Loading Tool, Loading System, Implant System and Loading Method for Implants

Abstract

The present invention provides a loading tool, a loading system, an implant system and a loading method for an implant; the loading tool includes: a pressing block for performing primary pressing on the implant through a pressing cavity; a pressing rod for straightening the grasping ears and supporting the implant during primary pressing; a funnel that moves axially when the funnel section and the cylindrical section are connected to perform secondary pressing on the implant and straighten the flange, and disconnects the connection between the funnel section and the cylindrical section after the implant in the secondary pressing state enters the cylindrical section; a loading housing that covers the outside of the outer sheath tube, and the distal end of the loading housing is joined to the end where the cylindrical section is connected to the funnel section, so that the implant in the secondary pressing state in the cylindrical section is introduced into the distal end of the outer sheath tube through the distal end of the loading housing; and a locking device for locking the loading housing during the process of introducing the implant into the outer sheath tube. The present invention can achieve the pressing and loading of an implant with a flange and grasping ears and the hanging ears provided at the inflow end.

Description

Technical Field

[0001] The present invention generally relates to the technical field of medical devices, and in particular to an implant loading tool, an implant loading system, an implant system and an implant loading method. Background Art

[0002] Heart valves are membrane-like structures that can open and close in the organs of humans or certain animals. There are four valves in each person's heart. They are the aortic valve that connects the left ventricle and the aorta, the pulmonary valve that connects the right ventricle and the pulmonary artery, the mitral valve that connects the left atrium and the left ventricle, and the tricuspid valve that connects the right atrium and the right ventricle. The valves all act as one-way valves, allowing blood to flow from one direction to another but not back.

[0003] With the development of social economy and the aging of population, the incidence of valvular heart disease has increased significantly. Studies have shown that the incidence of valvular heart disease in the elderly population over 75 years old is as high as 13.3%. At present, traditional surgical treatment is still the first choice for patients with severe valvular disease. However, for patients of advanced age, patients with multiple organ diseases, patients with a history of open-chest surgery, and patients with poor heart function, traditional surgical treatment has high risks and mortality rates, and some patients do not even have the opportunity to undergo surgery. Transcatheter valve replacement has the advantages of no need for open-chest surgery, less trauma, and faster patient recovery, and has received widespread attention from experts and scholars.

[0004] Before delivering the valve implant through the catheter, the valve implant needs to be loaded first, so that the valve implant collapses and is introduced into the catheter-based delivery system with a smaller profile. There are various structures of the existing loading systems for valve implants, and the loading systems are specifically designed according to the different structures of the stents. However, the existing loading systems are not suitable for loading stents with flanges, stents with hanging ears at the inflow end, and stents with grab ears.

[0005] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or suggestion in any form that the information constitutes prior art already known to those skilled in the art. Summary of the invention

[0006] The object of the present invention is to provide an implant loading tool, an implant loading system, an implant system and an implant loading method, which can realize the compression and loading of an implant with a flange and a gripping ear and the hanging ear is arranged at the inflow end.

[0007] To achieve the above object, the present invention provides a loading tool for an implant, which is used to load the implant into a delivery system. The implant includes a stent, and the inflow end of the stent is provided with a lug and a flange. The outflow end of the stent is connected with a grasping ear, and the grasping ear is bent and disposed around the stent. The loading tool includes:

[0008] A compression and gripping block having a compression and gripping cavity penetrating along its own axis. The compression and gripping block can radially contract and radially expand, and is used to perform a primary compression on the implant in its natural state through the compression and gripping cavity;

[0009] A compression and gripping rod having a through hole penetrating along its own axis. The compression and gripping rod is used to be inserted into the implant and support the implant and straighten the grasping ear during the primary compression;

[0010] A funnel including a funnel section and a cylindrical section. The funnel section and the cylindrical section are detachably connected. The funnel is used to move proximally along the axis of the delivery system when the funnel section and the cylindrical section are connected, so as to perform a secondary compression on the implant in the primary compression state and straighten the flange at the same time. The funnel is also used to disconnect the connection between the funnel section and the cylindrical section after the implant in the secondary compression state enters the cylindrical section;

[0011] A loading outer housing for covering the outside of the outer sheath tube in the delivery system. The distal end of the loading outer housing is used to engage with one end where the cylindrical section is connected to the funnel section, so that the implant in the secondary compression state in the cylindrical section can be introduced into the distal end of the outer sheath tube through the distal end of the loading outer housing; and,

[0012] A locking device for locking the loading outer housing during the process of introducing the implant into the outer sheath tube, and the locking device is also used to release the locking of the loading outer housing after the implant is introduced into the distal end of the outer sheath tube.

[0013] Optionally, the distal end of the loading outer housing is provided with a tapered hole, and the inner diameter of the large-diameter end of the tapered hole matches the inner diameter of the cylindrical section. After the implant in the secondary compression state leaves the cylindrical section, it is introduced into the distal end of the outer sheath tube through the tapered hole.

[0014] Optionally, the distal end of the loading outer housing is further provided with a straight hole, and the straight hole and the tapered hole are axially communicated; the large-diameter end of the tapered hole is connected to the proximal end of the straight hole; both the tapered hole and the straight hole are used to expose outside the distal end of the outer sheath tube, and the straight hole is used to cover one end where the cylindrical section is connected to the funnel section.

[0015] Optionally, the loading housing includes a distal portion and a proximal portion. The proximal portion is configured to wrap all or part of the rigid segment of the outer sheath tube in an interference fit manner; the distal portion is configured to wrap all of the flexible segment of the outer sheath tube in a clearance fit manner, or a soft elastic material is provided on the inner side of the distal portion, and all of the flexible segments of the sheath tube are wrapped in an interference fit manner through the soft elastic material.

[0016] Optionally, a limiting end face matching the outer step of the flexible segment of the sheath tube is provided inside the distal portion.

[0017] Optionally, the pressing block includes at least three pressing pieces. All the pressing pieces enclose and form a polygonal frame with the pressing cavity. The pressing pieces are telescopically connected in pairs, and the pressing cavity has a closed polygonal contour.

[0018] Optionally, the number of side lengths of the polygonal contour is an even number, and at least one pair of opposite sides of the polygonal contour form parallel planes.

[0019] Optionally, the pressing rod is sequentially provided with a circular main body section, a flat section, and a guiding groove section along its own axis;

[0020] A plurality of planes are provided on the outer peripheral surface of the flat section along the circumferential direction of the pressing rod. The number of the planes is the same as the number of the ear catches. The planes are used to straighten the bent sections of the ear catches;

[0021] A plurality of guiding grooves are provided on the outer peripheral surface of the guiding groove section along the circumferential direction of the pressing rod. The number of the guiding grooves is the same as the number of the ear catches. The guiding grooves are axially aligned with the planes, and the guiding grooves are used to embed and straighten the non-bent sections of the ear catches.

[0022] Optionally, the funnel section has a conical inner hole, a limiting plane, and a threaded inner hole. The inner diameter of the small-diameter end of the conical inner hole is smaller than the inner diameter of the threaded inner hole and forms the limiting plane; the inner diameter of the small-diameter end of the conical inner hole matches the inner diameter of the cylindrical section;

[0023] The cylindrical section has an external threaded section, and the outer diameter of the cylindrical section matches the inner diameter of the threaded inner hole;

[0024] One end of the cylindrical section is inserted into the threaded inner hole and is threadedly connected to the threaded inner hole through the external threaded section. The limiting plane is used to limit the depth of insertion of the cylindrical section into the threaded inner hole.

[0025] Optionally, the loading tool further includes a metal guiding rod. The metal guiding rod is a thin-walled tube, and one end of the metal guiding rod is provided with a tapered opening;

[0026] The metal guide rod is used to partially insert between the outer sheath and the inner sheath in the delivery system, and to expose the tapered mouth outside the distal end of the outer sheath; the implant in the secondary crimping state within the cylindrical segment can be introduced into the metal guide rod via the distal end of the loading shell; the metal guide rod is also used to withdraw from the delivery system after the implant in the secondary crimping state is introduced.

[0027] Optionally, the loading shell is a first type of loading shell, which is formed by buckling two half parts;

[0028] The distal end of the first type of loading shell is provided with an axially connected straight hole, a first tapered hole and a second tapered hole; the large diameter end of the first tapered hole is connected to the proximal end of the straight hole, and the inner diameter of the large diameter end of the first tapered hole matches the inner diameter of the cylindrical section; the large diameter end of the second tapered hole is connected to the small diameter end of the first tapered hole; the small diameter end of the first tapered hole is used to align with the expanded end of the tapered mouth;

[0029] The straight hole, the first tapered hole and the second tapered hole are all used to be exposed outside the distal end of the outer sheath; the second tapered hole is used to cover the entire tapered mouth; the straight hole is used to cover one end where the cylindrical section is connected to the funnel section; the implant in the secondary crimping state in the cylindrical section is used to be introduced into the metal guide rod through the first tapered hole.

[0030] Optionally, the metal guide rod is provided with symmetrically arranged limit blocks on its outer circumference except the tapered mouth, and the first loading shell is provided with a through groove, and the limit blocks are used to be exposed outside the distal end of the outer sheath tube and inserted into the through groove.

[0031] Optionally, the loading shell is a second type of loading shell, which is formed by buckling two half parts;

[0032] The distal end of the second type of loading shell is provided with an axially connected straight hole and a tapered hole; the large diameter end of the tapered hole is connected to the proximal end of the straight hole; the inner diameter of the large diameter end of the tapered hole matches the inner diameter of the cylindrical section; the tapered hole and the straight hole are both used to be exposed outside the distal end of the outer sheath tube; the straight hole is used to cover one end of the cylindrical section connected to the funnel section; the implant in the secondary crimping state in the cylindrical section can be introduced into the distal end of the outer sheath tube via the tapered hole.

[0033] Optionally, the loading tool comprises two types of loading outer shells, the two types of loading outer shells are respectively a first type of loading outer shell and a second type of loading outer shell, and both types of loading outer shells are formed by buckling two half parts;

[0034] The loading tool is configured to selectively load the implant into the delivery system using a first loading method or a second loading method;

[0035] The first loading outer shell is applied to the first loading method, which includes: inserting a metal guide rod between the outer sheath and the inner sheath in the delivery system, and making the tapered end of the metal guide rod exposed outside the distal end of the outer sheath, and after the funnel section is withdrawn from the outer sheath, the outer sheath and the tapered end are covered by the first loading outer shell, and then under the action of the inner sheath and the core rod, the implant in the secondary gripping state is introduced into the metal guide rod, and after the implant in the secondary gripping state is introduced into the metal guide rod, the locking device, the loading outer shell and the metal guide rod are removed in sequence;

[0036] The second loading outer shell is applied to the second loading method, which includes: directly introducing the implant in the secondary gripping state in the cylindrical segment into the distal end of the outer sheath tube via the distal end of the loading outer shell, and then removing the locking device and the loading outer shell in turn.

[0037] Optionally, at least one of the locking devices is arranged outside the distal end of the outer loading shell.

[0038] Optionally, the loading tool includes at least two locking devices, at least one of which is arranged at a position where the distal end of the outer sheath tube cooperates with the loading outer shell, and at least another of which is arranged at a position where the distal end of the loading outer shell cooperates with the cylindrical section.

[0039] Optionally, there are two types of locking devices, which are a first locking device and a second locking device. The first locking device clamps the loading outer shell through a concave-convex structure at the position where the distal end of the outer sheath tube cooperates with the loading outer shell, and the second locking device elastically clamps the loading outer shell through a groove at the position where the distal end of the loading outer shell cooperates with the cylindrical section.

[0040] Based on the same inventive concept, the present invention also provides an implant loading system, which comprises a delivery system and any one of the implant loading tools;

[0041] The delivery system comprises an outer sheath tube, an inner sheath tube and a core rod; the inner sheath tube is used to partially penetrate the lumen of the outer sheath tube, and the core rod is used to partially penetrate the lumen of the inner sheath tube;

[0042] The distal end of the mandrel is used for detachably connecting with the lug of the implant, and the distal end of the inner sheath tube is used for sleeving outside the lug; the inner sheath tube and the mandrel are used for synchronously moving proximally along the axial direction of the delivery system to introduce the implant in the secondary crimping state into the distal end of the outer sheath tube.

[0043] Based on the same inventive concept, the present invention further provides an implant system, which includes an implant and the loading system of the implant. The implant includes a stent. The inflow end of the stent is provided with a lug and a flange, and the outflow end of the stent is connected with a grasping ear. The grasping ear is bent and arranged outside the stent. The loading system is used for crimping the implant through the loading tool and introducing the crimped implant into the delivery system.

[0044] Optionally, the stent is a single-layer stent or a double-layer stent. When the stent is a double-layer stent, the lug is arranged at the inflow end of the inner stent, the flange is arranged at the inflow end of the outer stent, the grasping ear extends based on the outflow end of the outer stent or the inner stent, and the grasping ear is bent and arranged outside the outer stent.

[0045] Based on the same inventive concept, the present invention further provides a method for loading an implant, which uses the loading system of the implant to load the implant into the delivery system. The implant includes a stent. The inflow end of the stent is provided with a lug and a flange, and the outflow end of the stent is connected with a grasping ear. The grasping ear is bent and arranged outside the stent. The loading method includes:

[0046] Under the cooperation of the crimping block and the crimping rod, the implant in the natural state is crimped to the primary crimping state, and the grasping ear is straightened by the crimping rod during the primary crimping;

[0047] After the primary crimping, the implant in the primary crimping state is arranged at the distal end of the outer sheath tube, the distal end of the mandrel is detachably connected with the lug, and the distal end of the inner sheath tube is sleeved outside the lug;

[0048] During the secondary crimping, keep the implant stationary, and move the funnel axially from the distal end to the proximal end until the implant is changed from the primary crimping state to the secondary crimping state, and the cylindrical section is positioned to sleeve outside the implant in the secondary crimping state;

[0049] After the secondary crimping, release the connection between the cylindrical section and the funnel section, and move the funnel section proximally and withdraw it from the outer sheath tube;

[0050] After the funnel section is withdrawn from the outer sheath tube, the outer sheath tube is covered by the loading outer housing, and the loading outer housing is locked by the locking device. Then, the inner sheath tube and the mandrel are synchronously moved in the proximal direction until the implant in the secondary crimping state is introduced into the distal end of the outer sheath tube.

[0051] Optionally, based on at least one of the first loading method and the second loading method, the implant is loaded into the delivery system:

[0052] The first loading method includes: inserting a metal guiding rod between the outer sheath tube and the inner sheath tube, and exposing the tapered opening at one end of the metal guiding rod outside the distal end of the outer sheath tube. After the funnel section is withdrawn from the outer sheath tube, the outer sheath tube and the tapered opening are covered by the loading outer housing. Then, under the action of the inner sheath tube and the mandrel, the implant in the secondary crimping state is introduced into the metal guiding rod. After the implant in the secondary crimping state is introduced into the metal guiding rod, the locking device, the loading outer housing, and the metal guiding rod are sequentially removed.

[0053] The second loading method includes: directly introducing the implant in the secondary crimping state into the distal end of the outer sheath tube under the action of the inner sheath tube and the mandrel, and then sequentially removing the locking device and the loading outer housing.

[0054] As described above, in the implant loading tool, implant loading system, implant system, and loading method provided by the present invention, before the implant is introduced into the delivery system, the implant needs to be secondarily crimped by the loading tool. During the first crimping, it is completed through the cooperation of the crimping rod and the crimping block in the loading tool, and at the same time, the ear on the implant can be straightened. During the second crimping, uniform crimping is achieved through the funnel in the loading tool, and the flange on the implant can also be straightened. After the crimping of the implant is completed, the outer sheath tube in the delivery system is fixed by the loading outer housing and the locking device in the loading tool, and the connection between the outer sheath tube and the cylindrical section in the funnel is realized. On the premise of ensuring reliable locking, through the linkage of the inner sheath tube and the mandrel in the delivery system, the implant in the secondary crimping state is introduced into the distal end of the outer sheath tube through the distal end of the loading outer housing.

[0055] With such a configuration, the present invention can achieve the loading of an implant with a flange and an ear and the ear is provided at the inflow end, ensuring the loading requirements of such implants. Moreover, during the loading process, the outer sheath tube can be constrained by the loading outer housing, reducing the axial movement of the outer sheath tube and avoiding damages such as wrinkles and delamination. Finally, the implant can be safely and effectively loaded into the delivery system.

[0056] Furthermore, in the loading tool for the implant, the loading system for the implant, the implant system and the loading method provided by the present invention, the soft section of the sheath tube of the outer sheath tube can be protected by a metal guiding rod, or the soft section of the sheath tube can be wrapped by a soft elastic material layer for protection, so as to reduce the damage to the soft section of the sheath tube during the process of introducing the implant into the delivery system, and further ensure the performance of the outer sheath tube. Description of the Drawings

[0057] Those of ordinary skill in the art will understand that the provided drawings are used to better understand the present invention and do not constitute any limitation to the scope of the present invention. Among them:

[0058] Figure 1 is an exploded view of the pressing block of an embodiment of the loading tool for the implant of the present invention;

[0059] Figure 2 is an assembled view of the pressing block of an embodiment of the loading tool for the implant of the present invention;

[0060] Figure 3 is a schematic structural view of the pressing rod of an embodiment of the loading tool for the implant of the present invention;

[0061] Figure 4 is a schematic structural view of the funnel of an embodiment of the loading tool for the implant of the present invention;

[0062] Figure 5 is an axial sectional view of the funnel of an embodiment of the loading tool for the implant of the present invention;

[0063] Figure 6 is an exploded view of the first loading outer housing of an embodiment of the loading tool for the implant of the present invention;

[0064] Figure 7 is an exploded view of the second loading outer housing of an embodiment of the loading tool for the implant of the present invention;

[0065] Figure 8 is a schematic structural view of the first locking device of an embodiment of the loading tool for the implant of the present invention;

[0066] Figure 9 is a schematic structural view of the second locking device of an embodiment of the loading tool for the implant of the present invention;

[0067] Figure 10 is a schematic structural view of the metal guiding rod of an embodiment of the loading tool for the implant of the present invention;

[0068] Figure 11 is a schematic structural view of the implant with a double-layer stent in a natural state of an embodiment of the loading tool for the implant of the present invention;

[0069] Figure 12 It is a schematic structural diagram of an implant with a double-layer bracket in a first-stage compression state, which is an embodiment of the loading tool of the implant of the present invention;

[0070] Figure 13 It is a schematic structural diagram of an implant with a double-layer bracket in a second-stage compression state, which is an embodiment of the loading tool of the implant of the present invention;

[0071] Figure 14 It is a schematic operation principle diagram of the second step in the first loading method of the present invention;

[0072] Figure 15 It is a schematic operation principle diagram of the third step in the first loading method of the present invention;

[0073] Figure 16 It is a schematic operation principle diagram of the fourth step in the first loading method of the present invention. In the figure, the implant in the second-stage compression state is represented by the rectangular frame A placed in the cylindrical section of the funnel;

[0074] Figure 17 It is a schematic operation principle diagram of the fifth step in the first loading method of the present invention;

[0075] Figure 18 It is a schematic operation principle diagram of the sixth step in the first loading method of the present invention;

[0076] Figure 19 It is a schematic operation principle diagram of the seventh step in the first loading method of the present invention;

[0077] Figure 20 It is a schematic operation principle diagram of the eighth step in the first loading method of the present invention;

[0078] Figure 21 It is a schematic operation principle diagram of the second step in the second loading method of the present invention;

[0079] Figure 22 It is a schematic operation principle diagram of the third step in the second loading method of the present invention;

[0080] Figure 23 It is a schematic operation principle diagram of the fourth step in the second loading method of the present invention.

[0081] In the accompanying drawings:

[0082] 10 - Press - grip block; 11 - Press - grip piece; 101 - Press - grip cavity; 12 - Guide pin; 13 - Guide slot; 14 - Pin slot; 15 - Pin cap; 30 - Press - grip rod; 301 - Through - hole; 31 - Main body section; 32 - Flat section; 321 - Plane; 33 - Guide groove section; 331 - Guide groove; 50 - Funnel; 51 - Funnel section; 511 - Tapered inner hole; 512 - Limiting plane; 513 - Threaded inner hole; 52 - Cylindrical section; 521 - Outer diameter of the cylindrical section; 522 - External thread section; 523 - Inner diameter of the cylindrical section; 70 - Loading outer tool; 710 - First type of loading outer tool; 711 - Locking plane; 712 - Through - slot; 713 - Guide rib; 714 - Limiting cone block; 715 - Straight hole; 716 - First cone hole; 717 - Second cone hole; 718 - Clearance fit section; 719 - Limiting end face; 7110 - Concave - convex card slot; 7111 - Interference fit section; 720 - Second type of loading outer tool; 721 - Locking plane; 722 - Guide rib; 723 - Limiting cone block; 724 - Straight hole; 725 - Cone hole; 726 - Clearance fit section; 727 - Soft elastic material; 728 - Limiting end face; 729 - Concave - convex card slot; 7210 - Interference fit section; 90 - Locking device; 910 - First type of locking device; 911 - Arrow mark; 912 - Guide rib groove; 913 - Push - pull block; 914 - Limiting block cone groove; 920 - Second type of locking device; 921 - Pressing groove; 922 - Pulling block; 923 - Clamping plane; 924 - Card slot; 110 - Metal guide rod; 111 - Thin - walled tube; 112 - Tapered opening; 113 - Limiting block; 01 - Inner bracket; 011 - Hanging ear; 02 - Outer bracket; 021 - Flange; 022 - Grabbing ear; 0221 - Non - bent section; 0222 - Bent section; 100 - Implant in the first - level press - grip state; 200 - Implant in the second - level press - grip state; 20 - Outer sheath tube; 21 - Soft section of the sheath tube; 22 - Hard section of the sheath tube; 40 - Inner sheath tube; 60 - Mandrel. Detailed implementation manners

[0083] To make the objectives, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the accompanying drawings are in very simplified forms and are not drawn to scale, only for the purpose of facilitating and clearly assisting in explaining the objectives of the embodiments of the present invention. In addition, the structures shown in the accompanying drawings are often part of the actual structures. In particular, the emphasis that each accompanying drawing needs to show is different, and sometimes different scales are used.

[0084] As used in the present invention, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally used in the sense of including "and / or", the term "several" is generally used in the sense of including "at least one", the term "at least two" is generally used in the sense of including "two or more". In addition, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or at least two of such features. The terms "one end" and "the other end" and "proximal end" and "distal end" generally refer to two corresponding parts, which include not only the endpoints. The terms "mount", "connect" and "couple" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral one; it may be a mechanical connection, a direct connection, or an indirect connection through an intermediate medium. It may be the communication inside two elements or the interaction relationship between two elements. In addition, as used in the present invention, an element being disposed on another element generally only means that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the two elements may be directly or indirectly connected, coupled, cooperated or transmitted through an intermediate element, rather than being construed as indicating or implying the spatial position relationship between the two elements, that is, an element may be inside, outside, above, below or on one side of another element in any orientation, unless otherwise explicitly specified in the context. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention may be understood according to specific circumstances.

[0085] As used in this application document, the terms "distal end" and "proximal end" are used to refer to the position or direction relative to the operator (i.e., the surgical operator) when loading tools or delivery systems. Thus, the "distal end" refers to the position away from the operator or in the direction away from the operator, and the term "proximal end" refers to the position in the direction close to the operator. In addition, the "axial direction" as used in this application document refers to the direction along the central axis when loading tools or delivery systems, the "circumferential direction" refers to the direction around the central axis, and the "radial direction" refers to the direction perpendicular to the central axis.

[0086] The object of the present invention is to provide a loading tool for an implant, a loading system for an implant, an implant system and a loading method for an implant, aiming to load a valve-like implant with a stent in a crimped configuration into a catheter-based delivery system.

[0087] The present invention can achieve the loading of an implant with a flange and ear catches and the hanging ears provided at the inflow end, ensuring the loading requirements of such implants, and particularly considering the loading of implants with a double-layer stent.

[0088] The loading tool of the implant of the present invention is configured to be disposed above the distal end of the delivery system, while the implant is positioned after being compressed, so as to load the implant into the delivery system in a simple and reliable manner. During the loading process, the axial movement of the outer sheath tube can be reduced to avoid damages such as wrinkles and delamination, without affecting the performance of the outer sheath tube.

[0089] It should be understood that the implant includes a stent and a prosthetic valve, and the prosthetic valve includes at least two leaflets disposed and fixed within the stent. The delivery system finally delivers such an implant to a position in the heart. In order to pass through the catheter, the implant must be folded into a smaller profile, but the step of collapsing the implant to load it into the delivery system must be performed shortly before the implantation surgery, and the implant must be loaded into the delivery system in the correct manner, neither increasing the size of the outer sheath tube nor affecting the performance of the outer sheath tube.

[0090] The implant can be of various types of cardiac valve prostheses known to those skilled in the art. However, in the present invention, the implant has a single-layer stent or a double-layer stent. Whether it is a single-layer stent or a double-layer stent, the inflow end of the stent is provided with lugs and flanges, and the outflow end of the stent is provided with grasping ears, and the grasping ears are bent and disposed on the periphery of the stent. For the double-layer stent, it should be further noted that the lugs are disposed at the inflow end of the inner stent, the flanges are disposed at the inflow end of the outer stent, and the grasping ears can extend based on the outflow end of the outer stent or the inner stent, that is, the grasping ears can be directly connected to the inner stent and extend from the inside to the outside via the outer stent, or the grasping ears are directly connected to the outer stent and extend to the outside. The structures and functions of the flanges, lugs and grasping ears can be understood with reference to the prior art, and will not be described in detail in this application. Generally speaking, the lugs are used to detachably connect with the delivery system so that the delivery system can deliver the implant; the flanges can engage the tissue above the natural valve annulus, such as the surface above the valve annulus or some tissues in the atrium, so as to inhibit the migration of the implant; the grasping ears can cooperate with the stent to clamp the native leaflets, and clamp the native leaflets between the stent and the grasping ears to enhance the stability.

[0091] It should be further noted that when not in use, the implant is usually stored in a glutaraldehyde solution. When it is needed, the implant is taken out of the glutaraldehyde solution shortly before the surgery, and then the compression and loading of the implant are realized in the low-temperature environment provided by a low-temperature loading solution (such as an ice-water mixture).

[0092] The following description is made with reference to the accompanying drawings.

[0093] Figures 1 to 10 The structural schematic diagrams of the various components of an embodiment of the loading tool of the implant of the present invention are shown. Figures 11 to 13 The structural schematic diagram of an embodiment of the implant of the present invention is shown. Figures 14 to 23 The loading process diagram of the implant system of the present invention is shown.

[0094] As shown Figures 1~10 in the figure, the loading tool of the implant (referred to as the loading tool for short) includes a compression grip block 10, a compression grip rod 30, a funnel 50, a loading housing 70, and a locking device 90.

[0095] As shown Figures 11~13 in the figure, the implant includes a stent. The inflow end of the stent is provided with a hanging ear 011 and a flange 021. The outflow end of the stent is connected with a grasping ear 022. The grasping ear 022 is bent at the position corresponding to the outflow end, and after bending, it is arranged on the periphery of the stent. Taking a double-layer stent as an example, the hanging ear 011 is arranged at the inflow end of the inner stent 01, the flange 021 is arranged at the inflow end of the outer stent 02, and the grasping ear 022 extends based on the outflow end of the inner stent 01 and extends to the outside of the outer stent 02 after bending.

[0096] It should be understood that the implant has a compressed configuration for delivery within the vascular system and an expanded configuration for deployment within the body. In other words, the implant is configured to be radially compressed into a compressed configuration with a reduced diameter for delivery within the vascular system and to return to an expanded deployment configuration. In particular, the implant is a valve prosthesis with a stent, mainly a mitral valve prosthesis or a tricuspid valve prosthesis. In this article, an implant with a double-layer stent is taken as an example for illustrative purposes, but those skilled in the art should be able to modify the following description to achieve the loading of an implant with a single-layer stent.

[0097] As shown Figure 11 in the figure, in one embodiment, the implant has a double-layer stent, which includes an inner stent 01 and an outer stent 02. The inner stent 01 is placed in the inner cavity of the outer stent 02; one end of the inner stent 01 corresponding to the inflow channel is the inflow end, and the inflow end is provided with a hanging ear 011; the inflow end of the outer stent 02 is provided with a flange 021; one end of the outer stent 02 or the inner stent 01 corresponding to the outflow channel is the outflow end, and the outflow end is provided with a grasping ear 022, and the grasping ear 022 is bent at the outflow end. In some embodiments, the grasping ear 022 extends based on the inner stent 01, and in other embodiments, the grasping ear 022 extends based on the outer stent 02. In any case, in the natural state, the grasping ear 022 has a non-bent section 0221 (substantially a straight rod section) and a bent section 0222 (i.e., the arc rod section at the bending position).

[0098] Figure 11 The implant in the natural state shown in the figure needs to be compressed in two stages to reduce the profile, and through the first-stage compression, the grasping ear 022 is straightened and does not protrude outside the periphery of the outer stent 02, and through the second-stage compression, the flange 021 is straightened and does not protrude radially outward. As shown Figure 12 in the figure, during the first-stage compression, the grasping ear 022 is straightened and extends along the axis in the direction away from the inflow end at the outflow end. As shown Figure 13As shown, the secondary compression state is the form when the implant introduction and delivery system is in use, which is achieved through the funnel 50. The purpose is to straighten the flange 021 and extend it axially in the direction away from the outflow end at the inflow end. It should be understood that the natural state described in this specification refers to the size and shape of the implant without external force constraint.

[0099] As Figures 14 to 23 shown, an embodiment of the present invention further provides an implant system, including the implant and the loading system of the implant. The loading system of the implant includes a delivery system and a loading tool for the implant. The delivery system includes an outer sheath 20, an inner sheath 40, and a mandrel 60; the inner sheath 40 is partially disposed in the lumen of the outer sheath 20; the mandrel 60 is partially disposed in the lumen of the inner sheath 40. In practice, the implant is compressed by the loading tool for the implant, and then cooperates with the delivery system to introduce the compressed implant into the delivery system.

[0100] See Figure 1 and Figure 2 shown, the compression block 10 has a compression cavity 101 that penetrates axially along itself. The compression block 101 can radially contract and radially expand to adjust the size of the compression cavity 101; when the compression cavity 101 becomes larger, it can be sleeved outside the implant; when the compression cavity 101 becomes smaller, it can compress the implant inward. The radially maximum value defined by the compression cavity 101 should be greater than the outer diameter of the implant in the natural state. Based on this, the compression block 10 performs primary compression on the implant in the natural state (see Figure 11 ).

[0101] See Figure 3 shown, the compression rod 30 is a hollow round rod with a through hole 301 that penetrates axially along itself. The through hole 301 is not only used to reduce the overall weight of the compression rod 30, but also allows a cryogenic loading solution to penetrate through it during the loading process, quickly reducing the temperature of the compression rod 30, facilitating the compression of the implant, and reducing the springback of the implant. The function of the compression rod 30 is to insert into the implant and support the implant during primary compression, and is also used to straighten the grasping ear 022.

[0102] See Figure 4 and Figure 5As shown, the funnel 50 includes a funnel section 51 and a cylindrical section 52, which are detachably connected, including but not limited to threaded connection. The funnel 50 serves to uniformly compress the implant and is also used to straighten the flange 021. When the funnel section 51 and the cylindrical section 52 are connected, the funnel 50 is arranged at the distal end of the delivery system and then moves proximally along the axis of the delivery system to perform secondary compression on the implant in the primary compressed state while straightening the flange 021. Finally, the implant in the secondary compressed state enters the cylindrical section 52, and the cylindrical section 52 binds the implant after secondary compression and prepares for subsequent loading. After completing the secondary compression, the connection between the funnel section 51 and the cylindrical section 52 can be released, and then the funnel section 51 moves proximally away from the outer sheath tube 20 of the delivery system.

[0103] See Figure 6 and Figure 7 As shown, the loading housing 70 is formed by snapping together two sub-components. Its function is to wrap around the outside of the outer sheath tube 20 during the loading process to restrain the outer sheath tube 20 and prevent axial movement of the outer sheath tube 20. The loading housing 70 is also used to engage the distal end thereof with the end where the cylindrical section 52 and the funnel section 51 of the funnel 50 are connected, so that the implant in the secondary compressed state within the cylindrical section 52 can be introduced into the distal end of the outer sheath tube 20 through the distal end of the loading housing 70.

[0104] See Figure 8 and Figure 9 As shown, the locking device 90 is any lockable and unlockable device, especially considering quick-release and quick-attachment locking devices. The specific structure is not limited in the present invention. The function of the locking device 90 is to lock the loading housing 70 during the process of introducing the implant into the outer sheath tube 20, indirectly locking the outer sheath tube 20. After the implant is introduced into the distal end of the outer sheath tube 20, the locking device 90 can release the lock on the loading housing 70 to remove the loading housing 70.

[0105] The working principle of loading the implant in the present invention includes: First, under the cooperation of the compression block 10 and the compression rod 30, the implant in the natural state is compressed to the first-stage compression state, and the ear 022 is straightened by the compression rod 30 during the first-stage compression; after the first-stage compression, the compression block 10 and the compression rod 30 are removed, and before the second-stage compression, the implant in the first-stage compression state is arranged at the distal end of the outer sheath 20, and at the same time, the distal end of the mandrel 60 is detachably connected to the hanging ear 011, and the distal end of the inner sheath 40 is sleeved outside the hanging ear 011 to prevent the hanging ear 011 from detaching from the mandrel 60; then, the second-stage compression is performed. During the second-stage compression, the implant is kept stationary, and the funnel 50 is moved axially along the conveying system from the distal end to the proximal end until the funnel 50 changes the implant from the first-stage compression state to the second-stage compression state, and the cylindrical section 52 is positioned and sleeved outside the implant in the second-stage compression state, that is, the second-stage compression is completed; after the second-stage compression, the connection between the cylindrical section 52 and the funnel section 51 is released, and the funnel section 51 is moved alone to the proximal end of the conveying system and withdrawn (i.e., away from) the outer sheath 20; after the funnel section 51 withdraws from the outer sheath 20, the loading outer housing 70 wraps (holds tightly) the outer sheath 20, and then the loading outer housing 70 is locked by the locking device 90; after locking, the inner sheath 40 and the mandrel 60 are driven to move synchronously in the proximal direction of the conveying system until the implant in the second-stage compression state is introduced (pulled) into the distal end of the outer sheath 20. After the implant in the second-stage compression state is introduced into the distal end of the outer sheath 20, the locking device 90 and the loading outer housing 70 are removed, and the loading tool is separated from the conveying system.

[0106] It should be noted that the implant in the second-stage compression state can be indirectly or directly introduced into the distal end of the outer sheath 20. "Indirect introduction" means that the implant is first introduced into the metal guiding rod 110, and after the metal guiding rod 110 is withdrawn, the implant can be directly left in the distal end of the outer sheath 20.

[0107] With such a configuration, the present invention can realize the loading of the implant with the flange 021 and the ear 022, and the hanging ear 011 is arranged at the inflow end, meeting the loading requirements of such implants. In addition, during the entire loading process, the loading outer housing 70 can always hold tightly the outer sheath 20, avoiding the axial movement of the outer sheath 20. This not only enables the implant to enter the conveying system safely and effectively, but also can prevent the outer sheath 20 from being damaged such as wrinkling and delamination, ensuring the performance of the outer sheath 20.

[0108] In practice, the present invention can provide two loading methods, and one of the loading methods can be selectively used to load the implant into the conveying system.

[0109]

Example 1

[0110] First, the first loading method is introduced through Example 1. At this time, as Figure 10As shown, the loading tool of the implant of the present invention further includes a metal guiding rod 110. The metal guiding rod 110 is a thin-walled tube 111 as a whole. One end of it is provided with a tapered opening 112, and the rest is an equal-diameter cylinder. The end of the tapered opening 112 away from the equal-diameter cylinder is the large-diameter end. Preferably, the wall thickness of the metal guiding rod 110 is 0.05 mm to 0.2 mm, more preferably 0.1 mm. This wall thickness can ensure that the lumen size of the metal guiding rod 110 is sufficient to enclose the implant in the secondary compression grip, while also reducing the influence on the size of the outer sheath tube 20 and not increasing the size of the outer sheath tube 20.

[0111] During use, the metal guiding rod 110 is partially inserted between the outer sheath tube 20 and the inner sheath tube 40, and it is ensured that the tapered opening 112 is exposed outside the distal end of the outer sheath tube 20. The metal guiding rod 110 cannot move relative to the outer sheath tube 20. After the funnel section 51 is withdrawn from the outer sheath tube 20, the outer sheath tube 20 and the tapered opening 112 are covered by the loading outer tool 70, and the loading outer tool 70 is locked by the locking device 90. Then, under the action of the inner sheath tube 40 and the mandrel 60, the implant in the secondary compression grip state is introduced into the metal guiding rod 110. After the implant in the secondary compression grip state is introduced into the metal guiding rod 110, the locking device 90, the loading outer tool 70, and the metal guiding rod 110 are removed in sequence, and the loading of the implant can be completed.

[0112] Correspondingly, the loading outer tool 70 is the first loading outer tool 710 adapted to the metal guiding rod 110.

[0113] Figure 6 Shows the two-half structure of the first loading outer tool 710 in an embodiment. Refer to Figure 6 , the first loading outer tool 710 is a hollow structure and is formed by buckling two sub-components. The distal end of the first loading outer tool 710 is successively provided with an axially connected straight hole 715, a first tapered hole 716, and a second tapered hole 717. The large-diameter end (i.e., the flared end) of the first tapered hole 716 is connected to the proximal end of the straight hole 715. The inner diameter of the large-diameter end of the first tapered hole 716 should match the inner diameter 523 of the cylindrical section 52. The large-diameter end (i.e., the flared end) of the second tapered hole 717 is connected to the small-diameter end (i.e., the closed end) of the first tapered hole 716. The small-diameter end of the first tapered hole 716 is used to align with the flared end of the tapered opening 112 of the metal guiding rod 110. The inner diameter of the closed end of the first tapered hole 716 does not exceed the inner diameter of the flared end of the tapered opening 112 of the metal guiding rod 110. Preferably, the inner diameter of the closed end of the first tapered hole 716 is smaller than the inner diameter of the flared end of the tapered opening 112, so as to ensure that the implant in the cylindrical section 52 enters the metal guiding rod 110 through the first tapered hole 716 and the tapered opening 112 without obstruction.

[0114] When using the metal guiding rod 110, the first loading outer tool 710 wraps the tapered opening 112 of the metal guiding rod 110 through the second tapered hole 717, and at the same time wraps one end where the cylindrical section 52 is connected to the funnel section 51 through the straight hole 715. The straight hole 715, the first tapered hole 716, and the second tapered hole 717 are all exposed outside the distal end of the outer sheath tube 20. In addition, when one end of the cylindrical section 52 is inserted into the straight hole 715, the insertion depth of the cylindrical section 52 can be axially limited by the transition step between the straight hole 715 and the first tapered hole 716, that is, the inner diameter of the straight hole 715 is larger than the flared inner diameter of the first tapered hole 716 to form a transition step. In this way, the implant in the secondary compression state in the cylindrical section 52 can be introduced into the metal guiding rod 110 through the first tapered hole 716. The first tapered hole 716 can also further uniformly compress the implant, further reducing the radial profile of the implant originally compressed in the cylindrical section 52, and helping to smoothly introduce the implant into the metal guiding rod 110 without increasing the size of the outer sheath tube 20.

[0115] Continue to refer to Figure 10 , in an exemplary embodiment, symmetric limiting blocks 113 are provided on the outer peripheral surface of the equal-diameter cylinder of the metal guiding rod 110 except for the tapered opening 112; correspondingly, refer to Figure 6 , a through groove 712 is provided on the first loading outer tool 710 along the radial direction. Accordingly, when assembling the metal guiding rod 110, the limiting blocks 113 are exposed outside the distal end of the outer sheath tube 20 and inserted into the through groove 712, thereby limiting the metal guiding rod 110 in the circumferential and axial directions of the delivery system and preventing the metal guiding rod 110 from moving.

[0116] Refer to Figures 14 to 20 , the outer sheath tube 20 generally has a distal sheath soft section 21 and a proximal sheath hard section 22. The diameter (including the inner diameter and the outer diameter) of the sheath soft section 21 is the same as or different from the diameter (including the inner diameter and the outer diameter) of the sheath hard section 22. In this embodiment, the diameter of the sheath soft section 21 is larger than the diameter of the sheath hard section 22, but it is not limited thereto in practice. The sheath soft section 21 can be a one-piece structure with the same overall diameter or a multi-piece structure with different diameters, such as a two-piece structure.

[0117] The metal guiding rod 110, as a capsule structure, first receives the implant with the stent. The metal guiding rod 110 plays a role in protecting the sheath soft section 21 and reducing the damage to the sheath soft section 21 during the introduction process.

[0118] Furthermore, the first loading outer shell 710 includes a distal portion and a proximal portion distributed along its own axial direction, and the distal portion covers the entire sheath soft segment 21 of the outer sheath 20 in a clearance fit manner, thereby reducing the force on the sheath soft segment 21 during the loading process. When the clearance fit is adopted, the sheath soft segment 21 is hardly subjected to any force, and during the operation, damage such as delamination is avoided. As in this embodiment, the first loading outer shell 710 also has a clearance fit segment 718, which is the distal portion, which covers the entire sheath soft segment 21 in a clearance fit manner.

[0119] The proximal portion of the first loading outer shell 710 preferably covers all or part of the sheath tube hard section 22 of the outer sheath tube 20 in an interference fit manner. In this way, the outer sheath tube 20 can be better fixed, the axial movement of the outer sheath tube 20 during loading can be reduced, and the probability of damage such as wrinkling and delamination of the outer sheath tube 20 is reduced. As in this embodiment, the first loading outer shell 710 also has an interference fit section 7111, and the interference fit section 7111 is the proximal portion.

[0120] Continue to see Figures 14 to 20 In an exemplary embodiment, the outer sheath 20 has two sheath soft segments 21 with different diameters, and the diameter of the sheath soft segment 21 at the distal end is larger than the diameter of the sheath soft segment 21 at the proximal end, thereby forming an outer step between the two sheath soft segments 21. Preferably, the inner part of the distal portion, such as the clearance fitting segment 718, is provided with a limiting end face 719 that matches the outer step formed by the two sheath soft segments 21 with different outer diameters. The limiting end face 719 is defined by the two clearance fitting segments 718 with different inner diameters. The limiting end face 719 can further limit the movement of the outer sheath 20 in the axial direction.

[0121] Continue to see Figure 6 As an example, the first loading outer shell 710 is formed by two half parts connected by concave-convex snap-fitting through the concave-convex snap-fitting groove 7110. This structure is simple and easy to assemble and disassemble. In view of the fact that the loading outer shell 70 is subjected to relatively small force at the proximal end and relatively large force at the distal end during loading, it is preferred that the first loading outer shell 710 is directly connected at the proximal end through its own structure, and is further locked at the distal end by the locking device 90 to increase the locking force, thereby ensuring the safety and reliability of implant loading.

[0122] In any embodiment of the present invention, the first loading outer shell 710 can be locked by one or more locking devices 90, and preferably, at least one locking device 90 is arranged on the outside of the distal end of the first loading outer shell 710 and tightens the first loading outer shell 710. At the same time, more preferably, the first loading outer shell 710 is connected to the sheath hard section 22 through an interference fit section 7111. This structural design can more effectively reduce the axial movement of the outer sheath 20.

[0123] Preferably, the loading tool includes at least two locking devices 90, and more preferably, two locking devices 90 are used. Preferably, at least one locking device 90 is arranged at a position where the distal end of the outer sheath tube 20 cooperates with the first loading outer shell 710, and at least another locking device 90 is arranged at a position where the distal end of the first loading outer shell 710 cooperates with the cylindrical section 52.

[0124] The locking device 90 can lock the first loading outer shell 710 by any means such as shape locking, force locking, etc. In the present embodiment, there are two types of locking devices 90, namely, the first locking device 910 and the second locking device 920; the first locking device 910 clamps the first loading outer shell 710 through a concave-convex structure at the position where the distal end of the outer sheath 20 matches the first loading outer shell 710; the second locking device 920 elastically clamps the first loading outer shell 710 through a groove at the position where the distal end of the first loading outer shell 710 matches the cylindrical section 52, so that the joint between the cylindrical section 52 and the straight hole 715 will not be stretched open due to excessive force, thereby ensuring the reliability and effectiveness of the implant in the process of being introduced into the delivery system. However, in other embodiments, the first locking device 910 and the second locking device 920 can be arranged in reverse.

[0125] There are many structures for realizing the locking device 90, and at least one structure can be used to realize the locking device 90. The following is an exemplary description.

[0126] Figure 8 FIG. 1 shows the structure of a first locking device 910 in an embodiment. Figure 8 As shown, the first locking device 910 is an open annular lock buckle, which can be expanded and inserted into the outer side of the first loading shell 710. Optionally, the first locking device 910 has a guide rib groove 912 and a limit block tapered groove 914; the limit block tapered groove 914 is symmetrically arranged on the hole wall of the sleeve hole; the guide rib groove 912 is located between the limit block tapered grooves 914.

[0127] See also Figure 6, the first loading housing 710 is correspondingly provided with a guiding rib 713 and a limiting cone 714; the number of guiding ribs 713 is one, which extends from the distal end to the proximal end along the axial direction of the first loading housing 710; the guiding rib 713 cooperates with the guiding rib groove 912 in the first locking device 910 to realize the installation and positioning of the first locking device 910 on the first loading housing 710; the limiting cones 714 are symmetrically arranged on the side surface of the first loading housing 710; the limiting cones 714 cooperate with the limiting block cone grooves 914 in the first locking device 910 to achieve locking by relying on the taper, that is, the first locking device 910 and the first loading housing 710 are locked by the cooperation of the concave-convex structure. One or more groups of limiting cones 714 are arranged axially on the first loading housing 710, and each group includes two limiting cones 714 symmetrically arranged in the radial direction. Preferably, multiple groups of limiting cones 714 are arranged on the first loading housing 710, which is convenient for flexibly selecting the position to be locked, such as locking at the distal end, middle or proximal end of the first loading housing 710.

[0128] Optionally, the first locking device 910 also has an arrow mark 911, which can be used to indicate the extending direction of the limiting block cone groove 714, so as to visually indicate the operation direction of the first locking device 910. Further optionally, the first locking device 910 also has symmetrically arranged push-pull blocks 913, which are used to provide a force application platform during the disassembly and assembly of the first locking device 910.

[0129] Figure 9 The structure of the second locking device 920 in an embodiment is shown. As Figure 9 shown, the second locking device 920 elastically clamps the first loading housing 710 through a groove. Schematically, the second locking device 920 has a pressing groove 921, a pulling block 922, a clamping plane 923 and a clamping groove 924; the pressing groove 921 is used to provide a force application platform during the installation of the second locking device 920; the pulling block 922 is used to provide a force application platform during the removal of the second locking device 920; the clamping plane 923 is used to cooperate with the locking plane 711 on the first loading housing 710 to increase the contact area during clamping and increase the locking force; the clamping groove 924 plays a role in preventing the second locking device 920 from falling off the first loading housing 710.

[0130] It should be understood that, in addition to the structural forms of the locking device 90 listed in the embodiments of the present invention, those skilled in the art can completely find other alternative ways to implement the functions recorded by the locking device 90 described in the present invention or achieve the corresponding effects based on the description of the specification of the present invention, and it does not only include the solutions disclosed in the embodiments of the present invention. It should also be understood that the present invention may also provide only one locking device 90, and preferably select the first locking device 910, and the locking effect of the first locking device 910 is good; if two locking devices 90 are used simultaneously, it is beneficial to increase the tightening force at the distal end of the loading outer casing 70, making the operation process of the implant introduction and delivery system more reliable.

[0131]

Embodiment II

[0132] The present invention further introduces a second loading method through Embodiment II. At this time, instead of using the metal guide rod 110, the implant in the secondary compression state within the cylindrical section 52 is directly introduced into the distal end of the outer sheath tube 20. Correspondingly, the loading outer casing 70 adopts a second loading outer casing 720 adapted to the case without the metal guide rod 110.

[0133] Figure 7 A half-sectional view of the second loading outer casing 720 in an embodiment is shown. As Figure 7 shown, the second loading outer casing 720 is a hollow structure and is formed by buckling two half-sub-components. Similar to the first loading outer casing 710 in terms of structure and usage, the distal end of the second loading outer casing 720 is provided with an axially communicating straight hole 724 and a tapered hole 725, and there is only one tapered hole 725; the large-diameter end (i.e., the flared end) of the tapered hole 725 is connected to the proximal end of the straight hole 724; the inner diameter of the large-diameter end of the tapered hole 725 matches the inner diameter of the cylindrical section 52.

[0134] After the second loading outer casing 720 wraps the outer sheath tube 20, the straight hole 724 directly wraps the end of the cylindrical section 52 connected to the funnel section 51, and both the tapered hole 725 and the straight hole 724 are exposed outside the distal end of the outer sheath 20. The small-diameter end of the tapered hole 725 needs to be aligned with the distal port of the soft section 21 of the sheath tube. Preferably, the inner diameter of the constricted opening (i.e., the inner diameter of the small-diameter end) of the tapered hole 725 does not exceed the inner diameter of the distal port of the soft section 21 of the sheath tube. Usually, the inner diameters of the two match to ensure that the implant enters the distal end of the soft section 21 of the sheath tube through the tapered hole 725 without obstruction.

[0135] The function of the tapered hole 725 is basically the same as that of the first tapered hole 716 in the first loading outer shell 710. In any loading outer shell 70, the tapered hole can play a role in guiding and positioning, which can ensure that the implant is correctly loaded into the delivery system. The straight hole and the tapered hole are axially connected and coaxial. The end of the cylindrical section 52 connected to the funnel section 51 can be covered through the straight hole, so as to realize the connection between the cylindrical section 52 and the distal end of the loading outer shell 70, and position and align the port of the cylindrical section 52 with the delivery system.

[0136] The second loading outer shell 720 includes a distal part and a proximal part distributed along its own axis. The distal part of the second loading outer shell 720 preferably covers all the sheath soft sections 21 of the outer sheath tube 20 in a clearance fit manner, so as to reduce the force on the sheath soft sections 21 during the loading process. In this embodiment, the second loading outer shell 720 also has a clearance fit section 726, and the clearance fit section 726 is the distal part of the second loading outer shell 720, and it covers the entire sheath soft section 21 in a clearance fit manner.

[0137] Alternatively, a soft elastic material 727 is provided on the inner side of the distal part of the second loading outer shell 720, and all the sheath soft sections 21 are directly covered by the soft elastic material 727 to provide comprehensive protection for the sheath soft sections 21. The function of the soft elastic material 727 can also increase the friction force, which can further limit the axial movement of the outer sheath tube 20. Therefore, the soft elastic material 727 is equivalent to adding a "coat" that is both hard and soft and can increase the friction force to the sheath soft sections 21, which not only plays a role in protecting the sheath soft sections 21 but also can limit the axial movement. The soft elastic material 727 is made of a polymer material with a large friction coefficient and relatively soft, and the soft elastic material 727 fits on the entire inner surface of the distal part.

[0138] The proximal part of the second loading outer shell 720 preferably covers all or part of the sheath hard section 22 of the outer sheath tube 20 in an interference fit manner; in this way, the outer sheath tube 20 can be better fixed, and the axial movement of the outer sheath tube 20 during the loading process can be reduced, so that the probability of damage such as wrinkling and delamination of the outer sheath tube 20 is smaller. In this embodiment, the second loading outer shell 720 also has an interference fit section 7210, and the interference fit section 7210 is the proximal part of the second loading outer shell 720.

[0139] Preferably, a limiting end face 728 matching the outer step formed by two sheath soft sections 21 with different outer diameters is provided inside the distal part of the second loading outer shell 720, and the limiting end face 728 is formed by two distal parts with different inner diameters. The limiting end face 728 can further limit the axial movement of the outer sheath tube 20.

[0140] Continue to refer to Figure 7, in an exemplary embodiment, the second loading outer shell 720 is formed by snap-fitting two half sub-components through the concave-convex card slots 729, with a simple structure and convenient disassembly and assembly. Similarly, preferably, the second loading outer shell 720 is directly snap-fitted at the proximal end through its own structure, and further locked by the locking device 90 at the distal end to increase the locking force, ensuring the safety and reliability of the implant loading.

[0141] Similar to the first loading outer shell 710, the second loading outer shell 720 can be locked by one or more locking devices 90. And preferably, at least one locking device 90 is arranged outside the distal end of the second loading outer shell 720 to hoop the second loading outer shell 720. At the same time, the second loading outer shell 720 is connected to the hard section 22 of the sheath tube through the interference fit section 7210 at its proximal end; this locking method can firmly bind the outer sheath tube 20 at the distal and proximal ends of the second loading outer shell 720, better preventing the axial movement of the outer sheath tube 20.

[0142] The types of the locking device 90 are preferably at least two, and more preferably, two locking devices 90 are adopted. Preferably, at least one locking device 90 is arranged at the position where the distal end of the outer sheath tube 20 cooperates with the second loading outer shell 720, and at least another locking device 90 is arranged at the position where the distal end of the second loading outer shell 720 cooperates with the cylindrical section 52.

[0143] The locking device 90 can lock the second loading outer shell 720 by any one of form locking, force locking, etc. In this embodiment, there are two types of locking devices 90; the first locking device 910 hoops the second loading outer shell 720 through the concave-convex structure at the position where the distal end of the outer sheath tube 20 cooperates with the second loading outer shell 720; the second locking device 920 elastically clamps the second loading outer shell 720 through the groove at the position where the distal end of the second loading outer shell 720 cooperates with the cylindrical section 52, so that the joint of the cylindrical section 52 and the straight hole 715 will not be opened due to excessive force, ensuring the reliability and effectiveness during the process of implant introduction and delivery system.

[0144] The structures and locking methods of the first locking device 910 and the second locking device 920 can refer to the first loading outer shell 710, and will not be elaborated here.

[0145] Figure 7In a demonstration example of the description, the second loading housing 720 further has a guiding rib 722 and a limiting cone block 723; the number of the guiding ribs 722 is only one, and it extends from the distal end to the proximal end along the axial direction of the second loading housing 720; the guiding rib 722 cooperates with the guiding rib groove 912 in the first locking device 910 to realize the installation and positioning of the first locking device 910 on the second loading housing 720; the limiting cone blocks 723 are symmetrically arranged on the side surface of the second loading housing 720; the limiting cone blocks 723 cooperate with the limiting block cone grooves 914 in the first locking device 910 to realize locking by means of the taper, that is, the first locking device 910 and the second loading housing 720 are locked by the cooperation of the concave-convex structures. One group or multiple groups of limiting cone blocks 723 can be arranged in the axial direction of the second loading housing 720, and each group includes two limiting cone blocks 723 symmetrically arranged in the radial direction. Preferably, multiple groups of limiting cone blocks 723 are arranged on the second loading housing 720.

[0146] The second locking device 920 optionally has a clamping plane 923, and the clamping plane 923 is used to cooperate with the locking plane 721 on the second loading housing 720 to increase the contact area during clamping and increase the locking force. The clamping groove 924 in the second locking device 920 reduces the risk of the second locking device 920 falling off the second loading housing 720.

[0147] It should be further noted that any loading method can realize the loading of the implant with the flange 021 and the ear 022, and the hanging ear 011 is arranged at the inflow end, especially considering meeting the loading requirements of the implant with a double-layer stent.

[0148] Next, the preferred embodiments of the pressing block 10, the pressing rod 30, and the funnel 50 will be further described. It should be noted that the following description is only by way of example and cannot cover all implementation manners, and should not unduly limit the present invention.

[0149] See Figure 1 and Figure 2 , in an embodiment, the pressing block 10 includes at least three pressing pieces 11, and the pressing pieces 11 are pairwise combined to form a polygonal frame with a pressing cavity 101, wherein the pressing pieces 11 are pairwise telescopically connected.

[0150] The polygon frame may be a triangular structure, a quadrilateral structure, a pentagonal structure, a hexagonal structure or other polygon structures. The more sides the polygon structure has, the more conducive it is to pressing the implant into a circular shape. However, the more sides there are, the greater the manufacturing difficulty in the process. Based on this, preferably three pressing pieces 11 are used, and the polygon contour of the pressing cavity 101 defined by the three pressing pieces 11 is at least a triangular contour. The pressing pieces 11 are inserted into each other pairwise in the direction around the central axis of the pressing block 10, and the two inserted pressing pieces 11 are also telescopically connected by a guide pin 12. Optionally, the pressing pieces 11 are arranged in a staggered layer in the direction along the central axis of the pressing block 10 to facilitate the insertion and engagement. For example, in some embodiments, the pressing piece 11 has a plurality of inserted pieces arranged at intervals in the central axis direction, and a guide slot 13 is formed between the two inserted pieces. The plurality of inserted pieces of the pressing piece 11 are inserted into the corresponding guide slots 13 of another pressing piece 11 engaged with it in a staggered up and down manner, thereby forming the polygon frame of the pressing block 10. The pressing cavity 101 has a closed polygon contour, and the number of sides of the polygon contour is even or odd. Preferably, the pressing cavity 101 is a polygon contour with an even number of sides, and at least one pair of opposite sides in the polygon contour form parallel planes. At the same time, the pressing effect of this structure is good, and the roundness of the implant after pressing can be ensured. In this embodiment, the pressing cavity 101 is an octagonal contour, and three pressing pieces 11 are used at the same time.

[0151] To achieve the telescopic function of the pressing block 10, a pin slot 14 penetrating along the central axis direction may be provided on each pressing piece 11, and the pin slot 14 extends along the side length direction of the pressing piece 11. The guide pin 12 is inserted into the pin slot 14, thereby telescopically connecting the two pressing pieces 11. In practice, by sliding the guide pin 12 back and forth in the pin slot 14, the pressing block 10 is driven to compress inward or expand outward. To ensure that the guide pin 12 does not slide out of the pin slot 14, optionally, a pin cap 15 is additionally installed at one end of the guide pin 12, and the pin cap 15 buckles one end of the guide pin 12 to prevent the guide pin 12 from sliding out of the pin slot 14. So far, the pressing block 10 forms a stable polygon frame with uniform compression, expansion and change. However, it should be understood that the method of realizing the radial contraction and expansion of the pressing block 10 is not limited to this.

[0152] See Figure 3, in one embodiment, the pressing rod 30 is successively provided with a circular main body section 31, a flat section 32, and a guide groove section 33 along its own axis; the circular main body section 31 can be inserted into the implant, and provides the minimum pressing diameter for the primary pressing, and ensures the uniformity of pressing; the flat section 32 is provided with a plurality of flats 321 along the circumference of the pressing rod 30, and the number of the flats 321 is the same as the number of the ear catches 022. The flats 321 are used to straighten the bent sections 0222 of the ear catches 022 and serve as a platform to provide a force to ensure that the bent parts of the ear catches 022 can be straightened; the guide groove section 33 is provided with a plurality of guide grooves 331 along the circumference of the pressing rod 30, and the number of the guide grooves 331 is the same as the number of the ear catches 022. The guide grooves 331 are axially aligned with the flats 321; the guide grooves 331 are used to embed and straighten the non-bent sections 0221 of the ear catches 022; the guide grooves 331 are not only used to straighten the non-bent sections 0221 of the ear catches 022, but also used to provide circumferential limit for the implant during straightening. It should be understood that the length of the flat 321 is the same as the length of the bent section 0222 (i.e., the arc section) of the ear catch 022, or slightly greater than the bent section 0222 of the ear catch 022, and the length of the guide groove 331 is the same as the length of the non-bent section 0221 of the ear catch 022 or slightly less than the length of the non-bent section 0221 of the ear catch 022.

[0153] See Figure 4 and Figure 5 , in one embodiment, the funnel section 51 has a conical inner hole 511, a limiting flat 512, and a threaded inner hole 513; the inner diameter of the closed end (i.e., the inner diameter of the small diameter end) of the conical inner hole 511 is smaller than the inner diameter of the threaded inner hole 513 and forms the limiting flat 512; the cylindrical section 52 has an external threaded section 522; the outer diameter 521 of the cylindrical section 52 matches the inner diameter of the threaded inner hole 513; one end of the cylindrical section 52 is inserted into the threaded inner hole 513 and is threadedly connected to the threaded inner hole 513 through the external threaded section 522; during the process of screwing in the thread, the insertion depth of the cylindrical section 52 into the threaded inner hole 513 is limited by the limiting flat 512; the inner diameter of the closed end (the minimum inner diameter) of the conical inner hole 511 matches the inner diameter of the cylindrical section 52 to ensure that the implant can be uniformly compressed; the outer diameter 521 of the cylindrical section 52 matches the inner diameter of the straight hole 715 (or straight hole 724) of the loading housing 70, so that one end of the cylindrical section 52 can be inserted into the straight hole 715 (or straight hole 724) of the loading housing 70; the inner diameter 523 of the cylindrical section 52 is not greater than the inner diameter of the first tapered hole 716 (or tapered hole 725) of the loading housing 70 at the flared part, such as matching the inner diameter of the first tapered hole 716 (or tapered hole 725) at the flared part, or slightly smaller than the inner diameter of the flared part of the first tapered hole 716 (or tapered hole 725); thus, problems such as jamming and blocking are avoided during the process of introducing the implant 200 in the secondary pressing state of the cylindrical section 52 into the tapered hole.

[0154] The following refers to Figures 14 to 23, a further description of the method for loading the implant is provided. For the purpose of illustration, the implant in the first-stage crimping state is denoted by reference numeral 100, and the implant in the second-stage crimping state is denoted by reference numeral 200. Taking an implant with a double-layer stent as an example, those skilled in the art should be able to modify the following description to achieve the loading of a single-layer stent.

[0155] First, referring to Figures 14 to 20 , in a non-limiting mode of operation, the first loading method includes eight steps, namely the following first step to the eighth step.

[0156] First step: Use the crimping block 10 and the crimping rod 30 to complete the change of the implant with a double-layer stent from the natural state to the first-stage crimping state.

[0157] The specific operation process is as follows: Insert the crimping rod 30 into the outflow tract of the implant from one end of its circular main body section 31 until the starting point of the bent section 0222 of the ear 022 coincides with the starting point of the plane 321 of the crimping rod 30. Rotate the implant slightly circumferentially to ensure that the circumferential positions of the ear 022, the plane 321 of the crimping rod 30, and the guide groove 331 are consistent. During the first-stage crimping, sequentially press the non-bent sections 0221 of each ear 022 slightly into the corresponding guide groove 331 of the crimping rod 30, and press the bent section 0222 of the arched ear 022 slightly downward along the plane 321 of the crimping rod 30. Then, after expanding the crimping block 10, put the crimping block 10 on the outer stent 02. After that, by sliding the guide pin 12, press the crimping block 10 to radially compress the crimping block 10 to reduce the overall contour of the double-layer stent. Repeat the above steps until the contour of the double-layer stent changes to the crimping diameter required for the first-stage crimping state. After completing the first-stage crimping, immediately remove the crimping rod 30 and the crimping block 10. At this time, the implant with a double-layer stent continues to be retained in the low-temperature loading solution in the first-stage crimped form.

[0158] Second step: As Figure 14 shown, partially insert the metal guide rod 110 between the outer sheath 20 and the inner sheath 40, and expose the limit block 1133 and the tapered opening 112. It should be understood that the metal guide rod 110 does not need to be inserted too deep into the delivery system and only needs to partially overlap with the outer sheath 20.

[0159] Third step: As Figure 15 shown, use the funnel 50 to complete the change of the implant from the first-stage crimping to the second-stage crimping.

[0160] Specifically, before using the funnel 50, first hang the lug 011 of the inner stent 01 at the distal end of the mandrel 60 (such as a notch), and then operate the delivery system to advance or retract the inner sheath 40 to press against the lug 011 to prevent the lug 011 from disengaging from the mandrel 60, thereby realizing the connection between the implant with a double-layer stent and the delivery system. After that, after the funnel section 51 and the cylindrical section 52 of the funnel 50 are connected and fixed, the funnel 50 is axially aligned with the delivery system. The funnel section 51 gradually approaches the ear 022 of the double-layer stent (which has been straightened), and the funnel 50 is gradually pressed axially from the distal end to the proximal end over the outer stent 02 until the cylindrical section 52 of the funnel 50 covers the entire implant. During this process, the flange 021 is straightened axially by the funnel section 51 to obtain a secondary crimping configuration.

[0161] Step 4: As Figure 16 shown, separate the funnel section 51 and the cylindrical section 52, and move the funnel section 51 from the distal end to the proximal end direction to the rear of the outer sheath 20 (i.e., the proximal region) to prevent the funnel section 51 from affecting the operation of the front part (i.e., the distal region). It should be understood that the funnel section 51 needs to be moved to a position outside the length of the first loading housing 710 or the first loading housing 720. It should also be understood that after separating the funnel section 51 and the cylindrical section 52, the implant 200 in the secondary crimping state remains in the cylindrical section 52, but the distal end of the mandrel 60 is still connected to the lug 011, and at the same time, the distal end of the inner sheath 40 wraps around the lug 011.

[0162] Step 5: As Figure 17 shown, after removing the funnel section 51, first install half of the first loading housing 710. At this time, ensure that the large-diameter end face of the first tapered hole 716 is flush with the end face of the cylindrical section 52 of the funnel 50, the large-diameter end face of the second tapered hole 717 is flush with the large-diameter end face of the tapered opening 112 of the metal guide rod 110, and the limiting end face 719 is flush with the outer step of the two soft sections 21 of the sheath.

[0163] Step 6: As Figure 18 shown, install the other half structure of the first loading housing 710. The two half structures are positioned and fastened by the concave-convex card slot 7110, and at the same time, install the first locking device 910 and the second locking device 920 on the first loading housing 710. The first locking device 910 is locked on the proximal side of the second locking device 920, especially at the position where the metal guide rod 110 exposes the tapered opening 112 of the outer sheath 20 to strengthen the strength of this position; the second locking device 920 is locked at the mating position of the cylindrical section 52 of the funnel 50 and the straight hole 715 to strengthen the strength of this mating position.

[0164] Step 7: As Figure 19As shown, after fixing the two locking devices 90, operate the delivery system to retract the mandrel 60 and the inner sheath 40 together in the proximal direction, pulling the implant 200 in the cylindrical section 52 through the first tapered hole 716 and directly into the metal guide rod 110. During the process of introducing the implant into the metal guide rod 110, the metal guide rod 110 separates the direct contact between the implant and the inner wall of the outer sheath 20, so the soft section 21 of the sheath will not be damaged by delamination. At the same time, the distal end of the outer sheath 20 wraps around the tapered opening 112 of the metal guide rod 110 by the second tapered hole 717, and the proximal end of the outer sheath 20 is in an interference fit with the hard section 22 of the sheath by the interference fit section 7111. Based on this, the outer sheath 20 is firmly wrapped at both ends of the outer sheath 20, preventing the outer sheath 20 from axially moving and avoiding damage such as wrinkles on the outer sheath 20. At the same time, during the operation, the soft section 21 of the sheath and the clearance fit section 718 are in a clearance fit and will not be subjected to any force. Therefore, the soft section 21 of the sheath will not be damaged by delamination or the like.

[0165] Step Eight: As Figure 20 shown, after introducing the implant 200 into the metal guide rod 110, remove the locking device 90 and the first loading outer tool 710 in sequence, and then withdraw the metal guide rod 110, so that the implant 200 in the secondary crimping state is left inside the distal end of the soft section 21 of the sheath. It should be understood that the metal guide rod 110 can be taken out from the distal end of the delivery system in the direction away from the proximal end. Accordingly, the crimping and loading of the implant 200 are completed.

[0166] Secondly, referring to Figures 21 to 23 , and combining with Figure 15 , Figure 16 , Figure 18 , in a non-limiting operation, the second loading method includes six steps, namely the following Step One to Step Six, and the steps that are the same as those in the first loading method will not be described again.

[0167] Step One: The same as Step One in the first loading method.

[0168] Step Two: Refer to Step Three in the first loading method and see Figure 21 . Figure 21 In, there is no metal guide rod 110 between the outer sheath 20 and the inner sheath 40.

[0169] Step Three: Refer to Step Four in the first loading method and see Figure 22 . Similarly, Figure 22 there is no metal guide rod 110 in.

[0170] Step Four: As Figure 23As shown, after removing the funnel section 51, first install half of the second loading outer tool 720, and ensure that the large-diameter end face of the tapered hole 725 of the half structure is flush with the end face of the cylindrical section 52 of the funnel 50 (including fitting and alignment), the small-diameter end face of the tapered hole 725 is flush with the distal end face of the soft section 21 of the sheath tube, the limiting end face 728 is flush with the transition section of the two soft sections 21 of the sheath tube, and the soft elastic material 727 wraps the entire soft section 21 of the sheath tube.

[0171] Step 5: Refer to Step 6 in the first loading method, and see Figure 18 . Specifically, install the other half structure of the second loading outer tool 720. The two half structures are positioned and fastened by the concave-convex card slots 729, and at the same time, install the first locking device 910 and the second locking device 920 on the second loading outer tool 720. The first locking device 910 is locked on the proximal side of the second locking device 920, especially at the position of the distal end of the outer sheath tube 20, to strengthen the strength of this position; the second locking device 920 is locked at the mating position of the cylindrical section 52 of the funnel 50 and the straight hole 724, thereby strengthening the strength of this mating position.

[0172] Step 6: After fixing the locking device 90, operate the delivery system to make the mandrel 60 and the inner sheath tube 40 retreat together in the proximal direction, and pull the implant 200 in the cylindrical section 52 through the tapered hole 725 and directly enter the distal end of the soft section 21 of the sheath tube. During this operation process, due to the soft material property of the soft elastic material 727, when it is coated outside the soft section 21 of the sheath tube, it is always in an interference fit state and protects on the outside of the soft section 21 of the sheath tube. At the same time, due to the large-area contact between the soft elastic material 727 and the soft section 21 of the sheath tube, the friction force between the two is greatly increased, and through the interference fit between the interference fit section 7210 and the hard section 22 of the sheath tube, the outer sheath tube 20 is firmly wrapped. Therefore, during the operation process, under the action of the strong wrapping force and friction force, the outer sheath tube 20 avoids the possibility of axial movement and the risk of fold damage. Moreover, since the soft section 21 of the sheath tube and the clearance fit section 726 are in clearance fit and will not be subjected to any force, the soft section 21 of the sheath tube will not show delamination damage.

[0173] After introducing the implant into the distal end of the outer sheath tube 20, finally, remove the two locking devices 90 and the second loading outer tool 720, and the loading of the implant 200 is completed.

[0174] In summary, according to the technical solution provided by the embodiments of the present invention, the present invention can achieve the loading of an implant with a flange 021 and an ear 022, and an ear 011 provided at the inflow end, ensuring the loading requirements of such implants. During the loading process, the outer sheath tube 20 can be restrained by the loading outer shell 70 and the locking device 90, avoiding axial movement of the outer sheath tube 20 and preventing damage such as wrinkles and delamination of the outer sheath tube 20. Finally, the implant can be safely and effectively loaded into the delivery system without affecting the performance of the outer sheath tube 20. In addition, the present invention can protect the soft section 21 of the sheath tube of the delivery system by one or more means, reducing the damage to the soft section 21 of the sheath tube during the introduction of the implant into the delivery system, and further ensuring the performance of the outer sheath tube 20.

[0175] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention is also intended to include these modifications and variations.

Claims

1. A loading tool for an implant for loading the implant into a delivery system, the implant including a stent, the inflow end of the stent being provided with a lug and a flange, the outflow end of the stent being connected with a grasping ear, the grasping ear being bent and disposed around the stent, the loading tool comprising: A pressing block having a pressing cavity penetrating along its own axis, the pressing block being capable of radially contracting and radially expanding, and being used for performing primary pressing on the implant in a natural state through the pressing cavity; A pressing rod having a through hole penetrating along its own axis, the pressing rod being used for inserting into the implant and supporting the implant and straightening the grasping ear during primary pressing; A funnel including a funnel section and a cylindrical section, the funnel section and the cylindrical section being detachably connected, the funnel being used for moving proximally along the axis of the delivery system when the funnel section and the cylindrical section are connected, so as to perform secondary pressing on the implant in a primary pressing state and simultaneously straighten the flange, and the funnel being further used for disconnecting the connection between the funnel section and the cylindrical section after the implant in the secondary pressing state enters the cylindrical section; A loading housing for covering the outside of the outer sheath tube in the delivery system, the distal end of the loading housing being used for engaging with one end where the cylindrical section is connected to the funnel section, so that the implant in the secondary pressing state in the cylindrical section can be introduced into the distal end of the outer sheath tube through the distal end of the loading housing; and, A locking device for locking the loading housing during the process of introducing the implant into the outer sheath tube, and the locking device being further used for unlocking the loading housing after the implant is introduced into the distal end of the outer sheath tube.

2. The loading tool for the implant according to claim 1, characterized in that, The distal end of the loading housing is provided with a tapered hole, the inner diameter of the large-diameter end of the tapered hole matching the inner diameter of the cylindrical section, and the implant in the secondary pressing state enters the distal end of the outer sheath tube through the tapered hole after leaving the cylindrical section.

3. The loading tool for the implant according to claim 2, characterized in that, The distal end of the loading housing is further provided with a straight hole, the straight hole and the tapered hole being axially communicated; the large-diameter end of the tapered hole is connected to the proximal end of the straight hole; both the tapered hole and the straight hole are used for being exposed outside the distal end of the outer sheath tube, and the straight hole is used for covering one end where the cylindrical section is connected to the funnel section.

4. The loading tool for the implant according to claim 1 or 2, characterized in that, The loading housing includes a distal part and a proximal part, the proximal part being used for covering all or part of the hard sheath section of the outer sheath tube in an interference fit manner; the distal part being used for covering all the soft sheath sections of the outer sheath tube in a clearance fit manner, or a soft elastic material being provided inside the distal part and covering all the soft sheath sections in an interference fit manner through the soft elastic material.

5. The loading tool for the implant according to claim 4, characterized in that, The inside of the distal part is provided with a limiting end surface matching the outer step of the soft sheath section.

6. The loading tool for the implant according to claim 1 or 2, characterized in that, The pressing block includes at least three pressing pieces, all the pressing pieces enclosing and forming a polygonal frame with the pressing cavity, the pressing pieces being telescopically connected in pairs, and the pressing cavity having a closed polygonal contour.

7. The loading tool for the implant according to claim 6, characterized in that, The number of side lengths of the polygonal contour is an even number, and at least one pair of opposite sides of the polygonal contour form parallel planes.

8. The loading tool for an implant according to claim 1 or 2, characterized in that, The pressing and holding rod is successively provided with a circular main body section, a flat section, and a guiding groove section along its own axial direction; On the outer peripheral surface of the flat section, a plurality of flats are provided along the circumferential direction of the pressing and holding rod, the number of the flats being the same as the number of the ear catches, and the flats being used for straightening the bent sections of the ear catches; On the outer peripheral surface of the guiding groove section, a plurality of guiding grooves are provided along the circumferential direction of the pressing and holding rod, the number of the guiding grooves being the same as the number of the ear catches, the guiding grooves being axially aligned with the flats, and the guiding grooves being used for embedding and straightening the non-bent sections of the ear catches.

9. The loading tool for the implant according to claim 1 or 2, characterized in that, The funnel section has a conical inner hole, a limiting flat surface, and a threaded inner hole, the inner diameter of the small-diameter end of the conical inner hole being smaller than the inner diameter of the threaded inner hole and forming the limiting flat surface; the inner diameter of the small-diameter end of the conical inner hole is matched with the inner diameter of the cylindrical section; The cylindrical section has an external threaded section, and the outer diameter of the cylindrical section is matched with the inner diameter of the threaded inner hole; One end of the cylindrical section is inserted into the threaded inner hole and is threadedly connected with the threaded inner hole through the external threaded section, and the limiting flat surface is used for limiting the depth of insertion of the cylindrical section into the threaded inner hole.

10. The loading tool for the implant according to claim 1 or 2, characterized in that, The loading tool further includes a metal guiding rod, the metal guiding rod being a thin-walled tube, and one end of the metal guiding rod being provided with a tapered opening; The metal guiding rod is used for partially inserting between the outer sheath tube and the inner sheath tube in the delivery system, and making the tapered opening expose outside the distal end of the outer sheath tube; the implant in the second-level pressing and holding state in the cylindrical section can be introduced into the metal guiding rod through the distal end of the loading housing; the metal guiding rod is further used for withdrawing from the delivery system after introducing the implant in the second-level pressing and holding state.

11. The loading tool for the implant according to claim 10, characterized in that, The loading housing is a first type of loading housing, and the first type of loading housing is formed by buckling two half sub-components; At the distal end of the first type of loading housing, there are axially communicating straight holes, a first tapered hole, and a second tapered hole; the large-diameter end of the first tapered hole is connected to the proximal end of the straight hole, and the inner diameter of the large-diameter end of the first tapered hole is matched with the inner diameter of the cylindrical section; the large-diameter end of the second tapered hole is connected to the small-diameter end of the first tapered hole; the small-diameter end of the first tapered hole is used for aligning with the flared end of the tapered opening; The straight hole, the first tapered hole, and the second tapered hole are all used for exposing outside the distal end of the outer sheath tube; the second tapered hole is used for covering the whole tapered opening; the straight hole is used for covering the end of the cylindrical section connected to the funnel section; the implant in the second-level pressing and holding state in the cylindrical section is used for being introduced into the metal guiding rod through the first tapered hole.

12. The loading tool for the implant according to claim 11, characterized in that, Symmetric limiting blocks are provided on the outer peripheral surface of the metal guiding rod except for the tapered opening, and through slots are provided on the first type of loading housing, and the limiting blocks are used for exposing outside the distal end of the outer sheath tube and inserting into the through slots.

13. The loading tool for the implant according to claim 1 or 2, characterized in that, The loading housing is a second type of loading housing, and the second type of loading housing is formed by buckling two half sub-components; The distal end of the second type of loading shell is provided with an axially connected straight hole and a tapered hole; the large diameter end of the tapered hole is connected to the proximal end of the straight hole; the inner diameter of the large diameter end of the tapered hole matches the inner diameter of the cylindrical section; the tapered hole and the straight hole are both used to be exposed outside the distal end of the outer sheath tube; the straight hole is used to cover one end of the cylindrical section connected to the funnel section; the implant in the secondary crimping state in the cylindrical section can be directly introduced into the distal end of the outer sheath tube via the tapered hole.

14. The loading tool for the implant according to claim 1 or 2, characterized in that, The loading tool comprises two loading outer shells, the two loading outer shells are respectively a first loading outer shell and a second loading outer shell, and both loading outer shells are formed by buckling two half parts; The loading tool is configured to selectively load the implant into the delivery system using a first loading method or a second loading method; The first loading outer shell is applied to the first loading method, which includes: inserting a metal guide rod between the outer sheath and the inner sheath in the delivery system, and making the tapered end of the metal guide rod exposed outside the distal end of the outer sheath, and after the funnel section is withdrawn from the outer sheath, the outer sheath and the tapered end are covered by the first loading outer shell, and then under the action of the inner sheath and the core rod in the delivery system, the implant in the secondary gripping state is introduced into the metal guide rod, and after the implant in the secondary gripping state is introduced into the metal guide rod, the locking device, the loading outer shell and the metal guide rod are removed in sequence; The second loading outer shell is applied to the second loading method, which includes: directly introducing the implant in the secondary gripping state in the cylindrical segment into the distal end of the outer sheath tube via the distal end of the loading outer shell, and then removing the locking device and the loading outer shell in turn.

15. The loading tool for the implant according to claim 1 or 2, characterized in that, At least one of the locking devices is arranged outside the distal end of the stowage housing.

16. The loading tool for the implant according to claim 15, characterized in that, The loading tool comprises at least two locking devices, at least one of which is arranged at a position where the distal end of the outer sheath cooperates with the loading outer shell, and at least another of which is arranged at a position where the distal end of the loading outer shell cooperates with the cylindrical section.

17. The loading tool for the implant according to claim 16, characterized in that, There are two types of locking devices, which are a first locking device and a second locking device. The first locking device clamps the loading outer shell through a concave-convex structure at the position where the distal end of the outer sheath tube cooperates with the loading outer shell, and the second locking device elastically clamps the loading outer shell through a groove at the position where the distal end of the loading outer shell cooperates with the cylindrical section.

18. An implant loading system, characterized in that, A loading tool comprising a delivery system and an implant as claimed in any one of claims 1 to 17; The delivery system comprises an outer sheath tube, an inner sheath tube and a core rod; the inner sheath tube is used to partially penetrate the lumen of the outer sheath tube, and the core rod is used to partially penetrate the lumen of the inner sheath tube; The distal end of the mandrel is used for detachably connecting with the lug of the implant, and the distal end of the inner sheath tube is used for sleeving outside the lug; the inner sheath tube and the mandrel are used for synchronously moving proximally along the axial direction of the delivery system to introduce the implant in the secondary crimping state into the distal end of the outer sheath tube.

19. An implant system, characterized in that, It includes an implant and a loading system of the implant as described in claim 18. The implant includes a stent. The inflow end of the stent is provided with a lug and a flange, and the outflow end of the stent is connected with a grasping ear. The grasping ear is bent and arranged on the periphery of the stent. The loading system is used for crimping the implant through the loading tool and introducing the crimped implant into the delivery system.

20. The implant system according to claim 19, wherein The stent is a single-layer stent or a double-layer stent. When the stent is a double-layer stent, the lug is arranged at the inflow end of the inner stent, the flange is arranged at the inflow end of the outer stent, the grasping ear extends based on the outflow end of the outer stent or the inner stent, and the grasping ear is bent and arranged on the periphery of the outer stent.

21. A method for loading an implant, characterized in that, Using the loading system of the implant as described in claim 18 to load the implant into the delivery system. The implant includes a stent. The inflow end of the stent is provided with a lug and a flange, and the outflow end of the stent is connected with a grasping ear. The grasping ear is bent and arranged on the periphery of the stent. The loading method includes: Under the cooperation of the crimping block and the crimping rod, crimp the implant in the natural state to the primary crimping state, and straighten the grasping ear through the crimping rod during the primary crimping. After the primary crimping, arrange the implant in the primary crimping state at the distal end of the outer sheath tube, detachably connect the distal end of the mandrel with the lug, and sleeve the distal end of the inner sheath tube outside the lug. During the secondary crimping, keep the implant stationary, and move the funnel axially from the distal end to the proximal end until the implant is changed from the primary crimping state to the secondary crimping state, and the cylindrical section is positioned to sleeve outside the implant in the secondary crimping state. After the secondary crimping, release the connection between the cylindrical section and the funnel section, and move the funnel section proximally and withdraw it from the outer sheath tube. After the funnel section withdraws from the outer sheath tube, cover the outer sheath tube with the loading outer tool, lock the loading outer tool with the locking device, and then move the inner sheath tube and the mandrel synchronously proximally until the implant in the secondary crimping state is introduced into the distal end of the outer sheath tube.

22. The method for loading an implant according to claim 21, wherein Based on at least one of the first loading method and the second loading method, load the implant into the delivery system. The first loading method includes: inserting a metal guiding rod between the outer sheath tube and the inner sheath tube, and exposing the tapered opening at one end of the metal guiding rod outside the distal end of the outer sheath tube. After the funnel section is withdrawn from the outer sheath tube, the outer sheath tube and the tapered opening are covered by the loading housing. Then, under the action of the inner sheath tube and the mandrel, the implant in the secondary crimped state is introduced into the metal guiding rod. After the implant in the secondary crimped state is introduced into the metal guiding rod, the locking device, the loading housing, and the metal guiding rod are removed in sequence; The second loading method includes: directly introducing the implant in the secondary crimped state into the distal end of the outer sheath tube under the action of the inner sheath tube and the mandrel, and then removing the locking device and the loading housing in sequence.

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