Implantable device and manufacturing method therefor

Abstract

The present application belongs to the technical field of medical devices, and particularly relates to an implantable device and a manufacturing method for the implantable device. The implantable device comprises a body and an attachment portion, wherein the body comprises a first subportion and a second subportion. The first subportion is configured to fit against a wall of a lumen after the implantable device is implanted into the lumen. The second subportion is connected to the first subportion and is at least partially suspended after the implantable device is implanted into the lumen. The attachment portion is attached to the second subportion. The implantable device provided by the present application can improve overall safety of the device from multiple aspects.

Description

Implantable device and method of manufacturing the same Technical Field

[0001] The present application belongs to the field of medical device technology, and specifically relates to an implantable device and a method for manufacturing the implantable device. Background Art

[0002] Heart valves are one-way valves between the atria and ventricles, or between the ventricles and arteries. Valvular heart disease is one of the most common cardiovascular diseases. Clinically, structural or functional abnormalities of single or multiple valves caused by rheumatic inflammation, degenerative changes, congenital malformations, ischemic necrosis, trauma, and other factors can lead to valvular stenosis or insufficiency. Mild cases of valvular heart disease can be alleviated with medication, while severe cases can undergo valve repair. Patients not suitable for repair require artificial heart valve replacement.

[0003] Heart valve replacement refers to the replacement of an artificial mechanical valve made of synthetic materials or a bioprosthetic valve made of biological tissue. Since artificial heart valves have a limited service life and their size does not change, they need to be replaced multiple times, especially in children and adolescents, to compensate for the growth of the recipient. Before replacing a new artificial heart valve, the previously implanted artificial heart valve needs to be removed. However, due to tissue adhesions in the surgical area, surgical removal is difficult and risky. In view of this, the valve frames of some artificial heart valves are made of absorbable materials, and the valve frames will gradually degrade in the human body. When replacing a new artificial heart valve, there is no need to remove the old artificial heart valve, which greatly reduces the risk of surgery.

[0004] Although there are many advantages to using absorbable materials to manufacture valve frames, some absorbable materials, such as magnesium alloys, corrode too quickly, which can easily cause structural incompleteness in the short term after device implantation and lose its support for tissue, ultimately leading to device failure and seriously affecting the safety and reliability of the device. In addition, the wall thickness of the valve frame or stent is generally in the order of hundreds of microns, which can easily form sharp edges and cause damage to tissue, which will also affect the safety of the device to a certain extent. In addition, there is the possibility of localized stent fracture or large pieces of debris being shed due to corrosion and degradation, which can flow into downstream blood vessels and cause embolism. Furthermore, the human body structure is relatively complex and has individual differences, so the shape of the valve frame of an artificial heart valve is generally difficult to completely match the various shapes of the human body structure. After some artificial heart valves are implanted in the human body, the different degrees of fit between the valve frame and the lumen or the differences in blood flow rate lead to large differences in the endometrialization, and areas with slow endometrialization may cause thrombosis. In summary, the safety of current implantable devices is relatively low. Summary of the Invention

[0005] In response to the above technical problems, the technical solution of the present application provides an implantable device that can improve the overall safety of the device.

[0006] In a first aspect, the present application provides an implantable device, comprising: a body, the body comprising a first sub-section and a second sub-section, the first sub-section being adapted to abut against a lumen wall after the implantable device is implanted into the lumen, the second sub-section being connected to the first sub-section, and the second sub-section being at least partially suspended in the air after the implantable device is implanted into the lumen; and

[0007] The attachment portion is attached to the second sub-portion.

[0008] In some embodiments, the shape of the attachment portion is configured to change following a change in the shape of the second sub-portion.

[0009] In some embodiments, the implantable device further includes a limiting member, one end of the limiting member is connected to the first sub-portion, and the other end of the limiting member is connected to the second sub-portion and / or the attachment portion.

[0010] In some embodiments, there are at least two limiting members, and each limiting member is connected to a different position of the second sub-portion and / or the attachment portion.

[0011] In some embodiments, the second sub-section includes at least one support rod, and the attachment portion includes at least one winding wire, wherein the at least one winding wire is wound around the support rod in a plurality of turns to form the attachment portion.

[0012] In some embodiments, the wire width / diameter of the winding wire is 50-700 μm.

[0013] In some embodiments, the turn spacing between adjacent turns of the winding wire is 0 to 0.5 mm.

[0014] In some embodiments, each wound thread includes a plurality of fiber filaments, the fiber filaments have the same or different diameters and the diameter of the fiber filaments is 5 to 25 μm.

[0015] In some embodiments, the winding wire is wound around the support rod in a manner selected from the following: overlapping winding; flat winding; multi-layer winding; and winding with varying density.

[0016] In some embodiments, the angle between the winding wire and the axis of the strut is less than 90°.

[0017] In some embodiments, the angle between the wrap and the axis of the strut varies along the axis.

[0018] In some embodiments, the wire is wrapped around the support rod to form a plurality of binding knots, and the binding knots are adjacent or spaced apart.

[0019] In some embodiments, the attachment portion further includes a pulling layer, which is arranged along the length direction of the support rod of the second sub-portion. The winding wire and the pulling layer have several intersections, and the winding wire and the pulling layer at each intersection are connected or connected at intervals as a whole.

[0020] In some embodiments, the attachment portion includes a base layer and a plurality of fiber filaments extending from the base layer, the base layer is wrapped around the second sub-portion, and the distribution density of the fiber filaments is 10 to 500 filaments / mm 2 .

[0021] In some embodiments, the thickness of the attachment portion is 10 to 750 μm. Further, the thickness of the attachment portion is 10 to 150 μm.

[0022] In some embodiments, the second sub-portion includes a tip, and the thickness of the attachment portion at the tip is 50-150 μm.

[0023] In some embodiments, the second sub-portion includes an easy-to-break region that is prone to fracture, and the thickness of the attachment portion in the easy-to-break region is 20-100 μm.

[0024] In some embodiments, the attachment portion has a plurality of pores, and the diameter of each pore is less than 500 μm.

[0025] In some embodiments, the attachment portion includes a first density region and a second density region adjacent to each other, the first density region is provided with a plurality of holes with a pore size of 10 to 100 μm, and the second density region is provided with a plurality of holes with a pore size of 150 to 500 μm.

[0026] In some embodiments, the main body or the second subsection is degradable, and the degradation time of the second subsection is greater than the endometrialization time of the second subsection.

[0027] In some embodiments, the attachment portion is non-degradable or the degradation time of the attachment portion is greater than the endometrialization time of the second sub-portion.

[0028] In some embodiments, the surface of the attachment portion is corrugated and has a peak-to-valley difference of 0.03 to 0.7 mm.

[0029] In some embodiments, the permeability coefficient of the attachment portion is 1*10 -13 cm / s~1*10 -3 cm / s.

[0030] In some embodiments, the material of the attachment portion has a blood coagulation rate of 10% to 90%.

[0031] In some embodiments, the surface potential polarities of the attachment portion and the first sub-portion are negative, and the absolute value of the surface potential of the attachment portion is smaller than the absolute value of the surface potential of the first sub-portion.

[0032] In some embodiments, the main body further includes a plurality of hollow portions, which pass through the inner and outer surfaces of the main body, a flow channel is formed in the axial direction of the main body, the second sub-part is adjacent to at least one of the hollow portions, and the attachment portion is attached to the second sub-part in a manner that keeps the second sub-part suspended and / or keeps the fluid in the lumen able to flow out from the flow channel through the hollow portion adjacent to the second sub-part.

[0033] In some embodiments, the body is a hollow tubular structure, and the diameter of the first sub-section is smaller than the diameter of the second sub-section.

[0034] In some embodiments, the length of the first subsection is greater than the length of the second subsection.

[0035] In some embodiments, the implantable device further comprises a leaflet assembly and a skirt, wherein the leaflet assembly is fixed to an inner side of the first subsection.

[0036] In some embodiments, the skirt portion includes an inner skirt and / or an outer skirt, the inner skirt being used to connect the leaflet assembly to the body, and the outer skirt covering the outside of the first sub-portion.

[0037] Another aspect of the present application provides a method for manufacturing an implantable device, the method comprising:

[0038] selecting a substrate for preparing the implantable device;

[0039] Processing the substrate to prepare the body of the implantable device, wherein the body comprises a first sub-portion adapted to adhere to the lumen wall after implantation into the lumen and a second sub-portion at least partially suspended;

[0040] The attachment portion is formed in the second sub-portion.

[0041] The implantable device proposed in the present application, when implanted into a living body, the first sub-section of its body quickly undergoes tissue endothelialization and is fixed in the tissue due to its adhesion to the tissue of the living body, while the second sub-section, which is not in contact with the living body and is suspended in the air, is attached with an attachment portion. Therefore, the detached matter that may be generated by degradation, breakage, etc. of the second sub-section before tissue endothelialization occurs can be confined by the attachment portion, thereby preventing the detached matter from migrating in the living body and causing thrombosis, and avoiding damage to the tissue by the sharp body. At the same time, it can also reduce the device from puncturing the tissue or the delivery balloon during delivery. The attachment portion can also promote tissue endothelialization of the suspended second sub-section, improve the balance of endothelialization of various parts of the body, and regulate the corrosion degradation of the second sub-section to improve the degradation characteristics of the implantable device. Therefore, the implantable device can delay corrosion in the early stage of implantation to provide sufficient structural support to the lumen and quickly degrade in the later stage to remove unnecessary constraints on the lumen, thereby improving the overall safety of the implantable device during the implantation process and in all stages after implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0043] FIG1 is a schematic structural diagram of an implantable device provided in one embodiment of the present application;

[0044] FIG2 is a schematic diagram of an implantable device according to an embodiment of the present application after implantation;

[0045] FIG3 is an enlarged schematic diagram of part A of the implantable device shown in FIG1 ;

[0046] FIG4 is a schematic diagram of an exemplary structure of an attachment portion of an implantable device of the present application;

[0047] FIG5 is another exemplary structural diagram of the attachment portion of the implantable device of the present application;

[0048] FIG6 is another exemplary structural diagram of the attachment portion of the implantable device of the present application;

[0049] FIG7 is another exemplary structural diagram of the attachment portion of the implantable device of the present application;

[0050] 8 to 11 are schematic diagrams of implantable devices according to other embodiments of the present application;

[0051] FIG12 is a schematic flow chart of a method for manufacturing an implantable device according to an embodiment of the present application;

[0052] FIG13 is a partial SEM image of the attachment portion of the implantable device of Example 1 of the present application;

[0053] FIG14 is a diagram showing the endothelialization effect of the implantable device of Example 1 of the present application;

[0054] FIG15 is a local SEM image of the attachment portion shown in FIG14 at a higher magnification;

[0055] FIG16 is a partial SEM image of the implantable device of Example 1 of the present application after being implanted for a period of time;

[0056] FIG. 17 is a SEM image of portion E shown in FIG. 16 at a higher magnification. DETAILED DESCRIPTION

[0057] The following describes exemplary embodiments of the present application in more detail with reference to the accompanying drawings. Although exemplary embodiments of the present application are shown in the accompanying drawings, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. Instead, these embodiments are provided to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.

[0058] It should be noted that the symbol “ / ” in this application represents the meaning of “or”, such as “needed / applicable for in vivo use” means needed or applicable for in vivo use.

[0059] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In the event of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. The materials, methods, and examples disclosed herein are illustrative only and not restrictive.

[0060] The term "about" or "substantially" used with respect to an amount includes variations in the recited amount that are equivalent to the recited amount, eg, an amount that is not significantly different from the recited amount for the intended purpose or function.

[0061] For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figures, such as "inside," "outside," "inside," "outside," "below," "beneath," "above," and the like. Such spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "below" another element or feature would then be oriented as "above" or "above" another element or feature. Thus, the example term "below" can include both above and below orientations. The device may be otherwise oriented (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein are interpreted accordingly.

[0062] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "comprise", "include", "contain" and "have" are inclusive and therefore specify the presence of stated features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring them to be performed in the specific order described or illustrated, unless the order of execution is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0063] The present application proposes an implantable device, which can be a related stent implanted in the human body to achieve a supporting function, especially various stents, prostheses, filters, etc. suitable for implantation in various lumens of the human body, such as vascular stents, ureteral stents, biliary stents, esophageal stents, airway stents, renal artery stents, heart valves, occluders, vascular puncture port closure devices or vena cava filters. Depending on the location of the lesion, the corresponding type of implantable device is used to achieve treatment. In the embodiments of the present application, for the sake of convenience of explanation, the implantable device is explained by taking an artificial heart valve as an example, without limiting its functional scope.

[0064] Referring to Figures 1 to 3, the present application proposes an implantable device 1, which includes a body 11 and an attachment portion 15. The body 11 is configured into a preset shape as required, and a flow channel 102 is generally formed inside the body 11 to allow blood to flow normally through the internal flow channel 102. The flow channel 102 is generally formed along the axial direction of the body 11. For details, see Figure 2, in which a generally vertical upward arrow represents the blood flow through the flow channel 102 of the implantable device 1 within the lumen. Specifically, the implantable device 1 can be an artificial heart valve, and the opening of the leaflet assembly 12 can allow antegrade blood flow to flow out of the flow channel 102. The cross-sectional profile of the body 11 can be configured into different shapes according to different application requirements, such as circular, elliptical, pentagonal, hexagonal, or other suitable shapes. The body 11 is used to support the living body at the implantation location and / or to be fixed to the living body to achieve a positioning connection between the entire implantable device 1 and the living body. After the body 11 is implanted into the living body, at least a portion of the body 11 is in contact with the living body to provide support. If implanted at a location where a blood vessel is stenotic, the body 11 will adhere to the blood vessel, thereby providing support to the stenotic blood vessel and increasing the area of ​​the channel through which blood flows, thereby preventing stenosis.

[0065] The body 11 comprises a first subsection 111 and a second subsection 113. The first subsection 111 is configured to conform to the lumen wall after the implantable device 1 is implanted. The second subsection 113 is connected to the first subsection 111 and remains at least partially suspended in the air after the implantable device 1 is implanted. The body 11 is a hollow tubular structure comprising a plurality of hollow sections 114 extending through the inner and outer surfaces of the body 11. The attachment section 15 is attached to the second subsection 113. When the implantable device 1 is implanted in a living body, the first sub-portion 111 of the main body 11 is adhered to the tissue of the living body and is quickly fixed in the tissue by tissue endothelialization, while the second sub-portion 113 that is not adhered to the living body and is suspended is attached with the attachment portion 15. Therefore, the detached matter that may be generated by the second sub-portion 113 due to degradation, breakage, etc. before tissue endothelialization occurs can be limited by the attachment portion 15, thereby preventing the detached matter from migrating in the lumen of the living body and causing the formation of thrombus and embolism. It can also avoid the damage to the tissue caused by the sharp edge or fracture of the main body 11, and at the same time, it can also reduce the puncture of the tissue or the delivery balloon by the device during the delivery process, and can The invention promotes the endothelialization of the suspended second sub-section 113 and improves the balance of the endothelialization of different parts of the main body 11. The attachment portion 15 can also regulate the corrosion degradation of the second sub-section 113 to which it is attached, and appropriately delay or accelerate the degradation rate of the main body 11, so that the implantable device 1 can maintain its structural integrity within the expected time to fully and effectively support the lumen and quickly complete the degradation beyond the expected time, thereby ensuring the effectiveness of the implantable device 1 within the expected time and removing unnecessary constraints on the lumen as soon as possible after the implantable device 1 realizes its function, thereby improving the overall safety of the implantable device during the implantation process and in various stages after implantation.

[0066] In some feasible embodiments, the caliber of the first sub-portion 111 is smaller than the caliber of the second sub-portion 113. Furthermore, the second sub-portion 113 can be located at the end of the body 11, for example, at the outflow end of the implantable device 1, of course, it can also be located at the inflow end, or it can be located at various locations after implantation, such as a bifurcated blood vessel, a blood vessel opening, or the center of the lumen. The second sub-portion 113 with a larger caliber can stabilize the implantable device 1 at the target position in the living body, preventing the implantable device 1 from shifting due to various reasons (such as contraction and relaxation of the heart) and failing to provide stable support to the target position, thereby reducing the overall risk of implanting the implantable device 1 into a complex anatomical structure.

[0067] In some feasible embodiments, the attachment portion 15 is attached to the second sub-portion 113 in a manner that allows the fluid in the lumen to flow out of the flow channel 102 through the hollow portion 114 adjacent to the second sub-portion 113. As an example, as shown in Figures 1 and 2, the body 11 of the implantable device 1 is a valve frame of a heart valve, which is implanted in the pulmonary artery 80, wherein the first sub-portion 111 is in contact with the inner wall of the pulmonary artery 80, while the second sub-portion 113 is close to the outflow end and suspended at the intersection / connection of the pulmonary artery 80 and the pulmonary artery branches. The hollow portion 114 that runs through the inner and outer surfaces of the body can allow blood flowing along the flow channel 102 to flow out from the hollow portions 114 on the left and right sides and flow into the right pulmonary artery 801 and the left pulmonary artery 802 respectively (as shown by the arrows in Figure 2), so that the blood flow remains smooth, the blood flow abnormalities caused by the implanted device are reduced, thereby improving the blockage of the distal pulmonary artery branches and improving the safety of the implantable device 1 when implanted in complex anatomical structures such as the right ventricular outflow tract. As an example, the length of the first subsection 111 is greater than the length of the second subsection 113. As another example, the attachment portion 15 is attached to the second subsection 113 in a manner that keeps the second subsection 113 suspended in the air, that is, the second subsection 113 and the attachment portion 15 attached thereto are both kept suspended in the air. Of course, in other feasible embodiments, the attachment portion 15 is attached to the second subsection 113 in a manner that covers at least a portion of the hollow portion 114. As an example, the attachment portion 15 can be a film layer covering the surface of the second subsection and the hollow portion 114, and the film layer can be, for example, an electrospun layer.

[0068] In some feasible solutions, each part of the implantable device has a similar endothelialization time. The first sub-portion 111 of the main body 11 is in contact with the lumen wall, and tissue endothelialization will occur faster, so that the first sub-portion 111 is covered by the generated endothelial layer at a faster speed. Although the suspended second sub-portion 113 would cause delayed tissue endothelialization due to being suspended or having a gap with the living body, because the second sub-portion 113 is attached with the attachment portion 15, the attachment portion 15 can accelerate the capture of endothelial cells and endothelial progenitor cells in the blood without affecting the smooth blood flow in the lumen, so that the implantable device 1 has a similar endothelialization time in the suspended second sub-portion 113 (and the attachment portion 15) and the first sub-portion 111 attached to the wall, thereby improving the balance of the overall endothelialization process of the device, reducing the risk of thrombosis, and improving the safety of the device.

[0069] It should be understood that the term "convergence of endothelialization time" as used herein refers to the fact that, compared to a case where the implantable device 1 does not have the aforementioned attachment portion 15, the endothelialization time of the second sub-portion 113 with the attachment portion 15 is closer to that of the first sub-portion 111, or the endothelialization speed of the suspended second sub-portion 113 is accelerated, such that the endothelialization time of this portion is reduced by more than 50%, or even by 80% to 95%, compared to a case where the attachment portion 15 is not present. As an example, when the body 11 has the same wall thickness, the endothelialization time of the first sub-portion 111 is between 7 days and 3 months, and is usually achieved in about 1 month; the second sub-portion 113 without the attachment portion 15 cannot achieve endothelialization for more than 1 year or even 2 years; while the endothelialization time of the second sub-portion 113 with the attachment portion 15 is approximately 7 days to 3 months. The convergence of endometrialization time can also be defined in another way. For example, at the time of endometrialization of the first subsection 111 or a general empirical time point, such as 14 days, 1 month, 45 days, 2 months, etc., the coverage of the endometrial layer at the location of the second subsection 113 is roughly the same as that of the first subsection 111, and the difference in endometrial coverage between the two is within 10%. It should be understood that the endometrialization time of the second subsection 113 referred to herein refers to the time when the endometrial layer covering the attachment portion 15 and the corresponding second subsection 113 is formed. Specifically, it can be the time when the endometrial layer covering the second subsection 113 and the attachment portion 15 is formed within the area of ​​the second subsection 113 where the attachment portion 15 is provided. The area where the attachment portion is provided refers to the range defined by the boundary of the attachment portion 15. The endometrialization time of the first subsection 111 refers to the time when the endometrial layer covering the first subsection 111 is formed.

[0070] In some embodiments, the body 11 or the second sub-section 113 is degradable. For example, the first sub-section 111 and the second sub-section 113 may be made of the same degradable material or different degradable materials. The degradable material may be, for example, iron, an iron-based alloy, magnesium, a magnesium-based alloy, zinc, a zinc-based alloy, or an absorbable polymer. In some embodiments, as the second sub-section 113 gradually degrades, the wall thickness and width of the strut 100 also decrease. For example, the attachment portion 15 is attached to the strut 100 in a manner that wraps around it, thereby encapsulating large detached materials produced by strut 100 degradation. This allows only ions generated by degradation to escape from the attachment portion, preventing large detached materials from entering blood vessels and causing thrombosis. Furthermore, the shape of the attachment portion 15 can be configured to change in accordance with changes in the shape of the second sub-section 113. Thus, during the degradation of the second sub-section 113, the attachment portion 15 maintains a relatively tight connection with the second sub-section 113, preventing detached materials produced by degradation from the second sub-section 113 from easily escaping from the attachment portion 15. There are various ways to achieve the shape of the attachment portion 15 changing in response to changes in the shape of the second sub-portion 113. For example, the attachment portion 15 can be elastic, allowing it to elastically contract as the wall thickness and rod width of the second sub-portion 113 decrease. Alternatively, the attachment portion 15 can be made of a flexible material, allowing it to easily deform.

[0071] In some embodiments, the degradation time of the second sub-section 113 is longer than the endometriosis time of the second sub-section 113. The attachment portion 15 is used to attach the second sub-section 113, accelerating its endometriosis process. An endometrium layer is formed to wrap around the second sub-section 113 before degradation. The endometrium layer can hold large pieces of material that may be detached from the second sub-section 113 due to degradation or breakage, preventing them from entering the bloodstream, further reducing the risk of thrombosis and improving the safety and reliability of the device.

[0072] As an example, when the body 11 is a nitrided iron-based stent with a wall thickness of approximately 140 μm and the second sub-section 113 does not have the attachment portion 15, it begins to degrade approximately 3 months after implantation, degrades by approximately 20% (calculated by weight loss) at 6 months, degrades by approximately 40% at 12 months, degrades by approximately 60% at 24 months, and degrades by more than 80% at 36 months. As another example, a pure iron-based stent degrades by approximately 10% at 6 months, approximately 25% at 12 months, approximately 40% at 24 months, and approximately 50% at 36 months.

[0073] In some embodiments, the attachment portion 15 is made of a degradable material. Furthermore, the degradation time of the attachment portion 15 is greater than the endothelialization time of the second subsection 113. As an example, the attachment portion 15 is formed by wrapping a PLLA suture around the second subsection 113, and its degradation time is several months to two years. Of course, the attachment portion 15 can also be made of other polymer materials, such as PE, PCL, etc., which are not listed here. The attachment portion 15 degradation time is slower than the endothelialization time of the second subsection 113, ensuring that the attachment portion 15 has sufficient time to capture endothelial cells and ensure that the endothelial layer forms before the second subsection 113 ruptures. As an example, the attachment portion 15 is made of a soft material to cover any sharp edges and points of the second subsection 113, thereby reducing damage to surrounding tissues or components of the delivery device, such as the balloon, during or after implantation. Of course, the attachment portion 15 can also be made of a suitable mixture of partially degradable and partially non-degradable materials, or it can be made of a non-degradable material.

[0074] In some embodiments, different parts of the body 11, such as the first sub-section 111 and the second sub-section 113, can be integrally formed or detachably connected, for example, by sewing, bonding, or snapping. The attachment portion 15 can be attached to the second sub-section 113 by winding, coating, depositing, or wrapping.

[0075] Referring again to Figures 1 and 3 , in some embodiments, the second subsection 113 and the first subsection 111 each include multiple struts 100, a certain number of which can enclose a hollow portion 114. Specifically, the second subsection 113 is adjacent to at least one hollow portion 114. For example, the body 11 in Figure 1 has several hexagonal hollow portions 114 distributed circumferentially closest to the outflow end, with each side corresponding to a strut 100. The four struts 100 closer to the outflow end are covered with attachment portions 15 and, after implantation, are at least partially suspended in the air, representing the second subsection 113 of the body 11. The two struts 100 adjacent to the other two sides are exposed, not covered by attachment portions 15, and constitute the first subsection 111 of the body 11. In this example, the struts 100 can be stent rods or support rods of a vascular stent or valve stent. In other examples, such as the vena cava filter in Figure 10 , the corresponding struts are referred to as filter rods. Other examples are not listed here.

[0076] In some embodiments, the attachment portion 15 covers the strut 100 along its length, so that the strut 100 can be wrapped in the circumferential and length directions, so that the strut 100 has no exposed parts. As another example, the attachment portion 15 is attached to the strut 100 in a manner that surrounds it, and allows the surface of the strut 100 to be partially exposed. As an example, the second sub-portion 113 can form a corresponding attachment portion 15 by wrapping the strut 100 that is suspended in the air after implantation in a living body, and can form a corresponding attachment portion 15 by wrapping the strut 100 that is attached to the wall after implantation in a living body. As another example, the attachment portions 15 to which the second sub-portion 113 is attached after implantation in a living body, such as the strut 100 that is suspended in the air and the strut 100 that is attached to the wall, can have different surface morphologies, permeability coefficients, thicknesses, materials, etc., or of course, these can also be the same. In the embodiment of the present application, the proportion of the second sub-section 113 in the main body 11 is greater than 0%, and the proportion of the suspended portion of the second sub-section 113 after the second sub-section 113 is implanted in a living body is greater than 0%. The specific proportion may vary depending on the type of device, implantation site, and other conditions. Furthermore, the second sub-section 113 may account for 1 to 99% of the surface area of ​​the main body 11. Of course, the proportion may also be calculated in other ways, such as by calculating the length of the main body 11 and the length of the second sub-section 113. Furthermore, the portion of the second sub-section 113 that is suspended and not attached to the wall after the second sub-section 113 is implanted in a living body may account for 0.1% to 100% of the second sub-section 113. As a specific example, the second sub-section 113 of the implantable device 1 shown in Figure 1 accounts for 20% of the length of the main body 11, and the suspended portion of the second sub-section 113 after implantation accounts for 50% of the length of the second sub-section 113. As another example, referring to Figure 8 , the second subsection 313 accounts for 10% of the length of the main body, and the suspended portion of the second subsection 313 after implantation accounts for 85% of the length of the second subsection 313. As yet another example, referring to Figure 10 , the surface area of ​​the second subsection 413 accounts for 99% of the surface area of ​​the main body, and the suspended portion of the second subsection 413 after implantation accounts for 100% of the surface area of ​​the second subsection 413.

[0077] Referring to FIG4 , in some embodiments, the attachment portion 15 may be a winding layer, the winding layer including at least one winding 151, at least one winding 151 being wound around the support rod 100 of the second sub-portion 111. For example, each winding includes multiple fiber filaments, so that each turn of the winding simultaneously forms multiple wound fiber filaments. Furthermore, the angles at which the windings of adjacent turns intersect the axis of the support rod 100 are different, and may be relatively left-leaning or right-leaning. Adjacent turns of the windings may also overlap and be wound. This, on the one hand, prevents the winding layer from shifting on the support rod 100, and on the other hand, allows the fiber filaments of different turns to overlap and cover the support rod 100, forming a relatively three-dimensional wrapping structure. The interlaced gaps between the fiber filaments form more complex microfluidic channels, making it easier to control the permeability coefficient of the attachment portion 15 within a range that regulates the degradation characteristics of the support rod 100, thereby achieving regulation of the degradation rate of the support rod 100. Furthermore, the roughness of different areas of the attachment portion 15 is relatively balanced, and the difference between the peaks and valleys of the corrugated undulations formed in various places is smaller, which is conducive to balanced film formation in various areas of the attachment portion 15. Furthermore, the line width or diameter of the winding is 50 to 700 μm. The diameters of the fiber filaments are the same or different, and the diameter is 5 to 25 μm, preferably 9 to 16 μm, and specifically can be 9 μm, 10 μm, 11 μm, 12 μm, 13 μm, 14 μm, 15 μm, 16 μm, etc., which is conducive to forming a peak-to-valley difference of 0.03 to 0.7 mm in various areas of the winding layer surface, avoiding the formation of a relatively smooth local surface due to a local peak-to-valley difference being too small, so that endothelial cells can quickly and evenly attach to the attachment portion 15, so that the second sub-portion 113 can quickly complete the endothelialization. It should be understood that a winding 151 can be formed by twisting a plurality of fiber filaments into a strand or interweaving, or it can be formed by a plurality of fiber filaments in parallel to form a relatively loose bundle.

[0078] In some embodiments of the present application, the thickness of the attachment portion 15 can be 10 to 750 μm, so as to facilitate the formation of an undulating surface shape with a certain peak-to-valley difference on the surface of the attachment portion 15, thereby facilitating endometriosis and preventing the attachment portion 15 from being damaged and affecting the intended attachment morphology in the second sub-portion 113. Specifically, the thickness of the attachment portion 15 can be 10 to 200 μm, 50 to 250 μm, 100 to 300 μm, 150 to 400 μm, 200 to 500 μm, 350 to 600 μm, 400 to 700 μm, etc. Furthermore, the thickness of the attachment portion 15 can be 10 to 150 μm. On the basis of promoting endometriosis, it can also avoid excessive increase in the delivery diameter, ensure easy delivery, and avoid material waste. Specifically, the thickness of the attachment portion 15 may include but is not limited to 12-100 μm, 15-100 μm, 20-90 μm, 20-80 μm, 30-80 μm, 30-75 μm, 40-120 μm, 50-80 μm, 30-150 μm or 50-130 μm.

[0079] In some possible implementations, the thickness of the attachment portion 15 can be set to different thicknesses depending on the location, such as the thickness of the location that is relatively prone to degradation can be higher than the thickness of other locations that degrade relatively slowly. For another example, the thickness of the attachment portion 15 can be relatively thick in the width direction of the strut 100 and relatively thin in the wall thickness direction of the strut. In this way, the attachment portion 15 can reduce the impact on the delivery diameter while having a relatively good effect of promoting the endometrialization of the suspended strut. For example, when the attachment portion 15 is attached to the strut 100 of the second sub-section 113, the width of the strut 100 can be increased by 10 to 70 μm, and the wall thickness of the strut 100 can be increased by 50 to 100 μm. Of course, in other examples, the thickness of the attachment portion 15 in the width direction of the strut 100 can also be less than or equal to the thickness of the attachment portion 15 in the wall thickness direction of the strut 100.

[0080] In some embodiments, the strut 100 may include a tip 101, which can also be understood as the connection between two struts 100. The thickness of the attachment portion 15 at the tip 101 may be relatively thicker. As an example, the thickness of the attachment portion 15 at the tip may be 50 to 150 μm. Furthermore, the thickness of the attachment portion 15 at the tip may be 60 to 100 μm, 50 to 90 μm, 60 to 80 μm, 60 to 70 μm, 60 to 90 μm, or 55 to 85 μm, etc. The attachment portion 15 at the tip 101 is set to be relatively thicker, which can further ensure that the attachment portion 15 can achieve better coverage at the tip 101, so that the endometrialization process of the struts 100 and the strut connection of the second sub-section 113 is more balanced.

[0081] In some possible embodiments, the second subsection 113 may include a more easily broken region. The thickness of the attachment portion 15 in the easily broken region may be greater to reduce the probability of breakage in the easily broken region. This allows the second subsection 113 to have a more stable shape before the first subsection 111 is internalized, thereby stabilizing the implantable device 1. The thickness of the attachment portion 15 in the easily broken region may be 20 to 100 μm, which can also take into account the delivery diameter.

[0082] The aforementioned breakable area can be a portion of the support rod 100 with a notch or gap, or a portion with a smaller rod width or wall thickness, or a portion with a greater degree of stretch (such as a bend or corner). Without limitation, any portion of the support rod 100 that is more susceptible to breakage during degradation is within the scope of protection of this application.

[0083] In some embodiments, the winding layer is wound around the support rod in a manner selected from the following: overlapping winding; flat winding; multi-layer winding; and winding with varying density.

[0084] Please refer to Figure 4 again. As an example, the winding wire 151 of the winding layer can be wound around the support rod 100 of the second sub-section 113. The cross-section of the winding wire 151 can be rectangular, circular, olive-shaped, star-shaped or polygonal. The width of the winding wire 151 can be greater than, equal to or less than the thickness of the winding wire 151. The winding wire in Figure 4 adopts a single-layer flat winding method. Each turn formed by the winding is flat along the length direction of the support rod 100. The turn spacing between adjacent turns can be 0 to 0.5 mm. When the turn spacing is greater than 0.5 mm, the surface of the support rod 100 is relatively exposed, which is not conducive to wrapping and limiting the debris generated by the corrosion of the support rod 100. It also takes more time for the endothelial cells to gradually form a continuous inner membrane layer after clinging to the winding part.

[0085] The winding wire 151 can be arranged in a manner of circumferentially wrapping around the strut 100, and the angle α between the winding wire 151 and the axis O of the strut 100 can be less than 90°. As the strut 100 degrades, the width and wall thickness of the strut 100 gradually decrease, and the gap between the winding wire 151 and the strut 100 gradually increases. Setting the angle α between the winding wire 151 and the axis of the strut 100 to less than 90° will minimize the displacement of the winding wire 151 in the axial direction of the strut 100, which is beneficial for the winding wire 151 and the strut 100 to maintain a constant relative position, avoid excessive gaps between adjacent turns due to displacement, and thus facilitate the uniform attachment and growth of endothelial cells in the winding layer. Furthermore, the angle α between the winding wire 151 and the axis of the strut 100 can be 70° to 89° or 80° to 85°, etc., which can not only reduce the possibility of displacement, but also make the axial span of each turn relatively small, facilitating the completion of winding. As another example, the angle α between each winding wire turn and the axis O may be set to be different along the axis.

[0086] In one possible embodiment, the attachment portion 15 may further include a pulling layer 155, which is disposed along the length of the support rod 100. The wire winding 151 wound around the support rod 100 and the pulling layer 155 have several intersections, and the intersections are spaced apart by several turns, and binding knots 151a are formed at the intersections. The wire winding 151 and the pulling layer 155 at each intersection are connected or connected at intervals to form a whole. Specifically, the pulling layer 155 can be another wire winding layer located below the wire winding layer with a sparser winding density, and the axial span between adjacent turns of the pulling layer 155 is relatively larger. The pulling layer 155 can also be configured in a straight line, and its length will not change. In this way, the winding wire 151 is connected to the pulling layer 155, and the pulling layer 155 can be used to limit the length change of the winding wire 151 and the turn spacing between adjacent turns, thereby preventing the winding wire 151 wound on the support rod 100 from becoming longer in length or partially overflowing after the support rod 100 breaks or degrades. The pulling layer 155 can also be coated, bonded, or sewn onto the support rod 100. The pulling layer 155 can also include at least one of a connecting mesh, a connecting film, or a connecting coating. The pulling layer 155 can be applied to the support rod 100 by at least one of electrospinning, dipping, dripping, spraying, or brushing. When the pulling layer 155 is a connecting mesh, the connecting mesh includes mesh holes; when the pulling layer 155 is a connecting film or a connecting coating, the connecting film or the connecting coating can have holes.

[0087] In another possible embodiment, the wire wrap 151 itself may include multiple binding knots, each of which may be adjacent or spaced apart, for example, spaced apart by several turns. The binding knots can strengthen the adhesion between the wire wrap layer and the strut 100, preventing the attachment portion 151 from detaching from the strut 100. The binding knots can also increase the surface roughness of the attachment portion 151, thereby promoting tissue intimalization.

[0088] Optionally, the spacing between two adjacent binding knots 151a can be 0.1 to 2 mm. When the spacing between two binding knots 151a is less than 0.1 mm, the number of binding knots 151a is relatively large, increasing the difficulty of preparing and the delivery diameter of the implantable device 1. When the spacing between two binding knots 151a is greater than 2 mm, the connection between the winding wire 151 and the support rod 100 is not effective. Therefore, setting the spacing between two adjacent binding knots 151a within the above numerical range results in better overall performance.

[0089] In addition, the winding layer is woven using various methods, such as random weaving, flat knot weaving, single flat knot weaving, figure eight weaving, cross knot weaving, sparrow head knot weaving, double connection weaving, and single-line double connection weaving. Different weaving methods can differentiate the surface structure of the attachment part to meet the needs of different products or application scenarios.

[0090] Please refer to Figure 5. As an example, the attachment portion 15 is a spinning layer, which can evenly cover the support rod 100 and the tip 101 of the second sub-section 113. The spinning layer can be formed by winding a plurality of spinning strands on the support rod 100 at intervals, and forming micro gaps 156 between adjacent spinning strands. The width of the micro gap 156 is less than 500μm. Furthermore, the width of the micro gap 156 can include but is not limited to 5-80μm, 10-50μm, 20-40μm, 20-100μm, 150-250μm, 50-250μm, 20-200μm, 30-180μm or 100-300μm. Although the figure schematically shows a structure of the spinning layer using a single layer, the present application is not limited to a multi-layer structure.

[0091] 6 , as another example, the attachment portion 15 may include a base layer 153a and a plurality of fiber filaments 153b extending from the base layer 153a. The base layer 153a is tightly sleeved on the support rod 100 of the second sub-portion 113. The distribution density of the fiber filaments 153b is 10 to 500 pieces / mm. 2 . As a result, endothelial cells can grow faster and more evenly on the attachment portion 15, achieving balanced endothelialization. Among the multiple fiber filaments 153b, the orientation, length, and thickness of different fiber filaments 153b can be the same or different. The fiber filaments 153b can be in a coiled and curved shape, which can further facilitate the attachment of endothelial cells. Of course, the fiber filaments 153b can also be short and straight. One end of the fiber filament 153b can be connected to the basal layer 153a, and the other end is a free end; both ends of the fiber filament 153b can be connected to the basal layer 153a. The fiber filaments 153b can be natural fibers or synthetic fibers.

[0092] Please refer to Figure 7, which is a schematic diagram of the structure of an implantable device in another embodiment. As an example, the attachment portion 15 is a mesh layer attached to the second sub-portion 113, and the mesh layer has a plurality of small holes 154. In other embodiments, the attachment portion 15 can also be a perforated membrane. The shape of the hole is not limited to various shapes such as round, square, rectangular, diamond, triangle, etc. In some examples, the pore size of a single hole is less than 500μm. Furthermore, the diameter of a single hole can include but is not limited to 5-80μm, 10-50μm, 20-40μm, 20-100μm, 150-250μm, 50-250μm, 20-200μm, 30-180μm or 100-300μm, etc.

[0093] In the example of Figure 7 , the pores are uniform in size and evenly distributed. In other possible embodiments, the attachment portion 15 may include adjacent first and second density zones, with the pores in the second density zone having a larger diameter than the pores in the first density zone. Because contact with blood (liquid) accelerates the degradation of the strut 100, the portion of the strut 100 that is exposed to blood will degrade more rapidly. This arrangement allows the attachment portion 15 to regulate the degradation of the strut 100, specifically, to determine the area of ​​the strut 100 that is most likely to break first.

[0094] Furthermore, the diameter of a single hole in the first density region may be 10-100 μm, and the diameter of a single hole in the second density region may be 150-500 μm. Thus, the degradation of the support rod 100 can be regulated by setting different hole diameters.

[0095] In addition to the winding layer, the base layer with fiber filaments, the porous membrane, the woven mesh layer, and the spun layer, the structure of the attachment portion 15 can also be other forms of permeable membranes, permeable coatings, etc., and can also be a combination of different structures.

[0096] In some possible implementation schemes, the surface of the attachment portion 15 of the aforementioned various structures is corrugated and has a peak-to-valley difference of 0.03 to 0.7 mm. The attachment portion 15 with this surface feature can promote endothelialization, so that the endothelialization time of the second sub-portion 113 is within 3 months. When the peak-to-valley difference is less than 0.03 mm, the surface undulations are not obvious, and the endothelial cells cannot anchor well to the surface of the attachment portion 15 when passing through, making it difficult for endothelial cells to proliferate on the attachment portion 15. Failure to complete the coverage of the endothelial layer for a long time will cause platelets to adhere and aggregate, and inflammatory cells to infiltrate and form thrombi on the struts, affecting blood circulation, and the detachment of thrombi will also cause embolism. The implantable device 1 of the present application has an attachment portion 15 attached to the suspended second sub-portion 113 that promotes the reduction of endothelialization time to within 3 months, which can correspondingly reduce the formation of thrombi in the device and improve the safety of the device. When the peak-to-valley difference is greater than 0.7 mm, the surface ripples are excessive, and the thickness of the corresponding attachment portion 15, or a portion thereof, is too thick, which can easily cause adsorption of platelets and fibrin in the blood, resulting in device thrombosis in the short term. Furthermore, an excessively large peak-to-valley difference is also detrimental to the delivery of the implantable device. Furthermore, the peak-to-valley difference of the surface of the attachment portion 15 may include, but is not limited to, 0.05-0.2 mm, 0.06-0.3 mm, 0.08-0.5 mm, 0.1-0.4 mm, 0.15-0.55 mm, etc.

[0097] In some possible embodiments, the aforementioned various structures of the attachment portion 15 have a blood coagulation rate of 10% to 90%. The corrugated surface of the attachment portion 15 can better promote the endometriosis of the suspended second sub-portion 113 and the attachment portion 15, so that endometriosis is achieved in about one month. Furthermore, the attachment portion 15 has a blood coagulation rate of 15% to 80%, 15% to 60%, 15% to 40%, 20% to 75%, 25% to 50%, 30% to 70%, and 30% to 55%. Two samples are selected, both of which are blood from the same source. The thrombin time (PT) is measured on one sample, and the thrombin time (PT) is measured on the other sample by adding the attachment portion 15 (specifically, a portion of the second sub-portion 113 and the attachment portion 15 attached thereto). The blood coagulation rate is (PT-PT) / PT*100%. When the blood coagulation rate of the attachment portion 15 is lower than 10%, it is not conducive to the landing and growth of endothelial cells in the flowing blood in the attachment portion 15, so that the time required for the endothelialization of this part exceeds 3 months; and when the blood coagulation rate is higher than 90%, the attachment portion 15 may cause local coagulation of the strut 100 too quickly and produce device thrombosis.

[0098] In some possible embodiments, the surface potential polarity of the attachment portion 15 and the first sub-portion 111 of the various aforementioned structures is negative, and the absolute value of the surface potential of the attachment portion 15 is smaller than the absolute value of the surface potential of the first sub-portion 111. The negative surface potential polarity of the main body 11 can reduce the probability of thrombosis, while the absolute value of the surface potential of the attachment portion 15 is smaller than the absolute value of the surface potential of the first sub-portion 111, which can further optimize the endothelialization time of the main body 11 in the suspended portion and the wall-attached portion, thereby minimizing the difference between the two.

[0099] In some possible embodiments, the attachment portion 15 of the various structures described above is water permeable, and is used to allow water molecules and ions generated by the degradation of the implantable device 1 to pass through. In some embodiments, the permeability coefficient of the attachment portion can be between 1*10 -13 ~1*10 -3 cm / s, and can be further preferably 1*10 -11 ~1*10 -4 cm / s, 1*10 -10 ~1*10 -5 cm / s, 1*10 -9 ~1*10 -6 cm / s, 1*10 -8 ~1*10 -7cm / s, etc. Within this parameter range, the attachment portion 15 can optimize and control the degradation time of the covered strut 100. Specifically, when the strut 100 is made of a material with a fast degradation rate, such as magnesium alloy, the attachment portion 15 with the above-mentioned permeability coefficient can adjust the degradation time to delay the degradation of the strut 100, thereby preventing the strut 100 from degrading prematurely and failing to play a supporting role in the lumen or positioning role of the implantable device 1 within the expected time. At the same time, it can enable the strut 100 to quickly complete degradation after the expected time, thereby relieving unnecessary constraints on the implantation site.

[0100] For example, studies have shown that magnesium alloy vascular stents completely degrade within approximately 1 to 3 months after being implanted in a living body (such as into a coronary artery). It is reported that Biotronik's first-generation magnesium alloy stent, which contains 93% magnesium and 7% rare earth elements and has a stent wall thickness of 165 μm, completely degrades into ions after 60 days of implantation without a drug coating. If the second subsection 113 of the implantable device 1 is made of magnesium alloy material, the strut 100 will degrade in a relatively short period of time. Large pieces of debris that may be produced by degradation will flow into the distal end with the blood vessels, easily causing embolism of the distal blood vessels. At the same time, the first subsection 111 is likely to separate from the second subsection 113 and shift, causing, for example, the artificial pulmonary valve stent to slide from the right ventricular outflow tract to the right ventricle, causing the device to fail. The device failure rate is about 20%, which seriously affects the safety performance of the device. When the strut 100 is attached with the aforementioned attachment portion 15, the degradation time of the strut 100 can be extended to more than 1 year. Furthermore, when the permeability coefficient of the attachment portion 15 is between 1*10 -13 ~1*10 -9 When the weight loss rate is within the range of cm / s, the weight loss rate can be controlled within 5%, 20%, and 35% after 1 month, 2 months, and 3 months respectively. The weight loss after 3 months can even be controlled to less than 10%, and the device can be completely degraded within 1 to 2 years after implantation. Because the weight loss rate of the strut 100 is low during the relatively long period of time after implantation, it can maintain a good structural morphology during the expected time of device implantation, avoiding failure due to device displacement, and reducing the device failure rate from 20% to less than 1%. In addition, the degradation of the strut 100 can also be controlled to occur after the endometrialization is completed, so that the attachment portion 15 on the strut 100 and the endometrial layer can be used to wrap and limit the degraded material of the strut 100, thereby reducing embolism.

[0101] As another example, when the strut 100 is made of a material with a relatively slow degradation rate, such as an iron-based material, the attachment portion 15 having the above-mentioned permeability coefficient can ensure that the liquid in the lumen penetrates to the surface of the strut 100, and the attachment portion 15 made of a polymer material can maintain a relatively high concentration of acid environment around the wrapped strut 100 (degradation of the strut or the attachment portion will produce acidic substances), thereby preventing the acid concentration from being diluted by blood flow, thereby accelerating the corrosion of the iron-based stent to a certain extent, so that the weight loss rate of the strut 100 is controlled below 10% three months after implantation. The degradation rate increases to over 20% after 6 months, reaches 45% to 55% after 12 months, and can be completely degraded in about 2 to 3 years. At this time, the implantable device 1 has completed the repair or support function of the implant site. For example, the leaflet component 12 has formed a good connection with the endothelium of the blood vessel. The degradation of the body 11 can relieve the lumen of unnecessary constraints, allowing the leaflet component to grow with the patient, without affecting the secondary percutaneous intervention valve replacement for a larger artificial valve, and without causing psychological burden to the patient. It is suitable for patients of all ages. It should be understood that as the attachment portion 15 gradually degrades in the living body, its permeability coefficient will change to a certain extent.

[0102] The implantable device 1 of the embodiment of the present application regulates the corrosion degradation of the second sub-part to which it is attached through the attachment part 15, so that the degradation characteristics of the main body 11 made of absorbable materials with different degradation rates are improved, ensuring that the device can provide good structural support to the tissue in the early stage of implantation, and can complete the degradation of the main body as soon as possible when the device completes the treatment or repair purpose and no longer needs to support the tissue, avoiding unnecessary constraints of the device on the repaired or healthy lumen, reducing complications and reducing other treatments or device implants in the area, and realizing the improvement of the overall safety of implantable devices 1 made of different materials in the early and long term of implantation.

[0103] As another example of an embodiment of the present application, please refer to Figures 1, 5, and 7. In some possible embodiments of the present application, the implantable device 1 further includes a retaining member 152. One end of the retaining member 152 is connected to the attachment portion 15, and the other end is connected to a different position of the attachment portion 15, or is connected to the main body 11, specifically, it can be connected to the second sub-portion 113 or the first sub-portion 111. Specifically, the retaining member 152 can be a linear or strip-shaped structure, such as the retaining member 152 with multiple suspension wire structures shown in Figure 1. Of course, the retaining member can also be a mesh, sheet, membrane, or other type of structure. The retaining member 152 can further strengthen the retaining effect of the second sub-portion 113 after the structure changes after implantation, preventing the second sub-portion 113 from detaching from the attachment portion 15 due to degradation or breakage, or separating from the main body along with the attachment portion 15, causing the second sub-portion 113 to lose its positioning function on the first sub-portion 111, causing the first sub-portion to shift or deviate from the implantation site, causing the implantable device to fail. The broken part may fall off to other parts, causing embolism or affecting the normal organ function: for example, if the pulmonary artery stent breaks, it will run to the contralateral pulmonary artery, or it may run to the right ventricle, affecting the closure of the tricuspid valve, or it may run to the downstream blood vessels and form a source of embolism.

[0104] Specifically, when the strut 100 breaks in the early stage after implantation, it pulls the attachment portion 15 to cause displacement and deformation, and the corresponding position may shake disorderly under the action of blood flow and impact the surrounding tissue. By setting the limiter 152, the strut 100 of the main body 11 can be pulled and limited, reducing the occurrence of random shaking and improving the protection of the tissue. For example, in Figure 1, if one or some of the connections between the second sub-section 113 and the first sub-section 111 are broken, and because one end of the limiter 152 is connected to the first sub-section 111 and the other end is connected to the second sub-section 113 or the attachment portion 15, the second sub-section 113 can be prevented from being separated from the first sub-section 111 due to the break, thereby keeping the overall structure of the implantable device 1 in the expected state and position, and preventing the second sub-section 113 from shaking disorderly near the implantation position due to the breakage and damaging the tissue.

[0105] On the other hand, referring to FIG5 , if the support rod 100 of the second sub-section 113 is partially broken, for example, near the tip 101, the two ends of the broken portion may be displaced relative to each other, resulting in local structural deformation and the risk of tissue injury. The limiting members 152 fixed at both ends to different parts of the support rod 100 or the attachment portion 15 can pull and limit the support rod 100 on both sides of the broken portion, so that the two ends of the broken portion remain aligned and maintain a structural form that is basically consistent with that in the unbroken state, thereby preventing the second sub-section 113 from puncturing tissue due to displacement or structural change caused by the broken portion.

[0106] On the other hand, the limiting member 152 can be used to limit the detachment of large pieces of degradation products. The original structure of the second sub-section 113 changes during the degradation process. In addition to the degradation microparticles produced by normal degradation escaping from the attachment portion 15 and flowing away with the blood, there is also the possibility that some of the degradation products will fall off and become free substances. Because the attachment portion 15 is relatively flexible, under the impact of blood flow, for example, the attachment portion 15 arranged in a winding layer loses its support at the break of the second sub-section 113 it wraps. The winding is therefore locally stretched from the winding shape, resulting in a phenomenon of lengthening. This can cause the broken second sub-section 113 to protrude from the attachment portion 15 and pierce the tissue, or even fall out of the attachment portion 15 and flow into the blood. However, because the two ends of the limiting member 152 are relatively fixed and the length remains relatively unchanged, it can achieve the pulling and limiting of large pieces of degradation products produced by the second sub-section 113, reducing the phenomenon of them falling into the blood and causing thrombosis, and providing better protection for the tissue.

[0107] Specifically, the limiting member 152 can be a linear or strip-shaped structure. The number of limiting members 152 can be one, one end of which is connected to the first sub-section 111, and the other end is connected to the second sub-section 113 or the attachment portion 15. Alternatively, the number of limiting members 152 can be at least two, and each limiting member 152 is respectively connected to different positions of the second sub-section 113 and / or the attachment portion 15. Thus, by pulling and limiting in different directions, a more comprehensive limitation is achieved for the broken or detached second sub-section 113. As an example, referring to Figures 1 and 5, in some embodiments, the second sub-section 113 includes at least two support rods 100, and the two support rods 100 are connected at a certain angle to form a structural form with crests and troughs, and the attachment portion 15 is attached to each support rod 100, and each support rod 100 and the attachment portion 15 attached thereto are connected to at least one limiting member 152, further reducing the random movement of the detached objects caused by breakage or degradation, and improving the safety of the use of the implantable device 1.

[0108] Optionally, referring to FIG. 1 and FIG. 5 , both ends of the limiting member 152 are respectively connected to the middle portion or a position close to the middle portion of the two support rods 100 , thereby enabling the limiting member 152 to have a better limiting effect.

[0109] Optionally, when the number of the limiting members 152 is set to at least two, the limiting members 152 may be arranged in a cross or spaced manner.

[0110] For example, the attachment portion 15 can have a relatively high tensile strength, making it less susceptible to blood impact and breakage in vivo, thereby reducing the risk of large foreign particles entering the bloodstream. The attachment portion 15 can be easily broken by human force, so that when a new implantable device 1 is implanted, the attachment portion 15 does not significantly hinder implantation. Of course, the attachment portion 15 can also be difficult to break by human force.

[0111] For another example, the attachment portion 15 can absorb water and expand when it encounters liquid, thereby further improving the protective effect of the attachment portion 15 on living tissue. Of course, it is understandable that the attachment portion 15 may not expand when it encounters liquid.

[0112] For another example, the attachment portion 15 may be added with bioactive substances, such as anticoagulants that can promote endometrialization or prevent blood coagulation, or antiproliferative drugs that have anti-tissue proliferation properties.

[0113] Please refer to Figure 1 again. The implantable device includes a leaflet assembly 12 and a skirt. The leaflet assembly 12 is fixed to the inner side of the main body 11, preferably located on the inner side of the first sub-section 111. The implantable device 1 in this example is specifically an artificial heart valve. The skirt includes an inner skirt (obscured by the outer skirt 13 in Figure 1, not shown) and / or an outer skirt 13. The inner skirt covers the inner wall of the first sub-section 111 and is used to connect the leaflet assembly 12 to the main body 11. The outer skirt 13 covers the outer surface of the first sub-section 111, thereby increasing the friction force and improving the connection effect between the implantable device 1 and the living tissue. The outer skirt 13 can also prevent paravalvular leakage. The attachment portion 15 of the artificial heart valve adopts a winding layer, which can be sewn with the same universal suture material and similar process as the inner skirt or the outer skirt, which can simplify the preparation process of the artificial heart valve. As another aspect, the attachment portion 15 and the inner skirt can be integrated, which provides a better connection between the attachment portion 15 and the inner skirt. The attachment portion 15 can be in the form of a strip or sheet that wraps around the second sub-portion 113, and the inner skirt can also serve as a stopper. Of course, the attachment portion 15 and the inner skirt can also be provided separately.

[0114] The artificial heart valve 1 can be a pulmonary valve. After implantation, the valve frame of the artificial pulmonary valve is prone to losing contact with the wall near the outflow end. The attachment portion 15 prevents thrombosis caused by valve frame fragments and tissue damage caused by sharp fractures. The artificial heart valve in this example can also be an aortic valve, mitral valve, or tricuspid valve.

[0115] Please refer to Figures 8 to 11 for schematic diagrams of implantable devices according to other embodiments of the present application. In the embodiments described below, the first sub-section, second sub-section, and attachment portion of each implantable device, their interrelationships, and their specific structures, materials, and parameters, etc., can refer to all or part of the features of the attachment portion described in the previous embodiments, and have all or part of the corresponding beneficial effects, which will not be repeated below.

[0116] Figure 8 shows an implantable device 2, primarily suitable for implantation in branch vessels. The body of the implantable device 2 comprises a first subsection 211 and a connected second subsection 213. First subsection 211 is implanted adherently into a relatively small branch vessel. Second subsection 213 is coated with an attachment portion (not labeled). Part of second subsection 213 is suspended at the opening of the branch vessel, where it connects to the main vessel.

[0117] Figure 9 shows another implantable device 3, specifically a vascular stent, primarily suitable for implantation in a main vessel with branching vessels. The main body of the implantable device 3 comprises a first subsection 311 and a second subsection 313. The first subsection 311 is implanted adherently to the main vessel, while the second subsection 313 is covered with an attachment portion. A portion of the second subsection 313 faces the opening of the branch vessel, where it connects to the main vessel.

[0118] Figure 10 shows another implantable device 4, specifically a vena cava filter. The implantable device 4 is intended for implantation in the vena cava. Its main body includes a first subsection 411 and a second subsection 413. The first subsection 411 abuts the inner wall of the vena cava, while the second subsection 413 is suspended within the vena cava. The main body of the vena cava filter is composed of a plurality of intersecting filter rods. The filter rods have a general shape similar to the stent rods described in the previous embodiments, or can be woven from metal wire. An attachment portion is coated on the filter rods or metal wires of the second subsection 413. The attachment portion is attached to the suspended second subsection 413 in a manner that allows blood flow to flow through the hollows or gaps between the main body.

[0119] Figure 11 shows another implantable device 5, which is specifically a coated stent. Its main body is similar to the overall shape of the vascular stent and includes a first sub-section 511 and a second sub-section 513, wherein the first sub-section 511 is provided with a coating, and the first sub-section 511 together with the coating is in contact with the vascular wall, and the stent rod of the second sub-section 513 is wrapped with an attachment portion, and the second sub-section 513 is partially or completely suspended in the air after being implanted into a living body.

[0120] Referring to FIG. 12 , the present application further proposes a method for manufacturing an implantable device 1 , which may include the following steps:

[0121] S1: selecting a substrate for preparing the implantable device;

[0122] S2: processing the substrate to prepare a body of the implantable device, wherein the body comprises a first sub-portion adapted to adhere to a lumen wall after implantation into the lumen and a second sub-portion at least partially suspended;

[0123] S3: forming an attachment portion attached to the second sub-portion.

[0124] Specifically, a substrate for preparing an implantable device is selected and processed to form the body 11 of the implantable device 1. The prepared body 11 includes at least struts 100. As one example, hollow portions are formed between the struts 100. After the desired body 11 is prepared, an attachment portion 15 is formed to attach to the second sub-section 113. The attachment portion 15 is arranged at least along the length of the struts 100 to cover at least a portion of the outer surface of the second sub-section. After the attachment portion 15 is positioned at the desired location on the body 11, the implantable device 1 is completed.

[0125] Specifically, the substrate can be a tube or a stent filament. Tubes or stent filaments have different diameters, and the appropriate size of substrate can be selected based on the specifications of the implantable device to be manufactured. The specific materials of the body 11 and the materials and formation of the attachment portion 15 can be referred to the aforementioned description of the implantable device 1.

[0126] Specifically, when preparing the main body 11 of the implantable device 1, the main body 11 of the desired shape can be obtained by cutting and engraving the tube according to the cutting processing requirements; or the main body 11 of the desired shape can be obtained by weaving the stent wire according to the corresponding weaving method. In a possible embodiment, when the main body 11 is prepared by the weaving method, in addition to setting the attachment portion 15 after the main body 11 is completed, the attachment portion 15 can be formed at the corresponding portion of the main body 11 when the portion where the attachment portion 15 is required is completed during the weaving process of the main body 11, and then the main body 11 can be woven as a whole. In this way, it is convenient to set the attachment portion 15, and it is also convenient to adjust it in time, thereby improving the accuracy and reliability of the setting of the attachment portion 15.

[0127] Specifically, when the metal substrate is prepared into the main body 11 by drawing, engraving, cutting and other processes, after the required main body 11 is obtained by cutting the tube with a cutting device, the obtained main body 11 can be optimized first, such as performing surface roughness treatment to eliminate uneven structures such as burrs, pits or bumps at various positions, so that the surface of the bracket obtains the required degree of smoothness. The surface roughness treatment can be through mechanical grinding and polishing, or chemical polishing. In addition, the main body 11 can also be heat-treated to eliminate residual internal stress at various positions of the main body 11 and improve the strength of the overall structure. During the heat treatment, the main body 11 is placed in a heating furnace and slowly heated. When heated to about 400°C, it is then kept warm and maintained for 20-30 minutes, and then cooled with the furnace. After the heat treatment is completed, the main body 11 can be subjected to subsequent processing, such as the preparation or formation of the attachment portion 15.

[0128] The specific implementation method of the implantable device 1 of the present application is described in detail below in conjunction with the embodiments and comparative examples.

[0129] Example 1

[0130] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and its structure is generally similar to that of FIG1 . The main difference is that the hollow portion included in the implantable device 1 of this embodiment is a quadrilateral rather than the hexagonal shape shown in FIG1 , and the attachment portion 15 is attached only to some of the struts 100 included in the second subsection 113. The attachment portion 15 is a winding layer formed by winding PLLA sutures and covers some of the struts 100 of the second subsection 113 suspended at the outflow end. Please refer to FIG13 and FIG14 . The attachment portion 15 is formed by interweaving winding 151 around the struts. The winding 151 is formed by overlapping and winding multiple turns of a bundle of PLLA sutures containing multiple fiber filaments 1511. The width of each turn of the winding varies from approximately 80 to 150 μm, and the diameter of the fiber filament is approximately 12 μm. The surface of the winding layer is irregularly corrugated, with a peak-to-valley difference of approximately 0.05 to 0.08 mm. The thickness of the winding layer is approximately 110 μm, and the permeability coefficient is approximately 1*10 -3 cm / s, and the blood coagulation rate is about 20%; the valve frame material is nitrided iron-based material, and the wall thickness of its support rod 100 is about 140μm.

[0131] The implantable device 1 was implanted into an animal (dog, hereinafter the same). The animal survived 30 days after implantation. After the device was removed, it was first observed visually, as shown in Figure 15, which is a photograph taken with a standard mobile phone. In Figure 15, the labels C1 and C2 indicate the suspended stent rods after implantation. C1 indicates the rod wrapped with a wire wrapping layer, while C2 indicates the bare stent rod. C3 represents the site of the implantable device 1 attached to the wall. A translucent intimal layer had formed at C1, with a similar degree of intimalization as at C3, while no visible intimal layer was present at C2. The iron-based stent rod maintained its original shape, showing no signs of breakage or significant degradation. The weight loss of the wire wrapping rod was approximately 2%. Scanning electron microscopy (SEM) images of C1 and C2, as shown in Figures 16 and 17, show that the intimal layer had formed on the outer surface of the stent rod corresponding to C1, with a near-100% coverage. In contrast, the bare stent struts at the C2 position had only sporadic tissue attachment, with intimal coverage of less than 5%.

[0132] Example 2

[0133] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and its structure is shown in FIG1 . The valve frame material and the winding layer material are the same as those in Example 1. The difference is that the peak-to-valley difference of the winding layer in Example 2 is about 0.08 to 0.12 mm, the thickness of the winding layer is about 130 μm, and the permeability coefficient is about 1*10 -3cm / s, with a procoagulant rate of approximately 30%. After 14 days of implantation in animals, the animals survived, and upon device removal, it was observed that a substantially continuous and complete intimal layer had formed outside the second subsection 113, to which the attachment portion 15 was attached. The intimal coverage was greater than 90%, and the weight loss rate of the stent rod wrapped in the winding layer was approximately 1%.

[0134] Example 3

[0135] Implantable device 1 is an iron-based absorbable prosthetic pulmonary valve. It differs from Example 2 in that the peak-to-valley difference of the winding layer is approximately 0.03-0.05 mm, the winding layer thickness is approximately 110 μm, and the procoagulant rate is approximately 10%. After 30 days of implantation in an animal, the animal survived. Upon device removal, the intimal coverage of the attachment portion 15 was observed to be approximately 95%, and the weight loss of the stent strut wrapped by the winding layer was approximately 2%.

[0136] Example 4

[0137] Implantable device 1 is an iron-based absorbable prosthetic pulmonary valve. It differs from Example 2 in that the peak-to-valley difference of the winding layer is approximately 0.7 mm, the winding layer thickness is approximately 750 μm, and the procoagulant rate is approximately 90%. After 30 days of implantation in an animal, the animal survived. Upon device removal, the intimal coverage of the attachment portion 15 was observed to be 100%, and the weight loss of the stent strut wrapped by the winding layer was approximately 3%.

[0138] Example 5

[0139] Implantable device 1 is an iron-based absorbable prosthetic pulmonary valve. It differs from Example 2 in that the peak-to-valley difference of the winding layer is approximately 0.35 mm, the winding layer thickness is approximately 450 μm, and the procoagulant rate is approximately 50%. After 30 days of implantation in an animal, the animal survived. Upon device removal, the intimal coverage of the attachment portion 15 was observed to be 100%, and the weight loss of the stent strut wrapped by the winding layer was approximately 2%.

[0140] Example 6

[0141] Implantable device 1 is an iron-based absorbable prosthetic pulmonary valve. Differences from Example 2 are that each turn of the wire is approximately 500 μm wide, the turn spacing is 0.5 mm, and the pro-coagulant rate is approximately 10%. After 30 days of implantation in animals, the animals survived. Upon device removal, the intimal coverage of the attachment portion 15 was observed to be approximately 70%, and the weight loss of the stent strut wrapped in the wire wrapping was approximately 1%.

[0142] Examples 7 to 10

[0143] Implantable device 1 is an iron-based absorbable prosthetic pulmonary valve. Each embodiment is substantially identical to Example 2. In Examples 7-9, the attachment portion 15 is formed by wrapping PLLA sutures around the stent rod. In Example 10, the attachment portion 15 is a permeable PLLA membrane. The peak-to-valley difference of the attachment portion 15 in each embodiment ranges from 0.08 to 0.12 mm. The main differences between each embodiment and Example 2 are shown in Table 1. Animals survived after 30 days, 90 days, and one year of implantation. The device was removed at each time point, revealing 100% intimal coverage of the attachment portion 15. The weight loss of the stent rod wrapped in the wrapping layer is shown in Table 1.

[0144] Table 1

[0145] Examples 11 to 14

[0146] Implantable device 1 is an iron-based absorbable prosthetic pulmonary valve. Each embodiment is substantially identical to Example 2. Attachment portion 15 is a PCL spun layer formed from a stent rod, with a peak-to-valley difference of 0.08 to 0.12 mm. The key parameter differences between each embodiment and Example 2 are shown in Table 2. Animals survived after 30 days, 90 days, and one year of implantation. Device removal at each time point revealed 100% intimal coverage of attachment portion 15. The weight loss rate of the stent rod wrapped in the winding layer is shown in Table 2.

[0147] Table 2

[0148] Examples 15 to 17

[0149] Implantable device 1 is a magnesium alloy absorbable prosthetic pulmonary valve. Its structure is shown in Figure 1 . The wall thickness of the struts 100 is approximately 140 μm. The attachment portion 15 encapsulates all struts 100 contained within the body 11. The attachment portion 15 is made of PLLA. Example 15 specifically comprises a PLLA spunbond layer, while Examples 16-17 comprise permeable PLLA membranes with a peak-to-valley difference of 0.12-0.15 mm. For other parameters of each example, see Table 3. Animals survived after 30 days, 90 days, and one year of implantation. The device was removed at each time point, demonstrating 100% intimal coverage of the attachment portion 15. The weight loss of the stent struts encased in the winding layer is shown in Table 3.

[0150] Table 3

[0151] Example 18

[0152] Implantable device 1 is a nitrided iron-based vena cava filter with the structure shown in Figure 10. The filter rod wall thickness is 250 μm and the rod width is 400 μm. PLLA suture is wrapped around all filter rods to form the attachment portion. The wire width of the winding varies from 50 to 100 μm, the fiber diameter is about 12 μm, the peak-to-valley difference of the winding layer is about 0.03 to 0.05 mm, the thickness of the winding layer is about 130 μm, and the permeability coefficient is about 1*10 -3 cm / s, with a procoagulant rate of approximately 10%. Thirty days after implantation, the animals survived, and upon removal of the device, observations revealed 100% intimal coverage of the suspended stent struts, no fractures at the suspended sites, and approximately 3% weight loss of the stent struts wrapped in the wire wrapping.

[0153] Example 19

[0154] Implantable device 1 is a zinc alloy vena cava filter, with the structure shown in Figure 10. The filter rod wall thickness is 250 μm and the rod width is 400 μm. PLLA suture is wrapped around all filter rods multiple times to form the attachment portion. The wire width of the winding varies from 50 to 100 μm, the fiber diameter is approximately 12 μm, the peak-to-valley difference of the winding layer is approximately 0.03 to 0.05 mm, the thickness of the winding layer is approximately 130 μm, and the permeability coefficient is approximately 1*10 -3 cm / s, with a pro-coagulant rate of approximately 10%. Thirty days after implantation, the animals survived, and upon removal of the device, observations revealed 98% intimal coverage of the suspended stent struts, no fractures at the suspended sites, and approximately 4% weight loss of the stent struts wrapped in the wire wrapping.

[0155] Comparative Example 1

[0156] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and its structure is shown in FIG1 . The valve frame material and structure are the same as those in Example 1. The valve frame wall thickness is 140 μm. The attachment portion 15 is made of a PLLA permeable membrane. The peak-to-valley difference of the attachment portion 15 is about 0.01 mm. The thickness of the permeable membrane is about 20 μm, and the permeability coefficient is about 1*10 -5 cm / s, with a procoagulant rate of approximately 5%. Thirty days after implantation in an animal, the animal survived, and the artificial pulmonary valve was removed. It was observed that an intimal layer had formed locally but discontinuously in the suspended second subsection 113, to which the attachment portion 15 was attached, with an intimal coverage rate of less than 30%. Intima coverage of the adhering portion of the valve frame was 100%, and the weight loss rate of the stent strut wrapped by the permeable membrane was less than 2%.

[0157] Comparative Example 2

[0158] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and its structure is shown in FIG1 . The valve frame material and structure are the same as those in Example 1. The valve frame wall thickness is 140 μm. The attachment portion 15 is made of a PLLA permeable membrane. The peak-to-valley difference of the attachment portion 15 is about 0.8 mm. The thickness of the permeable membrane is about 850 μm, and the permeability coefficient is about 1*10 -4 cm / s, with a procoagulant rate of approximately 95%. Thirty days after implantation, the animal survived but exhibited signs of motor delay and lethargy. Upon removal of the artificial pulmonary valve, thrombosis was observed locally in the suspended second subsection 113, where the attachment portion 15 was attached, but had not yet fallen off.

[0159] Comparative Example 3

[0160] The implantable device 1 is a magnesium alloy absorbable artificial pulmonary valve. The valve frame is made of magnesium alloy and adopts the structure shown in Figure 1. The valve frame wall thickness is 140μm. The suspended stent rod is a bare stent without an attachment portion 15. In this case, moisture can instantly reach the surface of the stent rod, which is equivalent to a permeability coefficient greater than 1*10 -3 cm / s. The animal died 30 days after implantation. Autopsy and observation revealed partial loss of the suspended stent struts (i.e., the second subsection) at the outflow end of the valve frame, along with pulmonary embolism. Furthermore, partial separation occurred between the suspended and adherent portions of the valve frame, and the leaflet assembly 12 had deviated downward from its original implantation position (corresponding to the native annulus). Only sporadic tissue adhered to the remaining suspended stent struts, with no continuous intimal layer formed. The intimal coverage rate was less than 5%.

[0161] The above are only preferred specific implementation methods of the present application, but the protection scope of the present application is not limited thereto. Rather, any changes or replacements that can be easily thought of by any technician familiar with this technical field within the technical scope disclosed in this application should be included in the protection scope of the present application.

Claims

1. An implantable device, characterized in that, Comprising: A body, which includes a first sub - part and a second sub - part. The first sub - part is used to fit against the lumen wall after the implantable device is implanted into the lumen. The second sub - part is connected to the first sub - part, and at least part of the second sub - part is suspended after the implantable device is implanted into the lumen; And An attachment part, which is attached to the second sub - part.

2. The implantable device according to claim 1, characterized in that, The surface of the attachment part is wavy, and has a peak - valley difference of 0.03 - 0.7 mm.

3. The implantable device according to claim 1, wherein, The permeability coefficient of the attachment part is 1×10 -13 ~1×10 -3 cm / s.

4. The implantable device according to claim 1, wherein The material of the attachment part has a blood coagulation promotion rate of 10% - 90%; and / or the surface potential polarities of the attachment part and the first sub - part are negative, and the absolute value of the surface potential of the attachment part is less than the absolute value of the surface potential of the first sub - part.

5. The implantable device according to claim 1, characterized in that, The second sub - part includes at least one strut, and the attachment part includes at least one winding wire. The at least one winding wire winds around the strut for multiple turns to form the attachment part.

6. The implantable device according to claim 5, characterized in that, The width / diameter of the winding wire is 50 - 700 μm; and / or the turn - to - turn spacing between adjacent turns of the winding wire is 0 - 0.5 mm.

7. The implantable device according to claim 6, characterized in that, Each winding wire includes multiple filaments, and the diameters of the filaments are the same or different. The diameter of the filaments is 5 - 25 μm.

8. The implantable device according to claim 5, wherein, The way the winding wire winds around the strut is selected from one of the following or any combination thereof: overlapping winding; flat winding; multi - layer winding; winding with varying density; and / or the angle between the winding wire and the axis of the strut is less than 90°; and / or the angle between the winding wire and the axis of the strut varies along the axis.

9. The implantable device according to claim 5, wherein, The winding wire forms multiple binding knots on the strut, and the binding knots are adjacent or spaced; and / or the attachment part further includes a tension layer, which is arranged along the length direction of the strut of the second sub - part. The winding wire and the tension layer have several intersection positions, and at each intersection position, the winding wire and the tension layer are connected or spaced and connected as a whole.

10. The implantable device according to claim 1, characterized in that, The attachment part includes a base layer and a plurality of filaments extending from the base layer. The base layer wraps around the second sub-part, and the distribution density of the filaments is 10 to 500 filaments / mm 2 .

11. The implantable device according to claim 1, wherein, The thickness of the attachment part is 10 - 750 μm.

12. The implantable device according to claim 11, wherein, The second sub - part includes a tip, and the thickness of the attachment part at the tip is 50 - 150 μm; and / or the second sub - part includes an easily breakable breakable area, and the thickness of the attachment part in the breakable area is 20 - 100 μm.

13. The implantable device according to claim 1, wherein, The attachment part has multiple holes, and the aperture of a single hole is less than 500 μm; and / or the attachment part includes a first density area and a second density area arranged adjacent to each other. The first density area is provided with multiple holes with an aperture of 10 - 100 μm, and the second density area is provided with multiple holes with an aperture of 150 - 500 μm.

14. The implantable device according to claim 1, wherein The shape of the attachment part is configured to change following the change of the shape of the second sub - part.

15. The implantable device according to claim 1, characterized in that, The implantable device further includes: A limiting part, one end of the limiting part is connected to the first sub - part, and the other end of the limiting part is connected to the second sub - part and / or the attachment part.

16. The implantable device according to claim 15, wherein, The number of the limiting parts is multiple, and each limiting part is respectively connected to different positions of the second sub - part and / or the attachment part.

17. The implantable device according to claim 1, wherein, The body or the second sub - part is biodegradable, and the degradation time of the second sub - part is greater than the time for endothelialization of the second sub - part; and / or the attachment part is non - biodegradable or the degradation time of the attachment part is greater than the time for endothelialization of the second sub - part.

18. The implantable device according to claim 1, characterized in that, The implantable device further includes a plurality of hollow parts. A flow channel is formed axially in the body. The second sub - part is adjacent to at least one of the hollow parts. The attachment part is attached to the second sub - part in such a way that the fluid in the lumen can flow out from the flow channel through the hollow part adjacent to the second sub - part.

19. The implantable device according to any one of claims 1-18, characterized in that, Further comprising: A leaflet assembly, fixed to the inner side of the first sub - part; A skirt, the skirt includes an inner skirt and / or an outer skirt. The inner skirt is used to connect the leaflet assembly to the body, and the outer skirt covers the outside of the first sub - part.

20. A manufacturing method of an implantable device, which is used to manufacture the implantable device according to any one of claims 1-19, characterized in that, The method includes: Selecting a substrate for preparing the implantable device; Processing the substrate to prepare the body of the implantable device, wherein the body includes a first sub - part that fits against the lumen wall after implantation into the lumen and a second sub - part that is at least partially suspended; Forming an attachment part attached to the second sub - part.

Images