Implant loading tool, loading system and loading method

Abstract

The present invention provides a loading tool, a loading system and a loading method for an implant, wherein the loading tool for the implant comprises a guide cover, a blocking platform and at least one compression platform, wherein the compression platform can reduce the diameter of the implant in the first stage, and the implant after the reduction cooperates with the blocking platform and is limited, which can prevent the implant from escaping from the guide cover, and then the implant passes through the first end of the guide cover and reduces the diameter in the second stage. Thus, by compressing the implant in stages, it can be applied to implants with large volume, large diameter-to-axis ratio and large radial support force. Preferably, the compression platform can be used to block the blocking platform in the first inner cavity, which is a dual-purpose device, that is, the second inner cavity inside can be used as a reduction, and the whole can be used as a blocking device to block the blocking platform, which reduces the number of components of the loading tool, reduces the manufacturing cost, and avoids various problems caused by too many loading tools during the actual loading process.

Description

Technical Field

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

[0002] Interventional therapy is a new treatment method developed in recent years that integrates imaging diagnosis and clinical treatment. Under the guidance and monitoring of imaging equipment such as digital subtraction angiography, CT (computer tomography), ultrasound and magnetic resonance imaging, it uses puncture needles, catheters and other interventional equipment to introduce specific device implants into the lesion site of the human body through natural channels or tiny incisions for treatment. It has the advantages of accuracy, safety, high efficiency, wide indications and few complications, and has become the preferred treatment method for some diseases.

[0003] Vascular interventional technology is a type of interventional treatment technology. Simply put, it uses human blood vessels as a natural pathway to deliver implants to diseased cardiovascular sites for treatment. Its most intuitive feature is that the implants are large in size, especially interventional heart prosthetic valves and interventional occluders. Therefore, this technology requires the implant to be compressed to a very small diameter so that it can be loaded into the delivery catheter. Implants or biological tissues and polymer materials attached to implants are easily damaged due to excessive extrusion, uneven compression, or accidental local twisting and bending, which ultimately leads to defects in the implant's function, reduced lifespan, and even inability to perform normal implant work.

[0004] In addition, in order to meet the requirements of treatment, lesion site structure, design, materials, etc., the implant itself may face the dilemma of being difficult to compress. Existing loading tools are only suitable for compressing implants with relatively small volumes and a small ratio of radial dimension to axial length (such as traditional aortic valve prosthesis).

[0005] For implants with large volume or large ratio of radial dimension to axial length, such as mitral valve prosthesis and tricuspid valve prosthesis, when using existing loading tools to compress and load them, the prosthetic valve is very likely to be severely twisted, deformed, uneven, etc. At the same time, for some implants with large radial support force, it is completely impossible to compress them normally with existing loading tools. Take the mitral valve prosthesis as an example: due to the large size of the annulus of the native mitral valve of the heart in anatomy, the support structure (i.e., the stent) used to carry the artificial valve leaflets in the prosthetic valve implanted in the mitral valve needs to be larger in radial direction to fit the annulus and leaflets of the native mitral valve of the heart, so as to achieve the effect of anchoring and sealing. Anatomically, the aortic valve is adjacent to the mitral valve, so the mitral valve prosthesis with too large axial length will hinder the ejection function of the aortic valve and cause the obstruction of the left ventricular outflow tract. Based on the above two points, the radial dimension of the mitral valve prosthesis is about 30-80mm, and the ratio of radial dimension to axial length is large, usually between 1-3. (The radial dimension of a traditional aortic valve stent is about 15-30mm, and the ratio of radial dimension to axial length is about 0.5.) When the existing loading tool is used to load the mitral valve prosthesis, it is very easy for the prosthetic valve to tilt and twist in the loading tool due to uneven circumferential force, which eventually leads to the damage of the prosthetic valve. At the same time, the stent grid of the existing mitral valve prosthesis is mostly dense, which leads to a large circumferential support force of the prosthetic valve, and it is extremely difficult for the existing loading tool to compress it in one step. Summary of the invention

[0006] The object of the present invention is to provide a loading tool, a loading system and a loading method for an implant, so as to solve the problem that the existing loading device is not applicable to implants with larger volume, implants with larger diameter-to-axis ratio and implants with larger radial supporting force.

[0007] In order to solve the above problems, the present invention provides a loading tool for an implant, comprising:

[0008] A guide cap having a through first inner cavity for loading the implant, wherein the first inner cavity has a first end and a second end opposite to each other, and the caliber of the first end is smaller than the caliber of the second end;

[0009] a blocking platform, used to cooperate with the guide cover and inserted into the first inner cavity; and

[0010] at least one compression stage, having a through second inner cavity, the second inner cavity having a third end and a fourth end opposite to each other, the third end having a smaller diameter than the fourth end, and the third end having a larger diameter than the first end;

[0011] Wherein: the compression stage is configured to compress the implant using the second inner cavity before the implant is loaded into the first inner cavity;

[0012] The blocking platform is configured to be inserted into the first inner cavity together with the compressed implant.

[0013] Optionally, the blocking platform is provided with a circle of grooves with openings, and when the blocking platform is arranged in the first inner cavity, the openings face the first end portion; the grooves cooperate with the implant to limit the position of the implant.

[0014] Optionally, the outer contour of the blocking platform matches the first inner cavity, and the blocking platform is detachably connected to the guide cover. When the blocking platform is connected to the guide cover, the blocking platform is configured to have no radial and axial displacement relative to the guide cover.

[0015] Optionally, the guide cover is connected to the blocking platform by snap-fit ​​connection and / or shape matching.

[0016] Optionally, the outer contour of the blocking platform matches the first inner cavity, and at least one of the compression platforms is detachably connected to the guide cover. When the compression platform is connected to the guide cover, the compression platform is used to seal the blocking platform in the first inner cavity, and the blocking platform is configured to have no radial and axial displacement relative to the guide cover.

[0017] Optionally, the guide cover is connected to at least one of the compression stages via a snap connection and / or shape matching.

[0018] Optionally, the implant loading tool comprises n compression stages, wherein the calibers of the third ends of the first compression stage to the nth compression stage decrease in sequence, and the caliber of the third end of the i-th compression stage is not greater than the caliber of the fourth end of the i+1-th compression stage; wherein n is a natural number greater than 1, and i is a natural number less than n;

[0019] The n compression stages are configured such that, before the implant is loaded into the first inner cavity, the second inner cavities of the n compression stages compress the implant in sequence.

[0020] Optionally, the diameters of the third ends of the n successively decreasing compression stages decrease by a fixed difference, and the difference between the diameter of the third end of the nth compression stage and the diameter of the first end is also the fixed difference.

[0021] Optionally, any two compression stages may be detachably connected.

[0022] Optionally, the n compression stages are detachably connected in the order of decreasing diameters of the third ends.

[0023] Optionally, the blocking platform has a third inner cavity that penetrates axially.

[0024] Optionally, the implant has an outwardly warped structure, and the loading tool of the implant further comprises a pressing block, wherein the pressing block has a concave arc surface or a plane, and the pressing block is used to flatten the outwardly warped structure on the implant using the arc surface or the plane.

[0025] Optionally, at least one of the compression platforms includes a cylindrical section, and the cylindrical section is used for the implant to be sleeved on its outside, and the compression block is used to utilize the arc surface or the plane surface to cooperate with the cylindrical section to flatten the outward warped structure on the implant.

[0026] Optionally, one or more of the parts of the pressing block other than the arc surface or the plane, the outer contour of the guide cover, the outer contour of the blocking platform and the outer contour of the compression platform are provided with an anti-slip structure.

[0027] In order to solve the above problems, the present invention also provides an implant loading system, which comprises:

[0028] a delivery device for delivering an implant to a target location; and

[0029] The implant loading tool as described above is used to cooperate with the implant loading tool to load the implant into the delivery device.

[0030] To solve the above problems, the present invention further provides a method for loading an implant, using the implant loading system as described above, the implant loading method comprising:

[0031] placing the implant in a predetermined temperature environment;

[0032] The implant has a head end and a tail end opposite to each other, and the implant is passed through the second inner cavity of the compression stage along the direction from the tail end to the head end of the implant and along the direction from the fourth end to the third end of the compression stage, so as to compress the implant to a predetermined diameter;

[0033] Matching the end of the implant compressed to the predetermined diameter with the blocking platform to limit the position of the implant;

[0034] Insert the plugging platform equipped with the implant into the guide cover along the direction from the second end to the first end of the guide cover, with the implant facing the first end;

[0035] The implant is loaded into the delivery device from the implant loading tool.

[0036] Optionally, the implant loading tool includes n compression stages, the calibers of the third ends of the first compression stage to the nth compression stage decrease in sequence, and the caliber of the third end of the i-th compression stage is not greater than the caliber of the fourth end of the i+1-th compression stage; wherein n is a natural number greater than 1, and i is a natural number less than n; wherein the process of compressing the implant to a predetermined diameter includes:

[0037] The implant is compressed in sequence by utilizing the second inner chambers of the n compression stages in the order in which the diameter of the third end portion decreases, so as to compress the implant to the predetermined diameter in stages.

[0038] Optionally, the step of passing the implant through the second lumen of any one of the compression stages is repeated a plurality of times.

[0039] Optionally, the implant is provided with an outward warping structure, the implant loading tool further comprises a pressing block, the pressing block has a concave arc surface, and before the step of passing the implant through the second inner cavity of the compression platform, the step further comprises:

[0040] The arc surface is used to flatten the outward warping structure of the implant.

[0041] Optionally, at least one of the compression platforms includes a cylindrical segment, and before the step of flattening the outward warping structure of the implant using the arc surface, the step further includes:

[0042] sleeve the implant on the outer surface of the cylindrical section of the compression table;

[0043] The arc surface cooperates with the cylindrical segment to flatten the outward warping structure of the implant.

[0044] In summary, in the loading tool, loading system and loading method of the implant provided by the present invention, the loading tool of the implant includes a guide cover, a blocking platform and at least one compression platform, and the compression platform can reduce the diameter of the implant in the first stage, and the implant after the reduction cooperates with the blocking platform and is limited, which can prevent the implant from escaping from the guide cover, and then the implant passes through the first end of the guide cover to reduce the diameter in the second stage. Thus, by compressing the implant in stages, it can be suitable for implants with large volume, large diameter-to-axis ratio and large radial support force. Preferably, the compression platform can be used to block the blocking platform in the first inner cavity, which is a dual-purpose, that is, the second inner cavity inside can be used as a reduction, and the whole can be used as a blocking device to block the blocking platform, which reduces the number of components of the loading tool, reduces the manufacturing cost, and avoids various problems caused by too many loading tools during the actual loading process. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] 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.

[0046] Figure 1 It is a three-dimensional diagram of the plugging platform assembly of the implant loading tool provided in the first embodiment of the present invention;

[0047] Figure 2 is a three-dimensional diagram of a press-line assembly of a loading tool for an implant provided in Embodiment 1 of the present invention;

[0048] Figure 3 It is a front view of the plugging platform assembly of the implant loading tool provided in the first embodiment of the present invention;

[0049] Figure 4 yes Figure 3 The cross-sectional view of the blocking platform assembly along the line AA is shown;

[0050] Figure 5 is a three-dimensional diagram of a guide cover provided in Embodiment 1 of the present invention;

[0051] Figure 6 is a front view of the guide cover provided in the first embodiment of the present invention;

[0052] Figure 7 yes Figure 6 A cross-sectional view of the guide cover along line BB shown;

[0053] Figure 8 is a three-dimensional diagram of a guide cover provided in Embodiment 2 of the present invention;

[0054] Fig. 9 It is a three-dimensional diagram of the blocking platform provided by the first embodiment of the present invention;

[0055] Fig.10 This is a front view of the blocking platform provided by the first embodiment of the present invention;

[0056] Fig.11 yes Fig.10 The cross-sectional view of the blockage along the CC line is shown;

[0057] Fig.12 is a three-dimensional diagram of a first compression stage provided in Embodiment 1 of the present invention;

[0058] Fig.13 is a front view of a first compression stage provided in Embodiment 1 of the present invention;

[0059] Fig.14 yes Fig.13 A cross-sectional view of the first compression stage along line DD shown;

[0060] Fig.15is a three-dimensional diagram of a first compression stage provided in Embodiment 2 of the present invention;

[0061] Fig.16 is a three-dimensional diagram of a second compression stage provided in Embodiment 1 of the present invention;

[0062] Fig.17 is a front view of a second compression stage provided in Embodiment 1 of the present invention;

[0063] Fig.18 yes Fig.17 A cross-sectional view of the second compression stage along line EE is shown;

[0064] Fig.19 is a three-dimensional diagram of a pressing block provided in Embodiment 1 of the present invention;

[0065] Fig. 20 is a schematic axial cross-sectional view of an implant provided in Embodiment 1 of the present invention;

[0066] Fig.21 It is a schematic diagram of the compression block provided in the first embodiment of the present invention cooperating with the second compression platform to flatten the implant;

[0067] Fig. 22 is a schematic diagram of an implant provided by Embodiment 1 of the present invention passing through a first compression platform;

[0068] Fig.23 is a schematic diagram of loading an implant into a delivery device provided by Embodiment 1 of the present invention, wherein the blocking platform is provided with a groove;

[0069] Fig.24 is a schematic diagram of loading an implant into a delivery device provided by Embodiment 1 of the present invention, wherein the blocking platform is not provided with grooves;

[0070] Fig.25 is a schematic diagram of a conveying device provided in Embodiment 1 of the present invention;

[0071] Fig.26 is a schematic diagram of a guide cover provided in Embodiment 3 of the present invention, wherein the guide cover is provided with an anti-twist portion;

[0072] Fig. 27 is a schematic diagram of a first compression platform provided in Embodiment 3 of the present invention, wherein the first compression platform is provided with a flanging portion;

[0073] Fig.28 is a schematic diagram of a guide cover provided in Embodiment 3 of the present invention, wherein the guide cover is provided with a flange portion;

[0074] Fig.29 is a schematic diagram of a first compression platform provided in Embodiment 3 of the present invention, wherein the first compression platform is provided with an anti-twist portion;

[0075] Fig.30is a schematic diagram of a guide cover provided in a fourth embodiment of the present invention;

[0076] Fig.31 It is a schematic diagram of blocking the platform provided by the fourth embodiment of the present invention;

[0077] Fig.32 It is a schematic diagram of the first compression stage provided in the fifth embodiment of the present invention.

[0078] In the attached figure:

[0079] 1-guide cover; 100-first inner cavity; 101-first end; 102-second end; 11-slot; 12-first reduced diameter area; 13-first transition area; 14-slot area; 15-anti-twist portion; 16-flanged portion;

[0080] 2-blocking platform; 200-third inner cavity; 207-seventh end; 208-eighth end; 21-groove; 22-first protruding edge; 23-second protruding edge; 24-concave surface;

[0081] 3-first compression stage; 300-second inner cavity; 303-third end; 304-fourth end; 31-buckle; 32-buckle area; 33-base area; 34-second outlet area; 35-second transition area; 36-second reduced diameter area; 37-slot;

[0082] 4-second compression stage; 400-fourth inner cavity; 405-third end; 406-fourth end; 41-equal diameter section; 42-third outlet area; 43-third transition area; 44-third diameter reduction area;

[0083] 5-pressing block; 500-arc surface; 51-anti-slip structure;

[0084] 6-transport device; 61-fixed head; 62-sheath tube; 63-rope; 64-conical head;

[0085] 9-implant; 901-head end; 902-end end; 91-outward warping structure; 92-fixing ear. DETAILED DESCRIPTION

[0086] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail 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, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0087] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0088] The inventors have found that, as described in the background art, when using existing loading tools to compress and load implants with larger volumes, larger diameter-to-axis ratios, and larger radial support forces, prosthetic valves are prone to serious distortion, deformation, and unevenness. However, by compressing and loading implants that are difficult to load, such as those with large sizes, large forces, or large aspect ratios, in steps, this can effectively solve the problem that such implants are prone to tilting, distortion, and thus damage during loading. That is, by using multiple loading tools with different shrinking sizes, the size of the implant can be reduced to a certain extent when it passes through different loading tools in sequence, and finally reaches the required loading compression size.

[0089] The inventors also found that the existing support structures (i.e., stents) of implants that need to be reduced in diameter using loading tools are mostly made of shape memory alloys. Shape memory alloys have deformation recovery capabilities, that is, at low temperatures, shape memory alloys change into martensite phases, showing soft properties, and can be properly twisted, bent, compressed, and other operations. When the temperature rises, the shape memory alloy will return to its original form - the austenite phase. In addition to temperature, stress is also a factor that can cause a phase change in shape memory alloys. That is, applying a certain pressure to the shape memory alloy can also cause the shape memory alloy to change from austenite to martensite. The loading tool for the implant provided by the present invention utilizes this characteristic. After the stent enters the martensite phase under ice water, it is radially compressed and loaded, which can more effectively compress the stent and avoid rebound.

[0090] The inventors further discovered that the stent can be compressed to its final size relatively easily by leaving it in ice water through multiple steps of compression.

[0091] According to the above ideas, the present invention provides a loading tool, a loading system and a loading method for an implant, wherein the loading tool for the implant comprises: a guide cover, a blocking platform and at least one compression platform; the guide cover has a through first inner cavity for loading the implant, the first inner cavity has a first end and a second end opposite to each other, the caliber of the first end is smaller than the caliber of the second end; the blocking platform is used to cooperate with the guide cover and be inserted in the first inner cavity; at least one compression platform has a through second inner cavity, the second inner cavity has a third end and a fourth end opposite to each other, the caliber of the third end is smaller than the caliber of the fourth end, and the caliber of the third end is larger than the caliber of the first end; wherein: the compression platform is configured to compress the implant using the second inner cavity before the implant is loaded in the first inner cavity; the blocking platform is configured to cooperate with the compressed implant and be inserted into the first inner cavity together. With such configuration, the compression platform can reduce the diameter of the implant in the first stage, and then the implant cooperates with the blocking platform and is limited, which can prevent the implant from escaping from the guide cover, and then the implant passes through the first end of the guide cover to reduce the diameter in the second stage. Thus, by compressing the implant in stages, it can be suitable for implants with large volume, large diameter-to-axis ratio and large radial support force. Preferably, the compression platform can be used to seal the blocking platform in the first inner cavity, which is a dual-purpose device, that is, the second inner cavity inside can be used for reducing the diameter, and the whole can be used as a blocking device to block the blocking platform, which reduces the number of components of the loading tool, reduces the manufacturing cost, and avoids various problems caused by too many loading tools during the actual loading process.

[0092] Please refer to Figures 1 to 32 ,in, Figure 1 is a three-dimensional diagram of a plugging platform assembly of an implant loading tool provided in the first embodiment of the present invention, Figure 2 is a three-dimensional diagram of a press-line assembly of an implant loading tool provided in Embodiment 1 of the present invention, Figure 3 is a front view of a plugging platform assembly of an implant loading tool provided in the first embodiment of the present invention, Figure 4 yes Figure 3 The cross-section of the blocking platform assembly along the AA line is shown. Figure 5 is a three-dimensional diagram of a guide cover provided in Embodiment 1 of the present invention, Figure 6 is a front view of the guide cover provided in the first embodiment of the present invention, Figure 7 yes Figure 6 The cross-sectional view of the guide cover along the line BB shown, Figure 8 is a three-dimensional diagram of a guide cover provided in Embodiment 2 of the present invention, Fig. 9 is a three-dimensional diagram of a blocking platform provided in the first embodiment of the present invention, Fig.10 This is a front view of the blocking platform provided by the first embodiment of the present invention. Fig.11 yes Fig.10The cross-sectional view of the blockage along the CC line is shown. Fig.12 is a three-dimensional diagram of a first compression stage provided in Embodiment 1 of the present invention, Fig.13 is a front view of a first compression stage provided in Embodiment 1 of the present invention, Fig.14 yes Fig.13 The cross-sectional view of the first compression stage along the line DD is shown. Fig.15 is a three-dimensional diagram of a first compression stage provided in Embodiment 2 of the present invention, Fig.16 is a three-dimensional diagram of a second compression stage provided in Embodiment 1 of the present invention, Fig.17 is a front view of a second compression stage provided in Embodiment 1 of the present invention, Fig.18 yes Fig.17 The cross-sectional view of the second compression stage along the EE line is shown. Fig.19 is a three-dimensional diagram of a pressing block provided in Embodiment 1 of the present invention, Fig. 20 is a schematic axial cross-sectional view of an implant provided in Embodiment 1 of the present invention, Fig.21 is a schematic diagram of the compression block provided in the first embodiment of the present invention cooperating with the second compression platform to flatten the implant, Fig. 22 is a schematic diagram of an implant provided by Embodiment 1 of the present invention passing through a first compression stage, Fig.23 Schematic diagram of loading an implant into a delivery device provided by Embodiment 1 of the present invention, wherein the blocking platform is provided with grooves. Fig.24 Schematic diagram of an implant loaded into a delivery device according to a first embodiment of the present invention, wherein the blocking platform is not provided with grooves. Fig.25 is a schematic diagram of a conveying device provided in Embodiment 1 of the present invention, Fig.26 is a schematic diagram of a guide cover provided in Embodiment 3 of the present invention, wherein the guide cover is provided with an anti-twist portion. Fig. 27 is a schematic diagram of a first compression platform provided in Embodiment 3 of the present invention, wherein the first compression platform is provided with a flange portion, Fig.28 is a schematic diagram of a guide cover provided in Embodiment 3 of the present invention, wherein the guide cover is provided with a flange portion. Fig.29 is a schematic diagram of a first compression platform provided in Embodiment 3 of the present invention, wherein the first compression platform is provided with an anti-twist portion, Fig.30 is a schematic diagram of a guide cover provided in Embodiment 4 of the present invention, Fig.31 is a schematic diagram of blocking a platform provided by the fourth embodiment of the present invention, Fig.32 It is a schematic diagram of the first compression stage provided in the fifth embodiment of the present invention.

[0093] The following description is given with reference to the accompanying drawings.

[0094] Embodiment 1

[0095] Please refer to Figures 1 to 7 , Figures 9 to 14 as well as Figures 16 to 19This embodiment provides an implant loading tool, which includes: a guide cover 1, a blocking platform 2 and a first compression platform 3. Figures 5 to 7 As shown, the guide cap 1 has a through first inner cavity 100 for loading the implant, the first inner cavity 100 has a first end 101 and a second end 102 opposite to each other, the caliber of the first end 101 is smaller than the caliber of the second end 102. The blocking platform 2 is used to cooperate with the implant to limit the position of the implant. Figure 12 to Figure 14 As shown, the first compression platform 3 has a through second inner cavity 300, the second inner cavity 300 has a third end 303 and a fourth end 304 opposite to each other, the caliber of the third end 303 is smaller than the caliber of the fourth end 304, and the caliber of the third end 303 is larger than the caliber of the first end 101; wherein: the first compression platform 3 is configured to compress the implant using the second inner cavity 300 before the implant is loaded into the first inner cavity 100; the blocking platform 2 is configured to be inserted into the first inner cavity 100 together with the compressed implant. Preferably, as Figure 1 , Figure 3 and Figure 4 As shown, the first compression platform 3 is used to seal the blocking platform 2 in the first inner cavity 100 to form a blocking platform assembly, and the first compression platform 3 is detachably connected to the guide cover 1.

[0096] Preferably, Figure 7 As shown, the first inner cavity 100 of the guide cover 1 can be divided into: a first diameter reduction area 12, a first transition area 13 and a slot area 14 from the first end 101 to the second end 102. The caliber of the first end 101 is the smallest part of the diameter of the first inner cavity 100. The implant is used to pass through the first end 101 to transport the guide cover 1, so the caliber of the first end 101 is related to the final compression size of the implant. The first diameter reduction area 12 is a cone-shaped, which is used to guide the blocking platform 2 and limit the blocking platform 2. The first transition area 13 is connected between the first diameter reduction area 12 and the slot area 14, and the slot area 14 is used to be detachably connected to the first compression platform 3. The angle range between the side of the first diameter reduction area 12 and the axis of the guide cover 1 can be selected from 5° to 60°, and the axial height of the first diameter reduction area 12 can be set according to different implants, such as 20-100mm. The shell wall thickness of the guide cover 1 can be designed to be a shell with uniform wall thickness or a shell with thicker wall thickness in some areas according to different applicable implants. The shell wall thickness of the guide cover 1 can be selected to be 0.5-5 mm, for example.

[0097] Further, if Fig.14As shown, the second inner cavity 300 of the first compression stage 3 can be divided from the third end 303 to the fourth end 304 into: a second outlet area 34, a second transition area 35 and a second diameter reduction area 36. The second diameter reduction area 36 is a truncated cone, and its diameter near the fourth end 304 is larger than the diameter near the third end 303. The second transition area 35 is connected between the second diameter reduction area 36 and the second outlet area 34, and its generatrix is ​​preferably an arc, so that the second transition area 35 is in the shape of an arc, ensuring that the implant will not be scratched by the edges when passing through the second inner cavity 300. The second outlet area 34 is preferably cylindrical, so as to apply a continuous compressive gripping force to the implant passing through the second inner cavity 300. The diameter of the second outlet area 34 is smaller than the minimum diameter of the second diameter reduction area 36 (i.e., the diameter of the second diameter reduction area 36 near the third end 303). Preferably, the second outlet area 34, the second transition area 35 and the second diameter reduction area 36 have a smooth transition. In actual use, the implant enters the second inner cavity 300 from the fourth end 304, passes through the second reduced diameter area 36, ​​the second transition area 35 and the second exit area 34 in sequence, and then passes through the first compression platform 3 from the third end 303. During this process, the implant is compressed (i.e. reduced diameter, which means compressed in the radial direction) by the first compression platform 3. The specific axial height and radial size of the second reduced diameter area 36 can be set according to the size of the implant, and the angle between the side of the second reduced diameter area 36 and the axis of the first compression platform 3 can be selected between 5° and 60°, so as to facilitate the implant to smoothly pass through the second inner cavity 300 and be reduced in diameter.

[0098] More preferably, Figure 5 and Fig.12 As shown, combined with Figure 1The card slot area 14 of the guide cover 1 is provided with a card slot 11. The card slot 11 may be an "L"-shaped open area, one end of which starts from the second end 102 and extends to the first end 101, and then extends along the circumference of the card slot area 14 after turning. The outer surface of the first compression platform 3 is divided into a card slot area 32 and a base area 33. The card slot area 32 matches the card slot area 14 of the guide cover 1. The card slot area 32 and the card slot area 14 are both cylindrical, and have the same axial height. The outer diameter of the card slot area 32 is equal to or slightly smaller than the inner diameter of the card slot area 14. The surface of the card slot area 32 is provided with a raised card slot 31 that matches the card slot 11. The size of the card slot 31 is set according to the size of the card slot 11, so that the card slot 31 and the card slot 11 form a clearance fit. The card slots 31 are evenly distributed on the surface of the card slot area 32 along the circumference, preferably multiple, such as 2 to 4, and the shape, position and number of the card slots 31 match the card slot 11. It should be understood that the slot 11 is not limited to being L-shaped, but can also be various suitable forms such as "T" shape, "H" shape, etc. The slot width of the slot 11 is preferably 1-10 mm, and is slightly larger than the buckle 31 matched therewith. The base area 33 is preferably cylindrical, and its axial height can be set according to different implants, such as 10-30 mm. Of course, in some other embodiments, the slots and buckles of the guide cover 1 and the first compression platform 3 are interchangeable, that is, the buckle is provided on the guide cover 1, and the slot is provided on the matching first compression platform 3.

[0099] Furthermore, Figure 4 As shown, the outer contour of the blocking platform 2 matches the first inner cavity 100. When the first compression platform 3 is used to seal the blocking platform 2 in the guide cover 1, the blocking platform 2 is configured to have no radial and axial displacement relative to the guide cover 1. Figures 9 to 11 As shown, the blocking platform 2 has a seventh end 207 and an eighth end 208 opposite to each other, the outer diameter of the seventh end 207 is smaller than the outer diameter of the eighth end 208, and the blocking platform 2 is used to penetrate the first inner cavity 100 from the eighth end 208 to the seventh end 207, and is limited by the guide cover 1 in radial displacement and axial displacement toward the first end 101, and then, the first compression platform 3 is matched and connected with the guide cover 1, and abuts against the end 208 of the blocking platform 2, thereby limiting the axial displacement of the blocking platform 2 toward the second end 102. As a result, the blocking platform 2 is sealed in the guide cover 1, and has no radial and axial displacement relative to the guide cover 1.

[0100] like Figures 9 to 11 As shown, a circle of grooves 21 with openings is provided on the seventh end 207 of the blocking platform 2. The outer wall diameter of the groove 21 is preferably larger than the inner wall diameter. The outer wall of the groove 21 abuts against the first reduced diameter area 12. When the blocking platform 2 is used to be set in the first inner cavity 100 (please refer to Figure 4), the opening faces the first end 101; the groove 21 is used to cooperate with the implant to locate the position of the implant. Specifically, the implant can be compressed by the second inner cavity 300 of the first compression platform 3, and the end of the compressed implant is clamped in the groove 21. The groove 21 at least limits the axial displacement of the implant toward the second end 102. Preferably, the groove 21 also limits the radial expansion of the end of the implant. When the blocking platform 2 is blocked in the first inner cavity 100, the position of the implant is located to prevent the implant from moving or tilting in the first inner cavity 100. Preferably, the blocking platform 2 has a third inner cavity 200 that is axially connected (i.e., in the direction from the seventh end 207 to the eighth end 208) to facilitate the penetration of the conical head of the conveying device (i.e., the inner diameter of the third inner cavity 200 is not less than the diameter of the conical head). In some embodiments, the blocking platform 2 is a truncated cone-shaped shell, and the seventh end 207 thereof is provided with a first protrusion 22 and a second protrusion 23. The first protrusion 22 is a hollow thin-walled cylinder arranged along the axial direction, and the inner diameter of the first protrusion 22 is not less than the diameter of the conical head of the conveying device. The second protrusion 23 is an annular column arranged along the axial direction, surrounding the outer side of the first protrusion 22, and arranged coaxially with the first protrusion 22, so that the groove 21 is formed between the first protrusion 22 and the second protrusion 23. Preferably, the axial length (referring to the distance from the end of the first protrusion 22 to the bottom of the groove 21) and the wall thickness (referring to the thickness of the first protrusion 22 in the radial direction) of the first protrusion 22 can be set as needed, such as the axial length of the first protrusion 22 can be 3-30mm, the wall thickness can be 1-5mm, etc. The axial length (referring to the distance from the end of the second protrusion 23 to the bottom of the groove 21) of the second protrusion 23 can also be set as needed, such as the axial length of the second protrusion 23 can be 3-10mm, etc. Preferably, the width of the groove 21 (i.e., the spacing between the first protrusion 22 and the second protrusion 23) can be selected to be 3-10mm to accommodate the loading of the implant. It should be understood that the present invention has no limitation on the relative height of the first protrusion 22 and the second protrusion 23, that is, it is not limited to the axial length of the first protrusion 22 being greater than the axial length of the second protrusion 23. The axial length of the first protrusion 22 can also be less than the axial length of the second protrusion 23, or the axial lengths of the two are equal, which can form the groove 21. More preferably, the outer periphery of the first protrusion 22 forms a smooth inward surface at the end, so as to better enable the implant to gradually shrink when leaving the plugging platform 2, and avoid the implant from suddenly slipping off when leaving the plugging platform 2. Please refer to Fig.23 and Fig.24 ,in Fig.23 The blocking platform 2 is provided with a groove 21, and Fig.24This is the case where the plugging platform 2 is not provided with the groove 21. If the plugging platform 2 is not provided with the groove 21, when the implant is loaded on the plugging platform 2 and inserted into the guide cover 1, when the implant passes through the first end 101 of the first inner cavity 100 and is loaded into the delivery device, the implant is prone to rebound due to the material of the implant, so the implant will expand toward the inner wall of the plugging platform 2, resulting in an increase in the resistance to loading. On the contrary, if Fig.23 As shown, when the blocking platform 2 is provided with a groove 21, due to the limiting effect of the groove 21 (the second protrusion 23 limits the expansion tendency of the end of the implant), the expansion of the end of the implant can be effectively limited, the loading resistance of the implant can be reduced, and the loading difficulty can be reduced.

[0101] Furthermore, when the blocking platform 2 cooperates with the guide cover 1 and is inserted into the first inner cavity 100, the outer surface contour of the blocking platform 2, except for the outer surface of the protrusion 23 and the outer circumference of the eighth end 208, is smaller than the inner surface contour of the guide cover 1 at a matching height, that is, only the two ends of the blocking platform 2 are in contact with the guide cover 1, and there is a gap between the outer contour of the remaining middle section and the guide cover 1. Preferably, the outer surface shape of the blocking platform 2 can be a trapezoidal column, or it can be slightly concave to form a concave surface 24, so that the blocking platform 2 can be embedded in the guide cover 1. More preferably, when the blocking platform 2 is sealed in the first inner cavity 100, the eighth end 208 of the blocking platform 2 is flush with the end of the first transition zone 13 of the first inner cavity 100 close to the second end 102, and the outer diameter of the eighth end 208 is slightly smaller than the maximum inner diameter of the first transition zone 13, so that the guide cover 1 can limit the blocking platform 2 in the axial and radial directions. Fig.11 As shown, the side of the plugging platform 2 near the eighth end 208 is preferably a hollow thin-wall design, which can reduce the weight of the entire plugging platform 2 while achieving the structural strength and functionality of the plugging platform 2. The hollow area of ​​the plugging platform 2 near the eighth end 208 is connected to the hollow area of ​​the first protruding edge 22, together forming the third inner cavity 200, making the plugging platform 2 a vertical through body. The diameter of the hollow area of ​​the plugging platform 2 near the eighth end 208 is not less than the diameter of the hollow area of ​​the first protruding edge 22, so that the conical head can pass through.

[0102] Preferably, please refer to Figure 4, the first compression stage 3 is used to block the blocking stage 2 in the direction from the fourth end 304 to the third end 303. Specifically, the second inner cavity 300 of the first compression stage 3 is arranged along the axial direction of the first compression stage 3, and the first compression stage 3 forms a flat surface at one end of the third end 303 of the second inner cavity 300, which matches the eighth end 208 of the blocking stage 2. When the first compression stage 3 blocks the blocking stage 2 in the first inner cavity 100, the flat surface abuts against the eighth end 208, thereby limiting the displacement of the blocking stage 2 in the first inner cavity 100. More preferably, the caliber of the third end 303 is smaller than the outer diameter of the eighth end 208 of the blocking stage 2, so as to ensure that after the first compression stage 3 blocks the blocking stage 2 in the first inner cavity 100, the blocking stage 2 will not be separated from the hollow area (second inner cavity 300) of the first compression stage 3. It should be understood that in some embodiments, the first compression platform 3 can also be used to block the blocking platform 2 from the third end 303 to the fourth end 304. At this time, the diameter of the fourth end 304 should not be greater than the outer diameter of the eighth end 208 of the blocking platform 2. In some other embodiments, the second inner cavity 300 of the first compression platform 3 is not limited to being set along the axial direction of the first compression platform 3, but can also be set along the radial direction of the first compression platform 3, or even set in an oblique direction that is neither axial nor radial. The first compression platform 3 is formed with a platform surface that matches the eighth end 208 of the blocking platform 2, which is used to block the blocking platform 2, and the penetration direction of the second inner cavity 300 is not related to the platform surface. The two are set separately, and the second inner cavity 300 is only used to compress the implant. Further, the platform surface can also be provided with a blind hole or a through hole for the conical head of the conveying device to penetrate, which can be determined according to the different sizes of the guide cover 1, the blocking platform 2 and the conveying device.

[0103] Please refer to Figures 16 to 18In the present embodiment, the loading tool for the implant also preferably includes a second compression platform 4, which has a through fourth inner cavity 400, the fourth inner cavity 400 has a third end 405 and a fourth end 406 relative to each other, the caliber of the third end 405 is smaller than the caliber of the fourth end 406, and the caliber of the third end 405 is larger than the caliber of the first end 101 of the guide cover 1; further, the caliber of the third end 303 of the first compression platform 3, the caliber of the third end 405 of the second compression platform 4 and the caliber of the first end 101 of the guide cover 1 decrease successively; and the caliber of the fourth end 406 is not smaller than the caliber of the third end 303; the first compression platform 3 is used to first compress the implant using the second inner cavity 300, and then the second compression platform 4 is used to further compress the implant using the fourth inner cavity 400. Specifically, the caliber of the fourth end 304 of the first compression stage 3 is not less than the radial dimension of the implant (uncompressed), so that the uncompressed implant can be compressed for the first time through the second inner cavity 300. The caliber of the fourth end 406 is not less than the caliber of the third end 303, so that the implant after the first compression by the first compression stage 3 can enter the fourth inner cavity 400 from the fourth end 406, so that the implant can be compressed for the second time through the second compression stage 4. Preferably, the caliber of the fourth end 406 is not less than the stable radial dimension of the implant after the first compression. It should be understood that since the implant is generally made of memory metal, it will rebound to a certain extent after the first compression by the second inner cavity 300 of the first compression stage 3, so that its diameter is slightly larger than the caliber of the third end 303, but after expanding to a certain extent, it will stabilize at a certain size. The caliber of the fourth end 406 is larger than the caliber of the third end 303 and is not less than the stable radial dimension of the implant after the first compression, which can make it easier for the implant to enter the fourth inner cavity 400 of the second compression stage 4.

[0104] Preferably, Fig.18As shown, the fourth inner cavity 400 of the second compression stage 4 can be divided from the third end 405 to the fourth end 406 into: a third outlet area 42, a third transition area 43 and a third diameter reduction area 44. The third diameter reduction area 44 is a truncated cone, and its diameter near the fourth end 406 is larger than the diameter near the third end 405. The third transition area 43 is connected between the third diameter reduction area 44 and the third outlet area 42, and its generatrix is ​​preferably an arc, so that the third transition area 43 is in the shape of an arc, ensuring that the implant will not be scratched by the edges when passing through the fourth inner cavity 400. The third outlet area 42 is preferably cylindrical, so as to apply a continuous compressive gripping force to the implant passing through the fourth inner cavity 400. The diameter of the third outlet area 42 is smaller than the minimum diameter of the third diameter reduction area 44 (i.e., the diameter of the third diameter reduction area 44 near the third end 405). Preferably, the third outlet area 42, the third transition area 43 and the third diameter reduction area 44 have a smooth transition. In actual use, the implant enters the fourth inner cavity 400 from the fourth end 406, passes through the third diameter reduction area 44, the third transition area 43 and the third exit area 42 in sequence, and then passes through the second compression platform 4 from the third end 405. During this process, the implant is compressed (i.e., reduced in diameter, meaning compressed in the radial direction) by the second compression platform 4. The specific axial height and radial size of the third diameter reduction area 44 can be set according to the size of the implant, and the angle between the side of the third diameter reduction area 44 and the axis of the second compression platform 4 can be selected between 5° and 60° to facilitate the smooth passage and diameter reduction of the implant.

[0105] Further, the caliber of the third end 303, the caliber of the third end 405 and the caliber of the first end 101 decrease in sequence according to a fixed difference. The caliber of the third end 303 is related to the compression size of the implant in the first stage, the caliber of the third end 405 is related to the compression size of the implant in the second stage, and the caliber of the first end 101 is related to the final compression size of the implant. When the caliber of the third end 303, the caliber of the third end 405 and the caliber of the first end 101 decrease in sequence according to a fixed difference, the implant can be compressed in steps more evenly. For example, assuming that the radial dimension of the implant before compression is 4α, after the first compression stage 3 compresses the implant for the first time, the radial dimension of the implant is 3α, and then after the second compression stage 4 compresses the implant for the second time, the radial dimension of the implant is 2α, and after the guide cap 1 compresses the implant for the final time, the radial dimension of the implant is α. That is, the compression amount provided in each compression stage = total compression amount / number of steps. Of course, the compression amount of the implant in each compression stage is not limited to the uniform compression as described above, and the compression amount of different implants in each stage can also be set according to appropriate parameters such as strain and stress.

[0106] It should be noted that the present invention is not limited to using the first compression stage 3 to first compress the implant, and then using the second compression stage 4 to compress the implant for the second time. In some other embodiments, the second compression stage 4 can be used to compress the implant for the first time, and then the first compression stage 3 can be used to compress the implant for the second time. At this time, the caliber of the third end 405 of the second compression stage 4, the caliber of the third end 303 of the first compression stage 3, and the caliber of the first end 101 of the guide cover 1 are reduced in sequence; and the caliber of the third end 303 is not less than the caliber of the fourth end 406. The principle and method of using the second compression stage 4 to compress the implant before the first compression stage 3 are similar to using the first compression stage 3 to compress the implant before the second compression stage 4. Please refer to the above description for details, and no further description is given here.

[0107] Fig. 20 An implant 9 is shown, which has a head end 901 and a tail end 902 opposite to each other, and the outer surface of the implant 9 has an outward warping structure 91, such as a barb, a flange, etc. The head end 901 of the implant 9 has a fixing ear 92, which is used to connect with the fixing head or other connecting structure of the delivery device to apply force to the implant 9. In this embodiment, the implant 9 has a through structure, that is, Fig. 20 The open hollow section shown. Please refer to Figure 2 , Figures 16 to 19 The second compression stage 4 includes a constant diameter section 41, and the implant loading tool also includes a pressing block 5, the pressing block 5 has a concave arc surface 500, preferably the arc surface 500 matches the constant diameter section 41 (that is, the inner diameter of the arc surface 500 is the same as the outer diameter of the constant diameter section 41, or the inner diameter of the arc surface 500 is slightly larger than the outer diameter of the constant diameter section 41, and the two can match), to form a press lining assembly. Please refer to Fig.21 The equal diameter section 41 is used for the implant 9 to be sleeved on its outer side ( Fig.21 The pressing block 5 is used to utilize the arc surface 500 to cooperate with the equal diameter section 41 to flatten the outward warping structure 91 on the implant 9 ( Fig.21The right half of the implant 9). If the outward warping structure 91 of some implants 9 is not flattened but directly compressed by the first compression platform 3 or the second compression platform 4, it is easy to be damaged. Therefore, the pressing block 5 can be used to cooperate with the equal-diameter section 41 of the second compression platform 4 to first flatten the outward warping structure 91 of the implant 9 to facilitate subsequent compression. It should be understood that the outer surface of the second compression platform 4 can partially constitute the equal-diameter section 41, or the outer surface of the entire second compression platform 4 can be the equal-diameter section 41. Of course, in some other embodiments, the equal-diameter section 41 is not limited to being arranged on the second compression platform 4, and can also be a part of the first compression platform 3 to constitute the equal-diameter section 41, which can also allow the implant 9 to be sleeved on its outside to form support for the implant 9. In other embodiments, the shape of the equal diameter section 41 is not limited to a cylindrical shape, but may be a conical shape, a truncated cone shape, a convex parabola shape or other similar curved surface, preferably a rotating curved surface shape, and the pressing block 5 is not limited to having a concave arc surface, but may also have a plane, which can also be used to flatten the outer warping structure 91 of the implant 9. The present invention does not limit this. The equal diameter section 41 is set on any component provided in this embodiment, and the purpose of multiple uses can be achieved. Preferably, as Fig.19 As shown, one or more of the parts of the pressing block 5 other than the arc surface 500, the outer contour of the guide cover 1, the outer contour of the blocking platform 2, and the outer contour of the compression platform 3 are provided with an anti-skid structure 51, such as ridges, knurling or grooves and other structural designs that can increase friction, which are used to increase the friction between the pressing block 5, the guide cover 1, the blocking platform 2 or the compression platform 3 and the operator to prevent the operator from slipping during operation. Of course, the anti-skid structure 51 can also be formed by the structure of the pressing block 5, the guide cover 1, the blocking platform 2 or the compression platform 3, such as the pressing block 5 forming a step shape for easy gripping. The present invention does not limit the specific form of the anti-skid structure 51.

[0108] This embodiment also provides an implant loading system, which includes the implant loading tool as described above, and also includes a delivery device, the delivery device is used to deliver an implant to a target location. The implant loading tool is used to cooperate with the implant loading tool to load the implant into the delivery device. Figure 23 to Figure 25 As shown, the delivery device 6 includes a sheath 62, a conical head 64 and a fixed head 61. The fixed head 61 is fixedly connected to the conical head 64 and can be movably inserted into the sheath 62 to pull the implant 9 so as to load the implant 9 into the sheath 62. The conical head 64 is used to penetrate the guide cap 1 and guide the entire delivery device 6 with its tip. According to different forms of the delivery device 6, the conical head 64 may pass through one or more of the implant 9, the blocking platform 2 and the first compression platform 3, so the third inner cavity 200 of the blocking platform 2 and the second inner cavity 300 of the first compression platform 3 are also used for the conical head 64 to penetrate to adapt to the assembly process.

[0109] The following is a detailed description of a method for loading an implant using the implant loading system described above.

[0110] Step 1: Place an implant 9 in a predetermined temperature environment to cause the implant to undergo a phase change; specifically, the predetermined temperature environment is, for example, an ice-water mixture, or other low-temperature environment, preferably a temperature environment of 0°C-5°C, and maintain it for a predetermined time, such as about 3 minutes.

[0111] Step 2: If Fig. 22 As shown, along the direction from the end 902 to the head end 901 of the implant 9, the implant 9 is passed through the second inner cavity 300 of the first compression platform 3 along the direction from the fourth end 304 to the third end 303 of the first compression platform 3, so that the implant 9 is compressed to the first predetermined diameter; specifically, a rope 63 can be passed through the fixing ear 92 of the implant 9 to pull the implant 9. When pulling the rope 63, it is necessary to ensure that the pulling force of each rope 63 is equal and in the same direction to prevent the implant 9 from tilting, twisting, etc. due to uneven force. It should be understood that in addition to pulling, various suitable moving methods such as uniform force pushing can also be used to make the implant 9 pass through the second inner cavity 300 of the first compression platform 3 to achieve compression.

[0112] Step 3: The end 902 of the implant 9 compressed to the first predetermined diameter is matched with the blocking platform 2 to locate the position of the implant 9; specifically, the rope 63 on the fixing ear 92 can be removed and the end 902 of the implant 9 can be embedded in the groove 21 of the blocking platform 2.

[0113] Step 4: insert the plugging platform 2 equipped with the implant 9 into the guide cover 1 along the direction from the second end 102 of the guide cover 1 to the first end 101, with the implant 9 facing the first end 101;

[0114] Step 5: Use the first compression platform 3 to seal the blocking platform 2 in the guide cover 1 to prevent the blocking platform 2 from slipping out of the guide cover 1. At this time, because the guide cover 1, the blocking platform 2 and the first compression platform 3 are of the same size, the head end 901 of the implant 9 will be exposed from the first end 101 of the guide cover 1. Fig.23 shown.

[0115] Step 6: Load the implant 9 into the delivery device by the implant loading tool; specifically, fix the exposed fixing ear 92 of the implant 9 in the fixing head of the delivery device 6, and then move the sheath 62 to extract the implant 9 from the guide cover 1 and transfer it to the sheath 62 of the delivery device 6, thus completing the loading.

[0116] Preferably, when the first compression platform 3 is used to perform the first step of compression on the implant 9, and the second compression platform 4 is used to perform the second step of compression on the implant 9, after step 2, the method further includes: using the fourth inner cavity 400 of the second compression platform 4 to reduce the diameter of the implant 9 again, so that the implant 9 compressed to the first predetermined diameter is further compressed to a second predetermined diameter, and the second predetermined diameter is smaller than the first predetermined diameter.

[0117] Preferably, when the second compression platform 4 is used to perform the first step of compression on the implant 9, and the first compression platform 3 is used to perform the second step of compression on the implant 9, before step 2, the method also includes: using the fourth inner cavity 400 to first reduce the diameter of the implant 9 so that the implant 9 is first compressed to a third predetermined diameter, and the third predetermined diameter is larger than the first predetermined diameter.

[0118] The implant 9 can be compressed in steps by the first compression stage 3 and the second compression stage 4, respectively, so that the total compression amount of the implant can be decomposed into multiple times, thereby avoiding a large amount of compression of the implant 9 at one time.

[0119] It should be noted that the step of passing the implant 9 through the second inner cavity 300 of the first compression platform 3, or the step of passing the implant 9 through the fourth inner cavity 400 of the second compression platform 4 can be repeated multiple times, and of course, the step of passing the implant 9 through the second inner cavity 300 and the step of passing the implant 9 through the fourth inner cavity 400 can be repeated multiple times. When the implant 9 passes through the second inner cavity 300 or the fourth inner cavity 400, when a more obvious rebound occurs due to the shear force, the step of passing the implant 9 through the second inner cavity 300 or the fourth inner cavity 400 can be repeated multiple times, so that the implant 9 is more stably compressed to a predetermined radial size. It should also be noted that after completing each step of compression, step 1 is preferably performed once to dissipate the shear force of the implant 9. Or one or more steps from step 2 to step 6 are performed in a predetermined temperature environment, so that the implant 9 can be compressed while being in the martensite phase as much as possible.

[0120] Preferably, when the implant 9 has an outwardly warped structure 91, before the step of making the implant 9 pass through the second inner cavity 300 of the first compression platform 3 (if the implant 9 is first compressed using the second compression platform 4, it can be before the implant 9 passes through the fourth inner cavity 400), the implant 9 is sleeved on the outer surface of the equal-diameter section 41 of the second compression platform 4, and the arc surface 500 on the pressing block 5 cooperates with the equal-diameter section 41 to flatten the outwardly warped structure 91 of the implant 9.

[0121] Embodiment 2

[0122] Please refer to Figure 8and Fig.15 The loading tool, loading system and loading method of the implant provided in the second embodiment of the present invention are basically the same as those in the first embodiment, and the same parts will not be described again. Only the differences will be described below.

[0123] like Figure 8 As shown, in this embodiment, the slot area 14 of the guide cover 1 extends along the radial direction of the guide cover 1, and in particular, the slot area 14 is perpendicular to the axis of the guide cover 1. At this time, the curvature of the first transition area 13 of the guide cover 1 matches the extension direction of the slot area 14, that is, the slot area 14 and the first reduced diameter area 12 are smoothly transitioned. The slot area 14 is provided with a plurality of L-shaped slots 11.

[0124] like Fig.15 As shown, the buckle area 32 of the first compression platform 3 that matches the guide cover 1 of this embodiment also extends along the radial direction of the first compression platform 3, and the extension direction matches the extension direction of the slot area 14. In particular, when the slot area 14 is perpendicular to the axis of the guide cover 1, the extension direction of the buckle area 32 is perpendicular to the axis of the first compression platform 3. A plurality of buckles 31 are provided on the surface of the buckle area 32 that is used to match the slot area 14, and the shape, number, distribution position, etc. of the buckle 31 are all matched with the slot 11, so that the buckle 31 can be engaged with the slot 11.

[0125] It should be understood that the present invention does not impose any particular limitation on the arrangement direction and arrangement form of the card slot area 14 and the buckle area 32. As long as the two can be connected in a detachable manner and the first compression platform 3 can abut against the blocking platform 2 to block the blocking platform 2 in the first inner cavity 100, it will be sufficient.

[0126] In addition, in the present embodiment, an implant is provided, which does not have a through structure, but is provided with an outward warping structure. The implant, such as an occluder, has a closed structure at its end, and does not need to be supported by the equal-diameter section 41. Therefore, the outer side of the second compression platform 4 does not need to be provided with the equal-diameter section 41, and the shape of its outer contour is not limited. Correspondingly, the pressing block 5 has a concave arc surface 500 or a plane, and the pressing block 5 is used to directly flatten the outward warping structure on the implant using the arc surface 500 or the plane, without inserting the lining support (i.e., the equal-diameter section 41) into the implant. After the implant is flattened using the pressing block 5, the implant is passed through the inner cavity of the first compression platform 3 or the second compression platform 4 for compression. Similarly, an anti-slip structure may also be provided on the pressing block 5. For details, please refer to Example 1, which will not be repeated here.

[0127] In some other embodiments, the implant may not be provided with an outward warping structure. In this case, the loading system of the implant may not include the pressing block 5. The implant without an outward warping structure can be directly compressed through the inner cavity of the first compression platform 3 or the second compression platform 4 without the need for the pressing block 5 to flatten it in advance.

[0128] Embodiment 3

[0129] Please refer to Fig.26 and Fig. 27 The loading tool, loading system and loading method of the implant provided in the third embodiment of the present invention are basically the same as those in the first embodiment. The same parts will not be described again, and only the differences will be described below.

[0130] Fig.26 (A) shows a three-dimensional view of the guide cover 1 provided in this embodiment, Fig.26 (B) Fig.26 (A) is a three-dimensional view of the guide cover 1 as viewed from above. Fig. 27 (A) shows a three-dimensional view of the first compression stage 3 provided in this embodiment, Fig. 27 (B) Fig. 27 (A) is a perspective view of the first compression stage 3 as seen from below.

[0131] In this embodiment, the slot area 14 of the guide cover 1 includes a special-shaped (ie, non-circular) anti-twist portion 15 (eg, Fig.26 The outer peripheral wall of the anti-twist portion 15 forms a first anti-twist wall, and the cross section of the first anti-twist wall (referring to the cross section along the radial direction of the guide cover 1) is a special shape. Fig. 27 As shown, the buckle area 32 of the first compression platform 3 includes a flange portion 16 extending in the axial direction, and the inner side wall of the flange portion 16 forms a second anti-twist wall, and the cross section of the second anti-twist wall is also irregular. When the first compression platform 3 is engaged with the guide cover 1, the first anti-twist wall abuts against the second anti-twist wall, and the two are matched by the irregular shape, which can effectively prevent the guide cover 1 from sliding off due to circumferential rotation relative to the first compression platform 3. Preferably, the slot area 14 and the buckle area 32 are respectively provided with a slot 11 and a buckle 31, and the number and shape of the slot 11 and the buckle 31 match, so that the first compression platform 3 and the guide cover 1 can be engaged with each other, and then through the engagement of the slot 11 and the buckle 31, the guide cover 1 can be effectively prevented from sliding off due to axial movement and circumferential rotation relative to the first compression platform 3.

[0132] In some other embodiments, the flange portion 16 may be provided on the guide cover 1, and the anti-twist portion 15 may be provided on the first compression stage 3. Fig.28 and Fig.29 As shown. Among them, Fig.28 (A) shows a three-dimensional view of a guide cover 1 provided in another preferred embodiment, Fig.28 (B) Fig.28 (A) is a three-dimensional view of the guide cover 1 as viewed from above. Fig.29 (A) shows a three-dimensional view of the first compression stage 3 provided in another preferred embodiment, Fig.29 (B) Fig.29 (A) is a perspective view of the first compression stage 3 as seen from below. Fig.28 The guide cover 1 shown is provided with an elliptical flange portion 16. Fig.29 The first compression stage 3 shown is provided with Fig.28 The flange portion 16 of the guide cover 1 shown in the figure matches the anti-twist portion 15. The anti-twist portion 15 and the flange portion 16 cooperate with each other through the elliptical shape, which can also effectively prevent the guide cover 1 from rotating circumferentially relative to the first compression platform 3 and slipping off. Preferably, a buckle can be set on one of the guide cover 1 and the first compression platform 3, and the other one of the guide cover 1 and the first compression platform 3 is used as a snap-fit ​​body matching the buckle. Fig.28 and Fig.29 As shown, two buckles 31 are provided on the first compression platform 3, while the corresponding guide cover 1 has no special arrangement, and only the flange portion 16 of the guide cover 1 is used as a snap-fitting body for the buckle 31 to snap-fit. When the buckle 31 and the flange portion 16 are snap-fitted, the axial and circumferential displacements of the guide cover 1 relative to the first compression platform 3 can also be limited. It should be understood that the specific shapes of the flange portion 16 and the anti-twist portion 15, as well as the specific settings of the slot and the buckle, can be appropriately selected by those skilled in the art through the prior art, and the present invention is not limited thereto. For example, the slot and the buckle can be circular, elliptical or square, etc., and the number of the slot and the buckle is preferably greater than 1. For example, the cross-section of the first anti-twist wall and the cross-section of the second anti-twist wall can be various special-shaped (non-circular) shapes such as pentagonal flower, rounded triangle or elliptical.

[0133] Embodiment 4

[0134] Please refer to Fig.30 and Fig.31 The loading tool, loading system and loading method of the implant provided in the fourth embodiment of the present invention are basically the same as those in the first embodiment. The same parts will not be described again, and only the differences will be described below.

[0135] Fig.30 (A) shows a three-dimensional view of the guide cover 1 provided in this embodiment, Fig.30 (B) Fig.30 (A) is a three-dimensional view of the guide cover 1 as viewed from above. Fig.31 (A) shows a three-dimensional view of the blocking platform 2 provided in this embodiment, Fig.31 (B) Fig.31(A) is a three-dimensional view of the blocking platform 2 from an upward angle. In this embodiment, the second end 102 of the first inner cavity 100 of the guide cover 1 is elliptical, while the first end 101 is circular, and the first inner cavity 100 forms a three-dimensional curved surface. To match it, the eighth end 208 of the blocking platform 2 is also elliptical, the seventh end 207 and the groove 21 are circular, and the outer contour of the blocking platform 2 also forms a three-dimensional curved surface. In this configuration, when the guide cover 1, the blocking platform 2 and the first compression platform 3 are matched, the outer contour of the blocking platform 2 can be matched with the shape of the first inner cavity 100 to effectively prevent the torsion of the first compression platform 3 from driving the rotation of the blocking platform 2, thereby preventing the implant embedded in the groove 21 from twisting. Of course, in some other embodiments, the second end 102 and the eighth end 208 can also be designed as various special-shaped (non-circular) shapes such as square and flower shapes to achieve an anti-twist effect.

[0136] Embodiment 5

[0137] Please refer to Fig.32 The loading tool, loading system and loading method of the implant provided in the fifth embodiment of the present invention are basically the same as those in the first embodiment. The same parts will not be described again, and only the differences will be described below.

[0138] like Fig.32 As shown, in this embodiment, the implant loading tool includes a guide cover 1, a blocking platform 2 and a plurality of first compression platforms 3 ( Fig.32 , two first compression stages 3 are shown, but the present embodiment is not limited to two first compression stages 3). The specific forms of the multiple first compression stages 3 are basically similar to the first compression stage 3 of the first embodiment, and they all have a through second inner cavity 300. The second inner cavity 300 has a third end 303 and a fourth end 304 opposite to each other. The caliber of the third end 303 is smaller than that of the fourth end 304, and the caliber of the third end 303 is larger than that of the first end 101. In particular, the calibers of the third ends 303 of the second inner cavities 300 of the multiple first compression stages 3 are all different.

[0139] Here, for the convenience of description, the number of the multiple first compression platforms 3 is set to n (it should be understood that n is a natural number greater than 1), wherein the diameters of the third ends 303 of the 1st first compression platform 3 to the nth first compression platform 3 decrease successively, and the diameter of the third end 303 of the i-th first compression platform 3 is not greater than the diameter of the fourth end 304 of the i+1th first compression platform 3, i being a natural number less than n; the n first compression platforms 3 are configured such that, before the implant is loaded into the first inner cavity 100, the second inner cavities 300 of the n first compression platforms 3 compress the implant successively.

[0140] In some cases, multiple first compression stages 3 may be used to compress the implant multiple times in steps to achieve better results. Preferably, the calibers of the third ends 303 of the n first compression stages 3 that decrease in sequence decrease by a fixed difference, and the difference between the caliber of the third end of the nth compression stage and the caliber of the first end is also the fixed difference.

[0141] Specifically, if the diameters of the third ends 303 of the first compression stage 3 to the nth compression stage 3 are D1...D n The diameter of the first end portion 101 of the guide cover 1 is D x , then:

[0142] D n =D1-(n-1)*d

[0143] Wherein, d is the difference between the diameters of the third ends 303 of two consecutive first compression stages 3 (it should be understood that d here is the tolerance and is a positive number), and is also the difference between the diameter of the third end 303 with the smallest diameter and the diameter of the first end 101. That is, D1, D2...D n , D x Form an arithmetic progression.

[0144] With such configuration, the implant can be compressed step by step more evenly, and the compression amount of the implant in each step is a fixed value (tolerance d). Of course, in other embodiments, the diameters of the third ends 303 of the n successively decreasing first compression stages 3 are not limited to decreasing by a fixed difference, but can also decrease in equal proportion, or the diameters of the third ends 303 can be set differently according to appropriate parameters such as strain and stress.

[0145] In the implant loading method provided in this embodiment, the process of compressing the implant 9 to the first predetermined diameter includes: in the order of decreasing calibers of the third end 303, the second inner cavities 300 of the n first compression stages 3 are used to compress the implant in sequence, and the implant is compressed to the first predetermined diameter in stages. That is, the implant 9 can be compressed in steps by the n first compression stages 3, so that the total compression amount of the implant can be decomposed into multiple times, and a large amount of compression of the implant 9 can be avoided at one time.

[0146] For further information, please continue to refer to Fig.32, any two of the first compression platforms 3 can be detachably connected. In practice, the number of first compression platforms 3 required to be matched can be selected according to the situation, and these first compression platforms 3 can be connected in pairs. At least one of the first compression platforms 3 can be matched and connected with the guide cover 1. In this way, when multiple first compression platforms 3 are matched, the weight of the blocking platform assembly can be increased, thereby increasing the weight of the entire implant loading tool, preventing the operator from shaking with the conveying device due to the loading tool being too light when operating the handle.

[0147] When the plurality of first compression stages 3 are connected to each other, various suitable forms of cooperation such as wedge cooperation and snap cooperation can be adopted to prevent the plurality of first compression stages 3 from rotating. Fig.32 As shown, a buckle 31 and a slot 37 can be simultaneously provided on each first compression stage 3. The arrangement and engagement principle of the buckle 31 and the slot 37 can refer to the first embodiment, and will not be repeated here. When the buckles 31 and the slots 37 of the two first compression stages 3 are engaged, the second inner chambers 300 of the two first compression stages 3 are connected, and one end surface of the two second inner chambers 300 abuts against each other. Specifically, the third end 303 of the first first compression stage 3 can be abutted against the third end 303 of the second first compression stage 3, or the third end 303 of the first first compression stage 3 can be abutted against the fourth end 304 of the second first compression stage 3. This embodiment does not limit the connection direction of the multiple first compression stages 3.

[0148] In particular, the buckles 31 and the slots 37 of the plurality of first compression stages 3 are of the same configuration, so the plurality of first compression stages 3 can be connected to each other in any order.

[0149] Preferably, n first compression platforms 3 are detachably connected in the order of decreasing caliber of the third end 303. In this way, multiple first compression platforms 3 can be combined into one (or more) compression platform assembly, and the inner cavity of the compression platform assembly gradually decreases from one end to the other end. In some cases, the inner cavity of the compression platform assembly can also be used to compress the implant. For example, in some cases, four first compression platforms 3 can be combined into two compression platform assemblies to compress an implant in two steps, or they can be split into four first compression platforms 3 to compress an implant in four steps. More implants can be accommodated without changing the first compression platform 3.

[0150] Of course, in some other embodiments, a part (or all) of the n first compression platforms 3 may not be provided with buckles and slots, and this part of the first compression platforms 3 is only used to compress the implant using its second inner cavity 300 .

[0151] Embodiment 6

[0152] The loading tool, loading system and loading method of the implant provided in the sixth embodiment of the present invention are basically the same as those in the first embodiment, and the same parts will not be described again. Only the differences will be described below.

[0153] Different from the first embodiment, in this embodiment, the outer contour of the blocking platform 2 matches the first inner cavity 100 of the guide cover 1, and the blocking platform 2 can be directly connected to the guide cover 1 detachably. When the blocking platform 2 is connected to the guide cover 1, the blocking platform 2 is configured to have no radial and axial displacement relative to the guide cover 1. Similar to the connection method of the first compression platform 3 and the guide cover 1 in the first embodiment, the blocking platform 2 and the guide cover 1 can be connected by a snap connection or shape matching, and of course, the snap connection and shape matching can also be used at the same time. The snap connection here is such as setting a snap on one of the blocking platform 2 and the guide cover 1, and setting a slot on the other, and the snap and the slot match and engage, thereby limiting the blocking platform 2 to have no radial and axial displacement relative to the guide cover 1. Another example is that the shapes of the blocking platform 2 and the guide cover 1 are matched with each other (such as the shape matching of the blocking platform 2 and the guide cover 1 in the fourth embodiment). In this way, the first compression platform 3 can be used to limit the blocking platform 2. The first compression table 3 and the second compression table 4 can be used only to compress the implant in steps through the second inner cavity thereof, or to flatten the outward warping structure of the implant through the cooperation of the cylindrical segment and the pressing block. Of course, in this embodiment, it is not limited to the use of two compression tables, and only one compression table or multiple compression tables can also be used. Preferably, multiple compression tables can also be detachably connected to each other, and then the compression table can also be connected in cooperation with the guide cover 1 or the blocking table 2, but this connection is only used to increase the weight of the loading tool of the entire implant to prevent the operator from shaking with the conveying device due to the loading tool being too light when operating the handle, and it is not used to block the blocking table 2.

[0154] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

Claims

1. A loading tool for an implant, characterized in that: include: A guide cap having a through first inner cavity for loading the implant, wherein the first inner cavity has a first end and a second end opposite to each other, and the caliber of the first end is smaller than the caliber of the second end; a blocking platform, used to cooperate with the guide cover and inserted into the first inner cavity; and at least one compression stage, having a through second inner cavity, the second inner cavity having a third end and a fourth end opposite to each other, the third end having a smaller diameter than the fourth end, and the third end having a larger diameter than the first end; Wherein: the compression stage is configured to compress the implant using the second inner cavity before the implant is loaded into the first inner cavity; The blocking platform is configured to be inserted into the first inner cavity together with the compressed implant; the blocking platform is provided with a circle of grooves with openings, and when the blocking platform is set in the first inner cavity, the openings face the first end; the groove cooperates with the implant to limit the position of the implant; the outer contour of the blocking platform matches the first inner cavity, the blocking platform is detachably connected to the guide cover, and when the blocking platform is connected to the guide cover, the blocking platform is configured to have no radial and axial displacement relative to the guide cover; the outer contour of the blocking platform matches the first inner cavity, at least one compression platform is detachably connected to the guide cover, and when the compression platform is connected to the guide cover, the compression platform is used to seal the blocking platform in the first inner cavity, and the blocking platform is configured to have no radial and axial displacement relative to the guide cover; the blocking platform has a third inner cavity that passes through along the axial direction.

2. The implant loading tool according to claim 1, characterized in that: The guide cover is connected to the blocking platform by snap connection and / or shape matching.

3. The implant loading tool according to claim 1, characterized in that: The guide cover is connected to at least one of the compression stages by snap-fit ​​connection and / or shape matching.

4. The implant loading tool according to any one of claims 1 to 3, characterized in that: The implant loading tool comprises n compression stages, wherein the diameters of the third ends of the first compression stage to the nth compression stage decrease in sequence, and the diameter of the third end of the i-th compression stage is not greater than the diameter of the fourth end of the i+1-th compression stage; wherein n is a natural number greater than 1, and i is a natural number less than n; The n compression stages are configured such that, before the implant is loaded into the first inner cavity, the second inner cavities of the n compression stages compress the implant in sequence.

5. The implant loading tool according to claim 4, characterized in that: The diameters of the third ends of the n successively decreasing compression stages decrease according to a fixed difference, and the difference between the diameter of the third end of the nth compression stage and the diameter of the first end is also the fixed difference.

6. The implant loading tool according to claim 4, characterized in that: Any two compression stages can be detachably connected.

7. The implant loading tool according to claim 6, characterized in that: The n compression stages are detachably connected in the order in which the diameters of the third ends decrease successively.

8. The implant loading tool according to claim 1, characterized in that: The implant has an outwardly warped structure, and the loading tool of the implant also includes a pressing block, which has a concave arc surface or a plane. The pressing block is used to flatten the outwardly warped structure on the implant using the arc surface or the plane.

9. The implant loading tool according to claim 8, characterized in that: At least one of the compression platforms includes a cylindrical section, and the cylindrical section is used for the implant to be sleeved on its outer side. The compression block is used to utilize the arc surface or the plane surface to cooperate with the cylindrical section to flatten the outward warping structure on the implant.

10. The implant loading tool according to claim 8 or 9, characterized in that: One or more of the parts of the pressing block other than the arc surface or the plane, the outer contour of the guide cover, the outer contour of the blocking platform and the outer contour of the compression platform are provided with an anti-slip structure.

11. An implant loading system, characterized in that: include: a delivery device for delivering the implant to a target site; as well as The implant loading tool according to any one of claims 1 to 10 is used to cooperate with the implant loading tool to load the implant into the delivery device.

12. A method for loading an implant, using the implant loading system according to claim 11, characterized in that: include: placing the implant in a predetermined temperature environment; The implant has a head end and a tail end opposite to each other, and the implant is passed through the second inner cavity of the compression stage along the direction from the tail end to the head end of the implant and along the direction from the fourth end to the third end of the compression stage, so as to compress the implant to a predetermined diameter; Matching the end of the implant compressed to the predetermined diameter with the blocking platform to limit the position of the implant; Insert the plugging platform equipped with the implant into the guide cover along the direction from the second end to the first end of the guide cover, with the implant facing the first end; The implant is loaded into the delivery device from the implant loading tool.

13. The implant loading method according to claim 12, characterized in that: The implant loading tool comprises n compression stages, the calibers of the third ends of the first compression stage to the nth compression stage decrease in sequence, and the caliber of the third end of the i-th compression stage is not greater than the caliber of the fourth end of the i+1-th compression stage; wherein n is a natural number greater than 1, and i is a natural number less than n; wherein the process of compressing the implant to a predetermined diameter comprises: The implant is compressed in sequence by utilizing the second inner chambers of the n compression stages in the order in which the diameter of the third end portion decreases, so as to compress the implant to the predetermined diameter in stages.

14. The implant loading method according to claim 12 or 13, characterized in that: The step of passing the implant through the second lumen of any one of the compression stages is repeated a plurality of times.

15. The implant loading method according to claim 12, characterized in that: The implant is provided with an outward warping structure, the loading tool of the implant further comprises a pressing block, the pressing block has a concave arc surface, and before the step of passing the implant through the second inner cavity of the compression platform, the step further comprises: The arc surface is used to flatten the outward warping structure of the implant.

16. The implant loading method according to claim 15, characterized in that: At least one of the compression stages includes a cylindrical segment, and before the step of using the arc surface to flatten the outward warping structure of the implant, the step further includes: sleeve the implant on the outer surface of the cylindrical section of the compression table; The arc surface cooperates with the cylindrical segment to flatten the outward warping structure of the implant.

Images