Loading tool and loading system for implant, implant system, and loading method

Abstract

The present invention provides a loading tool and loading system for an implant, an implant system, and a loading method. The loading tool comprises a pressing and holding block configured for performing primary pressing and holding on the implant through a pressing and holding cavity; a pressing and holding rod configured for straightening a grabbing lug and supporting the implant during the primary pressing and holding; a funnel configured for moving in an axial direction when a funnel section is connected to a cylindrical section so as to perform secondary pressing and holding on the implant and straighten a flange and disconnect the funnel section from the cylindrical section after the implant in the secondary pressing and holding enters the cylindrical section; a loading outer casing surrounding an outer sheathe tube, wherein a distal end of the loading outer casing is connected to the end of the cylindrical section connected to the funnel section, such that the implant in a secondary pressing and holding state in the cylindrical section is guided into a distal end of the outer sheathe tube through the distal end of the loading outer casing; and a locking device configured for locking the loading outer casing in the process of guiding the implant into the outer sheathe tube. The present invention can achieve pressing and holding and loading of an implant provided with a flange, a grabbing lug and a hanging lug arranged at an inflow end.

Description

Implant loading tool, loading system, implant system and loading method 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 membranous structures that open and close in humans and certain animals. Every heart has four valves: the aortic valve, which connects the left ventricle to the aorta; the pulmonary valve, which connects the right ventricle to the pulmonary artery; the mitral valve, which connects the left atrium to the left ventricle; and the tricuspid valve, which connects the right atrium to the right ventricle. Each valve acts as a one-way valve, preventing blood from flowing in one direction but not in the opposite direction.

[0003] With socioeconomic development and an aging population, the incidence of valvular heart disease has increased significantly. Studies have shown that the prevalence of valvular heart disease in the elderly over 75 years old is as high as 13.3%. Currently, traditional surgical treatment remains the preferred treatment for patients with severe valvular disease. However, for patients of advanced age, those with multi-organ disease, those with a history of open-chest surgery, and those with poor cardiac function, traditional surgery carries significant risks and high mortality rates, and some patients may not even be eligible for surgery. Transcatheter valve replacement, with its advantages of not requiring a thoracotomy, minimal trauma, and rapid patient recovery, has garnered widespread attention from experts and scholars.

[0004] Before transcatheter delivery of a valve implant, it must be loaded, collapsing the implant and allowing it to be introduced into the catheter-based delivery system with a smaller profile. Existing loading systems for valve implants have various configurations, each designed specifically for the stent's structure. However, these existing loading systems are not suitable for loading stents with flanges, stents with lugs located at the inflow end, or stents with gripping lugs.

[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 any form of implication that the information constitutes prior art already known to those skilled in the art.

[0006] Summary of the Invention

[0007] 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.

[0008] To achieve the above-mentioned purpose, the present invention provides a loading tool for an implant, which is used to load an implant into a conveying system, wherein the implant includes a bracket, the inflow end of the bracket is provided with a hanging ear and a flange, the outflow end of the bracket is connected to a grab ear, and the grab ear is bent and arranged on the periphery of the bracket, and the loading tool includes: a gripping block, which has a gripping cavity that passes through along its own axis, the gripping block can radially contract and expand radially, and is used to perform a first-level grip on the implant in a natural state through the gripping cavity; a gripping rod, which has a through hole that passes through along its own axis, the gripping rod is used to be inserted into the implant and support the implant and straighten the grab ear during the first-level gripping; a funnel, which includes a funnel section and a cylindrical section, the funnel section and the cylindrical section can be detachably connected, and the funnel is used to squeeze along the cylindrical section when the funnel section and the cylindrical section are connected. The conveying system moves axially proximally to perform a secondary grip on the implant in the primary grip state and straighten the flange at the same time, and the funnel is also used to release the connection between the funnel segment and the cylindrical segment after the implant in the secondary grip state enters the cylindrical segment; a loading outer shell is used to cover the outside of the outer sheath tube in the conveying system, and the distal end of the loading outer shell is used to engage the end connected to the cylindrical segment and the funnel segment, so that the implant in the secondary grip state in the cylindrical segment can be introduced into the distal end of the outer sheath tube via the distal end of the loading outer shell; and a locking device is used to lock the loading outer shell during the process of introducing the implant into the outer sheath tube, and the locking device is also used to release the lock of the loading outer shell after the implant is introduced into the distal end of the outer sheath tube.

[0009] Optionally, a tapered hole is provided at the distal end of the loading shell, the inner diameter of the large diameter end of the tapered hole matches the inner diameter of the cylindrical segment, and the implant in the secondary gripping state leaves the cylindrical segment and is introduced into the distal end of the outer sheath through the tapered hole.

[0010] Optionally, a straight hole is further provided at the distal end of the loading shell, and the straight hole and the tapered hole are connected in the axial direction; the large diameter end of the tapered hole is connected to the proximal end of the straight hole; the tapered hole and the straight hole are both used to be exposed outside the distal end of the outer sheath tube, and the straight hole is used to cover the end where the cylindrical section is connected to the funnel section.

[0011] Optionally, the loading outer shell includes a distal part and a proximal part, the proximal part is used to cover all or part of the hard section of the outer sheath tube in an interference fit manner; the distal part is used to cover all the soft sections of the outer sheath tube in a clearance fit manner, or, the inner side of the distal part is provided with a soft elastic material, and the entire soft section of the sheath tube is covered by the soft elastic material in an interference fit manner.

[0012] Optionally, a limiting end surface is provided inside the distal portion to match the outer step of the sheath soft section.

[0013] Optionally, the crimping block includes at least three crimping pieces, all of which enclose and form a polygonal frame with the crimping cavity, the crimping pieces are telescopically connected in pairs, and the crimping cavity has a closed polygonal outline.

[0014] Optionally, the number of side lengths of the polygonal outline is an even number, and at least one set of opposite sides of the polygonal outline forms parallel surfaces.

[0015] Optionally, the pressure grip rod is provided with a circular main body section, a plane section and a guide groove section in sequence along its own axial direction; the outer circumferential surface of the plane section is provided with a plurality of planes along the circumference of the pressure grip rod, the number of the planes is consistent with the number of the grab ears, and the planes are used to straighten the bent sections of the grab ears; the outer circumferential surface of the guide groove section is provided with a plurality of guide grooves along the circumference of the pressure grip rod, the number of the guide grooves is consistent with the number of the grab ears, the guide grooves are aligned with the planes in the axial direction, and the guide grooves are used to embed and straighten the non-bent sections of the grab ears.

[0016] 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; the cylindrical section has an external threaded section, the outer diameter of the cylindrical section matches 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 to the threaded inner hole through the external threaded section, and the limiting plane is used to limit the depth of the cylindrical section inserted into the threaded inner hole.

[0017] Optionally, the loading tool also includes a metal guide rod, which is a thin-walled tube, and one end of the metal guide rod is set as a tapered mouth; 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 grip state within the cylindrical segment can be introduced into the metal guide rod via the distal end of the loading outer shell; the metal guide rod is also used to evacuate the delivery system after the implant in the secondary grip state is introduced.

[0018] Optionally, the loading outer shell is a first type of loading outer shell, which is formed by snapping together two half parts; the distal end of the first type of loading outer shell is provided with an axially connected straight hole, a first conical hole and a second conical hole; the large diameter end of the first conical hole is connected to the proximal end of the straight hole, and the inner diameter of the large diameter end of the first conical hole matches the inner diameter of the cylindrical section; the large diameter end of the second conical hole is connected to the small diameter end of the first conical hole; the small diameter end of the first conical hole is used to align with the flared end of the conical mouth; the straight hole, the first conical hole and the second conical hole are all used to be exposed outside the distal end of the outer sheath; the second conical hole is used to cover the entire conical mouth; the straight hole is used to cover one end of the cylindrical section connected to the funnel section; the implant in the secondary pressure-gripping state in the cylindrical section is used to be introduced into the metal guide rod through the first conical hole.

[0019] Optionally, the metal guide rod is provided with symmetrically arranged limit blocks on its outer circumference except the tapered mouth, and the first type of 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.

[0020] Optionally, the loading outer shell is a second type of loading outer shell, which is formed by snapping together two halves; the distal end of the second type of loading outer 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; the straight hole is used to cover one end of the cylindrical section connected to the funnel section; the implant in the secondary grip state in the cylindrical section can be introduced into the distal end of the outer sheath through the tapered hole.

[0021] Optionally, the loading tool includes 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 halves; the loading tool is configured to selectively adopt the first loading method or the second loading method to load the implant into the delivery system; the first loading outer shell is applied to the first loading method, and the first loading method includes: inserting a metal guide rod between the outer sheath and the inner sheath in the delivery system, and making one end of the metal guide rod tapered outside the distal end of the outer sheath, and the funnel section is withdrawn from the outer sheath. sheath, the first loading outer shell covers the outer sheath and the tapered mouth, and then under the action of the inner sheath and the core rod, the implant in the secondary crimping state is introduced into the metal guide rod. After the implant in the secondary crimping 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, and the second loading method includes: directly introducing the implant in the secondary crimping state in the cylindrical segment into the distal end of the outer sheath via the distal end of the loading outer shell, and then removing the locking device and the loading outer shell in sequence.

[0022] Optionally, at least one of the locking devices is arranged outside the distal end of the outer loading shell.

[0023] Optionally, the loading tool includes at least two locking devices, at least one locking device is arranged at a position where the distal end of the outer sheath cooperates with the loading outer shell, and at least another locking device is arranged at a position where the distal end of the loading outer shell cooperates with the cylindrical section.

[0024] Optionally, there are two types of locking devices, namely 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.

[0025] Based on the same inventive concept, the present invention also provides an implant loading system, which includes a delivery system and a loading tool for any one of the implants described; the delivery system includes an outer sheath, an inner sheath and a core rod; the inner sheath is used to be partially inserted into the lumen of the outer sheath, and the core rod is used to be partially inserted into the lumen of the inner sheath; the distal end of the core rod is used to be detachably connected to the lug of the implant, and the distal end of the inner sheath is used to be sleeved on the outside of the lug; the inner sheath and the core rod are used to move synchronously along the axial direction of the delivery system toward the proximal end to introduce the implant in the secondary grip state into the distal end of the outer sheath.

[0026] Based on the same inventive concept, the present invention also provides an implant system, which includes an implant and a loading system for the implant, wherein the implant includes a bracket, the inflow end of the bracket is provided with a hanging ear and a flange, the outflow end of the bracket is connected to a grab ear, and the grab ear is bent and arranged on the periphery of the bracket, and the loading system is used to press and grip the implant through the loading tool, and introduce the pressed implant into the conveying system.

[0027] Optionally, the bracket is a single-layer bracket or a double-layer bracket. When the bracket is a double-layer bracket, the hanging ear is arranged at the inflow end of the inner bracket, the flange is arranged at the inflow end of the outer bracket, the grab ear extends based on the outflow end of the outer bracket or the inner bracket, and the grab ear is bent and arranged on the periphery of the outer bracket.

[0028] Based on the same inventive concept, the present invention also provides a loading method for an implant, which uses the loading system of the implant to load the implant into the conveying system, wherein the implant includes a bracket, the inflow end of the bracket is provided with a hanging ear and a flange, the outflow end of the bracket is connected with a grab ear, and the grab ear is bent and arranged on the periphery of the bracket, and the loading method includes: under the cooperation of the gripping block and the gripping rod, the implant in the natural state is gripped to a first-level gripping state, and the gripping ear is straightened by the gripping rod during the first-level gripping; after the first-level gripping, the implant in the first-level gripping state is arranged at the distal end of the outer sheath, and the distal end of the core rod is detachably connected to the hanging ear, and the distal end of the inner sheath is sleeved On the outside of the ear; during the secondary crimping process, the implant is kept stationary, and the funnel is moved axially from the distal end to the proximal end until the implant is transformed from the primary crimping state to the secondary crimping state, and the cylindrical section is positioned on the outside of the implant in the secondary crimping state; after the secondary crimping, the connection between the cylindrical section and the funnel section is released, and the funnel section is moved proximally and evacuated from the outer sheath; after the funnel section is evacuated from the outer sheath, the outer sheath is covered by the loading outer shell, and the loading outer shell is locked by the locking device, and then the inner sheath and the core rod are moved synchronously in the proximal direction until the implant in the secondary crimping state is introduced into the distal end of the outer sheath.

[0029] Optionally, the implant is loaded into the delivery system based on at least one of the first loading method and the second loading method: the first loading method includes: inserting a metal guide rod between the outer sheath and the inner sheath, 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 loading outer shell, and then under the action of the inner sheath and the core rod, the implant in the secondary grip state is introduced into the metal guide rod, and after the implant in the secondary grip 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 method includes: under the action of the inner sheath and the core rod, the implant in the secondary grip state is directly introduced into the distal end of the outer sheath, and then, the locking device and the loading outer shell are removed in sequence.

[0030] 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 conveying system, the implant needs to be subjected to secondary crimping by the loading tool. During the primary crimping, it is completed by the cooperation of the crimping rod and the crimping block in the loading tool, and the grab ears on the implant can be straightened at the same time. During the secondary crimping, uniform crimping is achieved by the funnel in the loading tool, and the flange on the implant can be straightened. After the crimping of the implant is completed, the outer loading shell and the locking device in the loading tool are used to fix the outer sheath in the conveying system, and the connection between the outer sheath and the cylindrical section in the funnel is realized. Under the premise of ensuring reliable locking, the implant in the secondary crimping state is introduced into the distal end of the outer sheath through the distal end of the loading shell through the linkage of the inner sheath and the core rod in the conveying system.

[0031] Such a configuration enables the present invention to realize the loading of implants with flanges and grab ears and the hanging ears are arranged at the inflow end, ensuring the loading needs of such implants. Moreover, during the loading process, the outer sheath can be constrained by the loading shell, reducing the axial movement of the outer sheath to avoid wrinkling, delamination and other damages, and ultimately the implant can be safely and effectively loaded into the delivery system.

[0032] Furthermore, in the implant loading tool, implant loading system, implant system and loading method provided by the present invention, the soft segment of the outer sheath can be protected by a metal guide rod, or the soft segment of the sheath can be wrapped with a soft elastic material layer for protection, thereby reducing damage to the soft segment of the sheath during the introduction of the implant into the delivery system, and further ensuring the performance of the outer sheath. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0034] FIG1 is an exploded view of a crimping block of an implant loading tool according to an embodiment of the present invention;

[0035] FIG2 is an assembly diagram of a crimping block of an implant loading tool according to an embodiment of the present invention;

[0036] 3 is a schematic structural diagram of a gripping rod of an implant loading tool according to an embodiment of the present invention;

[0037] FIG4 is a schematic structural diagram of a funnel of an implant loading tool according to an embodiment of the present invention;

[0038] FIG5 is a schematic axial cross-sectional view of a funnel of an implant loading tool according to an embodiment of the present invention;

[0039] 6 is an exploded view of a first loading housing of an implant loading tool according to an embodiment of the present invention;

[0040] 7 is an exploded view of a second loading housing of an implant loading tool according to an embodiment of the present invention;

[0041] FIG8 is a schematic structural diagram of a first locking device of an implant loading tool according to an embodiment of the present invention;

[0042] 9 is a schematic structural diagram of a second locking device of an implant loading tool according to an embodiment of the present invention;

[0043] 10 is a schematic structural diagram of a metal guide rod of an implant loading tool according to an embodiment of the present invention;

[0044] 11 is a schematic structural diagram of an implant having a double-layer stent in a natural state according to an embodiment of an implant loading tool of the present invention;

[0045] 12 is a schematic structural diagram of an implant having a double-layer stent in a primary compression grip state according to an embodiment of an implant loading tool of the present invention;

[0046] 13 is a schematic structural diagram of an implant having a double-layer stent in a secondary crimping state according to an embodiment of an implant loading tool of the present invention;

[0047] FIG14 is a schematic diagram showing the operation principle of the second step in the first loading method of the present invention;

[0048] FIG15 is a schematic diagram showing the operation principle of the third step in the first loading method of the present invention;

[0049] 16 is a schematic diagram of the operation principle of the fourth step of the first loading method of the present invention, in which a rectangular frame A placed within the cylindrical section of the funnel represents the implant in the secondary crimping state;

[0050] FIG17 is a schematic diagram showing the operation principle of the fifth step in the first loading method of the present invention;

[0051] FIG18 is a schematic diagram showing the operation principle of the sixth step in the first loading method of the present invention;

[0052] FIG19 is a schematic diagram showing the operation principle of the seventh step in the first loading method of the present invention;

[0053] FIG20 is a schematic diagram showing the operation principle of the eighth step in the first loading method of the present invention;

[0054] FIG21 is a schematic diagram showing the operation principle of the second step in the second loading method of the present invention;

[0055] FIG22 is a schematic diagram showing the operation principle of the third step in the second loading method of the present invention;

[0056] FIG. 23 is a diagram showing the operating principle of the fourth step in the second loading method of the present invention. DETAILED DESCRIPTION

[0057] To make the objects, advantages, and features of the present invention more clearly apparent, the present invention is further described below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale. They are only used to conveniently and clearly assist in illustrating the purposes of the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may need to illustrate different focuses and sometimes use different scales.

[0058] As used in the present invention, the singular forms "a", "an", and "the" include plural referents, the term "or" is generally used to include "and / or", the term "several" is generally used to include "at least one", and the term "at least two" is generally used to include "two or more". In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features specified as "first" and "second" may explicitly or implicitly include one or at least two of the 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 endpoints, and the terms "mounted", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, a direct connection, or an indirect connection through an intermediate medium, and it can be the internal communication between two elements or the interaction relationship between two elements. In addition, as used in the present invention, "one element is disposed on another element" generally only indicates that there is a connection, coupling, cooperation, or transmission relationship between the two elements, and the connection, coupling, cooperation, or transmission between the two elements may be direct or indirect through an intermediate element. It should not be understood as indicating or implying a spatial positional relationship between the two elements. That is, one element can be in any orientation, such as inside, outside, above, below, or to one side of another element, unless the content clearly indicates otherwise. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0059] The terms "distal" and "proximal" as used herein are used in the following description to refer to a position or direction relative to a surgeon (i.e., a surgical operator) when loading a tool or delivery system. Thus, "distal" refers to a position away from the surgeon, or in a direction away from the surgeon, and "proximal" refers to a position in a direction closer to the surgeon. Furthermore, "axial" as used herein refers to a direction along the central axis when loading a tool or delivery system, "circumferential" refers to a direction around the central axis, and "radial" refers to a direction perpendicular to the central axis.

[0060] The present invention aims to provide an implant loading tool, an implant loading system, an implant system and an implant loading method, which are intended to load a valve implant with a stent into a catheter-based delivery system in a crimped configuration.

[0061] The present invention can realize the loading of implants with flanges and gripping ears, and the hanging ears are arranged at the inflow end, ensuring the loading requirements of such implants, and also particularly considering the loading of implants with double-layer brackets.

[0062] The loading tool of the implant of the present invention is configured to be arranged on the distal end of the delivery system. At the same time, the implant is positioned after being compressed, and the implant is loaded into the delivery system in a simple and reliable manner. During the loading process, the axial movement of the outer sheath can be reduced to avoid damage such as wrinkling and delamination, without affecting the performance of the outer sheath.

[0063] It should be understood that the implant comprises a stent and a prosthetic valve, wherein the prosthetic valve comprises at least two leaflets disposed and secured within the stent. The delivery system ultimately delivers the implant to a location within 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 fit within the delivery system must be performed shortly before the implantation procedure, and the implant must be properly loaded into the delivery system without increasing the size of the outer sheath or affecting the performance of the outer sheath.

[0064] The implant can be a variety of heart valve prosthesis types known to those skilled in the art, but in the present invention, the implant has a single-layer stent or a double-layer stent. Regardless of the single-layer stent or the double-layer stent, the inflow end of the stent is provided with a hook and a flange, and the outflow end of the stent is provided with a grab ear, which is bent and provided on the periphery of the stent. For the double-layer stent, it should be further explained that the hook is provided at the inflow end of the inner stent, and the flange is provided at the inflow end of the outer stent. The grab ear can be extended based on the outflow end of the outer stent or the inner stent, that is, the grab ear can be directly connected to the inner stent and then extend from the inside to the outside through the outer stent, or the grab ear can be directly connected to the outer stent and extend to the outside. The structure and function of the flange, hook and grab ear 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 to the delivery system so that the delivery system can deliver the implant; the flange can engage the tissue above the natural valve annulus, such as the surface above the valve annulus or some tissue in the atrium, thereby inhibiting the migration of the implant; the gripping ears can cooperate with the stent to clamp the native valve leaflets, clamping the native valve leaflets between the stent and the gripping ears to enhance stability.

[0065] It should be further explained that, when not in use, the implant is usually stored in a glutaraldehyde solution. When needed, the implant is removed from the glutaraldehyde solution shortly before surgery, and then compressed and loaded in a low-temperature environment provided by a low-temperature loading solution (such as an ice-water mixture).

[0066] 1 to 10 show schematic structural diagrams of the various components of an embodiment of a loading tool for an implant of the present invention, FIG11 to 13 show schematic structural diagrams of an embodiment of an implant of the present invention, and FIG14 to 23 show loading process diagrams of an implant system of the present invention.

[0067] As shown in FIG. 1 to FIG. 10 , the implant loading tool (hereinafter referred to as loading tool) includes a crimping block 10 , a crimping rod 30 , a funnel 50 , a loading housing 70 and a locking device 90 .

[0068] As shown in Figures 11 to 13, the implant comprises a stent, with a lug 011 and a flange 021 at the inflow end of the stent, and a gripping lug 022 connected to the outflow end of the stent. The gripping lug 022 is bent at the location corresponding to the outflow end and then positioned around the stent. In the example of a double-layer stent, the lug 011 is positioned at the inflow end of the inner stent 01, the flange 021 is positioned at the inflow end of the outer stent 02, and the gripping lug 022 extends from the outflow end of the inner stent 01 and, after bending, extends to the outside of the outer stent 02.

[0069] It will be understood that the implant has a compressed structure for delivery within the vascular system and an expanded structure 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 deployed configuration. In particular, the implant is a valve prosthesis with a stent, primarily a mitral valve prosthesis or a tricuspid valve prosthesis. This article uses an implant with a double-layer stent as an example for exemplary description, 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.

[0070] As shown in FIG11 , in one embodiment, the implant comprises a double-layer stent, comprising an inner stent 01 and an outer stent 02, wherein the inner stent 01 is placed within the inner cavity of the outer stent 02; the end of the inner stent 01 corresponding to the inflow channel is the inflow end, which is provided with a hook 011; the inflow end of the outer stent 02 is provided with a flange 021; the end of the outer stent 02 or the inner stent 01 corresponding to the outflow channel is the outflow end, which is provided with a gripping lug 022, which bends at the outflow end. In some embodiments, the gripping lug 022 extends from the inner stent 01, while in other embodiments, the gripping lug 022 extends from the outer stent 02. In any case, in its natural state, the gripping lug 022 comprises a non-bent segment 0221 (generally a straight rod segment) and a bent segment 0222 (i.e., an arcuate rod segment at the bend).

[0071] The implant in its natural state shown in FIG11 requires two levels of crimping to reduce its profile. The first level of crimping straightens the lugs 022 so that they do not protrude beyond the periphery of the outer support 02, and the second level of crimping straightens the flanges 021 so that they do not protrude radially outward. As shown in FIG12 , during the first level of crimping, the lugs 022 are straightened and extended axially from the outflow end toward the inflow end. As shown in FIG13 , the second level of crimping, which is the state in which the implant is introduced into the delivery system, requires the use of a funnel 50 to achieve this, aiming to straighten the flanges 021 and extend axially from the inflow end toward the outflow end. It should be understood that the natural state described in this specification refers to the size and shape of the implant when there are no external constraints.

[0072] As shown in Figures 14 to 23, an embodiment of the present invention further provides an implant system, comprising the implant and a loading system for the implant, wherein the loading system for the implant comprises a delivery system and an implant loading tool. The delivery system comprises an outer sheath 20, an inner sheath 40, and a core rod 60; the inner sheath 40 is configured to partially penetrate the lumen of the outer sheath 20; and the core rod 60 is configured to partially penetrate the lumen of the inner sheath 40. In practice, the implant loading tool is used to compress the implant, which then cooperates with the delivery system to introduce the compressed implant into the delivery system.

[0073] As shown in Figures 1 and 2 , the crimping block 10 has a crimping cavity 101 extending axially through it. The crimping block 10 can radially contract and expand to adjust the size of the crimping cavity 101. When the crimping cavity 101 is enlarged, it can be positioned over the outside of the implant; when it is reduced, it can compress the implant inward. The maximum radial dimension defined by the crimping cavity 101 should be greater than the implant's natural outer diameter. Therefore, the crimping block 10 uses the crimping cavity 101 to perform a primary crimping of the implant in its natural state (see Figure 11).

[0074] As shown in Figure 3, the crimping rod 30 is a hollow, round rod with a through-hole 301 extending axially through it. This through-hole 301 not only reduces the overall weight of the crimping rod 30 but also allows for the passage of a low-temperature loading solution during the loading process, rapidly lowering the temperature of the crimping rod 30, facilitating implant crimping and minimizing implant rebound. The crimping rod 30 is inserted into the implant and supports it during primary crimping. It also serves to straighten the gripping tab 022.

[0075] Referring to Figures 4 and 5, the funnel 50 includes a funnel section 51 and a cylindrical section 52, which are detachably connected, including but not limited to a threaded connection. The funnel 50 plays a role in uniformly compressing 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 conveying system, and then moves toward the proximal end of the conveying system along the axial direction of the conveying system to perform a secondary crimping on the implant in the primary crimping state and straighten the flange 021 at the same time. Finally, the implant in the secondary crimping state enters the cylindrical section 52, and the cylindrical section 52 restrains the implant after the secondary crimping and prepares for subsequent loading. After completing the secondary crimping, the connection between the funnel section 51 and the cylindrical section 52 can be released, and then the funnel section 51 moves toward the proximal end of the conveying system and away from the outer sheath 20.

[0076] As shown in Figures 6 and 7, the loading housing 70 is composed of two interlocking halves. Its function is to wrap around the exterior of the outer sheath 20 during the loading process, restraining the outer sheath 20 and preventing the outer sheath 20 from moving axially. The loading housing 70 is also configured to engage its distal end with the end of the cylindrical section 52 of the funnel 50 where it connects to the funnel section 51, allowing the implant in the secondary crimped state within the cylindrical section 52 to be introduced into the distal end of the outer sheath 20 through the distal end of the loading housing 70.

[0077] As shown in Figures 8 and 9, locking device 90 is any device capable of being locked and unlocked, particularly quick-release and quick-install locking devices. The present invention does not limit its specific structure. Locking device 90 functions to lock outer loading housing 70 during the process of inserting the implant into outer sheath 20, thereby indirectly locking outer sheath 20. After the implant is inserted into the distal end of outer sheath 20, locking device 90 can release the lock on outer loading housing 70, allowing it to be removed.

[0078] The working principle of the present invention for loading an implant includes: first, with the cooperation of the gripping block 10 and the gripping rod 30, the implant in a natural state is gripped to a first-level gripping state, and the gripping ear 022 is straightened by the gripping rod 30 during the first-level gripping; after the first-level gripping, the gripping block 10 and the gripping rod 30 are removed, and before the second-level gripping, the implant in the first-level gripping state is arranged at the distal end of the outer sheath 20, and at the same time, the distal end of the core rod 60 is detachably connected to the ear 011, and the distal end of the inner sheath 40 is sleeved on the outside of the ear 011 to prevent the ear 011 from separating from the core rod 60; then, the second-level gripping is performed, during which the implant is kept stationary and the funnel 50 is moved from the distal end to the proximal end along the axis of the conveying system. Move in the direction until the funnel 50 changes the implant from the primary gripping state to the secondary gripping state, and positions the cylindrical section 52 on the outside of the implant in the secondary gripping state, thus completing the secondary gripping; after the secondary gripping, release the connection between the cylindrical section 52 and the funnel section 51, and allow the funnel section 51 to move alone toward the proximal end of the delivery system and evacuate (i.e., away from) the outer sheath 20; after the funnel section 51 evacuates the outer sheath 20, the outer sheath 20 is covered (clamped) by the loading shell 70, and then the loading shell 70 is locked by the locking device 90; after locking, the inner sheath 40 and the core rod 60 are driven to move synchronously toward the proximal end of the delivery system until the implant in the secondary gripping state is introduced (pulled into) the distal end of the outer sheath 20. After the implant in the secondary gripping state is introduced into the distal end of the outer sheath 20, the locking device 90 and the loading shell 70 are removed to separate the loading tool from the delivery system.

[0079] It should be noted that the implant in the secondary grip state can be introduced directly or indirectly into the distal end of the outer sheath 20. "Indirect introduction" means that the implant is first introduced into the metal guide rod 110, and after the metal guide rod 110 is removed, the implant can be directly placed in the distal end of the outer sheath 20.

[0080] This configuration enables the present invention to load implants with flanges 021 and gripping ears 022, with the lugs 011 located at the inflow end, meeting the loading requirements of such implants. Furthermore, throughout the loading process, the loading housing 70 maintains a tight grip on the outer sheath 20, preventing axial movement of the outer sheath 20. This not only allows the implant to enter the delivery system safely and efficiently, but also prevents damage to the outer sheath 20, such as wrinkling and delamination, thereby ensuring its performance.

[0081] In practice, the present invention can provide two loading methods, and selectively adopt one of the loading methods to load the implant into the delivery system.

[0082] [Example 1]

[0083] First, the first loading method is introduced through Example 1. At this time, as shown in Figure 10, the loading tool of the implant of the present invention also includes a metal guide rod 110. The metal guide rod 110 is a thin-walled tube 111 as a whole, one end of which is set as a tapered mouth 112, and the rest is a cylinder of equal diameter. The end of the tapered mouth 112 away from the equal diameter cylinder is the large diameter end. Preferably, the wall thickness of the metal guide rod 110 is 0.05mm to 0.2mm, more preferably 0.1mm; this wall thickness can ensure that the lumen size of the metal guide rod 110 is sufficient to enclose the secondary pressure-gripped implant, while also reducing the impact on the size of the outer sheath 20 so as not to increase the size of the outer sheath 20.

[0084] During use, the metal guide rod 110 is partially inserted between the outer sheath tube 20 and the inner sheath tube 40, and ensure that the tapered mouth 112 is exposed outside the distal end of the outer sheath tube 20; the metal guide 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 mouth 112 are covered by the loading shell 70, and the loading shell 70 is locked by the locking device 90; then, under the action of the inner sheath tube 40 and the core rod 60, the implant in the secondary grip state is introduced into the metal guide rod 110; after the implant in the secondary grip state is introduced into the metal guide rod 110, the locking device 90, the loading shell 70 and the metal guide rod 110 are removed in turn to complete the loading of the implant.

[0085] Correspondingly, the loading outer shell 70 is a first type of loading outer shell 710 adapted to the metal guide rod 110 .

[0086] Figure 6 shows the two halves of a first type of loading shell 710 in one embodiment. Referring to Figure 6, the first type of loading shell 710 is a hollow structure formed by buckling two halves. The distal end of the first loading shell 710 is provided with an axially connected straight hole 715, a first tapered hole 716 and a second tapered hole 717 in sequence; 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 mouth 112 of the metal guide rod 110; the closed inner diameter of the first tapered hole 716 does not exceed the flared inner diameter of the tapered mouth 112 of the metal guide rod 110. Preferably, the closed inner diameter of the first tapered hole 716 is smaller than the flared inner diameter of the tapered mouth 112, thereby ensuring that the implant in the cylindrical section 52 enters the metal guide rod 110 through the first tapered hole 716 and the tapered mouth 112 without obstruction.

[0087] When using the metal guide rod 110, the first loading housing 710 wraps around the tapered opening 112 of the metal guide rod 110 through the second tapered hole 717, while simultaneously wrapping around the end of the cylindrical section 52 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 20. Furthermore, when one end of the cylindrical section 52 is inserted into the straight hole 715, the insertion depth of the cylindrical section 52 is axially limited by a transition step between the straight hole 715 and the first tapered hole 716. Specifically, the inner diameter of the straight hole 715 is larger than the inner diameter of the expanded first tapered hole 716, forming a transition step. This allows the implant, in the secondary crimped state within the cylindrical section 52, to be introduced into the metal guide rod 110 via the first tapered hole 716. The first tapered hole 716 can also further uniformly compress the implant, thereby further reducing the radial profile of the implant originally compressed in the cylindrical section 52 and helping to smoothly guide the implant into the metal guide rod 110 without increasing the size of the outer sheath 20 .

[0088] Continuing with Figure 10 , in one exemplary embodiment, the metal guide rod 110 is provided with symmetrical stoppers 113 on its outer circumference, which is a cylindrical surface of equal diameter, excluding the tapered opening 112. Accordingly, as shown in Figure 6 , the first type of outer housing 710 is provided with radially extending slots 712. Accordingly, when the metal guide rod 110 is assembled, the stoppers 113 are exposed at the distal end of the outer sheath 20 and inserted into the slots 712, thereby limiting the metal guide rod 110 in both the circumferential and axial directions of the delivery system and preventing its movement.

[0089] Referring to Figures 14 to 20, the outer sheath 20 generally includes a distal soft sheath segment 21 and a proximal hard sheath segment 22. The diameter (including inner diameter and outer diameter) of the soft sheath segment 21 is the same as or different from the diameter (including inner diameter and outer diameter) of the hard sheath segment 22. As in the present embodiment, the diameter of the soft sheath segment 21 is greater than the diameter of the hard sheath segment 22, but it is not limited to this. The soft sheath segment 21 can be a one-stage structure with the same overall diameter, or a multi-stage structure with different diameters, such as a two-stage structure.

[0090] The metal guide rod 110 acts as a capsule structure to receive the implant with the stent. The metal guide rod 110 protects the soft segment of the sheath tube 21 and reduces damage to the soft segment of the sheath tube 21 during the introduction process.

[0091] Furthermore, the first loading outer shell 710 includes a distal portion and a proximal portion arranged along its axial direction. The distal portion covers the entire sheath soft segment 21 of the outer sheath 20 with a clearance fit, thereby reducing the forces acting on the sheath soft segment 21 during loading. With a clearance fit, the sheath soft segment 21 is virtually insulated from any forces, preventing damage such as delamination during operation. In this embodiment, the first loading outer shell 710 further includes a clearance fit segment 718, which is the distal portion and covers the entire sheath soft segment 21 with a clearance fit.

[0092] The proximal portion of the first loading outer shell 710 preferably covers all or part of the outer sheath hard segment 22 of the outer sheath 20 with an interference fit. This effectively secures the outer sheath 20, reduces axial movement of the outer sheath 20 during loading, and minimizes the risk of damage to the outer sheath 20, such as wrinkling and delamination. In this embodiment, the first loading outer shell 710 further includes an interference fit segment 7111, which constitutes the proximal portion.

[0093] Continuing to refer to Figures 14 to 20, in an exemplary embodiment, the outer sheath 20 has two sections of sheath soft segments 21 with different diameters, the diameter of the distal sheath soft segment 21 being larger than the diameter of the proximal sheath soft segment 21, thereby forming an outer step between the two sections of the sheath soft segments 21. Preferably, the interior of the distal portion, such as the clearance fit segment 718, is provided with a limiting end face 719 that matches the outer step formed by the two sections of the sheath soft segments 21 with different outer diameters. The limiting end face 719 is defined by the two sections of the clearance fit segments 718 with different inner diameters. The limiting end face 719 can further limit the axial movement of the outer sheath 20.

[0094] Continuing with FIG6 , as an example, a first loading housing 710 is constructed from two halves connected by a concave-convex snap-fitting groove 7110. This structure is simple, convenient for assembly and disassembly. Given that during loading, the loading housing 70 experiences relatively low forces at the proximal end and high forces at the distal end, the first loading housing 710 preferably engages directly at the proximal end through its own structure, while further tightening at the distal end using a locking device 90 to enhance the locking force and ensure safe and reliable implant loading.

[0095] 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 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.

[0096] 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 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.

[0097] The locking device 90 can lock the first loading outer shell 710 by any means such as form locking and force locking. In this embodiment, there are two types of locking devices 90, namely a first locking device 910 and a second locking device 920. The first locking device 910 tightens the first loading outer shell 710 through a concave-convex structure at the distal end of the outer sheath 20 where it 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 distal end of the first loading outer shell 710 where it matches the cylindrical section 52, so that the junction 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 during the introduction into the delivery system. However, in other embodiments, the first locking device 910 and the second locking device 920 can be arranged in reverse.

[0098] 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.

[0099] Figure 8 illustrates the structure of a first locking device 910 in one embodiment. As shown in Figure 8 , the first locking device 910 is an open, annular locking buckle that can be expanded to snap onto the outside of the first loading shell 710. Optionally, the first locking device 910 includes guide rib grooves 912 and stopper grooves 914; the stopper grooves 914 are symmetrically arranged on the wall of the sleeve hole; the guide rib grooves 912 are located between the stopper grooves 914.

[0100] Referring to FIG6 , the first type of loading housing 710 is provided with a guide rib 713 and a stopper 714. There is one guide rib 713, which extends from the distal end to the proximal end along the axial direction of the first type of loading housing 710. The guide rib 713 cooperates with the guide rib groove 912 in the first type of locking device 910 to secure the first type of locking device 910 to the first type of loading housing 710. The stopper 714 is symmetrically arranged on the side of the first type of loading housing 710. The stopper 714 cooperates with the stopper groove 914 in the first type of locking device 910 to achieve locking via a taper. That is, the first type of locking device 910 and the first type of loading housing 710 are locked together via a concave-convex structure. One or more groups of stopper 714 are provided axially along the first type of loading housing 710, with each group comprising two stopper 714 symmetrically arranged radially. Preferably, multiple groups of limiting cone blocks 714 are provided on the first loading outer shell 710 , so as to conveniently and flexibly select the position to be locked, such as being able to lock at the distal end, middle end or proximal end of the first loading outer shell 710 .

[0101] Optionally, the first locking device 910 further includes an arrow mark 911 that can be used to indicate the extension direction of the limit block tapered groove 914, thereby visually indicating the operating direction of the first locking device 910. Further optionally, the first locking device 910 further includes symmetrically arranged push-pull blocks 913 that are used to provide a force application platform during the disassembly and assembly of the first locking device 910.

[0102] FIG9 illustrates the structure of a second locking device 920 in one embodiment. As shown in FIG9 , the second locking device 920 elastically clamps the first outer shell 710 via a groove. Schematically, the second locking device 920 comprises a pressing groove 921, a pull block 922, a clamping surface 923, and a latching groove 924. The pressing groove 921 provides a force-applying platform during installation of the second locking device 920; the pull block 922 provides a force-applying platform during removal of the second locking device 920; the clamping surface 923 cooperates with the locking surface 711 on the first outer shell 710 to increase the contact area during clamping and enhance the locking force; and the latching groove 924 prevents the second locking device 920 from falling off the first outer shell 710.

[0103] It should be understood that, in addition to the structural configuration of the locking device 90 described in the embodiment of the present invention, those skilled in the art can find other alternatives based on the description of the present invention to achieve the functions or corresponding effects of the locking device 90 described in the present invention, not including only the solutions disclosed in the embodiment of the present invention. It should also be understood that the present invention may also provide only one locking device 90, with the first type of locking device 910 being preferred, as the first type of locking device 910 has a better locking effect. If both locking devices 90 are used simultaneously, it is beneficial to increase the tightening force at the distal end of the loading housing 70, making the operation process of introducing the implant into the delivery system more reliable.

[0104] [Example 2]

[0105] The present invention further introduces a second loading method through Example 2. In this case, the metal guide rod 110 is not required. Instead, the implant in the secondary crimped state within the cylindrical segment 52 is directly introduced into the distal end of the outer sheath 20. Accordingly, the loading housing 70 employs a second type of loading housing 720 adapted for use without the metal guide rod 110. Figure 7 shows an exploded view of the two halves of the second loading housing 720 in one embodiment. As shown in Figure 7, the second loading housing 720 is a hollow structure composed of two interlocking sub-components. Similar in structure and usage to the first loading housing 710, the distal end of the second loading housing 720 is provided with an axially connected straight hole 724 and a tapered hole 725. There is only one tapered hole 725. The larger 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 larger diameter end of the tapered hole 725 matches the inner diameter of the cylindrical segment 52.

[0106] After the second loading housing 720 wraps around the outer sheath 20, the straight hole 724 directly wraps around the end where the cylindrical section 52 connects 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 must be aligned with the distal end of the sheath soft segment 21. Preferably, the inner diameter of the tapered hole 725 (i.e., the inner diameter of the small-diameter end) does not exceed the inner diameter of the distal end of the sheath soft segment 21. Typically, the inner diameters of the tapered hole 725 do not match, ensuring that the implant can enter the distal end of the sheath soft segment 21 through the tapered hole 725 without obstruction.

[0107] The function of the tapered hole 725 is substantially 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 serve as a guide and positioning function, ensuring that the implant is correctly loaded into the delivery system. The straight hole and the tapered hole are axially connected and coaxial, and the straight hole can cover the end where the cylindrical segment 52 connects to the funnel segment 51, thereby connecting the cylindrical segment 52 to the distal end of the loading outer shell 70 and aligning the end of the cylindrical segment 52 with the delivery system.

[0108] The second loading outer shell 720 includes a distal portion and a proximal portion extending along its axial direction. The distal portion of the second loading outer shell 720 preferably covers the entire sheath soft segment 21 of the outer sheath 20 with a clearance fit, thereby reducing the stress on the sheath soft segment 21 during loading. In this embodiment, the second loading outer shell 720 further includes a clearance fit segment 726, which is the distal portion of the second loading outer shell 720 and covers the entire sheath soft segment 21 with a clearance fit.

[0109] Alternatively, a soft elastic material 727 is provided on the inner side of the distal portion of the second loading outer shell 720, and the soft elastic material 727 directly covers the entire sheath soft segment 21, providing comprehensive protection for the sheath soft segment 21. The soft elastic material 727 can also increase friction, further limiting the axial movement of the outer sheath 20. Therefore, the soft elastic material 727 is equivalent to adding a layer of "outer coat" to the sheath soft segment 21 that is both hard and soft and can increase friction, which not only protects the sheath soft segment 21 but also limits axial movement. The soft elastic material 727 is made of a relatively soft polymer material with a large friction coefficient, and the soft elastic material 727 is adhered to the entire inner surface of the distal portion.

[0110] The proximal portion of the second loading outer shell 720 preferably covers all or part of the outer sheath hard section 22 of the outer sheath 20 with an interference fit. This better secures the outer sheath 20, reduces axial movement of the outer sheath 20 during loading, and minimizes the risk of damage to the outer sheath 20, such as wrinkling and delamination. In this embodiment, the second loading outer shell 720 further includes an interference fit section 7210, which constitutes the proximal portion of the second loading outer shell 720.

[0111] Preferably, the distal end of the second loading outer sheath 720 is provided with a limiting end surface 728 that matches the outer step formed by the two sheath soft segments 21 having different outer diameters. The limiting end surface 728 is defined by the two distal segments having different inner diameters. The limiting end surface 728 further restricts the axial movement of the outer sheath 20.

[0112] Continuing with FIG. 7 , in one exemplary embodiment, the second loading housing 720 is constructed from two halves connected by a concave-convex snap-fitting engagement groove 729, resulting in a simple structure and easy assembly and disassembly. Similarly, the second loading housing 720 preferably engages directly at the proximal end through its own structure, while further tightening at the distal end via a locking device 90 to enhance the locking force and ensure secure and reliable implant loading.

[0113] 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 on the outside of the distal end of the second loading outer shell 720 and tightens the second loading outer shell 720. At the same time, the second loading outer shell 720 is connected to the sheath hard section 22 at its proximal end through an interference fit section 7210; this locking method can firmly restrain the outer sheath 20 at the distal and proximal ends of the second loading outer shell 720, and better prevent the outer sheath 20 from axial movement.

[0114] There are preferably at least two types of locking devices 90, and more preferably, two types of 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 20 cooperates with the second type of loading outer shell 720, and at least another locking device 90 is arranged at a position where the distal end of the second type of loading outer shell 720 cooperates with the cylindrical section 52.

[0115] The locking device 90 can lock the second type of loading outer shell 720 by any means such as form locking and force locking. In this embodiment, there are two types of locking devices 90: the first type of locking device 910 clamps the second type of loading outer shell 720 through a concave-convex structure at the position where the distal end of the outer sheath 20 matches the second type of loading outer shell 720; the second type of locking device 920 elastically clamps the second type of loading outer shell 720 through a groove at the position where the distal end of the second type of loading outer shell 720 matches the cylindrical section 52, so that the junction 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 during the introduction into the delivery system. The structure and locking method of the first locking device 910 and the second locking device 920 can refer to the first type of loading outer shell 710, and will not be further described here.

[0116] In the exemplary embodiment depicted in FIG7 , the second type loading housing 720 further comprises a guide rib 722 and a stopper 723. A single guide rib 722 is sufficient, extending from the distal end to the proximal end along the axial direction of the second type loading housing 720. The guide rib 722 cooperates with the guide rib groove 912 in the first type locking device 910 to securely mount the first type locking device 910 on the second type loading housing 720. The stopper 723 is symmetrically disposed on the side of the second type loading housing 720. The stopper 723 cooperates with the stopper groove 914 in the first type locking device 910 to achieve locking via a taper. That is, the first type locking device 910 and the second type loading housing 720 are locked together via a concave-convex structure. One or more sets of stopper 723 may be disposed axially along the second type loading housing 720, with each set comprising two stopper 723 symmetrically disposed radially. Preferably, a plurality of groups of limiting cone blocks 723 are provided on the second loading outer shell 720 .

[0117] The second locking device 920 optionally includes a clamping surface 923, which is configured to cooperate with the locking surface 721 on the second outer housing 720 to increase the contact area during clamping and enhance the locking force. The locking groove 924 in the second locking device 920 reduces the risk of the second locking device 920 falling off the second outer housing 720.

[0118] It should be further explained that any loading method can realize the loading of implants with flanges 021 and grab ears 022, and with the hanging ears 011 arranged at the inflow end, especially considering the loading requirements of implants with double-layer stents.

[0119] Next, the preferred embodiments of the crimping block 10, the crimping rod 30, and the funnel 50 will be further described. It should be noted that the following description is merely an enumeration and cannot be exhaustive of all implementations, and should not constitute an undue limitation on the present invention.

[0120] 1 and 2 , in one embodiment, the crimping block 10 includes at least three crimping pieces 11 , which are coupled in pairs to form a polygonal frame with a crimping cavity 101 , wherein the crimping pieces 11 are telescopically connected in pairs.

[0121] The polygonal frame can be a triangular structure, a quadrilateral structure, a pentagonal structure, a hexagonal structure or other polygonal structures. The longer the sides of the polygonal structure, the more conducive it is to pressing the implant into a circle, but the longer the sides, the greater the difficulty of the production process. Based on this, it is preferred to use three pressing grips 11, and the polygonal outline of the pressing cavity 101 defined by the three pressing grips 11 is at least a triangular outline. The pressing grips 11 are inserted into each other in the direction around the central axis of the pressing block 10, and the two pairs of inserted pressing grips 11 are telescopically connected by a guide pin 12. Optionally, the pressing grips 11 are staggered in the direction along the central axis of the pressing block 10 to facilitate insertion and engagement. For example, in some embodiments, the pressing grip 11 has a plurality of inserts spaced apart in the direction of the central axis, and a guide slot 13 is formed between the two inserts. The plurality of inserts of the pressing grip 11 are inserted into the guide slot 13 corresponding to the other pressing grip 11 engaged therewith in an up-down staggered manner, thereby forming a polygonal frame of the pressing block 10. The crimping cavity 101 has a closed polygonal outline with an even or odd number of sides. Preferably, the crimping cavity 101 has an even-numbered polygonal outline, with at least one pair of opposing sides forming parallel planes. This structure provides excellent crimping performance and ensures the roundness of the implant after crimping. In this embodiment, the crimping cavity 101 has an octagonal outline and utilizes three crimping blades 11.

[0122] In order to achieve the retractability of the pressure grip block 10, a pin groove 14 penetrating along the central axis direction can be provided on each pressure grip piece 11, and the pin groove 14 extends along the side length direction of the pressure grip piece 11. The guide pin 12 is inserted into the pin groove 14, thereby telescopically connecting the two pressure grip pieces 11. In practice, the guide pin 12 slides back and forth in the pin groove 14, driving the pressure grip block 10 to compress inward or expand outward. To ensure that the guide pin 12 does not slide out of the pin groove 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 groove 14. At this point, the pressure grip block 10 forms a polygonal frame that is stably compressed, expanded, and uniformly changed. However, it should be understood that the method of achieving radial contraction and expansion of the pressure grip block 10 is not limited to this.

[0123] Referring to FIG3 , in one embodiment, the crimping rod 30 is provided with a circular main body section 31, a flat section 32, and a guide groove section 33 in sequence along its own axial direction; the circular main body section 31 can be inserted into the implant and provides the minimum crimping diameter for the first-level crimping and ensures the uniformity of the crimping; the flat section 32 is provided with a plurality of flat surfaces 321 along the circumference of the crimping rod 30, and the number of the flat surfaces 321 is consistent with the number of the gripping ears 022. The flat surfaces 321 are used to straighten the bent sections 0222 of the gripping ears 022 and serve as a platform to provide a support. The guide groove section 33 is provided with a plurality of guide grooves 331 along the circumference of the crimping rod 30. The number of guide grooves 331 matches the number of gripping ears 022, and the guide grooves 331 are axially aligned with the plane 321. The guide grooves 331 are used to engage and straighten the non-bent section 0221 of the gripping ear 022. The guide grooves 331 not only straighten the non-bent section 0221 of the gripping ear 022, but also provide circumferential positioning of the implant during straightening. It should be understood that the length of the plane 321 is the same as, or slightly longer than, the length of the bent section 0222 (i.e., the arc segment) of the gripping ear 022, and the length of the guide groove 331 is the same as, or slightly shorter than, the length of the non-bent section 0221 of the gripping ear 022.

[0124] 4 and 5 , in one embodiment, the funnel section 51 has a tapered inner hole 511, a limiting plane 512 and a threaded inner hole 513; the closing inner diameter of the tapered inner hole 511 (i.e., the inner diameter of the smaller diameter end) is smaller than the inner diameter of the threaded inner hole 513 and forms a limiting plane 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 threading process, the limiting plane 512 limits the depth of the cylindrical section 52 inserted into the threaded inner hole 513; the closing inner diameter (minimum inner diameter) of the tapered inner hole 511 matches the inner diameter of the cylindrical section 52 523 matches to ensure that the implant can be evenly 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 shell 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 shell 70; the inner diameter 523 of the cylindrical section 52 is not larger than the inner diameter of the first tapered hole 716 (or tapered hole 725) of the loading shell 70 at the flared part, such as matching with 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 first tapered hole 716 (or tapered hole 725) at the flared part; in this way, the implant 200 in the secondary pressing grip state of the cylindrical section 52 is prevented from getting stuck, blocking, etc. during the process of being introduced into the tapered hole.

[0125] The following further describes the implant loading method with reference to Figures 14 to 23. For illustrative purposes, the implant in the primary crimping state is designated by reference numeral 100, and the implant in the secondary crimping state is designated by reference numeral 200. An implant having a double-layer stent is used as an example, but those skilled in the art should be able to modify the following description to implement loading of a single-layer stent.

[0126] First, referring to FIG. 14 to FIG. 20 , in a non-limiting operation mode, the first loading method includes eight steps, which are the following first to eighth steps.

[0127] Step 1: Using the crimping block 10 and the crimping rod 30, the implant with the double-layer stent is transformed from the natural state to the first-level crimping state.

[0128] The specific operation process is as follows: insert the crimping rod 30 along one end of its circular main body section 31 from the outflow path of the implant until the starting point of the bent section 0222 of the gripping ear 022 is consistent with the starting point of the plane 321 of the crimping rod 30, and slightly rotate the implant circumferentially to ensure that the circumferential positions of the gripping ear 022, the plane 321 of the crimping rod 30, and the guide groove 331 are consistent; in the first-level crimping process, slightly press the non-bent section 0221 of each gripping ear 022 into the crimping rod 30 in turn. The crimping rod 30 is then slightly pressed down along the flat surface 321 of the crimping block 10. The crimping block 10 is then expanded and placed over the outer stent 02. The guide pin 12 then slides to compress the crimping block 10, causing it to radially compress and reduce the overall profile of the double-layer stent. These steps are repeated until the profile of the double-layer stent reaches the required crimping diameter for the first-stage crimping state. Upon completion of the first-stage crimping state, the crimping rod 30 and the crimping block 10 are immediately removed, leaving the double-layer stent implant in the low-temperature loading solution in its first-stage crimping state.

[0129] Step 2: As shown in Figure 14, the metal guide rod 110 is partially inserted between the outer sheath tube 20 and the inner sheath tube 40, and the limit block 113 and the tapered mouth 112 are exposed; it should be understood that the metal guide rod 110 does not need to be inserted too deep into the delivery system, and it is sufficient to partially overlap with the outer sheath tube 20.

[0130] Step 3: As shown in FIG15 , a funnel 50 is used to complete the change of the implant from the primary crimping to the secondary crimping.

[0131] Specifically, before using the funnel 50, the lug 011 of the inner stent 01 is first hooked onto the distal end (e.g., notch) of the core rod 60. The delivery system is then operated to move the inner sheath 40 forward or backward to press against the lug 011, preventing it from detaching from the core rod 60. This allows the implant with the double-layer stent to be connected to the delivery system. After the funnel section 51 of the funnel 50 is connected and fixed to the cylindrical section 52, the funnel 50 and the delivery system are aligned axially. The funnel section 51 gradually approaches the gripping lug 022 (which has been straightened) of the double-layer stent and is then gradually pressed over the outer stent 02 axially from the distal end to the proximal end until the cylindrical section 52 of the funnel 50 covers the entire implant. During this process, the flange 021 is axially straightened by the funnel section 51, resulting in a secondary gripping configuration.

[0132] Step 4: As shown in Figure 16, separate the funnel segment 51 and the cylindrical segment 52, and move the funnel segment 51 from the distal end to the proximal end to the rear portion (i.e., the proximal region) of the outer sheath 20 to prevent the funnel segment 51 from affecting the operation of the front portion (i.e., the distal region). It should be understood that the funnel segment 51 needs to be moved to a position outside the length of the first loading outer shell 710 or the second loading outer shell 720. It should also be understood that after separating the funnel segment 51 and the cylindrical segment 52, the implant 200 in the secondary pressure-grip state is retained in the cylindrical segment 52, but the distal end of the core rod 60 is still connected to the lug 011, and the distal end of the inner sheath 40 wraps around the lug 011.

[0133] Step 5: As shown in Figure 17, after removing the funnel section 51, first install half of the first loading shell 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 mouth 112 of the metal guide rod 110, and the limiting end face 719 is flush with the outer steps of the two sections of the sheath soft sections 21.

[0134] Step 6: As shown in FIG18 , the other half of the first loading housing 710 is installed. The two halves are positioned and fastened together via the concave-convex slots 7110. Simultaneously, the first locking device 910 and the second locking device 920 are installed on the first loading housing 710. The first locking device 910 is locked to the proximal side of the second locking device 920, particularly where the metal guide rod 110 protrudes from the tapered opening 112 of the outer sheath 20, thereby strengthening this location. The second locking device 920 is locked to the mating location between the cylindrical section 52 of the funnel 50 and the straight hole 715, thereby strengthening this mating location.

[0135] Step 7: As shown in FIG19 , after securing the two locking devices 90, the delivery system is operated to cause the core rod 60 and the inner sheath 40 to retreat proximally, pulling the implant 200 in the cylindrical segment 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 isolates the implant from direct contact with the inner wall of the outer sheath 20, thereby preventing delamination damage to the soft segment 21 of the sheath. At the same time, the distal end of the outer sheath 20 relies on the second tapered hole 717 to wrap the tapered mouth 112 of the metal guide rod 110, and the proximal end of the outer sheath 20 relies on the interference fit between the interference fit section 7111 and the sheath hard section 22. Based on this, the outer sheath 20 is firmly wrapped at both ends of the outer sheath 20, so that the outer sheath 20 will not move axially and avoid 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 clearance fit and will not be subjected to any force. Therefore, the soft section 21 of the sheath will not be damaged such as delamination.

[0136] Step 8: As shown in Figure 20 , after implant 200 is introduced into metal guide rod 110, locking device 90 and first loading housing 710 are sequentially removed. Metal guide rod 110 is then withdrawn, leaving implant 200 in the secondary crimped state within the distal end of the soft sheath segment 21. It should be understood that metal guide rod 110 can be removed from the distal end of the delivery system, away from the proximal end. This completes the crimping and loading of implant 200.

[0137] 21 to 23 , and in combination with FIG. 15 , FIG. 16 , and FIG. 18 , in a non-restrictive operation, the second loading method includes six steps, namely the following first to sixth steps, and the steps that are the same as those in the first loading method will not be described again.

[0138] Step 1: Same as the first step in the first loading method.

[0139] Step 2: Refer to the third step in the first loading method and see Figure 21. In Figure 21, there is no metal guide rod 110 between the outer sheath tube 20 and the inner sheath tube 40.

[0140] Step 3: Refer to step 4 in the first loading method and see Figure 22. Similarly, the metal guide rod 110 is not shown in Figure 22.

[0141] Step 4: As shown in Figure 23, after removing the funnel section 51, first install half of the second loading shell 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 sheath soft section 21, the limiting end face 728 is flush with the transition section between the two sheath soft sections 21, and the soft elastic material 727 wraps the entire sheath soft section 21.

[0142] Step 5: Refer to Step 6 of the first loading method, as shown in Figure 18. Specifically, the other half of the second loading outer shell 720 is installed. The two halves are positioned and fastened together via the concave-convex locking grooves 729. Simultaneously, the first locking device 910 and the second locking device 920 are installed on the second loading outer shell 720. The first locking device 910 is locked to the proximal side of the second locking device 920, particularly at the distal end of the outer sheath 20, thereby strengthening this location. The second locking device 920 is locked to the mating location between the cylindrical section 52 of the funnel 50 and the straight hole 724, thereby strengthening this mating location.

[0143] Step 6: After securing the locking device 90, the delivery system is operated to cause the core rod 60 and inner sheath 40 to retreat proximally, pulling the implant 200 in the cylindrical section 52 through the tapered hole 725 and directly into the distal end of the sheath soft segment 21. During this operation, due to the soft nature of the soft elastic material 727, it remains in a transitional fit while covering the sheath soft segment 21, providing protection on the outside of the sheath soft segment 21. At the same time, the soft elastic material 727 is in contact with the soft segment 21 of the sheath over a large area, and the friction between the two is greatly increased. The outer sheath 20 is firmly wrapped through the interference fit between the interference fit segment 7210 and the hard segment 22 of the sheath. Therefore, during operation, the outer sheath 20 is protected from axial movement and the risk of wrinkle damage under the action of strong wrapping force and friction force. Moreover, the soft segment 21 of the sheath and the clearance fit segment 726 are clearance fit and will not be subjected to any force. Therefore, the soft segment 21 of the sheath will not be damaged by delamination.

[0144] After the implant is introduced into the distal end of the outer sheath 20 , the two locking devices 90 and the second loading outer shell 720 are finally removed to complete the loading of the implant 200 .

[0145] In summary, according to the technical solution provided in the embodiment of the present invention, the present invention can realize the loading of the implant with flange 021 and grabbing ear 022, and the hanging ear 011 is located at the inflow end, and ensures the loading needs of this type of implant. During the loading process, the outer sheath tube 20 can be restrained by the loading shell tool 70 and the locking device 90, so that the outer sheath tube 20 is avoided from axial movement, and the outer sheath tube 20 is avoided from the damage such as wrinkles and delamination. Finally, the implant can be safely and effectively loaded into the delivery system, while not affecting the performance of the outer sheath tube 20. In addition, the present invention can protect the soft sheath tube segment 21 of the delivery system by one or more means, reduce the damage to the sheath tube segment 21 during the implant introduction delivery system, and further ensure the performance of the outer sheath tube 20.

[0146] While the present invention is disclosed above, it is not limited thereto. Those skilled in the art may make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, the present invention is intended to encompass such modifications and variations as long as they fall within the scope of the claims and their equivalents.

Claims

1. An implant loading tool, used for loading an implant into a delivery system, the implant comprising a bracket, the inflow end of the bracket being provided with a hanging ear and a flange, the outflow end of the bracket being connected with a grab ear, the grab ear being bent and arranged on the periphery of the bracket, the loading tool comprising: A crimping block having a crimping cavity extending axially therethrough, the crimping block being capable of radial contraction and radial expansion and being used for performing primary crimping of the implant in a natural state through the crimping cavity; A crimping rod having a through hole extending axially therethrough, the crimping rod being used to be inserted into the implant and to support the implant and straighten the grasping lug during primary crimping; A funnel, comprising a funnel section and a cylindrical section, wherein the funnel section and the cylindrical section can be disconnected, and the funnel is used to move proximally along the axial direction of the delivery system when the funnel section and the cylindrical section are connected, so as to perform secondary crimping on the implant in the primary crimping state and straighten the flange at the same time, and the funnel is also used to release the connection between the funnel section and the cylindrical section after the implant in the secondary crimping state enters the cylindrical section; A loading outer shell is used to cover the outside of the outer sheath in the delivery system, and the distal end of the loading outer shell is used to engage with one end of the cylindrical section connected to the funnel section, so that the implant in the secondary crimping state in the cylindrical section can be introduced into the distal end of the outer sheath through the distal end of the loading outer shell; and, The locking device is used to lock the outer housing when the implant is introduced into the outer sheath tube. The locking device is also used to release the locking of the outer housing after the implant is introduced into the distal end of the outer sheath tube.

2. The implant loading tool according to claim 1, characterized in that: The distal end of the loading outer shell is provided with a tapered hole, the inner diameter of the large diameter end of the tapered hole matches the inner diameter of the cylindrical section, and the implant in the secondary crimping state leaves the cylindrical section and is introduced into the distal end of the outer sheath tube through the tapered hole.

3. The implant loading tool according to claim 2, characterized in that: A straight hole is also provided at the distal end of the loading outer shell, and the straight hole and the tapered hole are connected in the axial direction; the large diameter end of the tapered hole is connected to the proximal end of the straight hole; the tapered hole and the straight hole are both used to be exposed outside the distal end of the outer sheath tube, and the straight hole is used to cover one end of the cylindrical section connected to the funnel section.

4. The implant loading tool according to claim 1 or 2, characterized in that: The loading outer shell includes a distal part and a proximal part, the proximal part is used to cover all or part of the hard segment of the outer sheath tube in an interference fit manner; the distal part is used to cover all the soft segments of the outer sheath tube in a clearance fit manner, or, a soft elastic material is provided on the inner side of the distal part, and the soft elastic material is used to cover all the soft segments of the sheath tube in an interference fit manner.

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

6. The implant loading tool according to claim 1 or 2, characterized in that: The crimping block comprises at least three crimping pieces, all of which enclose and form a polygonal frame with the crimping cavity, the crimping pieces are telescopically connected in pairs, and the crimping cavity has a closed polygonal outline.

7. The implant loading tool according to claim 6, characterized in that: The number of side lengths of the polygonal outline is an even number, and at least one set of opposite sides of the polygonal outline forms parallel planes.

8. The implant loading tool according to claim 1 or 2, characterized in that: The gripping rod is provided with a circular main body section, a plane section and a guide groove section in sequence along its axial direction; The outer circumferential surface of the planar segment is provided with at least one plane along the circumference of the gripping rod, the number of the planes is consistent with the number of the gripping ears, and the plane is used to straighten the bent section of the gripping ears; The outer peripheral surface of the guide groove section is provided with at least one guide groove along the circumference of the gripping rod, the number of the guide grooves is consistent with the number of the gripping ears, the guide groove is aligned with the plane in the axial direction, and the guide groove is used to embed and straighten the non-bending section of the gripping ear.

9. The implant loading tool according to claim 1 or 2, characterized in that: 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; The cylindrical section has an external thread section, and the outer diameter of the cylindrical section matches 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 to the threaded inner hole through the external thread section. The limiting plane is used to limit the depth of the cylindrical section inserted into the threaded inner hole.

10. The implant loading tool according to claim 1 or 2, characterized in that: The loading tool further comprises a metal guide rod, the metal guide rod is a thin-walled tube, and one end of the metal guide rod is configured as a cone; 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.

11. The implant loading tool according to claim 10, characterized in that: The loading shell is a first type of loading shell, which is formed by buckling two half parts; 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; 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.

12. The implant loading tool according to claim 11, characterized in that: The metal guide rod is provided with symmetrical limit blocks on its outer circumference except the tapered opening. The first loading outer shell is provided with a through slot. The limit blocks are used to be exposed outside the distal end of the outer sheath and inserted into the through slot.

13. The implant loading tool according to claim 1 or 2, characterized in that: The loading shell is a second type of loading shell, which is formed by buckling two half parts; The distal end of the second loading housing is provided with a straight hole and a tapered hole which are axially connected; The large diameter end 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 through the tapered hole.

14. The implant loading tool 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, 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 implant loading tool 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 implant loading tool 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 implant loading tool 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 core rod is used to be detachably connected to the ear of the implant, and the distal end of the inner sheath is used to be sleeved on the outside of the ear; the inner sheath and the core rod are used to synchronously move in the proximal direction along the axial direction of the delivery system to guide the implant in the secondary crimping state into the distal end of the outer sheath.

19. An implant system, characterized in that: An implant and a loading system for the implant as described in claim 18, wherein the implant includes a stent, the inflow end of the stent is provided with a hanging ear and a flange, the outflow end of the stent is connected with a grab ear, and the grab ear is bent and arranged on the periphery of the stent, and the loading system is used to press and grip the implant through the loading tool and introduce the pressed implant into the conveying system.

20. The implant system according to claim 19, characterized in that The bracket is a single-layer bracket or a double-layer bracket. When the bracket is a double-layer bracket, the hanging ear is arranged at the inflow end of the inner bracket, the flange is arranged at the inflow end of the outer bracket, the grab ear extends based on the outflow end of the outer bracket or the inner bracket, and the grab ear is bent and arranged on the periphery of the outer bracket.

21. A method for loading an implant, characterized in that: The implant loading system according to claim 18 is used to load the implant into the delivery system, wherein the implant comprises a bracket, the inflow end of the bracket is provided with a hanging ear and a flange, the outflow end of the bracket is connected with a grab ear, and the grab ear is bent and arranged on the periphery of the bracket, and the loading method comprises: 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; After the primary crimping, the implant in the primary crimping state is arranged at the distal end of the outer sheath, the distal end of the mandrel is detachably connected to the hanging ear, and the distal end of the inner sheath is sleeved outside the hanging ear; During the secondary crimping process, the implant is kept stationary and the funnel is moved axially from the distal end to the proximal end until the implant is transformed from the primary crimping state to the secondary crimping state, and the cylindrical segment positioning sleeve is arranged outside the implant in the secondary crimping state; After the second level of crimping, the connection between the cylindrical section and the funnel section is released, and the funnel section is moved toward the proximal end and withdrawn from the outer sheath; After the funnel section is withdrawn from the outer sheath, the outer sheath is covered by the loading shell and locked by the locking device. Then, the inner sheath and the core rod are moved synchronously in the proximal direction until the implant in the secondary grip state is introduced into the distal end of the outer sheath.

22. The implant loading method according to claim 21, characterized in that: loading the implant into the delivery system based on at least one of a first loading method and a second loading method; The first loading method comprises: inserting a metal guide rod between the outer sheath and the inner sheath, and making a 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 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; The second loading method comprises: under the action of the inner sheath and the core rod, directly introducing the implant in the secondary gripping state into the distal end of the outer sheath, and then removing the locking device and the outer loading shell in sequence.

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