Implantable medical device

Abstract

The utility model relates to implant medical apparatuses, including support framework and the multiple sharp body 4 of being located support framework outer surface, support framework's outer surface with the multiple sharp body 4 in with support framework axial x perpendicular same plane respectively form first projection 1' and second projection 4', second projection 4' with first projection 1' in support framework circumferential coincidence degree D satisfy: 60% less than or equal to D less than or equal to 100%. The utility model's apparatus has the sharp body, and has good anti -displacement performance after implanting lumen.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to an implantable medical device. Background Technology

[0002] With the improvement of people's living standards and changes in dietary structure, more and more diseases are also increasing, such as stenosis, rupture, and tumors in the human body's cavities.

[0003] To improve the symptoms of these diseases, a stent is usually implanted into the diseased duct to widen the narrowed area. However, stents are usually difficult to anchor stably in the duct for a long time and are prone to displacement over time.

[0004] Adding barbs to the stent can improve its anchoring effect at the lesion site after implantation, but the following problems exist: 1) Existing barbs have a certain angle, which can only prevent displacement in one direction. 2) Existing barbs are made of metal, and the manufacturing process is simple, such as cutting and polishing, resulting in relatively large sizes that can easily cause excessive tissue damage. 3) Due to limitations in the manufacturing process, such as cutting and polishing, the number of barbs fixed to the stent is limited. To achieve a good anti-displacement effect, the barbs need to be designed to be relatively long, resulting in a longer insertion length into the tissue, which can easily cause excessive tissue damage. 4) Existing barbed stents penetrate the tissue deeply, making removal difficult after a period of implantation and causing significant tissue trauma. 5) To ensure long-term stable anchoring after insertion, existing barbs are made of metal. If the stent framework and cladding are made of biodegradable materials, the barbs will remain in the body after the latter two degrade, making them prone to detachment and leading to more serious complications. Utility Model Content

[0005] To overcome the above-mentioned technical problems, this utility model provides an implantable medical device with strong anti-displacement performance.

[0006] The present invention provides an implantable medical device comprising a support frame and a plurality of pointed bodies disposed on the outer surface of the support frame. The outer surface of the support frame and the plurality of pointed bodies respectively form a first projection and a second projection in the same plane perpendicular to the axial direction of the support frame. The degree of overlap D between the second projection and the first projection in the circumferential direction of the support frame satisfies: 60% ≤ D ≤ 100%.

[0007] Preferably, the plurality of tips are multiple rows of tips, and each row of tips is spirally extending along the axial direction.

[0008] Preferably, the spacing between any two adjacent columns of the pointed bodies is equal.

[0009] Preferably, in each column of the tips, the spacing between two adjacent tips is equal.

[0010] Preferably, the area of ​​the outer surface of the supporting frame is dm. 2 The total number of the pointed structures is c, and the density c / d of the pointed structures satisfies: 1000 points / m². 2 ≤c / d≤5000 pieces / m 2 .

[0011] Preferably, all of the plurality of tips are either non-degradable tips or all are degradable tips.

[0012] Preferably, the support frame includes a wavering and a connecting rod, and the pointed body is fixed to the wavering and / or the connecting rod; or, the support frame includes a wavering, a connecting rod, and a coating fixed to the wavering and the connecting rod, and the pointed body is fixed to the outer surface of at least one of the coating, the wavering, and the connecting rod.

[0013] Preferably, the height H of the pointed body satisfies: 450um ≤ H ≤ 650um.

[0014] Preferably, the pointed body includes degradable pointed bodies and non-degradable pointed bodies, wherein the proportion of non-degradable pointed bodies is greater than or equal to 40% and less than 100%.

[0015] Preferably, the pointed body includes a distal end away from the support frame and a proximal end close to the support frame, and the line connecting the center points of the distal end and the proximal end extends radially along the support frame.

[0016] The implantable medical device of this invention limits the degree of overlap between the second projection formed by projecting multiple pointed bodies onto a plane perpendicular to the axis of the support frame and the first projection formed by the outer surface of the support frame in the plane in the circumferential direction of the support frame. This ensures the fixation effect of the multiple pointed bodies on the support frame and can prevent the support frame from shifting within the tube. Attached Figure Description

[0017] Figure 1 This is a three-dimensional view of the implantable medical device provided by this utility model;

[0018] Figure 2 yes Figure 1 A top view of a first embodiment of the implantable medical device shown;

[0019] Figure 3 yes Figure 1 A top view of a second embodiment of the implantable medical device shown;

[0020] Figure 4 yes Figure 1A top view of the third embodiment of the implantable medical device shown;

[0021] Figure 5 yes Figure 1 The image shown is a cross-sectional view of the implantable medical device after it has been inserted into the catheter.

[0022] Figure 6 yes Figure 1 A magnified view of part A of the implanted medical device shown;

[0023] Figure 7 yes Figure 6 A cross-sectional view along the CC line of the first embodiment of the pointed body shown;

[0024] Figure 8 yes Figure 6 A cross-sectional view along the CC line of a second embodiment of the pointed body shown;

[0025] Figure 9 yes Figure 1 A magnified view of part B of the implanted medical device shown.

[0026] Figure 10 yes Figure 9 The image shows a cross-sectional view of the implantable medical device along line DD.

[0027] Explanation of reference numerals in the attached drawings: 1-wave ring; 2-connecting rod; 3-film; 31-second covering part; 311-opening; 4-pointed body; 41-distal end; 42-proximal end; 43-first covering part; 5-hollowing out; 6-gap; 7-channel. Detailed Implementation

[0028] The implantable medical device provided by this utility model will be clearly and completely described below with reference to the accompanying drawings. It should be understood that the described embodiments are only some embodiments of this utility model, not all embodiments. This utility model can be implemented in many other ways different from those described herein.

[0029] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this specification is for description of particular embodiments only and is not intended to limit the scope of the invention.

[0030] It should be noted that all directional indications in the embodiments of this specification are only used to explain the relative positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indications will also change accordingly.

[0031] Furthermore, in this invention, descriptions involving "first," "second," etc., are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this specification, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0032] The technical solutions of the various embodiments of this utility model can be combined with each other, but must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the protection scope claimed by this utility model.

[0033] In this specification, axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the component; radial direction refers to the direction perpendicular to the axial direction; circumferential direction refers to the line of intersection between a plane perpendicular to the axial direction and the outer surface of the device, and the end of the tip closer to the covering support skeleton is defined as the proximal end, and the end farther from the covering support skeleton is defined as the distal end.

[0034] In one embodiment, such as Figures 1 to 10 As shown, the implantable medical device provided by this utility model includes a support frame and a plurality of pointed bodies 4 disposed on the support frame.

[0035] Preferably, the support frame is used to abut against the inner wall of the human body lumen to provide support and improve its narrowing effect, ensuring the normal flow of internal fluid. Multiple pointed objects 4 are disposed on the outer surface of the support frame. These pointed objects 4 can penetrate the inner wall of the human body lumen, thereby fixing the support frame and preventing its movement within the lumen. Furthermore, the pointed objects 4 can be drug-loaded objects to deliver medication to the tissue.

[0036] More preferably, the support frame is a tubular structure, such as a cylindrical structure, an elliptical cylindrical structure, or a frustum-shaped structure. In this embodiment, the support frame is preferably cylindrical; in other embodiments, the support frame may be a combination of one or more of the above structures.

[0037] More preferably, in a preferred embodiment, the support frame includes, as shown below: Figure 1 The diagram shows at least two wave coils 1 and a connecting rod 2 located between the wave coils 1. Preferably, the connecting rod 2 is located between two adjacent wave coils 1. The wave coils 1 are composed of Z-shaped waves, but other structures can also be used, which will not be described in detail here.

[0038] Furthermore, one end of the connecting rod 2 is fixedly connected to the corrugated coil 1 located at one end, and the other end of the connecting rod 2 is fixedly connected to the corrugated coil 1 located at the other end, thereby connecting and fixing two adjacent corrugated coils 1. The corrugated coil 1 and the connecting rod 2 can be welded to each other or integrally formed, etc., and the user can choose the fixing connection method according to the needs.

[0039] Furthermore, the wave coil 1 and / or connecting rod 2 are made of biocompatible materials, such as nickel-titanium alloy, iron, magnesium alloy, stainless steel, polylactic acid, etc., which can be selected and set as needed, so they will not be described in detail here.

[0040] Furthermore, multiple tips 4 can be disposed at any position on the outer surface of the supporting skeleton. These tips on the outer surface may or may not be drug-loaded. Multiple drug-loaded tips can also be disposed at any position on the inner surface of the supporting skeleton. It is understood that, according to the common knowledge of those skilled in the art, the outer surface of the supporting skeleton refers to the surface that contacts the tissue after implantation, and the inner surface of the supporting skeleton refers to the surface opposite to the outer surface. When the tips 4 are disposed on the outer surface of the supporting skeleton, they can penetrate the tissue. When the tips 4 are drug-loaded, the degraded drug solution can be introduced into the tissue, achieving a therapeutic effect. When the drug-loaded tips 4 are disposed on the inner surface of the supporting skeleton, the tips 4 are in a luminal medium, such as urine or water. After the surface of the tips 4 contacts the luminal medium, it degrades, allowing the degraded drug solution to flow into the luminal medium, thereby achieving a therapeutic effect.

[0041] Specifically, the supporting frame has a central axis X, such as Figure 7 As shown, the end of the pointed body 4 closest to the supporting skeleton is the proximal end 42, and the end furthest from the supporting skeleton is the distal end 41. The cross-sectional area of ​​the distal end 41 of the pointed body 4 is smaller than that of its proximal end 42, thereby ensuring that the pointed body 4 can penetrate the tissue. Furthermore, the pointed body 4 is preferably a cone, but it can also be a polygonal pyramid, etc. The shape of the pointed body 4 can be selected and set as needed, and will not be elaborated here.

[0042] When the cusp 4 is conical, it is easier to pierce the trachea. The cusp 4 can also be other shapes, such as a polygonal pyramid. The height H of the cusp 4 should satisfy: 450um ≤ H ≤ 650um. If the height of the cusp 4 is too small, after instrument implantation, the cusp 4 will penetrate the tissue only superficially and is prone to dislodgement; if the height of the cusp 4 is too large, the instrument will require a delivery device with a larger diameter, making it difficult to implant and prone to piercing the tissue wall, causing serious complications.

[0043] In one embodiment, such as Figures 1 to 4As shown, the outer surface of the support frame is projected onto a plane perpendicular to the instrument axis x to form a first projection 1'. The length of the first projection 1' in the circumferential direction of the support frame is a. Figure 2 As shown.

[0044] Preferably, the shape of the first projection 1' can be a ring or other annular structure. In this embodiment, the supporting frame is a cylinder, so the first projection 1' is annular. In other embodiments, the first projection 1' can also be other shapes.

[0045] More preferably, the length 'a' of the edge of the first projection 1' is the perimeter of the shape formed by projecting the outer surface of the supporting frame onto a plane perpendicular to the axis, such as... Figure 1 As shown, when the first projection 1' is annular, the length a of the edge of the first projection 1' is the circumference of the annulus.

[0046] Preferably, the second projection 4' formed by projecting a plurality of pointed bodies 4 onto a plane perpendicular to the axis partially coincides with the first projection 1' in the circumferential direction, that is, the second projection 4' covers at least a portion of the area of ​​the first projection 1', the circumferential length of which is b, such as... Figure 3 As shown.

[0047] In one embodiment, the plurality of pointed bodies 4 are projected onto the aforementioned same plane to form a second projection 4', and the overlap b / a between the second projection 4' and the first projection 1' in the circumferential direction of the supporting skeleton satisfies: 60% ≤ b / a ≤ 100%.

[0048] More preferably, the overlap ratio b / a can be any value between 60% and 100%, and the user can choose to set it as needed, without making a specific limitation here.

[0049] More preferably, when b / a equals 100%, the multiple pointed bodies 4 are arranged sequentially and continuously in the circumferential direction of the supporting frame, and there are no gaps 6 in the circumferential direction, thereby providing comprehensive fixation of the supporting frame in the circumferential direction and effectively preventing displacement of the supporting frame; when b / a is less than 100% but greater than or equal to 60%, the multiple pointed bodies 4 will produce gaps 6 in the circumferential direction of the supporting frame. In one embodiment, the gap 6 is one, such as... Figure 3 In other embodiments, the gaps 6 can be multiple and arranged at intervals, such as... Figure 4 As shown, this configuration can prevent the pointed objects 4 from concentrating in a small area of ​​the support frame in the circumferential direction, ensuring the fixation effect on the support frame and effectively preventing the support frame from shifting within the pipe 7.

[0050] In one embodiment, the plurality of tips 4 are multiple rows of tips, each row of tips 4 being spirally extending along the axial direction.

[0051] Preferably, such as Figure 1 As shown, multiple pointed bodies 4 are arranged in multiple rows, with the multiple rows of pointed bodies spaced apart from each other, which allows the multiple pointed bodies 4 to be arranged more evenly and dispersedly.

[0052] More preferably, such as Figure 1 As shown, each column of pointed bodies 4 is spirally extended along the axial direction, which allows the pointed bodies 4 to be more dispersed in the circumferential direction, ensuring uniform force on the supporting frame, preventing multiple pointed bodies 4 from being concentrated in a small area in the circumferential direction and affecting the overall stability of the supporting frame, thus increasing the stability of the supporting frame.

[0053] More preferably, the number of multiple rows of pointed bodies 4 is 2 to 12, which not only prevents the number of pointed bodies 4 from being too large and the density from being too high, thus increasing the patient's pain, but also prevents the number of pointed bodies 4 from being too small and the density from being too low, thus affecting the stability of the supporting skeleton.

[0054] In one embodiment, the spacing between any two adjacent columns of the pointed bodies 4 is equal. Preferably, as shown... Figure 1 As shown, when multiple pointed bodies 4 are arranged in multiple columns, the multiple columns of pointed bodies 4 are preferably arranged at equal intervals. At this time, the distance between two adjacent columns of pointed bodies 4 is equal, which can make them more evenly distributed, ensure the overall force balance on the supporting skeleton, and improve the structural stability.

[0055] In one embodiment, the spacing between two adjacent tips 4 in each column is equal. Preferably, in each column of tips 4, multiple tips 4 are arranged sequentially at equal intervals, that is, the spacing between two adjacent tips 4 is equal, thereby making the axial force on the support frame more uniform and enhancing the stability of the support frame.

[0056] In one embodiment, the outer surface area of ​​the supporting frame is dm. 2 The total number of the pointed bodies 4 is c, and the density c / d of the pointed bodies 4 satisfies: 1000 bodies / m². 2 ≤c / d≤5000 pieces / m 2 .

[0057] Preferably, the density of the aforementioned pointed bodies 4 can be 1000 per m³. 2 Up to 5000 / m 2 Users can choose any value between these ranges as needed; no specific restrictions are imposed here.

[0058] By limiting the density of the pointed structures to 1000 per m³ 2 Up to 5000 / m 2On the one hand, it can prevent the density of the tip 4 from being too high, which could cause damage to the tissue. On the other hand, it can prevent the density of the tip 4 from being too low, which could lead to an unsatisfactory effect on the stability of the supporting skeleton and affect the service life of the implanted medical device.

[0059] In one embodiment, each of the pointed bodies 4 is a non-degradable pointed body.

[0060] Preferably, the pointed body 4 is made of materials such as nickel-titanium alloy, stainless steel, iron alloy, PEEK (polyether ether ketone), PMMA (polymethyl methacrylate), PTFE (tetrafluoroethylene), etc., and the connection between the pointed body 4 and the supporting skeleton can be by welding or bonding.

[0061] More preferably, since the tip 4 is made of a non-degradable material and forms a long-term stable connection with the supporting skeleton, the tip 4 can form a stable connection with the tissue after it is inserted into the tissue, preventing the risk of the implanted medical device slipping out of the channel 7 and improving the structural stability.

[0062] In one embodiment, each of the tips 4 is a biodegradable tip.

[0063] Preferably, when each tip 4 is a degradable tip, the degradation rate of the tip 4 is less than the tissue's creeping rate. Specifically, since the supporting framework is attached to the tissue, during the degradation process of the tip 4, the tissue grows from both ends of the supporting framework, so that the tissue and the supporting framework are combined. When all the tips 4 are degraded, the tissue and the supporting framework can be firmly combined, thereby effectively preventing the supporting framework from shifting.

[0064] Furthermore, when multiple tips 4 are biodegradable, for example, the solvent of the raw material solution of tip 4 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 the tip 4 further contains dispersible liposomes prepared from phosphatidylcholine and cholesterol, both the raw material solution and the liposomes of tip 4 can carry different drugs, such as drugs for preventing hyperplasia, therapeutic purposes, and antibacterial purposes. Common drugs include paclitaxel, rapamycin and its derivatives (such as sirolimus, zotamoxetine, everolimus, tacrolimus, and pimecrolimus), amine-coupled polyurethane (SA-PU) polymers, etc. Thus, the tip 4 can degrade after penetrating the tissue, allowing the drug to exert a therapeutic effect on the tissue. The selection of the above materials allows the cusp 4 to be firmly integrated with the supporting framework after decomposition, effectively preventing displacement of the supporting framework.

[0065] More preferably, the drug can be added to the raw material solution to form the tip 4, wherein the drug content in the raw material solution of the tip 4 is 1% to 10%, and more preferably, the drug content in the raw material solution of the tip 4 is 1% to 5%. Alternatively, the drug can be coated on the surface of the tip 4, with a drug content of 1% to 20%, and more preferably, 10% to 15%, all of which are mass percentages. Furthermore, the total drug content of the implant is 30 to 300 μg. These limitations on the total amount and percentage of the drug ensure the therapeutic effect of the drug and reduce the occurrence of diseases such as endometrial hyperplasia.

[0066] More preferably, to meet the clinical needs of the target site for drug efficacy, the apex 4 can be designed with appropriate height, diameter, number, drug concentration, drug type, degradation rate, etc. For example, in places where the supporting framework exerts excessive pressure on the tissue, tissue stimulation is more likely to lead to hyperplasia, so more apex 4 can be set at that location; or, for example, where there is shear force at the point where the supporting framework contacts the tissue, hyperplasia or granuloma formation is more likely to occur, so more drug-loaded apex 4 can be set to achieve a certain amount of drug to achieve the effect of preventing hyperplasia and granuloma.

[0067] Furthermore, multiple pointed bodies 4 can be set on the supporting skeleton, and the multiple pointed bodies 4 can carry different drugs, thereby enabling the treatment of different diseases. Users can set them according to their needs, which will not be elaborated here.

[0068] In one embodiment, the support frame includes a wave coil 1 and a connecting rod 2, wherein the wave coil 1 and / or the connecting rod 2 are fixed with the pointed body 4.

[0069] Preferably, multiple wave coils 1 are arranged sequentially at intervals along the axial direction X, and a connecting rod 2 is provided between two adjacent wave coils 1, thereby connecting and supporting the wave coils 1.

[0070] More preferably, some of the pointed bodies 4 are disposed on the wavering coil 1; or, some of the pointed bodies 4 are disposed on the connecting rod 2; or, some of the pointed bodies 4 are disposed on both the wavering coil 1 and the connecting rod 2. The pointed bodies 4 disposed on the support frame can be selected and disposed at any position on the wavering coil 1 or the connecting rod 2 as needed, without specific limitations, as long as they can provide a stable support and fixation effect for the support frame.

[0071] In one embodiment, the support frame further includes a membrane 3 fixed to the wave coil 1 and the connecting rod 2, and the pointed body 4 is fixed to the membrane 3.

[0072] Preferably, the support frame also includes a hollow 5, which can be formed by a corrugated ring 1, a connecting rod 2, or a combination of corrugated ring 1 and connecting rod 2. When the hollow 5 is formed by a corrugated ring 1, the corrugated ring 1 is wavy or other geometric shape. When the hollow 5 is formed by a connecting rod 2, the connecting rod 2 is wavy or other geometric shape. Users can choose to set it according to their needs, and no specific limitation is made here.

[0073] More preferably, the covering 3 can be disposed on the inner surface of the supporting skeleton, such as the inner surface of the wave coil 1 or the connecting rod 2, or it can be disposed on the outer surface of the supporting skeleton, such as the outer surface of the wave coil 1 or the connecting rod 2. Furthermore, the covering 3 covers the perforated area 5, thereby preventing granulation tissue or tumors from entering the interior of the supporting skeleton and preventing the implanted medical device from malfunctioning.

[0074] More preferably, of the plurality of pointed bodies 4, except for the pointed body disposed on the supporting skeleton, the remaining pointed bodies 4 are disposed on the covering membrane 3. This allows the pointed bodies 4 to be distributed in areas not covered by the supporting skeleton, expanding the distribution space of the pointed bodies 4 and improving their fixation and therapeutic effects. Furthermore, the pointed bodies 4 can be disposed on the outer surface of the covering membrane 3, or simultaneously on both the inner and outer surfaces of the covering membrane 3. Users can choose the placement according to their needs, and no specific limitation is made here.

[0075] In one embodiment, the pointed body 4 includes biodegradable pointed bodies and non-biodegradable pointed bodies, wherein the proportion of non-biodegradable pointed bodies is greater than or equal to 40% and less than 100%. Specifically, the total number of pointed bodies 4 is c, and the number of non-biodegradable pointed bodies is e, wherein e / c is greater than or equal to 40% and less than 100%. By limiting the number of non-biodegradable pointed bodies, the fixing effect on the support frame can be improved, preventing slippage and displacement from inside the pipe 7. Preferably, the ratio of e / c can be any value between 40% and 100%, and the user can choose to set it as needed; no specific limitation is made here.

[0076] In one embodiment, the line connecting the center points of the distal end 41 and the proximal end 42 of the tip 4 extends radially along the supporting skeleton. Preferably, the line connecting the center points of the distal end 41 and the proximal end 42 of the tip 4 is the central axis of the tip 4. The radial extension of the central axis along the supporting skeleton ensures that the tip 4 is perpendicular to the surface of the supporting skeleton, thereby enabling the tip 4 to fix the supporting skeleton in all directions after it penetrates the tissue, preventing displacement of the supporting skeleton and enhancing the fixation effect on the supporting skeleton.

[0077] In one embodiment, such as Figure 6As shown in Figure 7, the proximal end 42 of the pointed body 4 is attached to and fixedly connected to the support frame. Preferably, the proximal end 42 of the pointed body 4 can be attached to the wave coil 1 or the connecting rod 2, and the user can choose the setting as needed, without specific limitation. More preferably, the connection method between the pointed body 4 and the support frame can be welding, bonding, etc., and the user can choose the setting as needed, without specific limitation.

[0078] In one embodiment, such as Figure 8 As shown, the pointed body 4 includes a first covering part 43, which can be a closed ring or an open arc. The first covering part 43 covers the support frame, thereby achieving a fixed connection with the support frame.

[0079] Preferably, the first covering part 43 and the pointed body 4 can be integrally formed, or they can be fixedly connected by bonding or other means. More preferably, the first covering part 43 covering the support frame specifically means that the first covering part 43 covers the wave coil 1 or the connecting rod 2.

[0080] In one embodiment, such as Figure 9 and Figure 10 As shown, the pointed body 4 is covered and connected to the film 3. Preferably, the film 3 has a second covering portion 31, and the second covering portion 31 has a covering space with an opening 311. The second covering portion 31 can be formed during the forming of the film 3, thereby simplifying the process and improving product yield. More preferably, the proximal end 42 of the pointed body 4 is received within the covering space of the second covering portion 31, and the distal end 41 extends from the opening 311 of the covering space. The area of ​​the proximal end 42 is larger than the area of ​​the opening 311, so that the proximal end 42 is movably restricted within the covering space of the second covering portion 31, realizing a stable connection between the film 3 and the pointed body 4 and preventing the pointed body 4 from detaching from the film 3.

[0081] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. The application scenarios of the implantable medical devices are not limited to the fields described in the text. Although this utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this utility model.

Claims

1. An implantable medical device, characterized in that, The implantable medical device includes a support frame and a plurality of pointed bodies (4) disposed on the outer surface of the support frame. The outer surface of the support frame and the plurality of pointed bodies (4) form a first projection (1') and a second projection (4') respectively in the same plane perpendicular to the axial direction (x) of the support frame. The degree of overlap D between the second projection (4') and the first projection (1') in the circumferential direction of the support frame satisfies: 60% ≤ D ≤ 100%.

2. The implantable medical device according to claim 1, characterized in that, The plurality of pointed bodies (4) are multiple rows of pointed bodies, and each row of pointed bodies (4) is spirally extending along the axial direction (x).

3. The implantable medical device according to claim 2, characterized in that, The spacing between any two adjacent columns of the pointed bodies (4) is equal.

4. The implantable medical device according to claim 3, characterized in that, In each column of the pointed bodies (4), the spacing between two adjacent pointed bodies (4) is equal.

5. The implantable medical device according to claim 1, characterized in that, The area of ​​the outer surface of the supporting frame is dm. 2 The total number of the pointed bodies (4) is c, and the density c / d of the pointed bodies (4) satisfies: 1000 / m³ 2 ≤c / d≤5000 pieces / m 2 .

6. The implantable medical device according to claim 1, characterized in that, The plurality of pointed bodies (4) are either non-degradable pointed bodies or all degradable pointed bodies.

7. The implantable medical device according to claim 1, characterized in that, The support frame includes a wavering (1) and a connecting rod (2), and the wavering (1) and / or the connecting rod (2) are fixed with the pointed body (4); or, the support frame includes a wavering (1), a connecting rod (2) and a covering film (3) fixed on the wavering (1) and the connecting rod (2), and the pointed body (4) is fixed to the outer surface of at least one of the covering film (3), the wavering (1) and the connecting rod (2).

8. The implantable medical device according to claim 1, characterized in that, The height H of the pointed body satisfies: 450um≤H≤650um.

9. The implantable medical device according to claim 1, characterized in that, The pointed body (4) includes degradable pointed bodies and non-degradable pointed bodies, wherein the proportion of non-degradable pointed bodies is greater than or equal to 40% and less than 100%.

10. The implantable medical device according to claim 1, characterized in that, The pointed body (4) includes a distal end (41) away from the support frame and a proximal end (42) close to the support frame, and the line connecting the center points of the distal end (41) and the proximal end (42) extends radially along the support frame.

Images