Implantable device and manufacturing method thereof

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an implantable instrument and a manufacturing method of the implantable instrument. The implantable instrument comprises a body and an attachment part, the body comprises a first sub-part and a second sub-part, the first sub-part is used for being attached to the wall of a lumen after the implantable instrument is implanted into the lumen, the second sub-part is connected with the first sub-part and is at least partially suspended after the implantable instrument is implanted into the lumen, and the attachment part is attached to the second sub-part. According to the implantable instrument provided by the invention, the overall safety of the instrument can be improved from multiple aspects.

Description

Technical Field

[0001] The present application belongs to the technical field of medical devices, 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. Heart valve disease is one of the most common cardiovascular diseases. Clinically, single / multiple valve structural or functional abnormalities caused by rheumatic inflammation, degenerative changes, congenital malformations, ischemic necrosis, trauma, etc. can lead to valvular stenosis or insufficiency. Mild cases of heart valve disease can be relieved by medication, severe cases can undergo valve repair, and patients who are not suitable for repair need to undergo artificial heart valve replacement.

[0003] Heart valve replacement refers to the use of artificial mechanical valves made of synthetic materials or artificial biological valves made of biological tissues for replacement. Since artificial heart valves have a service life limit and the size of artificial heart valves is constant, 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, but 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 make valve frames, some absorbable materials, such as magnesium alloys, corrode too quickly, which can easily cause structural incompleteness in the short term after the device is implanted and lose its support for the tissue, eventually 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 at the level of hundreds of microns, which can easily form sharp edges and cause damage to the tissue, which will also affect the safety of the device to a certain extent. In addition, there may be partial fracture of the stent or large pieces of detached material due to corrosion and degradation, and large pieces of detached material flow into the 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 the artificial heart valve is generally difficult to completely match the human body structure of various shapes. 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 velocity lead to large differences in the endometrialization, and the slow endometrialization site may cause thrombosis. In summary, the current implantable devices are less safe. 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 used to fit with 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 stopper, one end of which is connected to the first sub-portion, and the other end of which is connected to the second sub-portion and / or the attachment portion.

[0010] In some embodiments, the number of the limiting members is at least two, and each limiting member is respectively 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, and the at least one winding wire is wound around the support rod for multiple 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 0-0.5 mm.

[0014] In some embodiments, each winding wire 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; 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 wire 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 arranged adjacently or at intervals.

[0019] In some embodiments, the attachment portion further includes a pulling layer, which is disposed 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 a single 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 sub-section is degradable, and the degradation time of the second sub-section is greater than the endometrialization time of the second sub-section.

[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 0.03-0.7 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, wherein the hollow portions penetrate the inner surface and the outer surface of the main body, a flow channel is formed in the axial direction of the main body, the second sub-portion is adjacent to at least one of the hollow portions, and the attachment portion is attached to the second sub-portion in a manner to keep the second sub-portion suspended and / or to keep the fluid in the lumen able to flow out from the flow channel through the hollow portion adjacent to the second sub-portion.

[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 the 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 outer side 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 for being attached to the wall of the lumen after being implanted into the lumen and a second sub-portion which is at least partially suspended;

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

[0041] The implantable device proposed in the present application, when the implantable device is implanted in a living body, the first sub-part of its body is fixed in the tissue by rapid tissue endothelialization due to its adhesion to the tissue of the living body, while the second sub-part that is not in contact with the living body and is suspended in the air can be restricted by the attachment part due to the attachment part before the detached matter that may be generated by degradation, breakage, etc. of the second sub-part before tissue endothelialization occurs, thereby preventing the detached matter from wandering in the living body and causing the formation of thrombus, and avoiding the damage of the sharp body to the tissue, 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. The attachment part can also promote the tissue endothelialization of the suspended second sub-part, improve the balance of endothelialization of various parts of the body, and regulate the corrosion degradation of the second sub-part so that the implantable device has improved degradation characteristics, so that 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 various 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 drawings required for use in the embodiments will be briefly introduced below. 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 paying creative work.

[0043] Figure 1 is a schematic diagram of the structure of an implantable device provided in one embodiment of the present application;

[0044] Figure 2 This is a schematic diagram of the implantable device after implantation according to one embodiment of the present application;

[0045] Figure 3 yes Figure 1 An enlarged schematic diagram of part A of the implantable device shown;

[0046] Figure 4 is an exemplary structural schematic diagram of the attachment portion of the implantable device of the present application;

[0047] Figure 5 is another exemplary structural schematic diagram of the attachment portion of the implantable device of the present application;

[0048] Figure 6 is another exemplary structural schematic diagram of the attachment portion of the implantable device of the present application;

[0049] Figure 7 is another exemplary structural schematic diagram of the attachment portion of the implantable device of the present application;

[0050] Figure 8 to Figure 11 is a schematic diagram of an implantable device according to some other embodiments of the present application;

[0051] Fig.12 is a schematic flow chart of a method for manufacturing an implantable device according to an embodiment of the present application;

[0052] Fig.13 is a partial SEM image of the attachment portion of the implantable device of Example 1 of the present application;

[0053] Fig.14 This is a diagram showing the endothelialization effect of the implantable device of Example 1 of the present application;

[0054] Fig.15 yes Fig.14 The attached part is shown in a local SEM image at a higher magnification;

[0055] Fig.16 is a local SEM image of the implantable device of Example 1 of the present application after being implanted for a period of time;

[0056] Fig.17 yes Fig.16 Shown is a SEM image of site E at higher magnification. DETAILED DESCRIPTION

[0057] The exemplary embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although the 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. On the contrary, these embodiments are provided in order 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 the present 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 those of ordinary skill in the art to which the invention belongs. In the event of a 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 to implement or test the present invention. The materials, methods and embodiments disclosed herein are illustrative only and are 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, such as an amount that does not vary significantly from the recited amount for the intended purpose or function.

[0061] For ease of description, spatial 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 figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0062] It should be understood that the terms used herein are only for the purpose of describing specific example embodiments 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 "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence 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 interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order 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, and its functional scope is not limited.

[0064] See also 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 structure as required, and a flow channel 102 is usually formed inside the body 11 so that blood can flow normally through the internal flow channel 102. The flow channel 102 is usually formed along the axial direction of the body 11, and the details can be referred to in Figure 2 , the arrow pointing roughly vertically upward in the figure represents the blood flow in the lumen through the flow channel 102 of the implantable device 1. Specifically, the implantable device 1 can be an artificial heart valve, and the leaflet assembly 12 can be opened to allow the antegrade blood flow to flow out of the flow channel 102. The cross-sectional profile of the main body 11 can be configured into different shapes according to different application needs, such as circular, elliptical, or pentagonal or hexagonal shapes and other suitable shapes. The main body 11 is used to support the living body at the implantation position and / or to be fixed to the living body to achieve the positioning connection between the entire implantable device 1 and the living body. After the main body 11 is implanted into the living body, at least part of the main body 11 fits with the living body for support. For example, when implanted at a location where a stenotic lesion occurs in a blood vessel, the main body 11 fits with the blood vessel, thereby being able to provide support to the stenotic blood vessel, so that the channel area through which the blood vessel supplies blood becomes larger and no longer stenotic.

[0065] The body 11 includes a first sub-section 111 and a second sub-section 113, wherein the first sub-section 111 is used to fit with the wall of the lumen after the implantable device 1 is implanted into the lumen, and the second sub-section 113 is connected to the first sub-section 111 and at least partially suspended in the air after the implantable device 1 is implanted into the lumen. The body 11 is a hollow tubular structure, which includes a plurality of hollow sections 114, and the hollow sections 114 penetrate the inner surface and the outer surface of the body 11. The attachment section 15 is attached to the second sub-section 113. When the implantable device 1 is implanted in a living body, the first sub-portion 111 of the main body 11 is fixed in the tissue by rapid tissue endothelialization due to its close fit to the tissue of the living body, while the second sub-portion 113 which is not in close fit to the living body and is suspended in the air is attached with the attachment portion 15, so that the detached matter that may be generated due to degradation, breakage, etc. of the second sub-portion 113 before tissue endothelialization occurs can be limited by the attachment portion 15, thereby preventing the detached matter from wandering in the lumen of the living body and causing the formation of thrombus and embolism, and also preventing the sharp edge or fracture of the main body 11 from damaging the tissue, 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 attachment portion 15 can promote the endothelialization of the suspended second sub-portion 113 and improve 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-portion 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 releasing 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-section 111 is smaller than the caliber of the second sub-section 113. Furthermore, the second sub-section 113 may be located at the end of the body 11, such as at the outflow end of the implantable device 1, or at the inflow end, or at various locations such as bifurcated blood vessels, blood vessel openings, and the center of the lumen after implantation. The second sub-section 113 with a larger caliber can stabilize the implantable device 1 at the target position in the living body, avoid displacement of the implantable device 1 due to various reasons (such as contraction and relaxation of the heart) and fail to provide stable support to the target position, and reduce 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. Figure 2As shown, 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, and 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 branch, and the hollow portion 114 that runs through the inner and outer surfaces of the body can allow the 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 in FIG. Figure 2 As shown by the arrow, the blood flow remains smooth, and the abnormal blood flow caused by the implanted device is reduced, thereby improving the blockage of the distal pulmonary artery branch and improving the safety of the implantable device 1 implanted into a complex anatomical structure such as the right ventricular outflow tract. As an example, the length of the first sub-portion 111 is greater than the length of the second sub-portion 113. As another example, the attachment portion 15 is attached to the second sub-portion 113 in a manner that keeps the second sub-portion 113 suspended, that is, the second sub-portion 113 and the attachment portion 15 attached thereto are kept suspended together. Of course, in other feasible embodiments, the attachment portion 15 is attached to the second sub-portion 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 sub-portion and the hollow portion 114. The film layer can specifically be, for example, an electrospinning layer.

[0068] In some feasible schemes, 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 (with 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" herein refers to the endothelialization time of the second sub-portion 113 with the attachment portion 15 being closer to the endothelialization time of the first sub-portion 111, or the endothelialization speed of the suspended second sub-portion 113 being accelerated, so that the endothelialization time of this part is reduced by more than 50% compared with the case without the attachment portion 15, and can even be reduced by 80% to 95%. 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 endothelialization is usually achieved in about 1 month; the second sub-portion 113 without the attachment portion 15 cannot be endothelialized for more than 1 year or even 2 years; and the endothelialization time of the second sub-portion 113 with the attachment portion 15 is about 7 days to 3 months. The endometriosis time convergence can also be defined in another way, such as at the time of endometriosis of the first subsection 111 or a general empirical time point, such as 14 days, 1 month, 45 days, 2 months, etc., the situation where the second subsection 113 is covered by the endometrium layer is roughly the same as the situation where the first subsection 111 is covered by the endometrium layer, and the difference in the endometrium coverage rate between the two is within 10%. It should be understood that the endometriosis time of the second subsection 113 referred to herein refers to the time for forming the endometrium layer covering the attachment portion 15 and the corresponding second subsection 113, and specifically, it can be the time for forming the endometrium layer covering the second subsection 113 and the attachment portion 15 together within the area of ​​the second subsection 113 where the attachment portion 15 is provided, and the area range where the attachment portion is provided refers to the range defined by the boundary of the attachment portion 15. The endometriosis time of the first subsection 111 refers to the time for forming the endometrium layer covering the first subsection 111.

[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 the same degradable material, or may be different degradable materials. The degradable material may be, for example, iron, iron-based alloy, magnesium, magnesium-based alloy, zinc, zinc-based alloy or absorbable polymer material. In some embodiments, the wall thickness and rod width of the strut 100 of the second sub-section 113 may also decrease during the gradual degradation process. As an example, the attachment portion 15 is attached to the strut 100 in a manner of wrapping it, so that the large pieces of detached objects generated by the degradation of the strut 100 can be wrapped therein, and only the ions generated by the degradation are allowed to seep out of the attachment portion, so as to prevent the large pieces of detached objects from falling into the blood vessels and causing thrombosis. Further, the shape of the attachment portion 15 can be configured to change with the change of the shape of the second sub-section 113. Thus, during the degradation process of the second sub-section 113, the connection between the attachment portion 15 and the second sub-section 113 remains relatively tight, and the detached objects generated by the degradation of the second sub-section 113 are not easy to escape from the attachment portion 15. There are many ways to achieve the shape of the attachment portion 15 changing with the shape of the second sub-portion 113. For example, the attachment portion 15 may be elastic, and the attachment portion 15 may elastically shrink with the reduction of the wall thickness and the rod width of the second sub-portion 113. For another example, the attachment portion 15 may be made of a flexible material, and the attachment portion 15 may be easily deformed.

[0071] In some embodiments, the degradation time of the second sub-section 113 is greater than the endometriosis time of the second sub-section 113. The attachment portion 15 is used to attach the second sub-section 113 to accelerate its endometriosis process, and an endometrium layer wrapped around the second sub-section 113 is formed before the second sub-section 113 is degraded. The endometrium layer can hold large pieces of material that are separated from the second sub-section 113 due to degradation or breakage, etc., to prevent the large pieces of material from entering the blood, 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 about 140 μm, and the second sub-section 113 has no attachment portion 15, it begins to degrade about 3 months after implantation, degrades by about 20% (calculated by weight loss) in 6 months, degrades by about 40% in 12 months, degrades by about 60% in 24 months, and degrades by more than 80% in 36 months. As another example, a pure iron-based stent degrades by about 10% after 6 months of implantation, degrades by about 25% in 12 months, degrades by about 40% in 24 months, and degrades by about 50% in 36 months.

[0073] In some embodiments, the attachment portion 15 is made of a degradable material, and further, the degradation time of the attachment portion 15 is greater than the endothelialization time of the second sub-portion 113. As an example, the attachment portion 15 is formed by wrapping the second sub-portion 113 with PLLA suture, and its degradation time is several months to 2 years. Of course, the attachment portion 15 can also be other polymer materials, such as PE, PCL, etc., which are not listed here one by one. The degradation time of the attachment portion 15 is slower than the endothelialization time of the second sub-portion 113, which can ensure that the attachment portion 15 has sufficient time to capture endothelial cells and ensure that the endothelial layer is formed before the second sub-portion 113 breaks. As an example, the attachment portion 15 is a soft material that can wrap around the sharp edges and tips that may exist in the second sub-portion 113, reducing the damage of the device to the surrounding tissues or the balloon and other components in the delivery device during the implantation process or after the implantation. Of course, the attachment portion 15 can also be made of a partially degradable material and a partially non-degradable material mixed in a suitable proportion, or it can also be 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, may be integrally formed or detachably connected, such as by sewing, bonding or clamping. The attachment portion 15 may be attached to the second sub-section 113 by winding, coating, depositing or wrapping.

[0075] Please see again Figure 1 and Figure 3 In some embodiments, the second sub-section 113 and the first sub-section 111 respectively include a plurality of support rods 100, wherein a certain number of support rods 100 can be enclosed to form a hollow portion 114, that is, the second sub-section 113 is at least adjacent to one hollow portion 114, for example Figure 1 The middle body 11 has several hexagonal hollow parts 114 distributed in the circumference closest to the outflow end, and each side corresponds to a support rod 100. Among them, the four support rods 100 closer to the outflow end are covered with the attachment part 15, and at least partially suspended after implantation in the living body, belonging to the second sub-part 113 of the body 11; while the two adjacent support rods 100 on the other two sides are exposed and not covered by the attachment part 15, belonging to the first sub-part 111 of the body 11. In this example, the support rod 100 can be a stent rod or a support rod of a vascular stent or a valve frame. In other examples, such as Fig.10 The corresponding strut in the vena cava filter refers to the filter rod, and other examples are not listed one by one.

[0076] In some embodiments, the attachment portion 15 covers the strut 100 along the length direction of the strut 100, so that the strut 100 can be wrapped in the circumferential direction and the length direction, so that the strut 100 has no exposed part. As another example, the attachment portion 15 is attached to the strut 100 in a manner of surrounding it, and the surface of the strut 100 is allowed to be partially exposed. As an example, the second sub-portion 113 can form a corresponding attachment portion 15 in a wrapping manner on the strut 100 that is suspended in the air after being implanted in the living body, and the second sub-portion 113 can form a corresponding attachment portion 15 in a surrounding manner on the strut 100 that is attached to the wall after being implanted in the living body. As another example, the attachment portion 15 to which the second sub-portion 113 is attached to the strut 100 that is suspended in the air and the strut 100 that is attached to the wall after being implanted in the living body can have different surface morphologies, permeability coefficients, thicknesses, materials, etc., and of course these can also be the same. In an 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 proportion based on 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, Figure 1 The second sub-section 113 of the implantable device 1 shown accounts for 20% of the length of the 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, see Figure 8 , the second sub-portion 313 accounts for 10% of the length of the main body, and the suspended portion of the second sub-portion 313 after implantation accounts for 85% of the length of the second sub-portion 313. As another example, please refer to Fig.10 The surface area of ​​the second sub-portion 413 accounts for 99% of the surface area of ​​the main body, and the suspended portion of the second sub-portion 413 after implantation accounts for 100% of the surface area of ​​the second sub-portion 413.

[0077] Please see Figure 4In some embodiments, the attachment portion 15 may be a winding layer, the winding layer includes at least one winding 151, and at least one winding 151 is wound around the support rod 100 of the second sub-portion 111. As an example, each winding includes a plurality of fiber filaments, so that a plurality of wound fiber filaments are formed simultaneously for each turn of the winding. Furthermore, the angles at which the windings of adjacent turns intersect with the axis of the support rod 100 are different, and may be relatively left-biased or right-biased, and the windings of adjacent turns may also be overlapped and wound, which may make the winding layer less likely to shift on the support rod 100, and at the same time, may make the fiber filaments of different turns cover the support rod 100 in an interlaced manner, forming a relatively three-dimensional wrapping structure, so that the fiber filaments form a more complex microfluidic channel through the interlaced gaps, so as to facilitate the control of the permeability coefficient of the attachment portion 15 within the range that has a regulating effect on the degradation characteristics of the support rod 100, thereby achieving the regulation of the degradation rate of the support rod 100. Moreover, the roughness of different areas of the attachment portion 15 is relatively balanced, and the difference between the peak-to-valley difference 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. Further, the line width or diameter of the winding wire 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 surface of the winding layer, avoiding the formation of a relatively smooth local surface due to the local peak-to-valley difference being too small, so that the endothelial cells can quickly and evenly climb to the attachment portion 15, so that the second sub-portion 113 can quickly complete the inner membrane. It should be understood that a winding wire 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 10-750 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 endomembranization, and preventing the attachment portion 15 from being damaged, thereby affecting the expected attachment morphology in the second sub-portion 113. Specifically, the thickness of the attachment portion 15 can be 10-200 μm, 50-250 μm, 100-300 μm, 150-400 μm, 200-500 μm, 350-600 μm, 400-700 μm, etc. Further, the thickness of the attachment portion 15 can be 10-150 μm, which can not only promote endomembranization, but also avoid excessive increase in the delivery diameter, ensure the ease of delivery, and avoid waste of materials. 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 implementation schemes, the thickness of the attachment portion 15 can be set to different thicknesses according to different parts, such as the thickness of the parts that are relatively prone to degradation is higher than the thickness of other parts that are relatively slow to degrade. For 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 better effect of promoting the endomembranization of the suspended strut. For example, when the attachment portion 15 is attached to the strut 100 of the second sub-portion 113, the rod 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, and 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. Further, 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 inner membrane process of the strut 100 and the strut connection of the second sub-portion 113 is more balanced.

[0081] In some possible embodiments, the second sub-portion 113 may include an easy-to-break region that is more prone to breakage, and the thickness of the attachment portion 15 in the easy-to-break region may be thicker, which can reduce the probability of breakage in the easy-to-break region, so that the second sub-portion 113 has a more stable shape before the first sub-portion 111 is internalized, thereby stabilizing the implantable device 1. The thickness of the attachment portion 15 in the easy-to-break region may be 20 to 100 μm, which can take into account the delivery diameter at the same time.

[0082] The above-mentioned easy-to-break area can be a part of the support rod 100 with a notch or a gap, or a part with a smaller rod width and wall thickness, or a part with a greater degree of stretching (such as a bend or corner). Not limited to this, as long as the part of the support rod 100 is more likely to break during the degradation process, it is within the protection scope 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; winding with varying density.

[0084] Please see again Figure 4As 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, etc. The width of the winding wire 151 can be greater than, equal to or less than the thickness of the winding wire 151. Figure 4 The winding adopts a single-layer flat winding method, and 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 0-0.5mm. When the turn spacing is greater than 0.5mm, a large portion of the surface of the support rod 100 is exposed, which is not conducive to wrapping and limiting the fragments generated by the corrosion of the support rod 100. It also takes more time for endothelial cells to gradually form a continuous inner membrane layer after climbing to the winding position.

[0085] The winding wire 151 can be arranged in a manner of circumferentially winding 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°. When the strut 100 is degraded, the rod width and wall thickness of the strut 100 will gradually decrease, and the gap between the winding wire 151 and the strut 100 will gradually increase. The angle α between the winding wire 151 and the axis of the strut 100 is set to be less than 90°, and the displacement of the winding wire 151 in the axial direction of the strut 100 is relatively small, which is conducive to the winding wire 151 and the strut 100 to maintain the relative position unchanged, avoid excessive gaps between adjacent turns due to displacement, and thus facilitate the uniform attachment and growth of endothelial cells in the winding wire layer. Further, 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, which is convenient for completing the 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 a possible embodiment, the attachment portion 15 may further include a pulling layer 155, which is arranged along the length direction of the support rod 100. The winding wire 151 wound on the support rod 100 and the pulling layer 155 have several intersections, and the intersections are arranged at intervals of several turns, and a binding knot 151a is formed at the intersections. The winding wire 151 and the pulling layer 155 at each intersection are connected or connected at intervals as a whole. Specifically, the pulling layer 155 can be another winding layer with a sparser winding density located below the winding layer, and the axial span between adjacent turns of the pulling layer 155 is relatively larger. The pulling layer 155 can also be arranged in a straight line, and the length will not change. In this way, the winding wire 151 is connected to the pulling layer 155, and the length change of the winding wire 151 and the turn spacing of adjacent turns can be limited by the pulling layer 155, so as to avoid 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 sutured on the support rod 100. The pulling layer 155 can also include at least one of a connecting net, 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 net, the connecting net 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 winding wire 151 itself may also include a plurality of binding knots, each of which is adjacent or spaced apart, for example, spaced apart by several turns. The binding knots can strengthen the adhesion between the winding wire layer and the strut 100, so that the attachment portion 151 is not easy to be separated from the strut 100. At the same time, the binding knots can also increase the surface roughness of the attachment portion 151, which is conducive to promoting tissue endothelialization.

[0088] Optionally, the spacing between each two adjacent binding knots 151a can be 0.1 to 2 mm. When the spacing between the two binding knots 151a is less than 0.1 mm, the number of binding knots 151a is relatively large, which increases the difficulty of preparing the implantable device 1 and the delivery diameter. When the spacing between the two binding knots 151a is greater than 2 mm, the connection effect between the winding wire 151 and the support rod 100 is not good. Therefore, setting the spacing between the two adjacent binding knots 151a within the above-mentioned numerical range has excellent comprehensive performance.

[0089] In addition, the winding layer is woven by 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 see Figure 5As 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-portion 113. The spinning layer can be formed by winding a plurality of spinning strands at intervals on the support rod 100, and a micro gap 156 is formed between adjacent spinning strands. The width of the micro gap 156 is less than 500 μm. Further, the width of the micro gap 156 can include but is not limited to 5-80 μm, 10-50 μm, 20-40 μm, 20-100 μm, 150-250 μm, 50-250 μm, 20-200 μm, 30-180 μm or 100-300 μm, etc. Although the figure shows a structure of the spinning layer as a single layer, the present application is not limited to a multi-layer structure.

[0091] Please see Figure 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, and the distribution density of the fiber filaments 153b is 10 to 500 filaments / mm 2 . As a result, endothelial cells can grow on the attachment portion 15 faster and more evenly, 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 see Figure 7 , is a schematic diagram of the structure of an implantable device of another embodiment. As an example, the attachment portion 15 is a woven mesh layer attached to the second sub-portion 113, and the woven 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. Further, the diameter of a single hole may 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] Figure 7In the example of the embodiment, the size of the holes is consistent and the distribution is uniform; in other possible embodiments, the attachment portion 15 may include a first density area and a second density area arranged adjacent to each other, and the diameter of the holes in the second density area is greater than the diameter of the holes in the first density area. Because contact with blood (liquid) will accelerate the degradation of the strut 100, the degradation rate of the part of the strut 100 that contacts the blood with a larger area is faster. Through the above settings, the attachment portion 15 can play a certain role in regulating the degradation of the strut 100, that is, through the above settings, the area where the strut 100 breaks first can be set.

[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 the hole diameters in different sizes.

[0095] In addition to the winding layer, the base layer with fiber filaments, the perforated 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 having this surface feature can promote endometrialization, so that the endometrialization 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 ripples 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 endometrial layer for a long time will cause platelet adhesion and aggregation, inflammatory cell infiltration and formation of thrombus on the strut, affecting blood circulation, and thrombus detachment will also cause embolism. The implantable device 1 of the present application is attached with an attachment portion 15 that promotes the endometrialization time to be reduced to less than 3 months on the suspended second sub-portion 113, which can correspondingly reduce the formation of thrombus 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 too large, and the thickness or local thickness of the corresponding attachment portion 15 is too thick, which can easily cause adsorption of platelets and fibrin in the blood and cause device thrombosis in a short period of time. In addition, too large a peak-to-valley difference is not conducive to the delivery of implantable devices. Further, the surface peak-to-valley difference 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 implementation schemes, the aforementioned various structures of the attachment portion 15 have a blood coagulation rate of 10% to 90%, and 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 the endometriosis is achieved in about 1 month. Further, 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, and the two samples are blood from the same source. The thrombin time PT is measured on one of the samples, and the thrombin time PT' is measured by adding the attachment portion 15 (specifically, part of the second sub-portion 113 and the attachment portion 15 attached thereto can be intercepted) to the other sample. 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 at 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 implementations, the surface potential polarity of the attachment portion 15 and the first sub-portion 111 of the aforementioned various 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 polarity of the surface potential of the main body 11 can reduce the probability of thrombosis, 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, which can further optimize the endothelialization time of the main body 11 in the suspended portion and the wall-attached portion, making the difference between the two smaller.

[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,

[0100] 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 coated strut 100. Specifically, when the strut 100 is made of a material with a fast degradation rate, such as a 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 too early and failing to support the lumen or position 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.

[0101] For example, studies have shown that magnesium alloy vascular stents completely degrade in about 1 to 3 months after being implanted in a living body (such as into the coronary artery). It is reported that the first generation of magnesium alloy stents under Biotronik contains 93% magnesium and 7% rare earth elements, with a stent wall thickness of 165μm. Without drug coating, it is completely degraded into ions after 60 days of implantation. If the second sub-section 113 of the implantable device 1 is made of magnesium alloy material, the strut 100 will be degraded in a relatively short period of time. The large pieces of debris that may be produced by the degradation will flow into the distal end with the blood vessels, which may easily cause embolism of the distal blood vessels; at the same time, the first sub-section 111 is easy to separate from the second sub-section 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 more than 1 year. Furthermore, when the permeability coefficient of the attachment portion 15 is 1*10 -13 ~1*10 -9 cm / s, the weight loss rate after 1 month, 2 months, and 3 months after implantation can be controlled within 5%, 20%, and 35%, respectively, and the weight loss after 3 months can even be controlled below 10%, and it can be completely degraded within 1 to 2 years after implantation. Because the weight loss rate of the strut 100 is relatively low during a relatively long period of time at the beginning of implantation, it can maintain a good structural morphology within the expected time of device implantation, avoid failure due to device displacement, and reduce the device failure rate from 20% to below 1%. In addition, the degradation of the strut 100 can also be regulated to occur after the endometrialization is completed, so as to reduce embolism by wrapping and limiting the degradation detached materials of the strut 100 through the attachment portion 15 on the strut 100 and the endometrial layer.

[0102] 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 into 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% 3 months after implantation. The degradation rate is increased to more than 20% in 6 months, 45% to 55% in 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 implanted part. For example, the leaflet component 12 has formed a good connection with the endothelial layer of the blood vessel. The degradation of the body 11 can relieve the unnecessary constraints of the lumen, so that the leaflet component can grow with the patient, and will not affect the secondary percutaneous intervention of the valve to replace the larger artificial valve, and will not cause psychological burden to the patient. It is suitable for patients of all ages. It should be understood that as the attachment part 15 gradually degrades in the living body, its permeability coefficient will change to a certain extent.

[0103] 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 achieve good structural support for 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 tissue support, avoiding unnecessary constraints on the repaired or healthy lumen, reducing complications and reducing other treatments or device implants in this 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.

[0104] As another example of the implementation method of this application, please refer to Figure 1 , Figure 5 and Figure 7 In some possible implementations of the present application, the implantable device 1 further includes a stopper 152. One end of the stopper 152 is connected to the attachment portion 15, and the other end is connected to a different position of the attachment portion 15, or connected to the body 11, specifically, the second sub-portion 113 or the first sub-portion 111. Specifically, the stopper 152 can be a linear or strip-shaped structure, such as Figure 1The limiting member 152 of the multiple suspension wire structure shown in the figure. Of course, the limiting member can also be other types of structures such as mesh, sheet, membrane, etc. The limiting member 152 can further strengthen the limiting effect on the second sub-section 113 after the structure changes after implantation, so as to prevent the second sub-section 113 from escaping from the attachment portion 15 or separating from the main body together with the attachment portion 15 due to degradation or breakage, causing the second sub-section 113 to lose its positioning effect on the first sub-section 111, causing the first sub-section to shift or deviate from the implantation site and cause the implantable device to fail. The broken part falls off to other parts, causing embolism or affecting the normal organ function: for example, after 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 an embolic source.

[0105] Specifically, when the support rod 100 breaks in the early stage after implantation, the attachment portion 15 is pulled to shift and deform, and the corresponding position may shake disorderly under the action of blood flow and impact the surrounding tissues. By setting the limiter 152, the support rod 100 of the body 11 can be pulled and limited, reducing the occurrence of random shaking and improving the protection of tissues. Figure 1 If one or some of the connections between the second sub-section 113 and the first sub-section 111 are broken, since one end of the limiting member 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 disconnected 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 avoiding disordered shaking near the implantation position due to the break of the second sub-section 113 and damaging the tissue.

[0106] On the other hand, see Figure 5 If the support rod 100 of the second sub-section 113 is partially broken, for example, it is broken near the tip 101, which may cause the two ends of the broken part to be relatively displaced and cause local structural deformation, thereby posing a risk of puncturing tissue. 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 part, so that the two ends of the broken part are still aligned and maintain a structural form that is basically consistent with that in the state without fracture, thereby preventing the second sub-section 113 from puncturing tissue due to displacement or structural change caused by the fracture.

[0107] On the other hand, the limiting member 152 can be used to limit the 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 may also be a possibility of partial shedding and becoming free substances. Since the attachment portion 15 is relatively flexible, under the impact of the 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, and the winding is locally stretched from the winding state to become longer in length, causing the broken second sub-section 113 to protrude from the attachment portion 15 and stab the tissue, or even fall out of the attachment portion 15 and flow into the blood. Since the two ends of the limiting member 152 are relatively fixed and the length remains relatively unchanged, it is possible to pull and limit the large pieces of degradation products produced by the second sub-section 113, reduce the phenomenon of their falling into the blood and causing thrombosis, and play a better protective role on the tissue.

[0108] Specifically, the stopper 152 may be a linear or strip-shaped structure. The number of the stopper 152 may be one, one end of which is connected to the first sub-section 111, and the other end of which is connected to the second sub-section 113 or the attachment section 15. Alternatively, the number of the stopper 152 may be at least two, and each stopper 152 is connected to a different position of the second sub-section 113 and / or the attachment section 15. Thus, by pulling and limiting in different directions, a more comprehensive limit is achieved for the broken or detached second sub-section 113. As an example, refer to Figure 1 and Figure 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. 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 limit member 152, which further reduces the random movement of detached objects caused by breakage or degradation and improves the safety of the use of the implantable device 1.

[0109] Optionally, see Figure 1 and Figure 5 The two ends of the limiting member 152 are respectively connected to the middle part or a position close to the middle part of the two supporting rods 100, so that the limiting member 152 can have a better limiting effect.

[0110] 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.

[0111] For another example, the attachment portion 15 may have a relatively high tensile strength, so that the attachment portion 15 is not easily broken by the impact of blood in the living body, thereby reducing the generation of large foreign matter entering the blood. The attachment portion 15 can be easily broken by human power, so that when a new implantable device 1 is implanted, the attachment portion 15 will not cause obvious obstacles to the implantation. Of course, the attachment portion 15 may also not be easily broken by human power.

[0112] For another example, the attachment part 15 can absorb water and expand when it encounters liquid, thereby further improving the protective power of the attachment part 15 on living tissue. Of course, it is understandable that the attachment part 15 may not expand when it encounters liquid.

[0113] 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.

[0114] Please see again Figure 1 The implantable device includes a leaflet assembly 12 and a skirt. The leaflet assembly 12 is fixed to the inner side of the 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 ( Figure 1 The inner skirt 13 is covered by the outer skirt 13, not shown) and / or the outer skirt 13, and the inner skirt covers the inner wall of the first sub-section 111, which 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 a universal suture material and a similar process of 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 connected as one body, so that the connection effect between the attachment portion 15 and the inner skirt is better, and the attachment portion 15 can wrap the second sub-section 113 in a strip or sheet shape, and the inner skirt can also act as a limiter. Of course, the attachment portion 15 and the inner skirt can also be set separately.

[0115] The artificial heart valve 1 may be an artificial pulmonary valve. After the artificial pulmonary valve is implanted in the human body, the valve frame of the artificial pulmonary valve is more likely to be non-adherent to the wall near the outflow end. The attachment portion 15 is provided to avoid the formation of thrombus caused by the valve frame fragments and the damage to the tissue caused by the sharp fracture of the fragments. The artificial heart valve in this example may also be an artificial aortic valve, an artificial mitral valve, and an artificial tricuspid valve.

[0116] Please see Figure 8 to Figure 11, which is a schematic diagram of implantable devices of other embodiments of the present application. In the embodiments described below, the first sub-unit, the second sub-unit, the attachment unit and their mutual relationship, as well as their respective specific structures, materials, parameters, etc. included in each implantable device can refer to all or part of the features of the attachment unit described in the previous embodiments, and have all or part of the beneficial effects correspondingly, which will not be repeated below.

[0117] exist Figure 8 An implantable device 2 is shown, which is mainly suitable for the case where the implantation site is a branch lumen. The body of the implantable device 2 includes a first sub-section 211 and a second sub-section 213 connected thereto, wherein the first sub-section 211 is implanted into a relatively smaller branch vessel, and an attachment portion (not marked) is coated on the second sub-section 213, and the second sub-section 213 is partially suspended at the opening of the branch vessel, that is, the site connected to the main vessel.

[0118] Fig. 9 Another implantable device 3 is shown, specifically a vascular stent, which is mainly suitable for the case where the implantation site is a main blood vessel with branch blood vessels. The body of the implantable device 3 includes a first sub-section 311 and a second sub-section 313, wherein the first sub-section 311 is implanted into the main blood vessel in a wall-attached manner, an attachment portion is coated on the second sub-section 213, and a portion of the second sub-section 313 is facing the opening of the branch blood vessel, that is, the site connected to the main blood vessel.

[0119] Fig.10 Another implantable device 4 is shown, which is specifically a vena cava filter. The implantable device 4 is used to be implanted in the vena cava, and its body includes a first sub-section 411 and a second sub-section 413. The first sub-section 411 is against the inner wall of the vena cava, and the second sub-section 413 is suspended in the vena cava. The body of the vena cava filter is composed of a plurality of crossed filter rods, and the general shape of the filter rods is similar to the support rods described in the above embodiment, or can be woven from metal wires. An attachment portion is coated on the filter rods or metal wires of the second sub-section 413. The attachment portion is attached to the suspended second sub-section 413 in a manner that can keep blood flowing through the hollow or gap between the body.

[0120] Fig.11 Another implantable device 5 is shown, which is specifically a coated stent, whose 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 blood vessel 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.

[0121] See also Fig.12 The present application also proposes a method for manufacturing an implantable device 1, which may include the following steps:

[0122] S1: selecting a substrate for preparing the implantable device;

[0123] S2: Processing the substrate to prepare the body of the implantable device, wherein the body comprises a first sub-portion for being attached to the lumen wall after being implanted into the lumen and a second sub-portion which is at least partially suspended;

[0124] S3: forming an attachment portion attached to the second sub-portion.

[0125] Specifically, a substrate for preparing an implantable device is selected, and the substrate is processed to prepare the body 11 of the implantable device 1. The prepared body 11 includes at least a support rod 100. As one example, a hollow portion is formed between the support rods 100. After the required body 11 is prepared, an attachment portion 15 attached to the second sub-portion 113 is formed. The attachment portion 15 is at least arranged along the length direction of the support rod 100 to cover at least part of the outer surface of the second sub-portion. After the attachment portion 15 is arranged at the position set by the body 11 as required, the implantable device 1 is completed.

[0126] Specifically, the substrate can be a tube or a stent wire. The tube or stent wire has different diameters, and the substrate of appropriate size can be selected according to the specification requirements of the implantable device to be manufactured. The specific material of the body 11 and the material and formation method of the attachment part 15 can refer to the above description of the implantable device 1.

[0127] Specifically, when preparing the body 11 of the implantable device 1, the body 11 of the desired shape can be obtained by cutting and engraving the tube according to the cutting processing requirements through a cutting process; or the body 11 of the desired shape can be obtained by weaving the stent wire according to the corresponding weaving method. In a possible implementation, when the body 11 is prepared by a weaving method, in addition to setting the attachment part 15 after the production of the body 11 is completed, the attachment part 15 can be formed at the corresponding part of the body 11 when the production of the part where the attachment part 15 is required is completed on the body 11 during the weaving process of the body 11, and then the body 11 is woven as a whole. In this way, it is convenient to set the attachment part 15, and it is also convenient to adjust it in time, thereby improving the accuracy and reliability of the setting of the attachment part 15.

[0128] 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 surface roughness treatment, eliminating 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 mechanical grinding and polishing, or chemical polishing. In addition, the main body 11 can also be heat-treated to eliminate the residual internal stress at various positions of the main body 11 and enhance 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 subsequently processed, such as preparing or forming the attachment portion 15.

[0129] The specific implementation method of the implantable device 1 of the present application is described in detail below in combination with the embodiments and comparative examples.

[0130] Example 1

[0131] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and its structure is roughly similar to Figure 1 The main difference is that the hollow portion of the implantable device 1 of this embodiment is a quadrilateral instead of Figure 1 The hexagonal shape shown in FIG. 1 is a hexagonal shape, and the attachment portion 15 is attached only to some of the struts 100 included in the second sub-section 113. The attachment portion 15 is a winding layer formed by winding the PLLA suture thread, and covers some of the struts 100 of the second sub-section 113 suspended at the outflow end. Fig.13 and Fig.14 The attachment portion 15 is formed by interweaving and winding a winding wire 151 on the support rod. The winding wire 151 is formed by overlapping and winding a plurality of turns of a bundle of PLLA suture wires containing a plurality of fiber filaments 1511. The line width of each turn of the winding wire is about 80 to 150 μm, the diameter of the fiber filament is about 12 μm, the surface of the winding wire layer is irregularly corrugated, and the peak-to-valley difference formed is about 0.05 to 0.08 mm. The thickness of the winding wire layer is about 110 μm, and the permeability coefficient is about 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.

[0132] The implantable device 1 was implanted into an animal (dog, the same below). The animal survived 30 days after implantation. After the device was taken out, it was first observed with the naked eye. Fig.15 As shown, this is what is observed when taking photos with an ordinary mobile phone. Fig.15The marks C1 and C2 refer to the stent rods suspended in the air after implantation, of which the stent rod C1 refers to is wrapped with a wire winding layer, while the stent rod C2 refers to a bare stent. C3 is the wall-attached part of the implantable device 1. A translucent inner membrane layer has been formed at C1, and the degree of inner membraneization is equivalent to that at C3, while there is no obvious inner membrane layer at C2. The iron-based material stent rod maintains its original shape without any breakage or obvious degradation. The weight loss rate of the stent rod wrapped with the wire winding layer is about 2%. Scanning electron microscopy (SEM) is used to perform local imaging of C1 and C2, as shown in FIG. Fig.16 and Fig.17 As shown in the figure, it can be seen that the inner membrane layer with a coverage rate of almost 100% has been formed outside the stent rod corresponding to the C1 position. In contrast, there are only sporadic tissues attached to the bare stent rod suspended at the C2 position, and the inner membrane layer coverage rate is less than 5%.

[0133] Example 2

[0134] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and its structure is as shown in FIG. Figure 1 The material of the valve frame and the winding layer is the same as that of Example 1, except that the peak-to-valley difference of the winding layer of Example 2 is about 0.08-0.12 mm, the thickness of the winding layer is about 130 μm, and the permeability coefficient is about 1*10 -3 cm / s, and the blood coagulation rate was about 30%. After 14 days of implantation in animals, the animals survived, and when the device was removed, it was observed that a continuous and complete intima layer was basically formed outside the second sub-section 113 attached with the attachment part 15, the intima coverage rate was greater than 90%, and the weight loss rate of the stent rod wrapped by the winding layer was about 1%.

[0135] Example 3

[0136] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and the difference from Example 2 is that the peak-to-valley difference of the winding layer is about 0.03-0.05 mm, the thickness of the winding layer is about 110 μm, and the blood coagulation rate is about 10%. After implantation in an animal for 30 days, the animal survived, and the device was removed, and it was observed that the endothelial coverage of the attachment portion 15 was about 95%, and the weight loss rate of the stent rod wrapped by the winding layer was about 2%.

[0137] Example 4

[0138] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, which is different from Example 2 in that the peak-to-valley difference of the winding layer is about 0.7 mm, the thickness of the winding layer is about 750 μm, and the blood coagulation rate is about 90%. After implantation in an animal for 30 days, the animal survived, and the device was removed, and it was observed that the endothelial coverage of the attachment portion 15 was 100%, and the weight loss rate of the stent rod wrapped by the winding layer was about 3%.

[0139] Example 5

[0140] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, which is different from Example 2 in that the peak-to-valley difference of the winding layer is about 0.35 mm, the thickness of the winding layer is about 450 μm, and the blood coagulation rate is about 50%. After implantation in an animal for 30 days, the animal survived, and the device was removed, and it was observed that the endothelial coverage of the attachment portion 15 was 100%, and the weight loss rate of the stent rod wrapped by the winding layer was about 2%.

[0141] Example 6

[0142] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, which is different from Example 2 in that the width of each winding wire is about 500 μm, the winding spacing is 0.5 mm, and the blood coagulation rate is about 10%. After implantation in an animal for 30 days, the animal survived, and the device was removed, and it was observed that the endothelial coverage of the attachment portion 15 was about 70%, and the weight loss rate of the stent rod wrapped by the winding layer was about 1%.

[0143] Embodiments 7 to 10

[0144] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and each embodiment is substantially the same as embodiment 2, wherein the attachment portion 15 of embodiments 7 to 9 is formed by winding a stent rod with PLLA sutures, and the attachment portion 15 of embodiment 10 is a PLLA permeable membrane, and the surface peak-to-valley difference of the attachment portion 15 of each embodiment is 0.08 to 0.12 mm. The main differences between each embodiment and embodiment 2 are shown in Table 1. The animals survived after being implanted in the body for 30 days, 90 days, and 1 year. When the device was removed at each time point, it was observed that the endothelial coverage of the attachment portion 15 was 100%, and the weight loss rate of the stent rod wrapped by the winding layer was shown in Table 1.

[0145] Table 1

[0146]

[0147] Examples 11 to 14

[0148] The implantable device 1 is an iron-based absorbable artificial pulmonary valve. Each embodiment is substantially the same as Embodiment 2. The attachment portion 15 is a PCL spinning layer formed by a stent rod, and the surface peak-to-valley difference is 0.08-0.12 mm. The main parameter differences between each embodiment and Embodiment 2 are shown in Table 2. The animals survived after being implanted in the body for 30 days, 90 days, and 1 year. When the device was taken out at each time point, it was observed that the intima coverage of the attachment portion 15 was 100%, and the weight loss rate of the stent rod wrapped by the winding layer was shown in Table 2.

[0149] Table 2

[0150]

[0151] Embodiments 15 to 17

[0152] The implantable device 1 is a magnesium alloy absorbable artificial pulmonary valve, and its structure is as shown in FIG. Figure 1 The wall thickness of the strut 100 is about 140 μm, the attachment part 15 wraps all the struts 100 included in the body 11, and the material of the attachment part 15 is PLLA, wherein Example 15 is specifically a PLLA spinning layer, and Examples 16-17 are PLLA permeable membranes, with a surface peak-to-valley difference of 0.12-0.15 mm. For other parameters of each embodiment, please refer to Table 3. The animals were implanted in the body for 30 days, 90 days, and 1 year, and all the animals survived. When the device was removed at each time point, it was observed that the inner membrane coverage of the attachment part 15 was 100%, and the weight loss rate of the stent rod wrapped by the winding layer was shown in Table 3.

[0153] Table 3

[0154]

[0155] Embodiment 18

[0156] Implantable device 1 is a nitrided iron-based vena cava filter, using Fig.10 In the structure shown, the filter rod wall thickness is 250μm and the rod width is 400μm. PLLA suture is used to wrap multiple turns around all filter rods to form an attachment portion. The wire width of the winding wire varies from about 50 to 100μm, the diameter of the fiber is about 12μm, the peak-to-valley difference of the winding layer surface is about 0.03 to 0.05mm, the thickness of the winding layer is about 130μm, and the permeability coefficient is about 1*10 -3 cm / s, and the rate of blood coagulation was about 10%. The animals survived 30 days after implantation, and the device was removed and observed to have 100% coverage of the intima at the suspended stent rod, no fracture at the suspended part, and a weight loss rate of about 3% at the stent rod wrapped by the winding layer.

[0157] Embodiment 19

[0158] The implantable device 1 is a zinc alloy vena cava filter, which is Fig.10 In the structure shown, the filter rod wall thickness is 250μm and the rod width is 400μm. PLLA suture is used to wrap multiple turns around all filter rods to form an attachment portion. The wire width of the winding wire varies from about 50 to 100μm, the diameter of the fiber is about 12μm, the peak-to-valley difference of the winding layer surface is about 0.03 to 0.05mm, the thickness of the winding layer is about 130μm, and the permeability coefficient is about 1*10 -3 cm / s, and the rate of blood coagulation was about 10%. The animals survived 30 days after implantation, and the device was removed and observed that the coverage of the intima at the suspended stent rod was 98%, no fracture occurred at the suspended part, and the weight loss rate of the stent rod wrapped by the winding layer was about 4%.

[0159] Comparative Example 1

[0160] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and its structure is as shown in FIG. Figure 1 The material and structure of the valve frame are the same as those of Example 1. The wall thickness of the valve frame is 140 μm. The attachment portion 15 is made of 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, and the blood coagulation rate was about 5%. After 30 days of implantation in animals, the animals survived, and the artificial pulmonary valve was taken out to observe that an intima layer was partially formed in the suspended second sub-portion 113 attached with the attachment portion 15, but it was not continuous, and the intima coverage rate was less than 30%, while the intima coverage rate of the valve frame wall-attached part was 100%, and the weight loss rate of the stent rod wrapped by the permeable membrane was less than 2%.

[0161] Comparative Example 2

[0162] The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and its structure is as shown in FIG. Figure 1 The material and structure of the valve frame are the same as those of Example 1. The wall thickness of the valve frame is 140 μm. The attachment portion 15 is made of 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, and the blood coagulation rate was about 95%. After 30 days of implantation in the animal, the animal survived but showed slow movement and mental depression. When the artificial pulmonary valve was taken out, it was observed that thrombosis was formed locally in the suspended second sub-portion 113 to which the attachment portion 15 was attached and had not fallen off.

[0163] Comparative Example 3

[0164] The implantable device 1 is a magnesium alloy absorbable artificial pulmonary valve, which is made of a magnesium alloy material to make a valve frame and adopts Figure 1 In the structure shown, the wall thickness of the petal frame is 140 μm. The suspended stent rod is a bare stent without the attachment portion 15. At this time, water can instantly reach the surface of the stent rod, which is equivalent to a permeability coefficient greater than 1*10 -3 The animal died 30 days after implantation. After dissection and observation, it was found that the suspended stent rod (i.e., the second sub-section) at the outflow end of the valve frame was partially missing, and pulmonary embolism was found. At the same time, the suspended part of the valve frame was partially separated from the wall-attached part. The leaflet assembly 12 deviated downward relative to the original implantation position (corresponding to the native valve ring), and only sporadic tissue was attached to the remaining suspended stent rod, and no continuous endothelial layer was formed. The endothelial coverage rate was less than 5%.

[0165] The above are only preferred specific implementations of the present application, but the protection scope of the present application is not limited thereto. Rather, any changes or substitutions that can be easily conceived by any technician familiar with the technical field within the technical scope disclosed in the present application should be included in the protection scope of the present application.

Claims

1. An implantable device, characterized in that: include: A body, comprising a first sub-section and a second sub-section, wherein the first sub-section is used to fit with the wall of the lumen after the implantable device is implanted into the lumen, and the second sub-section is connected to the first sub-section, and the second sub-section is at least partially suspended after the implantable device is implanted into the lumen; as well as An attachment portion is attached to the second sub-portion.

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

3. The implantable device according to claim 1, characterized in that The permeability coefficient of the attached part is 1*10 -13 ~1*10 -3 cm / s.

4. The implantable device according to claim 1, characterized in that The material of the attachment portion has a blood coagulation rate of 10% to 90%; and / or 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.

5. The implantable device according to claim 1, characterized in that The second sub-section includes at least one support rod, and the attachment portion includes at least one winding wire, and the at least one winding wire is wound around the support rod for multiple turns to form the attachment portion.

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 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 of the winding wires comprises 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.

8. The implantable device according to claim 5, characterized in that The winding method of the winding wire on the support rod 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 support rod is less than 90°; and / or the angle between the winding wire and the axis of the support rod is different along the axis.

9. The implantable device according to claim 5, characterized in that: The wire wrap forms a plurality of binding knots on the support rod, and the binding knots are arranged adjacently or at intervals; and / or the attachment portion also includes a pulling layer, and the pulling layer is arranged along the length direction of the support rod of the second sub-portion, and the wire wrap and the pulling layer have several intersections, and the wire wrap and the pulling layer at each intersection are connected or connected at intervals as a whole.

10. The implantable device according to claim 1, characterized in that: 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 .

11. The implantable device according to claim 1, characterized in that: The thickness of the attachment portion is 10 to 750 μm.

12. The implantable device according to claim 11, characterized in that: The second sub-portion includes a tip, and the thickness of the attachment portion at the tip is 50-150 μm; and / or the second sub-portion includes an easy-to-break region, and the thickness of the attachment portion in the easy-to-break region is 20-100 μm.

13. The implantable device according to claim 1, characterized in that The attachment portion has a plurality of holes, and the diameter of a single hole is less than 500 μm; and / or the attachment portion includes a first density zone and a second density zone arranged adjacent to each other, wherein the first density zone is provided with a plurality of holes with a diameter of 10 to 100 μm, and the second density zone is provided with a plurality of holes with a diameter of 150 to 500 μm.

14. The implantable device according to claim 1, characterized in that The shape of the attachment portion is configured to change following a change in the shape of the second sub-portion.

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

16. The implantable device according to claim 15, characterized in that There are multiple limiting members, and each limiting member is respectively connected to a different position of the second sub-portion and / or the attachment portion.

17. The implantable device according to claim 1, characterized in that: The main body or the second sub-section is degradable, and the degradation time of the second sub-section is longer than the endometrialization time of the second sub-section; and / or the attachment section is non-degradable or the degradation time of the attachment section is longer than the endometrialization time of the second sub-section.

18. The implantable device according to claim 1, characterized in that The implantable device further includes a plurality of hollow portions, a flow channel is formed in the axial direction of the main body, the second sub-portion is adjacent to at least one of the hollow portions, and the attachment portion is attached to the second sub-portion in a manner that allows the fluid in the lumen to flow out from the flow channel through the hollow portion adjacent to the second sub-portion.

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

20. A method for manufacturing an implantable device, used for manufacturing the implantable device according to any one of claims 1 to 19, characterized in that: The method comprises: selecting a substrate for preparing the implantable device; Processing the substrate to prepare the body of the implantable device, wherein the body comprises a first sub-portion for being attached to the wall of the lumen after being implanted into the lumen and a second sub-portion which is at least partially suspended; An attachment portion attached to the second sub-portion is formed.

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