Device and method for estimating the diameter of artificial valves

Abstract

To provide devices, assemblies and methods for surely achieving proper implantation of a prosthetic valve in a designated part of implantation, such as a part of a natural valve which does not function normally, by real time measurement of an expanded diameter, and monitoring expansion of the prosthetic valve in a radial direction during prosthetic valve implantation procedures.SOLUTION: The present invention relates to devices, assemblies and methods for monitoring radial expansion of a prosthetic valve during prosthetic valve implantation procedures.SELECTED DRAWING: Figure 5E

Description

[Technical Field]

[0001] The present invention relates to a device and method for measuring the expansion diameter of an artificial valve. [Background technology]

[0002] Spontaneous heart valves, such as the aortic valve, pulmonary valve, and mitral valve, function to ensure proper directional flow to and from the heart and between the ventricles, supplying blood to the entire cardiovascular system. Various heart valve diseases can cause the valves to malfunction, requiring replacement with artificial valves. Surgical intervention may be performed to repair or replace heart valves. However, surgery is prone to many clinical complications, and therefore, alternative, less invasive techniques have been developed over the years, such as delivering artificial valves via catheter and implanting them over non-functioning native valves.

[0003] To date, different types of prosthetic valves are known, including balloon-inflatable valves, self-inflatable valves, and mechanically inflatable valves. Different methods of delivery and implantation are also known and may vary depending on the implantation site and the type of prosthetic valve. One exemplary technique involves the use of a delivery assembly to deliver a compressed prosthetic valve to a non-functioning native valve through an incision that may be placed in the patient's femoral or iliac artery. After the prosthetic valve is properly positioned at the desired implantation site, it is expanded to strike surrounding anatomical structures, such as the native valve annulus, and then the delivery assembly can be retrieved.

[0004] Mechanically expandable valves are a category of artificial valves that rely on a mechanical actuation mechanism for expansion. The actuation mechanism typically includes multiple actuation / locking assemblies, releasably connected to each actuating member of the valve delivery system, controlled via a handle to actuate the assembly to expand the valve to a desired diameter. The assemblies may optionally lock the valve in place to prevent undesirable recompression and detach the actuating members of the valve delivery system from the valve actuation / locking assembly so that the valve can be removed after it has been properly positioned at the desired implantation site. Various types of recompression assemblies may be used to recompress an expanded artificial valve to allow repositioning or recrossing procedures to be performed and to allow readjustment of the artificial valve expansion diameter.

[0005] When implanting an expandable prosthetic valve, it is desirable to expand the valve to the maximum size acceptable by the patient's anatomical considerations, while mitigating the risk of annular rupture, which can result in excessive expansion, and avoiding paravalvular regurgitation or other undesirable hemodynamic phenomena that may be associated with a mismatch between the valve expansion diameter and the surrounding tissue. To ensure the optimal implantation size, the diameter of the prosthetic valve should be monitored in real time during implantation surgery. While real-time monitoring can be important for all types of prosthetic valves, mechanically expandable valves may particularly benefit from such monitoring, as mechanically acting mechanisms provide greater control over the rate and range of valve expansion, allowing clinicians to adjust the expansion diameter in response to real-time monitoring data. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] U.S. Patent No. 6,730,118 [Patent Document 2] U.S. Patent No. 7,393,360 [Patent Document 3] U.S. Patent No. 7,510,575 [Patent Document 4] U.S. Patent No. 7,993,394 [Patent Document 5] U.S. Patent No. 8,252,202 [Patent Document 6] U.S. Patent Application No. 62 / 614,299 [Patent Document 7] U.S. Patent No. 9,827,093 [Patent Document 8] U.S. Patent Application Publication No. 2019 / 0060057 [Patent Document 9] U.S. Patent Application Publication No. 2018 / 0153689 [Patent Document 10] U.S. Patent Application Publication No. 2018 / 0344456 [Patent Document 11] U.S. Patent Application No. 62 / 870,372 [Patent Document 12] U.S. Patent Application No. 62 / 776,348 [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] This disclosure relates to devices, assemblies, and methods for monitoring the radial expansion of a prosthetic valve in a prosthetic valve implantation procedure. Real-time measurement of the expansion diameter ensures proper implantation of the prosthetic valve within a designated site of implantation, such as the site of a non-functioning native valve. [Means for solving the problem]

[0008] According to one aspect of the present invention, a delivery assembly is provided which includes an artificial valve and a delivery device. The artificial valve is movable between a radially compressed configuration and a radially expanded configuration. The delivery device comprises a handle, a delivery shaft extending distally from the handle, and a recompression assembly. The recompression assembly comprises a recompression shaft extending through the lumen of the delivery shaft and a recompression member extending through the lumen of the recompression shaft. The recompression member comprises a loop portion configured to surround the artificial valve, the loop portion comprising at least one radiopaque marker. Relative axial movement between the recompression member and the recompression shaft has the effect of tightening the loop portion around the artificial valve, thereby radially compressing the artificial valve.

[0009] According to some embodiments, at least one radiopaque marker includes a plurality of radiopaque markers spaced apart from each other along at least a portion of the loop.

[0010] According to some embodiments, the radiopaque marker includes a radiopaque band.

[0011] According to some embodiments, the radiopaque marker extends along a portion of the loop, which is at least half the length of the circumference of the prosthetic valve in a radially extended configuration.

[0012] According to some embodiments, at least one radiopaque marker is positioned along a minimum marking length at a location corresponding to the contact area between the loop portion and the circumference of the artificial valve.

[0013] According to some embodiments, the minimum marking length is at least as large as the circumference of the artificial valve in a radially extended configuration.

[0014] According to some embodiments, at least one radiopaque marker comprises a radiopaque coating.

[0015] According to some embodiments, the recompression member further comprises a releaseable connector. The releaseable connector comprises a proximal connector element and a distal connector element that are releaseably attached to each other, and the recompression member comprises a recompression member proximal segment coupled to the proximal connector element, and a loop portion coupled to the distal connector element.

[0016] According to some embodiments, the artificial valve includes a guide member, and at least a portion of the recompression member extends through the lumen of the guide member.

[0017] According to some embodiments, the artificial valve further comprises a sleeve disposed around at least a portion of the circumference of the artificial valve, with at least a portion of the loop extending through the sleeve.

[0018] According to another aspect of the present invention, a delivery assembly is provided which includes an artificial valve and a delivery device. The artificial valve is movable between a radially compressed configuration and a radially expanded configuration. The delivery device comprises a handle, a delivery shaft extending distally from the handle, and a recompression assembly. The recompression assembly comprises a recompression shaft extending through the lumen of the delivery shaft and a recompression member including at least one indicator radiopaque marker. The recompression shaft includes at least one reference radiopaque marker.

[0019] The recompression member comprises a proximal segment and a loop. The recompression member extends through the lumen of the recompression shaft. The loop extends distally from the recompression shaft. Relative axial movement between the recompression member and the recompression shaft has the effect of tightening the loop around the prosthetic valve, thereby compressing the prosthetic valve radially. The axial position of one indicator radiopaque marker with respect to at least one reference radiopaque marker indicates the diameter of the prosthetic valve.

[0020] According to some embodiments, at least one reference radiopaque marker comprises a plurality of reference radiopaque markers, each reference radiopaque marker associated with a different diameter of the artificial valve, and the alignment of an indicator radiopaque marker with any one of the reference radiopaque markers indicates the diameter associated with each reference radiopaque marker.

[0021] According to some embodiments, the proximal segment of the recompression member comprises at least one indicator radiopaque marker.

[0022] According to some embodiments, the recompression member further comprises connectors coupled to the proximal segment and loop portion of the recompression member.

[0023] According to some embodiments, the connector comprises at least one indicator radiopaque marker.

[0024] According to some embodiments, the connector is a releasable connector comprising a proximal connector element and a distal connector element that are releasably mounted to each other, wherein the proximal segment of the recompression member is coupled to the proximal connector element, and the loop portion is coupled to the distal connector element.

[0025] According to some embodiments, the artificial valve includes a guide member, and at least a portion of the recompression member extends through the lumen of the guide member.

[0026] According to some embodiments, the artificial valve further comprises a sleeve disposed around at least a portion of the circumference of the artificial valve, with at least a portion of the loop extending through the sleeve.

[0027] According to some embodiments, the delivery assembly further comprises a plurality of actuating arm assemblies coupled to an artificial valve, configured to move the artificial valve between a radially compressed configuration and a radially expanded configuration. The plurality of actuating arm assemblies comprises a plurality of loop attachment members, the loop portion being coupled to the plurality of loop attachment members and extending between the plurality of loop attachment members.

[0028] According to some embodiments, the handle further comprises a spring connected to the proximal segment of the recompression member and configured to apply an axially oriented tensile force to the proximal segment of the recompression member, the tensile force being sufficient to apply a minimum amount of tension to the loop portion.

[0029] According to some embodiments, the handle further comprises a pulley assembly including a first pulley and a second pulley. The first pulley is attached to the handle via a first pin and is rotatable around the first pin. The second pulley is attached to the handle via a second pin and is rotatable around the second pin. The proximal segment of the recompression member is partially routed around the first pulley and around the second pulley. The pulley assembly is configured to apply a minimum amount of tension to the loop portion.

[0030] According to another aspect of the present invention, a delivery assembly is provided which includes an artificial valve and a delivery device. The artificial valve is movable between a radially compressed configuration and a radially expanded configuration. The delivery device comprises a handle, a delivery shaft extending distally from the handle, a recompression assembly, and a diameter gauge.

[0031] The recompression assembly comprises a recompression shaft extending through the lumen of the delivery shaft and a recompression member extending through the lumen of the recompression shaft. The recompression member comprises a proximal segment and a loop portion extending distally from the recompression shaft. Relative axial movement between the recompression member and the recompression shaft applies tension to the loop portion, thereby compressing the artificial valve radially.

[0032] The diameter gauge is coupled to the recompression assembly at the gauge coupling point and is configured to provide real-time indication of the diameter of the artificial valve based on the axial position and / or axial translation of the gauge coupling point.

[0033] According to some embodiments, the delivery device further comprises a plurality of actuating arm assemblies coupled to an artificial valve, configured to move the artificial valve between a radially compressed configuration and a radially expanded configuration. The plurality of actuating arm assemblies further comprises a plurality of loop attachment members. The plurality of actuating arm assemblies comprises a plurality of loop attachment members, and the loop portion is coupled to the plurality of loop attachment members and extends between the plurality of loop attachment members.

[0034] According to some embodiments, the loop portion is configured to surround the artificial valve, so that the relative movement between the axial recompression member and the recompression shaft has the effect of tightening the loop portion around the artificial valve.

[0035] According to some embodiments, the handle further comprises a spring connected to the proximal segment of the recompression member and configured to apply an axially oriented tensile force to the proximal segment of the recompression member, the tensile force being sufficient to apply a minimum amount of tension to the loop portion.

[0036] According to some embodiments, the handle further comprises a pulley assembly. The pulley assembly comprises a first pulley attached to the handle via a first pin and rotatable around the first pin, and a second pulley attached to the handle via a second pin and rotatable around the second pin. The proximal segment of the recompression member is partially routed around the first pulley and around the second pulley. The pulley assembly is configured to apply a minimum amount of tension to the loop portion.

[0037] According to some embodiments, the second pulley further comprises a column and a gear portion, and the handle further comprises a rack. The rack is configured to engage with the gear portion, so that the axial translation of the rack has the effect of rotating the gear portion. The proximal segment of the recompression member is configured to wrap around the column portion.

[0038] According to some embodiments, the handle further comprises a display, and the real-time instructions are visual real-time instructions visible through the display.

[0039] According to some embodiments, the diameter gauge comprises an indicator mark that reflects a range of diameters of the prosthetic valve and a dial. The dial is coupled to the recompression assembly at the gauge coupling point and is configured to point to the indicator mark representing the diameter of the prosthetic valve.

[0040] According to some embodiments, the dial is attached to the handle via a dial pivot and is configured to rotate angularly about the dial pivot as the gauge coupling point is translated axially.

[0041] According to some embodiments, the dial is orthogonal to the longitudinal axis of the recompression proximal segment and is configured to move with the recompression assembly as the recompression proximal segment is translated axially.

[0042] According to some embodiments, the dial is attached to the proximal segment of the recompression member at the gauge coupling point.

[0043] According to some embodiments, the diameter gauge comprises a displacement sensor operably connected to a recompression assembly and configured to generate a signal, the magnitude of which is proportional to the position and / or axial displacement gauge connection point.

[0044] According to some embodiments, the displacement sensor further comprises a potentiometer, and the diameter gauge further comprises a wiper coupled to a recompression assembly at a gauge coupling point. The wiper is configured to contact the potentiometer at the end of the wiper opposite to the gauge coupling point.

[0045] According to some embodiments, the wiper is attached to the proximal segment of the recompression member at the gauge coupling point.

[0046] According to some embodiments, the recompression assembly further comprises a track member extending through the lumen of the recompression shaft. The track member comprises a proximal segment and a secondary loop extending distally from the recompression shaft.

[0047] According to some embodiments, the dial is attached to the proximal segment of the track member at the gauge coupling point.

[0048] According to some embodiments, the wiper is attached to the proximal segment of the track member at the gauge coupling point.

[0049] According to some embodiments, the actuating arm assemblies further comprise a plurality of secondary loop mounting members, the secondary loop portion being coupled to the plurality of secondary loop mounting members and extending between the plurality of loop mounting members.

[0050] According to some embodiments, the handle further comprises a track spring connected to a proximal segment of the track member and configured to apply an axially oriented tensile force to the proximal segment of the track member, the tensile force being sufficient to apply a minimum magnitude of tension to the secondary loop.

[0051] According to another aspect of the present invention, a method is provided for providing an indication of the expansion diameter of an artificial valve, the method comprising the steps of (i) obtaining at least one image of the frame of the artificial valve, (ii) deriving a dimensionless parameter from at least one image, (iii) relating a numerical value of the expansion diameter of the artificial valve to the dimensionless parameter, and (iv) providing a visual indication of the expansion diameter of the artificial valve.

[0052] According to some embodiments, the step of acquiring at least one image includes acquiring at least one angiographic X-ray image of a frame.

[0053] According to some embodiments, the step of acquiring at least one image includes acquiring at least one fluorescence-transmitted image of a frame.

[0054] According to some embodiments, the step of relating the numerical value of the expansion diameter of the artificial valve to a dimensionless parameter is based on either a mathematical formula, a graph, and / or a table.

[0055] According to some embodiments, the step of providing visual instructions includes visualizing the expansion diameter of the artificial valve on a digital screen as a number, a graphical symbol, a text message, or any combination thereof.

[0056] According to some embodiments, the dimensionless parameter is the aspect ratio between the frame length and the frame width.

[0057] According to some embodiments, the dimensionless parameter is the opening angle between two intersecting supports of the frame.

[0058] According to another aspect of the present invention, an artificial valve is provided comprising a frame and a frame belt. The frame is movable between a radially compressed configuration and a radially expanded configuration. The frame belt comprises at least one expansion force indicator. At least a portion of the frame belt extends along at least a portion of the circumference of the frame in the expanded configuration. The at least one expansion force indicator is configured to change its state when the frame is expanded and a force exceeding a certain magnitude is applied to it by the frame.

[0059] According to some embodiments, at least one expansion force indicator includes a radiopaque marker, and a change in the state of at least one expansion force indicator is visible under fluorescence fluoroscopy.

[0060] According to some embodiments, the radiation concentration of at least one expansion force indicator is higher than the radiation concentration of the flame.

[0061] According to some embodiments, at least one expansion force indicator includes an isolation zone.

[0062] According to some embodiments, the separation zone includes a frangible portion.

[0063] According to some embodiments, the flangable portion comprises a plurality of flangable portions, wherein at least two of the flangable portions are configured to collapse in response to different magnitudes of tensile forces applied thereto.

[0064] According to some embodiments, the separation zone comprises a separable portion.

[0065] According to some embodiments, the frame belt comprises a plurality of expandable portions and a plurality of bases attached thereto, and at least one isolation zone comprises a plurality of isolation zones, each isolation zone being included in its respective base. The consumable portion is configured to expand circumferentially with the frame.

[0066] According to some embodiments, the separation zone is provided with radiopaque markings, and a change in the state of at least one expansion force indicator includes a transition of the separation zone from an intact state to a separated state.

[0067] According to some embodiments, the expandable portion includes radiopaque markings, and a change in the state of at least one expandable force indicator includes a transition in the height of the respective expandable portion from a first height value to a second, shorter height value.

[0068] According to some embodiments, at least one expansion force indicator has a geometric feature, the geometric feature having a shape that is distinguishable from its adjacent zones along a frame belt, and a change in the state of at least one expansion force indicator includes translation of the geometric feature from a first zone to a second zone.

[0069] According to some embodiments, the artificial valve further comprises a restrictor configured to allow at least one geometric feature to pass through it after a tensile force exceeding a predetermined threshold is applied to the frame belt.

[0070] According to some embodiments, the first zone includes a radiopaque covering zone configured to mask geometric features when placed therein, and the second zone includes an exposure zone in which geometric features are visible under fluorescence when placed therein.

[0071] According to some embodiments, the first zone includes a first orientation of a portion of the frame belt, and the second zone includes a second orientation of a portion of the frame belt, the second orientation being angled with respect to the first orientation.

[0072] According to some embodiments, the artificial valve further comprises a reference radiopaque marker, wherein a first zone includes a first spatial location of a geometric feature with respect to the reference radiopaque marker, and a second zone includes a second spatial location of a geometric feature with respect to the reference radiopaque marker, and the first and second spatial locations are on the opposite side of the reference radiopaque marker.

[0073] According to some embodiments, the artificial valve further comprises a sleeve disposed around at least a portion of the circumference of the artificial valve, and at least a portion of the frame belt extends through the sleeve in at least one configuration of the artificial valve.

[0074] According to some embodiments, at least one geometric feature comprises a bead.

[0075] According to some embodiments, at least one geometric feature comprises a belt ratchet tooth.

[0076] According to some embodiments, the restrictor comprises a small hole.

[0077] According to some embodiments, the restrictor comprises a sleeve ratchet tooth.

[0078] According to some embodiments, the frame belt includes a bioreabsorbable material.

[0079] According to several embodiments, a delivery assembly is provided which includes an artificial valve and a delivery device. The delivery device comprises a handle and a belt puller, the belt puller extending distally from the handle and attached to a frame belt.

[0080] According to some embodiments, the delivery assembly further comprises a belt shaft extending distally from the handle, and at least a portion of the belt pulling member extends through the belt shaft and is axially movable relative to the belt shaft.

[0081] According to some embodiments, the artificial valve further comprises a guide member, and at least a portion of the frame belt extends through the lumen of the guide member.

[0082] According to some embodiments, the delivery assembly further comprises a releaseable connector. The releaseable connector comprises a proximal connector element and a distal connector element that are releaseably mounted to each other, the belt tensioning member being coupled to the proximal connector element and the frame belt being coupled to the distal connector element.

[0083] According to several embodiments, a delivery assembly is provided which includes an artificial valve and a delivery device. The delivery device comprises a handle and a transmission line. The transmission line extends distally from the handle and is coupled to a frame belt. At least one expansion force indicator includes a stretch sensor, the change in the state of the stretch sensor includes a change in the electrical properties of the stretch sensor when stretched over the artificial valve. The transmission line is configured to transmit an electrical signal from the stretch sensor toward the handle.

[0084] Some embodiments of the present invention may include some or all of the above advantages, or none of them. Further advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims contained herein. Aspects and embodiments of the present invention are further described below in this specification and the accompanying claims.

[0085] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art in the field relating to this invention. In case of any discrepancy, this specification shall prevail, including definitions. As used in the original English text herein, the indefinite articles “a” and “an” in English text mean “at least one” or “one or more” unless the context clearly indicates otherwise.

[0086] The following embodiments and aspects are described and illustrated in relation to systems, tools, and methods, which are intended to be illustrative and descriptive but not limiting in scope. In various embodiments, one or more of the above-described problems are reduced or eliminated, while other embodiments are directed toward other advantages or improvements.

[0087] Several embodiments of the present invention are described herein with reference to the accompanying drawings. The description, along with the drawings, will make it clear to those skilled in the art how some embodiments can be carried out. The drawings are for illustrative purposes only and no attempt has been made to show structural details of the embodiments in more detail than necessary for a basic understanding of the present invention. For clarity, some of the objects depicted in the drawings are not to scale. [Brief explanation of the drawing]

[0088] [Figure 1] This is a perspective view of a delivery assembly including a delivery device for carrying an artificial valve, according to several embodiments. [Figure 2] This is a perspective view of an artificial valve according to several embodiments. [Figure 3A] This is a perspective view of an inner member according to several embodiments. [Figure 3B] This is a perspective view of an actuator assembly according to several embodiments. [Figure 3C] Figure 3B is a perspective view of an artificial valve comprising multiple actuator assemblies of the type shown. [Figure 4A]This figure shows an actuator assembly of the type shown in Figure 3B in one of several different operating states. [Figure 4B] This figure shows an actuator assembly of the type shown in Figure 3B in one of several different operating states. [Figure 4C] This figure shows an actuator assembly of the type shown in Figure 3B in one of several different operating states. [Figure 5A] This figure shows one of several different steps utilizing a delivery assembly equipped with a recompression assembly, according to several embodiments. [Figure 5B] This figure shows one of several different steps utilizing a delivery assembly equipped with a recompression assembly, according to several embodiments. [Figure 5C] This figure shows one of several different steps utilizing a delivery assembly equipped with a recompression assembly, according to several embodiments. [Figure 5D] This figure shows one of several different steps utilizing a delivery assembly equipped with a recompression assembly, according to several embodiments. [Figure 5E] This figure shows one of several different steps utilizing a delivery assembly equipped with a recompression assembly, according to several embodiments. [Figure 6A] This figure shows a delivery assembly equipped with a recompression assembly having multiple radiopaque markers, according to several embodiments. [Figure 6B] This figure shows a delivery assembly equipped with a recompression assembly having a single continuous radiopaque marker, according to several embodiments. [Figure 7A] This figure shows one of several different steps utilizing a delivery assembly equipped with a recompression assembly having a releaseable connector, according to several embodiments. [Figure 7B]This figure shows one of several different steps utilizing a delivery assembly equipped with a recompression assembly having a releaseable connector, according to several embodiments. [Figure 7C] This figure shows one of several different steps utilizing a delivery assembly equipped with a recompression assembly having a releaseable connector, according to several embodiments. [Figure 8A] This figure shows a delivery assembly equipped with a recompression assembly having a distal segment extending between the actuating arm assemblies and a proximal segment coupled to a dial of a diameter gauge, according to several embodiments. [Figure 8B] This figure shows the delivery assembly of the artificial valve in the expanded state, as shown in Figure 8A. [Figure 8C] This figure shows a delivery assembly equipped with a recompression assembly having a distal segment surrounding the artificial valve and a proximal segment coupled to a dial of a diameter gauge, according to several embodiments. [Figure 8D] This figure shows the delivery assembly of the artificial valve in the expanded state, as shown in Figure 8C. [Figure 9] This figure shows a delivery assembly equipped with a recompression assembly coupled to a non-pivotable dial of a diameter gauge, according to several embodiments. [Figure 10A] This figure shows a delivery assembly equipped with a recompression assembly, which is coupled to a diameter gauge dial and routed through a pulley assembly, according to several embodiments. [Figure 10B] This figure shows a delivery assembly equipped with a recompression assembly, which is coupled to a diameter gauge dial and routed through a pulley assembly, according to several embodiments. [Figure 11] This figure shows a delivery assembly having a recompression assembly coupled to a displacement sensor of a diameter gauge, according to several embodiments. [Figure 12]This figure shows a delivery assembly having a track member of a recompression assembly coupled to a diameter gauge, according to several embodiments. [Figure 13A] This figure shows different states of a delivery assembly equipped with a recompression assembly having indicators and reference markers, according to several embodiments. [Figure 13B] This figure shows different states of a delivery assembly equipped with a recompression assembly having indicators and reference markers, according to several embodiments. [Figure 14A] This figure shows different states of a delivery assembly equipped with a recompression assembly having indicators and reference markers, according to an additional embodiment. [Figure 14B] This figure shows different states of a delivery assembly equipped with a recompression assembly having indicators and reference markers, according to an additional embodiment. [Figure 15A] This figure shows different states of a delivery assembly equipped with a recompression assembly having indicators and reference markers, according to an additional embodiment. [Figure 15B] This figure shows different states of a delivery assembly equipped with a recompression assembly having indicators and reference markers, according to an additional embodiment. [Figure 16A] This figure shows different states of a delivery assembly equipped with a recompression assembly having indicators and reference markers, according to an additional embodiment. [Figure 16B] This figure shows different states of a delivery assembly equipped with a recompression assembly having indicators and reference markers, according to an additional embodiment. [Figure 17] This is an enlarged view of a portion of a recompression assembly having multiple reference markers and multiple indicator markers, according to several embodiments. [Figure 18] This figure shows a delivery assembly having a track member for a recompression assembly, equipped with indicator markers and reference markers, according to several embodiments. [Figure 19A]This figure shows an artificial valve according to several embodiments, each having a length and diameter that changes between a crimped state and an expanded state. [Figure 19B] This figure shows an artificial valve according to several embodiments, each having a length and diameter that changes between a crimped state and an expanded state. [Figure 20] This figure shows curves representing the relationship between the aspect ratio and expansion diameter of an artificial valve in several embodiments. [Figure 21A] This figure shows an artificial valve according to several embodiments, each having an opening angle that changes between a compressed state and an expanded state. [Figure 21B] This figure shows an artificial valve according to several embodiments, each having an opening angle that changes between a compressed state and an expanded state. [Figure 22] This figure shows curves representing the relationship between the opening angle and the expansion diameter of an artificial valve, according to several embodiments. [Figure 23A] This figure shows different states of an artificial valve with a frame belt according to several embodiments. [Figure 23B] This figure shows different states of an artificial valve with a frame belt according to several embodiments. [Figure 23C] This figure shows different states of an artificial valve with a frame belt according to several embodiments. [Figure 24A] This figure shows different states of a portion of a frame belt with a frangible section, according to several embodiments. [Figure 24B] This figure shows different states of a portion of a frame belt with a frangible section, according to several embodiments. [Figure 25A] This figure shows different states of a portion of a frame belt with a separable part, according to several embodiments. [Figure 25B] This figure shows different states of a portion of a frame belt with a separable part, according to several embodiments. [Figure 26A]This figure shows different steps utilizing a delivery assembly equipped with a frame belt having multiple geometric features, according to several embodiments. [Figure 26B] This figure shows different steps utilizing a delivery assembly equipped with a frame belt having multiple geometric features, according to several embodiments. [Figure 26C] This figure shows different steps utilizing a delivery assembly equipped with a frame belt having multiple geometric features, according to several embodiments. [Figure 26D] This figure shows different steps utilizing a delivery assembly equipped with a frame belt having multiple geometric features, according to several embodiments. [Figure 27] This figure shows an artificial valve equipped with a frame belt extending through a guide member limiting portion, according to several embodiments. [Figure 28A] This figure shows different states of an artificial valve, comprising a frame belt with beads arranged around it, according to several embodiments. [Figure 28B] This figure shows different states of an artificial valve, comprising a frame belt with beads arranged around it, according to several embodiments. [Figure 29A] This figure shows different states of an artificial valve, comprising a ratchet frame belt arranged around it, according to several embodiments. [Figure 29B] This figure shows different states of an artificial valve, comprising a ratchet frame belt arranged around it, according to several embodiments. [Modes for carrying out the invention]

[0089] The following description explains various aspects of this disclosure. For illustrative purposes, specific configurations and details are described to aid in a full understanding of the different aspects of this disclosure. However, it will also be apparent to those skilled in the art that this disclosure may be implemented without the specific details presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure this disclosure. In the figures, similar reference numbers refer to similar parts throughout.

[0090] Throughout the drawings, different superscripts of the same reference number are used to indicate different embodiments of the same element. Embodiments of the disclosed devices and systems may include any combination of different embodiments of the same element. Specifically, any reference to an element without a superscript may refer to any alternative embodiment of the same element indicated by the superscript.

[0091] Figure 1 is a perspective view of a delivery assembly 100 according to several embodiments. The delivery assembly 100 may include an artificial valve 120 and a delivery device 102. The artificial valve 120 may be on the delivery device 102 or releasably coupled to the delivery device 102. The delivery device may comprise a handle 110 at its proximal end, a nose cone shaft 112 extending distally from the handle 110, a nose cone 114 attached to the distal end of the nose cone shaft 112, a delivery shaft 106 extending over the nose cone shaft 112, and optionally an outer shaft 104 extending over the delivery shaft 106.

[0092] The term “proximal” as used herein generally refers to the side or end of any device or component of a device that is closer to the handle 110 or the operator of the handle 110 when in use.

[0093] The term “distal” as used herein generally refers to any side or end of any device or component of a device that is located further away from the handle 110 or the operator of the handle 110 when in use.

[0094] The term “artificial valve” as used herein refers to any type of artificial valve that can be delivered to a patient’s target site on a catheter, which is radially expandable and compressible between a radially compressed state, i.e., a crimped state, and a radially expanded state. Thus, the artificial valve 120 is crimped or held in a compressed state by the delivery device 102 upon delivery, and then can be expanded to an expanded state after the artificial valve 120 reaches the implantation site. The expanded state may include a range of diameters to which the valve can expand between the compressed state and the maximum diameter achieved in the fully expanded state. Thus, multiple partial expanded states may relate to any expansion diameter between the radially compressed or crimped state and the fully expanded state.

[0095] The term "multiple," as used herein, means more than one.

[0096] The artificial valve 120 of this disclosure may include any artificial valve configured to be implanted in a natural aortic valve, natural mitral valve, natural pulmonary valve, and natural tricuspid valve. The delivery assembly 100 described in this disclosure includes a delivery device 102 and an artificial valve 120, but it should be understood that the delivery device 102 in any embodiment of this disclosure may be used for implanting other prosthetic devices separate from the artificial valve, such as a stent or graft.

[0097] According to some embodiments, the artificial valve 120 is a mechanically expandable valve, and the delivery device 102 further comprises a plurality of actuating arm assemblies extending from the handle 110 through the delivery shaft 106. The actuating arm assembly 165 may generally comprise an actuating member 166 (hidden in Figure 1, visible in Figures 4A-4C) releasably coupled at its distal end to each actuator assembly 138 of the valve 120, and a support sleeve 170 (annotated in Figure 3) disposed around each actuating member 166. Each actuating member 166 may be axially movable with respect to the support sleeve 170 covering it.

[0098] The artificial valve 120 can be delivered to the implantation site via a delivery assembly 100 that carries the valve 120, which is radially compressed or crimped, toward a target site where it is to be fitted against a natural anatomical structure by expanding the valve 120 via a mechanical expansion mechanism, as detailed below.

[0099] The delivery assembly 100 may be used, for example, to deliver an artificial aortic valve to be fitted to an aortic annulus, to deliver an artificial mitral valve to be fitted to a mitral annulus, or to deliver an artificial valve to be fitted to any other natural valve annulus.

[0100] The nose cone 114 may be connected to the distal end of the nose cone shaft 112. A guidewire (not shown) extends through the central lumen of the nose cone shaft 112 and the internal lumen of the nose cone 114, and the delivery device 102 may be advanced on the guidewire through the patient's vascular system.

[0101] The distal end of the outer shaft 104 extends over the prosthetic valve 120 in the delivery configuration of the delivery device 102 and can contact the nose cone 114. Thus, the distal end of the outer shaft 104 can act as a delivery capsule that accommodates or houses the prosthetic valve 120 in a radially compressed or crimped configuration for delivery through the patient's vascular system.

[0102] The outer shaft 104 and the delivery shaft 106 can be configured to be axially movable relative to each other, so that proximal movement of the outer shaft 104 relative to the delivery shaft 106, or distal movement of the delivery shaft 106 relative to the outer shaft 104, can expose the artificial valve from the outer shaft 104. In an alternative embodiment, the artificial valve 120 is not housed within the outer shaft 104 during delivery. Therefore, according to some embodiments, the delivery device 102 does not include an outer shaft 104.

[0103] As described above, the components of the nose cone shaft 112, the delivery shaft 106, the actuarial arm assembly 165, and, if present, the proximal end of the outer shaft 104, may be coupled to the handle 110. During delivery of the prosthetic valve 120, the handle 110 may be operated by an operator (e.g., a physician or surgeon) to advance or retract the components of the delivery device 102, such as the nose cone shaft 112, the delivery shaft 106, and / or the outer shaft 104, axially through the patient's vascular system, and further, to expand or contract the prosthetic valve 120 by, for example, manipulating the actuarial arm assembly 165, and to disconnect the prosthetic valve from the delivery device 102 by, for example, detaching the actuarial member 166 from the actuator assembly 138 of the valve 120, thereby retracting the prosthetic valve after it has been implanted at the implantation site.

[0104] The phrase "and / or" here is inclusive and means "and" and even "or". For example, "delivery shaft 106 and / or outer shaft 104" includes delivery shaft 106, outer shaft 104, and delivery shaft 106 with outer shaft 104, and such "delivery shaft 106 and / or outer shaft 104" may also include other elements.

[0105] According to some embodiments, the handle 110 may be equipped with one or more operating interfaces such as operable or rotatable adjustment knobs, levers, sliders, buttons (not shown), and other actuation mechanisms, which are operably connected to different components of the delivery device 102 and configured to cause axial movement of the delivery device 102 in the proximal and distal directions, and further to expand or contract the artificial valve 120 via various adjustment and actuation mechanisms as further described below.

[0106] According to some embodiments, the handle further comprises one or more visual or auditory information elements configured to provide visual or auditory information and / or feedback to the user or operator of the delivery device 102, such as a display 116, an LED light 118, a speaker (not shown), and the like.

[0107] Figure 2 shows an exemplary mechanically expandable prosthetic valve 120 in an expanded state according to several embodiments. The prosthetic valve 120 may comprise an inlet portion 124 defining an inlet end 125 and an outlet portion 122 defining an outlet end 123. The prosthetic valve 120 may define a longitudinal axis 121 extending through the inlet portion 124 and the outlet portion 122. In some examples, the outlet end 123 is the distal end of the prosthetic valve 120, and the inlet end 125 is the proximal end of the prosthetic valve 120. Alternatively, depending on the valve delivery approach, for example, the outlet end may be the proximal end of the prosthetic valve, and the inlet end may be the distal end of the prosthetic valve.

[0108] The term "outflow," as used herein, refers to the region of the artificial valve through which blood flows out of the valve 120, for example, between the longitudinal axis 121 and the outflow end 123.

[0109] The term "inflow" as used herein refers to the region of the artificial valve through which blood flows into the valve 120, for example, between the inflow end 125 and the longitudinal axis 121.

[0110] The valve 120 comprises a frame 126 composed of interconnected struts 127, which can be made from a variety of suitable materials such as stainless steel, cobalt-chromium alloy (e.g., MP35N alloy), or nickel-titanium alloy such as Nitinol. According to some embodiments, the struts 127 are arranged in a grid pattern. In the embodiment illustrated in Figure 2, the struts 127 are positioned diagonally when the valve 120 is in the extended position, or offset at an angle with respect to the longitudinal axis 121, or offset radially from the longitudinal axis 121. It will be apparent that the struts 127 can be offset at angles other than those shown in Figure 2, such as being oriented substantially parallel to the longitudinal axis 121.

[0111] According to some embodiments, the columns 127 are pivotally connected to one another. In the exemplary embodiment shown in Figure 2, the ends of the columns 127 form a vertex 129 at the outflow end 123 and a vertex 131 at the inflow end 125. The columns 127 may be connected to one another at an additional joint 130 formed between the outflow vertex 129 and the inflow vertex 131. The joints 130 may be spaced equally apart from each other and / or from the vertices 129, 131 along the length of each column 127. The frame 126 may have openings or openings in the areas of the vertices 129, 131 and the joints 130 of the columns 127. Each hinge may be provided via fasteners such as rivets or pins that extend through the openings in an arrangement where the openings of the columns 127 overlap each other. The hinges can allow the support columns 127 to pivot relative to each other when the frame 126 is expanded or compressed radially.

[0112] In alternative embodiments, the struts are not connected to one another via their respective hinges, but are pivotable or bendable in some other way relative to one another to allow the frame to expand or compress. For example, the frame may be formed from a single piece of material, such as a metal tube, through various processes such as laser cutting, electroforming, and / or physical vapor deposition, while retaining the ability to collapse / expand radially even in the absence of hinges and similar components.

[0113] The artificial valve 120 further comprises one or more leaflets 128, for example, three leaflets, configured to regulate blood flow through the artificial valve 120 from the inlet to the outlet. While three leaflets 128 configured to collapse in a tricuspid valve configuration are shown in the exemplary embodiment illustrated in Figure 2, it will be apparent that the artificial valve 120 may contain any other number of leaflets 128. The leaflets 128 are made of a flexible material derived from a biomaterial (e.g., bovine pericardium or pericardium from other sources), a biocompatible synthetic material, or other suitable material. The leaflets may be coupled directly to the frame 126 via commissures 134, or to other structural elements connected to or embedded in the frame 126, such as commissure posts. Further details regarding artificial valves, including configurations in which the valve leaflets can be attached to a frame, are described 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.

[0114] According to some embodiments, the artificial valve 120 may further include at least one skirt or sealing member, such as an inner skirt 136 shown in the exemplary embodiment illustrated in Figure 2. The inner skirt 136 is fitted to the inner surface of the frame 126 and may be configured to function, for example, as a sealing member to prevent or reduce paravalvular backflow. The inner skirt 136 may further function as a fixing area for the valve leaflets 128 to the frame 126 and / or may function to protect the valve leaflets 128 from damage that may be caused by contact with the frame 126, for example, during valve crimping or during the working cycle of the artificial valve 120. In addition to or alternatively, the artificial valve 120 may include an outer skirt 137 (for example, shown in Figures 7A-7C) fitted to the outer surface of the frame 126 and may be configured to function, for example, as a sealing member held between the frame 126 and the surrounding tissue of the natural valve annulus on which the artificial valve 120 is fitted, thereby reducing the risk of paravalvular backflow passing through the artificial valve 120. The inner skirt 136 and / or the outer skirt 137 can also be made from a variety of suitable biocompatible materials, including, but not limited to, various synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue).

[0115] According to some embodiments, the artificial valve 120, which may be a mechanical artificial valve 120, comprises a plurality of actuator assemblies 138 configured to facilitate the expansion of the valve 120 and, in some cases, to lock the valve in an expanded state and prevent unintended recompression, as will be described in more detail below. Although Figure 2 illustrates three actuator assemblies 138 mounted around the inner surface of a frame 126 and spaced evenly apart, it will be clear that different numbers of actuator assemblies 138 may be available, that the actuator assemblies 138 may be mounted on the frame 126 around their outer surfaces, and that the circumferential spacing between the actuator assemblies 138 may be uneven.

[0116] Figures 3A and 3B show an exemplary embodiment of the actuator assembly 138. The actuator assembly 138 may comprise a hollow outer member 140 fixed to a component of the valve 120, such as a frame 126, in a first arrangement, and an inner member 154 fixed to a component of the valve 120, such as a frame 126, in a second arrangement, spaced axially apart from the first arrangement.

[0117] Figure 3A is a perspective view of an exemplary inner member 154 having a proximal end 156 and a distal end 158. The inner member 154 includes an inner member coupling extension 164 near its distal end 158, which may be formed as a pin extending radially outward from the inner member 154, configured to be received into the opening or opening of the respective columns 127 intersecting at the joint 130 or vertices 129, 131. The inner member 154 may further include a linear rack having a plurality of teeth 162 along at least a portion of its length. According to some embodiments, one surface of the inner member 154 is provided with a plurality of teeth 162.

[0118] The phrases “include,” “equip,” and / or “have” are defined as “include” (i.e., non-restrictive) as used herein (including the specification and claims).

[0119] Figure 3B shows an operating inner member 154 disposed within the lumen 146 of the outer member 140. For clarity, the outer member 140 is shown partially transparent in Figure 3B. The outer member 140 comprises an outer member proximal end 142 defining a proximal opening and an outer member distal end 144 defining a distal opening. The outer member 140 may further include an outer member coupling extension 148 near its proximal end 142, which may be formed as a pin extending radially outward from the outer surface of the outer member 140, configured to be received in the opening or opening of the joint 130 or the respective openings or openings of the struts 127 intersecting at vertices 129, 131.

[0120] The outer member 140 may further comprise a spring-biased arm 150, which is attached to one side wall of the outer member 140 or extends from one side wall of the outer member 140, having teeth or claws 152 at its opposite end, and is biased inward toward the operating inner member 154 when disposed within the outer member lumen 146.

[0121] At least one of the inner member 154 or the outer member 140 is axially movable relative to one of the pair. The actuator assembly 138 in the illustrated embodiment includes a ratchet mechanism or ratchet assembly, wherein the pawl 152 of the outer member 140 is configured to engage with the teeth 162 of the inner member 154. The pawl 152 may have a shape complementary to the shape of the teeth 162, thereby allowing the pawl 152 to slide the inner member 154 in one direction relative to the outer member 140, for example, in a proximal-oriented direction, and resisting the sliding of the inner member 154 in the opposite direction, such as a distal-oriented direction, when the pawl 152 engages with the teeth 162 of the inner member 154.

[0122] The arm 150 may be formed from a flexible or elastic portion of the outer member 140 that extends over and contacts the opposing side of the outer surface of the inner member 154 at the claw 152. According to some embodiments, the arm 150 may be integrally formed with the outer member 140 or may take the form of a leaf spring that is formed separately and then connected to the outer member 140. The arm 150 is configured to apply a biasing force to the outer surface of the inner member 154 so as to ensure that the claw 152 remains engaged with the teeth 162 of the inner member 154 under normal operation.

[0123] According to some embodiments, the inner member 154 further comprises an inner member threaded bore 160 extending from its proximal end 156, configured to receive and screw into the threaded portion 168 (for example, shown in Figures 4B-4C) of the corresponding actuating member 166. Figure 3C is a perspective view of the extended valve 120 having its actuator assembly 138 connected to the actuating member 166 of the delivery device 102 (concealed invisibly within the support sleeve 170). The valve leaflets 128 and skirt 136 are omitted from Figure 3C to expose the actuator assembly 138 mounted on the frame 126. When the actuating member 166 is screwed into the inner member 154, the axial movement of the actuating member 166 causes the axial movement of the inner member 154 in the same direction.

[0124] According to some embodiments, the actuating arm assembly 165 is releasably coupled to the artificial valve 120 and configured to move the artificial valve 120 between a radially compressed configuration and a radially expanded configuration. Figures 4A to 4C show an uncoupled configuration representing the operation of the actuator assembly 138 via the actuating arm assembly 165 to expand the artificial valve 120 from a radially compressed state to a radially expanded state. Figure 4A shows the actuator assembly 138 having an outer member 140 fixed to the frame 126 in a first arrangement and an inner member 154 fixed to the frame 126 in a second arrangement. According to some embodiments, the first arrangement may be positioned at the outflow end portion 122, and the second arrangement may be positioned at the inflow end portion 124. In the illustrated embodiment, the outer member 140 is fixed to the outflow apex 129 via an outer member coupling extension 148, and the inner member 154 is fixed to the inflow apex 131 via an inner member coupling extension 164. The proximal portion of the inner member 154 extends into the outer member lumen 146 through the distal opening of the outer member distal end 144.

[0125] The actuator assembly 138 is shown in Figure 4A with the flame valve 120 in a radially compressed state, where the outlet apex 129 and the inlet apex 131 are spaced apart from each other along the axial direction, and the proximal end 156 of the inner member is positioned distal to the proximal end 142 of the outer member.

[0126] As further shown in Figure 4A, the distal portion 168 of the actuator 166 is screwed into the proximal threaded bore 160 at the proximal end 156 of the inner member 154. According to some embodiments, as shown in Figures 4A to 4C, the distal portion 168 of the actuator 166 has a male thread configured to engage with the female thread of the proximal bore 160 of the inner member 154. According to an alternative embodiment, the inner member may have a proximal extension having a male thread configured to be received and engage with the female thread of the distal bore formed within the actuator (embodiments not shown).

[0127] The support sleeve 170 surrounds the actuarial member 166 and may be connected to the handle 110. The support sleeve 170 and the outer member 140 are sized such that the distal lip portion 172 of the support sleeve 170 can abut against or engage with the proximal end 142 of the outer member, thereby preventing the outer member 140 from moving proximal beyond the support sleeve 170.

[0128] To radially expand the frame 126, and therefore the valve 120, the support sleeve 170 can be held firmly against the outer member 140. Then, as shown in Figure 4B, the actuator 166 can be pulled in the proximal-oriented direction 14. Since the support sleeve 170 is held against the outer member 140, which is connected to the outlet apex 129, the outlet end 123 of the frame 126 is prevented from moving relative to the support sleeve 170. As such, the movement of the actuator 166 in the proximal-oriented direction 14 can cause the movement of the inner member 154 in the same direction, thereby shortening the frame 126 axially and expanding it radially.

[0129] More specifically, as shown in Figure 4B, for example, the inner member coupling extension 164 extends through the opening of two interconnected pillars 127 at the inlet apex 131, and the outer member coupling extension 148 extends through the opening of two interconnected pillars 127 at the outlet apex 129. In such a case, when the inner member 154 is moved axially within the outer member 140, for example in a proximal orientation 14, the inner member coupling extension 164 moves with the inner member 154, thereby causing the portion to which the inner member coupling extension 164 is attached to move axially as well, thereby shortening the frame 126 axially and expanding it radially.

[0130] The support columns 127 to which the inner member connecting extension portion 164 is connected pivot freely relative to the connecting extension portion 164 and to each other when the frame is expanded or compressed. In this manner, the inner member connecting extension portion 164 acts as a fastener that forms a pivotable connection between the support columns 127. Similarly, the support columns 127 to which the outer member connecting extension portion 148 is connected also pivot freely relative to the connecting extension portion 148 and to each other when the frame is expanded or compressed. In this manner, the outer member connecting extension portion 148 also acts as a fastener that forms a pivotable connection between the support columns 127.

[0131] When the claw 152 is engaged with the tooth 162, the inner member 154 can move in one axial direction, such as the proximal-oriented direction 14, but cannot move in the opposite axial direction. This ensures that while the claw 152 is engaged with the tooth 162, the frame 126 can expand radially but cannot be compressed radially. Thus, after the artificial valve 120 is implanted in the patient, the frame 126 can be expanded to the desired diameter by pulling the actuating member 166. In this manner, the actuating mechanism also acts as a locking mechanism for the artificial valve 120.

[0132] After the desired diameter of the prosthetic valve 120 is reached, the actuator 166 can be disengaged from the inner member 154 by rotating it in direction 16, as shown in Figure 4C. This rotation engages and disengages the distal threaded portion 168 of the actuator 166 with the threaded bore 160 of the inner member, allowing the actuator arm assembly 165 to be pulled away from the patient's body and retracted together with the delivery device 102, thus leaving the prosthetic valve 120 implanted in the patient's body. The patient's natural anatomical structures, such as the natural aortic annulus in the case of transcatheter aortic valve implantation, may act as a source of radial forces on the prosthetic valve 120, which would attempt to compress the valve. However, the engagement between the claws 152 and the teeth 162 of the inner member 154 prevents such forces from compressing the frame 126, thereby ensuring that the frame 126 remains locked in the desired radially expanded state.

[0133] Therefore, after the actuator assembly 138 is actuated, the artificial valve 120 is radially expandable from the radially compressed state shown in Figure 4A to the radially expanded state shown in Figure 4B, such actuation involves bringing the second configuration closer to the first configuration of the valve. The artificial valve 120 can be further freed from the delivery device 102 by detaching each of the actuating arm assemblies 165 from each of the corresponding actuator assemblies 138 to which it was attached.

[0134] Although the inner member 154 and the outer member 140 are shown connected to the inlet apex 131 and the outlet apex 129, respectively, in the illustrated embodiment, it should be understood that they may be connected to other joints 130 of the frame 126. For example, the inner member connecting extension 164 may extend through an opening formed in the interconnected struts at the joint 130 of the inlet end portion 124, near the inlet apex 131. Similarly, the outer member connecting extension 148 may extend through an opening formed in the interconnected struts at the joint 130 of the outlet end portion 122, distal to the outlet apex 129.

[0135] Although the frame is shown above to expand radially outward by axially moving the inner member 154 in a direction oriented proximal to the outer member 140, it will be understood that similar frame expansion can be achieved by axially pushing the outer member 140 in a direction oriented distal to the inner member 154. Furthermore, although the illustrated embodiment shows the outer member 140 attached to the outflow end portion 122 of the frame 126 and the inner member 154 attached to the inflow end portion 124 of the frame 126, in an alternative embodiment the outer member 140 may be attached to the inflow end portion 124 of the frame 126 and the inner member 154 may be attached to the outflow end portion 122 of the frame 126.

[0136] According to some embodiments, the handle 110 may include a control mechanism that can be manually controlled by an operator to cause axial and / or rotational movement of different components of the delivery device 102, and may include operable or rotatable knobs, levers, buttons, and the like. For example, the handle 110 may include one or more manual control knobs, such as a manually rotatable control knob that has the effect of pulling the actuator 166 when rotated by an operator.

[0137] In other embodiments, control mechanisms in the handle 110 and / or other components of the delivery device 102 can be controlled electrically, pneumatically, and / or hydraulically. In some embodiments, the handle 110 can house one or more electric motors that can be operated by an operator, such as by pressing a button or switch on the handle 110, to cause movement of components of the delivery device 102. For example, the handle 110 may include one or more motors that can be operated to cause linear movement of components of the actuating arm assembly 165, and / or one or more motors that can be operated to cause rotational movement of the actuating member 166 to disconnect the distal threaded portion 168 of the actuating member from the threaded bore 160 of the actuating inner member. In some embodiments, one or more manual or electric control mechanisms are configured to cause all simultaneous linear and / or rotational movements of the actuating member 166.

[0138] While a specific operating mechanism utilizing a ratchet mechanism between the inner and outer members of the operating assembly 138 is described above, other mechanisms may be employed, for example, via a screw mechanism or other engagement mechanism, to facilitate relative movement between the inner and outer members of the operating assembly. Further details regarding the structure and operation of the mechanically expandable valve and its delivery system are described in U.S. Patent No. 9,827,093, U.S. Patent Application Publication No. 2019 / 0060057, U.S. Patent Application Publication No. 2018 / 0153689, and U.S. Patent Application Publication No. 2018 / 0344456, as well as U.S. Patent Application No. 62 / 870,372 and U.S. Patent Application No. 62 / 776,348, all of which are incorporated herein by reference.

[0139] Prior to implantation, the artificial valve 120 may be crimped onto the delivery device 102. This step may include positioning the radially compressed valve 120 within the outer shaft 104. After being delivered to an implantation site such as a natural valve ring, the valve 120 may be radially expanded within the valve ring, for example by acting on an actuator assembly 138 as described herein. However, during such an implantation procedure, it may be desirable to recompress the artificial valve 120 in place. Valve recompression may be achievable, for example, by providing a sufficiently smooth length (i.e., without ratchet teeth 162) along the actuator inner member 154, for example, when the mechanical valve 120 has not yet reached a locked state, allowing axial movement along a certain distance before the claw 152 engages with the teeth 162. Alternatively, or in addition, the delivery assembly 100 may further include a release member (not shown) configured to release the claw 152 from the teeth 162 to allow reversible movement that enables valve compression.

[0140] According to some embodiments, the delivery device 102 further comprises a recompression assembly 180 configured to facilitate the recompression of the artificial valve 120 after expansion.

[0141] Next, we refer to Figures 5A to 5E illustrating different optional stages utilizing the delivery assembly 100 equipped with the recompression assembly 180. Figure 5A shows a magnified view of the distal portion of the delivery assembly 100, which carries the prosthetic valve 120, held in a compressed or crimped state within the distal portion of the outer shaft 104, upon delivery to the implantation site. As described above, the distal portion of the outer shaft 104 can act as a delivery capsule covering the crimped prosthetic valve 120. After reaching the desired implantation site, the outer shaft 104 can be retracted to expose the prosthetic valve 120. Figure 5A shows partial retraction of the outer shaft 104, which exposes the distal portion of the valve 120, such as the inlet end portion 124.

[0142] Figure 5B shows the artificial valve 120 in an exposed state (i.e., no longer covered by the outer shaft 104). Some artificial valves 120, such as some mechanically expandable valves described above in relation to Figures 2-4C, may have internal elasticity to facilitate their partial expansion when expanded outward from the capsule or outer shaft 104. Furthermore, the mechanically expandable valve 120 may be further partially expanded to a larger diameter before being irreversibly locked by the engagement between the ratchet teeth 162 and the pawl 152. For example, a proximal toothless portion of the actuator inner member 154 may be provided between the proximal end 156 of the inner member and the ratchet teeth 162, allowing axial movement between the inner member 154 and the outer member 140, respectively, and the axial translation of the inner member 154 is reversible along it.

[0143] After the valve 120 has been at least partially expanded due to its inherent elasticity or due to its active expansion before it reaches a locked state, the recompression assembly 180 may be used to recompress the valve 120 to a narrower diameter. The recompression assembly 180 may also be used in combination with a self-expandable valve in a manner similar to the following description after the valve has been expanded, for example, when valve repositioning is required. Similarly, as stated above, the recompression assembly 180 may be used after the mechanically expandable valve 120 has been expanded to the locked state of the actuator assembly 138 by utilizing a release member that can engage and disengage the pawl 152 from the ratchet teeth 162 of the actuator assembly 138.

[0144] According to some embodiments, the recompression assembly 180 includes a recompression member 182 extending through the lumen of the recompression shaft 188. The recompression shaft 188 extends through the lumen of the delivery shaft 106. The recompression member 182 includes a flexible recompression member distal segment 184, which may be formed from a flexible wire, cable, suture, and the like. The flexible recompression member distal segment 184 is configured to extend distally through an opening formed at the distal end 192 of the recompression shaft and optionally surrounds either the valve 120 or a component attached to it, such as a support sleeve 170 of the actuation arm assembly 165.

[0145] The recompression member 182 further comprises a recompression member proximal segment 186, which extends through the lumen of the recompression shaft 188 toward the handle 110, and optionally toward the center. In some cases, the recompression member proximal segment 186 may be formed as a continuous extension of the flexible recompression member distal segment 184. Alternatively, the recompression member proximal segment 186 and the recompression member distal segment 184 may be provided as separate components mounted together, where both segments are formed from the same material and have the same dimensions, or both are formed from the same material but have different dimensions (e.g., one segment is thicker than the other), or each is formed from different materials but both have similar or different dimensions with respect to each other. For example, the recompression member proximal segment 186 may be formed from a material that is harder than the recompression member distal segment 184. In addition, or alternatively, the recompression member proximal segment 186 may be formed as a member that is thicker than the recompression member distal segment 184. Either the distal segment 184 and / or proximal segment 186 of the recompression member can take the form of, for example, a cord, suture, wire, cable, or any other flexible material that can be subjected to tension.

[0146] An enlarged portion of one exemplary recompression assembly 180 is shown in Figure 5B. In the exemplary embodiment shown, the recompression member 182 includes a recompression member proximal segment 186 and a recompression member distal segment 184, which are separate components attached to each other via a connector 194. According to some embodiments, the two proximal ends of the recompression member distal segment 184 are attached directly or indirectly to the distal end of the recompression member proximal segment 186. In the exemplary embodiment shown in Figure 5B, the recompression member distal segment 184 is looped through a ring-shaped portion of the connector 194 and has two parallel portions that extend distally from the connector 194 within the lumen of the recompression shaft 188. The connector 194 can take any other form configured to attach to the recompression member distal segment 184 and the recompression member proximal segment 186. Alternatively, the recompression assembly 180 may be provided without the connector 194. For example, the distal segment 184 of a recompression member can be directly attached to another proximal segment 186 of a recompression member. In another example, the distal segment 184 and the proximal segment 186 of the recompression member are integrally formed and each constitutes a different region of a single continuous recompression member 182.

[0147] As further shown in Figure 5B, the distal portion of the distal segment 184 of the recompression member extending from the distal end 192 of the recompression shaft may include a loop portion 183 configured to surround the artificial valve 120. The handle 110 may be operated, for example, via a knob, button, and the like, to adjust the tension of the loop portion 183. For example, a recompression operating mechanism (not shown) may be operated at the handle 110 to either increase the tension of the recompression member 182 or release such tension in order to readjust the diameter of the loop portion 183.

[0148] The diameter of the loop portion 183 can be adjusted, for example, by advancing the distal end 192 of the recompression shaft in a distally oriented direction relative to the distal end 192 of the recompression shaft, thereby reducing the diameter of the loop portion. By reducing the diameter of the loop portion 183 under tension, an inward force is applied to the valve 120, which has the effect of compressing the valve 120. Similarly, by retracting the distal end 192 of the recompression shaft in a proximal oriented direction relative to the distal segment 184 of the recompression member, such tension is released, allowing the valve 120 to re-expand due to the internal elasticity of the frame 126 or through the operation of an expansion mechanism such as the actuator assembly 138.

[0149] According to some embodiments, the recompression shaft 188 is operably connected to a recompression actuation mechanism in a handle 110, which is operable by a knob, button, switch, and the like. The recompression actuation mechanism can be used to axially translate the recompression shaft 188 in the proximal or distal direction with respect to the recompression member 182.

[0150] It should be noted that the relative axial movement between the recompression shaft 188 and the recompression member 182 refers to the movement of the recompression shaft 188 relative to the recompression member 182, and / or the movement of the recompression member 182 relative to the recompression shaft 188. According to some embodiments, the distal segment 184 of the recompression member may be retracted in a direction oriented proximal to the distal end 192 of the recompression shaft in order to facilitate the compression of the valve. Similarly, the distal segment 184 of the recompression member may be advanced in a direction oriented distal to the distal end 192 of the recompression shaft to release tension and allow valve expansion.

[0151] Figure 5B shows an exemplary state in which the valve 120 is partially expanded after being released from the outer shaft 104. In this state, the loop portion 183 is relatively loose around the valve 120, for example, loose enough to allow partial or complete valve expansion. In some embodiments, the loop portion 183 may be kept tensile around the crimped valve 120 upon delivery to the implantation site, thereby providing an additional means of keeping the valve 120 at the crimped diameter, which may be utilized in addition to or instead of covering the valve 120 within the capsule or the distal portion of the outer shaft 104. In such cases, the diameter of the loop portion 183 may be readjusted during the procedure. For example, the loop portion 183 may be loosened after the artificial valve 120 has reached the desired implantation site and / or after the outer shaft 104 has retracted and the valve 120 has been exposed. Partially loosening the loop portion 183 may allow control of the valve expansion diameter and expansion speed. Further loosening of the loop portion 183 may allow for full expansion of the valve 120.

[0152] Therefore, the relative movement between the axial recompression member 182 and the recompression shaft 188 has the effect of tightening the loop portion 183 around the artificial valve 120, thereby compressing the artificial valve 120 radially. Specifically, the tensile state of the recompression assembly 180 is defined as the state in which the tension of the distal segment 184 of the recompression member is sufficient to compress the valve 120 or holds the valve 120 so that it cannot expand beyond the maximum diameter (determined by the tension of the recompression member 182). The partially tensile state refers to any tensile state in which the valve 120 is partially expanded, and in any partially tensile state, the valve 120 cannot expand beyond the maximum diameter (determined by the tension of the loop portion 183), and the maximum diameter is greater than the diameter in the compressed state. The released state of the recompression assembly 180 is defined as the state in which the tension of the distal segment 184 of the recompression member does not resist the expansion of the valve, thereby allowing free valve expansion.

[0153] The recompression member 182 is tightly tensioned around the artificial valve 120 in the tensile state of the recompression assembly 180, but can loosely surround the artificial valve 120 when the tension is released, for example in the release state, or when the diameter of the artificial valve 120 is smaller than the maximum allowable diameter by the loop portion 183. In some cases, it may be desirable to keep the loop portion 183 constantly tensed around the artificial valve 120, including the release state when the artificial valve 120 can expand freely radially. The constant tension of the loop portion 183 around the artificial valve 120 may be advantageous, for example, when the loop portion 183 is used to estimate the diameter of the artificial valve 120, as will be explained in more detail below. Under such a configuration, the loop portion is tightly wrapped around the outer surface of the valve 120 over the entire range of potential valve diameters between the compressed state and the fully expanded state.

[0154] According to some embodiments, a minimum tension magnitude Ts is always applied to the distal segment 184 of the recompression member, more specifically, to the loop portion 183. Such tension is configured to keep the distal segment 184 of the recompression member in a minimum tensile state, even when there is no external force acting to crush the valve 120. For example, the minimum tension magnitude Ts may be applied when the recompression assembly 180 is in a released state. The minimum tension magnitude Ts is selected to apply a biasing force sufficient to keep the loop portion 183 in a tensile state around the valve 120 or other elements attached to it, such as the actuating arm assembly 165, but not high enough to withstand valve expansion. Thus, the tension applied by the distal segment 184 of the recompression member may be higher than Ts when the recompression assembly 180 is in a tensile state and equal to Ts when the recompression assembly 180 is in a released state.

[0155] Figure 5C shows an exemplary tensile state of the recompression assembly 180, achieved by pulling the distal segment 184 of the recompression member in a direction oriented proximal to the distal end 192 of the recompression shaft, thereby applying a radial force sufficient to tension the loop portion 183 and compress the valve 120. As illustrated, the position of the connector 194 in Figure 5C is proximal with respect to its position in Figure 5B. Such a configuration allows for the repositioning of the prosthetic valve 120 and / or recapture of the prosthetic valve for removal from the patient.

[0156] Figure 5D shows an exemplary released state of the recompression assembly 180, a state that may be applicable, for example, after reaching a desired implantation site (e.g., after repositioning the valve in the patient's body). In this state, the distal segment 184 of the recompression member is released, allowing the valve 120 to re-expand, for example, to its full expansion diameter. As illustrated, the position of the connector 194 in Figure 5D is distal with respect to the position in Figure 5C or Figure 5B.

[0157] According to some embodiments, the recompression shaft 188 and the proximal segment 186 of the recompression member may be retracted, for example, by operating the handle 110 and pulling them in a proximal orientation, as shown in Figure 5E, so that the loop portion 183 no longer tightly encloses the valve 120. Retraction of the recompression assembly 180 may be performed in the implantation process, for example, to allow unimpeded expansion of the valve 120. Alternatively, or in addition, the recompression assembly 180 may be retracted, for example, after the completion of the valve positioning and expansion procedure, instead of retraction of the delivery device 102.

[0158] Prosthetic valve expansion relative to surrounding tissues can carry various risks associated with a mismatch between the valve's expansion diameter and that of the surrounding tissue. One complication involves valve over-expansion, which can exert excessive radial force on the surrounding anatomical structures, potentially resulting in tissue damage or even annular rupture. Conversely, insufficient valve expansion may increase the risk of aortic or mitral regurgitation. Inadequate expansion can also result in undesirable hemodynamic performance for the valve, such as increased pressure gradients or flow turbulence resulting from the diameter mismatch, which may be associated with an increased risk of thrombus formation.

[0159] Therefore, in order to avoid any adverse effects such as annular rupture, reduced hemodynamic performance, or valve regurgitation resulting from over-expansion or under-expansion of the valve frame 126, the clinician should be able to control the degree of expansion of the frame 126 according to real-time feedback received during the procedure, for example, indicating the current valve diameter and / or expansion force.

[0160] According to one aspect of the present invention, the recompression assembly 180 is configured to provide real-time feedback, such as visual or auditory real-time feedback, with respect to the radial expansion diameter of the artificial valve 120.

[0161] According to some embodiments, the distal segment 184 of the recompression member comprises at least one radiopaque marker 196. At least one, and optionally multiple, radiopaque markers 196 may extend along at least a portion of the loop portion 183, preferably along the entire length of the loop portion 183. According to some embodiments, at least one, and optionally multiple, radiopaque markers 196 extend along the entire length of the distal segment 184 of the recompression member. The radiopaque markers 196 include a radiopaque material that is understood to be able to produce a relatively bright image on a fluoroscopy screen or other imaging technique during the implantation procedure of the artificial valve 120. The radiopaque material may include, but is not limited to, gold, platinum, tantalum, tungsten alloys, platinum-iridium alloys, palladium, and the like.

[0162] As described above, the loop portion 183 may be configured to always tightly wrap around the outer surface of the valve 120, either in the tensile or released state of the recompression assembly 180, by the magnitude Ts of the minimum tension applied to the distal segment 184 of the recompression member. Thus, at least one, and optionally multiple, radiopaque markers 196 disposed along the loop portion 183 wrapped around the valve 120 can provide a real-time visually detectable indication of the diameter of the artificial valve 120.

[0163] Figures 6A and 6B show different configurations of radiopaque markers 196 arranged along at least a portion of the distal segment 184 of the recompression member according to several embodiments. Figure 6A shows a modified example of the radiopaque markers 196, provided in the form of multiple radiopaque bands arranged along at least a portion of the length of the distal segment 184 of the recompression member. According to some embodiments, the multiple radiopaque markers 196, such as radiopaque marker bands, may be spaced apart at known distances from each other, for example, along a portion of the loop portion 183, and the radiopaque marker bands 196 may be used to provide a visual estimate of the diameter of the artificial valve 120. The multiple radiopaque markers 196 may be spaced apart along at least a portion of the loop portion 183 in any desired pattern. For example, the multiple radiopaque markers 196 may be spaced equally apart from each other or at varying distances from each other.

[0164] According to some embodiments, multiple radiopaque markers 196 are arranged at various positions along the loop portion 183, thereby providing a visual indication of the valve diameter. For example, the multiple radiopaque markers 196 may extend along a portion of the loop portion 183 that is substantially equal to at least half the circumference of the prosthetic valve when expanded to its maximum diameter, to ensure detection of any diameter below a maximum. Similarly, the positions of the multiple radiopaque markers 196 may be set to cover at least half the circumference of the prosthetic valve when fully expanded and to be circumscribed by the loop portion 183. In some cases, it may be preferable to cover the entire loop portion 183 with multiple radiopaque markers 196 to compensate for situations where the marked area does not coincide with the field of view when performing fluoroscopy.

[0165] According to some embodiments, the radiopaque marker 196 is formed using radiopaque ink and adhesive and can be attached to at least a portion of the distal segment 184 of the recompression member by many methods such as screen printing, high-speed roller printing, coating, and dipping. In further embodiments, the marker may be provided as a separately formed component, such as an annular ring or a C-shaped band, which is mounted on the distal segment 184 of the recompression member.

[0166] According to some embodiments, as shown in Figure 6B, a single radiopaque marker 196 is positioned along a minimum marking length, preferably corresponding to the contact area between the loop portion 183 and the circumference of the artificial valve 120. The minimum marking length may be selected to allow estimation of the valve diameter 120 over the entire range of the valve diameter 120. For example, the minimum marking length may correspond to the circumference of the valve 120 within the range between the minimum crimping diameter and the maximum expansion diameter. According to some embodiments, the minimum marking length is at least as large as the circumference of the artificial valve 120 when fully expanded. According to some embodiments, the entire length of the distal segment 184 of the recompression member comprises a single continuous radiopaque marking 196.

[0167] According to some embodiments, the radiopaque marking is formed as a radiopaque coating 196, and the distal segment 184 of the recompression member is coated with a radiopaque material along a minimum marking length, which optionally includes its entire length.

[0168] According to some embodiments, the connector 194 is a releasable connector configured to releasably attach the recompression member proximal segment 186 to the recompression member distal segment 184. Figures 7A–7C show one exemplary embodiment of a delivery assembly 100 equipped with a recompression assembly 180 having a releasable connector 194, according to some embodiments. Figure 7A shows the recompression assembly 180 with the recompression member proximal segment 186 connected to the recompression member distal segment 184 via the releasable connector 194. According to some embodiments, the releasable connector 194 comprises a proximal connector element 193 and a distal connector element 195 that are releasably attached to each other. The recompression member proximal segment 186 is coupled to the proximal connector element 193, and the recompression member distal segment 184 is coupled to the distal connector element 195. In the example shown, the recompression member distal segment 184 may be looped through a hole formed in the distal connector element 195, but any other type of coupling is also intended.

[0169] In some applications, the loop portion 183 of the distal segment 184 of the recompression member may extend through a circumferential sleeve that circumscribes the valve 120. In the exemplary embodiments illustrated in Figures 7A–7C, the outer skirt 137 includes, for example, a sleeve 132 integrally formed with it along the proximal edge of the outer skirt 137. The sleeve 132 may have an opening 133 into which the distal segment 184 of the recompression member can extend within the lumen of the sleeve 132. While the sleeve 132 is shown in Figures 7A–7C as being integrally formed with the outer skirt 137 or attached to (e.g., sewn to) the outer skirt 137, it will be apparent that in alternative applications, a standalone sleeve, such as the circumferential sleeve 830 illustrated (e.g., as shown in Figures 15A–16B), may be provided around the valve 120. Furthermore, it will be apparent that, according to any other embodiment of the invention, such as the embodiment described and illustrated in relation to the recompression assembly 180 having a releaseable connector 194 as shown in Figures 7A-7C, but also in relation to Figures 6A-6B, the distal segment 184 of the recompression member, which is looped around the valve 120, may also extend through the sleeve 130 or 830.

[0170] The sleeves 132 and 830 that circumscribing the valve 120 are configured to hold at least a portion of the distal segment 184 of the recompression member around at least a portion of the circumference of the valve 120. In some applications, the sleeves may be arranged around the entire circumference, as shown for sleeve 132 in Figures 7A to 7C and for sleeve 830 in Figures 15A to 16B. In some applications, the sleeves may be arranged around a portion of the circumference of the valve 120, as shown for sleeve 830 in Figures 28A to 29B. In some applications, the circumferential sleeve circumscribing the valve 120 may include a plurality of sleeve portions (not shown) arranged around the circumference of the artificial valve 120, spaced circumferentially apart from one another.

[0171] According to some embodiments, the valve 120 further comprises a guide member 840 disposed between the outlet end 123 and the sleeves 132, 830. The guide member 840 comprises a guide member lumen 842 defined between a proximal guide member end 844 and a distal guide member end 846. The proximal guide member end 844 may be aligned with the outlet end 123 or positioned distal to the outlet end 123. The distal guide member end 846 may be positioned proximal to the guide member sleeves 132, 830, and more specifically, proximal to the guide member sleeve openings 133, 833.

[0172] At least a portion of the recompression member 182 extends through the guide member lumen 842 and is axially movable through it. In the illustrated example, the proximal portion of the distal segment 184 of the recompression member, the releaseable connector 194, and the distal portion of the proximal segment 186 of the recompression member may extend through the member 840 and be axially movable within the member 840.

[0173] The distal segment 184 of the recompression member may comprise multiple radiopaque markers 196, as described and illustrated in relation to Figure 6A, or a single radiopaque marker 196 arranged along its minimum marking length, as described and illustrated in relation to Figure 6B. The sleeves 132, 830 may comprise a radiopaque material or include cutout windows, thereby allowing the radiopaque markers 196 to be visually inspected under fluorescence fluoroscopy, thereby enabling the recompression assembly 180, as shown in Figures 7A-7B, to be used to provide a real-time detectable indication of the diameter of the artificial valve 120 according to any of the embodiments described and illustrated in relation to Figures 6A-6B.

[0174] After the artificial valve 120 reaches the desired diameter, at least a portion of the recompression assembly 180 may be released from the valve 120. Specifically, as shown in Figure 7B, the proximal segment 186 of the recompression member may be released from the distal segment 184 of the recompression member, which may then remain around the expanded valve 120.

[0175] According to some embodiments, the distal connector element 195 is provided with a male thread which can engage with a threaded bore of the proximal connector element 193. In alternative applications, it will be apparent that the distal connector element 195 may be provided with a threaded bore and the proximal connector element 193 may be provided with a matching male thread. In embodiments in which the distal connector element 195 and the proximal connector element 193 are screwed together, the recompression member proximal segment 186 may include a relatively rigid material formed as a torque transmission wire, cable, and the like.

[0176] As shown in Figure 7B, the proximal connector element 193 can be released from the distal connector element 195 and pulled proximal together with the recompression member proximal segment 186, for example, through the lumen of the recompression shaft 188. Figure 7C shows a further step of pulling the recompression shaft 188 from the guide member 840. In some applications, the distal portion of the recompression shaft 188 is located within the guide member lumen 842. In addition to or alternatively, the distal portion or distal end of the recompression shaft 188 is releasably attached to the guide member 840.

[0177] The guide member 840 can be formed as a rigid hollow member, such as a tube or other hollow member having a circular or non-circular cross-section. The guide member 840 is rigidly attached to the frame 126, either directly or indirectly (e.g., via another component of the prosthetic valve 120 attached to the frame 126). According to some embodiments, the guide member 840 may be attached to a component of the actuator assembly 138, such as a crosslink post or an actuator outer member 140 as shown in FIGS. 7A-7C, and the attachment can be achieved by welding, adhesion, soldering, and similar means. Alternatively, the guide member 840 can be attached to the frame 126, such as by at least one joint 130 (alternative embodiments not shown).

[0178] Another example of the recompression assembly 180 is shown in FIGS. 8A-8B, where the recompression member distal segment 184 is wrapped around the support sleeve 170 or includes a distal loop portion 183 that extends between the support sleeves 170 instead of circumscribing the outer surface of the prosthetic valve 120. As shown in FIG. 8A, each support sleeve 170 can include a loop attachment member 176 near its distal end 172. The recompression member distal segment 184, and more specifically, the loop portion 183, is connected to the loop attachment member 176 of the actuator arm assembly 165 and extends therebetween. For example, the loop portion 183 can be screwed through a small-hole-shaped loop attachment member 176 as shown in an enlarged view of the attachment area between the upper-right actuator arm assembly 165 and the prosthetic valve 120 in FIG. 8A and an enlarged area of the distal portion of a single support sleeve 170 having the loop attachment member 176 in the upper-left of FIG. 8A.

[0179] The loop attachment member 176 can take the form of a small hole, hook, ring, clip, an opening in the support sleeve 170 and / or the actuator member 166, and any other structural element configured to hold the recompression member distal segment 184, and more specifically, the loop portion 183 therebetween and allow its elongation.

[0180] According to some embodiments, the axial relative movement between the recompression member 182 and the recompression shaft 188 applies tension to the loop portion 183 connected to the actuating arm assembly 165, and as a result, causes the actuating arm assembly 165 to move radially inward, thereby having the effect of radially compressing the artificial valve 120. FIG. 8A shows the loop portion 183 that extends between the support sleeves 170 in the tensioned state of the recompression assembly 180 and applies an inward force to the actuating arm assembly 165. As long as the actuating member 166 is attached to the actuator assembly 138, the frame 126 of the valve 120 is also proportionally radially compressed.

[0181] The tension of the recompression assembly 180 shown in FIG. 8A can be achieved by manipulating the handle to pull the recompression member proximal segment 186 in a direction oriented proximally with respect to the recompression shaft 188. The release of the tension can be achieved by releasing the pulling force and allowing the recompression member proximal segment 186 to translate in a direction oriented distally when the artificial valve 120 expands.

[0182] FIG. 8B illustrates the released state of the recompression assembly 180, and the artificial valve 120 is allowed to expand with respect to the compressed state of FIG. 8A. As illustrated, the loop portion 183 is rigidly stretched between the actuating arm assemblies 165 in both the expanded state (see FIG. 8B) and the compressed state (see FIG. 8A) of the artificial valve 120, for example due to the magnitude Ts of the minimum tension applied to the recompression member 幺82.

[0183] According to some embodiments, the recompression shaft 188 is immovable in the axial direction, thereby allowing adjustment of the tension applied to the loop portion 183 to be facilitated by either applying or releasing tensile force to the proximal segment 186 of the recompression member. Thus, the axial translation of the proximal segment 186 of the recompression member is proportional to the circumference of the loop portion 183 and proportional to the diameter of the artificial valve 120, insofar as the actuating arm assembly 165 to which the loop portion 183 is connected is coupled to the artificial valve 120 (for example, to the valve actuator assembly 138).

[0184] According to some embodiments, the delivery device 102, and more specifically the handle, further comprises a diameter gauge. The diameter gauge is coupled to the recompression assembly at the gauge coupling point, thereby having the effect of axial translation of the position of the gauge coupling point when the expansion or contraction of the artificial valve 120 is attached to the actuating arm assembly 165. The diameter gauge is configured to provide real-time indication of the valve diameter based on the axial position and / or axial translation of the gauge coupling point.

[0185] According to some embodiments, the real-time indication provided by the diameter gauge is a visual real-time indication. According to some embodiments, the real-time indication provided by the diameter gauge is a signal (e.g., an electrical signal or an optical signal) generated by the diameter gauge. According to some embodiments, the diameter gauge is coupled to the proximal segment 186 of the recompression member at the gauge coupling point.

[0186] Figures 8A and 8B show exemplary embodiments of the handle 210, which may be substantially similar to the handle 110. The main difference is that the handle 210 further comprises a diameter gauge 250 coupled to the proximal segment 186 of the recompression member and is configured to provide real-time indication of the diameter of the artificial valve 120 based on the axial position and / or axial translation of the gauge coupling point 270, as will be described in more detail below.

[0187] According to some embodiments, the recompression member proximal segment 186 extends into the handle 210 to connect to an internal mechanism housed within the handle 210, for example, and is configured to steer the recompression assembly 180 between a released state and a tensed state, including various partial tensed states that can correspond to various respective maximum valve diameters.

[0188] According to some embodiments, the handle 210 may include user-operable elements such as operable or rotatable adjustment knobs, levers, sliders, buttons (not shown), and the like, which are configured to allow the user to adjust the tension applied to the recompression member 182. In addition to or alternatively, the handle 210 may include an automated mechanism configured to readjust such tensile force in accordance with inputs received from a user interface or from sensors operably coupled to components of the delivery device 100.

[0189] In some cases, the tension applied to the recompression member 182, for example by applying a tensile force of a certain magnitude, can elongate the length of the recompression member 182 to some extent, with respect to its length in the released state or to its length at other magnitudes of tensile forces that may be applied to it. Such a change in the length of the recompression member 182 can change the position of the proximal segment 186 of the recompression member within the handle. Lengthening the recompression member 182 can consequently lead to inaccuracies in valve diameter estimation, as indicated by the diameter gauge, which are based on the position of the proximal segment 186 of the recompression member with respect to the diameter gauge.

[0190] According to some embodiments, the recompression member proximal segment 186 is connected to a spring 220 within the handle 210. The spring 220 may be attached to a spring support member 212 of the handle 210 at its first end 222. The second end 224 of the spring, opposite to the first end 222, may be connected to the recompression member proximal segment 186.

[0191] The spring 220 is configured to apply an axially oriented tensile force to the proximal segment 186 of the recompression member when released. The magnitude of the force applied by the spring 220 is sufficient to apply a minimum tension Ts to the loop portion 183 when there are no other external forces that have the effect of tightening the loop portion 183 around the actuating arm assembly 165.

[0192] Figures 8A and 8B illustrate a schematic of the interior of the handle 210, showing that the recompression member proximal segment 186 extends through the lumen of the delivery shaft 106 to the handle 210. A spring 220 is schematically illustrated, having a first spring end 222 attached to a spring support member 212 of the handle 210, located proximal to the mounting point between the second end 224 of the spring and the recompression member proximal segment 186. In such a configuration, the spring 220 is preferably a coil compression spring and has a spring constant suitable for pulling the recompression member proximal segment 186 with a tensile force matching a desired minimum tension magnitude Ts. Advantageously, by applying the minimum tension magnitude Ts to the loop portion 183, the diameter of the artificial valve can be measured more accurately.

[0193] The first end 222 and the second end 224 of the spring may be positioned in any number of alternative arrangements within the handle 210, which may determine the type of spring used in conjunction with the recompression assembly 180. For example, if the first end 222 of the spring is positioned distal to the second end 224 of the spring (configuration not shown), it may be necessary to implement a tension coil spring instead of a compression spring, and the spring 220 will extend the proximal segment 186 of the recompression member attached to its second end 224 in a proximal orientation, allowing a minimum tension magnitude Ts to be applied to the loop portion 183, as described above.

[0194] According to some embodiments, the first end 222 of the spring may include a hook, hole, ring, and the like, thereby being coupled to the spring support member 212 of the handle 210. According to some embodiments, the second end 224 of the spring may include a hook, hole, ring, and the like, thereby being coupled to the recompression member proximal segment 186, the dial 254 (described later), or both.

[0195] According to some embodiments, the handle 210 includes a user-operable mechanism (not shown in Figures 8A-8B) connected to the proximal segment 186 of the recompression member, configured to pull the proximal segment 186 of the recompression member in a proximal orientation, compressing the artificial valve 120 and / or holding it to its maximum desired diameter. Since the magnitude of the tension applied to the loop portion 183 in the tensile state of the recompression assembly 180 is greater than the magnitude of the minimum tension Ts, the tensile force applied to the proximal segment 186 of the recompression member in the tensile state is greater than the tensile force applied by the spring 220 in the released state.

[0196] When the tension is released in the released state of the recompression assembly 180, the only tensile force applied to the proximal segment 186 of the recompression member is the tensile force of the spring 220. This then allows the proximal segment 186 of the recompression member to translate in the distally oriented direction when the artificial valve 120 is expanded, thereby stretching the spring 220 (in the case of a compression spring) in the same direction, as shown in Figure 8B.

[0197] Instead of the coil compression spring 220, various types of springs may be used, such as tension springs, torsion springs, or leaf springs. Alternatively, the spring 220 may be replaced and / or additionally accompanied by other biasing members, such as a stretchable and / or elastic cord, an elastomer (e.g., silicone with a polyurethane component) that is compressible under an applied external force and returns to its original shape when such force is removed. Any such biasing member may replace the coil compression spring 220, insofar as it applies a biasing force sufficient to apply a minimum magnitude of tension to the loop portion 183.

[0198] According to some embodiments, the handle 210 includes a diameter gauge coupled to the proximal section 186 of the recompression member at a gauge coupling point 270. The diameter gauge 250 is configured to provide real-time visual indication of the diameter of the prosthetic valve 120 based on the axial position and / or axial translation of the gauge coupling point in the handle 210. The state of the diameter gauge 250 may be visible through a visual interface such as a display 116. In other words, the diameter gauge 250 may be configured to provide real-time visual indication of the diameter of the prosthetic valve 120 via the display 116.

[0199] According to some embodiments, as shown in Figures 8A-8B, the diameter gauge 250 includes a dial 254 directly or indirectly coupled to the proximal segment 186 of the recompression member at a gauge coupling point 270. The dial may be pivotably mounted to a dial support member 214 of the handle 210 via a dial pivot 256. The dial 254 is configured to rotate at an angle about the dial pivot 256 as the proximal segment 186 of the recompression member is translated axially.

[0200] According to some embodiments, the diameter gauge 250 comprises a scale or indicator mark 258, each indicator mark being in the form of a numerical value or any other symbol representing a particular diameter. The range of the indicator marks 258 can be selected to reflect the range of the prosthetic valve diameter between the compressed state and the expanded state. The dial tip 257, which can be the free end of the dial 254 opposite the dial pivot 256, faces the indicator mark 258. The dial tip 257 is configured to point to the indicator mark 258 representing the current diameter of the prosthetic valve 120.

[0201] According to some embodiments, the display 116 comprises a window through which the indicator mark 258 and the dial tip 257 are visible to an external viewer (e.g., an operator of the delivery assembly 100). According to some embodiments, the indicator mark 258 includes color marks such as green, yellow, red, etc. to provide a visual indication of, for example, a safe zone or a danger zone. According to some embodiments, the display 116 includes the indicator mark 258.

[0202] The diameter gauge 250 is configured to translate the axial movement and / or axial position of the gauge attachment point 270, which moves with the recompression member proximal segment 186, based on a predetermined mathematical relationship, to a corresponding position of the dial 254 that points to an indicator mark representing the current valve diameter. For example, the application of an axial tensile force to the recompression member proximal segment 186 that changes its position within the handle 210 is converted into a tension applied to the loop portion 183. Such tension applies a radially inward force to the actuating arm assembly 165, resulting in a proportional change in the circumference of the loop portion 183 that is wound around and / or extended between the actuating arm assemblies 165, thereby moving the actuating arm assemblies 165 radially inward towards each other.

[0203] In the example shown in Figures 8A and 8B, the loop portion 183 can be approximated as a substantially triangular loop. Since the artificial valve 120 is coupled to the actuarial arm assembly 165, the valve diameter changes proportionally in response to the inwardly oriented movement of the actuarial arm assembly 165. Assuming that the loop mounting member 176 is located near the distal end 172 of the support sleeve, the loop portion 183 is close to the valve outlet end 123. In such a case, it can be assumed that the circumference of the valve outlet end 123 approximately forms a circular circumference enclosing the triangular loop portion 183. This relationship can be used to derive the diameter of the valve 120.

[0204] It will be clear that the above-described relationship is simplified to illustrate a conceptual principle that the valve diameter can be derived from the axial translation or axial position of the proximal segment 186 of the recompression member. Such a relationship may be further adjusted to improve the accuracy of the measurement. For example, the actual shape of the loop portion 183 may be more complex due to the influence of the position of the distal end 192 of the recompression shaft relative to the loop mounting member 176. Furthermore, the number of actuating arm assemblies 165 may be other than 3, resulting in other potentially more complex loop contours.

[0205] As shown above, after the recompression member proximal segment 186 is released, the artificial valve 120 can be freely expanded due to the internal elasticity of the frame 126 or due to the active expansion of the artificial valve 120 by utilizing, for example, the mechanical expansion mechanism described above. During valve expansion, the actuating arm assembly 165 expands radially outward, thereby increasing the circumference of the loop portion 183, and then axially translates the recompression member proximal segment 186, together with the gauge coupling point 270, in a distally oriented direction.

[0206] As shown in Figure 8B, valve expansion, which involves axially translating the proximal segment 186 of the recompression member in a distally oriented direction along with the gauge coupling point 270, causes the dial 254 to rotate in an appropriate direction, such as counterclockwise, with respect to Figure 8A, as shown in Figure 8B. As a result, the position of the dial tip 257 changes, pointing to the indicator mark 258, which represents the valve diameter or an approximation thereof.

[0207] In the exemplary embodiments of Figures 8A and 8B, the gauge coupling point 270 is shown as the mounting point between the dial 254 and the proximal end of the recompression member proximal segment 186. However, this is a simplified, unconstrained, schematic representation of the location of the gauge coupling point 270, and it will be understood that any other portion of the recompression member proximal segment 186 may be coupled directly or indirectly to the dial 254.

[0208] In the exemplary embodiments of Figures 8A and 8B, the recompression member proximal segment 186 is shown to be attached at its proximal end to the second end 224 of the spring. This is a simplified, unconstrained, schematic representation of the coupling between the recompression member proximal segment 186 and the spring 220, and it will be understood that any other part of the recompression member proximal segment 186 may be coupled directly or indirectly to any other part of the spring 220.

[0209] Figures 8C and 8D show a recompression assembly 180 having a proximal segment 186 of a recompression member coupled to a diameter gauge 250 in the compressed and expanded states of the artificial valve 120, similar to the figures shown in Figures 8A to 8B, except that the recompression assembly 180 includes a loop portion 183 configured to circumvent the artificial valve 120 in a manner similar to that illustrated and described in relation to Figures 5A to 5E. All other embodiments described in Figures 8A to 8B are similarly applicable to the recompression assembly 180 shown in Figures 8C to 8D.

[0210] In the examples of Figures 8C and 8D, the loop portion 183 can be approximated as a substantially circular loop, which has a circumference that varies along the circumference of the artificial valve it encloses. This configuration often represents a simple relationship between the circumference of the loop portion 183 and the valve diameter, which can be used to derive the diameter of the valve 120.

[0211] Figure 9 shows another configuration of the handle 310 equipped with a diameter gauge 350, including a dial 354 attached to the proximal segment 186 of the recompression member at a gauge coupling point 370. The dial 354 has a distal tip 356 that points to a scale or indicator mark 358. The handle 310 is similar to the handle 210, except that it does not necessarily include a dial support member. The diameter gauge 350 is similar to the diameter gauge 250, except that the dial 354 is not pivotable around a pivot and is not connected to a dial support member. The non-pivotable dial 354 can be oriented substantially perpendicular to the longitudinal axis of the proximal segment 186 of the recompression member. Thus, the dial 354 moves together with the proximal segment 186 of the recompression member as it translates axially, and the dial tip 357 points to the indicator mark 358 to indicate the current diameter of the artificial valve 120, based on the principle described and illustrated in relation to Figures 8A-8B.

[0212] An additional embodiment of a handle 410, equipped with a diameter gauge 250 and operable for controlling a recompression assembly 180, is shown in Figure 10A. The handle 410 may be substantially similar to the handle 210, except that it comprises a pulley assembly 430 having a first pulley 432 and a second pulley 436, respectively. The first pulley 432 is mounted on any part of the handle 410. According to some embodiments, the first pulley 432 is connected to a first pulley support member 416 of the handle 410 via a first pin 434. The second pulley 436 may be mounted on any part of the handle 410 and may be offset laterally and / or axially from the first pulley 432. According to some embodiments, the second pulley 436 is connected to a second pulley support member 418 of the handle 410 via a second pin 438. The first pulley 432 and the second pulley 436 are freely rotatable around the first pin 234 and the second pin 238, respectively.

[0213] In the embodiment illustrated in Figure 10A, the recompression member proximal segment 186 is routed through a pulley assembly 430 in the handle 410. For example, the recompression member proximal segment 186 may be partially routed around a first pulley 432 and around a second pulley 436. According to some embodiments, the recompression member proximal segment 186 may be connected to a second pulley 436 and configured to wrap around the second pulley. The pulley assembly 430 may be adjusted to always apply a minimum tension magnitude Ts to the recompression member 182, including in the released state, without requiring a spring 220 attached to the recompression member proximal segment 186. According to other embodiments, in addition to the recompression member proximal segment 186 being routed through the pulley assembly 430, a spring 220 is attached to the recompression member proximal segment 186 according to any of the embodiments described above.

[0214] According to some embodiments, the pulley assembly 430 may include one or more additional pulleys around which the recompression member proximal segment 186 can be wound. According to some embodiments, the second pulley 436 includes a column portion 440 around which the recompression member proximal segment 186 may be wound, and a gear portion 442. The gear portion 442 may be configured to engage with, for example, a corresponding rack 444. Figure 10B is an enlarged perspective view of the second pulley 436 engaged with the rack 444. The rack 444 is configured to be directly or indirectly attached to a user-controllable element such as a steerable or rotatable adjustment knob, lever, slider, button (not shown), and the like, allowing the user to control the recompression assembly 180 by adjusting the tension applied to the recompression member 182.

[0215] A user-controllable element can be steered to translate the rack 444 axially in one direction, thereby rotating the second pulley 436 in the corresponding direction, for example, to facilitate further wrapping of the recompression member proximal segment 186 around the column 440. Similarly, a user-controllable element can be steered to translate the rack 444 axially in the opposite direction, thereby unwrapping the recompression member proximal segment 186 from the column 440 and releasing tension from the loop 183.

[0216] Figures 10A and 10B illustrate a drive mechanism including a rack 444 and a gear 442, but it will be understood that any other drive mechanism is intended to be used to control the rotation direction of the second pulley 436.

[0217] According to some embodiments, as illustrated in Figures 10A to 10B, the handle 410 is equipped with a diameter gauge 350 instead of a diameter gauge 250, and the recompression member proximal segment 186 is coupled to the dial 354 at a gauge coupling point 370. In such embodiments, the dial 354 moves together with the recompression member proximal segment 186 as it is translated axially, and has a dial tip 357 that points to an indicator mark 358 indicating the current valve diameter, as described above in relation to Figure 9.

[0218] Figure 11 shows yet another embodiment of the handle 510 having a diameter gauge 450. The handle 510 includes a pulley assembly 530, which is similar to the pulley assembly 430 but with some differences. The pulley assembly 530 comprises a first pulley 532 and a second pulley 536, respectively. The first pulley 532 may be mounted on any part of the handle 510 and connected to a first pulley support member 516 of the handle 510 via a first pin 534. The second pulley 536 may be mounted on any part of the handle 510 and may be offset laterally and / or axially from the first pulley 532. According to some embodiments, the second pulley 536 is connected to a second pulley support member 518 of the handle 510 via a second pin 538. The first pulley 532 and the second pulley 536 are freely rotatable around the first pin 534 and the second pin 538, respectively.

[0219] The main difference between pulley assembly 530 and pulley assembly 430 is that the second pulley 536 has no gear portion and is therefore not engaged with the rack. As shown in Figure 11, the recompression member proximal segment 186 may extend beyond the second pulley 536 in the proximal direction, for example, instead of being configured to be partially routed around the first pulley 532 and partially routed around the second pulley 536 and wrap around it. According to some embodiments, pulley assembly 530 may include one or more additional pulleys around which the recompression member proximal segment 186 can be routed. The recompression member proximal segment 186 may be attached to a tension mechanism (not shown) in a proximal position of the second pulley 536, the tension mechanism being configured to pull the recompression member proximal segment 186 in a proximal direction or to release the recompression member proximal segment 186.

[0220] The pulley assembly 530 can be adjusted to always apply a minimum tension Ts to the recompression member 182, including in the released state, in a manner similar to that described above for the pulley assembly 430. According to other embodiments, in addition to the recompression member proximal segment 186 being routed through the pulley assembly 530 (an embodiment not shown), a spring 220 is attached to the recompression member proximal segment 186 according to any of the embodiments described above.

[0221] The diameter gauge 450 is equipped with a displacement sensor 460, and at least one component of the diameter gauge 450 is coupled to the recompression assembly 180 at a gauge coupling point 470, and the displacement sensor 460 is operably connected to the recompression assembly 180.

[0222] The phrase "operably connected" refers to any kind of interaction between two components, as used herein, in which the movement of a first component has the effect of causing a reaction in a second component. For example, the displacement sensor 460 is operably connected to the recompression assembly 180 such that the axial movement of a component of the recompression assembly 180, such as a component having a gauge coupling point 470, has the effect of causing the displacement sensor 460 to generate a corresponding signal (e.g., an electrical or optical signal).

[0223] According to some embodiments, as shown in Figure 11, the displacement sensor 460 is operably connected to the proximal segment 186 of the recompression member at a gauge coupling point 470 and configured to generate a signal whose magnitude is proportional to the position and / or axial displacement of the gauge coupling point 470.

[0224] According to some embodiments, the displacement sensor 460 comprises a potentiometer, and the diameter gauge 450 further comprises a wiper 462 coupled to the recompression assembly 180 at a gauge coupling point 470. In the exemplary embodiment of Figure 11, the wiper 462 is coupled to the proximal segment 186 of the recompression member at the gauge coupling point 470. The wiper 462 is configured to move axially with the proximal segment 186 of the recompression member. The free end of the wiper 462 opposite to the gauge coupling point 470 is configured to contact the potentiometer 460, and the position relative to the potentiometer 460 affects the electrical signal generated by the potentiometer 460. The position of the wiper 462 and its contact with the potentiometer 460 are directly proportional to the circumference of the loop portion 183, and then proportional to the circumference of the artificial valve 120. Thus, the diameter of the artificial valve 120, which can be derived from the circumference, can be determined by measuring the electrical signal generated by the potentiometer 460 in contact with the wiper 462.

[0225] As the recompression member proximal segment 186 is moved axially within the handle 510 along with the gauge coupling point 470, the wiper 462 slides axially across the surface of the potentiometer 460, and the corresponding voltage can be transmitted to a control circuit (not shown). The control circuit may be embedded within the handle 510 and may include a processor for analyzing the voltage and appropriately deriving the valve expansion diameter.

[0226] It should be understood that the displacement sensor 460 is not limited to a potentiometer, and other displacement sensors, including linear displacement sensors, may be used. Exemplary alternative displacement sensors 460 may include linear variable differential transformers (LDVTs), optical linear encoders, optical sensors, capacitive sensors, or any combination thereof. Angle displacement sensors may also be used, for example, to measure the angle or rotational motion of a pulley extending around the recompression member 182, based on known correlations between such rotational motion and the axial displacement of the recompression member 182.

[0227] According to some embodiments, the displacement sensor 460 is operably coupled to a control unit via one or more wires or cables, or via a wireless communication link. The control unit may be configured to receive signals from the displacement sensor representing the axial movement of the proximal segment 186 of the recompression member. The control unit may be configured to continuously calculate the diameter of the artificial valve 120 based on the measurement input provided by the displacement sensor 460.

[0228] According to some embodiments, the displacement sensor 460 is operably coupled to a visual interface such as a display 116. According to some embodiments, the displacement sensor 460 is operably coupled to the display 116 via a control unit. The display 116 may include a digital screen which may display numerical values ​​indicating the valve current diameter, as well as other icons, text messages, or graphical symbols. In addition to or alternatively, the visual interface may include an LED light 118, a lamp, or other visual element configured to provide the user with a visual representation of the current valve diameter. According to some embodiments, the control unit is configured to display the diameter of the artificial valve 120 on the display 116 in real time as the artificial valve 120 is expanded and / or compressed during the implantation procedure.

[0229] According to some embodiments, the control unit further comprises memory. According to some embodiments, selected data, such as raw signal data or calculated data, may be stored in the memory. According to some embodiments, the control unit is configured to log data from the implantation procedure to the memory. According to some embodiments, the control unit is configured to transmit the logged data from the memory, and / or real-time data, to a remote device.

[0230] According to some embodiments, the control unit is configured to send an alert to the operator if the valve expands excessively within the natural valve ring. The alert may be an auditory alert, a visual alert, a tactile alert, or the like.

[0231] According to some embodiments, the control unit may be further configured to control the actuating arm assembly 165 and / or recompression assembly 180 to expand and / or contract the artificial valve 120 according to a pre-programmed expansion / contraction algorithm.

[0232] According to some embodiments, the control unit and / or display 116 are provided as separate components separated from the delivery device 102, which may be operably connected to them, for example, using wires or cables. According to some embodiments, the control unit and / or display 116 are configured to communicate wirelessly with the displacement sensor 460 via Bluetooth communication, radio waves, infrared signals, or other wireless communication protocols. According to additional embodiments, the control unit and / or display 116 are integrated within the handle 510. For example, the processor and other electrical components of the control unit may be located within the handle 510, and the display 116 may be located on the outer surface of the handle 510 so that it is visible to the physician during the implantation procedure.

[0233] According to some embodiments, the diameter gauge 450 may be used in combination with any other embodiment of the handle disclosed above herein. For example, the diameter gauge 450 may be embedded within the handle 310, which has a recompression member proximal segment 186 coupled to the wiper 462 and spring 220. In another example, the diameter gauge 450 may be embedded within the handle 410, which has a recompression member proximal segment 186 routed through the pulley assembly 430 instead of the pulley assembly 530.

[0234] As described above, the tension applied to the recompression member 182 may occasionally stretch its length to some extent with respect to its length in the uncompressed state or under the magnitude of other tensile forces that may be applied to it. Such changes in the length of the recompression member 182 may also change the positions of the gauge coupling points 270, 370, or 470. This, in turn, may lead to inaccurate estimations of the valve diameter.

[0235] According to some embodiments, the recompression assembly further comprises a tracking member that extends through the recompression shaft and is attached to the actuating arm assembly 165 via a secondary loop in a manner similar to that of the recompression member 182. However, unlike the recompression member 182, the tracking member is not configured to displace the actuating arm assembly 165 in any direction, but rather to passively follow their displacement in the radial direction.

[0236] Figure 12 shows a delivery device 102 equipped with a recompression assembly 680 and a handle 610 according to several embodiments. The recompression assembly 680 is similar to the recompression assembly 180, having a recompression member 182 extending through the lumen of the recompression shaft 688. However, the recompression assembly 680 further comprises a track member 682 that extends from the handle 610, through the recompression shaft 688, toward the distal end 172 of the support sleeve.

[0237] The track member 682 may be provided in the form of a wire, cable, string, etc. According to some embodiments, the track member 682 may be made of the same material as the recompression member 182 and may be provided in the form of a wire, cable, string, etc. According to some embodiments, the track member 682 includes a material that has higher resistance to axial elongation compared to the resistance to elongation of the recompression member 182 in the tensile state of the recompression assembly 680.

[0238] The track member 682 includes a track member proximal segment 686 and a track member distal segment 684, which are equivalents of the recompression member proximal segment 186 and recompression member distal segment 184 described in any of the embodiments above. In some cases, the recompression member proximal segment 686 may be formed as a continuous extension of the track member distal segment 684. Alternatively, the track member proximal segment 686 and the track member distal segment 684 may be provided as separate components mounted together, where both segments are formed from the same material and have the same dimensions, or both are formed from the same material but have different dimensions (for example, one segment is thicker than the other), or each is formed from different materials but both have similar or different dimensions with respect to each other.

[0239] According to some embodiments, the distal segment 684 of the track member can be attached to the proximal segment 686 of the track member via a connector 694, which can be implemented according to any embodiment relating to the connector 194.

[0240] According to some embodiments, each support sleeve 170 may include a secondary loop mounting member 177 that can be positioned adjacent to the corresponding loop mounting member 176 of the same support sleeve 170. The secondary loop mounting member 177 may be implemented according to any of the embodiments described for the loop mounting member 176. Each secondary loop mounting member 177 may be positioned at an axial distance from the corresponding loop mounting member 176, either distally or proximal to it. Alternatively, or in addition to the above, each secondary loop mounting member 177 may be offset at an angle along the support sleeve 170 with respect to the corresponding loop mounting member 176. For example, the secondary loop mounting member 177 and the loop mounting member 176 may be positioned diagonally opposite each other on the respective support sleeve 170.

[0241] The track member 682, as shown in Figure 12, extends from the handle 610 through the lumen of the recompression shaft 688, which extends distally from the distal end 692 of the recompression shaft and connects to the actuator arm assembly 165, forming a secondary loop 683 between them, and has a portion of its distal segment 684.

[0242] According to some embodiments, the secondary loop 683 is connected to and extends between the secondary loop mounting members 177 such that the secondary loop 683 is adjacent to the loop portion 183 that extends between the loop mounting members 176. According to an alternative embodiment, both the loop portion 183 and the secondary loop 683 may extend through the same loop mounting member 176.

[0243] According to some embodiments, both the track member 682 and the recompression member 182 may extend side by side through the same lumen of the recompression shaft 688. In alternative embodiments, the recompression shaft 688 is a multi-lumen shaft, with each of the track member 682 and the recompression member 182 extending through its other lumen.

[0244] According to some embodiments, the diameter gauge is attached to the proximal segment 686 of the track member at the gauge connection point (instead of being attached to the proximal segment 186 of the recompression member) and is configured to provide real-time indication of the diameter of the artificial valve 120 based on the axial position and / or axial translation of the gauge connection point.

[0245] The handle 610 shown in Figure 12 is similar to the handle 510 and comprises a pulley assembly 630 which may be identical to the pulley assembly 530, where similar numbers refer to similar components, and the recompression member proximal segment 186 may be routed through the pulley assembly 630. Alternatively, the recompression member proximal segment 186 may be routed through the pulley assembly 430 or connected to a tension mechanism configured to apply or release tensile force to the recompression member proximal segment 186 without extending it between any pulleys in the handle.

[0246] According to some embodiments, the magnitude of the minimum tension Ts' is always applied to the distal segment 684 of the track member, and more specifically to the secondary loop 683, and is configured to hold the secondary loop 683 in a minimum tension state between the actuarial arm assemblies 165 while allowing free radial expansion of the artificial valve 120. According to some embodiments, the magnitude of the minimum tension Ts' applied to the secondary loop 683 is substantially the same as the magnitude of the minimum tension Ts applied to the loop portion 183. According to some embodiments, the magnitude of the minimum tension Ts' differs from the magnitude of the minimum tension Ts due, for example, to different axial positions of the secondary loop 683 relative to the loop portion 183.

[0247] According to some embodiments, the handle 610 may further comprise a track spring 620, which may be identical in structure and function to the spring 220. The track spring 620 is attached to the spring support member 612 of the handle 610 via a first end 622 of the spring and to the proximal segment 686 of the track member via a second end 624 of the spring. Contrary to the embodiments described and illustrated with respect to the spring 220 in relation to Figures 8A to 9, the spring 620 is configured to apply an axially oriented tensile force to the proximal segment 686 of the track member instead of the proximal segment 186 of the recompression member. The magnitude of the force applied by the spring 620 is sufficient to apply a minimum tension magnitude Ts' to the secondary loop 683.

[0248] The recompression member 182 may be used to compress the valve 120, and it has a proximal segment 186 of the recompression member that is attached to and controllable by a user-controllable element, according to any of the embodiments described above in this specification. On the other hand, the track member 682 is not connected to a user-controllable element and is therefore not necessarily used to compress the valve 120. Rather, the track member 682 is configured to follow changes in valve diameter and has a secondary loop 683 that is configured to simply follow expansion or contraction of the artificial valve 120, similar to how the loop portion 183 is described in any of the embodiments described above in this specification.

[0249] Advantageously, since the maximum tension applied to the track member 682 is the magnitude of the minimum tension Ts' which is substantially lower than the tension applied to the recompression member 182 to compress the diameter of the artificial valve 120, the length of the track member 682 is not stretched to the same extent as the length of the recompression member 182 in the tensile state of the recompression assembly 680.

[0250] According to some embodiments, the diameter gauge is coupled to the proximal segment 686 of the track member (but not to the proximal segment 186 of the recompression member) at the gauge coupling point.

[0251] In the exemplary embodiment shown in Figure 12, a diameter gauge 450 equipped with a displacement sensor 460, such as a potentiometer, is coupled to the track member proximal segment 686 at a gauge coupling point 470. More specifically, a wiper 462 is attached to the track member proximal segment 686 at the gauge coupling point 470 and is configured to interact with the potentiometer 460 in the same manner as described and illustrated in relation to Figure 11. Thus, the valve diameter may be derived from the axial movement of the gauge coupling point 470, which has a corresponding indication, for example, shown on a display 116, in the same manner as described and illustrated in relation to Figure 11.

[0252] Advantageously, this configuration separates the functionality of the recompression member 182 from that of the diameter gauge, so that the recompression member 182 is used to recompress the artificial valve 120 as needed, while the diameter gauge follows such changes in diameter without being affected by the inaccuracies that may arise from the axial elongation of the recompression member 182 due to the tensile force applied to it during the tensioned state.

[0253] According to some embodiments, the track spring 620 may be further attached to the proximal segment 186 of the recompression member, thereby applying similar basic tensile forces to both the track member 682 and the proximal segment 186 of the recompression member (embodiments not shown). Alternatively, or in addition, the spring 220 may be attached to the proximal segment 186 of the recompression member, in addition to the track spring 620 optionally attached to the track member 682.

[0254] According to some embodiments, the recompression assembly 680 may be used in the same manner as described and illustrated with respect to the dial 254 and indicator mark 258 in relation to Figures 8A–8D, or in the same manner as described and illustrated with respect to the dial 354 and indicator mark 358 in relation to Figure 9, together with a track member proximal segment 686 attached to a dial pointing to an indicator mark. In such embodiments, the track member proximal segment 686 may be attached to a track spring 620 and / or routed around a pulley of a pulley assembly, similar to a pulley assembly 430 or a pulley assembly 530.

[0255] Figures 9 to 12 demonstrate recompression assemblies 180, 680 having loop portions 183 extending between loop attachment members 176. It will be apparent that all configurations and embodiments illustrated and described in relation to Figures 9 to 12 can be used in combination with a recompression assembly 180 having loop portions 183 circumscribing the artificial valve 120, similar to the configuration illustrated in Figures 8C to 8D.

[0256] In particular, as illustrated in Figure 12, a recompression assembly 680 comprising a recompression member 182 together with a loop portion 183 extending between loop attachment members 176 can similarly comprise a recompression assembly 180 having a loop portion 183 circumscribing the artificial valve 120 in some embodiments. In such embodiments, the track member 682 may also similarly comprise a secondary loop 683 circumscribing the artificial valve 120. All other embodiments described in relation to Figure 12 are similarly applicable to a recompression assembly 680 having loops 183 and 683 circumscribing the artificial valve 120.

[0257] Although not explicitly illustrated, additional embodiments of the recompression assembly 680 may be used in combination with a track member 682 having a recompression member 182 having a loop portion 183 extending between loop attachment members 176 and configured to apply sufficient tension to compress the artificial valve 120, and a secondary loop 683 circumferentially surrounding the artificial valve 120 and configured to simply track changes in the circumference of the artificial valve 120. Alternatively, embodiments of the recompression assembly 680 may be used in combination with a track member 682 having a recompression member 182 circumferentially surrounding the artificial valve 120 and configured to apply sufficient tension to compress the artificial valve 120, and a secondary loop 683 extending between loop attachment members 176 and configured to simply track changes in the circumference of the artificial valve 120.

[0258] According to several embodiments, the diameter gauge according to any embodiment of the present disclosure is operably coupled to a digital display 116 or an LED light 118. According to several embodiments, the diameter gauge is operably coupled to the digital display 116 or an LED light 118 via a control unit. The digital display 116 comprises a digital screen which may display a numerical value indicating the current diameter of the artificial valve 120. The digital display 116 may also display other icons, text messages, and / or graphical symbols. In addition to or alternatively, an LED light 118, a lamp, or other visual element may be configured to provide the user with a visual indication of the diameter of the artificial valve 120. According to several embodiments, the control unit is configured to display the diameter of the artificial valve 120 on the digital display 116 in real time as the artificial valve 120 is expanded and / or compressed during the implantation procedure.

[0259] According to some embodiments, the control unit further comprises a memory member in which selected data, such as raw signal data or calculated data, can be stored. The memory member may include, for example, a suitable memory chip or storage medium such as a PROM, EPROM, EEPROM, ROM, flash memory, solid-state memory, and the like. The memory member may be integrated with the control unit or may be detachably coupled to the control unit. According to some embodiments, the control unit is configured to record a log of data in the memory member during an implantation procedure. According to some embodiments, the control unit is configured to transmit the data recorded in the log from the memory member, and / or real-time data, to a remote device.

[0260] According to some embodiments, the control unit is configured to send an alert to the operator when the diameter of the artificial valve 120 exceeds a predefined threshold. The alert may be an auditory alert, a visual alert, a tactile alert, or the like.

[0261] According to some embodiments, the control unit may be further configured to control the actuating arm assembly 165 that extends the artificial valve 120 according to a pre-programmed extension algorithm.

[0262] According to some embodiments, the control unit and the display 116 may be separated from the delivery device 102 and provided as separate components that are operably connected, for example, using wires or cables. According to additional embodiments, the control unit and / or the display 116 may be integrally formed with the handle. For example, the processor and other electrical components of the control unit may be located within the handle, and the display 116 may be located on the outer surface of the handle, as shown in Figure 1, which is visible to the physician during the implantation procedure.

[0263] According to some embodiments, an axially fixed component of a delivery assembly 100, configured to maintain an axial position attached to the outlet end 123 during expansion or compression of the artificial valve 120, comprises at least one reference radiopaque marker 882, and an axially movable component of a recompression assembly 180, configured to be axially movable with respect to the outlet end 123 during expansion or compression of the artificial valve 120, comprises at least one indicator radiopaque marker 880.

[0264] According to some embodiments, as shown in Figures 13A to 13B, the axially fixed component is a recompression shaft 188, which comprises at least one reference radiopaque marker 882 around its outer surface, and the axially movable component is a recompression member proximal segment 186, which comprises at least one indicator radiopaque marker 880 around its outer surface. Each reference radiopaque marker 882 and each indicator radiopaque marker 880 may be implemented according to any of the embodiments described above herein with respect to the radiopaque marker 196 in relation to Figure 6A.

[0265] According to some embodiments, at least one indicator radiopaque marker 880 is configured to be visually distinguishable from at least one reference radiopaque marker 882, for example, by having different dimensions. In the exemplary embodiment of Figure 13A, the indicator radiopaque marker 880 is disposed around the outer surface of the proximal segment 186 of the recompression member, which is thinner than the recompression shaft 188 on which it is disposed, resulting in an indicator radiopaque marker 880 that is relatively smaller than each of the reference radiopaque markers 882. In some applications, the length of the indicator radiopaque marker 880 may differ from the length of the reference radiopaque markers 882.

[0266] According to some embodiments, the recompression shaft 188 contains a radiopaque material or has a cutout window that allows at least one indicator radiopaque marker 880 to be seen through it under fluorescence fluoroscopy.

[0267] Figure 13A shows the artificial valve 120 in a compressed state, and Figure 13B shows the valve 120 in an expanded state. The recompression shaft 188 may be coupled to the handle 110 and maintained in a predetermined position, and the position of any portion of the recompression shaft 188, which has a fixed length extending toward the valve 120 and includes a reference radiopaque marker 882 disposed around its outer surface, maintains the same axial position with respect to the outlet end 123 of the valve 120 when the artificial valve 120 is expanded (for example, from the compressed state in Figure 13A to the expanded state in Figure 13B) or compressed (for example, from the expanded state in Figure 13B to the compressed state in Figure 13A).

[0268] As shown in Figure 13B, when the valve expands, the loop portion 183 of the distal segment 184 of the recompression member expands along with it, translating the proximal segment 186 of the recompression member, and the indicator radiopaque marker 880 positioned thereon, axially in a distal orientation (i.e., toward the outlet end 123) with respect to its position in the compressed state shown in Figure 13A and with respect to the reference radiopaque marker 882.

[0269] As described above, the axial translation of the proximal segment 186 of the recompression member is proportional to the circumference of the loop portion 183, and then proportional to the diameter of the prosthetic valve 120. Therefore, at least one reference radiopaque marker 882 may act as a “scale,” and the indicator radiopaque marker 880 may act as a “dial” for the “scale,” indicating the diameter of the prosthetic valve 120. Thus, the recompression assembly 180 provided in the delivery assembly 100 to facilitate the recompression of the prosthetic valve 120 when needed may be further utilized to act as an auxiliary means for real-time monitoring of the prosthetic valve diameter during its expansion or compression, based on the alignment of at least one indicator radiopaque marker 880 with respect to the reference radiopaque marker 882 under fluoroscopy. In other words, the axial position of one indicator radiopaque marker with respect to the reference radiopaque marker 882 indicates the diameter of the prosthetic valve 120.

[0270] In applications where the recompression shaft 188 has three or more reference radiopaque markers 882, the reference radiopaque markers 882 may be spaced equally apart from each other. Alternatively, at least some of the reference radiopaque markers 882 may be spaced unevenly apart.

[0271] The recompression shaft 188 may have multiple reference radiopaque markers 882, such as the three reference radiopaque markers 882a, 882b, and 882 shown in Figures 13A and 13B, each corresponding to a specific diameter of the artificial valve 120. In the example shown, the most proximal reference radiopaque marker 882a may correspond to a first expansion diameter, such as 27 mm. The intermediate reference radiopaque marker 882b may correspond to a second expansion diameter, such as 28 mm, which is larger than the first diameter. The most distal reference radiopaque marker 882c may correspond to a third (potentially largest) expansion diameter, such as 29 mm, which is larger than the second diameter. Alignment of an indicator radiopaque marker 880 with any of the reference radiopaque markers 882 may indicate the valve diameter associated with the reference radiopaque marker 882. As shown in Figure 13B, the positioning of an indicator radiopaque marker 880 between any two reference radiopaque markers 882 may indicate an expanded diameter between the two diameters associated with each reference radiopaque marker 882. Similarly, an indicator radiopaque marker 880 positioned distal to the most distal reference radiopaque marker 882c may indicate an expanded diameter exceeding the maximum value.

[0272] While three reference radiopaque markers are shown in the exemplary embodiments illustrated in Figures 13A and 13B, it will be apparent that any other number of reference radiopaque markers 882 are also intended. For example, more than three reference radiopaque markers 882 may be used to provide a higher resolution of the “scale” they offer. Alternatively, a single reference radiopaque marker 882 may be provided to act, for example, only as a maximum threshold, and may indicate an expanded diameter beyond the maximum threshold when the indicator radiopaque marker 880 is translated distal to the single reference radiopaque marker 882 (embodiments not shown).

[0273] According to some embodiments, as shown in Figures 14A to 14B, the axially fixed component is a recompression shaft 188, which has at least one reference radiopaque marker 882 around its outer surface, and the axially movable component is a reconnector 194, which has at least one indicator radiopaque marker 880 around its outer surface.

[0274] Figures 14A and 14B show diagrams similar to those shown in Figures 13A and 13B, respectively, and the recompression mechanism 180 is identical to any embodiment described in relation to Figures 13A-13B, except that the axially movable component containing the indicator radiopaque marker 880 is a connector 194. If the connector 194 is a releasable connector, the radiopaque marker may be positioned around either or both of the proximal connector element 193 and the distal connector element 195.

[0275] Figures 13A to 14B show exemplary configurations of the loop portion 183 of the distal segment 184 of the recompression member, which is screwed into the small-hole shaped loop mounting member 176, as detailed in relation to Figures 8A to 8B. These configurations may be advantageous because both the connector 194 and the proximal segment 186 of the recompression member are always positioned proximal to the outlet end 123 of the valve 120, along with an indicator radiopaque marker 880 disposed on either of the aforementioned components. Thus, the indicator radiopaque marker 880, and furthermore, each reference radiopaque marker 882, are positioned proximal to the valve outlet end 123 so that they are visible throughout the expansion or compression of the valve 120 under fluorescence fluoroscopy without being potentially obstructed by the frame 126.

[0276] Figures 15A and 15B show diagrams similar to those shown in Figures 13A and 13B, respectively, and the recompression mechanism 180 is identical to any of the embodiments described in relation to Figures 13A to 14B, except that the loop portion 183 of the distal segment 184 of the recompression member is externally tangent to the artificial valve 120 instead of being screwed into the loop mounting member 176 of the actuator arm assembly 165. The frame 126 and other components of the artificial valve 120 have been removed from the enlarged views of Figures 15A to 15B for clarity.

[0277] In some applications, the loop portion 183 can enter the circumferential sleeve 830 through the circumferential sleeve opening 833. The circumferential sleeve 830 is arranged around the frame 126 and can be attached to it by adhesive, suture / stitching, etc. For example, the circumferential sleeve 830 can be sutured to several joints 130 and / or supports 127 of the frame 126. Although the loop portion 183 is illustrated in Figures 15A-15B as extending through the circumferential sleeve 830, it will be apparent that the loop portion 183 of the distal segment 184 of the recompression member can also be attached to a skirt such as the outer skirt 137 or extend through a sleeve 130 integrally formed with the skirt, in the same manner as described and illustrated in relation to Figures 7A-7C, or can be made into a loop directly above the valve 120 without extending through any kind of sleeve, in the same manner as described and illustrated in relation to Figures 5B-6B.

[0278] The configurations shown in Figures 15A to 15B illustrate a recompression mechanism 180 equipped with a releasable connector 194 disposed within a guide member 840, similar to the embodiments described and illustrated in relation to Figures 7A to 7C. Nevertheless, the embodiments described in relation to Figures 15A to 15B may be equipped with a non-releasable connector 194, similar to those described and illustrated in relation to Figures 5B to 6B, and will be equally applicable to configurations of the recompression mechanism 180 that do not necessarily extend through the guide member 840. For configurations including the guide member 840, it is preferable that the indicator radiopaque marker 880 and the reference radiopaque marker 882 are positioned proximal to the outlet end 123 of the valve 120, over the entire range of the expanded diameter. For example, the indicator radiopaque marker 880 and the reference radiopaque marker 882 are located proximal to the proximal end 844 of the guide member in both the compressed and expanded states shown in Figures 15A and 15B, respectively, thereby facilitating their visibility under fluorescence fluoroscopy without being potentially obstructed by the frame 126.

[0279] In some applications, reference radiopaque markers 882a, 882b, and 882c, such as those shown in Figures 16A and 16B (equivalent to those shown in Figures 15A and 15B, respectively), are positioned on the outer surface of the guide member 840 instead of the outer surface of the recompression shaft 188. Since the guide member 840 is mounted on the frame 126, which extends distally from the outlet end 123, the strut 127, due to its own inherent radiopaqueness, may mask such reference radiopaque markers 882 and / or indicator radiopaque markers 880. In some applications, the radiance of the reference radiopaque markers 882 and / or indicator radiopaque markers 880 is higher than the radiance of the strut 127 or other components of the artificial valve 120, so that the radiopaque markers 882 and 882 are visually distinguishable from the frame 126 or other components of the valve 120 under fluoroscopy.

[0280] According to some embodiments, multiple indicator radiopaque markers 880 may be utilized. For example, Figure 17 is an enlarged view of a part of a recompression mechanism 180, which may be implemented in combination with any of the configurations described and illustrated in relation to Figures 13A to 16B, wherein the recompression shaft 188 comprises three reference radiopaque markers 882a, 882b, and 882c, and the recompression member proximal segment 186 comprises two indicator radiopaque markers 880a and 880b. The distances between the multiple indicator radiopaque markers 880 may differ from the distances between equally spaced (or otherwise somehow spaced apart) reference radiopaque markers 882. For example, the potential resolution of the indicated diameter may be increased by setting the distance between indicator radiopaque markers 880a and 880b to half the distance between any two adjacent reference radiopaque markers 882.

[0281] As described above with respect to the embodiments explained and illustrated in relation to Figures 8A to 12, the tension applied to the recompression member 182 may occasionally stretch the length of the recompression member 182 to some extent with respect to its length in the uncompressed state or under the magnitude of other tensile forces that may be applied thereto. Such a change in the length of the recompression member 182 may also change the position of the indicator radiopaque marker 880. This, in turn, may lead to an inaccurate estimation of the valve diameter.

[0282] Accordingly, any of the embodiments described and illustrated in relation to Figures 13A to 17 may be used in combination with a handle including a spring 220 or equivalent connected to a proximal segment 186 of a recompression member according to any of the embodiments described and illustrated in relation to Figures 8A to 9. Similarly, any of the embodiments described and illustrated in relation to Figures 13A to 17 may be used in combination with a handle including a pulley assembly 430 or 530 according to any of the embodiments described and illustrated in relation to Figures 10A to 10 or Figure 11, respectively.

[0283] In further applications, any of the embodiments described and illustrated in relation to Figures 13A–14B and / or Figure 17 may be used in combination with a delivery device 102 equipped with a recompression assembly 680 according to any of the embodiments described and illustrated in relation to Figure 12. For example, Figure 18 shows a recompression assembly 680 comprising both a recompression member 182 and a track member 682, similar to any of the embodiments described and illustrated in relation to Figure 12. As illustrated, the recompression shaft 688 may be equipped with a reference radiopaque marker 882, and the proximal segment 686 of the track member (or, in an alternative embodiment, a connector 694) may be equipped with an indicator radiopaque marker 880. In such embodiments, the recompression member 182 may be used to facilitate valve compression when necessary, but the position of the indicator radiopaque marker 880 relative to the reference radiopaque marker 882 on the recompression shaft 688 may provide real-time indication of the valve diameter, as detailed above herein.

[0284] Although multiple reference radiopaque markers 882, such as three markers 882a, 882b, and 882c, are illustrated, it should be understood that a single reference radiopaque marker 882 may be similarly used in any of the embodiments described in relation to Figures 13A to 18. A single reference radiopaque marker 882 may represent a critical expansion diameter of interest, such as the maximum allowable expansion diameter, and the relative position of an indicator radiopaque marker 880 with respect to the reference radiopaque marker 882 may indicate valve over-expansion.

[0285] According to another aspect of the present invention, a method is provided for providing real-time estimation of the expansion diameter of an artificial valve 120 based on a relationship between the expansion diameter and a dimensionless parameter. The dimensionless parameter is either the opening angle of the artificial valve 120 or the aspect ratio between the length and diameter of the artificial valve 120 at each expansion diameter.

[0286] The frame of the artificial valve 120 includes a plurality of cells 135 defined between sections of struts 127 that intersect at joints 130. The shape of each cell 135, and its dimensions in different directions, change during expansion or contraction of the artificial valve 120. Since the artificial valve 120 has a plurality of cells, changes in the dimensions of the cells 135, for example, in the longitudinal and transverse directions, are also reflected in changes in the length and diameter of the artificial valve 120.

[0287] Figures 19A and 19B show a mechanically expandable prosthetic valve 120 in a compressed and expanded state, respectively. The exemplary prosthetic valve 120 shown in Figures 19A and 19B comprises struts 127 arranged in a grid pattern, interconnected at hinged joints 130 to form substantially rhomboid cells 135. In the compressed or crimped state shown in Figure 19A, the cells 135 have a maximum axial length and a minimum lateral width, and the prosthetic valve 120 has a maximum length L1 and a minimum diameter D1. In the expanded state shown in Figure 19B, the cells 135 are stretched laterally (e.g., after rotation at the hinged joints 130) to form substantially rhomboid cells. As a result, the prosthetic valve 120 has a length L2 shorter than L1 and a minimum diameter D2 smaller than D1. While certain types of mechanically expandable prosthetic valves 120 are shown in Figures 19A and 19B, other types of valves, which may include other cell shapes, are also intended.

[0288] The aspect ratio Rt of frame 126 can be defined as the ratio of the frame length L to the frame diameter D. The aspect ratio Rt changes when the artificial valve 120 is expanded or compressed. For example, the aspect ratio Rt1 in the compressed state is defined as L1 / D1, and the aspect ratio Rt2 in the compressed state is defined as L2 / D2. Figure 20 is an exemplary curve showing the relationship between the aspect ratio Rt and the expanded diameter D in several configurations. As illustrated, the aspect ratio Rt may have different values ​​for each expanded diameter D. While Figure 20 shows a specific nonlinear relationship, it will be apparent that other nonlinear or linear relationships may be applicable.

[0289] Figures 21A and 21B illustrate a mechanically expandable artificial valve 120 in a partially expanded and fully expanded state, respectively, showing exemplary opening angles of the frame 126. The opening angle may be defined between any two struts 127 intersecting at the joint 130, and this angle changes when the valve 120 is expanded or compressed. Depending on the orientation of the selected opening angle, various types of opening angles may be defined. For example, the longitudinally oriented opening angle α of the valve 120 can increase from, for example, the acute angle α1 shown in Figure 21A to the larger, potentially obtuse (or at least less acute) angle α2 shown in Figure 21B. Exemplary opening angles α are shown in Figures 21A and 21B between intersecting struts 127a and 127b.

[0290] Similarly, the circumferentially oriented opening angle β of the valve 120 can decrease, for example, from the obtuse angle β1 shown in Figure 21A to the smaller, potentially acute (or at least smaller obtuse) angle β2 shown in Figure 21B. Exemplary opening angles β are shown in Figures 21A and 21B between the intersecting supports 127b and 127c. In the case of a diamond or rhombic cell 135, angles α and β are complementary angles, i.e., each type of opening angle can be easily derived from the complementary angles. Thus, any reference to how to obtain the opening angle α also applies equally to obtaining the opening angle β.

[0291] Figure 22 shows exemplary curves illustrating the relationship between the opening angle α and the expansion diameter D in several configurations. As illustrated, the opening angle α may have different values ​​for each expansion diameter D. While specific relationships of the opening angle α increasing with the expansion diameter D are illustrated, it will be apparent that other types of relationships are also intended, including the relationship of the opening angle β decreasing as the expansion diameter D increases. Certain types of mechanically expandable artificial valves 120 are shown in Figures 21A and 21B, but other types of valves, including other cell shapes, are also intended.

[0292] The prosthesis implantation procedure is typically performed under fluoroscopy, and the frame 126 of the prosthetic valve 120 is radiopaque and can be viewed on an external monitor. As disclosed herein, known relationships between dimensionless parameters (i.e., aspect ratio Rt or opening angle α) and the expansion diameter D of the prosthetic valve 120 for a desired range of expansion diameter D can be used to derive the expansion diameter D or a precise approximation thereof during fluoroscopic imaging of the frame 126.

[0293] According to some embodiments, a method is provided that includes the steps of (1) obtaining at least one image of the frame 126 of the artificial valve 120, (2) deriving a dimensionless parameter from at least one image, (3) associating a value of the expansion diameter D of the artificial valve with the dimensionless parameter, and (4) providing an indication (e.g., a visual indication) of the expansion diameter D of the artificial valve 120.

[0294] According to some embodiments, the dimensionless parameter in steps (2) and (3) of the method of the present invention is the opening angle α (or β) between the two intersecting supports of the frame 126.

[0295] According to some embodiments, the dimensionless parameter in steps (2) and (3) of the method of the present invention is the aspect ratio Rt between the frame length and the frame width.

[0296] The terms "artificial valve diameter," "frame diameter," "valve diameter," and "expansion diameter" used herein are interchangeable.

[0297] According to some embodiments, the step of imaging frame 126 includes the step of acquiring at least one angiographic X-ray image of frame 126. According to some embodiments, the step of imaging frame 126 includes the step of acquiring at least one live fluoroscopy image of frame 126. According to some embodiments, the at least one acquired image of frame 126 is transmitted to a data control unit comprising a central processing unit (CPU). The data control unit is configured to identify informational data within the at least one acquired image, such as identifying or detecting radiopaque frames 126.

[0298] According to some embodiments, the data control unit is configured to obtain parameters representing the length and width of the frame 126, where the width represents the diameter of the frame 126. The length and width of the captured frame 126 may be assigned values ​​in arbitrary units, including the number of pixels in the image. The data control unit then calculates the aspect ratio Rt by dividing the length value by the width value. Alternatively, or in addition to this, the angular positions of the intersecting supports 127 may be used to derive the angle between them.

[0299] According to some embodiments, the control unit further includes memory. Information about at least one acquired image, including the measured length and width of the frame 126, the angular position of the intersecting supports 127, and the calculated / derived aspect ratio Rt or aperture angles α, β, can be stored in the memory.

[0300] According to some embodiments, known relationships between different aspect ratios Rt and valve expansion diameter D, and / or known relationships between opening angles α, β and valve expansion diameter D, are stored in memory. The numerical value of the expansion diameter D of frame 126 can be derived from the aspect ratio Rt and / or opening angles α, β based on any of the formulas, graphs, and / or tables that can be stored in memory. According to some embodiments, the step of providing a visual indication of the expansion diameter includes visualizing the expansion diameter on a digital screen as a numerical value, icon or other graphical symbol, text message, or any combination thereof.

[0301] Advantageously, the proposed method does not require the use of calibration components, such as a calibration ruler with radiopaque markings, to derive the expansion diameter. It is not necessary to directly measure the length and / or diameter of the valve 120, or even the magnitude (e.g., numerical values) of specific dimensions of the support column 127, because this method relies on measuring dimensionless parameters (i.e., aspect ratio Rt or opening angles α, β) that form the basis in which the expansion diameter is derived, based on known relationships between them.

[0302] A further advantage of the delivery assemblies and methods disclosed herein is that they enable continuous, real-time diameter monitoring, thereby providing clinicians with valuable feedback regarding valve expansion within the natural anatomical structure. This valuable information can help prevent, or at least reduce, potential trauma to tissue (e.g., the annulus). Clinicians can continuously readjust the diameter of the prosthetic valve 120 as needed until it expands to a diameter that best fits the natural annulus. For example, this diameter is sufficient to secure the prosthetic valve 120 in place in the surrounding tissue with little to no paravalvular regurgitation and without over-expansion of the prosthetic valve 120 to avoid or reduce the risk of rupture of the natural annulus.

[0303] According to another aspect of the present invention, an artificial valve is provided comprising a frame belt that circumsects at least a portion of a frame in an expanded state, the frame belt comprising at least one expansion force indicator, and preferably a plurality of expansion force indicators, which are preferably configured to provide the frame belt with indication of the circumferential force applied by the artificial valve 120 during its expansion. According to some embodiments, the expansion force indicator is a radiopaque marked expansion force indicator which is configured to provide a visual indication (e.g., under fluoroscopy) of the circumferential force applied to the frame belt by the artificial valve 120 during its expansion.

[0304] As described above, the natural anatomical structure that the prosthetic valve 120 encounters when it expands may exert a reactive radial force on the prosthetic valve 120 in the opposite direction. Therefore, the diameter of the prosthetic valve 120 correlates with the balance between the outwardly oriented expansion force exerted by the valve 120 on the surrounding anatomical structure and the inwardly oriented response force exerted on the valve 120 by the surrounding anatomical structure. Valve over-expansion can be defined as a situation in which the valve exerts an excessive radial force on the surrounding anatomical structure, resulting in potential tissue damage or even annular rupture. Assuming that the relationship between radial and circumferential forces is known for certain types of valves, the valve expansion force can be derived from the circumferential stress exerted by the valve on the frame belt, which can be detected by a change in the state of an expansion force indicator.

[0305] Figures 23A, 23B, and 23C show artificial valves 120 with a frame belt 860 in several embodiments, in a compressed state, a partially expanded state, and a fully expanded state, respectively. The frame belt 860 includes at least one frame belt diameter indicator 866 configured to change its state when a force exceeding a certain magnitude is applied by the frame 126 during its expansion. The change in state of the at least one frame belt diameter indicator 866 is visually distinguishable under fluorescence radiography.

[0306] In some applications, at least one frame belt diameter indicator includes a separation zone 866, and a visually distinguishable state includes a transition of the separation zone 866 from an intact state to a separated state. In particular, the separation zone 866 may include a radiopaque marker, according to any embodiment disclosed above for radiopaque markers 196 or 880, and the separated separation zone 866 is visible under fluoroscopy as a break in the radiopaque marker region that appeared as a continuous zone before its separation.

[0307] The phrases “broken” or “separated” refer to being interchangeable, torn, broken, or otherwise cut in any way, as used herein.

[0308] In some applications, at least one radiopaque expansion force indicator comprises a geometric feature 866 having a shape distinguishable from adjacent zones, where the visually distinguishable state includes a translation of the geometric feature 866 from a first zone to a second zone. In particular, the geometric feature 866 may include a radiopaque marker according to any embodiment disclosed above for radiopaque markers 196 or 880, where the spatial translation from the first zone to the second zone may be visible under fluorescence. In some modifications of this application, the first zone may comprise a radiopaque zone configured to conceal or mask a geometric feature 866 located behind or within its lumen from being visible under fluorescence, and the second zone may comprise an exposed (or otherwise in some other radiopaque) zone in which the geometric feature 866 may be visible under fluorescence. In some modifications of this application, the first zone may include a first orientation of a portion of the frame belt 860 defined between at least two geometric features 866, and the second zone may include a second orientation of a portion of the frame belt 860 defined between at least two geometric features 866, the second orientation being angled with respect to the first orientation and potentially perpendicular with respect to the second orientation. In some modifications of this application, the first zone may include a first spatial location of the geometric feature 866 with respect to a reference radiopaque marker, and the second zone may include a second spatial location of the geometric feature 866 with respect to a reference radiopaque marker, the first and second spatial locations being defined on the opposite side of the reference radiopaque marker (e.g., proximal and distal to the reference radiopaque marker).

[0309] In the exemplary embodiment illustrated in Figure 23A, the frame belt 860 is circumscribable to the valve 120 and remains intact unless the valve 120 is expanded to a diameter that applies a first critical tensile force to it. According to some embodiments, the frame belt comprises an expandable portion 868 configured to expand circumferentially with the frame 126 of the artificial valve 120, and a base 870 comprising a separation zone 866. Collapse of the separation zone 866 causes separation between the sections of the base 870 on either side thereof. Collapse of the separation zone 866 may occur after the application of a sufficient tensile force to facilitate such separation. The tensile force to facilitate separation may be applied to the separation zone 866 by the artificial valve 120 during its expansion.

[0310] The frame belt 860 illustrated in the exemplary embodiments of Figures 23A to 23C includes expandable portions 868 in the form of columns connected at joints to the corresponding bases 870. The resulting triangular cells are shown in Figures 23A to 23C, but it will be apparent that any other form is applicable, as long as the expandable portions 868 are expandable without collapsing when placed on or attached to the frame 126, and as long as at least one base 870 includes a separation zone 866 that can collapse or separate after sufficient tensile force is applied to it by the expansion of the frame 126.

[0311] The frame belt 860 may be arranged around the artificial valve 120, and after the application of a tensile force exceeding a first critical value, as illustrated in Figure 23B, at least one separation zone 866 collapses by fracture, tearing, cutting, detachment, and the like. Further expansion of the artificial valve 120 may result in the separation of additional separation zones 866. For example, Figure 23C shows the frame belt 860 with separation zones 866a and 866b collapsed, while separation zones 866c and 866d remain intact.

[0312] In some applications, at least some of the vertices of the expandable portion 868, and / or joints such as the joint connecting the expandable portion 868 and the base 870, of the frame belt 860 can be coupled to the joint 130 of the artificial valve 120 to facilitate simultaneous expansion of the expandable portion 868 by the frame 126.

[0313] Although the frame belt 860 shown in FIGS. 23A-23A is disposed over the entire circumference of the valve 120, it will be understood that in some applications, the frame belt 860 can be disposed over a portion of the circumference of the valve.

[0314] In some embodiments, the separation zone 866 comprises a frangible portion. FIGS. 24A-24B show a portion of the frame belt 860 a including a plurality of frangible portions 866 a In FIG. 24A, all of the frangible portions 866 a a, 866 a b, 866 a c, 866 a d and 866 a e are intact. FIG. 24B shows a continuous state that can be achieved with a partial expansion configuration of the valve as shown, for example, in FIG. 23B, in which the frangible zone 866 a a collapses (i.e., breaks or tears), while the other frangible portions such as 866 a b, 866 a c, 866 a d and 866 a e remain intact.

[0315] The frangible portion 866 a can be provided as a weakened portion along the frame belt 860 a In applications including the expandable portion 868, the weakened zones can be provided along their respective bases 870. The frangible portion 866 a is (the frame belt 860 a(Regarding other non-frangible parts) by reducing their thickness, or by including weakening features such as perforations, or frame belt 860 a It can be weakened by giving it different material properties from the other non-frangible parts.

[0316] Frame Belt 860 a This is a multiple flangable portion 866 a It can be equipped with multiple frangible parts 866 a At least two of these are configured to collapse (i.e., break or rupture) in response to different magnitudes of tensile forces applied to them. Figure 24A shows multiple flangable sections 866 of varying thicknesses. a An example is shown, frangible portion 866 a a is the thinnest flangable portion and is therefore likely to rupture or break first, as shown in Figure 24B, which could potentially correspond to the valve 120 applying the first critical tensile force of interest, as shown in Figure 23B. (Flangable portion 866) a a is the frangible portion 866 a Thicker than a, frangible portion 866 a c is the frangible portion 866 a Thicker than b, frangible portion 866 a d is the frangible portion 866 a Thicker than c, frangible portion 866 a e is the frangible portion 866 a It is thicker than d. Therefore, further expansion of the artificial valve 120 is required for the frame belt 860. a This can be used to apply a large tensile force to the subsequent flangable portion 866, as shown in Figure 23C, for example. a It may gradually tear or break.

[0317] Multiple frangible parts 866 aEach of these may be configured to collapse in response to different magnitudes of tensile forces that may occur at different expansion diameters of the artificial valve 120. In such a configuration, the expansion force is detected under fluorescence fluoroscopy by the radiopaque marked frame belt 860. a The amount of collapsed zone, represented by the discontinuity of the gapped zone along the frangible portion 866, can be assessed by visual inspection. a The amount can be determined according to the desired resolution of the monitored expansion force.

[0318] The base 870 may be formed from an extensible material, which may extend around the valve 120 until its collapse point while the expandable portion 868 expands. Alternatively, the base 870 may be provided in a folded or corrugated configuration, which may be folded around the valve 120 and then unfolded or straightened until its collapse point while the expandable portion 868 expands. It will be understood that the base 870 and the frangible portion 866 may be made from different materials than those of the expandable portion 868. For example, the expandable portion 868 may include a superelastic material (nitinol) or a non-superelastic material (e.g., stainless steel or cobalt-chromium alloy), while the base 870 may have greater flexibility, provided, for example, in the form of a wire, cable, suture, cord, or similar material.

[0319] In some applications, the expandable portion 868 may be marked with radiopaque markings so that changes in its geometric properties indicating a transition from a first state to a second state are visible under fluorescence radiography. For example, the height between the vertices of the expandable portion 868 and their respective bases 870 can act as such geometric properties. As shown in Figure 24A, the expandable portion 868 a The height of its respective flangable portion 860 may be equal to the height of all other expandable portions 868 in their intact state. a Expandable portion 868 after the collapse of a a The height of its corresponding flangeable portion is 860a The expandable portion 868 remains intact. b ,868 c ,868 d ,868 e It can be shorter than the height.

[0320] Frame Belt 860 a The frame belt 860 is shown in Figures 24A and 24B with the expandable portion 868, but in alternative applications, the frame belt 860 may be provided without the expandable portion 868. For example, the frame belt 860 may be provided as a flexible cable, wire, string, suture, and the like, having a frangible portion 866 disposed along it, and the frame belt 860 may be coupled to the frame 120 directly or via intermediate components such as skirts 136, 137 or sleeves 132, 830 around the valve. The coupling may be smoothed via biocompatible adhesives, sutures, and the like. The coupling may include a single coupling point or multiple coupling points around the valve 120. For example, each frangible portion 866 may be coupled to two adjacent joints 130 positioned circumferentially on both sides of each frangible portion 866 between two coupling points of the frame belt 860 to the valve 120.

[0321] In some implementations, the separation zone 866 is provided as a detachable portion configured to detach when a tension exceeding a predetermined magnitude is applied thereto. Figures 25A and 25B show the detachable portion 866 in its coupled and detached states, respectively. b This shows a portion of the frame belt including the "key and lock" type detachable portion 866. bIt may comprise a male portion (e.g., a flanged or ball-shaped head) and a complementary female portion (e.g., a slot or receptacle configured to fit snugly around the male portion), which may snap together or otherwise engage with each other in some way, as shown in Figure 25A. The male and female portions may detach from each other in response to a tensile force applied beyond a certain threshold (e.g., at both ends), as shown in Figure 25B. Other types of detachable portions 866 b The same applies to the detachable portion 866. b Regarding the type of collapse, only the frangible portion 866 a Unlike the above, it involves detachment or release instead of destruction or tearing. In other types of collapse, the detachable parts 866 b This is the frangible portion 866 a It may be used in accordance with any of the embodiments described.

[0322] Since the frame belt is arranged around the frame 126, the support 127 may mask such radiopaque marked expansion force indicator 866 due to its own inherent radiopaqueness. In some applications, the radiation intensity of the expansion force indicator 866 is higher than that of the support 127 or other components of the artificial valve 120, so that the radiopaque marked expansion force indicator 866 is visually distinguishable from the frame 126 or other components of the valve 120 under fluoroscopy.

[0323] In the exemplary embodiment illustrated in Figure 26A, the frame belt 860 having the geometric feature 866 may be configured to extend at least partially around the artificial valve 120, so that the amount of the geometric feature 866 visible along the portion of the frame belt 860 circumscribing the valve 120 varies as a function of the valve's expansion diameter. In some implementations, the geometric feature 866 is a bead 866 aThe materials are provided in the form shown. Each bead may be equipped with another indicator radiopaque marker 880, as shown in Figure 26A. Alternatively, a continuous portion of the frame belt 860, including its entire length, may be marked with a radiopaque marker 196, and a geometric feature 866, such as a bead, may be distinguished from other radiopaque marked areas due to its distinguishable size and / or shape, as shown in the example in Figure 27, for example.

[0324] According to some embodiments, the delivery assembly 100 further comprises a restrictor 848 configured to allow a geometric feature 866 to pass through it after a tensile force exceeding a predetermined threshold is applied to the frame belt 860. According to some embodiments, the artificial valve 120 comprises a restrictor 848. In some implementations, the restrictor 848 has a small hole 848 a It is provided in the form of bead 866 a This can restrict passage through the inside. In particular, small hole 848 a The inner diameter is bead 866 a It can be made slightly smaller than the outer diameter.

[0325] In the exemplary configuration shown in Figures 26A to 26D, there are multiple beads 866 c Frame belt 860 equipped with c The frame belt 860 comprises a portion partially arranged on the circle of the valve 120 and a portion that does not necessarily extend around the valve 120, and is shown in Figures 26A-26B to extend axially in an orientation that can be substantially parallel to the longitudinal axis 121 of the valve 120. The frame belt 860 includes a first end 862 of the frame belt that can be attached directly or indirectly to the frame 126. In some applications, the frame belt 860 extends around the frame 126. c The part is disposed within a sleeve such as the circumferential sleeve 830 shown in Figures 26A to 26D. In this case, the circumferential sleeve 830 is connected to the frame 126 and the frame belt 860. cIt can enter the circumferential sleeve lumen 832 through the circumferential sleeve opening 831. The first end 862 of the frame belt is attached to the circumferential sleeve 830 by means of, for example, adhesive, suture, and the like, and the frame belt 860 extends around the frame 126. c This portion can be defined as the area between the attachment point of the first end 862 of the frame belt to the circumferential sleeve 830 (shown in Figures 26A to 26D on the rear side of the frame) and the circumferential sleeve opening 831.

[0326] According to some embodiments, the delivery assembly 120 further comprises a belt pull member 886 extending from the handle 110 and attached to or integrally formed with the frame belt 860. The belt pull member 886 may be provided in the form of a cable, suture, wire, and the like and may be coupled to a tension mechanism at the handle 110 that can be operated by an operator to retract the belt pull member 886 together with at least a portion of the frame belt 860 when desired. According to some embodiments, the delivery assembly 120 further comprises a belt shaft 888 extending distally from the handle 110, allowing the belt pull member 886 to extend through its lumen together with at least a portion of the frame belt 860.

[0327] In some cases, as illustrated in the configurations shown in Figures 26A to 26B, a portion of the frame belt 860 may extend through a guide member 840 which may be included in the valve 120, and may be used in combination with the belt shaft 888, as in any of the embodiments described for use with the recompression shaft 188.

[0328] In the exemplary configuration shown in Figure 26A, the frame belt 860 c The beaded portion can extend axially through the lumens of the belt shaft 888 and / or guide member 840 toward the circumferential sleeve opening 831, and the frame belt 860 cThe non-beaded portion can extend circumferentially around the frame 126 within the circumferential sleeve lumen 832 in the crimped configuration of the artificial valve 120. In some applications, as shown in Figure 26A, the small hole 848 a The guide member distal end 846 and the circumferential sleeve opening 831 can be positioned between them, but the frame belt 860 c It extends through it. For example, small hole 848 a The distal end 846 of the guide member is attached to the frame 126 or the actuator assembly 138 (for example, the actuator outer member 140) and can potentially be aligned with it.

[0329] Figure 26B shows the partially expanded state of the artificial valve 120. In this state, beads 866 c world and 866 c Some beads, such as b, are positioned on the circle of the valve 120 within the circular sleeve 830, but beads 866 c e, 866 c f, 866 c gо866 c h, 866 c i, 866 c j and 866 c Other beads, such as k, remain outside the circular sleeve 830 and are disposed, for example, within the guide member 840 and / or belt shaft 888.

[0330] The circular sleeve 830 contains radiopaque marked beads 866 placed inside it. c To enable visibility, it may include radiopaque material or have a cutout window. Thus, the beads 866 arranged circumferentially around the valve 120 are visible under fluorescence radiography. c The number can indicate the valve's expansion diameter. For example, Figure 26C shows that valve 120 expands further, potentially to its final expansion diameter, and beads 866 c a, 866 c b, 866 c c, 866 c d, 866 ce, 866 c f, 866 c g and 866 c A larger number of beads, such as h, are positioned around the valve 120, but bead 866 c j and 866 c A smaller number of beads, such as k, remain outside the surrounding sleeve 830.

[0331] The sleeve 830 advantageously acts as a guide member, and after its expansion, geometric features 866 (beads 866) are placed around the valve 120. c The circumferential sleeve 830 is described and illustrated for use in combination with a frame belt 860 having geometric features 866, but it will be apparent that a sleeve 132 attached to or integrally formed with a skirt (e.g., an outer skirt 137) can be used instead in the same way. Furthermore, in some applications, the sleeve can be replaced with other means of circumferentially guiding the frame belt 860 around the valve 120, such as suture loops (not shown) that are looped around the frame 126 (e.g., around the support 127 of the joint 130) through which the frame belt 860 can pass as it slides. Further alternative applications may use the sleeve or other types of guiding means, and the frame belt 860 may be attached to the frame 126 directly (e.g., to the support 127 or the joint 130) or indirectly (e.g., to the skirt) at least at the first end 862 of the frame belt.

[0332] According to some embodiments, the belt pulling member 886 may be attached to the frame belt 860 via the connector 194, which, in some variations of the embodiments, can be a releasable connector 194. For example, as shown in FIG. 26C, upon completion of the extension procedure, the proximal connector element 193 may be released from the distal connector element 195, and the belt pulling member 886 may be retracted together with the proximal connector element 193 attached thereto, while the distal connector element 195 can remain, potentially together with a portion of the frame belt 860 attached thereto, such as with the extended valve 120 disposed within the guide member 840. As shown in FIG. 26D, subsequent steps can include retraction of the belt shaft 888 from the valve 120 and the guide member 840. This process can be implemented according to any of the embodiments of the recompression assembly 180 having a releasable connector 194, as described and illustrated in connection with FIGS. 7A-7C.

[0333] FIG. 26A shows a non-beaded portion initially circumferentially disposed around the valve 120 in a crimped configuration, although in an alternative configuration, beads 866 c will clearly be able to be disposed around the valve 126 even in a crimped configuration. In such a case, the initial amount of beads 866 c disposed around the valve 120 in this configuration can indicate the crimped diameter, and the expansion force can be estimated by the corresponding increased number of beads 866 c .

[0334] In some applications, the guide member 840, and / or at least a portion (e.g., the distal portion) of the belt shaft 888, includes a radiopaque zone (e.g., around their outer surfaces) configured to hide or mask geometric features 866 disposed within their lumens so as to be invisible under fluoroscopy. Such applications can advantageously simplify the visual identification of the number of geometric features 866 (e.g., beads 866 c ) around the valve 120, since only these beads are visible and not masked under fluoroscopy.

[0335] Multiple beads 866 c Although this is illustrated, an alternative configuration is a single bead 866 which can be hidden from view. c A single bead 866 that is positioned in an initial position in some other way and may change as the valve expands. c Such a configuration may include a single geometric feature, for example, the detection of the maximum expanded diameter, instead of measuring force, as seen in the bead 866. c Exposure of, or alternatively, positioning of, it in a second distinguishable location may result in over-extension.

[0336] As described above, the measuring mechanism located on the handle 110, which relies on the transmission of force from the region adjacent to the artificial valve 120 to the handle 110, may consequently result in inaccuracies in estimating the valve diameter due to stretching and / or multiple bending regions or twists that may form along the patient's winding vascular system, and additional means to compensate for such inaccuracies, such as springs or pulley assemblies, as described throughout this disclosure, may be required. A frame belt equipped with an expansion force indicator, including an indicator with separation zones and / or geometric features (e.g., beads) according to any embodiment disclosed herein, may be advantageous because it results in discrete transitions between states of the expansion force indicator (e.g., break / tear, “jump” through the restrictor, etc.), which are achieved only after the respective circumferential force thresholds have been applied thereto by the expansion frame 126.

[0337] According to some embodiments, the frictional force between either the belt pulling member 886 and / or the frame belt 860, and either the belt shaft 888, the guide member 840 and / or the sleeves 132, 830 is set lower than the estimated circumferential force applied to the frame belt 860 by the frame 126. This can be achieved by an appropriate selection of material properties, manufacturing such components with a desired surface roughness, or coating with a low friction layer.

[0338] Although not explicitly shown, the frame belt 860 having the geometric feature 860 can be utilized without passing through the guide member 840 and / or without passing through the belt shaft 888. Similarly, the frame belt 860 having the geometric feature 860 can extend through the guide member 840 and / or through the belt shaft 888, which does not mask the radiopaque markers around the geometric feature 866. In such a configuration, geometric features 866 c such as beads 866 may be visible both when positioned around the prosthetic valve 120 (e.g., within the sleeve) or along a portion of the frame belt 860 that does not circumscribe the valve 120 (e.g., proximal to the sleeve). The viewer (e.g., clinician) can, in such cases, distinguish the circumferential orientation of some of the beads 866 c from the non - circumferential orientation of other beads when viewed under fluoroscopy. For example, referring to FIG. 26B, beads 866 c a and 866 c b define a first orientation that is a circumferential orientation, and beads 866 c a, 866 c b, 866 c c, 866 c d, 866 c e, 866 c f, 866 c g and 866 cIt may be possible to identify that h defines a second orientation, which is a non-circular orientation, shown as an axial orientation substantially perpendicular to the first orientation. After the circumferential orientation is identified, the number of beads visible in that orientation may indicate the valve's expansion diameter.

[0339] According to some embodiments, the restrictor 848 includes a reference radiopaque marker 882. For example, a small hole 848 a It may include a reference radiopaque marker 882. Small hole 848 a Since it is rigidly attached to one frame component (for example, the actuator outer member 140), the reference radiopaque marker 882 remains stationary relative to the outflow end 123. In such cases, the observer can see the beads 866 positioned on either side of the reference radiopaque marker 882 when viewed under fluorescence fluoroscopy. c It is possible to distinguish between them. For example, referring to Figure 26B, bead 866 c world and 866 c b is a small hole 848 with a radiopaque mark. a Positioned distal to the bead 866 c a, 866 c b, 866 c c, 866 c d, 866 c e, 866 c f, 866 c g and 866 c h is a small hole with a radiopaque mark 848 a It may be possible to identify that it is located proximal to the reference radiopaque marker 882. The bead 866 is distal to the reference radiopaque marker 882. c The number of beads 866 visible on a specific side of the reference radiopaque marker 882, etc. c The number can indicate the valve expansion diameter.

[0340] In some implementations, the restrictor 848 is implemented as a narrow opening through which the frame belt 860 extends. For example, Figure 27 shows the guide member distal end 846 at the guide member constriction 848b Except for including bead 866, it shows a configuration similar to that shown in Figure 26C, which is bead 866 a The opening diameter is slightly smaller than the outer diameter, and therefore the small hole 848 a It may be formed as an inwardly flanged or tapered opening, which acts as an alternative to the guide member distal end 846, but in an alternative modified form, the guide member constriction 848 b These can be formed as narrow portions at the proximal end 844 of the guide member, or as localized narrow portions at any other location along the guide member lumen 842. Similarly, although not explicitly shown, narrow portions having an inner diameter slightly smaller than the inner diameter of the geometric feature 866 can be formed at the circumferential sleeve opening 831, as localized narrow portions within the circumferential sleeve lumen 832, or as narrow portions within the opening or lumen of the belt shaft 888.

[0341] According to some embodiments, a frame belt 860 having geometric features 866 circumscribing the artificial valve 120 such that the entire length of its bead portion is arranged around the frame 126. For example, Figure 28A shows an artificial valve 120 in a crimped configuration, which includes a circumferential sleeve 830 circumscribing a portion of the circumference of the valve 120. Also, the frame belt 866 c The non-beaded portion, shown in Figure 28A, is arranged around the artificial valve 120 such that its first portion extends from the circumferential sleeve 830 and another beaded portion is positioned within the circumferential sleeve lumen 832. The restrictor 848 is positioned within the frame belt 866 c At the opening of the sleeve 830 through which it extends, there is a sleeve constriction 848 c It can be provided in this form.

[0342] As shown in Figure 28B, when the artificial valve expands, beads 866 c a, 866 c b, 866 c c and 866 c At least some of the beads, such as d, are pulled out from the circumferential sleeve 830, but beads 866c e, 866 c f and 866 c Other beads, such as g, remain inside sleeve 830.

[0343] The circumferential sleeve 830 includes a first end 834 of the circumferential sleeve, which may be the enclosed end of the sleeve, and may be attached to the frame 126 (for example, to the joint 130) via an adhesive member 850. The adhesive member 850 may include sutures, biocompatible adhesives, etc. The circumferential sleeve 830 further includes a second end 834 of the circumferential sleeve, which may be an opening through which the frame belt 860 can pass as it extends. The circumferential sleeve 830 may be attached to the frame 126 along its additional attachment points via a sliding attachment member 852 (see Figure 28B), which may be provided in the form of suture loops, bands, and the like, thereby allowing the sleeve 830 to slide within it while the valve 120 expands.

[0344] The first end 862 of the frame bolt can similarly be attached to the frame 126 (for example, to the joint 130) via the adhesive member 850. Opposite, the second end 864 of the frame bolt can be a free end disposed within the circumferential sleeve lumen 832, allowing the frame bolt 860 to slide through the sleeve 830 and partially exit the sleeve 830 when the valve 120 expands.

[0345] Figure 28A shows the non-beaded portion exposed outside the sleeve 830 in the crimped state, but in an alternative configuration, the beads 866 c It will be clear that in this state, the bead 866 can be positioned around the valve 126 and outside the sleeve 830. In such a configuration, the bead 866 can be positioned outside the sleeve 130 in this state. c The initial amount of the bead 866 may indicate the crimped state of the valve and is further distinguishable due to its repositioning outside the sleeve 830. c The increase in the number of beads 866 means that the force applied to the valve when it expands is greater.c This indicates that the threshold required to displace has been exceeded.

[0346] In some applications, the circumferential sleeve 830 has, for example, a radiopaque zone around its outer surface and a bead 866 disposed within its lumen. c It is configured to conceal or mask the bead 866 so that it is not visible under fluorescence radiography. Thus, in the state shown in Figure 28A, the bead 866 is positioned within the circumferential three-lumen 832. c All of these may be hidden from view, as shown in Figure 28B, bead 866 c a, 866 c b, 866 c c and 866 c Only beads pulled out from sleeve 830, such as d, are exposed and visible under fluorescence radiography, and the amount of visible beads may indicate the valve's expansion diameter.

[0347] For alternative uses, see Beads 866 c The reference radiopaque markers may also be visible through the sleeve 830. In such applications, the valve 120 may further include reference radiopaque markers (not shown in Figures 28A-28B). For example, the second end 836 of the circumferential sleeve may include reference radiopaque markers. In such cases, the observer may see the beads 866 positioned on either side of the reference radiopaque marker when viewed under fluorescence fluoroscopy. c This allows for the distinction between them. In a further modification of this application, the valve 120 may lack a sleeve 130 (for applications not shown), but is rigidly mounted to the frame 126 and has a small hole 848 having a reference radiopaque marker thereon. a The frame belt 860 extends through a restrictor 848, and in a similar manner, the viewer has beads 866 positioned on either side of a reference radiopaque marker. c This makes it possible to distinguish between them.

[0348] Although not explicitly shown, beads 866 are related to Figures 26A to 28B.c It will be understood that all embodiments described and illustrated are similarly generally applicable to other geometric features 866, including, but not limited to, knots, balls, ribs, and spokes.

[0349] Figures 29A and 29B show the geometric features of the belt ratchet teeth 866. d The complementary sleeve ratchet teeth 848 are provided in the form of a restrictor 848 located within a circumferential sleeve lumen 832. d Except for being provided in the form shown, each shows a configuration similar to the configurations shown in Figures 28A and 28B. Figure 29B shows the belt ratchet teeth 866 exposed out of the sleeve 830 in the extended state of the valve 120. d a and the belt ratchet teeth 866 which may remain inside the sleeve 830 d Part of b is shown. Radiopaque marked ratchet teeth 866 exposed to the outside from sleeve 130. d The amount of a may indicate the valve expansion diameter. Furthermore, as explained and illustrated in relation to Figures 28A and 28B, beads 866 c Expansion belt 860 equipped c Any embodiment relating to this is illustrated in Figures 29A to 29B, such as the belt ratchet teeth 866 d Expansion belt 860 equipped d It is applied with a force equal to .

[0350] Multiple sleeve ratchet teeth 848 d As shown in Figures 29A and 29B, the restrictor 848 is a belt ratchet tooth 866 d It will be obvious that this can also be implemented as a single tooth or pawl configured to attach a ratchet mechanism.

[0351] The frame belt 860 is necessary to provide guidance for the valve's expansion force during the implantation procedure and is no longer necessary once the valve is positioned at the implantation site. According to some embodiments, it may include a bioreabsorbable material, such as a bioreabsorbable polymer, which is configured to dissolve over time. The reabsorption rate of the bioreabsorbable frame belt 860 can be controlled by various parameters such as the polymer material, additives, processing, and the like. Some examples of polymer reabsorbable materials include, but are not limited to, polylactide (PLA), poly-L-lactide (PLLA), polyglycolide (PGA), poly-e-caprolactone (PCL), trimethylene carbonate (TMC), poly-DL-lactide (PDLLA), poly-β-hydroxybutyrate (PBA), poly-p-dioxanone (PDO), poly-β-hydroxypropionate (PHPA), and poly-β-malic acid (PMLA). Preferably, according to some embodiments detailed above herein, the bioreabsorbable material is included in the frame belt 860 in such a manner that it does not interfere with its radiopaqueness.

[0352] According to some embodiments, the frame belt 860 comprises at least one conductive stretching force indicator. For example, the stretching force indicator 866 may include a stretch sensor configured to change its electrical resistivity when stretched on the frame 126 during the expansion of the frame 126. The stretch sensor can be operably coupled via a transmission line to a control unit and display in the handle 110. The transmission line may be implemented in a manner similar to that of the belt tensioning member 886 and can be releasably coupled via a releasable electrical connector similar to the releasable connector 194. The transmission line and releasable connector may include a variety of conductive materials, such as copper, aluminum, silver, gold, and various alloys such as tantalum / platinum, MP35N, and similar materials. An insulator may surround the transmission line and / or the releasable connector. The insulator may include a variety of electrical insulating materials, such as an electrical insulating polymer.

[0353] During use, the extension of frame 126 may result in the stretch sensor becoming longer or stretching, generating a corresponding electrical signal in the form of current, voltage, resistance, or changes thereof. The signal may be electrically transmitted to a control circuit in handle 110 via terminals connected to a potentially conductive openable connector and transmission line, and may be interpreted and displayed on display 116.

[0354] The transmission line may be releasably attached to the frame belt in a manner similar to the configuration illustrated in Figures 26A to 26D, the frame belt being bead 866 c A stretch sensor (not shown) may be included instead, and a detachable electrical connector is represented by a detachable connector 194, and a transmission line is represented by a belt puller 886 that may extend through a transmission line shaft represented by a belt shaft 888. According to some embodiments, when a conductive proximal connector element 193 is coupled to a conductive distal connector element 195 (as shown in Figures 26A-26B), the transmission line shaft 888 is sealed to a guide member 840 in such a way that the conductive connector 194 is sealed from the surrounding blood flow. Thus, when the transmission line is detached from the frame belt, in a configuration similar to that shown in Figure 26C, the exposed end of the proximal connector element 193 remains isolated from the surrounding environment of blood flow, which allows the transmission line to be safely detached through the shaft 888 while avoiding the risk of exposing the surrounding blood flow or other tissues to its current.

[0355] The shaft 888 can be screwed to the guide member 840. After the transmission line is detached from the frame belt and pulled away from it, the shaft 888 can be rotated to detach it from the guide member 840. According to some embodiments, the transmission line is pulled along a sufficient distance before the shaft 888 engages with and disengages from the guide member 840, so that after the shaft 88 is detached from the valve 120 and retracted in a manner similar to that shown in Figure 26D, the transmission line is not exposed to the blood flowing through the lumen of the shaft 888.

[0356] The use of the frame belt 860 with at least one expansion force indicator in the form of a stretch sensor, or other types of sensing elements configured to change their electrical properties (e.g., resistivity or capacitance) in response to the expansion force applied by the expanding valve 120, may be advantageous over visual detection of the radiopaque marked expansion force indicator 866, as described in relation to Figures 23A to 29B and illustrated by any of the embodiments, because it avoids potential interference that may result from the inherent radiopaqueness of the frame 126.

[0357] While embodiments are described and illustrated throughout this disclosure for use with the mechanically expandable valve 120, it will be apparent that methods and apparatus for providing real-time estimation of valve diameter based on the relationship between expansion diameter and dimensionless parameters, and further for providing real-time estimation of valve expansion force based on the frame belt 860 according to any of the embodiments disclosed herein, can be similarly used in combination with other types of valves, such as balloon expandable valves or self-expandable valves. However, conventional balloon expandable valves and self-expandable valves typically inflate or expand in a short period of time (e.g., in a burst), in a manner that provides limited control over valve expansion. In contrast, the use of the imaging methods described above, or the use of the frame belt 860 in combination with the mechanically expandable valve 120, is advantageous because the mechanical expansion mechanism (e.g., as described in relation to Figures 4A-4C) provides greater control over the rate and range of valve expansion, thereby allowing clinicians to adjust the expansion diameter in response to real-time feedback on valve diameter and / or expansion force.

[0358] For clarity, it will be understood that some features of the present invention described in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, for brevity, various features of the present invention described in the context of a single embodiment may also be provided separately, in appropriate partial combinations, or as appropriate in other described embodiments of the present invention. No feature described in the context of one embodiment shall be considered an essential feature of that embodiment unless it is explicitly specified as such.

[0359] Although the present invention is described in conjunction with its specific embodiments, it will be obvious to those skilled in the art that many alternative forms, modifications, and variations may exist. It should be understood that the present invention is not necessarily limited in its application to the structural and arrangement details of the components and / or methods described herein. Other embodiments may be implemented, and embodiments may be implemented in various ways. Therefore, the present invention encompasses all such alternative forms, modifications, and variations that fall within the scope of the appended claims. [Additional note 1] A delivery assembly, wherein the delivery assembly is An artificial valve that is movable between a radially compressed configuration and a radially expanded configuration, A delivery device, The handlebars and A delivery shaft extending distally from the handle, A recompression assembly, A recompression shaft extending through the lumen of the aforementioned delivery shaft, A recompression member having a loop portion that extends through the lumen of the recompression shaft and is configured to circumvent the artificial valve, wherein the loop portion is provided with at least one radiopaque marker, A recompression assembly comprising, A delivery device equipped with, It is equipped with, The relative movement between the recompression member and the recompression shaft in the axial direction has the effect of tightening the loop portion around the artificial valve, thereby compressing the artificial valve radially in the delivery assembly. [Additional note 2] The delivery assembly according to Appendix 1, comprising a plurality of radiopaque markers spaced apart from each other along at least a portion of the loop portion, wherein at least one of the radiopaque markers is spaced apart from each other along at least a portion of the loop portion. [Additional note 3] The radiopaque marker is the delivery assembly described in Appendix 2, which includes a radiopaque band. [Additional note 4] The radiopaque marker is the delivery assembly according to Appendix 2 or 3, extending along a portion of the loop portion which is at least half the length of the circumference of the prosthetic valve in the radially extended configuration. [Additional note 5] The delivery assembly according to Appendix 1, wherein at least one of the radiopaque markers is positioned along a minimum marking length to correspond to the contact area between the loop portion and the circumference of the artificial valve. [Additional note 6] The delivery assembly according to Appendix 5, wherein the minimum marking length is at least as large as the circumference of the artificial valve in the radially extended configuration. [Additional note 7] At least one of the radiopaque markers is a delivery assembly according to any one of the appendices 1 to 6, comprising a radiopaque coating. [Additional note 8] The delivery assembly according to any one of the appendix 1 to 7, wherein the recompression member further comprises a releasable connector comprising a proximal connector element and a distal connector element releasably attached to each other, the recompression member comprising a recompression member proximal segment coupled to the proximal connector element, and the loop portion coupled to the distal connector element. [Additional note 9] The artificial valve comprises a guide member, and at least a portion of the recompression member extends through the lumen of the guide member, as described in Appendix 6. [Additional Note 10] The delivery assembly according to appendix 8 or 9, further comprising a sleeve disposed around at least a portion of the circumference of the artificial valve, wherein at least a portion of the loop portion extends through the sleeve. [Additional Note 11] A delivery assembly, wherein the delivery assembly is An artificial valve that is movable between a radially compressed configuration and a radially expanded configuration, A delivery device, The handlebars and A delivery shaft extending distally from the handle, A recompression assembly, A recompression shaft extending through the lumen of the delivery shaft and equipped with at least one reference radiopaque marker, A recompression member comprising at least one indicator radiopaque marker, and having a proximal segment and a loop portion, A recompression assembly comprising, A delivery device equipped with, It is equipped with, The recompression member extends through the lumen of the recompression shaft, The aforementioned loop portion extends distally from the recompression shaft, The relative movement between the axial recompression member and the recompression shaft has the effect of tightening the loop portion around the artificial valve, thereby compressing the artificial valve radially. The axial position of one of the indicator radiopaque markers with respect to at least one of the reference radiopaque markers indicates the diameter of the prosthetic valve in the delivery assembly. [Additional Note 12] The delivery assembly according to Appendix 11, wherein at least one of the reference radiopaque markers comprises a plurality of reference radiopaque markers, each reference radiopaque marker being associated with a different diameter of the prosthetic valve, and the alignment of the indicator radiopaque marker and any one of the reference radiopaque markers indicates the diameter associated with each of the reference radiopaque markers. [Additional Note 13] The delivery assembly according to appendix 11 or 12, wherein the proximal segment of the recompression member comprises at least one of the indicator radiopaque markers. [Additional Note 14] The delivery assembly according to appendix 11 or 12 further comprises a connector coupled to the proximal segment and the loop portion of the recompression member. [Additional Note 15] The connector is a delivery assembly according to Appendix 14, comprising at least one of the indicator radiopaque markers. [Additional Note 16] The delivery assembly according to appendix 14 or 15, wherein the connector is a releasable connector comprising a proximal connector element and a distal connector element that are releasably mounted to each other, the proximal segment of the recompression member being coupled to the proximal connector element and the loop portion being coupled to the distal connector element. [Additional Note 17] The artificial valve comprises a guide member, and at least a portion of the recompression member extends through the lumen of the guide member, as described in any one of the delivery assemblies of Appendix 11 to 16. [Additional Note 18] The artificial valve further comprises a sleeve disposed around at least a portion of the circumference of the artificial valve, and at least a portion of the loop portion extends through the sleeve, as described in any one of the appendices 11 to 17. [Additional Note 19] The delivery assembly further comprises a plurality of actuating arm assemblies, which are coupled to the artificial valve and configured to move the artificial valve between a radially compressed configuration and a radially expanded configuration, wherein the plurality of actuating arm assemblies comprises a plurality of loop attachment members, the loop portion being coupled to the plurality of loop attachment members and extending between the plurality of loop attachment members, as described in any one of the appendices 11 to 16. [Additional Note 20] The delivery assembly according to any one of appendices 11 to 19, wherein the handle further comprises a spring configured to be connected to the proximal segment of the recompression member and to apply an axially oriented tensile force to the proximal segment of the recompression member, the tensile force being sufficient to apply a minimum tension to the loop portion. [Additional Note 21] The handle further comprises a pulley assembly, and the pulley assembly is A first pulley is attached to the handle via a first pin and is rotatable around the first pin, A second pulley is attached to the handle via a second pin and is rotatable around the second pin, The proximal segment of the recompression member is partially routed around the first pulley and around the second pulley. The delivery assembly according to any one of the appendices 11 to 19, wherein the pulley assembly is configured to apply a minimum amount of tension to the loop portion. [Additional Note 22] A delivery assembly, wherein the delivery assembly is An artificial valve that is movable between a radially compressed configuration and a radially expanded configuration, A delivery device, The handlebars and A delivery shaft extending distally from the handle, A recompression assembly, A recompression shaft extending through the lumen of the aforementioned delivery shaft, A recompression member extending through the lumen of the recompression shaft, comprising a proximal segment of the recompression member and a loop portion extending distally from the recompression shaft, A recompression assembly comprising, The diameter gauge is connected to the recompression assembly at the gauge connection point, A delivery device equipped with, It is equipped with, The relative movement between the axial recompression member and the recompression shaft applies tension to the loop portion, thereby having the effect of compressing the artificial valve in the radial direction. The diameter gauge is configured in a delivery assembly to provide real-time indication of the diameter of the artificial valve based on the axial position and / or axial translation of the gauge coupling point. [Additional Note 23] The delivery assembly according to Appendix 22 further comprises a plurality of actuating arm assemblies, which are coupled to the artificial valve and configured to move the artificial valve between a radially compressed configuration and a radially expanded configuration, wherein the plurality of actuating arm assemblies comprises a plurality of loop attachment members, the loop portion being coupled to the plurality of loop attachment members and extending between the plurality of loop attachment members. [Additional note 24] The delivery assembly according to Appendix 22, wherein the loop portion is configured to be externally tangent to the artificial valve, and relative axial movement between the recompression member and the recompression shaft has the effect of tightening the loop portion around the artificial valve. [Additional note 25] The delivery assembly according to any one of appendices 22 to 24, wherein the handle further comprises a spring configured to be connected to the proximal segment of the recompression member and to apply an axially oriented tensile force to the proximal segment of the recompression member, the tensile force being sufficient to apply a minimum tension to the loop portion. [Additional note 26] The handle further comprises a pulley assembly, and the pulley assembly is A first pulley is attached to the handle via a first pin and is rotatable around the first pin, A second pulley is attached to the handle via a second pin and is rotatable around the second pin, The proximal segment of the recompression member is partially routed around the first pulley and around the second pulley. The delivery assembly according to any one of the appendices 22 to 24, wherein the pulley assembly is configured to apply a minimum amount of tension to the loop portion. [Additional note 27] The delivery assembly according to Appendix 26, wherein the second pulley further comprises a column portion and a gear portion, the handle comprises a rack configured to engage with the gear portion, the axial translation of the rack has the effect of rotating the gear portion, and the proximal segment of the recompression member is configured to wrap around the column portion. [Additional note 28] The delivery assembly according to any one of the appendices 22 to 27, wherein the handle further comprises a display, and the real-time indication is a visual real-time indication visible through the display. [Additional note 29] The aforementioned diameter gauge is An indicator mark reflecting the diameter range of the artificial valve, A delivery assembly according to any one of the appendix 22 to 28, comprising: a dial coupled to the recompression assembly at the gauge coupling point and configured to point to the indicator mark representing the diameter of the artificial valve. [Additional note 30] The delivery assembly according to Appendix 29, wherein the dial is attached to the handle via a dial pivot, and the dial is configured to rotate at an angle about the dial pivot when the gauge coupling point is translated axially. [Additional note 31] The delivery assembly according to Appendix 29, wherein the dial is perpendicular to the longitudinal axis of the proximal segment of the recompression member and is configured to move together with the recompression assembly when the proximal segment of the recompression member is translated in the axial direction. [Additional note 32] The dial is attached to the proximal segment of the recompression member at the gauge coupling point, as described in any one of the appendices 29 to 31. [Additional note 33] The diameter gauge comprises a displacement sensor operably connected to the recompression assembly and configured to generate a signal, the magnitude of which is proportional to the position and / or axial displacement gauge coupling point, as described in any one of the appendices 22 to 28. [Additional note 34] The delivery assembly according to Appendix 33, wherein the displacement sensor includes a potentiometer, and the diameter gauge further comprises a wiper coupled to the recompression assembly at the gauge coupling point, wherein the wiper is configured to contact the potentiometer at the end of the wiper opposite to the gauge coupling point. [Additional note 35] The wiper is attached to the proximal segment of the recompression member at the gauge coupling point, as described in Appendix 34 of the delivery assembly. [Additional note 36] The recompression assembly further comprises a track member having a proximal segment of the track member and a secondary loop extending distally from the recompression shaft, wherein the dial is attached to the proximal segment of the track member at the gauge coupling point, according to any one of the appendix 29 to 31. [Additional note 37] The recompression assembly further comprises a track member having a proximal segment of the track member and a secondary loop extending distally from the recompression shaft, wherein the wiper is attached to the proximal segment of the track member at the gauge coupling point, according to the delivery assembly in Appendix 34. [Additional note 38] A delivery assembly according to appendix 36 or 37, further comprising a plurality of actuating arm assemblies, wherein a secondary loop is coupled to the plurality of secondary loop mounting members and extends between the plurality of secondary loop mounting members. [Additional note 39] The delivery assembly according to any one of the appendices 36 to 38, wherein the handle further comprises a track spring configured to be connected to the proximal segment of the track member and to apply an axially oriented tensile force to the proximal segment of the track member, the tensile force being sufficient to apply a minimum magnitude of tension to the secondary loop. [Additional note 40] A method for providing an indication of the expansion diameter of an artificial valve, (i) The step of obtaining at least one image of the frame of the artificial valve, (ii) A step of deriving a dimensionless parameter from at least one of the images, (iii) The step of relating the numerical value of the expansion diameter of the artificial valve to the dimensionless parameter, (iv) Providing a visual indication of the expansion diameter of the artificial valve, A method that includes this. [Additional note 41] The method according to appendix 40, wherein the step of acquiring at least one image includes the step of acquiring at least one angiographic X-ray image of the frame. [Additional note 42] The method according to appendix 40, wherein the step of acquiring at least one image includes the step of acquiring at least one fluorescence-transmitted image of the frame. [Additional note 43] The step of relating a numerical value of the expansion diameter of the artificial valve to the dimensionless parameter is the method described in any one of the appendix items 40 to 42, which is based on a formula, a graph, and / or a table. [Additional note 44] The method according to any one of Appendix 40 to 43, wherein the step of providing visual instructions includes the step of visualizing the expansion diameter of the artificial valve on a digital screen as a number, a graphical symbol, a text message, or any combination thereof. [Additional note 45] The method according to any one of appendices 40 to 44, wherein the dimensionless parameter is the aspect ratio of the length of the frame to the width of the frame. [Additional note 46] The method according to any one of appendices 40 to 44, wherein the dimensionless parameter is the opening angle between two intersecting supports of the frame. [Additional note 47] A frame that can move between a radially compressed configuration and a radially expanded configuration, A frame belt equipped with at least one extension force indicator, It is equipped with, At least a portion of the frame belt extends along at least a portion of the circumference of the frame in the extended configuration, An artificial valve comprising at least one expansion force indicator configured to change its state when a force exceeding a certain magnitude is applied to the frame during expansion. [Additional note 48] The artificial valve according to Appendix 47, wherein at least one of the expansion force indicators includes a radiopaque marker, and the change in the state of at least one of the expansion force indicators is visible under fluoroscopy. [Additional note 49] The artificial valve according to Appendix 48, wherein the radiation concentration of at least one of the expansion force indicators is higher than the radiation concentration of the frame. [Additional Note 50] At least one of the expansion force indicators comprises an isolation zone, as described in Appendix 48 or 49. [Additional note 51] The separation zone is the artificial valve according to Appendix 50, including the flangable portion. [Additional note 52] The artificial valve according to Appendix 51, wherein the flangable portion comprises a plurality of flangable portions, and at least two of the flangable portions are configured to collapse in response to tensile forces of different magnitudes applied thereto. [Additional note 53] The separation zone is the artificial valve according to appendix 50, including a detachable portion. [Additional note 54] The artificial valve according to any one of the appendices 50 to 53, wherein the frame belt comprises a plurality of expandable portions and a plurality of bases attached thereto, and at least one of the isolation zones comprises a plurality of isolation zones, each isolation zone being included in its respective base, and the consumable portion is configured to expand circumferentially together with the frame. [Additional note 55] The artificial valve according to any one of the appendix claims 50 to 54, wherein the separation zone is provided with radiopaque markings, and the change in the state of at least one of the expansion force indicators includes a transition of the separation zone from an intact state to a separated state. [Additional note 56] The artificial valve according to Appendix 54, wherein the expandable portion includes radiopaque markings, and the change in the state of at least one of the expandable force indicators includes a transition in the height of each of the expandable portions from a first height value to a second shorter height value. [Additional note 57] The artificial valve according to appendix 48 or 49, wherein at least one of the expansion force indicators has a geometric feature, the geometric feature having a shape distinguishable from its adjacent zones along the frame belt, and the change in the state of at least one of the expansion force indicators comprises translation of the geometric feature from a first zone to a second zone. [Additional note 58] The artificial valve according to appendix 57, further comprising a restrictor configured to allow at least one of the geometric features to pass through after a tensile force exceeding a predetermined threshold is applied to the frame belt. [Additional note 59] The artificial valve according to Appendix 57 or 58, wherein the first zone includes a radiopaque covering zone configured to mask the geometric features when the valve is placed therein, and the second zone includes an exposure zone in which the geometric features are visible under fluorescence when the valve is placed therein. [Additional note 60] The artificial valve according to appendix 57 or 58, wherein the first zone includes a first orientation of a portion of the frame belt, and the second zone includes a second orientation of a portion of the frame belt, the second orientation being angled with respect to the first orientation. [Additional note 61] The artificial valve further comprises a reference radiopaque marker, wherein the first zone includes a first spatial location of the geometric feature with respect to the reference radiopaque marker, and the second zone includes a second spatial location of the geometric feature with respect to the reference radiopaque marker, and the first and second spatial locations are on the opposite side of the reference radiopaque marker, as described in Appendix 57 or 58. [Additional note 62] The artificial valve according to any one of the appendix 57 to 61, further comprising a sleeve disposed around at least a portion of the circumference of the artificial valve, wherein at least a portion of the frame belt extends through the sleeve in at least one configuration of the artificial valve. [Additional note 63] At least one of the aforementioned geometric features is a bead, as described in any one of the appendices 57 to 62. [Additional note 64] At least one of the aforementioned geometric features is a belt ratchet tooth, as described in any one of the appendices 57 to 62. [Additional note 65] The restrictor is an artificial valve as described in Appendix 58, comprising a small hole. [Additional note 66] The restrictor is an artificial valve according to Appendix 58, comprising sleeve ratchet teeth. [Additional note 67] The frame belt is an artificial valve according to any one of the appendices 47 to 66, including a bioabsorbable material. [Additional note 68] The artificial valve described in any one of the appendices 57 to 66, A delivery device, The handlebars and A delivery assembly comprising a delivery device and a belt pulling member extending distally from the handle and attached to the frame belt. [Additional note 69] The delivery assembly according to appendix 68, further comprising a belt shaft extending distally from the handle, wherein at least a portion of the belt pulling member extends through the belt shaft and is axially movable relative to the belt shaft. [Additional note 70] The artificial valve further comprises a guide member, and at least a portion of the frame belt extends through the lumen of the guide member, as described in Appendix 68 or 69. [Additional note 71] The delivery assembly according to any one of the appendices 68 to 70, further comprising a releaseable connector comprising a proximal connector element and a distal connector element releasedly attached to each other, wherein a belt tensioning member is coupled to the proximal connector element, and the frame belt is coupled to the distal connector element. [Additional note 72] The artificial valve described in Appendix 47, A delivery device, The handlebars and The delivery device comprises a transmission line extending distally from the handle and connected to the frame belt, At least one of the extension force indicators comprises a stretch sensor, The change in the state of the stretch sensor includes the change in its electrical properties when it is stretched onto the artificial valve. The transmission line is a delivery assembly configured to transmit an electrical signal from the stretch sensor to the steering wheel. [Explanation of symbols]

[0360] 14 Directions oriented proximally 16 directions 100 Delivery Assembly 102 Delivery device 104 Outer shaft 106 Delivery shaft 110 Handle 112 Nose cone shaft 114 Nose cone 116 Digital Display 118 LED lights 120 Artificial valves 121 Longitudinal axis 122 Outflow end part 123 Outlet end 124 Inlet end part 125 Inlet end 126 frames 127 Post 127a and 127b support posts 127b and 127c supports 128 Valve Leaflet 129 vertices 130 Joint 131 vertices 132 sleeves 133 Opening 134 Commissure 135 cells 136 Inner skirt 137 Outer skirt 138 Actuator Assembly 140 Hollow outer member 142 Outer member proximal end 144 Outer member distal end 146 lumens 148 Outer member connection extension 150 Spring biasing arm 152 Teeth or nails 154 Operating inner member 156 Proximal end of inner member 158 Distal end of inner member 160 Internal threaded bore 162 teeth 164 Inner member connection extension 165 Actuator Arm Assembly 166 Operating member 168 Threaded part 170 Support Sleeve 172 Distal lip 176 Loop mounting component 177 Secondary loop mounting member 180 Recompression Assembly 182 Recompression Member 183 Loop section 184 Recompression member distal segment 186 Proximal segment of the recompression member 188 Recompression Shaft 192 Recompression shaft distal end 193 Proximal connector element 194 Connector 195 Distal connector element 196 Radiopaque Markers 210 Handle 212 Spring support member 214 Dial support member 220 springs 222 First end of the spring 224 The second end of the spring 234 First pin 238 Second pin 250 Diameter Gauge 254 Dial 256 Dial Pivot 257 Dial tip 258 scale or indicator marks 270 Gauge connection point 310 Handle 350 Diameter Gauge 354 Dial 356 Distal tip 358 scale or indicator marks 370 Gauge Joint 410 Handle 416 First pulley support member 418 Second pulley support member 430 Pulley Assembly 432 First pulley 434 First pin 436 Second pulley 438 Second pin 440 Column section 442 Gear section 444 racks 450 diameter gauge 460 Displacement Sensor 462 Wiper 470 Gauge coupling point 510 Handle 516 First pulley support member 518 Second pulley support member 530 Pulley Assembly 532 First pulley 534 First pin 536 Second pulley 538 Second pin 610 Handle 612 Spring support member 620 Track Springs 622 First end of the spring 624 The second end of the spring 630 Pulley Assembly 680 Recompression Assembly 682 Truck components 683 Second-order loop 684 Track component distal segment 686 Recompression member proximal segment 688 Recompression Shaft 692 Recompression shaft distal end 694 Connector 830-wrap sleeve 831 Peripheral sleeve opening 832 lumens per hour 833 Guide member sleeve opening 834 Second end of the circumferential sleeve 836 Second end of the circumferential sleeve 840 Guide member 842 Guide member lumens 844 Guide member proximal end 846 Guide member distal end 848 Restrictor 848 a small hole 848 b Guide member narrowed section 848 d Complementary sleeve ratchet teeth 850 Adhesive material 860 Frame Belt 860 a Frame belt 860 a a. Frangible portion 860 c Frame belt 864 Second end of frame bolt 862 First end of frame belt 866 Frame Belt Diameter Indicator 866 Separation Zone 866 Radiation-opaque marked expansion force indicator 866 a Frangible part 866 a beads 866 a and 866 b Separation zone 866 c and 866 d Separation zone 866 a a, 866 a b, 866 a c, 866 a d and 866 a e. Frangible part 866 b Detachable parts 866 c world and 866 c b beads 866 c c, 866 c d, 866 c e, 866 c f, 866 c gо866 c h, 866 c i, 866 c j and 866 c k beads 866d Belt ratchet teeth 866 d a Belt ratchet teeth 866 d b. Belt ratchet teeth 868 Expandable section 868 a Expandable parts 868 b ,868 c ,868 d ,868 e Expandable parts 870 base 880 Indicator Radiopaque Marker 880a, 880b Indicator Radiopaque Markers 882 Reference radiopaque markers 882 a ,882 b , 882 Reference radiopaque markers 886 Belt puller 888 Belt Shaft

Claims

1. A frame that can move between a radially compressed configuration and a radially expanded configuration, A frame belt equipped with at least one extension force indicator, It is equipped with, At least a portion of the frame belt extends along at least a portion of the circumference of the frame in the extended configuration, An artificial valve comprising at least one expansion force indicator configured to change its state when a force exceeding a certain magnitude is applied to the frame during expansion.

2. The artificial valve according to claim 1, wherein at least one of the expansion force indicators includes a radiopaque marker, and the change in the state of at least one of the expansion force indicators is visible under fluorescence fluoroscopy.

3. The artificial valve according to claim 2, wherein the radiation concentration of at least one of the expansion force indicators is higher than the radiation concentration of the frame.

4. The artificial valve according to claim 2 or 3, wherein at least one of the expansion force indicators comprises an isolation zone.

5. The artificial valve according to claim 4, wherein the separation zone includes a frangible portion.

6. The artificial valve according to claim 5, wherein the flangable portion comprises a plurality of flangable portions, and at least two of the flangable portions are configured to collapse in response to tensile forces of different magnitudes applied thereto.

7. The artificial valve according to claim 4, wherein the separation zone includes a detachable portion.

8. The artificial valve according to any one of claims 4 to 7, wherein the frame belt comprises a plurality of expandable portions and a plurality of bases attached thereto, at least one of the isolation zones comprises a plurality of isolation zones, each isolation zone is included in its respective base, and the expandable portion is configured to expand circumferentially together with the frame.

9. The artificial valve according to any one of claims 4 to 8, wherein the separation zone is provided with radiopaque markings, and the change in the state of at least one of the expansion force indicators includes a transition of the separation zone from an intact state to a separated state.

10. The artificial valve according to claim 8, wherein the expandable portion includes a vertex, a height between the vertex and the base of the frame belt, and radiopaque markings, and the change in the state of at least one of the expansion force indicators includes a transition in the height of each of the expandable portions from a first height value to a second shorter height value.

11. The artificial valve according to claim 2 or 3, wherein at least one of the expansion force indicators has a geometric feature, the geometric feature having a shape that is distinguishable from its adjacent zones along the frame belt, and the change in the state of at least one of the expansion force indicators includes translation of the geometric feature from a first zone to a second zone adjacent to the first zone.

12. The artificial valve according to claim 11, further comprising a restrictor configured to allow at least one of the geometric features to pass through after a tensile force exceeding a predetermined threshold is applied to the frame belt.

13. The artificial valve according to claim 11 or 12, wherein the first zone includes a radiopaque covering zone configured to mask the geometric features when the valve is placed therein, and the second zone includes an exposure zone in which the geometric features are visible under fluorescence when the valve is placed therein.

14. The artificial valve according to claim 11 or 12, wherein the first zone includes a first orientation of a portion of the frame belt, and the second zone includes a second orientation of a portion of the frame belt, the second orientation being angled with respect to the first orientation.

15. The artificial valve according to claim 11 or 12, further comprising a reference radiopaque marker, wherein the first zone includes a first spatial location of the geometric feature with respect to the reference radiopaque marker, and the second zone includes a second spatial location of the geometric feature with respect to the reference radiopaque marker, and the first and second spatial locations are on opposite sides of the reference radiopaque marker.

Images