Implantable medical device

Abstract

The utility model provides an implantable medical device which comprises a plurality of hollow supporting frameworks and a plurality of microneedles, each microneedle comprises a connecting layer and a first medicine carrying pointed body, the connecting layers are respectively connected with the supporting frameworks and the first medicine carrying pointed bodies, and the hardness of the connecting layers is larger than that of the first medicine carrying pointed bodies. The connecting layer with higher hardness is arranged between the first medicine carrying pointed body and the supporting framework, the first medicine carrying pointed body can be stably supported and fixed, the structure is stable, the effect is remarkable, the first medicine carrying pointed body can be effectively prevented from being broken, and the service life is prolonged.

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 diseases such as stenosis, rupture, and tumors in the human lumen, the main existing treatment method is to implant medical devices, such as stents, in the human lumen to open up the narrow part of the channel, thereby improving the treatment effect. However, stents can also cause a series of adverse reactions, such as neointimal hyperplasia and mid-term restenosis. In response to this, drug stents have also emerged. Drug stents are equipped with drug-loaded microneedles on the stents. The microneedles penetrate into the tissue to achieve the purpose of drug treatment, prevention of hyperplasia and infection. However, the drug-loaded microneedles on the drug stents are usually of low hardness, which makes it easy to break at the connection with the stent, and it is unable to provide stable support and fixation for the microneedles. At the same time, the microneedles are easily damaged when subjected to force. Utility Model Content

[0003] The utility model provides an implantable medical device capable of realizing a stable connection between a microneedle and a supporting frame.

[0004] As conceived above, the technical solution adopted by the utility model is to provide an implantable medical device, including a plurality of hollow support skeletons and a plurality of microneedles, each microneedle including a connecting layer and a first drug-carrying tip, the connecting layer being respectively connected to the support skeleton and the first drug-carrying tip, and the hardness of the connecting layer being greater than the hardness of the first drug-carrying tip.

[0005] Preferably, the connecting layer wraps around the supporting skeleton.

[0006] Preferably, the connecting layer and the first drug-carrying spike cooperate to surround the supporting framework.

[0007] Preferably, the connecting layer is in contact with the surface of the supporting frame.

[0008] Preferably, the connecting layer has a first covering portion, which covers the side surface of the first drug-carrying tip and exposes the tip of the first drug-carrying tip.

[0009] Preferably, the connection layer has a coating frame, the coating frame has a through hole, the first drug-carrying pointed body is accommodated in the coating frame, and a portion of the first drug-carrying pointed body is exposed from the through hole.

[0010] Preferably, the connecting layer is located between the supporting framework and the first drug-carrying spike.

[0011] Preferably, the first drug-carrying pointed body is a cone or a polygonal pyramid, the supporting frame is cylindrical, and the central axis of the first drug-carrying pointed body is colinear with the radius of the supporting frame.

[0012] Preferably, at least part of the outer wall and / or at least part of the inner wall of the support frame is provided with a coating, and a plurality of second drug-carrying spikes separated from each other are provided on the surface of the coating.

[0013] Preferably, the coating has at least one second covering portion, and each second covering portion covers the proximal end of one of the second drug-carrying tips.

[0014] The utility model has at least the following beneficial effects:

[0015] The implantable medical device of the utility model is provided with a connecting layer between the first drug carrying tip and the supporting frame, and the hardness of the connecting layer is greater than the hardness of the first drug carrying tip, so that the first drug carrying tip can be stably supported and the first drug carrying tip can be firmly fixed on the supporting frame, thereby achieving stable fixation of the implantable medical device of the utility model in the human body's lumen, with a stable structure and significant effect, and can effectively prevent the first drug carrying tip from breaking, thereby extending its service life. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a stereoscopic diagram of a first embodiment of the implantable medical device provided by the utility model;

[0017] Figure 2 yes Figure 1 A partial enlarged view of part A of the implantable medical device provided by the utility model is shown;

[0018] Figure 3 yes Figure 2 A cross-sectional view along line BB of the first embodiment of the microneedle provided by the utility model is shown;

[0019] Figure 4 yes Figure 2 A cross-sectional view along line BB of the second embodiment of the microneedle provided by the present invention is shown;

[0020] Figure 5 yes Figure 2 A cross-sectional view along line BB of the third embodiment of the microneedle provided by the present invention is shown;

[0021] Figure 6 yes Figure 2 A cross-sectional view along line BB of the fourth embodiment of the microneedle provided by the present invention is shown;

[0022] Figure 7 yes Figure 2 A cross-sectional view along line BB of the fifth embodiment of the microneedle provided by the present invention is shown;

[0023] Figure 8 yes Figure 2 A cross-sectional view along line BB of the sixth embodiment of the microneedle provided by the present invention is shown;

[0024] Fig. 9 yes Figure 1 The top view of the implantable medical device provided by the utility model is shown;

[0025] Fig.10 yes Fig. 9 A partial enlarged view of the C portion of the implantable medical device provided by the utility model is shown;

[0026] Fig.11 is a stereoscopic diagram of a second embodiment of the implantable medical device provided by the utility model;

[0027] Fig.12 yes Fig.11 The partial enlarged view of the D part of the implanted medical device provided by the utility model is shown;

[0028] Fig.13 yes Fig.12 The cross-sectional view along line EE of the implantable medical device provided by the present invention is shown;

[0029] Fig.14 yes Fig.11 The top view of the implantable medical device provided by the utility model is shown;

[0030] Fig.15 yes Fig.14 The enlarged partial view of the F part of the implantable medical device provided by the utility model is shown;

[0031] Fig.16 The utility model is a combined diagram of an implantable medical device, a sheath tube and a balloon.

[0032] Explanation of the reference numerals: 100 - implantable medical device; 1 - wave coil; 2 - connecting rod; 3 - microneedle; 31 - connecting layer; 311 - protrusion; 312 - first coating portion; 313 - coating frame; 3131 - through hole; 32 - first drug-carrying tip; 33 - separation layer; 4 - coating; 41 - second coating portion; 411 - opening; 5 - second drug-carrying tip; 51 - proximal end; 6 - sheath; 7 - balloon; 8 - hollow. DETAILED DESCRIPTION

[0033] 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 understandable 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] In this specification, the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the component; the radial direction refers to the direction perpendicular to the axial direction.

[0039] Figures 1 to 3 A first embodiment of the implantable medical device 100 provided by the utility model is shown. In this embodiment, the implantable medical device 100 is a tracheal stent, including a supporting skeleton with a plurality of hollows 8 and a plurality of microneedles 3, each of the microneedles 3 including a connecting layer 31 and a first drug-carrying pointed body 32, the connecting layer 31 is respectively connected to the supporting skeleton and the first drug-carrying pointed body 32, and the hardness of the connecting layer 31 is greater than the hardness of the first drug-carrying pointed body 32.

[0040] In other embodiments, the support frame is used to support the human lumen to prevent it from being narrowed, and may be an intraluminal implant or other implant, such as a one-way valve product used in lung volume reduction surgery.

[0041] Preferably, 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. In other embodiments, the support skeleton may also be a combination of one or more of the above structures.

[0042] Preferably, the support frame includes at least two wave coils 1 and a connecting rod 2 for connecting the 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 can also be made of other structures, which will not be repeated 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 can be welded and fixed to each other, or they can be integrally formed, etc., which will not be repeated here.

[0043] Furthermore, the wave ring 1 and / or the connecting rod 2 are made of materials 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.

[0044] In some preferred embodiments, Figure 3 As shown, the connecting layer 31 is plate-shaped, and the connecting layer 31 is attached to the surface of the supporting skeleton. Specifically, the connecting layer 31 is attached to the surface of the wave coil 1 or the surface of the connecting rod 2, so that the connecting layer 31 can be firmly fixed to the wave coil 1 or the connecting rod 2, such as adhesive fixation, etc. At the same time, the hardness of the connecting layer 31 is greater than the hardness of the first drug-carrying spike 32, so as to provide stable support and fixation for the first drug-carrying spike 32 and prevent the first drug-carrying spike 32 from breaking.

[0045] Furthermore, the connecting layer 31 is located between the first drug-carrying spike 32 and the supporting frame, one end of the connecting layer 31 is fixedly connected to the supporting frame, such as by bonding, and the other end of the connecting layer 31 is fixedly connected to the first drug-carrying spike 32, such as by bonding, thereby achieving a stable connection between the first drug-carrying spike 32 and the supporting frame, and the hardness of the connecting layer 31 is greater than the hardness of the first drug-carrying spike 32, thereby providing a stable support for the first drug-carrying spike 32, preventing the first drug-carrying spike 32 from breaking, and allowing it to stably penetrate the tissue, thereby ensuring the stability of the structure and the therapeutic effect.

[0046] Specifically, one end of the connecting layer 31 is fixedly connected to the supporting frame, that is, the connecting layer 31 is fixedly connected to the wave ring 1, or the connecting layer 31 is fixedly connected to the connecting rod 2, so that the microneedle 3 can be fixed at the required position on the supporting frame, such as the lesion position or the position that needs to be fixed.

[0047] Preferably, the connection layer 31 is made of a stable and non-degradable material, such as a metal material or a non-degradable non-metal material, preferably one or more of PVPK90 (polyvinylpyrrolidone), PEEK (polyetheretherketone), PMMA (polymethyl methacrylate), and PTFE (polytetrafluoroethylene). The connection layer 31 may 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 connection layer 31.

[0048] Furthermore, the first drug-loaded spike 32 is preferably made of a degradable material, so that the first drug-loaded spike 32 can be degraded in the tissue after penetrating the tissue, thereby allowing the drug in the first drug-loaded spike 32 to be released into the tissue, thereby having a therapeutic effect on the tissue and preventing the occurrence of tissue endothelial hyperplasia and the like.

[0049] In a preferred embodiment, a plurality of connection layers 31 are distributed on the outer surface of the support frame, which is the surface of the support frame in contact with the inner wall thereof after being implanted in a human body lumen or the like. The support frame has a central axis X, the end of the first drug-carrying spike 32 close to the support frame is the proximal end, and the end away from the support frame is the distal end, and the distal end cross-sectional area of ​​the first drug-carrying spike 32 is smaller than the proximal end cross-sectional area, thereby ensuring that the first drug-carrying spike 32 can penetrate the tissue. Furthermore, the first drug-carrying spike 32 is preferably a cone, or a polygonal cone, etc. The shape of the first drug-carrying spike 32 can be selected and set as needed, which will not be described in detail here.

[0050] In some preferred embodiments, Figure 4 As shown, the connecting layer 31 is in a closed ring shape or an unclosed arc shape, passing through two adjacent hollows 8 and wrapped around the supporting frame, thereby further enhancing the stability of the connection between the microneedle 3 and the supporting frame. Specifically, the connecting layer 31 is wrapped around the wave ring 1, or wrapped around the connecting rod 2, so that the first drug-loaded pointed body 32 can be fixed to the required position on the supporting frame, so as to treat or fix the required part.

[0051] More preferably, the connecting layer 31 cooperates with the first drug-carrying spike 32 to surround the support frame, such as around the wave ring 1, or around the connecting rod 2, or around the wave ring 1 and the connecting rod 2. The connecting layer 31 cooperates with the first drug-carrying spike 32 to surround the support frame specifically: part or all of the connecting layer 31 and part of the first drug-carrying spike 32 form an annular covering body that surrounds the support frame, so that the microneedle 3 and the support frame can be firmly connected to prevent the two from detaching, and the microneedle 3 can smoothly penetrate the tissue to achieve the effect of treating diseases and fixation.

[0052] In some preferred embodiments, Figure 5As shown, each microneedle 3 further includes a protrusion 311 , and the first drug-carrying pointed body 32 covers the protrusion 311 , wherein the protrusion 311 is located on at least a portion of the surface of the connecting layer 31 .

[0053] In this embodiment, the cross section of the protrusion 311 is triangular, and the protrusion 311 and the connecting layer 31 can be integrally formed, or the protrusion 311 can be fixed to the connecting layer 31, such as by bonding. The first drug-carrying spike 32 is needle-shaped, and the first drug-carrying spike 32 is coated on the outer surface of the protrusion 311, so that the first drug-carrying spike 32 can be firmly fixed to the connecting layer 31.

[0054] In other embodiments, the protrusion 311 and the connecting layer 31 cooperate to cover the support frame. The protrusion 311 and the connecting layer 31 together form an annular covering body covering the support frame, so that the microneedle 3 can be firmly fixed on the support frame, and the fixing effect is significant.

[0055] In some preferred embodiments, Figure 6 As shown, each microneedle 3 further includes a water-soluble separation layer 33 disposed between the connecting layer 31 and the first drug-carrying pointed body 32 .

[0056] Specifically, the water-soluble separation layer 33 is made of a material that is easily separated, preferably a water-soluble adhesive, such as polyethylene glycol hydrogel, so that it will quickly dissolve after encountering liquids such as water, thereby achieving the separation of the first drug-carrying tip 32 and the connecting layer 31; it can also be composed of hyaluronic acid and sucrose, with the mass ratio of hyaluronic acid to sucrose being 4:1, which can also play a role in separation.

[0057] Specifically, the separation layer 33 can play a specific separation role, such as withdrawing the implanted medical device 100, and the connection layer 31 and the first drug-carrying tip 32 can be separated only when the separation layer 33 is dissolved after contacting water or the like.

[0058] In some preferred embodiments, Figure 7 As shown, the connection layer 31 has a first covering portion 312 , and the first covering portion 312 covers the side surface of the first drug-carrying pointed body 32 . The first covering portion 312 exposes the tip of the first drug-carrying pointed body 32 .

[0059] Specifically, there is one first covering portion 312, and may also be provided with two or more. When there is one first covering portion 312, the first covering portion 312 is plate-shaped, and the first covering portion 312 is located on one side of the first drug-carrying tip 32; when there are two first covering portions 312, the first covering portions 312 are located on two adjacent sides or two opposite sides of the first drug-carrying tip 32, etc.; when there are multiple first covering portions 312, the first covering portions 312 are located on multiple adjacent sides or other multiple sides of the first drug-carrying tip 32, etc., and may be set at corresponding positions as needed.

[0060] More specifically, the first covering portion 312 can also be formed into a ring shape and wrapped around the end of the first drug-carrying tip 32 close to the supporting frame, thereby fully wrapping the end of the first drug-carrying tip 32, so as to firmly fix the first drug-carrying tip 32 on the supporting frame and provide support for the first drug-carrying tip 32. At the same time, the size of the first drug-carrying tip 32 can be designed to be smaller so that it can be more conveniently inserted into the tissue, thereby reducing costs and alleviating the patient's pain.

[0061] In the present embodiment, two first covering portions 312 are provided and are respectively located on both sides of the first drug loading point 32. The first covering portion 312 is preferably plate-shaped. The first covering portion 312 is abutted against the side surface of the first drug loading point 32, which is beneficial to fix the first drug loading point 32 and enhance the stability of the connection between the first drug loading point 32 and the connecting layer 31. The first covering portion 312 and the first drug loading point 32 can be adhesively fixed or otherwise fixedly connected. In other embodiments, the first covering portion 312 can be first formed or fixed on the supporting frame, and then the first drug loading point 32 can be molded with the cooperation of the first covering portion 312 and the mold, etc., so as to reduce the process difficulty and improve the product yield.

[0062] Furthermore, the first covering portion 312 and the connecting layer 31 may be bonded and fixed, or may be integrally formed, etc. The user may select and configure the configuration as required, which will not be described in detail herein.

[0063] In some preferred embodiments, Figure 8 As shown, the connecting layer 31 includes a covering frame 313, and the covering frame 313 has a plurality of through holes 3131. The first drug-carrying tip 32 is accommodated in the covering frame 313, and a portion of the first drug-carrying tip 32 is exposed from the through holes 3131. A plurality of through holes 3131 are provided and are arranged in sequence on the covering frame 313 at intervals, thereby increasing the exposed area of ​​the first drug-carrying tip 32, so that the area of ​​the first drug-carrying tip 32 in contact with the tissue is larger, and the treatment effect is more significant.

[0064] Specifically, the covering frame 313 is preferably a pointed body, such as a cone or a polygonal pyramid. The covering frame 313 and the connecting layer 31 can be bonded and fixed or integrally formed, and the user can choose the setting according to needs, and it only needs to achieve a firm connection between the covering frame 313 and the connecting layer 31.

[0065] Furthermore, the coating frame 313 is hollow, and the side of the coating frame 313 is provided with a through hole 3131 penetrating the inner and outer surfaces thereof, so that the inner and outer spaces of the coating frame 313 can be connected. The first drug-carrying spike 32 is contained in the coating frame 313, and part of the first drug-carrying spike 32 is exposed from the through hole 3131, so that the drug on the first drug-carrying spike 32 can contact with the inner wall tissue of the human lumen, air, water, etc., the surface of the first drug-carrying spike 32 is degraded, and the internal drug is released into the body, thereby exerting the effects of drug prevention and treatment, etc. At the same time, the setting of the coating frame 313 can further enhance the structural stability of the microneedle 3, prevent the first drug-carrying spike 32 from breaking, and further extend the service life of the utility model.

[0066] In some preferred embodiments, Fig. 9 and Fig.10 As shown, the first drug-carrying pointed body 32 is a cone or a multi-faceted pyramid, and the first drug-carrying pointed body 32 has a central axis y 2 , center axis y 2 is the line connecting the tip of the first drug-carrying spike 32 and the center point of its bottom surface, and the central axis y of the first drug-carrying spike 32 2 Collinear with a radius of the supporting skeleton.

[0067] The above-mentioned structure can make the first drug-carrying pointed body 32 stably penetrate into the tissue, prevent the first drug-carrying pointed body 32 from breaking, and achieve significant treatment and stabilization effects.

[0068] In some preferred embodiments, Figures 11 to 15As shown, at least part of the outer wall and / or at least part of the inner wall of the support frame is provided with a coating 4. When the coating 4 covers at least part of the outer wall or at least part of the inner wall of the support frame, the first drug-carrying spike (not shown) can be located on opposite sides of the support frame with the coating 4, or both are located on the same side of the support frame. When the coating 4 covers at least part of the outer wall and at least part of the inner wall of the support frame, the first drug-carrying spike passes through the coating 4. A plurality of second drug-carrying spikes 5 separated from each other are provided on the surface of the coating 4. In other embodiments, no second drug-carrying spike 5 is provided on the surface of the coating 4. The coating 4 is made of biocompatible materials, such as ePTFE (clothing fabric laminated with polytetrafluoroethylene microporous membrane and ordinary fabric), PET (polyethylene terephthalate), silk fibroin, silicone, etc. The coating 4 is fixed to the inner surface, or the outer surface, or both of the inner and outer surfaces of the supporting frame. Specifically, the coating 4 is fixed to the inner surface, or the outer surface, or both of the inner and outer surfaces of the wave ring 1.

[0069] Furthermore, when the second drug-carrying tip 5 and the coating 4 are made of the same material, such as silk fibroin, the second drug-carrying tip 5 and the coating 4 can be integrally formed, thereby making the connection between the two more firmly, reducing the process steps and difficulty, and lowering the cost.

[0070] Furthermore, the second drug-carrying spike 5 can be disposed on the outer surface of the coating 4, or on the inner surface of the coating 4, or on both the inner and outer surfaces of the coating 4. The outer surface of the coating 4 here refers to the surface of the coating 4 that is not in contact with the outer wall of the support frame, and the inner surface here refers to the surface of the coating 4 that is located in the inner cavity of the support frame and is not in contact with the inner wall of the support frame.

[0071] Furthermore, when the second drug-carrying spike 5 is disposed on the coating 4, the height h of the second drug-carrying spike 5 is 1 Less than the thickness of the supporting frame h 2 Therefore, the supporting frame can shield and protect the second drug-carrying pointed body 5, thereby preventing the second drug-carrying pointed body 5 from being broken or damaged when piercing the tissue.

[0072] Furthermore, the coating 4 has a second covering portion 41, that is, the coating 4 is provided with a plurality of second covering portions 41, and a covering space is formed inside each second covering portion 41, and the second covering portion 41 covers a portion of a second drug-carrying pointed body 5, that is, the proximal end 51 of the second drug-carrying pointed body 5 is accommodated in the covering space, and the area of ​​the opening 411 of the covering space is smaller than the area of ​​the proximal end 51 of the second drug-carrying pointed body 5, so that the proximal end 51 of the second drug-carrying pointed body 5 can be movably accommodated in the covering space and will not move out of the opening 411, so as to realize the connection between the second drug-carrying pointed body 5 and the second covering portion 41, and the second drug-carrying pointed body 5 can smoothly penetrate into the tissue. It should be noted that the proximal end 51 is the end of the second drug-carrying pointed body 5 close to the coating 4.

[0073] Further, the solvent of the raw material liquid of the first drug-carrying spike 32 and the second drug-carrying spike 5 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., preferably a degradable material. Liposomes can be further dispersed in the first drug-carrying spike 32 and the second drug-carrying spike 5, which are prepared from phosphatidylcholine and cholesterol. The raw material liquid and liposomes of the first drug-loaded spike 32 and the second drug-loaded spike 5 can carry different drugs. The added drugs are for preventing hyperplasia, treating diseases 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.

[0074] Furthermore, the drug can be added to the raw material liquid to form the first drug-carrying spike 32 or the second drug-carrying spike 5. The drug content in the raw material liquid of the first drug-carrying spike 32 and the second drug-carrying spike 5 is 1% to 10%, and more preferably, the drug content in the raw material liquid of the first drug-carrying spike 32 and the second drug-carrying spike 5 is 1% to 5%. The surfaces of the first drug-carrying spike 32 and the second drug-carrying spike 5 can also be coated with a drug content of 1% to 20%, and 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 implanted medical device 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.

[0075] Furthermore, in order to meet the clinical needs of the target site for drug efficacy, the first drug-carrying spike 32 and the second drug-carrying spike 5 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, more first drug-carrying spikes 32 and second drug-carrying spikes 5 can be set at this position because the stimulation of the tissue is more likely to cause hyperplasia. For another example, there is shear force at the position where the support frame contacts the tissue, so it is more likely to produce hyperplasia or form granulomas. Therefore, more first drug-carrying spikes 32 and second drug-carrying spikes 5 can be set to reach a certain amount of drug to achieve the effect of preventing hyperplasia and granuloma.

[0076] Furthermore, multiple first drug-carrying spikes 32 and second drug-carrying spikes 5 can be set on the same implantable medical device. The multiple first drug-carrying spikes 32 and second drug-carrying spikes 5 can adopt different heights, diameters, quantities, drug concentrations, degradation rates, etc., so as to meet the different needs of different parts and expand the application scope of the implantable medical device.

[0077] Furthermore, a plurality of first drug-carrying spikes 32 and second drug-carrying spikes 5 can be arranged on the supporting frame and the coating 4, and the plurality of first drug-carrying spikes 32 and second drug-carrying spikes 5 can carry different drugs, thereby achieving the treatment of different diseases. The user can set them according to needs, which will not be repeated here.

[0078] Further, such as Fig.16As 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 drug-carrying tip 32 and the second drug-carrying tip 5 are not damaged when loaded into the sheath 6, the distance between the tips of the first drug-carrying tip 32 and the second drug-carrying tip 5 and the inner wall of the sheath 6 is L, wherein 0.1mm≤L≤0.5mm, thereby preventing the first drug-carrying tip 32 and the second drug-carrying tip 5 from touching 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 drug-loaded spike 32 and the second drug-loaded spike 5 penetrate into the tissue. At this time, the entire first drug-loaded spike 32 and the second drug-loaded spike 5 can be selected to penetrate the tissue as needed, or the first drug-loaded spike 32 and the second drug-loaded spike 5 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 drug-loaded spike 32 and the second drug-loaded spike 5, there will be no compression on the tissue after degradation, reducing the risk of subsequent tissue hyperplasia. Compared with existing drug-carrying implantable medical devices, the first drug-carrying spike 32 and the second drug-carrying spike 5 can penetrate into the interior of the tissue, and as the first drug-carrying spike 32 and the second drug-carrying spike 5 degrade, the drugs are slowly released to extend the drug action time, and the first drug-carrying spike 32 and the second drug-carrying spike 5 can carry a variety of drugs and drugs of different concentrations to achieve different effects, and the first drug-carrying spike 32 is firmly connected to the supporting frame, and the second drug-carrying spike 5 is firmly connected to the coating 4, which effectively prevents the two from detaching, and has good stability and safety.

[0079] 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, comprising a support frame having a plurality of hollows (8) and a plurality of microneedles (3), characterized in that: Each of the microneedles (3) comprises a connecting layer (31) and a first drug-carrying pointed body (32), wherein the connecting layer (31) is connected to the supporting frame and the first drug-carrying pointed body (32) respectively, and the hardness of the connecting layer (31) is greater than the hardness of the first drug-carrying pointed body (32).

2. The implantable medical device according to claim 1, characterized in that: The connecting layer (31) wraps the supporting frame.

3. The implantable medical device according to claim 1, characterized in that: The connecting layer (31) and the first drug-carrying spike (32) cooperate to surround the supporting frame.

4. The implantable medical device according to claim 1, characterized in that: The connecting layer (31) is in contact with the surface of the supporting frame.

5. The implantable medical device according to claim 1, characterized in that: The connecting layer (31) has a first covering portion (312), wherein the first covering portion (312) covers the side surface of the first drug-carrying pointed body (32) and exposes the tip of the first drug-carrying pointed body (32).

6. The implantable medical device according to claim 1, characterized in that: The connecting layer (31) has a covering frame (313), the covering frame (313) has a through hole (3131), the first drug-carrying pointed body (32) is accommodated in the covering frame (313), and a portion of the first drug-carrying pointed body (32) is exposed from the through hole (3131).

7. The implantable medical device according to claim 1, characterized in that: The connecting layer (31) is located between the supporting skeleton and the first drug-carrying pointed body (32).

8. The implantable medical device according to claim 7, characterized in that: The first drug-carrying pointed body (32) is a cone or a polygonal pyramid, the supporting frame is cylindrical, and the central axis (y2) of the first drug-carrying pointed body (32) is colinear with the radius of the supporting frame.

9. The implantable medical device according to claim 1, characterized in that: At least part of the outer wall and / or at least part of the inner wall of the support frame is provided with a coating (4), and a plurality of second drug-carrying spikes (5) separated from each other are provided on the surface of the coating (4).

10. The implantable medical device according to claim 9, characterized in that: The coating (4) has at least one second covering portion (41), and each of the second covering portions (41) covers the proximal end of one of the second drug-carrying pointed bodies (5).

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