Detailed Description
Specific embodiments of the present disclosure will now be described with reference to the drawings, in which like reference numerals refer to identical or functionally similar elements.
The following detailed description describes examples of embodiments and is not intended to limit the technology or the application and uses of the technology. Although the embodiments herein are described in the context of a loading device for transcatheter heart valve prostheses, the present techniques may also be used with other devices. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.
Fig. 1A and 1B illustrate an example of a loading system 100 according to embodiments herein. Those skilled in the art will recognize that fig. 1A and 1B illustrate one example of a loading system, and that existing components illustrated in fig. 1A and 1B may be removed and/or additional components may be added to loading system 100. As shown in fig. 1A, 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 fig. 1A and 1B are depicted in opposite directions. In other words, balloon guide tube 110 is shown in fig. 1A to the right of loading cone 130, but is shown in fig. 1B to the left of loading cone 130. This is simply a change in viewing angle and the relative orientation of the parts with respect to each other is unchanged.
Balloon guide tube 110 is configured to be disposed on a balloon of a delivery system, as explained in more detail below. Balloon guide tube 110 includes a tube 111 having a first end 112, a second end 113, and a passageway or lumen 114 extending from first end 112 to second end 113, as shown in fig. 1B. Balloon guide tube 110 further includes a grip 115 coupled to the exterior of tube 111, and a locking member 116 configured to lock balloon guide tube 110 to a balloon of a delivery system, as explained in more detail below. The locking member 116 is disposed about 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 may 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. Fig. 1A shows a variation of balloon guide tube 110 in which grip 115 is combined with lock grip 117. Further, the lock tube 118 of the embodiment of fig. 1A extends from the grip/lock grip 115/117 in both directions toward the first end 112 and the second end 113 of the tube 111. The lock tube 118 of the embodiment of fig. 1A further includes a slit 120 between its various portions. As explained above and in more detail below, the balloon guide tube 110 of both fig. 1A and 1B locks onto the balloon of the delivery device.
As shown in fig. 1B, the first end 112 of the balloon guide tube 110 may include a shoulder 119 configured to interact with the second end of the loading cone 130 to prevent the tube 111 from extending beyond a distance into the loading cone 130. The portion 121 of the lumen 114 of the tube 111 of the balloon guide tube 110 between the shoulder 119 and the first end 112 thereof tapers in a direction away from the first end 112 such that the opening at the first end 112 is larger than the lumen 114 at the shoulder 119. This taper allows the first (distal) end 112 of the lumen of the balloon guide tube 110 to be larger, allowing the distal end of the balloon of the delivery system to expand during loading of the transcatheter heart valve prosthesis into the balloon. This reduces tissue compression during loading. Further, inflation (flaring) of the distal portion of the balloon may reduce the likelihood that the crown of the transcatheter heart valve prosthesis will seize the distal portion of the balloon during loading. Further, as a result of lip 122 extending radially inward into lumen 114, lumen 114 at shoulder 119 is smaller than lumen 114 toward second end 113 of balloon guide tube 110, as shown in fig. 1B. The lip 122 acts as a ring gauge to prevent incorrect loading of the 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. Thus, there is insufficient space for the tabs of the heart valve prosthesis to sit over the tab pockets of the main shaft of the delivery system. Thus, the lip 122 minimizes the possibility of false loading into the delivery system.
The loading cone 130 includes a body 145 that includes a first end 131, a second end 132, and a central passageway 133 extending from the first end 131 to the second end 132, as shown in fig. 1A and 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 the outflow portion of the transcatheter heart valve prosthesis 200 is initially loaded into the loading cone 130 via transcatheter delivery (via the aorta), 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 paths, 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 loading funnel.
The body 145 of the loading cone 130 includes a first cylindrical portion 134 adjacent the first end 131, a second cylindrical portion 136 adjacent 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 and second cylindrical portions 134, 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 need 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 is larger adjacent the first cylindrical portion 134 than the central passage 133 of the tapered portion 135 adjacent the second cylindrical portion 136. The tapered 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 degrees to 30 degrees, or 15 degrees to 25 degrees, or 18 degrees to 22 degrees. This cone angle alpha 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.
The loading cone 130 may also include vent holes 142, which are openings of the central passageway 133 extending from the outer surface of the body 145 to 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 vents 142 may be utilized in the proper location of the body 145. In other embodiments, the body 145 does not include a vent.
In the illustrated embodiment, the loading cone 130 further includes two locking arms 137 that extend radially outward from and longitudinally toward the first end 131 of the body 145. In the illustrated embodiment, two locking arms 137 are disposed 180 degrees apart from each other about the circumference of the body 145. Each of the locking arms 137 includes a support 138 extending radially outwardly 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 with respect to the support 138) that tapers from a first thickness adjacent the lip 141 to a second thickness at the 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 ramp 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.
As described above, the loading system 100 further includes a loading ring 150. The loading ring 150 is configured to couple to the loading cone 130 and seat the transcatheter heart valve prosthesis 200 therein, as shown in fig. 1A, 1B, and 2. As shown in fig. 3A-3B, the load 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 inward 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 load ring 150 further includes a platform 154 extending radially inward from the inner wall 153 opposite the base 151. The load ring 150 further includes a central lumen or passage 155 extending from the platform 154 to the base 151. The cylindrical wall 156 defines a central passage 155.
Still referring to fig. 3A and 3B, the load ring 150 further includes slots 157, wherein each slot 157 is configured to receive a corresponding locking arm 137 of the load cone 130 to rotationally couple the load ring 150 and the load cone 130. In the embodiment shown, there are two slots 157 in the load ring 150 that correspond to the two locking arms of the load cone 130. Each slot 157 is defined by an inner wall 158, an outer wall 159, and radially extending side walls 160 connecting the inner wall 158 to the outer wall 159. The inner wall 158 of each slot 157 comprises a portion of the outer wall 152 of the load ring 150 and continues to extend from the outer wall 152. In particular, the inner wall 158 of each slot 157 includes a portion of the outer wall 152 and extends upwardly therefrom (i.e., away from the base 151). The outer wall 159 of each slot 157 is spaced radially outwardly from the inner wall 158 of each slot 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 respective wall (if the walls extend circumferentially to define a complete circle). In particular, each inner wall 158 and each outer wall 159 may extend 40 degrees to 60 degrees around the circumference of such a circle. In other embodiments (not shown), the load ring 150 may include a single continuous groove extending around the entire load ring 150 instead of two grooves 157. In other embodiments, the load ring 150 may 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 may 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.
In an embodiment, the load ring 150 has a first diameter D1 of about 40mm to 45mm defined by the outer wall 152. The load ring 150 has a second diameter D2 of about 42mm to 46mm defined by the outer wall 159 of the slot 157. Further, the outer wall 152 of the load ring 150 may have a height H1 of about 20mm, the inner and outer walls 158, 159 of the slots 157 may have a height H2 of about 50mm, and the inner wall 153 of the load ring 150 may have a height of about 3.5 mm.
Fig. 4A and 4B illustrate an embodiment of a valve seat 170 of the loading system 100. The valve seat 170 includes a base 171 having a central aperture 173, and a wall 172 extending from the 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 the periphery of the orifice 173 in a second direction opposite 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 past the wall 156 defining the central passage 155 such that the lip 176 may prevent longitudinal movement of the valve seat 170 relative to the loading ring 150. However, the valve seat 170 may rotate relative to the loading ring 150 because the orifice wall 174 may 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 may be pressed radially inward (which may be facilitated by the slot 177 in the orifice wall 174) to enable the lip 176 to move away from the end of the wall 156. Fig. 8E, described below, shows the loading ring 150 and the valve seat 170 coupled to one another.
Fig. 4C shows another embodiment of a valve seat 170'. 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 aperture 173', a wall 172', and an aperture wall 174 'defining a central passageway 175'. As in the embodiment of fig. 4A and 4B, the orifice wall 174 'may include a lip (not shown) or similar feature to couple the valve seat 170' to the loading ring 150. Valve seat 170' is shown herein to demonstrate that the same loading cone 130, loading ring 150, tip guide tube 180, and balloon guide tube 110 can be used with various sizes of transcatheter heart valve prostheses by changing the valve seat. However, only two examples of valve seats are provided, and other embodiments may be used. By varying features of valve seat 170, such as, but not limited to, the height of wall 172 and the diameter of base 171, the same balloon guide tube 110, loading cone 130, loading ring 150, and tip guide tube 180 may be used to load various transcatheter heart valve prostheses into the delivery system.
Fig. 2 shows the loading ring 150 coupled to the loading cone 130 with the valve seat 170 coupled thereto (partially visible through the vent holes 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 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 in fig. 2. This prevents the loading cone 130 from moving longitudinally relative to the loading ring 150, but allows rotational movement between them. Further, to disengage the loading cone 130 from the loading ring 150, the arms 139 may be pushed radially inward such that the lips 141 are radially inward of the outer wall 159 of the slots 157, thereby no longer preventing the loading cone 130 and the loading ring 150 from moving longitudinally away from each other.
As described above, the loading system 100 further includes a tip guide tube 180, as shown in fig. 1A and 1B. Tip guide tube 180 includes a tube 182 and a grip 184. In the embodiment of fig. 1A and 1B, tube 182 and grip 184 are one-piece, however, this is not intended to be limiting. Tip guide tube 180 includes a first end 186 at the grip end of tip guide tube 180, and a second end 188 opposite first end 186. The tube 182 further includes a lumen 181 (see fig. 8L) disposed at least partially therethrough. The lumen is configured to receive a distal tip of a delivery system during a loading procedure, as described below. The tube 182 is laterally sized (diameter) such that it fits through the central passageway 175 of the valve seat 170. Tip guide tube 180 has a longitudinal length such that with loading cone 130 and loading ring 150 coupled to one another and grip 184 abutting base 151 of loading ring 150, tube 182 extends through loading ring 150 and loading cone 130 such that its second end 188 protrudes from second end 132 of body 145 of loading cone 130, as can be seen in fig. 8K.
Having described the loading system 100, a brief description of an example transcatheter heart valve prosthesis 200 and delivery system 300 will be provided. The heart valve prosthesis 200 is merely an example heart valve prosthesis on which the loading system 100 may be used to load the heart valve prosthesis 200 into the 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.
As shown in fig. 5, the 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. In the example transcatheter heart valve prosthesis 200 shown in fig. 5, the frame 202 is self-expandable. However, this is not intended to be limiting, and the frame 202 may be balloon-or mechanically-expandable. Transcatheter heart valve prosthesis 200 includes an inflow end 208 and an outflow end 210. Those skilled in the art will recognize that fig. 5 illustrates one example of a transcatheter heart valve prosthesis, and that existing components illustrated in fig. 5 may be removed and/or additional components may be added to the transcatheter heart valve prosthesis 200.
The prosthetic valve 204 includes at least one leaflet 206 disposed within and secured to the frame 202. In the exemplary embodiment shown in fig. 5, 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.
As shown in fig. 5, 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 such 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 to the outflow end 210 through the heart valve prosthesis 200. When the pressure at the outflow end 210 exceeds the pressure at the inflow end 208, the prosthetic leaflet 206 closes to prevent blood from flowing from the outflow end 210 to the inflow end 208. The transcatheter heart valve prosthesis 200 can also include a skirt 218 coupled to the prosthetic leaflets 206 and the frame 202. In an embodiment, as shown in fig. 5, the skirt 218 is disposed adjacent the inflow end 208 of the transcatheter heart valve prosthesis 200.
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 arranged circumferentially about the longitudinal axis LA of the transcatheter heart valve prosthesis 200 and longitudinally to form a tubular structure defining a central lumen of the transcatheter heart valve prosthesis 200. The struts 212 are defined herein as the elongate wire (wire) segments of the frame 202. The struts 212 are clustered together to form crowns or nodes 207. At the outflow end 210 of the frame 202, the frame 202 includes tabs 220 extending from two of the crowns. In the illustrated embodiment, there are two tabs 220 disposed 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 about the frame 202 as desired. As will be explained in more detail below, the tabs 220 are used to couple the frame 202 to the delivery system 300. Tab 220 may also be radiopaque to aid in visualizing frame 202 during delivery and deployment of transcatheter heart valve prosthesis 200.
Fig. 6A and 6B illustrate an example delivery system 300 for a self-expanding transcatheter heart valve prosthesis, such as transcatheter heart valve prosthesis 200. As noted above, the delivery system is merely an example delivery system that may be used with the loading system 100 described above. Further, those skilled in the art will recognize that fig. 6A and 6B illustrate one example of a delivery system, and that existing components illustrated in fig. 6A and 6B may be removed and/or additional components may be added to delivery system 300.
The delivery system 300 includes a handle 302. The handle 302 enables a clinician to manipulate a distal portion of the delivery system 300 and includes an actuator for moving portions of the delivery system relative to other portions, such as 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 the balloon 306) is configured to enclose the transcatheter heart valve prosthesis during delivery to a treatment site (e.g., a native heart valve) and retract 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 translates 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 distal tip 308 can also translate relative to the outer shaft 304 and handle 302 via a tip retractor. In the illustrated embodiment, an intermediate member 314 is disposed between the inner shaft 312 and the outer shaft 304, and the intermediate member 314 includes a retainer or spindle 310 attached to a distal portion thereof for receiving the tab 220 of the transcatheter heart valve prosthesis 200.
In the illustrated embodiment, the flush port 316 is provided on the handle 302. In the illustrated delivery system 300, when the transcatheter heart valve prosthesis 200 is properly loaded into the delivery system 300, there are certain relationships between features or between features of the transcatheter heart valve prosthesis 200 and the delivery system 300 that can assist in predicting the proper rotational orientation of the 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 pockets 318 of main shaft 310 that are 180 ° apart from each other, as shown in fig. 8R described below. One of the tabs 220 may include a C-shaped indicia (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 transcatheter heart valve prosthesis 200 is loaded into a delivery system, C-shaped tab 220 is positioned in tab recess 318 that is aligned with irrigation port 316 on handle 302 of delivery system 300.
As noted above, this is a brief description of an example delivery system 300. Other portions shown in fig. 6A and 6B are not described in detail herein and will be apparent to those skilled in the art.
Having described the loading system 100, the example transcatheter heart valve prosthesis 200, and the example delivery system 300, a method of loading the transcatheter heart valve prosthesis 200 into the delivery system 300 using the loading system 100 will now be described with respect to fig. 7 and 8A-8Y. While fig. 7 and 8A-8Y illustrate various operations that may be performed in the method, one skilled in the art will recognize that existing operations may be removed and additional operations may be added. Also, one skilled in the art will recognize that in some cases the order of operations may be changed.
Fig. 7 shows a storage and loading tray 350 that may 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.
As can be seen in fig. 7, the delivery system 300 is disposed in the loading tray 350, with the handle 302 of the delivery system 300 disposed in a first portion of the loading tray 350 and the distal portion of the delivery system 300 (including the bladder 306 and the tip 308) disposed in the reservoir 352 of the loading tray 350. As can also be seen in fig. 7, the actuator 303 of the delivery system 300 is retracted such that the balloon 306 of the delivery system 300 is retracted from the tip 308, thereby exposing the spindle 310. As can also be seen in fig. 7, portions of the loading system 100 (including the balloon guide tube 110, loading cone 130, loading ring 150, valve seat 170, and tip guide tube 180) are separated from one another in order to be ready for use. Further, transcatheter heart valve prosthesis 200 sits in a cold saline bath in reservoir 352 so that its frame 202 becomes more flexible for radial compression by loading system 100. It should be noted that the orientation of the loading system 100 shown in fig. 8A-8X is identical to that of fig. 1A, but opposite to that shown in fig. 1B.
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 arrows in 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. 8A and 8B. With balloon guide tube 110 in place, locking member 116 of balloon guide tube 110 is moved distally (see arrows in fig. 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. 8C.
In another step of the method, the loading ring 150 and the valve seat 170 are coupled to one another by inserting the orifice wall 174 of the valve seat 170 into the central passageway 155 of the loading ring 150, as indicated by the arrows in 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 past 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 fixed to each other, the valve seat 170 and the loading ring 150 may rotate relative to each other. Fig. 8E shows the valve seat 170 and the loading ring 150 secured to each other. Those skilled in the art will appreciate that the valve seat 170 and the loading ring 150 may be secured to one another either before or after the balloon guide tube 110 is secured to the balloon 306.
In another step of the method, the transcatheter heart valve prosthesis 200 is loaded into a valve seat 170 rotatably secured to the loading ring 150, as shown in fig. 8F and 8G. As explained above, the order of operation of the described methods is not intended to be limiting. Thus, for example, the transcatheter heart valve prosthesis 200 may 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, transcatheter heart valve prosthesis 200 may be slightly radially compressed by hand such that the inflow portion of the heart valve prosthesis is disposed radially inward of wall 172 of valve seat 170. The transcatheter heart valve prosthesis 200 and valve seat 170 combination may be rotated relative to the loading ring 150, as indicated by the arrows in fig. 8F. If the valve seat 670 shown in fig. 24-26 is used, the wall sections 672A, 672B are expanded prior to insertion of the transcatheter heart valve prosthesis 200 into the valve seat 670, thereby eliminating the hand compression described above.
In another step of the method, with the valve seat 170 secured to the loading ring 150 and the transcatheter heart valve prosthesis 200 disposed in the valve seat 170, the loading cone 130 and the loading ring are secured to one another, as shown in fig. 8H and 8I. In particular, the first end 131 (i.e., the larger diameter end) of the loading cone 130 slides over the transcatheter heart valve prosthesis 200 and toward the loading ring 150 until the arms 137 of the loading cone 130 extend through the respective slots 157 such that the lip 141 of each of the arms 137 extends past the outer wall 159 of the respective slot 157 and expands radially outward to couple the loading cone 130 to the 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 relative movement between the two is required so that loading ring 150 may be moved toward loading cone 130, and/or both loading ring 150 and loading cone 130 may be moved toward each other. With the loading cone 130 and the loading ring 150 secured to one another, the outflow portion of the transcatheter heart valve prosthesis 200 is radially compressed by the tapered portion 135 of the loading cone 130. When the loading cone 130 and the loading ring 150 are secured to each other, the outflow end 210 of the transcatheter heart valve prosthesis protrudes from the second end 132 (smaller diameter end) of the loading cone 130. With the loading cone 130 and the loading ring 150 fixed to each other and the transcatheter heart valve prosthesis 200 disposed within the loading cone 130 and the loading ring 150, the rotational orientation of the heart valve prosthesis 200 may be adjusted by rotating the loading cone 130 relative to the loading ring 150 (which correspondingly rotates the heart valve prosthesis 200 and the valve seat 170 relative to the loading ring 150).
In another step of the method, a tip guide tube 180 is inserted through the loading ring 150, valve seat 170, transcatheter heart valve prosthesis 200, and loading cone 130, as shown in fig. 8J-8L. In particular, in this embodiment, with the loading cone 130 and the loading ring 150 secured to one another, the second end 188 of the tip guide tube 180 is inserted into the central passageway 175 of the valve seat 170, which is disposed within the central passageway 155 of the loading ring 150, as shown in fig. 8I. The second end 188 of the tip guide tube 180 continues to be advanced through the central passageway 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. 8K and 8L. As shown in fig. 8L, the second end 188 of the tip guide tube 180 prevents the outflow end 210 of the transcatheter heart valve prosthesis 200 from collapsing radially inward. In other words, the second end 188 of the tip guide tube 180 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 182 of the tip guide tube 180 at the second end 188. This facilitates coupling tab 220 to tab cavity 318 of delivery system 300.
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 combination of the loading cone and the transcatheter heart valve prosthesis 200 disposed therein on the valve seat 170 is 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. 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 the spindle 310, as shown in fig. 8N.
In the next step of the method, tab 220 is placed in tab cavity 318 of spindle 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 recess 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 cavity 318, as shown in fig. 8O and 8P.
In the next step of the method, the tip guide tube 180 is completely removed from the loading cone 130/loading ring 150, as shown in fig. 8Q. Transcatheter heart valve prosthesis 200 is inspected to ensure that tabs 220 are located in tab pockets 318 and that the crowns at outflow end 210 are properly located at main shaft 310, as shown in fig. 8R. Fig. 8S shows transcatheter heart valve prosthesis 200 with tab 220 located in tab recess 318 of main shaft 310, wherein balloon 306 is proximal to main shaft 310 and the remainder of loading cone 130, loading ring 150, and inflow end 208 of transcatheter heart valve prosthesis 200 is distal to main shaft 310.
In the next step of the method, the actuator 303 is rotated to advance the balloon distally (i.e., toward the distal tip 308 of the delivery system). In particular, as shown in fig. 8T and 8U, the actuator 303 of the delivery system 300 is rotated as shown by the rotational arrow, which causes the balloon 306 of the delivery system 300 to translate distally as shown by the arrows in fig. 8T and 8U. As bladder 306 is advanced distally, bladder 306 first covers tabs 220 of transcatheter heart valve prosthesis 200 that are located in tab pockets 318. As the balloon 306 continues to be advanced, the balloon 306 and balloon guide tube 110 push the loading cone 130, loading ring 150, and valve seat 170 distally. Because distal translation of transcatheter heart valve prosthesis 200 is prevented by tabs 220 disposed in tab pockets 318 of spindle 310, loading cone 130 moves relative to transcatheter heart valve prosthesis 200 such that loading cone 130 radially compresses 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 exits the second end 132 (i.e., the smaller diameter end) and enters the open distal end of the balloon 306. This actuation of the actuator 303, distal advancement of the balloon 306, distal translation of the loading cone 130, radial compression of the transcatheter heart valve prosthesis 200, and capture of the transcatheter heart valve prosthesis 200 within the balloon 306, continues until the transcatheter heart valve prosthesis 200 is fully captured within the balloon 306, as shown in fig. 8V. The combination of the loading cone 130, loading ring 150, and valve seat 170 may then be removed from the distal tip 308 of the delivery system 300, as shown in fig. 8W.
In another step of the method, the balloon guide tube 110 may be unlocked and removed from the balloon 306 and removed distally beyond the distal tip 308 of the (over) delivery system 300, as shown in fig. 8X. In another step of the method, the actuator 303 is rotated, 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. 8Y. The delivery system 300 (with the transcatheter heart valve prosthesis 200 loaded into the balloon 306) is ready for transluminal delivery of the transcatheter heart valve prosthesis 200 to the site of the native heart valve, and deployment of the transcatheter heart valve prosthesis 200 from the delivery system 300.
Figures 9 and 10 illustrate a loading system 100 with an in-loading cone support 190. Those skilled in the art will recognize that fig. 9 and 10 illustrate one example of an inner loading cone support, and that the components illustrated in fig. 9 and 10 may be removed and/or additional components may be added to the inner loading cone support 190. The inner cone-carrying 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 load cone support 192. The inner cone carrier 190 includes a first portion 193 disposed adjacent the first end 191 and a second portion 194 disposed adjacent the second end 192. The first portion 193 includes a tapered outer surface 198 that tapers toward the first end 191 of the in-loading cone support 190.
The inner cone-carrying support 190 further includes a lumen 196 extending from the first end 191 to the second end 192. Lumen 196 is sized to receive tube 182 of tip guide tube 180 therein.
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 the second end 132 of the loading cone 130 and the second end 192 of the inner loading cone support 190 is disposed adjacent the first end 131 of the loading cone 130. An annular lumen 199 is defined between the outer surface of the inner loading cone support 190 and the inner surface of the loading cone 130, as shown in fig. 10. The annular lumen 199 is configured to receive a heart valve prosthesis 200 (not shown in fig. 9 and 10).
The inner loading cone support 190 provides an inner contoured surface (i.e., an outer surface of the inner cone support 190) to create a more linear compression of the prosthetic valve 204 of the transcatheter heart valve prosthesis 200 than would be possible using the loading system 100 with the loading cone 130 without the inner loading cone support 190 disposed within the loading cone 130. In other words, the inclusion of the inner loading cone support 190 avoids more abrupt compression near the second end 132 (smaller diameter end) of the loading cone 130. Fig. 9 shows a threshold diameter DC in which the cross-sectional area of the transcatheter heart valve prosthesis 200 (e.g., the frame 202 and the prosthetic valve 204) exceeds the cross-sectional area of the annular lumen 199. In the case of an empty loading cone 130 (i.e., without an inner loading cone support 190), the location of the threshold diameter is closer to the second (narrow) end 132 of the loading cone 130. As explained above, this can create rapid compression of the transcatheter heart valve prosthesis 200 and potentially increase stress on the prosthetic valve 204.
With the inner loading cone support 190, compression of the prosthetic valve 104 can begin immediately once the transcatheter heart valve prosthesis 200 is loaded into the loading cone 130, even when the transcatheter heart valve prosthesis 200 is stationary (i.e., before it is pulled through the loading cone 130). As the transcatheter heart valve prosthesis 200 is pulled through the loading cone 130 with the inner loading cone support 190, the 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 the prosthetic valve 204.
In an embodiment, the loading system 100 may include a compliant outlet 400, as shown in fig. 11-13. The compliant outlet 400 assists in loading the transcatheter heart valve prosthesis 200 into a delivery system. 300. In particular, the compliant outlet 400 facilitates loading the tabs 220 of the transcatheter heart valve prosthesis 200 into the tab pockets 318 of the main shaft 310 of the delivery system 300, as will be appreciated by those skilled in the art, one example of a compliant outlet 400 is illustrated in fig. 11-13, and the components illustrated in fig. 11-13 may be removed and/or additional components may be added to the compliant outlet 400.
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, as shown in fig. 11-13. The compliant outlet 400 follows the taper of the loading cone 130, with the fingers 406 of the compliant outlet 400 extending past the second end 132 of the loading cone 130. The fingers 406 of the compliant outlet 400 are more flexible than the loading cone 130 and thus may flex radially outward as the outflow end 210 of the transcatheter heart valve prosthesis 200 exits the second end 132 of the 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 second end 132 of loading cone 130 located at the same location as second end 408 of compliance outlet 400. Second end 132 of loading cone 130, which is less flexible, may be forced radially inward past outflow end 210 of catheter heart valve prosthesis 200 such that tab 220 needs to be maneuvered into placement in tab recess 318. The use of compliant outlet 400 enables tabs 220 to be more radially outward, thereby facilitating placement of tabs 220 into tab pockets 318.
Fig. 11 shows the compliant outlet 400 and the outflow end 210 of the transcatheter heart valve prosthesis 200 before the tip guide tube 180 is disposed through the loading cone 130. Fig. 12 shows the compliant outlet 400 with the tip guide tube 180 disposed through the loading cone 130 and the transcatheter heart valve prosthesis 200. FIG. 13 shows compliant outlet 400 after tip guide tube 180 has been withdrawn and with tab 220 of transcatheter heart valve prosthesis 200 inserted into tab recess 318 of main shaft 310.
Those skilled in the art will recognize that while the compliant outlet 400 is shown as a separate item coupled to the loading cone 130 as described, it may instead be part of the loading cone 130. For example, second end 132 of loading cone 130 may include fingers, such as fingers 406, or may be otherwise made more flexible or compliant to facilitate loading of tabs 220 into tab pockets 318.
Fig. 14-23 illustrate another embodiment of a loading system 500 according to embodiments herein. As with the embodiment of fig. 1-4C, the loading system 500 includes a balloon guide tube 510, a loading cone 530 and loading ring 550, and a valve seat 570 and a tip guide tube 580. Those skilled in the art will recognize that fig. 14-23 illustrate one example of a loading system, and that existing components illustrated in fig. 14-23 may be removed and/or additional components may be added to loading system 500. Further, portions and features of loading system 500 are interchangeable with similar portions and features of loading system 100 described above with respect to fig. 1-4C. 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 may be used with the remainder of the loading system 100. Moreover, since portions of loading system 500 are similar to like-numbered portions of loading system 100, the description of loading system 500 will focus on differences between loading system 500 and loading system 100.
As explained above, the balloon guide tube 510 is configured to be disposed on a balloon of a delivery system. As shown in fig. 14, 15, and 16A-16C, the balloon guide tube 510 includes a tube 511 having a first (distal) end 512, a second (proximal) end 513, and a passageway 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. A locking member 516 is disposed about tube 511 and includes a lock grip 517 and a lock tube 518.
Fig. 16A-16C illustrate some additional features of balloon guide tube 510 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, the inner rib 611 protrudes from the inner surface of the tube 511, as shown in fig. 15 and 16B. The inner ribs 611 are longitudinally spaced apart from each other and individually extend circumferentially (as shown in fig. 15 and 16B) or at an angle (e.g., spiral) as shown in fig. 16C. The internal ribs 611 distribute forces during loading.
In another example, balloon guide tube 510 includes proximal tab 612 and distal tab 613, as shown in fig. 16A and 16C. Proximal tab 612 and distal tab 613 are used in combination with locking member 516 to lock locking member 516 in place at the distal end of tube 511 in use, as described above. The illustrated embodiment includes four proximal tabs 612 equally distributed about the circumference of tube 511 and four distal tabs 613 equally distributed about the circumference of tube 511, although this is not intended to be limiting and other arrangements may be utilized.
The balloon guide tube 510 further includes an opening 614 adjacent the second (proximal) end 513 of the tube 511, as shown in fig. 15 and 16A. The openings 614 serve as snap-fit receivers for corresponding tabs 623 (fig. 15) extending from the inner surface of the grip 515 to couple the grip 515 to the tube 511. The second (proximal) end 513 of the tube 511 further comprises a longitudinally extending groove 615. The groove 615 is configured to receive a longitudinal extension 622 that extends 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.
As shown in fig. 16B, tube 511 of balloon guide tube 510 may be formed of two halves divided longitudinally. The two portions of tube 511 may be coupled together via mating tabs 616 and recesses 617. Thus, the tabs 616 of one half of the tube 511 are aligned with and received by corresponding recesses 617 in the other half of the tube 511, as shown in fig. 16B. Each of the halves of the tube 511 may further include longitudinal recesses 618 that align with corresponding longitudinal recesses 618 in the other half of the tube 511 to form windows 619 when the halves are coupled, as shown in fig. 16A. Window 619 allows tube 511 to flex in the area of window 619.
Fig. 16D shows an embodiment of the locking member 516. 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 (e.g., thumb grip/slide) is formed on an outer surface of lock tube 518 between proximal portion 620 and distal portion 621. In an embodiment, the inner diameter of lock tube 518 tapers from proximal portion 620 to distal portion 621. In a non-limiting example, the inner diameter at the proximal portion 620 is about 10.10mm and the inner diameter at the distal portion 621 is about 9.90mm. Thus, in the embodiment shown, it is a small taper.
Fig. 17A and 17B illustrate a loading cone 530 according to embodiments herein. The loading cone 530 of fig. 17B includes internal ribs 631 that are not included in the loading cone 530 of fig. 17A. The internal ribs 631 may reduce friction. As with the loading cone 130, the loading cone 530 includes a body 545 that includes 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 inner rib 631 may extend along the length of the tapered portion 535 of the main body 545. However, this is not intended to be limiting, and in other embodiments, the inner rib 631 may extend along only a portion of the tapered portion 535.
Similar to the loading cone 130, the loading cone 530 includes a locking arm 537 for coupling the loading cone 530 to the loading ring 550, as explained in more detail below. The locking arm 537 of the loading cone 530 extends 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 about 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 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 ramp between the lip 541 and the distal end of the arm 537. The locking arms 537 are configured to couple the loading cone 530 with the loading ring 550, as described in more detail below.
The load ring 550 of the loading system 500 is shown in fig. 18A-18B. The load 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 a central passage 555. Still referring to fig. 18A and 18B, the load ring 550 further includes two recesses 551 extending longitudinally along the inner surface of the wall 552. The recess 551 is sized and shaped to receive the locking arm 537 of the loading cone 530. The load ring 550 further slots 557 are provided at a distal end of the recess 551, wherein each slot 557 is configured to receive a corresponding locking arm 537 of the load cone 530. The locking arms 537 extend through the slots 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 slots 557 are sized to enable rotation of the loading cone 530 relative to the loading ring 550, as described above with respect to the loading system 100. However, although the groove 557 is sized to effect rotation, the locking arm 537 is disposed in the recess 551, thereby preventing rotation. Further, in other embodiments, the slots 557 may be sized such that the loading cone 530 may not rotate relative to the loading ring 550. Thus, rotation of the transcatheter heart valve prosthesis 200 for alignment may be achieved by rotation of the valve seat 570, as described below.
The load ring 550 may further include a rib 652 extending proximally from the platform 554. The ribs 652 extend 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.
The load ring 550 may further include openings 654 for creating air paths.
Fig. 19A and 19B illustrate a valve seat 570 according to embodiments herein. Similar to the valve seat 170 described above, the valve seat 570 includes a base 571 having a central aperture 573 and a wall 572 extending from a periphery of the base 571 in a first direction substantially perpendicular to the base 571. The valve seat 570 further includes an orifice wall 574 extending from the periphery of the orifice 573 in a second direction opposite the first direction and generally perpendicular to the base 571. The central passage 575 is defined by an aperture wall 574 and extends in a second direction from a central aperture 573 of the base 571. 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 the base 571, as shown in 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 past the wall 556 defining the central passage 555 such that the lip 576 may prevent longitudinal movement of the valve seat 570 relative to the loading ring 550. However, the valve seat 570 may rotate relative to the loading ring 550 because the orifice wall 574 may 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 may be pressed radially inward (which may be facilitated by the groove 577 in the orifice wall 574) to enable the lip 576 to move away from the end of the wall 556. The slots 577 in the orifice wall 574 also define four sections of the orifice wall 574. These four wall sections of the orifice wall 574 are configured to be received within recesses of the tip guide tube 580, with ribs of the tip guide tube 580 disposed in the grooves 577, as described in more detail below.
In the embodiment of fig. 19A, the valve seat 570 further includes ribs 578 extending along the wall 572. Ribs 578 extend inwardly and longitudinally from wall 572 as distributed around the circumference of wall 572. The ribs 578 assist the valve seat in engaging the transcatheter heart valve prosthesis 200 such that rotation of the valve seat 570 causes corresponding rotation of the transcatheter heart valve prosthesis 200.
As with valve seat 170 described above, various sizes of valve seats 570 may be used such 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.
Fig. 20 shows the loading cone 530, the loading ring 550 and the valve seat 570 separated from each other, and fig. 21 shows the loading cone 530, the loading ring 550 and the valve seat 570 coupled to each other. When used to load the transcatheter heart valve prosthesis 200 into a delivery system, the transcatheter heart valve prosthesis 200 will be disposed on the valve seat 570 within the loading cone 530 and loading ring 550.
Fig. 22 shows the tip guide tube 580 of the loading system 500. Tip guide tube 580 includes a tube 582 and a grip 584. Tube 582 includes a lumen 581 disposed at least partially therethrough and configured to receive tip 308 of delivery system 300, as described above with respect to fig. 8M. In the embodiment of fig. 22, the tube 582 includes recesses 681 and ribs 682 that are alternately disposed about 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 recess 681 is sized and shaped to receive four portions of the orifice wall 574 and the four ribs 682 are sized and shaped to extend through the four slots 577, as shown in fig. 23. However, this is not limiting and more or fewer recesses and ribs may be utilized to mate with more or fewer wall portions and grooves in the valve seat. As further shown in fig. 23, rotation of the tip guide tube 580 imparts corresponding rotation on the valve seat 570, which may rotate within the loading ring 550. With the transcatheter heart valve prosthesis 200 disposed in the valve seat 570, this rotation also imparts a corresponding rotation to the transcatheter heart valve prosthesis 200 to enable alignment of the transcatheter heart valve prosthesis 200 with the delivery system 300, as described above.
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 above-described method mentions rotation of the transcatheter heart valve prosthesis 200 to align its tabs with tab pockets, the tip guide tube 580 will be rotated in place of the loading cone 130 described above.
Fig. 24-26 illustrate a valve seat 670 according to embodiments herein. Fig. 24-26 show schematic illustrations of the valve seat 670. Those skilled in the art will recognize that other features may be added to the valve seat 670 shown in fig. 24-26. For example and without 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 the transcatheter heart valve prosthesis 200 is manually radially compressed to insert the transcatheter heart valve prosthesis 200 into the valve seat, the transcatheter heart valve prosthesis 200 is over-compressed and then bounces back to contact the wall of the valve seat. Such compression and recoil may inadvertently introduce recoverable strain (i.e., pseudo-elasticity) into the frame of the transcatheter heart valve prosthesis 200. Thus, the valve seat 670 includes a living hinge 679 that enables the valve seat 670 to open to receive the transcatheter heart valve prosthesis 200, as described below.
Similar to the valve seats 170, 570 described above, the valve seat 670 includes a base 671 having a central aperture 673, and a wall 672 extending from the periphery of the base 671 in a first direction generally perpendicular to the base 671. In the illustrated embodiment, the wall 672 includes a slot 676 extending in a 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 semi-circular such that the wall 672 and the slot 676 define a circumference about the base 671. The base 671 further includes a living hinge 679 that extends across the diameter of the base 671 from one of the slots 676 to the other of the slots 676 with interruption by the central aperture 673, as shown in 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 unfold or expand, as described below, may also be used.
The valve seat 670 further includes an orifice wall 674 extending from the periphery of the orifice 673 in a second direction opposite the first direction and generally perpendicular to the base 671. The central passage 675 is defined by an orifice wall 674 and extends in a second direction from a central orifice 673 of the base 671. The orifice wall 674 may include a lip or similar feature as described with respect to fig. 19A-19B to couple the valve seat 670 to the loading ring 550, as described above. The orifice wall 674 may also include a second lip or similar feature adjacent the base 671, as shown in fig. 19B. The orifice wall 674 in the embodiment of fig. 24-26 includes two slots 677 that divide the wall 674 into two wall segments 674A, 674B that are approximately semi-circular. The groove 677 enables the wall segments 674A, 674B to be squeezed together to enable a lip (not shown) to clear the end of the wall 556, as described above.
However, in the embodiment of fig. 24-26, pressing the two wall sections 274A, 674B together (as indicated by arrows A-A in the lower portion of fig. 26) causes the wall sections 672A, 672B to open, as indicated by arrow B in the upper portion of fig. 26, due to the living hinge 679 and the slot 676 dividing the wall 672 into the two wall sections 672A, 672B. In other words, where the wall segments 674A, 674B are not pressed 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. 26. When the wall segments 674A, 674B are pressed toward the central longitudinal axis CLA, the end portions 691 of the wall segments 672A, 672B opposite the base 671 flare outwardly relative to the central longitudinal axis CLA, as shown in fig. 25. Upon release of the radially inward force on the wall segments 674A, 674B, the wall segments 674A, 674B and 672A, 672B return to the configuration of fig. 25.
The outward flaring of the wall segments 672A, 672B enables the transcatheter heart valve prosthesis 200 to be inserted into the valve seat 670 without radially compressing the frame 202 of the transcatheter heart valve prosthesis 200. Thus, when the wall segments 674A, 674B are released, the frame 202 is only radially compressed to create a friction fit through the wall segments 672A, 672B, thereby returning the wall segments 672A, 672B to the configuration of fig. 25. Thus, excessive compression and subsequent recoil of the frame 202 is prevented. Instead, the frame 202 is compressed a single time to an appropriate amount of compression to achieve a friction frit (fit) between the transcatheter heart valve prosthesis 200 and the wall 672 of the valve seat 670. This single compression results in the highest interference fit and repeatable interference fit between the transcatheter heart valve prosthesis 200 and the wall 672 of the valve seat 670.
Other features described with respect to the valve seat 170, 570 may be included in the valve seat 670 of fig. 24-26. In particular and without limitation, circumferential ribs 576 and 578 on wall 574 may be included in orifice wall 674. Similarly, the rib 578 shown in fig. 19A 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 such that the same balloon guide tube 110, 510, loading cone 130, 530, loading ring 150, 550, and tip guide tube 180, 580 may be used with various sizes of transcatheter heart valve prostheses by using different valve seats.
Fig. 27-30 illustrate a valve seat 770 according to embodiments herein. Fig. 27-30 show schematic illustrations of the valve seat 770. Those skilled in the art will recognize that other features may be added to the valve seat 770 shown in fig. 27-30. For example and without limitation, features described with respect to valve seats 170, 570, and/or 670 may be included in valve seat 770, where applicable. Similarly, where applicable, features described below with respect to the valve seat 770 may be incorporated into the valve seat 170, the valve seat 570, and/or the valve seat 670. As described above with respect to loading system 500, the valve seat is rotated by the tip guide tube 580. As the valve holder rotates, the transcatheter heart valve prosthesis 200 also rotates. In some embodiments, it may be desirable to avoid the primary means by which the transcatheter heart valve prosthesis 200 is rotationally contacted between the valve seat and the tissue of the transcatheter heart valve prosthesis 200. Thus, as described below, the valve seat 770 includes grooves or pockets in its base that are configured to receive crowns of the transcatheter heart valve prosthesis 200.
Similar to the valve seats 170, 570, 670 described above, the valve seat 770 includes a base 771 having a central aperture 773 and a wall 772 extending from the periphery of the base 771 in a first direction generally perpendicular to the base 771. The valve seat 770 further includes an orifice wall 774 that extends from the periphery of the orifice 773 in a second direction opposite the first direction and generally perpendicular to the base 771.
The central passage 775 is defined by an orifice wall 774 and extends in a second direction from a central orifice 773 of the base 771. The orifice wall 774 may include a lip or similar feature as described with respect to fig. 19A-19B to couple the valve seat 770 to the loading ring 550, as described above. The orifice wall 774 may also include a second lip or similar feature adjacent the base 771, as shown in fig. 19B. In the embodiment of fig. 27-30, the orifice wall 774 includes two wall sections 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 two wall segments 774A, 774B such that the wall segments 774A, 774B and the extensions 778A, 778B alternate around the circumference of the central aperture 773. The valve seat 770 further includes four slots 777 defined between adjacent wall segments 774A, 774B and extensions 778A, 778B. The wall sections 774A, 774B and the extensions 778A, 778B are configured to be received within the recess 681 of the tip guide tube 580, with the ribs 682 of the tip guide tube 580 disposed in the slots 777, as described above. Although the valve seat 770 has been described as having two wall sections 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 sections 774, and more or fewer extensions 778 (including no extensions). Further, the valve seat 770 may include more or fewer slots 777 with the tip guide tube 580 having a corresponding number of ribs 682. It has been found that three of the four wall sections 774 provide increased stability during use. Further, the length of the wall section may vary. Longer legs have been found to provide easier assembly and disassembly of the valve seat from the loading ring 550.
The valve seat 770 further includes a plurality of grooves, recesses, dimples, or pockets 779 that extend into the base 771. Pockets 779 extend into the surface of base 771, which are configured to receive transcatheter heart valve prosthesis 200. In other words, the pocket 779 extends into the surface of the base 771 facing in the first direction. The pocket 779 is configured to receive the crown 207 of the frame 202 of the transcatheter heart valve prosthesis 200. In the illustrated embodiment, the crown 207 at the inflow end 208 of the frame 202 of the transcatheter heart valve prosthesis 200 is received within the pocket 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 without limitation, in the illustrated embodiment, there are fifteen pockets 779 corresponding to fifteen crowns 207 at the inflow end 208 of the frame 202. In the illustrated embodiment, the pocket 779 does not extend completely through the base 771 of the valve seat 770, as can be seen in fig. 28, wherein the pocket 779 is 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/post 212 at the inflow end 208 of the frame 202 that is not covered by the skirt 218 (noted L1 in FIG. 5). The crown 207, which is provided with the recess 779, provides the primary force to rotate the transcatheter heart valve prosthesis 200 when the valve seat 770 is rotated, such as by the tip guide tube 580. Since the primary force for rotating the transcatheter heart valve prosthesis 200 is due to the uncovered crown 207, tissue of the transcatheter heart valve prosthesis 200 (e.g., the prosthetic valve leaflets 206 and skirt 218) is less likely to be damaged than embodiments in which the surface surrounding the outer surface of the frame 202 interacts with the outer surface of the frame 202 to rotate the transcatheter heart valve prosthesis 200.
Other features described with respect to the valve seat 170, 570, 670 may be included in the valve seat 770 of fig. 27-30. In particular and without limitation, circumferential ribs 576 and 578 on wall 574 may be included in orifice wall 774. Similarly, the ribs 578 shown in fig. 19A may be included in the wall 772 of the valve seat 770, although such ribs should not be required due to the pockets 779. As with the valve seats 170, 570, 670 described above, various sizes of valve seats 770 may be used, such that the same balloon guide tube 110, 510, loading cone 130, 530, loading ring 150, 550, and tip guide tube 180, 580 may be used with various sizes of transcatheter heart valve prostheses by using different sizes of valve seats.
Fig. 31 shows a valve seat 870 according to embodiments herein. The valve seat 870 illustrated in fig. 31 is similar to the valve seats 170, 570, 670 and/or 770 described herein. Accordingly, all details of valve holder 870 will not be repeated. Thus, valve holder 870 generally includes a base 871 having a central aperture 873 and a wall 872 extending from the periphery of base 871 in a first direction generally perpendicular to base 871. Valve holder 870 further includes an orifice wall or leg 874 extending from the periphery of orifice 873 in a second direction opposite the first direction and generally perpendicular to base 871. In the embodiment of fig. 31, the wall 872 includes a surface treatment 878 at least partially surrounding the inner circumference of the wall 872 and disposed at least partially along the height of the wall 872. The surface treatment 878 is configured to retain the transcatheter heart valve prosthesis 200 such that when the valve seat 870 is rotated (such as by the pointed guide tube 570), the transcatheter heart valve prosthesis 200 rotates with the valve seat 870. Thus, the surface treatment 878 functions similarly to the rib 578 of the valve seat 570 shown in fig. 19A and the pocket 779 of the valve seat 770 shown in fig. 27-30. The surface treatment 878 may be a variety of injection molded surface finishes. For example and not by way of limitation, various matte layers may be used, such as SPI B-1 or VDI 24. The surface treatment 878 is selected so as to slightly increase friction between the heart valve prosthesis 200 and the valve seat 870 without damaging the inflow wrap/skirt at the inflow portion of the heart valve prosthesis 200. Although fig. 31 shows surface treatments 878 disposed around the entire inner circumference of the wall 872 and partially along the inner length of the wall 872. However, this is not intended to be limiting, and the surface treatment 878 is more or less the interior surface of the wall 872. Where applicable, features of other valve holders described herein may be included in valve holder 870. Similarly, the surface treatments 878 described herein with respect to valve holder 870 may be included in other valve holders described herein.
Fig. 32A and 32B illustrate a valve seat 970 according to embodiments herein. The valve seat 970 shown in fig. 32A and 32B is similar to other valve seats described herein. Accordingly, all details of the valve seat 970 will not be repeated. Thus, the valve seat 970 generally includes a base 971 having a central aperture 973, and a wall 972 extending from the periphery of the base 971 in a first direction generally perpendicular to the base 971. The valve seat 970 further includes an orifice wall or leg 974 extending from the periphery of the orifice 973 in a second direction opposite the first direction and generally perpendicular to the base 971. In the embodiment of fig. 32A and 32B, the wall 972 includes an opening 978 extending from an inner surface of the wall 972 to an outer surface of the wall 972. An opening 978 is provided adjacent to the base 971. The opening 978 enables a user to visualize when the transcatheter heart valve prosthesis 200 has been properly inserted into the valve seat 900. In other words, the opening 978 in the wall 972 adjacent to the base 971 enables a user to see that the crown 207 at the inflow end 208 of the transcatheter heart valve prosthesis 200 rests against the base 971. In the embodiment shown in fig. 32A and 32B, the wall 972 includes eight openings 978. However, this is not intended to be limiting and may include more or fewer openings.
Where applicable, features of other valve seats described herein may be included in valve seat 970. Similarly, the surface treatments 978 described herein with respect to the valve seat 970 may be included in other valve seats described herein. For example and without limitation, a pocket 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 pocket 779 of the base 970. Similarly, features described herein or other valve seats (such as, but not limited to, ribs 578 of valve seat 570 and/or surface treatments 878 of valve seat 870) may also be included in valve seat 970.
Fig. 33A and 33B illustrate similar valve seats 1070A and 1070B according to embodiments herein. The valve seats 1070A and 1070B shown in fig. 33A and 33B are similar to other valve seats described herein. Accordingly, all details of valve seats 1070A and 1070B will not be repeated. Thus, valve seats 1070A and 1070B generally include a base 1071 having a central aperture 1073, and a wall 1072 extending from the periphery of base 1071 in a first direction generally perpendicular to base 1071. Valve seats 1070A and 1070B further include orifice walls or legs 1074 that extend from the periphery of orifice 1073 in a second direction opposite the first direction and generally perpendicular to base 1071. In the embodiment of fig. 33A and 33B, the interior surface of each leg 1074 includes a protrusion 1075A, 1075B that extends toward the central longitudinal axis of the valve seat 1070A, 1070B. In the embodiment of fig. 33A, the protrusion 1075A is a bump. In the embodiment of fig. 33B, the protrusion 1075B is a protruding portion (ledge). However, this is not intended to be limiting and any protrusion compatible with the purposes described herein may be utilized. The protrusions 1075A, 1075B are configured for use 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 holders described herein may be included in valve holders 1070A, 1070B. Similarly, the protrusions 1075A, 1075B described herein with respect to valve holders 1070A, 1070B may be included in other valve holders described herein.
Fig. 34A and 34B illustrate a tip guide tube 780 according to embodiments herein. The tip guide tube 780 is similar to the tip guide tube 580. Accordingly, all details of the tip guide tube 780 will not be repeated. Further, the tip guide tube 780 may include any of the features described herein with respect to other embodiments of tip guide tubes. The tip guide tube 780 generally includes a tube 782 and a grip 784. Further, in the embodiment of fig. 34A and 34B, the tube 782 includes recesses 786 and ribs 788 that extend longitudinally along the tube 782 and are alternately disposed around the outer surface of the tube 782 along a portion of the length of the tube 782. In the embodiment shown in fig. 34A and 34B, there are two recesses 786 and two ribs 788, which correspond to a valve seat comprising two wall portions/legs and two grooves. However, this is not intended to be limiting, and the tube 782 may include any number of recesses 786 and ribs 788, which preferably correspond to the number of wall sections/legs and grooves in a corresponding valve seat with which the tube is used. In the embodiment of fig. 34A and 34B, the tip guide tube 780 further includes a plurality of circumferential ribs or bumps 789 adjacent the proximal end of the longitudinal ribs 786. In the illustrated embodiment, there are two circumferential ribs 789, and each 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 rib 789 interacts with the valve seat (such as valve seat 570) and in particular the wall section/leg 574 of the valve seat 570. The circumferential ribs 789 may interact with protrusions on the inner surfaces of the wall segments/legs (such as protrusions 1075A, 1075B of the valve holders 1070A, 1070B shown in fig. 33A-33B). However, this is not necessary, and the circumferential rib 789 may simply interact with the free end of the wall section/leg of the valve seat and/or the inner surface of the wall section/leg of the valve seat. The circumferential rib 789 provides tactile feedback to a user of the loading system regarding the position of the tip guide tube 780 relative to the valve seat 570 coupled to the loading ring 550. In particular, the tip guide tube 780 should be retracted a certain distance before the balloon 306 is advanced over the transcatheter heart valve prosthesis 200 disposed within the valve seat 570. The tactile feedback provided by the circumferential rib 789 interacting with the valve seat 570 enables the user to confirm that the tip guide tube 780 is properly retracted prior to advancing the balloon 306 of the delivery system 300. Those skilled in the art will recognize that references to particular embodiments of loading system 500 and components thereof are not intended to be limiting, and that other embodiments of these particular components may also be used with tip guide tube 780.
Fig. 35A and 35B illustrate a tip guide tube 880 according to embodiments herein. Tip guide tube 880 is similar to tip guide tube 580. Accordingly, all details of the tip guide tube 880 will not be repeated. Further, the tip guide tube 880 may include any of the features described herein with respect to other embodiments of tip guide tubes. Tip guide tube 880 generally includes a tube 882 and a grip 884. Further, in the embodiment of fig. 35A and 35B, tube 882 includes recesses 886 and ribs 888 that extend longitudinally along tube 882 and are alternately disposed around the outer surface of tube 882 along a portion of the length of tube 882. In the embodiment shown in fig. 35A and 35B, there are four recesses 886 and four ribs 888, which correspond to valve seats comprising four wall portions/legs and two grooves. However, this is not intended to be limiting, and the tube 882 may include any number of recesses 886 and ribs 888, which preferably correspond to the number of wall sections/legs and grooves in the corresponding valve seat with which the tube is used. In the embodiment of fig. 35A and 35B, the tip guide tube 880 further includes a pawl 889 adjacent the proximal end of the longitudinal rib 886. In the illustrated embodiment, there are two pawls 889 disposed approximately 180 degrees apart from each other (i.e., disposed opposite each other) about the circumference of the tube 882. In the illustrated embodiment, pawls 889 are disposed in recesses 886 of tube 882 between adjacent ribs 888. In the illustrated embodiment, the pawl 889 is located in a cutout section 883 of the wall of the tube 882. Pawl 889 is coupled to the tube via lateral connector 887. In the illustrated embodiment, the lateral connector 887 is located at an approximately mid-portion of the length of the pawl 889 such that the pawl 889 resembles a "see-saw" (see-saw) because the longitudinal ends are not attached to the wall of the tube 882. Thus, the pawl 889 can pivot inwardly and outwardly via about 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 the protrusion 885 thereof interacts with a valve seat (such as valve seat 570) and in particular the wall section/leg 574 of the valve seat 570. The detent 889 may interact with protrusions on the inner surfaces of the wall sections/legs (such as protrusions 1075A, 1075B of the valve holders 1070A, 1070B shown in fig. 33A-33B). However, this is not necessary, and the pawl 889 may simply interact with the free end of the wall section/leg of the valve seat and/or the inner surface of the wall section/leg of the valve seat. The pawl 889 provides tactile feedback to a user of the loading system regarding the position of the tip guide tube 880 relative to the valve seat 570 coupled to the loading ring 550. In particular, the tip guide tube 880 should be retracted a distance before the balloon 306 is advanced over the transcatheter heart valve prosthesis 200 disposed within the valve seat 570. The tactile feedback provided by the detents 889 interacting with the valve seat 570 enables the user to confirm that the tip guide tube 880 is properly retracted before advancing the balloon 306 over the transcatheter heart valve prosthesis 200. Those skilled in the art will recognize that references to particular embodiments of loading system 500 and components thereof are not intended to be limiting, and that other embodiments of these particular components may also be used with tip guide tube 880.
Fig. 36A-36C illustrate a tip guide tube 980 according to embodiments herein. The tip guide tube 980 is similar to the tip guide tube 580. Accordingly, all details of the tip guide tube 980 will not be repeated. Further, the tip guide tube 980 may include any of the features described herein with respect to other embodiments of tip guide tubes. Tip guide tube 880 generally includes a tube 982 and a grip 984. Further, in the embodiment of fig. 36A-36C, the tube 982 includes recesses 986 and ribs 988 that extend longitudinally along the tube 982 and are alternately disposed around the outer surface of the tube 982 along a portion of the length of the tube 982. In the embodiment shown in fig. 36A-36C, there are four recesses 986 and four ribs 988, which correspond to a valve seat comprising four wall portions/legs and four grooves. 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 grooves in a corresponding valve seat with which the tube is used. In the embodiment of fig. 36A-36C, 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, protrusions 989 are present in each recess 986, but this is not intended to be limiting, and only some of the recesses 986 may include protrusions 989. The protrusions 989 are 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 protrusions 989 interact with the valve seat (such as the valve seat 570) and particularly the wall segments/legs 574 of the valve seat 570 such that the tube 982 does not interfere with radial compression of the transcatheter heart valve prosthesis 200. As shown in fig. 36B and 36C, the protrusions 989 may interact with protrusions on the inner surfaces of the wall sections/legs (such as protrusions 1075A, 1075B of the valve holders 1070A, 1070B shown in fig. 33A-33B). However, this is not necessary, and the protrusion 989 may simply interact with the free end of the wall section/leg of the valve seat and/or the inner surface of the wall section/leg of the valve seat. The protrusions 989 provide tactile feedback to a user of the loading system regarding the position of the tip guide tube 980 relative to the valve seat 570 coupled to the loading ring 550. In particular, the tip guide tube 980 should be retracted a distance before the balloon 306 is advanced over the transcatheter heart valve prosthesis 200 disposed within the valve seat 570. The tactile feedback provided by the detents 989 interacting with the valve seat 570 enables the user to confirm that the tip guide tube 980 is properly retracted before advancing the balloon 306 over the transcatheter heart valve prosthesis 200. those skilled in the art will recognize that references to particular embodiments of loading system 500 and components thereof are not intended to be limiting, and that other embodiments of these particular components may also be used with tip guide tube 980.
Fig. 37 illustrates a tip guide tube 1080 according to embodiments herein. The tip guide tube 1080 is similar to the tip guide tube 580. Accordingly, all details of the tip guide tube 1080 will not be repeated. Further, the tip guide tube 1080 may include any of the features described herein with respect to other embodiments of tip guide tubes. Tip guide tube 1080 generally includes a tube 1082 and a grip 1084. Further, in the embodiment of FIG. 37, tube 1082 includes recesses 1086 and ribs 1088 that extend longitudinally along tube 1082 and are alternately disposed around the outer surface of tube 1082 along a portion of the length of tube 1082. In the embodiment shown in fig. 37, there are two recesses 1086 (only one shown in side view) and two ribs 1088, which correspond to a valve seat comprising four wall portions/legs and two grooves. However, this is not intended to be limiting, and the tube 1082 may include any number of recesses 1088 and ribs 1086, which preferably corresponds to the number of wall sections/legs and grooves in a corresponding valve seat with which the tube is used. In the embodiment of fig. 37, tip guide tube 1080 further includes protrusions 1089 disposed within recesses 1086 of tube 1082 (only one protrusion 1089 is shown in fig. 37 because the figure is a side view, but a second protrusion 1089 may be disposed opposite the illustrated protrusion 1089). The protrusions 1089 are disposed at longitudinal locations along the length of the tube 1082 such that when the tip guide tube 1080 is fully retracted from the valve annulus 550, the protrusions 1089 interact with the valve seat (such as valve seat 570) and in particular the wall sections/legs 574 of the valve seat 570 such that the tube 1082 does not interfere with radial compression of the transcatheter heart valve prosthesis 200. In the embodiment shown in fig. 37, each protrusion 1089 is formed from a cantilever 1085 that is coupled 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 disposed at a cut-out 1083 of the wall of the tube 1082 such that the free second end portion is movable radially inwardly and outwardly. The free second end of the cantilever 1085 includes a radially outward projection 1087. In the illustrated embodiment, the protrusions 1089, and in particular the radially outward protrusions 1087 thereof, interact with a valve seat (such as valve seat 570) and in particular the wall sections/legs 574 of the valve seat 570. The protrusions 1089 may interact with protrusions on the inner surfaces of the wall sections/legs (such as protrusions 1075A, 1075B of the valve holders 1070A, 1070B shown in fig. 33A-33B). However, this is not necessary, and the protrusions 1089 may simply interact with the free ends of the wall sections/legs of the valve seat and/or the inner surfaces of the wall sections/legs of the valve seat. The protrusions 1089 provide tactile feedback to a user of the loading system regarding the position of the tip guide tube 1080 relative to the valve seat 570 coupled to the loading ring 550. In particular, the tip guide tube 1080 should be retracted a distance before the balloon 306 is advanced over the transcatheter heart valve prosthesis 200 disposed within the valve seat 570. The tactile feedback provided by the protrusions 1089 interacting with the valve seat 570 enables the user to confirm that the tip guide tube 1080 is properly retracted before advancing the balloon 306 over the transcatheter heart valve prosthesis 200. those skilled in the art will recognize that references to particular embodiments of loading system 500 and components thereof are not intended to be limiting, and that other embodiments of these particular components may also be used with tip guide tube 880.
Fig. 38A-38C illustrate a tip guide tube 1180 according to embodiments herein. The tip guide tube 1180 is similar to the tip guide tube 580. Accordingly, all details of the tip guide tube 1180 will not be repeated. Further, the tip guide tube 1180 may include any of the features described herein with respect to other embodiments of tip guide tubes. The tip guide tube 1180 generally includes a tube 1182 and a grip 1184. Further, in the embodiment of fig. 38A-38C, tube 1182 includes recesses 1186 and ribs 1188 extending longitudinally along tube 1182 and alternately disposed around the outer surface of tube 1182 along a portion of the length of tube 1182. In the embodiment shown in fig. 38A-38C, there are four recesses 1186 and four ribs 1188, which correspond to a valve seat comprising four wall portions/legs and two grooves. However, this is not intended to be limiting, and the tube 1182 may include any number of recesses 1186 and ribs 1188, preferably corresponding to the number of wall sections/legs and grooves in a corresponding valve seat with which the tube is used. In the embodiment of fig. 38A-38C, the tip guide tube 1180 further includes a projection 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). Shoulder 1189 is stepped such that tube 1182 has a second outer diameter at recess 1186 that is greater than the first outer diameter in a direction from shoulder 1189 toward grip 1184 (i.e., at 1186B). In the illustrated embodiment, the shoulder 1189 interacts with a valve seat (such as valve seat 570) and in particular the wall section/leg 574 of the valve seat 570. Shoulder 1089 provides tactile feedback to a user of the loading system regarding the position of tip guide tube 1180 relative to valve seat 570 coupled to loading ring 550. In particular, the tip guide tube 1180 should be retracted a distance before the balloon 306 is advanced over 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 balloon 306 over 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 references to particular embodiments of loading system 500 and components thereof are not intended to be limiting, and that other embodiments of these particular components may also be used with tip guide tube 1180.
Fig. 39A and 39B illustrate a tip guide tube 1280 according to embodiments herein. The tip guide tube 1280 is similar to the tip guide tube 580. Accordingly, all details of the tip guide tube 1280 will not be repeated. Further, the tip guide tube 1280 may include any of the features described herein with respect to other embodiments of tip guide tubes. The tip guide tube 1280 generally includes a tube 1282 and a grip 1284. Further, in the embodiment of fig. 39A-39B, the tube 1282 includes recesses 1286 and ribs 1288 that extend longitudinally along the tube 1282 and are alternately disposed around an outer surface of the tube 1282 along a portion of the length of the tube 1282. In the embodiment shown in fig. 39A-39B, there are four recesses 1286 and four ribs 1288, which correspond to valve seats comprising four wall portions/legs and four grooves. 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 grooves in a corresponding valve seat with which the tube is used. In the embodiment of fig. 39A-39B, two of the ribs 1288 extend farther from the grip 1284 than the other two ribs 1288. Further, the longer ribs 1288 include protrusions 1289 that extend radially outward from the corresponding ribs 1288. The projections 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 sufficiently retracted from the valve annulus 550 so that the tube 1282 does not interfere with radial compression of the transcatheter heart valve prosthesis 200. In the illustrated embodiment, two of the ribs 1288 are elongated opposite one another about the circumference of the tube 1282 and include radial projections 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 projections 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 projections 1289. The radial projections 1289 can interact with the valve seat to provide tactile feedback. For example and without limitation, the radial projections 1289 may 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 projections 1289 may interact with any valve seat disclosed herein, and variations thereof, or other components of the loading system. As shown in fig. 39A-39B, the rib 1288 may include a series of protrusions 1289 that indicate a "safe zone" for retraction of the tip guide tube 1280. Those skilled in the art will recognize that references to particular embodiments of loading system 500 and components thereof are not intended to be limiting, and that other embodiments of these particular components may also be used with tip guide tube 1280.
Fig. 40A and 40B illustrate a tip guide tube 1380 according to embodiments herein. The tip guide tube 1380 is similar to the tip guide tube 580. Accordingly, all details of the tip guide tube 1380 will not be repeated. Further, the tip guide tube 1380 may include any of the features described herein with respect to other embodiments of tip guide tubes. The tip guide tube 1380 generally includes a tube 1382 and a grip 1384. Further, in the embodiment of fig. 40A-40B, the tube 1382 includes a tab or pin 1389 adjacent an end 1388 thereof extending radially outwardly of the tube 1382. In particular, in the illustrated embodiment, pins 1389 are disposed equidistantly around the circumference of tube 1382. As can be seen in fig. 40B, the end 1388 of the tip guide tube 1380 is the end that extends through the loading ring 550, the valve seat 570, the loading cone 530 and the transcatheter heart valve prosthesis 200 and protrudes past the smaller diameter end of the loading cone 530. As explained above with respect to fig. 8K and 8L, 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 tab 220 to tab cavity 318 of delivery system 300. The pins 1389 enable a user to align the crown 207 at the outflow end 210 of the transcatheter heart valve prosthesis 200 with the pins 1389. In particular, a user may manually manipulate crown 207 around pin 1389. Wrapping the crowns 207 around the pins 1389 ensures equidistant spacing of the crowns 207 of the outflow ends 210 of the transcatheter heart valve prosthesis 200, thereby mitigating potential outflow crowns crossing over 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.
Fig. 41A-41B illustrate a pusher 4100 according to embodiments herein. Those skilled in the art will appreciate that the pusher 4100 may include additional components not described herein, or that these components may be modified or removed to remain 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 illustrated embodiment, there are two arms 4104, but this is not intended to be limiting and more or fewer arms 4104 may be utilized to conform to the purposes of arms 4104 described herein. The plate 4102 includes an opening 4106 extending therethrough. As shown in fig. 41A-41B, opening 4106 is configured to receive balloon guide tube 510 of loading system 500. Further, arms 4104 are configured to extend around and past load ring 550 of load system 500. For example and without limitation, the load ring 550 may include grooves 4152 extending longitudinally and configured to receive the arms 4104 therein. As shown in fig. 41A, 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. 8T-8V, the pusher 4100 is advanced with the balloon guide tube 510, thereby pushing the grip 584 of the tip guide tube 580. The pusher 4100 thereby ensures that the tip guide tube 580 is retracted such that the tube 582 of the tip guide tube 580 does not interfere with radial compression of the transcatheter heart valve prosthesis 200.
Fig. 42A-42B illustrate a tip guide tube 4280 according to embodiments herein. Tip guide tube 4280 is similar to tip guide tube 580. Accordingly, 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 tip guide tubes. The tip guide tube 4280 generally includes a tube 4282 and a grip 4284. Adjacent to the grip 4284, the tube 4282 comprises a notch 4289. The notch 4289 is configured to interact with the slider 4252. The slide 4252 may be an extension of the load ring 550, as shown in fig. 42A-42B. The slider 4252 comprises a longitudinal portion 4254 and a radially extending portion 4256. The radially extending portion includes a shaped end 4258 configured to fit within a recess 4289 of the tip guide tube 4280. The tip guide tube 4280 comprises a first position shown in fig. 42A, wherein the notch 4289 is distal of the shaped end 4258 of the slide 4252. In this first portion, tip guide tube 4280 can be rotated to align tab 220 of transcatheter heart valve prosthesis 200 with tab recess 318 of main shaft 310 of delivery system 300, as described above. With tab 220 aligned with tab cavity 318, tip guide tube 4280 can be advanced proximally (i.e., to the left in fig. 42A) such that shaped end 4258 of slider 4258 is disposed in notch 4289, as shown in fig. 42B. With the shaped end 4258 disposed in the notch 4289, the tip guide tube 4250 may only retract (i.e., to the right in fig. 42B). The slider 4252 may comprise a button 4255 for engagement by a user to slide the tip guide tube distally (i.e., to the right in fig. 42B) to ensure that the tube 4282 of the tip guide tube 4280 does not interfere with radial compression of the transcatheter heart valve prosthesis 200.
Fig. 43A-43B illustrate a tip guide tube 4380 according to embodiments herein. Tip guide tube 4380 is similar to tip guide tube 580. Accordingly, 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 tip guide tubes. Tip guide tube 4380 generally includes a grip 4384 and a tube 4382 extending proximally from grip 4384. The tube 4282 includes a lumen 4281 extending from a proximal end thereof. As explained above with respect to fig. 8M-8N, 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. In the embodiment of fig. 43A-43B, a spring 4389 is disposed in the lumen 4381. Thus, as tip 308 of delivery system 300 is advanced into lumen 4381, tip 4380 compresses spring 4389. Accordingly, a force must be exerted on tip guide tube 4380 in first direction D1 to maintain tip guide tube 4380 in position to assist in preventing crown 207 at outflow end 210 of transcatheter heart valve prosthesis 200 from collapsing and to assist in positioning tab 220 in tab recess 318, as explained above. Tip guide tube 4380 may be released when tab 220 is positioned in tab cavity 318. The force of the spring 4389 returning to its expanded state (as shown in fig. 43A) will automatically force 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.
Fig. 44A-44B illustrate a tip guide tube 4480 according to embodiments herein. The tip guide tube 4480 is similar to the tip guide tube 580. Accordingly, all details of the tip guide tube 4480 will not be repeated. Further, the tip guide tube 4480 may include any of the features described herein with respect to other embodiments of tip guide tubes. The tip guide tube 4480 generally includes a tube 4482 and a grip 4484. Further, in the embodiment of fig. 44A-44B, the tip guide tube 4480 includes a spring 4489 disposed about the exterior of the tube 4482. In the illustrated embodiment, a first end of the spring 4489 as coupled to the tube 4482 or the grip 4484 is adjacent the grip 4484, and a second end of the spring 4489 extends toward the proximal end of the tube 4482, as shown in 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. 44B, the spring 4489 compresses against the loading ring 550 and grip 4484. Accordingly, a force must be exerted on tip guide tube 4480 in first direction D1 to maintain tip guide tube 4480 in the position shown in fig. 44B, thereby helping to prevent crown 207 at outflow end 210 of transcatheter heart valve prosthesis 200 from collapsing and helping to position tabs 220 in tab pockets 318, as explained above. Tip guide tube 4480 may be released when tab 220 is located in tab cavity 318. The force of the spring 4489 returning to its expanded state (as shown in fig. 43A) will automatically push the tip guide tube 4480 distally (i.e., in a second direction D2 opposite the first direction D1) with force, thereby retracting the tube 4482 of the tip guide tube 4480 sufficiently so that it does not interfere with radial compression of the transcatheter heart valve prosthesis 200.
Fig. 45A-45B illustrate a tip guide tube 4580 according to embodiments herein. Tip guide tube 4580 is similar to tip guide tube 580. Accordingly, 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 tip guide tubes, such as recesses 4586 and ribs 4588. Tip guide tube 4580 generally includes a tube 4582 and a grip 4584. In the embodiment of fig. 44A-44B, tube 4582 includes an enlarged or flared end 4589 (i.e., a proximal end or an end inserted into load ring 550) opposite grip 4484. Flared end 4589 has a diameter DI1 that is greater than the diameter of the distal portion of balloon 308 of delivery system 300. Flared end 4589 prevents tube 4582 of tip guide tube 4580 from entering into the distal end of balloon 308 of delivery system 300. Additionally, lumen 4581 of tube 4582 may taper in a distal direction (i.e., the diameter of lumen 4581 tapers in a direction away from flared end 4589).
Fig. 46 illustrates a tip guide tube 4680 in accordance with embodiments herein. Tip guide tube 4680 is similar to tip guide tube 580. Accordingly, all details of the tip guide tube 4680 will not be repeated. Further, the tip guide tube 4680 may include any of the features described herein with respect to other embodiments of tip guide tubes. Tip guide tube 4680 generally includes a tube 4682 and a grip 4684. Further, in the embodiment of fig. 46, tube 4682 includes recesses 4686 and ribs 4688 extending longitudinally along tube 4682 and alternately disposed about the outer surface of tube 4682 along a portion of the length of tube 4682. In the embodiment of fig. 46, in contrast to the tip guide tube 580 shown in fig. 22 and 23, the recess 4686 and rib 4688 extend along the tube 4682 to the grip 4684, while the recess 681 and rib 682 of the tip guide tube 580 are spaced apart from the grip 584. Further, the rib 4688 of fig. 46 extends proximally (opposite the grip 4684) farther than the rib 682 of the tip guide tube 580. Accordingly, the overall length of tip guide tube 4680 may be shorter than tip guide tube 580 while maintaining approximately the same length of ribs 4688, 682. The reduced overall length of the tip guide tube 4680 reduces the risk of the tip guide tube 4680 extending to the balloon 306 of the delivery system 300 during loading.
Fig. 47 illustrates a tip guide tube 4780 according to embodiments herein. The tip guide tube 4780 is similar to the tip guide tube 580. Accordingly, all details of the tip guide tube 4780 will not be repeated. Further, the tip guide tube 4780 may include any of the features described herein with respect to other embodiments of tip guide tubes. The tip guide tube 4780 generally includes a tube 4782 and a grip 4784. Further, in the embodiment of fig. 47, the tube 4782 includes recesses 4786 and ribs 4788 that extend longitudinally along the tube 4782 and are alternately disposed around the outer surface of the tube 4782 along a portion of the length of the tube 4782. In the embodiment of fig. 46, the ribs 4788 extend along the tube 4782 to the grip 4784 and a shorter distance away from the grip 4784 than the tip guide tube 580 shown in fig. 22 and 23, as shown in fig. 47. The tube 4782 includes a paddle section 4781 at an end thereof opposite the grip 4784. The paddle section 4781 is generally cylindrical and is configured to receive 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 paddle section 4781. The tube 4782 further includes a generally cylindrical section 4785 disposed between the flared section 4783 and the grip 4784. The section 4785 includes a plurality of cutouts 4787 through the wall of the tube 4782. The cut-out 4787 significantly reduces the total weight of the tip guide tube 4780 such that the tip guide tube 4780 floats in a saline bath. Thus, when the tip guide barrel 4780 is used in the method described above with respect to fig. 8A-8Y and in particular with respect to fig. 8O-8R, the tip guide tube 4780 may float out of the loading cone 530, valve seat 570 and loading ring 530, thereby automatically retracting the tube 4782 of the tip guide tube 4780 sufficiently so that it does not interfere with radial compression of the transcatheter heart valve prosthesis 200. Also shown in the embodiment of fig. 47 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 remainder of the loading system 500 prior to compressing the transcatheter heart valve prosthesis 200. Arrows 4789 may be used in any of the embodiments described herein, as may other features described with respect to tip guide tube 4780.
Fig. 48A-48B illustrate a tip guide tube 4880 according to embodiments herein. Tip guide tube 4880 is similar to tip guide tube 580. Accordingly, all details of tip guide tube 4880 will not be repeated. Further, the tip guide tube 4880 can include any of the features described herein with respect to other embodiments of tip guide tubes. Tip guide tube 4880 generally includes a tube 4882 and a grip 4884. Tube 4882 can include recesses (not shown), ribs (not shown), and lumens as described in other embodiments herein. In the embodiment shown in fig. 48A-48B, tip guide tube 4880 includes an arm 4887 extending proximally (i.e., in the same direction as tube 4882) from grip 4884. In the illustrated embodiment, the tip guide tube 4880 includes two arms 4887 that are disposed approximately 180 degrees apart around the circumference of the grip 4884. Further, arms 4887 are each disposed adjacent an outer perimeter of grip 4884, as shown. Each arm 4887 includes a clip 4889 at its proximal end. Each clip 4889 is a radially outward projection (projection) including an inclined surface 4885 such that the clip 4889 at the proximal end projects radially outward more than the adjacent arm 4887, as shown in fig. 48A and 48B. Fig. 48B shows a tip guide tube 4880 disposed within the loading ring 4850 as described above with respect to fig. 1A, 8J-8N, and 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 clasp 4889 of the tip guide tube 4800. In particular, as shown in fig. 48B, each arm 4887 is inserted into a corresponding slot 4852 at the distal end of the load ring 4850, with a corresponding clasp 4889 first entering the slot 4852. When the tip guide tube 4880 is advanced such that the clip 4889 is aligned with the corresponding opening 4854 of the load ring 4850, the clip 4889 pops out of the corresponding opening 4854, as shown in fig. 48B. The clasps 4889 may be squeezed together when it is time to retract the tip guide tube 480 so that it does not interfere with radial compression of the transcatheter heart valve prosthesis 200, thereby automatically retracting the tip guide tube 4880.
Fig. 49A-49E illustrate a balloon guide tube 4910 according to embodiments herein. The balloon guide tube 4910 may be similar to the balloon guide tube 510 described above. Accordingly, not all details of the balloon guide tube 4910 will be described. The balloon guide tube 4910 generally comprises a tube 4911 having a first (distal) end 4912, a second (proximal) end 4913, and a passageway or lumen 4914 extending from the first end 4912 to the second end 4913, such 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. A locking member 4916 is disposed about the tube 4911 and includes a lock grip 4917 and a lock tube 4918. One skilled in the art will recognize that fig. 49A-49D illustrate one example of a balloon guide tube, and that existing components illustrated in fig. 49A-49E may be removed and/or additional components may be added to balloon guide tube 4910.
The tube 4911 of the balloon-guiding tube 4910 further comprises a guide rail 4919 that extends radially outwardly and longitudinally along at least a portion of the tube 4911. In the embodiment of fig. 49A-49E, there are two guide rails 4919 that are diametrically opposed to each other. However, this is not intended to be limiting and more or fewer guide tracks 4919 may be utilized. The locking member 4916 further includes grooves 4920 along its inner surface that are configured to receive the guide rail 4919 therein. Thus, in the illustrated embodiment, there are two recesses 4920, with each recess receiving a corresponding one of the rails 4919 therein. When moving from the unlocked configuration shown in fig. 49A and 49C to the locked configuration shown in fig. 49B and 49D, the rail 4919 and the groove 4920 prevent off-axis movement (e.g., rotational movement) of the locking member 4916. In some embodiments, the guide track 4919 may have an outward taper to minimize rattle (rattle) of the locking member 4916 when the locking member 4916 is in the locked configuration.
The locking member 4916 of the balloon guide tube 4910 further includes a cantilever 4921 formed by a cut-out 4922 in the locking tube 4918 of the locking member 4916. As can be seen in fig. 49A and 49B, each cantilever 4921 extends in a longitudinal direction and is formed by a U-shaped cutout 4922. Further, in the illustrated embodiment, there are four cantilevered arms 4922, two 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 disposed diametrically opposite each other. In other words, the first cantilever 4921 is provided on the proximal side of the lock grip 4917. A second cantilever 4921 is also provided on the proximal side of the lock grip 4917 and is disposed diametrically opposite the first cantilever 4921. Similarly, a third cantilever 4921 is provided on the distal side of the lock grip 4917. A fourth cantilever 4921 is also provided on the distal side of the lock grip 4917 and is disposed diametrically opposite the third cantilever 4921. However, this is not intended to be limiting and other arrangements of cantilever 4921 are contemplated. Cantilever 4921 assists in adapting to dynamic systems. In other words, with the balloon 306 in the unloaded state (i.e., without the transcatheter heart valve prosthesis 200 loaded into the balloon 306) and in the loaded state (i.e., with the transcatheter heart valve prosthesis 200 loaded into the balloon 306), the balloon guide tube 4910 needs to be locked in place on the balloon 306 of the delivery system 300. The diameter of the balloon 306 changes from the unloaded state to the loaded state (e.g., inflated approximately 0.1 mm). Cantilever 4921 exerts a force on both halves of tube 4911 to hold tube 4911 closed during initial loading of tabs 220 of heart valve prosthesis 200. As the remainder of the transcatheter heart valve prosthesis 200 is loaded into the balloon 306, the radially outward force on the balloon guide tube 4910 increases. As the force increases, cantilever 4921 is configured to flex to allow the two halves of tube 4911 to expand (i.e., move away from each other) to reduce high loading forces while retaining tabs 220 of transcatheter heart valve prosthesis 200 within tab pockets 318 of main shaft 310.
Fig. 50A-50B illustrate a balloon guide tube 5010 according to embodiments herein. The balloon guide tube 5010 may be similar to the balloon guide tube 510 and balloon guide tube 4910 described above. Accordingly, not all details of the balloon guide tube 5010 will 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 passageway or lumen 5014 extending from the first end 5012 to the second end 5013 such 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. A locking member 5016 is disposed about the tube 5011 and includes a lock grip 5017 and a lock tube 5018. Similar to the embodiment of fig. 49A-49E, the balloon guide tube 5010 further includes a rail 5019 on the tube 5011 and a groove 5020 in the lock tube 5018. The balloon guide tube further includes a cantilever 5021 and a recess 5022 on the lock tube 5018 as described above. Those skilled in the art will recognize that fig. 50A-50B illustrate one example of a balloon guide tube, and that existing components illustrated in fig. 50A-50B 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 comprises two halves that are split longitudinally. In the embodiment of fig. 50A-50B, each half of the tube 5011 includes a pin 5023 and/or a recess 5024. The recess 5024 is configured to receive a 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 the recess 617 of the tube 511.
Fig. 51A-51C illustrate a balloon guide tube 5110 according to embodiments herein. The balloon guide tube 5110 may be similar to the balloon guide tube 510 and balloon guide tube 4910 described above. Accordingly, not all details of the balloon guide tube 5010 will 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 passageway or lumen 5114 extending from the first end 5112 to the second end 5113 such 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. In the embodiment of fig. 51A-51C, the tube 5111 includes an internal taper 5125. The inner taper 5125 is positioned approximately longitudinally where the proximal portion of the locking tube 5118 is where the locking member 5116 is in the locked configuration shown in fig. 51A. In particular, the lumen 5114 has a first diameter 5126A proximal to the inner taper 5125 and a second diameter 5126B distal to the inner taper 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 6.1mm and the second diameter 5126B can be approximately 5.9mm. However, this is not intended to be limiting, and the actual size depends on the size of the bladder 306 of the delivery system 300. For example and without limitation, these diameters may be selected based on the amount of radial compression desired, such as 0.1mm or 0.2 mm. Tube 5111 further includes a ramp 5127 on the outer surface of 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 51268. In a non-limiting embodiment, the first outer diameter 5128A can be approximately 8.9mm and the second outer diameter 5128B can be approximately 10.3mm. The axial position of the inner taper 5125 and the length of the outer ramp 5127 allow the balloon 306 to be compressed proximally. The axial position of the inner taper 5125 provides additional restraint to the region of the balloon 306 that expands minimally during loading, thus minimizing adverse effects on loading forces. The inner taper 5125 provides an interference fit with the bladder 306, rather than compressing the bladder 306. Although not described with respect to fig. 51A-51C, features of other embodiments described herein may be combined with the balloon guide tube 5110, such as, but not limited to, a rail on the tube and a groove in the lock tube, to prevent off-axis movement of the locking member 5116.
Fig. 52A-52C illustrate a balloon guide tube 5210 according to embodiments herein. Balloon guide tube 5210 can be used in a similar manner to 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 a proximal direction. The flared portion 5218 is configured to be received within a proximal end of the loading funnel 530. Lumen 5214 extends through tube 5211, locking member 5220 and flared portion 5218. Lumen 5214 is configured to receive balloon 306 (shown in phantom) therein.
A locking member 5220 is coupled to the proximal end of the tube 5211. The locking member 5216 includes a housing 5222 defining a portion of the lumen 5214. The latch 5230, compression spring 5240 and 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.
Compression lock 5230 is shown in detail in fig. 52B. The compression lock includes a base 5232 and compression legs 5236. The base 5232 includes a central opening 5234 configured to receive the balloon 306 of the delivery system 300 therethrough. The base 5232 abuts the distal end of the housing 5222 as shown in fig. 52C. The compression legs 5236 apply a radially inward force to an object, such as a bladder 306 disposed therethrough. In the illustrated embodiment, the compression leg 5236 includes 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 exert 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, and a bend 5239 at a 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 from the first portion 5233A (i.e., generally parallel to the central longitudinal axis of the lumen 5214). The second portion 5233B provides a smooth surface for interaction with the bladder 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 are moved radially apart, but exert a radially inward force on the balloon, thereby securing the balloon guide tube 5210 to the balloon 306.
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 such 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 clear of the housing 5222, thereby allowing a user to longitudinally move the actuator 5256 and thus the release slide 5250, as indicated by arrow A1 in fig. 52C.
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. 52C. The compression spring 5240 is disposed in the housing 5222 between the actuator 5256 (at the proximal end of the compression spring 5240) and a shoulder or wall 5222 of the housing 5222 (at the distal end of the compression spring 5240). Thus, as the actuator 5256 moves distally (i.e., in the direction of arrow A1), the compression spring 5240 compresses between the actuator 5256 and the shoulder 5222 and applies a force proximally (i.e., in the direction of arrow A2).
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 expanding the compression legs 5236 from one another. Then, the balloon guide tube 5210 can 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 forces the actuator and thus the release slide 5250, including the longitudinal portion 5252, proximally in the direction of arrow A2. With the longitudinal portion 5252 withdrawn from within the compression leg 5236, the compression leg 5236 moves radially inward, thereby securing the bladder 306 therein. After the transcatheter heart valve prosthesis 200 is loaded into the balloon 306, the actuator 5256 can be moved distally such that the longitudinal portion 5252 of the release slide 5250 expands the compression legs 5236, thereby releasing the balloon 306 from the balloon guide tube 5210. With the actuator 5256 actuated as described, the balloon guide tube 5210 can be removed from the balloon 306.
Balloon guide tubes, such as balloon guide tube 5210 with compression legs 5236, alleviate tight tolerances that may be required in other balloon guide tubes. Further, the balloon guide tube 5210 provides proximal compression (i.e., compression legs 5236 are provided at a proximal portion of the balloon 306). Compressing the balloon guide tube 5210 proximally onto the balloon 306 moves the compressive force on the balloon 306 proximally (i.e., away from the distal opening of the balloon 306). When the transcatheter heart valve prosthesis 200 is loaded into the balloon 306, the loading force is highest near the distal end of the balloon 306. Bringing the compressive force on the balloon 306 from the balloon guide tube at or near the highest loading force (which is the inflation force on the balloon 306) increases the loading force. Thus, moving the compressive force exerted by the balloon guide tube on the balloon 306 proximally reduces the loading force.
Fig. 53A-53C illustrate a balloon guide tube 5310 according to embodiments herein. The balloon guide tube 5310 may be similar to the balloon guide tube 510 described above. Accordingly, not all details of the balloon guide tube 5310 will 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 passageway or lumen 5314 extending from the first end 5312 to the second end 5313 such that the balloon guide tube 5310 can be disposed over the balloon 306 of the delivery system 300, as described above and shown in fig. 53A-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. In the embodiment of fig. 53A-53C, the tube 5311 includes an opening 5315 adjacent the proximal end 5213 thereof. An opening 5315 extends through the wall of 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 when moving the locking member 5316 to prevent the outer shaft 304 and the balloon 306 from moving during a locking procedure. Opening 5315 may 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 embodiment of fig. 53A-53C, the locking member 5316 is moved distally via rotation thereof, as indicated by arrow A3 in fig. 53A-53B. Moving the locking member 5316 via rotation rather than linear translation may provide more stability and control of movement. Further, rotation may typically better ensure that the locking action will be completed. In other words, there is a high risk that the locking member, which is moved via linear translation, may not slide completely into place.
Fig. 54A to 54B schematically illustrate a balloon guide tube 5410 according to embodiments herein. The balloon guide tube 5410 may be similar to the balloon guide tube 510 described above. Accordingly, not all details of the balloon guide tube 5410 will be described. Balloon guide tube 5410 generally tube 5411, grip 5415, and locking member 5416 configured to lock balloon guide tube 5410 to balloon 306 of delivery system 300, as explained above. Details of these features need not be repeated here. As explained with respect to other embodiments above, the locking member 5416 may include a lock grip 5417 and a lock tube 5418. In the embodiment of fig. 54A-54B, the locking member 5416 includes a window or opening 5320 through the wall of the lock tube 5418 at the distal end of the locking member 5416. The opening 5420 enables a user to visualize the distal end of the balloon 306 through the opening 5420 to ensure that the balloon guide tube 5410 and the balloon 306 are properly aligned when the locking member 5416 reaches the locked configuration shown in fig. 54A-54B. The opening 5420 may be incorporated into any of the embodiments described herein.
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. In the embodiment shown in fig. 55, the locking member 5516 is formed of an elastic material (such as rubber). As explained above, tube 511 of balloon guide tube 510 may be formed of two halves. Thus, the resilient material of the locking member 5516 provides resilient compression of the tube 511 of the balloon guide tube 510, thereby enabling the two halves of the tube 511 to deflect transiently during loading of the transcatheter heart valve prosthesis 200 into the balloon 310. This transient deflection reduces loading forces when loading the transcatheter heart valve prosthesis 200 into the balloon 306. For example and without limitation, the material of the locking member 5516 may be rubber (TPU, NR, SBR, IIR, NBR, CR, EPDM, Q, FKM, AU, HNBR), foam-based polymer (PUR, PVC, PE, ABS), and/or polymers having a shore a hardness value between 50A and 60 (e.g., medical grade thermoplastic polyurethane, thermoplastic elastomer, polyurethane, and silicone).
In another embodiment herein shown in fig. 56, the locking member 5616 may be formed from at least two materials. In particular, as shown in fig. 56, an inner material layer 5624 and an outer material layer 5625. The inner material layer 5624 may be an elastic material such as, but not limited to, rubber (TPU, NR, SBR, IIR, NBR, CR, EPDM, Q, FKM, AU, HNBR), foam-based polymer (PUR, PVC, PE, ABS), and/or polymer having a shore a hardness value between 50A and 60 (e.g., medical grade thermoplastic polyurethane, thermoplastic elastomer, polyurethane, and silicone). The outer material layer 5625 may be a hard polymeric material such as, but not limited to, high shore hardness polymers (ABS, PC), metal (SS, aluminum), glass, translucent polycarbonate (e.g., mold clone (Makrolon) 2458), acrylic (e.g., PMMA), and/or PETG. The resilient inner material layer 5624 enables transient deflection of the tube 511 of the balloon guide tube 510, as explained above with respect to fig. 55. The hard outer material layer 5625 improves ergonomics and provides an outer expansion limit for the tube 511, thereby preventing over-expansion of the tube 511 of the balloon guide tube 510.
Fig. 57 and 58 show two embodiments of loading cones 5730 and 5830. Loading cones 5730 and 5830 may be similar to loading cone 530 described above with respect to fig. 17A and 17B. The loading cones 5730 and 5830 of fig. 57 and 58, respectively, include bodies 5745, 5845 having sloped or contoured distal portions 5731, 5831, respectively. In other words, as shown in fig. 57 and 58, the respective distal end portions 5731, 5831 follow a contour that returns from one of the locking arms 5737, 5837 toward the proximal end portion 5732, 5832 of the main body 5745, 5845, and then toward the other locking arm 5737, 5837. This profile is repeated on opposite sides of the locking arm. The contoured distal portions 5731, 5831 of the bodies 5745, 5845 provide clearance between the loading cones 5730, 5830 and the loading ring 550 of the loading system 500. This gap enables air to escape the loading system 500, thereby alleviating any risk of air embolism. Although each of fig. 57 and 58 shows a repeating profile on opposite sides of the locking arms 5737, 5837, this is not intended to be limiting. In other embodiments, only one side of the distal portions 5731, 5831 need be contoured. Further, as explained above with respect to fig. 1A and 2, instead of or in addition to the contoured distal end of the loading cone, the loading cone may include a vent hole for air release (such as vent hole 142 described above).
It should be understood that the various embodiments disclosed herein may be combined in different combinations than specifically presented in the specification and drawings. It should also be appreciated that, according to an example, certain acts or events of any of the processes or methods described herein can be performed in a different order, may be added, combined, or omitted entirely (e.g., all of the described acts or events may not be necessary to implement the techniques). Furthermore, while certain aspects of the present disclosure are described as being performed by a single device or component for clarity, 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, medical devices.