CN119950119A

CN119950119A - Implantable device and method of manufacturing the same

Info

Publication number: CN119950119A
Application number: CN202411975184.3A
Authority: CN
Inventors: 张贵; 张德元
Original assignee: Biotyx Medical Shenzhen Co Ltd
Current assignee: Biotyx Medical Shenzhen Co Ltd
Priority date: 2023-12-29
Filing date: 2024-12-26
Publication date: 2025-05-09
Also published as: WO2025140546A1

Abstract

The present application belongs to the field of medical device technology, and specifically relates to an implantable device and a method for manufacturing the implantable device. The implantable device includes a body and an attachment portion, wherein the body includes a first sub-portion and a second sub-portion, the first sub-portion is used to fit with the wall of the lumen after the implantable device is implanted into the lumen, the second sub-portion is connected to the first sub-portion and at least partially suspended after the implantable device is implanted into the lumen, and the attachment portion is attached to the second sub-portion. The implantable device provided by the present application can improve the overall safety of the device from multiple aspects.

Description

Implantable device and method of manufacturing the same

Technical Field

The application belongs to the technical field of medical instruments, and particularly relates to an implantable instrument and a manufacturing method of the implantable instrument.

Background

The heart valve is a one-way valve between the atrium and ventricle or between the ventricle and artery. Heart valve disease is one of the most common cardiovascular diseases. Clinically, structural or functional abnormalities of the valve/valves caused by rheumatic inflammation, degenerative changes, congenital malformations, ischemic necrosis, trauma, etc. can lead to valve stenosis or insufficiency. The heart valve disease is mild and symptoms can be relieved by drug treatment, the serious patients can carry out valve repair, and patients unsuitable for repair need artificial heart valve replacement.

Heart valve replacement refers to replacement with a prosthetic mechanical valve made of synthetic material or a prosthetic biological valve made of biological tissue, since the prosthetic heart valve has a life span and the size of the prosthetic heart valve is unchanged, especially in children and young children, requiring multiple replacements to compensate for recipient growth. Before replacing a new prosthetic heart valve, the previously implanted prosthetic heart valve needs to be removed, but the difficulty and risk of surgical removal is relatively high due to tissue adhesions in the surgical field. In view of this, some prosthetic heart valves have valve holders made of absorbable materials that gradually degrade in the body, and the replacement of a new prosthetic heart valve does not require the removal of an old prosthetic heart valve, thereby greatly reducing the risk of surgery.

Although there are many benefits to using absorbable materials to make a valve frame, some absorbable materials, such as magnesium alloys, corrode too quickly, easily causing structural imperfections in the short term after implantation of the instrument and losing their supporting effect on the tissue, ultimately resulting in failure of the instrument and severely affecting the safety and reliability of the instrument. In addition, valve holders or stents, which typically have wall thicknesses on the order of hundred microns, are prone to sharp edges that can cause damage to tissue, which can also affect the safety of the instrument to some extent. In addition, there may be local fracture of the stent or massive sloughing due to corrosion degradation, which can flow into downstream vessels to cause embolism. Furthermore, the human body structure is complex and has individual variability, so that the shape of the valve frame of the artificial heart valve is generally difficult to completely match with the human body structure with various shapes, after some artificial heart valves are placed into the human body, the valve frame and the lumen are attached to each other in different degrees or the blood flow speed difference leads to larger difference in endocardization condition, and the part with slow endocardization speed may cause thrombus. In summary, current implantable devices are less safe.

Disclosure of Invention

Aiming at the technical problems, the technical scheme of the application provides an implantable device, which can improve the overall safety of the device.

The first aspect of the application provides an implantable device comprising a body comprising a first sub-portion for engaging a lumen wall after implantation of the implantable device into the lumen and a second sub-portion connected to the first sub-portion and at least partially suspended after implantation of the implantable device into the lumen, and

And an attaching portion attached to the second sub-portion.

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

In some embodiments, the implantable device further comprises a stop member having one end connected to the first sub-portion and the other end connected to the second sub-portion and/or the attachment portion.

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

In some embodiments, the second sub-portion comprises at least one strut and the attachment portion comprises at least one wire wrap wound a plurality of turns around the strut to form the attachment portion.

In some embodiments, the wire wrap has a wire width/diameter of 50 to 700 μm.

In some embodiments, the inter-turn spacing between adjacent turns is 0-0.5 mm.

In some embodiments, each wire wrap comprises a plurality of filaments having the same or different diameters and having a diameter of 5-25 μm.

In some embodiments, the wire wrap is wrapped around the strut in a manner selected from one or any combination of overlapping wrapping, tiling wrapping, multi-layer wrapping, and density changing wrapping.

In some embodiments, the wrap is at an angle of less than 90 ° to the axis of the strut.

In some embodiments, the angle between the wire and the axis of the strut is different along the axis.

In some embodiments, the wire wrap forms a plurality of binding knots in the strut, each binding knot being disposed adjacent or spaced apart.

In some embodiments, the attachment portion further comprises a pulling layer disposed along a length of the leg of the second sub-portion, the wire wrap and the pulling layer having a plurality of intersections, the wire wrap at each intersection being integrally connected or spaced apart from the pulling layer.

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

In some embodiments, the thickness of the attachment portion is 10 to 750 μm. Further, the thickness of the adhesion part is 10-150 μm.

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

In some embodiments, the second sub-portion includes a frangible region that is prone to fracture, and the thickness of the attachment portion in the frangible region is 20-100 μm.

In some embodiments, the attachment portion has a plurality of pores, the pore size of a single pore being less than 500 μm.

In some embodiments, the attachment portion includes a first density region and a second density region that are disposed adjacently, wherein the first density region is provided with a plurality of holes having a pore diameter of 10-100 μm, and the second density region is provided with a plurality of holes having a pore diameter of 150-500 μm.

In some embodiments, the body or the second sub-portion is degradable, the degradation time of the second sub-portion being greater than the internalization time at the second sub-portion.

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

In some embodiments, the surface of the attachment portion is undulating in a corrugation and has a peak-to-valley difference of 0.03 to 0.7 mm.

In some embodiments, the attachment portion has a permeability coefficient of 1 x 10 ^-13cm/s～1*10^-3 cm/s.

In some embodiments, the material of the attachment portion has a blood coagulation rate of 10% -90%.

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

In some embodiments, the body further comprises a plurality of hollowed-out parts penetrating through the inner surface and the outer surface of the body, a flow passage is formed in the axial direction of the body, the second sub-part is adjacent to at least one hollowed-out part, and the attaching part is attached to the second sub-part in a manner of keeping the second sub-part suspended and/or keeping fluid in the lumen flowing out from the flow passage through the hollowed-out part adjacent to the second sub-part.

In some embodiments, the body is a hollowed-out tubular structure, and the caliber of the first sub-portion is smaller than the caliber of the second sub-portion.

In some embodiments, the length of the first sub-portion is greater than the length of the second sub-portion.

In some embodiments, the implantable device further comprises a leaflet assembly secured to an inner side of the first sub-portion and a skirt.

In some embodiments, the skirt comprises an inner skirt for connecting the leaflet assembly to the body and/or an outer skirt covering the outer side of the first sub-portion.

Another aspect of the application provides a method of manufacturing an implantable device, the method comprising:

selecting a substrate from which the implantable device is prepared;

processing the substrate to prepare a body of the implantable device, wherein the body comprises a first sub-part which is used for being attached to a lumen wall after being implanted into the lumen and a second sub-part which is at least partially suspended;

The attachment portion is formed at the second sub-portion.

According to the implantable device provided by the application, after the implantable device is implanted into a living body, the first sub-part of the body is quickly fixed in the tissue through the tissue attached to the living body, and the second sub-part which is not attached to the living body and is suspended is attached with the attaching part, so that the release object possibly generated by the second sub-part due to degradation, fracture and the like before the tissue is internally membranized is limited by the attaching part, thrombus formation caused by the release object moving away in the living body is avoided, the damage of the sharp body to the tissue is avoided, meanwhile, the stabbing of the device to the tissue or the conveying saccule in the conveying process can be reduced, the attaching part can also promote the tissue membranization of the second sub-part in suspension, the uniformity of the membranization of each part of the body is improved, and the corrosion degradation of the second sub-part is regulated and controlled, so that the implantable device can improve the degradation characteristic, the implantable device can delay the corrosion at the initial stage of implantation, provide sufficient structural support for a tube cavity and can be quickly degraded at the later stage to release unnecessary constraint of the tube cavity, and the safety of the implantable device at each implantation stage is improved.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic illustration of the structure of an implantable device provided in one embodiment of the present application;

FIG. 2 is a schematic view of an implantable device according to one embodiment of the present application after implantation;

FIG. 3 is an enlarged schematic view of portion A of the implantable device of FIG. 1;

FIG. 4 is a schematic illustration of an exemplary configuration of an attachment portion of an implantable device of the present application;

FIG. 5 is another exemplary structural schematic view of an attachment portion of an implantable device of the present application;

FIG. 6 is a schematic view of yet another exemplary configuration of an attachment portion of an implantable device of the present application;

FIG. 7 is a schematic illustration of yet another exemplary configuration of an attachment portion of an implantable device of the present application;

FIGS. 8-11 are schematic views of implantable devices according to further embodiments of the present application;

FIG. 12 is a flow chart of a method of manufacturing an implantable device according to an embodiment of the present application;

FIG. 13 is a partial SEM image of the attachment portion of an implantable device of example 1 of the present application;

FIG. 14 is a view showing the effect of internalization of the implantable device of example 1 of the present application;

FIG. 15 is a partial SEM image of the attachment portion of FIG. 14 at a higher magnification;

FIG. 16 is a partial SEM image of the implantable device of example 1 of the present application after being implanted for a period of time;

fig. 17 is an SEM image of the portion E of fig. 16 at a higher magnification.

Detailed Description

Exemplary embodiments of the present application will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present application are shown in the drawings, it should be understood that the present application may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the application to those skilled in the art.

In the present application, the term "or" means "or" if the symbol "/" is used in the present application, and "in vivo use/application" means in vivo use or application.

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

The term "about" or "substantially" as used with respect to an amount includes variations of the recited amount that are equivalent to the recited amount, e.g., amounts that do not differ significantly from the recited amount for the intended purpose or function.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

The application provides an implantable device which can be a relevant bracket implanted in a human body to realize a supporting function, in particular to various brackets, prostheses, filters and the like which are suitable for being implanted in various lumens of the human body, and can be different types such as vascular brackets, urinary catheter brackets, biliary tract brackets, esophageal brackets, airway brackets, renal artery brackets, heart valves, occluders, vascular puncture closure devices or vena cava filters. Depending on the location of the lesion, the treatment is effected using an implantable device of the corresponding type. In the embodiments of the present application, for ease of explanation, the implantable device is exemplified by a prosthetic heart valve, and the scope of the function is not limited thereto.

Referring to fig. 1 to 3, an implantable device 1 according to the present application includes a body 11 and an attachment portion 15. The body 11 is configured in a preset shape structure as needed, and a flow passage 102 is generally formed inside the body 11 to allow normal flow of blood through the flow passage 102 inside. The flow passage 102 is formed generally axially of the body 11, and in particular, reference may be made to fig. 2, which shows the flow of blood through the flow passage 102 of the implantable device 1 in the lumen, and in particular, the implantable device 1 may be a prosthetic heart valve, and the leaflet assembly 12 may be opened to permit antegrade blood flow from the flow passage 102. The cross-sectional profile of the body 11 may be configured in different shapes, such as circular, oval or pentagonal or hexagonal, as appropriate for different applications. The body 11 is used for supporting a living body at the implantation site and/or for fixing to the living body to achieve a positional connection between the entire implantable device 1 and the living body. After the body 11 is implanted in a living body, at least part of the body 11 is attached to the living body to support. When implanted at a site where a stenosis occurs in a blood vessel, the body 11 is fitted to the blood vessel, so that the stenosed blood vessel can be supported, and the passage area of the blood vessel through which blood flows can be increased, and restenosis is prevented.

The body 11 comprises a first sub-portion 111 and a second sub-portion 113, wherein the first sub-portion 111 is adapted to fit the wall of the lumen after implantation of the implantable device 1 into the lumen, and the second sub-portion 113 is connected to the first sub-portion 111 and is at least partially suspended after implantation of the implantable device 1 into the lumen. The body 11 is a hollow tubular structure, and includes a plurality of hollow portions 114, wherein the hollow portions 114 penetrate through the inner surface and the outer surface of the body 11. The attaching portion 15 is attached to the second sub-portion 113. When the implantable device 1 is implanted into a living body, the first sub-portion 111 of the body 11 is fixed in the tissue in a relatively quick manner due to the adhesion of the tissue to the living body, and the second sub-portion 113 which is not adhered to the living body and is suspended is attached with the attachment portion 15, so that the release object possibly generated by the second sub-portion 113 due to degradation, fracture and other reasons before the tissue is internally membranized is limited by the attachment portion 15, the release object is prevented from moving in the lumen of the living body to cause thrombosis and embolism, the damage of the sharp edge or fracture of the body 11 to the tissue can be avoided, the stabbing of the device to the tissue or the conveying saccule in the conveying process can be reduced, the tissue internal membranization of the second sub-portion 113 which is not adhered to the living body can be promoted, the corrosion degradation of the second sub-portion 113 which is adhered to the body 11 can be regulated and controlled by the attachment portion 15, the degradation speed of the body 11 can be delayed or accelerated appropriately, the implantable device 1 can be kept in a desired time, the structural integrity of the implantable device can be kept in a desired time, the desired implantation device can be fully released in a desired time after the implantation device is completely carried out in a desired time, the desired implantation time is fully released in a desired time, the implantation time is completely and the implantation device is completely released in a desired time, and the implantation time is not desired time is fully released in a desired time, and the implantation time is completely released in a desired implantation time.

In some possible embodiments, the caliber of the first sub-portion 111 is smaller than the caliber of the second sub-portion 113. Further, the second sub-portion 113 may be located at an 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 the bifurcated vessel, the vessel opening, the lumen center, etc. after implantation. The second sub-portion 113 with a larger caliber can stabilize the implantable device 1 at the target position in the living body, so that the situation that the implantable device 1 cannot provide stable support for the target position due to displacement caused by various reasons (such as systole and diastole of the heart) is avoided, and the overall risk of implantation of the implantable device 1 into a complex anatomical structure is reduced.

In some possible embodiments, the attachment portion 15 is attached to the second sub-portion 113 in a manner that keeps the intraluminal fluid from the flow channel 102 out through the hollowed out portion 114 adjacent to the second sub-portion 113. As an example, as shown in fig. 1 and 2, the body 11 of the implantable device 1 is a valve frame of a heart valve, which is implanted in the pulmonary artery 80, wherein the first sub-portion 111 is attached to the inner wall of the pulmonary artery 80, and the second sub-portion 113 is close to the outflow end and is suspended at the junction/connection of the pulmonary artery 80 and the pulmonary artery branch, and the hollowed-out portions 114 penetrating the inner and outer surfaces of the body can allow the blood flowing along the flow channel 102 to flow out from the hollowed-out portions 114 on the left and right sides and into the right pulmonary artery 801 and the left pulmonary artery 802, respectively (as shown by arrows in fig. 2), so that the blood flow is kept smooth, the blood flow abnormality caused by the implantable device is reduced, thereby improving the blocking of the distal pulmonary artery branch, and improving the safety of the implantable device 1 implanted in a complex anatomical structure such as the outflow channel of the right chamber. 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 attaching portion 15 is attached to the second sub-portion 113 in such a way as to keep the second sub-portion 113 suspended, i.e. the second sub-portion 113 and the attaching portion 15 attached thereto together remain suspended. Of course, in other possible embodiments, the attachment portion 15 is attached to the second sub-portion 113 in a manner of covering at least part of the hollowed-out portion 114, and as an example, the attachment portion 15 may be a film layer covering the surface of the second sub-portion and the hollowed-out portion 114, and the film layer may specifically be an electrostatic spinning layer, for example.

In some possible versions, the implantable device has a converging endocardial time at each site. The first sub-portion 111 of the body 11 is adhered to the lumen wall, and tissue intimation occurs faster, so that the first sub-portion 111 is covered by the generated intima layer at a faster rate. Although the suspended second sub-portion 113 may delay the tissue internalization due to the suspension or the clearance between the suspended second sub-portion and the living body, the attaching portion 15 is attached to the second sub-portion 113, so that the capturing of endothelial cells and endothelial progenitor cells in blood can be accelerated on the basis that the smooth blood flow in the lumen is not affected by the attaching portion 15, and the implantable device 1 has a convergent internalization time between the suspended second sub-portion 113 (and the attaching portion 15) and the attached first sub-portion 111, thereby improving the uniformity of the overall internalization process of the device, reducing the risk of thrombus formation and improving the safety of the device.

It should be understood that the term "intimation time" as used herein refers to the fact that, in the case where the implantable device 1 does not have the attachment portion 15, the intimation time of the second sub-portion 113 with the attachment portion 15 is closer to that of the first sub-portion 111, or the intimation rate of the second sub-portion 113 suspended is increased, so that the intimation time of the portion is reduced by 50% or more, or even 80% -95% as compared to that in the case where the attachment portion 15 is not provided. By way of example, when the body 11 has the same wall thickness, the first sub-portion 111 is internally coated for about 7 days to 3 months, typically about 1 month, the second sub-portion 113 without the attachment portion 15 is not internally coated for more than 1 year or even 2 years, and the second sub-portion 113 with the attachment portion 15 is internally coated for about 7 days to 3 months. The intimation time convergence may be defined by another means, such as the time of intimation in the first sub-portion 111 or a common experience time point, such as 14 days, 1 month, 45 days, 2 months, etc., and the situation where the portion of the second sub-portion 113 is covered with the intima layer is substantially the same as the situation where the first sub-portion 111 is covered with the intima layer, and the difference of the intima coverage is within 10%. It should be understood that the time for forming the inner film layer of the second sub-portion 113 refers to the time for forming the inner film layer covering the attaching portion 15 and the corresponding second sub-portion 113, and specifically may be the time for forming the inner film layer covering the second sub-portion 113 and the attaching portion 15 together within the area where the attaching portion 15 is provided in the second sub-portion 113, and the area where the attaching portion is provided refers to the area defined by the boundary of the attaching portion 15. The internalization time of the first sub-portion 111 refers to the time for forming an inner film layer covering the first sub-portion 111.

In some embodiments, the body 11 or the second sub-portion 113 may be degradable, such as the first sub-portion 111 and the second sub-portion 113 may be the same degradable material or may be different degradable materials. The degradable material may be, for example, iron-based alloys, magnesium-based alloys, zinc-based alloys, or absorbable polymeric materials. In some embodiments, the second sub-portion 113 also becomes smaller in wall thickness and width of the strut 100 during the gradual degradation process. As an example, the attachment portion 15 is attached to the strut 100 in a manner of wrapping the strut 100, so that the massive detachments 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 from the attachment portion, thereby avoiding the massive detachments from falling into the blood vessel to cause thrombus. Further, the shape of the attaching portion 15 may be configured to be changeable following the change in the shape of the second sub-portion 113. Thus, during the degradation of the second sub-portion 113, the connection between the attachment portion 15 and the second sub-portion 113 remains relatively tight, and the release material generated by the degradation of the second sub-portion 113 is not easily released from the attachment portion 15. There are various ways of achieving a change in the shape of the attachment portion 15 following a change in the shape of the second sub-portion 113. For example, the attaching portion 15 may have elasticity, and the attaching portion 15 may elastically contract following the decrease in the wall thickness and the rod width of the second sub-portion 113. For another example, the attaching portion 15 may be made of a flexible material, and the attaching portion 15 is easily deformed.

In some embodiments, the degradation time of the second sub-portion 113 is greater than the internalization time of the second sub-portion 113. The second sub-part 113 is attached through the attaching part 15, so that the internal membranization process is accelerated, an external internal membranous layer is formed before the second sub-part 113 is degraded, and the internal membranous layer can be used for holding the massive disengagement generated by the second sub-part 113 due to degradation or fracture and the like, so that the massive disengagement is prevented from entering blood, the risk of thrombus generation is further reduced, and the safety and reliability of the instrument are improved.

As an example, when the body 11 is a nitrided iron based stent with a wall thickness of about 140 μm, the second sub-portion 113 starts to degrade around 3 months after implantation, around 20% for 6 months (calculated as weight loss), around 40% for 12 months, around 60% for 24 months, and over 80% for 36 months. As another example, a pure iron-based stent degrades by about 10% when implanted for 6 months, about 25% for 12 months, about 40% for 24 months, and about 50% for 36 months.

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 internalization time of the second sub-portion 113. By way of example, the attachment portion 15 is formed by wrapping PLLA suture around the second sub-portion 113, with degradation time of several months to 2 years. Of course, the attachment portion 15 may be made of other polymer materials, such as PE, PCL, etc., which are not shown here. The degradation time of the attachment portion 15 is slower than the endocardization time of the second sub-portion 113, so that it is ensured that the attachment portion 15 has enough time to capture endothelial cells, and an intima layer is formed before the second sub-portion 113 breaks. By way of example, the attachment portion 15 is a flexible material that can wrap around sharp edges and tips that may be present in the second sub-portion 113, reducing damage to surrounding tissue or components such as a balloon in the delivery device during or after implantation of the device in place. Of course, the attachment portion 15 may be made of a partially degradable material and a partially non-degradable material mixed in a proper ratio, or may be a non-degradable material.

In some embodiments, different portions of the body 11, such as the first sub-portion 111 and the second sub-portion 113, may be integrally formed, or may be detachably connected, such as a sewn connection, an adhesive connection, or a clamping connection. The attachment portion 15 may be attached to the second sub-portion 113 by winding, coating, depositing, wrapping, or the like.

Referring to fig. 1 and 3, in some embodiments, the second sub-portion 113 and the first sub-portion 111 respectively include a plurality of struts 100, wherein a certain number of struts 100 may be enclosed to form a hollowed-out portion 114, that is, the second sub-portion 113 is adjacent to at least one hollowed-out portion 114, for example, a plurality of hexagonal hollowed-out portions 114 are distributed in the circumferential direction of the body 11 closest to the outflow end in fig. 1, and each side is correspondingly adjacent to one strut 100. The four struts 100 closer to the outflow end are covered with an attachment portion 15 and at least partially suspended after being implanted into a living body, and belong to a second sub-portion 113 of the body 11, while the two struts 100 correspondingly adjacent to the other two sides are exposed and not covered by the attachment portion 15, and are the first sub-portion 111 of the body 11. In this example, struts 100 may be stent struts, struts of a vascular stent or valve stent, and in other examples, such as the corresponding struts in the vena cava filter of fig. 10, refer to filter struts, other examples not being listed.

In some embodiments, the attachment portion 15 wraps the strut 100 along the length of the strut 100 such that the strut 100 may be wrapped circumferentially and lengthwise such that the strut 100 has no exposed portions. As another example, the attachment portion 15 is attached thereto in such a manner as to surround the strut 100, and allows the surface of the strut 100 to be partially exposed. As an example, the strut 100 suspended in the air after the implantation of the second sub-portion 113 into the living body may form the corresponding attachment portion 15 in a wrapping manner, and the strut 100 attached to the second sub-portion 113 after the implantation of the living body may form the corresponding attachment portion 15 in a surrounding manner. As another example, the strut 100 to which the second sub-portion 113 is suspended after implantation in a living body and the attachment portion 15 to which the attached strut 100 is attached may have different surface morphology, permeability coefficient, thickness, material, etc., although these may be the same. In the embodiment of the present application, the proportion of the second sub-portion 113 in the body 11 is greater than 0%, and the proportion of the suspended portion in the second sub-portion 113 after the second sub-portion 113 is implanted in the living body is greater than 0%, and the specific proportion may be different depending on the type of the instrument, the implantation site, and the like. Further, the second sub-portion 113 may occupy 1-99% of the surface area of the main body 11, and the ratio may be calculated in other manners, for example, the ratio may be calculated according to the length of the main body 11 and the length of the second sub-portion 113. Further, the portion of the second sub-portion 113 that is suspended but not adhered to the living body after being implanted may be 0.1% -100% of the second sub-portion 113. As a specific example, the implantable device 1 shown in fig. 1 has a second sub-portion 113 that occupies 20% of the length of the body 11, and the second sub-portion 113 has a suspended portion that occupies 50% of the length of the second sub-portion 113 after implantation. As another example, referring to fig. 8, the second sub-portion 313 occupies 10% of the length of the body, and the second sub-portion 313 has a suspended portion that occupies 85% of the length of the second sub-portion 313 after implantation. As yet another example, referring to fig. 10, the second sub-portion 413 has a surface area of 99% of the surface area of the body, and the suspended portion of the second sub-portion 413 after implantation has a surface area of 100% of the surface area of the second sub-portion 413.

Referring to fig. 4, in some embodiments, the attachment portion 15 may be a wrap including at least one wrap 151, the at least one wrap 151 wrapped around the strut 100 of the second sub-portion 111. By way of example, each wire wrap includes a plurality of filaments, such that each turn of the wire wrap forms a plurality of wrapped filaments simultaneously. Further, the angles of intersection of the windings of the adjacent turns and the axis of the support rod 100 are different, the windings of the adjacent turns can be offset left or right relatively, and the windings of the adjacent turns can be overlapped and wound, so that on one hand, the windings are not easy to shift on the support rod 100, and meanwhile, the fiber filaments of the different turns are staggered to cover the support rod 100 to form a relatively three-dimensional wrapping structure, so that more complex micro-fluid channels are formed between the fiber filaments through staggered gaps, the permeability coefficient of the attachment part 15 is conveniently controlled in the range with an adjusting effect on the degradation characteristic of the support rod 100, and the degradation speed of the support rod 100 is adjusted and controlled. And the roughness of different areas of the attachment part 15 is relatively balanced, the difference between the peak and valley differences of the corrugated fluctuation formed at each area is smaller, and the uniform film formation in each area of the attachment part 15 is facilitated. Further, the line width or diameter of the winding is 50-700 μm. The diameters of the filaments are the same or different, and the diameters are preferably from 5 to 25 μm, and are preferably from 9 to 16 μm, and specifically may be, for example, from 9 μm,10 μm,11 μm,12 μm,13 μm,14 μm,15 μm,16 μm, etc., which is advantageous for forming a peak-valley difference of 0.03 to 0.7mm in each region of the surface of the wound layer, and for avoiding a local peak-valley difference being too small to form a relatively smooth local surface, so that endothelial cells can be quickly and uniformly climbed to the attachment portion 15, thereby enabling the second sub-portion 113 to quickly complete intimation. It should be appreciated that one cord 151 may be formed by twisting or interlacing a plurality of filaments, or may be formed by forming a relatively loose bundle of a plurality of filaments in parallel.

In some embodiments of the present application, the thickness of the attaching portion 15 may be 10-750 μm, so as to facilitate forming a relief surface shape with a certain peak-valley difference on the surface of the attaching portion 15, thereby facilitating the internalization, and avoiding the damage of the attaching portion 15 and affecting the expected attaching form of the second sub-portion 113. Specifically, the thickness of the adhesion part 15 may be 10 to 200 μm, 50 to 250 μm, 100 to 300 μm, 150 to 400 μm, 200 to 500 μm, 350 to 600 μm, 400 to 700 μm, etc., and further, the thickness of the adhesion part 15 may be 10 to 150 μm, and on the basis of promoting the filming, it is possible to avoid excessively increasing the conveying diameter, ensure the easiness of conveying, and avoid the waste of materials. Specifically, the thickness of the adhesion part 15 may include, but is not limited to, 12 to 100 μm, 15 to 100 μm, 20 to 90 μm, 20 to 80 μm, 30 to 75 μm, 40 to 120 μm, 50 to 80 μm, 30 to 150 μm, or 50 to 130 μm, etc.

In some possible embodiments, the thickness of the attachment portion 15 may be set to be different depending on the location, e.g., a location that is relatively more susceptible to degradation may be set to be thicker than other locations that are relatively slower in degradation rate. As another example, the thickness of the attachment portion 15 may be thicker in the width direction of the strut 100 and thinner in the wall thickness direction of the strut. The adhesion portion 15 can reduce the influence on the conveying diameter while having a relatively good effect of promoting the intimation of the suspension strut. For example, after the attaching portion 15 is attached to the strut 100 of the second sub-portion 113, the strut 100 may increase in the strut width by 10 to 70 μm, and the strut 100 may increase in the wall thickness by 50 to 100 μm. Of course, in other examples, the thickness of the attachment portion 15 in the widthwise direction of the strut 100 may also be less than or equal to the thickness of the attachment portion 15 in the wall thickness direction of the strut 100.

In some embodiments, the struts 100 may include a tip 101, and it may be understood that where two struts 100 are connected, the thickness of the attachment portion 15 at the tip 101 may be relatively thicker. As an example, the thickness of the attaching portion 15 at the tip may be 50 to 150 μm. Further, the thickness of the adhesion 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, 55 to 85 μm, or the like. The relatively thicker attachment portion 15 at the tip 101 may further ensure that the attachment portion 15 may achieve a better coating at the tip 101, so that the processes of endo-membranization of the struts 100 and the strut junctions of the second sub-portion 113 may be more balanced.

In some possible embodiments, the second sub-portion 113 may include a frangible region that is more prone to breakage, the thickness of the attachment portion 15 may be thicker at the frangible region, and the chance of breakage of the frangible region may be reduced, such that the second sub-portion 113 has a more stable shape prior to the endocardization of the first sub-portion 111, thereby stabilizing the implantable device 1. The thickness of the adhesion part 15 in the frangible region may be 20 to 100 μm, and the transport diameter may be simultaneously considered.

The frangible region may be a portion of the strut 100 having a gap or a slit, or a portion of the strut having a smaller width and thickness, or a portion having a greater degree of stretch (e.g., a bend or corner). Without being limited thereto, it is within the scope of the present application for the strut 100 to be more likely to break during degradation.

In some embodiments, the wrap is wrapped around the strut in a manner selected from one or any combination of overlapping wrapping, tiling wrapping, multi-layer wrapping, and density changing wrapping.

Referring again to fig. 4, as an example, the wrap wire 151 of the wrap wire layer may be wrapped around the struts 100 of the second sub-portion 113. The cross-section of the wire 151 may be rectangular, circular, olive-shaped, star-shaped, polygonal, etc. The width of the cord 151 may be greater than, equal to, or less than the thickness of the cord 151. The winding in fig. 4 adopts a single-layer tiling winding mode, each turn formed by winding is tiled along the length direction of the strut 100, the inter-turn distance between adjacent turns can be 0-0.5 mm, when the inter-turn distance is greater than 0.5mm, the exposed part of the surface of the strut 100 is more, which is not beneficial to wrapping and limiting fragments generated by corrosion of the strut 100, and more time is required for gradually forming a continuous inner membrane layer after endothelial cells climb to the winding part.

The wire 151 may be circumferentially wound around the strut 100, and the angle α between the wire 151 and the axis O of the strut 100 may be less than 90 °. When the strut 100 is degraded, the width and the wall thickness of the strut 100 are gradually reduced, the gap between the winding 151 and the strut 100 is gradually increased, the included angle alpha between the winding 151 and the axis of the strut 100 is set to be smaller than 90 degrees, the displacement of the winding 151 in the axis direction of the strut 100 is smaller, the relative positions of the winding 151 and the strut 100 are kept unchanged, the excessive gap between adjacent turns is avoided due to displacement, and therefore the uniform climbing and growth of endothelial cells in a winding layer are facilitated. Further, the included angle α between the winding 151 and the axis of the strut 100 may be 70 ° to 89 ° or 80 ° to 85 °, which not only reduces the displacement possibility, but also makes the axial span of each turn relatively small, so as to facilitate the realization of winding. As another example, the angle α of each turn wrap to the axis O may be set differently along the axis.

In one possible embodiment, the attachment portion 15 may further include a pulling layer 155, the pulling layer 155 being disposed along the length of the strut 100, the wire wrap 151 wound around the strut 100 having a plurality of intersections with the pulling layer 155, the intersections being disposed at a plurality of turn-to-turn intervals, and the binding junctions 151a being formed at the intersections. The windings 151 at each intersection are connected or spaced apart from the pulling layer 155. In particular, the pulling layer 155 may be another wrap with a more sparse winding density located below the wrap, with a relatively larger axial span between adjacent turns of the pulling layer 155. The pulling layer 155 may be provided in a straight line without a change in length. In this way, the length change of the wire 151 and the inter-turn distance between adjacent turns can be limited by the pulling layer 155 by connecting the wire 151 with the pulling layer 155, so that the wire 151 wound on the strut 100 is prevented from lengthening or locally overflowing after the strut 100 is broken or degraded. The pulling layer 155 may also be coated, adhered, and stitched to the strut 100. The traction layer 155 may further include at least one of a tie web, tie film, or tie coating. The traction layer 155 may be applied to the strut 100 by at least one of electrospinning, dip coating, drip coating, spray coating, or brush coating. When the pulling layer 155 is a tie net, the tie net includes mesh holes, and when the pulling layer 155 is a tie film or tie coating, the tie film or the tie coating may be perforated.

In another possible embodiment, the cord 151 itself may also comprise a plurality of binding knots, each binding knot being disposed adjacent or spaced apart, such as a plurality of turns spaced apart. The binding knot can strengthen the adhesive force between the winding layer and the supporting rod 100, so that the adhesion part 151 is not easy to scatter from the supporting rod 100, and meanwhile, the surface roughness of the adhesion part 15 can be increased through the binding knot, which is beneficial to promoting tissue intimation.

Alternatively, the interval between each two adjacent binding knots 151a may be 0.1 to 2mm. When the distance between the two binding knots 151a is less than 0.1mm, the number of binding knots 151a is relatively large, increasing the difficulty in manufacturing and diameter in delivery of the implantable device 1. When the interval between the two binding knots 151a is greater than 2mm, the connection effect of the wire 151 with the strut 100 is not good. Thus, the interval between two binding knots 151a adjacently disposed is set within the above-described numerical range, and the overall performance is excellent.

In addition, the winding layer is knitted by adopting methods such as random knitting, flat knitting, single flat knitting, splayed knitting, cross-shaped knitting, sparrow head knitting, double-connection knitting, single-line double-connection knitting and the like. The surface structure of the attachment part can be differentiated through different braiding modes, so that the requirements of different products or application scenes are met.

Referring to fig. 5, as an example, the attachment portion 15 is a spinning layer that can uniformly cover the struts 100 and tips 101 of the second sub-portion 113. The spin layer may be formed by winding a plurality of spin intervals around the strut 100, with micro-gaps 156 formed between adjacent spins. The width of the micro gap 156 is less than 500 μm, and further, the width of the micro gap 156 may include, but is not limited to, 5 to 80 μm, 10 to 50 μm, 20 to 40 μm, 20 to 100 μm, 150 to 250 μm, 50 to 250 μm, 20 to 200 μm, 30 to 180 μm, 100 to 300 μm, or the like. Although a single layer is schematically shown in the figures as a structure of the spinning layer, the present application is not limited to the use of a multi-layer structure.

Referring to fig. 6, as another example, the attaching portion 15 may include a base layer 153a and a plurality of filaments 153b extending from the base layer 153a, where the base layer 153a is tightly sleeved on the strut 100 of the second sub-portion 113, and the distribution density of the filaments 153b is 10 to 500 filaments/mm ². Thus, endothelial cells can grow on the attachment portion 15 more quickly and uniformly, and the uniformity of intimation can be achieved. In the plurality of filaments 153b, the orientation, length, and thickness of the different filaments 153b may be the same or different. The filament 153b may be wound and bent, which may further facilitate the climbing of endothelial cells. Of course, the filament 153b may be short and straight. One end of the filament 153b may be connected to the substrate layer 153a, and the other end is a free end, and both ends of the filament 153b may be connected to the substrate layer 153a. The filament 153b may be a natural fiber or a synthetic fiber.

Referring to fig. 7, a schematic view of another embodiment implantable device is shown. By way of example, the attachment portion 15 is a mesh layer attached to the second sub-portion 113, the mesh layer having a plurality of apertures 154. In other embodiments, the attachment portion 15 may also be a perforated membrane. The shape of the holes is not limited to various shapes such as a circle, a square, a rectangle, a diamond, a triangle, and the like. In some examples, the individual pores have a pore size of less than 500 μm. Further, the diameter of the individual holes may include, but is not limited to, 5 to 80 μm, 10 to 50 μm, 20 to 40 μm, 20 to 100 μm, 150 to 250 μm, 50 to 250 μm, 20 to 200 μm, 30 to 180 μm, 100 to 300 μm, or the like.

In the example of fig. 7, the holes are uniform in size and uniform in distribution, and in other possible embodiments, the attachment portion 15 may include a first density region and a second density region disposed adjacent to each other, the holes in the second density region having a diameter greater than the diameter of the holes in the first density region. Because contact with blood (fluid) accelerates degradation of the strut 100, the portion of the strut 100 that contacts the blood area is degraded more rapidly. By the above arrangement, the attachment portion 15 can play a certain role in controlling degradation of the strut 100, that is, by the above arrangement, the area where the strut 100 breaks first can be set.

Further, the diameter of the individual holes in the first density region may be 10 to 100 μm, and the diameter of the individual holes in the second density region may be 150 to 500 μm. Thus, the degradation of the strut 100 can be regulated by the arrangement of different diameters of the holes.

The structure of the attachment portion 15 may be other forms of permeable membrane, permeable coating, etc. besides a wrapping layer, a base layer with filaments, a perforated membrane, a mesh layer, a spinning layer, or a combination of different structures.

In some possible embodiments, the surface of the attachment portion 15 with the above-mentioned various structures is corrugated, and has a peak-to-valley difference of 0.03-0.7 mm, and the attachment portion 15 with the surface feature can promote intimation, so that the intimation time of the second sub-portion 113 is less than 3 months. When the peak-valley difference is less than 0.03mm, the surface corrugation fluctuation is not obvious, and endothelial cells can not anchor the surface of the attachment part 15 well when passing through, so that endothelial cells are difficult to proliferate on the attachment part 15, the coverage of an inner membranous layer can be not completed for a long time, the adhesion and aggregation of blood platelets can be caused, thrombus is formed on a supporting rod due to infiltration of inflammatory cells, blood circulation is affected, and embolism is caused by falling of the thrombus. The implanted device 1 of the present application has the attaching part 15 attached to the suspended second sub-part 113 to reduce the intimation time to 3 months or less, thus reducing the thrombus formation and improving the safety of the device. When the difference between the peaks and the valleys is greater than 0.7mm, the surface waviness is too large, and the thickness or local thickness of the corresponding attachment portion 15 is too thick, so that the adsorption of platelets and fibrin in blood is easily caused, and the thrombus is caused in a short period of time. In addition, too large a peak-to-valley difference is detrimental to delivery of the implantable device. Further, the surface peak-to-valley difference of the attaching portion 15 may include, but is not limited to, 0.05 to 0.2mm, 0.06 to 0.3mm, 0.08 to 0.5mm, 0.1 to 0.4mm, 0.15 to 0.55mm, and the like.

In some possible embodiments, the adhesion portion 15 with the above structures has a blood coagulation acceleration rate of 10% -90%, and the adhesion portion 15 and the surface of the adhesion portion 15 are in a corrugated undulating fit, so that the floating second sub-portion 113 and the adhesion portion 15 can be better promoted to be endoconized, and the endoconizing is realized in about 1 month. Further, the adhesion part 15 has a blood coagulation acceleration rate of 15% -80%, 15% -60%, 15% -40%, 20% -75%, 25% -50%, 30% -70%, 30% -55%. Two samples were taken, one of which was taken as the subject for measuring the thrombin time PT, and the other sample was added with an attachment portion 15 (specifically, the second sub-portion 113 of the cleavable portion and the attachment portion 15 attached thereto) for measuring the thrombin time PT ', and the coagulation acceleration rate of the blood was (PT-PT')/PT x 100%. When the blood coagulation rate of the attachment portion 15 is less than 10%, the landing and growth of endothelial cells in flowing blood at the attachment portion 15 are not facilitated, so that the time required for the site to be internalized exceeds 3 months, whereas when the blood coagulation rate is more than 90%, the attachment portion 15 may cause the strut 100 to locally coagulate too fast to generate an instrument thrombus.

In some possible embodiments, the surface potential polarities of the attachment portion 15 and the first sub-portion 111 of the aforementioned various structures are negative, and the surface potential absolute value of the attachment portion 15 is smaller than the surface potential absolute value of the first sub-portion 111. The negative polarity of the surface potential of the body 11 can reduce the probability of thrombus occurrence, and the absolute value of the surface potential of the attachment portion 15 is smaller than that of the first sub-portion 111, so that the intimation time of the body 11 at the suspended portion and the attachment portion can be further optimized, and the difference between the two is smaller.

In some possible embodiments, the attachment portion 15 of the various structures described above has a water permeability for passing ions generated by, for example, water molecules, degradation of the implantable device 1, and in some embodiments, the attachment portion may have a permeability coefficient in the range of 1 x 10 ^-13～1*10^-3 cm/s, and may further preferably be 1 x 10 ^-11～1*10^-4cm/s、1*10^-10～1*10^-5 cm/s,

In the range of 1 x 10 ^-9～1*10^-6cm/s、1*10^-8～1*10^-7 cm/s, the degradation time of the coated strut 100 can be optimally controlled by the attachment portion 15 in the parameter range, specifically, when the strut 100 is a material with high degradation speed, such as magnesium alloy, the attachment portion 15 with the permeability coefficient can adjust the degradation time to delay degradation of the strut 100, so that the strut 100 is prevented from being degraded prematurely to play a supporting role on a lumen or a positioning role of the implantable device 1 in an expected time, and meanwhile, the strut 100 can be degraded quickly after the expected time, and unnecessary constraint on an implantation site is relieved.

For example, studies have shown that magnesium alloy vascular stents degrade completely within about 1-3 months after implantation into living subjects (e.g., into the coronary arteries), and that the first generation magnesium alloy stents, which contain 93% magnesium and 7% rare earth elements, have been reported to degrade completely to ions in the absence of a drug coating for 60 days when implanted with a wall thickness of 165 μm. If the second sub-portion 113 of the implantable device 1is made of magnesium alloy, the strut 100 is degraded in a short time, and massive falling objects possibly generated by degradation flow into the distal end along with the blood vessel to easily cause embolism of the distal end blood vessel, while the first sub-portion 111 is easily separated from the second sub-portion 113 to displace, so that the artificial pulmonary valve frame slides down from the outflow channel of the right ventricle to the right ventricle, thereby causing failure of the device, the failure rate of the device is about 20%, and the safety performance of the device is seriously affected. When the attaching portion 15 is attached to the supporting rod 100, the degradation time of the supporting rod 100 can be more than 1 year, and further, when the permeability coefficient of the attaching portion 15 is within a range of 1x 10 ^-13～1*10^-9 cm/s, the weight loss rates of 1 month, 2 months and 3 months after implantation can be respectively controlled within 5%, 20% and 35%, even the weight loss of 3 months can be controlled below 10%, and the supporting rod can be completely degraded within 1-2 years after implantation. Because the strut 100 has a low weight loss rate during a relatively long period of time at the initial stage of implantation, a good structural form can be maintained during the expected time of implantation of the instrument, failure caused by displacement of the instrument is avoided, and the failure rate of the instrument can be reduced from 20% to below 1%. In addition, the degradation of the strut 100 can be regulated and controlled to occur after the endocardization is completed, so that the degradation and falling objects of the strut 100 are wrapped and limited together through the attachment part 15 on the strut 100 and the inner membranous layer to reduce embolism.

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 with the above permeability coefficient can ensure that the intraluminal fluid permeates to the surface of the strut 100, while the attachment portion 15 made of a polymer material can maintain a relatively high concentration of acid environment around the wrapped strut 100 (acidic substances are generated by degradation of the strut or degradation of the attachment portion), so as to avoid the dilution of the acid concentration due to blood flow, thereby accelerating corrosion of the iron-based stent to a certain extent, so that the weight loss rate of the strut 100 after implantation is controlled to be less than 10% 3 months, the degradation rate of 6 months is increased to be more than 20%, the degradation rate of 12 months is up to 45% -55%, and the degradation of the attachment portion can be completely completed within about 2-3 years, at which time the implantable device 1 has completed repairing or supporting functions for the implantation site, such as the leaflet assembly 12 has been well connected to the endothelial layer of blood vessel, the degradation of the body 11 can release unnecessary constraints of the lumen, allow the leaflet assembly to be inserted into a patient, and also does not affect the replacement of the percutaneous valve, and the psychological burden on the patient for various stages of the patient. It will be appreciated that as the attachment 15 degrades gradually in vivo, its permeability coefficient will change somewhat.

According to the implantable device 1 provided by the embodiment of the application, the second sub-part attached to the implantable device 1 is subjected to corrosion degradation regulation and control through the attachment part 15, so that the degradation characteristics of the body 11 made of the absorbable materials with different degradation speeds are improved, the device is ensured to realize good structural support of tissues at the early stage of implantation, the device can complete the treatment or repair purpose, the body can be degraded as soon as possible when the device is not required to support the tissues, unnecessary constraint of the device on the repaired or healthy lumen is avoided, complications are reduced, other treatments or implantation of the device on the part are reduced, and the overall safety of the implantable device 1 made of different materials at the early stage and long term of implantation is improved.

As another example of an embodiment of the present application, referring again to fig. 1, 5 and 7, in some possible embodiments of the present application, implantable device 1 further comprises stop 152. The stopper 152 has one end connected to the attaching portion 15 and the other end connected to a different position of the attaching portion 15, or connected to the body 11, specifically, may be connected to the second sub-portion 113 or the first sub-portion 111. Specifically, the stop 152 may be a linear or bar-like structure, such as the stop 152 shown in fig. 1 in a multiple wire-suspension configuration. Of course, the limiting member can also be in other types of structures such as net, sheet, film and the like. The limiting member 152 can further enhance the limiting effect of the second sub-portion 113 after the structure of the second sub-portion 113 is changed after implantation, so as to avoid the second sub-portion 113 from being separated from the attachment portion 15 or being separated from the main body portion together with the attachment portion 15 due to degradation or fracture, which results in the second sub-portion 113 losing the positioning effect on the first sub-portion 111, causing the first sub-portion to shift or deviate from the implantation site, and thus causing the failure of the implantation apparatus. The broken part falls off to other parts, so that embolism or influence on normal organ functions is caused, for example, after the pulmonary artery stent breaks, the broken part runs to the contralateral pulmonary artery, possibly also runs to the right ventricle, influences the tricuspid valve to close, and possibly also runs to a downstream blood vessel to form an embolism source.

Specifically, when the strut 100 breaks at the initial stage after implantation to pull the attachment portion 15 to displace and deform, and the corresponding position may shake randomly under the action of blood flow to generate impact to surrounding tissues, the strut 100 of the body 11 may be pulled and limited by the limiting member 152, so that the occurrence of random shake is reduced, and the protection effect on the tissues is improved. For example, if the second sub-portion 113 and the first sub-portion 111 are broken at one or more connection points in fig. 1, because one end of the limiting member 152 is connected to the first sub-portion 111 and the other end is connected to the second sub-portion 113 or the attachment portion 15, the second sub-portion 113 is prevented from being separated from the connection with the first sub-portion 111 due to the breakage, so that the overall structure of the implantable device 1 is maintained in a desired state and position, and damage to tissues due to disordered shaking occurring near the implantation position caused by the breakage of the second sub-portion 113 is avoided.

On the other hand, referring to fig. 5, if the strut 100 of the second sub-portion 113 is broken locally, for example, near the tip 101, it may cause relative displacement of two ends of the broken portion and cause local structural deformation to damage tissue, while the limiting members 152 fixed at two ends at different positions of the strut 100 or the attachment portion 15 may pull and limit the strut 100 at two sides of the broken portion, so that two ends of the broken portion are still aligned and maintain a substantially consistent structural configuration with the non-broken portion, thereby avoiding the second sub-portion 113 from damaging tissue due to displacement or structural change of the broken portion.

On the other hand, the limiting member 152 may be configured to disengage and limit the bulk degradation product. The second sub-portion 113 changes its original structure during degradation, and in addition to the degraded microparticles generated by normal degradation escaping from the attachment portion 15 and flowing away with blood, there may be a possibility that the degraded microparticles partially fall off to become free substances, and due to the relative flexibility of the attachment portion 15, under the impact of blood flow, the attachment portion 15, for example, being arranged in a wrapping manner, loses support at the broken position of the second sub-portion 113 wrapped by the attachment portion, the wrapping wire is partially stretched by the wrapping wire, thereby causing a phenomenon that the length of the wrapping wire becomes long, and causing the broken second sub-portion 113 to protrude from the attachment portion 15 to stab tissues, even fall out of the attachment portion 15 to flow into blood. And because the two ends of the limiting piece 152 are relatively fixed and the length is relatively unchanged, the large-scale degradation product generated by the second sub-part 113 can be pulled and limited, the phenomenon that the large-scale degradation product falls into blood to cause thrombus is reduced, and the tissue is better protected.

Specifically, the limiting member 152 may have a linear or bar-shaped structure. The number of the stoppers 152 may be one, and one end thereof is connected to the first sub-portion 111 and the other end thereof is connected to the second sub-portion 113 or the attaching portion 15. Or the number of the limiting members 152 may be at least two, and each limiting member 152 is connected to a different position of the second sub-portion 113 and/or the attachment portion 15. Thus, by pulling the limit in different directions, a more comprehensive limit is achieved for the broken or detached second sub-portion 113. As an example, referring to fig. 1 and 5, in some embodiments, the second sub-portion 113 includes at least two support rods 100, the two support rods 100 are connected at an angle to form a structure with peaks and valleys, the attachment portion 15 is attached to each support rod 100, and at least one limiting member 152 is connected to each support rod 100 and the attachment portion 15 attached thereto, so as to further reduce random movement of the release object generated by fracture or degradation, and improve the safety of the implantable device 1 in use.

Alternatively, referring to fig. 1 and 5, both ends of the limiting member 152 are respectively connected to the middle or near the middle of the two struts 100, so that the limiting member 152 can have a better limiting effect.

Alternatively, when the number of the stoppers 152 is set to at least two, the stoppers 152 may be arranged in a staggered or spaced arrangement.

For another example, the adhesion part 15 may have a relatively high tensile strength, so that the adhesion part 15 is not easily broken by blood impact in a living body, and the generation of large-particle foreign matters into blood is reduced. The attachment portion 15 can be easily broken by manual force, whereby the attachment portion 15 does not significantly hinder the implantation when a new implantable device 1 is implanted. Of course, the attachment portion 15 may not be easily broken by a human force.

For another example, the attaching portion 15 can expand when absorbing water with liquid, and thus the protective force of the attaching portion 15 against the living tissue can be further improved. Of course, it will be appreciated that the attachment portion 15 may not expand in response to liquid.

For another example, the attachment portion 15 may incorporate bioactive substances such as anticoagulants that promote intimation or prevent coagulation, antiproliferatives that have antiproliferative properties, or the like.

Referring again to fig. 1, the implantable device comprises a leaflet assembly 12 and a skirt, the leaflet assembly 12 being secured to the inner side of the body 11, preferably on the inner side of the first sub-portion 111, the implantable device 1 in this example being embodied as a prosthetic heart valve. The skirt comprises an inner skirt (hidden by the outer skirt 13 in fig. 1, not shown) and/or the outer skirt 13, the inner skirt covering the inner wall of the first sub-portion 111 for connecting the leaflet assembly 12 to the body 11. The outer skirt 13 covers the outer surface of the first sub-portion 111, thereby increasing friction force and improving the connection effect between the implantable device 1 and the living tissue, and the outer skirt 13 also has an effect of preventing perivalvular leakage. The attachment part 15 of the artificial heart valve adopts a winding layer, can be sewn with a common suture thread material of the inner skirt or the outer skirt and the like, and can simplify the preparation process of the artificial heart valve. On the other hand, the attachment portion 15 and the inner skirt may be integrally connected, so that the connection effect between the attachment portion 15 and the inner skirt is relatively good, the attachment portion 15 may be strip-shaped or sheet-shaped to wrap the second sub portion 113, and the inner skirt may also function as a limiting member. Of course, the attaching portion 15 and the inner skirt may be provided separately.

The prosthetic heart valve 1 may be an artificial pulmonary valve. After the artificial pulmonary valve is implanted into a human body, the valve frame of the artificial pulmonary valve is easy to be unadhered at the part close to the outflow end, and thrombus formation caused by valve frame residues and damage of sharp fractures of the residues to tissues can be avoided through the arrangement of the attachment part 15. The prosthetic heart valve in this example may also be a prosthetic aortic valve, a prosthetic mitral valve, and a prosthetic tricuspid valve.

Referring to fig. 8-11, schematic views of implantable devices according to further embodiments of the present application are shown. In the embodiments described below, the first sub-portion, the second sub-portion, the attachment portion, and the interrelationships thereof, as well as the specific structures, materials, parameters, and the like of each of the implantable devices may refer to all or part of the features of the attachment portion described in the foregoing embodiments, and correspond to all or part of the advantageous effects, which will not be described in detail below.

In fig. 8 an implantable device 2 is shown, which is mainly suitable for cases where the implantation site is a lateral lumen. The body of the implantable device 2 comprises a first sub-portion 211 and a second sub-portion 213 connected with the first sub-portion 211, wherein the first sub-portion 211 is implanted in a relatively finer branch vessel in an adherence manner, an attaching portion (not marked) is coated on the second sub-portion 213, and the second sub-portion 213 is partially suspended at an opening of the branch vessel, namely a portion connected with the main vessel.

Fig. 9 shows another implantable device 3, in particular a vascular stent, which is mainly suitable for cases where the implantation site is a main vessel with a branched vessel. The body of the implantable device 3 comprises a first sub-portion 311 and a second sub-portion 313, wherein the first sub-portion 311 is implanted in the main blood vessel in an adhering manner, the second sub-portion 213 is covered with an adhering portion, and a part of the second sub-portion 313 is opposite to the opening of the branch blood vessel, namely, the connecting portion with the main blood vessel.

Fig. 10 shows another implantable device 4, in particular a vena cava filter, the implantable device 4 being intended for implantation into a vena cava, the body of which comprises a first sub-portion 411 and a second sub-portion 413, the first sub-portion 411 being against the inner wall of the vena cava and the second sub-portion 413 being suspended within the vena cava. The body of the vena cava filter is formed of a plurality of intersecting filter rods, the general shape of which is similar to the stent rods described in the previous embodiments, or may be woven from wire. The filter rod or wire of the second sub-portion 413 is covered with an attachment portion. The attachment portion is attached to the suspended second sub-portion 413 in a manner that keeps blood flow through the hollow or gap between the bodies.

Fig. 11 shows a further implantable device 5, in particular a stent graft, the body of which is shaped like the whole vessel stent and comprises a first sub-portion 511 and a second sub-portion 513, wherein the first sub-portion 511 is provided with a coating, the first sub-portion 511 is attached to the vessel wall together with the coating, the stent strut of the second sub-portion 513 is wrapped with an attachment portion, and the second sub-portion 513 is suspended partly or entirely after implantation in a living body.

Referring to fig. 12, the present application also provides a method for manufacturing the implantable device 1, which may include the following steps:

s1, selecting a substrate for preparing the implantable device;

S2, processing the base material to prepare a body of the implantable device, wherein the body comprises a first sub-part and a second sub-part, wherein the first sub-part is used for being attached to a lumen wall after being implanted into the lumen, and the second sub-part is at least partially suspended;

s3, forming an attaching part attached to the second sub-part.

Specifically, a base material for preparing the implantable device is selected, the base material is processed to prepare the body 11 of the implantable device 1, the prepared body 11 at least includes struts 100, and as one example, hollowed-out portions are formed between the struts 100. After the desired body 11 is prepared, an attachment portion 15 is formed to attach to the second sub-portion 113, the attachment portion 15 being disposed at least along the length of the strut 100 to encase at least a portion of the outer surface of the second sub-portion. After the attachment portion 15 is set in the set position of the body 11 as needed, the implantable device 1 is prepared.

Specifically, the substrate may be a tube or a stent wire. The tube or the stent wire has different diameters, and the base material with proper size can be selected according to the specification requirements of the implantable device to be manufactured. The specific materials of the body 11 and the materials and manner of formation of the attachment portion 15 may be found in the foregoing description of the implantable device 1.

Specifically, when the body 11 of the implantable device 1 is prepared, the body 11 with a required shape can be obtained by cutting and carving the tube according to the cutting and processing requirements through a cutting process, or the body 11 with a required shape can be obtained by a braiding process through a braiding method of a stent wire according to a corresponding braiding method. In one possible embodiment, when the body 11 is manufactured by using the knitting method, in addition to the arrangement of the attaching portion 15 after the completion of the manufacture of the body 11, the formation of the attaching portion 15 may be performed at the corresponding portion of the body 11 before the integral knitting of the body 11 is performed when the manufacture of the portion of the body 11 where the attaching portion 15 is required is completed in the process of knitting the body 11. Thus, the attachment part 15 is convenient to set, and meanwhile, the adjustment is convenient in time, so that the accuracy and the reliability of the setting of the attachment part 15 are improved.

Specifically, when the metal substrate is prepared into the body 11 by drawing, carving, cutting and other processes, after the pipe is cut by the cutting equipment to obtain the required body 11, the obtained body 11 can be optimized, such as surface roughness treatment, to eliminate burrs, pits or bumps and other uneven structures at various positions, so that the surface of the bracket obtains the required degree of smoothness. The surface roughness may be treated by mechanical polishing or chemical polishing. Furthermore, the body 11 may be heat treated to eliminate residual internal stress at each position of the body 11, thereby improving the strength of the overall structure. When heat treatment is carried out, the body 11 is put into a heating furnace to be slowly heated, when the temperature is about 400 ℃, then heat preservation is carried out for 20-30min, and then the body is cooled along with the furnace. After the heat treatment is completed, the body 11 may be subjected to subsequent processing, such as preparation or formation of the attachment portion 15.

The following describes in detail the implementation of the implantable device 1 according to the application with reference to examples and comparative examples.

Example 1

The implantable device 1 is an iron-based absorbable artificial pulmonary valve, and the structure thereof is substantially as shown in fig. 1, and the main difference is that the hollowed-out portion included in the implantable device 1 of the present embodiment is a quadrangle instead of the hexagons shown in fig. 1, and the attachment portion 15 is attached to only a portion of the struts 100 included in the second sub-portion 113. The attachment portion 15 is a wrap of PLLA suture and covers some of the struts 100 of the second sub-portion 113 suspended at the outflow end. Referring to fig. 13 and 14 together, the attachment portion 15 is formed by interlacing and winding a winding wire 151 around a strut, the winding wire 151 is formed by overlapping and winding a bundle of PLLA suture lines containing a plurality of filaments 1511, the line width of each winding wire is about 80-150 μm, the diameter of the filament is about 12 μm, the surface of the winding wire layer is irregularly corrugated, the peak-valley difference formed by the winding wire layer is about 0.05-0.08 mm, the thickness of the winding wire layer is about 110 μm, the permeability coefficient is about 1 x 10 ^-3 cm/s, the procoagulant rate is about 20%, the valve frame material is an iron-based material with the wall thickness of the strut 100 being about 140 μm.

The implantable device 1 is implanted into an animal (dog, hereinafter the same) body, the animal survives 30 days after implantation, after the device is taken out, the situation is observed by naked eyes firstly, as shown in fig. 15, the situation is observed by photographing a common mobile phone, the suspended support rods marked by C1 and C2 in fig. 15 are covered by a winding layer after implantation, the support rod marked by C1 is a bare support, the support rod marked by C2 is an adherence part of the implantable device 1, a semitransparent inner membranous layer is formed at the C1 position, the intimation degree is equal to that at the C3 position, and no obvious inner membranous layer is formed at the C2 position. The original shape of the support rod made of the iron-based material is maintained, the conditions of fracture and obvious degradation are avoided, and the weight loss rate of the support rod wrapped by the winding layer is about 2%. Partial imaging of C1 and C2 using a Scanning Electron Microscope (SEM) showed that an inner membrane layer with almost 100% coverage had been formed outside the stent rods corresponding to the C1 position, as shown in fig. 16 and 17. In contrast, only sporadic tissues are attached to the bare bracket rod suspended at the C2 position, and the coverage rate of the inner membranous layer is lower than 5%.

Example 2

The implantable device 1 is an iron-based absorbable prosthetic pulmonary valve, and has the same structure as in example 1 with reference to fig. 1, the valve frame material and the wrapping material being different in that the wrapping peak-valley difference of example 2 is about 0.08-0.12 mm, the thickness of the wrapping is about 130 μm, the permeability coefficient is about 1 x 10 ^-3 cm/s, and the procoagulant rate is about 30%. The animals survived after 14 days of implantation in the animals, and the removal of the device was observed to form a substantially continuous and complete inner film layer outside the second sub-portion 113 with the attached attachment portion 15, with an inner film coverage of greater than 90% and a weight loss of the stent rod wrapped by the wrapping layer of about 1%.

Example 3

The implantable device 1 is an iron-based absorbable prosthetic pulmonary valve, differing from example 2 in that the difference between the peaks and valleys of the windings is about 0.03-0.05 mm, the thickness of the windings is about 110 μm, and the procoagulant rate is about 10%. The stent rod is implanted in the animal body for 30 days, the animal survives, the coverage rate of the inner membrane of the attachment part 15 can be observed to be about 95% when the device is taken out, and the weight loss rate of the stent rod wrapped by the wrapping layer is about 2%.

Example 4

The implantable device 1 is an iron-based absorbable prosthetic pulmonary valve, differing from example 2 in that the difference in peak-to-valley of the wire wrap is about 0.7mm, the thickness of the wire wrap is about 750 μm, and the procoagulant rate is about 90%. The animals survived after 30 days of implantation in the animals, and the stent rod weight loss rate wrapped by the wrapping layer was about 3% when the device was taken out and the coverage rate of the inner membrane of the attachment portion 15 was 100%.

Example 5

The implantable device 1 is an iron-based absorbable prosthetic pulmonary valve, differing from example 2 in that the difference in peak-to-valley of the wire wrap is about 0.35mm, the thickness of the wire wrap is about 450 μm, and the procoagulant rate is about 50%. The animals survived after 30 days of implantation in the animals, and the stent rod weight loss rate wrapped by the wrapping layer was about 2% when the device was removed and the coverage rate of the inner membrane of the attachment portion 15 was 100%.

Example 6

The implantable device 1 is an iron-based absorbable prosthetic pulmonary valve, differing from example 2 in that the line width of each turn of wire is about 500 μm, the turn spacing is 0.5mm, and the procoagulant rate is about 10%. The animal survived after 30 days of implantation in the animal, the device was removed, and the coverage rate of the inner membrane of the attachment portion 15 was observed to be about 70%, and the weight loss rate of the stent rod wrapped with the wrapping layer was about 1%.

Examples 7 to 10

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 7-9 is formed by winding a support rod with PLLA suture, the attachment portion 15 of embodiment 10 is a PLLA permeable membrane, the peak-valley difference of the surface of the attachment portion 15 of each embodiment is 0.08-0.12 mm, and the main differences of each embodiment and embodiment 2 are shown in table 1. Animals survived after 30 days, 90 days, and 1 year implantation, and at each time node the device was removed to observe 100% coverage of the intima of the attachment portion 15, and the weight loss of the stent rod wrapped with the wrapping layer was as shown in table 1.

TABLE 1

Examples 11 to 14

The implantable device 1 is an iron-based absorbable artificial pulmonary valve, the embodiments are similar to the embodiment 2, the attachment portion 15 is a PCL spinning layer formed by a stent rod, the surface peak-valley difference is 0.08-0.12 mm, and the main parameter differences of the embodiments and the embodiment 2 are shown in table 2. Animals survived after 30 days, 90 days, and 1 year implantation, and at each time node the device was removed to observe 100% coverage of the intima of the attachment portion 15, and the weight loss of the stent rod wrapped with the wrapping layer was as shown in table 2.

TABLE 2

Examples 15 to 17

The implantable device 1 is a magnesium alloy absorbable artificial pulmonary valve, the structure of which is shown in fig. 1, the wall thickness of the strut 100 is about 140 μm, the attachment portion 15 wraps all struts 100 contained in the body 11, the material of the attachment portion 15 is PLLA, wherein example 15 is specifically a PLLA spinning layer, examples 16-17 are PLLA permeable membranes, the peak-valley difference of the surface is 0.12-0.15 mm, and other parameters of each example are shown in table 3. Animals survived after 30 days, 90 days, and 1 year implantation, and at each time node the device was removed to observe 100% coverage of the intima of the attachment portion 15, and the weight loss of the stent rod wrapped with the wrapping layer was as shown in table 3.

TABLE 3 Table 3

Example 18

The implantable device 1 was a nitrided iron-based vena cava filter, and the filter rod had a wall thickness of 250 μm and a rod width of 400 μm using the structure shown in fig. 10. PLLA sutures are adopted to wind a plurality of turns on all the filter rods to form an attachment part, the line width of the winding is about 50-100 mu m, the diameter of the fiber filaments is about 12 mu m, the peak-valley difference of the surface of the winding layer is about 0.03-0.05 mm, the thickness of the winding layer is about 130 mu m, the permeability coefficient is about 1 x 10 ^-3 cm/s, and the procoagulant rate is about 10%. The animal survived 30 days after implantation in the animal body, the coverage rate of the inner membrane at the suspended stent rod is 100%, the suspended part is not broken, and the weight loss rate of the stent rod wrapped by the winding layer is about 3%.

Example 19

The implantable device 1 was a zinc alloy vena cava filter, and the filter rod had a wall thickness of 250 μm and a rod width of 400 μm, using the structure shown in fig. 10. PLLA sutures are adopted to wind a plurality of turns on all the filter rods to form an attachment part, the line width of the winding is about 50-100 mu m, the diameter of the fiber filaments is about 12 mu m, the peak-valley difference of the surface of the winding layer is about 0.03-0.05 mm, the thickness of the winding layer is about 130 mu m, the permeability coefficient is about 1x 10 ^-3 cm/s, and the procoagulant rate is about 10%. The animal survived 30 days after implantation in the animal body, the coverage rate of the inner membrane at the suspended stent rod is 98%, the suspended part is not broken, and the weight loss rate of the stent rod wrapped by the winding layer is about 4%.

Comparative example 1

The implantable device 1 is an iron-based absorbable artificial pulmonary valve, the structure of which is shown in fig. 1, the material and structure of a valve frame are the same as those of the embodiment 1, the wall thickness of the valve frame is 140 mu m, a PLLA osmotic membrane is adopted as an attaching part 15, the peak-valley difference of the surface of the attaching part 15 is about 0.01mm, the thickness of the osmotic membrane is about 20 mu m, the osmotic coefficient is about 1 x10 ^-5 cm/s, and the procoagulant rate is about 5%. After being implanted into an animal body for 30 days, the animal survives, the artificial pulmonary artery valve is taken out, an inner membranous layer is formed on a part of the suspended second sub-part 113 attached with the attachment part 15 but is discontinuous, the coverage rate of the inner membranous layer is lower than 30%, the coverage rate of the inner membranous layer of the attached part of the valve frame is 100%, and the weight loss rate of the support frame rod wrapped by the permeable membrane is lower than 2%.

Comparative example 2

The implantable device 1 is an iron-based absorbable artificial pulmonary valve, the structure of which is shown in fig. 1, the material and structure of a valve frame are the same as those of the embodiment 1, the wall thickness of the valve frame is 140 mu m, a PLLA osmotic membrane is adopted for an attaching part 15, the peak-valley difference of the surface of the attaching part 15 is about 0.8mm, the thickness of the osmotic membrane is about 850 mu m, the osmotic coefficient is about 1 x 10 ^-4 cm/s, and the procoagulant rate is about 95%. After 30 days of implantation in the animal, the animal survived but had a listless appearance of bradykinesia, and removal of the artificial pulmonary valve was observed, and thrombus formation was locally seen to be temporarily not detached in the suspended second sub-portion 113 to which the attachment portion 15 was attached.

Comparative example 3

The implantation device 1 is a magnesium alloy absorbable artificial pulmonary valve, a valve frame is made of a magnesium alloy material, and the wall thickness of the valve frame is 140 mu m by adopting a structure shown in figure 1. The suspended bracket rod is a bare bracket, and is not provided with an attachment part 15, so that moisture can reach the surface of the bracket rod instantaneously, and the permeability coefficient is equal to or greater than 1 x 10 ^-3 cm/s. After the implantation of the stent is carried out in an animal body for 30 days, the animal is dead, the part of the stent rod (namely the second sub-part) suspended at the outflow end of the stent is dissected and observed, pulmonary embolism is found, meanwhile, the suspended part of the stent is partially separated from the adherent part, the leaflet assembly 12 is downwards deviated and shifted relative to the original implantation position (corresponding to the original annulus), only sporadic tissues are attached on the residual suspended stent rod, a continuous inner membranous layer is not formed, and the coverage rate of the inner membranous layer is lower than 5%.

The present application is not limited to the above-mentioned embodiments, but any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present application are included in the scope of the present application.

Claims

1. An implantable device, comprising:

the body comprises a first sub-part and a second sub-part, wherein the first sub-part is used for being attached to the wall of the tube cavity after the implantation type instrument is implanted into the tube cavity, the second sub-part is connected with the first sub-part and is at least partially suspended after the implantation type instrument is implanted into the tube cavity, and

And an attaching portion attached to the second sub-portion.

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

3. The implantable device of claim 1, wherein the attachment portion has a permeability coefficient of 1 x 10 ^-13～1*10^-3 cm/s.

4. The implantable device according to claim 1, wherein the material of the attachment portion has a blood coagulation rate of 10% -90% and/or the surface potential polarity of the attachment portion and the first sub-portion is 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 of claim 1, wherein the second sub-portion comprises at least one strut, the attachment portion comprises at least one wire wrap, and the at least one wire wrap is wrapped around the strut a plurality of turns to form the attachment portion.

6. An implantable device according to claim 5, wherein the wire wrap has a width/diameter of 50-700 μm and/or the inter-turn distance between adjacent turns is 0-0.5 mm.

7. The implantable device of claim 6, wherein each wire wrap comprises a plurality of filaments, the filaments having the same or different diameters, the filaments having diameters of 5-25 μm.

8. The implantable device of claim 5, wherein the wire wrap is wrapped around the strut in a manner selected from one or any combination of overlapping wrapping, tiling wrapping, multi-layer wrapping, density changing wrapping, and/or the wire wrap is less than 90 ° from the axis of the strut, and/or the wire wrap is different from the axis of the strut along the axis.

9. The implantable device of claim 5, wherein the wire wrap forms a plurality of binding knots on the strut, each binding knot being disposed adjacent to or spaced apart from each other, and/or wherein the attachment portion further comprises a pulling layer disposed along a length of the strut of the second sub-portion, the wire wrap having a plurality of intersecting locations with the pulling layer, the wire wrap at each intersecting location being integrally connected to or spaced apart from the pulling layer.

10. The implantable device of claim 1, wherein the attachment portion comprises a base layer and a plurality of filaments extending from the base layer, the base layer being wrapped around the second sub-portion, the filaments having a distribution density of 10-500 filaments/mm ².

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

12. The implantable device according to claim 11, wherein the second sub-portion comprises a tip, the thickness of the attachment portion at the tip is 50-150 μm, and/or the second sub-portion comprises a frangible zone that is prone to breaking, the thickness of the attachment portion at the frangible zone is 20-100 μm.

13. The implantable device according to claim 1, wherein the attachment portion has a plurality of holes, the diameter of a single hole is smaller than 500 μm, and/or the attachment portion comprises a first density region and a second density region which are adjacently arranged, wherein the first density region is provided with a plurality of holes with a diameter of 10-100 μm, and the second density region is provided with a plurality of holes with a diameter of 150-500 μm.

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

15. The implantable device of claim 1, wherein the implantable device further comprises:

And one end of the limiting piece is connected with the first sub-part, and the other end of the limiting piece is connected with the second sub-part and/or the attachment part.

16. The implantable device of claim 15, wherein the number of the limiting members is plural, and each of the limiting members is connected to a different location of the second sub-portion and/or the attachment portion, respectively.

17. The implantable device of claim 1, wherein the body or the second sub-portion is degradable, the second sub-portion has a degradation time greater than an internalization time at the second sub-portion, and/or the attachment portion is non-degradable or the attachment portion has a degradation time greater than an internalization time of the second sub-portion.

18. The implantable device of claim 1, further comprising a plurality of hollowed-out portions, wherein the body is axially formed with a flow channel, wherein the second sub-portion is adjacent to at least one of the hollowed-out portions, and wherein the attachment portion is attached to the second sub-portion in a manner that maintains fluid within the lumen from the flow channel out through the hollowed-out portion adjacent to the second sub-portion.

19. The implantable device according to any one of claims 1-18, further comprising:

A leaflet assembly secured to an inner side of the first sub-portion;

a skirt comprising an inner skirt for connecting the leaflet assembly to the body and/or an outer skirt covering the outer side of the first sub-portion.

20. A method of manufacturing an implantable device according to any one of claims 1-19, comprising:

selecting a substrate from which the implantable device is prepared;

Forming an attachment portion attached to the second sub-portion.