阅读说明：本技术 用于装载支架和人工心脏瓣膜的卷曲装置 (Crimping device for loading stents and prosthetic heart valves ) 是由 杰森·福克斯 大卫·特拉斯克 于 2018-05-30 设计创作，主要内容包括：本文公开了用于卷曲医疗设备的系统和装置以及相关方法。根据本技术的实施方案配置的卷曲装置可以包括例如框架、可移动构件和多个叶片,所述框架包括固定板,所述叶片被布置为形成通道,并且每个叶片包括穿过可移动构件上的槽和固定板上的相应槽突出的销。卷曲装置可被驱动以相对于固定板移动可移动构件,使得沿着由槽限定的路径驱动销,从而径向向内驱动叶片以卷曲位于通道内的医疗设备。(Systems and devices for crimping medical devices and related methods are disclosed herein. A crimping device configured in accordance with embodiments of the present technology may include, for example, a frame including a stationary plate, a movable member, and a plurality of blades arranged to form a channel, and each blade including a pin protruding through a slot on the movable member and a corresponding slot on the stationary plate. The crimping device may be driven to move the movable member relative to the fixed plate such that the pins are driven along the path defined by the slots, thereby driving the blades radially inward to crimp the medical device located within the channel.)

A crimping device of the type , comprising:

a fixed plate having a plurality of th slots;

a movable member having a plurality of second slots, wherein each second slot is aligned with a portion of a respective th slot;

a plurality of movable vanes circumferentially arranged to form a channel having a central axis extending therethrough, wherein

Each vane has an th end and a second end, and wherein the second end is more radially distal from the central axis than the th end,

each blade includes a pin extending from a second end of the blade, an

Each pin extending through of the th slots and of the corresponding second slots, and

a drive device operatively connected to the movable member and configured to move the movable member relative to the fixed plate, wherein movement of the movable member drives the plurality of pins along a path defined by the th and second slots such that the plurality of blades move radially inward to reduce a diameter of the channel, and wherein radially inward movement of the blades is configured to reduce a diameter of a medical device located within the channel to accommodate a size of a delivery capsule implanted in the medical device using a minimally invasive procedure.

2. The crimping device of claim 1, wherein the blade includes an th side and a second side facing away from the th side, the securing plate is a th securing plate facing a th side of the blade, the movable member is a th movable member facing a th side of the blade, and each pin is a th pin on a th side of each blade, and wherein the crimping device further comprises:

a second fixing plate facing a second side surface of the blade, the second fixing plate having a plurality of third grooves;

a second movable member facing a second side of the blade, the second movable member having a plurality of fourth slots,

wherein (A) ─

Each blade includes a second pin extending from the second end on the second side of the blade,

each second pin extends through of the third slots and of the corresponding fourth slots, an

A drive device is operatively connected to the th and second movable members and configured to move the th and second movable members relative to the th and second stationary plates to drive the plurality of blades to change the diameter of the passage.

3. The crimping device of claim 1, wherein the second slot defines an arcuate path having an th end and a second end closer to the channel than a th end.

4. The crimping device according to claim 1, wherein a diameter of the passage varies along the central axis.

5. The crimping device of claim 1, wherein the blade has an inner surface defining the channel, and wherein the shape of the inner surface is such that the channel has a generally funnel-like shape.

6. The crimping device according to claim 1, wherein the plurality of blades comprises twelve blades.

7. The crimping device of claim 1, wherein — -

The movable member has an th position, the passageway has a maximum diameter at the th position,

the movable member has a second position in which the passage has a minimum diameter, and

the pin is radially further from the central axis in the th position than in the second position.

8. The crimping device of claim 1, further comprising the steps of:

a frame; and

a retainer removably connected to the frame and configured to retain a medical device within the channel when the blade reduces a diameter of the medical device.

9. The crimping device of claim 8, wherein — -

The movable member has a th position and a second position,

the diameter of the passageway at the second location is less than the diameter at the th location, and

the retainer includes a plurality of fingers configured to engage portion of the medical device in the position and configured to disengage from portion of the medical device in the second position.

10. The crimping device according to claim 1, wherein said th slot defines a straight path extending radially away from said central axis.

11. The crimping device according to claim 1, wherein a length of the second slot is longer than a length of the th slot.

12. The crimping device according to claim 1, wherein said th slot and said second slot are angularly equally spaced about said central axis.

13. The crimping device of claim 1, further comprising a connector connected to the movable member and having a threaded bore extending therethrough, wherein —)

The movable member is a rotatable member that is,

the drive means is a threaded shaft and extends through a threaded bore of the connector, and

driving the rotatable member includes rotating the threaded shaft about a longitudinal axis of the threaded shaft such that the connector moves along the threaded shaft.

14. The crimping device of claim 1, wherein the channel is configured to receive a prosthetic heart valve device for implantation in a native mitral valve, and wherein the leaflets are configured to reduce an outer diameter of the prosthetic heart valve device from 1.300 inches to 0.4 inches or less.

15, a system for reducing the size of a stent device, the system comprising:

A crimping device, comprising

A frame having a fixed plate having a plurality of th slots,

a movable member having a plurality of second slots, wherein the movable member is movable relative to the fixed plate,

a plurality of movable vanes circumferentially arranged to define a channel having a central axis extending therethrough, wherein

The channel is configured to receive a prosthetic heart valve device in an unexpanded state,

the movable member is located between the blade and the fixed plate,

each vane having an th end and a second end, the second end being more radially distal from the central axis than the th end,

each vane includes a pin projecting from the second end and extending through of the th slots and of the corresponding second slots, an

A drive device configured to move the movable member to drive the plurality of vanes between a position where the channel has a th cross-sectional dimension and a second position where the channel has a second cross-sectional dimension less than th cross-sectional dimension, wherein moving the vanes from the position to the second position reduces the outer dimension of the cradle device, and wherein the th slot is configured to maintain a relative position between the vanes as the vanes move between the th position and the second position, and

a retainer removably connected to the frame and configured to retain the bracket device within the channel when the blade is in the th position.

16. The system of claim 15, wherein the leaflets are configured to continuously pinch the prosthetic heart valve device as the leaflets move from the position to the second position.

17. The system of claim 15, wherein the channel has a funnel shape.

18. The system of claim 15, further comprising a tray defining the reservoir configured to receive the crimping device therein.

19. The system of claim 18, wherein the reservoir is configured to contain a cooling liquid therein, and wherein the liquid fills the channel when the crimping device is positioned within the reservoir.

20. The system of claim 18, wherein the tray includes an aperture extending through the tray to the reservoir, wherein the channel of the crimping device is accessible through the aperture to allow the prosthetic heart valve device to be positioned within the channel.

21. The system of claim 15, wherein — -

The retainer includes a plurality of fingers configured to engage an attachment feature of a prosthetic heart valve device at the th location, and

the blade is sized and shaped to press against the finger to disengage the connecting member from the retainer when the blade is moved from the th position to the second position.

22. The system of claim 15, wherein the pin is more radially away from the central axis of the passage in the position than in the second position.

23, a method for reducing the size of a medical device loaded into a delivery capsule, comprising:

positioning the medical device within a channel of the crimping device, wherein —

The channel is defined by a plurality of movable vanes arranged circumferentially about a central axis of the channel,

each vane includes a pin extending from an end of the vane, the pin being radially spaced from the channel, and

each pin projecting through a th slot in the fixed plate and a second slot in the movable member between the fixed plate and the vane, and

driving the vanes radially inward from the th position to a second position to reduce a cross-sectional dimension of the channel to reduce an outer diameter of the medical device, wherein driving the vanes includes moving the movable member relative to the fixed plate to move the pins along the respective arcuate paths defined by the respective second slots.

24. The method of claim 23, wherein driving the vane radially inward comprises driving the vane from the th position to the second position, wherein the th position channel has a minimum cross-sectional dimension of at least 1.300 inches and the second position channel has a minimum cross-sectional dimension of at most 0.4 inches.

25. The method of claim 23, wherein driving the vanes radially inward comprises moving each pin from an th end of the arcuate path to a second end of the arcuate path, wherein the second end of the arcuate path is closer to the central axis of the channel than the th end.

26. The method of claim 23, wherein driving the blades radially inward comprises continuously compressing the medical device.

27. The method of claim 23, wherein the medical device is a prosthetic heart valve device, and wherein the method further comprises:

removably connecting a plurality of engagement features of the prosthetic heart valve device to a corresponding plurality of fingers of a retainer, wherein the retainer retains the prosthetic heart valve device when the leaflets are in the th position, and

wherein driving the paddle radially inward presses the paddle against the outer surface of the finger to disengage the engagement feature from the retainer.

28. The method of claim 23, wherein the blade has an inner surface defining the channel, wherein the inner surface is shaped such that the channel has a generally funnel-like shape, and further comprising:

after driving the blade to the second position, moving the medical device through the passageway toward the delivery capsule to further reduce the outer diameter of the medical device.

29. The method of claim 23, further comprising immersing the crimping device in a liquid such that the medical device is immersed in the liquid when positioned within the channel.

Technical Field

Specifically, embodiments of the present technology relate to compact crimping devices for reducing the size of prosthetic heart valve devices.

Background

Medical devices such as stents and prosthetic valve devices may be introduced into the lumen of a body vessel by percutaneous catheterization.

For example, some prosthetic mitral valves may have an expanded cross-sectional dimension of 1.97 inches or more.

Drawings

In addition, for clarity, elements may be shown in some views as transparent, rather than to indicate that the illustrated elements must be transparent.

Fig. 1 is an isometric view of a system for reducing the size of a medical device, the system configured in accordance with embodiments of the present technique.

Fig. 2 and 3 are isometric views of a crimping device of the system of fig. 1 in and a second position, respectively, in accordance with embodiments of the present technique.

Fig. 4 is a partially exploded view of the crimping device shown in fig. 2 and 3.

Fig. 5 is an isometric view of the blades of the crimping device shown in fig. 2-4, configured in accordance with embodiments of the present technique.

Fig. 6 is an isometric view of a medical device holder releasably coupled to portion of a prosthetic heart valve device for use with the system of fig. 1 in accordance with embodiments of the present technique.

Fig. 7 and 8 are isometric and cross-sectional views, respectively, of the medical device holder of fig. 6 coupled to the crimping apparatus of fig. 2-4, shown in accordance with embodiments of the present technique.

Fig. 9 is a top view of a tray of the system of fig. 1, the system tray configured in accordance with various embodiments of the present technique.

Detailed Description

Although many embodiments are described with respect to devices, systems, and methods for crimping, loading, and delivering a prosthetic heart valve device to a native mitral valve, other applications and other embodiments in addition to those described herein are within the scope of the present technology.

With respect to the terms "distal" and "proximal" in this specification, unless otherwise indicated, these terms may refer to the relative position of portions of the prosthetic valve device and/or associated delivery device with respect to the operator and/or a location in the vascular system or heart. For example, in reference to a delivery catheter adapted to deliver and position the various prosthetic valve devices described herein, "proximal" may refer to a location closer to a device operator or an incision into the vasculature, and "distal" may refer to a location further away from the device operator or from the incision along the vasculature (e.g., the end of the catheter).

SUMMARY

Fig. 1 shows an embodiment of a crimping and loading system 10 ("system 10") for reducing the size of a medical device in accordance with the present techniques, specifically, the system 10 may be used to crimp or compact a medical device to enable loading of the medical device into a delivery system for percutaneous delivery of the medical device to a patient in embodiments, the medical device may be a prosthetic heart valve device, more specifically, the medical device may be a mitral valve device for implanting a native mitral valve, and the delivery system may be a delivery system for delivering the mitral valve device to the native mitral valve, such as PCT/US2014/029549 international patent application No. (1) filed on 3/14 of 2012, (2) PCT/US2012/061219 international patent application No. (3) filed on 10/19 of 2012, (3) PCT/US2012/061215 international patent application No. (4) filed on 6/21 of 2012, (5) US 3618 of 2017, (36 of 2017) international patent application No. (53918 of 2017, and No. (53918 of wo 36 of wo 6/53918).

As shown in FIG. 1, system 10 includes crimping apparatus 100, a medical device holder 200 ("holder 200"), a tray 300, and a stent 400. crimping apparatus 100 includes a plurality of blades (not visible; described in further detail below at ) that define a channel 115 and a drive member 105, channel 115 configured to receive a medical device in an expanded state, drive member 105 operably connected to the blades. a user may manipulate drive member 105 to change or reduce a cross-sectional dimension (e.g., diameter) of channel 115 to thereby reduce an outer dimension of the medical device located within channel 115. in some embodiments , holder 200 is releasably connected to the medical device and then detachably connected to inlet side 101 of crimping apparatus 100 such that holder 200 properly positions the medical device within channel 115 of crimping apparatus 100 prior to and/or during crimping.

As shown in fig. 1, crimping device 100 may be at least partially positioned within reservoir 310 in tray 300. in embodiments, tray 300 includes a plurality of flanges 305, flanges 305 protruding into reservoir 310 and defining recesses 315, recesses 315 sized and shaped to retain crimping device 100 such that channels 115 are positioned within reservoir 310. in other embodiments, tray 300 may include different or additional features, such as fasteners, interlocking surfaces, and/or other suitable retaining features, for retaining and properly positioning crimping device 100 within tray 300. when crimping device 100 is positioned within recesses 315, reservoir 310 may contain a liquid (e.g., frozen saline) that submerges channels 115. as shown in step of fig. 1, tray 300 may also include apertures 320 for receiving therethrough portions of delivery system 600 and facilitating loading of crimped medical devices into delivery system 600. for example, elongate body 610 of delivery system 600 may be inserted through apertures and/or delivery capsule 320, and outlet side 103 of crimping device 100 may be positioned adjacent to exit side port 300 in alignment with delivery system 300, or may include multiple sealing features 595 for allowing fluid to be removed from reservoir 300 in embodiments, including seal carrier 300, 400, or seal carrier assembly 300 may be positioned within reservoir 300, or may include multiple sealing features, 592, and/or seal components, such that when crimping device 100 is positioned within recess 315.

In operation, crimping device 100 is positioned within recess 315 of tray 300 when the medical apparatus is in its expanded state (e.g., unconstrained state), the medical apparatus, such as a prosthetic heart valve device, is releasably connected to retainer 200, and then retainer 200 is connected to inlet side 101 of crimping device 100 such that the medical apparatus extends into channel 115. in embodiments, retainer 200 is attached to inlet side 101 of crimping device 100 before crimping device 100 is positioned within recess 315 of tray 300. in embodiments, the medical apparatus may be packaged with retainer 200 and pre-attached to retainer 200. in embodiments, retainer 200 is omitted and the medical apparatus may be placed itself in channel 115 and/or releasably attached to another portion of crimping device 100 to retain the medical apparatus in channel 115. before or after the medical apparatus is positioned in channel 115, reservoir 310 of tray 300 may be filled with a liquid (e.g., frozen saline) such that channel 115 of crimping device 100 and the medical apparatus positioned therein may be submerged in the liquid to reduce the size of the medical apparatus when the crimping device 100 is in a submerged cooling external medical apparatus.

When the system 10 is used to facilitate loading of the device into the delivery system 600, the distal portion of the catheter body 605 may be positioned through the aperture 320 such that the delivery capsule 610 at the distal end of the catheter body 605 is located on the exit side 103 of the crimping device 100, adjacent the channel 115 in embodiments, the distal nose cone (nose cone) of the delivery capsule 610 and the elongate central shaft attached thereto are inserted at least partially through the channel 115 and the unconstrained medical device (e.g., toward the entrance side 101 of the crimping device 100, beyond the distal end of the medical device). the stent 400 may be positioned to support the catheter body 605 and/or other portions of the delivery system 600 outside of the tray 300 and align the delivery system 600 with the aperture 320 of the tray 300 and the channel 115 of the crimping device 100.

once the delivery system 600 and medical device are properly positioned relative to the crimping device 100, the user can manipulate the drive member 105 of the crimping device 100 to reduce the cross-sectional dimension of the channel 115, thereby reducing the outer dimension of the medical device (i.e., "crimp" the medical device). in embodiments, the medical device is crimped to accommodate the size of the delivery capsule 610 for implantation of a minimally invasive procedure into the medical device. in embodiments, reducing the cross-sectional dimension of the channel 115 disengages the retainer 200 from the medical device such that the medical device is no longer attached to the retainer 200, allowing the medical device to be later removed from the channel 115 (e.g., via the exit side 103 or entrance side 101 of the crimping apparatus 100).

upon crimping of the medical device, the medical device may be loaded into the delivery system 600 for subsequent delivery to the patient. for example, the portion of the delivery system 600 may be configured to engage the medical device and pull the crimped medical device into the delivery capsule 610 and/or catheter body 605. in embodiments , the piston means of the delivery system 600 engages a feature of the medical device and then retracts to pull the medical device into the delivery capsule 610. in embodiments , the channel 115 of the crimping device 100 has a generally funnel-like shape wherein the diameter of the channel 115 decreases along an axis from the inlet side 101 to the outlet side 103 (i.e., away from the holder 200 and toward the delivery capsule 610). in such embodiments, as the medical device is pulled from the wider diameter portion of the channel 115 and through the narrower diameter portion of the channel 115, the medical device is pulled into the delivery capsule 610 may be advanced steps to crimp the portion of the medical device, in embodiments , the medical device is pulled into the delivery system 600 while the fluid in the reservoir 310 is in the reservoir, the balloon 600 is configured to be fully loaded with the delivery system 600, thereby providing a sterile, the balloon 600, the delivery system 600, the balloon may be configured to be fully loaded, and then loaded, and subsequently, and then, loaded, and then, loaded with the balloon 10, or the balloon 10, and the system, or the balloon, and then, or the balloon, or the system, and the balloon, loaded system, or.

Selected embodiments of crimping apparatus, medical device holders, and related methods

Fig. 2 and 3 are isometric views of the crimping device 100 of fig. 1 showing the crimping device 100 in a th position and in a second position, wherein the channel 115 in a th position has a th cross-sectional dimension (fig. 2) and the channel 115 in the second position has a second cross-sectional dimension (fig. 3). fig. 4 is an isometric partially exploded view of the crimping device 100 of fig. 2 (i.e., showing the crimping device 100 in a th position). in embodiments, the th and second cross-sectional dimensions are maximum and minimum cross-sectional dimensions, respectively.a crimping device 100 includes a frame 110, a plurality of movable vanes 140, the movable vanes 140 being circumferentially disposed within the frame 110 to define the channel 115, the channel 115 having a central axis 107 extending therethrough.

Referring to fig. 4, the frame 110 may include a th plate 120 and a second plate 130 (collectively " plates 120, 130"), the th plate 120 having a plurality of slots 122 extending through a portion of the th plate 120, the second plate 130 having a plurality of second slots 132 extending through a portion of the second plate 130. the crimping apparatus 100 further includes a th movable member 160 and a second movable member 170 (collectively " movable members 160, 170") movable (e.g., rotatable) relative to the th and second plates 120 and 130. for example, the movable members 160, 170 may be configured to rotate about the central axis 107 of the channel 115. the th movable member 160 is positioned between the blade 140 and the th plate 120, and the th movable member 160 includes a plurality of third slots 162 extending through a portion of the th movable member 160. similarly, the second movable member 170 is positioned between the blade 140 and the second plate 130, and the second movable member 170 includes a plurality of fourth slots 162 extending through portions of the movable member 160. similarly, the second movable member 170 may be aligned with the fourth slots 172, generally referred to as "reflective slots 172 and the fourth slots 172, 132 extending generally as" vertical slots 172 ".

Each blade 140 may include a pin 142 projecting from a portion of the blade 140 spaced from the central axis 107 (e.g., outside of the blade 140). at the outlet side 103 of the crimping device 100, each pin 142 extends through of the th slot 122 of the second plate 120 and of the corresponding third slot 162 of the th movable member 160. at the inlet side 101 of the crimping device 100, each pin 142 extends through of the second slot 132 of the second movable member 170 and of the corresponding fourth slot 172. thus, the number of slots 122, 132, 162, 172 on each plate 120, 130 and movable members 160, 170 may correspond to the number of blades 140. in operation, the user may manipulate the drive component 105 to rotate, slide or otherwise move the first and second movable members 160 and 170 relative to the second and second plates 120 and 130. this may be done along a path defined by the corresponding slots 122, 132, 162, 142, so as to drive the blade 140 radially inward to reduce the cross-sectional size of the blade 140 to deliver a medical device such as a medical device using the radial motion of the movable blade 140, e.g., a movable member 140, a medical device 120, , which may be used to deliver a heart capsule delivery device, e.g., a heart valve delivery device 100, a delivery device, e.g., an internal cross-external heart capsule delivery device, a delivery device 100, a delivery device, e.g., a delivery device, such as shown in which may be used to reduce the size of which may be used to deliver a.

The plates 120, 130 may have a generally rectangular shape such that the frame 110 has a generally rectangular cross-section, in other embodiments, the plates 120, 130 may have other shapes, such as circular, hexagonal, polygonal, etc., and may have different shapes from one another, for example, when the plates 120, 130 have a circular shape, the frame 110 may include a stable bottom region, in embodiments, the plates 120, 130 may be internal components located within a housing defining the frame 110. the frame 110 may have a shape configured to fit closely within the recess 315 (FIG. 1) of the tray 300. the drive component 105 may be located on the upper surface 112 (FIG. 2) of the frame 110 such that it may be conveniently used by a user during crimping.

The th and second slots 122 and 132 may each define a linear path extending radially away from the central axis of the channel 115, as shown in FIG. 4, each plate 120, 130 may include twelve slots 122, 132 spaced at equal intervals about the central axis 107 of the channel 115, however, in embodiments, each plate 120, 130 may include less or more than twelve slots (e.g., six slots, eight slots, fourteen slots, etc.) depending on the number of blades 140, and/or the slots 122, 132 may be arranged in other configurations and may have different shapes.

The third slots 162 on the -th movable member 160 may each define an arcuate or angled path having a -th end 163a and a second end 163b, the second end 163b being radially closer to the central axis of the channel 115 than the -th end 163a in -th movable member 160 includes twelve arcuate slots 162 spaced apart from each other at equal intervals about the central axis 107 of the channel 115 in other embodiments, the plurality of third slots 162 may include less or more than twelve slots (e.g., eight slots) depending on the number of vanes 140 and may be arranged in other configurations and may have different shapes.

The to fourth slots 122, 132, 162, 172 define a path of movement of the pin 142. for example, the size and shape of the and second slots 122 and 132 may be adjusted to maintain the position of the respective blades 140 relative to each other, the size and shape of the third and fourth slots 162 and 172 may be adjusted to drive the blades 140 radially inward or outward, thus, movement of the pin 142 along the slot path causes the blades 140 to slide relative to each other and move radially inward or outward. for example, the th movable member 160 moves relative to the 1 plate 120 to move the drive pin 142 along the path defined by the third slot 162 of the th movable member 160 and is limited by the path of the th slot 122 of the th plate 120. similarly, the second movable member 170 moves relative to the second plate 130 to move the drive pin 142 along the path defined by the fourth slot 172 of the second movable member 170, and is limited by the path of the second slot 132 of the second pin 142 when the pin 142 is in the initial or third th position (or fifth slot) and the blade 140, or fifth slot 140 may be disposed as a smaller blade 140, or fifth or sixth, or fifth slot 140, when the blade 140 is disposed at a smaller cross-sectional dimension (140, the size may be reduced from the maximum size of the cross-10, 140-2 cross-2 cross-10-7-2-7-2-7-2-7-2 configuration as the size configuration when the blade-140 cross-140 cross-140-or-140-7-or-7-2-or-7-or-2-140-or-7-140 cross-140-7-140-or-2-140-7-2-7-140-7-or-2-7-or-7-2-7-2 cross-2-7-140-2-7-2-7-2-140-or.

As shown in fig. 4, second plate 130 includes a plurality -th connection features 133 and a plurality of second connection features 135-the -th connection features 133 may be holes, flange surfaces, and/or other connection mechanisms configured to releasably connect medical instrument holder 200 (fig. 1) to second plate 120 of frame 110-the second connection features 135 are configured to provide attachment mechanisms for forming frame 110 (e.g., connecting the -th plate 120 to the second plate 130) -as shown, the second connection features 135 may be hooks or fasteners shaped to mate with corresponding holes 125 on the -plate 120-in embodiments, the second connection features 135 allow frame 110 of crimping device 100 to be disassembled to allow, for example, cleaning of individual components within the frame (e.g., blade 140 and movable members 160, 170) -in embodiments, the and second plates 120 and 130 may be fixedly connected to one another by bonding, welding, and/or other connection methods.

As shown by step in FIG. 4, the crimping device 100 may further include a drive device 150, the drive device 150 operatively connected to the th and second movable members 160 and 170 and configured to move the th and second movable members 160, 170 with respect to the th and second plates 120 and 130. in 2 embodiments, as shown in FIG. 4, the drive device 150 includes a drive component 105 coupled to the threaded shaft 152 and a connector 154, the connector 154 having a threaded shaft 156 extending therethrough. the connector 154 is coupled to the th and second movable members 160, 170. turning the drive component 105 turns the threaded shaft 152 about the longitudinal axis of the threaded shaft 152, which in turn moves the connector 154 along the length of the threaded shaft 152. movement of the connector 154 moves the th and second movable members 160, 170 so as to move inwardly or outwardly along the path defined by the plates 120, 130 and the slots 122, 132, 162, 172 of the movable members 160, 170. for example, a user may press the drive component 160, 162, 172, 160, 172, 160, 170 in a clockwise direction to compress the drive channel 150 and may be configured to move the drive component 100 in a clockwise direction to compress the cross-sectional area of the movable member 150, 160, 170, 160, and 130 to achieve a combined clockwise direction of a smaller cross-transverse cross-sectional area of the combined, 160, and a smaller, 160, and a lower, 120, 160, 120, and a lower, 120, and a lower cross-type of a lower cross-direction of a lower, and a lower.

In embodiments, the drive device 150 can include different mechanisms to drive movement of the movable members 160, 170, and/or the drive device 150 can be coupled to the movable members 160, 170 in different manners for example, in embodiments, the drive device 150 can include a lever coupled to the movable members 160, 170.

Fig. 5 is an isometric view of blades 140 of crimping apparatus 100 (fig. 1-4). each blade 140 may include a end 141a, a second end 141b, a 0 side 143a and a second side 143 b. the pin 142 of each blade 140 may include a pin 142a protruding from the 1 side 143a of the blade 140 (e.g., toward the inlet side 101 of the crimping apparatus 100 of fig. 1-4), and a second pin 142b protruding from the second side 143b of the blade 140 (e.g., toward the existing side 103 of the crimping apparatus 100 in fig. 1-4). the pin 142a and the second pin 142b (collectively "pins 142a, 142 b") may be separate pins extending through the blade 140 and/or integrally formed with the blade 140 (e.g., a single shaft), or the pins 142a, 142b may be separate pins protruding from either side of the blade 140 (e.g., a single shaft) or the blades 142b may be separate pins that protrude from either blade 140 and/or the blade 140 side (e.g., a single shaft) or the center 142 b) or the center axis 142b may be spaced apart from the blade 140 a, thus the blade 140 may be positioned radially outward when the overall blade 140 is not necessarily moved by the maximum or by the radial dimension of the blade 140, i.g., the radial dimension of the entire feeding device 140, or the radial dimension of the entire feeding device 140, including the radial dimension of the blade 140, or the radial dimension of the entire feeding pin 142, such as shown as the blade 140, or the entire feeding device 140, or the radial dimension of the entire feeding device 140 is reduced, or the radial dimension of the radial feeding device 140, or the radial dimension of the entire feeding device 140, which is increased, or the blade 140, or the radial dimension of the blade 140, or the radial.

As further shown in fig. 5 at , the blades 140 include inner and outer surfaces 146a, 146 b. , the inner and outer surfaces 146a, 146b are configured to enable adjacent blades 140 to slide relative to one another and define the shape of the channel 115 of the crimping device 100. more specifically, the inner surface 146a can be generally inclined along an axis extending between the and second sides 143a, 143b of the blades 140 (e.g., along the central axis 107 of the channel 115 shown in fig. 2-4.) the outer surface 146b can have a portion that is generally shaped to match the shape of the inner surface 146a of the adjacent blade 140 and is configured to slide against the inner surface 146a of the adjacent blade 140 when the pin portions 142a, 142b are actuated (e.g., driven radially inward or outward along the slots 122, 132 and slots 162, 172).

The portions of the inner surface 146a of the blades 140 (e.g., the portions not covered by the outer surface 146b of adjacent blades 140) collectively define the channel 115 of the crimping device 100 when the blades 140 having the inclined inner surfaces 146a are circumferentially arranged, the channel 115 may have a generally funnel-like shape (e.g., as shown in fig. 8) — that is, the channel 115 may have a cross-sectional dimension closer to the second side 143b of the blade 140 (e.g., closer to the second plate 130 at the inlet side 101 of the crimping device 100) than the side 143a of the blade 140 (e.g., closer to the th plate 120 at the outlet side 103 of the crimping device).

In embodiments of the present technology, the crimping device 100 may omit or more of the components described above with reference to fig. 2-5. for example, the crimping device 100 may include only of the movable members 160, 170, and each blade 140 may include only of the pins 142a or 142b to drive the blade 140 inward to reduce the size of the medical device, however, the redundancy (redendancy) of the two movable members 160, 170 and the two plates 120, 130 at the and second sides 101 and 103 of the crimping device 100 effectively supports each blade 140 at the and second sides 143a, 143b of the blade 140. including the two movable members 160, 170 may also reduce the amount of force required to drive the blade 140 and may facilitate at least substantially equal distribution of the drive force on the blade 140 between the and second sides 143a, 143 b. in embodiments, the crimping device 100 may include less than twelve blades (e.g., four blades, five blades 160, 143b, 160, and twenty blades, etc.) and may be modified by more than sixteen blades 132, e.g., as there are four movable members 122, 162, 170, and eight blades, etc.

2-5, the components of crimping apparatus 100 may be manufactured using suitable processes, such as three-dimensional printing, injection molding, and/or other processes for supporting and compressing medical devices during crimping.

In use, the crimping device 100 can provide a compact yet effective mechanism for reducing the size of a prosthetic heart valve device or other medical device. The slots 122, 132 of the plates 120, 130 and the slots 162, 172 of the movable members 160, 170 define a path for the pins 142, the pins 142 sliding the vanes 140 radially inward relative to each other to reduce the diameter of the channel 115. This radially inward force is continuous along the surface of the blade 140 that contacts the medical instrument within the channel 115, thus providing continuous compression of the medical instrument. Thus, continuous compression allows the user to pause or terminate the crimping process at any time (i.e., not just at the maximum and minimum diameters of the channel 115). Furthermore, the funnel shape of the channel 115 provided by the blade shape allows parts of the medical device to be compacted more than other parts during inward movement of the blade. For example, a larger portion of the medical device may be located in a larger portion of the passage 115 (e.g., toward the inlet side 101 of the crimping apparatus 100) and not experience as much compression as a portion of the medical device located in a smaller portion of the passage 115 (e.g., toward the outlet side 103 of the crimping apparatus 100). This may inhibit the compressive crimping force from moving the medical device laterally toward the inlet side 101 of crimping apparatus 100 and may help retain the medical device within channel 115 during crimping. Further, the location of the pins 142 outside of the blades 140 reduces the length of the pin travel path required for the blades 140 to move inward to achieve a desired curl range. For example, the pin 142 may travel a distance of 0.26 inches (6.604mm) to reduce the channel diameter from about 1.3 inches to 0.4 inches or less. Thus, the arrangement of the pins 142, the blades 140, the movable members 160, 170, and the plates 120, 130, along with the actuation device 150, allows the crimping device 100 to have a compact size, and the clinician can easily move the crimping device 100 into and out of a sterile field while still providing a large crimping range suitable for reducing the size of a prosthetic heart valve to allow percutaneous delivery of the device.

Fig. 6 is an isometric view illustrating a medical device holder 200 ("holder 200") configured and coupled to an exemplary medical device 500 in accordance with embodiments of the present technique in some embodiments as shown in fig. 6, the medical device 500 is a valve holder for a prosthetic heart valve device the holder 200 includes a base 202 having a th side 203a, a second side 203b, and an opening 205 extending therebetween, the base 202 may include a plurality of connectors 201 on the second side 203b and be configured to removably couple the holder 200 to a crimping device 100 (e.g., coupled to the connecting feature 113 of the second plate 130 of fig. 2-4). as shown in fig. 6, the base 202 may have a generally annular shape including a radially outer surface 209a and a radially inner surface 209b, both extending between the th side 203a and the second side 203 b. the outer surface 209a may include a plurality of grooves 207 and/or ridges to make the holder 200 easy to grasp and operate, even if the holder 200 is also including a plurality of th and second side 203a plurality of fingers 207 and/or ridges to retain the medical device 200 circumferentially extending from at least the base 202, 206 "through the opening 206" and the medical device 202 "to be generally referred to as a crimping process of crimping device 202, 206".

As shown in fig. 6, the fourth fingers 206 may be spaced apart about a central axis of the opening 205 to engage the medical device 500 at more than points about a circumference of the medical device 500 the 0 fingers 206 include a -th portion 206a extending radially inward from the inner surface 209b of the base 202 toward the central axis of the opening 205, a second portion 206b extending from the -th portion 206a of the base 202 and away from the second side 203b, a third portion 206c extending from the second portion 206b and radially inward toward the central axis of the opening 205, and a fourth portion 206d configured to engage the medical device 500 the fourth portion 206d, the fourth portion 206d may include an indexing feature (index feature)206e shaped to engage a -portion of the medical device 500, e.g., as shown in fig. 6, the medical device 500 may be a stent device including a frame 580, the frame 580 may include a plurality of frame units 582, each frame unit 582 may have a hexagonal shape, and the struts may include pairs of struts 583, 365, 28, 584, 2, 26, 2, 500, 2, 9, 2, 9, 2, 9, 2.

In some embodiments, the finger 206 is flexible such that they bend radially inward or outward in response to an external force applied to the th finger 206. for example, when the retainer 200 is not attached to the medical device 500, the fourth portion 206d of the finger 206 may be positioned a distance away from the central axis of the opening 205 that is slightly greater than the cross-sectional dimension of the medical device 500. to connect the medical device 500, the finger 206 may bend radially inward until the fourth portion 206d of the finger 206 is within the medical device 500 and then released. thus, the indexing feature 206e of the finger 206 may press against (e.g., the finger 206 is biased slightly radially outward) the radially inner side of the medical device 500 to hold or grasp the medical device 500. when no other force is applied to the finger 206, the finger feature 206e may prevent the medical device 500 from sliding off the retainer 200. when the retainer 200 is attached to the crimping apparatus 100 (fig. 1-4), the size may decrease as the channel 115 is pressed down to the retainer 206 to cause the blade 206 to bend downward and then release the retainer 200 to load the retainer 140, thereby subsequently releasing the retainer 200, the 8291, 734, and subsequently loading the medical device 500.

The second fingers 208 may each include a -th portion 208a extending radially inward from the inner surface 209b of the base 202 toward the central axis of the opening 205, a second portion 208b extending from the -th portion 208a of the base 202 and away from the second side 203b, and a third portion 206c extending radially inward from the second portion 208b toward the central axis of the opening 205. it is noted that the -th portion 208a of each second finger 208 is longer than the -th portion 206a of each -th finger 206. thus, the second portion 206b of the -th finger 206 is radially farther from the central axis of the opening 205 than the second portion 208b of the second finger 208. as shown, the third portion 208c of the second finger 208 may be shaped and positioned to receive the apex 587 of the medical device 500. thus, the second finger 208 may provide additional support for holding the medical device 500 in place. in embodiments of , the retainer 200 may include fingers 208 having other shapes, 206, numbers, etc. the fingers 208 may include fewer than just the number of fingers 208, 35200, or , more than just as appropriate for holding the medical device 500.

Fig. 7 and 8 are isometric and cross-sectional side views, respectively, showing the retainer 200 of fig. 6 connected to the crimping apparatus 100 shown in fig. 2-4. for ease of illustration, the medical device 500 is not shown in fig. 7 and 8. referring first to fig. 7, the retainer 200 may be removably coupled to the inlet side 101 of the crimping apparatus 100 via the second plate 130 of the frame 110. more specifically, the connector 201 of the retainer 200 (as shown in fig. 6) may be connected to the connecting feature 133 disposed on the frame 110. in some embodiments of , the connector 201 is at least of a hook, fastener, clip, locking feature, etc. that engages (e.g., mates with) the connecting feature 133 to removably secure the retainer 200 to the crimping apparatus 100. in some embodiments of , the connector 201 is inserted into the connecting feature 113 and the retainer 200 is rotated to secure the retainer 200. the is secured, the central axis of the opening 205 of the retainer 200 may be generally aligned with the central axis 107 of the passage 115 of the crimping apparatus 100. with the retainer 200 aligned with the central axis of the medical device 500 being generally symmetrically spaced apart with respect to facilitate uniform crimping of the medical device 500.

As shown in FIG. 8, the fingers 206, 208 of the retainer 200 may protrude at least partially into the channel 115 of the crimping device 100. thus, the fingers 206, 208 of the retainer 200 may retain the medical device 500 (FIG. 6) in a position that is entirely within the channel 115 FIG. 8 also shows embodiments wherein the channel 115 has a generally funnel-like shape wherein the cross-sectional dimension (e.g., diameter) of the channel 115 decreases along the central axis 107 moving from the inlet side 101 of the crimping device 100 to the outlet side 103 of the crimping device 100.

Referring to fig. 6-8, to crimp the medical device 500, the drive member 105 is manipulated to reduce the diameter of the channel 115 as described above, portions of the blades 140 may contact portions of the -th fingers 206 and/or portions of the second fingers 208 within the channel 115 as the diameter of the channel 115 decreases, in particular, the blades 140 first contact the second portions 206b of the -th fingers 206 as they are radially farther from the central axis of the channel 115 than the second portions 208b (fig. 6) of the second fingers 208, as the diameter of the channel 115 decreases by steps, the blades 140 exert an inward force on the second fingers 208 that flexes the fingers 208 radially inward and causes the fourth portion 206d of the -th finger 206 to disengage from the medical device 500, the blades 140 do not contact the -th finger 206 until contacting the second finger 208 as the second portion 208b of the second finger 208 is radially closer to the central axis 206b of the channel 115 than the second portion 206b of the -th finger 206 is radially closer to the central axis of the channel 115, thus the second finger 208 may resist lateral movement of the medical device 500, e.g., lateral movement of the medical device 500, after the crimping device 500, the medical device 500 may counteract lateral movement of the medical device 500, the lateral engagement between the apex of the crimping device 500, the lateral movement of the medical device 500, the lateral engagement of the medical device 500, the crimping apparatus 500, the lateral engagement of the medical device 500, the lateral engagement of the funnel 500, the lateral engagement arrangement 500.

In embodiments, the diameter of channel 115 can be reduced to a diameter small enough to disengage holder 200 from medical device 500 (e.g., disengage fingers 206), but maintain a larger diameter such that fingers 206, 208 located within medical device 500 do not interfere with the crimping of medical device 500. for example, holder 200 and crimping apparatus 100 can be configured such that holder 200 (i) holds (e.g., engages and grips) medical device 500 when channel 115 of crimping apparatus 100 has a maximum diameter (e.g., the th position shown in FIG. 2), and (ii) disengages from medical device 500 when channel 115 of crimping apparatus 100 has a minimum diameter (e.g., the second position shown in FIG. 3. in embodiments, holder 200 can be removed from crimping device 100 after holder 200 disengages from medical device 500. in such embodiments, the diameter of channel 115 can be further reduced to further crimp medical device 500.

Selected embodiments of a tray for receiving a crimping device

FIG. 9 is a top view of the tray 300 of the crimping and loading system 10 of FIG. 1 configured in accordance with embodiments of the present technique, the tray 300 may be formed using a thermoforming process and/or other suitable tray forming process, as shown, the interior walls of the tray 300 define a reservoir 310 for containing a liquid (e.g., chilled brine). The reservoir 310 may include a th portion 312, a second portion 314, and a third portion 316. the th portion 312 may be sized and shaped to receive the crimping device 100 (FIGS. 1-4), with the inlet side 101 or the outlet side 103 facing down against the bottom surface of the tray 300 prior to use (e.g., during storage and/or transport). The second portion 314 of the reservoir 310 is defined by a flange 305 of the tray 300 and includes a recess 315, the recess 315 being configured to hold the crimping device 100 (FIGS. 1-4) in a stable upright position during crimping.

The third portion 316 of the reservoir 310 may be located on the exit side 103 of the crimping apparatus 100 (e.g., as shown in fig. 1), and may provide a region where crimped medical devices may be loaded into a delivery system (e.g., the delivery system of fig. 1) in embodiments , the third portion 316 of the reservoir 310 may also provide regions to visualize the channel 115 of the crimping apparatus 100 and/or portions of the delivery system located adjacent to the crimping apparatus 100 during apparatus loading (fig. 1). for example, the tray 300 may include angled sidewalls (identified as rd angled sidewall 317a and second angled sidewall 317b, respectively; collectively, "angled sidewalls 317"), upon which or more mirrors may be placed to provide alternative views of the crimping apparatus 100 (fig. 1-4) and/or the delivery system. in embodiments , the tray 300 has a generally flat lower surface in the third portion 316, mirrors are disposed on the lower surface to be visible during apparatus loading.the third portion 316 of the reservoir 310 may also be formed to receive the stent 400 (fig. 1), so that the tray may be located in a sterile storage system, such as may be located in a pre-sterile storage system (fig. 10) and/or a streamlined tray assembly for use, such as may be located in a storage system before the tray 300, and/or in a method .

As shown in steps of fig. 9, the walls of tray 300 may further include apertures 320 for receiving portions of a delivery system (e.g., delivery system 600 of fig. 1), and or more grooves (identified individually as groove 319a and second groove 319 b; collectively "grooves 319"), located on either side of apertures 320, grooves 319 may be configured to receive a ridge (dam) member (not shown) for sealing reservoir 310 and preventing escape of liquid through apertures 320. in embodiments , portions of a suitable delivery system may pierce a ridge member located within grooves 319 so as to position the portion of the delivery system adjacent crimping device 100 (fig. 1). in embodiments , tray 300 may include valves and/or sealing devices located on the sidewalls of tray 300 (e.g., in apertures 320 or other apertures) and in fluid communication with reservoir 310, and may be moved from the delivery system (e.g., in apertures 320 or other apertures) and into fluid communication with reservoir 310, while the valve and/or sealing devices may be positioned in the sidewall 300 to prevent fluid from leaking from the reservoir 300, such as in embodiments of a one-way valve and/or sealing devices, such as may be moved from a gasket, such as in a one-way valve and/or sealing devices, such as may be moved from a fluid loading device, such as may be moved from a container 300, in a container 300, such as may be moved from a container, in embodiments, a one-way valve and/or a container 300, such as may be moved from a container, in a one-way valve and/or a container, a one-way valve, a container, or.