Instruments and methods for monitoring valve expansion

Abstract

The present invention provides a method and apparatus for monitoring the radial expansion of an artificial valve inside a patient's body, and therefore the size of the artificial valve, or a method and apparatus for locking the artificial valve at a desired expansion diameter. [Solution] An embodiment of a prosthetic valve delivery device is disclosed. The delivery device includes a first portion configured to maintain a constant spatial relationship with respect to a first end of the prosthetic valve, and a second portion configured to maintain a constant spatial relationship with respect to a second end of the prosthetic valve during radial expansion of the prosthetic valve. The first portion includes one or more reference radiopaque markers, and the second portion includes an indicator radiopaque marker. At the position of the indicator radiopaque marker relative to one or more reference radiopaque markers, the axial distance between the first end and the second end of the prosthetic valve is measured, indicating the corresponding diameter of the prosthetic valve when it is radially expanded from a radially compressed state to a radially expanded state.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 793,116, filed on January 16, 2019, which is incorporated herein by reference.

[0002] This disclosure relates to embodiments of systems and methods for monitoring the radial expansion of an artificial valve.

Background Art

[0003] The human heart can be affected by various valvular diseases. These valvular diseases can cause significant heart dysfunction and may ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are several known repair devices (e.g., stents) and artificial valves, as well as several known methods for implanting these devices and valves into humans. Due to the drawbacks associated with conventional open - heart surgery, percutaneous and minimally invasive surgical approaches have received attention. In one technique, artificial organs are configured to be implanted in a less invasive procedure by a catheter method. For example, a collapsible trans - catheter artificial heart valve can be crimped into a compressed state and introduced percutaneously in the compressed state on a catheter and expanded to a functional size at a desired location. Despite recent advances in percutaneous valve technology, improved trans - catheter heart valves and delivery devices for such valves are still needed.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

[0005] This disclosure relates to methods and devices for monitoring the radial expansion of an artificial valve, and therefore the size of the artificial valve, within a patient's body. This disclosure also relates to methods and devices for locking the artificial valve at a desired expansion diameter. [Means for solving the problem]

[0006] One embodiment of the present disclosure relates to a delivery device configured to provide visual feedback of the radial expansion of an artificial valve. In a typical embodiment, the delivery device includes a first part and a second part. The first part is configured to maintain a constant spatial relationship with respect to a first end of the artificial valve, and the second part is configured to maintain a constant spatial relationship with respect to a second end of the artificial valve during the radial expansion of the artificial valve. The first part may include one or more reference radiopaque markers, and the second part may include an indicator radiopaque marker. At the position of the indicator radiopaque marker relative to one or more reference radiopaque markers, the axial distance between the first and second ends of the artificial valve can be measured, indicating the corresponding diameter of the artificial valve as it radially expands from a radially compressed state to a radially expanded state.

[0007] In one embodiment, the first portion may be configured to be detachably connected to the artificial valve, and the second portion may be configured to move axially relative to the first portion when the artificial valve is radially expanded from a radially compressed state to a radially expanded state.

[0008] In one embodiment, the second portion may be configured to be detachably connected to the artificial valve, and the first portion may be configured to move axially relative to the second portion when the artificial valve is radially expanded from a radially compressed state to a radially expanded state.

[0009] In one embodiment, the reference radiopaque marker and indicator radiopaque marker may be configured to be positioned outside the frame of the prosthetic valve in order to improve the visibility of the reference radiopaque marker and indicator radiopaque marker under fluoroscopy during radial expansion of the prosthetic valve.

[0010] In one embodiment, one or more reference radiopaque markers may include a first reference radiopaque marker and a second reference radiopaque marker spaced apart from the first reference radiopaque marker. While the prosthetic valve expands from a radially compressed state to a radially expanded state, the alignment of the indicator radiopaque marker and the first reference radiopaque marker can indicate a first expanded diameter of the prosthetic valve, and the alignment of the indicator radiopaque marker and the second reference radiopaque marker can indicate a second expanded diameter of the prosthetic valve.

[0011] In one embodiment, the first and second parts are configured to work in conjunction with an expansion mechanism of the artificial valve, so that relative motion between the first and second parts in a first direction expands the artificial valve from a radially compressed state to a radially expanded state, and relative motion between the first and second parts in a second direction opposite to the first direction compresses the artificial valve from a radially expanded state to a radially compressed state.

[0012] In one embodiment, the expansion mechanism may include a locking mechanism configured to lock the artificial valve to a certain diameter. The locking mechanism may be activated when a locking member is moved to the locked position by a first or second part.

[0013] In one embodiment, at least one of the indicator radiopaque marker and the reference radiopaque marker may be configured to align with or be adjacent to the radiopaque portion of the artificial valve when the locking member is moved to the locked position.

[0014] Certain embodiments of the present disclosure also relate to an artificial valve delivery assembly. The assembly may include an artificial valve having an inflow end and an outflow end, and a delivery device having a first portion and a second portion. The second portion may be configured to move axially relative to the first portion as the artificial valve expands radially from a radially compressed state to a radially expanded state. The first portion may include one or more reference radiopaque markers, and the second portion may include an indicator radiopaque marker. The axial length of the artificial valve may be measured at the position of the indicator radiopaque marker relative to the one or more reference radiopaque markers to indicate the corresponding diameter of the artificial valve.

[0015] In certain embodiments, the first portion can maintain a fixed spatial relationship with respect to the outflow end, and the second portion can maintain a fixed spatial relationship with respect to the inflow end during radial expansion of the artificial valve.

[0016] In certain embodiments, the first portion can maintain a fixed spatial relationship with respect to the inflow end, and the second portion can maintain a fixed spatial relationship with respect to the outflow end during radial expansion of the artificial valve.

[0017] In certain embodiments, the artificial valve may include a valve expansion mechanism. The valve expansion mechanism may include an inner member at least partially received within an outer member. Axial movement of the inner member relative to the outer member may cause radial expansion or compression of the artificial valve.

[0018] In certain embodiments, the first portion may be configured to be connected to the outer member, and the second portion may be configured to be connected to the inner member, such that axial movement of the inner member relative to the outer member occurs when the second portion is retracted axially relative to the first portion.

[0019] In one embodiment, the reference radiopaque marker and indicator radiopaque marker may be configured to be positioned outside the frame of the prosthetic valve in order to increase the visibility of the marker under fluoroscopy during radial expansion of the prosthetic valve.

[0020] In one embodiment, at least one reference radiopaque marker may include a first reference radiopaque marker and a second reference radiopaque marker spaced apart from the first reference radiopaque marker. While the prosthetic valve expands from a radially compressed state to a radially expanded state, the alignment of the indicator radiopaque marker and the first reference radiopaque marker can indicate a first expanded diameter of the prosthetic valve, and the alignment of the indicator radiopaque marker and the second reference radiopaque marker can indicate a second expanded diameter of the prosthetic valve.

[0021] One embodiment of the present disclosure further relates to a method for implanting a valve prosthesis. This method may include the steps of: positioning the valve prosthesis at a target site in the patient's body using a delivery device; radially expanding the valve prosthesis from a radially compressed state to a radially expanded state; and monitoring the diameter of the valve prosthesis based on the change in position of an indicator radiopaque marker relative to one or more reference radiopaque markers under fluoroscopy. The indicator radiopaque marker and the reference radiopaque marker may be located on the delivery device.

[0022] In one embodiment, the act of expanding the artificial valve may include the steps of holding the first end of the artificial valve in place and applying an axial force to the second end of the artificial valve to move the second end toward the first end, thereby reducing the axial length and increasing the diameter of the artificial valve.

[0023] In one embodiment, the act of expanding the artificial valve may include the step of activating a valve expansion mechanism. The valve expansion mechanism may include an inner member that is at least partially received inside an outer member. The axial movement of the inner member relative to the outer member may cause radial expansion or compression of the artificial valve.

[0024] In one embodiment, the delivery device may include a first part and a second part. The second part may be connected to an inner member, and the act of acting the valve expansion mechanism may include the step of moving the inner member axially relative to the outer member by retracting the second part while holding the first part in contact with one end of the outer member and holding the second part in contact with the outer member.

[0025] In one embodiment, one or more reference radiopaque markers may be located on a first portion, and indicator radiopaque markers may be located on a second portion.

[0026] In one embodiment, the delivery device may include a first part and a second part. The second part may be configured to move axially relative to the first part as the artificial valve is radially expanded from a radially compressed state to a radially expanded state. One or more reference radiopaque markers may be located on the first part, and indicator radiopaque markers may be located on the second part.

[0027] In one embodiment, the method may further include the step of locking the artificial valve to a certain diameter by moving a locking member to a locked position.

[0028] In one embodiment, the method may further include the step of confirming that the locking member has been moved to the locked position by ensuring that at least one of the indicator radiopaque marker and the reference radiopaque marker is in close proximity to the radiopaque portion of the artificial valve under X-ray fluoroscopy.

[0029] The aforementioned objectives, features, and advantages of the present invention, as well as other objectives, features, and advantages, will become even more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. [Brief explanation of the drawing]

[0030] [Figure 1] This is a side view of an embodiment of an artificial valve delivery assembly. [Figure 2A] This is a side perspective view of the inner member of a valve expansion mechanism according to one embodiment. [Figure 2B] This is a side perspective view of the valve expansion mechanism. [Figure 2C] Figure 2B is a side perspective view of one embodiment of an artificial valve that includes multiple expansion mechanisms of the type shown. [Figure 3] Figure 2B shows one of the valve expansion mechanisms and a cross-sectional view of the components of the delivery device. [Figure 4] Figure 2B shows one of the valve expansion mechanisms and a perspective view of the components of the delivery device. [Figure 5] This figure shows an artificial valve in a radially compressed configuration. [Figure 6] Figure 5 shows an artificial valve in a radially expanded configuration with an unlocked radial diameter. [Figure 7] This figure shows the artificial valve in Figure 5 after the locking mechanism has been activated to lock the artificial valve in an expanded position. [Figure 8] This figure shows some alternative embodiments of a delivery device having multiple indicator radiopaque markers and multiple reference radiopaque markers. [Modes for carrying out the invention]

[0031] This specification describes embodiments of artificial implant delivery assemblies and their components that can improve the physician's ability to monitor and / or control the size of mechanically expandable artificial implants, such as artificial valves (e.g., artificial heart valves or venous valves), stents, or grafts, and to lock the size of the artificial implant during implantation procedures. The artificial heart valves disclosed herein may be implanted inside any of the heart's own valves (aortic valve, mitral valve, tricuspid valve, and pulmonary valve).

[0032] The artificial valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the artificial valve can be crimped or held in a radially compressed state on an implant delivery device during delivery, and then expanded to a radially expanded state once the artificial valve reaches the implantation site.

[0033] Figure 1 shows an embodiment of an artificial implant delivery assembly 10 according to one embodiment of the present disclosure. The delivery assembly 10 may include two main components, namely an artificial valve 200 and a delivery device 100. The artificial valve 200 may be releasably connected to the delivery device 100 via one or more retaining and actuator assemblies 110, as further described below. It should be understood that the delivery device 100 and other delivery devices disclosed herein may be used to implant artificial organs other than artificial valves, such as stents or grafts.

[0034] The delivery device 100 may include a handle 102 at its proximal end. The delivery device 100 may include one or more shafts 104 connected to the handle 102. During delivery of the artificial valve 200, the handle 102 can be operated by the surgeon to advance and retract the delivery device 100 through the patient's vascular structure. In some embodiments, the handle 102 may include a number of knobs or other actuation mechanisms for controlling various components of the delivery device 100 to expand and / or deploy the artificial valve 200. For example, the handle 102 may include one or more knobs or other actuation mechanisms, each configured to operate the respective retaining and actuator assemblies 110 of the delivery device 100 to interact with the corresponding valve expansion mechanism 300 (also called the “valve actuator”) to expand or compress the artificial valve 200 and / or lock the artificial valve 200 to a desired diameter, as will be further described below.

[0035] Figure 2C is a perspective view of the prosthetic valve 200. In certain embodiments, the prosthetic valve 200 may be implanted within the annulus of the patient's own aortic valve, but it may also be implanted in other locations within the heart, including within the patient's own mitral valve, pulmonary valve, and tricuspid valve. The prosthetic valve 200 may include an annular stent or frame 204 having a proximal end 206 and a distal end 208. In some embodiments, the proximal end 206 may be the outflow end and the distal end 208 may be the inflow end. In other embodiments, the proximal end 206 may be the inflow end and the distal end 208 may be the outflow end. For example, in a retrograde transfemoral approach to implant the prosthetic valve, the proximal end 206 may be the outflow end and the distal end 208 may be the inflow end. In another embodiment, in an antegrade transseptal route for implanting an artificial valve, the proximal end 206 can be the inflow end and the distal end 208 can be the outflow end.

[0036] The artificial valve 200 may also include a valve-like structure 202, which is mounted on a frame 204 and configured to regulate the flow of blood through the artificial valve 200 from the inlet end to the outlet end. For example, the valve-like structure may include a leaflet assembly comprising one or more leaflets made of a flexible material. The leaflets of the leaflet assembly may be made in whole or in part from a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). Further details relating to transcatheter artificial heart valves, including how the valve-like structure may be mounted on the frame of the artificial valve, can be found, for example, in U.S. Patents 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,252,202, and U.S. Patent Application No. 62 / 614,299, all of which are incorporated herein by reference in their entirety.

[0037] Although not shown, the prosthetic valve 200 may also include one or more skirts or sealing members. For example, the prosthetic valve 200 may include an inner skirt mounted on the inner surface of the frame. The inner skirt may serve as a sealing member that prevents or reduces perialvalvular leakage, secures the valve leaflets to the frame, and / or protects the valve leaflets from damage caused by contact with the frame during crimping and the operating cycle of the prosthetic valve. The prosthetic valve 200 may also include an outer skirt mounted on the outer surface of the frame 204. The outer skirt may serve as a sealing member of the prosthetic valve by sealing in contact with the tissue of the annulus and helping to reduce perialvalvular leakage beyond the prosthetic valve. The inner and outer skirts may be formed from any of a variety of suitable biocompatible materials, including a variety of synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue).

[0038] The frame 204 may be made of any of a variety of suitable materials, such as stainless steel, cobalt-chromium alloy (e.g., MP35N alloy), or nickel-titanium alloy ("NiTi"), e.g., Nitinol. As shown, the frame 204 may include a plurality of interconnected struts 210 arranged in a grid pattern. The struts 210 are shown as being positioned obliquely or offset at an angle with respect to the longitudinal axis 214 of the prosthetic valve 200, and radially offset from the longitudinal axis 214 when the prosthetic valve 200 is in an extended configuration. In other embodiments, the struts 210 may be offset by a different amount than depicted in Figure 2C, or some or all of the struts 210 may be positioned parallel to the longitudinal axis of the prosthetic valve 200.

[0039] In the illustrated embodiment, the struts 210 are pivotably connected to each other at one or more pivot joints along the length of each strut. For example, each strut 210 may be formed with holes 212 at both ends of the strut and spaced-out holes 212 along the length of the strut. Hinge may be formed where the struts 210 overlap each other via fasteners such as rivets or pins 216 (see, for example, Figure 3) extending through these holes. The hinges allow the struts 210 to pivot relative to each other when the frame 204 is radially expanded or compressed, such as during the assembly, preparation, or implantation of the artificial valve 200.

[0040] In some embodiments, the frame 204 may be constructed by forming individual components (e.g., struts and fasteners of the frame) and then mechanically assembling and connecting the individual components to one another. In other embodiments, the struts 210 are not connected to one another by their respective hinges, but are instead pivotable or bendable relative to one another, allowing for radial expansion and contraction of the frame 204. For example, the frame 204 may be formed from a single piece of material (e.g., a metal tube) (e.g., via laser cutting, electroforming, or physical vapor deposition). Further details regarding the construction of frames and artificial valves that may be used with the delivery devices disclosed herein are described in U.S. Patent Applications Publications 2018 / 0153689, 2018 / 0344456, 2015 / 0135506, 2014 / 0296962, and U.S. Patent Application No. 16,105,353, all of which are incorporated herein by reference.

[0041] As mentioned above, the artificial valve 200 may further include one or more valve expansion mechanisms 300. As shown in Figure 1, each expansion mechanism 300 may be configured to form a retractable connection to the respective retainer of the delivery device 100 and to the actuator assembly 110. In some embodiments, the valve expansion mechanisms 300 may be mounted on the inner surface of the frame 204 and equally spaced around it. For example, Figure 2C shows three valve expansion mechanisms 300 equally spaced around the inner surface of the frame 204. It should be understood that the artificial valve 200 may have any number of valve expansion mechanisms that are mounted on the outer surface of the frame or unevenly spaced around the frame.

[0042] As described below, the valve expansion mechanism 300 may be used to radially expand or compress the artificial valve 200. In some embodiments, the valve expansion mechanism 300 may also be used to lock the artificial valve 200 in a radially expanded position.

[0043] Referring to Figures 2A to 2C, the valve expansion mechanism 300 in the illustrated embodiment may include an internal member or actuator screw 302 (functioning as a linear actuator or push-pull member in the illustrated embodiment), which includes a relatively long upper or distal portion 304 and a relatively short lower or proximal portion 306 at the proximal end of the actuator screw 302, the proximal portion 306 having a smaller diameter than the upper portion 304. Both the distal portion 304 and the proximal portion 306 of the actuator screw 302 may have male thread surfaces.

[0044] The actuator screw 302 may have a distal mounting component 308 attached to its distal end, which has a radially extending distal valve connector 310. The distal mounting component 308 may be fixed to the actuator screw 302 (e.g., welded together or manufactured as a single piece). The distal valve connector 310 may extend through an opening at or near the distal end of the frame 204, formed at a location on the frame where two or more struts intersect as shown in Figure 2C. The distal valve connector 310 may be fixed to the frame 204 (e.g., welded). Depending on the shape of the struts, the distal end of the frame 204 includes a series of alternating distal joints 250 and distal vertices 252. In the illustrated embodiment, the distal valve connectors 310 of three valve expansion mechanisms 300 are connected to the frame 204 through the distal joints 250. In other embodiments, one or more distal valve connectors 310 may be connected to the frame 204 through the distal vertices 252. In other embodiments, the distal valve connector 310 may be connected to the joint near the proximal end 206 of the frame 204.

[0045] The valve expansion mechanism 300 may further include an outer member or sleeve 312. The sleeve 312 may be positioned annularly around the distal portion 304 of the actuator screw 302 and may accommodate axial openings at its proximal and distal ends through which the actuator screw 302 can extend. The axial openings and lumen within the sleeve 312 may have a diameter larger than the diameter of the distal portion 304 of the actuator screw 302, thereby allowing the screw to move freely within the sleeve (the actuator screw 302 can move proximal and distal to the sleeve 312). Since the actuator screw 302 can move freely within the sleeve, it may be used to radially expand and / or contract the frame 204, as will be disclosed in more detail below.

[0046] The sleeve 312 may have a proximal valve connector 314 extending radially from its outer surface. The proximal valve connector 314 may be fixed (e.g., welded) to the sleeve 312. The proximal valve connector 314 may be axially spaced apart from the distal valve connector 310, thereby allowing the proximal valve connector to extend through an opening at or near the proximal end of the frame 204. The proximal end of the frame 204 includes a series of alternating proximal joints 260 and proximal vertices 262. In the illustrated embodiment, the proximal valve connectors 314 of three valve expansion mechanisms 300 are connected to the frame 204 through the proximal joints 260. In other embodiments, one or more proximal valve connectors 314 may be connected to the frame 204 through the proximal vertices 262. In other embodiments, the proximal valve connector 314 may be connected to a joint near the distal end of the frame 204.

[0047] It should be understood that the distal connector 310 and the proximal connector 314 do not need to be connected to both ends of the frame 204. The valve expansion mechanism 300 can be used to expand and compress the frame 204, insofar as the distal and proximal connectors are connected to their respective joints on the frame that are axially spaced apart from each other.

[0048] The lock nut 316 may be positioned inside the sleeve 312 and may have a female threaded surface that can engage with the male threaded surface of the actuator screw 302. The lock nut 316 may have a notched portion 318 at its proximal end, the purpose of which is described below. The lock nut may be used to lock the frame 204 in an expanded state, particularly radially, as discussed below.

[0049] Figures 3 and 4 show a valve expansion mechanism 300 that works in conjunction with the components of the retaining and actuator assembly 110 of the delivery device 100. As shown, the retaining and actuator assembly 110 includes a support tube 120, an actuator member 122, and a locking tool 124. The proximal end of the support tube 120 may be connected to a handle or other control device (not shown) used by a physician or operator of the delivery assembly to operate the valve expansion mechanism 300 as described herein. Similarly, the proximal ends of the actuator member 122 and the locking tool 124 may be connected to a handle.

[0050] The support tube 120 encircles the proximal portion of the locking tool 124 in an annular manner, thereby allowing the locking tool 124 to extend through the lumen of the support tube 120. The support tube 120 and sleeve 312 are sized such that the distal end of the support tube 120 can abut or engage with the proximal end 330 of the sleeve 312, thereby preventing the support tube 120 from moving distally beyond the sleeve 312.

[0051] The actuator member 122 may extend through the lumen of the locking tool 124. The actuator member 122 may be, for example, a shaft, rod, cable, or wire. The distal end portion of the actuator member 122 may be releasably connected to the proximal portion 306 of the actuator screw 302. For example, the distal end portion of the actuator screw 302 may have a female threaded surface that can engage with the male thread of the proximal portion 306 of the actuator screw 302. Alternatively, the actuator member may have a male thread that engages with the female threaded portion of the screw. Other releasable connection mechanisms (e.g., hoop-and-loop, buckle, clip, magnet, etc.) may also be used. Thus, once the actuator member 122 is passed over the actuator screw 302, the axial movement of the actuator member 122 can cause the axial movement of the actuator screw 302.

[0052] The distal portion of the locking tool 124 can encircle the actuator screw 302 in an annular manner and extend through the lumen of the sleeve 312, while the proximal portion of the locking tool 124 can encircle the actuator member 122 in an annular manner and extend through the lumen of the support tube 120 to the handle 102 of the delivery device 100. The locking tool 124 may have a female threaded surface that can engage with the male threaded surface of the actuator screw 302, so that rotation of the locking tool 124 clockwise or counterclockwise causes the locking tool 124 to advance distally or proximal, respectively, along the actuator screw 302.

[0053] The distal end of the locking tool 124 may include a notched portion 326, as is best seen in Figure 4. The notched portion 326 of the locking tool 124 may have an engaging surface 327, which is configured to engage with a correspondingly shaped engaging surface 319 of the notched portion 318 of the lock nut 316, so that rotation of the locking tool (e.g., clockwise) causes the lock nut 316 to rotate in the same direction (e.g., clockwise) and advance distally along the actuator screw 302. The notched portions 318, 326 in the illustrated embodiment are configured such that rotation of the locking tool 124 in the opposite direction (e.g., counterclockwise) causes the notched portion 326 of the locking tool 124 to disengage the notched portion 318 of the lock nut 316, i.e., rotation of the locking tool 124 in the direction that moves the locking tool 124 proximal does not cause the corresponding rotation of the lock nut 316.

[0054] In alternative embodiments, the distal end portion of the locking tool 124 may have various other configurations, such as any of the tool configurations described herein, configured to engage with the locking nut 316 to move the nut distally and to cause rotation of the locking nut when the locking tool 124 is rotated. In some embodiments, the distal end portion of the locking tool 124 may be configured to cause rotation of the locking nut 316 in both directions to move the locking nut 316 distally and proximal along the actuator screw 302.

[0055] During pre-implantation operations, the actuator member 122 may be screwed onto the proximal portion 306 of the actuator screw 302, and the lock nut 316 may be rotated to position it on the proximal end of the actuator screw 302. The frame 204 may then be folded radially, and the delivery assembly 200 may be inserted into the patient. Once the artificial valve is in the desired implantation site, the frame 204 may be expanded radially as described herein.

[0056] To radially expand the frame 204, the support tube 120 can be held firmly in contact with the sleeve 312. The actuator member 122 can then be pulled proximal through the support tube 120, for example, by pulling the proximal end of the actuator member 122 or by activating a control knob on a handle that causes proximal movement of the actuator member 122. Since the support tube 120 is held in contact with the sleeve 312, which is connected to the proximal end of the frame 204 by the proximal valve connector 314, the proximal end of the frame 204 is prevented from moving relative to the support tube 120. Therefore, the proximal movement of the actuator member 122 can cause the proximal movement of the actuator screw 302 (since the actuator member 122 passes over the actuator screw 302), thereby shortening the frame 204 axially and expanding it radially. Alternatively, the frame 204 can be expanded by moving the support pipe 120 distally while holding the actuator member 122 in a stationary position, or by moving the support pipe 120 distally while moving the actuator member 122 proximal.

[0057] After the frame 204 has been expanded to a desired radially expanded size, the frame 204 can be locked in this radially expanded size as described herein. Locking the frame 204 can be achieved by rotating the locking tool 124 in one direction (e.g., clockwise) to engage the notched portion 326 of the locking tool with the notched portion 318 of the lock nut 316, thereby advancing the lock nut 316 distally along the actuator screw 302. The locking tool 124 can be rotated in this manner until the lock nut 316 abuts against the internal shoulder at the distal end of the sleeve 312 and the lock nut 316 can no longer advance distally (see, for example, Figure 4). This prevents the actuator screw 302 from advancing distally relative to the sleeve 312 and compressing the frame 204 radially. However, in the illustrated embodiment, the lock nut 316 and actuator screw 302 can still move proximal through the sleeve 312, thereby further expanding the frame 204 during implantation or during subsequent valve-in-valve procedures, such as those described in U.S. Patent Application Publication 2018 / 0153689, incorporated herein by reference.

[0058] Once the frame 204 is locked in the radially expanded position, the locking tool 124 can be rotated in a direction that moves the locking tool 124 proximal (for example, counterclockwise) to disengage the notched portion 326 from the notched portion 318 of the lock nut 316, thereby loosening and removing the locking tool 124 from the actuator screw 302. Furthermore, the actuator member 122 can be rotated in a direction that loosens and removes it from the proximal portion 306 of the actuator screw 302 (for example, the actuator member 122 may be configured to disengage from the actuator screw 302 when rotated counterclockwise). Once the locking tool 124 and the actuator member 122 are loosened and removed from the actuator screw 302, they can be removed from the patient along with the support tube 120, leaving the actuator screw 302 and sleeve 312 connected to the frame 204, as shown in Figure 2C, and the frame 204 is locked, particularly in the radially expanded position.

[0059] In an alternative embodiment, the locking tool 124 may be formed without a female thread that engages with the male thread of the actuator screw 302, thereby allowing the locking tool 124 to slide distally and proximal along the actuator screw 302 through the sleeve 312 to engage and disengage the lock nut 316.

[0060] In yet another embodiment, instead of using the lock nut 316 and actuator screw 302 as described above, the frame may be locked to an expanded size using a different locking mechanism, for example, a ratchet mechanism as described in U.S. Patent Application Publication 2018 / 0153689, International Application PCT / US2019 / 64373 filed December 4, 2019, U.S. Patent Application 62 / 928,291 filed October 30, 2019, and U.S. Patent Application 62 / 950,005 filed December 18, 2019, all incorporated herein by reference. In certain embodiments, instead of the expansion mechanism 300, the artificial valve 200 may include one or more ratchet mechanisms, such as those described in those previously filed applications. One or more ratchet mechanisms may be connected to each actuator 110 and may be configured to radially expand and compress the frame and lock the frame at a desired expanded diameter.

[0061] Any of the delivery assemblies disclosed herein may have a variety of handle configurations, each comprising one or more actuators or control devices configured to produce motion of the assembly components that expand and compress an artificial valve (or another type of implant). In some embodiments, the handle may have an actuator, which can be operated by the user by manually rotating and / or manually pushing / pulling the actuator on the handle. In other embodiments, the actuator on the handle and / or other components of the assembly may be controlled electrically, pneumatically, and / or hydraulically.

[0062] For example, in some embodiments, the handle 102 may house one or more electric motors operated by the user to produce motion of components of the delivery assembly, such as one or more motors operable to produce linear motion of actuator screws 302 and one or more motors operable to produce rotational motion of locking tools 124 (for rotating lock nuts 316). In one specific embodiment, one electric motor is used to produce linear motion of all actuator screws 302 mounted on the artificial valve, and another electric motor is used to produce rotational motion of all locking tools 124 included in the assembly. In another embodiment, one electric motor may be provided for each actuator screw and for each locking tool 124. Further details relating to handle configurations including electric motors for controlling components of the delivery assembly are disclosed in U.S. Patent Application Publication 2014 / 0296962, which is incorporated herein by reference.

[0063] Furthermore, any of the delivery assemblies disclosed herein may include software and / or hardware operable to control the expansion of the artificial valve, as further disclosed in U.S. Patent Application Publication 2014 / 0296962. In certain embodiments, the delivery assembly may include a programmable controller (e.g., housed in a handle) operable to expand the artificial valve radially according to a specific algorithm. For example, the delivery assembly may include one or more motors (e.g., electric motors) controlled by the electronic controller to expand the artificial valve radially according to a specific algorithm. In one embodiment, for example, the controller may be programmed to produce a pulsatile radial expansion of the artificial valve, as further disclosed in U.S. Patent Application Publication 2014 / 0296962.

[0064] As described below, the delivery device 100 may be configured to provide real-time visual feedback on the radial expansion of the artificial valve 200. In one embodiment, the delivery device 100 may also be configured to provide visual confirmation that the artificial valve 200 is locked in at the desired radially expanded size.

[0065] In one embodiment, one or more reference radiopaque markers 140 may be located on the outer surface of a support tube 120 within a retaining and actuator assembly 110, and at least one indicator radiopaque marker 142 may be located on the outer surface of a locking tool 124 within the same retaining and actuator assembly 110.

[0066] The indicator radiopaque marker 142 and the reference radiopaque marker 140 may each contain a radiopaque material, such as gold, platinum, tungsten, platinum-iridium alloy, or palladium, so that they are visible under fluoroscopy when the artificial valve is delivered into the patient's body by the delivery device. The markers may be formed using any of the various techniques known in the art. In some embodiments, the radiopaque markers 140 and 142 are formed from radiopaque inks and adhesives and may be applied to the components of the delivery device in several ways, such as screen printing, high-speed roller printing, coating, or dipping. In other embodiments, the markers may be separately formed components (for example, in the form of an annular ring or C-shaped band mounted on the components of the delivery device). Except for the reference radiopaque marker 140, the distal end portion of the support tube 120 may contain a radiopaque material or have a cutout window so that the indicator radiopaque marker 142 on the locking tool 124 is visible under fluoroscopy.

[0067] In some embodiments, the reference radiopaque marker 140 is configured to be visually distinguishable from the indicator radiopaque marker 142 under X-ray fluoroscopy. For example, the reference radiopaque marker 140 may have a different width and / or circumferential length than the indicator radiopaque marker 142.

[0068] As described above, in order to radially expand the frame 204, the distal end of the support tube 120 can be held firmly in contact with the sleeve 312, thereby preventing the proximal end of the frame 204 from moving relative to the support tube 120. Thus, the support tube 120 and the reference radiopaque marker 140 located therein maintain a constant spatial relationship with respect to the proximal end 206 of the frame 204 during the radial expansion of the artificial valve.

[0069] As mentioned above, pulling the actuator member 122 proximal through the support tube 120 can cause proximal movement of the actuator screw 302 (or, if the ratchet mechanism is used as described in U.S. Patent Application Publication 2018 / 0153689, International Application PCT / US2019 / 64373, U.S. Patent Application 62 / 928,291, or U.S. Patent Application 62 / 950,005, the ratchet rack), which can then shorten the frame 204 axially and expand it radially. Since the locking tool 124 is screwed to the actuator screw 302, the locking tool 124 can move together with the actuator screw 302 during the radial expansion of the frame 204. Thus, the locking tool 124 and the radiopaque indicator marker 142 located thereon can maintain a constant spatial relationship with respect to the distal end 208 of the frame 204 during the radial expansion of the artificial valve.

[0070] Therefore, the axial length of the frame 204 (i.e., the distance between the proximal end 206 and the distal end 208) can be measured at the position of the indicator radiopaque marker 142 relative to one or more reference radiopaque markers 140, which indicates the corresponding diameter of the prosthetic valve as it radially expands from a radially compressed state to a radially expanded state. In other words, the reference radiopaque marker 140 can effectively serve as a “scale,” and the indicator radiopaque marker 142 can effectively serve as a “dial” or “pointer,” thereby indicating the corresponding diameter of the prosthetic valve at the location of the “dial” relative to the “scale.”

[0071] Therefore, when the operator expands the prosthetic valve radially by activating the valve expansion mechanism 300, the operator can monitor and / or measure the diameter of the prosthetic valve in real time under fluoroscopic examination, based on the alignment of the indicator radiopaque marker 142 with one of the reference radiopaque markers 140.

[0072] The indicator radiopaque marker 142 is preferably configured to be located outside the frame 204 to ensure that the indicator radiopaque marker 142 is always visible under fluoroscopy during the radial expansion of the prosthetic valve. For example, in some embodiments, the indicator radiopaque marker 142 may be located along the proximal portion of the locking tool 124 between the proximal end 206 of the frame 204 and the proximal end 330 of the sleeve 312. In other embodiments, the indicator radiopaque marker 142 may be located along the proximal portion of the locking tool 124, but more proximal to the proximal end 330 of the sleeve 312.

[0073] As mentioned above, the support tube 120 may include multiple reference radiopaque markers 140. For example, Figures 5 to 7 show three reference radiopaque markers 140a, 140b, and 140c, but it should be understood that any number of reference radiopaque markers 140 may be used. Each reference radiopaque marker 140 may correspond to a specific diameter of the prosthetic valve. For example, while the prosthetic valve expands from a radially compressed state to a radially expanded state, the alignment of the indicator radiopaque marker 142 with the most distal reference radiopaque marker 140a can indicate the first expanded diameter of the prosthetic valve, the alignment of the indicator radiopaque marker 142 with the intermediate reference radiopaque marker 140b can indicate the second expanded diameter of the prosthetic valve, which is larger than the first diameter, and the alignment of the indicator radiopaque marker 142 with the nearest reference radiopaque marker 140c can indicate the third expanded diameter of the prosthetic valve, which is larger than the second diameter.

[0074] In the depicted embodiment, a more distal reference radiopaque marker indicates a smaller diameter of the prosthetic valve compared to a more proximal reference radiopaque marker. For example, the prosthetic valve may be expanded to a diameter within an operating range defined by a minimum diameter Dmin and a maximum diameter Dmax. Thus, reference radiopaque marker 140a may indicate the minimum diameter Dmin, reference radiopaque marker 140c may indicate the maximum diameter Dmax, and reference radiopaque marker 140b may indicate the intermediate diameter Dmed. In an exemplary embodiment, reference radiopaque markers 140a, 140b, and 140c may indicate that the prosthetic valve has been expanded to diameters of 27 mm, 28 mm, and 29 mm, respectively.

[0075] It should be understood that the support tube 120 may have any number of reference radiopaque markers. For example, the number of reference radiopaque markers 140 can be just one, two, or more than three.

[0076] In some embodiments, the multiple reference radiopaque markers 140 located on the support tube 120 are evenly spaced, and the distance between any two adjacent reference radiopaque markers is equal. In other embodiments, the multiple reference radiopaque markers 140 may be spaced at uneven distances.

[0077] The embodiments shown in Figures 5 to 7 illustrate a configuration where only one extension mechanism 300 is connected to the retaining and actuator assembly 110. However, it should be understood that each extension mechanism can be connected to a corresponding retaining and actuator assembly, as shown in Figure 1. In some embodiments, one or a selected retaining and actuator assembly 110 may have a corresponding set of indicator and reference radiopaque markers. In other embodiments, each retaining and actuator assembly may house its respective indicator radiopaque marker and reference radiopaque marker, facilitating the operator to view the radiopaque markers regardless of the angular position of the prosthetic valve.

[0078] While the embodiments depicted in Figures 5 to 7 show only one type of expansion and locking mechanism 300 connected to the retaining and actuator assembly 110, it should be understood that the same concept of using radiopaque markers to indicate lock confirmation of the radial diameter and / or frame of the artificial valve may apply when other expansion and locking mechanisms are used, such as one or more ratchet mechanisms described in U.S. Patent Application Publication 2018 / 0153689, International Application PCT / US2019 / 64373, U.S. Patent Application 62 / 928,291, or U.S. Patent Application 62 / 950,005.

[0079] As previously mentioned and further shown in Figures 6-7, the frame 204 can be locked to a radially expanded size by rotating the locking tool 124 to advance the lock nut 316 to the distal end of the sleeve 312. According to one embodiment, at least one radiopaque marker may be used to visually confirm under fluoroscopy that the lock nut 316 has been moved to the desired position for locking the frame 204.

[0080] For example, the indicator radiopaque marker 142 may be configured to align with or be close to the proximal end portion 332 of the sleeve 312 when the locking tool 124 advances the lock nut 316 to the distal end of the sleeve 312. In one embodiment, the proximal end portion 332 of the sleeve 312 may include a radiopaque marker, thereby making it visible under fluoroscopy. In other embodiments, the proximal end portion 332 of the sleeve 312 does not house a radiopaque marker. Instead, the proximal end portion 332 of the sleeve 312 may be sized and / or molded to be visually distinguishable from surrounding structures under fluoroscopy. For example, the proximal end portion 332 may have a larger diameter than the distal end support tube 120. Thus, the lock of the frame 204 can be confirmed by ensuring that the indicator radiopaque marker 142 is aligned with the proximal end portion 332 of the sleeve 312. As an example, Figure 6 shows an indicator radiopaque marker 142 in an "unlocked" position, spaced proximal to the frame 204, while Figure 7 shows an indicator radiopaque marker 142 in a "locked" position, aligned with or close to the proximal end portion 332 of the sleeve 312.

[0081] In some embodiments, the delivery device 100 includes just one pair of radiopaque markers (e.g., markers 140 and 142) used to provide both visual feedback regarding the radial diameter of the prosthetic valve and visual confirmation of frame locking. In other embodiments, the delivery device may include one pair of radiopaque markers used solely for visual feedback regarding the radial diameter of the prosthetic valve, and / or one or more different radiopaque markers used for visual confirmation of frame locking.

[0082] Alternative Embodiments Systems and methods for monitoring valve expansion and confirming frame lock have been described with specific embodiments as shown in Figures 1 to 7. However, it should be noted that the disclosed embodiments are non-limiting, and the general concepts disclosed herein may be implemented in alternative embodiments.

[0083] For example, in one embodiment, the indicator radiopaque marker may be located on the actuator member 122 instead of the locking tool 124. Since valve expansion occurs by pulling the actuator member 122 proximal to the support tube 120, the position of the indicator radiopaque marker on the actuator member 122 relative to a reference radiopaque marker on the support tube 120 can also indicate the diameter of the artificial valve during radial expansion.

[0084] In other embodiments, the relative locations of the indicator radiopaque markers and the reference radiopaque markers can be switched. For example, one or more reference radiopaque markers may be located on the outer surface of the locking tool 124, and at least one indicator radiopaque marker may be located on the outer surface of the support tube 120. Thus, the indicator radiopaque markers remain stationary while the reference radiopaque markers move axially relative to the indicator radiopaque markers during valve expansion. Similarly, the alignment of the indicator radiopaque markers with one or more of the reference radiopaque markers may indicate the corresponding expansion diameter of the prosthetic valve.

[0085] The valve expansion mechanism 300 described above includes a movable inner member (actuator screw 302) and a fixed outer member (sleeve 312), but it should be noted that the valve expansion mechanism can be configured in any other way, as long as it can push the first end of the artificial valve toward the second end, or the second end toward the first end. In some embodiments, the first end is the inlet end and the second end is the outlet end. In other embodiments, the first end is the outlet end and the second end is the inlet end.

[0086] For example, in the embodiments described above with respect to Figures 5 and 6, the artificial valve can be expanded by holding the proximal end of the artificial valve in a stationary position and pulling the inner member proximal to the outer member. In another embodiment, the artificial valve can be expanded by holding the distal end of the artificial valve in a stationary position and pushing the inner member distally to the outer member. In yet another embodiment, the artificial valve can be expanded by pushing the proximal end distally and pulling the distal end proximal to the outer member.

[0087] Alternatively, the valve expansion mechanism may be configured to include a fixed inner member and a movable outer member that surrounds the inner member in an annular manner. To expand the artificial valve, the outer member may be configured to hold the inlet end (or outlet end) of the artificial valve in a stationary position, and the inner member may be configured to pull (or push) the outlet end (or inlet end) of the artificial valve toward the inlet end (or outlet end).

[0088] More generally, a valve expansion mechanism may be configured to have two members that can move axially relative to each other. In some embodiments, the two members may be arranged side by side rather than coaxially. To expand the artificial valve, one member may be configured to hold the inlet end (or outlet end) of the artificial valve in a stationary position, and the other member may be configured to pull (or push) the outlet end (or inlet end) of the artificial valve toward the inlet end (or outlet end).

[0089] Regardless of how the valve expansion mechanism is configured, monitoring the diameter of the expanded artificial valve can be achieved by applying the same concepts described above. For example, a delivery device may include a first part releasably connected to a first member of the valve expansion mechanism, and a second part releasably connected to a second member of the valve expansion mechanism, wherein the first and second members are configured to be axially movable relative to each other. One or more reference radiopaque markers may be located on the first part (or the second part), and an indicator radiopaque marker may be located on the second part (or the first part). The axial movement of the second part relative to the first part may cause a corresponding axial movement between the first and second members, thereby causing axial compression and radial expansion of the artificial valve. Thus, the alignment of the indicator radiopaque marker with one or more reference radiopaque markers may indicate the diameter of the expanded artificial valve.

[0090] Although the prosthetic valve is described as having a mechanically expandable frame, it should be recognized that the same concepts disclosed herein may also apply to other types of prosthetic valves, such as balloon-inflatable and self-expandable prosthetic valves. For example, a delivery device may include a first part releasably connected to the inlet (or outlet) end of the prosthetic valve and a second part releasably connected to the outlet (or inlet) end of the prosthetic valve. One or more reference radiopaque markers may be located on the first part (or second part), and an indicator radiopaque marker may be located on the second part (or first part). When the prosthetic valve is expanded radially, either through a self-expansion mechanism or by inflating an inflatable balloon, the distance between the inlet and outlet ends of the prosthetic valve decreases. As a result, the second part moves axially relative to the first part. Thus, the alignment of the indicator radiopaque marker with one or more reference radiopaque markers may indicate the diameter of the expanded prosthetic valve.

[0091] In yet another embodiment, two or more indicator radiopaque markers may be used in conjunction with one or more reference radiopaque markers. For example, Figure 8 shows an embodiment of a retaining and actuator assembly 110 having three reference radiopaque markers 440a, 440b, and 440c equally spaced at a distance d1, and two indicator radiopaque markers 442a and 442b spaced at a distance d2, which may be half of d1. The diameter of the artificial valve is indicated as D1, D2, or D3 when the nearest indicator radiopaque marker 442b is aligned with the reference radiopaque markers 440a, 440b, or 440c, respectively. On the other hand, if the nearest indicator radiopaque marker 442b is located between reference radiopaque markers 440a and 440b (or between 440b and 440c), and the farthest indicator radiopaque marker 442a is aligned with reference radiopaque marker 440a (or 440b), the diameter of the prosthetic valve may be expressed as an intermediate value between D1 and D2 (or between D2 and D3), for example, the average of D1 and D2 (or the average of D2 and D3). Thus, using multiple indicator radiopaque markers with different intervals than the reference radiopaque marker can provide different resolutions for measuring the valve diameter.

[0092] It should be understood that the retaining and actuator assembly may be configured to have any number of indicator radiopaque markers and any number of reference radiopaque markers. The spacing between indicator radiopaque markers may be greater than or less than the spacing between reference radiopaque markers. Furthermore, the spacing between indicator radiopaque markers and / or the spacing between reference radiopaque markers may be uniform or non-uniform.

[0093] General Overview It should be understood that the disclosed embodiments may be configured to deliver an artificial tube and implant it into any of the heart's own valve annuclei (e.g., the pulmonary annucleus, mitral annucleus, and tricuspid annucleus) and may be used in conjunction with any of the various delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0094] For the purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, this disclosure covers all novel and non-obvious features and aspects of the various disclosed embodiments, both individually and in various combinations and partial combinations thereof. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require that any one or more particular advantages exist or problems be solved. Technology from any embodiment may be combined with technology described in any one or more of the other embodiments. Given the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred embodiments and should not be understood as limiting the scope of the disclosed technology.

[0095] While some of the operations of the disclosed embodiments are described in a particular order for the sake of presentation, it should be understood that this style of description is inclusive of reordering unless a specific order is required by the specific terms described below. For example, operations described consecutively may, in some cases, be reordered or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not illustrate the various ways in which the disclosed methods may be used in conjunction with other methods. In addition, the description may use terms such as “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstract concepts of the actual operations performed. The actual operations corresponding to these terms may vary depending on the particular embodiment and will be readily identifiable to those skilled in the art.

[0096] As used herein with respect to artificial valves, delivery devices, and other components of delivery assemblies, “proximal” refers to a location, orientation, or part of the device that is near the handle of the delivery assembly on the outside of the patient, and “distal” refers to a location, orientation, or part of the device that is far from the handle. The terms “longitudinal” and “axial” refer to axes extending in the proximal and distal directions, respectively, unless otherwise clearly defined.

[0097] As used in this application and claims, the singular forms “a,” “an,” and “the” include the plural form unless otherwise specified in the context. Furthermore, the term “includes” means “comprises.” Furthermore, the terms “coupled” and “connected” generally mean connected or linked electrically, electromagnetically, and / or physically (e.g., mechanically or chemically), and do not preclude the existence of intermediate elements between connected or associated items unless a specific opposite term is used.

[0098] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate the discussion of principles in the drawings and herein, but are not intended to be restrictive. For example, certain terms may be used, such as “inside,” “outside,” “top,” “down,” “interior,” and “exterior.” Such terms are used, where applicable, to provide clarity in describing relative relationships, particularly with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the “upper” portion may become the “lower” portion simply by turning the object upside down. Nevertheless, it is still the same portion, and the object remains the same. As used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0099] Considering the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the exemplary embodiments are merely preferred embodiments of the invention and should not be understood as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. [Explanation of Symbols]

[0100] 10 Artificial implant delivery assembly 100 Delivery Device 102 Handle 104 Shaft 110 Retaining and Actuator Assembly 120 Support tube 122 Actuator component 124 Locking Tools 140 Standard radiopaque markers 140a Standard radiopaque marker 140b Reference radiopaque marker 140c standard radiopaque marker 142 Indicator Radiopaque Marker 200 artificial valves 202 Valve-like structure 204 frames 206 Proximal end 208 Distal end 210 Strut 212 holes 214 Longitudinal axis 216 pins 250 Distal junction 252 Distal vertex 260 Proximal junction 262 Proximal vertex 300 valve expansion mechanism 302 Actuator Screw 304 Distal portion 306 Proximal portion 308 Distal mounting parts 310 Distal valve connector 312 Sleeves 314 Proximal valve connector 316 Lock Nut 318 Notched section 319 Engagement surface 326 Notched section 327 Engagement surface 330 Proximal end 332 Proximal end portion 440a Standard radiopaque marker 440b Reference radiopaque marker 440c standard radiopaque marker 442a Indicator Radiopaque Marker 442b Indicator: Radiopaque Marker Dmin Minimum diameter Dmax Maximum diameter Dmed Intermediate Diameter D1 Diameter of the artificial valve D2 Diameter of the artificial valve D3 Diameter of the artificial valve d1 distance d2 distance

Claims

1. A delivery device configured to provide visual feedback of the radial expansion of an artificial valve, wherein the delivery device is It includes a first portion configured to maintain a constant spatial relationship with respect to the first end of the artificial valve, and a second portion configured to maintain a constant spatial relationship with respect to the second end of the artificial valve during radial expansion of the artificial valve, A delivery device comprising, firstly, one or more reference radiopaque markers, and secondly, an indicator radiopaque marker, which measures the axial distance between the first end and the second end of the prosthetic valve, indicating the corresponding diameter of the prosthetic valve when it is radially expanded from a radially compressed state to a radially expanded state, at the position of the indicator radiopaque marker relative to the one or more reference radiopaque markers.

2. The delivery device according to claim 1, wherein the first portion is configured to be detachably connected to the artificial valve, and the second portion is configured to move axially relative to the first portion when the artificial valve is radially expanded from a radially compressed state to a radially expanded state.

3. The delivery device according to claim 1, wherein the second portion is configured to be detachably connected to the artificial valve, and the first portion is configured to move axially relative to the second portion when the artificial valve is radially expanded from a radially compressed state to a radially expanded state.

4. The delivery device according to any one of claims 1 to 3, wherein the reference radiopaque marker and the indicator radiopaque marker are configured to be positioned outside the frame of the artificial valve.

5. The delivery device according to any one of claims 1 to 4, wherein the one or more reference radiopaque markers include a first reference radiopaque marker and a second reference radiopaque marker spaced apart from the first reference radiopaque marker, and while the artificial valve expands from the radially compressed state to the radially expanded state, the alignment of the indicator radiopaque marker and the first reference radiopaque marker indicates a first expanded diameter of the artificial valve, and the alignment of the indicator radiopaque marker and the second reference radiopaque marker indicates a second expanded diameter of the artificial valve.

6. The delivery device according to any one of claims 1 to 5, wherein the first and second parts are configured to work in conjunction with an expansion mechanism of the artificial valve, so that relative movement between the first and second parts in a first direction causes the artificial valve to expand from a radially compressed state to a radially expanded state, and relative movement between the first and second parts in a second direction opposite to the first direction causes the artificial valve to compress from a radially expanded state to a radially compressed state.

7. The delivery device according to claim 6, wherein the expansion mechanism includes a locking mechanism configured to lock the artificial valve to a certain diameter, the locking mechanism being activated when a locking member is moved to a locked position by the first or second part.

8. The delivery device according to claim 7, wherein at least one of the indicator radiopaque marker and the reference radiopaque marker is configured to align with the radiopaque portion of the artificial valve when the locking member is moved to the locked position.

9. An artificial valve delivery assembly, An artificial valve having an inlet end and an outlet end, A delivery device including a first part and a second part, The second portion is configured to move axially relative to the first portion when the artificial valve expands radially from a radially compressed state to a radially expanded state. An artificial valve delivery assembly comprising a first portion comprising one or more reference radiopaque markers, and a second portion comprising an indicator radiopaque marker, wherein the axial length of the artificial valve is measured, indicating the corresponding diameter of the artificial valve at the position of the indicator radiopaque marker relative to the one or more reference radiopaque markers.

10. The assembly according to claim 9, wherein the first portion maintains a constant spatial relationship with respect to the outflow end, and the second portion maintains a constant spatial relationship with respect to the inflow end during the radial expansion of the artificial valve.

11. The assembly according to claim 9, wherein the first portion maintains a constant spatial relationship with respect to the inlet end, and the second portion maintains a constant spatial relationship with respect to the outlet end during the radial expansion of the artificial valve.

12. The assembly according to any one of claims 9 to 11, wherein the artificial valve includes a valve expansion mechanism, the valve expansion mechanism includes an inner member at least partially received inside an outer member, and the axial movement of the inner member relative to the outer member causes radial expansion or compression of the artificial valve.

13. The assembly according to claim 12, wherein the first part is configured to be connected to the outer member, and the second part is configured to be connected to the inner member, so that when the second part is retracted axially relative to the first part, axial movement of the inner member relative to the outer member occurs.

14. The assembly according to any one of claims 9 to 13, wherein the reference radiopaque marker and the indicator radiopaque marker are configured to be positioned outside the frame of the prosthetic valve so that the reference radiopaque marker and the indicator radiopaque marker are visible under fluoroscopy during radial expansion of the prosthetic valve.

15. The assembly according to any one of claims 9 to 14, wherein the at least one reference radiopaque marker includes a first reference radiopaque marker and a second reference radiopaque marker spaced apart from the first reference radiopaque marker, and while the prosthetic valve expands from the radially compressed state to the radially expanded state, the alignment of the indicator radiopaque marker and the first reference radiopaque marker indicates a first expanded diameter of the prosthetic valve, and the alignment of the indicator radiopaque marker and the second reference radiopaque marker indicates a second expanded diameter of the prosthetic valve.

16. A method for implanting an artificial valve, wherein the method is The steps include positioning the artificial valve at a target site in the patient's body using a delivery device, A step of radially expanding the artificial valve from a radially compressed state to a radially expanded state, A method comprising the steps of monitoring the diameter of the artificial valve based on the change in position of an indicator radiopaque marker relative to one or more reference radiopaque markers under X-ray fluoroscopy, wherein the indicator radiopaque marker and the reference radiopaque marker are located on the delivery device.

17. The method according to claim 16, wherein the act of expanding the artificial valve includes the steps of holding the first end of the artificial valve in place and applying an axial force to the second end of the artificial valve to move the second end toward the first end, thereby reducing the axial length and increasing the diameter of the artificial valve.

18. The method according to claim 17, wherein the act of expanding the artificial valve includes the step of activating a valve expansion mechanism, the valve expansion mechanism includes an inner member at least partially received inside an outer member, and the axial movement of the inner member relative to the outer member causes radial expansion or compression of the artificial valve.

19. The method according to claim 18, wherein the delivery device comprises a first portion and a second portion, the second portion being connected to the inner member, and the act of operating the valve expansion mechanism includes the step of moving the inner member axially relative to the outer member by moving the inner member backward by moving the first portion in contact with one end of the outer member and moving the second portion backward.

20. The method according to claim 19, wherein the one or more reference radiopaque markers are located on the first portion, and the indicator radiopaque marker is located on the second portion.

21. The method according to any one of claims 16 to 18, wherein the delivery device comprises a first portion and a second portion, the second portion being configured to move axially relative to the first portion when the artificial valve is radially expanded from a radially compressed state to a radially expanded state, the one or more reference radiopaque markers being located on the first portion, and the indicator radiopaque marker being located on the second portion.

22. The method according to any one of claims 16 to 21, further comprising the step of locking the artificial valve to a certain diameter by moving a locking member to a locked position.

23. The method of claim 22, further comprising the step of confirming that the locking member has been moved to the locked position by verifying under X-ray fluoroscopy that at least one of the indicator radiopaque marker and the reference radiopaque marker is aligned with the radiopaque portion of the artificial valve.

24. A delivery device configured to provide visual feedback of the radial expansion of an artificial valve, wherein the delivery device is It includes a first part and a second part configured to work in conjunction with the valve expansion mechanism of the artificial valve, The second portion is configured to move axially relative to the first portion when the valve expansion mechanism is activated for radial expansion or compression of the artificial valve, The first part comprises one or more reference radiopaque markers, and the second part comprises an indicator radiopaque marker. A delivery device in which the position of the indicator radiopaque marker relative to one or more reference radiopaque markers indicates the radial diameter of the artificial valve.

25. The delivery device according to claim 24, wherein the first portion is configured to maintain a constant spatial relationship with respect to the inlet end of the artificial valve, and the second portion is configured to maintain a constant spatial relationship with respect to the outlet end of the artificial valve during radial expansion of the artificial valve.

26. The delivery device according to claim 24 or 25, wherein the first portion is releasably connected to a first member of a valve expansion mechanism, and the second portion is releasably connected to a second member of the valve expansion mechanism, and the axial movement of the second portion relative to the first portion is associated with the corresponding axial movement of the second member relative to the first member of the valve expansion mechanism, causing radial expansion or compression of the artificial valve.

27. The delivery device according to claim 26, wherein the second portion is configured to move a locking member mounted on the second member of the expansion mechanism to a locked position, thereby locking the artificial valve to a certain diameter.

28. The delivery device according to claim 27, wherein the indicator radiopaque marker is configured to align with the proximal end portion of the first member of the valve expansion mechanism when the locking member is moved to the locked position.

29. The delivery device according to any one of claims 24 to 28, wherein the indicator radiopaque marker is configured to be positioned outside the frame of the prosthetic valve during radial expansion or compression of the prosthetic valve.

30. The delivery device according to any one of claims 24 to 29, wherein the one or more reference radiopaque markers include a first reference radiopaque marker and a second reference radiopaque marker spaced apart from the first reference radiopaque marker, and while the prosthetic valve expands from a radially compressed state to a radially expanded state, the alignment of the indicator radiopaque marker and the first reference radiopaque marker indicates a first expanded diameter of the prosthetic valve, and the alignment of the indicator radiopaque marker and the second reference radiopaque marker indicates a second expanded diameter of the prosthetic valve.

31. The delivery device according to claim 30, wherein the second reference radiopaque marker is located proximal to the first reference radiopaque marker, and the second expanded diameter is larger than the first expanded diameter.

32. The delivery device according to any one of claims 24 to 31, wherein the one or more reference radiopaque markers include at least three reference radiopaque markers spaced equally apart from any pair of adjacent reference radiopaque markers.

33. The delivery device according to any one of claims 24 to 31, wherein the one or more reference radiopaque markers include at least three reference radiopaque markers spaced at non-uniform distances from multiple pairs of adjacent reference radiopaque markers.

34. The delivery device according to any one of claims 24 to 33, wherein the indicator radiopaque marker is one of a plurality of indicator radiopaque markers, and the distance between at least one pair of adjacent indicator radiopaque markers is different from the distance between at least one pair of adjacent reference radiopaque markers.

35. A delivery device configured to provide visual feedback of the radial expansion of an artificial valve, wherein the delivery device is Support pipe and A locking tool extending through the lumen of the support tube, The locking tool includes an actuator member extending through the lumen of the locking tool, The support tube is configured to interlock with the sleeve of the valve expansion mechanism, the locking tool and the actuator member are configured to interlock with the actuator screw of the valve expansion mechanism, and the axial movement of the actuator screw relative to the sleeve causes radial expansion or compression of the artificial valve. A delivery device comprising a support tube including one or more reference radiopaque markers, a locking tool including an indicator radiopaque marker, the position of the indicator radiopaque marker relative to the one or more reference radiopaque markers indicating the radial diameter of the artificial valve.

36. The delivery device according to claim 35, wherein the distal end of the support tube is configured to abut against the proximal end of the sleeve to prevent the support tube and the sleeve from moving further toward each other, and the distal end portion of the actuator member is configured to be releasably connected to the proximal portion of the actuator screw, thereby causing the axial movement of the actuator member relative to the support tube to cause the axial movement of the actuator screw relative to the sleeve, thereby causing radial expansion or compression of the artificial valve.

37. The delivery device according to claim 35 or 36, wherein the locking tool is screw-connected to the actuator member, and as a result of the rotation of the locking tool, the locking tool moves axially along the actuator screw.

38. The delivery device according to claim 37, wherein the distal end of the locking tool is configured to engage with or disengage a lock nut mounted on the actuator screw, so that rotation of the locking tool in a first direction causes the locking tool to engage with the lock nut, and rotation of the locking tool in a second direction opposite to the first direction causes the locking tool to disengage the lock nut.

39. Further rotation of the locking tool in the first direction after engagement with the locking nut causes the locking nut to move distally along the actuator screw to a locked position located at the distal end of the sleeve, thereby locking the artificial valve to a certain diameter, according to claim 38.

40. The delivery device according to claim 39, wherein the indicator radiopaque marker is configured to align with the proximal end portion of the sleeve when the lock nut is moved to the locked position.

41. The delivery device according to any one of claims 35 to 40, wherein the indicator radiopaque marker is configured to be positioned outside the frame of the prosthetic valve during radial expansion or compression of the prosthetic valve.

42. The distal end portion of the support tube comprises a radiolucent material, thereby making the indicator radiopaque marker on the locking tool visible under X-ray fluoroscopy, according to any one of claims 35 to 41.

43. The delivery device according to any one of claims 35 to 42, wherein the distal end portion of the support tube includes a cutout window, thereby making the indicator radiopaque marker on the locking tool visible through the cutout window under X-ray fluoroscopy.

44. The delivery device according to any one of claims 35 to 43, wherein the one or more reference radiopaque markers are spaced far apart on the support tube, so that during radial expansion of the artificial valve, the alignment of the indicator radiopaque marker and the one or more reference radiopaque markers indicates the corresponding diameter of the artificial valve.

45. An artificial valve delivery assembly, An artificial valve including a valve expansion mechanism, A delivery device including a first part and a second part that are interlocked with the valve expansion mechanism, The second portion is configured to move axially relative to the first portion when the valve expansion mechanism is activated for radial expansion or compression of the artificial valve. The first part comprises one or more reference radiopaque markers, and the second part comprises an indicator radiopaque marker. An artificial valve delivery assembly in which the position of the indicator radiopaque marker relative to one or more reference radiopaque markers indicates the radial diameter of the artificial valve.

46. The assembly according to claim 45, wherein the first portion is configured to maintain a constant spatial relationship with respect to the inlet end of the artificial valve, and the second portion is configured to maintain a constant spatial relationship with respect to the outlet end of the artificial valve during radial expansion of the artificial valve.

47. The assembly according to claim 45 or 46, wherein the valve expansion mechanism includes an inner member at least partially received inside an outer member, and the axial movement of the inner member relative to the outer member causes radial expansion or compression of the artificial valve.

48. The assembly according to claim 47, wherein the first part is configured to be connected to the outer member, and the second part is configured to be connected to the inner member, so that the axial movement of the inner member relative to the outer member causes a corresponding axial movement of the second part relative to the first part.

49. The assembly according to claim 47 or 48, wherein the distal end of the first portion is configured to abut against the proximal end of the outer member to prevent the first portion and the outer member from moving further toward each other.

50. The assembly according to claim 49, wherein the delivery device further includes an actuator member, the distal end portion of the actuator member being configured to be releasably connected to the proximal portion of the inner member, so that the axial motion of the actuator member can cause a corresponding axial motion of the inner member relative to the outer member, thereby causing radial expansion or compression of the artificial valve.

51. The assembly according to any one of claims 47 to 50, wherein the second part is screw-connected to the inner member, and as a result of the rotation of the second part, the second part moves axially along the inner member.

52. The assembly according to claim 51, wherein the distal end of the second portion is configured to engage with or disengage from a locking member mounted on the inner member, so that rotation of the second portion in a first direction causes the second portion to engage with the locking member, and rotation of the second portion in a second direction opposite to the first direction causes the second portion to disengage from the locking member.

53. The assembly according to claim 52, wherein the locking member is configured to lock the artificial valve to a certain diameter when the locking member is located in a predetermined locking position inside the outer member.

54. The assembly according to claim 53, wherein further rotation of the second member in the first direction after engagement with the locking member causes the locking member to move along the inner member to the predetermined locking position.

55. The assembly according to claim 54, wherein the indicator radiopaque marker is configured to align with the proximal end portion of the outer member when the locking member is moved to the predetermined locking position.

56. The assembly according to any one of claims 45 to 55, wherein the indicator radiopaque marker is configured to be positioned outside the frame of the prosthetic valve during radial expansion or compression of the prosthetic valve.

57. The assembly according to any one of claims 45 to 56, wherein the one or more reference radiopaque markers are very spaced apart on the first portion, so that during radial expansion of the prosthetic valve, the alignment of the indicator radiopaque marker and the one or more reference radiopaque markers indicates the corresponding diameter of the prosthetic valve.

58. The assembly according to any one of claims 45 to 57, wherein the one or more reference radiopaque markers are configured to be visually distinguishable from the indicator radiopaque marker under X-ray fluoroscopy.

59. A method for implanting an artificial valve, wherein the method is The steps include positioning the artificial valve at a target site in the patient's body using a delivery device, The steps include expanding the artificial valve in the radial direction, A method comprising the step of confirming that the artificial valve has been expanded to a predetermined diameter based on the observation that an indicator radiopaque marker is aligned with a reference radiopaque marker under X-ray fluoroscopy, wherein the indicator radiopaque marker and the reference radiopaque marker are located on the delivery device.

60. The method according to claim 59, further comprising the step of locking the artificial valve to the predetermined diameter after observing that the indicator radiopaque marker is aligned with the reference radiopaque marker under X-ray fluoroscopy.

61. The method according to claim 60, further comprising the step of confirming that the prosthetic valve is locked to the predetermined diameter by observing under X-ray fluoroscopy that the indicator radiopaque marker aligns with a predetermined portion of the prosthetic valve.

62. The method according to any one of claims 59 to 61, wherein the step of expanding the artificial valve includes holding the first end of the artificial valve in place and applying an axial force to the second end of the artificial valve to move the second end toward the first end, thereby reducing the axial length and increasing the diameter of the artificial valve.

63. The method according to claim 62, wherein the step of expanding the artificial valve includes the step of activating a valve expansion mechanism, the valve expansion mechanism includes an inner member at least partially received inside an outer member, and the axial movement of the inner member relative to the outer member causes radial expansion or compression of the artificial valve.

64. The method according to claim 63, wherein the step of activating the valve expansion mechanism includes the step of installing the support pipe of the delivery device in contact with the proximal end of the outer member.

65. The method according to claim 64, wherein the step of activating the valve expansion mechanism includes connecting the actuator member of the delivery device to the proximal end portion of the inner member.

66. The method according to claim 65, wherein the step of activating the valve expansion mechanism includes holding the support pipe in a stationary position and retracting the actuator member in the proximal direction to move the inner member in the proximal direction relative to the outer member.

67. The method according to claim 65, wherein the step of activating the valve expansion mechanism includes holding the actuator member in a stationary state and pushing the support pipe distally to move the outer member distally relative to the inner member.

68. The method according to claim 65, wherein the step of activating the valve expansion mechanism includes pushing the stationary support pipe distally and retracting the actuator member proximally, thereby moving the inner member and the outer member in opposite directions.

69. The method according to any one of claims 64 to 68, wherein the reference radiopaque marker is located on the outer surface of the support tube.

70. The method according to any one of claims 65 to 69, wherein the indicator radiopaque marker is located on the actuator member.

71. The method according to any one of claims 63 to 70, further comprising the step of connecting the locking tool of the delivery device to the inner member, wherein the indicator radiopaque marker is located on the outer surface of the locking tool.

72. The method according to claim 71, wherein the step of locking the artificial valve includes rotating the locking tool in a first direction to engage with a locking member mounted on the inner member and moving it to a locked position, wherein the locking member is configured to lock the artificial valve to a certain diameter when the locking member is in the locked position.

73. The method according to claim 72, wherein the step of locking the artificial valve further includes, after the locking member has been moved to the locked position, the step of rotating the locking tool in a second direction opposite to the first direction to disengage the locking member from the locking tool.

74. The method according to claim 72 or 73, wherein the indicator radiopaque marker is configured to align with the proximal end portion of the outer member when the locking member is moved to the locked position.

75. The method according to any one of claims 59 to 74, wherein the reference radiopaque marker is one of a plurality of reference radiopaque markers, and the plurality of reference radiopaque markers are very spaced apart on the delivery device, so that the alignment of the indicator radiopaque marker and each of the plurality of reference radiopaque markers indicates the corresponding diameter of the artificial valve.

76. A method for implanting an artificial valve, wherein the method is The steps include positioning the artificial valve at a target site in the patient's body using a delivery device, The steps include: expanding the artificial valve radially to a predetermined diameter; The steps include locking the artificial valve to the predetermined diameter, A method comprising the step of confirming that the prosthetic valve is locked to the predetermined diameter based on the observation that an indicator radiopaque marker is aligned with a predetermined portion of the prosthetic valve under X-ray fluoroscopy, wherein the indicator radiopaque marker is located on the delivery device.

77. The method of claim 76, further comprising the step of confirming that the artificial valve has been expanded to the predetermined diameter based on the observation that the indicator radiopaque marker is aligned with a reference radiopaque marker under X-ray fluoroscopy, wherein the reference radiopaque marker is located on the delivery device.

78. The method according to claim 76 or 77, wherein the step of expanding the artificial valve includes the step of activating a valve expansion mechanism, the valve expansion mechanism includes an inner member at least partially received inside an outer member, the axial movement of the inner member relative to the outer member causes radial expansion or compression of the artificial valve, the predetermined portion is located at the proximal end portion of the outer member.

79. The method according to claim 78, wherein the step of activating the valve expansion mechanism includes the step of installing the support pipe of the delivery device in contact with the proximal end of the outer member.

80. The method according to claim 79, wherein the step of activating the valve expansion mechanism includes connecting the actuator member of the delivery device to the proximal end portion of the inner member.

81. The method according to claim 80, wherein the step of activating the valve expansion mechanism includes holding the support pipe in a stationary position and retracting the actuator member in the proximal direction to move the inner member in the proximal direction relative to the outer member.

82. The method according to claim 80, wherein the step of activating the valve expansion mechanism includes holding the actuator member in a stationary state and pushing the support pipe distally to move the outer member distally relative to the inner member.

83. The method according to claim 80, wherein the step of activating the valve expansion mechanism includes pushing the stationary support pipe distally and retracting the actuator member proximally, thereby moving the inner member and the outer member in opposite directions.

84. The method according to any one of claims 79 to 83, wherein the reference radiopaque marker is located on the support tube.

85. The method according to any one of claims 78 to 84, further comprising the step of connecting the locking tool of the delivery device to the inner member, wherein the indicator radiopaque marker is located on the locking tool.

86. The method according to claim 85, wherein the step of locking the artificial valve includes rotating the locking tool in a first direction to engage with a locking member mounted on the inner member and moving it to a locked position, the locking member being configured to lock the artificial valve to a certain diameter when the locking member is in the locked position.

87. The method according to claim 86, wherein the step of locking the artificial valve further includes, after the locking member has been moved to the locked position, the step of rotating the locking tool in a second direction opposite to the first direction to disengage the locking member from the locking tool.

88. The method according to any one of claims 77 to 87, wherein the reference radiopaque marker is one of a plurality of reference radiopaque markers, and the plurality of reference radiopaque markers are very spaced apart on the delivery device, so that the alignment of the indicator radiopaque marker and each of the plurality of reference radiopaque markers indicates the corresponding diameter of the artificial valve.

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