Implantable medical device

Abstract

The utility model provides an implantable medical instrument, which comprises a membrane supporting skeleton and a plurality of first pointed bodies for carrying medicine, the membrane supporting skeleton comprises a supporting skeleton with a plurality of hollows and a membrane which is fixed on the supporting skeleton and covers at least part of the hollows, the plurality of first pointed bodies are positioned in the membrane area corresponding to the hollows, and the first pointed bodies are positioned in the membrane area corresponding to the hollows. 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 utility model, the plurality of first pointed bodies for carrying medicines are arranged on the covering film corresponding to the hollow part of the support framework, so that 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] The utility model relates to the technical field of medical devices, in particular to an implantable medical device. Background Art

[0002] For lesions such as stenosis, rupture, and tumors in the human lumen, medical devices are usually implanted inside the human lumen, such as stents, so that the narrow part of the human lumen can be opened to achieve the normal circulation of the internal fluid. Stents are divided into bare stents and coated stents according to their morphology. Coated stents mainly play the role of isolating the lumen wall and the liquid in the lumen by adding a coating on the bare stent, and can avoid rupture of the lumen wall, but these coated stents will cause a series of adverse reactions after implantation, such as neointimal hyperplasia and mid-term restenosis. In order to reduce the occurrence of adverse reactions, drug-loaded microneedles are usually set on the outer surface of the bare stent, and the drug-loaded microneedles are inserted into the tissue to act on the tissue, with significant therapeutic effects. However, since the bare stent has a large number of hollow areas, the area of ​​the support rod used to set the drug-loaded microneedles is limited, and the arrangement of the drug-loaded microneedles is limited by the shape and structure of the support rod, resulting in the device implanted in the lesion position. After the lesion, the tissue corresponding to the support rod can only be treated, and the tissue corresponding to other areas except the support rod cannot be treated, which greatly limits the scope of application of the device. Utility Model Content

[0003] The utility model provides an implantable medical device with a wide treatment range.

[0004] As conceived above, the technical solution adopted by the implantable medical device provided by the utility model is:

[0005] An implantable medical device includes a membrane supporting frame and a plurality of drug-loaded first pointed bodies, wherein the membrane supporting frame includes a supporting frame having a plurality of hollow portions, a membrane fixed to the supporting frame and covering at least a portion of the hollow portions, the plurality of first pointed bodies are located in the membrane areas corresponding to the hollow portions, and the first pointed bodies are connected to the membrane or adapted to be movably limited by the membrane.

[0006] Preferably, the first pointed body and the coating are integrally formed.

[0007] Preferably, the coating has a plurality of support layers separated from each other, each of the support layers is fixed to the surface of the coating, the first pointed body is fixedly connected to the support layer, and the hardness of the support layer is greater than the hardness of the first pointed body.

[0008] Preferably, the coating has a plurality of covering spaces, the opening area of ​​the covering space is smaller than the area of ​​the proximal bottom of the first pointed body, and the proximal bottom of each first pointed body can be movably received in the covering space and limited by the coating.

[0009] Preferably, the plurality of first pointed bodies are only provided on the inner surface of the coating; or the plurality of first pointed bodies are only provided on the outer surface of the coating; or the plurality of first pointed bodies are provided on both the inner surface and the outer surface of the coating.

[0010] Preferably, a portion of the plurality of first pointed bodies is arranged close to the edge of the supporting frame, and a proximal bottom of each of the first pointed bodies in the portion is fixed to the surface of the coating.

[0011] Preferably, the height of each of the first pointed bodies in this portion is smaller than the thickness of the supporting frame.

[0012] Preferably, the coating is provided with a plurality of covering spaces, the proximal bottom of each of the remaining parts of the plurality of first pointed bodies can be movably received in one of the covering spaces and limited by the coating, and the opening area of ​​the covering space is smaller than the area of ​​the proximal bottom of the first pointed body.

[0013] Preferably, the coating is located at one end of the supporting frame in the axial direction; or the coating is located in the middle region of the supporting frame in the axial direction.

[0014] Preferably, the implantable medical device also includes a plurality of second pointed bodies fixedly connected to the supporting frame and loaded with medicine, wherein the second pointed bodies are arranged on the inner wall of the supporting frame; or the second pointed bodies are arranged on the outer wall of the supporting frame; or the second pointed bodies are arranged on the outer wall and the inner wall of the supporting frame.

[0015] The utility model has at least the following beneficial effects:

[0016] The implantable medical device provided by the utility model expands the treatment area by arranging multiple first drug-loaded pointed bodies on the hollow corresponding coating of the supporting skeleton, so as to meet the treatment needs of different situations. The first pointed bodies are connected to the coating, which effectively prevents the first pointed bodies from detaching from the coating, thereby ensuring the stability of the structure and extending the service life. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a three-dimensional diagram of an implantable medical device provided by an embodiment of the utility model;

[0018] Figure 2 yes Figure 1 A partial enlarged view of the A portion of the implanted medical device;

[0019] Figure 3 yes Figure 2 A cross-sectional view of the implanted medical device along line CC;

[0020] Figure 4 yes Figure 1 A partial enlarged view of part B of the implanted medical device;

[0021] Figure 5 yes Figure 4 A cross-sectional view of the implanted medical device along line DD;

[0022] Figure 6 It is a top view of an implantable medical device provided by an embodiment of the utility model;

[0023] Figure 7 yes Figure 6 A partial enlarged view of the E portion of the implanted medical device;

[0024] Figure 8 It is a stereoscopic diagram of an implantable medical device provided by an embodiment of the utility model without a covering film;

[0025] Fig. 9 yes Figure 8 A partial enlarged view of the F portion of the implanted medical device;

[0026] Fig.10 yes Fig. 9 The cross-sectional view along line GG of the first embodiment of the implantable medical device provided by the utility model is shown;

[0027] Fig.11 yes Fig. 9 The cross-sectional view along line GG of the second embodiment of the implantable medical device provided by the utility model is shown;

[0028] Fig.12 The utility model is a combined diagram of an implantable medical device, a sheath tube and a balloon.

[0029] Explanation of the reference numerals: 100 - implantable medical device; 1 - wave ring; 11 - outer surface; 12 - side; 13 - inner surface; 2 - connecting rod; 3 - second pointed body; 31 - base; 4 - coating; 41 - covering space; 411 - opening; 5 - first pointed body; 51 - proximal bottom; 6 - sheath; 7 - balloon; 8 - hollow. DETAILED DESCRIPTION

[0030] The following provides a clear and complete description of the implantable medical device provided by the utility model in conjunction with the accompanying drawings. It is understood that the described embodiments are only some embodiments of the utility model, not all embodiments, and the utility model can be implemented in many other ways different from those described herein.

[0031] Unless otherwise defined, all technical terms and scientific terms used in this specification have the same meanings as those commonly understood by ordinary technicians in the technical field to which the utility model belongs. The terms used in this specification are only for describing specific embodiments and are not intended to limit the utility model.

[0032] It should be noted that all directional indications in the embodiments of this specification are only used to explain the relative position relationship, movement status, etc. between the components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0033] In addition, in the present invention, the descriptions of "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this specification, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0034] The technical solutions of the various embodiments of the present utility model can be combined with each other, but it must be based on the fact that ordinary technicians in the field can implement it. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by the present utility model.

[0035] In this specification, axial refers to the direction parallel to the line connecting the distal center and the proximal center of the component; radial refers to the direction perpendicular to the above axial direction; "proximal end" refers to the end close to the surface of the membrane support frame, and "distal end" refers to the end away from the surface of the membrane support frame. "Connection" can be a direct connection between two components or a connection through an intermediate medium.

[0036] The implantable medical device provided by the utility model can be an intraluminal implant, such as a tracheal stent, or can be other implants, such as a one-way valve used in lung volume reduction surgery.

[0037] Figures 1 to 7 The structure diagram of the implantable medical device 100 provided by an embodiment of the utility model is shown. Specifically, the implantable medical device 100 is a microneedle coated stent, including a coated support frame and a plurality of first drug-carrying spikes 5 disposed on the coated support frame. The coated support frame includes a support frame with a plurality of hollows 8 and a coating 4. The plurality of first spikes 5 are disposed on the outer surface of the coating 4. The outer surface here refers to the surface of the coating 4 away from the central axis X of the implantable medical device 100. The implantable medical device 100 also includes Figure 2 and Figure 3The plurality of second pointed bodies 3 provided on the outer wall of the supporting frame and loaded with drugs are shown. The outer wall here refers to the surface of the supporting frame away from the central axis X of the implanted medical device 100.

[0038] In one embodiment, the coating 4 covers the entire support skeleton and covers the entire hollowing 8. It is understandable that in other embodiments, the coating 4 may only cover part of the hollowing 8, that is, only cover part of the support skeleton, and the first pointed body 5 may also be only provided on the inner surface of the coating, that is, the surface close to the central axis X of the instrument, or may be provided on both the outer surface and the inner surface of the coating. Preferably, the support skeleton is mainly used to support the inner wall of the narrow part of the human body lumen so as to open it, thereby reducing the adverse effect of the narrow channel on the internal liquid circulation. The support skeleton is preferably a tubular structure, such as a cylindrical structure, an elliptical cylindrical structure, a frustum structure, etc. In the present embodiment, the support skeleton is preferably cylindrical, and in other embodiments, the support skeleton may also be a combination of one or more of the above structures.

[0039] Preferably, a plurality of first spikes 5 are located in the region of the coating 4 corresponding to the hollow 8, and the first spikes 5 are connected to the coating 4 or adapted to be movably limited by the coating 4. Compared with the prior art, by arranging the first spikes 5 in the region of the coating 4 corresponding to the hollow 8, the layout range of the first spikes 5 is expanded, breaking through the limitation of the support frame on the arrangement of the drug-loaded microneedles, so that after the device is implanted into the lesion tissue, the area other than the corresponding area of ​​the support frame can be treated, thereby improving the patient's disease to the greatest extent.

[0040] More preferably, if Figure 8 As shown, the support skeleton includes a support rod. The support rod may include a plurality of wave coils 1 and a connecting rod 2 for connecting two wave coils 1. The connecting rod 2 is located between two adjacent wave coils 1. The wave coil 1 is composed of a Z-shaped wave, and may also be made of other structures, which will not be described here. Furthermore, one end of the connecting rod 2 is fixedly connected to the wave coil 1 located at one end thereof, and the other end of the connecting rod 2 is fixedly connected to the wave coil 1 located at the other end thereof, thereby connecting and fixing the two adjacent wave coils 1. The wave coil 1 and the connecting rod 2 may be welded and fixed to each other, or may be integrally formed, etc., which will not be described here.

[0041] Furthermore, the wave ring 1 and / or the connecting rod 2 can be made of a material with good biocompatibility, such as nickel-titanium alloy, iron, magnesium alloy, stainless steel, polylactic acid, etc., which can be selected and set according to needs, so they are not described here.

[0042] Preferably, the coating 4 is made of commercially available biocompatible materials, such as ePTFE (clothing fabric laminated with polytetrafluoroethylene microporous membrane and ordinary fabric), PET (polyethylene terephthalate), silk fibroin, silicone, and the like.

[0043] More preferably, when the first pointed body 5 and the coating 4 are made of the same material, such as silk fibroin, the first pointed body 5 and the coating 4 can be integrally formed, so that the connection between the two can be more firmly made, and the process steps and difficulty can be reduced, thereby reducing costs.

[0044] 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. The added drugs can be anti-hyperplasia, therapeutic drugs and antibacterial drugs, etc. Common drugs are paclitaxel, rapamycin and its derivatives (such as sirolimus, zotarolimus, everolimus, tacrolimus and pimecrolimus), amine-coupled polyurethane (SA-PU) polymers, etc.

[0045] The coating 4 can cover the outer wall of the supporting frame, or the inner wall of the supporting frame. When the coating 4 is arranged on the outer wall of the supporting frame, the coating 4 can cover the entire outer wall of the supporting frame, or part of the outer wall of the supporting frame, such as covering one or both ends of the axial direction of the supporting frame, or covering the middle area of ​​the axial direction of the supporting frame, or covering other areas of the supporting frame, etc.; similarly, when the coating 4 is arranged on the inner wall of the supporting frame, the coating 4 can be attached to the entire inner wall of the supporting frame, or part of the inner wall of the supporting frame, such as attached to one or both ends of the axial direction of the supporting frame, or attached to the middle area of ​​the axial direction of the supporting frame, or attached to other areas of the supporting frame, etc.

[0046] More specifically, when a coating 4 is provided in the axial middle region of the support skeleton, the coating 4 in the middle region can better play a supporting and fixing role, and at the same time, a second drug-loaded pointed body 3 can be provided at both ends of the support skeleton at the same time, thereby having a therapeutic effect on the tissue, such as preventing granulation hyperplasia.

[0047] Preferably, the end of the first pointed body 5 facing the coating 4 is the proximal end, and the end away from the coating 4 is the distal end. The distal end is needle-shaped, and the cross-sectional area of ​​the distal end is smaller than that of the proximal end.

[0048] For details, please refer to Figures 5 to 7, the central axis y1 of the first spike 5, that is, the connection line y1 between the distal end point of the first spike 5 and the center of the proximal bottom 51 extends along the radial direction y2 of the implantable medical device 100. Thus, when the device is released at the lesion site, the radial support force or balloon expansion force from the membrane 4 acting on the first spike 5 is in the same direction as the central axis y1 of the first spike 5. Most of these forces act on the first spike 5, making the pressure of the head end of the first spike 5 piercing the tissue the largest, and it is easier to pierce the tissue. At the same time, the forces acting in other directions of the central axis y1 of the first spike 5 are smaller, such as the force in the direction perpendicular to the central axis y1 of the first spike 5, etc., which can prevent the first spike 5 from breaking. When the first spike 5 is also fixed to the inner surface of the membrane 4 (i.e., the surface close to the central axis X of the device), the first spike 5 extends towards the direction of the central axis X of the support framework and contacts and dissolves with the medium such as water in the support framework cavity, so as to achieve the therapeutic effect on the internal environment of the support framework.

[0049] Furthermore, there are multiple first spikes 5 and they are spaced apart from each other. The position of the first spikes 5 can be selected according to the position of diseases such as intimal hyperplasia or the position where the support framework needs to be fixed, etc. And the multiple first spikes 5 are spaced apart from each other, so that they can successfully pierce the tissue and achieve the treatment of diseases such as intimal hyperplasia.

[0050] Further, the first spike 5 can be directly fixed to the membrane 4. For example, the first spike 5 is adhesively fixed to the membrane 4, or the first spike 5 is integrally formed with the membrane 4, or other fixing connection methods are adopted between the first spike 5 and the membrane 4, which will not be elaborated here.

[0051] There are various connection methods between the first spike 5 and the membrane 4. As an exemplary embodiment, the membrane 4 can have multiple covering parts. These multiple covering parts can be directly formed when the membrane 4 is molded, thus reducing the process difficulty and improving the molding yield. Specifically, the covering part has a covering space 41 as shown, and the covering space 41 has an opening 411. The proximal bottom 51 of the first spike 5 is movably received in the covering space 41 and is limited by the membrane 4. The area of the opening 411 is smaller than the area of the proximal bottom 51 of the first spike 5, so as to prevent the first spike 5 from moving out from the opening 411, and make the first spike 5 movably restricted at the covering space 41. Figure 5 As shown, the covering space 41 has an opening 411, and the proximal bottom 51 of the first spike 5 is movably received in the covering space 41 and is limited by the membrane 4. The area of the opening 411 is smaller than the area of the proximal bottom 51 of the first spike 5, so as to prevent the first spike 5 from moving out from the opening 411, and make the first spike 5 movably restricted at the covering space 41.

[0052] In some other preferred embodiments, multiple first spikes 5 are close to the support framework and arranged along the edge of the support framework. The proximal bottom of each first spike 5 can be directly fixedly connected to the membrane 4, such as adhesively fixed, etc.

[0053] Specifically, part of the first spikes 5 can be arranged along the edge of the supporting frame, that is, the first spikes 4 are arranged close to the supporting frame, so that the supporting frame can partially shield and protect the first spikes 5 on its edge, making it difficult for the first spikes 5 to fall off.

[0054] In some preferred embodiments, some of the first spikes 5 are arranged along the edge of the support frame, and the proximal bottom 51 of each of the remaining first spikes 5 can be as shown in FIG. Figure 5 As shown, it is movably confined in an enclosing space 41 of the covering film 4 .

[0055] More specifically, since the supporting skeleton includes at least two wave coils 1 and a connecting rod 2 connecting the two wave coils 1, some 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 edges of both the wave coil 1 and the connecting rod 2, so that the first spikes 5 can be set at the desired position, expanding the arrangement range of the first spikes 5 and enhancing the stability of the structure and the therapeutic effect.

[0056] Furthermore, the first pointed body 5 arranged along the edge of the supporting frame can be directly fixed on the coating 4, for example, the first pointed body 5 and the coating 4 are adhesively fixed, or the first pointed body 5 and the coating 4 are integrally formed, or the first pointed body 5 and the coating 4 are fixedly connected in other ways, which will not be repeated here.

[0057] Preferably, the coating 4 has a plurality of mutually separated support layers (not shown), each support layer is fixedly connected to the coating 4, such as adhesive fixation, etc., and the plurality of support layers correspond to the plurality of first spikes 5 one by one, and each first spike 5 is fixedly connected to a support layer, and the hardness of the support layer is greater than the hardness of the first spike 5. The material of the support layer can be one or more of PVPK90 (polyvinylpyrrolidone), PEEK (polyetheretherketone), PMMA (polymethyl methacrylate), PTFE (polytetrafluoroethylene), or a metal material, such as nickel-titanium alloy. Preferably, the support layer can be a multi-layer structure, such as two layers, three layers, four layers or more layers, and the multi-layer support layers are stacked together to achieve stable support for the first spike 5, so that the first spike 5 can smoothly penetrate the tissue; further, each support layer can be made of different materials, so as to meet the requirements of different hardness, strength, etc. for each layer, and expand the scope of application.

[0058] Specifically, the support layer can be a cuboid or a cylinder, etc. The shape of the support layer can be set as needed. The support layer is fixedly connected to the coating 4 and the first pointed body 5, respectively, such as by adhesive fixation or other fixed connection methods, which will not be repeated here. The hardness of the support layer is greater than the hardness of the first pointed body 5, so that the connection strength between the first pointed body 5 and the coating 4 can be enhanced, and the first pointed body 5 can be stably supported, so that it can be smoothly inserted into the tissue.

[0059] Preferably, the first pointed body 5 is a cone or a polygonal pyramid, so that it can penetrate the tissue smoothly 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 repeated here.

[0060] Preferably, the height h of the first pointed body 5 is 1 Less than the thickness of the supporting frame h 2 The height h of the first pointed body 5 1 is the distance between the proximal bottom surface and the distal end of the first pointed body 5, and the thickness h of the supporting skeleton 2 is the distance between the outer surface of the supporting frame and its inner surface, such as Figure 7 The height of the first pointed body 5 is less than the thickness of the supporting frame, so that the supporting frame can protect the first pointed body 5 and prevent the first pointed body 5 from falling off or breaking. When the first pointed body 5 needs to penetrate the tissue, the coating 4 expands radially outward, so that the first pointed body 5 moves radially outward accordingly, so as to penetrate into the tissue, thereby achieving the effect of drug administration and fixation of the tissue.

[0061] The second pointed body 3 can be arranged only on the inner wall of the support frame, or only on the outer wall of the support frame, or on both the outer wall and the inner wall of the support frame. When the second pointed body 3 is arranged on the outer wall of the support frame, it can not only penetrate into the tissue to fix it, but also apply medicine to the tissue to achieve a therapeutic effect. When the second pointed body 3 is arranged on the inner wall of the support frame, it can contact and dissolve with an internal medium such as water, so that medicine can be applied to the internal environment of the support frame to achieve a therapeutic effect. The user can arrange the second pointed body 3 at the required position of the support frame as needed to meet different usage requirements.

[0062] like Fig. 9 and Fig.10 As shown, in one embodiment of the utility model, the second spike 3 is fixed on the support frame. A base 31 is provided between each second spike 3 and the support frame, the base 31 is fixedly connected to the support frame, the second spike 3 is fixedly connected to the base 31, and the hardness of the base 31 is greater than the hardness of the second spike 3.

[0063] Specifically, when the coating 4 covers at least part of the outer wall or at least part of the inner wall of the supporting frame, the second pointed body 3 and the coating 4 can be located on opposite sides of the supporting frame, or both are located on the same side of the supporting frame; when the coating 4 covers at least part of the outer wall and at least part of the inner wall of the supporting frame, the second pointed body 3 passes through the coating 4, specifically: when the second pointed body 3 is fixed on the outer wall of the supporting frame, the coating 4 covering the outer wall of the supporting frame covers one side of the tip of the second pointed body 3, and the tip of the second pointed body 3 passes through the coating 4, so that the coating 4 is smoothly wrapped on the outer wall of the supporting frame; or, when the second pointed body 3 is fixed on the inner wall of the supporting frame, the coating 4 covering the inner wall of the supporting frame covers one side of the tip of the second pointed body 3, and the tip of the second pointed body 3 passes through the coating 4, so that the coating 4 is smoothly fixed on the inner wall of the supporting frame.

[0064] More specifically, Fig.10 As shown, the base 31 is plate-shaped, and the base 31 is attached to the surface of the supporting frame and fixedly connected thereto. Specifically, the base 31 is attached to the surface of the wave coil 1 or the surface of the connecting rod 2, so that the base 31 can be firmly fixedly connected to the wave coil 1 or the connecting rod 2, such as by bonding, etc. At the same time, the hardness of the base 31 is greater than the hardness of the second pointed body 3, thereby providing stable support and fixing for the second pointed body 3.

[0065] Furthermore, one end of the base 31 is fixedly connected to the support frame, that is, the base 31 is fixedly connected to the wave ring 1, or the base 31 is fixedly connected to the connecting rod 2, so that the pointed body can be fixed to a required position on the support frame, such as a lesion position or a position that needs to be fixed, etc.

[0066] The substrate 31 is preferably made of one or more of PVPK90 (polyvinylpyrrolidone), PEEK (polyetheretherketone), PMMA (polymethyl methacrylate), PTFE (polytetrafluoroethylene), or a metal material, etc., which only needs to be harder than the second pointed body 3 and meet the support requirements. The substrate 31 can also be composed of a multi-layer structure, and each layer is made of one of the above materials, so as to meet different structural and strength requirements of the substrate 31.

[0067] In some preferred embodiments, Fig.11 As shown, the base 31 is in a closed ring shape, passing through two adjacent hollows 8 and wrapped around the support frame, thereby further enhancing the stability of the connection between the spike 3 and the support frame. The base 31 can be wrapped around the wave ring 1 or the connecting rod 2, so that the second spike 3 can be fixed to the required position on the support frame, so as to treat or fix the required part.

[0068] The matrix 31 can also only wrap part of the surface of the supporting skeleton, for example, the matrix 31 is wrapped on the outer surface 11 and part of the side surface 12 of the wave ring 1 or the connecting rod 2; or the matrix 31 is wrapped on the outer surface 11, side surface 12 and inner surface 13 of the wave ring 1 or the connecting rod 2; or the matrix 31 is wrapped on the inner surface 13 and part of the side surface 12 of the wave ring 1 or the connecting rod 2, etc.

[0069] In addition, the base 31 can also cooperate with the second pointed body 3 to surround the support frame, that is, the two cooperate to form a Fig.11 The annular matrix shown wraps the support frame. Specifically, part or all of the matrix 31 and part of the second pointed body 3 form an annular covering body that surrounds the support frame.

[0070] 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 (polyetheramine), gelatin, hyaluronic acid, silk protein, etc., and degradable materials are preferably used. Liposomes can be further dispersed in the first pointed body 5 and the second pointed body 3, which are prepared from phosphatidylcholine and cholesterol. The raw material liquid and liposomes of the first pointed body 5 and the second pointed body 3 can carry different drugs. The added drugs are for preventing hyperplasia, therapeutic drugs and antibacterial drugs, etc. Common drugs are paclitaxel, rapamycin and its derivatives (such as sirolimus, zotarolimus, everolimus, tacrolimus and pimecrolimus), amine-coupled polyurethane (SA-PU) polymers, etc.

[0071] Furthermore, the drug can be added to the raw material liquid to form the first spike 5 or the second spike 3. The drug content in the raw material liquid of the first spike 5 and the second spike 3 is 1% to 10%, and more preferably, the drug content in the raw material liquid of the first spike 5 and the second spike 3 is 1% to 5%. It can also be coated on the surface of the first spike 5 and the second spike 3, and the drug content is 1% to 20%. More preferably, the drug content is 10% to 15%, and the above ratio ranges are all mass percentages. Furthermore, the total drug content of the implant is 30 to 300ug. The above-mentioned total amount and percentage of the drug can ensure the therapeutic effect of the drug and reduce the occurrence of diseases such as intimal hyperplasia.

[0072] Furthermore, in order to meet the clinical needs of the target site, the first spike 5 and the second spike 3 can be designed with appropriate height, diameter, number, drug concentration, drug type, degradation rate, etc. For example, where the support frame exerts too much pressure on the tissue, it is easier to cause hyperplasia due to stimulation of the tissue, so more second spikes 3 can be set at this position; for another example, there is a shear force at the position where the support frame contacts the tissue, so it is easier to cause hyperplasia or form granulomas, so more drug-carrying second spikes 3 can be set to achieve a certain amount of drug to achieve the effect of preventing hyperplasia and granulomas. Multiple first spikes 5 and second spikes 3 can all carry different drugs, so that different diseases can be treated. Users can set them according to their needs, which will not be repeated here.

[0073] Further, such as Fig.12 As shown, when the implantable medical device of the utility model is used for tracheal or bronchial stenosis, the supporting frame is first pressed and gripped onto the surface of the balloon 7, and then loaded into the sheath 6 together. To ensure that the first spike 5 and the second spike 3 are not damaged when loaded into the sheath 6, the distance between the tips of the first spike 5 and the second spike 3 and the inner wall of the sheath 6 is L, wherein 0.1mm≤L≤0.5mm, thereby preventing the first spike 5 and the second spike 3 from hitting the sheath 6 during assembly, or preventing the contour of the sheath 6 from being too large, making it unsuitable for some patients. Then, under the guidance of the guide wire, the part of the sheath 6 loaded with the implanted medical device is transported to the target position, and liquid is injected into the balloon 7 and pressurized to 16 to 26 atmospheres, so that the support frame begins to expand under the push of the balloon 7, and then the first spike 5 and the second spike 3 penetrate into the tissue. At this time, the entire first spike 5 and the second spike 3 can be selected to penetrate the tissue as needed, or the first spike 5 and the second spike 3 can be partially penetrated into the tissue. If the support frame is a degradable material and the degradation rate is greater than the degradation rate of the first spike 5 and the second spike 3, there is no pressure on the tissue after degradation, reducing the risk of subsequent tissue hyperplasia. Compared with existing drug-carrying implantable medical devices, the first spike 5 and the second spike 3 can penetrate into the tissue, and as the first spike 5 and the second spike 3 degrade, the drug is slowly released to extend the drug's action time. The first spike 5 and the second spike 3 can carry a variety of drugs and drugs of different concentrations to achieve different effects. The first spike 5 and the second spike 3 are firmly connected to the supporting frame to effectively prevent the two from detaching, and have good stability and safety.

[0074] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it, and the application scenarios of the implanted medical devices are not limited to the fields described in the text; although the present invention has been described in detail with reference to the aforementioned embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some of the technical features therein with equivalents; and these 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 various embodiments of the present invention.

Claims

1. An implantable medical device, characterized in that: It comprises a coating support frame and a plurality of first drug-loaded pointed bodies (5), wherein the coating support frame comprises a supporting frame having a plurality of hollows (8), a coating (4) fixed to the supporting frame and covering at least a portion of the hollows (8), the plurality of first pointed bodies (5) being located in the coating (4) region corresponding to the hollows (8), and the first pointed bodies (5) being connected to the coating (4) or adapted to be movably limited by the coating (4).

2. The implantable medical device according to claim 1, characterized in that: The first pointed body (5) and the coating (4) are integrally formed.

3. The implantable medical device according to claim 1, characterized in that: The coating (4) has a plurality of support layers separated from each other, each of the support layers is fixed to the surface of the coating (4), the first pointed body (5) is fixedly connected to the support layer, and the hardness of the support layer is greater than the hardness of the first pointed body (5).

4. The implantable medical device according to claim 1, characterized in that: The coating (4) has a plurality of covering spaces (41), the area of ​​the opening (411) of the covering space (41) is smaller than the area of ​​the proximal bottom (51) of the first pointed body (5), and the proximal bottom (51) of each first pointed body (5) can be movably received in the covering space (41) and limited by the coating (4).

5. The implantable medical device according to claim 1, characterized in that: The plurality of first pointed bodies (5) are only provided on the inner surface of the coating (4); or the plurality of first pointed bodies (5) are only provided on the outer surface of the coating (4); or the plurality of first pointed bodies (5) are provided on both the inner surface and the outer surface of the coating (4).

6. The implantable medical device according to claim 1, characterized in that: A portion of the plurality of first pointed bodies (5) is arranged close to the edge of the supporting frame, and the proximal bottom of each of the first pointed bodies (5) in the portion is fixed to the surface of the coating (4).

7. The implantable medical device according to claim 6, characterized in that: The height of each of the first pointed bodies (5) in this part is smaller than the thickness of the supporting frame.

8. The implantable medical device according to claim 7, characterized in that: The coating (4) is provided with a plurality of covering spaces (41), and the proximal bottom (51) of each of the remaining parts of the plurality of first pointed bodies (5) can be movably received in one of the covering spaces (41) and limited by the coating (4), and the area of ​​the opening (411) of the covering space (41) is smaller than the area of ​​the proximal bottom (51) of the first pointed body (5).

9. The implantable medical device according to claim 1, characterized in that: The coating (4) is located at one end of the supporting frame in the axial direction; or the coating (4) is located in the middle region of the supporting frame in the axial direction.

10. The implantable medical device according to claim 1, characterized in that: The implantable medical device also includes a plurality of second pointed bodies (3) fixedly connected to the supporting frame and loaded with medicine, wherein the second pointed bodies (3) are arranged on the inner wall of the supporting frame; or the second pointed bodies (3) are arranged on the outer wall of the supporting frame; or the second pointed bodies (3) are arranged on the outer wall and the inner wall of the supporting frame.

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