Implantable medical device

Abstract

The utility model provides an implantable medical device which comprises a support with a plurality of hollowed-out parts and a plurality of microneedles arranged on the support, the implantable medical device further comprises buffer pieces arranged between the support and the microneedles, and the buffer pieces are fixedly connected with the support and the microneedles respectively. According to the utility model, the buffer piece is arranged between the microneedle and the bracket, so that the stress concentration at the connecting position of the microneedle and the bracket is reduced, thereby effectively preventing the connecting position of the microneedle and the bracket from generating a gap or breaking and the like, and ensuring the use safety.

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] With the aging of the population and changes in dietary structure, the incidence of some diseases such as coronary artery stenosis, aneurysm, tracheal stenosis, urethral stenosis, etc. has increased year by year.

[0003] The current main treatment for these diseases is to implant medical devices, such as stents, into the body's lumen to expand the narrowed passages, thereby improving the therapeutic effect. Existing stents are divided into metal stents and non-metallic stents based on their material. Metal stents are further divided into bare stents and covered stents. These stents can cause a series of adverse reactions after implantation, such as neointimal hyperplasia, stent thrombosis, and mid-term restenosis. With the advent of drug-eluting stents, the drugs in drug-eluting stents act on the target location over the long term, such as for therapeutic administration, prevention of hyperplasia, and prevention of infection, with significant long-term therapeutic effects.

[0004] To securely secure a stent within the lumen, microneedles are typically placed on the stent, which then penetrate the tissue to secure the stent within the lumen. However, microneedles are typically quite hard, and the joint between the microneedle and the stent is particularly hard. This can lead to stress concentration and cracks or breakage at the joint when the microneedle penetrates the tissue or when the tissue moves, compromising safety. Utility Model Content

[0005] In order to overcome the above technical problems, the utility model provides an implantable medical device that prevents gaps or breaks from forming at the connection between the microneedle and the bracket.

[0006] As conceived above, the technical solution adopted by the utility model is:

[0007] An implantable medical device comprises a bracket having multiple hollow parts and a plurality of microneedles arranged on the bracket. The implantable medical device also comprises a buffer member arranged between the bracket and each of the microneedles, and the buffer member is fixedly connected to the bracket and the microneedles respectively.

[0008] Preferably, the hardness of the buffer is smaller than the hardness of the microneedle.

[0009] Preferably, the bracket includes a supporting frame, the microneedle includes a first pointed body, and the buffer member includes a first buffer portion, and the first buffer portion is fixed between the first pointed body and the supporting frame.

[0010] Preferably, the first buffer portion covers at least a portion of the supporting frame.

[0011] Preferably, the first pointed body is provided with a first groove, and the first buffer portion is fixed in the first groove.

[0012] Preferably, the first pointed body is provided with a first channel, and the first buffer portion passes through the first channel.

[0013] Preferably, the first buffer portion includes a covering portion, which covers a side surface of the first pointed body and exposes a tip of the first pointed body.

[0014] Preferably, the first buffer portion further includes a fixing portion, the first pointed body is provided with a receiving groove, and the fixing portion is received in the receiving groove.

[0015] Preferably, the first buffer portion includes a protrusion, and the first pointed body covers and is fixed to the protrusion.

[0016] Preferably, the stent further includes a coating, the microneedle includes a second pointed body, the buffer member includes a second buffer portion, and the second buffer portion is fixed between the second pointed body and the coating.

[0017] The utility model has at least the following beneficial effects:

[0018] The implantable medical device of the utility model provides a buffer between the microneedle and the bracket, thereby reducing stress concentration at the connection between the microneedle and the bracket, effectively preventing gaps or breakage at the connection between the microneedle and the bracket, ensuring safety of use. The provision of the buffer makes the connection between the microneedle and the bracket more stable, simplifying the process difficulty. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a perspective view of a first embodiment of the implantable medical device provided by the present invention;

[0020] Figure 2 yes Figure 1 a top view of the implanted medical device shown;

[0021] Figure 3 yes Figure 2 A partial enlarged view of site A of the implanted medical device;

[0022] Figure 4 yes Figure 3 A schematic cross-sectional view of the first pointed body shown;

[0023] Figure 5 yes Figure 3 A cross-sectional view of a first embodiment of the first tip and the stent is shown;

[0024] Figure 6 yes Figure 3A cross-sectional view of a second embodiment of the first tip and the support is shown;

[0025] Figure 7 yes Figure 3 a cross-sectional view of a third embodiment of the first tip and the stent;

[0026] Figure 8 yes Figure 3 a cross-sectional view of a fourth embodiment of the first tip and stent shown;

[0027] Figure 9 yes Figure 3 a cross-sectional view of a fifth embodiment of the first tip and stent shown;

[0028] Figure 10 yes Figure 3 a cross-sectional view of a sixth embodiment of the first tip and stent shown;

[0029] Figure 11 yes Figure 3 a cross-sectional view of a seventh embodiment of the first tip and stent shown;

[0030] Figure 12 yes Figure 3 a cross-sectional view of an eighth embodiment of the first tip and stent shown;

[0031] Figure 13 yes Figure 3 a cross-sectional view of a ninth embodiment of the first tip and stent;

[0032] Figure 14 This is a perspective view of a second embodiment of the implantable medical device provided by the present invention;

[0033] Figure 15 yes Figure 14 A partial enlarged view of part B of the implantable medical device provided by the present invention is shown;

[0034] Figure 16 yes Figure 15 The cross-sectional view of the implantable medical device provided by the present invention along the CC line is shown;

[0035] Figure 17 This is a combined diagram of the implantable medical device, sheath and balloon provided by the present invention.

[0036] Explanation of the reference numerals: 100 - implantable medical device; 1 - wave coil; 11 - second groove; 2 - connecting rod; 3 - first pointed body; 31 - first groove; 32 - first channel; 33 - receiving groove; 4 - first buffer portion; 41 - second channel; 42 - protrusion; 43 - covering portion; 44 - fixing portion; 45 - separation portion; 5 - coating; 6 - second pointed body; 7 - second buffer portion; 8 - sheath; 9 - balloon; 10 - hollow. DETAILED DESCRIPTION

[0037] The following is a clear and complete description of the implantable medical device provided by the present invention in conjunction with the accompanying drawings. It is understood that the embodiments described are only some embodiments of the present invention, not all embodiments, and the present invention can be implemented in many other ways than those described herein.

[0038] Unless otherwise defined, all technical and scientific terms used in this specification have the same meanings as those commonly understood by those skilled in the art to which this utility model belongs. The terms used in this specification are only for describing specific embodiments and are not intended to limit this utility model.

[0039] 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 various components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0040] In addition, the terms "first," "second," and so on, used in this disclosure are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Therefore, features specified as "first" or "second" may explicitly or implicitly include at least one such feature. Throughout this specification, "plurality" means at least two, such as two or three, unless otherwise specifically defined.

[0041] The technical solutions of the various embodiments of the present invention can be combined with each other, but they must be based on the fact that they can be implemented by ordinary technicians in this field. 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 this utility model.

[0042] In this specification, the axial direction refers to a direction parallel to the line connecting the distal center and the proximal center of the component; the radial direction refers to a direction perpendicular to the axial direction.

[0043] The following combination Figures 1 to 17 Provide a clear and complete description of the implantable medical device of the present invention.

[0044] The implantable medical device of the present invention includes a bracket with multiple hollows 10 and multiple microneedles arranged on the bracket. The implantable medical device also includes a buffer member arranged between the bracket and the microneedles, and the buffer member is fixedly connected to the bracket and the microneedles respectively.

[0045] Preferably, the stent can be a bare stent, such as Figure 1 As shown; it can also be a covered stent, such as Figure 14 When the stent is a coated stent, the stent comprises a bare stent and a coating 5 provided on the bare stent, and the coating 5 covers at least a portion of the inner wall and / or outer wall of the bare stent.

[0046] More preferably, the microneedles are fixed on the stent, and the microneedles are used to penetrate into the tissue of the inner wall of the lumen to achieve the purpose of firmly fixing the stent in the lumen. A plurality of microneedles can be provided, and they can be randomly distributed on the stent or regularly distributed to achieve the purpose of firmly fixing the stent in the lumen.

[0047] More preferably, the buffer is fixed between the microneedle and the bracket, so that it can buffer the stress transmitted to the microneedle, reduce the stress concentration at the connection between the microneedle and the bracket, and prevent gaps or fractures from occurring at the connection between the buffer and the bracket, thereby significantly improving safety.

[0048] Furthermore, the hardness of the buffer is lower than that of the microneedles. Preferably, the buffer is made of an elastic material, such as ePTFE (a garment fabric made by laminating a microporous polytetrafluoroethylene membrane with ordinary fabric), silk fibroin, silicone, etc. The selection of such materials makes the buffer harder than the microneedles, resulting in a more ideal cushioning effect and further improving safety in use.

[0049] The following describes the implantable medical device of the present invention using a bare stent as the first embodiment and a coated stent as the second embodiment.

[0050] First implementation method

[0051] In this embodiment, a bare stent is used as an example for description. Figures 1 to 13 As shown, the bracket includes a supporting frame, which is a tubular structure, such as cylindrical, elliptical, frustum, cone, etc. The supporting frame can also be a combination of the above structures, etc. Its specific shape can be selected and set according to needs, and is not specifically limited here.

[0052] Furthermore, the support frame includes a plurality of corrugations 1 and a connecting rod 2 connecting any two corrugations 1. The corrugations 1 are Z-shaped and arranged in sequence. Preferably, the central axes of the corrugations 1 are collinear, so that the corrugations 1 can be arranged neatly.

[0053] Furthermore, a connecting rod 2 is located between two adjacent corrugated rings 1, with one end of the connecting rod 2 fixedly connected to the corrugated ring 1 at one end, and the other end of the connecting rod 2 fixedly connected to the corrugated ring 1 at the other end, thereby connecting and fixing the two adjacent corrugated rings 1. The corrugated rings 1 and the connecting rod 2 can be welded to each other or integrally formed, which will not be described in detail here.

[0054] Furthermore, the wave ring 1 and the connecting rod 2 are made of materials with good biocompatibility, such as nickel-titanium alloy, iron, magnesium alloy, stainless steel, polylactic acid, silk fibroin, etc. The wave ring 1 and the connecting rod 2 are preferably formed in one piece, which can simplify the process and improve the structural stability.

[0055] In one embodiment, the microneedle includes a first pointed body 3 , and the buffer member includes a first buffer portion 4 , and the first buffer portion 4 is fixed between the first pointed body 3 and the supporting frame.

[0056] Preferably, the first pointed body 3 includes a proximal end and a distal end, wherein the proximal end is the end close to the supporting frame and the distal end is the end away from the supporting frame, wherein the cross-sectional area of ​​the distal end of the first pointed body 3 is smaller than the cross-sectional area of ​​the proximal end, thereby ensuring that the first pointed body 3 can smoothly penetrate the tissue. Furthermore, the first pointed body 3 is a cone, a polygonal pyramid, etc. The shape of the first pointed body 3 can be selected and set according to needs, and no specific limitation is made here.

[0057] More preferably, if Figure 4 As shown, when the first pointed body 3 is a cone, the height H of the first pointed body 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 the tissue to a small depth, or failing to penetrate the tissue, thereby failing to achieve good fixation and treatment effects; on the other hand, it can prevent the height from being too large and easily piercing the tube wall, causing bleeding or tissue fistula.

[0058] More preferably, if Figure 4 As shown, the diameter D of the bottom surface of the first pointed body 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 penetrating the tissue, resulting in failure to penetrate the tissue; on the other hand, prevent the diameter D from being too large and exceeding the expandable hole of the tissue, resulting in the first pointed body 3 being unable to penetrate the tissue.

[0059] Further preferably, the top angle a of the first pointed body 3 is 5° to 90°. The limitation of the above angle range, on the one hand, prevents the top angle a of the first pointed body 3 from being too small to affect the strength of the first pointed body 3 and cause deformation or breakage, and on the other hand, prevents the top angle a of the first pointed body 3 from being too large to penetrate the tissue.

[0060] It is understandable that parameters such as the shape, height, bottom diameter and top angle of the first pointed body 3 can be set according to actual application scenarios.

[0061] In order to ensure that the first pointed body 3 penetrates the tissue with maximum efficiency and plays a role, the line y2 connecting the distal end and the proximal end center of the first pointed body 3 is collinear with a radial direction y1 of the supporting frame, as shown in FIG. Figure 2 and Figure 3 shown.

[0062] Furthermore, the first buffer portion 4 is located between the first spike 3 and the supporting frame, such as between the first spike 3 and the wave ring 1, or between the first spike 3 and the connecting rod 2, thereby achieving a stable connection between the first spike 3 and the supporting frame.

[0063] Furthermore, the first buffer portion 4 and the first pointed body 3 or the supporting frame are connected by covering or fixed by gluing, etc. The user can choose the setting according to needs, and no specific limitation is made here.

[0064] In one embodiment, the first buffer portion 4 at least covers a portion of the supporting frame.

[0065] Preferably, when the first buffer portion 4 is provided on the wave ring 1, Figure 5 As shown, the first buffer portion 4 is flat and is located between the first pointed body 3 and the wave ring 1, thereby achieving a stable connection between the first pointed body 3 and the wave ring 1; similarly, when the first buffer portion 4 is arranged on the connecting rod 2, the first buffer portion 4 can also be flat and located between the first pointed body 3 and the connecting rod 2, thereby achieving a stable connection between the first pointed body 3 and the connecting rod 2.

[0066] More preferably, if Figure 7 As shown, when the first buffer portion 4 is arranged on the wave coil 1, a second channel 41 is provided in the first buffer portion 4, the wave coil 1 passes through the second channel 41 and is fixedly connected to the first buffer portion 4. At this time, the first buffer portion 4 is in a closed ring shape and covers the wave coil 1, thereby achieving a firm connection between the first pointed body 3 and the wave coil 1; similarly, when the first buffer portion 4 is arranged on the connecting rod 2, the first buffer portion 4 is provided with a second channel 41 and the connecting rod 2 passes through the second channel 41. The first buffer portion 4 is in a closed ring shape and covers the connecting rod 2, thereby achieving a firm connection between the first pointed body 3 and the connecting rod 2.

[0067] In one embodiment, a second groove 11 is provided on the support frame, and the lower end of the first buffer portion 4 is fixed in the second groove 11 .

[0068] Preferably, if Figure 6 As shown, when the second groove 11 is provided on the corrugated ring 1, the second groove 11 is formed by being recessed inward from the outer surface of the corrugated ring 1. The shape of the second groove 11 can be selected and set as needed and is not specifically limited here. The lower end of the first buffer portion 4 is received in the second groove 11 and is fixedly connected to the corrugated ring 1.

[0069] In other embodiments, when the second groove is provided on the connecting rod 2, the second groove is formed by being recessed inward from the outer surface of the connecting rod 2. The shape of the second groove can be selected and set as needed and is not specifically limited here. The lower end of the first buffer portion 4 is received in the second groove and is fixedly connected to the connecting rod 2.

[0070] In one embodiment, the first pointed body 3 is provided with a first groove 31 , and the first buffer portion 4 is fixed in the first groove 31 .

[0071] Preferably, if Figure 9 As shown, the first groove 31 is formed inwardly from the proximal end surface of the first pointed body 3. The shape of the first groove 31 is adapted to the shape of the first buffer portion 4, so that the first buffer portion 4 is received in the first groove 31 and fixedly connected to the first pointed body 3. In some embodiments, the first buffer portion 4 can be entirely received in the first groove 31. In some embodiments, the first buffer portion 4 can be partially received in the first groove 31. The user can select the setting as needed, and no specific limitation is given here.

[0072] More preferably, if Figure 9 As shown, the wave coil 1 passes through the second channel 41 of the first buffer portion 4 and is fixedly connected to the first buffer portion 4. In other embodiments, the first buffer portion 4 can also be a non-closed ring and fixedly connected to the wave coil 1 and the first pointed body 3 respectively, thereby achieving a fixed connection between the first pointed body 3 and the wave coil 1 and achieving a buffering effect on the first pointed body 3.

[0073] More preferably, in other embodiments, when the first buffer portion 4 is provided on the connecting rod 2 , it can refer to the connection method between the first buffer portion 41 and the wave ring 1 described above, which will not be repeated here.

[0074] In one embodiment, the first pointed body 3 is provided with a first channel 32 , and the first buffer portion 4 passes through the first channel 32 .

[0075] Preferably, if Figure 10As shown, the first channel 32 passes through the front and rear surfaces of the first pointed body 3. The shape of the first channel 32 can be selected and set as needed and is not specifically limited here. In this embodiment, the cross-section of the first channel 32 is a triangle.

[0076] More preferably, if Figure 10 As shown, the first buffer portion 4 is accommodated in the first channel 32 and fixedly connected thereto. The shape of the first buffer portion 4 is adapted to the shape of the first channel 32, so that the outer surface of the first buffer portion 4 is firmly in contact with and fixedly connected to the inner wall of the first channel 32. In this embodiment, the cross-section of the first buffer portion 4 is triangular.

[0077] More preferably, if Figure 10 As shown, the corrugated ring 1 passes through the second channel 41 of the first buffer portion 4 and is fixedly connected thereto, thereby achieving a stable connection between the first spike 3 and the corrugated ring 1. In other embodiments, for example, when the first spike 3 is disposed on the connecting rod 2, the connecting rod 2 passes through the second channel 41 of the first buffer portion 4 and is fixedly connected thereto, thereby achieving a stable connection between the first spike 3 and the connecting rod 2.

[0078] In one embodiment, the first buffer portion 4 includes a covering portion 43, which covers the side surface of the first pointed body 3 and exposes the tip of the first pointed body 3. Figure 11 shown.

[0079] Preferably, the covering portion 43 can be annular, radially covering a portion of the circumference of the first pointed body 3; in other embodiments, the covering portion 43 can also be plate-shaped or arc-shaped, that is, it is a non-closed ring along the radial direction of the first pointed body 3 and only covers a portion of the circumference of the first pointed body 3.

[0080] More preferably, the covering portion 43 covers the proximal circumference of the first pointed body 3 and is provided with an opening at the distal end, thereby exposing the tip of the first pointed body 3, that is, the distal end of the first pointed body 3. Thus, the covering portion 43 can play a structural reinforcement role for the first pointed body 3 and prevent it from breaking.

[0081] More preferably, only one covering portion 43 may be fixed to the circumferential surface of the first pointed body 3, or multiple covering portions 43 may be fixed at the same time. When multiple covering portions 43 are fixed to the circumferential surface of the first pointed body 3, multiple covering portions 43 may be sequentially terminated and closely attached to the circumferential surface of the first pointed body 3, or multiple covering portions 43 may be arranged at intervals and attached to the circumferential surface of the first pointed body 3.

[0082] Furthermore, preferably, the shape of the covering portion 43 matches the shape of the first pointed body 3. For example, when the first pointed body 3 is a cone, the covering portion 43 is preferably truncated cone-shaped. For example, when the first pointed body 3 is a polygonal pyramid, the covering portion 43 is preferably polygonal pyramid-shaped. With the above definition, the contact between the first pointed body 3 and the covering portion 43 is made tighter and more secure, thereby enhancing the stability of the overall structure.

[0083] Furthermore, the covering portion 43 can be a frame, the covering portion 43 has a cavity, and the opening at its distal end is connected to the cavity. The proximal end of the first pointed body 3 is formed in the cavity of the covering portion 43, and the proximal end of the first pointed body 3 is accommodated in the covering portion 43, and the distal end of the first pointed body 3 is exposed from the opening, so that the distal end of the first pointed body 3 can smoothly contact the tissue, so as to penetrate the tissue and have a therapeutic effect on the tissue.

[0084] More preferably, the covering portion 43 and the first buffer portion 4 are integrally formed, thereby enhancing structural stability and simplifying the process difficulty. In other embodiments, the covering portion 43 can also be made of other materials used to reinforce the first pointed body 3. The user can choose the setting according to needs, and no specific limitation is made here.

[0085] In one embodiment, the first buffer portion 4 further includes a fixing portion 44, the first pointed body 3 is provided with a receiving groove 33, and the fixing portion 44 is received in the receiving groove 33. Figure 12 shown.

[0086] Preferably, the receiving groove 33 is formed by being recessed inward from the proximal end surface of the first pointed body 3 . The shape of the receiving groove 33 can be selected and set as needed. In this embodiment, the cross-section of the receiving groove 33 is rectangular.

[0087] More preferably, the fixing portion 44 is fixedly connected to the first buffer portion 4. In other embodiments, the fixing portion 44 and the first buffer portion 4 are integrally formed. The user can select and set it according to needs, and no specific limitation is made here.

[0088] More preferably, the shape of the fixing portion 44 matches the shape of the receiving groove 33 . In this embodiment, the cross section of the fixing portion 44 is rectangular.

[0089] Further preferably, the fixing portion 44 is received in the receiving groove 33 and fixedly connected to the first pointed body 3 , thereby further enhancing the stable connection between the first pointed body 3 and the first buffer portion 4 and preventing the first pointed body 3 from detaching from the first buffer portion 4 .

[0090] In one embodiment, the first buffer portion 4 includes a protrusion 42, and the first pointed body 3 covers and is fixed to the protrusion 42. Figure 8 shown.

[0091] Preferably, the protrusion 42 is arranged on the surface of the first buffer portion 4 facing the first pointed body 3, and the protrusion 42 is fixedly connected to the first buffer portion 4. In other embodiments, the protrusion 42 and the first buffer portion 4 are integrally formed, thereby enhancing structural stability and simplifying process difficulty.

[0092] More preferably, the cross-section of the protrusion 42 can be triangular, rectangular, semicircular, etc. The user can choose to set it according to needs, and no specific limitation is made here. In this embodiment, the cross-section of the protrusion 42 is triangular.

[0093] More preferably, the first pointed body 3 is covered on the outer surface of the protrusion 42, and the first pointed body 3 is fixedly connected to the protrusion 42, thereby not only increasing the contact area between the first pointed body 3 and the first buffer portion 42 to enhance the stability of the connection, but also providing a stable support for the first pointed body 3. In this embodiment, the first pointed body 3 is in an inverted V shape.

[0094] In one embodiment, the implantable medical device further includes a separation portion 45, which is disposed between the first pointed body 3 and the first buffer portion 4, and the separation portion 45 is fixedly connected to the first pointed body 3 and the first buffer portion 4, respectively. Figure 13 shown.

[0095] Preferably, the separation portion 45 is a water-soluble separation portion, which is made of an easily separable material, preferably a water-soluble adhesive, such as polyethylene glycol gel, so that it will quickly dissolve after encountering liquids such as water and blood, thereby achieving the separation of the first pointed body 3 and the first buffer portion 4; 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.

[0096] More preferably, the separation portion 45 can be provided to play a specific separation role, such as withdrawing the implanted medical device 100, and the separation of the first buffer portion 4 and the first pointed body 3 can be achieved only when the separation portion 45 is dissolved after contact with water.

[0097] Second implementation method

[0098] In this embodiment, the stent graft is used as an example for description. Figures 14 to 16 As shown, the stent includes a supporting frame and a covering 5 arranged on the supporting frame.

[0099] The first pointed body 3 may or may not be provided on the supporting frame. When the first pointed body 3 is provided on the supporting frame, the structure and connection relationship between the first pointed body 3 and the supporting frame may refer to the first embodiment described above and will not be repeated here.

[0100] In one embodiment, the coating 5 is fixedly connected to the supporting frame.

[0101] Preferably, the membrane 5 is made of a material with good biocompatibility, such as ePTFE (a garment fabric formed by laminating a microporous polytetrafluoroethylene membrane with ordinary fabric), PET (polyethylene terephthalate), silk fibroin, silicone, etc. The membrane 5 is fixed to the inner surface, or the outer surface, or both the inner and outer surfaces of the support frame. Specifically, the membrane 5 is fixed to the inner surface, or the outer surface, or both the inner and outer surfaces of the corrugated ring 1.

[0102] In one embodiment, the microneedle includes a second pointed body 6 , and the buffer member includes a second buffer portion 7 , and the second buffer portion 7 is fixed between the second pointed body 6 and the covering film 5 .

[0103] Preferably, the second buffer portion 7 is arranged between the coating 5 and the second pointed body 6, so as to achieve a stable connection between the second pointed body 6 and the coating 5, and the second buffer portion 7 can play a buffering role on the second pointed body 6 to prevent gaps or fractures from occurring at the connection between the second pointed body 6 and the coating 5.

[0104] More preferably, the second pointed body 6 can be provided on the outer surface of the covering 5, or can be provided on both the inner and outer surfaces of the covering 5. The outer surface of the covering 5 here refers to the surface of the covering 5 that is not in contact with the outer wall of the supporting frame, and the inner surface here refers to the surface of the covering 5 that is located in the inner cavity of the supporting frame and is not in contact with the inner wall of the supporting frame.

[0105] The first and second embodiments are further described below:

[0106] First, the first pointed body 3 and / or the second pointed body 6 can be made of a degradable material or a non-degradable material. When the first pointed body 3 and / or the second pointed body 6 are both made of degradable materials, the solvent of the raw material liquid of the first pointed body 3 and the second pointed body 6 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 fibroin, etc., and degradable materials are preferably used; when the first pointed body 3 and the second pointed body 6 are both made of non-degradable materials, such as nickel-titanium alloy, stainless steel, iron alloy, PEEK (polyetheretherketone), PMMA (polymethyl methacrylate), PTFE (polytetrafluoroethylene), silk fibroin, silicone, etc.

[0107] Secondly, in some embodiments, the first spike 3 and the second spike 6 can be drug-loaded spikes. Specifically, the drug can be added to the raw material liquid to form the first spike 3 or the second spike 6. The drug content in the raw material liquid of the first spike 3 and the second spike 6 is 1% to 10%. More preferably, the drug content in the raw material liquid of the first spike 3 and the second spike 6 is 1% to 5%. The surfaces of the first spike 3 and the second spike 6 can also be coated with the drug content of 1% to 20%. More preferably, the drug content is 10% to 15%. The above ratio ranges are all mass percentages. Furthermore, the total drug content of the implanted medical device is 30 to 300 ug. The above-mentioned limitations on the 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.

[0108] Secondly, in order to meet the clinical needs of the drug efficacy of the target site, the first spike 3 or the second spike 6 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, it is more likely to cause hyperplasia due to stimulation of the tissue, so more first spikes 3 or second spikes 6 can be set at this position; for example, there is shear force at the position where the support skeleton contacts the tissue, so it is more likely to cause hyperplasia or granuloma formation, therefore, more drug-loaded first spikes 3 or second spikes 6 can be set to achieve a certain amount of drug to achieve the effect of preventing hyperplasia and granuloma.

[0109] Furthermore, microneedles can carry different drugs, with different drug actions occurring simultaneously or in stages. This can be achieved by using different microneedle media types and sizes. For example, for tracheal cancer, the proximal and distal ends of the stent typically extend 1-2 cm beyond the lesion, respectively. Granulation growth must be prevented in the extended portion. The stent covering the original lesion requires two types of microneedles: one to prevent granulation growth, and the other to deliver the tumor-killing drug. The timing and manner of drug release can meet the following requirements: First, the two microneedles can simply perform their respective functions independently; second, one of the two microneedles can release first, followed by the other, for example, the microneedle carrying the tumor-killing drug kills tumor cells first, followed by the microneedle carrying the anti-granulation drug; third, two or more drugs can be released separately, generating a new component that exerts a clinical effect; fourth, two or more drugs can be implanted at the target site, where the new action is activated by the environment at the target site.

[0110] Finally, if Figure 17As shown, when the implantable medical device of the present invention is used for tracheal or bronchial stenosis or other lumen stenosis, the implantable medical device is first pressed onto the surface of the balloon 9 and then loaded into the sheath 8 together. To ensure that the first spike 3 and the second spike 6 are not damaged when loaded into the sheath 8, the distance between the tips of the first spike 3 and the second spike 6 and the inner wall of the sheath 8 is L, where 0.1mm≤L≤0.5mm, thereby avoiding the first spike 3 and the second spike 6 from hitting the sheath 8 during assembly, or the contour of the sheath 8 being too large to be suitable for some patients. Then, under the guidance of the guide wire, the sheath 8 loaded with the implanted medical device is transported to the target position, liquid is injected into the balloon 9, and the pressure is increased to 16 to 26 atmospheres, so that the stent begins to expand under the push of the balloon 9, and then the first spike 3 and the second spike 6 penetrate the tissue. At this time, the entire first spike 3 and the second spike 6 can be selected to penetrate the tissue as needed, or the first spike 3 and the second spike 6 can be partially penetrated into the tissue. If the stent is made of a degradable material and the degradation rate is greater than the degradation rate of the first spike 3 and the second spike 6, there will be no pressure on the tissue after degradation, reducing the risk of subsequent tissue hyperplasia. Compared with existing implantable medical devices, the first spike 3 and the second spike 6 can penetrate into the tissue, and the first buffer portion 4 can play an effective buffering role between the first spike 3 and the supporting frame, preventing the first spike 3 from generating gaps or breaking at the connection between the supporting frame, thereby increasing safety in use; at the same time, the second buffer portion 7 can play an effective buffering role between the second spike 6 and the coating 5, preventing the second spike 6 from generating gaps or breaking at the connection between the second spike 6 and the coating 5, thereby increasing safety in use.

[0111] 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. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions 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 having a plurality of hollows (10) and a plurality of microneedles arranged on the support, characterized in that: The implantable medical device further includes a buffer component disposed between the bracket and the microneedle, and the buffer component is fixedly connected to the bracket and the microneedle respectively.

2. The implantable medical device according to claim 1, wherein: The hardness of the buffer member is smaller than the hardness of the microneedles.

3. The implantable medical device according to claim 2, characterized in that The bracket includes a supporting frame, the microneedle includes a first pointed body (3), and the buffer component includes a first buffer portion (4), and the first buffer portion (4) is fixed between the first pointed body (3) and the supporting frame.

4. The implantable medical device according to claim 3, wherein: The first buffer portion (4) covers at least a portion of the supporting frame.

5. The implantable medical device according to claim 4, characterized in that The first pointed body (3) is provided with a first groove (31), and the first buffer portion (4) is fixed in the first groove (31).

6. The implantable medical device according to claim 4, characterized in that The first pointed body (3) is provided with a first channel (32), and the first buffer portion (4) passes through the first channel (32).

7. The implantable medical device according to claim 4, characterized in that The first buffer portion (4) comprises a covering portion (43), wherein the covering portion (43) covers the side surface of the first pointed body (3) and exposes the tip of the first pointed body (3).

8. The implantable medical device according to claim 7, wherein: The first buffer portion (4) further includes a fixing portion (44); the first pointed body (3) is provided with a receiving groove (33); and the fixing portion (44) is received in the receiving groove (33).

9. The implantable medical device according to claim 4, wherein: The first buffer portion (4) comprises a protrusion (42), and the first pointed body (3) covers and is fixed to the protrusion (42).

10. The implantable medical device according to claim 1 or 2, characterized in that: The bracket also includes The covering film (5), the microneedle includes a second pointed body (6), and the buffer member includes a second buffer portion (7). The second buffer portion (7) is fixed between the second pointed body (6) and the coating (5).

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