Implantable medical device

Abstract

The invention provides an implantable medical device which comprises a film-covered supporting skeleton and a plurality of first pointed bodies for carrying drugs, the film-covered supporting skeleton comprises a supporting skeleton with a plurality of hollowed-out parts and a film fixed to the supporting skeleton and covering at least part of the hollowed-out parts, and the first pointed bodies are located in film-covered areas corresponding to the hollowed-out parts. The first pointed body is connected with the covering film or matched with the covering film so that the first pointed body can be movably limited by the covering film. According to the invention, a plurality of first pointed bodies for carrying medicines are arranged on the covering film corresponding to the hollow part of the support framework, the treatment area of the instrument is enlarged, and the first pointed bodies are connected with the covering film or limited by the covering film, so that the first pointed bodies are effectively prevented from being separated from the covering film.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to an implantable medical device. Background Technology

[0002] With the improvement of people's living standards and changes in dietary structure, health and disease issues have received increasing attention, including lesions such as narrowing, rupture, and tumors in the human body's cavities.

[0003] To treat the aforementioned diseases, medical devices, such as stents, are typically implanted inside the body's cavities to open up narrow passages and allow for normal fluid flow. Stents are classified into bare stents and covered stents. Covered stents primarily function by adding a covering to the bare stent, isolating the lumen wall from the intraluminal fluid and preventing rupture. However, these covered stents can cause a series of adverse reactions, such as neointimal hyperplasia and intermediate-term restenosis. To reduce adverse reactions, drug-eluting microneedles are usually placed on the outer surface of the bare stent. These microneedles penetrate the tissue to deliver medication, resulting in significant therapeutic effects. However, because bare stents have numerous open areas, the area available for placing drug-eluting microneedles on the support rod is limited. Furthermore, the placement of the microneedles is constrained by the shape and structure of the support rod. This means that after implantation, the device can only treat the tissue corresponding to the support rod, failing to treat tissues in other areas, significantly limiting the device's application range. Summary of the Invention

[0004] This invention provides an implantable medical device with a wide range of therapeutic applications.

[0005] Based on the above concept, the technical solution adopted by the implantable medical device provided by this invention is as follows:

[0006] An implantable medical device includes a covered support frame and a plurality of drug-loaded first tips. The covered support frame includes a support frame with a plurality of perforations, a cover fixed to the support frame and covering at least a portion of the perforations, and the plurality of first tips are located in the cover area corresponding to the perforations. The first tips are connected to or adapted to the cover to be movably limited by the cover.

[0007] Preferably, the first pointed body is integrally formed with the coating.

[0008] Preferably, the coating has a plurality of mutually spaced support layers, each of the support layers being fixed to the surface of the coating, the first tip being fixedly connected to the support layer, and the hardness of the support layer being greater than the hardness of the first tip.

[0009] Preferably, the film has a plurality of covering spaces, and the opening area of the covering spaces is smaller than the area of the proximal end bottom of the first pointed body, and the proximal end bottom of each of the first pointed bodies is movably accommodated in the covering space and is limited by the film.

[0010] Preferably, the plurality of first pointed bodies are arranged only on the inner surface of the film, or only on the outer surface of the film, or on both the inner surface and the outer surface of the film.

[0011] Preferably, a part of the plurality of first pointed bodies is arranged near the edge of the supporting framework, and the proximal end bottom of each of the first pointed bodies in the part is fixed to the surface of the film.

[0012] Preferably, the height of each of the first pointed bodies in the part is smaller than the thickness of the supporting framework.

[0013] Preferably, the film has a plurality of covering spaces, and the proximal end bottom of each of the remaining part of the plurality of first pointed bodies is movably accommodated in one of the covering spaces and is limited by the film, and the opening area of the covering spaces is smaller than the area of the proximal end bottom of the first pointed body.

[0014] Preferably, the film is located at one end of the supporting framework in the axial direction, or the film is located in the middle region of the supporting framework in the axial direction.

[0015] Preferably, the implantable medical device further comprises a plurality of second pointed bodies fixedly connected to the supporting framework and loaded with drugs, wherein the second pointed bodies are arranged on the inner wall of the supporting framework, or the second pointed bodies are arranged on the outer wall of the supporting framework, or the second pointed bodies are arranged on both the outer wall and the inner wall of the supporting framework.

[0016] The present application has at least the following beneficial effects:

[0017] The implantable medical device provided by the present application expands the treatment area by arranging a plurality of first pointed bodies loaded with drugs on the corresponding film of the hollow supporting framework, so as to meet the treatment needs of different situations, and the first pointed bodies are connected with the film, effectively preventing the first pointed bodies from being separated from the film, ensuring the stability of the structure and prolonging the service life. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 is a perspective view of an implantable medical device provided by an embodiment of the present application;

[0019] Figure 2 is Figure 1 is a partial enlarged view of the A part of the implantable medical device shown in the figure;

[0020] Figure 3 is a sectional view of the implantable medical device along line C-C shown in Fig. 1; Figure 2

[0021] Figure 4 is a partial enlarged view of part B of the implantable medical device shown in Fig. 1; Figure 1

[0022] Figure 5 is a sectional view of the implantable medical device along line D-D shown in Fig. 1; Figure 4

[0023] Figure 6 is a top view of the implantable medical device according to an embodiment of the present application;

[0024] Figure 7 Figure 6 is a partial enlarged view of part E of the implantable medical device shown in Fig. 1;

[0025] Figure 8 is a perspective view of the implantable medical device according to an embodiment of the present application without the covering membrane;

[0026] Figure 9 Figure 8 is a partial enlarged view of part F of the implantable medical device shown in Fig. 1;

[0027] Figure 10 Figure 9 is a sectional view of the implantable medical device according to a first embodiment of the present application along line G-G shown in Fig. 1;

[0028] Figure 11 is a sectional view of the implantable medical device according to a second embodiment of the present application along line G-G shown in Fig. 1; Figure 9

[0029] is a combination view of the implantable medical device, the sheath and the balloon according to the present application. Figure 12 BRIEF DESCRIPTION OF THE DRAWINGS

[0030] DETAILED DESCRIPTION

[0031] The implantable medical device according to the present application will be described in detail below with reference to the accompanying drawings. It can be understood that the described embodiments are only some embodiments of the present application, but not all embodiments of the present application, and the present application can be implemented in many other ways different from those described herein.

[0032] ​​​​​​​Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention.

[0033] It should be noted that all directional indications in the embodiments of this specification are only used to explain the relative positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indications will also change accordingly.

[0034] Furthermore, in this invention, descriptions involving "first," "second," etc., are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this specification, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0035] The technical solutions of the various embodiments of the present invention can be combined with each other, but only if they are based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by the present invention.

[0036] In this specification, axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the component; radial direction refers to the direction perpendicular to the aforementioned axial direction; "proximal end" is the end closest to the surface of the film-supported skeleton, and "distal end" is the end furthest from the surface of the film-supported skeleton. "Connection" can refer to a direct connection between two components or a connection via an intermediate medium.

[0037] The implantable medical device provided by this invention can be an intraluminal implant, such as a tracheal stent, or other implants, such as a one-way valve used in lung volume reduction surgery.

[0038] Figures 1 to 7 The diagram illustrates the structure of an implantable medical device 100 according to an embodiment of the present invention. Specifically, the implantable medical device 100 is a microneedle-covered scaffold, including a covered support frame and a plurality of drug-loaded first tips 5 disposed on the covered support frame. The covered support frame includes a support frame with a plurality of perforations 8 and a cover 4. The plurality of first tips 5 are disposed on the outer surface of the cover 4. Here, the outer surface refers to the surface of the cover 4 away from the central axis X of the implantable medical device 100. The implantable medical device 100 also includes, for example, Figure 2 and Figure 3The diagram shows multiple second pointed bodies 3 disposed on the outer wall of the support frame and carrying drug. Here, the outer wall refers to the surface of the support frame that is away from the central axis X of the implanted medical device 100.

[0039] In one embodiment, the membrane 4 covers the entire supporting skeleton and all the perforations 8. It is understood that in other embodiments, the membrane 4 may only cover part of the perforations 8, i.e., only partially cover the supporting skeleton. The first pointed body 5 may be located only on the inner surface of the membrane, i.e., the surface near the central axis X of the device, or it may be located on both the outer and inner surfaces of the membrane. Preferably, the supporting skeleton mainly serves to support the inner wall of narrow passages in the human body, thereby opening them up and reducing the adverse effects of narrow passages on the flow of internal fluids. The supporting skeleton is preferably a tubular structure, such as a cylindrical structure, an elliptical cylindrical structure, a frustum-shaped structure, etc. In this embodiment, the supporting skeleton is preferably cylindrical; in other embodiments, the supporting skeleton may be a combination of one or more of the above structures.

[0040] Preferably, a plurality of first pointed bodies 5 are located within the region of the covering membrane 4 corresponding to the perforation 8, and the first pointed bodies 5 are connected to or adapted to the covering membrane 4 so as to be movably limited by the covering membrane 4. Compared with the prior art, by setting the first pointed bodies 5 in the region of the covering membrane 4 corresponding to the perforation 8, the layout range of the first pointed bodies 5 is expanded, breaking through the limitation of the supporting skeleton on the placement of drug-loaded microneedles. Therefore, after the device is implanted into the lesion tissue, it can treat areas other than those corresponding to the supporting skeleton, thereby maximizing the improvement of the patient's disease.

[0041] More preferably, such as Figure 8 As shown, the support frame includes support rods. Each support rod may include multiple corrugated coils 1 and connecting rods 2 for connecting two corrugated coils 1. The connecting rod 2 is located between two adjacent corrugated coils 1. The corrugated coils 1 are composed of Z-shaped waves, but can also be made of other structures, which will not be elaborated here. Furthermore, one end of the connecting rod 2 is fixedly connected to the corrugated coil 1 located at one end, and the other end of the connecting rod 2 is fixedly connected to the corrugated coil 1 located at the other end, thereby connecting and fixing two adjacent corrugated coils 1. The corrugated coils 1 and the connecting rod 2 can be welded together or integrally formed, etc., which will not be elaborated here.

[0042] Furthermore, the wave coil 1 and / or connecting rod 2 can be made of biocompatible materials, such as nickel-titanium alloy, iron, magnesium alloy, stainless steel, polylactic acid, etc., which can be selected and set as needed, so they will not be described in detail here.

[0043] Preferably, the membrane 4 is made of commercially available biocompatible materials, such as ePTFE (clothing fabric made by laminating a polytetrafluoroethylene microporous membrane with ordinary fabric), PET (polyethylene terephthalate), silk fibroin, silicone, etc.

[0044] More preferably, when the first pointed body 5 and the covering film 4 are made of the same material, such as silk fibroin, the first pointed body 5 and the covering film 4 can be integrally formed, so that the two can be connected more firmly, and the process steps and difficulty are reduced, and the cost is reduced.

[0045] The first pointed body 5 can be used to carry drugs to achieve a therapeutic effect. The first pointed body 5 can carry different drugs, and the added drugs can be used for preventing hyperplasia, treatment, and antibacterial, etc. Common drugs are paclitaxel, rapamycin and its derivatives (such as sirolimus, zotarolimus, everolimus, tacrolimus, and pimecrolimus), amine-coupled polyurethane (SA-PU) polymer, etc.

[0046] The covering film 4 can cover the outer wall of the support framework, or can cover the inner wall of the support framework. When the covering film 4 is arranged on the outer wall of the support framework, the covering film 4 can cover the entire outer wall of the support framework, or can cover part of the outer wall of the support framework, such as covering one end or both ends of the support framework in the axial direction, or covering the middle region of the support framework in the axial direction, or covering other regions of the support framework, etc. Similarly, when the covering film 4 is arranged on the inner wall of the support framework, the covering film 4 can be attached to the entire inner wall of the support framework, or can be attached to part of the inner wall of the support framework, such as being attached to one end or both ends of the support framework in the axial direction, or being attached to the middle region of the support framework in the axial direction, or being attached to other regions of the support framework, etc.

[0047] More specifically, when the middle region of the support framework in the axial direction is provided with the covering film 4, the covering film 4 in the middle region can better play a supporting and fixing role, and at the same time, the two ends of the support framework can be provided with the drug-loaded second pointed body 3, so as to play a therapeutic effect on the tissue, such as preventing granulation hyperplasia, etc.

[0048] Preferably, one end of the first pointed body 5 towards the covering film 4 is the proximal end, and the end away from the covering film 4 is the distal end, and the distal end is needle-shaped, and the cross-sectional area of the distal end is smaller than that of the proximal end.

[0049] Specifically, please refer to Figures 5 to 7, the center axis y1 of the first pointed body 5, i.e. the line y1 connecting the distal end point of the first pointed body 5 and the center of the proximal bottom 51, extends along the radial direction y2 of the implanted medical instrument 100, so that when the instrument is released at the lesion site, the radial support force from the covering membrane 4 or the balloon expansion force on the first pointed body 5 is mostly in one direction of the center axis y1 of the first pointed body 5, which maximizes the pressure of the head end of the first pointed body 5 penetrating into the tissue, and more easily penetrates into the tissue, while the force in the other direction of the center axis y1 of the first pointed body 5 is small, such as the force in the direction perpendicular to the center axis y1 of the first pointed body 5, etc., which can prevent the first pointed body 5 from breaking. When the first pointed body 5 is still fixed to the inner surface of the covering membrane 4 (i.e. the surface close to the center axis X of the instrument), the first pointed body 5 extends towards the axis X close to the support skeleton, and contacts the medium such as water in the cavity of the support skeleton to dissolve, so as to achieve a therapeutic effect on the internal environment of the support skeleton.

[0050] Further, the first pointed body 5 is provided with multiple and spaced apart first pointed bodies 5, and the position of the first pointed body 5 can be selected according to the position of the intimal hyperplasia or other diseases or the position where the support skeleton needs to be fixed, etc., and the multiple first pointed bodies 5 are spaced apart, so that they can successfully penetrate into the tissue and achieve the treatment of intimal hyperplasia and other diseases.

[0051] Further, the first pointed body 5 can be directly fixed to the covering membrane 4, such as being adhesively fixed to the covering membrane 4, or being integrally formed with the covering membrane 4, or being fixed to the covering membrane 4 by other fixing connection methods, which will not be described herein.

[0052] The connection method of the first pointed body 5 and the covering membrane 4 has multiple forms. As an exemplary embodiment, the covering membrane 4 can have multiple covering portions. The multiple covering portions can be directly formed when the covering membrane 4 is formed, thereby reducing the process difficulty and improving the forming yield. Specifically, the covering portion has a covering space 41 as shown in Figure 5 , the opening 411 of which has an area smaller than that of the proximal bottom 51 of the first pointed body 5, so that the first pointed body 5 can be movably limited in the covering space 41.

[0053] In other preferred embodiments, the multiple first pointed bodies 5 are arranged close to the support skeleton and along the edge of the support skeleton, and the proximal bottom of each first pointed body 5 can be directly fixed to the covering membrane 4, such as being adhesively fixed, etc.

[0054] Specifically, part of the first spikes 5 can be arranged along the edge of the support framework, i.e., the first spikes 4 are arranged close to the support framework, so that the support framework can partially shield the first spikes 5 on the edge, so that the first spikes 5 are not easy to fall off.

[0055] In some preferred embodiments, part of the first spikes 5 are arranged along the edge of the support framework, and the proximal end of the remaining first spikes 5 can be movably limited in a covering space 41 of the covering film 4 as shown. Figure 5

[0056] More specifically, since the support framework includes at least two wave coils 1 and a connecting rod 2 connecting the two wave coils 1, some of the first spikes 5 can be arranged along the edge of the wave coil 1, or along the edge of the connecting rod 2, or along the edge of both the wave coil 1 and the connecting rod 2, so that the first spikes 5 can be arranged at the desired position, the arrangement range of the first spikes 5 is expanded, and the stability of the structure and the treatment effect are enhanced.

[0057] Further, the first spikes 5 arranged along the edge of the support framework can be directly fixed to the covering film 4, such as adhesively fixed, or integrally formed, or other fixed connection manner, which will not be repeated here.

[0058] Preferably, the covering film 4 has a plurality of spaced support layers (not shown), each of which is fixedly connected to the covering film 4, such as adhesively fixed, and the plurality of support layers correspond one-to-one to the plurality of first spikes 5, each of which is fixedly connected to a support layer, and the hardness of the support layer is greater than that of the first spike 5. The material of the support layer can be one or more of PVPK90 (polyvinylpyrrolidone), PEEK (polyether ether ketone), PMMA (polymethyl methacrylate), PTFE (polytetrafluoroethylene), or a metal material such as nickel-titanium alloy. Preferably, the support layer can have a multi-layer structure, such as two layers, three layers, four layers or more, and the multi-layer support layers are stacked together to stably support the first spikes 5 and enable them to smoothly penetrate into the tissue.

[0059] Specifically, the support layer can be a cuboid or a cylinder, and the shape of the support layer can be set as needed, and the support layer is fixedly connected to the covering film 4 and the first spike 5, such as adhesively fixed or other fixed connection manner, which will not be repeated here. The hardness of the support layer is greater than that of the first spike 5, so as to enhance the connection strength of the first spike 5 and the covering film 4, and to stably support the first spike 5 and enable it to smoothly penetrate into the tissue.​

[0060] Preferably, the first pointed body 5 is a cone or a multi-faceted pyramid, which can smoothly penetrate the tissue and reduce the difficulty of penetrating the tissue. In other embodiments, the first pointed body 5 can also be other geometric shapes, which will not be described in detail here.

[0061] Preferably, the height h1 of the first pointed body 5 is less than the thickness h2 of the supporting frame. The height h1 of the first pointed body 5 is the distance between its proximal bottom surface and distal end surface, and the thickness h2 of the supporting frame is the distance between its outer surface and its inner surface. Figure 7 As shown. The height of the first pointed body 5 is less than the thickness of the supporting skeleton, which allows the supporting skeleton to protect the first pointed body 5, preventing it from falling off or breaking. When the first pointed body 5 needs to penetrate the tissue, the covering membrane 4 expands radially outward, causing the first pointed body 5 to move radially outward to penetrate the tissue, thus achieving the effects of drug delivery and fixation.

[0062] The second point 3 can be located solely on the inner wall of the supporting framework, solely on the outer wall, or simultaneously on both walls. When positioned on the outer wall, the second point 3 can not only penetrate the tissue for fixation but also apply medication, achieving a therapeutic effect. When positioned on the inner wall, the second point 3 can dissolve upon contact with internal media such as water, thereby applying medication to the internal environment of the supporting framework and achieving a therapeutic effect. Users can place the second point 3 at the desired location on the supporting framework to meet different usage needs.

[0063] like Figure 9 and Figure 10 As shown, in one embodiment of the present invention, the second pointed body 3 is fixed to the support frame. A base 31 is provided between each second pointed body 3 and the support frame, the base 31 is fixedly connected to the support frame, the second pointed body 3 is fixedly connected to the base 31, and the hardness of the base 31 is greater than the hardness of the second pointed body 3.

[0064] Specifically, when the film 4 covers at least part of the outer wall or at least part of the inner wall of the support framework, the second pointed body 3 can be located on the opposite side of the support framework with the film 4, or both are located on the same side of the support framework; when the film 4 covers at least part of the outer wall and at least part of the inner wall of the support framework, the second pointed body 3 penetrates the film 4, specifically: when the second pointed body 3 is fixed on the outer wall of the support framework, the film 4 covering the outer wall of the support framework covers one side of the pointed head of the second pointed body 3, and the pointed head of the second pointed body 3 penetrates the film 4, so as to smoothly cover the film 4 on the outer wall of the support framework; or, when the second pointed body 3 is fixed on the inner wall of the support framework, the film 4 covering the inner wall of the support framework covers one side of the pointed head of the second pointed body 3, and the pointed head of the second pointed body 3 penetrates the film 4, so as to smoothly fix the film 4 on the inner wall of the support framework.

[0065] More specifically, as shown in Figure 10 The base body 31 is plate-shaped, and is attached to and fixedly connected with the surface of the support framework, specifically: the base body 31 is attached to the surface of the wave coil 1 or the surface of the connecting rod 2, so that the base body 31 can be stably fixedly connected with the wave coil 1 or the connecting rod 2, such as adhesive fixing, etc., and the hardness of the base body 31 is greater than that of the second pointed body 3, so as to stably support and fix the second pointed body 3.

[0066] Further, one end of the base body 31 is fixedly connected with the support framework, that is, the base body 31 is fixedly connected with the wave coil 1 or the connecting rod 2, so that the pointed body can be fixed at the required position of the support framework, such as the lesion position or the position requiring fixation, etc.

[0067] The base body 31 is preferably made of one or more of PVPK90 (povidone), PEEK (polyether ether ketone), PMMA (polymethyl methacrylate), and PTFE (polytetrafluoroethylene), or a metal material, etc., which only needs to have a hardness greater than that of the second pointed body 3 and meet the support requirements. The base body 31 can also be composed of multiple layers, and each layer is made of one of the above materials, so as to meet the different structure and strength requirements of the base body 31.

[0068] In some preferred embodiments, as shown in Figure 11 The base body 31 is closed and annular, and is wrapped on the support framework through two adjacent hollows 8, so as to further enhance the stability of the connection between the pointed body 3 and the support framework. The base body 31 can be wrapped on the wave coil 1 or the connecting rod 2, so as to fix the second pointed body 3 at the required position of the support framework, so as to treat or fix the required part.

[0069] The base 31 can also only wrap part of the surface of the support framework, for example, the base 31 wraps the outer surface 11, part of the side surface 12 of the wave coil 1 or the connecting rod 2; or the base 31 wraps the outer surface 11, the side surface 12 and the inner surface 13 of the wave coil 1 or the connecting rod 2; or the base 31 wraps the inner surface 13 and part of the side surface 12 of the wave coil 1 or the connecting rod 2, etc.

[0070] In addition, the base 31 can also be cooperated with the second pointed body 3 to surround the support framework, that is, the two are cooperated to form a ring-shaped base wrapping the support framework as shown in the figure. Figure 11 Specifically, part or all of the base 31 and part of the second pointed body 3 can form a ring-shaped coating body to surround the support framework.

[0071] The solvent of the raw material liquid of the first pointed body 5 and the second pointed body 3 is water, and the solute is at least one of chitosan, sodium alginate, polyethylene glycol, PLGA (polylactic acid-hydroxy acid), PCL (polycaprolactone), PMMA (polymethyl methacrylate), PGA (polyglycolic acid), PLA (polylactic acid), PEA (polyether amine), gelatin, hyaluronic acid, silk fibroin, etc., and a degradable material is preferably selected. The first pointed body 5 and the second pointed body 3 can further disperse liposomes prepared from phosphatidylcholine and cholesterol. The raw material liquid and the liposomes of the first pointed body 5 and the second pointed body 3 can carry different drugs. The added drugs are for preventing hyperplasia, treatment and antibiosis, etc. Common drugs are paclitaxel, rapamycin and its derivatives (such as sirolimus, zotarolimus, everolimus, tacrolimus and pimecrolimus), amine-coupled polyurethane (SA-PU) polymer, etc.

[0072] Further, the drugs can be added to the raw material liquid to form the first pointed body 5 or the second pointed body 3. The drug content in the raw material liquid of the first pointed body 5 and the second pointed body 3 is 1% to 10%, and further preferably, the drug content in the raw material liquid of the first pointed body 5 and the second pointed body 3 is 1% to 5%. The drugs can also be coated on the surface of the first pointed body 5 and the second pointed body 3, and the drug content is 1% to 20%, and further preferably, the drug content is 10% to 15%. The above-mentioned proportion range is mass percentage. Further, the total drug content of the implant is 30-300ug. The above-mentioned total amount and percentage of the drugs can ensure the treatment effect of the drugs and reduce the occurrence of diseases such as intimal hyperplasia.

[0073] Further, in order to meet the clinical needs of the target site, the first spikes 5 and the second spikes 3 can be designed with appropriate height, diameter, number, drug loading concentration, drug loading type, degradation rate, etc. For example, the place where the supporting scaffold exerts excessive pressure on the tissue is more likely to cause hyperplasia due to stimulation of the tissue, and therefore more second spikes 3 can be arranged at this position. For another example, the position where the supporting scaffold contacts the tissue is subjected to shearing force, and therefore is more likely to cause hyperplasia or form granuloma, and therefore more drug-loaded second spikes 3 can be arranged to achieve a certain amount of drugs to achieve the effect of preventing hyperplasia and granuloma. The plurality of first spikes 5 and the second spikes 3 can carry different drugs, so as to achieve the treatment of different diseases, and the user can set according to the needs, which will not be described here.

[0074] Further, as shown in Figure 12 When the implantable medical device of the present application is used for tracheal or bronchial stenosis, the supporting scaffold is first pressed onto the surface of the balloon 7, and then loaded into the sheath tube 6. In order to ensure that the first spikes 5 and the second spikes 3 are not damaged when loaded into the sheath tube 6, the distance between the tip of the first spikes 5 and the second spikes 3 and the inner wall of the sheath tube 6 is L, wherein 0.1mm≤L≤0.5mm, so as to avoid the first spikes 5 and the second spikes 3 from colliding with the sheath tube 6 during assembly, or the profile of the sheath tube 6 being too large to be suitable for some patients. Then, under the guidance of the guide wire, the part of the sheath tube 6 loaded with the implantable medical device is delivered to the target position, liquid is injected into the balloon 7, and the pressure is increased to 16 to 26 atmospheres, so that the supporting scaffold starts to expand under the pushing action of the balloon 7, and then the first spikes 5 and the second spikes 3 penetrate into the tissue. At this time, the entire first spikes 5 and the second spikes 3 can be selected to penetrate into the tissue according to the needs, or the local first spikes 5 and the second spikes 3 can be selected to penetrate into the tissue. If the supporting scaffold is a degradable material and the degradation rate is greater than the degradation rate of the first spikes 5 and the second spikes 3, the tissue will not be compressed after degradation, reducing the risk of subsequent tissue hyperplasia. Compared with the existing drug-loaded implantable medical device, the first spikes 5 and the second spikes 3 can penetrate into the tissue, slowly release the drug with the degradation of the first spikes 5 and the second spikes 3, prolong the action time of the drug, and the first spikes 5 and the second spikes 3 can carry multiple drugs, different concentrations of drugs, in order to achieve different effects, and the first spikes 5 and the second spikes 3 are stably connected with the supporting scaffold, effectively preventing the two from separating, and having good stability and safety.

[0075] Finally, it should be noted that the above examples are only used to illustrate the technical solutions of the present application, and are not limited thereto. The application scenarios of the implanted medical devices are not limited to the fields described herein. Although the present application has been described in detail with reference to the foregoing examples, those skilled in the art should understand that the technical solutions described in the foregoing examples can be modified, or some technical features can be replaced by equivalent features. Such modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. An implantable medical device, comprising: The implantable medical device comprises a covering membrane support framework and a plurality of first drug-loaded spikes (5). The covering membrane support framework comprises a support framework with a plurality of hollows (8), a covering membrane (4) fixed to the support framework and covering at least part of the hollows (8), and the plurality of first spikes (5) are located in the covering membrane (4) area corresponding to the hollows (8). The first spikes (5) are connected with the covering membrane (4) or are movably limited by the covering membrane (4).

2. The implant medical device of claim 1, wherein, The first spikes (5) are integrally formed with the covering membrane (4).

3. The implant medical device of claim 1, wherein, The covering membrane (4) has a plurality of mutually spaced support layers, each of which is fixed to the surface of the covering membrane (4), and the first spikes (5) are fixedly connected with the support layers, and the hardness of the support layers is greater than the hardness of the first spikes (5).

4. The implant medical device of claim 1, wherein, The covering membrane (4) has a plurality of covering spaces (41), and the opening (411) area of the covering space (41) is smaller than the area of the proximal end bottom (51) of the first spike (5). The proximal end bottom (51) of each first spike (5) is movably accommodated in the covering space (41) and limited by the covering membrane (4).

5. The implant medical device of claim 1, wherein, The plurality of first spikes (5) are only arranged on the inner surface of the covering membrane (4); or the plurality of first spikes (5) are only arranged on the outer surface of the covering membrane (4); or the plurality of first spikes (5) are arranged on both the inner surface and the outer surface of the covering membrane (4).

6. The implant medical device of claim 1, wherein, A part of the plurality of first spikes (5) is arranged near the edge of the support framework, and the proximal end bottom of each of the first spikes (5) in this part is fixed to the surface of the covering membrane (4).

7. The implant medical device of claim 6, wherein, The height of each of the first spikes (5) in this part is less than the thickness of the support framework.

8. The implant medical device of claim 7, wherein, The covering membrane (4) is provided with a plurality of covering spaces (41), and the proximal end bottom (51) of each of the remaining part of the plurality of first spikes (5) is movably accommodated in one of the covering spaces (41) and limited by the covering membrane (4). The opening (411) area of the covering space (41) is smaller than the area of the proximal end bottom (51) of the first spike (5).

9. The implant medical device of claim 1, wherein, The covering membrane (4) is located at one end of the support framework in the axial direction; or the covering membrane (4) is located in the middle region of the support framework in the axial direction.

10. The medical implant of claim 1, wherein, The implantable medical device further comprises a plurality of second drug-loaded spikes (3) fixedly connected with the support framework, wherein the second spikes (3) are arranged on the inner wall of the support framework; or the second spikes (3) are arranged on the outer wall of the support framework; or the second spikes (3) are arranged on the outer wall and the inner wall of the support framework.

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