Implantable medical device

Abstract

The utility model provides an implantable medical instrument which comprises a supporting framework and a plurality of first microneedles carrying medicine, and the supporting framework is provided with a plurality of supporting rods and a plurality of hollows. A base body is arranged between each first microneedle and the supporting rod. The base body wraps the supporting rod, and the first microneedle is located on the base body; or the base body and the first microneedles are matched to wrap the supporting framework. According to the utility model, the substrate wraps the support skeleton or the substrate and the first microneedle cooperatively wrap the support skeleton, so that the first microneedle is stably connected with the support skeleton, and the first microneedle can stably penetrate into tissues, thereby realizing the effects of administration treatment and support skeleton fixation.

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] As people's living standards improve, their dietary structure has changed dramatically. The incidence of some diseases has increased year by year, and lesions such as stenosis, rupture, and tumors have appeared in the lumen of the human body.

[0003] For the treatment of the above diseases, implanted medical devices are currently commonly used to improve the above diseases, such as implanting stents in the human lumen. Existing stents are divided into balloon-expandable stents and self-expanding stents according to the release method, bare stents and covered stents according to the shape, and absorbable stents and permanent stents according to the stability. Although implanted stents can achieve good clinical results, they can also cause a series of adverse reactions, such as neointimal hyperplasia, mid-term restenosis, etc. Therefore, drug-loaded implantable medical devices, such as drug-eluting stents, came into being.

[0004] Providing drug-loaded microneedles on the supporting frame of the implanted medical device can solve the above problems to a certain extent and achieve good long-term treatment effects, but the drug-loaded microneedles are prone to fall off during assembly, release or flushing before piercing the diseased tissue. Utility Model Content

[0005] The utility model provides an implantable medical device in which a drug-loaded microneedle is firmly connected to a supporting frame of the implantable medical device.

[0006] As conceived above, the technical solution adopted by the utility model is to provide an implantable medical device, including a supporting skeleton and a plurality of first drug-loaded microneedles, the supporting skeleton having a plurality of supporting rods and a plurality of hollows, a matrix being provided between each of the first microneedles and the supporting rods, the matrix covering the supporting rods, and the first microneedles being fixed on the matrix; or, the matrix and the first microneedle cooperate to cover the supporting rods.

[0007] Preferably, the hardness of the matrix is ​​greater than the hardness of the first microneedle.

[0008] Preferably, the substrate further comprises a protrusion, and the first microneedle covers the protrusion. The protrusion is located on at least a part of the surface of the substrate; or the protrusion cooperates with the substrate to cover the supporting frame.

[0009] Preferably, a water-soluble separation layer is provided between each of the first microneedles and the matrix.

[0010] Preferably, the implantable medical device also includes a coating, which covers at least part of the outer wall or at least part of the inner wall of the supporting skeleton, and the first microneedle and the coating are located on opposite sides or the same side of the supporting skeleton; or the coating covers at least part of the outer wall and at least part of the inner wall of the supporting skeleton, and the first microneedle passes through the coating.

[0011] Preferably, a plurality of mutually separated second drug-loaded microneedles are fixed on the surface of the covering film corresponding to the hollowing.

[0012] Preferably, the covering film has a plurality of covering portions, each of which covers the proximal end of one of the second microneedles.

[0013] Preferably, the support frame is cylindrical, and the central axis of the first microneedle extends along the radial direction of the support frame.

[0014] Preferably, the height of the second microneedle is less than or equal to the thickness of the supporting skeleton.

[0015] Preferably, the support rod comprises at least two corrugations and a connecting rod connecting the two corrugations, wherein the matrix covers the corrugations or the connecting rod; or, the matrix cooperates with the first microneedle to cover the corrugations or the connecting rod.

[0016] The implantable medical device provided by the utility model realizes a stable connection between the first microneedle and the supporting frame by coating the supporting frame with a matrix or by cooperating between the matrix and the first microneedle to coat the supporting frame. The first microneedle can stably penetrate the tissue to achieve the effects of drug administration and fixing the supporting frame. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a stereoscopic diagram of a first embodiment of the implantable medical device provided by the utility model;

[0018] Figure 2 yes Figure 1 A partial enlarged view of part A of the implantable medical device provided by the utility model is shown;

[0019] Figure 3 yes Figure 2 A cross-sectional view of the first embodiment of the first microneedle along line BB is shown;

[0020] Figure 4 yes Figure 2 A cross-sectional view of the second embodiment of the first microneedle along line BB is shown;

[0021] Figure 5 yes Figure 2 A cross-sectional view of the third embodiment of the first microneedle along line BB is shown;

[0022] Figure 6 yes Figure 2 A cross-sectional view of the fourth embodiment of the first microneedle along line BB;

[0023] Figure 7 It is a top view of the implantable medical device provided by the utility model;

[0024] Figure 8 yes Figure 7 A partial enlarged view of the C portion of the implantable medical device provided by the utility model is shown;

[0025] Fig. 9 yes Figure 8 A cross-sectional schematic diagram of a first microneedle of the present invention is shown;

[0026] Fig.10 is a stereoscopic diagram of a second embodiment of the implantable medical device provided by the utility model;

[0027] Fig.11 yes Fig.10 The partial enlarged view of the D part of the implanted medical device provided by the utility model is shown;

[0028] Fig.12 yes Fig.11 The cross-sectional view along line EE of the implantable medical device provided by the present invention is shown;

[0029] Fig.13 yes Fig.10 The top view of the implantable medical device provided by the utility model is shown;

[0030] Fig.14 yes Fig.13 The enlarged partial view of the F part of the implantable medical device provided by the utility model is shown;

[0031] Fig.15 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 ring; 11 - outer surface; 12 - side; 13 - inner surface; 2 - connecting rod; 3 - first microneedle; 31 - matrix; 311 - protrusion; 32 - separation layer; 4 - coating; 41 - covering; 5 - second microneedle; 6 - sheath; 7 - balloon; 8 - hollow. DETAILED DESCRIPTION

[0033] The following is 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 , Figure 7 and Figure 8 The first embodiment of the implantable medical device 100 provided by the utility model is shown, which is a drug-loaded bare stent, including a support frame with multiple hollows 8 and multiple support rods, and multiple drug-loaded first microneedles 3.

[0040] Specifically, the support frame is used to abut against the inner wall of the lumen to support it and improve its stenosis effect, ensuring the normal circulation of the internal liquid. A plurality of drug-loaded first microneedles 3 are arranged on the support rod, and the plurality of first microneedles 3 can penetrate into the inner wall of the lumen, so that on the one hand, the support frame can be fixed to prevent it from moving inside the lumen, and on the other hand, the first microneedles 3 can play a role in drug treatment of tissues.

[0041] Furthermore, the support frame is preferably a tubular structure, such as a cylindrical structure, an elliptical cylindrical structure, a frustum structure, etc. In this embodiment, the support frame is preferably cylindrical, and in other embodiments, the support frame may also be a combination of one or more of the above structures.

[0042] Further, in a preferred embodiment, the support rods of the support frame include: Figure 1 At least two corrugations 1 are shown and a connecting rod 2 is located between the corrugations 1. Preferably, the connecting rod 2 is located between two adjacent corrugations 1, and the corrugations 1 are composed of Z-shaped corrugations, and may also be made of other structures, which will not be described in detail here.

[0043] Preferably, one end of the connecting rod 2 is fixedly connected to the corrugated ring 1 at one end thereof, and the other end of the connecting rod 2 is fixedly connected to the corrugated ring 1 at the other end thereof, thereby connecting and fixing two adjacent corrugated rings 1. The corrugated ring 1 and the connecting rod 2 can be fixedly welded to each other or integrally formed, and the user can select the fixed connection method of the two as needed.

[0044] Preferably, the wave ring 1 and / or the connecting rod 2 are 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 in detail.

[0045] Preferably, a plurality of first microneedles 3 are arranged on the support frame. Specifically, a plurality of first microneedles 3 are arranged at any position on the outer surface of the support frame, or at any position on the inner surface of the support frame, or at any position on both the inner and outer surfaces of the support frame. It is understandable that, according to the common knowledge of ordinary technicians in this field, the outer surface of the support frame refers to the surface that contacts the tissue after it is implanted into the tissue, and the inner surface of the support frame refers to the surface opposite to the outer surface. When the first microneedle 3 is arranged on the outer surface of the support frame, it can penetrate the tissue, and the degraded liquid medicine on the surface of the first microneedle 3 can be introduced into the tissue to achieve a therapeutic effect; and when the first microneedle 3 is arranged on the inner surface of the support frame, the first microneedle 3 is in the tubular cavity medium, such as urine or water, and the surface of the first microneedle 3 degrades after contacting the tubular cavity medium, so that the degraded liquid medicine flows into the tubular cavity medium, thereby achieving a therapeutic effect.

[0046] Further, in a preferred embodiment, a plurality of first microneedles 3 are distributed on the outer surface of the support frame. The support frame has a central axis X, the end of the first microneedle 3 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 microneedle 3 is smaller than the proximal end cross-sectional area, thereby ensuring that the first microneedle 3 can penetrate the tissue. Further, the first microneedle 3 is preferably a cone, or a polygonal pyramid, etc. The shape of the first microneedle 3 can be selected and set as needed, which will not be repeated here.

[0047] like Fig. 9As shown, when the first microneedle 3 is a cone, the height H of the first microneedle 3 can be 450 μm to 650 μm, such as 450 microns, 500 microns, 550 microns, 600 microns, 650 microns, etc. The limitation of the above height range can, on the one hand, prevent the height from being too small and penetrating into the tissue to a small depth, or failing to penetrate the tissue, thereby failing to achieve a good fixation and treatment effect; on the other hand, it can prevent the height from being too large and easily piercing the lumen, causing bleeding or tissue fistula.

[0048] like Fig. 9 As shown, the diameter D of the bottom surface of the first microneedle 3 is 250 μm to 300 μm, such as 250 microns, 260 microns, 270 microns, 280 microns, 290 microns, 300 microns, etc. The limitation of the above diameter range can, on the one hand, prevent the diameter D from being too small, resulting in low strength, and easily deformed or broken when piercing the tissue, resulting in failure to penetrate the tissue; on the other hand, prevent the diameter D from being too large and exceeding the hole that can be expanded in the tissue, resulting in the first microneedle 3 being unable to penetrate the tissue.

[0049] like Fig. 9 As shown, the apex angle a of the first microneedle 3 is 5° to 90°. The above angle range is limited to prevent the apex angle a of the first microneedle 3 from being too small to affect the strength of the first microneedle 3 and cause deformation or breakage, and to prevent the apex angle a of the first microneedle 3 from being too large to penetrate the tissue.

[0050] It is understandable that the parameters such as the shape, height, bottom diameter and top angle of the first microneedle 3 can be set according to the actual application scenario.

[0051] Further, such as Figure 3 As shown, it shows a first embodiment of the first microneedle 3, which has a pointed cross-section and is fixed to the support rod of the support frame 1 through a substrate 31. The substrate 31 and the first microneedle 3 can be made of different materials, the hardness of the substrate 31 is greater than the hardness of the first microneedle 3, and the two can be bonded and fixed to each other; in other embodiments, the substrate 31 and the first microneedle 3 can also be made of the same material. In this case, the substrate 31 and the first microneedle 3 can be integrally formed or step-by-step formed, etc., which can be selected and set according to needs, and will not be repeated here.

[0052] Preferably, if Figure 3As shown, the matrix 31 passes through two adjacent hollows 8 and covers the wave ring 1 of the support frame in a closed ring shape. The first microneedle 3 is directly fixed on the surface of the matrix 31, that is, the matrix 31 is located between the first microneedle 3 and the support frame, thereby realizing a stable connection between the first microneedle 3 and the support frame, and enhancing the stability of the overall structure. In other embodiments, the matrix 31 can also cover the support rod in an unclosed ring shape, and only cover part of the surface of the support rod of the support frame. Specifically, the matrix 31 covers the outer surface 11 and part of the side 12 of the support frame, or covers the inner surface 13 and part of the side 12 of the support frame, or covers the outer surface 11, side 12 and part of the inner surface 13 of the support frame, or covers the inner surface 13, side 12 and part of the outer surface 11 of the support frame, etc., as long as the matrix 31 can be firmly connected to the support frame, the matrix 31 covering the support rod without closing can make the volume of the matrix 31 smaller, and then can be compressed into a smaller sheath tube, so as to expand the application scene and scope.

[0053] Specifically, the substrate 31 covering the support frame can be understood as the substrate 31 covering the wave ring 1, or the substrate 31 covering the connecting rod 2, or the substrate 31 covering the wave ring 1 and the connecting rod 2 at the same time, so that the first microneedle 3 can be firmly connected to the support frame, effectively preventing detachment, and the first microneedle 3 can smoothly penetrate the tissue, ensuring the stability and safety of the structure. The first microneedle 3 is located on the surface of the substrate 31 and is fixedly connected to the substrate 31, such as by bonding, so as to ensure the stability of the structure.

[0054] Preferably, if Figure 5 As shown, the matrix 31 and the first microneedle 3 can cooperate to cover the support frame, such as covering the wave circle 1, or covering the connecting rod 2, or covering the wave circle 1 and the connecting rod 2 at the same time. The matrix 31 and the first microneedle 3 cooperate to cover the support frame specifically: part or all of the matrix 31 and part of the first microneedle 3 form a closed or unclosed ring to cover the support frame, so that the first microneedle 3 can be firmly connected to the support frame to prevent the two from detaching, and the first microneedle 3 can smoothly penetrate the tissue to achieve the effect of treating diseases and fixation.

[0055] Furthermore, the substrate 31 is preferably made of one or more of PVPK90 (polyvinylpyrrolidone), PEEK (polyetheretherketone), PMMA (polymethyl methacrylate), and PTFE (polytetrafluoroethylene). The substrate 31 may also be composed of a multilayer structure, and each layer is made of one of the above materials, and the hardness of each layer can be set to be different, so as to meet different structural and strength requirements of the base layer 31.

[0056] Furthermore, the hardness of the matrix 31 is greater than the hardness of the first microneedle 3, thereby increasing the hardness and strength of the bottom of the first microneedle 3, so as to provide stable support for the first microneedle 3 and enable the first microneedle 3 to penetrate the tissue smoothly and firmly, thereby ensuring that the first microneedle 3 is not easily damaged and allowing the first microneedle 3 to function with maximum efficiency.

[0057] When the substrate 31 and the first microneedle 3 are integrally formed, the substrate 31 adopts the material of the first microneedle 3, that is, the substrate 31 and the first microneedle 3 are both made of degradable materials, so that they can be degraded during use, and can improve structural stability, reduce process difficulty and process steps, and save costs.

[0058] Figure 4 The second embodiment of the first microneedle 3 is shown. The first microneedle 3 can be designed with a multilayer structure, and each layer of the structure can contain different drugs or be made of materials with different degradation rates, so as to meet the treatment conditions of different diseases. For example, the distal needle tip of the first microneedle 3 uses an anti-infective drug and the proximal bottom uses an anti-intimal hyperplasia drug, so that after the first microneedle 3 penetrates the tissue, anti-infective treatment can be performed first, and then intimal hyperplasia can be prevented, so as to meet the treatment conditions of different diseases or diseases of different orders and achieve the best treatment effect.

[0059] In some embodiments, Figure 5 As shown, it is a third embodiment of the first microneedle 3, specifically, each substrate 31 also includes a protrusion 311, and the first microneedle 3 covers the protrusion 311, wherein the protrusion 311 is fixed to at least a portion of the surface of the substrate 31, and the substrate 31 covers the support rod of the support skeleton in a closed ring shape, thereby fixing the first microneedle 3 on the substrate 31.

[0060] In some embodiments, the cross section of the protrusion 311 is triangular, and the protrusion 311 is fixed to the outer surface of the base 31 (i.e., the outer surface of the supporting frame). The protrusion 311 and the base 31 can be integrally formed, or the protrusion 311 can be fixed to the base 31, such as by bonding. The first microneedle 3 is coated on the outer surface of the protrusion 311.

[0061] In other embodiments, a plurality of protrusions (not shown) are provided on the outer surface of the protrusion 311. The protrusions may be arranged equidistantly, in a matrix, or as needed on the outer surface of the protrusion 311. The protrusions may be hemispherical, triangular pyramidal, cone-shaped, etc. The shape of the protrusions may be selected and set as needed. The protrusions and the protrusions 311 may be integrally formed or bonded and fixed, and the connection method between the protrusions and the protrusions 311 may also be selected and set as needed. The first microneedle 3 is coated on the protrusions, thereby enhancing the stable connection between the first microneedle 3 and the protrusion 311 and ensuring the stability of the overall structure.

[0062] In other embodiments, the protrusion 311 cooperates with the base 31 to cover the support frame 1, that is, the base 31 is in an unclosed ring shape and only covers a portion of the surface of the support frame 1. The proximal end of the protrusion 311 and the base 31 together form a closed ring or an unclosed ring to cover the support frame 1, so that the first microneedle 3 can be firmly fixed on the support frame, and the fixing effect is significant.

[0063] In some embodiments, Figure 6 As shown, it is a fourth embodiment of the first microneedle 3 , and specifically, a water-soluble separation layer 32 is provided between each first microneedle 3 and the matrix 31 .

[0064] Specifically, the water-soluble separation layer 32 is made of a material that is easily separated, preferably a water-soluble adhesive, such as polyethylene glycol hydrogel, so that when the device encounters the liquid in the lumen at a predetermined position, it will quickly dissolve, thereby achieving the separation of the first microneedle 3 and the matrix 31; it can also be composed of hyaluronic acid and sucrose, with a mass ratio of hyaluronic acid to sucrose of 4:1, which can also play a role in separation.

[0065] The separation layer 32 can play a specific separation role, such as withdrawing an implanted medical device, and the separation of the matrix 31 and the first microneedle 3 can be achieved only when the separation layer 32 is dissolved after contacting the lumen medium.

[0066] In some embodiments, Figure 7 and Figure 8 As shown, the first microneedle 3 is a cone or a polygonal pyramid, and the first microneedle 3 has a central axis y 2 , center axis y 2 is the line connecting the distal tip of the first microneedle 3 and the center point of the proximal bottom surface, and the central axis y of the first microneedle 3 2 Along the radial direction of the support frame 1 The radial support force or balloon expansion force received by the first microneedle 3 from the support frame is extended to the central axis y of the first microneedle 3. 2 In one direction, the pressure of the tip of the first microneedle 3 penetrating the tissue is maximized, making it easier to penetrate the tissue. 2 The force in the vertical direction is relatively small, thereby preventing the first microneedle 3 from breaking.

[0067] Figures 10 to 14 The second embodiment of the implantable medical device provided by the utility model is shown, which has a support frame with the same structure as the first embodiment, except that the device is a membrane-covered stent, that is, the surface of the support frame 1 provided in the first embodiment is covered with a membrane 4, and a plurality of mutually separated second drug-carrying microneedles 5. The second microneedles 5 are fixed to the surface of the membrane 4 located in the hollow 8.

[0068] The coating 4 can be fixed to the inner surface or the outer surface of the support frame, or to both the inner surface and the outer surface of the support frame. 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 microneedle (not shown) and the coating 4 can be located on opposite sides of the support frame, or both can be 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 distal end of the first microneedle passes through the coating 4. In other embodiments, the surface of the coating 4 is not provided with the second microneedle 5.

[0069] The membrane 4 is made of a material with good biocompatibility, such as ePTFE (clothing fabric laminated with polytetrafluoroethylene microporous membrane and ordinary fabric), PET (polyethylene terephthalate), silk fibroin, silicone, etc. The membrane 4 can be fixed on the inner surface of the corrugated ring 1, or the outer surface of the corrugated ring 1, or fixed on both the inner surface and the outer surface of the corrugated ring 1.

[0070] In some preferred embodiments, the second microneedle 5 and the coating 4 can be made of the same material, such as silk fibroin. In this case, the second microneedle 5 and the coating 4 can be integrally formed, so that the connection between the two can be more firmly connected, and the process steps and difficulty can be reduced, thereby reducing costs.

[0071] Furthermore, the second microneedle 5 can be arranged 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 contacts the tissue after the device is implanted into the tissue, 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.

[0072] Furthermore, when the second microneedles 5 are simultaneously arranged on the inner surface and the outer surface of the coating 4, the second microneedles 5 on the inner surface and the outer surface of the coating 4 can carry different drugs, so that different therapeutic effects can be achieved according to the different environments inside and outside the coating 4. In other embodiments, the second microneedles 5 on the inner surface and the outer surface of the coating 4 can carry the same drugs, which will not be repeated here.

[0073] Furthermore, the coating 4 has a plurality of covering portions 41, such as Fig.12As shown, the partially formed covering portion 41 of the coating 4 has a covering space, and the covering portion 41 covers the proximal end of the second microneedle 5, that is, the proximal end of the second microneedle 5 can be movably 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 microneedle 5, so that the proximal end 51 of the second microneedle 5 can be confined in the covering space, and at the same time, its distal end extends out of the covering portion 41 to prevent the proximal end 51 of the second microneedle 5 from moving out of the opening 411, so that the connection between the second microneedle 5 and the coating 4 can be achieved, and the second microneedle 5 can be protected, and at the same time, the second microneedle 5 can be smoothly inserted into the tissue.

[0074] like Fig.13 and Fig.14 As shown, the second microneedle 5 is disposed on the outer surface of the film 4 and is located in the hollow area 8 corresponding to the support frame. Preferably, the height h of the second microneedle 5 is 1 (the distance between the distal needle tip and the center of the proximal bottom) is smaller than the distance between the radial outer surface 11 of the support frame 1 and its radial inner surface 13, that is, smaller than the thickness h of the support frame 1 2 , so that the supporting skeleton 1 can protect the second microneedle 5, prevent the second microneedle 5 from falling off from the covering film 4, and ensure the stability of the structure.

[0075] Further, the solvent of the raw material liquid of the first microneedle 3 and / or the second microneedle 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. The first microneedle 3 and / or the second microneedle 5 can further be dispersed with liposomes, which are prepared from phosphatidylcholine and cholesterol. The raw material liquid and liposomes of the first microneedle 3 and / or the second microneedle 5 can carry different drugs, and 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.

[0076] Further, the drug can be added to the raw material liquid to form the first microneedle 3 and / or the second microneedle 5, and the drug content in the raw material liquid of the first microneedle 3 and / or the second microneedle 5 is 1% to 10%, and more preferably, the drug content in the raw material liquid of the first microneedle 3 and / or the second microneedle 5 is 1% to 5%. The surface of the first microneedle 3 and / or the second microneedle 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. Further, 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.

[0077] Furthermore, in order to meet the clinical needs of the target site for drug efficacy, the first microneedle 3 and / or the second microneedle 5 can be designed with appropriate height, diameter, number, drug concentration, drug type, degradation rate, etc. For example, where the support skeleton exerts too much pressure on the tissue, more first microneedles 3 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 skeleton contacts the tissue, so it is more likely to produce hyperplasia or form granulomas. Therefore, more drug-loaded first microneedles 3 can be set to achieve a certain amount of drug to achieve the effect of preventing hyperplasia and granulomas.

[0078] Furthermore, a plurality of first microneedles 3 may be arranged on the support frame as described in the first embodiment, and the plurality of first microneedles 3 may carry different drugs, thereby achieving the treatment of different diseases. The user may set them as needed, which will not be described in detail here.

[0079] Further, such as Fig.15As shown, when the implantable medical device provided by the utility model is used to treat tracheal or bronchial stenosis, the support skeleton 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 microneedle 3 and / or the second microneedle 5 are not damaged when loaded into the sheath 6, the distance between the tip of the first microneedle 3 and / or the second microneedle 5 and the inner wall of the sheath 6 is L, wherein 0.1mm≤L≤0.5mm, thereby preventing the first microneedle 3 and / or the second microneedle 5 from touching the sheath 6 during assembly, or preventing the contour of the sheath 6 from being too large, making it inapplicable to 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 skeleton begins to expand under the push of the balloon 7, and then the first microneedle 3 and / or the second microneedle 5 penetrates the tissue. At this time, the entire first microneedle 3 and / or the second microneedle 5 can be selected to penetrate the tissue as needed, or the first microneedle 3 and / or the second microneedle 5 can be partially penetrated into the tissue. If the support skeleton is a degradable material and the degradation rate is greater than the degradation rate of the first microneedle 3 and / or the second microneedle 5, 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 microneedle 3 and / or the second microneedle 5 can penetrate into the tissue, and as the first microneedle 3 and / or the second microneedle 5 degrade and slowly release the drug, the drug's action time is prolonged. The first microneedle 3 and / or the second microneedle 5 can carry a variety of drugs and drugs of different concentrations to achieve different effects. The first microneedle 3 and / or the second microneedle 5 are firmly connected to the supporting frame, effectively preventing the two from detaching, and have good stability and safety.

[0080] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the utility model, 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 utility model is described in detail with reference to the above embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the above embodiments, or replace some of the technical features therein with equivalents; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the various embodiments of the utility model.

Claims

1. An implantable medical device, comprising a support frame and a plurality of first drug-loaded microneedles (3), wherein the support frame has a plurality of support rods and a plurality of hollows (8), characterized in that: A matrix (31) is provided between each of the first microneedles (3) and the support rod; the matrix (31) covers the support rod, and the first microneedle (3) is fixed on the matrix (31); or the matrix (31) and the first microneedle (3) cooperate to cover the support rod.

2. The implantable medical device according to claim 1, characterized in that: The hardness of the matrix (31) is greater than the hardness of the first microneedle (3).

3. The implantable medical device according to claim 1, characterized in that: The substrate (31) further comprises a protrusion (311), the first microneedle (3) covers the protrusion (311), and the protrusion (311) is located on at least a portion of the surface of the substrate (31); or, the protrusion (311) cooperates with the substrate (31) to cover the supporting skeleton.

4. The implantable medical device according to claim 1, characterized in that: A water-soluble separation layer (32) is provided between each of the first microneedles (3) and the matrix (31).

5. The implantable medical device according to claim 1, characterized in that: The implantable medical device also includes a coating (4), wherein the coating (4) covers at least part of the outer wall or at least part of the inner wall of the supporting skeleton, and the first microneedle (3) and the coating (4) are located on opposite sides or on the same side of the supporting skeleton; or, the coating (4) covers at least part of the outer wall and at least part of the inner wall of the supporting skeleton, and the first microneedle (3) passes through the coating (4).

6. The implantable medical device according to claim 5, characterized in that: A plurality of mutually separated and drug-carrying second microneedles (5) are fixed on the surface of the covering film (4) corresponding to the hollowing.

7. The implantable medical device according to claim 6, characterized in that: The covering film (4) has a plurality of covering portions (41), and each covering portion (41) covers the proximal end of one of the second microneedles (5).

8. The implantable medical device according to claim 1, characterized in that: The support frame is cylindrical, and the central axis (y2) of the first microneedle (3) extends along the radial direction (y1) of the support frame.

9. The implantable medical device according to claim 6, characterized in that: The height of the second microneedle is less than or equal to the thickness of the supporting frame.

10. The implantable medical device according to claim 1, characterized in that: The support rod comprises at least two wave coils (1) and a connecting rod (2) connecting the two wave coils (1), wherein the matrix (31) covers the wave coils (1) or the connecting rod (2); or, the matrix (31) cooperates with the first microneedle (3) to cover the wave coils (1) or the connecting rod (2).

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