Implantable medical device

Abstract

The utility model provides an implantable medical instrument, which comprises a membrane-covered support framework and a plurality of medicine-carrying pointed bodies which are separated from one another, and the plurality of pointed bodies are at least partially arranged on the inner surface of the membrane-covered support framework. According to the utility model, the inner surface of the support skeleton is provided with the pointed body for carrying the medicine, and the pointed body is dissolved after being contacted with the medium, such as water and the like, in the coated support skeleton, so that the medicine can be fused into the medium, the medicine can be conveniently applied to the interior of the coated support skeleton, and an ideal treatment effect is achieved.

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, they pay more and more attention to health issues, especially some important diseases, such as stenosis, rupture, tumors and other lesions in the human body's lumen.

[0003] The treatment of the above diseases is currently mainly improved by implanting medical devices into the body, such as implanting stents into the human lumen to expand the narrow part, thereby preventing it from obstructing the internal fluid flow. Existing stents are divided into bare stents and covered stents according to their shapes. Covered stents play the role of isolating the lumen wall and the fluid in the lumen, and can prevent the wall from rupturing and form different environments inside and outside the cover. However, existing covered stents cannot apply drugs to their inner environment, which affects the treatment effect and application field. Utility Model Content

[0004] In view of the technical defects existing in the prior art, the utility model provides an implantable medical device capable of applying medicine to the inner environment of the membrane-covered implantable device.

[0005] As conceived above, the technical solution adopted by the utility model is:

[0006] An implantable medical device comprises a membrane-covered support frame and a plurality of mutually separated drug-carrying spikes, wherein the plurality of spikes are at least partially arranged on the inner surface of the membrane-covered support frame.

[0007] Preferably, the membrane-covered support skeleton comprises a support skeleton having a plurality of hollows and a plurality of support rods, and the plurality of spikes comprises a plurality of first drug-loaded spikes at least arranged on the inner surface of the support skeleton.

[0008] Preferably, a connecting portion is provided between the first pointed body and the support rod, and the first pointed body is fixedly connected to the connecting portion, wherein the connecting portion surrounds and is fixed to the support rod; or the connecting portion is abutted against and fixed to the surface of the support rod.

[0009] Preferably, the coated support frame also includes a coating provided on the surface of the support frame and covering at least a portion of the hollow coating, and the multiple pointed bodies also include a plurality of drug-loaded second pointed bodies provided on the inner surface of the coating, or provided on the inner and outer surfaces of the coating.

[0010] Preferably, the second pointed body and the coating are integrally formed.

[0011] Preferably, the coating has a plurality of covering portions, each of which covers a proximal end of the second pointed body, and an opening area of ​​the covering portion is smaller than an area of ​​the proximal end of the second pointed body.

[0012] Preferably, a connection layer is provided between the second pointed body and the coating, and the second pointed body is fixed to the surface of the coating corresponding to the hollow through the connection layer, and the hardness of the connection layer is greater than the hardness of the second pointed body.

[0013] Preferably, part of the second pointed body is disposed on the outer surface of the coating and close to the edge of the support rod, and the height of the second pointed body is less than or equal to the thickness of the support rod.

[0014] Preferably, the coating covers one axial end of the supporting frame; or the coating covers the axial middle region of the supporting frame.

[0015] Preferably, the support rod is provided with a groove, the proximal end of the first pointed body is fixed in the groove, and the distal end thereof protrudes out of the groove.

[0016] The utility model provides an implantable medical device with a drug-carrying spike on the inner surface of a coated support frame. The drug-carrying spike dissolves after contacting a medium such as water inside the coated support frame, thereby allowing the drug to be integrated into the medium, so that the drug can be applied to the inside of the coated support frame, thereby expanding the application range of the drug-carrying implantable device. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0019] Figure 3 yes Figure 2 The cross-sectional view along the CC line of the implantable medical device provided by the present invention is shown;

[0020] Figure 4 yes Figure 1 A partial enlarged view of part B of the implanted medical device provided by the utility model is shown;

[0021] Figure 5 yes Figure 4 The cross-sectional view along line DD of the implantable medical device provided by the utility model is shown;

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

[0023] Figure 7 yes Figure 6 A partial enlarged view of the E portion of the implantable medical device provided by the utility model is shown;

[0024] Figure 8 It is a three-dimensional diagram of the support frame of the implanted medical device provided by the utility model;

[0025] Fig. 9 yes Figure 8 The enlarged partial view of the F part of the implantable medical device provided by the utility model is shown;

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

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

[0028] Fig.12 yes Fig. 9 The cross-sectional view along line GG of the third embodiment of the implantable medical device provided by the utility model is shown;

[0029] Fig.13 yes Figure 8 The top view of the support frame provided by the utility model is shown;

[0030] Fig.14 yes Fig.13 The enlarged partial view of the H 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. DETAILED DESCRIPTION

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] Figures 1 to 7 The implantable medical device 100 provided by an embodiment of the utility model is shown. The implantable medical device 100 includes a coated support frame and a plurality of drug-carrying spikes, and the plurality of spikes are arranged spaced apart from each other. In this embodiment, the coated support frame is a coated tracheal stent, including a support frame 1 having a plurality of hollows 8 and a plurality of support rods, and a coating 4 provided on the surface of the support frame and covering at least part of the hollows 8. Figure 8 As shown, the plurality of support rods include a plurality of corrugations 11 and a connecting rod 2, and the plurality of support rods are enclosed to form a plurality of hollows 8. The pointed body is at least arranged on the inner surface of the film support frame, for example, the pointed body is arranged on the inner surface of the film support frame or on the inner surface and the outer surface of the film support frame. Specifically, the pointed body includes Figure 2 The first pointed body 3 shown is fixed to the inner surface of the supporting frame 1 (support rod) and the Figure 5 The second spike 5 is shown as being at least provided on the inner surface of the coating corresponding to the hollow 8. It is understandable that in other embodiments, the spike may only include the second spike 5, or only include the first spike 3. Both the first spike 3 and the second spike 5 are loaded with drugs.

[0039] The support frame 1 is mainly used to support the inner wall of the narrow part of the lumen so as to open it, thereby reducing the adverse effect of the narrow channel on the internal liquid circulation. The support frame 1 is preferably a tubular structure, such as a cylindrical structure, an elliptical cylindrical structure, a frustum structure, etc. In this embodiment, the support frame 1 is cylindrical. In other embodiments, the support frame 1 can also be a combination of one or more of the above structures.

[0040] See also Figure 8 , the connecting rod 2 of the supporting skeleton 1 is located between two adjacent wave coils 11, and the wave coil 11 is composed of Z-shaped waves, and can also be made of other structures, which will not be repeated here. Furthermore, the two ends of the connecting rod 2 are respectively fixedly connected to the two adjacent wave coils 11, thereby connecting and fixing the two adjacent wave coils 11. The wave coils 11 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. Both the wave coil 1 and the connecting rod 2 can be made of good biocompatible materials, such as nickel-titanium alloy, iron, magnesium alloy, stainless steel, polylactic acid, etc., which can be selected and set according to needs, so it will not be repeated here.

[0041] Preferably, 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 can be fixed only on the inner surface of the support frame 1, or only on the outer surface of the support frame 1, or fixed on both the inner and outer surfaces of the support frame 1.

[0042] The coating 4 may cover a portion of the outer wall of the supporting skeleton 1 , such as covering one or both axial ends of the supporting skeleton 1 , or covering the axial middle area of ​​the supporting skeleton 1 , or covering other areas of the supporting skeleton 1 .

[0043] When the coating 4 only covers the middle area of ​​the support frame 1 , the coating 4 in the middle area can better play a supporting and fixing role, and at the same time, the first drug-carrying pointed bodies 3 can be provided at both ends of the support frame 1 .

[0044] The first pointed body 3 and the second pointed body 5 can be arranged only on the inner surface of the membrane support frame, or both can be arranged partially on the inner surface of the membrane support frame and the rest on the outer surface of the membrane support frame.

[0045] Furthermore, the second pointed body 5 can be arranged on the inner surface of the coating 4, or on both the inner surface and the outer surface of the coating 4. The outer surface of the coating 4 here refers to the surface that contacts the tissue after the device is implanted in the tissue, and the inner surface here refers to the surface of the coating 4 located in the inner cavity of the supporting frame.

[0046] Furthermore, the position of the second pointed body 5 can be selected according to the location of the disease such as intimal hyperplasia or the location where the supporting frame needs to be fixed, and multiple second pointed bodies 5 are separated from each other, so as to play a stable fixing role while achieving the treatment of diseases such as intimal hyperplasia.

[0047] In other embodiments, preferably, Figure 6 and Figure 7 As shown, part of the second spike 5 can be close to the support rod of the support frame 1 and arranged along the edge of the support rod. 1 Less than or equal to the thickness h of the support rod 1 2 . The height h1 of the second spike 5 is the distance between the end of the second spike 5 farthest from the coating 4 and the end closest to the coating 4, and the thickness h2 of the support skeleton 1 is the distance between the outer surface of the support skeleton 1 and its inner surface, specifically the distance between the outer surface and the inner surface of the wave coil 11, or the distance between the outer surface and the inner surface of the connecting rod 2. It can be understood that the support skeleton 1 is usually cut from a nickel-titanium alloy tube, and the thickness of the wave coil 11 and the connecting rod 2 are equal and are the thickness of the support skeleton 1. By setting the height of the second spike 5 to be less than or equal to the thickness of the support skeleton 1, the support skeleton 1 can partially shield and protect the second spike 5 at its edge to prevent the second spike 5 from falling off or breaking, and when the second spike 5 needs to penetrate the tissue, the coating 4 expands radially outward, so that the second spike 5 moves radially outward accordingly, so as to penetrate into the interior of the tissue, thereby achieving the effect of drug administration and fixation to the tissue.

[0048] The second pointed body 5 can be directly fixed to the surface of the coating 4, for example, the second pointed body 5 and the coating 4 are bonded and fixed, or the second pointed body 5 and the coating 4 are integrally formed, or the second pointed body 5 and the coating 4 are fixedly connected in other ways, which will not be described here.

[0049] The second pointed body 5 can be made of the same material as the covering film 4, such as silk fibroin. In this case, the two can be integrally formed, so that the connection between the two can be more firmly established, and the process steps and difficulty can be reduced, thereby reducing the cost.

[0050] Preferably, the coating 4 may have a plurality of Figure 5 The covering parts 41 shown, each covering part 41 covers the proximal end of a second pointed body 5. In this specification, the "proximal end" refers to the end close to the surface of the membrane support frame, and the "distal end" refers to the end away from the surface of the membrane support frame.

[0051] Specifically, the coating 4 can form a covering portion 41 at multiple locations. The covering portion 41 is preferably integrally formed with the coating 4, and other molding methods can also be used. A covering space is formed inside the covering portion 41. Except for the second spikes 5 arranged along the edge of the supporting frame 1, the proximal ends 51 of the remaining second spikes 5 can be movably accommodated in their corresponding covering spaces, and the area of ​​the opening 411 of the covering space is smaller than the area of ​​the proximal end 51 of the second spike 5, thereby preventing the proximal end 51 of the second spike 5 from moving out of the opening 411, so that the proximal end 51 of the second spike 5 can be movably confined in the covering space, thereby realizing the connection between the second spike 5 and the coating 4.

[0052] In some preferred embodiments, the proximal end of the second pointed body 5 arranged along the edge of the supporting frame 1 can also be movably received in the covering portion 41 of the coating 4 to achieve connection with the second pointed body 5. The user can set it as needed, which will not be repeated here.

[0053] More specifically, the covering portion 41 and the second pointed body 5 can be fixed by bonding or other fixed connection methods to strengthen the fixed connection between the second pointed body 5 and the coating 4, which will not be described in detail here.

[0054] Preferably, there is a connecting layer (not shown) between the second pointed body 5 and the coating 4 , and the second pointed body 5 is fixed to the surface of the coating 4 corresponding to the hollow area 8 through the connecting layer, and the hardness of the connecting layer is greater than the hardness of the second pointed body 5 .

[0055] Specifically, a plurality of connection layers may be provided on the coating 4, and the connection layer may be a cuboid or a cylinder, etc. The shape of the connection layer may be provided as required, and the connection layer is provided between the coating 4 and the second pointed body 5, and is fixedly connected to the coating 4 and the second pointed body 5, respectively, such as adhesive fixation or other fixed connection methods, etc., which will not be repeated here. The hardness of the connection layer is greater than the hardness of the second pointed body 5, so that the connection strength of the second pointed body 5 and the coating 4 can be enhanced, and the second pointed body 5 can be provided with a stable support so that it can be smoothly inserted into the tissue. In the present embodiment, the connection layer is composed of PVPK90 (polyvinylpyrrolidone). It is understandable that the connection layer may also be a material commonly used in the art, such as one or more of PEEK (polyetheretherketone), PMMA (polymethyl methacrylate), PTFE (polytetrafluoroethylene), or a metal material, such as nickel-titanium alloy. The connection layer may be a multilayer structure, and each layer is made of one of the above materials, so that different structural and strength requirements of the connection layer can be met.

[0056] like Fig.10 and Fig.11 As shown, the first pointed body 3 is fixed to the support rod of the support frame 1 through a connecting portion 31, and the connecting portion 31 is located between the first pointed body 3 and the support rod.

[0057] Specifically, the connecting portion 31 is plate-shaped, and the connecting portion 31 is fixedly connected to the supporting frame 1 and the first pointed body 3, respectively. The connecting portion 31 is abutted against the supporting rod, thereby fixing the first pointed body 3 to the surface of the supporting frame. The hardness of the connecting portion 31 is greater than the hardness of the first pointed body 3. In the present embodiment, the connecting portion 31 is composed of PVPK90 (polyvinylpyrrolidone). In other embodiments, the connecting portion 31 may be made of one or more of PEEK (polyetheretherketone), PMMA (polymethyl methacrylate), PTFE (polytetrafluoroethylene), or may be implanted with a metal material such as nickel-titanium alloy. The connecting portion 31 may also include a multi-layer structure, and each layer is made of one of the above materials, so as to meet the different structural and strength requirements of the connecting portion 31.

[0058] See also Fig.13 The support frame 1 has a central axis X, and the distal cross-sectional area of ​​the first pointed body 3 is smaller than the proximal cross-sectional area, thereby ensuring that the first pointed body 3 can penetrate the tissue. Further, the first pointed body 3 is preferably a cone, or a polygonal pyramid, etc. The shape of the first pointed body 3 can be selected and set as needed, and will not be repeated here.

[0059] In some preferred embodiments, Fig.11 As shown, the connecting portion 31 is in a closed ring shape, or an unclosed curved shape. The connecting portion 31 passes through two adjacent hollows 8 and surrounds the surface of the supporting frame 1, thereby further enhancing the stability of the connection between the first pointed body 3 and the supporting frame 1. Specifically, the connecting portion 31 surrounds the wave ring 11, or surrounds the connecting rod 2, thereby fixing the first pointed body 3 at the required position on the supporting frame, so as to treat or fix the required part.

[0060] In other embodiments, the connection portion 31 may cooperate with the first pointed body 3 to surround the support rod of the support frame 1 . Specifically, part or all of the connection portion 31 and part of the first pointed body 3 may form an annular covering body that surrounds the support frame 1 .

[0061] In some embodiments, Fig.12 As shown, the support frame 1 is provided with a groove 11, the proximal end of the first pointed body 3 is fixed in the groove 11, and the distal end thereof protrudes out of the groove 11, thereby realizing a stable connection between the first pointed body 3 and the support frame 1, and improving the stability of the structure. Fig.13 and Fig.14 As shown, the first pointed body 3 is a cone or a polygonal pyramid, and the first pointed body 3 has a central axis y 2 , center axis y 2 is the line connecting the distal end of the first pointed body 3 and the center point of the bottom surface of the proximal end thereof, and the central axis y of the first pointed body 3 is 2 Along the radial direction of the support frame1 Extension can make the first pointed body 3 stably penetrate into the tissue, prevent the first pointed body 3 from deviating from the predetermined direction during the penetration process, and avoid the first pointed body 3 from breaking.

[0062] As an example, the solvent of the raw material liquid of the pointed body can be water, and the solute can be 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 also be dispersed in the pointed body, for example, prepared from phosphatidylcholine and cholesterol. The raw material liquid and liposomes of the pointed body can carry different drugs, and the added drugs are for preventing hyperplasia, therapeutic drugs and antibacterial drugs, such as common drugs such as paclitaxel, rapamycin and its derivatives (such as sirolimus, zotarolimus, everolimus, tacrolimus and pimecrolimus), amine-coupled polyurethane (SA-PU) polymers, etc.

[0063] Furthermore, the drug can be added to the raw material liquid to form a pointed body, and the drug content in the raw material liquid of the pointed body is 1% to 10%. More preferably, the drug content in the raw material liquid of the pointed body is 1% to 5%. The pointed body can also be coated on the surface of the pointed body, and the drug content is 1% to 20%. It is further preferred that the drug content is 10% to 15%. The above ratio ranges are all mass percentages. Furthermore, the total drug content of the implant is 30 to 300ug. The above-mentioned total amount and percentage of the drug can ensure the therapeutic effect of the drug and reduce the occurrence of diseases such as intimal hyperplasia.

[0064] Furthermore, in order to meet the clinical needs of the target site for drug efficacy, the spikes 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 spikes 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 spikes can be set to achieve a certain amount of drug to achieve the effect of preventing hyperplasia and granulomas.

[0065] Furthermore, each pointed body can carry different medicines, so as to achieve the treatment of different diseases. The user can set it according to needs, which will not be elaborated here.

[0066] Further, such as Fig.15As shown, when the implantable medical device 100 of the utility model is used to treat tracheal or bronchial stenosis, the support 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 pointed body is not damaged when loaded into the sheath 6, the distance between the tip of the pointed body and the inner wall of the sheath 6 is L, wherein 0.1mm≤L≤0.5mm, so that the pointed body can be prevented from hitting the sheath 6 during assembly, or the contour of the sheath 6 is too large to be suitable for some patients. Then, under the guidance of the guide wire, the part of the sheath 6 loaded with the implantable medical device is transported to the target position, and liquid is injected into the balloon 7, pressurized to 16 to 26 atmospheres, so that the support frame begins to expand under the push of the balloon 7, and then the pointed body penetrates the tissue. At this time, the entire pointed body can be selected to penetrate the tissue, or the part of the pointed body can be selected to penetrate the tissue according to needs. If the support frame is a degradable material, and the degradation rate is greater than the degradation rate of the pointed body, 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 tip can penetrate into the tissue, and as the tip degrades, the drug is slowly released to prolong the drug's duration of action. The tip can carry a variety of drugs and drugs of different concentrations to achieve different effects. The tip is firmly connected to the supporting frame, effectively preventing the two from detaching, and is stable and safe.

[0067] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it, and the application scenarios of the implanted medical devices are not limited to the fields described in the text; although the present invention has been described in detail with reference to the aforementioned embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some of the technical features therein with equivalents; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. An implantable medical device, characterized in that: It comprises a film-covered support frame and a plurality of mutually separated drug-carrying pointed bodies, wherein the plurality of pointed bodies are at least partially arranged on the inner surface of the film-covered support frame.

2. The implantable medical device according to claim 1, characterized in that: The film-covered support frame includes a support frame having a plurality of hollows and a plurality of support rods, and the plurality of pointed bodies include a plurality of first pointed bodies loaded with drugs which are at least arranged on the inner surface of the support frame.

3. The implantable medical device according to claim 2, characterized in that: A connecting portion is provided between the first pointed body and the support rod, and the first pointed body is fixedly connected to the connecting portion, wherein the connecting portion surrounds and is fixed to the support rod; or the connecting portion is abutted against and fixed to the surface of the support rod.

4. The implantable medical device according to claim 2, characterized in that: The coated support frame also includes a coating disposed on the surface of the support frame and covering at least a portion of the hollowed-out coating, and the plurality of pointed bodies also include a plurality of drug-loaded second pointed bodies disposed on the inner surface of the coating, or on the inner and outer surfaces of the coating.

5. The implantable medical device according to claim 4, characterized in that: The second pointed body and the coating are integrally formed.

6. The implantable medical device according to claim 4, characterized in that: The coating has a plurality of covering portions, each of which covers the proximal end of one of the second pointed bodies, and an opening area of ​​the covering portion is smaller than an area of ​​the proximal end of the second pointed body.

7. The implantable medical device according to claim 4, characterized in that: A connection layer is provided between the second pointed body and the coating, and the second pointed body is fixed to the surface of the coating corresponding to the hollow through the connection layer, and the hardness of the connection layer is greater than the hardness of the second pointed body.

8. The implantable medical device according to claim 4, characterized in that: Part of the second pointed body is disposed on the outer surface of the coating and close to the edge of the support rod, and the height of the second pointed body is less than or equal to the thickness of the support rod.

9. The implantable medical device according to claim 4, characterized in that: The coating covers one axial end of the supporting frame; or the coating covers the middle area of ​​the supporting frame in the axial direction.

10. The implantable medical device according to claim 2, characterized in that: The support rod is provided with a groove, the proximal end of the first pointed body is fixed in the groove, and the distal end thereof protrudes out of the groove.

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