 9.90 mm. Therefore, in the embodiment shown, it is a small taper.

[0165] Fig.17A and Fig. 17B A loading cone 530 according to embodiments herein is shown. Fig. 17B The loading cone 530 includes internal ribs 631 that are not included in the Fig.17A 530. The internal ribs 631 can reduce friction. As with the loading cone 130, the loading cone 530 includes a body 545 including a first (distal) end 531, a second (proximal) end 532, and a central passage 533 extending from the first end 531 to the second end 532. The internal ribs 631 can extend along the length of the tapered portion 535 of the body 545. However, this is not intended to be limiting, and in other embodiments, the internal ribs 631 can extend along only a portion of the tapered portion 535.

[0166] Similar to the loading cone 130, the loading cone 530 includes locking arms 537 for coupling the loading cone 530 to the loading ring 550, as explained in more detail below. The locking arms 537 of the loading cone 530 extend distally from the first (distal) end 531 of the body 545. In the illustrated embodiment, two locking arms 537 are disposed 180 degrees apart from each other around the circumference of the body 545. Each of the locking arms 537 extends longitudinally from the body 545 and has a distal portion that tapers from a first thickness adjacent to the lip 541 to a second thickness at the distal end of the arm 539 that is less than the first thickness. In other words, the distal portion of each arm 537 includes a slope between the lip 541 and the distal end of the arm 537. The locking arms 537 are configured to couple the loading cone 530 to the loading ring 550, as described in more detail below.

[0167] FIG. 18A to FIG. 18B 5 shows a loading ring 550 of the loading system 500. The loading ring 550 includes a generally cylindrical wall 552, a platform 554 extending inwardly from the wall 552, and a central lumen or passage 555 extending through the platform 554. The cylindrical wall 556 defines the central passage 555. Still referring to Fig.18A and Fig.18B, the loading ring 550 further has two recesses 551 extending longitudinally along the inner surface of the wall 552. The recesses 551 are sized and shaped to receive the locking arms 537 of the loading cone 530. The loading ring 550 further has grooves 557 disposed at the distal end of the recesses 551, wherein each groove 557 is configured to receive a corresponding locking arm 537 of the loading cone 530. The locking arms 537 extend through the grooves 557, and the lips 541 of the locking arms 537 engage the distal surface of the wall 552 to couple the loading cone 530 to the loading ring 550. In the illustrated embodiment, the grooves 557 are sized to enable the loading cone 530 to rotate relative to the loading ring 550, as described above with respect to the loading system 100. However, although the grooves 557 are sized to enable rotation, the locking arms 537 are disposed in the recesses 551, thereby preventing rotation. Further, in other embodiments, slot 557 may be sized such that loading cone 530 cannot rotate relative to loading ring 550. Thus, rotation of transcatheter heart valve prosthesis 200 for alignment may be accomplished by rotation of valve seat 570, as described below.

[0168] The loading ring 550 can further include a rib 652 extending proximally from the platform 554. The rib 652 extends circumferentially around the platform 554 to reduce friction between the valve seat 570 and the platform 554 during rotation of the valve seat 570 relative to the loading ring 550. Although a single circumferential rib 652 is shown, this is not intended to be limiting.

[0169] The load ring 550 may further include openings 654 for creating an air path.

[0170] Fig.19A and Fig.19B A valve seat 570 according to an embodiment herein is shown. Similar to the valve seat 170 described above, the valve seat 570 includes: a base 571 having a central orifice 573; and a wall 572 extending from the periphery of the base 571 along a first direction generally perpendicular to the base 571. The valve seat 570 further includes an orifice wall 574 extending from the periphery of the orifice 573 along a second direction opposite to the first direction and generally perpendicular to the base 571. The central passage 575 is defined by the orifice wall 574 and extends from the central orifice 573 of the base 571 along the second direction. The orifice wall 574 may include a lip 576 or similar feature to couple the valve seat 570 to the loading ring 550, as described above. The orifice wall 574 may also include a second lip 579 or similar feature adjacent to the base 571, as Fig.19B. The orifice wall 574 of the valve seat 570 is configured to extend through the central passage 555 of the loading ring 550 until the lip 576 of the orifice wall 574 extends through the wall 556 defining the central passage 555, so that the lip 576 can prevent the valve seat 570 from moving longitudinally relative to the loading ring 550. However, the valve seat 570 can rotate relative to the loading ring 550 because the orifice wall 574 can rotate within the wall 556 of the loading ring 550. If the valve seat 570 and the loading ring 550 need to be separated from each other, the orifice wall 574 of the valve seat 570 can be squeezed radially inward (which can be made easier by the groove 577 in the orifice wall 574) to enable the lip 576 to leave the end of the wall 556. The groove 577 in the orifice wall 574 also defines four sections of the orifice wall 574. The four wall sections of the aperture wall 574 are configured to be received within a recess of the tip guide tube 580 with the ribs of the tip guide tube 580 disposed in the grooves 577 as described in more detail below.

[0171] exist Fig.19A In the embodiment of the present invention, the valve seat 570 further includes ribs 578 extending along the wall 572. The ribs 578 extend inwardly and longitudinally from the wall 572, as distributed around the circumference of the wall 572. The ribs 578 assist the valve seat in engaging the transcatheter heart valve prosthesis 200, so that rotation of the valve seat 570 causes a corresponding rotation of the transcatheter heart valve prosthesis 200.

[0172] As with valve seat 170 described above, various sizes of valve seat 570 may be used so that the same balloon guide tube 510, loading cone 530, loading ring 550, and tip guide tube 580 may be used with various sizes of transcatheter heart valve prostheses by using different valve seats.

[0173] Fig. 20 The loading cone 530, the loading ring 550 and the valve seat 570 are shown separated from each other, and Fig.21 Loading cone 530 , loading ring 550 , and valve seat 570 are shown coupled to one another. When used to load transcatheter heart valve prosthesis 200 into a delivery system, transcatheter heart valve prosthesis 200 will be positioned on valve seat 570 within loading cone 530 and loading ring 550 .

[0174] Fig. 22 The tip guide tube 580 of the loading system 500 is shown. The tip guide tube 580 includes a tube 582 and a grip 584. The tube 582 includes a lumen 581 disposed at least partially through the tube and configured to receive the tip 308 of the delivery system 300, as described above with respect to FIG. Figure 8M Described. Fig. 22In the embodiment of the present invention, the tube 582 includes recesses 681 and ribs 682 arranged alternately around the outer surface of the tube 582. In the embodiment shown, there are four recesses 681 and four ribs 682, which correspond to the four portions of the orifice wall 574 and the four grooves 577 of the valve seat 570, respectively. The recesses 681 are sized and shaped to receive the four portions of the orifice wall 574, and the four ribs 682 are sized and shaped to extend through the four grooves 577, as shown in FIG. Fig.23 However, this is not limiting, and more or fewer recesses and ribs may be utilized to match more or fewer wall portions and grooves in the valve seat. Fig.23 As further shown in FIG. 5 , rotation of tip guide tube 580 imparts a corresponding rotation on valve seat 570, which can be rotated within loading ring 550. With transcatheter heart valve prosthesis 200 disposed in valve seat 570, such rotation also imparts a corresponding rotation of transcatheter heart valve prosthesis 200 to enable alignment of transcatheter heart valve prosthesis 200 with delivery system 300, as described above.

[0175] The method described above with respect to loading system 100 is substantially similar to the method used with respect to loading system 500. However, when the method described above refers to the rotation of transcatheter heart valve prosthesis 200 to align its tabs with the tab pockets, tip guide tube 580 will be rotated in place of loading cone 130 described above.

[0176] Figure 24 to Figure 26 A valve seat 670 according to embodiments herein is shown. Figure 24 to Figure 26 A schematic diagram of a valve seat 670 is shown. Those skilled in the art will recognize that other features may be added to Figure 24 to Figure 26 . For example and not by way of limitation, features described with respect to valve seat 170 and / or valve seat 570 may be included in valve seat 670. Similarly, features described below with respect to valve seat 670 may be incorporated into valve seat 170 and / or valve seat 570. In some embodiments, when transcatheter heart valve prosthesis 200 is manually radially compressed to insert transcatheter heart valve prosthesis 200 into the valve seat, transcatheter heart valve prosthesis 200 is over-compressed and then rebounds to contact the wall of the valve seat. Such compression and rebound may inadvertently introduce recoverable strain (i.e., pseudo-elasticity) into the frame of transcatheter heart valve prosthesis 200. Therefore, valve seat 670 includes a living hinge 679 that enables valve seat 670 to open to receive transcatheter heart valve prosthesis 200, as described below.

[0177] Similar to the valve seats 170, 570 described above, the valve seat 670 includes: a base 671 having a central orifice 673; and a wall 672 extending from the periphery of the base 671 along a first direction generally perpendicular to the base 671. In the illustrated embodiment, the wall 672 includes a slot 676 extending along the first direction, thereby dividing the wall 672 into two sections. In the illustrated embodiment, the wall 672 includes two sections 672A, 672B that are approximately semicircular, such that the wall 672 and the slot 676 define a circumference around the base 671. The base 671 further includes a living hinge 679 that extends from one of the slots 676 to the other of the slots 676 across the diameter of the base 671 while being interrupted by the central orifice 673, as shown in FIG. Fig.24 In the illustrated embodiment, the living hinge 679 is a channel in the first and second surfaces of the base 671, but other arrangements for enabling the wall 672 to be deployed or opened may also be used, as described below.

[0178] The valve seat 670 further includes an orifice wall 674 extending from the periphery of the orifice 673 in a second direction opposite to the first direction and substantially perpendicular to the base 671. The central passage 675 is defined by the orifice wall 674 and extends from the central orifice 673 of the base 671 in the second direction. The orifice wall 674 may include a FIG. 19A to FIG. 19B The orifice wall 674 may also include a second lip or similar feature adjacent to the base 671, such as Fig.19B as shown in . Figure 24 to Figure 26 The orifice wall 674 in the embodiment includes two grooves 677, which divide the wall 674 into two approximately semicircular wall segments 674A, 674B. The grooves 677 enable the wall segments 674A, 674B to be squeezed together to enable the lip (not shown) to leave the end of the wall 556, as described above.

[0179] However, in Figure 24 to Figure 26 In the embodiment of the present invention, the two wall sections 274A, 674B are squeezed together (such as by the living hinge 679 and the groove 676 that divides the wall 672 into two wall sections 672A, 672B). Fig.26 ) causes the wall segments 672A, 672B to open, as indicated by the arrows AA in the lower portion of Fig.26 In other words, when the wall segments 674A and 674B are not squeezed together, the wall segments 574A, 574B and 672A, 672B are substantially parallel to the central longitudinal axis CLA of the valve seat 670, as shown in FIG. Fig.26When the wall segments 674A, 674B are squeezed toward the central longitudinal axis CLA, the end portions 691 of the wall segments 672A, 672B opposite to the base 671 are expanded outwardly relative to the central longitudinal axis CLA, as shown in FIG. Fig.25 When the radially inward force on wall segments 674A, 674B is released, wall segments 674A, 674B and 672A, 672B return to Fig.25 Configuration.

[0180] The outward expansion of wall segments 672A, 672B enables transcatheter heart valve prosthesis 200 to be inserted into valve seat 670 without radially compressing frame 202 of transcatheter heart valve prosthesis 200. Therefore, when wall segments 674A, 674B are released, frame 202 is only radially compressed to create a friction fit with wall segments 672A, 672B, thereby restoring wall segments 672A, 672B to their original position. Fig.25 Thus, over-compression and subsequent springback of frame 202 are prevented. Instead, frame 202 is compressed once to an appropriate amount of compression to achieve a friction frit between transcatheter heart valve prosthesis 200 and wall 672 of valve seat 670. This single compression produces the highest interference fit force and repeatable interference fit force between transcatheter heart valve prosthesis 200 and wall 672 of valve seat 670.

[0181] Other features described with respect to valve seat 170, 570 may include Figure 24 to Figure 26 In the valve seat 670. In particular and not by way of limitation, the circumferential ribs 576 and 578 on the wall 574 may be included in the orifice wall 674. Similarly, Fig.19A The ribs 578 shown in FIG. 5 may be included in the wall 672 of the valve seat 670. As with the valve seats 170, 570 described above, various sizes of valve seats 670 may be used so that the same balloon guide tubes 110, 510, loading cones 130, 530, loading rings 150, 550, and tip guide tubes 180, 580 may be used with various sizes of transcatheter heart valve prostheses by using different valve seats.

[0182] Figures 27 to 30 A valve seat 770 according to embodiments herein is shown. Figures 27 to 30 A schematic diagram of a valve seat 770 is shown. Those skilled in the art will recognize that other features may be added to Figures 27 to 30. For example and not by way of limitation, where applicable, the features described with respect to valve seats 170, 570, and / or 670 may be included in valve seat 770. Similarly, where applicable, the features described below with respect to valve seat 770 may be incorporated into valve seat 170, valve seat 570, and / or valve seat 670. As described above with respect to loading system 500, the valve seat is rotated by tip guide tube 580. When the valve seat is rotated, transcatheter heart valve prosthesis 200 also rotates. In some embodiments, it may be desirable to avoid a primary device by which transcatheter heart valve prosthesis 200 is rotationally contacted between the valve seat and the tissue of the transcatheter heart valve prosthesis 200. Therefore, as described below, valve seat 770 includes grooves or recesses in its base that are configured to receive the crown of transcatheter heart valve prosthesis 200.

[0183] Similar to the valve seats 170, 570, 670 described above, the valve seat 770 includes a base 771 having a central orifice 773 and a wall 772 extending from the periphery of the base 771 along a first direction substantially perpendicular to the base 771. The valve seat 770 further includes an orifice wall 774 extending from the periphery of the orifice 773 along a second direction opposite to the first direction and substantially perpendicular to the base 771.

[0184] The central passage 775 is defined by the aperture wall 774 and extends from the central aperture 773 of the base 771 in the second direction. The aperture wall 774 may include FIG. 19A to FIG. 19B The orifice wall 774 may also include a second lip or similar feature adjacent to the base 771, such as Fig.19B As shown in Figures 27 to 30In the embodiment of the invention, the orifice wall 774 includes two wall segments 774A, 774B. However, the valve seat 770 further includes two extensions 778A, 778B extending radially inward from the base 771, wherein each extension 778A, 778B is disposed between the two wall segments 774A, 774B, such that the wall segments 774A, 774B and the extensions 778A, 778B alternate around the circumference of the central orifice 773. The valve seat 770 further includes four slots 777 defined between adjacent wall segments 774A, 774B and the extensions 778A, 778B. The wall segments 774A, 774B and the extensions 778A, 778B are configured to be received within the recess 681 of the tip guide tube 580, wherein the rib 682 of the tip guide tube 580 is disposed in the slot 777, as described above. Although the valve seat 770 has been described as having two wall segments 774A, 774B, two extensions 778A, 778B, and four slots 777, this is not intended to be limiting. In other embodiments, the valve seat may include three or four or more wall segments 774, and more or fewer extensions 778 (including no extensions). Further, the valve seat 770 may include more or fewer slots 777, wherein the tip guide tube 580 has a corresponding number of ribs 682. It has been found that three of the four wall segments 774 provide increased stability during use. Further, the length of the wall segments can vary. It has been found that longer legs provide easier assembly and disassembly of the valve seat with the loading ring 550.

[0185] The valve seat 770 further includes a plurality of grooves, depressions, recesses or pockets 779 extending into the base 771. The pockets 779 extend into the surface of the base 771, which pockets are configured to receive the transcatheter heart valve prosthesis 200. In other words, the pockets 779 extend into the surface of the base 771 facing the first direction. The pockets 779 are configured to receive the crowns 207 of the frame 202 of the transcatheter heart valve prosthesis 200. In the illustrated embodiment, the crowns 207 at the inflow end 208 of the frame 202 of the transcatheter heart valve prosthesis 200 are received within the pockets 779. Thus, the number of pockets 779 matches the number of crowns 207 at the inflow end 208 of the frame 202 of the transcatheter heart valve prosthesis 200. For example and not by way of limitation, in the illustrated embodiment, there are fifteen pockets 779 corresponding to the fifteen crowns 207 at the inflow end 208 of the frame 202. In the illustrated embodiment, the recess 779 does not extend completely through the base 771 of the valve seat 770, as may be seen in FIG. Fig.28, where the pockets 779 are not visible because it is a bottom isometric view of the valve seat 770. In an embodiment, the depth of each pocket 779 is less than the length of the crown 207 / strut 212 at the inflow end 208 of the frame 202 that is not covered by the skirt 218 (in Figure 5 779). When valve seat 770 is rotated (e.g., by tip guide tube 580), crown 207, arranged together with recess 779, provides the primary force for rotating transcatheter heart valve prosthesis 200. Because the primary force for rotating transcatheter heart valve prosthesis 200 is due to uncovered crown 207, tissue of transcatheter heart valve prosthesis 200 (e.g., prosthetic valve leaflets 206 and skirt 218) is less likely to be damaged than in embodiments in which a surface surrounding the outer surface of frame 202 interacts with the outer surface of frame 202 to rotate transcatheter heart valve prosthesis 200.

[0186] Other features described with respect to valve seats 170, 570, 670 may include Figures 27 to 30 In the valve seat 770. In particular and not by way of limitation, the circumferential ribs 576 and 578 on the wall 574 may be included in the orifice wall 774. Similarly, Fig.19A The ribs 578 shown in Figure 7 may be included in the wall 772 of the valve seat 770, although these ribs should not be required due to the recess 779. As with the valve seats 170, 570, 670 described above, various sizes of valve seats 770 may be used so that the same balloon guide tubes 110, 510, loading cones 130, 530, loading rings 150, 550, and tip guide tubes 180, 580 may be used with various sizes of transcatheter heart valve prostheses by using valve seats of different sizes.

[0187] Fig.31 A valve seat 870 according to embodiments herein is shown. Fig.31 The valve seat 870 shown in is similar to the valve seats 170, 570, 670 and / or 770 described herein. Therefore, all details of the valve seat 870 will not be repeated. Therefore, the valve seat 870 generally includes: a base 871 having a central orifice 873; and a wall 872 extending from the periphery of the base 871 along a first direction generally perpendicular to the base 871. The valve seat 870 further includes an orifice wall or legs 874 extending from the periphery of the orifice 873 along a second direction opposite to the first direction and generally perpendicular to the base 871. In Fig.31In an embodiment, wall 872 includes a surface treatment 878 disposed at least partially around the inner circumference of wall 872 and at least partially along the height of wall 872. Surface treatment 878 is configured to retain transcatheter heart valve prosthesis 200 so that when valve seat 870 is rotated (e.g., by tip guide tube 570), transcatheter heart valve prosthesis 200 rotates with valve seat 870. Thus, surface treatment 878 is similar to Fig.19A The rib 578 of the valve seat 570 shown in FIG. Figures 27 to 30 Surface treatment 878 can be a variety of injection molded surface finishes. For example and not by way of limitation, various matte finishes can be used, such as SPI B-1 or VDI 24. Surface treatment 878 is selected so as to slightly increase the friction between heart valve prosthesis 200 and valve seat 870 without damaging the inflow wrap / skirt at the inflow portion of heart valve prosthesis 200. Although Fig.31 Surface treatment 878 is shown disposed around the entire interior circumference of wall 872 and partially along the interior length of wall 872. However, this is not intended to be limiting, and surface treatment 878 is more or less the interior surface of wall 872. Where applicable, features of other valve seats described herein may be included in valve seat 870. Similarly, surface treatment 878 described herein with respect to valve seat 870 may be included in other valve seats described herein.

[0188] Fig.32A and Fig.32B A valve seat 970 according to embodiments herein is shown. Fig.32A and Fig.32B The valve seat 970 shown in is similar to the other valve seats described herein. Therefore, all details of the valve seat 970 will not be repeated. Therefore, the valve seat 970 generally includes: a base 971 having a central orifice 973; and a wall 972 extending from the periphery of the base 971 along a first direction generally perpendicular to the base 971. The valve seat 970 further includes orifice walls or legs 974 extending from the periphery of the orifice 973 along a second direction opposite to the first direction and generally perpendicular to the base 971. In Fig.32A and Fig.32B In an embodiment of the present invention, wall 972 includes an opening 978 extending from the inner surface of wall 972 to the outer surface of wall 972. Opening 978 is disposed adjacent to base 971. Opening 978 enables a user to visualize when transcatheter heart valve prosthesis 200 has been properly inserted into valve seat 900. In other words, opening 978 in wall 972 adjacent to base 971 enables a user to see that crown 207 at inflow end 208 of transcatheter heart valve prosthesis 200 rests against base 971. Fig.32A and Fig.32B In the embodiment shown in , the wall 972 includes eight openings 978. However, this is not intended to be limiting, and more or fewer openings may be included.

[0189] Where applicable, features of other valve seats described herein may be included in the valve seat 970. Similarly, the surface treatment 978 described herein with respect to the valve seat 970 may be included in other valve seats described herein. For example and not by way of limitation, the recess 779 of the valve seat 770 may be included in the valve seat 970. In such a combination, the opening 978 of the valve seat 970 will enable a user to confirm that the crown 207 at the inflow end 208 of the heart valve prosthesis 200 is inserted into the recess 779 of the base 970. Similarly, features described herein or other valve seats (such as, but not limited to, the ribs 578 of the valve seat 570 and / or the surface treatment 878 of the valve seat 870) may also be included in the valve seat 970.

[0190] Fig.33A and Fig.33B Similar valve seats 1070A and 1070B are shown according to embodiments herein. Fig.33A and Fig.33B The valve seats 1070A and 1070B shown in are similar to the other valve seats described herein. Therefore, all details of the valve seats 1070A and 1070B will not be repeated. Therefore, the valve seats 1070A and 1070B generally include: a base 1071 having a central orifice 1073; and a wall 1072 extending from the periphery of the base 1071 along a first direction generally perpendicular to the base 1071. The valve seats 1070A and 1070B further include orifice walls or legs 1074 extending from the periphery of the orifice 1073 along a second direction opposite to the first direction and generally perpendicular to the base 1071. In Fig.33A and Fig.33B In the embodiment of the present invention, the inner surface of each leg 1074 includes a protrusion 1075A, 1075B extending toward the central longitudinal axis of the valve seat 1070A, 1070B. Fig.33A In the embodiment of FIG. 1 , the protrusion 1075A is a bump. Fig.33BIn an embodiment of the present invention, protrusion 1075B is a ledge. However, this is not intended to be limiting, and any protrusion compatible with the purposes described herein may be utilized. Protrusions 1075A, 1075B are configured to be used with the features of the tip guide tube described herein to provide tactile feedback of the position of the tip guide tube and / or to engage the valve seat 1070 with the tip guide tube, as explained below. Where applicable, features of other valve seats described herein may be included in valve seats 1070A, 1070B. Similarly, protrusions 1075A, 1075B described herein with respect to valve seats 1070A, 1070B may be included in other valve seats described herein.

[0191] Fig.34A and Fig.34B A tip guide tube 780 is shown according to an embodiment of the present invention. The tip guide tube 780 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 780 will not be repeated. Further, the tip guide tube 780 can include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 780 generally includes a tube 782 and a grip 784. Further, in Fig.34A and Fig.34B In the embodiment of the present invention, the tube 782 includes recesses 786 and ribs 788 that extend longitudinally along the tube 782 and are alternately arranged around the outer surface of the tube 782 along a portion of the length of the tube 782. Fig.34A and Fig.34B In the embodiment shown in , there are two recesses 786 and two ribs 788, which correspond to a valve seat including two wall sections / legs and two slots. However, this is not intended to be limiting, and the tube 782 may include any number of recesses 786 and ribs 788, which preferably corresponds to the number of wall sections / legs and slots in the corresponding valve seat used with the tube. Fig.34A and Fig.34B In an embodiment of the present invention, the tip guide tube 780 further includes a plurality of circumferential ribs or protrusions 789 adjacent the proximal end of the longitudinal ribs 786. In the illustrated embodiment, there are two circumferential ribs 789, and each circumferential rib extends around the entire circumference of the tube 782. However, this is not intended to be limiting, and there may be more or fewer circumferential ribs 789, and the circumferential ribs 789 may extend around only a portion of the circumference of the tube 782. The circumferential ribs 789 interact with the valve seat (such as the valve seat 570) and in particular the wall segments / legs 574 of the valve seat 570. The circumferential ribs 789 may interact with protrusions on the inner surface of these wall segments / legs (such as FIG. 33A to FIG. 33BCircumferential ribs 789 interact with protrusions 1075A, 1075B of valve seat 1070A, 1070B shown in . However, this is not required, and circumferential ribs 789 may simply interact with free ends of wall segments / legs of the valve seat and / or inner surfaces of wall segments / legs of the valve seat. Circumferential ribs 789 provide tactile feedback to a user of the loading system regarding the position of tip guide tube 780 relative to valve seat 570 coupled to loading ring 550. In particular, tip guide tube 780 should be retracted a certain distance before capsule 306 is advanced past transcatheter heart valve prosthesis 200 disposed within valve seat 570. The tactile feedback provided by circumferential ribs 789 interacting with valve seat 570 enables the user to confirm that tip guide tube 780 is properly retracted before advancing capsule 306 of delivery system 300. Those skilled in the art will recognize that reference to specific embodiments of loading system 500 and its components are not intended to be limiting, and that other embodiments of these specific components may also be used with tip guide tube 780 .

[0192] Fig.35A and Fig.35B A tip guide tube 880 is shown according to an embodiment of the present invention. The tip guide tube 880 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 880 will not be repeated. Further, the tip guide tube 880 can include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 880 generally includes a tube 882 and a grip 884. Further, in Fig.35A and Fig.35B In the embodiment of the present invention, the tube 882 includes recesses 886 and ribs 888 that extend longitudinally along the tube 882 and are alternately arranged around the outer surface of the tube 882 along a portion of the length of the tube 882. Fig.35A and Fig.35B In the embodiment shown in , there are four recesses 886 and four ribs 888, which correspond to a valve seat including four wall segments / legs and two slots. However, this is not intended to be limiting, and the tube 882 may include any number of recesses 886 and ribs 888, which preferably corresponds to the number of wall segments / legs and slots in the corresponding valve seat used with the tube. Fig.35A and Fig.35BIn the embodiment of the present invention, the tip guide tube 880 further includes a detent 889 adjacent to the proximal end of the longitudinal rib 886. In the embodiment shown, there are two detents 889 spaced approximately 180 degrees apart from each other around the circumference of the tube 882 (i.e., disposed opposite to each other). In the embodiment shown, the detent 889 is disposed in the recess 886 of the tube 882, between adjacent ribs 888. In the embodiment shown, the detent 889 is located in the cut-out section 883 of the wall of the tube 882. The detent 889 is coupled to the tube via a lateral connector 887. In the embodiment shown, the lateral connector 887 is located at approximately the middle portion of the length of the detent 889, so that the detent 889 resembles a "see-saw" because the longitudinal ends are not attached to the wall of the tube 882. Thus, the detent 889 can pivot inwardly and outwardly around the lateral connector 887. Each pawl 889 further includes two protrusions 885 extending radially outward, wherein the protrusions 885 of each pawl 889 are disposed at opposite longitudinal ends of the pawl 889. The pawl 889 and in particular its protrusions 885 interact with the valve seat (e.g., valve seat 570) and in particular the wall segments / legs 574 of the valve seat 570. The pawl 889 can interact with the protrusions on the inner surface of these wall segments / legs (e.g., FIG. 33A to FIG. 33B 870A, 870B) of the valve seat 1070A, 1070B shown in the figure. However, this is not required, and the pawl 889 can simply interact with the free end of the wall segment / leg of the valve seat and / or the inner surface of the wall segment / leg of the valve seat. The pawl 889 provides tactile feedback to the user of the loading system regarding the position of the tip guide tube 880 relative to the valve seat 570 connected to the loading ring 550. In particular, the tip guide tube 880 should be retracted a certain distance before the sac 306 is advanced past the transcatheter heart valve prosthesis 200 disposed in the valve seat 570. The tactile feedback provided by the pawl 889 interacting with the valve seat 570 enables the user to confirm that the tip guide tube 880 is properly retracted before the sac 306 is advanced past the transcatheter heart valve prosthesis 200. Those skilled in the art will recognize that reference to specific embodiments of loading system 500 and its components are not intended to be limiting, and that other embodiments of these specific components may also be used with tip guide tube 880 .

[0193] FIG. 36A to FIG. 36C A tip guide tube 980 is shown according to an embodiment of the present invention. The tip guide tube 980 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 980 will not be repeated. Further, the tip guide tube 980 can include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 880 generally includes a tube 982 and a grip 984. Further, in FIG. 36A to FIG. 36CIn the embodiment of the present invention, the tube 982 includes recesses 986 and ribs 988 that extend longitudinally along the tube 982 and are alternately arranged around the outer surface of the tube 982 along a portion of the length of the tube 982. FIG. 36A to FIG. 36C In the embodiment shown in , there are four recesses 986 and four ribs 988, which correspond to a valve seat including four wall sections / legs and four slots. However, this is not intended to be limiting, and the tube 982 may include any number of recesses 986 and ribs 988, which preferably corresponds to the number of wall sections / legs and slots in the corresponding valve seat used with the tube. FIG. 36A to FIG. 36C In the embodiment of the tip guide tube 980, the tip guide tube 980 further includes a protrusion 989 extending radially outward from the tube 982. In the illustrated embodiment, the protrusion 989 is disposed in a recess 986 of the tip guide tube 980. Further, in the illustrated embodiment, a protrusion 989 is present in each recess 986, but this is not intended to be limiting and only some of the recesses 986 may include a protrusion 989. The protrusion 989 is positioned along the length of the tube 982 such that when the tip guide tube 980 is fully retracted from the valve annulus 550, the protrusion 989 interacts with the valve seat (such as the valve seat 570) and in particular the wall segments / legs 574 of the valve seat 570 such that the tube 982 does not interfere with the radial compression of the transcatheter heart valve prosthesis 200. As shown in FIG. Fig.36B and Fig.36C As shown in FIG. 1 , the protrusions 989 can be aligned with protrusions on the inner surfaces of the wall segments / legs (e.g. FIG. 33A to FIG. 33B 570B). However, this is not required, and the protrusion 989 may simply interact with the free end of the wall segment / leg of the valve seat and / or the inner surface of the wall segment / leg of the valve seat. The protrusion 989 provides tactile feedback to the user of the loading system regarding the position of the tip guide tube 980 relative to the valve seat 570 connected to the loading ring 550. In particular, the tip guide tube 980 should be retracted a certain distance before the sac 306 is advanced past the transcatheter heart valve prosthesis 200 disposed within the valve seat 570. The tactile feedback provided by the pawl 989 interacting with the valve seat 570 enables the user to confirm that the tip guide tube 980 is properly retracted before the sac 306 is advanced past the transcatheter heart valve prosthesis 200. Those skilled in the art will recognize that reference to specific embodiments of loading system 500 and its components are not intended to be limiting, and that other embodiments of these specific components may also be used with tip guide tube 980 .

[0194] Fig.37A tip guide tube 1080 is shown according to an embodiment of the present invention. The tip guide tube 1080 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 1080 will not be repeated. Further, the tip guide tube 1080 can include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 1080 generally includes a tube 1082 and a grip 1084. Further, in Fig.37 In the embodiment of the present invention, the tube 1082 includes recesses 1086 and ribs 1088 that extend longitudinally along the tube 1082 and are alternately disposed around the outer surface of the tube 1082 along a portion of the length of the tube 1082. Fig.37 In the embodiment shown in , there are two recesses 1086 (only one is shown in the side view) and two ribs 1088, which correspond to a valve seat including four wall sections / legs and two slots. However, this is not intended to be limiting, and the tube 1082 may include any number of recesses 1088 and ribs 1086, preferably corresponding to the number of wall sections / legs and slots in the corresponding valve seat used with the tube. Fig.37 In the embodiment of the invention, the tip guide tube 1080 further includes a protrusion 1089 ( Fig.37 Only one protrusion 1089 is shown in FIG. 1 because the figure is a side view, but a second protrusion 1089 can be positioned opposite the protrusion 1089 shown). Protrusion 1089 is positioned at a longitudinal position along the length of tube 1082 so that when tip guide tube 1080 is fully retracted from valve annulus 550, protrusion 1089 interacts with the valve seat (such as valve seat 570) and particularly the wall segment / leg 574 of valve seat 570 so that tube 1082 does not interfere with radial compression of transcatheter heart valve prosthesis 200. Fig.37 In the embodiment shown in , each protrusion 1089 is formed by a cantilever 1085 that is connected to the tube 1082 at a first end of the cantilever 1085, wherein the cantilever 1085 has a free second end opposite the first end. The cantilever 1085 is arranged at a cutout 1083 in the wall of the tube 1082 so that the free second end can move radially inward and outward. The free second end of the cantilever 1085 includes a radially outward protrusion 1087. In the embodiment shown, the protrusion 1089 and in particular its radially outward protrusion 1087 interacts with the valve seat (such as the valve seat 570) and in particular the wall segment / leg 574 of the valve seat 570. The protrusion 1089 can interact with the protrusions on the inner surface of these wall segments / legs (such as FIG. 33A to FIG. 33B570B). However, this is not required, and the protrusion 1089 may simply interact with the free end of the wall segment / leg of the valve seat and / or the inner surface of the wall segment / leg of the valve seat. The protrusion 1089 provides tactile feedback to the user of the loading system regarding the position of the tip guide tube 1080 relative to the valve seat 570 connected to the loading ring 550. In particular, the tip guide tube 1080 should be retracted a certain distance before the sac 306 is advanced past the transcatheter heart valve prosthesis 200 disposed within the valve seat 570. The tactile feedback provided by the protrusion 1089 interacting with the valve seat 570 enables the user to confirm that the tip guide tube 1080 is properly retracted before the sac 306 is advanced past the transcatheter heart valve prosthesis 200. Those skilled in the art will recognize that reference to specific embodiments of loading system 500 and its components are not intended to be limiting, and that other embodiments of these specific components may also be used with tip guide tube 880 .

[0195] FIG. 38A to FIG. 38C A tip guide tube 1180 is shown according to an embodiment of the present invention. The tip guide tube 1180 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 1180 will not be repeated. Further, the tip guide tube 1180 can include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 1180 generally includes a tube 1182 and a grip 1184. Further, in FIG. 38A to FIG. 38C In the embodiment of the present invention, the tube 1182 includes recesses 1186 and ribs 1188 that extend longitudinally along the tube 1182 and are alternately arranged around the outer surface of the tube 1182 along a portion of the length of the tube 1182. FIG. 38A to FIG. 38C In the embodiment shown in , there are four recesses 1186 and four ribs 1188, which correspond to a valve seat including four wall sections / legs and two slots. However, this is not intended to be limiting, and the tube 1182 may include any number of recesses 1186 and ribs 1188, which preferably corresponds to the number of wall sections / legs and slots in the corresponding valve seat used with the tube. FIG. 38A to FIG. 38CIn the embodiment of the present invention, the tip guide tube 1180 further includes a protrusion or shoulder 1189 extending circumferentially around the circumference of the tube 1182 in the recess 1186. In particular, in the illustrated embodiment, the tube 1182 has a first outer diameter at the recess 1186 in a direction away from the grip 1184 (i.e., at 1186A). The shoulder 1189 is a step such that the tube 1182 has a second outer diameter at the recess 1186 that is greater than the first outer diameter in a direction from the shoulder 1189 toward the grip 1184 (i.e., at 1186B). In the illustrated embodiment, the shoulder 1189 interacts with a valve seat (such as the valve seat 570) and in particular the wall segment / leg 574 of the valve seat 570. The shoulder 1089 provides tactile feedback to a user of the loading system regarding the position of the tip guide tube 1180 relative to the valve seat 570 coupled to the loading ring 550. In particular, the tip guide tube 1180 should be retracted a certain distance before the capsule 306 is advanced past the transcatheter heart valve prosthesis 200 disposed within the valve seat 570. The tactile feedback provided by the shoulder 1189 interacting with the valve seat 570 enables the user to confirm that the tip guide tube 1180 is properly retracted before advancing the capsule 306 past the transcatheter heart valve prosthesis 200. Thus, the location of the shoulder 1189 along the length of the tube 1182 is such that when the wall portion / leg of the valve seat moves from the second outer diameter to the first outer diameter, tactile feedback is provided and the tip guide tube 1182 is properly retracted. Those skilled in the art will recognize that reference to specific embodiments of the loading system 500 and its components is not intended to be limiting, and other embodiments of these specific components may also be used with the tip guide tube 1180.

[0196] Fig.39A and Fig.39B A tip guide tube 1280 is shown according to an embodiment of the present invention. The tip guide tube 1280 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 1280 will not be repeated. Further, the tip guide tube 1280 can include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 1280 generally includes a tube 1282 and a grip 1284. Further, in FIG. 39A to FIG. 39B In the embodiment of the present invention, the tube 1282 includes recesses 1286 and ribs 1288 that extend longitudinally along the tube 1282 and are alternately arranged around the outer surface of the tube 1282 along a portion of the length of the tube 1282. FIG. 39A to FIG. 39BIn the embodiment shown in , there are four recesses 1286 and four ribs 1288, which correspond to a valve seat including four wall sections / legs and four slots. However, this is not intended to be limiting, and the tube 1282 may include any number of recesses 1286 and ribs 1288, which preferably corresponds to the number of wall sections / legs and slots in the corresponding valve seat used with the tube. FIG. 39A to FIG. 39B In the embodiment shown, two of the ribs 1288 extend further from the grip 1284 than the other two ribs 1288. Further, the longer ribs 1288 include protrusions 1289 extending radially outward from the corresponding ribs 1288. The protrusions 1289 are positioned lengthwise along the corresponding ribs 1288 to provide tactile feedback to the user so that the user knows that the tip guide tube 1280 is fully retracted from the valve annulus 550 so that the tube 1282 does not interfere with the radial compression of the transcatheter heart valve prosthesis 200. In the illustrated embodiment, two of the ribs 1288 that are opposite to each other around the circumference of the tube 1282 are lengthened and include radial protrusions 1289. However, this is not intended to be limiting, and in other embodiments, more or fewer of the ribs 1288 may be lengthened and / or may include radial protrusions 1289. In another example, all of the ribs 1288 may have the same length, and some or all of the ribs 1288 may include radial protrusions 1289. The radial protrusions 1289 can interact with the valve seat to provide tactile feedback. For example and not by way of limitation, the radial protrusions 1289 can interact with the base 571 of the valve seat 570 or the extension 778 of the valve seat 770. However, this is not intended to be limiting, and the radial protrusions 1289 can interact with any valve seat disclosed herein and variations thereof, or other components of the loading system. FIG. 39A to FIG. 39B , rib 1288 may include a series of protrusions 1289 that indicate a "safe zone" for retracting the tip guide tube 1280. Those skilled in the art will recognize that reference to specific embodiments of the loading system 500 and its components is not intended to be limiting, and other embodiments of these specific components may also be used with the tip guide tube 1280.

[0197] Fig.40A and Fig.40B A tip guide tube 1380 is shown according to an embodiment of the present invention. The tip guide tube 1380 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 1380 will not be repeated. Further, the tip guide tube 1380 can include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 1380 generally includes a tube 1382 and a grip 1384. Further, in FIG. 40A to FIG. 40BIn the embodiment shown, the tube 1382 includes a protrusion or pin 1389 extending radially outward from the tube 1382 adjacent to its end 1388. In particular, in the embodiment shown, the pins 1389 are arranged equidistantly around the circumference of the tube 1382. As can be seen in Fig.40B As seen in FIG. 1 , end 1388 of tip guide tube 1380 is the end that extends through loading ring 550, valve seat 570, loading cone 530, and transcatheter heart valve prosthesis 200 and protrudes past the smaller diameter end of loading cone 530. Figure 8K and Figure 8L As explained, the end 1388 of the tip guide tube 1380 prevents the outflow end 210 of the transcatheter heart valve prosthesis 200 from collapsing radially inward, i.e., maintains the outflow end 210 of the transcatheter heart valve prosthesis 200 at an inner diameter that is substantially equal to the outer diameter of the tube 1382 of the tip guide tube 1380 at the end 1388. This facilitates coupling the tab 220 to the tab pocket 318 of the delivery system 300. The pin 1389 enables a user to align the crown 207 at the outflow end 210 of the transcatheter heart valve prosthesis 200 with the pin 1389. In particular, the user can manually manipulate the crown 207 around the pin 1389. Wrapping the crown 207 around the pin 1389 ensures equidistant spacing of the crown 207 of the outflow end 210 of the transcatheter heart valve prosthesis 200, thereby mitigating potential crossover of the outflow crown on the transcatheter heart valve prosthesis 200. Other features of the tip guide tube 1380 are not described herein and may be as described herein for other embodiments.

[0198] FIG. 41A to FIG. 41B A pusher 4100 is shown in accordance with an embodiment of the present invention. Those skilled in the art will appreciate that the pusher 4100 may include additional components not described herein, or that such components may be modified or removed to be consistent with the description herein. The pusher 4100 includes a plate 4102 and a plurality of arms 4104 extending distally from the plate 4102. In the embodiment shown, there are two arms 4104, but this is not intended to be limiting, and more or fewer arms 4104 may be utilized to be consistent with the purpose of the arms 4104 described herein. The plate 4102 includes an opening 4106 extending therethrough. As shown in FIG. FIG. 41A to FIG. 41B As shown in , opening 4106 is configured to receive balloon guide tube 510 of loading system 500. Further, arm 4104 is configured to extend around and through loading ring 550 of loading system 500. For example and not by way of limitation, loading ring 550 may include grooves 4152 that extend longitudinally and are configured to receive arm 4104 therein. Fig.41AAs shown in FIG. 4 , the distal end 4108 of the arm 4104 engages the grip 584 of the tip guide tube 580. Thus, when the balloon guide tube 510 is advanced with the balloon 306 of the delivery system 300, as described above with respect to FIG. Figure 8T to Figure 8V As depicted, pusher 4100 is advanced with balloon guide tube 510, thereby pushing grip 584 of tip guide tube 580. Pusher 4100 thereby ensures that tip guide tube 580 is retracted so that tube 582 of tip guide tube 580 does not interfere with radial compression of transcatheter heart valve prosthesis 200.

[0199] FIG. 42A to FIG. 42B A tip guide tube 4280 is shown according to an embodiment of the present invention. The tip guide tube 4280 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 4280 will not be repeated. Further, the tip guide tube 4280 may include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 4280 generally includes a tube 4282 and a grip 4284. Adjacent to the grip 4284, the tube 4282 includes a notch 4289. The notch 4289 is configured to interact with the slide 4252. The slide 4252 may be an extension of the loading ring 550, such as FIG. 42A to FIG. 42B As shown in FIG. 4250 , the slider 4252 includes a longitudinal portion 4254 and a radially extending portion 4256. The radially extending portion includes a shaped end portion 4258 that is configured to fit into a recess 4289 of a tip guide tube 4280. The tip guide tube 4280 includes Fig.42A 4289 is distal to the shaped end 4258 of the slider 4252. In this first portion, the tip guide tube 4280 can be rotated to align the tab 220 of the transcatheter heart valve prosthesis 200 with the tab recess 318 of the main shaft 310 of the delivery system 300, as described above. With the tab 220 aligned with the tab recess 318, the tip guide tube 4280 can be moved proximally (i.e., in Fig.42A 4289, so that the shaped end 4258 of the slide 4258 is disposed in the recess 4289, as shown in FIG. Fig.42B With the shaped end 4258 disposed in the recess 4289, the tip guide tube 4250 may only be retracted (i.e., Fig.42B Slide 4252 may include a button 4255 for a user to engage to move the tip guide tube distally (i.e., Fig.42B The tip of the guide tube 4280 is slid to the right in the center of the catheter to ensure that the tube 4282 of the tip guide tube 4280 does not interfere with the radial compression of the transcatheter heart valve prosthesis 200.

[0200] FIG. 43A to FIG. 43BA tip guide tube 4380 is shown according to an embodiment of the present invention. The tip guide tube 4380 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 4380 will not be repeated. Further, the tip guide tube 4380 may include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 4380 generally includes a gripping portion 4384 and a tube 4382 extending proximally from the gripping portion 4384. The tube 4282 includes a lumen 4281 extending from its proximal end. As described above with respect to Figures 8M to 8N As explained, when the delivery device 300 is inserted through the loading system (100, 500), the tip 308 of the delivery system 300 extends within the lumen 4381 of the tip guide tube 4280. FIG. 43A to FIG. 43B In an embodiment, spring 4389 is disposed in lumen 4381. Thus, when tip 308 of delivery system 300 is advanced into lumen 4381, tip 4380 compresses spring 4389. Thus, a force must be applied to tip guide tube 4380 in a first direction D1 to maintain tip guide tube 4380 in a proper position to assist in preventing collapse of crown 207 at outflow end 210 of transcatheter heart valve prosthesis 200 and to assist in positioning tab 220 in tab recess 318, as explained above. When tab 220 is located in tab recess 318, tip guide tube 4380 can be released. Spring 4389 returns to its expanded state (eg, Fig.43A The force of the tip guide tube 4380 (shown in FIG. 24 ) will automatically push the tip guide tube 4380 distally, thereby retracting the tube 4382 of the tip guide tube 4380 sufficiently so that it does not interfere with the radial compression of the transcatheter heart valve prosthesis 200.

[0201] FIG. 44A to FIG. 44B A tip guide tube 4480 is shown according to an embodiment of the present invention. The tip guide tube 4480 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 4480 will not be repeated. Further, the tip guide tube 4480 can include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 4480 generally includes a tube 4482 and a grip 4484. Further, in FIG. 44A to FIG. 44B In the embodiment of the present invention, the tip guide tube 4480 includes a spring 4489 disposed around the exterior of the tube 4482. In the illustrated embodiment, the first end of the spring 4489, such as coupled to the tube 4482 or the grip 4484, is adjacent to the grip 4484, and the second end of the spring 4489 extends toward the proximal end of the tube 4482, such as Fig.44A When the tip guide tube 4482 is inserted through the loading ring 550, valve seat 570 and loading cone 530 of the loading system 500, as shown in FIG. Fig.44BAs shown in FIG. 4 , the spring 4489 is compressed against the loading ring 550 and the gripping portion 4484. Therefore, a force must be applied to the tip guide tube 4480 in the first direction D1 to maintain the tip guide tube 4480 in the Fig.44B , thereby helping to prevent the crown 207 at the outflow end 210 of the transcatheter heart valve prosthesis 200 from collapsing and assisting in positioning the tab 220 in the tab pocket 318, as explained above. When the tab 220 is located in the tab pocket 318, the tip guide tube 4480 can be released. The spring 4489 returns to its expanded state (as shown in FIG. 1 ). Fig.43A ) will automatically push tip guide tube 4480 distally (ie, in a second direction D2 opposite to first direction D1 ), thereby retracting tube 4482 of tip guide tube 4480 sufficiently so that it does not interfere with radial compression of transcatheter heart valve prosthesis 200 .

[0202] FIG. 45A to FIG. 45B A tip guide tube 4580 is shown according to an embodiment of the present invention. The tip guide tube 4580 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 4580 will not be repeated. Further, the tip guide tube 4580 may include any of the features described herein with respect to other embodiments of the tip guide tube, such as the recess 4586 and the rib 4588. The tip guide tube 4580 generally includes a tube 4582 and a grip 4584. FIG. 44A to FIG. 44B In an embodiment of the present invention, the tube 4582 includes an enlarged or flared end 4589 (i.e., the proximal end or the end inserted into the loading ring 550) opposite the grip 4484. The flared end 4589 has a diameter DI1 that is greater than the diameter of the distal end of the balloon 308 of the delivery system 300. The flared end 4589 prevents the tube 4582 of the tip guide tube 4580 from entering the distal end of the balloon 308 of the delivery system 300. Additionally, the lumen 4581 of the tube 4582 can taper in the distal direction (i.e., the diameter of the lumen 4581 tapers in a direction away from the flared end 4589).

[0203] Fig.46 A tip guide tube 4680 is shown according to an embodiment of the present invention. The tip guide tube 4680 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 4680 will not be repeated. Further, the tip guide tube 4680 can include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 4680 generally includes a tube 4682 and a grip 4684. Further, in Fig.46 In the embodiment of the present invention, the tube 4682 includes recesses 4686 and ribs 4688 that extend longitudinally along the tube 4682 and are alternately arranged around the outer surface of the tube 4682 along a portion of the length of the tube 4682. Fig.46 In the embodiment, Fig. 22 and Fig.23 Compared to the tip guide tube 580 shown in FIG, the recess 4686 and the rib 4688 extend along the tube 4682 to the grip 4684, while the recess 681 and the rib 682 of the tip guide tube 580 are spaced apart from the grip 584. Further, Fig.46 The ribs 4688 of the tip guide tube 4680 extend further proximally (opposite the grip 4684) than the ribs 682 of the tip guide tube 580. Thus, the overall length of the tip guide tube 4680 can be shorter than that of the tip guide tube 580 while maintaining approximately the same length of the ribs 4688, 682. The reduced overall length of the tip guide tube 4680 reduces the risk of the tip guide tube 4680 extending into the balloon 306 of the delivery system 300 during loading.

[0204] Fig.47 A tip guide tube 4780 is shown according to an embodiment of the present invention. The tip guide tube 4780 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 4780 will not be repeated. Further, the tip guide tube 4780 can include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 4780 generally includes a tube 4782 and a grip 4784. Further, in Fig.47 In the embodiment of the present invention, the tube 4782 includes recesses 4786 and ribs 4788 that extend longitudinally along the tube 4782 and are alternately arranged around the outer surface of the tube 4782 along a portion of the length of the tube 4782. Fig.46 In the embodiment, Fig. 22 and Fig.23 Compared to the tip guide tube 580 shown in FIG. 4 , the rib 4788 extends along the tube 4782 to the grip portion 4784 and extends a shorter distance away from the grip portion 4784, as shown in FIG. Fig.47 . Tube 4782 includes a paddle section 4781 at its end opposite to the grip 4784. Paddle section 4781 is generally cylindrical and is configured to accommodate the crown 207 and paddle 220 at the outflow end of the transcatheter heart valve prosthesis 200, as described above. Tube 4782 includes an outwardly flared section 4783 distal to the paddle section 4781. Tube 4782 further includes a generally cylindrical section 4785 disposed between the flared section 4783 and the grip 4784. Section 4785 includes a plurality of cutouts 4787 passing through the wall of tube 4782. The cutouts 4787 significantly reduce the overall weight of the tip guide tube 4780, causing the tip guide tube 4780 to float in a saline bath. Therefore, when described above with respect to FIG. 8A to FIG. 8Y And especially about Figures 8O to 8RWhen tip guide barrel 4780 is used in the described method, tip guide tube 4780 can float out of loading cone 530, valve seat 570 and loading ring 530, thereby automatically retracting tube 4782 of tip guide tube 4780 sufficiently so that it does not interfere with radial compression of transcatheter heart valve prosthesis 200. Fig.47 Also shown in the embodiment of the present invention is an arrow 4789 disposed on the grip portion 4784 of the tip guide tube 4780. The arrow 4789 serves as a reminder to remind the user to withdraw the tip guide tube 4780 from the rest of the loading system 500 before compressing the transcatheter heart valve prosthesis 200. The arrow 4789 may be used in any of the embodiments described herein, as may the other features described with respect to the tip guide tube 4780.

[0205] FIG. 48A to FIG. 48B A tip guide tube 4880 is shown in accordance with an embodiment herein. The tip guide tube 4880 is similar to the tip guide tube 580. Therefore, all details of the tip guide tube 4880 will not be repeated. Further, the tip guide tube 4880 may include any of the features described herein with respect to other embodiments of the tip guide tube. The tip guide tube 4880 generally includes a tube 4882 and a grip 4884. The tube 4882 may include a recess (not shown), ribs (not shown), and a lumen, as described in other embodiments herein. In FIG. 48A to FIG. 48B In the embodiment shown in , the tip guide tube 4880 includes an arm 4887 extending proximally (i.e., in the same direction as the tube 4882) from the grip portion 4884. In the embodiment shown, the tip guide tube 4880 includes two arms 4887 that are spaced approximately 180 degrees apart around the circumference of the grip portion 4884. Further, the arms 4887 are each disposed adjacent to the outer circumference of the grip portion 4884, as shown. Each arm 4887 includes a clip 4889 at its proximal end. Each clip 4889 is a radially outward projection that includes an inclined surface 4885, such that the clip 4889 at the proximal end projects more radially outward than the adjacent arm 4887, as shown. Fig.48A and Fig.48B as shown in . Fig.48B A tip guide tube 4880 is shown disposed within a loading ring 4850, as described above with respect to Figure 1A , Figures 8J to 8N and Fig.14 However, the loading ring 4850 includes a slot 4852 configured to receive the arm 4887 of the tip guide tube 4880, and an opening 4854 configured to receive the hook 4889 of the tip guide tube 4800. In particular, as Fig.48BAs shown in FIG. 4 , each arm 4887 is inserted into a corresponding slot 4852 at the distal end of the loading ring 4850, wherein the corresponding hook 4889 first enters the slot 4852. When the tip guide tube 4880 is advanced so that the hook 4889 is aligned with the corresponding opening 4854 of the loading ring 4850, the hook 4889 pops out of the corresponding opening 4854, as shown in FIG. Fig.48B When it is time to retract tip guide tube 480 so that it does not interfere with radial compression of transcatheter heart valve prosthesis 200, clasps 4889 can be squeezed together, thereby automatically retracting tip guide tube 4880.

[0206] FIG. 49A to FIG. 49E A balloon guide tube 4910 is shown according to an embodiment herein. The balloon guide tube 4910 can be similar to the balloon guide tube 510 described above. Therefore, all details of the balloon guide tube 4910 will not be described. The balloon guide tube 4910 generally includes a tube 4911 having a first (distal) end 4912, a second (proximal) end 4913, and a passage or lumen 4914 extending from the first end 4912 to the second end 4913, so that the balloon guide tube 4910 can be disposed over the balloon 306 of the delivery system 300, as described above. The balloon guide tube 4910 further includes a grip 4915 coupled to the exterior of the tube 4911, and a locking member 4916 configured to lock the balloon guide tube 4910 to the balloon 306 of the delivery system 300, as explained above. The locking member 4916 is disposed around the tube 4911 and includes a lock grip 4917 and a lock tube 4918. Those skilled in the art will recognize that FIG. 49A to FIG. 49D An example of a balloon guide catheter is shown, and FIG. 49A to FIG. 49E Existing components shown in FIG. 49 may be removed and / or additional components may be added to balloon guide tube 4910 .

[0207] Tube 4911 of balloon guide tube 4910 further includes a guide rail 4919 extending radially outward and longitudinally along at least a portion of tube 4911. FIG. 49A to FIG. 49E In the embodiment shown, there are two guide rails 4919 diametrically opposed to each other. However, this is not intended to be limiting, and more or fewer guide rails 4919 may be utilized. The locking member 4916 further includes grooves 4920 along its inner surface that are configured to receive the guide rails 4919 therein. Thus, in the embodiment shown, there are two grooves 4920, each of which receives a corresponding one of the guide rails 4919 therein. Fig.49A and Fig.49C Move the unlock configuration shown in Fig.49B and Fig.49DIn the locked configuration shown in , the guide rail 4919 and the groove 4920 prevent the locking member 4916 from moving out of the axis (e.g., rotational movement). In some embodiments, the guide rail 4919 can have an outward taper to minimize the rattle of the locking member 4916 when the locking member 4916 is in the locked configuration.

[0208] The locking member 4916 of the balloon guide tube 4910 further includes a cantilever 4921 formed by a cutout 4922 in the locking tube 4918 of the locking member 4916. Fig.49A and Fig.49B As can be seen in the figure, each cantilever 4921 extends in the longitudinal direction and is formed by a U-shaped cutout 4922. Further, in the illustrated embodiment, there are four cantilever arms 4922, two of which are on the proximal side of the lock grip 4917 and two on the distal side of the lock grip 4917. Further, the corresponding two cantilever arms 4921 on each side of the lock grip 4917 are arranged diametrically opposite to each other. In other words, the first cantilever arm 4921 is arranged on the proximal side of the lock grip 4917. The second cantilever arm 4921 is also arranged on the proximal side of the lock grip 4917 and is arranged diametrically opposite to the first cantilever arm 4921. Similarly, the third cantilever arm 4921 is arranged on the distal side of the lock grip 4917. The fourth cantilever arm 4921 is also arranged on the distal side of the lock grip 4917 and is arranged diametrically opposite to the third cantilever arm 4921. However, this is not intended to be limiting, and other arrangements of cantilever 4921 are contemplated. Cantilever 4921 assists in accommodating a dynamic system. In other words, with bag 306 in an unloaded state (i.e., without a transcatheter heart valve prosthesis 200 loaded into bag 306) and a loaded state (i.e., with a transcatheter heart valve prosthesis 200 loaded into bag 306), bag guide tube 4910 needs to be locked in place on bag 306 of delivery system 300. The diameter of bag 306 changes from the unloaded state to the loaded state (e.g., expands by approximately 0.1 mm). Cantilever 4921 exerts a force on both halves of tube 4911 to keep tube 4911 closed during initial loading of tabs 220 of heart valve prosthesis 200. As the remainder of transcatheter heart valve prosthesis 200 is loaded into bag 306, the radially outward force on bag guide tube 4910 increases. As the force increases, cantilever 4921 is configured to flex to allow the two halves of tube 4911 to expand (ie, move away from each other), thereby reducing high loading forces while retaining tabs 220 of transcatheter heart valve prosthesis 200 within tab pockets 318 of main shaft 310 .

[0209] FIG. 50A to FIG. 50BA balloon guide tube 5010 is shown according to an embodiment herein. The balloon guide tube 5010 can be similar to the balloon guide tube 510 and the balloon guide tube 4910 described above. Therefore, all details of the balloon guide tube 5010 will not be described. The balloon guide tube 5010 generally includes a tube 5011 having a first (distal) end 5012, a second (proximal) end 5013, and a passage or lumen 5014 extending from the first end 5012 to the second end 5013, so that the balloon guide tube 5010 can be disposed over the balloon 306 of the delivery system 300, as described above. The balloon guide tube 5010 further includes a grip 5015 coupled to the exterior of the tube 5011, and a locking member 5016 configured to lock the balloon guide tube 5010 to the balloon 306 of the delivery system 300, as explained above. The locking member 5016 is disposed around the tube 5011 and includes a lock grip 5017 and a lock tube 5018. FIG. 49A to FIG. 49E In the embodiment of the present invention, the balloon guide tube 5010 further includes a guide rail 5019 on the tube 5011 and a groove 5020 in the locking tube 5018. The balloon guide tube further includes a cantilever 5021 and a groove 5022 on the locking tube 5018, as described above. Those skilled in the art will recognize that FIG. 50A to FIG. 50B An example of a balloon guide catheter is shown, and FIG. 50A to FIG. 50B Existing components shown in the figure may be removed and / or additional components may be added to balloon guide tube 5010. As described above with respect to tube 511, tube 5011 includes two halves that are longitudinally divided. FIG. 50A to FIG. 50B In the embodiment of the present invention, each half of the tube 5011 includes a pin 5023 and / or a recess 5024. The recess 5024 is configured to receive the pin 5023 of the other half of the tube 5011 to couple the halves together, as described above with respect to the tab 516 and recess 617 of the tube 511.

[0210] FIG. 51A to FIG. 51C shows a balloon guide tube 5110 according to an embodiment herein. The balloon guide tube 5110 can be similar to the balloon guide tubes 510 and 4910 described above. Therefore, all details of the balloon guide tube 5010 will not be described. The balloon guide tube 5110 generally includes a tube 5111 having a first (distal) end 5112, a second (proximal) end 5113, and a passage or lumen 5114 extending from the first end 5112 to the second end 5113, so that the balloon guide tube 5110 can be disposed over the balloon 306 of the delivery system 300, as described above. The balloon guide tube 5110 further includes a grip (not shown) coupled to the exterior of the tube 5111, and a locking member 5016 configured to lock the balloon guide tube 5110 to the balloon 306 of the delivery system 300, as explained above. The locking member 5116 is disposed around the tube 5111 and includes a lock grip 5117 and a lock tube 5118. FIG. 51A to FIG. 5 In the embodiment of FIG. 1C, the tube 5111 includes an internal tapered portion 5125. The internal tapered portion 5125 is positioned approximately longitudinally where the proximal portion of the locking tube 5118 is located, wherein the locking member 5116 is Fig.51A . In particular, the lumen 5114 has a first diameter 5126A proximal to the inner tapered portion 5125 and a second diameter 5126B distal to the inner tapered portion 5125, wherein the second diameter 5126B is smaller than the first diameter 5126A. In a non-limiting embodiment, the first diameter 5126A can be approximately 6.1 mm and the second diameter 5126B can be approximately 5.9 mm. However, this is not intended to be limiting, and the actual size depends on the size of the capsule 306 of the delivery system 300. For example and not as a limitation, these diameters can be selected based on the desired radial compression amount, such as 0.1 mm or 0.2 mm of radial compression. The tube 5111 further includes a ramp 5127 on the outer surface of the tube 511. In particular, the tube 5111 has a first outer diameter 5128A proximal to the ramp 5127 and a second outer diameter 5128B distal to the ramp 5127, wherein the second outer diameter 5128B is greater than the first outer diameter 5126A. In a non-limiting embodiment, the first outer diameter 5128A can be approximately 8.9 mm and the second outer diameter 5128B can be approximately 10.3 mm. The axial position of the internal tapered portion 5125 and the length of the external ramp 5127 allow the sac 306 to be compressed proximally. The axial position of the internal tapered portion 5125 provides additional constraint to the area of ​​the sac 306 that expands the least during loading, thereby minimizing adverse effects on loading forces. The internal tapered portion 5125 provides an interference fit with the sac 306, rather than compressing the sac 306. Although not described herein, the internal tapered portion 5125 can be a plurality of tapered portions that are substantially parallel to the sac 306, and the tapered portion 5125 can be substantially parallel to the sac 306. FIG. 51A to FIG. 51C is described, but features of other embodiments described herein may be combined with the balloon guide tube 5110, such as but not limited to guide rails on the tube and grooves in the locking tube to prevent the locking member 5116 from moving out of the axis.

[0211] FIG. 52A to FIG. 52C A balloon guide tube 5210 is shown according to an embodiment herein. The balloon guide tube 5210 can be used in a manner similar to the balloon guide tubes 110 and 510 described above. The balloon guide tube 5210 includes a tube 5211 and a locking member 5220. The balloon guide tube includes a first (distal) end 5212 and a second (proximal) end 5213. The first end 5212 of the balloon guide tube 5210 includes a flared portion 5218 that flares in the proximal direction. The flared portion 5218 is configured to be received within the proximal end of the loading funnel 530. A lumen 5214 extends through the tube 5211, the locking member 5220, and the flared portion 5218. The lumen 5214 is configured to receive a balloon 306 (shown in phantom) therein.

[0212] The locking member 5220 is coupled to the proximal end of the tube 5211. The locking member 5216 includes a housing 5222 that defines a portion of the lumen 5214. A spring lock 5230, a compression spring 5240, and a release slide 5250 are disposed within the housing 5222. The locking member 5220 is configured to lock the balloon guide tube 5210 to the balloon 306 and release the balloon 306 from the balloon guide tube 5210 when desired.

[0213] Fig.52B The compression lock 5230 is shown in detail in FIG. The compression lock includes a base 5232 and compression legs 5236. The base 5232 includes a central opening 5234 that is configured to receive the capsule 306 of the delivery system 300 therethrough. The base 5232 is adjacent to the distal end of the housing 5222, as shown in FIG. Fig.52C. The compression legs 5236 apply a radially inward force to an object, such as a balloon 306 disposed therethrough. In the illustrated embodiment, the compression legs 5236 include three legs 5236. However, this is not intended to be limiting, and more or fewer legs 5236 may be utilized, provided that the compression legs 5236 apply sufficient radially inward force to maintain the balloon guide tube 5210 locked to the balloon 306. In the illustrated embodiment, each compression leg 5236 is generally U-shaped. Thus, each compression leg 5236 includes a first leg portion 5237 extending proximally from the base 5232, a bend 5239 at the proximal end of the first leg portion 5237, and a second leg portion 5238 extending distally and radially inwardly from the bend 5239. In the illustrated embodiment, each second leg portion 5239 includes a first portion 5233A extending radially inward and proximally from the bend 5239, and a segment portion 5233B extending generally proximally (i.e., generally parallel to the central longitudinal axis of the lumen 5214) from the first portion 5233A. The second portion 5233B provides a smooth surface for interacting with the balloon 306. The second portion 5233B forms a cylindrical opening 5235 having a diameter that is smaller than the diameter of the balloon 306 of the delivery system 300. Thus, when the balloon is inserted through the cylindrical opening 5235, the second leg portions 5238 of the compression legs 5236 move radially apart, but exert a radially inward force on the balloon, thereby securing the balloon guide tube 5210 to the balloon 306.

[0214] The release slide 5250 is configured to expand the compression legs 5236 of the compression lock 5230 to release the balloon guide tube 5210 from the balloon 306. In the illustrated embodiment, the release slide 5250 includes a longitudinal portion 5254 having a lumen 5254 extending therethrough. The lumen 5254 is configured to receive the balloon 306 of the delivery system 300 therein. However, the diameter of the lumen 5254 is greater than the diameter of the balloon 306 so that the longitudinal portion 5254 does not exert a radially inward force on the balloon 306 and the longitudinal portion 5254 can slide relative to the balloon 306 with the balloon 306 disposed in the lumen 5256. The release slide 5250 further includes an actuator 5256 configured to enable a user to actuate the release slide 5250. In the illustrated embodiment, the actuator 5256 extends substantially perpendicular to the longitudinal portion 5252 such that the actuator 5256 is away from the housing 5222, thereby allowing a user to longitudinally move the actuator 5256 and thereby move the release slide 5250, as shown by Fig.52C Indicated by arrow A1.

[0215] The compression spring 5240 of the locking member 5220 of the balloon guide tube 5210 is configured to maintain the release slide 5250, and in particular the longitudinal portion 5252 of the release slide 5250, spaced apart from the compression lock 5230, as shown in FIG. Fig.52C The compression spring 5240 is disposed in the housing 5222, between the actuator 5256 (located at the proximal end of the compression spring 5240) and the shoulder or wall 5222 of the housing 5222 (located at the distal end of the compression spring 5240). Therefore, when the actuator 5256 moves distally (i.e., in the direction of arrow A1), the compression spring 5240 is compressed between the actuator 5256 and the shoulder 5222 and applies a force proximally (i.e., in the direction of arrow A2).

[0216] In operation, to install the balloon guide tube 5210 over the balloon 306, the actuator 5256 is moved distally in the direction of arrow A1. This movement must overcome the force of the compression spring 5240 acting in the direction of arrow A2. As the actuator 5256 moves distally, the longitudinal portion 5252 also moves distally. The longitudinal portion 5252 moves between the compression legs 5236 of the compression lock 5230, thereby causing the compression legs 5236 to open to each other. The balloon guide tube 5210 can then be placed over the balloon 306 by relative axial movement of the balloon guide tube 5210 and the balloon 306. When the balloon guide tube 5210 is properly positioned, the actuator 5256 is released. The compression spring 5240 pushes the actuator and thus the release slide 5250 including the longitudinal portion 5252 proximally in the direction of arrow A2. With longitudinal portions 5252 withdrawn from compression legs 5236, compression legs 5236 move radially inward, thereby securing balloon 306 therein. After transcatheter heart valve prosthesis 200 is loaded into balloon 306, actuator 5256 can be moved distally so that longitudinal portions 5252 of release slider 5250 cause compression legs 5236 to expand, thereby releasing balloon 306 from balloon guide tube 5210. With actuator 5256 actuated as described, balloon guide tube 5210 can be removed from balloon 306.

[0217] A balloon guide tube, such as balloon guide tube 5210 having compression legs 5236, alleviates tight tolerances that may be required in other balloon guide tubes. Further, balloon guide tube 5210 provides proximal compression (i.e., compression legs 5236 are disposed at a proximal portion of balloon 306). Proximally compressing balloon guide tube 5210 onto balloon 306 moves the compressive force on balloon 306 proximally (i.e., away from the distal opening of balloon 306). When transcatheter heart valve prosthesis 200 is loaded into balloon 306, the loading force is highest near the distal end of balloon 306. Having the compressive force from the balloon guide tube on balloon 306 at or near the highest loading force (which is the expansion force on balloon 306) increases the loading force. Thus, moving the compressive force applied by the balloon guide tube on balloon 306 proximally reduces the loading force.

[0218] FIG. 53A to FIG. 53C A balloon guide tube 5310 is shown according to an embodiment herein. The balloon guide tube 5310 can be similar to the balloon guide tube 510 described above. Therefore, all details of the balloon guide tube 5310 will not be described. The balloon guide tube 5310 generally includes a tube 5311 having a first (distal) end 5312, a second (proximal) end 5313, and a passage or lumen 5314 extending from the first end 5312 to the second end 5313, so that the balloon guide tube 5310 can be disposed over the balloon 306 of the delivery system 300, as described above and in FIG. 53A to FIG. 53C The balloon guide tube 5310 further includes a locking member 5316 configured to lock the balloon guide tube 5310 to the balloon 306 of the delivery system 300, as explained above. FIG. 53A to FIG. 53C In the embodiment of the present invention, the tube 5311 includes an opening 5315 adjacent to its proximal end 5213. The opening 5315 extends through the wall of the tube 5311. The opening 5315 enables a user to grasp both the tube 5311 and the outer shaft 304 or the balloon 306 of the delivery system 300 through the opening 5315 while moving the locking member 5316 to prevent the outer shaft 304 and the balloon 306 from moving during the locking procedure. The opening 5315 can be used with any of the embodiments described herein. As explained with respect to other embodiments herein, the locking member 5316 of the balloon guide tube 5310 is moved distally to lock the balloon guide tube 5310 to the balloon 306. In the present invention, the locking member 5316 of the balloon guide tube 5310 is moved distally to lock the balloon guide tube 5310 to the balloon 306. FIG. 53A to FIG. 53C In the embodiment of the present invention, the locking member 5316 is moved distally via its rotation, such as by FIG. 53A to FIG. 53B Indicated by arrow A3 in FIG. Moving the locking member 5316 via rotation rather than linear translation can provide more stability and control of the movement. Further, rotation can typically better ensure that the locking action will be completed. In other words, there is a higher risk that a locking member moved via linear translation may not slide completely into place.

[0219] FIG. 54A to FIG. 54B A balloon guide tube 5410 is schematically illustrated according to an embodiment herein. The balloon guide tube 5410 can be similar to the balloon guide tube 510 described above. Therefore, all details of the balloon guide tube 5410 will not be described. The balloon guide tube 5410 generally includes a tube 5411, a grip 5415, and a locking member 5416 configured to lock the balloon guide tube 5410 to the balloon 306 of the delivery system 300, as explained above. The details of these features need not be repeated here. As explained with respect to other embodiments above, the locking member 5416 can include a lock grip 5417 and a lock tube 5418. In FIG. 54A to FIG. 54B In the embodiment of the present invention, the locking member 5416 includes a window or opening 5320 through the wall of the locking tube 5418 at the distal end of the locking member 5416. The opening 5420 enables the user to visualize the distal end of the balloon 306 through the opening 5420 to ensure that the locking member 5416 is in a closed position when it reaches the distal end. FIG. 54A to FIG. 54B 5410 and balloon 306 are properly aligned when the locked configuration is shown in FIG. Opening 5420 may be incorporated into any of the embodiments described herein.

[0220] The locking members described herein may be formed of any material suitable for locking the balloon guide tube 510 to the balloon 306 of the delivery system 300. Fig.55 In the embodiment shown in , the locking member 5516 is formed of an elastic material (such as rubber). As explained above, the tube 511 of the balloon guide tube 510 can be formed of two halves. Therefore, the elastic material of the locking member 5516 provides elastic compression of the tube 511 of the balloon guide tube 510, thereby enabling the two halves of the tube 511 to be transiently deflected during the loading of the transcatheter heart valve prosthesis 200 into the sac 310. When the transcatheter heart valve prosthesis 200 is loaded into the sac 306, this transient deflection reduces the loading force. For example and not as a limitation, the material of the locking member 5516 can be rubber (TPU, NR, SBR, IIR, NBR, CR, EPDM, Q, FKM, AU, HNBR), a foam-based polymer (PUR, PVC, PE, ABS) and / or a polymer having a Shore A hardness value between 50A and 60 (e.g., medical grade thermoplastic polyurethane, thermoplastic elastomer, polyurethane and silicone).

[0221] exist Fig.56 In another embodiment of the present invention shown in , the locking member 5616 can be formed of at least two materials. In particular, as Fig.56As shown in , inner material layer 5624 and outer material layer 5625. Inner material layer 5624 can be an elastic material, such as but not limited to rubber (TPU, NR, SBR, IIR, NBR, CR, EPDM, Q, FKM, AU, HNBR), foam-based polymers (PUR, PVC, PE, ABS) and / or polymers with Shore A hardness values ​​between 50A and 60 (e.g., medical grade thermoplastic polyurethane, thermoplastic elastomer, polyurethane and silicone). Outer material layer 5625 can be a hard polymer material (such as but not limited to high Shore hardness polymers (ABS, PC)), metal (SS, aluminum), glass, translucent polycarbonate (e.g., Makrolon 2458), acrylic (e.g., PMMA) and / or PETG. The elastic inner material layer 5624 enables the tube 511 of the balloon guide tube 510 to be transiently deflected, as described above with respect to Fig.55 The hard outer material layer 5625 improves ergonomics and provides an outer expansion limit to the tube 511, thereby preventing over-expansion of the tube 511 of the balloon guide tube 510.

[0222] Fig.57 and Fig.58 Two embodiments of loading cones 5730 and 5830 are shown. Loading cones 5730 and 5830 can be similar to those described above with respect to Fig.17A and Fig. 17B A loading cone 530 is depicted. Fig.57 and Fig.58 The loading cones 5730 and 5830 of the embodiment include a body 5745, 5845, respectively, having an inclined or contoured distal end 5731, 5831, respectively. Fig.57 and Fig.58 , the respective distal end portions 5731, 5831 follow a profile from one of the locking arms 5737, 5837 toward the proximal end portion 5732, 5832 of the body 5745, 5845 and then back toward the other locking arm 5737, 5837. This profile is repeated on the opposite side of the locking arm. The contoured distal end portions 5731, 5831 of the body 5745, 5845 provide a gap between the loading cone 5730, 5830 and the loading ring 550 of the loading system 500. This gap enables air to escape the loading system 500, thereby mitigating any risk of air embolism. Although Fig.57 and Fig.58 Each of the locking arms 5737, 5837 shows a profile that is repeated on opposite sides, but this is not intended to be limiting. In other embodiments, only one side of the distal end portion 5731, 5831 needs to be contoured. Further, as described above with respect to Figure 1A and Figure 2As explained, the loading cone may include vent holes (such as vent holes 142 described above) for air release in lieu of or in addition to the contoured distal end of the loading cone.

[0223] It should be understood that the various embodiments disclosed herein may be combined into combinations different from those specifically presented in the specification and drawings. It should also be understood that, by way of example, certain actions or events of any process or method described herein may be performed in a different order, may be added, combined, or omitted entirely (e.g., all described actions or events may not be necessary to implement these techniques). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single device or component, it should be understood that the techniques of the present disclosure may be performed by a combination of devices or components associated with, for example, a medical device.

Claims

1. A loading system for loading a heart valve prosthesis into a delivery system, the loading system comprising: a loading cone including a passage extending therethrough, the passage including a tapered portion; a loading ring configured to be coupled to the loading cone; and A valve seat is configured to be coupled to the loading ring, the valve seat being rotatable relative to the loading ring when the valve seat and the loading ring are coupled together, the valve seat being configured to receive the heart valve prosthesis.

2. The loading system of claim 1, further comprising a balloon guide tube, wherein: The distal end of the balloon guide tube is configured to be positioned adjacent to the proximal end of the loading cone, and wherein the balloon guide tube is configured to lock onto a balloon of the delivery system.

3. The loading system of claim 1 , further comprising a tip guide tube configured to extend through the loading ring, the valve seat, and the loading cone.

4. The loading system according to claim 1, wherein: The tapered portion of the passageway tapers in a proximal direction such that a distal end of the tapered portion has a larger diameter than a proximal end of the tapered portion.

5. The loading system according to claim 1, wherein: The loading cone includes a plurality of ribs extending inwardly from an inner surface of the loading cone.

6. The loading system of claim 1, wherein: The loading cone includes a vent extending through a surface thereof, the vent being configured to release air from the loading cone.

7. The loading system of claim 1, wherein: The loading cone includes a contoured distal edge such that a gap between the contoured distal edge and the loading ring enables release of air from the loading cone.

8. The loading system of claim 1, wherein: The loading ring includes a base and a central passage extending through the base, and wherein the valve seat includes: a seat base having a central orifice extending through it; a wall extending from the periphery of the seat base in a first direction; and an orifice wall extending from the periphery of the central orifice in a second direction opposite to the first direction, wherein the orifice wall is configured to be disposed in the central passage of the loading ring so that the valve seat can rotate relative to the loading ring.

9. The loading system of claim 8, wherein: The seat base and the wall of the valve seat are configured to receive the heart valve prosthesis.

10. The loading system of claim 8, wherein: The wall of the valve seat includes a plurality of ribs or surface treatments configured to assist the valve seat in engaging the heart valve prosthesis such that rotation of the valve seat produces a corresponding rotation of the heart valve prosthesis.

11. The loading system of claim 8, wherein: The seat base includes a plurality of recesses configured to receive a crown at a first end of a frame of the heart valve prosthesis such that rotation of the valve seat produces a corresponding rotation of the heart valve prosthesis.

12. The loading system according to claim 8, in, The wall of the valve seat comprises two wall sections separated by two wall grooves, wherein the seat base of the valve seat further comprises a living hinge, wherein the living hinge is configured to enable the seat base to bend so that the two wall segments can open, and wherein compressing the orifice wall radially inwardly causes the two wall segments to expand radially outwardly to receive the heart valve prosthesis therein.

13. The loading system of claim 8, wherein: The orifice wall of the valve seat includes a circumferential lip such that the circumferential lip inhibits longitudinal movement between the valve seat and the loading ring when the valve seat is coupled to the loading ring.

14. The loading system according to claim 8, in, The loading cone is non-rotatably coupled to the loading ring, and wherein the loading cone, the loading ring and the valve seat are configured to receive the heart valve prosthesis therein, and when the loading cone, the loading ring and the valve seat are connected together and the heart valve prosthesis is loaded therein, the valve seat and the heart valve prosthesis are configured to rotate relative to the loading ring and the loading cone.

15. The loading system of claim 14, further comprising a tip guide tube configured to engage an inner surface of an orifice wall of the valve seat, wherein Rotation of the tip guide tube rotates the valve seat relative to the loading ring.

16. The loading system of claim 15, wherein: The tip guide tube includes a plurality of ridges configured to engage a corresponding plurality of grooves in an orifice wall of the valve seat to rotatably engage the tip guide tube with the valve seat.

17. The loading system of claim 15, wherein: The tip guide tube includes tactile feedback regarding the position of the tip guide tube relative to the valve seat connected to the loading ring, such that the tactile feedback enables a user to confirm that the tip guide tube is properly retracted distally a sufficient distance before advancing the balloon of the delivery system over the transcatheter heart valve prosthesis.

18. The loading system of claim 15, wherein: The tip guide tube includes an inner spring or an outer spring configured to urge the tip guide tube distally relative to the delivery system.

19. The loading system according to claim 2, in, The balloon guide tube comprises: a tube comprising two longitudinal halves; and a locking member configured to lock the tube to the balloon of the delivery system, wherein the tube includes a guide rail and the locking member includes a groove configured to receive the guide rail therein such that during longitudinal translation of the locking member relative to the tube, out-of-axis movement is prevented.

20. The loading system of claim 2, wherein: The distal end of the balloon guide tube includes an opening configured to enable a user to visualize the distal end of the balloon 306 of the delivery system through the opening to ensure that the balloon guide tube and the balloon are properly aligned.

21. A method of loading a heart valve prosthesis into a delivery system, the method comprising: sliding a balloon guide tube over the delivery system so that a distal end of the balloon guide tube is adjacent to an open distal end of a balloon of the delivery system; coupling a loading ring and a valve seat together so that the valve seat can rotate relative to the loading ring; loading the heart valve prosthesis into the valve seat; With the valve seat secured to the loading ring and the heart valve prosthesis disposed in the valve seat, securing a loading cone to the loading ring, thereby forming a loading system; loading the loading system onto the delivery system; rotating the valve seat and the heart valve prosthesis to align the heart valve prosthesis relative to the delivery system; coupling the heart valve prosthesis to the delivery system; translating the balloon distally to cover a portion of the heart valve prosthesis; as well as The balloon is further translated distally so that the balloon and the balloon guide tube push the loading cone, the loading ring and the valve seat distally, and because the heart valve prosthesis is prevented from translating distally by being coupled to the delivery system, the loading cone radially compresses the heart valve prosthesis, and the heart valve prosthesis leaves the proximal end of the loading cone and enters the open distal end of the balloon.

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