Prosthetic valve, delivery device, and transcatheter prosthetic valve replacement system

Abstract

The utility model relates to a kind of artificial valve, conveying device and percutaneous artificial valve replacement system, the system includes artificial valve and conveying device, wherein, artificial valve is circumferentially provided with multiple connecting ears, at least one connecting ear is correspondingly provided with characteristic development mark, and the characteristic development mark is aligned with one specific circumferential feature of artificial valve in circumferential direction;The distal end of conveying device is provided with multiple fixing claws, for being releasably connected with connecting ear, wherein the fixing claw corresponding with characteristic development mark has structural feature distinguished from other fixing claws, forms characteristic fixing claw. Through the utility model, it can effectively solve the technical problems that artificial valve loading direction is difficult to determine in prior art, valve twist monitoring is inconvenient during release process, and wrinkles appear when valve is released, and it is difficult to find in time.

Description

Technical Field

[0001] This utility model relates to the field of medical devices for cardiac surgery, and in particular to an artificial valve, a delivery device, and a transcatheter artificial valve replacement system. Background Technology

[0002] Valvular heart disease is a common cardiovascular condition, encompassing disorders of the mitral, tricuspid, aortic, and pulmonary valves. These disorders affect normal blood flow, leading to abnormal heart function. For valvular regurgitation, transcatheter valve replacement (TCVPR) has become an important minimally invasive treatment. Taking the mitral valve as an example, TCVPR utilizes a valve delivery system to deliver an artificial valve to the original mitral valve location, replacing its function. It offers advantages such as minimal trauma and rapid recovery.

[0003] However, existing transcatheter valve replacement techniques still face several challenges in practical applications, especially for D-shaped artificial valve structures. The straight edge of the valve needs precise alignment with the anterior leaflet of the mitral valve, and the rounded edge needs precise alignment with the posterior leaflet to achieve ideal fit and avoid left ventricular outflow tract obstruction. However, in existing technologies, the lack of clear directional guidance during valve loading easily leads to deviations or errors in the circumferential direction of valve loading. These errors may not be detected during loading and may only become apparent after valve release. Secondly, during in vivo release, existing technologies struggle to determine in real time whether the valve has twisted, resulting in inaccurate valve positioning. Thirdly, if unexpected situations such as valve folding or stent kinking occur during release, there is a lack of effective means to ensure accurate valve alignment.

[0004] Due to the aforementioned problems, the artificial valve may not fit tightly with the original valve annulus after being released in the body, leading to paravalvular leakage or insecure fixation. Furthermore, there is currently a lack of effective means to visually determine the valve orientation both in vivo and in vitro, making precise positioning difficult.

[0005] Therefore, there is an urgent need to develop a transcatheter artificial valve replacement system that can achieve accurate positioning throughout the entire process of valve loading, delivery and release, so that doctors can clearly and intuitively determine the valve direction, monitor in a timely manner whether the valve is tortuous, and ensure accurate valve alignment during release, thereby improving the success rate of the operation and the prognosis of patients. Utility Model Content

[0006] This utility model discloses an artificial valve, a delivery device, and a transcatheter artificial valve replacement system, aiming to solve the technical problems existing in the prior art.

[0007] The present invention adopts the following technical solution:

[0008] On the one hand, this utility model embodiment provides an artificial valve, which has a plurality of connecting ears in the circumferential direction, and at least one connecting ear is provided with a feature imaging mark, which is aligned with a specific circumferential feature of the artificial valve in the circumferential direction.

[0009] Specific circumferential features include circumferentially differentiated structures on artificial valves that have specific anatomical adaptations or functional orientations.

[0010] As a preferred technical solution, at least one cross-sectional segment of the artificial valve is configured with an asymmetrical shape adapted to the native valve. The asymmetrical shape is formed by multiple edges with different curvatures, and at least one edge with a specific curvature constitutes a specific circumferential feature, which corresponds circumferentially to the feature imaging mark.

[0011] As a preferred technical solution, the artificial valve also has a skirt portion, the cross-section of which is configured as an asymmetrical shape, a characteristic imaging mark is set on the skirt portion, and multiple standard imaging marks are also distributed on the skirt portion, the characteristic imaging mark and the standard imaging mark having distinguishable differences in shape and / or size.

[0012] As a preferred technical solution, the characteristic development mark and the standard development mark are configured as different shapes in non-closed curves, closed rings, polygons or irregular graphics, so that the two present distinguishable development features under the imaging device.

[0013] Secondly, the present invention provides a delivery device for delivering an artificial valve as described in any of the preceding claims. The distal end of the delivery device is provided with a plurality of fixing claws for releasably connecting to a connecting ear. The fixing claws corresponding to the feature imaging marks have structural features that distinguish them from other fixing claws, forming feature fixing claws. The feature fixing claws are axially aligned with a visual indicator structure on the external part of the delivery device.

[0014] As a preferred technical solution, the connecting ear corresponding to the feature imaging mark corresponds to a specific circumferential feature, so that when the feature fixing claw engages with the connecting ear corresponding to the feature imaging mark, the artificial valve can be released to the target position according to the preset anatomical orientation.

[0015] As a preferred technical solution, multiple fixation claws and multiple connecting ears are arranged in a one-to-one correspondence in the circumferential direction. The feature fixation claw has a distinguishable difference in structure and / or size compared with other fixation claws, so that it presents distinguishable imaging features under imaging equipment, so as to achieve accurate orientation of artificial valve during implantation.

[0016] As a preferred technical solution, the feature fixing claw is distinguished from other fixing claws by at least one of the following methods: length difference, width difference, geometric shape difference, fixing mechanism structure difference, or surface texture difference.

[0017] As a preferred technical solution, the visualization indicator structure can be directly observed outside the human body and is used to indicate the circumferential positioning of the artificial valve during the release process. The visualization indicator structure is selected from at least one of the following:

[0018] Tubular structures, raised markings, axially extending indicator lines, directional marks, or other shaped structures on the conveying device.

[0019] Thirdly, embodiments of this utility model provide a transcatheter artificial valve replacement system, comprising:

[0020] - An artificial valve has multiple connecting ears in the circumferential direction, and at least one connecting ear has a corresponding feature imaging mark, which is aligned with a specific circumferential feature of the artificial valve in the circumferential direction.

[0021] - A conveying device, the distal end of which is provided with multiple fixing claws for releasable connection with connecting ears, wherein the fixing claw corresponding to the feature development mark has structural features that are different from other fixing claws, forming a feature fixing claw.

[0022] The technical solution adopted in this utility model can achieve the following beneficial effects:

[0023] This invention provides an artificial valve, a delivery device, and a transcatheter artificial valve replacement system. The artificial valve has a characteristic imaging mark that corresponds circumferentially to a circumferentially differentiated structure on the artificial valve with specific anatomical adaptation or functional guidance, and further corresponds to a connecting ear. The delivery device is used to deliver the artificial valve, and its distal end has a characteristic fixing claw that can connect to the connecting ear corresponding to the characteristic imaging mark. Preferably, the external part of the delivery device may also have a visualization structure corresponding to the axial direction of the characteristic fixing claw. In use, the artificial valve and the delivery device can be combined to form a transcatheter artificial valve replacement system, which can effectively solve the technical problems in the prior art, such as difficulty in determining the loading direction of the artificial valve, inconvenience in monitoring valve torsion during release, and difficulty in timely detection of wrinkles during valve release.

[0024] Specifically, when loading an artificial valve, simply match and connect the connecting ear corresponding to the feature imaging mark with the feature fixing claw to determine the correct installation direction of the artificial valve, effectively avoiding improper release of the artificial valve due to incorrect loading direction.

[0025] During the delivery and implantation of artificial valves, the circumferential orientation of the artificial valve can be determined by the direction of the externally located visual indicator structure. During the release of the artificial valve, doctors can observe the relative positional relationship between the characteristic imaging markers and the characteristic fixation claws through imaging equipment to monitor in real time whether the artificial valve has been twisted. If the characteristic imaging markers and the characteristic fixation claws remain on the same axis, it indicates that the artificial valve is correctly oriented. If there is a significant deviation between the two, it suggests that the artificial valve may have been twisted or wrinkled. Doctors can adjust or withdraw the artificial valve in time to avoid surgical failure or serious complications.

[0026] In particular, for artificial valves with asymmetrical shapes, such as those with D-shaped skirts, this invention significantly improves the fit and seal of the implanted valve by ensuring that specific circumferential features (such as the arcuate edge of the artificial valve) correspond precisely to the specific anatomical structures of the native valve (such as the posterior leaflet of the mitral valve), thereby reducing the risk of paravalvular leakage and improving the overall success rate of the surgery. Attached Figure Description

[0027] To more clearly illustrate the technical solutions of the embodiments of this utility model, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of this utility model. The illustrative embodiments of this utility model and their descriptions explain this utility model and do not constitute an improper limitation of this utility model. In the accompanying drawings:

[0028] Figure 1 This is a top view of the artificial valve in a preferred embodiment of the present invention;

[0029] Figure 2 This is a schematic diagram of the remote structure of the conveying device in a preferred embodiment of the present invention;

[0030] Figure 3 This is a connection diagram of the artificial valve and the distal end of the delivery device in a preferred embodiment of the present invention, shown under an imaging device.

[0031] Figure 4 This is a schematic diagram of the conveying device in a preferred embodiment of the present invention;

[0032] Figure 5 for Figure 4 Sectional view along axis AA;

[0033] Figure 6 This is a cross-sectional view of the far end of the conveying device in a preferred embodiment of the present invention;

[0034] Figure 7 This is a schematic diagram of a fixing claw in a preferred embodiment of the present invention;

[0035] Figure 8This is a schematic diagram of the fixing claw in another preferred embodiment of the present invention.

[0036] Explanation of reference numerals in the attached figures:

[0037] Artificial valve 100, main valve support 110, connecting ear 111, artificial valve leaflet 120, skirt 130, edge with specific curvature 131, characteristic imaging mark 140, standard imaging mark 150, delivery device 200, fixing claw 210, characteristic fixing claw 211, operating handle 220, threaded tube 221, rotating moving part 222, drain tube 223, release button 224, transmission assembly 230, outer tube 231, inner tube 232, special-shaped tube 233, movement limiting tube 234, nickel-titanium wire 235. Detailed Implementation

[0038] To make the objectives, technical solutions, and advantages of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this utility model, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly stated otherwise.

[0039] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance. The term "proximal end" refers to the end along the length of the conveying device that is closer to the operator, and the term "distal end" refers to the end along the length of the conveying device that is farther from the operator.

[0040] Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0041] To address the problems existing in the prior art, this utility model provides an artificial valve 100, a delivery device 200 for delivering the artificial valve, and a transcatheter artificial valve replacement system. The system includes the aforementioned artificial valve 100 and delivery device 200. The proximal end of the artificial valve 100 is releasably connected to the distal end of the delivery device 200 to ensure that the artificial valve 100 can be confined during delivery and released when it reaches the target position in the heart.

[0042] In some embodiments, the transcatheter artificial valve replacement system can be used for the replacement of the mitral valve, tricuspid valve, aortic valve, and pulmonary valve.

[0043] In some embodiments, the artificial valve 100 includes at least a main valve stent 110 and artificial leaflets 120. The main valve stent 110 is made of metal or polymer material and has a cylindrical or similar cylindrical structure, including several interconnected grid structures. Adjacent grid structures are connected by elastic wave rods or nodes. The grids can be selected from rhomboid, pentagonal, hexagonal, or other units that can form a closed shape. The main valve stent 110 can be collapsed during delivery and radially expanded during release by self-expansion or balloon expansion, and positioned within the original valve annulus.

[0044] refer to Figure 1 , Figure 2 In some embodiments, the proximal circumferential portion of the artificial valve 100 is provided with a plurality of connecting ears 111, and at least one connecting ear 111 is provided with a corresponding feature imaging mark 140, which is aligned circumferentially with a specific circumferential feature of the artificial valve 100.

[0045] It should be noted that the artificial valve 100 has two forms: compression and expansion. During delivery, the artificial valve 100 is in a compressed state, roughly in the shape of a long and thin cylinder, with the characteristic imaging mark 140 aligned circumferentially and axially with the specific circumferential feature; during release, the artificial valve 100 returns to an expanded large cylindrical shape, with the characteristic imaging mark 140 aligned circumferentially and radially with the specific circumferential feature.

[0046] In some embodiments, the feature imaging marker 140 is configured as an imaging point made of a radiopaque material. The imaging point is preferably located at the proximal end of the artificial valve 100 and is fixedly connected to the artificial valve 100 by means of suturing or other methods. By suturing or externalizing the feature imaging marker 140, it is necessary to ensure that its position can be directly identified by the naked eye and that it has obvious image contrast under X-ray fluoroscopy. The location of the imaging point maintains a fixed spatial relationship with a specific circumferential feature of the artificial valve 100. The specific circumferential feature is preferably a specific anatomical landmark on the artificial valve 100 that can be adapted to the original valve, so as to accurately indicate the circumferential orientation of the artificial valve 100.

[0047] In some embodiments, the specific circumferential feature may be selected as different functional regions of the artificial leaflet 120 adapted to the physiological characteristics of the native valve, or a certain artificial leaflet 120. By maintaining circumferential alignment with this specific circumferential feature through the feature imaging mark 140, it can be ensured that the arrangement of the artificial leaflet 120 after the artificial valve 100 is released is consistent with the anatomical direction of the target valve position, so as to optimize hemodynamic performance.

[0048] In some embodiments, the main valve stent 110 may be provided with grid regions of different densities / thicknesses or sealing membrane regions in the circumferential direction to adapt to the anatomical structure of the native valve. The precise correspondence between the feature imaging markers 140 and these differentiated structural regions can ensure the optimal match between the main valve stent 110 and the specific anatomical region after implantation.

[0049] In some embodiments, the circumferential distribution of the anchoring structures can also serve as a specific circumferential feature. The anchoring structures can be barbs or fixing arms. In some artificial valve designs 100, the anchoring structures are non-uniformly distributed circumferentially to specifically enhance fixation with the tissues surrounding the valve annulus. The positions of these anchoring structures are indicated by feature imaging markers 140, allowing the operator to precisely control their correspondence with the target anatomical structures, thereby improving valve anchoring stability and reducing the risk of valve displacement and paravalvular leakage.

[0050] refer to Figure 1 In some embodiments, the artificial valve 100 is applied to the mitral valve. Since the mitral valve is generally saddle-shaped, at least one cross-sectional segment of the artificial valve 100 is configured with an asymmetrical shape adapted to the native valve, such as a general D-shape, crescent shape, or saddle shape. The asymmetrical shape is formed by multiple edges with different curvatures. At least one edge 131 with a specific curvature forms a specific circumferential feature and corresponds circumferentially to a feature imaging mark 140. Preferably, the feature imaging mark 140 is located at the middle position of the edge 131 with a specific curvature so that the feature imaging mark 140 can correctly indicate the circumferential orientation of the specific circumferential feature.

[0051] In some embodiments, the proximal end of the main valve stent 110 is provided with a skirt portion 130 to prevent paravalvular leakage. Preferably, the cross-section of the skirt portion 130 has the aforementioned asymmetrical shape, wherein the edge 131 with a specific curvature has a relatively small radius of curvature, i.e., a larger arc, to adapt to the arcuate edge of the posterior leaflet of the mitral valve; the edge opposite to the edge 131 with a relatively large radius of curvature, or approximately straight, to adapt to the structure of the anterior leaflet of the mitral valve. It should be noted that between the edge 131 with the specific curvature and the edge opposite to it, there is also a transition section between the two types of edges. This transition section is located at the junction of the anterior and posterior leaflets of the mitral valve, and its structure and curvature are not specifically defined in this embodiment.

[0052] In some embodiments, the characteristic imaging mark 140 is sewn onto the skirt portion 130, and a plurality of standard imaging marks 150 are circumferentially distributed on the skirt portion 130. The characteristic imaging mark 140 and the standard imaging mark 150 have distinguishable differences in shape and / or size. Optionally, the characteristic imaging mark 140 and the standard imaging mark 150 are made of the same radiopaque material, but they are respectively selected from different shapes such as non-closed curves, closed rings, polygons or irregular patterns, so that they present distinguishable imaging features under imaging equipment.

[0053] In some embodiments, the characteristic imaging marker 140 may be a larger circle or multiple connected circles, while the standard imaging marker 150 may be a smaller circle, dot, or line structure. This differentiated design allows the operator to quickly identify the location of the characteristic imaging marker 140 in X-ray fluoroscopy images, thereby accurately determining the circumferential orientation of the specific curvature edge 131 and ensuring the precise correspondence between the artificial valve 100 and the native mitral valve anatomy.

[0054] In some embodiments, the distal end of the delivery device 200 is provided with a plurality of fixing claws 210, which are matched one by one with the connecting ears 111 and can be releasably connected. The fixing claw 210 corresponding to the feature imaging mark 140 has structural features that are different from the other fixing claws 210, forming a feature fixing claw 211. The feature fixing claw 211 is axially aligned with a visual indicator structure on the external part of the delivery device 200.

[0055] In some embodiments, the multiple fixation claws 210 are all made of a radiopaque material, providing a clearly discernible image under X-ray fluoroscopy. The characteristic fixation claw 211 differs significantly from the other fixation claws 210 in size or structural design, such as differences in length, width, geometry, fixation mechanism structure, or surface texture, allowing the operator to quickly identify it visually or through X-ray imaging. This differentiated structural design ensures that during loading, the physician can accurately determine whether the circumferential installation direction of the artificial valve 100 is correct by observing the corresponding fit between the connecting ear 111 where the characteristic imaging mark 140 is located and the characteristic fixation claw 211, thereby avoiding loading errors.

[0056] In some embodiments, the length of the feature fixing claw 211 can be appropriately lengthened or shortened to distinguish it from other fixing claws 210; in other embodiments, the fixing claws 210 can be configured with different shapes / structures, and a fixing claw 210 with a specific structure can be selected as the feature fixing claw 211, such as... Figure 7 or Figure 8 .

[0057] Specifically, when the artificial valve 100 and delivery device 200 are combined into a transcatheter artificial valve replacement system, during the intracardiac release of the artificial valve 100, the operator can confirm the circumferential orientation of the artificial valve 100 in two ways: Firstly, the visual indicator structure on the external part of the delivery device 200, which maintains an axial alignment with the feature fixation claw 211, can indirectly indicate the circumferential orientation of the artificial valve 100; secondly, the relative positional relationship between the feature imaging mark 140 and the feature fixation claw 211 can be monitored in real time using X-ray imaging equipment. When the two are kept on the same axis, such as... Figure 3 The red circle indicates that the imaging mark 140 and the feature fixing claw 211 are on the same axis, which means that the artificial valve 100 is correctly oriented. If an axial deviation or relative displacement is observed between the two, it indicates that the artificial valve 100 may have been twisted, displaced, or locally wrinkled and deformed. At this time, the operator can take timely adjustment measures according to the degree of deviation, such as slightly rotating the delivery device 200 to reorient it, or, if necessary, completely withdrawing the artificial valve 100 and reloading it, thereby effectively avoiding the occurrence of valvular insufficiency, paravalvular leakage or other serious complications caused by improper valve orientation.

[0058] In some embodiments, the radiopaque material includes materials such as platinum-iridium alloy and stainless steel. The characteristic imaging marker 140 and the fixation claw 210 can be made of the same or different materials. Since the characteristic imaging marker 140, as a component of the artificial valve 100, will be implanted in the human body for a long period of time, its material selection must meet strict biocompatibility requirements and long-term stability standards. Due to its excellent biocompatibility, corrosion resistance, mechanical stability, and significant radiopaqueness, platinum-iridium alloy is preferred as the material for the characteristic imaging marker 140. As a component of the delivery device 200, the fixation claw 210 is withdrawn from the body along with the delivery device 200 after the artificial valve 100 is released. Its residence time in the body is relatively short. Considering the balance between cost-effectiveness and functional requirements, the fixation claw 210 is preferably made of materials such as medical-grade stainless steel.

[0059] During the loading of the artificial valve 100, the operator needs to precisely align the feature imaging mark 140 with the feature fixing claw 211 to ensure that the specific curvature edge 131 of the D-shaped skirt 130 faces the predetermined direction. At this time, the operator can directly observe the relative positional relationship between the feature imaging mark 140 and the feature fixing claw 211 with the naked eye to complete the correct loading of the artificial valve 100.

[0060] During valve release, by observing the circumferential fit between the characteristic imaging marker 140 and the characteristic fixing claw 211, the directional stability of the artificial valve 100 can be assessed in real time to determine whether undesirable torsion or wrinkling has occurred. When the specific curvature edge 131 of the skirt portion 130 is correctly aligned with the posterior leaflet of the mitral valve, the skirt portion 130 can maximize its adaptation to the anatomical morphology of the native mitral valve annulus, significantly improving the sealing effect and reducing the risk of paravalvular leakage. At the same time, the imaging system composed of the characteristic imaging marker 140 and the standard imaging marker 150 allows the operator to monitor the radial expansion and circumferential orientation of the skirt portion 130 in real time, ensuring that the skirt portion 130 maintains the expected D-shaped contour during radial expansion and avoiding skirt deformation or directional deflection caused by uneven radial force distribution.

[0061] In some embodiments, a plurality of connecting ears 111 are circumferentially spaced at the proximal end of the main valve stent 110 and extend in the proximal direction to connect to the fixing claw 210 at the distal end of the delivery device 200; wherein, since the connecting ears 111 corresponding to the feature imaging mark 140 correspond to a specific circumferential feature, as long as the connecting ears 111 and the feature fixing claw 211 can be stably connected, the artificial valve 100 can be released to the target position according to the preset anatomical orientation.

[0062] In some embodiments, the connecting ear 111 includes a first mating structure, and the fixing claw 210 includes a second mating structure adapted to the first mating structure. The first mating structure and the second mating structure can be detachably engaged to achieve a releasable connection between the artificial valve 100 and the delivery device 200.

[0063] In some embodiments, the first mating structure is configured as a protruding structure with an outer periphery that is approximately fan-shaped or semi-circular, and the second mating structure is configured as a groove structure adapted to the protruding structure. The groove structure is used to provide circumferential and axial positioning constraints on the protruding structure to maintain the connection relationship and predetermined spatial position relationship between the artificial valve 100 and the delivery device 200.

[0064] In some embodiments, a visual indicator structure is configured on the external portion of the delivery device 200 to more intuitively monitor and confirm the circumferential positioning status of the artificial valve 100 in vivo; the visual indicator structure is precisely aligned axially with the feature fixing claw 211, and through this spatial correspondence, the operator can determine the orientation of specific circumferential features of the artificial valve 100 by directly observing the externally visible indicator structure without relying on imaging equipment.

[0065] In some embodiments, the visual indicator structure is selected from at least one of the following: a tubular structure on the conveying device 200, a raised mark, an axially extending indicator line, a directional mark, or other shaped structure.

[0066] Specifically, when raised markings or axially extending indicator lines serve as visual indicator structures, they typically employ textured structures or continuous lines of prominent color that protrude from the surface of the delivery device 200, extending from the proximal end of the delivery device 200 to the direction corresponding to the feature fixing claw 211. These structures not only provide visual guidance but also allow for tactile perception of their position, enabling the operator to quickly determine the circumferential positioning of the artificial valve 100 through tactile feedback.

[0067] Specifically, when the visualization indicator structure is selected as a tubular structure on the delivery device 200, this tubular structure can be configured as a tube on the delivery device 200 with a prominent color or protruding structure. In a preferred embodiment of this invention, the drain tube 223 at the proximal end of the delivery device 200 is used as the visualization indicator structure. The drain tube 223 is strictly axially aligned with the feature fixing claw 211. When the operator adjusts the rotation angle of the delivery device 200, the orientation change of the drain tube 223 can be directly observed, and the release orientation of the artificial valve 100 can be precisely controlled according to the predetermined correspondence. By setting the drain tube 223 as the visualization indicator structure, the existing structure of the delivery device 200 is fully utilized, avoiding the complexity added by additional components. At the same time, it provides highly intuitive in vitro visualization operation guidance, significantly improving the convenience of operation and the accuracy of orientation during surgery.

[0068] refer to Figure 4 — Figure 6 In some embodiments, the delivery device 200 further includes an operating handle 220 and a transmission assembly 230. The operating handle 220 is provided with a threaded tube 221, a rotating moving part 222, a drain tube 223, and a release button 224. The transmission assembly 230 includes an outer tube 231, an inner tube 232, a shaped tube 233, a movement limiting tube 234, and a nickel-titanium wire 235. It should be noted that the utility model of this embodiment does not lie in the specific structural details of the operating handle 220. Those skilled in the art can choose other types of operating handle 220 structures to replace it according to actual needs, as long as it can achieve precise loading, directional control, and controlled release of the artificial valve 100.

[0069] Specifically, in this embodiment, the rotating moving part 222 is threaded onto the threaded tube 221, and its rotation is used to drive the axial movement of the outer tube 231. The artificial valve 100 is loaded between the inner tube 232 and the outer tube 231. The moving limiting tube 234 is sleeved on the outside of the inner tube 232, and multiple irregular tubes 233 are connected to the moving limiting tube 234 and share a cavity. The proximal end of the moving limiting tube 234 is fixedly connected to the threaded tube 221. Several grooves are formed on the side wall of the irregular tube 233, so that it can bend radially outward with the expansion of the artificial valve 100 during the release process, which promotes the easy release and expansion of the artificial valve 100.

[0070] Each shaped tube 233 has a nickel-titanium wire 235 inserted inside. The nickel-titanium wire 235 can move axially relative to the shaped tube 233 and the moving limiting tube 234. The proximal end of the nickel-titanium wire 235 is fixedly connected to the tailstock at the proximal end of the operating handle 220. The tailstock is fixedly set at the proximal end of the operating handle 220. The distal end of the nickel-titanium wire 235 is connected to the fixing claw 210.

[0071] In the delivery state, when the release button 224 is not pressed, the proximal end of the moving limit tube 234 is in a limited state and cannot move axially. When it is necessary to release the artificial valve 100, first press the release button 224 to release the axial limitation of the moving limit tube 234, then hold the rotating moving part 222 and pull it backward, which will drive the moving limit tube 234 and the special tube 233 to move backward, exposing the fixing claw 210 connected to the nickel-titanium wire 235. Since the radial limitation of the fixing claw 210 and the connecting ear 111 is released, the fixing claw 210 is separated from the connecting ear 111, and finally the artificial valve 100 is accurately released.

[0072] Specifically, when loading the artificial valve 100, the rotating moving part 222 is first rotated to retract the outer tube 231, exposing multiple fixing claws 210 at the distal end of the moving limiting tube 234. The operator can directly observe the correspondence between the characteristic imaging mark 140 at the proximal end of the artificial valve 100 and the characteristic fixing claw 211, ensuring that the connecting ear 111 corresponding to the characteristic imaging mark 140 is precisely aligned with the characteristic fixing claw 211. After the connection is completed, the rotating moving part 222 is rotated in the opposite direction, causing the distal end of the outer tube 231 to move forward and cover the outside of the compressed artificial valve 100, completing the loading process.

[0073] When releasing the artificial valve 100, the operator first needs to observe the orientation of the drain tube 223 to confirm whether the specific circumferential features of the artificial valve 100 point in the expected anatomical direction. If necessary, the rotation angle of the entire delivery device 200 can be adjusted to ensure that the orientation of the drain tube 223 is consistent with the preset reference direction. After confirming that the orientation is correct, the moving part 222 is rotated again to retract the outer tube 231, exposing the artificial valve 100. Under fluoroscopic imaging, it can be observed whether the feature imaging mark 140 and the feature fixing claw 211 remain on the same axis to confirm that the artificial valve 100 has not been twisted. Finally, press the release button 224, grasp the rotating threaded part 221 and pull it backward, which will cause the moving limiting tube 234 to move backward, and then cause the special tube 233 to move backward, exposing the fixing claw 210 connected to the nickel-titanium wire 235. Since the radial limiting of the fixing claw 210 and the connecting ear 111 is released, the second mating structure on the fixing claw 210 is finally disengaged from the first mating structure on the connecting ear 111, thereby realizing the precise release of the artificial valve 100.

[0074] Compared with the prior art, the present invention effectively solves the technical problems in the prior art, such as the difficulty in determining the loading direction of the artificial valve 100, the inconvenience in monitoring valve torsion during release, and the difficulty in timely detection of wrinkles that occur during valve release.

[0075] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of the present invention.

Claims

1. An artificial valve, characterized in that, The artificial valve is provided with a plurality of connecting ears in the circumferential direction, and at least one of the connecting ears is provided with a characteristic imaging mark, which is aligned with a specific circumferential feature of the artificial valve in the circumferential direction. The specific circumferential features include circumferentially differentiated structures on the artificial valve that have specific anatomical adaptability or functional guidance.

2. The artificial valve according to claim 1, characterized in that, At least one cross-sectional segment of the artificial valve is configured as an asymmetrical shape adapted to the native valve. The asymmetrical shape is formed by multiple edges with different curvatures, and at least one edge with a specific curvature constitutes the specific circumferential feature, which corresponds circumferentially to the feature imaging mark.

3. The artificial valve according to claim 2, characterized in that, The artificial valve also has a skirt portion, the cross-section of which is configured in the asymmetrical shape, the characteristic imaging mark is disposed on the skirt portion, and a plurality of standard imaging marks are also distributed on the skirt portion, the characteristic imaging mark and the standard imaging mark having distinguishable differences in shape and / or size.

4. The artificial valve according to claim 3, characterized in that, The characteristic development mark and the standard development mark are respectively configured as different shapes among non-closed curves, closed rings, polygons or irregular graphics, so that the two present distinguishable development features under imaging equipment.

5. A delivery device for delivering an artificial valve as described in any one of claims 1-4, characterized in that, The distal end of the delivery device is provided with a plurality of fixing claws for releasably connecting to the connecting ear, wherein the fixing claw corresponding to the feature imaging mark has structural features that distinguish it from the other fixing claws, forming a feature fixing claw, and the feature fixing claw is axially aligned with a visual indicator structure on the external part of the delivery device.

6. The conveying device according to claim 5, characterized in that, The connecting ear corresponding to the feature imaging mark corresponds to the specific circumferential feature, so that when the feature fixing claw engages with the connecting ear corresponding to the feature imaging mark, the artificial valve can be released to the target position according to the preset anatomical orientation.

7. The conveying device according to claim 5, characterized in that, Multiple fixation claws and multiple connecting ears are arranged in a one-to-one correspondence in the circumferential direction. The feature fixation claw has a distinguishable difference in structure and / or size compared with other fixation claws, so that it presents a distinguishable imaging feature under the imaging device, so as to achieve accurate orientation of the artificial valve during the implantation process.

8. The conveying device according to claim 7, characterized in that, The feature fixing claw is distinguished from other fixing claws by at least one of the following methods: length difference, width difference, geometric shape difference, fixing mechanism structure difference, or surface texture difference.

9. The conveying device according to claim 6, characterized in that, The visualization indicator structure can be directly observed outside the human body and is used to indicate the circumferential positioning of the artificial valve during deployment. The visualization indicator structure is selected from at least one of the following: The conveying device may have tubular structures, raised markings, axially extending indicator lines, or directional markings.

10. A transcatheter artificial valve replacement system, characterized in that, include: - An artificial valve has multiple connecting ears in the circumferential direction, and at least one of the connecting ears has a corresponding feature imaging mark, which is aligned with a specific circumferential feature of the artificial valve in the circumferential direction; - A conveying device having a plurality of fixed claws at its distal end for releasably connecting to the connecting ear, wherein the fixed claw corresponding to the feature development mark has structural features that distinguish it from the other fixed claws, forming a feature fixed claw.

Images